Comments on ECHA’s Draft 12th Recommendation for Melamine (EC number: 203-615-4) and references to responses

The present document compiles the comments received during the public consultation on the draft 12th recommendation for inclusion of substances in Annex XIV of REACH for Melamine (EC number: 203-615-4). The consultation took place between 7 February 2024 and 7 May 2024. Response to the comments received will be provided by ECHA when finalising the recommendation (indicative timeline: April 2025).

Public version

Content
	
I - General comments on the recommendation to include the substance in Annex XIV
II - Transitional arrangements. Comments on the proposed dates
III - Comments on uses that should be exempted from authorisation, including reasons for that

I - General comments on the recommendation to include the substance in Annex XIV
Number / Date	Submitted by (name, submitter type, country)	Comment	
5096
2024/04/02	PCC Prodex Sp. z o. o.,
Company,
Poland	WDU - melamine used as an ingredients for viscoelastic foams. This is not an CONS use type, but applications of our polyols mixtures are IND,  which does not determine the score 15, but 5. In the recomendation of priority substances melamine achived WDU score 12.
VOLUME - melamine used as monomer in the amount lower than 1t/year. It is used in formulations in low level, but in many significant products.

5097
2024/04/22	The European Apparel and Textile Confederation (EURATEX),
Industry or trade association,
Belgium	Please find the comments from EURATEX attached.	
		5097_EURATEX input to ECHA consultation.pdf	
5100
2024/04/29	Raschig GmbH,
Company,
Germany	The "Draft background document for melamine,"1 dated February 7th, 2024, was formulated within
the framework of ECHA’s twelfth recommendation for the inclusion of substances in Annex XIV. In
this document, melamine was assigned a total scoring of 40. However, EMPA, participating in this
public consultation, offers dissent regarding the assigned score for melamine, advocating for a
revised scoring of 21 and providing rationale to support this adjustment.
Inherently properties – ECHA’s score= 13; EMPA’s score= 1
Volume – ECHA’s score= 15; EMPA’s score= 12
Wide dispersiveness of uses – ECHA’s score= 12; EMPA’s score= 8
Total score – ECHA’s score= 40; EMPA’s score= 21
The draft background document for melamine (7th February 20924) applies a score of 13 to the
intrinsic properties of melamine. However no justification or explanation is provided for selecting this
score. It is therefore assumed that the default selection has been derived from the Prioritisation
Approach document update from 5th March 202018
.
However, EMPA points out that the default selection is incorrect and that the intrinsic property score
for melamine should be 1, and not 13. The basis for this conclusion is that:
1. Melamine does not meet the criteria for identification as Carcinogenic, Mutagenic or
Reprotoxic according to the provisions of REACH Article 57 (a-c).
2. Melamine does not meet the criteria for identification as a PBT or vPvB substance according
to the provisions of REACH Article 59 (d, e).
3. Melamine’s identification as a substance of very high concern (SVHC) has been based on
Article 57(f). Melamine is not an endocrine disruptor and it is also not a PBT or vPvB
substance, essentially because melamine is not bioaccumulative. A clear connection to
PBT/vPvB substances has not been established as required by the scoring guidance.
It can therefore only be concluded that melamine, in accordance with the approach laid out in the
scoring guidacne, attracts a score of 1 for intrinsic/inherent properties.	
		5100_Melamine Inherently Properties and Prioritization and General issues ans uses to be extemped.zip	
5102
2024/04/30	Grupa Azoty Zaklady Azotowe "Pulawy" S.A.,
Company,
Poland	I. Prioritization

We would like to inform you that melamine produced by our company is used only in industrial process where the risk management capacity is very high, there is site-based technical infrastructure to control releases. As a result of the above applications, melamine reacted to other substances and is not found in finished article or waste related to the finished article. Our melamine has no professional or consumer uses. Consumer and professional applications do not apply to melamine, but to resins obtained from melamine.
The draft background document of melamine from February, 7th 2024 contains conflicting information regarding what uses of melamine are in or out of scope of authorization. The background document lacks clarity around the intermediate use of melamine for the production of melamine-based polymers. Furthermore, it's important to clarify that there are no articles made of melamine; rather, there are articles made of melamine-based polymers.
Taking into account the fact that the annual volume used in the scope of authorisation is taken as the basis for assessing this criterion and that melamine is used only as a transported intermediate (in accordance with Art.2(8)(b) and Generic exemptions from the authorization requirement, this use is not subject to the authorization procedure. The concluding assessment result on the priority of a melamine per Article 58(3) regarding the volume score and the wide dispersive use was assessed incorrectly.
Authorities confuse the uses of melamine-as-such with the uses of the melamine-based polymer(resin) synthesized from the monomer melamine. The majority of the melamine applications are not related to articles made of melamine but articles made of melamine-based polymer used as resins. Melamine is one of the starting monomers, an intermediate, to synthesize the melamine-based polymer used as resins. These resins are further processed to produce final articles. The melamine uses are all intermediate uses and consequently out of scope of authorisation.
Against the backdrop of the definition for intermediate use within REACH, melamine is demonstrably used as an intermediate because melamine is manufactured  and used with the intention to transform into another substance. The transformation is a chemical process (synthesis) that is contained by technical means on an industrial site (i.e. in a closed reactor).

II. General Issues

In our opinion the efficacy of REACH authorization in regulating the uses of melamine to safeguard human health and the environment cannot be substantiated due to:
o The sources of melamine in the environment remain unidentified, making it difficult to establish a direct connection to specific melamine uses. There are other potential sources of melamine found in the environment which would not be affected by the authorization requirements:

a. Melamine is formed as a metabolite from the biocide cyromazine when applied on fields and in stables.
b. Potential releases of melamine from the use of cyanamide-containing fertilizers.
c. HMMM (Hexamethoxymethylmelamine, EC 221-422-3), used in special coatings and tires can degrade to melamine.1 HMMM is found in surface water. Tyre abrasion is an ubiquitous phenomenon in Europe and could be a significant contributor of melamine/melamine derivatives in the environment.

Emission of melamine from melamine production sites and industrial sites using melamine cannot be accounted for the levels of melamine found in the environment. Melamine manufacturers and Downstream Users of melamine have implemented operational conditions to limit environmental emissions and worker exposures during manufacturing and handling. The industrial processes are as enclosed as possible; from the manufacturing start via transport and further processing by DU’s.

III. Other EU regulation.

The information below follows a summary of EU current regulations applicable for the substance melamine. The following regulations ensure that the risks to melamine are properly controlled.

o Food Contact
Melamine has been authorized for use in the European Union under Regulation 10/2011/EU as a monomer in Food Contact Recycled Plastic Materials and Articles (FCM).

o Biocidal
Melamine is formed as a metabolite of the biocidal product Cyromazine. Cyromazine was authorized 2023 for product type PT18 (insecticides, acaricides and products to control other arthropods) in the EU. It was assessed by ECHA that the metabolite melamine poses no risk to humans, animals or the environment.

o Drinking water
Melamine is included in the European positive lists of starting substances, compositions and constituents authorized for use in the manufacture of materials or products that come into contact with water intended for human consumption COMMISSION IMPLEMENTING DECISION (EU) …/… of 23.1.2024 laying down rules for the application of Directive (EU) 2020/2184 of the European Parliament and of the Council by establishing the European positive lists of starting substances, compositions and constituents authorised for use in the manufacture of materials or products that come into contact with water intended for human consumption.

Confidential attachment removed	
5103
2024/04/30	Grupa Azoty Zaklady Azotowe "Pulawy" S.A.,
Company,
Poland	I. Prioritization

We would like to inform you that melamine produced by our company is used only in industrial process where the risk management capacity is very high, there is site-based technical infrastructure to control releases. As a result of the above applications, melamine reacted to other substances and is not found in finished article or waste related to the finished article. Our melamine has no professional or consumer uses. Consumer and professional applications do not apply to melamine, but to resins obtained from melamine.
The draft background document of melamine from February, 7th 2024 contains conflicting information regarding what uses of melamine are in or out of scope of authorization. The background document lacks clarity around the intermediate use of melamine for the production of melamine-based polymers. Furthermore, it's important to clarify that there are no articles made of melamine; rather, there are articles made of melamine-based polymers.
Taking into account the fact that the annual volume used in the scope of authorisation is taken as the basis for assessing this criterion and that melamine is used only as a transported intermediate (in accordance with Art.2(8)(b) and Generic exemptions from the authorization requirement, this use is not subject to the authorization procedure. The concluding assessment result on the priority of a melamine per Article 58(3) regarding the volume score and the wide dispersive use was assessed incorrectly.
Authorities confuse the uses of melamine-as-such with the uses of the melamine-based polymer(resin) synthesized from the monomer melamine. The majority of the melamine applications are not related to articles made of melamine but articles made of melamine-based polymer used as resins. Melamine is one of the starting monomers, an intermediate, to synthesize the melamine-based polymer used as resins. These resins are further processed to produce final articles. The melamine uses are all intermediate uses and consequently out of scope of authorisation.
Against the backdrop of the definition for intermediate use within REACH, melamine is demonstrably used as an intermediate because melamine is manufactured  and used with the intention to transform into another substance. The transformation is a chemical process (synthesis) that is contained by technical means on an industrial site (i.e. in a closed reactor).

II. General Issues

In our opinion the efficacy of REACH authorization in regulating the uses of melamine to safeguard human health and the environment cannot be substantiated due to:
o The sources of melamine in the environment remain unidentified, making it difficult to establish a direct connection to specific melamine uses. There are other potential sources of melamine found in the environment which would not be affected by the authorization requirements:

a. Melamine is formed as a metabolite from the biocide cyromazine when applied on fields and in stables.
b. Potential releases of melamine from the use of cyanamide-containing fertilizers.
c. HMMM (Hexamethoxymethylmelamine, EC 221-422-3), used in special coatings and tires can degrade to melamine.1 HMMM is found in surface water. Tyre abrasion is an ubiquitous phenomenon in Europe and could be a significant contributor of melamine/melamine derivatives in the environment.

Emission of melamine from melamine production sites and industrial sites using melamine cannot be accounted for the levels of melamine found in the environment. Melamine manufacturers and Downstream Users of melamine have implemented operational conditions to limit environmental emissions and worker exposures during manufacturing and handling. The industrial processes are as enclosed as possible; from the manufacturing start via transport and further processing by DU’s.

III. Other EU regulation.

The information below follows a summary of EU current regulations applicable for the substance melamine. The following regulations ensure that the risks to melamine are properly controlled.

o Food Contact
Melamine has been authorized for use in the European Union under Regulation 10/2011/EU as a monomer in Food Contact Recycled Plastic Materials and Articles (FCM).

o Biocidal
Melamine is formed as a metabolite of the biocidal product Cyromazine. Cyromazine was authorized 2023 for product type PT18 (insecticides, acaricides and products to control other arthropods) in the EU. It was assessed by ECHA that the metabolite melamine poses no risk to humans, animals or the environment.

o Drinking water
Melamine is included in the European positive lists of starting substances, compositions and constituents authorized for use in the manufacture of materials or products that come into contact with water intended for human consumption COMMISSION IMPLEMENTING DECISION (EU) …/… of 23.1.2024 laying down rules for the application of Directive (EU) 2020/2184 of the European Parliament and of the Council by establishing the European positive lists of starting substances, compositions and constituents authorised for use in the manufacture of materials or products that come into contact with water intended for human consumption.

Confidential attachment removed	
5104
2024/04/30	himolla Polstermöbel GmbH,
Company,
Germany	We, the company himolla Polstermöbel GmbH, produce upholstered furniture for private use. One important market for us is the United Kingdom. Upholsterd Furnitures for UK must be flame retardant due to national regulations in accordance with BS5852. This standard can only be achieved  through the use of special PUR soft foams and these commercial products we purchase all contain melamine as flame retardant. According to our suppliers, melamine-free alternative materials are not yet availabel. A Melamin ban would mean the end of our business relationships with the UK and this in an already difficult economic situation.	
			
5105
2024/05/02	Association of Chemical Industry of the Czech Republic,
Industry or trade association,
Czech Republic	Inclusion of Melamine in Annex XIV to REACH would likely have a severe impacts on the chemical industry (Melamine producers) as well as downstream users ( producers of binders containing melamine, wood-based panel industry, furniture industry)
1. Inclusion of substances in Annex XIV to REACH requires a valid identification as substance of very high concern (SVHC). While Melamine is identified as SVHC only since 17 January 2023, it should be noted that two actions for annulment are pending before the General Court (Cases T-163/23 and T-167/23), addressing severe concerns regarding the underlying scientific assessment as well as procedural shortcomings. If these actions are successful, the inclusion of Melamine would be deprived of its legal basis. Insofar, initiating the next phase of the authorisation process already now seems to be not reasonable as regards procedural economy.

2. The proposal to prioritise Melamine is also not convincing against the background of the principles for the prioritisation of SVHC for inclusion in Annex XIV (ECHA Prioritisation Approach). Melamine is not identified as being bioaccumulative and, therefore, does not qualify as PBT or vPvB substance. In addition, SVHC identification was not based on concerns regarding endocrine (ED) properties. In May 2023, France also concluded that ED properties are neither confirmed for human health nor the environment and, therefore, stated that Melamine does not meet the definition of an endocrine disruptor (cf. https://www.consultations-publiques.developpement-durable.gouv.fr/projet-de-rmoa-analyse-de-la-meilleure-option-de-a2906.html?lang=fr). It is, thus, questionable as to how a significant high score for Melamine was established.

We would like to point out, that the ECHA Prioritisation Approach does not establish a sufficient basis to consider other properties such as mere persistence or long-range transport potential (LRTP) in connection with the decision to prioritise substances. Although it is not excluded, in general, that further considerations are taken into account, the underlying ECHA Prioritisation Approach does not refer to other inherent properties that would justify a high score. In particular, for substances identified under Article 57(f) REACH the scoring for PBT/vPvB substances shall only be applied on a case-by-case basis requiring additional justification. Exactly this question whether the same concern as for PBT/vPvB substances applies to Melamine is subject to the pending court proceedings.

Furthermore, criteria for PMT and vPvM substances have been incorporated in Annex I to CLP and, therefore, it would be reasonable to re-assess whether these additional legal developments need to be reflected in the ECHA Prioritisation Approach.  ECHA seems to apply criteria for the prioritisation, which are not yet reflected in Article 57 REACH and, in this case, are even questionable.

3. Moreover, we would like to recall that Germany, having proposed Melamine for identification as SVHC and having indicated the intention regarding a further harmonized classification and labelling, was not aiming at an authorisation requirement for Melamine but a further restriction. As stated in the corresponding Risk Management Option Analysis (RMOA) Conclusion Document (available at https://www.reach-clp-biozid-helpdesk.de/DE/REACH/Verfahren/SVHC-Verfahren/Stoffliste-DE/Stoffliste-DE_node.html), the overall aim of the SVHC identification was, that industry has to minimize emissions of this substance to the environment by the help of substance-tailored operational conditions and risk management measures. We would like to confirm that industry has already established corresponding measures by operational and technical means and increases efforts to that end above and beyond legal requirements.

Germany also concluded in its RMOA that only in the case, that corresponding market changes and a certain pressure towards substitution of melamine will not be achieved by SVHC identification and additional harmonized classification, a specific restriction might be required. This entire approach will be jeopardized by initiating an authorisation process already now and legitimate expectations of both, industry and authorities would be disappointed.

4. We would like to emphasize that already the SVHC identification of Melamine was not supported by all Member States. Irrespective the concerns raised by Member States and irrespective the regulatory intention as enshrined in the RMOA, ECHA seems to strive for the hastily completion of processes without having regard to divergent positions.

Insofar, we are of the opinion that the objectives and interests of Member States are ignored. It is stated that a restriction proposal should only be drawn up after the further market effects have been evaluated. On the one hand, ECHA acknowledges that ongoing restriction developments could justify postponing the recommendation of a substance for authorisation. On the other hand, however, the inclusion of Melamine in the 12th recommendation ignores the underlying regulatory intention and leaves no options for Member States to evaluate and decide upon specific restriction proposals, as preparation and drafting of such proposals takes some time and is linked to specific procedural requirements.

Based on the above arguments, we do not agree with  the draft recommendation  of Melamine (CAS-No.: 108-78-1, EC-No.: 203-615-4) for inclusion in Annex XIV to REACH.

5106
2024/05/02	Hilti AG,
Company,
Liechtenstein		
		
Confidential attachment removed	
5107
2024/05/02	fedustria,
Industry or trade association,
Belgium	Melamine is used in high volumes, but in 95% of the cases it used as an intermediate. Intermediates are to be exempted  according to art3.(15) “REACH”) and according to Art. 2(8)(b) REACH.
There is no evidence that the occurence of the substance in the tested river waters is comming from the production of melamine nor from the products where melamine was used as an intermediate to produced those. Melamine is also a decomposition product from other substances or products used in agriculture, construction, auto-motive and electricity sector.
As long as there is no evidence or proof what the cause is of this contamination, every measure taken to stop the use of this substance can be of no result for the contamination itselve. A lot of new studies added on the ECHA website shows that melamine has no vPvM characteristics. They show that melamine is not bioaccumaltive. An the RMOA study of France shows that melamine has no endocrine disruptieve properties. Several tests with active sludge shows a ready degradability of melamine. it can be easily removed from wast waters.
A study in Germany on waters showed a seasonal character with 5 time higher peaks in summer.there is no such seasonal character in industrial processes.
The conclusion can only be that he source for this contamination has no industrial character and the influence on environment and health is nihil.	
			
5108
2024/05/02	KRONOSPAN, s.r.o.,
Company,
Slovakia	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company	
			
5109
2024/05/02	DIAKOL Strazske s.r.o.,
Company,
Slovakia	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company	
			
5110
2024/05/03	Gesamtverband Textil und Mode e.V.,
Industry or trade association,
Germany	See Annex "Statement of the Confederation of the German Textile and Fashion Industry on the draft recommendation of substances for inclusion in Annex XIV and on the call for information (on behalf of the EU Commission) on the possible socio-economic consequences of the authorisation requirement"
	
		5110_final_t+m Statement consultation melamine 20240503.pdf	
5111
2024/05/03	DUKOL Ostrava, s.r.o.,
Company,
Czech Republic	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.	
			
5112
2024/05/03	KRONOSPAN CR, spol. s r.o.,
Company,
Czech Republic	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.	
			
5113
2024/05/03	KRONOSPAN OSB, spol. s r.o.,
Company,
Czech Republic	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.	
			
5115
2024/05/03	Rudolf Hensel GmbH,
Company,
Germany	1. Introduction
The course of the authorisation procedure so far gives rise to the suspicion that the procedure is being artificially accelerated or at least treated precipitately. Hence this document aims to challenge the prioritisation score given to melamine in the “Draft background document for melamine” from ECHA published on 07. February 2024.
According to the document, the score was allocated as follows:

Figure 1: ECHA allocation of prioritisation scores to melamine
(See additional information document to access the Figure)

The link between the verbal descriptions and the assigned scores can be found in the ECHA document “Prioritisation of substances of very high concern (SVHCs) for inclusion in the Authorisation List (Annex XIV)”. This will be addressed in more detail in the following chapters.

Rudolf Hensel GmbH proposes that the score of the inherent properties should be amended to 0 instead of 13. This claim is backed up by ECHA’s own scoring system and the preliminary report of the “Analysis of the most appropriate risk management option (RMOA)” conducted by the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) on 16. May 2023.
A more in-depth look to this will be given in the following chapter.

Melamine has been subjected to six DEv’s over the years. The first DEv assessment dates back to 2013 (Decision number: CCH-D-0000004755-67-01/F) with the scope of “following standard information requirements relating to “Aquatic toxicity” and related environmental hazard assessment. The assessment’s status is given today as concluded which indicates that the registrant provided compliant information. This shows that the substance has been monitored and tested over a long period of time in accordance with strict scientific and toxicological standards. And even after repeated concerns and considerations, there were never any grounds for complaint.

Additionally, melamine is currently member of the registry of CLH intentions until outcome. There is a proposed change in the harmonized classification of the substance. The expected date of submission of the CLH dossier is set to be 30. June 2024. The intended classifications namely are:

• Carc. 2, H351
• STOT RE 2, H373
• Reproductive toxicity (category not specified)
• Persistent, mobile, toxic/very persistent, very mobile

For Carc. 2, H351 and STOT RE 2, H373 (urinary tract) there is already a classification ac-cording to CLP annex VI since the 18th Adaptation to Technical Progress (ATP) and in addition an industrywide self-classification for these properties is in place.
The PMT properties of the proposed classifications are going to be challenged in this document.

To illustrate the circumstance the point has to be made that the CLH consultation process takes place after the prioritisation consultation. This means that the potential results of the former cannot be utilised for the latter. This is a peculiar temporal arrangement to say the least.

Rudolf Hensel GmbH also wants to point out that there are two ongoing court cases which are appealing the SVHC identification of melamine. Namely:

• T-163/23 - Fritz Egger u.a. / ECHA
• T-167/23 - LAT Nitrogen Piesteritz und Cornerstone / ECHA

Both cases are currently heard by the European Court of Justice and have yet to receive a judgement and “judgements are not expected before late 2024-early 2025”. The statement in ECHA document “Prioritisation assessment results of the Candidate List substances assessed - Substances included in the Candidate List by July 2023 and not yet recommended for inclusion in Annex XIV” published on 07. February 2024 concerning this issue is:

“Melamine being currently concluded as SVHC, it is considered for
possible recommendation for inclusion in Annex XIV.”

Common sense would dictate to await the judgements on the appeals in order to observe if the plaintiffs in the court cases are upheld and the SVHC classification of melamine has to be withdrawn regardless of the court's decision. The occurrence of this event would render all previous efforts in the authorisation process obsolete and all resources spent on advancing the process wasted.

This and the following contents of this document cast doubt on the adherence to proper assessment procedures and objective scientific evaluation and gives rise to the suspicion that there has been a rush to act in the case of the authorisation of melamine.
 
2. Basics on the scores of the draft background document

According to the ECHA approach to prioritization and in consequence REACH Article 58 (3), “priority shall normally be given to substances with

(a) PBT or vPvB properties, or
(b) wide dispersive use, or
(c) high volumes.

The rating of the article 58(3) criteria is standardised as a score from 0 to 15, with 0 representing no risk and 15 representing high risk. Each criteria possesses its own categorisation and scoring system.

In the following section, emphasis is given to the scoring of the “Inherent properties” since the focus of this document is the contestation of this criterion.

2.1. Scoring of the inherent properties

Excerpt from the ECHA approach to prioritization:

"The legal text requires giving priority to substances with PBT or vPvB properties, therefore PBT/vPvB substances get significantly higher priority (i.e. score) compared to non-PBT sub-stances. To reflect the current focus on concerns related to substances having endocrine disrupting (ED) properties, these properties get a medium score."

"The different categories for the inherent property criterion are given according to the respective Article 57 property that the identification of a substance as SVHC is based on."

The inherent property score is assessed as follows:

Figure 2: Assessment of the inherent property score
(See additional information document to access the Figure)

For a better readability of the scoring board and understanding of the arguments to make, an overview of REACH article 57 is given in the following:
 
Article 57: Substances to be included in Annex XIV

The following substances may be included in Annex XIV in accordance with the procedure laid down in Article 58:

(a) substances meeting the criteria for classification in the hazard class carcinogenicity category 1A or 1B in accordance with section 3.6 of Annex I to Regulation (EC) No 1272/2008;
(b) substances meeting the criteria for classification in the hazard class germ cell mutagenicity category 1A or 1B in accordance with section 3.5 of Annex I to Regulation (EC) No 1272/2008;
(c) substances meeting the criteria for classification in the hazard class reproductive toxicity category 1A or 1B, adverse effects on sexual function and fertility or on development in accordance with section 3.7 of Annex I to Regulation (EC) No 1272/2008;
(d) substances which are persistent, bioaccumulative and toxic in accordance with the criteria set out in Annex XIII of this Regulation;
(e) substances which are very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII of this Regulation;
(f) substances — such as those having endocrine disrupting properties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfil the criteria of points (d) or (e) — for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances listed in points (a) to (e) and which are identified on a case-by-case basis in accordance with the procedure set out in Article 59.

As mentioned in chapter 2. the score of the inherent properties allocated to melamine in the draft background document for melamine was 13. The justification for the scoring can be seen in chapter 2.1. of that document. A key argument for this assessment is the equivalent level of concern to other substances listed in Article 57 (a) to (e) of REACH. These will be challenged in the following chapters.

2.1.1. Challenging of the PBT / vPvB properties

According to the RMOA report for melamine published by ANSES, on the 16. May 2023 in chapter 6.3 a maximum bioconcentration factor (BCF) of 3.8 L/kg was determined. According to REACH Annex XII Chapter 1.1.2 and 1.2.2 this value is way below the required thresh-old of ≥ 2,000 and ≥ 5,000 l/kg to be considered bioaccumulative.

Furthermore, the log Kow value was determined. It is defined as the n-octanol-water partition coefficient. This means it is a partition coefficient for the two-phase system of n-octanol and water. For melamine it was determined to be -1.22. This also indicates a low bioaccumulation potential. The RMOA assessment states the same:

"The substance is not considered as bioaccumulative in aquatic organisms according to the bioaccumulation criteria of REACH Annex XIII."

and even:

"Terrestrial bioaccumulation is considered to be low."

These statements refute the claim that melamine is a vPvB or even a PBT substance

2.1.2. Challenging of the endocrine disrupting (ED) properties

The SVHC support document mentions several times that melamine has endocrine disrupting potential. This was examined in the before mentioned draft RMOA conducted by ANSES. In chapter 9 and 10 a detailed assessment of the endocrine disruption of melamine takes place.

In said chapter 9 of that paper the assessment of the endocrine disruption of the human health is described. The overall conclusion in section 9.5 states:

"Taken together, the ANSES expert working group on endocrine disruptors concluded that spermatogenesis alteration occurred primarily in the absence of an endocrine MoA
(Author's note: Mode of Action) (testosterone decrease) and could involve general cellular biology alterations (reduction in energy metabolism, oxidative stress, apoptosis). Testosterone decrease may amplify this direct effect at higher doses in some protocols."

and:

"[…] the observed effects appear at doses above those leading to nephrotoxicity and general toxicities. Therefore, it is concluded that ED properties are not confirmed for human health."

Chapter 10 (of that document)  gives an overview of the ED assessment concerning the environment. Section 10.5 presents the overall conclusion:

"It was concluded that, in the present state of knowledge, the substance melamine is not considered to have endocrine disruption properties with regards to environmental (non-mammalian) species. The information shows that the substance does not meet the criteria for endocrine disruption as defined by the WHO/IPCS (2002)."

2.1.3. Challenging of the PMT / vPvM properties

According to the brief dossier on trace substances for melamine published by UBA-Germany as of November 2023 the water solubility of melamine is in a range of 3.16 to 3,48 g/l at 20 °C and a pH of 7.7.

It is obvious that the general opinion from the ECHA documents tends to regard this as high value. First: This is not correct. Melamine has a low water solubility at 20°C or lower temperatures. According to Europäisches Arzneibuch [1] at 15-25°C: A substance with V(Solvent) of 100-1000 ml/g substance is classified as hardly soluble. GESTIS-database as well as GISChem database is also confirming that melamine is hardly soluble. For example, the solubility of table salt (NaCl) is one hundred times higher than melamine, corresponding to 317 g/l at 20 °C. and second: It is only at ideal conditions that this value is reached.

In Germany for example the water temperature values as of months have been monitored. For the following statistic the survey period was from 1991 until 2020 [2]:

Figure 3: Depiction of the average water temperature in degree celcius [2]
(See additional information document to access the Figure)

Although this statistic takes a very general approach, The qualitative temperature distribution by month can be clearly recognised.

It can be seen that the average water temperature only reaches 20°C in the warmest month of August. During the remaining months of the year, the solubility is lower, which makes melamine less or even not soluble in water. For example: at 10,0 °C the water solubility de-clines to 2,08 g/l and at 5,0 °C the water solubility is only at 1,78 g/l [3].

2.1.4. Challenging of the use of log Koc based assessments

Another parameter used to underline the mobility of melamine is the log Koc.

In the member state committee (MSC) support document for identification of melamine as an SVHC in chapter 3.2 Environmental distribution it is described that for assessing the ad-sorption behaviour of melamine the log Koc is used.

The log Koc is defined as the soil organic carbon sorption coefficient. It usually finds use in risk assessment models. Its purpose is to determine the potential for a substance to adsorb to organic matter in various soil types.

Since this value is one of the Key argument points of that document for the environmental distributiveness of melamine, the following chapter endeavours to refute this narrative.

The MSC support document further states:

"It is possible to have an estimate for the log Koc from the log Kow by applying the respective equations. This approach is often applied for non-ionic molecules."

ECHA states that its QSAR calculations normally refer to the non-ionic form of a substance. The fact that melamine is an ionisable substance (at pH lower than 6,5) renders the employed models of little use, and the data obtained as not meaningful.

This is not to say that the log Koc has no value; it is very useful for sifting through data efficiently. However, it is this very efficiency and simplistic nature of this metric that makes it unsuitable to assess complex correlations.

In the technical report no. 123 of the European centre for ecotoxicology and toxicology of chemical (ECETOC) published in January 2014 it is stated [4]:

"[Koc] Estimation methods based on KOW [...] tend to be based on regression analysis."

Typically, such a regression analysis takes the form of [4; 5]:

log Koc = a ∙ log Kow + c  ……………………………………………………..(Eq. 01)

As can be easily determined, this equation is a first-order polynomial or linear function. This serves as an indicator at the simplistic character of this assessment.

The ECETOC6 report states:

"[…] Caution is recommended when applying these regressions for ionisable organic com-pounds."

[…] because:

"[...] A confounding issue associated with the use of linear regression-based methods is how Kow is defined, i.e. whether it is measured or estimated, and whether the value reflects the neutral or ionised species, and what the pH of the reference system is in relation to the pKa (authors note: acid dissociation constant) of the substance. Given the importance of Koc in estimating the removal of organic chemicals by sorption processes, particularly in a wastewater treatment system, there appears to be a need to re-examine how Koc is estimated in a regulatory context, particularly for ionisable organic compounds."

This means in essence that the far-reaching relationships between substances (e.g. ionisation state) and different soil compositions (e.g. pH value) are too complex to be assessed from the perspective of a mere linear regression.

This is confirmed by the recently published ECETOC Report [6]:

"The use of log Koc (or log Kow, log Dow) to identify a chemical’s potential to move through soil is insufficient to characterise mobility in the environment, as fate and partitioning processes differ depending on the environmental compartment."

The conclusion of this document reads:

"However, the analyses presented […] did not show any indications that log Koc is a major fac-tor of groundwater or surface water contamination by readily or non-readily biodegradable chemicals."

It is safe to say that neither the use of linear regression to obtain Koc nor the use of Koc to determine the mobility of substances are appropriate methods for making statements such as those made by ECHA.
 
2.1.5. Additional arguments on the point of mobility

The SVHC support document includes arguments derived from the NORMAN Empodat data base [7]. They were used to make the claim of an already wide environmental distribution of melamine. Rudolf Hensel GmbH conducted an in-depth analysis of that database to refute this argument.

The NORMAN Empodat Database contains 1541 entries for the substance Melamine in Eu-rope with a collection period between 2017 and 2020. Out of the total entries, 676 used a non-standardized analytical method for data collection. The carrying out laboratories of these methods were accredited to ISO 17025, but they were not accredited for Melamine as an analyte. The remaining 865 entries carry no statement neither on the used analytical method nor about the laboratory whatsoever.

The temperatures of the water samples during specimen collection were monitored. As stat-ed above melamine possesses an increased water solubility at higher temperatures. The collected data is reflecting this for the most part. The data shows a noticeable tendency for the Melamine concentration to be higher during warmer temperatures in summer.

Monitoring sites for the water levels of a river are regularly built on riverbanks. For example, the “river basin community Elbe (FGG)” maintains a monitoring site at new Darchau at Elb kilometre 536,51 and provides an online data base for the water levels of the river Elbe since 2008.

In Figure 4 it can be seen that the river Elbe had exceptional low water levels from May to August of 2018.

Figure 4: Water levels of the River Elbe during May and August 2018 represented in the graph as present value[8]
(See additional information document to access the Figure)

Furthermore, there was a low overall precipitation in Germany during that period.
(See Figure 5)

Figure 5: Difference in mean precipitation in Germany [9]
(See additional information document to access the Figure)

Since this simple but important part of the Data evaluation hasn’t been taken into account, it can be assumed that the data interpretation is inaccurate. Most of the higher melamine concentrations which were stated in the SVHC support document were taken during a period of elevated water temperature (see Figure 3) and low water levels. Assuming that the absolute melamine content in the monitored water didn’t change during the sampling it is easy to see why the concentration of melamine is higher at these conditions considering the properties of the substance.

It is safe to say that the data collection methods of the NORMAN Empodat database are in-consistent and not suitable for an assessment to claim mobility properties for melamine. The main concerns in this regard are that none of the melamine concentrations collected were analysed using a standardised method and none of the laboratories were accredited for the given analyte.

In addition, the lack of accreditation of the laboratories performing the tests means that there is no guarantee that what has been measured is definitely melamine or what the origin of that melamine would be.

The stating of isolated elevated melamine concentration values in the SVHC supporting doc-ument does not prove anything (neither PBT- nor PMT-properties) unless it is stated how and under what circumstances these values were determined.

Even if the values were to be correct:

The Recommended Daily Intake (RDI) for melamine has been set at 0.2 mg/kg body weight. Using the German drinking water ordinance of 125 µg/l for melamine, an average adult weighing 75 kg would have to drink 120 l of maximally contaminated water in one day to reach the RDI. The maximum melamine concentration measured in Europe according to the NORMAN Empodat database was 5.0 µg/l. An average adult would have to drink 3000 litres of this water to reach the RDI.
 
This indicates that existing legislation already provides adequate and sufficient protection for human health.

2.1.6. Developments to remove melamine from wastewater

There have been a number of efforts in the past to develop technologies to remove mela-mine from wastewater. In patent document EP 2894130 B1 published back in July 2015 for example is described how to remove melamine from wastewater using thermal hydrolysis utilizing steam bubbling.

Other technologies for the same purpose include for example activated carbon filters10 or using biological processes [11].

2.1.7. Cyromazine as a degradation product of Melamine

In the paper Melamine in the environment [12] written by Lütjens et al. states that both in Germany and the Netherlands, Cyromazine (CAS: 66215-27-8) is authorized as an active ingredient in insecticidal- and biocidal-products which are used to protect crops from insect growth. However, uses in plant protection products (PPP) are prohibited in Austria and Germany.

The effect of cyromazine inhibits the moulting and pupation of certain insect larvae. When applied, it is absorbed by both the leaves and roots of plants and therefore has a systemic effect. It is likely that the substance is released into the environment through these uses.
Whether in plants animals or after entering the environment, cyromazine undergoes a degradation process. During a first step. the cyclopropyl group gets eliminated from the molecule to form melamine [13]. In a possible second step, melamine degrades to cyanuric acid. However, this is only possible in an aqueous and acidic environment.

Figure 6: Degradation pathway of cyromazine [12]
(See additional information document to access the Figure)

It is indicated that Melamine is the primary metabolite and degradation product of Cyromazine. Yet this process rarely occurs in a natural setting.
 
The REACH registration of cyromazine indicates that the substance is manufactured or im-ported as a component of mixtures in quantities of less than 10 tons per year in Europe. Even if the substance is not used on a large scale, it is remarkable that it is not included in the prioritization assessment.

2.1.8. Views on the relative extent of the environmental distribution of melamine.

In order to shed more light on the extent of the environmental threat posed by melamine, a relative perspective on the distribution of the substance is provided here. The data for German rivers is used as an example and melamine used in nonintermediate uses is considered. The average annual volume of this melamine used in the EU27 is 7,525 tons, distributed into 825 tons for intumescent coatings and 6,700 tons used in flexible polyurethane foam production.

In the following, we assume – as a worst case approach – that the total amount of 7,525 tons of melamine are dissolved the concentrations of melamine in the Rhine and Danube rivers are considered as if the entire amount of melamine used in Germany annually were dis-solved in these rivers. These two rivers were chosen because they have the highest average annual discharge of all rivers in Germany. Average annual river discharge:

• Rhine River 2.900 m3/s
• Danube River 6.855 m3/s

If the total amount of 7,525 tons of melamine were discharged into the combined annual runoff of these two rivers, the maximum melamine concentration would be only 25 µg/l. Considering the German Drinking Water Ordinance with a maximum level of 125 µg/l, the contamination of all European river waters with melamine is negligible. This worst-case approach deals with the scenario that all melamine used in non-intermediate uses is released into the environment. This assumption is clearly unrealistic. The maximum level of 125 µg of melamine per litre also includes the protection of vulnerable groups such as infants, which underlines a sufficient level of protection. Challenging of the CMR properties.

Criteria (a), (b) and (c) of Article 57 relate to the CMR properties of substances. To follow
ECHA's own logic from dealing with the ongoing court cases (see chapter 1), it has to be said that at the time of the authorisation consultation there is no CMR classification of category 1 existent for melamine and therefore no score can be assigned for these criteria.

2.1.9. Conclusion on the scoring of the inherent properties

The score for the inherent properties for melamine in the draft background document (see Figure 1) is set to 13 out of 15. The verbal description of “equivalent concern […] meeting the criteria of Article 57 (f)” is given. The reasoning for that is not stated in that document but likely stems from the ECHA general approach to authorization document (see section 2.1). In the above chapter all of the Article 57 subitems were challenged and refuted.

Melamine is not PBT nor vPvB as shown in section 2.1.1.. Hence it does not meet the identification criteria of Article 57 (d) and (e).

Melamine is not an endocrine disruptor as shown in section 2.1.2.. Hence it does not meet the identification criteria of Article 57 (f).

Melamine is not a CMR substance as shown in section 2.1.8.. Hence it does not meet the identification criteria of Article 57 (a), (b) and (c).

Additionally, melamine is not mobile nor very mobile as shown in sections 2.1.3. to 2.1.8. respectively. This refutes the environmental distribution concern in the SVHC identification document and the PMT/cPvM concerns of the CLH dossier.

According to this assessment the score for the inherent properties should be set to 0.

It is questionable whether it makes sense to continue the authorization process in this situation.

2.2. Scoring of the Volume

The score for the annual volume is assessed as follows:

Figure 7: Scoring scheme of substance Volume
(See additional information document to access the Figure)

The Volume score for melamine was set to the highest possible value 15 out of 15.

It is estimated that 95 % of the used melamine are going to be except from authorisation due to its uses as intermediate in the production of plastics. This leads to the conclusion that only 5 percent of the total annual volume should be considered. This would result in a volume score of 12.

However, it should be noted that the ease with which the score can be achieved due to tonnage is disproportionate to the serious consequences of this allocation.

2.3. Scoring of the wide dispersiveness of uses (WDU)

The score of the WDU is assessed as follows:

Figure 8: Scoring scheme of the WDU
(See additional information document to access the Figure)

Whereas:

IND =  Industrial use
PROF =  Professional use
CONS =         Consumer use

The WDU score for melamine was set to 10 out of 15 as initial score and in a subsequent step to a refined score of 12 because of the volume of higher than 10t/y. The reason for this is:

"[…], if a substance without consumer uses ends up in articles and there is no reliable information that releases are unlikely during article service life and waste phase, this can lead to an increase of its WDU score, too."

2.3.1. Challenging of the refined WDU score

It is remarkable that in this category the annual tonnage can increase the score, even though the annual tonnage is already included in the volume score. In other words: In the case of melamine 17 scoring points in total were allocated due to Volume.

The scoring logic is too arbitrary and the range of steps is too wide. For example, there are strict laws, regulations, and processing guidelines in professional applications that serve the very purpose of preventing unintentional disclosure.

Furthermore, according to ECHA's scoring rationale, a refined score is only possible if there are no reliable data for an unlikely release. On the other hand, there is not even data to confirm an unintended release, as such data has never been collected.

All of this leads to the definite conclusion that the refined score should be removed from the examination.

2.3.2. Conclusion on the scoring of the WDU

It has been officially confirmed that intumescent fire protection (IC) coatings do not leach melamine. According to the German approval principals for IC for steel aging tests requests real weathering exposure up to ten years. After 10 years of exposure fire tests have been carried out and many IC provided proof that no significant deterioration in fire performance was observed. Since without melamine no intumescence reaction would take place and significant leaching would result in reduced fire performance, it has been shown that melamine will remain in the coating even after extensive weathering. Obviously, all paint ingredients are locked into the polymeric paint matrix, which protect water soluble substance against leaching effects. In addition, the “German Institute for Buildings Construction” (DIBt = Deutsches Institut für Bautechnik) officially describes 10 years real weathering as statistically safe, means if an IC remains stable after 10 years exposure it can be hardly assumed that no effect will occur in the years after.

Concerning the end-of-life phase if has been confirmed by the steel manufacturer Arcelor Mittal that steel coated with IC can be used unmodified in a steel recycling process using electrical arc furnaces. The steel will melt and at temperatures up to 3,500°C all organic compounds – like melamine and others will decompose. Therefore, contamination of the environment by melamine in the end-of-phase is highly unlikely.

The score of the WDU should be reduced to 10 for the reasons given above. If the ECHA guidelines would allow a further reduction, there would be no better score than the WDU. The measures taken by the control authorities, which impose strict regulations on the use of melamine products, prevent the accidental release of any substance into the environment.
 
3. Overall conclusion

Rudolf Hensel GmbH, a manufacturer of intumescent fire protection coatings based in Börnsen – Germany, has prepared this document to comment on the consultation of the draft recommendation for the inclusion of melamine in the Authorization List (Annex XIV). ECHA documents, standard literature and independent scientific reports in the form of scientific papers were examined.

After a thorough review of the documents and our own research, we have determined that the overall prioritization score for melamine should be reduced to 22. This assessment is composed as follows:

• Intrinsic Properties:           Score: 0
• Volume:             Score: 12
• Wide dispersiveness of uses:  Score: 10

The respective origins of these assessments can be found in the relevant chapters and sections.

The decision to classify melamine as a PMT/vPvM substance was taken too hastily and superficially. All concerns in this regard have been logically and scientifically considered and refuted. It is recommended that these considerations be included in the CLH dossier before its consultation starts in June 2024.

In addition, the publication of the ANSES RMOA report has shed new light on the PMT/vPvM issue. The document shows that melamine has neither PBT nor ED properties. And therefore, conversely, it cannot have PMT properties. It would be negligent to ignore these findings and allow the authorisation process to continue unimpeded.

For intumescent fire protection coatings, the life cycle was assessed based on the service life and the waste phase. It was concluded that there is no risk of accidental release of mela-mine at any stage of the life cycle.

An important point to consider is that the two court cases mentioned in Chapter 1 are still ongoing. Although their judgments are considered to have a guiding role in the authorization phase, the SVHC classification of melamine should be withdrawn regardless of the pending judgments. 

4. References

1. Arzneibuch, Deutsches. "Deutsches Arzneibuch: DAB 11." (2020).
2. https://de.statista.com/statistik/daten/studie/1393536/umfrage/durchschnittliche-wassertemperatur-in-c-in-frankreich-nach-monaten/
3. Chapman, R. P., P. R. Averell, and R. R. Harris. "Solubility of melamine in water." Indust-rial & Engineering Chemistry 35.2 (1943): 137-138.
4. ECETOC – January 2014 – Technical Report No. 123 - Environmental risk assessment of ionisable compounds
5. Szabó, Gyula, et al. "Comparison of different HPLC stationary phases for determination of soil-water distribution coefficient, KOC values of organic chemicals in RP-HPLC system." Chemosphere 39.3 (1999): 431-442.
6. ECETOC – May 2021 – Technical Report No. 139 - Persistent chemicals and water re-sources protection
7. https://www.norman-network.com/nds/empodat/
8. Taken from: Flussgebietsgemeinschaft Elbe on 02.08.2023 Gewässergüte - FGG Elbe (fgg-elbe.de)
9. Taken from Statista on 02.08.2023 - https://de.statista.com/statistik/daten/studie/1380871/umfrage/anomalien-niederschlag/
10. Schumann, Pia, et al. "Pilot-scale removal of persistent and mobile organic substances in granular activated carbon filters and experimental predictability at lab-scale." Science of The Total Environment 884 (2023): 163738.
11. Giulia Turtù. “Biological Treatment of Melamine Containing Wastewater” (2023)
12. Lütjens et al; Melamine in the environment: a critical review of available information 2023 https://doi.org/10.1186/s12302-022-00707-y
13. Cabras, Paolo, Marco Meloni, and Lorenzo Spanedda. "High-performance liquid chromatographic separation of cyromazine and its metabolite melamine." Journal of chromatography 505.2 (1990): 413-416.
	
		5115_Additional Information.pdf	
5116
2024/05/04	KRONOSPAN GmbH,
Company,
Germany	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.	
			
5118
2024/05/06	Kronospan ApS,
Company,
Denmark	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.	
			
5119
2024/05/06	Kaindl GmbH,
Company,
Austria		
		5119_Melamine - Kaindl GmbH.docx	
5120
2024/05/06	Slovakia,
Member State	SK CA would like to express concern about the recommendation of melamine for inclusion in Annex XIV for the following reasons. We have doubts about whether the authorisation is the most appropriate regulatory measure for regulation of risks related to the melamine uses. While we understand the need to replace SVHCs with less hazardous substances; however, before placing substances on the authorisation list, a thorough analysis should be carried out - whether the authorisation is the best regulatory measure at EU level, including an assessment of the availability and suitability of alternatives for all uses. We understand that according to current prioritisation criteria melamine has got high prioritisation score due to its properties, high volume and wide-dispersive uses; however, due to the complexity of supply chains and countless uses, the expected number of applications for authorisation might lead to an unforeseen workload for industry as well as authorities (ECHA, its scientific Committees and to all parties involved in the decision making phase including MSs, EC) stemming from the high number of applications for authorisation for individual uses of the substance (similar to of CrVI case). That´s why we consider it rather challenging and problematic in the view of manageability of the process as well as we see inevitable to consider carefully the best regulatory measure just before possible recommendation of melamine for inclusion in Annex XIV. In addition, authorisation constitutes disadvantages for EU companies comparing to non-EU ones as it is applicable only to EU uses and doesn´t cover the import of articles.
Regarding the possible occupational safety and health concern - it should primarily be addressed via OSH legislation, e.g. by setting Occupational Exposure Limits (OELs) for melamine as outlined in the RMOA document prepared by DE. DE also intends to submit a proposal to CLH. In case there is a legitimate need to regulate specific uses of a substance posing a risk at EU level, we consider the use of a restriction to be a more appropriate regulatory measure; in the RMOA document provided by DE CA, a restriction on certain uses of melamine posing a risk is also identified as a possible regulatory measure.	
			
5121
2024/05/06	Kronospan Polska Sp. z o.o.,
Company,
Poland	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.	
			
5122
2024/05/06	ICDLI International Committee of the Decorative Laminates Industry aisbl,
Industry or trade association,
Belgium	As the leading association of HPL manufacturers in Europe whose member companies are directly affected by the current ECHA procedure, we state that prioritizing melamine at this point in time is in our view disproportionate for several reasons (see attached position statement).	
		5122_ICDLI position statement for ECHA on current Melamine public consultation.pdf	
5123
2024/05/06	KRAIBURG TPE GmbH & Co. KG,
Company,
Germany	--	
		5123_KRAIBURG TPE Kommentar zum Authorisierungsverfahren Melamin.pdf	
5124
2024/05/06	Kronochem GmbH,
Company,
Germany	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.	
			
5125
2024/05/06	Kronospan Chemical Szczecinek Sp. z o.o.,
Company,
Poland	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.	
			
5126
2024/05/06	Melamin, d.d. Kočevje,
Company,
Slovenia		
		5126_Melamine letter ECHA.zip	
5127
2024/05/06	Celanese,
Company,
Germany		
		
Confidential attachment removed	
5128
2024/05/06	BASF SE,
Company,
Germany	We support the general comments of the European Melamine Producers Association (EMPA) and would like to stress the scoring calculation considerations laid down in their contribution that result in a score of 21 points.
In section 2.3 (page 2) of the draft background document for melamine published by ECHA “substance in article notifications” are listed to justify the prioritisation proposal. We would like to point out that a potential REACH authorisation will apply to REACH uses of the substance melamine and that “substance in article notifications” are not validated in terms of misunderstandings of the terminology nor consider the presence of the substance as impurity or as monomer of polymeric article components.
They don’t clearly link to REACH uses and don’t allow quantification or justification of regulatory measures as specifically article imports do not require REACH authorisation. The impact of a REACH authorisation requirement on the listed types of articles remains unclear and demonstrates the need for a better quantification of emissions to identify proportionate and targeted regulatory measures.
The sources of melamine in the environment remain unidentified and unquantified, making it difficult to establish a direct connection to specific melamine uses. There are other potential sources of melamine found in the environment apart from the REACH uses and imported articles which would not be affected by the authorisation requirement like biocide uses, uses in plant protection products and others. Non targeted regulatory measures will create bureaucratic burden for industry and authorities and lower European competitiveness, will not allow for substitution planning and do foster non-EU investment.	
			
5129
2024/05/06	EUROPUR,
Industry or trade association,
Belgium	Attached is a more readable version of the comments below complemented with hyperlinks to further public sources.

EUROPUR Submission to Public Consultation on the 12th Draft Prioritisation for Authorisation concerning Melamine

6 May 2024 – For more information contact Patrick de Kort, Regulatory Affairs Manager, EUROPUR, p.dekort@europur.org

EUROPUR, is the European Association of Flexible Polyurethane Foam Blocks Manufacturers. Our membership covers around 70 – 80% of all flexible polyurethane foam produced within Europe.

It is with great interest that we have read the documentation surrounding draft 12th prioritisation for authorisation, which includes melamine. In this document we will explain how melamine is used in our industry which is relevant for the volume estimation and dispersiveness of use scores. We will also elaborate on our views with regards to the scoring for inherent properties.

Flexible foam production in general
Relevant chemistry
One of the key raw materials for the production of flexible polyurethane foam are polyether polyols. These are produced upstream by the chemical industry by reacting a starter molecule, which is a multifunctional alcohol such a glycerol, with either propylene oxide (most common type of polyether polyol used in flexible foam production) or ethylene oxide (more rarely used in flexible foam production). These polyether polyols are polymers with average weights of thousands of Dalton. They retain flexibility in their molecular structure and contribute to the flexibility of the final material to a great extent. For an exemplar reaction see Figure 1, naturally the resulting polyether polyol is a polymer with a molecular size distribution spanning a certain range.
[see attachment for figure]
Figure 1 Example reaction of glycerol (blue) and propylene oxide (red) resulting in a polyether polyol with a molecular weight of about 1600 Dalton.
The polyether polyols produced by the chemical industry used are liquids delivered in bulk to flexible polyurethane slabstock foam plants.
The production of polyurethane foam is a reaction of such polyether polyols, with diisocyanates, and water where the reactions in Figure 2 occur.
[see attachment for figure]
Figure 2 the blowing and gelling reaction that occur in flexible polyurethane foam production.
The reaction between isocyanate groups (-NCO) and water causes the formation of an amine group (-NH2) and carbon dioxide. The carbon dioxide is gaseous and causes the formation of bubbles in the reaction mixture. This reaction is therefore a “blowing” reaction as it blows gas into the reacting mixture.
In parallel isocyanate groups on the diisocyanates react with hydroxyl groups (-OH) on the polyether polyols to form urethane bonds. Isocyanate groups that have been reduced by the reaction of water to amine groups also react with isocyanate groups to form urea bonds. Both result in aggregation of the liquid raw materials to a solid three-dimensional polymer network material as such these are called “gelling” reactions. As a side note, isocyanate groups have a much greater affinity for reacting with amine groups and thus the residual amine content in the polymer tends to be lower.
The speed of these reactions needs to be carefully modulated to create flexible polyurethane foam. Too rapid blowing would result in the gas bubbling out of the liquid raw materials and thus result in a plaque of polyurethane without foam structure. Too rapid gelling would cause the matrix to set and subsequent gas generation would rip the material apart. This molecular balancing act is achieved by the use of specific catalysts in the right proportions that preferentially speed up either the blow reaction or the gel reaction.
Relevant engineering
The raw materials are brought together in a mixing head and in slabstock foam production are deposited on a conveyer belt. The film of reaction mixture on the conveyer belt at the pour point is just a few centimetres thick and will expand in a mere minutes to rise to 1 – 2 meters height. In those minutes the vast majority of isocyanate groups will have been consumed.
[see attachment for figure]
Figure 3 Schematic representation of a flexible polyurethane foam line
At the end of the line the foam is solid and cut into either long or short blocks and transported to a curing area. These blocks remain there for a period of at least 24 hours, a period in which the final residual chemical reactions take place, and the foam obtains its final physical mechanical properties.

Use of melamine in flexible foam production

Melamine is a solid and the use of solid powders in the production process of flexible polyurethane foam is not easy and tends to reduce physical mechanical properties such as tear strength. It is only because melamine is such an effective flame retardant that it is used. It functions particularly well with phosphate containing flame retardants.
Melamine is so effective because when there is a combustion process happening or starting to happen the heat of the gas phase combustion process result in two complementary reactions. Firstly, melamine sublimes at around 260 °C which firstly is an endothermic process, meaning the sublimation absorbs heat (~29 kcal/mole). Once volatilised the melamine in the combustion zone (flame) will decompose into breakdown products, a second endothermic reaction absorbing another amount of heat (~470 kcal/mol).  Part of these breakdown products are nitrogen which dilutes the fuel in the flame with this inert gas. Secondly, melamine can strengthen a char layer that is formed by a phosphate ester flame retardant that is normally used in the production of combustion modified flexible polyurethane foam.. This char layer acts as a shield between the gas phase combustion processes and the foam which prevents further degradation of the foam to gaseous substances that would otherwise fuel the gas phase combustion process. As such melamine interacts strongly synergistically with phosphorus flame retardants in flexible polyurethane foam.  This is essential to achieve the extreme fire safety standards placed on foam fillings in the United Kingdom (see below).
Solid powder raw materials must first be ideally dissolved- (not possible for melamine) or put into suspension- in polyol before being piped to the mixing head. Once dispersed the polyol and diisocyanates will form a three dimensional polymer network in which the melamine becomes embedded.
In terms of release potential of this melamine, it should be noted that the vapour pressure of melamine is very low, which will likely be the result of an internal crystalline structure with the strong internal hydrogen bonding the molecule is able to achieve [2, 3]. The release of melamine molecules from its crystalline lattice is not likely to be substantial. Furthermore, the movement of solid particles in polymer matrixes has been the subject of intense study and it has been shown that even nanoparticles (which melamine is not as the particle size is substantially larger than the nano range) would not migrate to any appreciable degree in polymeric materials [1]. All in all, one can say that:
Melamine, when present in flexible polyurethane foam, is a solid crystalline structure embedded in the polyurethane polymer matrix.
Only if there would be substantial contact with water would there be a potential for release since this would disrupt the crystalline structure of melamine. However, the vast majority of flexible polyurethane foam is used in applications without water contact. For the minute niche applications in which flexible polyurethane foam is used in contact with water (e.g. substrate for hydroponics), the use of flame retardants in general would not be needed; the substantial water contact eliminates fire risks on its own.

Volume of Use in Flexible Polyurethane Foam
Flexible slabstock foam producers purchase melamine directly from producers/importers and thus there is no “formulation” use in between the production/importation of melamine and the production of flexible polyurethane foam.
EUROPUR, the European Association of Flexible Polyurethane Foam Blocks Manufacturers, collects annual statistics from its members on the amount of foam produced in the industry which is complemented by extensive market research to ascertain the volumes produced by non-members. In total, 60 kT of combustion modified foam was produced in 2023 within the EU27. Members were interviewed to determine how much melamine is used to produce combustion modified foam. For the production of combustion modified foam on average 11% of melamine is used, meaning that around 6.7 kT of melamine were used in the EU27 in flexible polyurethane foam production.
The United Kingdom is in the process of revising its  UK Furniture and Furnishings (Fire) (Safety) Regulations (F&F Regulations). Draft legislation on which the Office of for Product Safety and Standards is consulting no longer specifies that foam fillings have to resist the Crib-5 energy source, but rather a not further defined flaming and non-flaming ignition source [4]. The interpretation of which is expected to be left to the standardisation process. The British Standards Institute (BSI) has a working group FW/6 that is working on a draft standard titled: Furniture fire safety. Specification for resistance to ignition of upholstered furniture for domestic use. It is expected that this working group will conclude on an energy source challenge that is lower than the Crib-5 source, which may not require melamine to fulfil. This would in due time potentially eliminate a substantial fraction (50 – 80%) of melamine use in the EU27.

The article service life of foam containing melamine
Flexible polyurethane foam is generally used in: upholstered furniture (50%), bedding (35%), transportation (10%), and miscellaneous niche applications (5%). However, the melamine containing foam use pattern is rather different. This foam is used almost exclusively in the production of upholstered furniture and bedding and only when fire safety standards require it.
In continental Europe there are no real fire safety standards for domestic (i.e. residential) mattresses and furniture. In some countries there are requirements on low-hazard public places (hotels, restaurants, theatres) or at least requirements on operators of public spaces to keep occupants safe from fire which are then interpreted by operators as a requirement to ensure fire safety. For these kinds of low hazard public spaces, it is customary to require whole mattresses to comply with EN 597-1 and EN 597-2, resistance to cigarette and match testing and to have whole upholstered furniture to comply with EN 1021-1 and EN 1021-2, also resistance to cigarette and match testing. These are rather low intensity heat sources and with the testing on the final product the right selection of fabric can already result in compliance. If foam is relied on to contribute to the solution, melamine would not be needed, medium to slightly higher density foams can resist such heat sources without flame retardants. For designers of furniture and mattresses that wish to use lower density foams, the addition of easier to use liquid flame retardants on their own, such as phosphate esters, would be sufficient.
In the United Kingdom however the situation is radically different. The UK F&F Regulations require foam filling used in domestic furniture and mattresses to resist a Crib-5 heat source on its own. The Crib-5 heat source is a wooden construction with a sprinkling of isopropyl alcohol which is set ablaze (see Figure 4). The total heat release is 285 kJ versus 2 kJ that is the result of match testing. The Crib-5 heat source is thus 143 times more intense than a match test. For a comparison of heat sources used in furniture fire safety testing see Table 1.
[see attachment for figure]
Figure 4 Ignited Wooden crib – Ignition source 5 or ‘Crib 5’ Credit: satra.com
Since the foam on its own has to resist the Crib-5 energy source, no fabric or interliner solution can be relied upon to pass the test. Given the extreme nature of the energy source the combination of a phosphate-based flame retardant and melamine is required to pass. As explained above the phosphate and melamine form a char layer and the melamine has an independent function to sublime and decompose in the gas phase by which energy is absorbed.

Table 1 Characteristics of BS 5852 heat sources. Based on work by Krasny et al. [5] * EN 597-2 and EN 1021-2 require the application of the flame for just 15 seconds.
Ignition Source  Total heat release (kJ)  Flame height (mm)  Heat flux (kW/m²)  Fuel supply rate  Time to 90% mass loss (s)  Burn time (s)
Cigarette  16  —  —  —  —  1200
Gas Flame 1  2  35–40  30–40  45 ml/min  —  20*
Gas Flame 2  12  140–150  20–40  160 ml/min  —  40
Gas Flame 3  46  185–240  20–40  350 ml/min  —  70
Wood Crib-4  142  150–245  15  6 g/min  180  195
Wood Crib-5  285  250–335  18  10 g/min  150  180
Wood Crib-6  1040  250–350  23  15 g/min  330  360
Wood Crib-7  2110  345–490  25  32 g/min  375  390
[see attachment for more readable table]

There are niches in continental Europe where such requirements are placed on foam filling. The best and worst example of this are prisons and psychiatric hospitals; these are normally regarded as very high hazard spaces in terms of fire safety. Occupants of these facilities struggling with depression have in the past in these institutions attempted to utilise their mattress or furniture to commit suicide, by placing the article against the door and setting it ablaze. Overall, the final use of complex objects built with melamine containing foam within the EU27 is rare and limited to niches where fire safety (standards) demands it.
These niches in society in the EU27 certainly do not require 60 kT of combustion modified flexible polyurethane foam. There are however within the EU mattress and furniture producers that export their products to the United Kingdom.
In terms of furniture, Italy for example is a historical example of a producer of furniture with a refined design that is popular in the United Kingdom. A surprising giant in the furniture world has been Poland, which today has an upholstered furniture production in value that eclipsed the Italians. “Made in Poland” means something in the world of furniture. A third and significant furniture producer is Germany, an export powerhouse in the EU.
The mattress producing sector is strong in Germany, Spain, Italy, and the Benelux and many of the mattresses sold in the UK originate from these countries in the EU27.
The use of such melamine containing foam is almost exclusively for the production of mattresses and furniture for export to the United Kingdom.

Dispersiveness of use
Flexible slabstock foam production is performed in around 100 sites in the European Union, the location of which is known. A substantial fraction of these sites is not equipped to handle powders and thus cannot use melamine. Of those that are able to process powders, there are those that use it exclusively for the addition of fillers (e.g. calcium carbonate) to make foam with a superior cost profile and inferior physical mechanical properties. Melamine is used in perhaps 20 – 50 sites that use melamine in a controlled industrial setting for the manufacture of flexible polyurethane foam.
The criteria in the approach for prioritisation of SVHCs do not allow to take into consideration the fact that there is only a limited number of sites using melamine for the manufacture of flexible polyurethane foam. The use of melamine at industrial sites will result in a score of 5.
With regards to the article service life of the flexible polyurethane foam, from the moment it is produced to the moment it is in use in complex objects such as mattresses and furniture, the foam will be handled indoors. Rainwater contact is avoided at all costs, since foam is a sponge and drying flexible polyurethane foam takes an enormous amount of time. Furthermore, when foam has been wet, its physical mechanical properties are maintained but is smells different. This would cause rejection by customers of mattresses and furniture.
In the absence of water contact in the industrial value chain the melamine particles are embedded in the polymer matrix and the melamine molecules in the powder particles are part of a crystalline structure from with release is unlikely.
The use phase of mattresses and furniture built with melamine containing foam is for the overwhelming majority taking place in the United Kingdom and not in the EU27 since this is the region requiring foam to resist the Crib-5 energy source. During the use phase, given the above considerations and the absence of water contact, release of melamine seems unlikely. With regards to the waste phase, the UK has taken the position that all seating waste must be treated as POP waste and destroyed by incineration (unless evidence to the contrary is generated) *. As such most seating is directed towards incineration in the UK (only things such as pure wooden chairs can be presumed not to contain POPs). On mattresses the UK has effectively been reducing its reliance on landfill as a final disposal method for all wastes over the past decade [6]. When mattresses and furniture placed on the market today are disposed of in 10 – 30 years, landfill will have likely been almost eliminated.
[*The presence of POPs in seating furniture in the UK is a result of their F&F Regulation that was adopted in 1988, which drove up the use of flame retardants in furniture. To the best of our knowledge, PBDEs were not added to the foam in the past, but rather the textile (backcoating). This explains the non-functional ppm levels that are found in End-of-Life UK furniture foam, as ingress of textile (backcoating) material. The presence of POPs in seating waste in the EU27 is unlikely. ]
The sparse use of mattresses and furniture containing melamine within the EU27 tends to be restricted to high fire safety hazard locations such as prisons and mental hospitals. Such users tend to ensure that mattresses and furniture is directed towards incineration.
All in all, the use phase of melamine containing foam is overwhelmingly outside of the EU27 and emissions from the article service life of should be considered as unlikely. Therefore, an additional score for the article service life should not be applied because of the use of melamine in flexible polyurethane foam.

Inherent properties
The criteria in the approach for prioritisation of SVHCs on intrinsic properties are repeated in Box 1.
Box 1 Criteria for inherent properties as stated in the approach for prioritisation of SVHCs
[see attachment for Box]
For substances identified under article 57(f) there should be a case-by-case assessment as to whether it is appropriate to apply PBT scoring. On the one hand, the SVHC support document for melamine mentions in section 6.3.3. it is concluded that melamine give rise to an equivalent level of concern to those of other substances listed in points (a) to (e) of Article 57 of the REACH Regulation. As such it is unsurprising that a score of 13 is assigned. On the other hand, a more detailed evaluation of the SVHC proposal and the resulting background document can result in a different conclusion that we would like to highlight.
The primary argument that is included in the SHVC Proposal is that emissions of melamine into “the aquatic environment” would result in increased concentrations of melamine in this environmental compartment. Remediation techniques commonly employed to purify water from “the aquatic environment” would not be able to remove melamine. As a result, there may be a point in the future where all drinking water would reach a concentration of melamine that would cause exposure to (vulnerable subgroups) of humans that triggers toxicologically relevant effects. This argument is graphically described in Figure 5.
[see attachment for figure]
Figure 5 Main argumentation in the SVHC Identification Document
As clarified in the EUROPUR comments to the SVHC identification proposal*, we consider that this one-compartment model of the aquatic environment is simplistic to a point that it does violence to reality. It completely ignores the hydrological cycle (see Figure 6) that could contextualise the finding of melamine in the various sub compartments of our true aquatic environment.
For example, the highest concentrations of melamine were found in rivers which empty in a matter of weeks into the ocean. While there are few measurements of melamine in the ocean, and these were predominantly in areas that could be classified as estuaries, these measurements are order of magnitude lower. Rivers are thus more a dynamic equilibrium that on the one hand are replenished with pristine water that has in essence been distilled from the ocean and deposited on mountains and land by precipitation lowering the melamine concentration. On the other hand, human activity contributes to emissions of wastewater into these rivers increasing the melamine concentration.
[* See the attachment to comment numbered 5667 in the RCOM document that is available on the Registry of SVHC intentions until outcome page of melamine]
A more refined model was presented in our submission whereby the ocean concentration of melamine (which would comprise the vast majority of “the aquatic environment”) was modelled assuming no degradation of melamine whatsoever, 2000 ng/L as an average concentration of melamine in rivers, and 46 103 km³ yr–1 of river water is discharged annually into the ocean. All this would result in a yearly increase of 0.07 ng/L/y, a rate that would result in centuries before any risk to human health would occur. In a more dynamic model, which assumed 0.1% degradation of melamine stocks in the ocean per year, a stable concentration of 70 ng/L would be reached in a number of millennia. Again, a concentration that is considered safe when compared to toxicological benchmarks existing today.

[see attachment for figure]
Figure 6 Diagram of the global hydrological cycle in the Anthropocene. a,b, Major water pools (expressed in 103 km3) (a) and water fluxes (expressed in 103 km3 yr–1) (b). Uncertainty represents the range of recent estimates expressed in %. In b, we separate total human water use (~24 103 km3 yr–1) into green (soil moisture used by human crops and rangelands, green arrows); blue (consumptive water use by agriculture, industry and domestic activity, blue arrows); and grey (water necessary to dilute human pollutants, which is represented with pink shading, pink arrows). This averaged depiction of the hydrological cycle does not represent important seasonal and interannual variation in many pools and fluxes. Source: [7]
Of course, if there were uncertainties about the toxicological benchmark and good indications that the current benchmarks are not protective of human health, the presence of melamine in water could still be a concern. The SVHC Proposal indicates that at this point in time the Tolerable Daily Intake (TDI) derived by the European Food Safety Authority (EFSA), which takes into account vulnerable sub-groups, is not exceeded:
At the current stage the TDI is not exceeded via nutrition including beverages and tap water, and there are currently no risks for human health via this exposure pathway. (page 9- SVHC Proposal)
At the current stage the TDI is not exceeded via nutrition including beverages and tap water, and there are currently no risks for human health via this exposure pathway. (page 54 - SVHC Proposal)
At the current stage the TDI is not exceeded via nutrition including beverages and tap water, and there are currently no risks for human health via this exposure pathway. (page 61- SVHC Proposal)
Paradoxically the SVHC Proposal goes on to highlight that co-exposure to structural analogues such as cyanuric acid could potentiate the toxicological effect of melamine, since the main mechanism of action of melamine is the precipitation of melamine in the urinary tract, followed by damage to the urinary tract epithelium (see Figure 7). Repeated damage to any tissue and subsequent repair through cell division introduces an increased risk of tumorigenesis.
Indeed, the increased risk related to the potential for co-exposure was also highlighted in the EFSA opinion in which the TDI was derived [8]. There it is clarified that the melamine stones formed in the urinary tract lining are complexes with uric acid, but that cyanuric acid can also form such complexes and thus potentiate the risk of melamine.
[see attachment for figure]
Figure 7 Short term mechanism of action of melamine. Source: figure specifically created for EUROPUR for explanation to member companies in the process of setting up a biomonitoring campaign.
We concur that for risk assessment purposes the potential for co-exposure should be evaluated. It is for this reason that in a biomonitoring study that we initiate following the classification of melamine, we requested the laboratory analysing the samples that next to a quantification of melamine and creatinine a quantification of cyanuric acid (and ammeline and ammelide*) be done. The results show that the concentration of cyanuric acid (and ammeline and ammelide*) in urine is not elevated in workers exposed to melamine versus control samples taken from office workers and generally extremely low **. As such co-exposure was addressed, the EFSA TDI could be used without reservations.
[* Ammeline and Ammelide are biological degradation products of melamine.
** In the tens of nanogram per millilitre range, which is more a feat of extraordinary analytical chemistry than it is a cause for concern for human health. ]
The findings of the biomonitoring study show that there is indeed exposure when handling melamine as such (e.g. unloading big bags) and about one or two orders of magnitude lower exposure when handling flexible polyurethane foam containing melamine which was not elevated when compared with the general population. All workers were operating safely with the current risk management measures in place. The full report is available on request.
Other authorities have simply found a way to take into account the potential for co-exposure in the derivation of toxicological benchmarks. For example, the Dutch National Institute for Public Health and the Environment (RIVM) derived a drinking water limit value of 0.28 µM/L (=35 µg/L) for melamine, when cyanuric acid is present above 10 µg/L or when it has not been measured in the water and a limit of 2 µM (252 µg/L) for when cyanuric acid has been determined to be below 10 µg/L [9].
Of course, at the time of the public consultation on the SVHC identification there were also concerns about endocrine disruption, which is generally considered either non-threshold or occurring with an extremely low threshold. The French Agency for Food, Environmental and Occupational Health & Safety (ANSES) has since prepared a draft Risk Management Option Analysis (RMOA) in which it concludes that melamine does not meet the definition of endocrine disruptor as set out by the WHO and accepted at European level [10].
All in all, we do believe that as long as co-exposure is factored in, either by quantification or a worst-case assumption, it would be possible to perform quantitative risk assessment for human health. For example, if we assume that an adult consumes 1.5 L of water per day and weighs 60 kg and this adult drinks directly from a river containing 3000 ng/L of melamine (not an unreasonable concentration for rivers), the daily intake of melamine of this person would be 75 ng/kg/d, which is 2667 times lower than the TDI of EFSA. The unlikely assumption that individuals would drink directly from rivers combined with the safety margin of a factor 2667 would quite effectively cover any potential risk from co-exposure to cyanuric acid. Based on this we feel confident to conclude that:
At the current stage human exposure levels from drinking water are more than a factor 1000 lower than the EFSA TDI well covering the potential risk should there be a similarly low level of cyanuric acid exposure, and there are currently no risks for human health via this exposure pathway.
At the same time, we do acknowledge that in the SVHC proposal there were also (auxiliary) arguments questioning the safety of melamine for the environment. For example:
Therefore, the substance properties raise the concern that these effects or yet unknown effects could appear in the environment and lead to population-relevant effects, due to long-term exposure over the whole life and over several generations, keeping in mind continuous exposure via water and potentially increasing concentrations. (page. 10- SVHC Proposal)
On this we would like to note that since the draft ANSES conclusion on endocrine disruption cover the environment as well, there is no reason to assume the standard ecotoxicological assessment framework included in the REACH Registration dossier would be inadequate to address this concern. No Observed Effect Concentrations (NOECs) for fish, daphnia, and algae range from 5.1 – 98 mg/L and a PNEC for fresh water of 0.51 mg/L has been derived. A relatively worst-case concentration measured in rivers would be around 3000 ng/L, which is 0.003 mg/L or about 170 times lower than the PNEC.
Given the above, the remaining concern related to melamine in the end boils down to a non-endocrine disruption based effect on human health. An effect that is at the current stage in time not really occurring and which may or may not occur in the distant future. Therefore, we believe that in line with footnote 6 of the approach for prioritisation of SVHCs this case-by-case assessment shows that the score that should be applied to melamine for inherent properties should be 1 instead of 13.

References
[1] J. Bott, A. Störmer, and R. Franz, "A Comprehensive Study into the Migration Potential of Nano Silver Particles from Food Contact Polyolefins," in Chemistry of Food, Food Supplements, and Food Contact Materials: From Production to Plate, vol. 1159, (ACS Symposium Series, no. 1159): American Chemical Society, 2014, ch. 5, pp. 51-70.
[2] E. W. Hughes, "The Crystal Structure of Melamine," Journal of the American Chemical Society, vol. 63, no. 6, pp. 1737-1752, 1941/06/01 1941, doi: 10.1021/ja01851a069.
[3] J. Grabska, K. B. Beć, C. G. Kirchler, Y. Ozaki, and C. W. Huck, "Distinct Difference in Sensitivity of NIR vs. IR Bands of Melamine to Inter-Molecular Interactions with Impact on Analytical Spectroscopy Explained by Anharmonic Quantum Mechanical Study," Molecules, vol. 24, no. 7, doi: 10.3390/molecules24071402.
[4] OPSS. "Closed consultation - Smarter Regulation: Fire safety of domestic upholstered furniture." https://www.gov.uk/government/consultations/smarter-regulation-fire-safety-of-domestic-upholstered-furniture (accessed 7 March, 2024).
[5] J. Krasny, W. Parker, and W. Babrauskas, Fire Behavior of Upholstered Furniture and Mattresses. 2000.
[6] DEFRA. "Official Statistics UK statistics on waste." https://www.gov.uk/government/statistics/uk-waste-data/uk-statistics-on-waste (accessed 7 March, 2024).
[7] B. W. Abbott et al., "Human domination of the global water cycle absent from depictions and perceptions," Nature Geoscience, vol. 12, no. 7, pp. 533-540, 2019/07/01 2019, doi: 10.1038/s41561-019-0374-y.
[8] E. F. a. P. A. Efsa Panel on Contaminants in the Food Chain and Efsa Panel on Food Contact Materials, "Scientific Opinion on Melamine in Food and Feed," EFSA Journal, https://doi.org/10.2903/j.efsa.2010.1573 vol. 8, no. 4, p. 1573, 2010/04/01 2010, doi: https://doi.org/10.2903/j.efsa.2010.1573.
[9] E. Smit, "Notitie onderbouwing melamine drinkwaterrichtwaarde [Briefing  supporting the melamine drinking water guideline value]," RIVM, 2019.
[10] ANSES, "Draft Analysis of the most appropriate risk management option (RMOA): Melamine," 2023. Accessed: 26 March 2024. [Online]. Available: https://www.consultations-publiques.developpement-durable.gouv.fr/projet-de-rmoa-analyse-de-la-meilleure-option-de-a2906.html?lang=fr	
		5129_EUROPUR PC Submission 12th Draft PfA Melamine.pdf	
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2024/05/06	PPG Industries,
Company,
United States of America		
		
Confidential attachment removed	
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2024/05/06	Bundesverband Brandschutz e.V. (BVB),
Industry or trade association,
Germany	

Contents
1 Executive summary 3
2 Inherently properties 3
3 Uses in scope of authorisation, input for Volume and Dispersiveness use scoring 3
1.1 Flame Retardant in Flexible Polyurethane Foam 3
1.2 Intumescent blowing agent Applications 4
1.2.1 Spumific/Blowing agent in Intumescent Coatings 4
1.2.2 Intumescent Blowing – other applications 5
1.3 Article service life (ASL) 5
1.3.1 Comments about item 1 of the background document. Main (sector of) uses and relative share of the total tonnage 6
1.3.2 Comments about item 2. Structure and complexity of the supply chains 7
4 Conclusion Prioritization 7
1.4 Volume 7
1.5 Dispersiveness of Use 8
5 General Issues 8
1.6 Effectivity of authorization process 8
1.7 Other EU regulations 10
1.7.1 Food Contact 10
1.7.2 Biocidal 10
1.7.3 Drinking water 10
Terms used
Melamine as such: The substance Melamine, being a white powder. Similar term is free melamine
Melamine-based polymer: substance resulting from the synthesis of melamine and formaldehyde. The melamine-based polymer is used as resins in the production of articles. Similar term is melamine resins.

1 Executive summary
The "Draft background document for melamine,"1 dated February 7th, 2024, was formulated within the framework of ECHA’s twelfth recommendation for the inclusion of substances in Annex XIV. In this document, melamine was assigned a total scoring of 40. However, BVB and EMPA, participating in this public consultation, offers dissent regarding the assigned score for melamine, advocating for a revised scoring of 21 and providing rationale to support this adjustment.

Inherently properties – ECHA’s score= 13; EMPA’s score= 1
Volume – ECHA’s score= 15; EMPA’s score= 12
Wide dispersiveness of uses – ECHA’s score= 12; EMPA’s score= 8
Total score – ECHA’s score= 40; EMPA’s score= 21

The comments of this document submitted in this public consultation are referenced to the aforementioned background document.
2 Inherently properties
For the Inherently Properties see separate document “Prioritization - Inherently Properties”.
3 Uses in scope of authorisation, input for Volume and Dispersiveness use scoring

The document detailing the approach for prioritisation of SVHCs (dated 10 February 2014) clarifies that only the annual volume used in scope of authorisation is taken as a basis for this criterion. In practice this means all non-intermediate use in the EU-27 would be in scope. The non-intermediate use of melamine identified and reported by the melamine REACH consortium, is restricted to just two uses: as a flame retardant in flexible polyurethane foam and for the use in intumescent applications.
1.1 Flame Retardant in Flexible Polyurethane Foam
Around 6.7 kT (2023) of melamine is used as such in industrial sites to produce around 60 kT of combustion modified (CM) foam within the EU27. Melamine is used in perhaps 20 – 50 sites in a controlled industrial setting for the manufacture of flexible polyurethane foam.
The use in flexible polyurethane foam is more extensively described in the EUROPUR submission to this public consultation. Below follows a short summary.
Melamine, when present in flexible polyurethane foam, is a solid crystalline structure with a surface covalently bound to the polyurethane polymer matrix. As such in the absence of water contact, there is unlikely to be any emission from the combustion modified foam.
Water contact in the industrial value chain is avoided since this strongly negatively impacts the quality of flexible polyurethane foam in general (combustion modified or not). The article service life of CM foam containing melamine is restricted to mattresses and furniture and thus during the use phase will not be any water contact that would disrupt the crystalline structure of the melamine particles; thus, making emissions unlikely.

1 https://echa.europa.eu/documents/10162/12eec174-67fb-71c6-c8ce-d622c2e5497f
2 Reference is to “Draft Background document for melamine”

The use of melamine to produce CM foam is driven by the UK Furniture and Furnishings (Fire) (Safety) Regulations (F&F Regulations), which stipulate that foam fillings have to be able to resist a rather extreme Crib-5 energy source. This so far has only been achieved by the addition of melamine in combination with a chlorinated phosphate ester. Nearly all CM foam containing melamine is either directly exported to the UK to mattress and furniture manufacturers or sold to mattress and furniture manufacturers in the EU27 for the production of products destined for the UK market.
All in all, the low likelihood of water contact that would disrupt the crystalline matrix and the fact that the CM foam is not used in the EU27 should result in the conclusion that emissions from Article Service Life are unlikely from flexible polyurethane foam.
What is left is the waste stage. Melamine contained in CM foams would be destroyed in incineration and the release from specifically engineered landfills would be limited. Since most CM foam containing melamine would become waste in the UK, the UK waste management system is the most relevant to evaluate the fate of melamine. Mattresses and furniture would be collected in “(residual) bulky waste", a fraction for which the predominant waste treatment option today is incineration with energy recovery and landfill is increasingly being phased out.
Emissions from the article service life of melamine in flexible polyurethane foam are thus unlikely and no additional article service life score should be applied for this use.
1.2 Intumescent blowing agent Applications
1.2.1 Spumific/Blowing agent in Intumescent Coatings
Around 0.825 kT (2023) of melamine is used as such in intumescent applications within the EU27. Source of data is CEPE (The European Council of the Paint, Printing Ink, and Artist’s Colours Industry) Study TEAM Analysis.
The use in intumescent coatings is more extensively described in the CEPE submission to this public consultation. Below follows a short summary.
Intumescent coatings are used to protect steelwork, timber, and concrete from the effects of fire in both the petrochemical industry, infrastructure, and the built environment.
They are a unique form of fire protection that develop a heat-insulating protective foam when exposed to high temperatures, such as would be experienced from a fire and ensures that the structural integrity of the construction remains intact in the event of a fire. When all benefits and properties are considered, intumescent coating is the most important and efficient fire protection coatings available. The combination of an aesthetically pleasing coating and excellent fire protection properties has led to a huge reliance on this technology. The wide range of applications on different types of substrates such as textiles, wood, plastics, cables and steel are a major reason for the appeal of this technology. In particular, the use of intumescent coatings to protect structural steel.
As they provide solutions to the different needs of the industrial sector, intumescent coatings are available in three main technologies; thermoplastic water based, solvent based coating and thermosetting, reactive coatings.
Intumescent coatings applied on a building will remain in place for its lifetime. In the absence of contact with water or a fire, the intumescent coating remains stable, and no melamine is expected to leach out, as it is within the coating film.
Intumescent coatings are produced in few production sites around Europe under well controlled industrial conditions in factories that are regulated and audited.

Application of intumescent coatings will be completed by professional and industrial users and may be done after the steelwork has been erected at the intended location, “on-site”, or prior to final erection in a paint shop or modular construction yard/facility, “off-site”.

On-site application is a common approach across Europe, accounting for approximately 50% of the intumescent coatings volume sold and typically involves professional users. Health protection for these users of intumescent coatings is well described in the product SDS and includes, but is not limited to, respiratory, eye and skin protection. Responsible construction projects will have a requirement for good waste management procedures following local regulations. This should mean there is little chance of melamine being released into the environment.
Off-site application occurs on a more industrial scale and standard. It involves application of pre-
erection or modular elements in a controlled paint ‘shop’.
While the quality of paint shops and modular construction facilities will vary, it seems reasonable to expect all will be enclosed and have suitable and regulated waste management procedures.
The chances of off-site (paint shop) application of intumescent coatings being a source of environmental melamine are low. These facilities are required, for example, to employ a closed system of drainage to ensure liquids are collected and disposed of as waste and will not enter the wider water system.
The steel producers have declared that the vast majority (96% from SCI) of all structural steel is recycled after use, this recycling process will involve thermal processing of the steel. Coatings, such as intumescent coatings will be thermally degraded, and melamine will be destroyed by this process. It is not envisaged that end of life disposal of intumescent coated steelwork will result in melamine release into the environment. No additional article service life score should be applied for this use.

1.2.2 Intumescent Blowing – other applications
There is a second similar application of intumescent formulation containing up to 15% melamine for fire protection. This intumescent formulation is applied to a textile fabric (glass fibers or others).
These articles are used for cable sheathing and as fire protection mats or bandages. Manufacturers of these fire protection articles use a preformulated intumescent paste which is supplied or mix it directly and coat the fabric. This is done amongst others by SMEs.
The fire protection bandages are used by professionals to close wall breakthroughs (in case of pipes or cables) to guarantee fire protection. When pipes or their insulation deform in a fire, a gap in the wall or ceiling is created, through which fire and smoke can spread. The fire protection bandage for pipes prevents this, since such products foam up when heated and thus expand to seal the gap automatically, creating a smoke-tight and fire-resistant barrier.
The small companies will not be able to apply for an authorization (resources and costs). Authorization is not seen as the right regulatory measure, these fire protection bandages can easily be manufactured outside EU and imported (likely with problems on quality).

1.3 Article service life (ASL)

The Annex I "Further information on uses" of the "Draft background document for melamine" indicates a confusion among authorities regarding the distinction between the uses of melamine-as- such and the uses of melamine-based polymers (resins) synthesized from the melamine monomer. The Annex I “Further information on uses” of the “Draft background document for melamine” reflects that authorities confuse the uses of melamine-as-such with the uses of the melamine-based
polymer(resin) synthesized from the monomer melamine. Consequently authorities made an error of assessment of the article service life scoring. The detailed comments that follow below aim to clarify the misunderstanding in question.

1.3.1 Comments about item 1 of the background document. Main (sector of) uses and relative share of the total tonnage
A RELEVANT CLARIFICATION
The background document mentions that the use of resins with unreacted residual melamine was reported by registrants of the substances. This is correct, this is use 002 reported under item 3.5.3 Uses at industrial sites in the IUCLID file of the melamine lead registrant. In the REACH dossier of October 2023 the registrants updated the name of the use 002 to Use as a monomer (intermediate) in melamine-based resins before curing. The inclusion of the use 002 in the REACH dossier reflected the point of view of the registrants. The aim was to risk assess all possible exposure scenarios and document safe use conditions also for special cases in the Chemical Safety Report (REACH CSR) and provide an harmonized assessment to the co-registrants and their DUs. It was not the intention of the registrants to describe an additional high-volume use of melamine! Registrants wanted to make clear with the new wording of the scenario that the unreacted melamine is an impurity, a constituent of the synthesized melamine-based polymer (resins). In conclusion, the mentioned use is no use of melamine but rather the use of the melamine-based polymer and out of scope of the authorisation requirements.

The majority of the Annex 1 listed applications are not related to articles made of melamine but articles made of melamine-based polymer used as resins. Melamine is one of the starting monomers, an intermediate, to synthesize the melamine-based polymer used as resins. These resins are further processed to produce final articles. The below listed uses in Annex I, are all intermediate uses and consequently out of scope of authorisation.
• Surface coatings and paints: etherification of melamine and alcohols in conjunction with a) plasticising resins yields stoving finishes for automotive applications that have high alkali resistance, b) epoxide or epoxide ester resins affords wood finishes for floor seals.
• Laminates: in furniture industry, paper or fabric webs are impregnated with melamine resin to generate impact-resistant and scratch-resistant coatings for particle board and plywood.
• Glues and binders: melamine resins are used as binders for top-quality, water-proof particle board and for reinforcing wood glues.
• Paper finishing: addition of melamine resin increases the wet strength and wetabrasion resistance of paper.
• Compression-moulding materials: melamine resins are processed with cellulose or cotton linters to produce thermosetting, impact-resistant plastics for the manufacture of household appliances or kitchen utensils.
• Textile and leather finishing: cellulose-containing fabric is impregnated with melamine resins in order to enhance dimensional stability, abrasion resistance and wet strength. To some extent, the flammability of fibres is also decreased.
• Melamine resins are moreover used to increase durability and abrasion resistance in the tanning of leather.
• Other: literature reports the possible use of melamine resins as filler in the rubber industry and as matrix for ion-exchanger resins.
Furthermore, in the referred Annex I, the reference made to other intermediate uses reflects the same confusion.

• Intermediate uses of melamine are mentioned where melamine salts are formed such as melamine phosphate, melamine polyphosphate, melamine cyanurate, melamine-poly (zinc phosphate) or melamine borate. These salts are used as flame retardants for fire safety of the different applications. All listed uses are not uses of melamine but uses of other substances like

melamine-cyanurate and melamine-polyphosphate), and can therefore not be in scope of REACH authorisation.

• Melamine as such is used as flame retardant additive in flexible PU foams and in intumescent coatings but not in rubbers or thermosets. In these applications the melamine- based polymeric resins and/or HMMM are used but not melamine.

• Additional uses in the manufacture of coating, adhesives and inks, production of formica, recycling, textile coatings/applications, leather manufacturing process are listed. These are all uses of the melamine-based polymer (resins), not of melamine as such and therefore not in scope of the authorisation.
1.3.2 Comments about item 2. Structure and complexity of the supply chains
Clarifications regarding the number of industrial sites and uses
There are 56 active registrants of melamine (April 2024). Out of these 56 registrants only 4 are manufacturers within the EU, all other registrants are DUs and importers and ORs of manufacturers located outside the EU. The vast majority of DUs are resin manufacturers and their use of melamine as monomer/intermediate is out of scope of the authorisation.

The registration dossiers contain uses of melamine in several product categories, like PC 1, 9a, 9b, 9c, 15, 18, 23, 26, 32, 34, 35, 41. These are not uses of melamine as such but of melamine salts or melamine-based polymeric resins. This is also applicable for the different indicated sectors of use: SU 1, 2a, 5, 6a, 6b, 8, 9, 11, 12, 13, 17, 18, 19, 23. The only direct use of melamine as a substance is as a flame retardant additive in flexible PU foams and blowing agent in intumescent applications, all other uses are uses of melamine salts or melamine resins.

The indicated articles (AC 1, 2, 4, 5, 6, 7, 8, 10, 11, 13, 31) are also not manufactured of melamine but from either melamine salts or melamine-based polymeric resins and can therefore not be in scope of the authorisation.

In conclusion, the refined score with an additional score of 2 is not correct. No additional score should be given to due to articles service live, as those listed articles are not articles of the substance melamine, but rather articles made of other substances like melamine-based polymers (resins) or melamine-based salts.
4 Conclusion Prioritization
1.4 Volume

Within the EU27 the volume of melamine used in non-intermediate uses amounts to 6.7 kT in flexible polyurethane foam production and .825 kT in intumescent applications. Note that volume of the other intumescent application is not accounted yet, but it is expected to be a low volume.

Volume  ECHA’s score  Corrected Score
Combustion Modified Foam Production 6 700 tons
Intumescent Applications (coatings + other) 825 tons
15                  12
TOTAL  15                  12

1.5 Dispersiveness of Use
The scoring regarding dispersiveness of use was assessed considering the three major use types, industrial, professional and consumers with a score of 10 and an additional score of 2 due to uncertainties about releases of melamine during Article Service Life.
The score of 10 is in principle correct and reflects the professional use of melamine in intumescent applications. However, it's important to highlight that this represents the sole professional use of melamine, with an estimated annual tonnage of approximately 500 tonnes, constituting slightly over 50% of total intumescent applications. Therefore, we advocate that score of 8 is more appropriate. The additional score of 2 assigned for Article Service Life is incorrect as explained in this document. No additional score should be given since most of the ASL do not result in any pertinent releases.

Wide dispersiveness of use ECHA’s score Corrected Score
Professional use (Intumescent Applications) 500 tons 10 8
Refined score Article Service Live 2 0
TOTAL                                        12          8

5 General Issues
1.6 Effectivity of authorization process
The background document for melamine mentions “Some uses appear not to be in the scope of authorization, such as uses as intermediate (including use as monomer at industrial sites)”2 this text is not reassuring transparency to what uses are in scope or are not in scope of authorization. We would like to confirm the comments of the industry made during the SVHC consultation that the uses of melamine as intermediate, exempted from authorization, are estimated as 95% of the total tonnage (RCOM, 2022). A major part of this volume of melamine is used as a monomer in the synthesis of a melamine-based polymer (resins) and a smaller volume as a reactant in the synthesis of melamine salts. For more detailed information about the uses of melamine as a monomer, and by definition an intermediate, see separate document “Uses exempted from the Authorisation Requirement” as part of this consultation.
There are only two uses with relevant volume of the substance as such, i.e. non-intermediate uses, identified and reported by the melamine REACH consortium. Those uses are as blowing agent for intumescent applications and as flame retardant in polyurethane foams.
BVB's position is that the efficacy of REACH authorization in regulating the uses of melamine to safeguard human health and the environment cannot be substantiated due to:

1. Emission of melamine from melamine production sites and industrial sites using melamine cannot be accounted for the levels of melamine found in the environment. Melamine manufacturers and Downstream Users of melamine have implemented operational conditions to limit environmental emissions and worker exposures during manufacturing and handling. These levels are far below DNELs and PNECs. The industrial processes are as enclosed as possible; from the manufacturing start via transport and further processing by DU’s. Industrial use of melamine is regulated via the Industry Emission Directive
2. A concern for the general public is exposure to melamine. A TDI (tolerable daily intake) has been derived for melamine. Migration of melamine during use of food contact materials and articles (for instance dinnerware) is regulated by a specific migration limit.

3. There is no data currently showing health concerns related to exposure to drinking water. Drinking Water standards have been developed in Germany and the Netherlands. These safe levels are at least from 15 up to 100 above melamine levels actually found in surface water.
4. The melamine articles service life (intumescent applications and polyurethane foams) have limited emissions. The emissions cannot account for the levels of melamine found in the environment.

5. Imported articles will not be affected by authorization. Examples are articles based on the polymeric melamine resins like wood-based panels, laminate flooring, furniture, clothing, specific types of paper, intumescent applications, etc. Additionally, food contact applications, the majority of which are imported as final articles, also contribute to the challenge of regulating melamine use effectively under REACH authorization.
6. The sources of melamine in the environment remain unidentified, making it difficult to establish a direct connection to specific melamine uses. There are other potential sources of melamine found in the environment which would not be affected by the authorization requirements:

a. Melamine is formed as a metabolite from the biocide cyromazine when applied on fields and in stables.
b. Potential releases of melamine from the use of cyanamide-containing fertilizers.
c. Melamine is used as a formaldehyde scavenger in POM (Polyoxymethylene) and other formaldehyde containing polymers.
d. HMMM (Hexamethoxymethylmelamine, EC 221-422-3), used in special coatings and tires can degrade to melamine.1 HMMM is found in surface water. Tyre abrasion is an ubiquitous phenomenon in Europe and could be a significant contributor of melamine/melamine derivatives in the environment.
e. Specific articles, manufactured from polymeric resins, which have been synthesized from melamine as monomer might release melamine during the use or waste phase, especially when landfilled. Possible articles are dinnerware, washing powder containing specific encapsulated fragrances, specific textiles, paper with improved wet strength.
It is questionable if authorization requirements imposed on melamine use within the EU27 will offer additional protection to human health or the environment. However, these requirements could potentially prompt the relocation of article production outside the EU.
BVB asserts that due to insufficient data and knowledge, it is not advisable to enact any regulatory measures at this time. BVB recognizes the importance of identifying the causes of melamine presence in the environment. Therefore, gathering more data and knowledge to pinpoint the origin of melamine found in the environment is a prerequisite before effective regulation can be adopted. BVB and EMPA, along with the downstream industry, is actively collecting data and is open to collaborating with other stakeholders, including European and national competent authorities, in a joint effort.

1.7 Other EU regulations
As information below follows a summary of EU current regulations applicable for the substance melamine.

1.7.1 Food Contact
Melamine has been authorized for use in the European Union under Regulation 10/2011/EU as a monomer in Food Contact Recycled Plastic Materials and Articles (FCM). The original specific migration limit (SML) of 30 mg/kg was reduced to 2.5 mg/kg in 2011. The EFSA opinion of 13 April 20105 recommended that EU limits for the migration of melamine into food should be reconsidered, given that food is not the only source of exposure. Therefore, EFSA proposed to lower (as far as exposure from food contact materials is concerned) the Tolerable Daily Intake and consequently also the migration limit from 30 mg/kg to 2.5 mg/kg. The SML has been derived as a safe limit for consumers. Article manufacturers have to comply with this requirement when placing such products on the EU market. Articles which are fulfilling this obligation have been assessed by authorities as posing no threats to human health. It should be highlighted, that the vast majority of FCM made of melamine resins are manufactured outside the EU and are imported as final articles and would not be affected by a possible authorization process.

1.7.2 Biocidal
Melamine is formed as a metabolite of the biocidal product Cyromazine. Cyromazine was authorized 2023 for product type PT18 (insecticides, acaricides and products to control other arthropods) in the EU. It was assessed by ECHA that the metabolite melamine poses no risk to humans, animals or the environment6, 7.

1.7.3 Drinking water
Melamine is included in the European positive lists of starting substances, compositions and constituents authorized for use in the manufacture of materials or products that come into contact with water intended for human consumption. It is authorized until December 31st 2028 as monomer or other reactant in all categories of drinking water contact materials. Total Maximum Tolerable Concentration at the tap (MTC(T)tap, organics) is 125 µg/l. This is the maximum permitted concentration of Melamine migrating from organic materials into water intended for human consumption.

Contents Inherently Properties
1 Introduction 2
2 Relevant observations on the SVHC identification process for melamine 3
3 New data and clarifications on the SVHC identification process 4
3.1 Hazard assessment includes the derivation of DNELs, PNECs, TDIs and Drinking Water Standards 5
3.2 Melamine is not an Endocrine Disrupting Chemical 7
3.3 Melamine is not a PBT substance 8
3.4 Melamine’s potential for Mobility has been misrepresented 9
3.4.1 Log KOC is an inappropriate metric of melamine’s mobility 10
3.4.2 Field studies on Cyromazine, where melamine was also measured, indicate a limited mobility in soils. 13
3.4.3 Monitoring data do not support the view that melamine is a widespread contaminant of water systems 14
3.4.4 The LRTP tool was used inappropriately 16
3.4.5 Melamine can be effectively removed from water using activated carbon filters, even under alkaline conditions. 16
4 Conclusions 17
5 References: 18
6 Annex 1: Assessment of the Pote (1994) study for its relevance in determining the mobility of melamine in soils 21
1 Introduction
The ‘Draft background document for melamine’1 of February 7th 2024 gives the score 13 (high concern category ) for Intrinsic properties (IP) on the basis that ‘melamine has equivalent level of concern having probable serious effects to human health and to the environment meeting the criteria of Article 57 (f)’. However no justification or explanation is provided for selecting this score.
BVB and EMPA point out that the default selection is incorrect and that the intrinsic property score for melamine should be 1, and not 13. The basis for this conclusion is the General Prioritisation Approach document update from 5th March 2020, and referencing the intrinsic properties of melamine as laid out below.
Melamine has been well studied in standard guideline physical/chemical property, toxicology and ecotoxicology tests, meets the REACH standard information requirements, and has undergone six dossier compliance checks, with no outstanding issue2. The Lead registrant dossier was updated in October 2023 and is live on the new ECHA Chemical Database (ECHACHEM)3.

1 https://echa.europa.eu/documents/10162/12eec174-67fb-71c6-c8ce-d622c2e5497f
2 https://echa.europa.eu/information-on-chemicals/dossier-evaluation-status/-/dislist/substance/100.003.288
3 https://chem.echa.europa.eu/100.003.288/overview?searchText=melamine

BVB points out that there is a pending CLH process for melamine with the intention to harmonise its classification for PMT properties, and as a reproductive toxicant. The submitting Member State (Germany) has indicated to ECHA that it will submit their CLH dossier by 30th June 2024.
Melamine is already self-classified and notified as a Reprotoxic category 2 substance. However, the proposal to classify melamine as a PMT substance will be vigorously contested based on new data that has become available since SVHC identification, and by pointing out errors and inconsistencies in the SVHC identification process. Concerns have already been raised about the lack of CLP guidance on PMT properties, which is not due to be finalised before the CLH public consultation process.

Additionally, it must be noted that there are two parallel assessments for melamine underway at ECHA: Endocrine Potential (ANSES FR) and PBT assessment (DE). Neither has been yet completed. However, the preliminary report of ANSES agrees with the comprehensive assessment available in the Melamine REACH dossier that melamine does not pose any real concern for endocrine disruption. Melamine should not even be considered as PBT due to its proven lack of bioaccumulative potential. The basis for these conclusions is discussed below.
It should also be noted that melamine’s inclusion in the SVHC candidate list is currently subject to
legal challenges through the European Court of Justice.

BVB points out that the drive to prioritise melamine for inclusion in Annex XIV is premature and that due consideration should be given to the pending CLH process and the court proceedings. The failure to allow for the conclusion of these parallel processes is opposite to ongoing attempts by the EU Commission to provide for a more transparent chemical assessment process in line with the ‘one substance, one assessment’ approach’. The chemicals industry has long called for clearer interfaces between different chemical legislations in order to provide for regulatory coherence.
BVB presents below a number of critical scientific considerations on melamine related to its intrinsic properties which must be taken into account during the prioritisation process. The purpose is not to retrace the arguments already presented during the previous public consultation during the SVHC identification phase, but rather to point to the existence of new scientific data and indicate where empirical errors were forwarded as fact to the MSC. The new data should be taken into account, and the errors of assessment acknowledged and corrected.

2 Relevant observations on the SVHC identification process for melamine

Melamine was formally added to the Annex XVI SVHC candidate list on 17th January 2023 after adoption of the Dossier Submitter proposals during the Member State Committee plenary meeting (MSC-80) held between 13th-15th- December 2022.

4 https://echa.europa.eu/registry-of-clh-intentions-until-outcome/-/dislist/details/0b0236e187dde605
5 https://ec.europa.eu/commission/presscorner/detail/en/ip_23_6413
6 https://cefic.org/app/uploads/2023/04/Cefic-position-on-Regulatory-Requirements-on-Substance-of- Concernes-SoCs.pdf

SVHC identification was according to Article 57(f) is on the basis of ‘scientific evidence of probable serious effects to the environment and human health (man via the environment) which give rise to an equivalent level of concern to those of other substances listed in paragraphs (a) to (e) of Article 57 of the REACH Regulation.’
The justification for identification was based on very high persistency, high mobility in water, potential for being transported in the water phase over long distances, difficulty of remediation from the environment and water purification, urinary tract toxicity, carcinogenic effects and reproductive toxicity of melamine and effects on fish and aquatic invertebrates and reproductive toxicity in rats and other mammals.

Four MSC members abstained from voting: AT, CZ, DK, HU. One MSC member (AT) provided a written justification for their abstention:
‘It is currently not clear, which, if any, risk management measure will follow the SVHC identification of melamine. Therefore - notwithstanding the question as to whether melamine fulfils the criteria under art. 57 (f) REACH – Austria is of the opinion that melamine is not adequate for an eventual inclusion in Annex XIV in the sense of art. 59 (1) REACH. Thus, Austria abstains from voting.’

Subsequently, serious concerns were raised over the procedure used, and these have been expanded in the court challenges, which are not discussed here.

3 New data and clarifications on the SVHC identification process

BVB and other stakeholders had submitted comments to the SVHC identification public consultation, which closed on 17th October 2022.

The RCOM responses provided by the Dossier Submitter (DS) contained a number of misunderstandings and factual errors related to intrinsic properties which were later inserted into the MSC support document without any discussion, recourse or provision for the public consultees to further clarify. Since then, relevant new data have also become available.

These points are expanded below, along with pointers to new data, all of which BVB believes should be taken into consideration in the prioritisation process.

We re-iterate our understanding that the SVHC identification and Annex XIV prioritisation processes specifically excludes considerations around exposure and risk assessment and must focus on hazard assessment. However, BVB is adamant that key aspects of the hazard assessment process were erroneously excluded based on the Dossier Submitter’s evident misunderstanding of what
constitutes ‘Hazard assessment’ as it is defined and practiced under REACH, in the various ECHA guidance documents, as well as how safe limits are routinely derived in the fields of toxicology and ecotoxicology.

3.1 Hazard assessment includes the derivation of DNELs, PNECs, TDIs and Drinking Water Standards

BVB points out that the derivation of ‘No Effect’ levels is an integral part of substance hazard assessment and should have been be taken into account during the SVHC identification phase. It was erroneously assumed that discussion around the existence of safe levels for melamine (and potential co-exposures to cyanuric acid) constitutes an element of exposure assessment, but this is a patently false assumption.
In the context of REACH, Derived No Effect Levels (DNELs) for Human Health, and Predicted No Effect Concentrations (PNECs) for environmental health are derived based on the no effect levels emerging from standard toxicological and ecotoxicological assays. Such no-effect levels are then further refined by the application of ‘Uncertainty’ or ‘Assessment’ factors which take into account intra-/inter- species variability, dose extrapolations, and data quality for example.

DNELs and PNECs have been derived for melamine based on the latest available data, using standard guideline test, and these have nowhere been challenged in the SVHC identification phase, or in dossier compliance checks. Indeed, they have been ignored on the misunderstanding that their consideration implies an exposure and risk assessment. This is false.
Further, it has been suggested that safe levels for human and environmental health cannot be established based on existing data. This is a disingenuous misrepresentation of how toxicological hazard assessment works.

There has been a failure to acknowledge that it is well established practice in toxicological hazard assessment to derive safe levels for humans based on the use of uncertainty / assessment factors. The REACH guidance Chapter R.8: Characterisation of dose concentration-response for human health explains and expands on the concept of using assessment factors in the derivation of Derived No Effect levels (DNELs) for human health hazard, which is a registration requirement. According to the guidance:
“Assessment factors are numerical values. They are used to address the differences between the experimental data and the human situation, taking into account the uncertainties in the extrapolation procedure and in the available data set.”
Also,

“Several aspects are involved in the extrapolation of experimental data to the human situation, inter alia, from the variability in the experimental data and from intra- and inter- species variation, the nature and severity of the effect, and the sensitivity of the human (sub-
)population (REACH Annex I, Section 1.4.1).”

Melamine is acknowledged to be a threshold toxicant. That is, below certain dose levels it is unlikely to cause an adverse effect. The toxicological basis for the existence of a practical threshold for melamine urinary tract toxicity and carcinogenicity is well established and has been confirmed by RAC:

“Melamine is not genotoxic. Precipitation of melamine within the urine is responsible of
calculi and subsequent tumour formation..
.. RAC notes the existence of a secondary mode of action, with the implication of a practical threshold above a certain dose level for calculi formation and chronic stimulation of cell proliferation.” (RAC 2020)7
It is acknowledged that it is difficult or impossible to establish a precise quantitative safe limit for threshold toxicants based only on data from animal assays, however it is standard practice in toxicological hazard assessment to derive health-based limits for human and environmental health based on the application of ‘uncertainty’ factors. In this way, safe limits for melamine – an acknowledged threshold toxicant - are calculated and expressed as Derived No `effect Levels (DNELs) and Predicted No Effect Concentrations (PNECs) in the REACH registration dossier.
Similarly, as has been pointed out previously, safe limits for melamine – expressed as Tolerable Daily Intakes (TDIs) - have also been derived by the World Health Organisation and the European Food Safety Authority (EFSA). These safe limits are calculated so as to encompass all possible exposures groups, including specifically sensitive or vulnerable populations such as infants. Thus, the derived safe levels are sufficiently protective.

Due consideration is also given to the possibility of co-exposure to Cyanuric acid .
The DNELs and TDIs for melamine were calculated without consideration of mixture toxicity to cyanuric acid as "the potential of melamine to form crystals is increased by concomitant exposure to cyanuric acid, and therefore the TDI is not appropriate for protection of consumer health in the presence of such concomitant exposure."
Further, Drinking Water Standards have been developed in Germany and the Netherlands based on the same hazard assessment process using Assessment Factors. In the Netherlands, safe limits were derived to account for the possibility of co-exposure to cyanuric acid, using the standard Assessment Factor approach (350 µg/L for melamine if cyanuric acid is also present at greater than 10 µg/L, 35 µg/L when cyanuric acid is also present at greater than 10µg/L). The validity of this derivation was not scientifically challenged.

In Germany (German Drinking Water Ordinance (TrinkwV) 3rd amendment as at 7 March 2022) has set the restriction limit for melamine in tap water of 125 µg/l. The validity of these standards also have not been challenged. We must point out that the German values have only recently been derived and implemented in legislation. The dossier submitter cannot have been unaware of this glaring contradiction.

The concept of safe limits derived as an element of hazard assessment is critically important because it provides a quantitative indication or hazard and therefore of the concern related to potential exposure to a particular substance. These safe limits are used as a starting point in risk assessment, however as standalone values they already provide a clear indication of the level of concern posed by a particular substance.

7 https://echa.europa.eu/documents/10162/2d2ae641-e9f5-8120-d2d4-07efba0b5a0e
8 EFSA Scientific opinion; EFSA Journal 2010; 8(4):1573

In the SVHC public consultation, BVB and EMPA compared existing data from monitoring studies against the lowest drinking water standard (35 µg/L when cyanuric acid is also present) and showed that in no case were the standards ever exceeded. In most cases the levels were multiples lower than the drinking water standards indicating that there is no risk to human or environmental health from currently detected melamine levels in European drinking water sources. These comparisons were ignored because, in the DS view they constitute an exposure assessment.
However, regarding the acceptance of exposure data during the SVHC identification process via Article 57(f), we refer to the case of 1,4 dioxane, which was added to Candidate list in July 2021 with a scope of 57(f) Environment & Human Health. The introduction of Exposure-based argumentation against ELOC was rejected on the following basis:

‘it is the consistent case-law of the EU Courts that the identification of SVHC on the basis of Article 57(f) of REACH does not necessarily need to take into account information other than information on hazards arising from the intrinsic properties of a substance. In other words, it is a possibility, but not an obligation.’9
In BVB and EMPA’s view the refusal of the DS to express this possibility in the face of a clear demonstration of effective safe levels means the assessment was performed in bad faith.

On the basis of this simple comparison of existing facts it is entirely obvious that melamine does not pose an ‘Equivalent Level of Concern (ELOC)’ according to Article 57(f), which speaks of ‘scientific evidence’. Scientific evidence cannot be selective – it must include all considerations related to a particular hypothesis.

3.2 Melamine is not an Endocrine Disrupting Chemical

The SVHC support document references in several places the ongoing assessment of Melamine’s Endocrine Disrupting potential, which was used to add plausibility to the claim of ‘yet unknown effects’ in the environment.

The melamine REACH dossier (update October 2023) contains a comprehensive assessment of endocrine potential, performed in accordance with the ECHA/EFSA guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009 (ECHA/EFSA 2018). The potential for Estrogenic, Androgenic, Thyroid and Steroid (EATS) modulation potential was assessed against all available relevant data, including in vivo studies. While some data gaps were identified, it was concluded that there was no convincing evidence to support EATS- mediated endocrine activity. In particular, thyroid effects were ruled out, while there was no evidence for EAS receptor binding or transactivation. The effects on testes and sperm parameters observed in the EOGRTS study were deemed to be without an endocrine pattern of effects.

9 case T-636/17 the General Court

BVB and EMPA also refer to development of the ANSES assessment, which was published as a Risk Management Option Analysis (RMOA) on the 11th August 2023. After a comprehensive analysis incorporating all lines of evidence and potential modalities, ANSES concluded that melamine is not considered to have endocrine disruption properties with regards to environmental (non-mammalian) species. ANSES also concluded that the observed speramtologic effects seen in male animals during the Extended One Generation Reproductive Toxicty study (EOGRTS) was not endocrine-mediated and that ‘melamine is not considered to have endocrine disrupting properties based on these effects’.
Questions remained regarding the possibility of thyroid effects based on the lack of available data. Nevertheless, the suggestion that melamine poses an endocrine hazard has been largely debunked and therefore the contentious suggestion of ‘yet unknown effects’ based on a suspicion of endocrine action must be firmly disregarded.

3.3 Melamine is not a PBT substance

The scoring guidance clearly states that the PBT scoring is only applicable if the substance is
“associated with concerns similar to PBT/vPvB substances”.

Despite any argumentation on the P/vP property – it is clear that melamine is not bioaccumulative and therefor neither an PBT or even vPvB substance. If there is an argument for an Art. 57 (f) ELOC based on PMT however, a clear connection to PBT/vPvB must be established according to the guidance provided by ECHA to justify the scoring.
While PMT/vPvM substance are suspected to accumulate in drinking water resources, PBT/vPvB chemicals accumulate in food chains and humans. In detail the question arises from Mobility and Persistence properties. Only because two fundamentally different properties are argued to cause an overall “equivalent level of concern” their equal treatment in scoring is not necessarily justified.

On the contrary, the legislator has explicitly regulated only substances with bioaccumulative potential and not mobile substances. It is therefore clear that the scoring simply lacks the legal foundation. It is not within the competence of the authority to make an excessive assessment if the underlying regulation (REACH) clearly regulates the facts of the case. In this special case the list of properties under Art. 58 is to be seen as clearly exhaustive. The latest motion to add PMT as standalone hazard category to Art. 57 further underlines this interpretation.

It is acknowledged that melamine is evaluated as persistent in laboratory screening tests and thus the P and vP criteria are met in this basis.

However there are other factors that must be considered when applying these findings to the environment. As has been amply demonstrated, melamine is actively biodegraded in the environment by microorganisms, evidenced by high degradation rates observed in adapted Wastewater Treatment Plants (WWTP), adapted environmental systems, and soils. The species of

10 https://www.consultations-publiques.developpement-durable.gouv.fr/IMG/docx/ec_203-615- 4_melamine_dgpr.docx

microorganisms that facilitate this biodegradation have been identified (Tolleson et al. 2009, Takagi et al 2011, Hatakeyama et al 2016, Hatakeyama and Takagi 2016).
It is also acknowledged that melamine meets the T criterion based on it’s notified reproductive
toxicity effects in male rats by the substance registrants.

Regarding bioaccumulation, melamine’s Log Kow is less than/equal 4.5, with a calculated bioconcentration factor (BCF) of greater than= 2,0000 and 5,000 L/kg, meaning it does not meet the screening criterion for bioaccumulation (B).

The MSC support document concludes that ‘melamine is assessed as being not bioaccumulative in aquatic organisms’. On terrestrial bioaccumulation, it was claimed that no conclusion can be drawn, but this contradicted by the ample empirical data to show that melamine undergoes rapid renal clearance, unchanged, in multiple mammalian species, and humans (ECHA RAC 2020)11. An estimated half-life of approximately 6 hours was derived for urinary melamine elimination in humans. This conclusion is supported by EFSA (2010) and ECHA RAC (2020) who reviewed multiple kinetic studies performed in rats, monkeys, pigs, cows, sheep and humans, all demonstrating that melamine undergoes rapid renal clearance, unchanged, in mammalian species.

On this basis, melamine can never be considered as meeting the PBT criteria because does not have the empirical capacity to bioaccumulate. By corollary, it cannot pose an ‘equivalent level of concern’ to other PBT substances.

3.4 Melamine’s potential for Mobility has been misrepresented

The MSC support document bases its conclusions on mobility through a combination of the substance intrinsic properties persistency, mobility and potential for being transported in the water phase over long distances. In the MSC’s view, this presents a potential to cause an irreversible presence in the aquatic environment, together with a widespread contamination of the aquatic environment.
The MSC support document used primarily modelling and monitoring data to support these conclusions, however the reliability of these data were overstated, as discussed below. In any case, the Public Consultees were denied the opportunity to challenge the false assumptions. Further, it must be acknowledged that Mobility is currently not a prescribed REACH endpoint. Although mobility is recognised as an endpoint within the new CLP hazard classes, updated guidance on the application of CLP criteria for mobility have yet to be published.

Melamine is a soluble, weak base and an ionisable substance. Suggestions that it is highly mobile in
the environment, threatening remote ‘pristine’ areas, are not supported by empirical data. Field data confirm that it is largely retained in soils and sediments, while data from adapted sewage treatment plants, provided in the public consultation responses, show significant biodegradation.

11 https://echa.europa.eu/documents/10162/bfeec668-edf2-d959-3af9-861020103a4d

BVB points to new data that has become available since the MSC decision, including field measurements, while reiterating that the models used were inappropriately applied, leading to a distorted assessment. It is BVB’s contention that melamine is not as mobile as indicated in the SVHC assessment, based on the following observations.

3.4.1 Log KOC is an inappropriate metric of melamine’s mobility

The REACH dossier for melamine was updated in October 2023 to include new data on adsorption/desorption. Two key studies were provided, summarised in Table 1.

The purpose a Log Koc assessment is to determine the potential for a substance to adsorb to organic matter in various soil types, which is considered a surrogate indicator of soil mobility.
While the range of log Koc values for melamine suggests a medium-low potential for adsorption to organic content, the use of log Koc alone as an indicator of mobility is subject to limitations. Apart from its poor applicability to soils with low organic carbon content, it does not describe the behaviour of very polar or ionisable substances such as melamine. It also does not account for long- term sorption increase (aged sorption) or non-linear (Freundlich) type sorption behaviours (ECETOC 2021). The Koc, while useful as a screening criterion, is overly simplistic and does not consider these complex sorption behaviours that chemicals can undergo in soils and sediments nor the hydraulic conditions in river-banks, where water transits over multiple years.
Further, it is apparent that the adsorption potential of melamine is primarily drive by pH, not organic carbon content. The key study of Deneer et al (2003) acknowledges this by stating that

“For each of the test compounds the organic carbon partition coefficient (Koc) was calculated for each of the soils. As was expected, values of Koc clearly differed between the
soils, indicating that the Koc concept is not valid for the compounds under consideration.”

Table 1: Key OECD TG 106 Adsorption / Desorption. Studies quoted in updates melamine REACH dossier (October 2023)

Soil type %OC Soil pH KF (L/kg) KF OC (L/kg) 1/n Log KF OC
Horst loamy sand 1 1.3 5.9 5.5 423 0.8 2.6
Westmaas loam 1 1.5 7.5 1.45 97 0.8 2.0

12 ECETOC TR 139 (2021) https://www.ecetoc.org/wp-content/uploads/2021/10/ECETOC-TR-139-Persistent- chemicals-and-water-resources-protection-2.pdf

Naaldwijk loamy sand 1 1.8 6.8 2.77 154 0.83 2.2
Borstel loamy sand 2 1.5 4.2 5.57 371 0.715 2.6

References:
1. Deneer et al (2003) Adsorption/desorption of cyromazine and melamine to/from three soils (OECD 106)
2 Jonas (2001) Adsorption/Desorption of [14C]-CGA 235129 (OECD 106)
A modelled estimate of log Dow for melamine as a function of pH using Chemaxon, Marvionsketch version 20.1 shows that a pHs lower than 6.5 melamine predominantly exists in ionised form, thus suggesting a greater tendency for adsorption (Figure 1). The higher sorption at low pH may be explained by the affinity for ionised molecules in soils with a higher cation exchange capacity.

Wang et al. (2014) demonstrated high variability of the log Koc for melamine depending on the type of soil and also on the pH of the soil. At low pH the cationic ionized melamine strongly couples to anionic acids like humic acids. Therefore, melamine’s mobility in soil has been shown to be dependent on pH, with melamine being largely retained in acidic soils.
The environmental relevance of pH-dependence must also be considered. The standard environmental conditions used by ECHA do not correlate with reality particularly regarding soil pH.
The European Soil Data Research Centre (ESDAC), part of the EU Commission’s Joint Research Centre (JRC) has produced as quantitative map of estimates soil pH types from a compilation of over 12,000 soil pH measurements (Figure 2)

In view that the Log Koc values for melamine suggest a ‘false positive’ due to the strong correlation with pH vs OC, more robust empirical evidence should be used to confirm that melamine is not as mobile as Log Koc values suggest.

13 https://esdac.jrc.ec.europa.eu/content/soil-ph-europe

3.4.2 Field studies on Cyromazine, where melamine was also measured, indicate a limited mobility in soils.

Cyromazine is an approved biocidal active substance on the EU market (PT 18, BAS number 1334). Melamine is the major degradation product of cyromazine.

Laboratory and field studies on cyromazine, conducted with a variety of soils indicate that:
• Melamine is the major degradation product found in the soils.
• Cyromazine half lives (DT50) varied widely, ranging from 2.9 to 107 days14
• Significant cyromazine conversion to melamine in soils
• Cyromazine and melamine residues typically not found in deeper soil layers15

During the SVHC identification phase, a published study on cyromazine (Pote 1994) was referenced as empirical evidence against melamine mobility. The validity of this study was challenged on the basis that it was not conducted according to test guidelines, and that the Limit of Quantitation (LoQ) used for melamine was not sensitive enough. However, detailed calculations (Annex 1) show that these data are more than sufficient to demonstrate a lack of significant soil mobility.

This is empirical evidence, subjected to expert evaluation, that contributes to the weight of evidence that melamine has a low mobility in soil.
Further, these findings of Pote are supported by the results of other, unpublished, field studies on cyromazine that typically found 1) high conversion rates of cyromazine to melamine in various soil types under differing conditions, 2) that cyromazine was rarely found below depths of 30cm after 1 year, and 3) Melamine was always found at greater depths but never more than 100cm after 2/3 years (FAO 2007, ECHA 2016)

14 https://echa.europa.eu/documents/10162/5c6b6b81-3f4d-dfc7-1b1d-fdd8dd8af773
15 Report of the Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Core Assessment Group on Pesticide Residues Geneva, Switzerland, 18-27 September 2007 https://www.fao.org/3/a1556e/a1556e.pdf

Efforts are currently being made to access the original field studies (April 2024).

3.4.3 Monitoring data do not support the view that melamine is a widespread contaminant of water systems

A key source of monitoring data used in the SVHC support document is the NORMAN EMPODAT database16. In the SVHC RCOM responses, the Dossier Submitter references this database to state:

‘..melamine is detected above LOQ in 958 cases and in 267 below LOQ in 10 countries, including Bulgaria, Croatia, Czech Republic, Germany, Hungary, Netherland, Ukraine, Romania, Serbia, and Slovakia’

The NORMAN network claims it is concerned with QA/QC issues, interlaboratory validation etc. and have published guidelines17. However, it is clear that these guidelines have not been followed by some of the data uploaded for melamine.
In particular, it should be noted that most of the data related to 'widespread contamination' i.e. the data for countries other than Germany and Netherlands come from 2 sources, one of which is University of Athens, and the other is unidentified.

These results were from single 'grab' samples and indeed have no statistical value. In the RCOM responses, the Dossier Submitter disallowed the introduction of more comprehensive and recent monitoring data on the basis that it did not have sufficient statistical power. However, the Dossier Submitter still felt it appropriate to erroneously use single detected samples as evidence to support the claim of widespread distribution. This is a case of double standards and false bias.
Also, the complaint that data are biased towards surface waters is hard to justify, as the purpose of the database is to collect voluntary submissions, and it just happens that most of these were surface water samples. It is not a strategic sampling / monitoring project, just a collection of data.

In any case the clear bias is towards measurements in 2 countries – most data are from Germany and The Netherlands – and 4 rivers, with most data available from the Rhine and the Maas/Meuse.

16 https://www.norman-network.com/nds/empodat/
17 https://www.norman-network.com/?q=node/25

It is important to state that available spot samples may indicate melamine presence but do not provide evidence for mobility per se.

A study by Neuwald et al (2022) looked at the distribution of PMT substances in surface waters, groundwaters and bank filtrates. Although the data are limited, they indicate that melamine is effectively removed by bank filtration. These data were brushed over in the final publication, where statistical methods were dishonestly used to artificially inflate the measured melamine concentrations.

Although melamine is sometimes detected in large rivers, it has rarely been detected in wells using riverbank filtrates (Neuwald et al, 2022; Lütjens et al., 2023). Neuwald et al. (2022) reported that, for melamine, median concentrations in bank filtrate were at least one order of magnitude lower than in surface water, but the differences between both sample sets were not shown to be statistically significant. Nevertheless, this indicates the potential for river-bank filtration and of soil adsorption.

3.4.4 The LRTP tool was used inappropriately

The Dossier Submitter used the OECD Long Range Transport Potential (LRTP) tool and unrealistic input parameters resulting in a LRET value of more than 3000 km. According to the documentation of the LRTP tool, is not suited for ionisable substances, and should only be used as a ‘decision support’ tool. The DS used the outputs uncritically as the basis to ‘prove’ that melamine is subject to long range transport. However, in the public consultation, BVB and EMPA clearly showed that the output of the tool was dependent on a single key input.

In any case, the OECD have recently published a review of the LRTP tool 15 years after its release. The limitations of the tool are clearly re-stated. In particular, that it is not suited to the assessment of ionising substances such as melamine, and that hazard assessment with the tool is only meaningful for specific substance classes, and that the use of screening level data lead to a high degree of uncertainty (OECD 2023).

3.4.5 Melamine can be effectively removed from water using activated carbon filters, even under alkaline conditions.

Recent studies on the removal potential of melamine using activated carbon filters indicates

moderate to good adsorptive removal of melamine in batch tests (Hynes et al., 2020; Schumann et al., 2023).
It is likely that adsorption accounts for a major part of the elimination. A surprisingly high adsorption potential of melamine alkaline solutions was reported despite its high polarity was recently attributed to the capability of the unprotonated melamine species to not only bond to the activated carbon surface but also to interconnect with neighbouring melamine molecules via hydrogen bonding (Hynes et al., 2020).

This is further proof that melamine can be effectively removed from water by absorptive processes

4 Conclusions

The draft background document for melamine (7th February 20924) applies a score of 13 to the intrinsic properties of melamine. However no justification or explanation is provided for selecting this score. It is therefore assumed that the default selection has been derived from the Prioritisation Approach document update from 5th March 202018.

However, BVB points out that the default selection is incorrect and that the intrinsic property score for melamine should be 1, and not 13. The basis for this conclusion is that:

1. Melamine does not meet the criteria for identification as Carcinogenic, Mutagenic or Reprotoxic according to the provisions of REACH Article 57 (a-c).

2. Melamine does not meet the criteria for identification as a PBT or vPvB substance according to the provisions of REACH Article 59 (d, e).

3. Melamine’s identification as a substance of very high concern (SVHC) has been based on Article 57(f). Melamine is not an endocrine disruptor and it is also not a PBT or vPvB substance, essentially because melamine is not bioaccumulative. A clear connection to PBT/vPvB substances has not been established as required by the scoring guidance.
It can therefore only be concluded that melamine, in accordance with the approach laid out in the scoring guidance, attracts a score of 1 for intrinsic/inherent properties.

18 https://echa.europa.eu/documents/10162/133a6f7e-616b-f321-174c-bab66b25ea34

5 References:

Arp, H.P and Hale, S.E. (2019). REACH: Improvement of guidance and methods for the
identification and assessment of PMT/vPvM substances. Final Report on behalf of the German Environment Agency (Umweltbundesamt,
UBA) https://www.umweltbundesamt.de/sites/default/files/medien/1410/publikationen/
2019-11-29_texte_126-2019_reach-pmt.pdf

Broneder (2022) Melamine in The Environment. A report prepared for European Melamine
Producers Association (EMPA) a sector group of CEFIC, 02 February 2022 (The ‘Ramboll Study’).
ECETOC (2021). Persistent chemicals and water resources protection. ECETOC Technical Report No. 139
https://www.ecetoc.org/wp-content/uploads/2021/10/ECETOC-TR-139-Persistent-chemicals-and-

ECHA (2016) Cyromazine: Assessment Report Evaluation of active substances Product-type 18; Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products
https://echa.europa.eu/documents/10162/5c6b6b81-3f4d-dfc7-1b1d-fdd8dd8af773

ECHA RAC (2020) Committee for Risk Assessment: RAC Opinion proposing harmonised classification and labelling at EU level of Melamine EC Number: 203-615-4 CAS Number: 108-78-1 Adopted 10 December 2020 https://echa.europa.eu/documents/10162/bfeec668-edf2-d959-3af9- 861020103a4d
ECHA RAC (2020). Opinion proposing harmonised classification and labelling at EU level of Melamine. Background document https://echa.europa.eu/documents/10162/bfeec668-edf2- d959-3af9-861020103a4d

EFSA (2010) Scientific Opinion on Melamine in Food and Feed. European Food Safety Authority (EFSA)
https://www.efsa.europa.eu/en/efsajournal/pub/1573

ECHA/EFSA (2018) European Chemical Agency (ECHA) and European Food Safety Authority (EFSA) with the technical support of the Joint Research Centre (JRC) et al. “Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC)
No 1107/2009.” EFSA journal. European Food Safety Authority vol. 16,6 e05311. 7 Jun. 2018, doi:10.2903/j.efsa.2018.5311
FAO (2007) Report of the Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Core Assessment Group on Pesticide Residues Geneva,
Switzerland, 18-27 September 2007 https://www.fao.org/3/a1556e/a1556e.pdf Cyromazine Pages 98-112

Hai-Yan Wang, Hui Wand, Ling-Li Tang, Yuan-Hua Dong, Ling Zhao, and Gurpal Toor
(2014b). Sorption characteristics of cyromazine and its metabolite melamine in typical agricultural soils of China. Environ Sci Pollut Res, 2014, 21: 979-985.
Hatakeyama T, Takagi K, Ito K. (2016) Biodegradation of cyromazine by melamine-degrading bacteria. J Pestic Sci. 2016 Feb 20;41(1):20-24. doi: 10.1584/jpestics.D15-044. PMID: 30364893; PMCID: PMC6200052.
Hatakeyama T, Takagi K. (2016) Bacterial biodegradation of melamine-contaminated aged soil: influence of different pre-culture media or addition of activation material. Environ Sci Pollut Res Int. 2016 Aug;23(15):14997-5002. doi: 10.1007/s11356-016-6616-2. Epub 2016 Apr 15. PMID: 27080407.
Hynes L, Montiel G, Jones A, Riel D, Abdulaziz M, Viva F et al. (2020). Melamine adsorption on carbon materials: impact of carbon texture and surface chemistry. Mater. Adv.
2020;1(2):262–70.
Lütjens, L. H., Pawlowski, S., Silvani, M., Blumenstein, U. and Richter, I. (2023). Melamine in the environment: a critical review of available information. Environmental Sciences Europe (2023) 35:2.
Neuwald, I. J., Huebner, D., Wiegand, H. L., Valkov, V., Borchers, U., Noedler, K., Scheurer, M., Hale, S. E., Arp, H. and Zahn, D. (2022). Occurrence, Distribution, and Environmental Behavior of Persistent, Mobile, and Toxic (PMT) and Very Persistent and Very Mobile (vPvM) Substances in the Sources of German Drinking Water. Environmental Science & Technology. 56(15), 10857-10867.
OECD (2023) Review of the OECD POV and LRTP Screening Tool 15 years after its release. ENV/CBC/MONO(2023)36
https://one.oecd.org/document/ENV/CBC/MONO(2023)36/en/pdf

Pote, D. H.; Daniel, T. C.; Edwards, D. R.; Mattice, J. D.; Wickliff, D. B. (1994). Effect of drying and rainfall intensity on cyromazine loss from surface-applied caged-layer manure. Journal of Environmental Quality (1994), 23(1), 101-4.
Schumann P, Müller D, Eckardt P, Muschket M, Dittmann D, Rabe L, Kerst K, Lerch A, Reemtsma T, Jekel M, Ruhl AS (2023). Pilot-scale removal of persistent and mobile organic substances in granular activated carbon filters and experimental predictability at lab-scale. Sci Total Environ. 2023 Aug 1;884:163738. doi: 10.1016/j.scitotenv.2023.163738. Epub 2023 Apr 27. PMID: 37116805.
Takagi K, Fujii K, Yamazaki K, Harada N, Iwasaki A. Biodegradation of melamine and its hydroxy derivatives by a bacterial consortium containing a novel Nocardioides species. Appl Microbiol Biotechnol. 2012 Jun;94(6):1647-56. doi: 10.1007/s00253-011-3673-9. Epub 2011 Nov 22. PMID: 22105542.

Tolleson WH, Diachenko GW, Folmer D, Doell D, Heller D. 2009. Background paper on the
chemistry of melamine alone and in combination with related compounds. Prepared for the WHO expert meeting on toxicological and health aspects of melamine and cyanuric acid. In collaboration with FAO, supported by Health Canada. Health Canada, Ottawa, Canada. 1–4 December 2008.
Wang HY, Wang H, Tang LL, Dong YH, Zhao L, Toor G. (2014) Sorption characteristics of cyromazine and its metabolite melamine in typical agricultural soils of China. Environ Sci Pollut Res Int. 2014 Jan;21(2):979-85. doi: 10.1007/s11356-013-1956-7.

6 Annex 1: Assessment of the Pote (1994) study for its relevance in determining the mobility of melamine in soils

The Pote publication describes two experiments.
The experiment of interest used caged hen manure which was spread on test plots of 9m2. This manure was confirmed analytically to contain cyromazine at levels of 633 ug/L. It is well known that cyromazine quickly breaks down in the environment and that melamine is the major resulting metabolite. Based on the data provided in the published report, it is possible to derive information that adds value to Weight of Evidence assessment. This includes calculations that show the sufficiency of the LoQ, which Germany states is too low.

Manure was spread on test plots (soild with organic matter 1.9%) at a concentration of up 17.7 Megagrams / hectare (1 megagram = 1000kg = 1 metric tonne).
For the purpose of the lysimeter measurements, two test plots: a control with no manure, and the
17.7 metric tonnes / ha plots were used. This equates to 148 m3 / hectare by wet weight (the manure was 88% water by weight). This equates to 14.8 litres of manure per m2. As each plot was 9m2, the calculated starting point is that the plot contained 133.2 litres of manure at a concentration of 633g/L cyromazine = approx 84,000 g cyromazine per plot

As a first experimental step, the plots were exposed to artificial rain to simulate worst case conditions, as a way to measure run-off, and as such therefore to measure cyromazine loss in such run-off. 23% of the cyromazine was lost in runoff. Thus, after the runoff phase, approximately 64,000
ug of cyromazine would remain on the plot.

The plots were then uncovered and left exposed to normal rainfall for a period of one year. Lysimeter pans were installed at a depth of 60cm and the collected soil leachate was analysed every week for one year (and not just at the end of the experiment as claimed in Paragraph 17).

Notable from the Pote report is the detection of nitrate movement (in a parallel study) which showed that some manure constituents reached the lysimeter pans after 30 days, indicating good soil penetration.
Cyromazine conversion to melamine in soil is up to 73% after 28 days, but we use a more conservative figure of 50% over 1 year and considering a mol conversion of 126 melamine /166.19 cyromazine = 76%. 64,000 ug x 50% x 76% = 24,000 ug melamine would be the maximum amount of melamine left in the soil. Some of this melamine would itself undergo biodegradation, but as the SVHC process identified melamine as being very persistent and very mobile, it would be anticipated that at least some of this melamine would penetrate through to the lysimeter pans and be detected at levels far above the 5ug/L LoQ.

If 24,000 ug of melamine remained in the soil as calculated, it would require dilution by 4,800 litres of (rain) water (the Vmax). This equates to 20.98 inches of rain falling in the 9m2 plot. In 1991 the average rainfall at the location of the test (Fayetteville, Arkansas) was 43.55 inches.

As the solubility of melamine is very high (3g or 300,000 ug/ litre), it is an obvious and realistic expectation that at least some of the 52 weekly measurements should have detected melamine in the lysimeter pans. However, no cyromazine or melamine were detected, indicating that they were retained in the soil above a depth of 60cm after one year.

			
5132
2024/05/06	ANFTA,
Industry or trade association,
Portugal		
		5132_ANFTA PT_ECHA Public Consultation MELAMINE.pdf	
5133
2024/05/06	MBDA France,
Company,
France		
		
Confidential attachment removed	
5134
2024/05/06	Aerospace Industries Association,
Industry or trade association,
United States of America	We understand that REACH registrations are the main source of information for ECHA's assessment.  However, uses in the aerospace and defense (A&D) sector are typically small and may not be fully reflected in registration dossiers.  This can be especially true of imports of specialty formulations where the tonnage may fall well below registration thresholds, but that provide critical functionality needed by our industry and its products.
AIA member companies rely on melamine as a flame retardant and additive in products and formulations for the manufacture, maintenance and repair of aerospace products.  Identified aerospace uses include the following uses
• Potting compound
• Adhesive
• Intumescent coating
• Low friction coating
• Dry film solder mask
• Anti-corrosion compound

	
			
5135
2024/05/06	KRONOSPAN SAS,
Company,
France	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.	
			
5136
2024/05/06	KRONOSPAN SAS,
Company,
France	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.	
			
5139
2024/05/06	KRONOSPAN SAS,
Company,
France	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.	
			
5142
2024/05/07	SIA "KRONOSPAN Riga",
Company,
Latvia	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.	
			
5143
2024/05/07	Kronospan Mielec Sp. z o.o.,
Company,
Poland	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.	
			
5144
2024/05/07	Kronospan KO Sp. z o.o.,
Company,
Poland	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.	
			
5147
2024/05/07	AZOMURES S.A.,
Company,
Romania	Azomures support the EMPA statement "Melamine Recommendation for inclusion in the Authorization List":
document 1. Prioritization and general Issues, dated 5th of May 2024
document 2. Inherently Properties, dated 5th of May 2024.
	
		5147_Melamine.zip	
5148
2024/05/07	Kronospan HPL Sp. z o. o.,
Company,
Poland	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.	
			
5149
2024/05/07	Kronospan S.L.,
Company,
Spain	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.	
			
5150
2024/05/07	Kronospan Chemicals, S.L.,
Company,
Spain	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company	
			
5153
2024/05/07	European Aerospace, Security and Defence Industries Association (ASD),
Industry or trade association,
Belgium	ASD members have indicated the use of Melamine in a number of mixtures and formulations including resin, adhesive, fire protection, insulation foam, intumescent coatings and moulding compounds. Where melamine is used in the hardener of epoxy-based resins, adhesives or coatings, only traces are expected to remain in the final product after curing.
These melamine uses are considered as niche applications in industrial settings, and the risk of release or human exposure is very low, or non-existent.	
			
5154
2024/05/07	Kronospan GmbH,
Company,
Germany	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.	
			
5155
2024/05/07	European Panel Federation,
Industry or trade association,
Belgium		
		5155_LF_ECHA_1.1.11.2024.0160.0188.pdf
Confidential attachment removed	
5156
2024/05/07	Health and Environment Alliance (HEAL),
International NGO,
Belgium	HEAL strongly supports the inclusion of melamine in the Authorisation List of REACH since it is a substance recognised as being toxic for human health and the environment. Melamine is recognised as a substance being persistent which does not readily biodegrade, and it is very mobile creating a potential for widespread contamination of the water environment. Moreover, uses in food contact materials is identified as one of the most significant sources of human exposure to melamine. As regard human health effects melamine is classified under CLP as STOT RE 2 and Carcinogenic category 2 due to its urinary tract toxicity and it is also classified as reprotoxic category 2 given the testicular and sperm effects identified in experimental animals. We stress that, in general, no uses of substances should be exempted from the authorisation requirement when the substances are included in the Authorisation list. The authorisation process, not the Annex XIV listing, is the appropriate venue for discussion of social benefits and the presence or lack of suitable alternatives.

Melamine is a high-volume substance (registered at 100,000-1,000,000 tonnes/annum), which is used in a multitude of different industrial and consumer products. Melamine is used in products including building materials (flooring walls, plywood, adhesives, paints, coatings, flame retardants etc), textiles, fertilisers, cosmetics, personal care products, stain and water-resistant clothing, detergents, fragrances, electrical and household appliances, and plastic products including reusable plastic tableware and toys. Due to the many uses on the market and its persistence in the environment, exposure to workers, the general public, and wildlife is of high concern (ECHA, last accessed 30/04/2024).

Melamine was added to the Candidate List for authorisation on 17 January 2023 after it was identified as a substance meeting the criteria of Article 57(f) of Regulation (EC) 1907/2006 as it is a substance for which there is scientific evidence of probable serious effects to the environment and human health which give rise to an equivalent level of concern to those of other substances listed in points (a) to (e) of Article 57 of REACH.

The toxicity for the human health and the environment of melamine is not disputed. As underlined by the Annex XV dossier and independent studies, melamine is not readily biodegradable in the environment and therefore fulfils P and vP criteria of REACH Annex XIII. It is also very mobile with a predicted characteristic travel distance (CTD) of 3530 km. Both the persistent and mobile properties of melamine indicates that there is a potential for widespread contamination of the water environment, and it is not possible to derive a safe concentration limit for the environment by the means of standardised acute and chronic ecotoxicological tests and the assessment criteria investigated within (German Competent Authorities, 2022). As regard human health effects melamine is classified under CLP as STOT RE 2 and Carcinogenic category 2 due to its urinary tract toxicity. The Annex XVI also reports testicular and sperm effects of melamine identified in experimental animals are of concern which warrants self-classification in Repr. category 2 (H361f).

The inclusion of melamine in the authorisation list is therefore urgent to respond to the serious human and environmental health. Due its use in a broad range of application, including wide-dispersive uses and uses in articles, no uses of melamine should be exempted from the authorisation requirement as in order to reduce the use of SVHC in Europe, exemptions and derogations should be used only where there are truly no alternatives. We note that it is the authorisation process—and not the use of exemptions in the Annex XIV entry—that is the proper mechanism for establishing the socioeconomic need for an SVHC and the presence or absence of suitable alternatives. Given the widespread use and the health and environment concerns at stake, HEAL calls on ECHA to maintain the fastest possible timeline in each case.	
		5156_HEAL_contribution_PC_AnnexXIV_incl_Melamine.pdf	
5157
2024/05/07	Kronospan Chemical Szczecinek,
Company,
Poland	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.	
			
5158
2024/05/07	Federlegnoarredo,
Industry or trade association,
Italy	FederlegnoArredo (Italian federation of furniture and woodworking industries) considers the assigned score for melamine too high. Below or comments on that.
In the "Draft background document for melamine", formulated within the framework of ECHA’s twelfth recommendation for the inclusion of substances in Annex XIV, melamine was assigned a total score of 40.
The score should be lowered in each of the three components that contribute to determining it:
1) Inherently properties: we point out that the default selection is incorrect and that the intrinsic properties score for melamine should be lower than the one proposed. As we have already stated in the public consultation on SVHC identification, we don’t agree that melamine presents an Equivalent Level of Concern to Human Health or the Environment. In particular, the inclusion approach based on PMT (Persistent in the environment, Mobile in the environment, Toxic) criteria is not sufficiently supported by scientific evidence in two out of three of the criteria: persistence and mobility.
2) Volume: starting from the assumption that the use of melamine as an intermediate is exempt from authorisation process, the only non-intermediate use of the same, identified and reported by the melamine REACH consortium, is related to only two uses: “flame retardant in flexible polyurethane foam” and “use in intumescent applications”. All other uses reported in the “Draft background document for melamine” refer to uses of melamine-based resins and not to melamine itself. For all these reasons (the sum of the tons of uses in the above applications (approximately 7,500 tons) and the score assigned to Article service life (in relation to wide dispersiveness of uses)) the overall score for volume is wrong and should be lowered.
3) Wide dispersiveness of uses: if we consider that the dispersive use of melamine could only occur in professional use in intumescent applications and that such use represents approximately 50% of the total use for this application, the score should be lowered compared to what was proposed.
Therefore, considering the above, in our opinion the overall score should be lowered, leading to the unnecessary inclusion of melamine in the list of substances subject to authorisation.

5159
2024/05/07	Melamine REACH Consortium,
Other contributor,
Belgium	The Melamine REACH Consortium supports and had collaborated with the EMPA and others submission to the ECHA public consultation of Recommendation for Inclusion in the Authorisation List for melamine substance.

The "Draft background document for melamine,"  dated February 7th, 2024, was formulated within the framework of ECHA’s twelfth recommendation for the inclusion of substances in Annex XIV. In this document, melamine was assigned a total scoring of 40. However, the Melamine REACH Consortium, advocates for a revised scoring of 21. The full rationale can be found the EMPA submission of this consultation.
Inherent properties; ECHA’s score= 13; EMPA’s score=   1
Volume: ECHA’s score= 15;  EMPA’s score= 12
Wide dispersiveness of uses; ECHA’s score= 12;  EMPA’s score=   8
Total score ; ECHA’s score= 40;  EMPA’s score= 21

Inherent properties score
The Melamine REACH Consortium believes the correct inherent property score for melamine should be 1. The basis for this conclusion is the document Prioritisation of substance of very high concern (SVHC) for inclusion in the Authorisation List (Annex XIV), Prioritisation Approach, update 5/03/2020, in view of the inherent properties of melamine.
Substances designated as SVHC under Article 57(f) attract a priority score of 1, with two exceptions: endocrine disruptors, and substances with concerns similar to PBT/vPvB substances, are assessed on a case-by-case basis.
There is no convincing evidence that melamine has endocrine disrupting potential.
Further, no case has been presented in the ECHA background document to show that melamine has concerns equivalent to PBT/vPvB substances, as is required. According to the ECHA Prioritisation Approach document referred above substances identified under Article 57(f) and associated with concerns similar to PBT/vPvB substances are assessed case-by-case applying the PBT related scoring. EMPA presents the case that the comparison of melamine to PBT/vPvB substances is presumptive and not supported by the evidence, nor by law
Volume score
Within the EU27 the volume of melamine used in in 2023 for non-intermediate uses amounts to 6.7 kT (source EUROPUR) in flexible polyurethane foam production and 0.835 kT (source CEPE and German Textile and Fashion Federation) in intumescent applications. Therefore, in our view the correct score is 12.

Wide dispersiveness of uses
The scoring regarding dispersiveness of use was assessed considering the three major use types, industrial, professional and consumers with a score of 10 and an additional score of 2 due to uncertainties about releases of melamine during Article Service Life.
The score of 10 is in principle correct and reflects the professional use of melamine in intumescent applications. However, it's important to highlight that this represents the sole professional use of melamine, with an estimated annual tonnage of approximately 500 tonnes, constituting slightly over 50% of total intumescent applications. Therefore, we advocate that a score of 8 is more appropriate.
As explained in item 5 the additional score of 2 assigned for Article Service Life is incorrect, almost all listed articles are not related to articles made of melamine but articles made of melamine-based polymers. In our opinion no additional score should be given since most of the ASL do not result in pertinent releases.

5160
2024/05/07	Kronospan Italia S.r.l.,
Company,
Italy	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.	
			
5161
2024/05/07	Federchimica,
Industry or trade association,
Italy	Federchimica (Italian Federation of the chemical industry) considers the assigned score for melamine too high. Below or comments on that.
In the "Draft background document for melamine", formulated within the framework of ECHA’s twelfth recommendation for the inclusion of substances in Annex XIV, melamine was assigned a total score of 40.
The score should be lowered in each of the three components that contribute to determining it:
1) Inherently properties: we point out that the default selection is incorrect and that the intrinsic properties score for melamine should be lower than the one proposed. As we have already stated in the public consultation on SVHC identification, we don’t agree that melamine presents an Equivalent Level of Concern to Human Health or the Environment. In particular, the inclusion approach based on PMT (Persistent in the environment, Mobile in the environment, Toxic) criteria is not sufficiently supported by scientific evidence in two out of three of the criteria: persistence and mobility.
2) Volume: starting from the assumption that the use of melamine as an intermediate is exempt from authorisation process, the only non-intermediate use of the same, identified and reported by the melamine REACH consortium, is related to only two uses: “flame retardant in flexible polyurethane foam” and “use in intumescent applications”. All other uses reported in the “Draft background document for melamine” refer to uses of melamine-based resins and not to melamine itself. For all these reasons (the sum of the tons of uses in the above applications (approximately 7,500 tons) and the score assigned to Article service life (in relation to wide dispersiveness of uses)) the overall score for volume is wrong and should be lowered.
3) Wide dispersiveness of uses: if we consider that the dispersive use of melamine could only occur in professional use in intumescent applications and that such use represents approximately 50% of the total use for this application, the score should be lowered compared to what was proposed.
Therefore, considering the above, in our opinion the overall score should be lowered, leading to the unnecessary inclusion of melamine in the list of substances subject to authorisation.
For more details about the “correct” score for melamine, please refer to EMPA contribution.

5162
2024/05/07	European Semiconductor Industry Association (ESIA),
Industry or trade association,
Belgium	Please see attached document	
		5162_ESIA input to the consultation on draft recommendation for inclusion in the Authorisation List of Melamine and DTBPO.pdf	
5164
2024/05/07	Kronospan Bulgaria EOOD,
Company,
Bulgaria	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.	
			
5165
2024/05/07	Kronospan CRO d.o.o.,
Company,
Croatia	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.	
			
5166
2024/05/07	European Panel Federation,
Industry or trade association,
Belgium	The calculation of the prioritization score for melamine as conducted by ECHA, resulting in a score of 40, is based on a manifest error of assessment and severe infringements of underlying procedural requirements. While minor adjustments as regards the score attributed to melamine due to related volumes and its wide dispersive use are necessary, it is particularly the fact that ECHA failed to conduct a case-by-case assessment to demonstrate that due to the intrinsic properties of melamine it is justified to attribute a score similar to PBT/vPvB substances.
And even if ECHA would have conducted a case-by-case assessment, new and upcoming scientific evidence should have been taken into account. Against the background of the distinct differences between PBT/vPvB substances and PMT/vPvM substances a reduced score would have been justified.
Other than presumed by ECHA, the actual score for melamine is 22 and, thus, other substances should have been prioritized, while melamine should not have been selected for prioritisation.
Irrespective of this, the draft recommendation is disproportionate and therefore unlawful.	
		5166_20240507 EPF Statement ECHA Consultation Prioritisation.pdf	
5167
2024/05/07	European Melamine Producers Association (EMPA), a sector group of Cefic,
Industry or trade association,
Belgium	Recommendation for Inclusion of Melamine in the Authorisation List

Chapter Prioritisation and General Issues

EMPA Public Consultation Response Report
Executive summary

The "Draft background document for melamine,"1 dated February 7th, 2024, was formulated within the framework of ECHA’s twelfth recommendation for the inclusion of substances in Annex XIV. In this document, melamine was assigned a total scoring of 40. However, EMPA, participating in this public consultation advocates for a revised scoring of 21 and provides the rationale to support this adjustment.

Inherent properties   – ECHA’s score= 13;  EMPA’s score=   1

Volume    – ECHA’s score= 15;  EMPA’s score= 12

Wide dispersiveness of uses  – ECHA’s score= 12;  EMPA’s score=   8

Total score    – ECHA’s score= 40;  EMPA’s score= 21

The comments of this document submitted in this public consultation are referenced to the aforementioned background document.

Acknowledgement: This report was developed by the EMPA Public Consultation Working Group, a sub-group of the Melamine Steering Committee, composed of experts from various industries of the melamine value chain. The organisations below jointly submit this report with EMPA: Formacare, CEPE, PINFA, European Panel Federation, Melamine REACH Consortium, EPRA, ACEA, ECCA, ICDLI.

Inherent properties

For the Inherent Properties scoring information for prioritisation, we refer to our submission “Prioritisation – Inherent Properties”.  EMPA makes the case for score 1.

Recommendation for Inclusion of Melamine in the Authorisation List

Chapter Prioritisation - Inherent Properties

EMPA Public Consultation Response Report

Executive Summary

The European Melamine Producers Association (EMPA) makes the case that the inherent property score of melamine should be 1 and not 13 as proposed in the ECHA background document for melamine because:

Melamine is not an Endocrine Disrupting Chemical.

Melamine is not a PBT/vPvB substance, nor has a clear Equivalent Level of Concern (ELOC) to PBT substances been established.

This submission document is part of the melamine scoring assessment for priority for authorisation, it complements the document Prioritisation and General Issues of EMPA public consultation submission.

Acknowledgement: This report was developed by the EMPA Public Consultation Working Group, a sub-group of the Melamine Steering Committee, composed of experts from various industries of the melamine value chain. The organisations below jointly submit this report with EMPA: Formacare, CEPE, PINFA, European Panel Federation, Melamine REACH Consortium, EPRA, ACEA, ECCA, ICDLI.

Note: Please refer to attached zipped PDF reports for the complete consultation response.	
		5167_EMPA Response to ECHA Consultation_FINAL_07052024.zip	
5168
2024/05/07	Diakol Strazske, s.r.o.,
Company,
Slovakia	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.	
			
5169
2024/05/07	KRONOSPAN-MOFA Hungary Kft.,
Company,
Hungary	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.	
			
5170
2024/05/07	FALCO Zrt.,
Company,
Hungary	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.	
			
5171
2024/05/07	KRONOSPAN TRADING SRL,
Company,
Romania	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.	
			
5172
2024/05/07	Polish Chamber of Chemical Industry,
Industry or trade association,
Poland	General Issues:
The draft recommendation significantly overestimates the environmental and health risks associated with melamine. Research confirms that melamine does not accumulate in the environment or in organisms and is rapidly excreted by humans. Its primary use under controlled industrial conditions, where safety measures mitigate potential risks, supports this finding.
PIPC supports the conclusions from the European Melamine Producers Association (EMPA) report regarding the SVHC identification process for melamine, which states:
1. Melamine does not meet the criteria for identification as carcinogenic, mutagenic, or reprotoxic (CMR) according to REACH Article 57 (a-c).
2. Melamine does not meet the criteria for identification as a Persistent, Bioaccumulative, and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) substance according to REACH Article 59 (d, e).
3. The identification of melamine as a substance of very high concern (SVHC) under Article 57(f) is unfounded as it is neither an endocrine disruptor nor a PBT/vPvB substance, mainly because melamine is not bioaccumulative. There is no established clear connection to PBT/vPvB substances as required by the scoring guidance, leading to a score of 1 for intrinsic/inherent properties.

Additional Regulatory Assessments:
Melamine has been assessed through various EU regulatory processes to ensure that risks associated with its use are adequately controlled. These include:
• Food Contact: Authorized under Regulation 10/2011/EU as a monomer in food contact recycled plastic materials and articles (FCM).
• Biocidal Products: Produced as a metabolite of Cyromazine, authorized in 2023 for product type PT18 in the EU, with assessments showing no significant risk to humans, animals, or the environment.
• Drinking Water: Included in the European positive lists for substances authorized for use in materials that come into contact with water intended for human consumption, according to the Commission Implementing Decision (EU) of January 23, 2024.
Environmental Trace of Melamine:
We would like to pointed out that, emission of melamine from melamine production sites and industrial sites using melamine cannot be accounted for the levels of melamine found in the environment. Melamine manufacturers and Downstream Users of melamine have implemented operational conditions to limit environmental emissions and worker exposures during manufacturing and handling. It is also important to mentioned that melamine is used only in industrial process where the risk management capacity is very high, there is site-based technical infrastructure to control releases. As a result of the above applications, melamine reacted to other substances and is not found in finished article or waste related to the finished article.
The sources of melamine in the environment remain unidentified, making it difficult to establish a direct connection to specific melamine uses. There are other potential sources of melamine found in the environment which would not be affected by the authorization requirements:
a. Melamine is formed as a metabolite from the biocide cyromazine when applied on fields and in stables.
b. Potential releases of melamine from the use of cyanamide-containing fertilizers.
c. HMMM (Hexamethoxymethylmelamine, EC 221-422-3), used in special coatings and tires can degrade to melamine.1 HMMM is found in surface water. Tyre abrasion is an ubiquitous phenomenon in Europe and could be a significant contributor of melamine/melamine derivatives in the environment.

Volume used in the scope of authorization.
The draft background document likely overstates the usage volume of melamine, as most applications involve its transformation into polymers, which are not released into the environment. Thus, the actual volume contributing to exposure is significantly lower than suggested.

The draft background document of melamine from February, 7th 2024 contains conflicting information regarding what uses of melamine are in or out of scope of authorization. The background document lacks clarity around the intermediate use of melamine for the production of melamine-based polymers. Furthermore, it's important to clarify that no articles are made solely of melamine; instead, they are made from melamine-based polymers.
Taking into account the fact that the annual volume used in the scope of authorisation is taken as the basis for assessing this criterion and that melamine is used only as a transpotrated intermediate (in accordance with Art.2(8)(b) and Generic exemptions from the authorization requirement, this use is not subject to the authorization procedure. The concluding assessment result on the priority of a melamine per Article 58(3) regarding the volume score and the wide dispersive use was assessed incorrectly:
Tonnage  ECHA Score
≥ 10,000 t/y  15

Wide dispersive use  ECHA Score
15

According to the presented data on melamine uses, the score for the volume and wide dispersive use of melamine should be as follows due to the lack of the annual volume used in the scope of authorization and the lack of professional and consumer uses of melamine as such:
Tonnage  Category  Score
no volume  zero  0

Use type  Category  Score
IND  low  5

There was a confusion with the uses of melamine-as-such with the uses of the melamine-based polymer(resin) synthesized from the monomer melamine. The majority of the melamine applications are not related to articles made of melamine but articles made of melamine-based polymer used as resins. Melamine is one of the starting monomers, an intermediate, to synthesize the melamine-based polymer used as resins. These resins are further processed to produce final articles. The above listed uses are all intermediate uses and consequently out of scope of authorisation.

Against the backdrop of the definition for intermediate use within REACH, melamine is demonstrably used as an intermediate because melamine is manufactured  and used with the intention to transform into another substance.
	
		5172_PIPC - MELAMINA - Public consultation Comments - ECHA.pdf	

II - Transitional arrangements. Comments on the proposed dates
Number / Date	Submitted by (name, submitter type, country)	Comment	Reference to responses	
5096
2024/04/02	PCC Prodex Sp. z o. o.,
Company,
Poland	18 months between LAD and Sunset dates could not be enough time to consider by ECHA the all applications for autorisation and after the sunset dates it will be no longer possible to use melamine without authorization, if we won’t submit the application before the LAD. There is also no clear information what will be the time between addition melamine to Annex XIV and LAD. As a company that doesn’t have any experience in the authorization process, we have to know clearly how much time we have to get the knowledge which one of our delivers (producers) of melamine takes our applications into account preparing the submission.		
				
5097
2024/04/22	The European Apparel and Textile Confederation (EURATEX),
Industry or trade association,
Belgium			
		5097_EURATEX input to ECHA consultation.pdf		
5100
2024/04/29	Raschig GmbH,
Company,
Germany			
		5100_Melamine Inherently Properties and Prioritization and General issues ans uses to be extemped.zip		
5102
2024/04/30	Grupa Azoty Zaklady Azotowe "Pulawy" S.A.,
Company,
Poland			
		
Confidential attachment removed		
5103
2024/04/30	Grupa Azoty Zaklady Azotowe "Pulawy" S.A.,
Company,
Poland			
		
Confidential attachment removed		
5106
2024/05/02	Hilti AG,
Company,
Liechtenstein	In the event that exemption for specific use categories are not granted and for now no alternatives available for the industry yet, it is imperative to acknowledge that industries will require a sufficient transition period to adapt and comply.
It has been a LAD of 12 month proposed. However, we must express our concern that such a short timeline would not provide adequate time or resources for industries to adjust to the new regulations effectively. Therefore, we address a LAD of at least 24 month which might be still not sufficient in this context.		
		
Confidential attachment removed		
5107
2024/05/02	fedustria,
Industry or trade association,
Belgium	No LAD should be proposed since the source of contamination is not known yet.		
				
5108
2024/05/02	KRONOSPAN, s.r.o.,
Company,
Slovakia	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company		
				
5109
2024/05/02	DIAKOL Strazske s.r.o.,
Company,
Slovakia	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company		
				
5110
2024/05/03	Gesamtverband Textil und Mode e.V.,
Industry or trade association,
Germany	See Annex "Statement of the Confederation of the German Textile and Fashion Industry on the draft recommendation of substances for inclusion in Annex XIV and on the call for information (on behalf of the EU Commission) on the possible socio-economic consequences of the authorisation requirement"
		
		5110_final_t+m Statement consultation melamine 20240503.pdf		
5111
2024/05/03	DUKOL Ostrava, s.r.o.,
Company,
Czech Republic	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5112
2024/05/03	KRONOSPAN CR, spol. s r.o.,
Company,
Czech Republic	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5113
2024/05/03	KRONOSPAN OSB, spol. s r.o.,
Company,
Czech Republic	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5115
2024/05/03	Rudolf Hensel GmbH,
Company,
Germany			
		5115_Additional Information.pdf		
5116
2024/05/04	KRONOSPAN GmbH,
Company,
Germany	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5118
2024/05/06	Kronospan ApS,
Company,
Denmark	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5119
2024/05/06	Kaindl GmbH,
Company,
Austria			
		5119_Melamine - Kaindl GmbH.docx		
5121
2024/05/06	Kronospan Polska Sp. z o.o.,
Company,
Poland	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5122
2024/05/06	ICDLI International Committee of the Decorative Laminates Industry aisbl,
Industry or trade association,
Belgium			
		5122_ICDLI position statement for ECHA on current Melamine public consultation.pdf		
5123
2024/05/06	KRAIBURG TPE GmbH & Co. KG,
Company,
Germany	--		
		5123_KRAIBURG TPE Kommentar zum Authorisierungsverfahren Melamin.pdf		
5124
2024/05/06	Kronochem GmbH,
Company,
Germany	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5125
2024/05/06	Kronospan Chemical Szczecinek Sp. z o.o.,
Company,
Poland	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5126
2024/05/06	Melamin, d.d. Kočevje,
Company,
Slovenia			
		5126_Melamine letter ECHA.zip		
5127
2024/05/06	Celanese,
Company,
Germany			
		
Confidential attachment removed		
5129
2024/05/06	EUROPUR,
Industry or trade association,
Belgium	-		
		5129_EUROPUR PC Submission 12th Draft PfA Melamine.pdf		
5130
2024/05/06	PPG Industries,
Company,
United States of America			
		
Confidential attachment removed		
5132
2024/05/06	ANFTA,
Industry or trade association,
Portugal			
		5132_ANFTA PT_ECHA Public Consultation MELAMINE.pdf		
5133
2024/05/06	MBDA France,
Company,
France			
		
Confidential attachment removed		
5134
2024/05/06	Aerospace Industries Association,
Industry or trade association,
United States of America	At this stage of assessment AIA member companies (comprising mainly OEMs) consider that Authorisation would likely be required for some uses of melamine until alternatives can be developed, qualified and substituted.  AIA envisages that our member companies would actively support development and submission of applications for Authorisation for their uses where they do not have alternatives.  Members would not necessarily seek Authorisation themselves but rather as part of joint upstream applications.  Upstream applications supported by OEMs are essential for business continuity in the A&D sector.  A&D supply chains are complex and typically global with many actors at different levels.  OEMs control the end user requirements for the products they produce.  Upstream actors in the chemical supply chain (e.g. formulators, importers of formulations), however, are better placed to hold Authorisations and distribute chemicals to the various users (e.g. processors, component manufactures, OEMs, etc.) of the substances.

The main challenge in preparing an upstream application is obtaining detailed information about site operations for lower tier suppliers of OEMs.  A typical A&D sector supply chain may have four or five or more tiers or levels of companies that supply each other.  Each tier of the supply chain is responsible for establishing contracts with lower tiers to obtain products that meet their requirements, but they rarely share sensitive business information (such as supplier identity) with higher-tier suppliers or the OEM that can inhibit their competitiveness.  This structure allows for the deliberate flow of requirements, but not of sensitive business information (such as employee exposure data, socioeconomic business date, etc.) essential for Authorisation applications.  The A&D sector relies instead on surveys and encourages affected downstream users (DUs) to collaborate in Authorisation consortia (by joining or contributing) and voluntarily provide relevant data to third party consultants that aggregate the available data.  This approach is both time consuming and dependent on supplier cooperation.  In the short 18 to 24 month timeframe after substance listing on Annex XIV and the Last Application Date there is not always sufficient time to encourage enough supply chain actors to gather the pertinent data and develop a solid application.

Because of the many supply chain actors that need to be coordinated we strongly suggest that a longer transition period be adopted (i.e., at least 24 months).

5135
2024/05/06	KRONOSPAN SAS,
Company,
France	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5136
2024/05/06	KRONOSPAN SAS,
Company,
France	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5139
2024/05/06	KRONOSPAN SAS,
Company,
France	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5142
2024/05/07	SIA "KRONOSPAN Riga",
Company,
Latvia	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5143
2024/05/07	Kronospan Mielec Sp. z o.o.,
Company,
Poland	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5144
2024/05/07	Kronospan KO Sp. z o.o.,
Company,
Poland	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5147
2024/05/07	AZOMURES S.A.,
Company,
Romania	no comments		
		5147_Melamine.zip		
5148
2024/05/07	Kronospan HPL Sp. z o. o.,
Company,
Poland	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5149
2024/05/07	Kronospan S.L.,
Company,
Spain	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5150
2024/05/07	Kronospan Chemicals, S.L.,
Company,
Spain	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company		
				
5153
2024/05/07	European Aerospace, Security and Defence Industries Association (ASD),
Industry or trade association,
Belgium	It is considered challenging to meet the early (18-month LAD) timescale for the aerospace industry as no there are currently no equivalent (developed and qualified) alternatives available nor likely to be available in the near term. Hence, if not exempted or granted a longer LAD, Authorisations for the sector would be required. Based on prior sector experience for developing Authorisation submissions for other substances, typically ca. 2+ years is required to develop the necessary dossiers prior to submission. Sufficient timelines for industry to be able to develop required dossiers must be provided for to ensure continuity of the value chain.		
				
5154
2024/05/07	Kronospan GmbH,
Company,
Germany	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5155
2024/05/07	European Panel Federation,
Industry or trade association,
Belgium			
		5155_LF_ECHA_1.1.11.2024.0160.0188.pdf
Confidential attachment removed		
5156
2024/05/07	Health and Environment Alliance (HEAL),
International NGO,
Belgium	As a result of the identification of melamine as a SVHC in accordance with Article 57(f) of REACH as it is a substance for which there is scientific evidence of probable serious effects to the environment and human health, ECHA has recommended to include melamine in Annex XIV. This is a welcome and urgent inclusion, and should be held to the shortest timeline possible, namely 18 months for the latest application date and 18 months after the latest application date for the sunset date for all uses.		
		5156_HEAL_contribution_PC_AnnexXIV_incl_Melamine.pdf		
5157
2024/05/07	Kronospan Chemical Szczecinek,
Company,
Poland	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5159
2024/05/07	Melamine REACH Consortium,
Other contributor,
Belgium	The Melamine REACH Consortium supports and had collaborated with the EMPA submission to the ECHA public consultation of Recommendation for Inclusion in the Authorisation List for melamine substance.  EMPA submission was developed by the EMPA Public Consultation Working Group, a sub-group of the Melamine Steering Committee, composed of experts from various industries of the melamine value chain. The organisations below jointly submit this report with EMPA: Formacare, CEPE, PINFA, European Panel Federation, Melamine REACH Consortium, EPRA, ACEA, ECCA, ICDLI.

Assuming that only non-intermediate uses of melamine fall within the scope of REACH Authorisation, EMPA is not formally requesting an extended extension for LAD and Sunset dates. However, if intermediate uses, which have a more complex supply chain, were within the scope of authorisation, EMPA's approach would be different.

This submission explains that non-intermediate uses of melamine present limited risk to human health and the environment during the production and service life of articles. As such, including melamine in Annex XIV at this time does not appear to be an effective regulatory measure. Doing so would place additional demands on ECHA’s capacity, which could otherwise be allocated to higher priority risk.

In addition, as regards ECHA´s capacity, it must be borne in mind that it would be at least counterintuitive as there are still pending court cases as regards the SVHC identification of melamine (cf. Cases T-163/23 and T-167/23). As their outcome decides whether the identification of melamine as SVHC is valid and provides for a suitable legal basis for the inclusion of melamine in Annex XIV to REACH, any involvement of the authorities (and industry) with applications is in danger to be in vain.

Moreover, the inclusion of a PMT/vPvM substance in Annex XIV will enter new legal territory, which on the one hand will lead to an increased effort for the industry to prepare the applications and on the other hand will also require a certain amount of time on the part of the authorities to prepare for the application phase.

5160
2024/05/07	Kronospan Italia S.r.l.,
Company,
Italy	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.

				
5162
2024/05/07	European Semiconductor Industry Association (ESIA),
Industry or trade association,
Belgium	Please see attached document		
		5162_ESIA input to the consultation on draft recommendation for inclusion in the Authorisation List of Melamine and DTBPO.pdf		
5164
2024/05/07	Kronospan Bulgaria EOOD,
Company,
Bulgaria	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5165
2024/05/07	Kronospan CRO d.o.o.,
Company,
Croatia	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5166
2024/05/07	European Panel Federation,
Industry or trade association,
Belgium	The recommended transitional timelines are to tight/short. Having regard to the number of industrial use sites affected and the high workload for industry to prepare applications for authorisation a late LAD slot should be chosen for melamine. In addition, as regards ECHA´s capacity an early LAD would result in the risk that related efforts would be in vain, due to still pending court cases as regards the SVHC identification of melamine (cf. Cases T-163/23 and
T-167/23).
Moreover, the inclusion of a PMT/vPvM substance in Annex XIV will enter new legal territory, which on the one hand will lead to an increased effort for the industry to prepare the applications and on the other hand will also require a certain amount of time on the part of the authorities to prepare for the application phase. This in particular holds true, as scientific evidence on the intrinsic properties of melamine is evolving and a variety of new data needs to be considered for the preparation of applications as well as their assessment.		
		5166_20240507 EPF Statement ECHA Consultation Prioritisation.pdf		
5167
2024/05/07	European Melamine Producers Association (EMPA), a sector group of Cefic,
Industry or trade association,
Belgium	Assuming that only non-intermediate uses of melamine fall within the scope of REACH Authorisation, EMPA is not formally requesting an extended extension for LAD and Sunset dates. However, if intermediate uses, which have a more complex supply chain, were within the scope of authorisation, EMPA's approach would be different.

This submission explains that non-intermediate uses of melamine present limited risk to human health and the environment during the production and service life of articles. As such, including melamine in Annex XIV at this time does not appear to be an effective regulatory measure. Doing so would place additional demands on ECHA’s capacity, which could otherwise be allocated to higher priority risk.

In addition, as regards ECHA´s capacity, it must be borne in mind that it would be at least counterintuitive as there are still pending court cases as regards the SVHC identification of melamine (cf. Cases T-163/23 and T-167/23). As their outcome decides whether the identification of melamine as SVHC is valid and provides for a suitable legal basis for the inclusion of melamine in Annex XIV to REACH, any involvement of the authorities (and industry) with applications is in danger to be in vain.

Moreover, the inclusion of a PMT/vPvM substance in Annex XIV will enter new legal territory, which on the one hand will lead to an increased effort for the industry to prepare the applications and on the other hand will also require a certain amount of time on the part of the authorities to prepare for the application phase.		
		5167_EMPA Response to ECHA Consultation_FINAL_07052024.zip		
5168
2024/05/07	Diakol Strazske, s.r.o.,
Company,
Slovakia	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5169
2024/05/07	KRONOSPAN-MOFA Hungary Kft.,
Company,
Hungary	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5170
2024/05/07	FALCO Zrt.,
Company,
Hungary	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5171
2024/05/07	KRONOSPAN TRADING SRL,
Company,
Romania	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5172
2024/05/07	Polish Chamber of Chemical Industry,
Industry or trade association,
Poland	Comments on the proposed Latest Application (LAD) and Sunset dates:
Melamine's role as a monomer in the synthesis of melamine-based polymers meets the criteria for classification as an intermediate under REACH, which should exempt it from authorization requirements. It is crucial that this exemption be clearly stated in the final recommendations to avoid misinterpretation that could impose unnecessary burdens on the industry. However, we recommend extending the Latest Application Date (LAD) and Sunset Dates for melamine to ensure that all requirements, including those related to the specific conditions of intermediate use and confinement to a controlled environment, are met and well documented.
Conclusion
The Polish Chamber of Chemical Industry strongly urges the European Chemicals Agency (ECHA) and the Member State Committee to reevaluate the prioritization and proposed measures  concerning melamine, based on the comprehensive evidence and arguments presented. As a primary recommendation, we insist that exemptions for intermediate uses be explicitly articulated in the final documentation. It is essential to ensure that the actual volume of melamine, which impacts human health and the environment, is accurately assessed to facilitate a regulatory response that is both fair and proportional. Should ECHA decide to continue the process of including melamine in Annex XIV of the REACH Regulation, we then recommend that exemptions for intermediate uses be clearly stated and Latest Application Date (LAD) and Sunset Dates will be extended to provide adequate time to meet all requirements for intermediate use.
		
		5172_PIPC - MELAMINA - Public consultation Comments - ECHA.pdf		

III - Comments on uses that should be exempted from authorisation, including reasons for that
Number / Date	Submitted by (name, submitter type, country)	Comment	Reference to responses	
5096
2024/04/02	PCC Prodex Sp. z o. o.,
Company,
Poland	Melamine used as flame retardant in polyurethane foams is actually the most available and the cheapest raw material. Additionally the solid state of melamine makes it suitable , that melamine is the only effective flame retardant for certain PU foams. Due to the fact that melamine in the PU industry is consumed in small quantities, the authorisation requirement should be exempted for PU foam industry or eventually the application should be included in Annex XVII (not in Annex XIV).		
				
5097
2024/04/22	The European Apparel and Textile Confederation (EURATEX),
Industry or trade association,
Belgium			
		5097_EURATEX input to ECHA consultation.pdf		
5099
2024/04/24	Germany,
Member State	Exemption of plastic food contact materials could be considered. Human health risks are sufficiently controlled by Regulation (EU) No 10/2011 setting a specific migration limit (SML) of 2.5 mg/kg food.		
				
5100
2024/04/29	Raschig GmbH,
Company,
Germany	Melamine used as a monomer to produce melamine-based polymers fulfils the conditions for intermediate use under REACH.
In the event that the European Commission ultimately decides to include Melamine in REACH Annex
XIV, all intermediate uses of melamine would be exempted from the scope of authorisation.
Therefore it needs to excluded for use in Resins or in thermosetting moulding compounds. See attached		
		5100_Melamine Inherently Properties and Prioritization and General issues ans uses to be extemped.zip		
5102
2024/04/30	Grupa Azoty Zaklady Azotowe "Pulawy" S.A.,
Company,
Poland			
		
Confidential attachment removed		
5103
2024/04/30	Grupa Azoty Zaklady Azotowe "Pulawy" S.A.,
Company,
Poland			
		
Confidential attachment removed		
5106
2024/05/02	Hilti AG,
Company,
Liechtenstein	We are requesting an exemption for the use in and for structural intumescent fire protection coatings for professional and industrial use.
Presently, there exists no alternative on the market that matches the exceptional performance attributes provided by Melamine which fulfil the fire rating requirements on structural fire protection coating in the construction industry. A fire protection coating protects building elements, e.g. steel elements, from heat and delays the collapse of the building in the event of a fire. Please find more information on tested alternative materials in the confidential attachment.
We do not expect high exposure to the environment
• the application of structural steel coatings is typically entrusted to specifically trained personnel, ensuring proper usage and adherence to safety standards.
• after the hardening process, Melamine becomes integral to the solid product matrix and remain in the building until the end of the lifetime.
Given these critical considerations, we urge for the granting of exemptions for the aforementioned categories within the intumescent fire protection coating sector.		
		
Confidential attachment removed		
5107
2024/05/02	fedustria,
Industry or trade association,
Belgium	if an exemption would be required than an exemption should be made on intermediate use of melamine. or at least for the melamine used in the polymer production of resins used in the wood based panel industry. test on finished products have shown that WBP has no release of melamine and the end product fulfils the requirement of having less than 0,1% of free melamine. So free movement of those WBP coming from outside EU would still be possible.		
				
5108
2024/05/02	KRONOSPAN, s.r.o.,
Company,
Slovakia	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company		
				
5109
2024/05/02	DIAKOL Strazske s.r.o.,
Company,
Slovakia	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company		
				
5110
2024/05/03	Gesamtverband Textil und Mode e.V.,
Industry or trade association,
Germany	See Annex "Statement of the Confederation of the German Textile and Fashion Industry on the draft recommendation of substances for inclusion in Annex XIV and on the call for information (on behalf of the EU Commission) on the possible socio-economic consequences of the authorisation requirement"
		
		5110_final_t+m Statement consultation melamine 20240503.pdf		
5111
2024/05/03	DUKOL Ostrava, s.r.o.,
Company,
Czech Republic	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5112
2024/05/03	KRONOSPAN CR, spol. s r.o.,
Company,
Czech Republic	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5113
2024/05/03	KRONOSPAN OSB, spol. s r.o.,
Company,
Czech Republic	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5115
2024/05/03	Rudolf Hensel GmbH,
Company,
Germany	This Document seeks to comments on uses (or categories of uses) that should be exempted from authorisation (Annex XIV) requirement of intumescent coatings.

Intumescent coatings are surface or joint coatings that protect against fire and smoke penetration into adjacent spaces. The intumescent coating forms a light carbon foam, a light ash, with low conductivity. This effect is often used to protect cables and structural steel. During intumescence, water is released which dilutes acids and has an endothermic/cooling effect. Intumescent materials increase in volume and decrease in density when exposed to heat. Typically, intumescent materials are used in preventive structural fire protection where they can perform the following functions.

Foam to form a lightweight insulating layer as a heat barrier. When added to the insulating sheath of an electrical cable, for example, it forms a "foamed" ash layer with the burning insulation material, impeding the supply of oxygen - and thus the spread of flames.

Formation of a fire barrier by expansion pressure, e.g. when filling the cavity left by a melting plastic pipe in a wall or ceiling opening.

Intumescent building materials are also known as "intumescent formers". In Germany, intumescent building materials, building products containing them, and types of construction using them are subject to approval.

Melamine is one of the essential components of the intumescent reaction, along with ammonium polyphosphate and pentaerythritol. Melamine can begin to decompose at temperatures above 250°C to produce a large volume of gas. This allows the intumescent coating to form into a foamed, insulating layer (known as a char) that provides the essential insulation properties to protect the substrate from heat. The other degradation compounds of melamine then assist in the reinforcement of the char to ensure persistence for the duration of the fire.
All aspects of an intumescent coating are designed during development projects that typically last longer than three years. The temperature at which melamine degrades and the volume of gas it produces has been found to be ideally matched to the other reactions taking place in an intumescent. If these gases were to be generated at higher or lower temperatures then an insulating char will not be formed. Combined with the fact that melamine then reinforces and strengthens the char formed means that no commercial replacement that meets all these criteria has been identified in the, over 100 years, that the intumescent reaction has been known.

In addition to fire performance intumescent coating must also pass rigorous flame spread and emissions testing.

Melamine also contributes to the paint properties of intumescent coatings. These include application and drying profiles, resistance to the environment and aesthetic appearance.

Intumescent coatings are fully tested as described within EN13381, of particular relevance is part 8. This is a lengthy (up to 12 months) and costly (up to EUR 500,000 per product) process that is required to be completed after the development of the product before it can be placed on the European market.
		
		5115_Additional Information.pdf		
5116
2024/05/04	KRONOSPAN GmbH,
Company,
Germany	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5118
2024/05/06	Kronospan ApS,
Company,
Denmark	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5119
2024/05/06	Kaindl GmbH,
Company,
Austria			
		5119_Melamine - Kaindl GmbH.docx		
5121
2024/05/06	Kronospan Polska Sp. z o.o.,
Company,
Poland	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5122
2024/05/06	ICDLI International Committee of the Decorative Laminates Industry aisbl,
Industry or trade association,
Belgium			
		5122_ICDLI position statement for ECHA on current Melamine public consultation.pdf		
5123
2024/05/06	KRAIBURG TPE GmbH & Co. KG,
Company,
Germany	Use of Melamine and its derivatives to prevent flame retardant additives (e.g. polyphosphates) from hydrolysis. Without the use of melamine and its derivatives existing solutions to halogen free flame retardant finishings of Thermoplastic Elastomers are at stake. Such Thermoplastic Elastomer compounds do find important use in e.g. railway cars for public transportation, building and construction (esp. of public buildings) as well as in the electrics & electronics industry.		
		5123_KRAIBURG TPE Kommentar zum Authorisierungsverfahren Melamin.pdf		
5124
2024/05/06	Kronochem GmbH,
Company,
Germany	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5125
2024/05/06	Kronospan Chemical Szczecinek Sp. z o.o.,
Company,
Poland	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5126
2024/05/06	Melamin, d.d. Kočevje,
Company,
Slovenia			
		5126_Melamine letter ECHA.zip		
5127
2024/05/06	Celanese,
Company,
Germany			
		
Confidential attachment removed		
5129
2024/05/06	EUROPUR,
Industry or trade association,
Belgium	-		
		5129_EUROPUR PC Submission 12th Draft PfA Melamine.pdf		
5130
2024/05/06	PPG Industries,
Company,
United States of America			
		
Confidential attachment removed		
5131
2024/05/06	Bundesverband Brandschutz e.V. (BVB),
Industry or trade association,
Germany	

Contents
1 Introduction 2
2 Executive summary; The generic exemption of melamine monomer, an intermediate used in the melamine-based polymer synthesis 3
3 What are amino resins? 3
4 Three cumulative conditions to fulfil the definition for intermediate use 5
5 ECHA guidance on monomers and polymers, February 2023 6
6 Conclusion 7

1 Introduction
This document has been prepared in response to the ECHA draft 12th recommendation for the inclusion of melamine (EC 203-615-4 CAS 108 78-1) in the Authorisation List, dated February 7th 2024.
The draft background document of melamine from February, 7th 2024 contains conflicting information regarding what uses of melamine are in or out of scope of authorization. The background document lacks clarity around the intermediate use of melamine for the production of melamine-based polymers. Under item 2.3 it is mentioned that registered uses of melamine in the scope of authorization includes the use in resin and that the substance is used in e.g. wood articles. The industry understands that the mentioned uses in resins are intermediate uses and are exempt from authorization. Furthermore, it's important to clarify that there are no wood articles made of melamine; rather, there are articles made of melamine-based polymers.
Several conflicting pieces of information were reported in the background document for melamine and subsequently clarified during this consultation. For further details, please refer to the comments provided in the BVB and EMPA document Prioritization and General Issues of this consultation.
A coalition of industries producing, supplying and distributing melamine or melamine-based chemical products has initiated, reviewed, and finalised this document with the intention to demonstrate that the use of melamine in the production of melamine-based polymers fulfils the REACH criteria for intermediate use and is in accordance with ECHA Guidance on intermediates, Version 3.1, January 2023, and on monomers and polymers, Version 3.0, February 2023.
From the guidance on intermediate, three specific conditions must be met in order to fulfil the definition of intermediate use under REACH:
1. Manufacture and use with the intention to transform the intermediate into another substance
2. Containment by technical means in a chemical process known as synthesis
3. Confinement to a controlled environment

Although it is generally accepted that on-site isolated intermediates and transported isolated intermediates are among the generic exemptions from the authorisation requirements, and that according to ECHA, when “a use falls under the generic exemptions from authorisation, there is no need to propose an additional specific exemption”, it was deemed necessary by the industries to demonstrate this with respect to the use of melamine as a monomer in the synthesis of melamine based polymer.

For this purpose, the example of melamine-based polymers is used within the context of the production of amino resin, but this would be equally valid for any intermediate uses of melamine in for other types of resins (e.g. phenol-melamine resins).
2 Executive summary; The generic exemption of melamine monomer, an intermediate used in the melamine-based polymer synthesis
Amino resins are a class of products that are made by reaction of formaldehyde with melamine (MF) or urea (UF) separately or with both melamine and urea together (MUF). The reaction products are thermoset polymers that fulfils the REACH polymer definitions. The finished amino resins are typically used as adhesives.
REACH defines a monomer as a substance which is capable of forming covalent bonds with a sequence of additional like or unlike molecules under the conditions of the relevant polymerforming reaction used for the particular process (Article 3(6)). In amino resin manufacture, melamine is used as a monomer in the synthesis of melamine-based polymers. In this context, the intention is to produce sequential polymer chains made up of repeating units of formaldehyde and melamine (or formaldehyde, melamine and urea). During this synthesis (polymerisation), the melamine is consumed. At the point where the synthesis is stopped, some unreacted monomer can still be present as an impurity in the polymer.
Consequently, in amino resins, any melamine used as a monomer to produce melamine-based polymers fulfils the conditions of intermediate use under REACH.

3 What are amino resins?
Products
Amino resins are produced by polymerisation of formaldehyde (EC 200-001-8; CAS 50-00-0) with either one or several monomers, the most common being urea (EC 200-315-5; CAS 57-13-6) and melamine (EC 203-615-4; CAS 108-78-1) . All starting monomers are REACH registered.
The reaction products fulfil the REACH polymer definitions and are exempted from REACH registration.

The polymers are thermosetting in nature and typically used for adhesives.

Manufacturing process

The manufacturing of amino resins is performed either in batch reactors or continuously. Independent of choice of reactor design, the production consists of several steps, without isolation of specific intermediates.

Chemical reactions
During production of amino resins, two key reactions are involved in polymer formation: an initial addition reaction and a subsequent condensation reaction.

- The addition reaction results in the formation of methylol groups (-CH2OH) and so is also known as methylolation.
- The condensation reaction arises when a methylol group reacts with an amino group of urea or melamine or when two methylol groups react with each other. This reaction results in methylene (-CH2-) and methylene ether (-CH2-O-CH2-) bonds (links) within the resultant polymer chains.

Both reactions take place in the reactor and are conducted at elevated temperature and under varying pH conditions. Different molar ratios of monomers and reaction conditions are typically used to control chemical composition and quality of the finished resin, while other techniques such as viscosimetry, water tolerance measurement and infra-red (IR) spectroscopy can be used to determine the desired endpoint for the polymerization reaction. In modern resin reactors, this can be done using online monitoring techniques. The composition of the final resin and the need for additives to modify resin performance (e.g. thickeners, flow promotors, wetting agents, etc.) are highly dependent on its intended end-use.

Use
During end use, under conditions of high temperature and/or low pH, the same polymerization reactions previously described, result in the rapid formation of a fully crosslinked, solid polymer matrix. This process is generally referred to as the “curing step” in which the resin is said to be “cured”.

In terms of industrial applications in general, and as far as wood-based panels are specifically concerned, the amino resins involved are “cured” into articles. In wood-based panel production, the curing step involves high pressure and elevated temperatures, which complete the conversion of the melamine-based polymer present in the resin into the final fully cross-linked, solid, three dimensional and inert matrix by the further aforementioned rapid polymerization.
Furthermore, we want to clarify that any unreacted melamine monomer in a finished amino resin is present only as an impurity and is not intended or required to serve any specific technical function in the final curing of the resin. At the conclusion of the curing step, the resins is said to be “fully cured”.

Examples of amino resins and their uses:
Type of polymer Example of uses Monomers Other reactants Explanations
MF
(in water) Impregnation resins Melamine and formaldehyde
Typically, the aqueous solutions are placed on the market.

MF (in solvent) Crosslinkers Melamine and formaldehyde methanol, n- butanol and/or isobutaneol
Typically, the solvent borne solutions are placed on the market. In some cases, the resins are marketed as high solid low VOC resins.

MF
(powder)
Flooring plywood; in case of long transport distances Melamine and formaldehyde
In some cases, the liquid resin solution is spray-dried and marketed as a powder.

MUF (in water)
Panelboards Construction resins
Melamine, urea, and formaldehyde
Typically, the aqueous solutions are placed on the market.

4 Three cumulative conditions to fulfil the definition for intermediate use
Against the backdrop of the definition for intermediate use within REACH, melamine is demonstrably used as a monomer in the manufacture of amino resins, primarily melamine-formaldehyde (MF) and melamine-urea-formaldehyde (MUF) resins. During manufacture of these resins, melamine reacts with formaldehyde, or with formaldehyde and urea together, and the outcome of this chemical synthesis is a melamine-based polymer. Any unintentionally residual monomer left over from the synthesis step is considered an impurity of the polymer. The finished resin product is a mixture comprising the melamine-based polymer (inclusive of any residual monomer impurity), together with any additives
that may have been added after the synthesis (polymerisation) step and a solvent, which is generally water.

Condition 1: manufacture and use with the intention to transform the intermediate into another substance:
This condition is fulfilled because melamine is produced and used with the intended purpose of being transformed during the synthesis into a polymer. See section for “What are amino resin?”.

Condition 2: containment by technical means in a chemical process known as synthesis
This condition is also fulfilled because the transformation of the monomers into a polymer is a chemical process (synthesis) that is contained by technical means on an industrial site (i.e. in a closed reactor). See section for “What are amino resin?”.

Condition 3: confinement to a controlled environment
This condition is also fulfilled for the reasons listed below:
- With respect to control measures, melamine is handled and charged to reactors in line with key guidelines outlined in the Safety Data Sheet (SDS) provided by melamine suppliers. During the charging of melamine, a variety of different extraction and localised ventilation systems are used by amino resins producers to avoid exposure to the environment.

- Amino resins producers also reported using dust collection and dedusting systems. Where manual handling operations are necessary (e.g. charging melamine bags into an exhaust to the reactor and handling these same empty bags), personal protective equipment (PPE) is used. Typical PPE in place involves, but is not limited to, filter type mask (e.g. FFP2 or P3/P2 EN 143, EN 149), protective eyeglasses or chemical safety goggles (e.g. EN 166), appropriate protective gloves (e.g. EN 374, EN 420) and full suit/clothing to prevent skin exposure. In case of possible long-term exposure, full-face masks such as ABEK model (EN 143, EN 149) can be used.

- In the absence of an EU-harmonised Occupational Exposure Limit (OEL) for melamine, amino resins producers follow existing safety protocols for dust and dust-type particles.

- Concerning the environmental fate of melamine, amino resins producers use dedicated charging areas that can be equipped with exhaust ventilation and mechanical filtration systems. This helps minimise environmental exposure. The reactors in which amino resins are made are generally equipped with a water-based washing system, with any wastewater resulting from the cleaning being preferably recycled within the factory itself or redirected to on-site or external wastewater treatment facilities.

5 ECHA guidance on monomers and polymers, February 2023
To quote the above referred guidance, page 8:
- “REACH defines a monomer as a substance which is capable of forming covalent bonds with a sequence of additional like or unlike molecules under the conditions of the relevant
polymerforming reaction used for the particular process (Article 3(6)). In other words, it is a substance which, via the polymerisation reaction, is converted into a repeating unit of the polymer sequence. Substances exclusively involved in the catalysis, initiation or termination of the polymer reaction are not monomers. Any substance used as a monomer in the manufacturing of a polymer is therefore by definition an intermediate. Nonetheless, the specific provisions for the registration of intermediates under REACH do not apply to monomers”.

Amino resins producers and industry partners fully support this guidance from ECHA, which states that “any substance used as a monomer in the manufacturing of a polymer is […] by definition an intermediate”. Accordingly, and for the reasons above addressed, we are of the view that the in the manufacture of amino resins, the use of melamine as a monomer for the polymerisation of melamine formaldehyde and melamine urea formaldehyde polymers is by definition an intermediate use under REACH.
Furthermore, we want to clarify that any unreacted melamine monomer in a finished amino resin is present only as an impurity and is not intended or required to serve any specific technical function in the final curing of the resin. This is acknowledged by ECHA guidance for the identification and naming of substances under REACH and CLP, page 3:
-  “Where residues of the intermediate are found in the synthesised substance, they are covered – as an impurity – by the registration and evaluation of that other substance.”
In this context, it can be further concluded that the melamine-based polymers, produced in the synthesis step of the resin production process, are substances containing impurities of unreacted monomer, and not mixtures (as long as additives and solvents have not been added after the synthesis step). For additional clarity on this point, this means that the addition of extra melamine as an additive to a melamine-based polymer would not meet Condition 1 for intermediate use under REACH, in that any such addition of melamine after the synthesis (polymerisation) step is not being done with the intention to create a new substance.

6 Conclusion
Melamine used as a monomer to produce melamine-based polymers fulfils the conditions for intermediate use under REACH.
In the event that the European Commission ultimately decides to include melamine in REACH Annex XIV, all intermediate uses of melamine would be exempted from the scope of authorisation.

5132
2024/05/06	ANFTA,
Industry or trade association,
Portugal			
		5132_ANFTA PT_ECHA Public Consultation MELAMINE.pdf		
5133
2024/05/06	MBDA France,
Company,
France			
		
Confidential attachment removed		
5135
2024/05/06	KRONOSPAN SAS,
Company,
France	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5136
2024/05/06	KRONOSPAN SAS,
Company,
France	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5139
2024/05/06	KRONOSPAN SAS,
Company,
France	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5142
2024/05/07	SIA "KRONOSPAN Riga",
Company,
Latvia	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5143
2024/05/07	Kronospan Mielec Sp. z o.o.,
Company,
Poland	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5144
2024/05/07	Kronospan KO Sp. z o.o.,
Company,
Poland	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5147
2024/05/07	AZOMURES S.A.,
Company,
Romania	Azomures support the EMPA statement "Melamine Recommendation for inclusion in the Authorization List":
document 3. Uses exempted from the Authorization requirement, dated 5th of May 2024.		
		5147_Melamine.zip		
5148
2024/05/07	Kronospan HPL Sp. z o. o.,
Company,
Poland	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5149
2024/05/07	Kronospan S.L.,
Company,
Spain	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5150
2024/05/07	Kronospan Chemicals, S.L.,
Company,
Spain	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company		
				
5153
2024/05/07	European Aerospace, Security and Defence Industries Association (ASD),
Industry or trade association,
Belgium	Since the use of formulations containing melamine are qualified for use in A&D processes, replacement of these requires alternatives to be developed, that demonstrate equivalent performance. This is critical to ensuring product safety of A&D products is not compromised by any change.
To achieve substitutes will require new formulations (not containing melamine or relying on melamine as precursors) to be developed by formulators and then tested by each A&D design owner for each affected part, process and product. Including maintenance, repair and overhaul uses. Successful substitution in one type of part or product, or by one design owner, does not mean others can also be substituted – the required testing has to be undertaken at all levels.
To achieve successful development, testing, qualification and certification for all melamine-replacement formulations across all affected parts, processes and products is resource and time-consuming. Testing is step-wise, with alternatives required to pass earlier phases of testing before they can be progressed. Failure of an alternative at any stage, would mean the process returns to the beginning.
Depending on the complexity of the affected parts and products, it can take 10 years or more in some cases, if successful alternatives can be found.
Considering the current lack of equivalent alternatives, safe use associated with  melamine in an industrial controlled environment , Aerospace and Defense applications may need to be exempted. The substance reacts with the epoxy group, and only traces remain on the final product with no release or exposure to workers foreseen.
Melamine may also be used as a precursor for other substances, materials and formulations used by ASD members, but not necessarily visible to those companies e.g. where it remains on parts or in formulations below 0.1%. This causes difficulties for identifying where necessary Authorisations will be needed in those cases (since it is upstream of the affected A&D design owners and may not be visible) and could also result in associated obsolescence of critical formulations and parts if uses cease as a result.		
				
5154
2024/05/07	Kronospan GmbH,
Company,
Germany	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5155
2024/05/07	European Panel Federation,
Industry or trade association,
Belgium			
		5155_LF_ECHA_1.1.11.2024.0160.0188.pdf
Confidential attachment removed		
5156
2024/05/07	Health and Environment Alliance (HEAL),
International NGO,
Belgium	We reiterate our support for a decision based on intrinsic hazard properties of melamine, which are very concerning for human health and the environment and therefore we support not to recommend exemptions for any uses of melamine from the authorisation requirement. Arguments based on risk-benefit analysis or concerns over costs are not appropriate in this setting. The authorisation process, not the Annex XIV listing, is the appropriate venue for discussion of social benefits and the presence or lack of suitable alternatives.

Uses of melamine that are the most significant to human exposure are of particular concern. We comment on specific uses of melamine below.

Food Contact materials and exposure via drinking water

Annex XV dossier identifies uses of melamine in food contact materials as one of the most significant sources of human exposure. There are a great many safer, melamine-free materials appropriate for FCM, such as tableware, and no uses of melamine should therefore be exempted from the authorisation requirement in FCM.

In 2010, EFSA has established the tolerable daily intake (TDI) for melamine at 0.2 mg/kg bw/day (EFSA, 2010) leading to the conclusion that at the current stage the TDI is not exceeded via nutrition including beverages and tap water, and there are currently no risks for human health via this exposure pathway. However, in its Regulatory Management Option Analysis Conclusion Document assessing the endocrine disrupting profile of melamine, the French competent authority observed deleterious effects on the reproductive function at doses lower than the BMDL10 used for the derivation of the current TDI. These effects were observed in three studies published after the determination of the current TDI. The French competent authority therefore recommends EFSA to analyse the new available data pointed out by ANSES to possibly consider the revision of the tolerable daily intake value (ANSES, 2024). Although consideration about a revision of the TDI for melamine is beyond the scope of this consultation, in the light of these new findings and considering that the current TDI was established more than a decade ago, and that exposure of humans via drinking water is expected to increase over time due to persistency and mobility (German Competent Authorities, 2022), we urge ECHA to take this information into account when assessing in accordance with Article 58(2) of the REACH Regulation any request for exemption from the authorisation requirement in relevant uses.

Flame retardants.

Annex XV dossier also identifies articles containing melamine as flame retardant as a significant source of human exposure. There is a critical need to assess the actual efficacy from use of flame retardants and open flame tests compared with other non-hazardous fire safety interventions. In fact, a report from the EU commission supports the conclusion that non-flammability requirements such as open flame tests are not indicative of real-life scenarios and these requirements have little bearing on fire safety overall (Arcadis EBRC, 2011). Instead, flame retardants may actually be compounding the injuries and harms associated with exposure to toxic fumes and smoke during a fire that contain such hazards as carbon monoxide, cyanide, dioxins and furans (Page et al., 2023). We therefore urge ECHA to take this information into account when assessing any request for exemption from the authorisation requirement in relevant uses.		
		5156_HEAL_contribution_PC_AnnexXIV_incl_Melamine.pdf		
5157
2024/05/07	Kronospan Chemical Szczecinek,
Company,
Poland	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5159
2024/05/07	Melamine REACH Consortium,
Other contributor,
Belgium	The Melamine REACH Consortium supports and had collaborated with the EMPA and others submission to the ECHA public consultation of Recommendation for Inclusion in the Authorisation List for melamine substance.

The draft background document on melamine, dated February 7th, 2024, contains some information that may need clarification regarding which uses of melamine fall within the scope of authorisation and which do not.

Melamine used as a monomer in the synthesis of melamine-based polymer is a generic exemption of REACH authorisation.

REACH defines a monomer as a substance which is capable of forming covalent bonds with a sequence of additional like or unlike molecules under the conditions of the relevant polymer-forming reaction used for the particular process. Melamine is used as a monomer in the synthesis of melamine-based polymers. In this context, the intention is to produce sequential polymer chains made up of repeating units of formaldehyde and melamine (or formaldehyde, melamine and urea). During this synthesis of the melamine-based polymer, the melamine is consumed. At the point where the synthesis is stopped, some unreacted monomer can still be present as an impurity in the polymer. Consequently, in the production (synthesis) of melamine-based polymers, melamine used as a monomer fulfils the conditions of intermediate use under REACH and therefore exempted from REACH authorisation.

Several articles mentioned in the back ground document are not articles of melamine but rather articles based on melamine-based polymers, which is a new substance, as melamine ceased to exist.

5160
2024/05/07	Kronospan Italia S.r.l.,
Company,
Italy	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.

				
5162
2024/05/07	European Semiconductor Industry Association (ESIA),
Industry or trade association,
Belgium	Please see attached document		
		5162_ESIA input to the consultation on draft recommendation for inclusion in the Authorisation List of Melamine and DTBPO.pdf		
5164
2024/05/07	Kronospan Bulgaria EOOD,
Company,
Bulgaria	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5165
2024/05/07	Kronospan CRO d.o.o.,
Company,
Croatia	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5166
2024/05/07	European Panel Federation,
Industry or trade association,
Belgium	Furthermore, as regards specific uses, exemptions according to Art. 58(2) REACH should be considered in case the European Commission decides to include melamine in Annex XIV to REACH irrespective the raised legal and procedural concerns. This specifically holds true for uses of melamine within the scope of Regulation (EU) No. 10/2011.
In addition, exemptions with respect to the upcoming Regulation establishing a framework for setting ecodesign requirements for sustainable products and repealing Directive 2009/125/EC should be considered.		
		5166_20240507 EPF Statement ECHA Consultation Prioritisation.pdf		
5167
2024/05/07	European Melamine Producers Association (EMPA), a sector group of Cefic,
Industry or trade association,
Belgium	

Recommendation for Inclusion of Melamine in the Authorisation List

Chapter - Uses exempted from the Authorisation requirement

EMPA Public Consultation Response Report

Date: 7 May 2024

Acknowledgments

This report was developed by the EMPA Public Consultation Working Group, a sub-group of the Melamine Steering Committee, composed of experts from various industries of the melamine value chain. For a list of associations endorsing this report, see the last page.

​​Contents

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Terms used

Melamine:

Base chemical in organic chemistry; reacts via its NH2-groups.

Melamine monomer:

Melamine is used as a monomer (= substance) in the preparation (= synthesis) of melamine-based polymers (substance); e.g. the synthesis reaction for the wood-based panels industry is the reaction of (i) melamine with formaldehyde or (ii) melamine with urea and formaldehyde.

Melamine-based polymer (a substance):

Is formed in the synthesis by the reaction of melamine with formaldehyde, depending on the further application other reactants can be added.

Resin (a mixture):

Chemical term, which is used in different way; in the context with the wood-based panels industry a resin is used as adhesive or for impregnating papers for decorative surfaces. Resins usually are thermosetting; depending on the chemical composition and the addition of hardeners or catalysts they cure preferably under the impact of heat, in few cases also at room temperature.

Amino-resin (a mixture):

Resin based on polymers with usually urea and/or melamine as amino component and formaldehyde; if melamine is used as monomer or as one of the monomers, the amino resin consists of the melamine-based polymer (including the unreacted melamine from the synthesis) as main component and various other components, which are added to the melamine-based polymer after the synthesis has been stopped. This addition of these other components does not trigger a chemical reaction, therefore the amino-resin (can be also called as “ready-to-use” resin) is a mixture and used for the production of articles, e.g., a particleboard.

(Amino) Adhesive resin:

Resin used to the production of wood-based panels or, basically, to bond two pieces of wood; as adhesive usually so-called MUF-resins are used, with melamine and urea as the two amino monomers in the synthesis of the polymer. The proportion of melamine in the amino resin can vary in large range, depending on the application.

(Amino) Impregnating resin:

Resin used for the impregnation of paper for the production of decorative surfaces. For this application usually MF-resins (with only melamine as amino monomer) are used.

(Amino) Coating resin:

Resin used as crosslinker for coating applications. For this application usually MF-resins reacted with butanol/methanol (with only melamine as amino monomer) are used.

Thermosetting system:

Chemical system which cures, yielding a three-dimensionally crosslinked molecular structure, which cannot be molten for reprocessing.

Urea:

One of the two main monomers for amino polymers (amino resins).

Formaldehyde:

Reacts with the NH2-groups of melamine and/or urea in the synthesis of amino-based polymers.

Note: The two terms “polymer” and “resin” are often used in industry in synonym mode. Based on ECHA-Guidance’s, the term “polymer” shall be used as the product generated in the synthesis where monomers were used as starting material (e.g. melamine). It can be defined (i) a melamine-based polymer as substance (including residual melamine as impurity) and (ii) an e.g., amino resin as a mixture, containing the melamine-based polymer as main component, plus other components, which are added to the polymer after the synthesis.

Introduction

This document has been prepared in response to the ECHA draft 12th recommendation for the inclusion of melamine (EC 203-615-4 CAS 108-78-1) in the Authorisation List, dated February 7th, 2024. 

The draft background document on melamine, dated February 7th, 2024, contains some information that may need clarification regarding which uses of melamine fall within the scope of authorisation and which do not. In particular, it could benefit from additional clarity regarding the intermediate use of melamine for the production of melamine-based polymers. Under item 2.3 it is mentioned that registered uses of melamine in the scope of authorisation include the use of resin and that the substance is used in e.g. wood articles. The industry understands that the use of melamine as monomer in the synthesis of melamine-based polymers is an intermediate use and exempt from authorisation and is distinct to the use of melamine-based polymer, another substance. It is essential to clarify that while there are no wood articles made of melamine, there are articles that utilize melamine-based polymers as the primary component in e.g. wood adhesives. This document and the comments provided in the EMPA document “Prioritization and General Issues” of this consultation’ provide this distinction which will be helpful for better understanding.

A coalition of industries producing, supplying and distributing melamine or melamine-based chemical products has initiated, reviewed, and finalised this document with the intention to demonstrate that the use of melamine in the production of melamine-based polymers fulfils the REACH criteria for intermediate use and is in accordance with ECHA Guidance on intermediates, Version 3.1, January 2023, and on monomers and polymers, Version 3.0, February 2023.

From the guidance on intermediate, three specific conditions must be met in order to fulfil the definition of intermediate use under REACH: 

Manufacture and use with the intention to transform the intermediate into another substance 

Containment by technical means in a chemical process known as synthesis 

Confinement to a controlled environment 

 

Although it is generally accepted that on-site isolated intermediates and transported isolated intermediates are among the generic exemptions from the authorisation requirements, and that according to ECHA, when “a use falls under the generic exemptions from authorisation, there is no need to propose an additional specific exemption”, it was deemed necessary by the industries to demonstrate this with respect to the use of melamine as a monomer in the synthesis of melamine- based polymers.

For this purpose, the example of melamine-based polymers is used within the context of the production of amino resins, but this would be equally valid for any intermediate uses of melamine for other types of resins (e.g. phenol-melamine resins). In the wood -product industry such resins are used especially as adhesive resins (wood adhesives) and as impregnating resins. 

Executive summary; the generic exemption of melamine monomer, an intermediate used in the melamine-based polymer synthesis

Melamine-based polymers are made by reaction of formaldehyde with melamine (MF) or with both melamine and urea together (MUF). The reaction products are polymers that fulfils the REACH polymer definitions.

REACH defines a monomer as a substance which is capable of forming covalent bonds with a sequence of additional like or unlike molecules under the conditions of the relevant polymer-forming reaction used for the particular process (Article 3(6)). Melamine is used as a monomer in the synthesis of melamine-based polymers. In this context, the intention is to produce sequential polymer chains made up of repeating units of formaldehyde and melamine (or formaldehyde, melamine and urea). During this synthesis of the melamine-based polymer, the melamine is consumed. At the point where the synthesis is stopped, some unreacted monomer can still be present as an impurity in the polymer. Consequently, in the production (synthesis) of melamine-based polymers, melamine used as a monomer fulfils the conditions of intermediate use under REACH.

N.B.: In accordance with the interpretation of ECHA and the European Commission, polymers or other substances cannot be considered intermediates when they are used in the production of articles. However, it is important to note that the substance being proposed by ECHA for Annex XIV prioritisation is melamine and not melamine-based polymers.

Acknowledgments

This report was developed by the EMPA Public Consultation Working Group, a sub-group of the Melamine Steering Committee, composed of experts from various industries of the melamine value chain. The organisations below jointly submit this report with EMPA: Formacare, CEPE, PINFA, European Panel Federation, Melamine REACH Consortium, EPRA, ACEA, ECCA, ICDLI.

What are amino resins?

Products

Melamine-based polymers are produced by chemical reaction (synthesis) of formaldehyde (EC 200-001-8; CAS 50-00-0) with melamine (EC 203-615-4; CAS 108-78-1) and in some cases with urea (EC 200-315-5; CAS 57-13-6) as another monomer. All starting monomers are REACH-registered.

The reaction products fulfil the REACH polymer definitions and are exempted from REACH registration.

A white background with black text

Description automatically generated

The two terms “polymer” and “resin” are often used in industry in synonym mode. In this document, also based on the nomenclature as stated by the various ECHA-Guidance's, the term “polymer” shall be used as the product generated in the synthesis. In the special case here, we can define (i) a melamine-based polymer as substance (including residual melamine as impurity) and (ii) an amino resin as mixture, containing the melamine-based polymer as main component, but also other components, which are added to the polymer after the synthesis, without triggering a chemical reaction. These mixing procedures, when preparing the amino adhesive resin or the amino impregnating resin, can be performed immediately after the synthesis in the same reactor or in a separate reactor or suitable vessel.

Manufacturing process

The manufacturing of melamine-based polymers (synthesis) is performed either in batch reactors or continuously. Independent of choice of reactor design, the production consists of several steps, without isolation of specific substances or chemicals during the synthesis.

Chemical reactions

During production of melamine-based polymers, two key reactions are involved: an initial addition reaction and a subsequent condensation reaction.

The addition reaction results in the formation of methylol groups (-CH2OH) and so is also known as methylolation.

The condensation reaction arises when a methylol group reacts with an amino group of urea or melamine or when two methylol groups react with each other. This reaction results in methylene (-CH2-) and methylene ether (-CH2-O-CH2-) bonds (links) within the resultant polymer chains.

Both reactions take place in the reactor and are conducted at elevated temperature and under varying pH-conditions. Different molar ratios of monomers and reaction conditions are typically used to control chemical composition and quality of the polymer, while other techniques such as  viscosimetry, water tolerance measurement and infra-red (IR) spectroscopy can be used to determine the desired endpoint for the synthesis. In modern resin reactors, this can be done using online monitoring techniques.

Use

The melamine-based polymer is the main component when producing adhesive resins or impregnating resins, as they are used in the wood product industry. The composition of these resins, with the melamine-based polymer as main component (including the non-reacted melamine of the synthesis as impurity), but including also other components, such as thickeners, flow promotors, wetting agents, etc., highly depends on their intended use, such as wood adhesive or impregnating resin. During the use of these resins, under conditions of high temperature and/or low pH, the above-mentioned condensation reaction within the melamine-based polymer continues, resulting in the rapid formation of a fully crosslinked, solid matrix. This process is generally referred to as the “curing step” in which the resin is said to be “cured”.

In terms of industrial applications in general, and as far as wood-based panels are specifically concerned, the amino resins are used to bond wood particles or wood fibres when producing particleboards or MDF (Medium-density fibreboard); these boards are articles according to REACH. In wood-based panel production, the curing step involves high pressure and elevated temperatures, which complete the conversion of the melamine-based polymer present in the resin into the final fully crosslinked, solid, three-dimensional matrix by the further aforementioned rapid condensation reaction.

Furthermore, we want to clarify that any unreacted melamine monomer from the synthesis is an impurity in the melamine-based polymer and is not intended or required to serve any specific technical function in the final curing when producing articles, such as wood-based panels.

Examples of amino resins and their uses:

Type of polymer

Example of uses

Monomers

Other reactants

Explanations

MF

(in water)

Impregnation resins

Melamine and formaldehyde

Typically, the aqueous resins are placed on the market.

MF (in solvent)

Crosslinkers

Melamine and formaldehyde

methanol, n-butanol and/or isobutanol

Typically, the solvent borne solutions are placed on the market. In some cases, the resins are marketed as high solid low-VOC resins.

MF

(powder)

Flooring

plywood; in case of long transport distances

Melamine and formaldehyde

In some cases, the liquid resin solution is spray-dried and marketed as a powder.

MUF (in water)

Panelboards

Construction resins

Melamine, urea, and formaldehyde

Typically, the aqueous resins are placed on the market.

Three cumulative conditions to fulfil the definition for intermediate use

Against the backdrop of the definition for intermediate use within REACH, melamine is demonstrably used as a monomer in the manufacture (synthesis) of melamine-based polymers, primarily melamine-formaldehyde (MF) and melamine-urea-formaldehyde (MUF) polymers. During manufacture of these polymers, melamine reacts with formaldehyde or with formaldehyde and urea together, and the outcome of this chemical synthesis is a melamine-based polymer. Any unintentionally residual monomer left over from the synthesis step is considered an impurity in the polymer. The various resins, as they are used as adhesive resin or as impregnating resins, to mention the two most important uses, are a mixture comprising the melamine-based polymer (inclusive of any residual monomer impurity) as main component, together with any additives or other substances that may have been added after the synthesis step.

Condition 1: manufacture and use with the intention to transform the intermediate into another substance:

This condition is fulfilled because melamine is produced and used with the intended purpose of being transformed during the synthesis into a polymer. See section for “What are amino resin?”.

Condition 2: containment by technical means in a chemical process known as synthesis

This condition is also fulfilled because the transformation of the monomers into a polymer is a chemical process (synthesis) that is contained by technical means on an industrial site (i.e., in a closed reactor). See section for “What are amino resin?”.

Condition 3: confinement to a controlled environment

This condition is also fulfilled for the reasons listed below:

With respect to control measures, melamine is handled and charged to reactors in line with key guidelines outlined in the Safety Data Sheet (SDS) provided by melamine suppliers. During the charging of melamine, a variety of different extraction and localised ventilation systems are used to avoid exposure to the environment.

Producers of melamine-based polymers also reported using dust collection and dedusting systems. This also includes suitable measures where manual handling operations are necessary (e.g. charging melamine big bags into an exhaust to the reactor and handling the empty bags); only in addition, personal protective equipment (PPE) might be used. Typical PPE involves, but is not limited to, filter type mask (e.g. FFP2 or P3/P2 EN 143, EN 149), protective eyeglasses or chemical safety goggles (e.g. EN 166), appropriate protective gloves (e.g. EN 374, EN 420) and full suit/clothing to prevent skin exposure. Also, full-face masks such as ABEK model (EN 143, EN 149) can be used.

There are no designated EU Occupational Exposure Limits (OELs) for melamine, it is generally controlled as a nuisance dust, and downstream users are advised to adhere to the Derived No Effect Levels (DNELs) detailed in the Chemical Safety Report and communicated in supplier extended Safety Data Sheets (eSDS)

Concerning the environmental fate of melamine, producers of melamine-based polymers use dedicated charging areas that can be equipped with exhaust ventilation and mechanical filtration systems. This helps minimise environmental exposure. The reactors in which the melamine-based polymers are made are generally equipped with a water-based washing system, with any wastewater resulting from the cleaning being preferably recycled within the factory itself or redirected to on-site or external wastewater treatment facilities.

ECHA guidance on monomers and polymers, February 2023

To quote the above referred guidance, page 8:

“REACH defines a monomer as a substance which is capable of forming covalent bonds with a sequence of additional like or unlike molecules under the conditions of the relevant polymerforming reaction used for the particular process (Article 3(6)). In other words, it is a substance which, via the polymerisation reaction, is converted into a repeating unit of the polymer sequence. Substances exclusively involved in the catalysis, initiation or termination of the polymer reaction are not monomers. Any substance used as a monomer in the manufacturing of a polymer is therefore by definition an intermediate. Nonetheless, the specific provisions for the registration of intermediates under REACH do not apply to monomers”.

Producers of melamine-based polymers and of amino resins and industry partners fully support this guidance from ECHA, which states that “any substance used as a monomer in the manufacturing of a polymer is […] by definition an intermediate”. Accordingly, and for the reasons above addressed, we are of the view that in the manufacture of melamine-based polymers, the use of melamine as a monomer in the synthesis of melamine formaldehyde and melamine urea formaldehyde polymers is by definition an intermediate use under REACH.

Furthermore, we want to clarify that any unreacted melamine monomer in the polymer is present only as an impurity and is not intended or required to serve any specific technical function in the further use of the polymer, e.g., as main component of adhesive resins or impregnating resins. This is acknowledged by ECHA guidance for the identification and naming of substances under REACH and CLP, page 3:

“Where residues of the intermediate are found in the synthesised substance, they are covered – as an impurity – by the registration and evaluation of that other substance.”

In this context, it can be further concluded that the melamine-based polymers, produced in the synthesis, are substances containing impurities of unreacted monomer, and not mixtures, (as long as no additives, other substances, or solvents have been added after the synthesis step). For additional clarity on this point, this means that the addition of extra melamine as a component to a melamine-based polymer would not meet Condition 1 for intermediate use under REACH, given that any such addition of melamine after the synthesis is not being done with the intention to create a new substance.

Conclusion

Melamine used as a monomer to produce melamine-based polymers fulfils the conditions for intermediate use under REACH.

In the event that the European Commission ultimately decides to include melamine in REACH Annex XIV, all intermediate uses of melamine would be exempted from the scope of authorisation.

Acknowledgments

This report was developed by the EMPA Public Consultation Working Group, a sub-group of the Melamine Steering Committee, composed of experts from various industries of the melamine value chain. The organisations below jointly submit this report with EMPA: Formacare, CEPE, PINFA, European Panel Federation, Melamine REACH Consortium, EPRA, ACEA, ECCA, ICDLI.

Note: Please refer to attached zipped PDF reports for the complete consultation response.

		5167_EMPA Response to ECHA Consultation_FINAL_07052024.zip		
5168
2024/05/07	Diakol Strazske, s.r.o.,
Company,
Slovakia	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5169
2024/05/07	KRONOSPAN-MOFA Hungary Kft.,
Company,
Hungary	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5170
2024/05/07	FALCO Zrt.,
Company,
Hungary	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5171
2024/05/07	KRONOSPAN TRADING SRL,
Company,
Romania	The submitting company appreciates and refers to the comments given in the submission of the European Panel Federation (EPF) in Brussels, Belgium. The submission of the EPF is fully in line with the opinion of the submitting company.		
				
5172
2024/05/07	Polish Chamber of Chemical Industry,
Industry or trade association,
Poland			
		5172_PIPC - MELAMINA - Public consultation Comments - ECHA.pdf