Comments on ECHA’s Draft 9th Recommendation for 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (DOTE) (EC number: 239-622-4) and references to responses

The present document compiles the comments received during the public consultation on the draft 9th recommendation for inclusion of substances in Annex XIV of REACH for 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (DOTE) (EC number: 239-622-4). The public consultation took place between 5 September 2018 and 5 December 2018.

For each of the comments there is also a reference to specific section(s) of a document containing the responses to comments (“Response document”, available at https://echa.europa.eu/documents/10162/13640/9th_recom_respdoc_dote_dotemote_en.pdf). The responses in the Response document are arranged by thematic block and level of information (see more detailed explanations at the beginning of that document).

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	Reference to responses	
3296
2018/11/26	Germany,
Member State	RAC is currently assessing a CLH dossier for DOTE in which it is proposed to revise the current classification from "toxic for reproduction, category 1B" to "suspected of damaging the unborn child, category 2".
We propose to await the outcome of the RAC discussion and thus, postpone the prioritisation of DOTE. In case RAC recommends maintaining the current classification (cat. 1B) we are in support of the prioritisation of DOTE.
	A.2.01. Consider RAC conclusion on the proposal to revise DOTE harmonised classification	
				
3319
2018/12/04	Organotin REACH Consortium,
Company,
Belgium	DOTE Annex XIV Comments:
Intrinsic properties
Based on new data on pure DOTE itself instead of reading across from structural similar surrogates, the German CA BAUA has prepared and submitted a dossier to reclassify DOTE. The first result of their evaluation was that DOTE was not reprotoxic. Later this was changed to a precautionary classification of Repro 2.If the substance is reclassified as Repro 2 it would no longer meet the criteria of Article 57 (c)  and a listing in Annex XIV would be obsolete.
Volumes used within the scope of authorization
Downstream users submitted the following information: DOTE is used in a volume band of 400-500 t/a  in applications within the scope of Regulation (EC) No 1935/2004. (Food Contact Films and Immediate packaging for medication). Thus, these uses are exempted from authorization.
The volume DOTE used in the manufacturing of immediate packaging for pharmaceuticals is covered by Directive 2001/83/EC referring to the European Pharmacopoeia. Thus this volume is not within the scope of REACH (Article 2).
DOTE in these uses is directly added during the manufacturing step. It is mixed with virgin PVC and other additives, and without any further isolation of a compound manufactured into the finished article.

Clarification of volume reporting
According to Section 4.2.2.4 of ECHA Guidance for identification and naming of substances under REACH and CLP, the registrants of DOTE and MOTE chose the option which allows the registration of multi-constituents substances as individual constituents.
In order to keep transparency about the manufactured / imported volumes, the registrants of DOTE modified section 3.2 of their dossiers and reported both, the volumes of DOTE which meet the definition of a pure substance and volumes of DOTE as a constituent in a substance meeting the criteria of a multi-constituent substance.
The sum of both is the total manufactured / imported DOTE
If ECHA  would insist on a differentiation of DOTE and DOTE in the virtual reaction mass DOTE/MOTE, then also in a differentiated scoring for DOTE the low volume of the pure substance should be considered.

Wide-dispersiveness of uses
In 2016 all DOTE registrants have updated their registration, removing the service life in articles from the technical dossier (IUCLID) and the CSR. The lead registrant has provided additional information to support the statement that the substance mostly transforms into another substance when processed into articles.
The purpose of a heat stabilizer like DOTE is to prevent the formation of HCl during manufacturing of PVC articles caused by heat and shear The background information (Frenkel, 2016) attached to the registration dossier shows that while acting as a heat stabilizer, DOTE is consumed during PVC processing and transformed.  Unlike other  additives like plastisizers or pigments, DOTE is not only embedded in the polymer matrix but  in additionchemically modified by the PVC.  . (DOTE reacts with any HCl generatedto form the stable DOTEC, a reaction also found in the in vitro metabolism of the substance)
As a consequence the volume of DOTE, as such, in PVC gets dramatically reduced when a PVC article is produced.
In accordance with Article 3(15) of the REACH Regulation, an intermediate is “a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance”. Consequently, DOTE functions as an intermediate during the PVC stabilization process.
We therefore believe two priorisation points which reflect article service life are not justified.
Further considerations for priority setting (grouping)
Reaction Mass DOTE/MOTE: According to Section 4.2.2. of the ECHA Guidance for identification and naming of substances under REACH and CLP, the registrants of DOTE chose the option not to use the reaction mass DOTE/MOTE, but to register   its  multi-constituent  substances as individual constituents .
A Reaction Mass DOTE/MOTE, as it appears in the SVHC list and which is also subject to ECHA’s ninth recommendation for the inclusion of substances in Annex XIV, has never been registered.
However, it seems to be ECHA’s view to treat a not-registered substance exactly like a fully registered substance.
As a negative consequence the priorisation grouping for the reaction mass DOTE/MOTE is mentioned as a further consideration. This grouping does not exist since the reaction mass DOTE/MOTE has not been registered. So DOTE is grouped here with itself as a constituent in a virtual substance.
We believe priorisation based on this grouping is not justified.
Socio-Economic Aspects
DOTE in Mixtures is the only stabilizer system which is listed in the European Pharmacopoeia (3.1.10 Materials based on non-plasticised poly(vinyl chloride) for containers for non-injectable, aqueous solutions and 3.1.11 Materials based on non-plasticised poly(vinyl chloride) for containers for solid dosage forms for oral administration) which are manufactured within the EU. A restriction of this stabilizer system would directly impact the marketability of pharmaceuticals or would move the market towards stabilizers manufactured outside the EU.
DOTE is used to a high extent in the building and construction sector ( for example profiles. Uses in these applications are not generically exempted from Authorisation. In this sector, for the vast majority of applications, a substitution of DOTE is not feasible in an economically viable way without loss of performance and quality of the end use. Here, clearly, the EU would likely have a significant migration of production capacity to non-EU facilities.
DOTE in final Article
The migration properties of DOTE within or out of PVC has been examined and is extremely low. The Specific Migration Limit in the Commission Regulation (EU) 10/2011 is set to 0.006 mg/kg (as Tin). This low migration limit is achieved by manufacturers and frequently checked by authorized testing facilities for the specific applications.
Although the compliance with this migration limit is only verified for uses in the scope of Regulation (EC) No 1935/2004, the low migration properties of DOTE in technical applications can be considered comparable.
Furthermore, there is clear documentation that DOTE, in its technical function as a heat stabilizer, gets chemically transformed. This means the concentration within the final application [i.e. end-stage products] is significantly lower than the stated nominal concentration .
Recycling of DOTE-stabilized PVC is possible. There is no negative impact on new PVC products from the stabilizer in the recycled PVC. Any unreacted DOTE in recycled PVC will perform the same function as newly added DOTE and during the production and will extend the service life of the PVC article.
Recycling systems are well established in different industrial sectors which drive high recycling rates for stabilized PVC.

Risk Considerations
The risks to human health or the environment from the manufacturing and use of DOTE are well controlled. This is documented in the CSR of the substance. The substance currently meets the criteria of Article 57 (c), and it is possible to derive threshold limits in accordance with Section 6.4 of Annex I (DNEL/PNEC). The calculated RCRs are well below 1.
Supply Chain Considerations
DOTE is mainly used as PVC stabilizer. PVC is an extremely versatile polymer, which is used in hundreds of different applications.  So although the life cycle of DOTE manufacturing – formulation – industrial use looks manageable, we are afraid that in case of adding DOTE to Annex XIV a high number of authorization applications might be necessary to authorize the numerous  applications where a substitution of DOTE is technically not feasible.  This would result in an extreme workload for all stakeholders in this process.

	A.1.3.3. Refinement of WDU score based on article service-life

A.1.5.2. Authorisation is disproportionate and/or means a ban

A.1.5.4. Control of risks

A.1.5.5. Availability of suitable alternatives

A.2.01. Consider RAC conclusion on the proposal to revise DOTE harmonised classification

A.2.02. The substance as listed in the SVHC list has not been registered / Candidate List entries do not match registrations

A.2.03. Questioning the volume score assigned to DOTE (mono-constituent)

A.2.04. Prioritisation score for service life in articles considered not justified

A.2.05. Claim the use as stabilisers during PVC 
processing as intermediate

A.2.06. Questioning the grouping consideration on the basis that "DOTE:MOTE reaction mass" as not been registered as such

A.2.07. Perception that grouping is considered for scoring purpose

C.2.01. Exemption for applications in packaging of medicinal products (reference to Directive 2001/83/EC and Regulation (EC) No 726/2004)

C.2.02. Exemption for applications for food contact (reference to Regulation 1935/2004/EC)	
				
3334
2018/12/05	ChemSec,
International NGO,
Sweden	ChemSec supports the prioritisation of 2-ethylhexyl 10-ethyl-4,4- dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (DOTE) for inclusion in Annex XIV.	Thanks for your comment.	
				
3356
2018/12/05	Norway,
Member State	The Norwegian CA supports the prioritisation of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (DOTE) and the reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate and 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (reaction mass of DOTE and MOTE) for inclusion in Annex XIV.
In general, the Norwegian CA supports grouping of substances of very high concern to avoid substitution with substances with similar properties within the same use categories.	Thanks for your comment.	
				
3384
2018/12/05	CHEM Trust,
National NGO,
United Kingdom	CHEM Trust strongly supports the prioritisation of 2-ethylhexyl 10-ethyl-4,4- dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (DOTE) for inclusion in Annex XIV.	Thanks for your comment.	
				
3413
2018/12/05	EuPC,
Industry or trade association,
Belgium	The European Plastics Converters (EuPC) is the leading EU-level Trade Association, based in Brussels, representing European Plastics Converters. EuPC now totals about 51 European Plastics Converting national and European industry associations, it represents close to 50,000 companies, producing over 45 million tonnes of plastic products every year. The European plastics industry makes a significant contribution to the welfare in Europe by enabling innovation, creating quality of life to citizens and facilitating resource efficiency and climate protection. More than 1.6 million people are working in about 50,000 companies (mainly small and medium sized companies in the converting sector) to create a turnover in excess of 220 billion € per year.

Those stabilizers are mainly used for stabilizing the transparent and opaque rigid film and sheet applications, granting them performances unmatched by any alternative molecules. Those applications will be found mainly in the packaging, construction and automotive sector. For exemption in case the substance would be prioritized see below.
Volumes : we refer to the updated information provided by the registrants.
Wide dispersiveness of uses:
As correctly evaluated by Echa, the use is only at industrial site. We would however question the  added refined score for the presence in article. Although some residues will be present it is the function of DOTE to react during processing. It is questionable whether the levels of DOTE in the finished article will exceed for all uses the 0,3% threshold depending on the original concentration of DOTE added.
The additional 2 score points are therefore in our view not warranted.

Further considerations on grouping :
Only DOTE was registered and the part of DOTE in complex substances. Grouping those 2 entries would actually lead to a double counting. Grouping should not be taken into account for scoring purposes.

	A.2.02. The substance as listed in the SVHC list has not been registered / Candidate List entries do not match registrations

A.2.04. Prioritisation score for service life in articles considered not justified

A.2.07. Perception that grouping is considered for scoring purpose	
		Attachment: 3413_2018-12-05_EuPC_ECHA Consultation responses on DOTE_FINAL.pdf
		
3419
2018/12/05	ESPA aisbl,
Industry or trade association,
Belgium	Comments on the draft recommendation of substances for inclusion in Annex XIV
Substance name: 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (DOTE)
EC Number: 239-622-4
ESPA (ETINSA)* comments to the Public Consultation – Non  confidential
Volumes used within the scope of authorization
DOTE is used in applications within the scope of Regulation (EC) No 1935/2004 (Food Contact Films and Immediate packaging for medication). Thus, these uses are exempted from authorization.
The volume DOTE used in the manufacturing of immediate packaging for pharmaceuticals is covered by Directive 2001/83/EC referring to the European Pharmacopoeia. Thus this volume is not within the scope of REACH (Article 2).
DOTE in these uses is directly added during the manufacturing step. It is mixed with virgin PVC and other additives, and without any further isolation of a compound manufactured into the finished article.
Clarification of volume reporting
According to Section 4.2.2.4 of ECHA Guidance for identification and naming of substances under REACH and CLP, the registrants of DOTE chose the option which allows the registration of multi-constituents substances as individual constituents.
In order to keep transparency about the manufactured / imported volumes, the registrants of DOTE modified section 3.2 of their dossiers and reported both, the volumes of DOTE which meet the definition of a pure substance and volumes of DOTE as a constituent in a substance meeting the criteria of a multi-constituent substance.
The sum of both is the total manufactured / imported DOTE.
Wide-dispersiveness of uses
In 2016 all DOTE registrants have updated their registration, removing the service life in articles from the technical dossier (IUCLID) and the CSR.
The purpose of a heat stabilizer like DOTE is to prevent the formation of HCl during manufacturing of PVC articles caused by heat and shear.  Unlike other  additives like plasticizers or pigments, DOTE is not only embedded in the polymer matrix but  in addition chemically modified by the PVC.
As a consequence the volume of DOTE, as such, in PVC gets dramatically reduced when a PVC article is produced.
In accordance with Article 3(15) of the REACH Regulation, an intermediate is “a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance”. Consequently, DOTE functions as an intermediate during the PVC stabilization process.
We therefore believe two priorisation points which reflect article service life are not justified.
Further considerations for priority setting (grouping)
Reaction Mass DOTE/MOTE: According to Section 4.2.2. of the ECHA Guidance for identification and naming of substances under REACH and CLP, the registrants of DOTE chose the option not to use the reaction mass DOTE/MOTE, but to register  its  multi-constituent  substances as individual constituents.
A Reaction Mass DOTE/MOTE, as it appears in the SVHC list and which is also subject to ECHA’s ninth recommendation for the inclusion of substances in Annex XIV, has never been registered.
However, it seems to be ECHA’s view to treat a not-registered substance exactly like a fully registered substance.
As a negative consequence the priorisation grouping for the reaction mass DOTE/MOTE is mentioned as a further consideration. This grouping does not exist since the reaction mass DOTE/MOTE has not been registered. So DOTE is grouped here with itself as a constituent in a virtual substance.
We believe priorisation based on this grouping is not justified.
Additional information on uses
DOTE in Mixtures is the only stabilizer system which is listed in the European Pharmacopoeia (3.1.10 Materials based on non-plasticised poly(vinyl chloride) for containers for non-injectable, aqueous solutions and 3.1.11 Materials based on non-plasticised poly(vinyl chloride) for containers for solid dosage forms for oral administration) which are manufactured within the EU.
DOTE is used to a high extent in the building and construction sector (for example profiles). Uses in these applications are not generically exempted from Authorisation.
 
DOTE in final Article
The migration properties of DOTE within or out of PVC has been examined and is extremely low. The Specific Migration Limit in the Commission Regulation (EU) 10/2011 is set to 0.006 mg/kg (as Tin). This low migration limit is achieved by manufacturers and frequently checked by authorized testing facilities for the specific applications.
Although the compliance with this migration limit is only verified for uses in the scope of Regulation (EC) No 1935/2004, the low migration properties of DOTE in technical applications can be considered comparable.
Recycling of DOTE-stabilized PVC is possible. There is no negative impact on new PVC products from the stabilizer in the recycled PVC. Any unreacted DOTE in recycled PVC will perform the same function as newly added DOTE and during the production and will extend the service life of the PVC article.
Recycling systems are well established in different industrial sectors which drive high recycling rates for stabilized PVC.
Risk Considerations
The risks to human health or the environment from the manufacturing and use of DOTE are well controlled. This is documented in the CSR of the substance. The substance currently meets the criteria of Article 57 (c), and it is possible to derive threshold limits in accordance with Section 6.4 of Annex I (DNEL/PNEC). The calculated RCRs are well below 1.
Supply Chain Considerations
DOTE is mainly used as PVC stabilizer. PVC is an extremely versatile polymer, which is used in hundreds of different applications.  So although the life cycle of DOTE manufacturing – formulation – industrial use looks manageable, we are afraid that in case of adding DOTE to Annex XIV a high number of authorization applications might be necessary to authorize the numerous  applications where a substitution of DOTE is technically not feasible.  This would result in an extreme workload for all stakeholders in this process.

 

*About ESPA

ESPA (the European Stabiliser Producers Association) is a pan-European trade association representing more than 95% of the PVC stabiliser industry across Europe. ESPA is a founding member of VinylPlus, the Voluntary Commitment of the European PVC industry towards sustainability.

ETINSA, the European Tin Stabiliser producers Association, is a sub-group of ESPA.

ESPA mission is to promote the use of stabiliser additives for vinyl applications and to provide a forum for the study and discussion of matters of scientific, technical, and environmental interest. ESPA also cooperates with national and supranational organisations and other industry associations, consumer organisations and non-governmental organisations and will carrying out joint projects of matters of technical, scientific and regulatory interests for stabilisers used in PVC.

aisbl
www.stabilisers.eu
European Stabiliser Producers Association
Avenue E. van Nieuwenhuyse 4 (Box 2)
B-1160 Brussels - Belgium
(From January 2019: Belliard 40 – B-1040)

espa@cefic.be
www.stabilisers.eu
www.vinylplus.eu
	A.1.3.3. Refinement of WDU score based on article service-life

A.1.5.2. Authorisation is disproportionate and/or means a ban

A.1.5.4. Control of risks

A.1.5.5. Availability of suitable alternatives

A.2.01. Consider RAC conclusion on the proposal to revise DOTE harmonised classification

A.2.02. The substance as listed in the SVHC list has not been registered / Candidate List entries do not match registrations

A.2.03. Questioning the volume score assigned to DOTE (mono-constituent)

A.2.04. Prioritisation score for service life in articles considered not justified

A.2.05. Claim the use as stabilisers during PVC processing as intermediate

A.2.06. Questioning the grouping consideration on the basis that "DOTE:MOTE reaction mass" as not been registered as such

A.2.07. Perception that grouping is considered for scoring purpose

C.2.01. Exemption for applications in packaging of medicinal products (reference to Directive 2001/83/EC and Regulation (EC) No 726/2004)

C.2.02. Exemption for applications for food contact (reference to Regulation 1935/2004/EC)	
		Confidental attachment removed		

II - Transitional arrangements. Comments on the proposed dates
Number / Date	Submitted by (name, submitter type, country)	Comment	Reference to responses	
3413
2018/12/05	EuPC,
Industry or trade association,
Belgium	The PVC sector contains many SMEs (several thousands). Organizing those using DOTE for authorization will be a considerable effort. We would therefore advice the maximum period for a latest application date.	B.2.01. Advice the maximum period for a LAD	
		See the corresponding embedded attachment in table 1 of Part I:
3413_2018-12-05_EuPC_ECHA Consultation responses on DOTE_FINAL.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	
3319
2018/12/04	Organotin REACH Consortium,
Company,
Belgium	Generic Excemptions:
Uses within the scope of Regulation 1935/2004/EC
Uses within the scope of irective 2001/83EC	C.1.1. General principles for exemptions under Art. 58(2)

C.1.2. Generic exemptions

C.2.01. Exemption for applications in packaging of medicinal products (reference to Directive 2001/83/EC and Regulation (EC) No 726/2004)

C.2.02. Exemption for applications for food contact (reference to Regulation 1935/2004/EC)

3413
2018/12/05	EuPC,
Industry or trade association,
Belgium	The substances should not be subject to authorization in case their classification is revised by RAC.
The following applications would benefit from exemptions under REACH : the registrants registered DOTE not the reaction mass of DOTE and MOTE. Grouping the 2 “substances” actually is a double counting of same volumes.
- Applications for food contact  (DOTE is allowed in regulation 10/2011EC) as exempted under article as per article 56.5.b of REACH
- Application as immediate packaging of pharmaceuticals (falling within the scope of directive 2001/83/EC) as per article 2.5.a. of REACH
	A.2.01. Consider RAC conclusion on the proposal to revise DOTE harmonised classification

C.1.1. General principles for exemptions under Art. 58(2)

C.1.2. Generic exemptions

C.2.01. Exemption for applications in packaging of medicinal products (reference to Directive 2001/83/EC and Regulation (EC) No 726/2004)

C.2.02. Exemption for applications for food contact (reference to Regulation 1935/2004/EC)
	
		See the corresponding embedded attachment in table 1 of Part I:
3413_2018-12-05_EuPC_ECHA Consultation responses on DOTE_FINAL.pdf