Comments on ECHA’s Draft 9th Recommendation for Trilead dioxide phosphonate (EC number: 235-252-2) 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 Trilead dioxide phosphonate (EC number: 235-252-2). 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_lead_stabilisers_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	
3284
2018/09/26	REHAU AG + Co.,
Company,
Germany	The ECHA draft documents reference that the „uses are still reported in registrations“. Existing registrations do not necessarily mean that the substances are still in production. A registration is required to enable recycling of the substance (according to (EC) No 1907/2006, Article 2 Paragraph 7 Letter d). Therefore, a registrant of the substance will keep his registration active to enable recycling, even if he does not produce the lead compound any more.	A.2.03. Claim that a registrant may keep its registration active and report uses as stabiliser to enable recycling even though the substance is not produced any more	
				
3292
2018/11/26	Germany,
Member State	The use of this substance as a stabiliser in PVC will be banned once the restriction on lead in PVC will come into force. However, the restriction proposal drafted by ECHA foresees to allow the use of recycled PVC for another 15 years with concentra-tions up to 2% of lead compounds which we strongly support.
It remains unclear whether this exact use of recycled PVC is in the scope of the authorisation regime. We therefore recommend including a reflection on the interplay between the restriction of lead in PVC and a potential authorisation requirement for this substance in recycled materials in the final background document.	A.2.05. Interplay between the restriction of lead in PVC and a potential authorisation requirement for leads in recycled materials	
				
3306
2018/11/30	Lead REACH Consortium c/o International Lead Association,
Industry or trade association,
United Kingdom	We would question the relevance and effectiveness of including this substance in the 9th recommendation and in REACH Annex XIV.

The major use of trilead dioxide phosphonate (EC 235-252-2, CAS 12141-20-7), historically, was as a stabiliser for PVC; minor uses also identified in the REACH Registration dossier are in industrial formulation and application of mirror backing, and in industrial rubber production.

As noted in the draft background report, the stabiliser sector made a voluntary commitment to replace Pb-based stabilisers in all formulations sold on the EU market by the end of 2015. According to Vinylplus progress reports 2016 and 2017, Industry completed the replacement of according to foreseen timelines.

Furthermore, in April 2018, ECHA sent a combined RAC and SEAC opinion to the Commission in favour of a REACH Restriction on the use of lead compounds in PVC articles and the placing on the market of PVC articles containing lead compounds such as this substance. With such a Restriction and the voluntary commitment in place, the only recognised EU use of this substance in the context of PVC stabilisers would be formulation for export-only.

According to the Chemical Safety Report, the specialist industrial use of this substance in mirror backing is carried out by a very limited number of workers using either lead oxide sulfate and/or trilead dioxide phosphonate. The CSR reports 12 workers involved in the application of the lead-based mirror backing for the period 2010-2011; the 90th percentile blood lead level reported in the CSR was less than 8 µg/dL.

The other specialist industrial use of trilead dioxide phosphonate, i.e. in rubber production, is also carried out by a limited number of workers: the CSR reports 33 workers involved in the use for the period 2009-2012. Again, the 90th percentile blood lead level reported in the CSR was less than 8 µg/dL. Furthermore, during the Consortium's 2009-2012 blood lead survey, the rubber sector reported that some companies had ceased using lead compounds entirely by virtue of substitution. Therefore, this niche use of trilead dioxide phosphonate should be noted as in decline.

In light of ECHA’s draft 9th recommendation, a number of registrants have recently deactivated their registrations of the lead compounds included in the list in order to indicate cease manufacture/import and to facilitate an update to the total registered tonnage band. As Secretariat to the Consortium, ILA has also recently advised active registrants to update their dossiers to clarify volumes manufactured, volumes directly exported, and volumes used in EU uses, i.e. formulation for export, rubber production, and mirror backing – only the EU uses would be in scope of Authorisation – given the Vinylplus voluntary replacement initiative and the impending REACH Restriction.

As such, we contest the volume estimated by ECHA to be in scope of Authorisation and we disagree with the volume score of 15 and the total score of 23 as reported in the current draft background document. According to registration from the Registered Substances Database (ECHA, 2018), as at 30 October the total tonnage range is 1,000-10,000 tpy, not 10,000-100,000 tpy as reported in the current draft background document. Furthermore, the volume score should be based on EU uses, taken from registration dossiers, rather than total registered tonnage. We note that at least two of the six active registrants have submitted dossier updates during 2018. Therefore, we would request ECHA to re-evaluate the volume score based on the latest registration information, which would reduce it to no more than 12, per the “Prioritisation of substances of very high concern (SVHCs) for inclusion in the Authorisation List (Annex XIV)” (ECHA, 2014).

As EU use of this substance is restricted to the workplace, we propose that a review of existing EU binding occupational and biological limit values for lead and compounds would be a more proportionate risk management option than REACH Authorisation. We would request that ECHA and MSC consider any precedent that might be established in this regard for other lead compounds that have previously been included in ECHA recommendations for SVHCs to be added to the Authorisation List.
	A.1.1.4. Information taken into consideration for the draft recommendation

A.1.1.5. New information and next steps towards the final recommendation

A.1.5.1. Potential other regulatory actions

A.2.01. Questioning scoring and general priority of the substances	
		Attachment: 3306_Annex 1 - About the Consortium and list of members.pdf
		
3307
2018/11/30	Meggitt PLC,
Company,
United Kingdom	Use of trilead dioxide phosphonate in aerospace & defence industry - anti-friction coating & lubrication applications for many aircraft & defence parts	A.1.5.2. Authorisation is disproportionate and/or means a ban

B.1.2.2. Lack of alternatives, socio-economic aspects	
		Attachment: 3307_Meggitt trilead dioxide phosphonate recomm 9 consultcomment 30.11.18.docx
		
3328
2018/12/05	ADS Group Limited,
Industry or trade association,
United Kingdom	The substance Trilead Dioxide Phosphonate was identified as an SVHC and added to the REACH Candidate List on 19th Dec 2012 due to its Toxic for Reproduction (Article 57C) properties and is currently in the 9th recommendation to be added to Annex XIV.
Trilead Dioxide Phosphonate is used in anti-friction coating mixtures both inside and outside of the EU for critical aerospace and military applications such as the coating and lubrication of torque tubes in brake systems, wheel faces/flanges and key slots for aircraft and to prevent thread seizure in other applications.  Should these aircraft brake systems/other applications be subject to maintenance, repair and overhaul activities in the EU requiring the use of such anti-friction or anti-thread seizure mixtures, then the Aerospace and Defence industry would like to use this opportunity to identify its need for the continued use of such mixtures at this time.
GIFAS (Groupement des Industries Françaises Aeronautiques et Spatiales) indicated during the svhc public consultation (RCOM, 2012) that the use of this substance in greases (anti-friction coating) may have alternatives potentially available in the future however to date, suitable replacement(s) for all applications listed have yet to be fully tested and qualified.
	A.1.5.2. Authorisation is disproportionate and/or means a ban

B.1.2.2. Lack of alternatives, socio-economic aspects

Please see also response to comment #3307	
				
3341
2018/12/05	ChemSec,
International NGO,
Sweden	ChemSec supports the prioritisation of trilead dioxide phosphonate for inclusion in Annex XIV and support grouping it with other lead substances used as stabilisers	Thanks for your comment.	
				
3362
2018/12/05	Norway,
Member State	In general, the Norwegian REACH CA supports measures that will reduce the use and emission of lead and lead compounds. We also support grouping of lead substances to avoid substitution with substances with similar properties within the same use categories. We consider the prioritisation criteria to be fulfilled and support that trilead dioxide phosphonate is prioritised for inclusion in Annex XIV.	Thanks for your comment.	
				
3377
2018/12/05	CHEM Trust,
National NGO,
United Kingdom	CHEM Trust strongly supports the prioritisation of trilead dioxide phosphonate for inclusion in Annex XIV and agrees with the importance of grouping it with other lead substances used as stabilisers, as proposed by ECHA.	Thanks for your comment.	
				
3410
2018/12/05	AeroSpace and Defence Industries Association of Europe (ASD),
Industry or trade association,
Belgium		A.1.5.2. Authorisation is disproportionate and/or means a ban

B.1.2.2. Lack of alternatives, socio-economic aspects	
		Attachment: 3410_ASD input_on_trilead dioxide phosphonate .pdf

II - Transitional arrangements. Comments on the proposed dates
Number / Date	Submitted by (name, submitter type, country)	Comment	Reference to responses	
3284
2018/09/26	REHAU AG + Co.,
Company,
Germany	If the obligation for Authorization will come into effect, this will disable the recycling of post-consumer PVC-U material/articles.	A.1.5.2. Authorisation is disproportionate and/or means a ban

3306
2018/11/30	Lead REACH Consortium c/o International Lead Association,
Industry or trade association,
United Kingdom	If this substance were to be included in Annex XIV, the standard LAD slots would not appear to be inappropriate.	Thanks for your comment.	
		See the corresponding embedded attachment in table 1 of Part I:
3306_Annex 1 - About the Consortium and list of members.pdf		
3307
2018/11/30	Meggitt PLC,
Company,
United Kingdom	Consideration should be given re LADs/sunset dates due to lengthy validation periods required to industrialise an alternative where currently none exist	B.1.2. Aspects not considered by ECHA when proposing latest application dates/sunset dates

B.1.2.2. Lack of alternatives, socio-economic aspects
	
		See the corresponding embedded attachment in table 1 of Part I:
3307_Meggitt trilead dioxide phosphonate recomm 9 consultcomment 30.11.18.docx		
3328
2018/12/05	ADS Group Limited,
Industry or trade association,
United Kingdom	This product covers safety critical aerospace uses such as aircraft braking systems and since the make-up and physical aspects of aircraft designs vary widely across programs, multiple tests would be needed to validate any changes, as substitute products may perform differently in different applications.
Consequently to fully qualify and industrialise an alternative product used in the aerospace and defence industries, once a viable alternative is identified, the qualification time would be a lengthy process which we anticipate would exceed the estimated time to the sunset date given in the draft background document published on the 5th September 2018.
	B.1.2.2. Lack of alternatives, socio-economic aspects

Please see also response to comment #3307	
				
3362
2018/12/05	Norway,
Member State	In general, we are in favour of the shortest LAD slot.	Thank you for your opinion.
B.1.1.3. ECHA's proposal for latest application dates

3401
2018/12/05	Aerospace Industries Association (AIA),
Industry or trade association,
United States	The aerospace sector relies on surveys and encourages affected dowsntream users to collaborate in authorisation consortia (by joining or contributing) and voluntarily provide relevant data to third party consultants that aggregate the available data.  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 develop an accurate and comprehensive application.	B.1.1.3. ECHA's proposal for latest application dates

B.1.2.1. Extensive time needed in the supply chain to get organised for preparing application (e.g. due to high number of users)

3410
2018/12/05	AeroSpace and Defence Industries Association of Europe (ASD),
Industry or trade association,
Belgium		A.1.5. Aspects not considered in ECHA's prioritisation

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

B.1.2. Aspects not considered by ECHA when proposing latest application dates/sunset dates

B.1.2.2. Lack of alternatives, socio-economic aspects
	
		See the corresponding embedded attachment in table 1 of Part I:
3410_ASD input_on_trilead dioxide phosphonate .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	
3284
2018/09/26	REHAU AG + Co.,
Company,
Germany	o PVC pipes and window profiles are expected to last between 10 and up to 100 years. It can be assumed that there will be certain amounts of lead stabilized recycling PVC for the next decades in the market. Hence, there should be an exemption for recycling PVC that still allows the use of lead compounds listed on Annex XIV. The use of recycling PVC is beneficial for the environment.  Furthermore, it is not necessary to take any particular precautionary measures when dealing with recycling PVC articles as the lead compounds are bound in the polymeric matrix and are not released in hazardous quantities when being used according to regulations.
o For the recycling material, it is not possible to make a differentiation between the four lead compounds that are proposed to be included in REACh Annex XIV (Dioxobis(stearato)trilead; Fatty acids, C16-18, lead salts; Trilead dioxide phosphonate; Sulfurous acid, lead salt, dibasic). Analytic methods can only detect the total amount of lead remaining in the product. It is a grey area whether the limit value of 0.1% for one specific lead compound is exceeded or not. Therefore, it cannot be proven whether there is an authorization requirement or whether the product falls under the exemption according to (EC) No 1907/2006, Article 56 Paragraph 6 Letter a.
o One specific authorization requirement for each of the four lead compounds causes an unnecessary effort for recycling companies, especially since the authorization is limited temporarily. During the recycling process, the four lead compounds are used simultaneously and there will be exactly the same toxicity risk regardless of using only one or all four of them.	A.2.07. Burden of the Afa requirement (in particular for SMEs in the recycling sector)

A.2.08. Questioning the practicability of the authorisation requirement for uses of legacy lead compounds in PVC recyclate considering that single substances cannot be differentiated by analytical methods

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

C.1.3. Aspects not justifying an exemption from authorisation

C.2.02. Exemption request for recycling of PVC containing lead based on worker safety legislation and upcoming restriction

3306
2018/11/30	Lead REACH Consortium c/o International Lead Association,
Industry or trade association,
United Kingdom	We note that, in the draft background document, ECHA proposes not to recommend exemptions for uses of this substance on the basis of Article 58 (2) of the REACH Regulation (Section 3.3.1).

However, we would highlight that the Commission has discretion for granting a REACH Article 58 (2) exemption for uses in the EU that are restricted to industrial processing, such as formulation for export-only, given the framework of existing legislation established to address risk in and from the workplace.

Should this substance be included in Annex XIV without relevant (Article 58 (2)) exemptions, there is a strong case for the use of a Simplified Authorisation Process for of trilead dioxide phosphonate, given the two small-volume, specialist end uses involving a very limited number of workers with demonstrably low exposure to Pb.
	A.2.09. Simplified authorisation process for low volume end-uses

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

C.2.03. Exemption request for uses restricted to industrial processing (such as 'formulation for export')	
		See the corresponding embedded attachment in table 1 of Part I:
3306_Annex 1 - About the Consortium and list of members.pdf		
3328
2018/12/05	ADS Group Limited,
Industry or trade association,
United Kingdom	See above.	Please see references to responses in section I

Please see also response to comment #3307	
				
3362
2018/12/05	Norway,
Member State	Norway does not support that any exemptions from the authorisation requirement should be proposed.	Thanks for your comment.