Comments on ECHA’s Draft 9th Recommendation for Lead oxide sulfate (EC number: 234-853-7) 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 Lead oxide sulfate (EC number: 234-853-7). 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	
3303
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 lead oxide sulfate in the 9th recommendation and in REACH Annex XIV.

Lead oxide sulfate (EC 234-853-7; CAS 12036-76-9) has only one small-volume, specialist end use in the EU which is in the application of mirror backing, i.e. the coating of glass with a reflective surface. There is only one active registrant, based in the UK, and no inactive registrants. The total registered tonnage is 0-10 tpy; the LR dossier was last updated in September 2018, in particular to update some of the environmental aspects of the dossier, including aquatic and sediment PNECs.

While we agree with the total priority setting score of 5 as reported in the conclusion of the current draft background document (Section 2.5), we question the grouping of lead oxide sulfate “with other lead substances used as stabilisers”. This substance is NOT used as a stabiliser in PVC, as has been indicated in at least the last three significant updates to the Chemical Safety Report Part B submitted in the last five years. Dossier updates submitted by the LR in 2014, 2016 and 2018 DID NOT identify a use of this substance as a stabiliser for PVC, only its use in formulation and subsequent mirror backing application.

According to the Chemical Safety Report, this specialist industrial use 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.

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.1.5.1. Potential other regulatory actions
A.1.5.3. Use specific considerations
A.1.5.4. Control of risks
A.2.01. Questioning scoring and general priority of the substances
A.2.04. Challenging the grouping of lead oxide sulfate with other lead substances used as stabilisers	
		Attachment: 3303_Annex 1 - About the Consortium and list of members.pdf
		
3345
2018/12/05	ChemSec,
International NGO,
Sweden	Chemsec supports the prioritisation of lead oxide sulfate for inclusion in Annex XIV and asupports grouping with other lead substances used as stabilisers.	Thank you for your opinion.	
				
3361
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 lead oxide sulfate is prioritised for inclusion in Annex XIV.	Thank you for your opinion.	
				
3371
2018/12/05	CHEM Trust,
National NGO,
United Kingdom	CHEM Trust strongly supports the prioritisation of lead oxide sulfate for inclusion in Annex XIV and agrees with the importance of grouping it with other lead substances used as stabilisers, as proposed by ECHA.	Thank you for your opinion.	
				
3397
2018/12/05	ESPA aisbl,
Industry or trade association,
Belgium	LEAD OXIDE SULFATE

General comments

The European Stabiliser Producers Association (ESPA) would like to clarify information reported in the Draft background document for lead oxide sulfate (EC 234-853-7; CAS 12036-76-9) prepared by the ECHA (5 September 2018).

In section 2.4, paragraph 2, the following is reported:

“Although the use as stabiliser is no longer reported in registration dossiers of lead oxide sulfate that use was reported in previous dossier versions. The substance is also included in the restriction proposal on lead compounds used as stabilisers in PVC that ECHA sent to the Commission in April 2018 (ECHA, 2018b), thereby indicating that lead oxide sulfate could potentially replace other lead stabilisers in some of their uses. “

ESPA informs that lead oxide sulfate is not / has not been used as a stabiliser for PVC and is not reported in the registration dossier as an identified use.

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.

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.

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.2.04. Challenging the grouping of lead oxide sulfate with other lead substances used as stabilisers
Thank you for the information provided	

II - Transitional arrangements. Comments on the proposed dates
Number / Date	Submitted by (name, submitter type, country)	Comment	Reference to responses	
3303
2018/11/30	Lead REACH Consortium c/o International Lead Association,
Industry or trade association,
United Kingdom	We question the relevance of recommending lead oxide sulfate for Authorisation. However, if the substance were to be included in Annex XIV, the standard LAD slots would not appear to be inappropriate.	Thank you for your opinion.	
		See the corresponding embedded attachment in table 1 of Part I:
3303_Annex 1 - About the Consortium and list of members.pdf		
3361
2018/12/05	Norway,
Member State	In general, we are in favour of the shortest LAD slot.	B.1.1.3. ECHA's proposal for latest application dates

Thank you for your opinion.	

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	
3303
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 lead oxide sulfate 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 that are restricted to industrial processing 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 lead oxide sulfate, given the small-volume, specialist end use 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.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:
3303_Annex 1 - About the Consortium and list of members.pdf		
3361
2018/12/05	Norway,
Member State	Norway does not support that any exemptions from the authorisation requirement should be proposed.	Thank you for your opinion.