Comments on ECHA’s Draft 9th Recommendation for [Phthalato(2-)]dioxotrilead (EC number: 273-688-5) 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 [Phthalato(2-)]dioxotrilead (EC number: 273-688-5). 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	
3289
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	
				
3302
2018/11/30	Lead REACH Consortium c/s 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.

We dispute the volume estimated by ECHA to be in scope of Authorisation and therefore disagree with the priority score of 11 reported in the conclusion of the current draft background document (Section 2.5).

As noted in the draft background report, the stabiliser sector made a voluntary commitment to replace Pb-based stabilisers in all formulations sold in 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 and as such there is no remaining EU use of this substance.

The LR dossier for [phthalato(2-)]dioxotrilead was updated in October 2018 (to revise certain environmental aspects of the dossier, including aquatic and sediment PNECs). There was only one active registrant (the LR) at the time; that company has since deactivated its registration to indicate cease manufacture/import. As such, there is no longer an active REACH Registration for this substance.

Therefore, we would propose a volume score of zero to be more appropriate. In addition, we propose that the wide dispersiveness of uses (WDU) score should also be reduced to zero based on ‘no use’, per the ECHA ‘Prioritisation of substances of very high concern (SVHCs) for inclusion in the Authorisation List (Annex XIV)’.	A.2.01. Questioning scoring and general priority of the substances	
		Attachment: 3302_Annex 1 - About the Consortium and list of members.pdf
		
3343
2018/12/05	ChemSec,
International NGO,
Sweden	ChemSec supports the prioritisation of [Phthalato(2-)]dioxotrilead for inclusion in Annex XIV and supports grouping with other lead substances used as stabilisers.	Thank you for your opinion.	
				
3373
2018/12/05	CHEM Trust,
National NGO,
United Kingdom	CHEM Trust strongly supports the prioritisation of [Phthalato(2-)]dioxotrilead 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.	
				
3375
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 [phthalato(2-)]dioxotrilead is prioritised for inclusion in Annex XIV.	Thank you for your opinion.	
				
3418
2018/12/05	EuPC, PRE, VinylPlus,
Industry or trade association,
Belgium	This questionnaire is not adapted to recycling activities:
• Recyclers are receiving some PVC containing legacy lead stabilizers embedded in the polymer matrix, as these stabilizers have been used during many years in the PVC industry (especially for the production of pipes and profiles)
• Recyclers are not selecting PVC wastes because they contain lead stabilizer, and therefore lead compounds present in PVC to be recycled can be considered as impurities according to the ECHA guidance on waste and recovered substances
• Recyclers are not adding any virgin lead stabilizer during the recycling process.
• Thus this questionnaire is not well adapted to recycling activities: thus it is important to fill in a questionnaire related in a way strictly limited to recycling activities, in order to be clear on these specificities
• This answer focuses solely on the recycling of PVC waste containing legacy lead impurities (done at the recyclers) and the downstream uses in compounding and converting.

• Recycling of post-consumer PVC
A lot of efforts have been made by industry to establish a well working system to recycle PVC, including for complex articles like windows. Mechanical recycling of PVC allows to save the embedded carbon and save energy and resources otherwise needed to produce fresh PVC  resin.
• Taking into account the existing legislation and the upcoming restriction on Pb in PVC, we believe that all relevant risks are addressed.
• The only additional risk is related to workers’ exposure, which is covered by a binding EU OEL. Current exposure levels of workers are not significantly different from background Pb level in the general population and are well below the current binding EU Occupational Exposure Limit. In case this limit is not considered protective enough the EC should take action. The PVC industry from its side ensured to reach minimized workers exposure levels already.
• It is our opinion that recycling of PVC containing lead should be exempted from authorization based on article 58.2 of REACH.
• Recyclers are largely SMEs and most would not be able to face this challenge and hence drop the recycling of PVC.

• More info on www.vinylplus.eu

Comments on scoring:

Pb contained in recyclate is not intentionally placed on the market (legacy additive). Pb quantities are towards the lower end of the tonnage band 1000-10,000 T. Individual compounds are estimated to be below 1000 T.
	A.1.5.1. Potential other regulatory actions
A.1.5.3. Use specific considerations
A.1.5.4. Control of risks
A.2.02. Quantities of legacy lead in recyclate
A.2.06. Claim that lead compounds present in PVC recyclate can be considered as impurities
A.2.07. Burden of the Afa requirement (in particular for SMEs in the recycling sector)
C.2.02. Exemption request for recycling of PVC containing lead based on worker safety legislation and upcoming restriction	
		Attachment: 3418_2018-12_05_ECHA Consultation V+ EuPc PRE responses on Pb stabilizers.pdf

II - Transitional arrangements. Comments on the proposed dates
Number / Date	Submitted by (name, submitter type, country)	Comment	Reference to responses	
3302
2018/11/30	Lead REACH Consortium c/s International Lead Association,
Industry or trade association,
United Kingdom	Since there are no EU uses of this substance remaining, and no active registration, we question the relevance and effectiveness of recommending this substance 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: 3302_Annex 1 - About the Consortium and list of members.pdf		
3375
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.	
				
3418
2018/12/05	EuPC, PRE, VinylPlus,
Industry or trade association,
Belgium	As mentioned above, we do not think authorization is an appropriate risk management option for this case. It is also to be considered, that a Restriction proposal on Lead compounds is close to be finalised (https://www.echa.europa.eu/web/guest/previous-consultations-on-restriction-proposals/-/substance-rev/16119/term).
We  therefore invite to take into account what will be the result of this risk management option, before considering proceeding into an eventual authorisation process.
However, in case this route would be chosen and taking into account the size and number of the recycling companies (more than 100), the latest application date and sunset date should be foreseen with a much longer timeframe than the one envisaged.
	A.1.5.1. Potential other regulatory actions
A.2.05. Interplay between the restriction of lead in PVC and a potential authorisation requirement for leads in recycled materials
B.2.01. Longer LAD and SSD required considering the size and number of recycling companies	
		See the corresponding embedded attachment in table 1 of Part I: 3418_2018-12_05_ECHA Consultation V+ EuPc PRE responses on Pb stabilizers.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	
3302
2018/11/30	Lead REACH Consortium c/s International Lead Association,
Industry or trade association,
United Kingdom	There is no active REACH Registration for this substance, and no identified uses in the EU that would be in scope of Authorisation or require Article 58 (2) exemption.	Thank you for your opinion.	
		See the corresponding embedded attachment in table 1 of Part I: 3302_Annex 1 - About the Consortium and list of members.pdf		
3375
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.	
				
3418
2018/12/05	EuPC, PRE, VinylPlus,
Industry or trade association,
Belgium	• Taking into account the existing legislation and the upcoming restriction, it is questionable whether more measures are needed to adequately control risks to human health and the environment. Indeed, there exists already an EU binding occupational exposure limit. In case this binding EU occupational limit is not considered sufficiently protective , the EC should take action by a suitable adaptation of the legislation protecting workers. One sector cannot be penalized by the inability of the EC to update its regulations according to latest scientific developments. The PVC industry from its side ensured to reach minimized workers exposure levels already.

• It is our opinion that recycling of PVC containing legacy lead impurities should be exempted from authorization based on article 58.2 of REACH. The relevant area of risk is already regulated via worker safety regulations.
• The use of the above substances for scientific research and development according to article 56(3) of REACH should be exempted from authorization. Indeed, the development of new applications (articles) for recyclate containing legacy lead impurities should remain possible  .
	A.1.5.1. Potential other regulatory actions
C.1.1. General principles for exemptions under Art. 58(2)
C.2.01. Exemption request for the use of recyclate containing legacy lead compounds for the development of new applications (articles)
C.2.02. Exemption request for recycling of PVC containing lead based on worker safety legislation and upcoming restriction	
		See the corresponding embedded attachment in table 1 of Part I: 3418_2018-12_05_ECHA Consultation V+ EuPc PRE responses on Pb stabilizers.pdf