Comments on ECHA’s Draft 9th Recommendation for Fatty acids, C16-18, lead salts (EC number: 292-966-7) 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 Fatty acids, C16-18, lead salts (EC number: 292-966-7). 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	
3282
2018/09/26	REHAU AG + Co.,
Company,
Germany	o 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	
				
3293
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	
				
3305
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.

Fatty acids, C16-C18, lead salts (EC 292-966-7, CAS 91031-62-8) has historical use in the EU as a stabiliser for PVC. No other uses were identified in the REACH Registration dossier.

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 would be formulation for export-only.

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 formulation for export – only the latter 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 data 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 use alone, i.e. formulation for export, rather than total registered tonnage, taken from registration dossiers. We note that at least three 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). Additionally, as the EU use of this substance in articles has been phased out, we propose a wide dispersiveness of uses (WDU) score of 5, not the 7 as currently proposed. In summary, we would expect to see a revised total priority score of less than 18 for this substance, i.e. below the threshold chosen by the ECHA MSC for the 9th recommendation.

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: 3305_Annex 1 - About the Consortium and list of members.pdf
		
3340
2018/12/05	ChemSec,
International NGO,
Sweden	ChemSec supports the prioritisation of fatty acids, C16-18, lead salts for inclusion in Annex XIV and supports grouping with other lead substances used as stabilisers.	Thanks for your comment.	
				
3360
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 fatty acids, C16-18, lead salts is prioritised for inclusion in Annex XIV.	Thanks for your comment.	
				
3379
2018/12/05	CHEM Trust,
National NGO,
United Kingdom	CHEM Trust strongly supports the prioritisation of fatty acids, C16-18, lead salts 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.	
				
3415
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.1.5.4. 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)

A.2.10. Document attached to comment relates to different substance

C.2.02. Exemption request for recycling of PVC containing lead based on worker safety legislation and upcoming restriction	
		Attachment: 3415_2018-12-05_EuPC_ECHA Consultation responses on DOTE_FINAL.pdf

II - Transitional arrangements. Comments on the proposed dates
Number / Date	Submitted by (name, submitter type, country)	Comment	Reference to responses	
3282
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

3305
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:
3305_Annex 1 - About the Consortium and list of members.pdf		
3360
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

3415
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:
3415_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	
3282
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

3305
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.	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:
3305_Annex 1 - About the Consortium and list of members.pdf		
3360
2018/12/05	Norway,
Member State	Norway does not support that any exemptions from the authorisation requirement should be proposed.	Thanks for your comment.	
				
3415
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:
3415_2018-12-05_EuPC_ECHA Consultation responses on DOTE_FINAL.pdf