Comments on ECHA’s Draft 7th Recommendation for Pentalead tetraoxide sulphate (EC number: 235-067-7) and references to responses

The present document compiles the comments received during the public consultation on the draft 7th recommendation for inclusion of substances in Annex XIV of REACH for Pentalead tetraoxide sulphate (EC number: 235-067-7). The public consultation took place between 18 November 2015 and 18 February 2016

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/10162/13640/7th_recom_respdoc_leads_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

Pentalead tetraoxide sulphate was also included in the 6th draft recommendation and underwent a three months public consultation in 2014. All comments and responses to comments* related to the 6th draft recommendation are available on ECHA’s ‘Submitted recommendations’ web page: http://echa.europa.eu/addressing-chemicals-of-concern/authorisation/recommendation-for-inclusion-in-the-authorisation-list/previous-recommendations  (See ‘Comments and response to comments’ in the ‘Substance Details’ information). The present document contains only the comments submitted in the public consultation on the 7th draft recommendation.
 
* except for the assessment of the exemption requests under Art. 58(2)

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	
3051
2016/02/03	International Lead Association,
Industry or trade association,
United Kingdom	Detailed comments were already provided in a previous consultation the context of the 6th priority list recommendation and are not repeated here unless not adequately reported in the current draft background document.

We disagree with the total priority setting score of 23 reported in the conclusions and justification of current draft background document (Section 2.5) based upon the volume in scope of authorization and description of uses. The use of pentalead tetraoxide sulphate in plastics is scheduled to be phased out at the end of 2015 as a result of a voluntary commitment to replace lead based stabilisers in PVC. As such the additional score of 2 applied to the WDU score of 5 due to “non-negligible release from articles as the integrity and stability of the plastic matrix is difficult to guarantee over time” should not be considered. Therefore we would contend that a total score of 21 be applied to pentalead tetraoxide sulphate
	See responses referred to in comment #3053 (ILA)	
		3051_Pentalead tetraoxide sulphate 7th Priority List Comments.pdf

3053
2016/02/03	International Lead Association,
Industry or trade association,
United Kingdom	Detailed comments were already provided in a previous consultation the context of the 6th priority list recommendation and are not repeated here unless not adequately reported in the current draft background document.

We disagree with the total priority setting score of 23 reported in the conclusions and justification of current draft background document (Section 2.5) based upon the volume in scope of authorization and description of uses. The use of pentalead tetraoxide sulphate in plastics is scheduled to be phased out at the end of 2015 as a result of a voluntary commitment to replace lead based stabilisers in PVC. As such the additional score of 2 applied to the WDU score of 5 due to “non-negligible release from articles as the integrity and stability of the plastic matrix is difficult to guarantee over time” should not be considered. Therefore we would contend that a total score of 21 be applied to pentalead tetraoxide sulphate.

We would also like to highlight that there is an error in the reported volumes in sections 2.2 and 2.5. In our opinion the total EU volume for this substance should be 100,000-1,000,000 t/y and not >1,000,000tpa. This error accounts for the discrepancy noted in section 4.1 comparing the EUROBAT tonnage with the total tonnage registered. Battery manufacturing is 95% of the total use. We will re-contact registrants to request that they check volumes reported in dossiers.
	A.2.10. WDU score should be lower / Ask ECHA to consider that the use of lead-stabilisers is phased out
A.2.9. Volume overestimated / Ask ECHA to consider that the use of lead-stabilisers in PVC is phased out
C.1.1. General principles for exemptions under Art. 58(2)
C.2.1. Response to requests for exemptions under Art. 58(2)
Please (also) refer to the response(s) given to your comment submitted during the public consultation on the 6th draft recommendation (available on ECHA's website)	
		3053_Pentalead tetraoxide sulphate 7th Priority List Comments.pdf

3077
2016/02/15	ASD,
Industry or trade association,
Belgium	See attachment	A.1.5. Aspects not considered in ECHA's prioritisation
A.1.5.2. Authorisation is disproportionate and/or means a ban
A.1.5.3. Use specific considerations
A.1.5.5. Availability of suitable alternatives
A.1.5.7. Burden for industry and potential competitive disadvantage
B.1.1. General principles for setting latest application dates/sunset dates
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
Please (also) refer to the response(s) given to your comment submitted during the public consultation on the 6th draft recommendation (available on ECHA's website)	
		3077_ASD repsonse to ECHA Consultation - Lead Compounds - February 2016.pdf

3095
2016/02/16	Arbeitsgemeinschaft PVC und Umwelt e.V.,
Industry or trade association,
Germany	Comments are made for the 2 lead substances: Pentalead tetraoxide sulfate and tetralead trioxide sulphate.
AGPU is representing substance producing companies, downstream users and recycling companies in Germany of the PVC supply chain. Priority is low since the Voluntary Committment of the European PVC industry (Vinyl 2010 and VinyPlus) is on track with the replacement process - lead based stablisers have been replaced by end of 2015 in a 15 year process. During the period of use no relevant cases / issues on Human Health or the Environment have be reported which were related to the manufacture or use of the lead substances for PVC in Germany. Today the substance is firmly enbedded in the PVC matrix of the finished articles. When these useful articles - mainly products in the building and construction sector with very long life times - become waste they are recovered. An actual study confirmes very high recovery rates for all PVC wastes in Germany - almost 40% is mechanically recycled and about 60% incinerated with energy recovery (Consultic Study 2013 PVC). A very large number (about 60) of SME are involved in PVC recycling in Germany and contribute to the Recycling target of the Voluntary Committment - if authorisation is required for the recyclates the majority of these recyclers will not continue PVC recycling. Today recyclates substitute about 18% of virgin PVC in Germany for the manufacture of PVC window profiles for the German market. This recyclate saves energy and other resources and reduces CO2 emissions (e.g. a window profile recyclate emmites about 10% of the CO2 of a virgin PVC resin). Therefore we recommend to exclude PVC-recycling applications from a potential authorisation process. We fully support the statements made by our European partner organisations ESPA and VinylPlus.	C.1.1. General principles for exemptions under Art. 58(2)
C.1.3. Aspects not justifying an exemption from authorisation
C.2.1. Response to requests for exemptions under Art. 58(2)
C.2.2. Recycling of lead containing PVC: specifics of that industry need to be considered by e.g. realistic limit values or exemption

Please see also response to comment #
3096 (VinylPlus) and # 3134 (ESPA)	
				
3096
2016/02/17	VinylPlus,
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
A.1.5.6. Socio-economic benefits of continued use
C.2.2. Recycling of lead containing PVC: specifics of that industry need to be considered by e.g. realistic limit values or exemption	
		3096_2016_02_13 Lead substances 7th priority list for authorisation, comments-VinylPlus.pdf

3104
2016/02/17	WVMetalle,
Industry or trade association,
Germany	We support the comments submitted in this section by the International Lead Association on behalf of the Pb REACH Consortium.	See responses referred to in comment #3053 (ILA)	
				
3106
2016/02/17	ZVEI - German Electrical and Electronic Manufacturers’ Association,
Industry or trade association,
Germany	A first response regarding the possible authorisation for lead compounds in battery manufacturing was provided during the public consultation for the 6th Priority list recommendation in December 2014.

The ‘ZVEI - German Electrical and Electronic Manufacturers’ Association’ wants to point out that several investments during the last years ensured the compliance with the requirements of OSH legislation within the frame of a “continuous improvement process”.

Furthermore the ZVEI supports the request of the Lead REACH Consortium for an exemption from an authorization requirement for lead monoxide, lead tetroxide, pentalead tetraoxide sulphate and tetralead trioxide sulphate if used for the manufacturing of lead-based batteries (Exemption according to article 58.2 of the REACH regulation).

For further information or if you have any questions please do not hesitate to contact us.	C.1.1. General principles for exemptions under Art. 58(2)
C.2.1. Response to requests for exemptions under Art. 58(2)
Please (also) refer to the response(s) given to your comment submitted during the public consultation on the 6th draft recommendation (available on ECHA's website)
See responses referred to in comment #3053 (ILA)	
				
3112
2016/02/17	RPS S.p.A.,
Company,
Italy		A.1.5. Aspects not considered in ECHA's prioritisation
A.1.5.2. Authorisation is disproportionate and/or means a ban
A.1.5.3. Use specific considerations
A.1.5.5. Availability of suitable alternatives
A.1.5.6. Socio-economic benefits of continued use
A.1.5.7. Burden for industry and potential competitive disadvantage
A.2.15. Questionnaire on socio-economic consequences
C.1.1. General principles for exemptions under Art. 58(2)
C.2.1. Response to requests for exemptions under Art. 58(2)

Please see also response to comment #
3053 (ILA) and comment #3120 (EUROBAT).	
		3112_recom_com_call_RPS SpA.docx

3120
2016/02/17	EUROBAT,
Industry or trade association,
Belgium	EUROBAT supports the request of the Lead REACH Consortium for an exemption from an authorization requirement for lead monoxide, lead tetroxide, pentalead tetraoxide sulphate and tetralead trioxide sulphate if used for the manufacturing of lead-based batteries (Exemption according to article 58.2 of the REACH regulation).	C.1.1. General principles for exemptions under Art. 58(2)
C.2.1. Response to requests for exemptions under Art. 58(2)

Please see also response to comment #
3053 (ILA)	
				
3132
2016/02/18	ANIE-CSI,
Industry or trade association,
Italy	1. Lead monoxide, lead tetroxide, pentalead tetraoxide sulphate and tetralead trioxide sulphate are essential and irreplaceable in the manufacture of lead-based batteries with no substitutes currently available. During the manufacturing phase of lead-based batteries, all four compounds are transformed into other substances within the battery (article). Only trace amounts of the four substances are (<0.1%) present in the finished battery.
2. There are no alternatives to the four lead compounds in the manufacturing of lead-based batteries , the response to the public consultation focuses on the essential applications of lead-based batteries.
3. Lead-based batteries are by far the most widely used electrochemical system in Europe and worldwide for automotive and industrial applications, due to their proven safety, excellent performance, low cost and operate in a closed loop with over 99% of batteries placed on the market being collected and recycled at end-of-life.
4. There are no substitutes for the substances and lead-based batteries are essential for vehicles – conventional ICE vehicles, conventional ICE vehicles with Start-Stop and basic micro-hybrid technologies, all hybrid vehicles (mild, micro and Plug-in-HEV, PHEV) and full electric vehicles (EV). In common with automotive batteries, the use of the lead compounds is essential in industrial lead-based batteries, cannot be substituted in the manufacturing process and is only present in trace amounts in the final article placed on the market.
5. The use of the 4 substances in the manufacturing of lead-based batteries is already extensively regulated by existing Community OHS regulation that provides lead-specific binding and enforceable minimum requirements for the control of risks (including a binding occupational exposure and biological limit for lead, supported by additional measures such as medical surveillance).
6. We support the request of EUROBAT, the Association of European Automotive and Industrial Battery Manufacturers and ILA, the International Lead Association, for an exemption from an authorization requirement for lead monoxide, lead tetroxide, pentalead tetraoxide sulphate and tetralead trioxide sulphate if used for the manufacturing of lead-based batteries (Exemption according to article 58.2 of the REACH regulation).

ANIE Federation is the Confindustria member representing the electrotechnical and electronic companies operating in Italy, ANIE is one of the largest italian industry organization in weight, size and representativeness, with 1,200 members, 410,000 employees with a turnover (in late 2014) of 55 billion euros..

The CSI Association, within ANIE, represents the major manufacturers operating on the Italian territory in the battery industry and accumulators, including the producers of lead based batteries.

Marco Ottaviani
ANIE - CSI
Environmental Coordinator
Via Lancetti, 43
20158 Milan - Italy
Tel +39 02 3264268
Fax +39 02 3264289
-----------------------
Mobile. 335 1415017
Phone/Fax 0444 596102
e-mail: marco.ottaviani1@gmail.com
Skype: marcottaviani
	A.1.5. Aspects not considered in ECHA's prioritisation
A.1.5.2. Authorisation is disproportionate and/or means a ban
A.1.5.3. Use specific considerations
A.1.5.5. Availability of suitable alternatives
C.1.1. General principles for exemptions under Art. 58(2)
C.2.1. Response to requests for exemptions under Art. 58(2)

Please see also response to comment #
3053 (ILA) and comment #3120 (EUROBAT).	
				
3134
2016/02/18	ESPA (European Stabiliser Producers Association,
Industry or trade association,
Belgium	About the volumes used for PVC stabilisers as referred in section 4.1 of ECHA’s background document the following must be highlighted.  Further to the completion of the Voluntary Commitment* of replacing lead-based stabilisers by the end of 2015 the volume of the substance must now be zero.  Hence the potential inaccuracy on the volume ratio of 95/5 for use in batteries/stabilisers for manufacturing articles in PVC, becomes irrelevant.
*More info on www.vinylplus.eu	A.2.9. Volume overestimated / Ask ECHA to consider that the use of lead-stabilisers in PVC is phased out	
				
3149
2016/02/18	Germany,
Member State	The German CA would like to point out that our comments on the lead compounds provided earlier as part of the 6th prioritization still apply.

Additionally, the German CA is wondering how the prioritization of the lead compounds interrelates with the scheduled restriction of lead in PVC. All four lead compounds proposed for prioritization are used as stabilizer in PVC, and cannot be subject to both restriction and authorisation at the same time. According to Article 58, Paragraph 5 of the REACH Regulation, substances that have been included in Annex XIV cannot become subject to new restrictions. Therefore, if at all, inclusion of the lead compounds to Annex XIV should be suspended until the restriction for lead in PVC is completed.
	A.2.11. Ask ECHA to assess / question the regulatory effectiveness of inclusion of lead substances in AXIV and stresses the high workload for authorities related to these substances at Afa stage
A.2.12. Interrelation between the recommendation (and authorisation process) and the scheduled restriction on the use of lead in PVC	
				
3159
2016/02/18	Joint comment : Plastics Recyclers Europe and European Plastics Converters,
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 has been used during many years in PVC industry (specially for the production of pipes and profiles)
• Recyclers are not selecting PVC waste because they contain lead stabilizer, and therefore lead compounds present in PVC to be recycled can be considered as impurities according to ECHA guidance on waste and recovered substances
• Recyclers are not adding any fresh lead stabilizer during the recycling process.
• Thus this questionnaire is not well adapted to recycling activities: thus it is important to fill a questionnaire related to recycling activities 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.
• In the current legal framework it seems that an Authorisation may be required to simply re-use articles (posing no issues) once they are chopped in granules in order to remelt them  in new articles.
• 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. This should be evaluated by the European Commisssion.
• It is our opinion that recycling of PVC containing lead should be exempt from authorization based on article 58.2 of REACH.
• Regarding restriction,  it should not impose unrealistic low limits on the content of legacy lead  in PVC articles made thereof, especially for building applications: with service life exceeding  generally 20 years they offer a safe place for those compounds which remain firmly embedded in the plastic matrix.
• Recyclers are largely SMEs and most would unlikely be able to face this challenge and would drop the recycling of PVC.

• More info on www.vinylplus.eu
	A.1.5. Aspects not considered in ECHA's prioritisation
A.1.5.6. Socio-economic benefits of continued use
A.1.5.7. Burden for industry and potential competitive disadvantage
A.2.14. Applicability of the authorisation requirement for recycling / recycled materials
C.1.1. General principles for exemptions under Art. 58(2)
C.2.1. Response to requests for exemptions under Art. 58(2)
C.2.2. Recycling of lead containing PVC: specifics of that industry need to be considered by e.g. realistic limit values or exemption
C.2.3. Request for exemption of use in R&D acc. to Art.56(3)	
		3159_2016-02-18_EuPC-EuPR - input Echa Pb_final (extended).pdf

3166
2016/02/18	Austrian Non Ferrous Metals Association,
Industry or trade association,
Austria	The Austrian Non Ferrous Metals Association supports the comments made by International Lead Association (ILA) to this public consultation (see attachment).	See responses referred to in comment #3053 (ILA)	
		3166_16.04.Pentalead tetraoxide sulphate 7th Priority List Comments (3).pdf

3175
2016/02/18	The Federation of Finnish Technology Industry,
Industry or trade association,
Finland	This consultation is focused of pentalead tetraoxide sulphate use in manufacturing lead-acid batteires	A.1.5. Aspects not considered in ECHA's prioritisation
A.1.5.2. Authorisation is disproportionate and/or means a ban
A.1.5.3. Use specific considerations
A.1.5.5. Availability of suitable alternatives
A.1.5.6. Socio-economic benefits of continued use
A.1.5.7. Burden for industry and potential competitive disadvantage
A.2.15. Questionnaire on socio-economic consequences	
		3175_Comments on the draft recommendation of pentalead tetraoxide sulphate for inclusion in Annex XIV.docx

II - Transitional arrangements. Comments on the proposed dates
Number / Date	Submitted by (name, submitter type, country)	Comment	Reference to responses	
3051
2016/02/03	International Lead Association,
Industry or trade association,
United Kingdom	Given that the vast majority of the total use volume of this substance is related to battery manufacturing and supply chains are not complex we consider 24 months to be an appropriate LAD.	See responses referred to in comment #3053 (ILA)	
		3051_Pentalead tetraoxide sulphate 7th Priority List Comments.pdf		
3053
2016/02/03	International Lead Association,
Industry or trade association,
United Kingdom	Given that the vast majority of the total use volume of this substance is related to battery manufacturing and supply chains are not complex we consider 24 months to be an appropriate LAD.	Thank you for your opinion.	
		3053_Pentalead tetraoxide sulphate 7th Priority List Comments.pdf		
3134
2016/02/18	ESPA (European Stabiliser Producers Association,
Industry or trade association,
Belgium	As ESPA members are no longer placing lead stabilisers on the EU market, Authorisation dates (LAD and SSD) are not relevant for them.  The converters and recyclers will likely comment on this, because in case Registration of legacy lead stabilisers would become the route for continuing recycling, a longer transition period is desirable.	B.2.2. Longer transition period requested for plastic converters and recyclers	
				
3159
2016/02/18	Joint comment : Plastics Recyclers Europe and European Plastics Converters,
Industry or trade association,
Belgium	As mentioned above, we do not think authorization is an appropriate risk management option for this case. 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 envisaged 42 months.	B.1.1. General principles for setting latest application dates/sunset dates
B.1.1.2. ECHA's proposal for sunset dates
B.1.1.3. ECHA's proposal for latest application dates
B.1.2.1. Extensive time needed in the supply chain to getting organised for preparing application (e.g. due to high number of users)	
		3159_2016-02-18_EuPC-EuPR - input Echa Pb_final (extended).pdf		
3175
2016/02/18	The Federation of Finnish Technology Industry,
Industry or trade association,
Finland	Pentalead tetraoxide sulphate should be released from authorisation for the time period to develope economically and environmentally effective substitutes.	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	
		3175_Comments on the draft recommendation of pentalead tetraoxide sulphate for inclusion in Annex XIV.docx		

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	
3051
2016/02/03	International Lead Association,
Industry or trade association,
United Kingdom	We note in the background document that ECHA proposes not to recommend exemptions for uses of pentalead tetraoxide sulphate on the basis of Article 58(2) of the REACH regulation (section 3.3.1). In previous submissions we have provided strong arguments that would indicate that Commission does have discretion for granting a REACH Article 58(2) exemption for use of pentalead tetraoxide sulphate in battery manufacturing (and possibly other uses that are restricted to industrial processing and where pentalead tetraoxide sulphate is not present in the article placed on the market)

A detailed explanation for this conclusion was provided in the public consultation for the 6th priority list but in summary we believe that the industrial use of pentalead tetraoxide sulphate (such as the case for the production of lead based batteries) meets ALL requirements of REACH Article 58(2) in that:
• Existing Community legislation already addresses the use categories to be exempted.
• The existing legislation provides binding and enforceable minimum requirements for the control of risks from industrial use of pentalead tetraoxide sulphate. In having a binding occupational exposure and biological limit for lead, supported by additional measures such as medical surveillance, Council Directive 98/24/EC ensures that harmonized, EU wide standards operate (although Member States can establish more stringent but not less stringent requirements)

This conclusion is further supported by the recent General Court ruling (T-360/13, Vecco and others) in relation to chromium trioxide and REACH Article 58(2).

We do not agree with ECHA’s opinion in response to comments provided during the public consultation for the 6th Priority list (doc ECHA/MSC-41/2015/029) and further in the MSC draft opinion on ECHA’s sixth draft recommendation that “given the wealth of EU legislation governing lead and it’s compounds the uses with perhaps the strongest case for Art 58(2) exemption are those for which a legislative regime is already in place to push for substitution in a similar manner to the authorization requirement ….” We believe ECHA and the MSC have included the concept of substitution that is an additional element that goes beyond the criteria of Article 58 (2) of REACH which concerns legislation imposing minimum requirements relating to the protection of human health or the environment that ensures proper control of risks”.

Support for this proposition is provided by observations that the General Court ruling in relation to REACH Article 58(2) arguments made by Vecco and others did not suggest in any way a push for substitution to be relevant for the assessment of Community legislation per Article 58(2) of REACH. Moreover, it is notable that REACH Articles 57 and 58 do not include any reference to the aim for substitution and that Article 55 itself does not push for all SVHCs to be replaced, but only those subject to authorization (ie uses not exempted under Article 58(2)).
In addition the ECHA guidance on preparation of draft Annex XIV entries does not mention any condition for substitution that should be enshrined in a specific Community legislation in order to grant an exemption on the basis of Article 58(2) and no Annex XIV recommendations by ECHA over the last 6 years refer to substitution requirements of existing community legislation in the context of Article 58(2) exemptions.
An evaluation of the only current existing Article 58(2) exemption that concerns phthalates in immediate packaging of medicinal products by Commission Regulation 143/2011 highlights that no assessment regarding substitutes was made in the process and Commission granted the exemption purely on basis that there was “specific Community legislation imposing minimum requirements relating to the protection of human health or the environment that ensures proper control of risks”.

We believe that ECHA’s opinion in relation to recommendation for substances to be included in the 6th Priority list that “the case for REACH Article 58(2) of uses not covered by RoHS and ELV is weaker than use in automotive battery use as there does not appear to be a legislative regime in place to push for substitution in a similar manner to authorization requirement” is a somewhat flawed argument and that consideration of Article 58(2) exemption should be based solely upon whether “existing specific Community legislation imposing minimum requirements relating to the protection of human health or the environment for the use of the substance, the risk is properly controlled…”

Notwithstanding the comments made above we are surprised that Section 3.3.1 of the Background Document does not refer to any of the previous discussions and opinions on REACH Article 58(2) exemption that ECHA and MSC made in relation to the 6th Priority List recommendation. It was our understanding that at least for uses of pentalead tetraoxide sulphate that are currently exempted under RoHS and/or ELV, ECHA concluded that exemptions from authorisation might be considered. We understand that this conclusion was reached on the basis that ELV and RoHS already push for substitution in a similar manner to authorization requirement. Whilst we question the rationale for citing end of life legislation when the substance pentalead tetraoxide sulphate  is not present in articles that would be subject to this legislative regime (it is fully transformed in the manufacturing process), we do not understand why the “push for substitution of lead” in the Batteries Directive (2006/66/EU) is less similar to the REACH substitution intention than the one provided by ELV.  Article 5 of the Batteries Directive requires that “Member States which have manufacturers established on their territory shall promote research and encourage improvements in the overall environmental performance of batteries and accumulators throughout their entire life cycle as well as the development and marketing of batteries and accumulators which contain smaller quantities of dangerous substances or which contain less polluting substances, in particular as substitutes for mercury, cadmium and lead.” Moreover, the Batteries Directive includes several other provisions aimed at substituting heavy metals (e.g. Article 4-Prohibitions). We therefore contend that if “end of life” or waste legislation is used to highlight an equivalent drive for substitution as REACH authorization then both the Batteries Directive and ELV should be included in such an analysis.

We conclude that an analysis as to whether REACH Article 58(2) may apply should be restricted to the use for which authorization would be required. In the case of battery use, as pentalead tetraoxide sulphate is not present in the article (automotive or industrial battery) placed on the market the analysis should be restricted to the industrial use in manufacturing of the article. In this case the binding occupational exposure limit set out for lead and lead compounds and other requirements of existing Occupational health legislation (such as compulsory medical surveillance and protection of pregnant and breastfeeding workers through Directive 92/85/EEC) constitutes “existing specific Community legislation imposing minimum requirements relating to the protection of human health” for the toxicological endpoint for which pentalead tetraoxide sulphate is placed on the Candidate list. Thus ALL requirement necessary to consider REACH Article 58(2) exemption for the use of pentalead tetraoxide sulphate in battery manufacturing would appear to have been met.
We contend that the wording used by ECHA and MSC in relation to the 6th Priority List opinion that includes a requirement for an existing legislative regime to “push for substitution “  in a similar manner to REACH authorization is an additional element that goes beyond the legal text requirement of Article 58 (2) of REACH. However, notwithstanding this we believe that the General Court Vecco ruling (T-360/13) supports the observation that for an industrial use the Chemicals Agents Directive (98/24) includes a provision  that drives substitution through its hierarchy of controls that requires replacement of dangerous substances by less hazardous ones (Article 6). Moreover, in the case of lead batteries, product legislation in the form of the ELV Directive and Batteries Directive also support the case that a legislative regime already exists that encourages substitution of this technology where this is technically and economically feasible.

We therefore urge ECHA and Members States to consider an opinion that the industrial use of pentalead tetraoxide sulphate (such as the case in battery manufacturing) be recommended for exemption from the authorization requirement under Article 58(2).
	See responses referred to in comment #3053 (ILA)	
		3051_Pentalead tetraoxide sulphate 7th Priority List Comments.pdf		
3053
2016/02/03	International Lead Association,
Industry or trade association,
United Kingdom	We note in the background document that ECHA proposes not to recommend exemptions for uses of pentalead tetraoxide sulphate on the basis of Article 58(2) of the REACH regulation (section 3.3.1). In previous submissions we have provided strong arguments that would indicate that Commission does have discretion for granting a REACH Article 58(2) exemption for use of pentalead tetraoxide sulphate in battery manufacturing (and possibly other uses that are restricted to industrial processing and where pentalead tetraoxide sulphate is not present in the article placed on the market)

A detailed explanation for this conclusion was provided in the public consultation for the 6th priority list but in summary we believe that the industrial use of pentalead tetraoxide sulphate (such as the case for the production of lead based batteries) meets ALL requirements of REACH Article 58(2) in that:
• Existing Community legislation already addresses the use categories to be exempted.
• The existing legislation provides binding and enforceable minimum requirements for the control of risks from industrial use of pentalead tetraoxide sulphate. In having a binding occupational exposure and biological limit for lead, supported by additional measures such as medical surveillance, Council Directive 98/24/EC ensures that harmonized, EU wide standards operate (although Member States can establish more stringent but not less stringent requirements)

This conclusion is further supported by the recent General Court ruling (T-360/13, Vecco and others) in relation to chromium trioxide and REACH Article 58(2).

We do not agree with ECHA’s opinion in response to comments provided during the public consultation for the 6th Priority list (doc ECHA/MSC-41/2015/029) and further in the MSC draft opinion on ECHA’s sixth draft recommendation that “given the wealth of EU legislation governing lead and it’s compounds the uses with perhaps the strongest case for Art 58(2) exemption are those for which a legislative regime is already in place to push for substitution in a similar manner to the authorization requirement ….” We believe ECHA and the MSC have included the concept of substitution that is an additional element that goes beyond the criteria of Article 58 (2) of REACH which concerns legislation imposing minimum requirements relating to the protection of human health or the environment that ensures proper control of risks”.

Support for this proposition is provided by observations that the General Court ruling in relation to REACH Article 58(2) arguments made by Vecco and others did not suggest in any way a push for substitution to be relevant for the assessment of Community legislation per Article 58(2) of REACH. Moreover, it is notable that REACH Articles 57 and 58 do not include any reference to the aim for substitution and that Article 55 itself does not push for all SVHCs to be replaced, but only those subject to authorization (ie uses not exempted under Article 58(2)).
In addition the ECHA guidance on preparation of draft Annex XIV entries does not mention any condition for substitution that should be enshrined in a specific Community legislation in order to grant an exemption on the basis of Article 58(2) and no Annex XIV recommendations by ECHA over the last 6 years refer to substitution requirements of existing community legislation in the context of Article 58(2) exemptions.
An evaluation of the only current existing Article 58(2) exemption that concerns phthalates in immediate packaging of medicinal products by Commission Regulation 143/2011 highlights that no assessment regarding substitutes was made in the process and Commission granted the exemption purely on basis that there was “specific Community legislation imposing minimum requirements relating to the protection of human health or the environment that ensures proper control of risks”.

We believe that ECHA’s opinion in relation to recommendation for substances to be included in the 6th Priority list that “the case for REACH Article 58(2) of uses not covered by RoHS and ELV is weaker than use in automotive battery use as there does not appear to be a legislative regime in place to push for substitution in a similar manner to authorization requirement” is a somewhat flawed argument and that consideration of Article 58(2) exemption should be based solely upon whether “existing specific Community legislation imposing minimum requirements relating to the protection of human health or the environment for the use of the substance, the risk is properly controlled…”

Notwithstanding the comments made above we are surprised that Section 3.3.1 of the Background Document does not refer to any of the previous discussions and opinions on REACH Article 58(2) exemption that ECHA and MSC made in relation to the 6th Priority List recommendation. It was our understanding that at least for uses of pentalead tetraoxide sulphate that are currently exempted under RoHS and/or ELV, ECHA concluded that exemptions from authorisation might be considered. We understand that this conclusion was reached on the basis that ELV and RoHS already push for substitution in a similar manner to authorization requirement. Whilst we question the rationale for citing end of life legislation when the substance pentalead tetraoxide sulphate  is not present in articles that would be subject to this legislative regime (it is fully transformed in the manufacturing process), we do not understand why the “push for substitution of lead” in the Batteries Directive (2006/66/EU) is less similar to the REACH substitution intention than the one provided by ELV.  Article 5 of the Batteries Directive requires that “Member States which have manufacturers established on their territory shall promote research and encourage improvements in the overall environmental performance of batteries and accumulators throughout their entire life cycle as well as the development and marketing of batteries and accumulators which contain smaller quantities of dangerous substances or which contain less polluting substances, in particular as substitutes for mercury, cadmium and lead.” Moreover, the Batteries Directive includes several other provisions aimed at substituting heavy metals (e.g. Article 4-Prohibitions). We therefore contend that if “end of life” or waste legislation is used to highlight an equivalent drive for substitution as REACH authorization then both the Batteries Directive and ELV should be included in such an analysis.

We conclude that an analysis as to whether REACH Article 58(2) may apply should be restricted to the use for which authorization would be required. In the case of battery use, as pentalead tetraoxide sulphate is not present in the article (automotive or industrial battery) placed on the market the analysis should be restricted to the industrial use in manufacturing of the article. In this case the binding occupational exposure limit set out for lead and lead compounds and other requirements of existing Occupational health legislation (such as compulsory medical surveillance and protection of pregnant and breastfeeding workers through Directive 92/85/EEC) constitutes “existing specific Community legislation imposing minimum requirements relating to the protection of human health” for the toxicological endpoint for which pentalead tetraoxide sulphate is placed on the Candidate list. Thus ALL requirement necessary to consider REACH Article 58(2) exemption for the use of pentalead tetraoxide sulphate in battery manufacturing would appear to have been met.
We contend that the wording used by ECHA and MSC in relation to the 6th Priority List opinion that includes a requirement for an existing legislative regime to “push for substitution “  in a similar manner to REACH authorization is an additional element that goes beyond the legal text requirement of Article 58 (2) of REACH. However, notwithstanding this we believe that the General Court Vecco ruling (T-360/13) supports the observation that for an industrial use the Chemicals Agents Directive (98/24) includes a provision  that drives substitution through its hierarchy of controls that requires replacement of dangerous substances by less hazardous ones (Article 6). Moreover, in the case of lead batteries, product legislation in the form of the ELV Directive and Batteries Directive also support the case that a legislative regime already exists that encourages substitution of this technology where this is technically and economically feasible.

We therefore urge ECHA and Members States to consider an opinion that the industrial use of pentalead tetraoxide sulphate (such as the case in battery manufacturing) be recommended for exemption from the authorization requirement under Article 58(2).
	See responses referred to in your comment in section I (same comment number).	
		3053_Pentalead tetraoxide sulphate 7th Priority List Comments.pdf		
3095
2016/02/16	Arbeitsgemeinschaft PVC und Umwelt e.V.,
Industry or trade association,
Germany	PVC recyclates should be exempted (please see general comments).	C.1.1. General principles for exemptions under Art. 58(2)
C.2.2. Recycling of lead containing PVC: specifics of that industry need to be considered by e.g. realistic limit values or exemption
Please see references to responses in section I

Please see also response to comment #
3096 (VinylPlus) and # 3134 (ESPA)	
				
3096
2016/02/17	VinylPlus,
Industry or trade association,
Belgium	Uses in recycled PVC should be exempted
Please see attached document	C.1.1. General principles for exemptions under Art. 58(2)
C.2.2. Recycling of lead containing PVC: specifics of that industry need to be considered by e.g. realistic limit values or exemption	
		3096_2016_02_13 Lead substances 7th priority list for authorisation, comments-VinylPlus.pdf		
3120
2016/02/17	EUROBAT,
Industry or trade association,
Belgium	EUROBAT supports the request of the Lead REACH Consortium for an exemption from an authorization requirement for lead monoxide, lead tetroxide, pentalead tetraoxide sulphate and tetralead trioxide sulphate if used for the manufacturing of lead-based batteries (Exemption according to article 58.2 of the REACH regulation).	See responses referred to in your comment in section I (same comment number).

Please see also response to comment #
3053 (ILA)	
				
3134
2016/02/18	ESPA (European Stabiliser Producers Association,
Industry or trade association,
Belgium	Recycled PVC granules,  containing any of the 2 substances subject to this PC as legacy impurities, should be exempted for use as secondary raw material in the production of new PVC articles.
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 energy otherwise needed to produce fresh PVC resin.
In the current regulatory framework it seems that an Authorisation may be required to re-use articles (posing no issues) containing substances subject to Authorisation once they have been shredded/granulated in order to re-melt them to form new articles.
In order not to make these efforts worthless, any Authorisation/Restriction proposal should take this into account. In particular it should not impose unrealistic low limits on the content of legacy lead  in PVC articles made thereof, especially for building applications: with service life exceeding  generally 20 years they offer a safe place for those compounds which remain firmly embedded in the plastic matrix.
*More info on www.vinylplus.eu
It is also worth to highlight that, according to the ECHA’s Public Consultation (Call for information & Evidences) on the use of lead compounds in PVC,  closed on Feb. 15, a Restriction is currently under development.  Assuming that this Restriction will be finalized, then Authorisation will just be a duplication.
	A.2.13. Assuming that the restriction on lead in PVC is finalised authorisation will be a duplication
C.1.1. General principles for exemptions under Art. 58(2)
C.2.2. Recycling of lead containing PVC: specifics of that industry need to be considered by e.g. realistic limit values or exemption	
				
3159
2016/02/18	Joint comment : Plastics Recyclers Europe and European Plastics Converters,
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. This should be evaluated by the European Commisssion.
• It is our opinion that recycling of PVC containing legacy lead impurities should be exempt from authorization based on article 58.2 of REACH.
• The use of Pentalead tetraoxide sulphate and tetralead trioxide sulfate 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 be possible  .
	C.1.1. General principles for exemptions under Art. 58(2)
C.1.3. Aspects not justifying an exemption from authorisation
C.2.1. Response to requests for exemptions under Art. 58(2)
C.2.2. Recycling of lead containing PVC: specifics of that industry need to be considered by e.g. realistic limit values or exemption
C.2.3. Request for exemption of use in R&D acc. to Art.56(3)	
		3159_2016-02-18_EuPC-EuPR - input Echa Pb_final (extended).pdf		
3175
2016/02/18	The Federation of Finnish Technology Industry,
Industry or trade association,
Finland	The use in manufacturing lead-acid batteries, because today there are no effective alternatives.	C.1.1. General principles for exemptions under Art. 58(2)
C.2.1. Response to requests for exemptions under Art. 58(2)	
		3175_Comments on the draft recommendation of pentalead tetraoxide sulphate for inclusion in Annex XIV.docx		
3179
2016/02/18	Industry or trade association,
Belgium	1. Lead monoxide, lead tetroxide, pentalead tetraoxide sulphate and tetralead trioxide sulphate are essential and irreplaceable in the manufacture of lead-based batteries with no substitutes currently available. During the manufacturing phase of lead-based batteries, all four compounds are transformed into other substances within the battery (article). Only trace amounts of the four substances are (<0.1%) present in the finished battery.
2. As an association that represents downstream users of lead-based batteries, the response to the public consultation focuses on the essential applications of lead-based batteries.
3. Industrial lead-batteries for consumer uses are sealed articles so that consumers do not have any contact to any of the contained substances. Industrial lead-based batteries for commercial uses might be refilled with water under safe conditions. Contact to the contained substances is excluded.
4. Lead-based batteries are by far the most widely used electrochemical system in Europe and worldwide for automotive and industrial applications, due to their proven safety, excellent performance, low cost and operate in a closed loop with over 99% of batteries placed on the market being collected and recycled at end-of-life.
5. Lead batteries are essential in a number of areas as a source of back-up power. Lead batteries are also an essential requirement in several sectors to start electrically operated equipment and maintain its operation in the absence of main power. Electric forklift trucks in material handling applications, golf carts and naval applications (electric boats etc.) are all dependent on motive power batteries to fulfil their needs for startup and motive power. Industrial lead-acid batteries stand out because of their low cost/kWh, closed-loop recycling and their well-established sales & service networks limiting non-productive downtime. Industrial lead-acid batteries have an extremely robust design which has proven its value for many years, and have been the predominant industrial battery technology for over 100 years. They are comparably simple in terms of operation and maintenance. The industry producing industrial lead-acid batteries is a very mature industry with well-established manufacturing, distribution, service and recycling options.
6. The use of the 4 substances in the manufacturing of lead-based batteries is already extensively regulated by existing Community OHS regulation that provides lead-specific binding and enforceable minimum requirements for the control of risks (including a binding occupational exposure and biological limit for lead, supported by additional measures such as medical surveillance).
7. We support the request of EUROBAT, the Association of European Automotive and Industrial Battery Manufacturers and ILA, the International Lead Association, for an exemption from an authorization requirement for lead monoxide, lead tetroxide, pentalead tetraoxide sulphate and tetralead trioxide sulphate if used for the manufacturing of lead-based batteries (Exemption according to article 58.2 of the REACH regulation).
	A.1.5. Aspects not considered in ECHA's prioritisation
A.1.5.2. Authorisation is disproportionate and/or means a ban
A.1.5.3. Use specific considerations
A.1.5.6. Socio-economic benefits of continued use
C.1.1. General principles for exemptions under Art. 58(2)
C.2.1. Response to requests for exemptions under Art. 58(2)

Please see also response to comment #
3053 (ILA) and #3120 (EUROBAT) in section I.