Comments on ECHA’s Draft 7th Recommendation for Orange lead (lead tetroxide) (EC number: 215-235-6) 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 Orange lead (lead tetroxide) (EC number: 215-235-6). 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

Orange lead (lead tetroxide) 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	
3050
2016/02/04	Company,
Germany	No substitute is able to replace lead in e.g. PZT or PTC-ceramics, and the use of these substances is still a necessity. The information from last consultation are updated.	A.1.5. Aspects not considered in ECHA's prioritisation
A.1.5.2. Authorisation is disproportionate and/or means a ban
A.1.5.5. Availability of suitable alternatives
A.1.5.7. Burden for industry and potential competitive disadvantage
A.2.1. Claim the use in the manufacture of technical ceramic materials as intermediate
A.2.15. Questionnaire on socio-economic consequences
C.1.1. General principles for exemptions under Art. 58(2)
C.1.2. Generic exemptions
C.2.1. Response to requests for exemptions under Art. 58(2)	
		
Confidential attachment removed		
3054
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 agree with the total priority setting score of 28 reported in the conclusions and justification of the current draft background document (Section 2.5) based upon the volume in scope of authorization and description of uses. We would like to re-emphasize points made in the previous consultation for the 6th priority list that certain uses are not in the scope of authorization and should not be considered in tonnage estimates (although the reduction of volumes in scope is approximately 20% and does not materially affect the prioritization scoring). These uses are as intermediates in the manufacture of certain pigments, frits and glass (both lead special glass and crystal glass) and technical ceramics (PZT, PTC etc) as confirmed in a workshop hosted by Eurometaux and CEFIC and attended by ECHA staff in 2015. In addition any uses as a laboratory reagent are also out of scope of authorization and volumes should not be considered for priority scoring.
	A.1.1. General, recommendation process
A.1.1.5. New information and next steps toward the final recommendation
A.1.2. Prioritisation: Volume
A.2.1. Claim the use in the manufacture of technical ceramic materials as intermediate
A.2.2. Claim the use in the manufacture of frits as intermediate
A.2.5. Claim the use of lead monoxide in the manufacture of stabilisers for PVC processing as intermediate
A.2.6. Claim the use of lead monoxide in the manufacture of explosives as intermediate
A.2.7. Claim the use in the manufacture of lead glass (including lead special glass and lead crystal glass) as intermediate
A.2.8. Certain uses of lead monoxide and orange lead confirmed as intermediate uses in workshop attended by ECHA's staff in 2015
B.1.1. General principles for setting latest application dates/sunset dates
B.1.1.3. ECHA's proposal for latest application dates
B.2.1. ECHA needs to consider the opinion from the MSC on the 6th draft recommendation adopted on 11th June 2015 in favour of a 35 months' LAD and referring among other to the precedent created by chromate compounds
C.1.1. General principles for exemptions under Art. 58(2)
C.1.2. Generic exemptions
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)	
		3054_Lead Tetroxide 7th Priority List Comments.pdf
		
3069
2016/02/10	European Domestic Glass & European Special Glass Associations,
Industry or trade association,
Belgium	EDG and ESGA note that the volumes of uses of lead tetroxide in glass were excluded from the priority setting in the 6th priority list, on the ground that lead tetroxide is used as an intermediate in the production glass (both special glass and crystal glass).  This approach was confirmed in a workshop hosted by Eurometaux and CEFIC and attended by ECHA staff in 2015.	A.1.2. Prioritisation: Volume
A.1.2.1. Volume in the scope of authorisation
A.2.7. Claim the use in the manufacture of lead glass (including lead special glass and lead crystal glass) as intermediate
A.2.8. Certain uses of lead monoxide and orange lead confirmed as intermediate uses in workshop attended by ECHA's staff in 2015	
				
3080
2016/02/16	Producers and Importers of frits, E.E.I.G. (Frit Consortium),
Industry or trade association,
Spain	This substance is considered an intermediate for the manufacture of frits. In the reaction process, the substance is transformed into a new substance (frit). The frit is later used in the preparation of mixtures and articles (e.g. ceramic tiles, decorative colours for glass and dinnerware, specific electronic devices). Therefore, the substance under discussion is not used by consumers or directly introduced in articles, at least in the sectors specified.	A.1.5. Aspects not considered in ECHA's prioritisation
A.1.5.2. Authorisation is disproportionate and/or means a ban
A.1.5.5. Availability of suitable alternatives
A.2.2. Claim the use in the manufacture of frits as intermediate
C.1.1. General principles for exemptions under Art. 58(2)
C.1.2. Generic exemptions
C.2.1. Response to requests for exemptions under Art. 58(2)	
		3080_2016-02-11-intermediate use lead oxides in frits.docx
		
3082
2016/02/16	E.E.I.G. for Inorganic Pigments (Inorganic Pigments Consortium),
Industry or trade association,
Spain	This substance is considered an intermediate for the manufacture of inorganic pigments. In the reaction process, the substance is transformed into a new substance (pigment). The pigment is later used in the preparation of mixtures and articles (e.g. ceramics). Therefore, the substance under discussion is not used by consumers or directly introduced in articles, at least in the sectors specified.
To the knowledge of the IP Consortium, this substance is being used only for manufacture of one inorganic pigment (pyrochlore, antimony lead yellow, EC 232-382-1)
	A.2.3. Claim the use in the manufacture of complex inorganic pigments (CIPs) as intermediate
C.1.2. Generic exemptions	
		3082_2016-02-09-pigments intermediates.pdf

3084
2016/02/16	Asociacion Nacional de Fabricantes de Fritas, Esmaltes y Colores Ceramicos (ANFFECC),
Industry or trade association,
Spain	This substance is considered an intermediate for the manufacture of frits and inorganic pigments. ANFFECC would like to support the comments issued by the Frit Consortium and the Inorganic Pigments Consortium	See responses referred to in comment #3080 (Frit Consortium)
See responses referred to in comment #3082 (Inorganic Pigments Consortium)	
				
3092
2016/02/16	Company,
Spain	This substance is considered an intermediate for the manufacture of frits. In the reaction process, the substance is transformed into a new substance (frit). The frit is later used in the preparation of mixtures and articles (e.g. ceramic tiles, decorative colours for glass and dinnerware, specific electronic devices). Therefore, the substance under discussion is not used by consumers or directly introduced in articles, at least in the sectors specified.	See responses referred to in comment #3080 (Frit Consortium)	
				
3098
2016/02/17	Company,
Czech Republic	This substance is considered an intermediate for the manufacture of frits. In the reaction process, the substance is transformed into a new substance (frit). The frit is later used in the preparation of mixtures and articles (e.g. ceramic tiles, decorative colours for glass and dinnerware, specific electronic devices). Therefore, the substance under discussion is not used by consumers or directly introduced in articles, at least in the sectors specified	See responses referred to in comment #3080 (Frit Consortium)	
				
3103
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 #3054 (ILA)	
				
3107
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 #3054 (ILA)	
				
3111
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 #
3054 (ILA) and comment #3118 (EUROBAT).	
		3111_recom_com_call_RPS SpA.docx

3118
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 #
3054 (ILA)	
				
3119
2016/02/17	Company,
Spain	This substance is considered an intermediate for the manufacture of frits. In the reaction process, the substance is transformed into a new substance (frit). The frit is later used in the preparation of mixtures and articles (e.g. ceramic tiles, decorative colours for glass and dinnerware, specific electronic devices). Therefore, the substance under discussion is not used by consumers or directly introduced in articles, at least in the sectors specified.	See responses referred to in comment #3080 (Frit Consortium)	
				
3127
2016/02/17	Ceramicolor - Federchimica,
Industry or trade association,
Italy	Ceramicolor  is the Italian association representing manufacturers of all materials involved in the production of tiles: frits for the ceramic industry or for applications on metal supports; inorganic pigments to be used as colorants for ceramics or as enamel for metal; metal oxides used in chemical processes leading to frits and pigments, but also to anti-rust and stabilisers. Ceramicolor believes this substance is considered an intermediate for the manufacture of frits and inorganic pigments. Ceramicolor would like to support the comments issued by the Frit Consortium and the Inorganic Pigments Consortium.	See responses referred to in comment #3080 (Frit Consortium)
See responses referred to in comment #3082 (Inorganic Pigments Consortium)	
				
3131
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 #
3054 (ILA) and comment #3118 (EUROBAT).	
				
3138
2016/02/18	Company,
Belgium		A.1.1.5. New information and next steps toward the final recommendation	
		
Confidential attachment removed		
3145
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	
				
3155
2016/02/18	Company,
Germany	Lead compounds are used within the solar panel industry. Lead tetra oxide is used in very low volumes for its anti-corrosion properties. Due to their properties their use within the solar panel is specific and directly linked to maintain its linkage to the silver on the solar panel.  Solar panels materials must be able to withstand extreme conditions including temperatures, humidity, during normal use. Authorization of lead-tetra oxide - before there is a certified alternative in place - is creating a severe disadvantage for the solar coating industry in Europe. We are assessing alternatives but so far we have prototypes but do not have a customer proven zero lead alternatives for solar mirror application yet. The solar mirror industry needs long term field experiences to guarantee more than 30 years durability	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	
				
3156
2016/02/18	Ferro GmbH,
Company,
Germany	This substance is considered an intermediate for the manufacture of substance ‘pyrochlore, antimony lead yellow’, EC 232-382-1. In the reaction process, the substance is transformed into a new substance. ‘Pyrochlore, antimony lead yellow’ is later used in the preparation of mixtures and articles (e.g. ceramics). Therefore, the substance under discussion is not used by consumers or directly introduced in articles, at least in the sectors specified.	A.2.3. Claim the use in the manufacture of complex inorganic pigments (CIPs) as intermediate
C.1.2. Generic exemptions

Please see also response to comment #
3082 (Inorganic Pigments Consortium)	
				
3165
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 #3054 (ILA)	
		3165_16.04.Lead Tetroxide 7th Priority List Comments.pdf

3170
2016/02/18	The Federation of Finnish Technology Industry,
Industry or trade association,
Finland	This consultation is focused on orange lead in the production of lead-acid batteries	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	
		3170_Comments on the draft recommendation of orange lead 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	
3054
2016/02/03	International Lead Association,
Industry or trade association,
United Kingdom	As highlighted in the paper submitted to the MSC by Eurometaux we believe that latest application dates (LAD) should be established taking into consideration the number of uses, complexity of the supply chain and workload of the applicant rather than to manage potential ECHA workload. In the context of the 6th priority list recommendation the MSC acknowledged the complex supply chains that may exist for lead tetroxide uses and referred to precedent created by chromate compounds (Regulation 348/2013) where a 35 month latest application date was applied.   We note that in the latest draft background document that a LAD of 24 months is proposed for lead tetroxide. We respectfully request that this is extended to 35 months based upon arguments made previously and in line with the MSC opinion adopted on 11th June 2015.	See responses referred to in your comment in section I (same comment number).	
		3054_Lead Tetroxide 7th Priority List Comments.pdf		
3170
2016/02/18	The Federation of Finnish Technology Industry,
Industry or trade association,
Finland	Orange lead should be released from authorisation for the time period needed to develope economically and environmentally effective alternatives.	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	
		3170_Comments on the draft recommendation of orange lead 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	
3050
2016/02/04	Company,
Germany	PZT or PTC-ceramic production for automotive applications, reasons please refer to attached papers.	See responses referred to in your comment in section I (same comment number).	
		
Confidential attachment removed		
3054
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 on lead tetroxide 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 lead tetroxide in battery manufacturing (and possibly other uses that are restricted to industrial processing and where lead tetroxide Is not present in the article placed on the market- e.g laboratory uses >1tpa)

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 lead tetroxide (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 lead tetroxide. 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 lead tetroxide 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 lead tetroxide 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, lead tetroxide 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 lead tetroxide is placed on the Candidate list. Thus ALL requirement necessary to consider REACH Article 58(2) exemption for the use of lead tetroxide 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 lead tetroxide (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).	
		3054_Lead Tetroxide 7th Priority List Comments.pdf		
3069
2016/02/10	European Domestic Glass & European Special Glass Associations,
Industry or trade association,
Belgium	Additionally, we would like also to emphasize that lead compounds are highly regulated in the EU legislation (cf. our former submission) by specific EU legislation and therefore properly controlled.  In our understanding, lead tetroxide would also qualify in this respect, for an exemption on the basis of Article 58(2) of the REACH regulation (section 3.3.1), along the conclusions of the so-called Vecco case (General Court ruling (T-360/13).

Moreover, the Industry exemptions renewal requests to the ROHS Directive for electric and electrical applications were lodged for

13a         Pb used in white glass used for optical applications
13b         Cadmium and Lead in Filter Glasses and Glasses Used for Reflectance Standards
29  Pb bound in crystal glass as defined in Directive 69/493/EEC

The Commission consultant’s report delivered so far on cases 13a and 13b recommend an exemption renewal, in light of the lack of sufficient alternatives to allow for substitution or elimination of the need for [these applications] for the full product range.

http://rohs.exemptions.oeko.info/fileadmin/user_upload/reports/20160129_RoHS_Exemptions_Pack7_Final_Report.pdf pp. 53, 73
	A.2.7. Claim the use in the manufacture of lead glass (including lead special glass and lead crystal glass) as intermediate
C.1.1. General principles for exemptions under Art. 58(2)
C.1.2. Generic exemptions
C.2.1. Response to requests for exemptions under Art. 58(2)	
				
3080
2016/02/16	Producers and Importers of frits, E.E.I.G. (Frit Consortium),
Industry or trade association,
Spain	This substance is considered an intermediate in the manufacture of frits.An updated version of the justification of the intermediate position is attached	See responses referred to in your comment in section I (same comment number).	
		3080_2016-02-11-intermediate use lead oxides in frits.docx		
3082
2016/02/16	E.E.I.G. for Inorganic Pigments (Inorganic Pigments Consortium),
Industry or trade association,
Spain	This substance is considered an intermediate in the manufacture of inorganic pigments. An updated version of the justification of intermediates for inorganic pigments is attached. This document is generic for all inorganic pigments and the raw materials that may be intentionally used. The specific document for substance pyrochlore, antimony lead yellow was delivered in the Public Consultation of the 6th draft recommendation and is still valid (generic descriptions of life-cycle have been updated in the attached document).	See responses referred to in your comment in section I (same comment number).	
		3082_2016-02-09-pigments intermediates.pdf		
3084
2016/02/16	Asociacion Nacional de Fabricantes de Fritas, Esmaltes y Colores Ceramicos (ANFFECC),
Industry or trade association,
Spain	This substance is considered an intermediate for the manufacture of frits and inorganic pigments. ANFFECC would like to support the comments issued by the Frit Consortium and the Inorganic Pigments Consortium	See responses referred to in your comment in section I (same comment number).	
				
3092
2016/02/16	Company,
Spain	This substance is considered an intermediate in the manufacture of frits. The Frit Consortium has recently submitted an updated version of the argumentation used to demonstrate the intermediate status of this substance. We support the information provided by the Frit Consortium and the consideration of this substance as an intermediate in the manufacture of frits, according to the definition of intermediate in the REACH Regulation.	See responses referred to in your comment in section I (same comment number).	
				
3098
2016/02/17	Company,
Czech Republic	This substance is considered an intermediate in the manufacture of frits. The Frit Consortium has recently submitted an updated version of the argumentation used to demonstrate the intermediate status of this substance. We support the information provided by the Frit Consortium and the consideration of this substance as an intermediate in the manufacture of frits, according to the definition of intermediate in the REACH Regulation	See responses referred to in your comment in section I (same comment number).	
				
3118
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 #
3054 (ILA)	
				
3119
2016/02/17	Company,
Spain	This substance is considered an intermediate in the manufacture of frits. The Frit Consortium has recently submitted an updated version of the argumentation used to demonstrate the intermediate status of this substance. We support the information provided by the Frit Consortium and the consideration of this substance as an intermediate in the manufacture of frits, according to the definition of intermediate in the REACH Regulation.	See responses referred to in your comment in section I (same comment number).	
				
3127
2016/02/17	Ceramicolor - Federchimica,
Industry or trade association,
Italy	This substance is considered an intermediate for the manufacture of frits and inorganic pigments. Ceramicolor would like to support the comments issued by the Frit Consortium and the Inorganic Pigments Consortium.	See responses referred to in your comment in section I (same comment number).	
				
3155
2016/02/18	Company,
Germany	Because of the following reasons lead tetra -oxide  also should not be included into the annex XiV: • During article manufacturing, the risk associated to potential exposure to lead-oxides is properly controlled • Lead tetra - oxides are strictly bound into the matrix, so there is no danger for humans and the environment caused by foreseen use of the lead-tetra oxides-containing solar panels products. End of life of solar panels, the concentration of lead tetra oxide is far below classification when applied to the solar panels. Hence , solar panels do fall under the normal Waste Regulation.

	A.1.5. Aspects not considered in ECHA's prioritisation
A.1.5.4. Control of risks
C.1.1. General principles for exemptions under Art. 58(2)
C.1.2. Generic exemptions	
				
3156
2016/02/18	Ferro GmbH,
Company,
Germany	This substance is considered an intermediate in the manufacture of ‘pyrochlore, antimony lead yellow’. The Inorganic Pigments Consortium has recently submitted an updated version of the argumentation used to demonstrate the intermediate status of this substance. We support the information provided by the Inorganic Pigments Consortium and the consideration of this substance as an intermediate in the manufacture of ‘pyrochlore, antimony lead yellow’, according to the definition of intermediate in the REACH Regulation.	See responses referred to in your comment in section I (same comment number).

Please see also response to comment #
3082 (Inorganic Pigments Consortium)	
				
3170
2016/02/18	The Federation of Finnish Technology Industry,
Industry or trade association,
Finland	The use in manufacturing lead-acid batteries.	C.1.1. General principles for exemptions under Art. 58(2)
C.2.1. Response to requests for exemptions under Art. 58(2)	
		3170_Comments on the draft recommendation of orange lead for inclusion in Annex XIV.docx		
3180
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 #
3054 (ILA) and #3118 (EUROBAT) in section I.