Comments on ECHA’s Draft 7th Recommendation for Lead monoxide (lead oxide) (EC number: 215-267-0) 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 Lead monoxide (lead oxide) (EC number: 215-267-0). 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	

Lead monoxide (lead oxide) 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	
3049
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		
3055
2016/02/03	International Lead Association,
Industry or trade association,
United Kingdom	Detailed comments were already provided in a previous consultation in 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 23 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 at most they represent some 6.5% of the total volume of lead monoxide and hence do not materially affect the prioritization scoring). These uses are as intermediates in the manufacture of PVC stabilisers, technical ceramics, frits, explosives and glass (both lead special glass and crystal glass) as confirmed in a workshop hosted by Eurometaux and CEFIC and attended by ECHA staff in 2015. In addition uses as a laboratory reagent and in chemical analysis 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)	
		3055_Lead Monoxide 7th Priority List Comments.pdf

3068
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 oxide in glass were excluded from the priority setting in the 6th priority list, on the ground that lead oxide 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	
				
3076
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)	
		3076_ASD repsonse to ECHA Consultation - Lead Compounds - February 2016.pdf

3079
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)	
		3079_2016-02-11-intermediate use lead oxides in frits.docx

3081
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	
		3081_2016-02-09-pigments intermediates.pdf

3083
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 #3079 (Frit Consortium)
See responses referred to in comment #3081 (Inorganic Pigments Consortium)	
				
3089
2016/02/16	Precious Metals and Rhenium Consortium,
Industry or trade association,
Belgium	The Precious Metals and Rhenium Consortium (PMC - http://www.epmf.be/index.php/reach-consortiumleft) is in charge of the REACH and CLP implementation for its member companies which are involved in the mining, refining, recycling, manufacturing, importing, trading and banking of precious metals. The PMC is hosted by the European Precious Metals Federation (EPMF - http://www.epmf.be).The PMC supports the contribution submitted by the International Lead Association to this consultation and to the one on lead compounds in the context of ECHA’s 6th draft recommendation list. In addition, we would like to comment on the use of lead oxide as “laboratory reagent and in chemical analysis”, as reported in ECHA’s draft background document for lead monoxide. In the precious metals industry, lead monoxide is used in the determination of the precious metals content in secondary raw materials and other complex materials. The outcome of this analysis is critical to identify with the highest accuracy the precious metals content to be recovered from the received materials.
In this method, also called “fire assay”, lead monoxide is added to the flux used for precious metals analysis. The volume of lead oxide used in fire assaying is estimated to be around 15-20 tonnes per year for the entire precious metals industry in Europe
Lead monoxide is consumed during the reaction and is not present under this form in the next steps of the process. The process does not lead to the production of an article.
The use of lead oxide in fire assaying is covered by the EU binding occupational exposure limit value on lead and lead compounds set forth under the Chemical Agents Directive (98/24/EC). Accordingly, specific risk management measures are implemented in order to avoid exposure of workers (personnel protective equipment, exhaust ventilation equipment, regular blood testing). Risks for the environment are also adequately controlled due to waste water collection and off-gas cleaning systems, in accordance with the Industrial Emissions Directive and the BREFs on Best Available Techniques for non-ferrous metals production. Furthermore, fire assays are performed by trained staff. The use of lead monoxide in fire assaying is critical because this is the method with the highest precision and accuracy in the analysis of precious metals concentration in materials. There is no alternative to the use of lead monoxide at present when it comes to the determination of precious metals content for commercial purposes. Alternatives may be used for applications with lower precision requirements.	A.1.1. General, recommendation process
A.1.1.5. New information and next steps toward the final recommendation
A.1.5. Aspects not considered in ECHA's prioritisation
A.1.5.4. Control of risks
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 #
3055 (ILA).	
		3089_Precious Metals Consortium PbO FINAL.pdf

3093
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 #3079 (Frit Consortium)	
				
3102
2016/02/17	WVMetalle,
Industry or trade association,
Germany	We support the comments submitted in this scetion by the International Lead Association on behalf of the Pb REACH Consortium.	See responses referred to in comment #3055 (ILA)	
				
3109
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 #3055 (ILA)	
				
3110
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 #
3055 (ILA) and comment #3117 (EUROBAT).	
		3110_recom_com_call_RPS SpA.docx

3115
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 #3079 (Frit Consortium)	
				
3117
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 #
3055 (ILA)	
				
3125
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 #3079 (Frit Consortium)
See responses referred to in comment #3081 (Inorganic Pigments Consortium)	
				
3129
2016/02/17	Wirtschaftskammer Österreich,
Other contributor,
Austria	See document attached	A.1.2. Prioritisation: Volume
A.1.2.1. Volume in the scope of authorisation
A.1.3. Prioritisation: Wide-dispersiveness of uses
A.1.3.1. Scope of the assessment of wide-dispersiveness of uses
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.1.5.4. Control of risks
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.2.1. 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
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.2.1. Response to requests for exemptions under Art. 58(2)	
		3129_bd_16_Stellungnahme_Priorisierung_Bleioxid_Bleiverbindungen.pdf

3130
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 #
3055 (ILA) and comment #3117 (EUROBAT).	
				
3146
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	
				
3163
2016/02/18	Roxel (UK Rocket Motors) Limited,
Company,
United Kingdom	Roxel (UK Rocket Motors) Limited, has noted with interest the call by ECHA, 18th November 2015 - 18th February 2016, for comments on proposals to include a number of lead based substances, including lead monoxide, in Annex XIV of the REACH Regulation as substances of very high concern (SVHC) which would require authorisation for use. Detailed documents were provided in the previous consultation, 6th Recommendation for inclusion of substances in Annex XIV 1st September - 30th November 2014, and are not repeated here unless to re-emphasize or due to the addition of supportive information.	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)	
				
3164
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 #3055 (ILA)	
		3164_16.04.Lead Monoxide 7th Priority List Comments.pdf

3171
2016/02/18	The Federation of Finnish Technology Industry,
Industry or trade association,
Finland	This consultation is focused on lead monoxide use 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	
		3171_Comments on the draft recommendation of lead monoxide 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	
3055
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 monoxide 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 monoxide. 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).	
		3055_Lead Monoxide 7th Priority List Comments.pdf		
		3089_Precious Metals Consortium PbO FINAL.pdf		
3110
2016/02/17	RPS S.p.A.,
Company,
Italy		-

Please see also response to comment #
3055 (ILA) and comment #3117 (EUROBAT).	
		3110_recom_com_call_RPS SpA.docx		
		3129_bd_16_Stellungnahme_Priorisierung_Bleioxid_Bleiverbindungen.pdf		
3163
2016/02/18	Roxel (UK Rocket Motors) Limited,
Company,
United Kingdom	Roxel are aware from the "Draft background document for lead monoxide" that a latest application date (LAD) of 24 months is proposed. Lead substances, (including lead monoxide), have been assigned to the third LAD slot due to the potentially high number of uses, overall complexity of the supply chain and workload of the applicant. However, Roxel feel that this would not give sufficient time to continue R & D research and implement alternatives. This is based upon previous attempts to identify replacements over the past 30 years, which have failed. We therefore request that a LAD of 35 months be applied as per the precedent created by chromate compounds (Regulation 348/2013 item 14: "Concerning the seven chromium compounds the Agency proposed the latest application date to be set at 21 months after entry into force of this Regulation. However, based on a discussion with Member States, a broader appreciation of the significance of the specific structure of relevant markets and the related supply chain leads to the conclusion that the latest application date should be set at 35 months after entry into force of this Regulation"). This request for a latest application date of 35 months is also based on the appreciation that the Aerospace and Defence industry operates very long life cycle products and consequently the upkeep of legacy products to ensure the maintaining of the Defence of the Realm Act (DORA), ie to secure the safety of her majesty's forces and ships is also a factor.	A.1.5. Aspects not considered in ECHA's prioritisation
A.1.5.2. Authorisation is disproportionate and/or means a ban
B.1.1. General principles for setting latest application dates/sunset dates
B.1.1.3. ECHA's proposal for latest application dates
B.1.2. Aspects not considered by ECHA when proposing latest application dates/sunset 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)
B.1.2.2. Lack of alternatives, socio-economic aspects
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
B.2.3. Raising the need to use certain substances in legacy products and request longer LAD	
				
3171
2016/02/18	The Federation of Finnish Technology Industry,
Industry or trade association,
Finland	Lead monoxide should be released from authorisation for the time period that is needed to develope economicaly 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	
		3171_Comments on the draft recommendation of lead monoxide 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	
3049
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		
3055
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 lead monoxide 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 lead monoxide in battery manufacturing (and possibly other uses that are restricted to industrial processing and where lead monoxide 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 monoxide (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 monoxide. 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 monoxide 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 monoxide 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 lead monoxide 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 monoxide is placed on the Candidate list. Thus ALL requirement necessary to consider REACH Article 58(2) exemption for the use of lead monoxide 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 monoxide (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).	
		3055_Lead Monoxide 7th Priority List Comments.pdf		
3068
2016/02/10	European Domestic Glass & European Special Glass Associations,
Industry or trade association,
Belgium	Lead monoxide is used as an intermediate in the production of Crystal glass and certain specialty glass.
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 propertly controlled.  In our understanding, lead oxide 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)	
				
		3076_ASD repsonse to ECHA Consultation - Lead Compounds - February 2016.pdf		
3079
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 document to demonstrate intermediate use is attached	See responses referred to in your comment in section I (same comment number).	
		3079_2016-02-11-intermediate use lead oxides in frits.docx		
3081
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).	
		3081_2016-02-09-pigments intermediates.pdf		
3083
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).	
				
3089
2016/02/16	Precious Metals and Rhenium Consortium,
Industry or trade association,
Belgium	ECHA’s draft background document indicates that “the conditions for the generic exemption for SRD may not always be met (based on the tonnage for that use).” We confirm that the tonnage per legal entity often exceeds 1 tonne per year. Furthermore, we are of the view that regardless of the tonnage, and therefore of the SRD exemption possibility, the use of lead monoxide in the determination of precious metals content meets the conditions of Article 58(2) exemption.
Article 58(2) foresees that “uses or categories of uses may be exempted from the authorisation requirement provided that, on the basis of the 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”.
Lead and lead compounds are one of the few substances for which a specific binding OELV has been established under the Chemical Agents Directive. In having a binding occupational exposure and biological limit for lead and lead compounds, supported by additional measures such as medical surveillance, the Chemicals Agents Directive ensures proper control of risks EU wide (Member States can establish more stringent but not less stringent requirements), as required by Article 58(2).
	See responses referred to in your comment in section I (same comment number).

Please see also response to comment #
3055 (ILA).	
		3089_Precious Metals Consortium PbO FINAL.pdf		
3093
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).	
				
3110
2016/02/17	RPS S.p.A.,
Company,
Italy		Please see also response to comment #
3055 (ILA) and comment #3117 (EUROBAT).	
		3110_recom_com_call_RPS SpA.docx		
3115
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).	
				
3117
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 #
3055 (ILA)	
				
3125
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).	
				
3128
2016/02/17	Company,
France	Our company, as a manufacturer of catalysts and adsorbents, would like to comment the prioritization of Lead Monoxide. Our products are mixtures regarding REACh regulation and some of them contain Lead monoxide on an alumina carrier.
The Lead monoxide is produced from Lead salts (acetate, nitrate, etc.) for manufacturing of catalysts and catalysts precursors.
We manufacture two types of products:
- Catalysts that contain Lead Monoxide (PbO) as such
- Catalyst Precursors on which  Lead Monoxide is post transformed in Lead Sulfide (PbS). In this case, PbO containing product is a catalyst precursor and PbS containing product is a catalyst.

1-Use of Catalysts Precursors (PbO totally transformed into PbS)

In this application, PbO can be considered as an INTERMEDIATE because it is manufactured for and consumed in chemical processing in order to be transformed into PbS in the final product called Catalyst.
So, this application is in line with the definition of intermediates and thereby should be exempted of authorization under Article 2(8) of REACh regulation.
Please note that comments in the following section §2 are also applicable for the use of PbO as intermediate.

2-Use of Catalysts (PbO contained in the final product)

With regards to manufacturing process in our facility, specific equipment and procedures are in place to prevent workers from lead monoxide exposure. Typically Restricted access to production line (closed)
- Specific Personnel Protective Equipment (PPE) are used such as:
o Disposable suits to be worn over working clothes
o Goggle glasses
o Breathing masks (FFP3)
- Used PPE are daily changed and eliminated as hazardous waste in a properly registered way. This could include safety helmets and safety shoes if they are not covered by the disposable suits or other additional protections.
- Each worker is medically monitored before, during and after production campaign through biomonitoring made by blood test.
- Workers exposure measurement for each production campaign (static and ambulatory)

Moreover lead monoxide catalysts are only used in confined industrial process reactors in oil refining and petrochemicals industries. These catalysts will never be in contact with professionals or consumers during all their life cycle and therefore are not wide dispersive.

Finally, the binding occupational exposure limit (OEL) sets out for lead and lead compounds and other requirements of existing Occupational health regulation (such as compulsory medical surveillance and protection of pregnant and breastfeeding workers through Directive 92/85/EEC, SCOEL recommendations in SUM/83 or local regulation on application of OEL mandatory in France) constitutes “existing specific Community regulation imposing minimum requirements relating to the protection of human health” for the toxicological endpoint for which lead monoxide is placed on the Candidate list.

So, for all this reasons, we request that the use of Lead Monoxide related to catalyst manufacturing industry should be recommended for exemption from the authorization requirement under Article 58(2) of REACh regulation.
	A.1.1. General, recommendation process
A.1.1.5. New information and next steps toward the final recommendation
A.1.3. Prioritisation: Wide-dispersiveness of uses
A.1.3.1. Scope of the assessment of wide-dispersiveness of uses
A.1.5. Aspects not considered in ECHA's prioritisation
A.1.5.4. Control of risks
A.2.4. Intermediate status of the use of lead monoxide in catalyst applications
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)	
				
3129
2016/02/17	Wirtschaftskammer Österreich,
Other contributor,
Austria	See document attached	See responses referred to in your comment in section I (same comment number).	
		3129_bd_16_Stellungnahme_Priorisierung_Bleioxid_Bleiverbindungen.pdf		
3163
2016/02/18	Roxel (UK Rocket Motors) Limited,
Company,
United Kingdom	Roxel are aware from the "Draft background document for lead monoxide" that ECHA proposes not to recommend exemptions for uses of lead monoxide on the basis of Article 58(1) in combination with Article 58(2) of the REACH Regulation. Fromm reviewing the responses to the 6th Recommendation, it is felt that ECHA and MSC have included the concept of substitution as an additional element which is beyond the criteria of Article 58(2):"given the wealth of EU legislation governing lead and its compounds the uses with perhaps the strongest case for Article 58(2) exemption are those for which a legislative regime is already in place to push for substitution in a similar manner to the authorisation requirement." It is felt that this assumption cannot be given for all uses of lead monoxide and Roxel is of the opinion that the Commission does not have the authority to refuse every exemption under Article 58(2).

With respect to the Article 58(2) definition, in the comments submitted for the 6th Recommendation, Roxel provided strong arguments that is uses for lead monoxide complied, ie "uses may be exempted from authorisation requirement provided that, on the basis of the 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." Roxel wishes to re-emphasize that it is certified to:
ISO14001:2004.
Roxel also wishes to re-emphasize that when lead based ingredients are incorporated into Roxel materials on site, registered legislation is followed. These being/including:
Workplace (Health, Safety, Welfare) Regulations 1992.
Health and Safety at Work Act 1974.
Management of Health and Safety at Work Regulations 1999.
Control of Lead at Work Regulations 1998.
PPR at Work Regulations 1992.
COSHH 2002.
CLP (Classification, Labelling and Packaging Regulation)

Article 58(2) definition also specifies that, "In the establishment of such exemptions, account shall be taken, in particular, of the proportionality of risk to human health and the environment related to the nature of the substance, such as where the risk is modified by the physical form." Roxel feel that their application justifies an exemption since as stated in our response to the 6th Recommendation, "one of the primary uses of this product by Roxel is in the manufacture of propellants and maximum usage is 500kg per year."	C.1.1. General principles for exemptions under Art. 58(2)
C.2.1. Response to requests for exemptions under Art. 58(2)	
				
		3164_16.04.Lead Monoxide 7th Priority List Comments.pdf		
3171
2016/02/18	The Federation of Finnish Technology Industry,
Industry or trade association,
Finland	Lead monoxide in manufacturing lead-acid batteries should be exempted.	C.1.1. General principles for exemptions under Art. 58(2)
C.2.1. Response to requests for exemptions under Art. 58(2)	
		3171_Comments on the draft recommendation of lead monoxide for inclusion in Annex XIV.docx		
3178
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 #
3055 (ILA) and #3117 (EUROBAT) in section I.