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Pb Consortium Meetings
13 December 2016
REACH General Assembly
Oxford & Cambridge Club
71 Pall Mall,
SW1Y 5HD
LONDON
8 March 2017
REACH Steering Committee
ILA Offices
LONDON
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Editorial
An intensive year for the Consortium
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by Lisa Allen, REACH Manager
As 2016 draws to an end I’m pleased to say that the Lead REACH Consortium has achieved significant results across its workplan. There have been updates to the Lead Registration dossiers for lead metal and 10 lead compounds and the implementation of the harmonised classification in the 9th ATP to CLP. Meanwhile key Member States..
have supported the Consortium’s call to the Commission to consider proportionality when updating Annex XIV, of the REACH Authorisation List.
In addition, the new Lead REACH Consortium website has been launched, making it easier for members, and other stakeholders, to stay up to date with the latest developments.
The intensive advocacy campaign addressing ECHA’s draft 7th Priority List for Authorisation has not delivered any certainty for an exemption for the use of four lead compounds prioritised by ECHA, however the outcome of the Member State Committee (MSC) has definitely energised the Consortium’s campaign.
If you have questions or comments about the workplan or any other concerns please do not hesitate to contact me ( allen@ila-lead.org).
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AUTHORISATION UPDATE |
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MSC votes in favour of prioritising four lead compounds
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Despite a number of abstentions, the MSC voted unanimously, at its 49th meeting, to adopt an Opinion supporting ECHA’s recommendation to include four lead compounds on the 7th priority list for authorisation.
Discussions with Member States, and interventions at the MSC meetings, were crucial in achieving two important results:
- a significant minority of abstentions from the MSC vote, and
- an MSC Opinion which recognises that “there could be possible grounds for exemptions for uses that are regulated under RoHS and ELV” (i.e. Article 58(2) exemption), and clarifies uses which could be considered as intermediate uses (i.e. automatically exempted from authorisation).
However, the minutes of the MSC meeting are expected to reflect comments by several countries that to subject the four lead compounds to authorisation would not be proportional to the benefits of risk reduction given the existing extensive regulatory environment for lead and its compounds.
Lead monoxide, lead tetroxide, tetralead trioxide sulphate and pentalead tetraoxide sulphate will now be considered by the European Commission for inclusion in Annex XIV, the list of substances subject to authorisation.
Battery producing member companies, supported by the Secretariat, conducted advocacy meetings with Member States, ahead of the September vote, highlighting the lack of proportionality in the inclusion of the four substances in Annex XIV, and vigorously contesting the non-applicability of Article 58(2) exemption presented by ECHA. These interventions emphasised that that all battery uses (automotive and industrial) and all life cycle stages of the four lead compounds were adequately covered by existing EU-wide legislation.
The Secretariat also stressed that it was beyond the mandate of ECHA and MSC to judge the effectiveness of existing legislation, such as the binding OEL for lead and its compounds. The Secretariat also strongly challenged the notion that substitution should be embedded into the interpretation of proper control required by Article 58(2).
In collaboration with EUROBAT, the Consortium developed a communication package – a position paper, an infographic, and a slidedeck – designed to ensure effective and consistent delivery of key messages.
Secretariat plans next phase of advocacy
Although Member State endorsement for REACH Article 58(2) exemption for battery production was not achieved in the MSC process, there are opportunities to press our case on exemption still further.
There are now key phases for the campaign coming up:
- The Commission will consider the MSC Opinion and the formal 7th recommendation from ECHA when drafting the update to REACH Annex XIV.
- The proposed amendment to Annex XIV is expected to be presented to the REACH Article 133 Committee from March 2017. Ahead of this vote, advocacy work will continue at Member State level with two objectives: to maintain the support of Member States sympathetic to the cause, and to urge other Member States to support the call for Article 58(2) exemption.
- Targeted at the European Parliament, this phase will advocate a vote in plenary that supports Article 58(2) exemption for the use in lead-based battery production.
Any inclusion of the four lead compounds in Annex XIV could not reasonably take place before June 2017. The Secretariat then expects a minimum transitional period of 42 months: 24 months to the Latest Application Date and 18 months to the Sunset Date, after which time uses must be authorised by the European Commission unless an exemption applies.
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CLASSIFICATION UPDATE
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Consortium FAQs on 9th ATP to CLP
The Secretariat has published a set of frequently asked questions (FAQ) to address common queries about the harmonised classification for lead metal introduced by the 9th ATP to CLP. This ATP (Adaptation to Technical Progress) introduces harmonised health classification for lead metal, listing lead powder (particle diameter <1mm) and lead massive (particle diameter ≥1mm) separately.
The FAQ clarifies the different concentration limits for powder and massive forms, and the distinction between effects on fertility and those on development. For mixtures including alloys, the document also summarises the SDS obligations, health classification and label elements as a function of lead content.
The harmonised classification entries introduced by the 9th ATP will apply formally from 1 March 2018. However, the Consortium has already adopted the harmonised classification voluntarily, incorporating it into its self-classification for lead metal:
- A registration dossier update was submitted by the Lead Registrant in June;
- Revised SDS templates were issued in July and are available from the Members’ section of the Consortium’s new website
- The Secretariat requested an update to MeClas in Q4 2016.
Denmark environmental classification proposal for lead metal imminent
Denmark’s updated proposal for harmonised environmental classification (ENV CLH) for lead metal is imminent; the consequent public consultation is expected to start in November, lasting 45 days.
Despite the unequivocal test data which justify the interpretation that lead metal in massive form does not require environmental classification, the Secretariat is anticipating another single ENV CLH proposal for all forms of lead metal. If adopted, transport legislation on the carriage of dangerous goods, such as ADR, and the Seveso Directive, would newly apply to lead metal in massive form.
Once the submitted dossier has been processed by ECHA a 45-day public consultation will take place. The Secretariat will prepare and submit a response to the consultation which emphasises and defends the Consortium’s differentiation between the two forms.
ECHA’s Committee for Risk Assessment (RAC) must prepare its scientific opinion within 18 months of the CLH proposal, taking into account the comments received during the public consultation. ECHA has confirmed that the earliest the lead metal ENV CLH proposal could be on the agenda is for the RAC meeting in June 2017; the 18-month period would expire in or after April 2018 – but RAC may of course adopt its opinion ahead of that deadline.
A transitional period of at least 18 months is usually incorporated into Adaptations to Technical Progress (ATP) which amend Annex VI to CLP. Therefore, the Secretariat estimates that ENV CLH could – in a reasonable worst case – apply to lead metal from the second half of 2019.
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RESTRICTION UPDATE |
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Use of lead shot under double scrutiny
During discussions on a potential restriction on all consumer uses of lead metal as a substance or in mixtures and alloys, the Secretariat has re-emphasised the status of lead shot as an article with the European Commission. The Consortium has also actively participated in the ECHA Stakeholder Workshop on lead shot use in wetlands.
Consumer use of lead shot during the process of reloading spent ammunition rounds is identified in the Consortium’s Chemical Safety Report for lead metal. It is widely recognised by industry that lead shot is an article, an interpretation which the European Commission (DG GROW) called into question during a recent informal call for evidence. In providing an unequivocal justification for Industry’s position to DG GROW, the Secretariat reinforced the strong message that lead shot is outside the scope of the Commission’s potential restriction on consumer use of CMR substances.
Due to its harmonised classification as a Category 1A reproductive toxicant, the  European Commission is drafting legislation to include lead metal in Appendix 5 to Annex XVII of REACH. Appendix 5 is one of the six which list CMR substances that cannot be 'placed on the market, or used, as a substance, as a constituent of other substances, or,
in mixtures, for supply to the general public when the individual concentration in the substance or mixture is equal to or greater than the relevant concentration limit'.
This potential restriction on lead metal would apply under Entry 30 of Annex XVII from 1 March 2018; it would not affect professional or industrial use of lead metal, nor the consumer use of lead articles.
Stakeholder Workshop on lead shot in wetlands
Lead shot is also under scrutiny by ECHA, in the context of risks to wildlife and the environment exposed to lead shot and to human health from eating waterfowl hunted with lead shot.
In 2015, the European Commission requested ECHA to prepare a restriction proposal to harmonise the conditions of use of lead in shot in wetlands, a priority at EU level. Under the auspices of the Agreement on the Conservation of African-Eurasian Migratory Waterbirds (AEWA), national or regional legislation has been enacted in all but three Member States.
The expected submission date for ECHA’s restriction proposal is April 2017, with a public consultation starting in June-July. The Secretariat expects it to restrict the use of shot made from lead or lead alloys with more than 1% lead, in areas of marsh, fen, peatland or water, including areas of marine water where the low tide water depth does not exceed six metres.
The Secretariat continues to provide technical support and advice to the Association of European Manufacturers of Sporting Ammunition, AFEMS, as requested. The Consortium will also respond to the public consultation, to defend the predicted no effect concentrations (PNECs) presented in the registration dossier. This is because the PNEC will apply to all uses of lead and therefore set a precedent.
Because the PNEC (and should probably add DNELs) apply to all uses of lead. If ECHA establish lower values for the ammo case then this sets precedent that will hurt us for battery use etc..
Proposal to restrict lead-based stabilisers delayed
The anticipated proposal to restrict the use of lead-based stabilisers in PVC has been postponed until December.
Such a restriction would complement the success of the voluntary initiative under VinylPlus to replace lead-based stabilisers in the EU-28 by the end of 2015. The Consortium and the European Stabiliser Producers Association (ESPA) do not expect the potential restriction to constrain the manufacturing of lead-based stabilisers for export, instead addressing EU use of the stabilisers, as well as the first placing on the market of lead-stabilised articles. It does, however, have the potential to hinder the recycling of lead-stabilised PVC articles.
A six-month public consultation is expected to start in Q2 2017; the final restriction is likely to be published in the Official Journal of the European Union from Q3 2018.
Working closely with ESPA, the Secretariat will respond on behalf of the Consortium ahead of the first plenary discussions by ECHA’s Committee for Risk Assessment (RAC) in June 2017. The response will focus on mitigating potential negative consequences for other uses of lead substances and other potential regulatory threats, in particular the issue of human exposure via the environment, and to advocate wording of the restriction which does not hinder recycling and recognises the benefits of the circular economy.
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RESEARCH UPDATE |
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Medical surveillance study on track
By Steve Binks, ILA Director of Regulatory Affairs
The industry-sponsored medical surveillance project designed to track health impacts of lead exposure over a number of years, in a cohort previously not exposed to lead, is on track.
 The first group of workers to join the study will be reaching their year 1 milestone soon and we anticipate that the research team from the University of Leuven will submit a preliminary report on initial findings for publication in early 2017. It is anticipated that the full study cohort of 500 workers will be achieved by June 2017.
CSR update with emphasis on the revision of lead secondary poisoning
By Jasim Chowdhury, ILA Science Manager
A revision of the Consortium’s Chemical Safety Reports (CSR) is currently underway, primarily to update the information on secondary poisoning, and also to review existing PNECs and ERVs (ecotoxicity reference values) reflective of direct toxicity in freshwater and marine environments.
Secondary poisoning largely refers to wildlife toxicity, via the food chain, and it is the most critical pathway for lead toxicity in soil. The soil PNEC used in the current REACH dossiers for secondary poisoning to mammals is 109 mg/kg(soil), almost one half of the PNEC (212 mg/kg(soil)) derived for direct toxicity to soil organisms (plants, invertebrates and microorganisms).
Because of the higher sensitivity to wildlife, one Member State has recently used this route of toxicity as a driver for its soil screening value (SSV) for lead. In contrast to the direct toxicity to soil organisms, the secondary poisoning database for lead is less robust and has not been thoroughly reviewed after the voluntary risk assessment ( VRAL). As a result, the Member State has identified this gap as an uncertainty in the SSV derivation and thus, downward modified the PNEC using a large assessment factor.
The revision will focus on updating literature data on chronic toxicity of lead to mammals and birds in order to strengthen the weight of evidence and decrease the uncertainty in lead secondary poisoning. The PNEC will be revised if applicable and stronger arguments in relation to the use of lower assessment factor will be provided.
This revision appears to be critical and timely; a Danish dossier proposing harmonized environmental classification of lead is expected to be submitted to ECHA soon for review and public consultation. Previous CSR updates only included information on direct environmental toxicity published before 2011. Therefore, the update will also review new information published on freshwater and marine water and revise PNECs and ERVs if needed.
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OTHER NEWS |
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Launch of new Lead REACH Consortium website
October saw the launch of the Consortium’s new website, including a members-only section. Featured as part of ILA’s main website, the new REACH pages have replaced the original website with fresh, more user friendly and readily accessible resource for Consortium Members and external stakeholders.
Members-only section
Each Consortium member will receive an email directly from the website administrator, which will provide instructions on setting up individual access to the password-protected document library – affiliate members and LOA and LTU holders do not have access to this section. This password-protected section provides a central repository for essential Consortium documents including:
- Safety Data Sheet templates
- Consortium circulars and the papers for General Assembly meetings since December 2014
- Back issues of the REACH newsletter.
The Secretariat would like to thank Consortium Members for their support in the development of the new website. We hope that Members will find it to be a user-friendly and essential resource.
Eurometaux REACH Forum: achievements and aspirations
Authorisation continues to be a key priority for the Consortium and for Eurometaux. The REACH Forum, through its Authorisation and Restriction Platform, has established a workplan to support companies and consortia preparing to make Applications for Authorisation (AfA)s.
The Forum campaign will involve regulatory and legal activities, as
well as  technical projects. The former aims to influence the activities of ECHA and the European Commission to achieve the best possible outcome for the metals sector – particularly regarding the interpretation of Article 58(2) for exemption, and supporting recycling, the Circular Economy, and sustainability.
The main objectives of the technical projects will be to facilitate capacity-building, helping Industry to prepare robust, high-quality AfAs. The work program foresees scientific seminars and workshops on exposure to ‘Man via the Environment’, perhaps the most significant weakness in previous AfAs, and consolidating learning points from previous AfAs, particularly those submitted for the Cr(VI) compounds. Guidance complementing these events will be developed by the Forum and members will be invited to attend relevant AfA events, and will be asked by the Secretariat to provide feedback on draft guidance to ensure its practicability.
The REACH Review
The 2017 REACH Review provides an excellent opportunity to industry, society and authorities to take stock after ten years of practical experience of the Regulation. Alongside its extensive technical and regulatory work programme, the REACH Forum is advocating improvement of REACH implementation.
Given the current challenges faced by the Consortium, the Secretariat is eager to explore changes that would facilitate use-specific risk management options – something that could make the authorisation process more effective and efficient for Industry and for authorities.
With consultations in the context of aligning REACH with the Circular Economy expected to start in Q4, Consortium members will be invited to provide feedback on relevant draft responses.
The Secretariat will continue its active involvement in a REACH Review Task Force set up by the REACH Forum, making recommendations on how REACH could be made more efficient at achieving its goals.
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