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Reach Newsletter
www.reach-lead.eu Spring 2016  
 
Contents
Pb Consortium Meetings
 
28 June 2016
REACH General Assembly 
10am-4pm
Metals Conference Centre, 100 rue du Duc-5th Floor, 1150 Brussels
 

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Editorial

Welcome to the first REACH Newsletter from your new Consortium Manager


by Lisa Allen, REACH Manager

In just three months I have already discovered that one of the most rewarding aspects of the role of REACH Manager is the opportunity to help Members in the face of an ever-changing landscape. I am pleased to be part of the team at ILA and I am looking forward to taking an active role in the defence of lead and policy developments which could adversely affect our industry. 
 
In this issue of the REACH Newsletter we present some of the recent REACH developments and activities, but if you have any further questions or concerns about the challenges the industry faces, or about the extensive workplan we have in place to address them, please do not hesitate to contact me (allen@ila-lead.org).

I look forward to working with you in 2016.

 Editorial
 

AUTHORISATION UPDATE

 

Lead compounds under the spotlight again
 

 
ECHA’s three-month public consultation on the 7th draft recommendation for inclusion in the Authorisation List has closed. Among the eleven substances proposed are four lead compounds managed by the Lead REACH Consortium: lead oxide, lead tetroxide, pentalead tetraoxide sulphate and tetralead trioxide sulphate. The Secretariat submitted a response to the public consultation on behalf of the Pb REACH Consortium members, addressing four key concerns:   
 
  • Prioritisation: although in agreement with the prioritisation scores for the two lead oxides, the Secretariat disputed those assigned to the two sulphates.
  • Scope of authorisation: the Secretariat emphasised that certain uses of the two lead oxides are not in the scope of authorisation and should not be considered in tonnage estimates.
  • Transitional arrangements: the MSC previously acknowledged the complex supply chains that may exist for uses of the two lead oxides, and referred to precedent created by chromate compounds (Regulation 348/2013) where a 35-month latest application date (LAD) was applied. Despite the MSC opinion adopted on 11th June 2015, a LAD of only 24 months was proposed for the two lead oxides in the latest draft background documents. The Secretariat’s comments requested an extension to 35 months for those substances.
  • Uses (or categories of use) exempted from authorisation: the principal aspect of the Secretariat’s response was the defence of Article 58(2) exemptions for uses where sufficient lead-specific EU legislation already exists and ensures any risk is properly controlled, and the substance is not present in the final article. The Secretariat strongly challenged ECHA’s recommendation that no use be granted an Article 58(2) exemption; in particular it presented the case for exemption for use in lead-based battery production, where legislation already exists that manages the risk.
The Secretariat also worked closely with EUROBAT and other downstream users, providing support for their responses to the Commission’s parallel call for information on socio-economic consequences of the authorisation requirement.

Next Steps
The decision on whether to include a substance in Annex XIV, and whether to grant exemptions for specific uses according to Article 58(2), is taken by the Commission. However, The REACH Committee must return a “qualified majority” before the proposal can be adopted. In practice, this means the proposal must be supported by Member States representing at least 65% of the total EU population, and at least 16 Member States on the REACH Committee must vote in favour.

Therefore, during 2016, the priority for the Secretariat, working with EUROBAT, will to deliver strong advocacy messages to the Commission, Member States MEPs and other key stakeholders, to advocate exemptions for use of the four lead compounds in lead-based battery manufacturing.

The opinion of the ECHA committees, which will be sent to the Commission for consideration in the decision-making process, is expected in the summer. The Secretariat expects that any inclusion of substances from the 7th prioritisation in Annex XIV – the Authorisation List – would take place in June 2017. In the event that the Commission does not use its discretion to grant Article 58(2) exemption, a legal challenge must be initiated within 30 days of publication of the revised Annex XiV.

In parallel with its advocacy work, the Secretariat will seek legal advice on the likely costs and chance of success to better inform any decision on taking the case to the EU Court in summer 2017.

Candidate listing
 


CLASSIFICATION UPDATE 


No impact from 9th ATP to CLP on lead compounds

Accepted unanimously by REACH Committee in February, the 9th ATP to CLP will introduce harmonised classification and labelling (CLH) for lead metal as a Category 1A reproductive toxicant (H360FD) and for effects via lactation (H362).     

The 9th ATP, which is expected to be published in Q2 2016, will introduce two new entries to Annex VI to the CLP Regulation for lead metal, one for the massive form (particle diameter ≥1mm), and one for lead metal powder (particle diameter <1mm). Recognising the difference in bioavailability between the two forms, the entry for lead metal powder will include a specific concentration limit (SCL) of 0.03% for Category 1A effects on development (H360D), whereas the generic concentration limit of 0.3% will apply to massive forms.

Substance grade data sheets for the four REACH registered grades of lead metal (three massive forms and one lead metal powder) have already been updated to reflect the agreed CLH and the latest industry self-classifications in light of the systemic availability of the lead ion, the primary mediator of lead toxicity.

Further actions
Lead compounds are not impacted by the CLH agreed for lead metal, nor by its SCL for effects on development. Some lead compounds, such as lead diacetate, already have specific entries in Annex VI to CLP. Those not otherwise specified are already covered by the group entry for lead compounds (Index Number 082-001-00-6) and are subject to SCLs of 2.5% for Category 2 reproductive toxicity (effects on fertility; H361f) and 0.5% for Category 2 STOT RE (H373); these percentages are calculated by weight of the metallic element with reference to the total weight of the mixture.

The industry self-classification of complex lead substances such as slags is due for review in 2016 using MeCLAS. However, where lead metal is not the lead species present in the UVCB, the 9th ATP entry and its SCL for lead metal will not affect the overall classification.

Work has begun to update the IUCLID registration dossier and Chemical Safety Report (CSR) for lead metal. Although companies will have 18 months to implement the changes in classification once the 9th ATP is published (likely Q2 2016), a more timely dossier update demonstrates registrants’ willingness to comply, in particular regarding the additional industry self-classification for specific target organ toxicity – repeated exposure.

The Secretariat is preparing Frequently Asked Question for Members to use should customers or employees ask about the change in classification for lead metal.


Lead metal registration dossier update

The Secretariat has started work to update the registration dossier for lead metal in light of the agreed harmonised classification for lead metal. But while the changes to classification alone are sufficient to trigger an update to the registration dossier, it also provides a good opportunity to present significant positive developments for lead.   

Blood lead data
In preparation for the 2010 registration deadline, worker blood lead data were collected for the years 2005-2007, with the 75th percentile included in the exposure assessment (Section 9 of the CSR). Data requested for the years 2009-2012 now shows that the 90th percentile of occupational exposure is below the DNEL of 40 μg/dL and will be reported in the updated CSR. Looking ahead to next year, blood lead data collection from Q1 2017 will be used to demonstrate the benefit of the voluntary target of no employee having a blood lead level above 30 µg/dL by the end of 2016.

As a consequence of recent studies in the United States and the EU, the reduction in the baseline blood lead level in the general population, from 2 µg/dL to 1 µg/dL, will also be reported in the updated CSR.

Recent human health and environmental studies reported in literature will be incorporated into the IUCLID dossier and the CSR updated accordingly. As a consequence, an increase in the predicted no effect concentrations (PNECs) will be reported for marine water and soil, alongside a decrease in the PNEC for freshwater. 

Timescales
Submission of the Lead Registrant’s dossier is anticipated soon. Subsequently, the datasets for lead metal and the other substances under the remit of the Lead REACH Consortium will be migrated to the new IUCLID platform and reviewed for technical completeness and dossier quality.

The existing registration and CSR for lead metal reflects the uses reported in the 2007 Voluntary Risk Assessment. Therefore a review of the use scenarios to better reflect current usage will be carried out. Members may subsequently need to update their registration dossiers, using the new IUCLID 6 format.

Support on the use of IUCLID 6 will be provided later in the year, but for more information please read the article Changes to IT systems: REACH-IT 3 and IUCLID 6.
 
Sweden targets consumers
 
   

RESTRICTION UPDATE


European Commission starts to apply fast-track procedure

REACH Article 68(2) allows the European Commission to apply a fast-track Restriction procedure to consumer uses of Category 1A/1B carcinogens, mutagens and reproductive toxicants (CMRs) on their own, in mixtures, or in articles.  A fast-track case regarding CMRs in construction articles was discussed in a closed session at the CARACAL 20 in March, where the final report on a Commission scoping study was presented.    

This study was carried out to identify groups of construction articles and CMR substances likely to be present, and to explore cases to confirm release and consumer exposure to those substances from articles in scope. Two substances under the remit of the Consortium (lead tetroxide, trilead dioxide phosphonate) and three other lead compounds (lead chromate, lead sulfochromate yellow and lead chromate molybdate sulphate red) were identified among the 31 substances potentially in scope.

The fast-track procedure to introduce consumer restrictions bypasses a number of important stages in the standard Restriction process: the need for socio-economic analysis, scrutiny by ECHA’s Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC), and public consultation.

In our view, the lack of impact assessment for a restriction with such broad scope is of concern. This case is currently at a pre-feasibility stage and is not yet a proposal for Annex XVII listing. However, through Eurometaux, the Secretariat provided feedback to the Commission in April. The Secretariat will also follow closely any developments relating to the scope – the list of substances, the types of construction products, whether outdoor articles such as roofing materials are to be included – and specifically the potential impact to the lead sheet sector.

RMOA conclusions and developments affecting PVC and ammunition

Increasingly, Member States and ECHA use Risk Management Option Analysis (RMOA) to determine whether further regulatory risk management activities are required for a substance of potential concern, and to identify the most appropriate instrument to address a confirmed concern. As a consequence of two RMOA conclusions recently published, the Secretariat anticipates increased Restriction activity in 2016 concerning lead stabiliser use in PVC, and lead shot in wetlands.  

Lead Stabilisers
Traditionally, lead-based stabilisers have been used in pipes and other rigid PVC construction products, and in flexible PVC cables. Under the terms of the 2000 VinylPlus Voluntarily Commitment, the European PVC industry committed to replace lead stabilisers in virgin PVC in the EU by the end of 2015. Despite the success of this initiative, however, it is noted that recycled PVC may still contain these stabilisers as a legacy impurity embedded in the plastic matrix.

Parallel to the industry initiative, ECHA’s RMOA concluded that a REACH Restriction concerning lead stabilisers in PVC was appropriate. In support of its Circular Economy Action Plan, which addresses the presence of hazardous substances in certain plastics and recyclability, the European Commission requested ECHA to prepare an Annex XV Restriction report

Given the contribution of PVC recycling to the circular economy, it is anticipated that any restriction proposed would be worded to address the placing on the market of lead stabilisers for intentional addition to PVC compounds – rather than a more generic restriction based on the lead content of PVC, unless specifically exempting articles produced from recycled PVC.

ECHA has indicated an expected submission date of 7th October 2016 for the Restriction report; a six-month public consultation on the report is likely to start in December 2016, with the first draft opinion of the Risk Assessment Committee anticipated in March 2017. Once published, the Secretariat will review the proposal, preparing a response to the consultation on behalf of Consortium members and providing necessary support to the European Stabiliser Producers Association (ESPA) as appropriate.

The General Assembly in June will feature a presentation by the European Stabiliser Producers Association (ESPA) on the proposed Annex XVII Restriction relating to lead stabilisers in PVC. For a preview, please turn to the article below.

Lead Shot
ECHA has initiated a call for evidence on the use of lead in shot over wetlands, which closes on 21 June. The objective of this consultation is to gather information on the scope and impact of a possible REACH Restriction, including the suitability of alternatives to lead shot and to see if action on an EU-wide basis, beyond any measures already in place, is necessary. ILA will work with the Association of European Manufacturers of Sporting Ammunition (AFEMS) to help them construct a response which takes into consideration current scientific evidence.

ECHA’s Risk Management Option Analysis (RMOA) report published in January concluded that an EU-wide REACH Restriction is required regarding the use of lead shot for shooting in wetlands. National legislation has already been enacted by some Member States (or regions in some Member States) further to international action through the Agreement on the Conservation of African-Eurasian Migratory Waterbirds (AEWA) under the auspices of the UN Environment Programme (UNEP) to which the EU is a Party. Therefore the REACH Restriction is seen as a harmonisation exercise to ensure that all EU Member States adopt such measures.

Restriction is one of six possible outcomes of the RMOA process. Substances for which RMOA analysis is underway or is been completed since 2013 are listed in the Public Activities Coordination Tool (PACT), along with any conclusion documents.

Socioeconomic analysis
 
   

RESEARCH UPDATE


Medical surveillance study on track
By Steve Binks, ILA Director of Regulatory Affairs
 
The longitudinal medical surveillance study designed to follow health status of 500 new hires over a period of at least two years is on track.  

A number of issues were encountered by the host sites during the pilot phase of the study including collection of sophisticated measures of cardiovascular function (Pulse Wave Analysis and Pulse Wave Velocity) and measuring ambulatory blood pressure. These have now been addressed. Data collection has been completed on 128 new hires and is on schedule for completion of cohort recruitment of the full 500 subjects by end of 2016.  The study will then progress for at least another two years before conclusions can be drawn by the University Research team. 

Separate worker health study
ILA has provided modest funding to allow the Institute of Occupational Medicine (IOM), Edinburgh, to participate in an IARC study, which is being led by Professor Kyle Steenland (Emory University), designed to assess cancer risks in workers undergoing medical surveillance for lead. Cohorts from the US, UK, Australia, Finland and South Korea were considered for inclusion in the pooled analyses, but upon review of the available data it was decided to exclude the South Korean and Australian data.

The study will carry out an external analyses of mortality (and cancer incidence) using standardised mortality or morbidity ratios, in which the referent groups will be country specific and will explore exposure-response relationships. IOM has now completed the exposure assessment for the pooled analysis and IARC are currently working on the pooled mortality and cancer incidence analysis with a target to have this completed ready for presentation at an International epidemiology conference in early September. 

Environmental programmes plug gaps in REACH dossiers
By Jasim Chowdhury, ILA Science Manager

ILA environmental programmes have now completed most of the research work to address data gaps identified in the EU Voluntary Risk Assessment report and the initial REACH registration dossiers for effects assessment of lead in freshwater and terrestrial ecosystems.  

Funded partially by the REACH Consortium, the multi-year research has generated a significant amount of new data to better understand the bioavailability and toxicity of lead in freshwater, saltwater and soil, and allowed updating of the REACH dossiers with more scientifically-credible information on lead risk assessment and classification for regulatory defence.

The programme activities in 2016 include relatively minor research focusing on system boundaries of the lead BLM to ensure that the model is applicable to all water chemistries in Europe. Some desk work is also underway to develop a simplified, user-friendly interface for lead Biotic Ligand Model (BLM), as it is anticipated that such a computer tool will be necessary in the near future for uses by EU member states to assess EQS compliance under the EU Water Framework Directive. In addition, efforts continue to publish research in peer reviewed scientific journals and disseminate the findings including regulators. A new list of publications and reports that have been produced from the ILA environmental research programmes between 2006 and 2015 is now available on the ILA website. 

Last year ILA research efforts reached two significant milestones of scientific and regulatory importance in Europe. The first is the development of the lead Biotic Ligand Model (BLM) that has now been made widely available to facilitate risk assessment of lead in freshwaters. The second is the development of a soil metal PNEC calculator for undertaking risk assessment of lead and other metals to soil organisms. Specifically for lead, this tool adds an option of calculating secondary effects through food chain in addition to direct effects of soil lead on terrestrial organisms. The new data and the tools have been integrated into the REACH Chemical Safety Report by their applications to derive bioavailability-based safe levels of lead in European surface waters and soils.
Intermediates

 
 
   

OTHER NEWS


Lisa Allen joins ILA as REACH Consortium Manager

Lisa Allen has been appointed as the new Lead REACH Consortium Manager. In her role at the International Lead Association she will be responsible for the overall management of the Lead REACH Consortium and will also work directly on a range of REACH technical issues.   

Lisa spent the last seven years at as manager of REACHReady Ltd, a subsidiary of the UK Chemical Industries Association, providing guidance, training, consultancy, hands-on IUCLID support to companies large and small, established and start-up.

Lisa said: "I always strive to go the extra mile to help companies understand the inner workings of REACH, recognise the potential impact of decisions taken under the legislation, follow the latest developments for their substance, or simply to maintain cost-effective compliance."


Brief Profiles and Info Cards 

120,000 Brief Profiles and Info Cards were published on the ECHA website in January as a means to provide EU citizens with access to information on chemicals. These tools are part of ECHA’s new three-tier, substance-centric approach to making information extracted automatically from its database more accessible.   

Info Cards are the first level, providing basic information on the substance in lay terms. At the second level are Brief Profiles, providing additional information on the physico-chemical, health and environmental properties of the substance. The third tier, the most detailed, is the source data, including information disseminated from REACH Registration and Classification and Labelling notification dossiers.

Through Eurometaux, the Secretariat has highlighted to ECHA a number of inaccuracies in the Info Cards and Brief Profiles for lead metal and the lead compounds. Feedback from ECHA on the comments submitted, including ECHA’s implementation of improvements, is expected in Q2 2016.

Contact Lisa Allen if you have any concerns about the Info Cards and Brief Profiles.
 

Harmonised classification
 
   
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For further information please contact: Lisa Allen +44 (0)20 7833 8090 allen@ila-lead.org
International Lead Association, Bravington House, 2 Bravingtons Walk, Regent Quarter, London N1 9AF
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