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Reach Newsletter
www.reach-lead.eu Summer 2014  
 
Contents
Pb Consortium Meetings
 
9 October 2014REACH Steering Committee meeting 
ILA Offices, London

13 December 2014
REACH General Assembly meeting 
TBC


 


 

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Editorial

Dossier updates high on the agenda


by Aggie Kotze, REACH Manager

For the last couple of months the Secretariat has been working on these key issues:
  • Ensuring the completion of the UVCB complex Article 10 full substance registration dossiers
  • Updating lead compound dossiers at ECHA’s request to ensure a better priority scoring for the 6th Priority List of substances for authorisation
  • Advocacy work on the harmonised classification of lead metal
  • Public consultation and final rap up of the restriction proposal on use of lead and compounds in consumer articles 
The main priority in the coming months will be to co-ordinate the input of downstream user sectors  into the public consultation if some of the candidate listed lead compounds are included on the 6th priority list (the next stage in the REACH authorisation process). Advocacy initiatives with the Member States and the Commission on both prioritisation and the harmonised classification proposals will also be required.  

In addtion technical work is now needed to support the development of the bio-elution protocol as a tool for refining classification of alloys containing lead metal at levels higher than the proposed SCL of 0.03%.

Lastly, although significant work has been done behind the scenes to update the environmental and health assessments in lead metal and compound CSRs and IUCLID files, we anticipate that there will be a requirement for lead registrants to submit the revised dosssiers before the end of the fourth quarter.   

The next General Assembly meeting will take place in London in December (venue to be announced).

This is a great opportunity for you to find out more about developments in the ever evolving REACH process, learn about the progress of the consortiums extensive work plans and allow you to network with other consortium members and ask questions on any issue of importance to your company. We look forward to seeing you there.


 Editorial
Editorial Photo  

REACH Authorisation -
ECHA delays latest public consultation

 


by Aggie Kotze

 

Following the General Assembly there have been some new developments whereby it has been decided that the public consultation on the 21 substances proposed by ECHA to be placed on the 6th priority list will be delayed until 1 September. The public consultation will last for three months and will end 30 November 2014.   

We now understand that it is probable that the consultation will include seven lead compounds including the four high volume lead compounds used in batteries (Lead monoxide, lead teroxide, Tetralead trioxide sulphate, Pentalead tetraoxide sulphate) and three additional low volume lead compounds not managed by the Lead REACH Consortium that are believed to be interchangeable in the use of glass and ceramics.  

The consultation will focus on two aspects: information on uses and response to prioritisation, which will be assessed by ECHA for their recommendation, and additional socio-economic information which will be transmitted to the Commission.   The latter, will help the Comission gain more information on the impacts of authorisation on the European economy before making any final decisions on which substances will be added to Annex XIV (authorisation list). 

In the coming weeks the Secretariat will:
  • prepare a template to provide downstream user sectors advice on information they will need to gather in support of the public consultation
  • work further on an advocacy strategy with our downstream users partners to argue that as lead compounds are already heavily regulated throughout their life cycle they should not be a priority for authorisation.

Candidate listing
 

REACH Authorisation -
How we got our message across

 
 
by Aggie Kotze
 
Throughout 2014 ILA has been increasingly active in ensuring that key stakeholders and opinion leaders in the REACH authorisation process are made aware of the main arguments against prioritising lead compounds for authorisation. Key messages around the value of lead based products to the EU economy and the already extensive and effective EU legislation covering lead have been delivered with the support of EUROBAT and Eurometaux.  At the Consortium’s General Assembly last month the Secretariat provided feedback to members on the MSC meetings, advocacy initiatives and what the next steps are for the Consortium and its downstream user sectors in the coming months.   

Meeting the Commission
In February the Secretariat, including a group of other metal consortia, developed a strategy and advocacy paper with Eurometaux that regulation of metal compounds where concern relates predominantly to workplace exposures, should be via the Chemical Agents Directive (CAD) through occupational exposure limits (OELs) or biological limit values (BLVs) instead of REACH authorisation and/or restriction. 

During meetings with Commission officials it was emphasised that a formal review of all existing Risk Management options should be undertaken before any decisions are made on prioritisation/inclusion of lead compounds in Annex XIV, especially when existing EU legislation already imposes minimum legal requirements for the control of the occupational risks through the binding biological exposure limits for lead.The arguments presented to both DG Employment and DG Enterprise highlighted overlaps with objectives of REACH and CAD have been well received and it is understood that talks at the Commission level will continue in the coming months with the objective of making REACH authorisation more proportionate for substances such as lead and compounds that are already extensively regulated. 

DG Employment and DG Enterprise both recognised that the use of lead compounds in battery manufacturing has a good case to qualify for a REACH Article 58(2) exemption - if the substances are eventually included in REACH Annex XIV. DG Employment also took the opportunity to request help from industry with the Scientific Committee on the Occupational Exposure Limits (SCOEL) process to provide any new data that can support the ongoing SCOEL revision of its 2003 opinion on a health-based occupational exposure limit for lead.

ECHA scoring methodology

In March, ECHA applied the new priority scoring methodology to all the substances that were candidate listed in preparation for Member State Committee (MSC) Meeting 35.   During this meeting they presented a list of the highest scoring substances for their proposal for a 6th Priority list together with a list of lead compounds.  To help ECHA accurately assess prioritisation needs the Secretariat was asked to urgently update registration dossiers of substances in the candidate list.    

These updates were required to show that there were no longer any consumer users of lead compounds and that any existing uses are covered by the existing workplace legislation.  All lead compound registrants (lead and co-registrants) were requested to update their dossiers in time for the MSC-36 meeting in June to try to convince regulators that authorisation is still not the appropriate risk management measure for lead compounds.  Many Members States and the Commission, still question the logic of including the already heavily regulated lead compounds in the 6th Priority List before the ongoing risk management option analysis is concluded by the Commission. 
 
Last year 21 lead compounds were put on the candidate list (including 10 managed by the Pb REACH Consortium). ECHA was then requested by the Commission to carry out a risk management option (RMO) analysis to establish whether authorisation, restriction or another measure is more appropriate to manage residual risks.
Comment on this article
 

Responding to ECHA on proposed restriction of Pb/Pb Compounds in consumer articles

 

by Aggie Kotze

 

ILA and the Consortium, together with the International Lead Zinc Research Organization (ILZRO) have been participating in the development of the proposed restriction on the use of lead in consumer products through the public consultation and in ECHA meetings including the Socio Economic Committee (SEAC).    This was to ensure that arguments made by the regulators were proportionate and that the scope of the Regulation was limited to those articles containing lead where a risk to children through mouthing was possible. It is not believed that this restriction will have any direct impact on Consortium member companies.

ECHA initiated a second public consultation on the SEAC draft opinion on the proposal between last December and February.  Through effective collaboration with a number of downstream user sectors the Consortium was very successful in obtaining derogations which ensured that the scope of the legislation was more proportionate than initial drafts.  The Secretariat was also effective in building credibility and engaging with both RAC and SEAC on some important scientific and socio-economic principles to ensure that no precedent was established that would adversely impact future REACH activity focused on the marketing of other lead-based products.

SEAC finalised its opinion in March and the final opinion was sent to the Commission.  In order for the Restriction proposal to become law it must obtain a qualified majority vote at REACH 133 Committee (255/345 votes).

The Commission will prepare and adopt the decision by the end of 2014 with the REACH regulation amended to include the restriction in Annex XVII. 


Comment on this article
 

Advocacy action on Lead Metal Harmonised Classification

by Steve Binks
Editorial Photo
A Pb CLP Task Force has been established at Eurometaux to co-ordinate an advocacy campaign targeting Member States with the position that the harmonised classification proposed by ECHA
that lead metal should not be included in the 7th ATP to the CLP
Regulation until issues concerning the specific concentration limit of 0.03% have been resolved  The Taskforce provided evidence to Member States ahead of the CARACAL meeting in March of significant socio-economic and technical issues associated with the SCL.
 

This campaign was successful in that several prominent Member States highlighted at CARACAL their concerns about the SCL and proposed that the 7th ATP only include an SCL for lead in powder form. 
Continued pressure has now been exerted at the Commission with several meetings targeted to highlight the potential impact of a lower SCL to the EU circular economy and the future marketing of metal alloys that could be classified as toxic to reproduction as a result of their lead content. Unfortunately,the Commission was not amenable to changing the RAC opinion and it is now probable that lead will be included in the 7th ATP voted on by Member States in September 2014.  

Latest developmentsFurther advocacy aimed at players involved in the Commission’s Inter-service Consultation has been initiated, but if this is not successful we believe that it is highly unlikely that Member States will vote down the entire 7th ATP on the basis of one substance. If the  harmonised classification is adopted we expect that Sweden will register its intention to propose lead metal for inclusion in the REACH Candidate list during 2015. 

If there are no positive developments we expect that the lead metal harmonised classification will appear in the Official Journal publication of the 7th ATP in the first half of 2015.  

Companies will then have 18 months to comply by amending safety data sheets and labels etc.


Harmonised classification
 
   

Complex UVCB Intermediate upgrades update

by Aggie Kotze

After a great deal of intensive activity by the Secretariat, consultants and also individual companies UVCB dossiers were
successfully submitted to ECHA by the registrants who required Article 10 full substance upgrades by the 30 April deadline.  

ECHA was very supportive in assisting with any REACH-IT related issues and regular exchanges with ECHA prevented co-registrants being penalised for submission delays.

The Eurometaux Intermediates task force met in May to identify how to organise future activities related to UCVB registrations and representatives from EBRC and ARCHE attended the General Assembly in June to highlight the potential future needs to support these dossiers.

Safety data sheets are still to be updated and will follow as a multi-metallic approach for the development of exposure scenarios for complex materials.  

ARCHE has been requested to develop an example for one of the lead UVCB complex intermediates which will be discussed at the next Eurometaux exposure task force meeting in July.
Sweden targets consumers
 
   

Company inspections of complex UVCB intermediates

by Evert Hamblok (Metallo-Chimique)

Elmet S.L.U. which is Metallo-Chimique’s
operating facility in Spain, had a recent inspection by the Spanish competent authorities on various legislations including REACH. It was
the first time a company in our sector had to show that they fulfil Strictly Controlled Conditions
(SCC) and cases where it did not.    
The company was well prepared as we ensured that for the intermediates that fulfil SCC we had supportive documentation showing that we fulfilled SCC. Internal documentation of the assessment performed to prove SCC was also included and in addition we referred to the Appendix 3 which we submitted to ECHA in the dossiers etc. 

In June ECHA published a practical guide on intermediates which aims to support registrants and downstream users of intermediates in checking if their use of the substance complies with the definition of intermediate under REACH. The Intermediates Taskforce under the Eurometaux umbrella will be reviewing the document to see whether we need to consult ECHA on any important points that should be addressed on behalf of our sector.
Export Q&A
 
   

Lead and lead compounds dossier updates

by Aggie Kotze

It was recognised that the health data contained in REACH registration dossiers was somewhat out of date and in need of updates to reflect the rapidly developing science on human health impacts of lead. ILZRO identified over 3000 new publications in the literature and 300 of these were deemed to be of sufficient quality to be included in the Chemical Safety Report and as robust study summaries in IUCLID.

ILA has also carried out an internal review which has resulted in a large portion of IUCLID dossiers being updated. 

It is envisaged that the project will be completed in the third quarter of 2014 and  the dossiers will then be sent to lead registrants for submission to ECHA. This is required to support any future REACH activity initiated by ECHA on lead compounds.
Socioeconomic analysis
 
   

Site visit hosted on authorisation and recycled substances 

By Aggie Kotze
 
Recent developments concerning the authorisation application of di (2-ethylhexyl) phthalate (DEHP) has raised concern in the metals sector.  PVC recyclers need to submit authorisation applications under the current proposal and for this reason the non-ferrous metals industry has launched a project aimed at better understanding how REACH authorisation applies to recycled metals and metal compounds produced, used and imported into the EU by metals plants.    

The objective is to help recyclers determine their obligations related to authorisation when one of the substances they produce, use or import, or which is present in a material stream they produce, use or import, is subject to authorisation.

The non-ferrous sector under the Eurometaux umbrella has highlighted concerns to the Commission and ECHA that the precedent established for phthalates could have detrimental impacts on the metals recycling industry.  

A meeting and site visit was kindly hosted by Metallo-Chimique in Beerse, Belgium, in June to highlight the potential impacts authorisation could have on the competitiveness of the EU non-ferrous metals recycling industry.  The meeting was attended by eight Commission representatives, seven representatives from the Belgium competent authorities plus staff from Agoria, ECI, Eurometaux and ILA.  
The meeting was very well received by the regulators who appreciated seeing first-hand how metal recycling is undertaken and this education will support the Consortium’s continued efforts to ensure that REACH authorisation does not adversely affect the industry. 
Intermediates

 
 
   
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For further information please contact: Aggie Kotze +44 (0)20 7833 8090 kotze@ila-lead.org
International Lead Association, Bravington House, 2 Bravingtons Walk, Regent Quarter, London N1 9AF
Vat No: GB242304504 | Company No: 06391803