Copy
   
Reach Newsletter
www.reach-lead.eu Summer 2015  
 
Contents
Pb Consortium Meetings
 
9 July 2015
REACH General Assembly 
Metals Conference Centre, 100 rue du Duc-5th Floor, 1150 Brussels

7 October 2015
REACH Steering Committee
ILA Offices, London


 


 

Visit the Consortium website

www.reach-lead.eu
Subscribe

Editorial

Authorisation of lead compounds and
harmonised classification of lead high
on the agenda


by Aggie Kotze, REACH Manager

The last couple of months have been busy for the Secretariat on the REACH/CLP front working on these key issues:
  • Ensuring completion of comments for the public consultation into the four lead compounds recommended for the 6th priority list
  • Inputs into the Member State Committee meetings
  • Significant updates to the lead compound registration dossiers
  • Advocacy work with the Commission and Member States
  • Support for Eurometaux on the lead harmonised classification Specific Concentration Limit 
The main priority in the coming months will be advocacy initiatives with Member States and the Commission ahead of a decision on which compounds are selected for the 6th Priority list and ultimately for inclusion in REACH Annex XIV. In addition more inputs into the bio-elution discussions ahead of an anticipated REACH Committee vote in December on inclusion of lead metal in the 9th Adaption to Technical Progress of the CLP Regulation.  

Finally a brief reminder about the General Assembly meeting which will take place at the Metals Conference Centre in Brussels on the 9 July. The Secretariat always encourages members to attend as this is a great opportunity for you to find out more about developments in the ever evolving REACH process, learn about the progress on the consortiums extensive work plan and allow you to network with other companies and ask questions on any issue of importance to your company.


 Editorial
Editorial Photo  

REACH Authorisation update

 

Next stages in the REACH authorisation process with potential timings if lead compounds are included in Annex XIV  - CLICK TO ENLARGE
 

 
by Aggie Kotze

A three month public consultation took place on the proposal by ECHA to include seven lead compounds in the 6th priority list for authorization. Four of the compounds are managed by the Lead REACH consortium (lead monoxide, lead tetroxide, pentalead tetraoxide sulphate and tetralead trioxide Sulphate).   

For the first part of the consultation the Secretariat prepared comments on the priority scoring, latest application date (LAD) and potential for certain uses to be granted exemptions.  

For the first time the Commission sought to understand the potential socio-economic implications for industry sectors of authorisation and the Secretariat worked closely with EUROBAT to prepare an extensive response for battery use of the four substances that included all phases of the life cycle of a battery, including recycling, and covered socio-economic impacts both upstream and downstream of the battery manufacturing process. 

Early in 2015 the Secretariat focused on updating and refining of the registration dossiers for the four lead compounds to ensure that they are in alignment with the arguments submitted into the public consultation.

Candidate listing
 

ECHA recommends prioritisation to MSC meetings

Following the public consultation two Member State Committee (MSC) meetings (MSC40, MSC 41) have taken place ahead of a final recommendation by ECHA to the Commission on the prioritisation of the lead compounds.   

In preparation for the MSC-41 (20-23 April) meeting ECHA prepared response documents (RCOM) to comments submitted during last year’s public consultation which the MSC members received. The RCOM documents focused on the priority scoring, latest application dates and most importantly on the comments submitted by industry (including those related to exemption requests).   

It was recommended at MSC-41 meeting that the all substances subject to the public consultation, excluding three low volume lead compounds (Silicic acid, lead salt, pyrochlore, antimony lead yellow and acetic acid, lead salt, basic) should be forwarded for prioritisation. Therefore lead monoxide, lead tetroxide, pentalead tetraoxide sulphate and tetralead trioxide sulphate are likely to be included in the 6th priority list prepared for ECHA. 

However, ECHA highlighted that there was potentially a good case for an article 58 (2) exemption for use of the substances in the manufacture of automotive batteries and a somewhat weaker case for this exemption for uses in manufacturing of industrial batteries, frits, glass, glass frits and PZT. The Commission, rather than ECHA, will ultimately decide whether any use exemptions should be included in the Annex XIV entry for any substance subject to authorization. 

ECHA also concluded that some uses, such as lead monoxide and orange lead used in the production of lead special glass, lead crystal glass and frit and the use of lead monoxide in the manufacture of stabilisers for PVC processing may be considered as intermediates and thus exempt from authorisation. However, they stressed that the prioritisation exercise is not taking a formal position whether certain uses of substances are regarded as intermediates as it is the responsibility of industry to determine whether their use meets the legal definition of intermediate and for Member States to enforce this. The situation concerning intermediate use is not straightforward and it has been proposed that a clarification workshop will be organised by Eurometaux and CEFIC at the end of June involving representatives from ECHA, Commission and Member States to further explore intermediate arguments.

The final opinion from ECHA and the MSC on substances to be on the 6th priority list will likely be formed during MSC-42 in the week of 8 June

The final opinion from ECHA and the MSC on substances to be on the 6th priority list will likely be formed during MSC-42 in the week of 8 June.This will then be submitted to the Commission, but we are advised that no new substances will proposed for inclusion in REACH Annex XIV (Authorisation list) until the ongoing authorisation simplification review is completed during Q4 2015.
 
Advocacy supports consortium position

Starting at the end of 2014 ILA and EUROBAT combined to increase the political pressure with the new Commission leadership on the lack of proportionality of REACH authorisation for the four lead compounds used in lead battery manufacture and highlighted adverse socio-economic impacts that may result for the European battery manufacturing sector. 

Meetings were held with Klaus Berend and Gwenole Cozigou, who lead on REACH issues in DG Grow, and with cabinets of Elżbieta Bieńkowska (DG Grow) and Marianne Thyssen (DG Employment).

In addition a co-ordinated Europe wide advocacy campaign has been undertaken at Member State level, involving National Federations and ILA and EUROBAT member companies, to highlight the case for exemptions for battery use of lead compounds. 


Harmonised classification
 
   

REACH Restriction of lead/lead compounds in consumer articles 

by Aggie Kotze

The European Commission has now adopted and published the REACH Restriction on consumer articles containing lead that may present a risk to children by mouthing.   This brings to a close work that ILA initiated in 2012 to ensure that the restriction was proportionate and the scope narrowed compared to the original proposal tabled by Sweden. The restriction is notable in that ECHA Committees accepted industry bioelution evidence on reduced bioavailability of lead from brass articles that resulted in a higher concentration limit (0.5 vs 0.05%) for articles made from this alloy.

This Regulation shall enter into force on the twentieth day following that of its publication (22 April 2015) in the Official Journal of the European Union.

What is considered in scope of the restriction?

An article supplied to the general public may be included within the scope of this restriction, if:
  • It does not exceed a size of 5 cm in all of its three dimensions, so that it can be placed in the mouth;
  • It has accessible parts, detachable or protruding parts with at least one dimension smaller than 5cm, which can be placed in the mouth.
Further to the dimensions of the article, two additional criteria need to be considered for the scope definition in terms of “mouthability” namely accessibility and normal or reasonably foreseeable conditions of use. More information on what is considered in scope can be found in the draft guideline that ECHA has started developing.

Derogations

A long list of uses are considered out of scope and derogations were provided for the below-mentioned applications:
  • jewellery articles covered by paragraph 1;
  • crystal glass as defined in Annex I (categories 1, 2, 3 and 4) to Directive 69/493/EEC
  • non-synthetic or reconstructed precious and semi-precious stones (CN code 7103 as established by Regulation (EEC) No 2658/87) unless they have been treated with lead or its compounds or mixtures containing these substances
  • enamels, defined as vitrifiable mixtures resulting from the fusion, vitrification or sintering of mineral melted at a temperature of at least 500 °C
  • keys and locks, including padlocks
  • musical instruments
  • articles and parts of articles comprising brass alloys, if the concentration of lead (expressed as metal) in the brass alloy does not exceed 0,5 % by weight
  • the tips of writing instruments
  • religious articles
  • portable zinc-carbon batteries and button cell batteries
  • articles within the scope of:
  • (i)    Directive 94/62/EC
  • (ii)   Regulation (EC) No 1935/2004
  • (iii)  Directive 2009/48/EC of the European Parliament and of the       Council(*)
  • (iv)  Directive 2011/65/EU of the European Parliament and of the       Council(**)
The scope and derogations will be re-evaluated by July 2019 in the light of any new scientific information available, including the availability of alternatives which may require the amendment of this entry.

 
Sweden targets consumers
 
   

Lead Metal Harmonised Classification - Update

by Steve Binks, ILA Director of Regulatory Affairs 

Following an advocacy campaign at Member State level co-ordinated by ILA and Eurometaux, the European Commission has removed the lead metal harmonised classification proposal from the 7th ATP of the CLP Regulation. It was clear before any vote at the REACH Committee that there was insufficient support from Member States.    

The Commission agreed to review how the concept of an effective concentration based upon bioaccessibility of lead from an alloy, rather than an absolute concentration could be applied to mixture classification under the framework of Article 12(b). To that end a meeting of Member State experts was arranged in April to establish if there was support for the use of bio-elution in calculating an effective concentration and begin preliminary discussions on how this could be achieved in practice. A Eurometaux team, involving ILA, played a central role in the workshop. The meeting was a success, although it is clear that quite some work will be required in the coming years to gain regulatory acceptance for bio-elution testing.

The Commission agreed to hold a follow up meeting in September and it is expected that the Commission will table a revised entry for lead metal harmonised classification for inclusion in the 9th ATP that is likely to be tabled for a vote by the REACH Committee towards the end of 2015.

A timetable for the adoption of the harmonised EU classification of lead metal as Repro 1A is included below - CLICK TO ENLARGE.






Socioeconomic analysis
 
   

Medical surveillance project 

By Steve Binks
 
The longitudinal medical surveillance study designed to follow new lead industry employees is now well underway. The study will follow workers through the first two years of exposure to lead and will monitor, amongst other things, sensitive changes in blood pressure, kidney and neurological function in relation to changes in blood lead levels.  

The study design is somewhat unique and it is hoped that it will provide some answers to the questions raised by some academics and regulators about the subtle effects of occupational lead exposure resulting in blood lead levels below 20mcg/dL. Medical staff at the site hosting the study have now received the necessary training and have spent the last few months ensuring that they can conduct the test in a reproducible manner that meets the criteria of the university research team leading the project.

It is expected that data collection will begin on the study cohort recruits this month. Results however will not be available for at least another two years. Further details of the study can be viewed at ClinicalTrials.gov

 
Intermediates

 
 
   
A member of Lead REACH Consortium. You can manage your subscription or unsubscribe at any time using the links:  Edit your subscription | Unsubscribe instantly 

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