June 2010 (10B-141)

Bulletin Summary       On 21 June 2010, the European Chemicals Agency (ECHA) published a press release presenting two proposals made by France that would amend the REACH Regulation. One would restrict lead in jewellery and the other would restrict Dimethylfumarate in consumer products. Interested parties are invited to provide comment in public consultation.

Background

For the first time, France, an EU member state, proposed two restrictions to amend Annex XVII of the REACH Regulation. In preparing a draft opinion on the proposals, ECHA invited stakeholders to publicly comment on the restriction reports prepared by France. The consultation period will end on 21 September 2010. The final Committee opinions on the proposals are scheduled for release by June 2011.

Lead in Jewellery

The proposed restriction of lead and its compounds would apply to all types of jewellery (both precious and costume) and would amend Annex XVII of REACH. The suggested safe limit is 0.09 μg/cm²/hr to protect children as well as adults from lead migration. Tests will be performed according to the requirements of standard EN 71-3. The French proposal is based on several serious incidents that occurred with lead-containing children’s products. Lead and lead compounds can cause major harm and even result in death. Some common health problems are headaches and stomach cramps. Continued exposure to lead increases the severity of symptoms and may be irreversible.

Dimethylfumarate

Currently, Dimethylfumarate (DMFu) is restricted temporarily in the EU under Directive 2010/153/EU. This restriction is valid until 15 March 2011. France’s proposal would aim to restrict DMFu permanently under Annex XVII of REACH. The restriction would apply to all types of consumer articles containing DMFu and the limit of 0.1 mg/kg would be applied for each component part of the article. Dimethylfumarate (CAS: 624-49-7) is a fine white crystalline powder generally used in consumer products to avoid the growth of mould fungus. Dimethylfumarate has been found to be an allergic sensitizer at very low concentrations, producing extensive, pronounced eczema that is difficult to treat. Concentrations as low as 1 ppm may produce allergic reactions. Several reports were published in the EU’s rapid alert system for dangerous consumer products (RAPEX) on articles containing DMFu.

  

Additional Information

>ECHA press release:

http://echa.europa.eu/doc/press/pr_10_13_restrictions_20100621.pdf

>Public consultation on lead:

http://echa.europa.eu/consultations/restrictions/information_note_lead_in_jewellery_en.asp

>Public consultation on Dimethylfumarate:

http://echa.europa.eu/consultations/restrictions/information_note_DMFu_en.asp

Bureau Veritas Solutions and Services

Bureau Veritas offers a wide range of chemical management solutions to help you overcome the
challenges of complying with the REACH Regulation. To find out how we can assist you in meeting the requirements REACH poses to your business, visit – www.bureauveritas.de/cps, www.bureauveritas.co.uk/cps, www.bureauveritas.fr, or email: cps-hamburg@de.bureauveritas.com

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