…RAC opinions on restrictions for dimethyl fumarate and lead

ECHA’s Risk Assessment Committee (RAC) has adopted its first two opinions on proposals from France for the restriction of two chemicals – dimethyl fumarate (DMFu) and lead. The proposal on DMFu would restrict its presence in articles, or any parts thereof, to concentrations no greater than 0.1 mg/kg. This would make permanent an existing temporary ban that was introduced following cases of severe skin reactions (dermatitis) in consumers exposed to DMFu in articles such as leather sofas and shoes. The proposal on lead would restrict its level in the metallic and non‑metallic parts of jewellery to no greater than 0.05% by weight of the part, unless the rate of lead released from the jewellery does not exceed 0.05 µg/cm2/hour. This restriction is intended to limit children’s exposure to lead. The RAC deliberations, which were announced in a press release (ECHA/PR/11/07) dated 14 March 2011, are available from the ECHA website (visit http://echa.europa.eu/reach/restriction/restrictions_under_consideration_en.asp). {187591-2}

…Amendments to REACH Regulation

Two amendment regulations to the REACH Regulation, (EC) No. 1907/2006, revise Annex XVII, which covers restrictions on the manufacture, placing on the market and use of certain dangerous substances, preparations and articles. Commission Regulation (EU) No. 366/2011 of 14 April 2011 relates to acrylamide in grouts, while Commission Regulation (EU) No. 207/2011 of 2 March 2011 relates to the entries for pentabromodiphenyl ether and perfluorooctanesulphonates. The changes bring the REACH Annex into line with provisions in other legislation covering these substances (visit http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:101:0012:0013:EN:PDF and http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:058:0027:0028:EN:PDF).

…Other REACH items of interest

Companies must notify ECHA about certain Substances of Very High Concern in articles no later than 1 June 2011 (http://echa.europa.eu/news/pr/201104/pr_11_08_notify_about_svhc_in_articles_june_20110413_en.asp).

ECHA announces webinar to help companies prepare their notifications of Candidate List Substances (Substances of Very High Concern) in articles (http://echa.europa.eu/news/na/201105/na_11_20_webinar_on_notification_of_susbtances_in_articles_en.asp).

A substance evaluation fact sheet for REACH is now available (http://echa.europa.eu/doc/reach/substance_evaluation_fact_sheet_20110414_en.pdf).

Notifications of substances in articles and downstream user reports may now be submitted through REACH-IT (http://echa.europa.eu/news/na/201104/na_11_19_notifications_sia_through_reach-it_20110413_en.asp).

Testing proposals involving vertebrate animals: request for information from third parties for over 40 substances (15 and 29 April 2011) (http://echa.europa.eu/consultations/test_proposals/test_prop_cons_en.asp?consultations_status=current).

The above items were taken from the June 2011 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here for more details).

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