…Insufficient information on intermediates in dossiers

Under REACH, the information that companies need to provide for certain types of isolated intermediates may be reduced in comparison with that required for other substances. As announced in a news alert (ECHA/NA/11/21) dated 11 May 2011, ECHA’s screening of over 400 registration dossiers for substances registered as intermediates suggested that 86% of them may contain insufficient information to demonstrate compliance with the specific conditions for intermediates (described in REACH Article 3(15) and in the “Guidance on intermediates”). ECHA stresses that “in order to demonstrate that a substance’s use fulfils the criteria of an isolated intermediate, a registrant should provide information on the identity of the transformation products resulting from the use of the substance and/or information on the manufacturing processes related to the registered substances”, with the registration dossier including information on risk management measures and how strictly controlled conditions are met.

…Proposals for harmonised classification and labelling: fluazinam and 4-vinylcyclohexene

Under Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging, there is a legal obligation for suppliers to evaluate the hazards of chemicals (substances and mixtures) to be placed on the market, and to classify and label them appropriately. An option also exists for Member State competent authorities or industry to ask for the classification and labelling of a substance to be harmonised across Europe, whereupon ECHA organises a public consultation period of 45 days. Harmonisation proposals have been submitted recently by the Austrian and French authorities for fluazinam and 4-vinylcyclohexene. Comments are invited by 4 and 14 July 2011 respectively; visit for further details. {187703; 187729}

…ECHA identifies seven new Substances of Very High Concern (SVHCs)

ECHA has announced in a press release (ECHA/PR/11/13) dated 31 May 2011 that seven more substances, all of which are either carcinogenic, mutagenic or reprotoxic (CMR), will soon be added to the SVHC “Candidate List”. The substances are: 2-ethoxyethyl acetate; strontium chromate; 1,2-benzenedicarboxylic acid, di-C7-11 branched and linear alkyl esters; hydrazine; 1‑methyl-2‑pyrrolidone; 1,2,3-trichloropropane; and 1,2-benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich. In addition, cobalt(II) chloride, a substance already on the Candidate List because of its carcinogenic properties, has also been identified as toxic for reproduction. Member State Committee documents in support of inclusion of these substances will soon be obtainable (via http://echa.europa.eu/chem_data/authorisation_process/candidate_list_table_en.asp). {179528; 187762-4; 187766-9}

…Latest ChemSec SIN list and ‘undesirable’ chemicals named by Danish EPA

A second version of the Substitute It Now (SIN) List was released in May 2011. The SIN List is produced by the International Chemical Secretariat (ChemSec) and other environmental NGOs (non-governmental organisations) using the criteria set up in REACH to identify SVHCs. The aim is “to speed up the REACH process and give guidance to companies regarding which chemicals they need to substitute”. For the latest version, only chemicals with endocrine disrupting properties were considered. This added a further 22 substances to the list, bringing the total to nearly 400 chemicals. Visit http://www.chemsec.org/images/stories/2011/chemsec/SIN_List_2.0_all_378.pdf for a full version of SIN List 2.0, http://w3.chemsec.org/ to access the SIN List Database, or http://www.sinlist.org/ for background information on the project. {187713}

Also recently published is the Danish EPA’s updated List of Undesirable Substances (LOUS), which highlights substances that the Agency considers to be dangerous and whose use should be reduced, or stopped completely. The list contains 40 chemical substances and groups of substances with ‘undesirable’ effects that are used in Denmark in significant quantities; generally, there is wide overlap between criteria for inclusion in LOUS and in the REACH Candidate List for SVHCs.

[Danish Environmental Protection Agency (2011). List of Undesirable Substances 2009. Environmental Review No. 3 2011 (http://www2.mst.dk/udgiv/publications/2011/05/978-87-92708-95-3.pdf).] {187771}

…Amendment to REACH Regulation

Commission Regulation No. 494/2011 of 20 May 2011 amends Reach Regulation (No. 1907/2006) by revising Annex XVII (Restrictions on the manufacture, placing on the market and use of certain dangerous substances, preparations and articles). The amendment prohibits the use of cadmium and its oxide in all types of jewellery products, brazing sticks and all articles made from polyvinyl chloride, bringing the Annex into line with other legislative provisions on the chemicals (visit http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:134:0002:0005:EN:PDF).

…Other REACH items of interest

ECHA to publish more information on chemical substances (http://echa.europa.eu/news/pr/201105/pr_11_09_ECHA_to_publish_more_info_on_chemicals_en.asp).

ECHA and the Australian Government’s National Industrial Chemicals Notification and Assessment Scheme (NICNAS), Department of Health and Ageing, start working together (http://echa.europa.eu/news/pr/201105/pr_11_12_mou_australia_en.asp).

Testing proposals involving vertebrate animals: request for information from third parties for twelve more substances (16 May 2011) (http://echa.europa.eu/consultations/test_proposals/test_prop_cons_en.asp?consultations_status=current).

Selection criteria for substance evaluation have been developed and will be used by ECHA and Member States to find suitable candidate substances for the first Community Rolling Action Plan (CoRAP), to be adopted in early 2012 (http://echa.europa.eu/news/na/201105/na_11_23_substance_evaluation_corap_en.asp).

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

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