…REACH and socio-economic analysis advice

The European Commission has released a two-part report that aims to assist regulatory decision-making under REACH, which requires a comparison of the environmental and health impacts of authorisations or restrictions with other socio-economic impacts, such as the costs to businesses and consumers. Part 1 (literature report and recommendations) reviews the methods behind the identification and evaluation of human health impacts, exposure levels and environmental risks in the context of a socio-economic analysis (SEA), identifying problems and uncertainties with the current approach, as well as providing recommendations for further research. Part 2 (the proposed logic framework and supporting case studies) gives a framework for assessing the impacts of restriction proposals, and the refusing or granting of authorisations, on human health and the environment. Two case studies on substances of very high concern, tris(2-chloroethyl) phosphate (TCEP) and hexabromocyclododecane (HBCDD), are used to illustrate the approach in the context of human health and environmental effects, respectively.

[European Commission, Directorate-General Environment. Assessing the health and environmental impacts in the context of socio-economic analysis under REACH. ENV.D.1/SER/2009/0085r. March 2011. For Part 1: literature review and recommendations, visit while for Part 2: the proposed logic framework and supporting case studies, access online.] {187862}

…Ten opinions adopted by RAC

As announced in a June 2011 news alert (ECHA/NA/11/27) on the adoption of ten scientific opinions by ECHA’s Committee for Risk Assessment, RAC agreed with proposals, from ECHA and Norway respectively, to restrict mercury in measuring devices, and the manufacture and use of phenylmercury compounds. The aim is to reduce emissions of mercury, a highly toxic metal linked to a range of serious adverse effects in humans.

Also considered were eight proposals from different Member States (Denmark, France, Germany, the Netherlands and the UK) to harmonise classification and labelling. In this case, RAC agreed with proposals on the following substances: three types of white spirit, for classification as causing central nervous system damage following repeated or prolonged inhalational exposure; bifenthrin, for classification as a suspected carcinogen, as acutely toxic (orally and by inhalation), as a skin sensitizer, for toxicity to the nervous system following repeated exposure, and as hazardous to the aquatic environment; 2,4,4-trimethylpentene as a flammable liquid and vapour, as an aspiration hazard, and as capable of causing drowsiness or dizziness after single exposure; indoxacarb and indoxacarb (enantiomeric reaction mass 75:25 S:R) as acutely toxic by oral and inhalation routes, as a skin sensitizer, as toxic to the blood, heart and nervous system following repeated exposure, and as hazardous to the aquatic environment; flufenoxuron, for classification as harmful to breast-fed babies and hazardous to the aquatic environment; and vinyl acetate, for classification as acutely toxic by the inhalation route, toxic to the respiratory system after single exposure, and as a suspected carcinogen.

RAC disagreed with the following proposals (from France, Germany and the Netherlands) to harmonise classification and labelling: chloroform, for classification as causing mutagenicity; aluminium-magnesium-zinc-carbonate-hydroxide, to remove the classification as being hazardous to the aquatic environment (although it was agreed that the category should be lowered); flufenoxuron for red blood cell toxicity following repeated exposure; and vinyl acetate, for the addition of “may form explosive peroxides” to non-stabilised vinyl acetate.

The RAC decisions on these substances will be made available on ECHA’s website (via http://echa.europa.eu/about/organisation/committees/rac/committee_opinions_en.asp). {187890‑9}

…Proposals for classification and labelling of proquinazid, cymoxanil and ethephon

Under Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging (CLP), 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. Recently submitted harmonisation proposals (by the UK, Austria and the Netherlands) relate to proquinazid, cymoxanil and ethephon. Comments on these proposals should be submitted by 22 July 2011 (proquinazid) and 29 July 2011 (cymoxanil and ethephon). For further details, visit online. {187859-61}

…Other REACH items of interest

Presentations and recordings of the webinars on downstream user reports (31 May 2011) and the inquiry process (25 May 2011) are now available (http://echa.europa.eu/news/webinars_en.asp).

A recording of ECHA’s sixth Stakeholders’ Day is accessible (http://www.echa.europa.eu/news/events/6th_stakeholders_day_en.asp).

Testing proposals involving vertebrate animals: request for information from third parties on over 80 substances (31 May 2011; 16 June 2011; 23 June 2011; 1 July 2011) (http://echa.europa.eu/consultations/test_proposals/test_prop_cons_en.asp?consultations_status=current).

ECHA launches a public consultation on its draft recommendation of thirteen new substances to be prioritised from the Candidate List for the Authorisation List (trichloroethylene, five cobalt compounds and seven chromium compounds) (http://echa.europa.eu/news/na/201106/na_11_26_public_cons_inclusion_of_susb_in_auth_list_en.asp).

Committee for Socio-economic Analysis (SEAC) adopts its first opinion (in June 2011), on a restriction of dimethyl fumarate (DMFu) in articles, and agrees on two draft opinions on restriction proposals under REACH concerning mercury in measuring devices and phenylmercury compounds (http://echa.europa.eu/news/pr/201106/pr_11_14_seac_20110617_en.asp).

A new version of ECHA’s Chemical safety and reporting tool CHESAR 1.1.3, compatible with IUCLID 5.3.0, is now available for users of Chesar 1.1.2 (http://chesar.echa.europa.eu/).

ECHA provides updated questions and answers on inquiry and substance identification (http://echa.europa.eu/doc/reachit/inquiry_qa.pdf). {178835}

Draft revised Guidance on Data sharing sent to PEG (Partner Expert Group) (http://guidance.echa.europa.eu/docs/draft_documents/270611_Draft%20Guidance%20on%20data%20sharing.pdf). {172208}

Draft update of the health hazard classification chapters of the CLP Criteria guidance sent to PEG (http://guidance.echa.europa.eu/docs/draft_documents/CLP_Guidance_Document_HH.pdf). {182930}

ECHA has published two unique reports – on the operation of REACH and CLP, and on the use of alternatives to testing chemicals on vertebrate animals. These reports are legal requirements of the REACH Regulation ).

Guidance on information requirements and chemical safety assessment. Part B: Hazard Assessment. Draft new chapter B.8 Scope of Exposure Assessment sent to CARACAL (the Competent Authorities for REACH and the CLP Regulations) (http://guidance.echa.europa.eu/docs/draft_documents/Inforeq_CSR_B_en_draft_update_V04.pdf).

An extensive review of the REACH Regulation is to be carried out by the European Commission, and published by 1 June 2012 (http://ec.europa.eu/enterprise/sectors/chemicals/documents/reach/review2012/index_en.htm).

Survey on the impact of REACH on the single market and the competitiveness of the European chemicals industry (http://cses.co.uk/reach_survey).

ECHA and Japanese government institutions start working together (http://echa.europa.eu/news/pr/201106/pr_11_16_soi_japan_20110620_en.asp).

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

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