…Review of criteria for non-aquatic organisms within PBT/vPvB frameworks

The current European and international criteria for assessing the persistent, bioaccumulative and toxic (PBT) or very persistent/very bioaccumulative (vPvB) nature of chemicals largely focus on the behaviour of these substances in aquatic species. There are, however, indications that some organic chemicals not classified as PBT/vPvB (from aquatic data) can bioaccumulate in non-aquatic food chains and exert toxic effects on top predators (including humans). A report by JRC reviews the relevant literature and regulatory information on available criteria for the ecotoxicity assessment of non-aquatic species, aiming to support an eventual revision of relevant guidance documents e.g. for REACH.

Hartmann NB et al. (2014). Review of available criteria for non-aquatic organisms within PBT/vPvB frameworks. Part 2: Toxicity assessment. Joint Research Centre of the European Commission, Institute for Health and Consumer Protection. JRC Science and Policy Reports. EUR 26737 EN. https://ec.europa.eu/jrc/sites/default/files/lbna26737enn.pdf


…Clarification on the REACH registration of cosmetic ingredients

Under Regulation (EC) No. 1223/2009, cosmetics are not permitted on the European market if they or their ingredients have been subject to testing on laboratory animals. Conversely, if those same ingredients need to be registered under REACH, testing on laboratory animals is usually a requirement for certain endpoints. The European Commission has recently provided clarification on this apparent contradiction. For substances exclusively used in cosmetics, the testing and marketing bans in the Cosmetics Regulation do not apply to laboratory animal tests for worker health or environmental endpoints under REACH. Registrants of ingredients that are also used for non-cosmetic purposes are permitted to perform laboratory animal testing, as a last resort, for all human health and environmental endpoints.

European Chemicals Agency. Clarity on interface between REACH and the Cosmetics Regulation. ECHA/NA/14/46. 27 October 2014.http://echa.europa.eu/view-article/-/journal_content/title/clarity-on-interface-between-reach-and-the-cosmetics-regulation


…ECHA drafts update of its community rolling action plan (CoRAP)

As announced in a recent news alert, ECHA proposes to update CoRAP with 134 substances planned for review by Member States between 2015 and 2017.

European Chemicals Agency. Draft CoRAP update with new substances for evaluation in 2015-2017. ECHA/NA/14/49. 30 October 2014. http://echa.europa.eu/view-article/-/journal_content/title/draft-corap-update-with-new-substances-for-evaluation-in-2015-2017-published


…Proposals for harmonised classification and labelling

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. Under this scheme, proposals have been submitted by the Dutch, French, German and UK authorities to standardise the classification and labelling of azadirachtin, dichlofluanid, Margosa extract, methylhydrazine, salicylic acid and terbuthylazine.

European Chemicals Agency. CLH reports. Proposals for harmonised classification and labelling based on Regulation (EC) No. 1272/2008 (CLP Regulation), Annex VI, Part 2.

Azadirachtin. Version 2. August 2014. http://echa.europa.eu/documents/10162/82e3fb33-e04a-47b7-af42-0657966fe5d5

Dichlofluanid. Version 2. September 2014. http://echa.europa.eu/documents/10162/412106b3-33b7-43c7-b593-fbc9aad1e1e0

Margosa, ext. Version 2. August 2014. http://echa.europa.eu/documents/10162/3b3e5025-a1f0-4dca-9cc8-b174a5f1fc4d

Methylhydrazine. Version 3. August 2014. http://echa.europa.eu/documents/10162/8f7d2b50-b8e5-47b5-8ee2-60c9929fd08b

Salicylic acid. Version 2. September 2014. http://echa.europa.eu/documents/10162/9159532f-8623-453e-a4a2-625355b53608

Terbuthylazine. Version 1. September 2014. http://echa.europa.eu/documents/10162/6b6662e2-b3a6-41d7-a50c-a061b7dddc79


…Applications for authorisation of trichloroethylene

Seventeen applications have been submitted to ECHA for the authorisation of certain uses of trichloroethylene. A public consultation has been launched, and will run until 7 January 2015.

European Chemicals Agency (2014). Applications for authorisation – current consultations. http://echa.europa.eu/addressing-chemicals-of-concern/authorisation/applications-for-authorisation


…Other items of interest

ECHA publishes a corrigendum to its guidance for downstream users. http://echa.europa.eu/documents/10162/13634/du_en.pdf
Testing proposals involving vertebrate animals: request for information from third parties on 4 substances (deadline 2 January 2015).



The above items were taken from the December 2014 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here)


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