…Consultations on potential substances of very high concern (SVHCs)

Member State competent authorities and the European Chemicals Agency may prepare Annex XV dossiers for SVHCs, as defined in Article 57 of the REACH regulation. SVHCs include substances that are carcinogenic, mutagenic or toxic to reproduction (CMR), persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), or of an equivalent level of concern. The latest Annex XV dossiers, released by the Dutch and Swedish authorities, cover:

  • 1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters and/or 1,2-benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters, with at least 0.3% dihexyl phthalate (as CMR substances – toxic for reproduction)
  • isomers of 5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane and/or 5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane (and any combination thereof) (as vPvB substances)

European Chemicals Agency. Annex XV dossiers. Proposals for identification of substances of very high concern on the basis of the criteria set out in REACH Article 57. The proposals, dated February 2015, are available for comment until 16 April 2014. http://echa.europa.eu/addressing-chemicals-of-concern/authorisation/substances-of-very-high-concern-identification


…Proposal for harmonised classification and labelling of 5-chloro-2-(4-chlorophenoxy)phenol

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. It is under this scheme that a proposal has been submitted by the Austrian authorities to standardise the classification and labelling of 5-chloro-2-(4-chlorophenoxy)phenol.

European Chemicals Agency. CLH report. Proposal for harmonised classification and labelling based on Regulation (EC) No. 1272/2008 (CLP Regulation), Annex VI, Part 2. 5-Chloro-2-(4-chlorophenoxy)phenol. Version 3. 19 December 2014. http://echa.europa.eu/documents/10162/890a2778-4a1c-4f03-81fe-4f14d3609424


…Other items of interest

European Commission responds to public campaign on the testing of cosmetic ingredients on animals. http://echa.europa.eu/view-article/-/journal_content/title/european-commission-responds-to-campaign-on-testing-cosmetic-ingredients-on-animals


ECHA releases its annual evaluation report.http://echa.europa.eu/view-article/-/journal_content/title/echa-annual-evaluation-report-published
Draft update to the guidance on information requirements and chemical safety assessment (IR&CSA) Chapter R.7a (Section R.7.2 related to irritation/corrosion only) sent for consultation by the Committee for Risk Assessment and Member State Committee.http://echa.europa.eu/documents/10162/13643/ir_csa_r7a_r7-2_msc_rac_draft_en_201502_en.pdf
Testing proposals involving vertebrate animals: request for information from third parties on twelve substances (deadline 30 April).



The above items were taken from the April 2015 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here)


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