…Guidance pages on EU chemicals legislation

New support pages from ECHA provide information on the European chemicals legislation to companies not yet familiar with their obligations. The webpages come together with an introductory guidance document.

European Chemicals Agency (2015). How to get started with EU chemicals legislation. ECHA/NI/15/29. http://echa.europa.eu/view-article/-/journal_content/title/how-to-get-started-with-eu-chemicals-legislation



…Updated guidance on the compilation of safety data sheets

Version 3.0 of ECHA’s guidance on the compilation of safety data sheets takes into account the full implementation of the CLP regulation ((EC) No 1272/2008). This marks the end of the transitional period during which classification and labelling could be done according to both CLP and the, now obsolete, Dangerous Preparation Directive (DPD) or Dangerous Substances Directive (DSD). All safety data sheets must now only include CLP designations.

European Chemicals Agency (2015). Guidance on the compilation of safety data sheets. Version 3.0. August 2015. http://echa.europa.eu/documents/10162/13643/sds_en.pdf


…Practical guide on the downstream user chemical safety assessments and associated reports

ECHA’s latest practical guide aims to assist downstream users, whose use of a substance is not covered by the supplier’s envisaged exposure scenarios, in the preparation of chemical safety reports. It describes the approaches downstream users can take to determine the risks associated with their use of the substance, and to document their safety evaluations.

European Chemicals Agency (2015). How to prepare a downstream user chemical safety report. Practical Guide 17. Version 1, ECHA-15-B-14-EN. http://echa.europa.eu/documents/10162/13655/pg17_du_csr_final_en.pdf



…Report on the identification of SVHCs of an ‘equivalent level of concern’

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 are of an equivalent level of concern (ELoC). The latter group includes chemicals with a potential to have serious effects on human health or the environment. There is currently no specific guidance or criteria by which ELoC chemicals are identified.

JRC has assessed whether substances (particularly neurotoxins and immunotoxins) classified under CLP as causing category 1 or 2 specific target organ toxicity (STOT) should also be considered as ELoC SVHCs. It identified, characterised and compared the levels of concern that exist for these substances (e.g. from the irreversibility and severity of effects) with those of CMRs. JRC determined that some STOT substances indeed present an equivalent level of concern to that of CMRs, so potentially qualify as SVHCs. Case-by-case justification was considered necessary.

Pesudo LQ and Aschberger K (2015). Identification of substances of very high concern (SVHC) under the ‘equivalent level of concern’ route (REACH Article 57(f)) – neurotoxicants and immunotoxicants as examples. Joint Research Centre of the European Commission, Institute for Health and Consumer Protection. JRC Science for Policy Report. EUR 27383 EN. http://publications.jrc.ec.europa.eu/repository/bitstream/JRC96572/jrc96572-identification%20svhc%20reach%20article%2057f.pdf



…Consultations on seven potential SVHCs

Member State competent authorities and the European Chemicals Agency may prepare Annex XV dossiers for the identification of SVHCs; the latest have been released by ECHA and the Austrian, German and Swedish authorities, and cover:

  • 2-(2H-benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol (UV-350)
  • 2,4-di-tert-butyl-6-(5-chlorobenzotriazol-2-yl)phenol (UV-327)
  • dicyclohexyl phthalate (DCHP)
  • hexamethylene diacrylate
  • nitrobenzene
  • perfluorononanoic acid (PFNA) and its sodium and ammonium salts
  • 1,3-propanesultone

European Chemicals Agency (2015). Annex XV dossiers. Proposals for identification of substances of very high concern on the basis of the criteria set out in REACH Article 57. Proposals, dated August 2015, available for comment until 15 October. http://echa.europa.eu/addressing-chemicals-of-concern/authorisation/substances-of-very-high-concern-identification



…Testing proposals involving vertebrate animals

ECHA has made a request for information from third parties on five substances including trimethoxyoctylsilane and tri(isopropyl)silyl acrylate. The deadline for submitting relevant information is 15 October.

European Chemicals Agency (2015). Current testing proposals.



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

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