…Updated guidance on (quantitative) structure-activity relationships

ECHA has updated its practical guide on the use and reporting of (Q)SARs, providing further advice on using these in REACH registrations. Practical examples cover the prediction of Log Kow, ready biodegradability, short-term toxicity to fish and acute toxicity to rats.

European Chemicals Agency (2016). Practical Guide 5 – How to use and report (Q)SARs. Version 3.0. March 2016. http://echa.europa.eu/documents/10162/13655/pg_report_qsars_en.pdf


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

Member State competent authorities and the European Chemicals Agency may prepare Annex XV dossiers for the identification of SVHCs which are carcinogenic, mutagenic or reprotoxic (CMR), persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), or of an equivalent level of concern (ELoC). The latest dossiers have been released by the German and Swedish authorities, and cover:

  • benzo(a)pyrene (CMR (as it is carcinogenic, mutagenic and toxic to reproduction), PBT and vPvB)
  • 3-benzylidene camphor (ELoC (endocrine disruption))
  • dicyclohexyl phthalate (DCHP) (CMR (toxic to reproduction), ELoC (endocrine disruption))
  • 4-methylbenzylidene camphor (ELoC (endocrine disruption))

European Chemicals Agency (2016). Annex XV dossiers. Proposals for identification of substances of very high concern on the basis of the criteria set out in REACH Article 57.

Benzo[def]chrysene (benzo[a]pyrene). 23 February 2016. http://echa.europa.eu/documents/10162/75eb6bd5-3375-4d68-854c-138fb87f0067

Dicyclohexyl phthalate (DCHP). 17 February 2016. http://echa.europa.eu/documents/10162/0f8a6fd1-835f-4686-8cca-bcbbdc137b73

(±)-1,7,7-Trimethyl-3-[(4-methylphenyl)methylene)] bicyclo[2.2.1]heptan-2-one (4-methylbenzylidene camphor). 25 February 2016. http://echa.europa.eu/documents/10162/a9e12f40-872c-4096-8141-f379b57f2037

1,7,7-Trimethyl-3-(phenylmethylene)bicyclo[2.2.1]heptan-2-one (3-benzylidene camphor). 25 February 2016. http://echa.europa.eu/documents/10162/2f164a37-b092-4393-8336-2909f8a4526e


…Restriction proposal on octamethylcyclotetrasiloxane (D4) and decamethylcyclopentasiloxane (D5)

ECHA’s Committee for Risk Assessment (RAC) supports a proposal to restrict the placing on the market of D4 and D5 in personal care products intended to be used or disposed with water (e.g. shower gels, shaving foams and shampoos). The chemicals have a potential to accumulate in the environment, with long-term effects that are difficult to predict or reverse. European Chemicals Agency (2016). Annex to news alert ECHA/NA/16/10. http://echa.europa.eu/documents/10162/21774240/Annex_RAC_36.pdf


…Other items of interest

An amendment (Regulation (EU) 2016/266) to Regulation (EC) No 440/2008, which lays down test methods pursuant to REACH, includes methods for determining partition coefficients, ecotoxicity and environmental fate.



The current substance evaluation process under REACH has been considered in an external report and an ECHA workshop report.




Draft updates to the guidance on information requirements and chemical safety assessment (IR&CSA):

  • Chapter R.7a (parts on sensitisation)
  • Chapter R.7b (parts on the sediment compartment)
  • Chapter R.15 (consumer exposure)
  • Chapter R.16 (environmental exposure)
  • Part E (risk characterisation)



From 31 May 2016, ECHA will refrain from further updates to REACH guidance documents that impact registration for the 2018 REACH deadline.



The 2015 progress report on evaluation under REACH has been published.



ECHA’s Committee for Socio-Economic Analysis (SEAC) has concluded on a restriction proposal for methanol, has drafted opinions on restricting D4 and D5, and has drafted an opinion on applications for the authorisation of chromium trioxide.



Testing proposals involving vertebrate animals: ECHA requests information from third parties on nine chemicals/mixtures including shale oils and 2,2-dimethylpropane-1,3-diyl dibenzoate (by 14 or 28 April).



The above items were taken from the April 2016 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here)

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