…Test requirements for skin sensitisation updated

Updates to the information requirements on skin sensitisation for substances manufactured in, or imported into, the EU in quantities of 1 tonne or more (Annex VII) entered into force in October. For these substances, in vivo tests should now only be conducted if a) no such test results are already available and b) either approved in vitro or in chemico test methods are not applicable, or the results obtained from these studies are not adequate for classification and risk assessment.

European Commission (2016). Commission Regulation (EU) 2016/1688 of 20 September 2016 amending Annex VII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards skin sensitisation. Official Journal of the European Union L255, 14-16. http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32016R1688&from=EN

…Proposed update to the Community rolling action plan (CoRAP)

Between 2017 and 2019, under CoRAP, Member States will be evaluating 117 substances, of which 22 are newly selected. ECHA encourages registrants of the listed substances to start coordinating their actions and to contact the evaluating Member States.

European Chemicals Agency (2016). Member States plan to evaluate 117 substances in 2017-2019. ECHA/NA/16/33. https://echa.europa.eu/-/member-states-plan-to-evaluate-117-substances-in-2017-2019



…Nine substances of very high concern (SVHC) recommended for authorisation

Nine SVHCs considered toxic to reproduction have been put forward by ECHA in its seventh recommendation for inclusion in Annex XIV of the REACH regulation (Authorisation List). The substances are:

  • 1,2-benzenedicarboxylic acid, dihexyl ester, branched and linear
  • dihexyl phthalate
  • lead monoxide
  • orange lead
  • pentalead tetraoxide
  • sodium perborate
  • sodium peroxometaborate
  • tetralead trioxide sulphate
  • trixylyl phosphate

Hexahydrophthalic anhydride (HHPA) and methyl HHPA (MHHPA) were excluded from the final recommendation due to a change in their prioritisation after public consultation. They will be reconsidered in future recommendation rounds.

The final decision on the inclusion of the substances in Annex XIV will be taken by the European Commission in collaboration with Member States and the European Parliament.

European Chemicals Agency (2016).

ECHA proposes nine substances for authorisation. ECHA/PR/16/14. https://echa.europa.eu/-/echa-proposes-nine-substances-for-authorisation

Recommendation of the European Chemicals Agency of 10 November 2016 for the inclusion of substances in Annex XIV to REACH (list of substances subject to authorisation). https://echa.europa.eu/documents/10162/13630/7th_axiv_recommendation_november2016_en.pdf/3e11377b-edd8-46d3-a29c-1978c41db3ad

…Other items of interest

ECHA has issued a call for evidence to gather information relating to the restriction of diarsenic trioxide, diarsenic pentaoxide and recycled rubber granules. https://echa.europa.eu/addressing-chemicals-of-concern/restriction/calls-for-comments-and-evidence


A draft updated guidance report is available on the identification and naming of substances under REACH and CLP. https://echa.europa.eu/documents/10162/13643/sid_guidance_sip_caracal_en.pdf/d5406cb3-6e9e-4aee-ace1-d1cb51bc16c0


Applications have been made to authorise uses of 1,2-dichloroethane, 2,2′-dichloro-4,4′-methylenedianiline (MOCA) and various chromium compounds (chromium trioxide, ammonium, potassium and sodium dichromates, and disodium chromate). https://echa.europa.eu/addressing-chemicals-of-concern/authorisation/applications-for-authorisation


Chesar has been updated (to version 3.1) to support the use of sector-specific use maps, and to allow users to generate their exposure scenarios for communication in a standardised ESComXML format. https://echa.europa.eu/-/update-of-chesar-3-supports-use-maps


ECHA has requested information from third parties (by 5 December or 3 January) on testing proposals involving vertebrate animals on:

  • bis(α,α-dimethylbenzyl) peroxide
  • 5,5′-dithiodi-1,3,4-thiadiazole-2(3H)-thione
  • fatty acids, C14-18 and C16-18-unsaturated, maleated
  • [1,3-phenylenebis(1-methylethylidene)]bis[tert-butyl] peroxide
  • reaction products of a polyol of pentaerythritol and propylene oxide, epichlorohydrin and hydrogen sulphide
  • ((3-(sec-butyl)-4-(decyloxy)phenyl)methanetriyl)tribenzene
  • trinonyl benzene-1,2,4-tricarboxylate



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

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