…Draft update of ECHA’s endpoint-specific guidance for human health effects

ECHA has drafted an update of Chapter R.7a of its guidance on information requirements and chemical safety assessment (IR&CSA). The update fully revises the content relating to acute toxicity testing, and includes new information on in vitro assays, and on non-laboratory methods such as (quantitative) structure-activity relationships ((Q)SARs), for the prediction of a chemical’s potential acute toxicity.

European Chemicals Agency (2015). Guidance on information requirements and chemical safety assessment. Chapter R.7a: Endpoint specific guidance. Draft Version 5.0. October 2015. http://echa.europa.eu/documents/10162/13643/ircsa_r7a_r7-4_acute_tox_draft_peg_en.pdf


…ECHA opens consultation on eleven substances proposed for authorisation

ECHA considers that the following eleven substances of very high concern (SVHCs) should be included in its authorisation list (Annex XIV of REACH):

  • 1,2-benzenedicarboxylic acid, dihexyl ester (branched and linear)
  • dihexyl phthalate (DnHP)
  • hexahydrophthalic anhydride (HHPA)
  • lead monoxide
  • lead tetraoxide
  • methylhexahydrophthalic anhydride (MHHPA)
  • pentalead tetraoxide sulphate
  • sodium perborate
  • sodium peroxometaborate
  • tetralead trioxide sulphate
  • trixylyl phosphate

Comments are welcomed by 17 February 2016.

European Chemicals Agency (2015). ECHA consults on 11 substances to be proposed for authorisation. ECHA/PR/15/15. http://echa.europa.eu/view-article/-/journal_content/title/echa-consults-on-11-substances-to-be-proposed-for-authorisation

Background documents available via http://echa.europa.eu/addressing-chemicals-of-concern/authorisation/recommendation-for-inclusion-in-the-authorisation-list


…Upcoming RAC/SCOEL consideration of occupational N-methylpyrrolidone (NMP)

In response to a request from the European Commission, ECHA has submitted a mandate to its Committee for Risk Assessment (RAC) to produce an opinion with the Scientific Committee on Occupational Exposure Limits (SCOEL) on the solvent N-methylpyrrolidone (NMP), considering the differences between the ECHA‑recommended derived no-effect levels (DNELs) for workers (10 mg/m3 by inhalation and 4.8 mg/kg bw/day dermally) and the SCOEL indicative occupational exposure limit value (IOELV) of 40 mg/m3. The joint opinion is expected to be adopted in February 2016.

European Chemicals Agency (2015). Ref: Request to the Committee for Risk Assessment for a joint opinion of the Committee for Risk Assessment (RAC) and the Scientific Committee on Occupational Exposure Limits (SCOEL) to resolve the differences in scientific opinion as regards exposure levels for NMP. I(2015)0255 1 (2). 8 September 2015. http://echa.europa.eu/documents/10162/13641/rac_mandate_exposure_levels_nmp-scoel_en.pdf


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

ECHA has proposed to update CoRAP with 138 substances to be evaluated in 2016-2017, including 53 which are newly selected.

European Chemicals Agency (2015). Draft CoRAP to evaluate 138 substances in 2016-2018 published. http://echa.europa.eu/view-article/-/journal_content/title/draft-corap-to-evaluate-138-substances-in-2016-2018-published


…Other items of interest

Forum for Exchange of Information on Enforcement starts projects on internet trade of chemicals and on substances in articles. http://echa.europa.eu/view-article/-/journal_content/title/forum-starts-projects-on-internet-trade-of-chemicals-and-on-substances-in-articles


ECHA asks registrants to show how they considered alternative methods before consulting on testing proposals. http://echa.europa.eu/view-article/-/journal_content/title/echa-asks-registrants-to-show-how-they-considered-alternative-methods-before-consulting-on-testing-proposals


Draft updates to the guidance on IR&CSA: Chapter R.7b (endpoint specific guidance; sediment compartment only) sent to ECHA’s RAC and Member State Committee (MSC) for consultation; Chapter R.16 (environmental exposure assessment) sent to RAC, MSC and Forum. R.7b: http://echa.europa.eu/documents/10162/13564/r7b_draft_v30_sediments_rac_msc_en.pdf R.16: http://echa.europa.eu/support/guidance/consultation-procedure/ongoing-reach?panel=r16v30
The above items were taken from the December 2015 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here)

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