…Draft amendment of information requirements for acute toxicity, irritation and sensitisation

A draft EU Regulation amends the information requirements for substances manufactured in, or imported into, the EU in quantities of 1 tonne or more (Annex VII) and of 10 tonnes or more (Annex VIII) each year. It aims to remove in vivo test requirements for skin and eye irritation, while allowing the waiving of in vivo acute dermal toxicity testing (when substances are non-toxic by the oral route) and of skin sensitisation testing (when sufficient information can be generated by alternative methods).

European Commission (2015). Draft Commission Regulation amending Annexes VII and VIII 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 corrosion/irritation, serious eye damage/eye irritation, skin sensitisation and acute toxicity.



…ECHA’s Committee for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) conclude on PFOA restriction…

RAC has adopted an opinion in support of a proposal from the German and Norwegian authorities to restrict the manufacture, marketing and use of perfluorooctanoic acid (PFOA) and related substances, on the basis that PFOA and its ammonium salt (APFO) are substances of very high concern (SVHC) under REACH. Although the full opinion has not yet been released [so further details are not available], RAC was said to support a higher concentration limit than that proposed by the Member State authorities (which was 2 ppb), as well as additional derogations for industrial sectors posing lower risks. SEAC has also drafted an opinion supporting the same restriction proposal, concluding on its socio‑economic costs and benefits.

European Chemicals Agency (2015).

RAC concludes on PFOA restriction […].15 September 2015. http://echa.europa.eu/documents/10162/13579/annex_to_rac_news_alert_15_september_2015.pdf

SEAC concludes on […] PFOA restrictions […]. 15 September 2015. http://echa.europa.eu/view-article/-/journal_content/title/seac-concludes-on-bisphenol-a-decabde-and-pfoa-restrictions-and-finalises-two-opinions-for-authorisation


…and two applications for authorisation

Final opinions have been drafted by RAC and SEAC on uses of trichloroethylene in industrial parts cleaning and lead chromate in the manufacture of ammunition.

European Chemicals Agency (2015).

RAC […] finalises two opinions for authorisation […].15 September 2015. http://echa.europa.eu/documents/10162/13579/annex_to_rac_news_alert_15_september_2015.pdf

SEAC […]finalises two opinions for authorisation. 15 September 2015. http://echa.europa.eu/view-article/-/journal_content/title/seac-concludes-on-bisphenol-a-decabde-and-pfoa-restrictions-and-finalises-two-opinions-for-authorisation


…Other items of interest

Draft update to the guidance on Information Requirements and Chemical Safety Assessment (IR&CSA): Chapter R.12 (use description) sent for Competent Authorities for REACH and CLP (CARACAL) consultation.

ECHA is to update its guidance on substances in articles.



SEAC has drafted opinions on the socio-economic side of restriction proposals from ECHA and the French authorities relating to bisphenol A and decabromodiphenyl ether (decaBDE).



New webpages are available on the ECHA site to provide guidance to industry on how to successfully substitute hazardous chemicals or techniques with safer alternatives.



A webform is now available for downstream users to notify ECHA of uses covered by a REACH authorisation.



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

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