PISC Statement on REACH Annex inclusion of EORGTS

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PISC Statement on REACH Annex inclusion of EORGTS

Author: Jessica Sandler, People for the Ethical Treatment of Animals

Three years after the extended one-generation reproductive toxicity test (EORGTS) – which has the potential to halve the number of animals used in reproductive tests – was accepted by the OECD, the EORGTS has been incorporated into the REACH Annexes. At the same time, however, the REACH death toll on animals is set to skyrocket as the European commission considers 200 dossiers that include reproductive toxicity tests that will require a minimum of 260,000 animals. To minimise this cost in animal suffering – as required by the REACH legislation — it is essential that the European Chemicals Agency (ECHA) and the European Commission adopt a standard policy that does not require the breeding of a second generation of animals or testing for developmental immunotoxicity or neurotoxicity endpoints. Because reproductive toxicity testing is the most animal intensive test required for REACH, it is imperative that the European Commission and industry urgently invest in the development of alternatives to reproductive toxicity testing and that ECHA allow the use of existing alternatives as part of a weight-of-evidence approach.

Gilly Stoddart PhD | Associate Director
PETA International Science Consortium, Ltd. (PISC)
Society Building
8 All Saints Street
London N1 9RL
Tel: +44 (0)20 7837 6327
PETA International Science Consortium, Ltd. – a company with its registered address at Society Building, 8 All Saints Street, London N1 9RL. Registered in England and Wales as company number 08312511

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  • Horst Spielmann

    REACH Information requirements for reproductive toxicity changed

    The REACH annexes VIII, IX and X have been amended with the inclusion of the extended one-generation reproductive toxicity study (EOGRTS, EU B.56, OECD TG 443). EOGRTS will now be the information requirement for reproductive toxicity in REACH instead of the two-generation reproductive toxicity study (EU B.35, OECD TG 416). The updated annexes will enter into force 13 March 2015. ECHA is updating its guidance on reproductive toxicity to reflect the regulatory changes and aims to finalise it by July 2015. A draft is already available on ECHA’s website.
    For details use the following links

    ECHA News 25 Ferbuary 2015

    EU Commission News
    REACH: new method to test chemicals for adverse effects on reproduction http://ec.europa.eu/environment/chemicals/news_en.htm

    ECHA G U I D A N C E on information requirements and Chemical Safety Assessment
    Chapter R.7a: Endpoint specific guidance

    EU COMMISSION REGULATION 2015/282 of 20 February 2015 amending Annexes VIII, IX and
    X 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 the Extended One-Generation Reproductive Toxicity Study (ERGOTS)

    Prof. Dr. med. Horst Spielmann
    Institute of Pharmacy
    Faculty of Biology, Chemistry, Pharmacy
    Freie Universität Berlin, Germany
    Zerbster Str. 22
    12209 Berlin, Germany
    phone: +49-30-7118661, fax: +49-30-71581672
    mobile: +49-1773144554
    e-mail: horst.spielmann@fu-berlin.de

  • Horst Spielmann

    The European Commission has today published its response to concerned citizens about the use of animal testing for cosmetics ingredients under the REACH Regulation.
    The public campaign was initiated by the People for the Ethical Treatment of Animals UK (PETA). You can see the Commission’s response on their website.