Community Blog
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
www.piscltd.org.uk
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
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
http://fceg.espsrv.com/f/rnl.aspx/?kfg=u_utu1&x=pv&-jj=u/di9=xuwz9d6&a=&x=pv&eehk5fe.0&x=pv&b7da&x=pp&u1&h280ea.d28&NCLM
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
http://echa.europa.eu/documents/10162/13643/ir_csa_r7a_r76_reprotox_draft_en.pdf
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)
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:JOL_2015_050_R_0001&from=EN
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
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.
http://ec.europa.eu/environment/chemicals/reach/animal_en.htm