Answer given by Mr Dalli on behalf of the Commission

31.8.2011

Plant protection products are regulated, since 14 June 2011, by Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC[1].

This regulation provides that the applicant, who bears the burden of proof as regards the safety of the product, submits the necessary evidence, in line with the data requirements set out in Regulation (EU) No 544/2011[2] and in Regulation (EC) No 545/2011[3]. Furthermore, when submitting a dossier for an active substance, the applicant shall also add scientific peer-reviewed open literature concerning side-effects on health, the environment and non-target species published within the last 10 years before the date of submission of the dossier.

Glyphosate is currently approved and its approval has to be reviewed before the end of 2015, based on a dossier that shall be submitted by the applicant before 31 May 2012. This dossier will also include the scientific peer-reviewed literature. A decision on the possible renewal will be performed in the light of the new criteria for approval laid down in Annex II to Regulation (EC) No 1107/2009.

The Commission does not know all specific works the Honourable Member refers to, but is aware of several public reports and scientific publications concerning glyphosate and more specifically its formulated product Roundup. In that respect, the Honourable Member is invited to refer to the reply to Written Questions P‑10522/2010, E‑6365/2011, E‑6135/2011 and E‑7160/2011[4].

• [1] OJ L 309, 24.11.2009.
• [2] OJ L 155, 11.6.2011.
• [3] OJ L 155, 11.6.2011.
• [4] http://www.europarl.europa.eu/QP-WEB/application/home.do?language=EN

OJ C 146 E, 24/05/2012