EN Official Journal of the European Union CE 78/333

(2004/C 78 E/0351)

WRITTEN QUESTION P-3892/03

by Nicole Thomas-Mauro (UEN) to the Commission

(10 December 2003)

Subject: Opinion of AFSSA

In its opinion of 3 December 2003 the French Food Safety Agency (Agence française de sécurité sanitaire des aliments — AFSSA) expressed serious reservations about BT 11 maize and took the view that the tests carried out on animals by the Swiss firm Syngenta, which is presenting the application, were insufficient.

The matter was referred to the agency by the French Government on 18 November, in advance of the European vote, in which France will be taking part in Brussels on Monday, to decide whether or not to authorise importation of this tinned maize for human consumption. The opinion of AFSSA was of course sought on a consultative basis.

This is the third time that the food safety agency has delivered an opinion on this subject. It has twice issued unfavourable opinions, on 21 July 2000 and 20 March 2001, stressing the inadequacy of the tests carried out on animals.

The Commission wishes to authorise BT 11 maize, but what account does it take of the opinions of the national agencies working with EFSA, including the abovementioned opinion?

Answer given by Mr Byrne on behalf of the Commission

(14 January 2004)

The first opinion of the French Food Safety Agency (AFSSA) on the genetically modified sweet maize, BT 11, delivered on 21 July 2000, was submitted to the Commission in the context of reasoned objections by France to the initial assessment report of sweet maize BT 11 carried out by the competent authorities of the Netherlands under Article 4 of the Novel Food Regulation (EC) No 258/97 (1).

These objections, and those raised by other Member States, were referred by the Commission to the Scientific Committee on Food (SCF). The subsequent AFSSA opinion, of 20 March 2001, was also transmitted to the SCF for consideration.

On 17 April 2002, the SCF delivered its opinion that BT 11 sweet maize, is as safe for human food use as its conventional counterparts. This opinion focused, as requested by the Commission, on the issues raised in the comments made by Member States' authorities, namely: the scope of the request, molecular characterisation, compositional analysis on BT 11 sweet maize, toxicity studies and labelling.

The data provided by the applicant and the safety assessment of the product carried out followed the criteria and requirements laid down in Commission Recommendation 618/97/EC (2). The methodology used for the safety assessment of BT 11 was also in line with the recent guidelines prepared by the Scientific Steering Committee concerning the assessment of genetically modified organism (GMOs), GM food and GM feed (3) and with the Codex Principles and Guidelines on Foods Derived from Biotechnology (4). The concerns raised in the two above-mentioned AFSSA opinions, which were again reiterated in another AFSSA opinion of 3 December 2003, do not bring any new scientific elements in addition to the initial assessment of sweet maize BT 11 carried out by the competent authorities of the Netherlands. These concerns were duly considered by the SCF in its opinion of 17 April 2002, which confirmed the findings of the initial assessment carried out by the competent authorities of the Netherlands that BT 11 sweet maize is as safe for human food use as conventional maize.

(1) Regulation (EC) no 258/97 of the Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients, OJ L 43, 14.2.1997.

(2) Commission Recommendation of 29 July 1997 concerning the scientific aspects and the presentation of information necessary to support applications for the placing on the market of novel foods and novel food ingredients and the preparation of initial assessment reports under Regulation EC No 258/97 of the European Parliament and of the Council, OJ L 253, 16.9.1997.

(3) ‘Guidance Document for the Risk Assessment of Genetically Modified Plants and Derived Food and Feed’ Joint Working Group on Novel foods and GMOS, 6-7 March 2003. http://europa.eu.int/comm/food/fs/sc/ssc/out327_en.pdf.

(4) Codex Alimentarius Commission, 2003. Codex Principles and Guidelines on Foods Derived from Biotechnology. Joint FAO/WHO Food Standards Programme, Food and Agriculture Organisation: Romeftp://ftp.fao.org/codex/standard/en/CodexTextsBiotechFoods.pdf.