92000E1064

WRITTEN QUESTION E-1064/00

by Hiltrud Breyer (Verts/ALE) to the Commission

(4 April 2000)

Subject: Registration of GMOs in the USA based on deception and the misrepresentation of evidence

According to Steven M. Drucker, a Doctor of Laws and specialist in administrative law, the Commission's decisions on registering genetically modified plant varieties are based on erroneous assessments by the US Food and Drug Administration.

For instance, when the American authorisation body permitted the marketing of the Flavr Savr tomato which is also marketed in the EU in the form of tomato concentrate and ketchup, it was acting contrary to the specific test results of its own scientists. For laboratory tests show that when these tomatoes are fed to rats, this leads to a bleeding of the stomach walls. In view of this high health risk, the scientists advised against the authorisation of this product as a foodstuff. The safety tests on GMOs that have been authorised since then have been even less demanding in many cases, no tests at all were carried out.

1. Is the Commission aware of this information?

2. Is the Commission prepared to examine these latest findings regarding the bleeding of stomach walls? If not, why not?

3. What lessons will the Commission draw from these latest findings?

Answer given by Mr Byrne on behalf of the Commission

(19 June 2000)

The Commission is aware of the lawsuit which a number of organisations in the United States have filed against the Food and Drug Administration (FDA) concerning assessment of genetically modified food.

The specific product mentioned by the Honourable Member has not been subject to any request for authorisation or notification in the Community and can therefore not be legally marketed in the Community. It is up to the Member States to do the controls.

The Commission is always prepared to ask the scientific committee on food (SCF) to evaluate new scientific findings which cast doubts on the safety of genetically modified organism (GMO) derived products authorised or notified in accordance with Regulation (EC) No 258/97 of the Parliament and of the Council of 27 Janaury 1997 concerning novel foods and novel food ingredients(1) to be on the European market.

In the light of the results of the feeding experiments on rats with the Flavr Savr salad tomato, the Commission has asked the SCF for complementary information with respect to its opinion concerning the safety of products derived from genetically modified processing tomatoes for which the company Zeneca has applied for authorisation.

The Community legislation on novel foods and novel food ingredients ensures that a safety assessment is carried out prior to the placing on the market in the Community of GMO food and food ingredients. Article 12 of the Novel Food Regulation(2) also provides for the possibility to revise or revoke any decision on specific products in the light of new findings.

(1) OJ L 43, 14.2.1997.

(2) OJ L 43, 14.2.1997.