WRITTEN QUESTION E-1025/97 by Hiltrud Breyer (V) to the Commission (19 March 1997)

Subject: Health testing of genetically produced or modified foods

The European Parliament and Council regulation on novel foods and novel food ingredients provides for health testing of genetically modified or produced foods.

1. (a) What criteria are envisaged for such health testing?

(b) What testing methods are available?

2. (a) How is a genetically modified or produced food tested for allergenic effects?

(b) What testing methods are available for this purpose?

(c) What is the Commission's response to the fact that the US Food and Drug Administration claims that no testing methods are currently available for assessing the allergenic effects of genetically modified or produced foods?

3. Does the Commission agree that this state of affairs in effect makes consumers guinea-pigs?

Answer given by Mr Bangemann on behalf of the Commission (9 June 1997)

To resolve the scientific questions arising during the assessment of novel foods (NF) and novel food ingredients (NFI), the Commission has asked the scientific committee for food (SCF), pursuant to Article 4(4) of European Parliament and Council Regulation (EC) No 258/97 concerning novel foods and novel food ingredients ((OJ L 43, 14.2.1997. )), for an opinion on the scientific aspects of the information necessary for the approval of applications for the placing of NF and NFI on the market.

This opinion has existed in the form of recommendations since January 1997 and is currently being published by the Office for official publications, which publishes reports by the SCF. The recommendations contain, along with general explanatory notes, detailed plans for the testing of all the groups of NF cited in Regulation (EC) No 258/97, including those produced by genetic engineering.

In the light of these recommendations, the Honourable Member's questions can be specifically answered as follows:

1 (a) In order to evaluate the safety of novel foods, the scientific committee for food identified the following elements:

- specification of the NF;

- the effects of the production process used for the NF;

- previous experience with the organism used as a source for the new NF;

- the effects of gene modification on the properties of the host organism;

- the genetic stability of the genetically modified organism (GMO) used as the source of the NF;

- specificity of the expression of the novel genetic material;

- the transfer of genetic material from GMOs;

- ability of the genetically modified microorganisms to survive in the human intestine and to colonize it;

- expected consumption or degree of use of NF;

- information regarding previous exposure of man to the NF or its source;

- nutritional information about the NF;

- microbiological information about the NF;

- toxicological information about the NF.

1 (b) To obtain toxicological information to assess NF or NFI, different testing methods are available. These include in vitro and in vivo mutagenicity studies, reproduction and teratogenicity studies, as well as long term feeding studies, following a tiered approach on a case-by-case basis. In the case of novel foods or isolated novel food components, which differ by identifiable characteristics from traditional foods, it is possible to restrict testing to only those characteristics rather than the whole NF. Defined chemical substances can be tested by methods described in the SCF report No 10. This includes mutagenicity studies and an appropriate feeding study in a rodent species. Toxicological endpoints that may be analysed could include metabolism, toxicokinetics, chronic toxicity and carcinogenicity, reproductive function, teratogenicity, and possibly neurotoxicity and immunotoxicity.

2 (a) and (b) As a general principle of assessment, the immunological reactivity of individuals who react to a traditional food counterpart or a novel protein expressed by genes derived from a source known to be associated with food allergy inserted into the novel food, should be tested by appropriate in vitro and in vivo tests. If the novel protein is expressed by genes derived from a source known to be associated with food allergy, sera of people with confirmed allergies to that source can be subjected to specific immunological tests, e.g. Western Blotting or radioallergosorbent test (RAST). If in vitro tests are negative, in vivo skin prick tests or clinically supervised double blind placebo controlled challenges on volunteers may be performed.

A number of factors can serve as indicators of the potential allergenicity of novel proteins, such as sequence epitope homology with known allergens, heat stability, sensitivity to pH, digestibility by gastrointestinal proteases, detectable amounts in plasma, and molecular weight.

2 (c) The Commission is not aware of such an opinion having been expressed by the Food and drug administration.

3. The Commission does not agree. Rather, the Commission's concern is to ensure, by comprehensive testing of NF and NFI, that European consumers are as safe with NF and NFI as they are with traditional foodstuffs.