WRITTEN QUESTION No. 2205/97 by Hiltrud BREYER to the Commission. Novel food regulation No 258/97 - Transparency of authorizations of novel food products (SUPPLEMENTARY ANSWER)
8. 6. 98 EN Official Journal of the European Communities C 174/11 (98/C 174/46) WRITTEN QUESTION E-2205/97 by Hiltrud Breyer (V) to the Commission (25 June 1997) Subject: Novel food regulation No 258/97 › Transparency of authorizations of novel food products 1. 2. How will the requisite level of long-term public transparency and information be guaranteed? Are the consumer organizations to be informed of all the products that have been authorized? 3. What guarantees are there that this information will be complete and up-to-date? Supplementary joint answer to Written Questions E-2113/97, E-2115/97, E-2117/97, E-2119/97, E-2121/97, E-2123/97, E-2127/97, E-2129/97, E-2131/97, E-2133/97, E-2135/97, E-2137/97, E-2139/97, E-2141/97, E-2143/97, E-2145/97, E-2147/97, E-2149/97, E-2151/97, E-2153/97, E-2155/97, E-2157/97, E-2159/97, E-2161/97, E-2163/97, E-2165/97, E-2167/97, E-2169/97, E-2171/97, E-2173/97, E-2175/97, E-2177/97, E-2179/97, E-2181/97, E-2183/97, E-2185/97, E-2187/97, E-2189/97, E-2191/97, E-2193/97, E-2195/97, E-2197/97, E-2199/97, E-2201/97, E-2203/97 and E-2205/97 given by Mr Bangemann on behalf of the Commission (11 November 1997) Further to its answer of 17 September 1997 (1), the Commission can now provide the following information. E-2113/97, E-2115/97, E-2117/97, E-2119/97, E-2123/97, E-2149/97 At the present time, seeds covered by Directives 70/457/EEC and 70/458/EEC, be they genetically modified organisms (GMOs) or not, must be registered in the common catalogue of varieties before being placed on the market within the Community. Before being registered, it must be established that they are distinct, stable and sufficiently uniform. Where seeds are GMOs, they must, in addition, undergo a human safety and environmental risk assessment under Council Directive No 90/220/EC of 23 April 1990 concerning the deliberate release of genetically modified organisms into the environment. The labelling of such products, ie transgenic seeds, must be carried out in accordance with Annex III to that directive. Furthermore, since 15 May 1997, all foods and food ingredients containing, consisting of, or derived from GMOs, which have not hitherto been consumed to a significant degree within the Community, must follow the procedures laid down in Regulation (EC) 258/97 concerning novel foods and novel food ingredients. Article 8 of that Regulation also lays down the labelling rules that apply to such products. As the Honourable Member is aware, Regulation (EC) 258/97 initiates the so-called áone-stopí policy. This means that it is possible to carry out the risk assessment relating to Directive 90/220/EC in the framework of the Regulation. Moreover, the Commission has submitted a proposal to amend the directives relating to the marketing of seeds (2). This proposal, on which Parliament has given its opinion, stipulates that an applicant must have the environmental risks pursuant to Directive 90/220/EC assessed within the framework of the seeds directive, and also stipulates the possibility of having novel food characteristics analysed, in order to simplify administrative procedures, again in accordance with the áone-stopí principle. This possibility, envisaged in Article 3(2) of Regulation (EC) 258/97, has not yet been implemented, pending the adoption of the new rules on seeds. E-2121/97 Normally, the safety evaluation of a novel food will cover all uses of the foodstuff concerned. Thus the safety evaluation of a genetically modified tomato would cover tomato concentrate, and processed foods containing that concentrate. However, in certain cases, a separate evaluation of secondary products may be required