WRITTEN QUESTION No. 2128/97 by Hiltrud BREYER to the Council. Novel food regulation No 258/97 - Reporting
C 82/32 EN Official Journal of the European Communities 17. 3. 98 (98/C 82/45) WRITTEN QUESTION E-2128/97 by Hiltrud Breyer (V) to the Council (24 June 1997) Subject: Novel food regulation No 258/97 › Reporting 1. Will new or unmodified products which do not have to be authorized, pursuant to the novel food regulation (1), be subject to a reporting obligation? 2. If not, how will national and EU authorities be informed of the market launch of such products? How can these authorities test whether there is an obligation to label such products pursuant to the novel 3. food regulation? (1) OJ L 43, 14. 2. 1997, p. 1. (98/C 82/46) WRITTEN QUESTION E-2130/97 by Hiltrud Breyer (V) to the Council (24 June 1997) Subject: Novel food regulation No 258/97 › Requirements for authorization What exactly are the test criteria, in accordance with which applications for authorization for products under the novel food regulation (1) have to be assessed to see whether permission is required or whether simple registration will be deemed to be sufficient if the manufacturer has not applied for permission? (1) OJ L 43, 14. 2. 1997, p. 1. Joint answer to Written Questions E-2126/97, E-2128/97 and E-2130/97 (20 October 1997) Article 3 (4) of Regulation No 258/97 on novel foods and novel food ingredients provides for a derogation form the authorization procedure laid down in that Regulation, where foods or food ingredients, on the basis of the scientific evidence available and generally recognized or on the basis of an opinion delivered by one of the competent bodies, are substantially equivalent to existing foods and food ingredients as regards their composition, nutritional value, etc. Where necessary, it may be determined in accordance with the procedure laid down in Article 13 of the Regulation whether a type of food or food ingredient falls under the derogation in question. The arrangements for notification of these products are laid down in Article 5 of the Regulation. (98/C 82/47) WRITTEN QUESTION E-2132/97 by Hiltrud Breyer (V) to the Council (24 June 1997) Subject: Novel food regulation No 258/97 › Requirements for authorization: checking information supplied by manufacturers 1. What information is supposed to be used as the basis for assessment? 2. Is there provision for independent testing of the data submitted by manufacturers?