4 Amendments of Lambert van NISTELROOIJ related to 2008/0002(COD)
Amendment 48 #
Proposal for a regulation
Recital 3
Recital 3
(3) Community rules on novel foods were established by Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients and by Commission Regulation (EC) No 1852/12001 of 20 September 2001 laying down detailed rules for making certain information available to the public and for the protection of information submitted pursuant to European Parliament and Council Regulation (EC) No 258/975. For the sake of clarity, Regulation (EC) no 258/97 should be repealed and replaced by this Regulationand Commission Regulation (EC) No 1852/2001 should be repealed. Regulation (EC) No 258/97 should be replaced by this Regulation. Recommendation 97/618/EC should be replaced by updated guidance specific to novel foods, but Recommendation 97/618/EC remains available for use by applicants until replaced by revised guidance.
Amendment 66 #
Proposal for a regulation
Recital 20
Recital 20
(20) Under specific circumstances iIn order to stimulate research and development within the agri-food industry, and thus innovation, tit is appropriate to protect the investment made by innovators generating data supporting an application under this regulation. The newly developed scientific evidence and proprietary data provided in support of an application for inclusion of a novel food in the Community list should not be used to the benefit of another applicant during a limited period of time, without the agreement of the first applicant. During this limited period of time the authorisation is provided to the first applicant only, which does not preclude the right of another applicant to submit its own application. The protection of scientific data provided by one applicant should not prevent other applicants from seeking the inclusion in the Community list of novel foods on the basis of their own scientific data.
Amendment 106 #
Proposal for a regulation
Article 5
Article 5
Community list of novel foods 1. Only novel foods included in the Community list of novel foods (hereinafter "the Community list") may be placed on the market. 2. Where the authorisation of a novel food included in the Community List is based on proprietary scientific evidence in accordance with Article 12, only the named applicant can place it on the market for the first five year period. If, however, the Commission decides that the novel food can be or could have been included in the list provided for under paragraph 1 without the submission of data designated as proprietary by the first applicant, the authorisation is not restricted for use by the first applicant only and is therefore available for general use within the Community. The decision shall be adopted in accordance with the procedure referred to in article 14(2) and shall indicate, in addition to the information referred to in article 7(2): (a) the date of entry of the novel food in the Community list; (b) the fact that the entry is based on newly developed scientific evidence and/or proprietary data protected in accordance with this Article; (c) the name and address of the applicant; (d) the fact that the novel food is restricted for use unless a subsequent applicant obtains authorisation for the food without reference to the proprietary data of the original applicant.
Amendment 155 #
Proposal for a regulation
Article 9
Article 9