Activities of Mojca DRČAR MURKO related to 2008/0002(COD)
Plenary speeches (1)
Novel foods (debate)
Amendments (13)
Amendment 59 #
Proposal for a regulation
Recital 13
Recital 13
(13) Whether a food was used for human consumption to a significant degree before 15 May 1997, should be based on information available in the Member States. Where the Commission does not have information on human consumption before 15 May 1997, a simple and transparent procedure for collecting that information should be established involving the Member States and any interested partiesThe classification of a Novel Food, e.g. on the basis of its use, to a significant degree, for human consumption before the date of application of the legislation or by making use of well known food production methods, should be based on information available in the Member States and in addition by any interested parties. A procedure for collecting that information should be established. This procedure should be simple and transparent, whilst avoiding any unjustified disruption of the market.
Amendment 67 #
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 71 #
Proposal for a regulation
Recital 22
Recital 22
(22) Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods17 harmonises the provisions in the Member States which relate to nutrition and health claims. Therefore, claims regarding novel foods should only be made in accordance with that Regulation. Where an applicant intends that a novel food should carry a health claim that must be authorised in accordance with article 17 or 18 of Regulation (EC) No 1924/2006 and the novel food and health claim applications include requests for the protection of proprietary data, at the request of the applicant, the period of data protection should start together and run concurrently.
Amendment 73 #
Proposal for a regulation
Recital 25
Recital 25
(25) Novel foods placed on the Community market under Regulation (EC) No 258/97 should continue to be placed on the market. Novel foods authorised in accordance with Regulation (EC) No 258/97 should be included in the Community list of novel foods established by this Regulation. In addition, applications submitted under Regulation (EC) No 258/97, and for which a final decision has not been take before the date of application of the present Regulation, should be considered as applications under this Regulationwhere the initial assessment report provided for under Article 6(3) of Regulation (EC) No 258/97 has not yet been forwarded to the Commission, as well as in all cases where an additional assessment report is required in accordance with Article 6(3) or (4) of Regulation (EC) No 258/97 before the date of application of this Regulation should be considered as an application under this Regulation. When required to give an opinion the Authority and the Member States shall take the outcome of the initial assessment into account. Other requests submitted under Article 4 of Regulation (EC) No 258/97 before the date of application of this Regulation shall be processed under the provisions of Regulation (EC) No 258/97.
Amendment 76 #
Proposal for a regulation
Article 1
Article 1
This Regulation lays down harmonised rules for the placing of novel foods on the market in the Community with a view to ensuring a high level of human health and consumers’ protection, whilst ensuring the effective functioning of the internal market and stimulating innovation within the agri-food industry.
Amendment 98 #
Proposal for a regulation
Article 4 – title
Article 4 – title
Collection of information regarding the useof a food for human consumption classification of a Novel Food
Amendment 99 #
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. The Commission mayshall collect information from the Member States and/or from food business operators to determine or any other interested party to determine the Novel Food status of applications and, in case of questions raised on the existence of products already on the market, to what extent a food has been used for human consumption within the Community before 15 May 1997the date of application of this legislation.
Amendment 103 #
Proposal for a regulation
Article 4 – paragraph 1 a (new)
Article 4 – paragraph 1 a (new)
1a. The Commission shall make public the conclusion drawn from this data collection and the non-confidential data supporting it.
Amendment 105 #
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 129 #
Proposal for a regulation
Article 7 – paragraph 3 – point (c a) (new)
Article 7 – paragraph 3 – point (c a) (new)
(ca) the fact that the novel food may only be placed on the market by the named applicant, unless a subsequent applicant obtains authorisation for the food without reference to the proprietary data of the original applicant.
Amendment 132 #
Proposal for a regulation
Article 7 – paragraph 4 a (new)
Article 7 – paragraph 4 a (new)
4a. By way of derogation from the third paragraph of Article 7 of Regulation (EC) No [common procedure], the updating of the Community list with a novel food, shall be decided according to the procedure referred to in [Article 8 a] where: a) the equivalence of the novel food to existing foods, in composition, metabolism and level of undesirable substances, is sufficient to demonstrate that it poses no safety concern to the health of the consumer under the intended consumption conditions; b) the novel food consists of or contains food previously used exclusively as or in food supplements, in compliance with applicable legislation, and where the new intended use can reasonably be expected not to significantly increase the intake of consumers, including vulnerable groups.
Amendment 174 #
Proposal for a regulation
Article 12 – paragraph 1
Article 12 – paragraph 1
1. On request by the applicant, supported by appropriate and verifiable information included in the application dossier, newly developed scientific evidence and proprietary scientific data provided to support the applications, may not be used for the benefit of another application during a period of five years from the date of the inclusion of the novel food in the Community list without the agreement of the applicant.
Amendment 179 #
Proposal for a regulation
Article 12 – subparagraph 1 a (new)
Article 12 – subparagraph 1 a (new)
1a. Where the newly developed scientific evidence and proprietary scientific data protected under article 12 are the results of tests on vertebrate animals or clinical study in human beings and repetition of the tests on vertebrate animals or clinical studies in human beings should be avoided from an ethical perspective as being scientifically unnecessary, a second or subsequent applicant may request that the first applicant gives access to the protected data. The first applicant should consent to such request, with effect from the end of the first year of the data protection period defined in article 12, provided that the second applicant reimburses the first applicant for the costs of these studies. In the same way, such consent should also be given to any subsequent applicants, in which case the second and subsequent applicants shall use their best efforts to reach fair agreement on sharing of the costs.