Activities of Philip BUSHILL-MATTHEWS related to 2008/0002(COD)
Plenary speeches (1)
Novel foods (debate)
Amendments (8)
Amendment 54 #
Proposal for a regulation
Recital 6 a (new)
Recital 6 a (new)
(6a) Whereas the European Group on Ethics in Science and New Technologies stated in its Opinion (no. 23) on ethical aspects of animal cloning for food supply of 16 January 2008 that it ‘does not see convincing arguments to justify the production of food from clones and their offspring’. Whereas the Scientific Committee of the European Food Safety Authority concluded in its Opinion1 of 15 July 2008 that ‘the health and welfare of a significant proportion of clones … have been found to be adversely affected, often severely and with a fatal outcome’’. 1 The EFSA Journal (2008) 767, 1-49
Amendment 80 #
Proposal for a regulation
Article 2 – paragraph 2 – point b a (new)
Article 2 – paragraph 2 – point b a (new)
(ba) foods derived from cloned animals and their descendants. Before the date of entry into force of this Regulation referred to in Article 20, the Commission shall present a legislative proposal to prohibit the placing on the market in the Community of foods derived from cloned animals and their descendants. The proposal shall be forwarded to the European Parliament and the Council.
Amendment 130 #
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 133 #
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 151 #
Proposal for a regulation
Article 8 a (new)
Article 8 a (new)
Article 8 a 1. A food business operator intending to place on the market a food referred to in Article 7 (5) (new) shall notify the Commission of his intention and the notification shall be accompanied, as appropriate, by relevant data demonstrating that the food meets the conditions established therein. 2. The Commission shall forward the notification including the accompanying data referred to in paragraph 1 without delay to the Member States and the Authority. 3. Within four months from the date on which the notification provided for in paragraph 2 is forwarded to the Commission, the Authority shall deliver an opinion 4. If no reasoned safety objections, based on scientific evidence, have been raised and no information thereof has been communicated to the food business operator, the food may be placed on the market in the Community after 5 months from the date of the notification in accordance with paragraph 1. The Community list will be updated accordingly. 5. Detailed rules for the implementation of this Article, which are designed to amend non-essential elements of this Regulation, inter alia by supplementing it, may be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3).
Amendment 171 #
Proposal for a regulation
Article 12
Article 12
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. unless the subsequent applicant has agreed with the prior applicant that such data and information may be used, where: (a) the scientific data and other information has been designated as proprietary by the prior applicant at the time the prior application was made; and (b) the prior applicant had exclusive right of reference to the proprietary data at the time the prior application was made; and (c) the novel food could not have been authorized without the submission of the proprietary data by the prior applicant.
Amendment 180 #
Proposal for a regulation
Article 12 a (new)
Article 12 a (new)
Article 12 a Aligned data protection Notwithstanding the authorisation of a novel food according to the provisions of Articles 7 and 14 of Regulation (EC) No [common procedure] and the authorisation of a health claim according to the provisions of Articles 17, 18 and 25 of Regulation (EC) No 1924/2006/EC, where it is intended to seek authorisation of a novel food and of a health claim or claims to be made on that food, and where data protection is justified under the provisions of both Regulations and if requested by the applicant, the dates of authorisation and/or publication of the authorisation in the Official Journal shall coincide and the periods of data protection shall run concurrently.
Amendment 181 #
Proposal for a regulation
Article 12 b (new)
Article 12 b (new)
Article 12 b 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.