Activities of Magor Imre CSIBI related to 2008/0002(COD)
Plenary speeches (1)
Novel foods (debate)
Amendments (30)
Amendment 34 #
Proposal for a regulation – amending act
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 parties. The procedure should be simple and transparent, whilst avoiding any unjustified disruption to the market, and should be adopted no later than six months after the entry into force of this Regulation.
Amendment 35 #
Proposal for a regulation – amending act
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 foods 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 a novel food to carry a health claim authorised in accordance with Articles 17 or 18 of that Regulation, and where the novel food and health claim applications are introduced at the same time and both include a request for the protection of proprietary data, at the request of the applicant the periods of data protection should start together and run concurrently.
Amendment 37 #
Proposal for a regulation – amending act
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 Regulation. where the initial assessment report provided for by 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 that Regulation before the date of application of this Regulation, applications submitted under Regulation (EC) No 258/97 should be considered as applications under this Regulation. When required to give an opinion, the Authority and the Member States should 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 should be processed under the provisions of Regulation (EC) No 258/97.
Amendment 38 #
Proposal for a regulation – amending act
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 and animal health and welfare, whilst ensuring the effective functioning of the internal market and stimulating innovation within the agri- food industry.
Amendment 50 #
Proposal for a regulation
Recital 5 a (new)
Recital 5 a (new)
5a. Foods with a new or intentionally modified primary molecular structure, foods consisting of, or isolated from, micro-organisms, fungi or algae, new strains of micro-organism with no history of safe use as well as concentrates of substances that naturally occur in plants are considered as novel under the definition of the present Regulation.
Amendment 51 #
Proposal for a regulation – amending act
Article 8 – paragraph 1 – subparagraph 2
Article 8 – paragraph 1 – subparagraph 2
The notification shall be accompanied by documented data demonstrating the history of safe food use in theany third country.
Amendment 53 #
Proposal for a regulation – amending act
Article 8 – paragraph 3 – subparagraph 2
Article 8 – paragraph 3 – subparagraph 2
In that case, the food shall not be placed on the market in the Community and Articles 5 to 7 shall apply. The notification as referred to in paragraph 1 shall be considered as an application referred to in Article 3(1) of the Regulation XX/XXX [common procedure]. Alternatively, the applicant may choose to withdraw the notification.
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 56 #
Proposal for a regulation – amending act
Article 9
Article 9
Amendment 62 #
Proposal for a regulation – amending act
Article 18 – paragraph 1
Article 18 – paragraph 1
1. AWhere the initial assessment report provided for by Article 6(3) of Regulation (EC) No 258/97 has not been forwarded to the Commission by ...+, any request for placing a novel food on the market submitted to a Member State under Article 4 of that Regulation (EC) No 258/97 and for which a final decision has not been taken before the date of applicatshall be considered as an application under this Regulation. Other requests submitted under Article 3(4) and Articles 4 and 5 of Regulation (EC) No 258/97 before ...+ shall be processed under the provisions of thisat Regulation shall be considered as an. ___________ + The date of application underof this Regulation.
Amendment 63 #
Proposal for a regulation – amending act
Article 18 – paragraph 2
Article 18 – paragraph 2
Amendment 72 #
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 where the novel food and health claim applications are introduced at the same time and both 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 74 #
Proposal for a regulation
Recital 25
Recital 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 takewhere 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 the presentis Regulation, should be considered as an applications under this Regulation. 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 77 #
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, animal health and welfare, protection of the environment, whilst ensuring the effective functioning of the internal market and stimulating innovation within the agri-food industry.
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 91 #
Proposal for a regulation
Article 3 – paragraph 2 - point (a) (iii)
Article 3 – paragraph 2 - point (a) (iii)
(iii) food to which is applied a new production process, not used before 15 May 1997, where that production process gives rise to significant changes in the composition or structure of the food which affect its nutritional value, metabolism or level of undesirable substances; in all circumstances foods produced using nanotechnology and nanoscience are considered as food to which is applied a new production process. In accordance with the regulatory procedure referred to in Article 14(2) the Commission shall adopt a definition on foods produced using nanotechnology and nanoscience.
Amendment 101 #
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 or any other interested party to determine to what extent a food has been used for human consumption within the Community before 15 May 1997. Business operators and other interested parties are obliged to transfer information on the extent a food has been used for human consumption within the Community before 15 May 1997 if the Commission or a national authority of a Member State asks for this information.
Amendment 110 #
Proposal for a regulation
Article 6 – point (c a) (new)
Article 6 – point (c a) (new)
(ca) its use does not have a negative impact on the environment; the novel food or break-down products of it shall not be persistent and accumulative in the environment after the novel food has been used as a food; (cb) a novel food that may have any adverse effects on particular groups of the population will only be authorised if specific measures preventing such unwished effects have been implemented; (cc) if safe use so requires maximum intake levels of a novel food as such or as part of another foodstuff or categories of foodstuffs will be laid down; (cd) cumulative effects of novel foods that are used in different foodstuffs of categories of foodstuffs have been assessed;
Amendment 122 #
Proposal for a regulation
Article 7 – paragraph 2 a (new)
Article 7 – paragraph 2 a (new)
2a. A post-marketing monitoring shall be required for all novel foods. All novel foods which have been allowed onto the market shall be reviewed once after 5 years and when more scientific evidence becomes available. In the monitoring, special attention should be paid to the categories of the population with the highest dietary intakes.
Amendment 123 #
Proposal for a regulation
Article 7 – paragraph 2 b (new)
Article 7 – paragraph 2 b (new)
2b. In case a novel food is a substance with a risk linked with consuming too much of it, it should get approval for use with maximum level in certain foods or food categories.
Amendment 131 #
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 143 #
Proposal for a regulation
Article 8 – paragraph 2
Article 8 – paragraph 2
2. The notification shall be accompanied by documented data demonstrating the history of safe food use in theany third country.
Amendment 146 #
Proposal for a regulation
Article 8 – paragraph 3 – subparagraph 2 a (new)
Article 8 – paragraph 3 – subparagraph 2 a (new)
Alternatively, the applicant may choose to withdraw the notification instead.
Amendment 154 #
Proposal for a regulation
Article 9
Article 9
Amendment 158 #
Proposal for a regulation
Article 10 – point (a)
Article 10 – point (a)
(a) compare, where appropriatto the extent that is possible, if the food is as safe as food from a comparable food category already on the market in the Community or as the food that the novel food is intended to replace, while also taking into account the implications of any new characteristics;
Amendment 166 #
Proposal for a regulation
Article 11 – paragraph 1
Article 11 – paragraph 1
1. The Commission mayshall impose for food safety reasons and following the opinion of the Authority, a requirement for post- market monitoring. The food business operators placing the food in the Community market shall be responsible for the implementation of the post-marketing requirements specified in the entry of the food concerned in the Community list of novel food. The monitoring shall take into account food safety aspects, the environmental impact if appropriate, animal health and welfare aspects if appropriate. All novel foods allowed on the market shall be reviewed once after five years.
Amendment 173 #
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 theunless 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 184 #
Proposal for a regulation
Article 12 a (new)
Article 12 a (new)
Amendment 185 #
Proposal for a regulation
Article 12 b (new)
Article 12 b (new)
Article 12b 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.
Amendment 189 #
Proposal for a regulation
Article 18
Article 18
1. Any request for placing a novel food on the market submitted to a Member State under Article 4 of Regulation (EC) No 258/97 and for which a final decision has not been taken before the date of application of this Regulation shall be considered as an application under this Regulation. 2. Any appropriate transitional measures for the application of paragraph 1, which are designed to amend non-essential elements of this Regulation, inter alia by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3).where the initial assessment report provided for under Article 6(3) of Regulation (EC) No 258/97 has not yet been forwarded to the Commission before the date of application of this Regulation shall be considered as an application under this Regulation. Other requests submitted under Article 3(4), 4 and 5 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. deleted