Activities of Renate SOMMER related to 2008/0002(COD)
Plenary speeches (1)
Novel foods (debate)
Amendments (19)
Amendment 52 #
Proposal for a regulation
Recital 6
Recital 6
(6) It should also be clarified that a food should be considered as novel and covered by this Regulation when it is applied a production technology which was not previously used. In particular, emerging technologies in breeding and food production processes, which have an impact on food and thus might have an impact on food safety, should be covered by this Regulation. Novel food should therefore include foods derived from plants and animals, produced by non- traditional breeding techniques, and foods modified by new production processes, such as nanotechnology and nanoscience, which might have an impact on foodaffects safety or nutrition. Food derived from new plant varieties, or animal breeds produced by traditional breeding techniques, should not be considered as novel foods.
Amendment 64 #
Proposal for a regulation
Recital 20
Recital 20
Under specific circumstances in order to stimulate research and development within the agri-food industry, and thus innovation, 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. 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. Data protection and confidentiality must be ensured as foreseen under Art 30 and 31 of Regulation (EC) No 1829/2003 on genetically modified food and feed.
Amendment 70 #
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 87 #
Proposal for a regulation
Article 3 – paragraph 2 - point (a) (i) – introduction
Article 3 – paragraph 2 - point (a) (i) – introduction
(i) food that has not been used for human consumption to a significant degre history of safe use within the Community before 15 May 1997;
Amendment 88 #
Proposal for a regulation
Article 3 – paragraph 2 - point (a) (ii)
Article 3 – paragraph 2 - point (a) (ii)
(ii) food of plant or animal origin when to the plant and animal is applied a non- traditionalew breeding technique not used before 15 May 1997; and which gives rise to significant changes in the composition or structure of the food which affect safety or nutrition.
Amendment 90 #
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 and which gives rise to significant changes in the composition or structure of the food which affect its nutritional value, metabolism or level of undesirable substancessafety or nutrition.
Amendment 92 #
Proposal for a regulation
Article 3 – paragraph 2 - point (b)
Article 3 – paragraph 2 - point (b)
(b) "traditional food from a third country" means novel food with a history of food use in a third country, meaning that the food in question has been and continues to be part of the normal diet for at least one generation30 years in a large part of the population of the country;
Amendment 93 #
Proposal for a regulation
Article 3 – paragraph 2 - point (c)
Article 3 – paragraph 2 - point (c)
(c) "history of safe food use" means that the safety of the food in question is confirmed with compositional data and from experience of use and continued use in the normalfor at least 30 years in the customary diet of a large part of the population of a country.
Amendment 100 #
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 operator through public consultations to determine to what extent a food has been used for human consumption within the Community before 15 May 1997. The Commission shall publish its conclusions drawn from this and other non-confidential data.
Amendment 118 #
Proposal for a regulation
Article 7
Article 7
Amendment 129 #
Council position – amending act
Recital 19 a (new)
Recital 19 a (new)
(19a) Ethical and environmental aspects must be considered as part of the risk management during the authorisation procedure. These aspects should be assessed by the European Group on Ethics in Science and New Technologies and the European Environment Agency respectively.
Amendment 137 #
Proposal for a regulation
Article 8 – title
Article 8 – title
Traditional food from a third country
Amendment 138 #
Council position – amending act
Article 8 – point c a (new)
Article 8 – point c a (new)
(ca) the opinion of the European Environment Agency, which shall be published no later than the day of the publication of the EFSA assessment, concerning the extent to which the production process and normal consumption have a harmful impact on the environment, is taken into account in the risk management;
Amendment 138 #
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. A food business operator intending to place a traditional food from the Community or a third country on the market in the Community shall notify it to the Commission, indicating the name of the food, its compositionharacteristics and country of origin. The notification shall be accompanied by documented data demonstrating the history of safe food use in the third country.
Amendment 139 #
Council position – amending act
Article 8 – point c b (new)
Article 8 – point c b (new)
(cb) the opinion of the European Group on Ethics in Science and New Technologies, which shall be published no later than the day of the publication of the EFSA assessment, concerning the extent to which there are ethical objections, is taken into account in the risk management;
Amendment 141 #
Council position – amending act
Article 8 – paragraph 1 a (new)
Article 8 – paragraph 1 a (new)
Foods to which production processes have been applied that require specific risk assessment methods (for example, foods containing engineered nanomaterials) may be included in the Union list provided that appropriate risk assessment methods are available and deemed suitable by EFSA to assess that the use of the food concerned is safe.
Amendment 148 #
Proposal for a regulation
Article 8 – paragraph 4 a (new)
Article 8 – paragraph 4 a (new)
4a. The entry of a novel food in the Community list shall comprise a specification of the food and, where appropriate, specification of the conditions of use, specific additional labelling requirements for the end user’s information and/or the requirement for monitoring after placing on the market.
Amendment 170 #
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. Data protection and confidentiality must be ensured as foreseen under Art 30 and 31 of Regulation (EC) No 1829/2003 on genetically modified food and feed.
Amendment 182 #
Proposal for a regulation
Article 12 a (new)
Article 12 a (new)
Article 12a 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