Activities of Angélique DELAHAYE related to 2013/0435(COD)
Plenary speeches (1)
Novel foods (A8-0046/2014 - James Nicholson) FR
Shadow opinions (1)
OPINION on the proposal for a regulation of the European Parliament and of the Council on novel foods
Amendments (35)
Amendment 60 #
Proposal for a regulation
Recital 11
Recital 11
(11) The placing on the market within the Union of traditional foods from third countries should be facilitated, where the history of safe food use in a third country has been demonstrated. Those foods should have been consumed in a third country for at least 25 years as a part of the customary diet within a largesignificant part of the population of the country. The history of safe food use should not include non-food uses or uses not related to normal diets.
Amendment 61 #
Proposal for a regulation
Recital 11 a (new)
Recital 11 a (new)
(11a) The determination of whether or not consumption of a food by the population of a third country is significant should be based on information supplied by food business operators and, where appropriate, backed up by other information available in the third country. When there is insufficient information on human consumption of a food, a simple and transparent procedure involving the Commission, the EFSA and food business operators should be established for collecting such information. Implementing powers should be conferred on the Commission to specify the procedural steps in such a consultation process.
Amendment 106 #
Proposal for a regulation
Recital 5
Recital 5
(5) The existing categories of novel food laid downisted in Article 1 of Regulation (EC) No 258/97 should be clarified and updated by replacing the existing categories with a reference to the general definition of food provided for in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council15. __________________ 15 Before the date of application of this Regulation, the Commission should adopt guidance, after consulting the stakeholders, on the categories of novel foods which would assist the applicants and Member States in understanding whether a food falls within the scope of this Regulation and into which category of novel food a food falls. __________________ 15 Regulation (EC) No 178/2002 of the Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).
Amendment 116 #
Proposal for a regulation
Article 2 – paragraph 2 – point a – introductory part
Article 2 – paragraph 2 – point a – introductory part
(a) " novel food " means all food that was not used for human consumption to a significant degree within the Union before 15 May 1997 irrespective of the date of accession of the various Member States to the Union and includes in particularthat falls into at least one of the following categories:
Amendment 121 #
Proposal for a regulation
Article 2 – paragraph 2 – point a – point -i (new)
Article 2 – paragraph 2 – point a – point -i (new)
(-i) food with a new or intentionally modified molecular structure;
Amendment 122 #
Proposal for a regulation
Article 2 – paragraph 2 – point a – point -i a (new)
Article 2 – paragraph 2 – point a – point -i a (new)
(-ia) food containing, consisting of or produced from micro-organisms, fungi, algae and other materials of biological or mineral origin;
Amendment 123 #
Proposal for a regulation
Article 2 – paragraph 2 – point a – point -i b (new)
Article 2 – paragraph 2 – point a – point -i b (new)
Amendment 124 #
Proposal for a regulation
Article 2 – paragraph 2 – point a – point -i c (new)
Article 2 – paragraph 2 – point a – point -i c (new)
(-ic) food containing, consisting of or produced from animals or parts of animals, with the exception of animals that have been reared using traditional rearing methods and have a proven history of safe food use on the Union market;
Amendment 126 #
Proposal for a regulation
Article 2 – paragraph 2 – point a – point i
Article 2 – paragraph 2 – point a – point i
(i) food to whichresulting from a new production process not used for food production within the Union before 15 May 1997 is applied, where that production processwhich gives rise to significant changes in the composition or structure of the food which affect its nutritional value, the way it is metabolised or the level of undesirable substances;
Amendment 129 #
Proposal for a regulation
Recital 11 a (new)
Recital 11 a (new)
(11a) The determination as to whether or not a food was consumed by the population of a third country to a significant degree should be based on information provided by food business operators and, where appropriate, supported by other information available in the third countries. Where there is insufficient information on human consumption of a food, a simple and transparent procedure involving the Commission, the EFSA and food business operators should be established to collect such information. Implementing powers should be conferred on the Commission to set out in detail the procedural stages of that consultation process.
Amendment 136 #
Proposal for a regulation
Article 2 – paragraph 2 – point a – point iii – indent 1
Article 2 – paragraph 2 – point a – point iii – indent 1
– a new production process has been applied as referred to in point (i) of this paragraphnot used for food production in the Union before 15 May 1997 has been applied; or
Amendment 140 #
Proposal for a regulation
Recital 16
Recital 16
Amendment 141 #
Proposal for a regulation
Article 2 – paragraph 2 – point c
Article 2 – paragraph 2 – point c
(c) "history of safe food use in a third country" means that the safety of the food in question has been confirmed with compositional data and from experience of continued use for at least 25 years in the customary diet of a largesignificant part of the population of a third country, prior to a notification referred to in Article 13;
Amendment 154 #
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
2. Food business operators shall consult a Member State where they are unsure whether or not a food which they intend to place on the market within the Union falls within the scope of this Regulation. In that case, fFood business operators shall provide the necessary information to the Member State on request to enable it to determine in particular the extent to which the food in question was used for human consumption within the Union before 15 May 1997whether or not a food comes within the scope of this Regulation.
Amendment 190 #
Proposal for a regulation
Article 8 – paragraph 2 – point c
Article 8 – paragraph 2 – point c
(c) adding, removing or changing the conditions, specifications or restrictionspecifications, conditions of use, additional specific labelling requirements or post-market monitoring requirements associated with the inclusion of a novel food on the Union list.
Amendment 207 #
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 1
Article 9 – paragraph 1 – subparagraph 1
The procedure for authorising the placing on the market within the Union of a novel food and updating of the Union list provided for in Article 8 shall start either on the Commission's initiative or following an application to the Commission by an applicant. The Commission should allow Member States to have sight of the application.
Amendment 208 #
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 – point -a (new)
Article 9 – paragraph 1 – subparagraph 2 – point -a (new)
-a) the name and address of the applicant;
Amendment 222 #
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. The Commission mayshall request EFSA to render its opinion if the update is liable to have an effect on human health.
Amendment 251 #
Proposal for a regulation
Article 13 – paragraph 2 – point -a (new)
Article 13 – paragraph 2 – point -a (new)
-a) the name and address of the applicant;
Amendment 258 #
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
1. The Commission shall forward the valid notification provided for in Article 13 without delayin one month to the Member States and to EFSA.
Amendment 259 #
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
Amendment 263 #
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
2. Food business operators shall consult a Member State where they are unsure whether or not a food which they intend to place on the market within the Union falls within the scope of this Regulation. In that case, fFood business operators shall provide the necessary information to the Member State on request to enable it to determine in particular the extent to which the food in question was used for human consumption within the Union before 15 May 1997whether or not a food comes within the scope of this Regulation.
Amendment 265 #
Proposal for a regulation
Article 14 – paragraph 4
Article 14 – paragraph 4
4. Where no reasoned safety objections are made in accordance with paragraph 2 within the time-limit laid down in that paragraph, the Commission shall authorise the placing on the market within the Union of the traditional food concerned and update without delay the Union list within one month.
Amendment 269 #
Proposal for a regulation
Article 16 – paragraph 2 – point b a (new)
Article 16 – paragraph 2 – point b a (new)
(ba) whether the novel food meant to replace another food does not have different properties that result in nutritional disadvantages for the consumer;
Amendment 275 #
Proposal for a regulation
Article 18
Article 18
Amendment 294 #
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
No later than … 23 the Commission shall, by means of an implementing act, establish the Union list by entering novel foods authorised or notified under Articles 4, 5 or 7 of Regulation (EC) N° 258/97 in the Union list, including any existing authorisation conditionsthe authorisation conditions, the date of authorisation and the name and address of the applicant. __________________ 23 Publications Office: please insert date: 24 months after the date of entry into force of this Regulation.
Amendment 298 #
Proposal for a regulation
Article 27 – paragraph 2 – subparagraph 2
Article 27 – paragraph 2 – subparagraph 2
Where the opinion of the committee is to be obtained by written procedure, that procedure shall be terminated without result whenif, within the time-limit for delivery of the opinionsix months, the chair of the committee so decides or a simple majority of committee members so request.
Amendment 301 #
Proposal for a regulation
Article 27 – paragraph 3 – subparagraph 2
Article 27 – paragraph 3 – subparagraph 2
Where the opinion of the committee is to be obtained by written procedure, that procedure shall be terminated without result whenif, within the time-limit for delivery of the opinionsix months, the chair of the committee so decides or a simple majority of committee members so request.
Amendment 404 #
Proposal for a regulation
Article 16 – paragraph 2 – point b a (new)
Article 16 – paragraph 2 – point b a (new)
(ba) whether the novel food meant to replace another food does not have different properties that result in nutritional disadvantages for the consumer;
Amendment 447 #
Proposal for a regulation
Article 23 – paragraph 2 – introductory part
Article 23 – paragraph 2 – introductory part
Amendment 451 #
Proposal for a regulation
Article 24 – paragraph 1
Article 24 – paragraph 1
1. On request by the applicant, supported by appropriate and verifiable information included in the application provided for in Article 9(1), newly developed scientific evidence or scientific data supporting the application may not be used for the benefit of a subsequent application during a period of five10 years from the date of the authorisation and the inclusion of the novel food in the Union list without the agreement of the prior applicant.
Amendment 456 #
Proposal for a regulation
Article 24 – paragraph 2 – subparagraph 1 – point b
Article 24 – paragraph 2 – subparagraph 1 – point b
(b) the prior applicant had exclusive right of reference to the proprietary scientific evidence or scientific data at the time the first application was made, whether or not the data was published, and
Amendment 469 #
Proposal for a regulation
Article 27 – paragraph 2 – subparagraph 2
Article 27 – paragraph 2 – subparagraph 2
Where the opinion of the committee is to be obtained by written procedure, that procedure shall be terminated without result whenif, within the time-limit for delivery of the opinionsix months, the chair of the committee so decides or a simple majority of committee members so request.
Amendment 474 #
Proposal for a regulation
Article 27 – paragraph 3 – subparagraph 2
Article 27 – paragraph 3 – subparagraph 2
Where the opinion of the committee is to be obtained by written procedure, that procedure shall be terminated without result whenif, within the time-limit for delivery of the opinionsix months, the chair of the committee so decides or a simple majority of committee members so request.
Amendment 481 #
Proposal for a regulation
Article 29 – paragraph 3 a (new)
Article 29 – paragraph 3 a (new)
3a. Where a novel food authorised under Article 4 of Regulation (EC) No 258/97 is included on the Union list in accordance with Article 7, the marketing of that novel food in the Union shall be granted exclusively to the applicant for a period of 10 years from the date of authorisation, unless a subsequent applicant obtains an authorisation for that novel food.