18 Amendments of Elisabetta GARDINI related to 2013/0435(COD)
Amendment 112 #
Proposal for a regulation
Recital 7
Recital 7
(7) Emerging technologies in food production processes may have an impact on food and thereby on food safety. Therefore, it should also be clarifiedthis Regulation should further specify that a food should be considered as a novel food where a production process which was not previously used for food production in the Union and which results in differences in the structure, composition and nutritional properties of the finished product is applied to that food or when foodproducts contain or consist of engineered nanomaterials, as defined in Article 2(2)(t) of Regulation (EU) No 1169/2011 of the European Parliament and of the Council16. __________________ 16 Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulation (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directive 2002/67/EC and 2008/5/EC and Commission Regulation (EC No 608/2004 (OJ L 304, 22.11.2011, p. 18).
Amendment 142 #
Proposal for a regulation
Recital 17
Recital 17
(17) Novel foods should be authorised and used only if they fulfil the criteria laid down in this Regulation. Novel foods should be safe and their use should not mislead the consumer. Therefore, where a novel food is intended to replace another food, it should not differ from that food in a way that would be nutritionally less advantageous for the consumer.
Amendment 153 #
Proposal for a regulation
Recital 19
Recital 19
(19) It is appropriate to authorise a novel food by updating the Union list subject to the criteria and the procedures laid down in this Regulation. A procedure that is efficient, time-limited and transparent should be put in place. As regards traditional foods from third countries having a history of safe use it is appropriate to providethe applicants should be able to opt for a faster and simplified procedure to update the Union list if, so as to ensure that access times are similar to those for similar EU products. That procedure should be authorised in cases where no reasoned safety objections are expressed. As the updating of the Union list implies the application of criteria laid down in this Regulation, implementing powers should be conferred on the Commission in that respect.
Amendment 196 #
Proposal for a regulation
Article 1 – paragraph 2 a (new)
Article 1 – paragraph 2 a (new)
Amendment 197 #
Proposal for a regulation
Article 2 – paragraph 2 – point a – introductory part
Article 2 – paragraph 2 – point a – introductory part
(a) ‘"novel food’" means allny 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 under at least one of the following categories:
Amendment 211 #
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) foods and food ingredients with a new or intentionally modified primary molecular structure;
Amendment 216 #
Proposal for a regulation
Article 2 – paragraph 2 – point a – point i h (new)
Article 2 – paragraph 2 – point a – point i h (new)
(ih) foods and food ingredients consisting of or isolated from microorganisms, fungi or algae;
Amendment 219 #
Proposal for a regulation
Article 2 – paragraph 2 – point a – point i k (new)
Article 2 – paragraph 2 – point a – point i k (new)
(ik) foods and food ingredients consisting of or isolated from plants and food ingredients isolated from animals, except for foods and food ingredients obtained by traditional propagating or breeding practices and having a history of safe food use;
Amendment 237 #
Proposal for a regulation
Article 2 – paragraph 2 – point a – point iv d (new)
Article 2 – paragraph 2 – point a – point iv d (new)
(ivd) food containing, consisting of, or obtained from cellular or tissue cultures;
Amendment 326 #
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. TWithin one month of receiving an application, the Commission mayshall request that EFSA to renders its opinion if the update is liable to have an effect on human healthto the Union list is liable to pose a safety risk to human health and the environment.
Amendment 331 #
Proposal for a regulation
Article 9 – paragraph 2 a (new)
Article 9 – paragraph 2 a (new)
2a. The Commission shall acknowledge receipt of the application to the applicant within 15 days of receiving the application. Within one month after reception of the application, the Commission shall verify the validity of the application. Where the application has not been considered as valid, the Commission shall inform the applicant thereof, specifying the reasons and stop the procedure.
Amendment 340 #
Proposal for a regulation
Article 10 – paragraph 1 – subparagraph 1
Article 10 – paragraph 1 – subparagraph 1
Where the Commission requests an opinion from EFSA, it shall forward the valid application to EFSA. EFSA shall adopt its opinion within ninesix months from the date of receipt of a valid application.
Amendment 355 #
Proposal for a regulation
Article 11 – paragraph 1 – subparagraph 1 – introductory part
Article 11 – paragraph 1 – subparagraph 1 – introductory part
Within ninesix months from the date of publication of EFSA's opinion, the Commission shall submit to the committee referred to in Article 27(1) a draft implementing act updating the Union list taking account of:
Amendment 368 #
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
2. Where the Commission has not requested an opinion from EFSA in accordance with Article 9(2), the ninesix- month period provided for in paragraph 1 shall start from the date on which the Commission received a valid application in accordance with Article 9(1).
Amendment 428 #
Proposal for a regulation
Article 21 a (new)
Article 21 a (new)
Article 21a Alignment of time periods with Regulation (EC) 1924/2006 If the applicant requests data protection in accordance with Article 24 of this Regulation and Article 21 of Regulation (EC) 1924/2006, the Commission may adjust the time periods provided for in Articles 10(1), 11(1) or (2), 16(1) and 17(1) in order to align them with those in Regulation (EC) 1924/2006 so that the two periods of data protection run concurrently. In such cases the applicant shall be consulted before the Commission takes a decision on the alignment. In addition to this alignment of intellectual property protection periods, health claim and novel food evaluation and authorisation procedures should, where possible, also be synchronised, with a view to ensuring that the market in such products operates smoothly and applicants are afforded proper protection.
Amendment 454 #
Proposal for a regulation
Article 24 – paragraph 2 – subparagraph 1 – point a
Article 24 – paragraph 2 – subparagraph 1 – point a
(a) the newly developed scientific evidence or scientific data was designated as proprietary by the priorinitial applicant at the time the first application was made, regardless of whether the data has been published in a scientific journal and without there being an obligation for that data to be forwarded immediately to the regulatory authorities;
Amendment 455 #
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 tocan demonstrate ownership of the proprietary scientific evidence or scientific data, by means of verifiable proof at the time the first application was made and
Amendment 471 #
Proposal for a regulation
Article 27 – paragraph 3 – subparagraph 1
Article 27 – paragraph 3 – subparagraph 1
Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. The committee shall deliver its opinion within six months after adoption of the proposal referred to in Articles 11(1) and 17(1).