43 Amendments of Mireille D'ORNANO related to 2013/0435(COD)
Amendment 95 #
Proposal for a regulation
Recital 1
Recital 1
(1) The free movement of safe and wholesome food is an essential aspect of the internal market and contributes significantly to the health and well-being of citizens, as well as benefitting their social and economic interests. Differences between national laws concerning the safety assessment and authorisation of novel foods may hinder the free movement of such food, thereby creating unfair conditions of competitionfood must not have any a priori legitimacy, and the implementation of the internal market must be subordinate to a public health imperative which each country is free to define.
Amendment 99 #
Proposal for a regulation
Recital 3
Recital 3
(3) The Union’s rules on novel foods were established by Regulation (EC) No 258/97 of the European Parliament and of the Council8 and by Commission Regulation (EC) No 1852/20019. Those rules need to be updated to simplify the current authorisation procedures, improve consumer safety and to take account of recent developments in Union law. For the sake of clarity of Union legislation, Regulations (EC) No 258/97 and (EC) No 1852/2001 should be repealed and Regulation (EC) No 258/97 should be replaced by this Regulation. __________________ 8 Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (OJ L 43, 14.2.1997, p. 1). 9 Commission Regulation (EC) No 1852/2001 of 20 September 2001 laying down detailed rules for making certain information available to the public and for the protection of information submitted pursuant to European Parliament and Council Regulation (EC) No 258/97 (OJ L 253, 21.9.2001, p. 17).
Amendment 100 #
Proposal for a regulation
Recital 4
Recital 4
(4) Foods which are intended to be used for technological purposes and genetically modified food shouldmust not fall within the scope of this Regulation as they are already covered by other Union rules. Therefore, genetically modified food falling within the scope of Regulation (EC) No 1829/2003 of the European Parliament and of the Council10, enzymes falling within the scope of Regulation (EC) No 1332/2008 of the European Parliament and of the Council11, food used solely as additives falling within the scope of Regulation (EC) No 1333/2008 of the European Parliament and of the Council12, flavourings falling within the scope of Regulation (EC) No 1334/2008 of the European Parliament and of the Council13 and extraction solvents falling within the scope of Directive 2009/32/EC of the European Parliament and of the Council14 should be excluded from the scope of this Regulation. __________________ 10 Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (OJ L 268, 18.10.2003, p. 1). 11 Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes (OJ L 354, 31.12.2008, p. 7). 12 Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ L 354, 31.12.2008, p. 16). 13 Regulation (EC) No 1334 /2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods (OJ L 354, 31.12.2008, p. 34). 14 Directive 2009/32/EC of the European Parliament and of the Council of 23 April 2009 on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients (recast) (OJ L 141, 6.6.2009, p. 3).
Amendment 108 #
Proposal for a regulation
Recital 5
Recital 5
(5) The existing categories of novel food laid down 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. The categories to be defined should take into account the possibilities of technological innovation to ensure that such innovations, even disruptive innovations, follow the same authorisation procedures. __________________ 15 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 118 #
Proposal for a regulation
Recital 8
Recital 8
(8) Vitamins, minerals and other substances intended to be used in food supplements or to be added to food including infant formula and follow-on formulae, processed cereal-based food and baby food for infants and young children, food for special medical purposes, and total diet replacement for weight control are subject to the rules provided for in Directive 2002/46/EC of the European Parliament and of the Council17, in Regulation (EC) No 1925/2006 of the European Parliament and of the Council18 and in Regulation (EU) No 609/2013 of the European Parliament and of the Council19. Those substances should also be assessed in accordance with the rules laid down in this Regulation when they fall within the definition of novel food laid down in this Regulation. Infant formula and follow-on formula, processed cereal-based food and baby food for infants and young children and food for special medical purposes shall be subject to special rules in view of the particular fragility of the consumers concerned. __________________ 17 Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51). 18 Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods (OJ L 404, 30.12.2006, p. 26). 19 Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35).
Amendment 124 #
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 thirrestricted and 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 large 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 dietsols on these foods enhanced, even where the history of safe food use in a third country has been demonstrated.
Amendment 131 #
Proposal for a regulation
Recital 12
Recital 12
(12) It should be clarified that foods from third countries which are regarded as novel foods in the Union should only be considered as traditional foods from third countries when they are derived from primary production as defined in Article 3 of Regulation (EC) No 178/2002, regardless of whether or not they are processed or unprocessed foods. Therefore, where a new production process has been applied to this foodcess which had not previously been used for this type of food is applied to it or where the food contains or consists of ‘engineered nanomaterials’ as defined in Article 2(2)(t) of Regulation (EU) No 1169/2011, the food should not be considered to be traditional.
Amendment 145 #
Proposal for a regulation
Recital 18
Recital 18
(18) Novel foods should not be placed on the market or used in food for human consumption unless they are included in a Union list of novel foods authorised to be placed on the market within the Union (‘the Union list’). Therefore, it is appropriate to establish, by means of an implementing act, a Union list of novel foods by entering novel foods already authorised or notified in accordance with Article 4, 5 or 7 of Regulation (EC) No 258/97 in the Union list, including any existing authorisation conditions. As those novel foods have already been evaluated for their safety, have been legally produced and marketed in the Union and have not given rise to health concerns in the past, the advisory procedure should be used for the initial establishment of the Union list. This list must be approved by each Member State and any harmonisation of legislation based on this Regulation should be subject to the provisions of Article 114(4) TFEU. The list must be transparent, easily accessible and regularly updated.
Amendment 151 #
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 procedure should be put in place. As regards traditional foods from third countries having a history of safe use it is appropriate to provide for a faster and simplifiedmore rigorous procedure to update the Union list if 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 conferredEach Member State must issue a favourable opinion on the updating of the Union list for a food from a third country. In the case of an unfavourable opinion, the Member State may decide whether or not to allow the free movement in its territory onf the Commission in that respectfood from a third country.
Amendment 167 #
Proposal for a regulation
Recital 23
Recital 23
(23) Under specific circumstances, in order to stimulate research and development within the agri-food industry, and thus innovation, it is appropriate to protect the investment made by innovators in gathering the information and data provided in support of an application for a novel food made in accordance with this Regulation. The newly developed scientific evidence and proprietary data provided in support of an application for inclusion of a novel food in the Union list should be protected. Those data and information should, for a limited period of time, not be used to the benefit of a subsequent applicant, without the agreement of the prior applicant. The protection of scientific data provided by one applicant should not prevent other applicants from seeking the inclusion in the Union list on the basis of their own scientific data or by referring to the protected datathose of an initial applicant, with the agreement of the prior applicantlatter. However, the overall five year period of data protection which has been granted to the prior applicant should not be extended due to the granting of data protection to subsequent applicants.
Amendment 174 #
Proposal for a regulation
Recital 27
Recital 27
Amendment 179 #
Proposal for a regulation
Recital 28
Recital 28
Amendment 186 #
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
1. This Regulation lays down rules for the placing of novel foods on the market within the Union in order to ensure the effective functioning of the internal market while providing a high level of protection of human health, animals and consumer interests. The following provisions should apply to products intended for human consumption and for consumption by animals, whether livestock or pets.
Amendment 195 #
Proposal for a regulation
Article 1 – paragraph 2 – point c a (new)
Article 1 – paragraph 2 – point c a (new)
(ca) food which consists of engineered nanomaterials, including vitamins and minerals where these products consist of engineered nanomaterials.
Amendment 243 #
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 yearssince 1989 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 250 #
Proposal for a regulation
Article 3 – title
Article 3 – title
Amendment 253 #
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
In order to ensure the uniform implementation of this Regulation, the Commission may decide, by means of implementing acts,at national food specificities are respected, the Commission shall submit requests for authorisation or updating of the Union list to the Member States, with the aim of jointly determining whether or not a particular food falls within the definition of novel food, as laid down in Article 2(2)(a).
Amendment 256 #
Proposal for a regulation
Article 3 – paragraph 2
Article 3 – paragraph 2
Amendment 265 #
Proposal for a regulation
Article 4 – paragraph 3 – subparagraph 1
Article 4 – paragraph 3 – subparagraph 1
The Commission may, by means of implementingdelegated acts, specify the procedural steps of the consultation process provided for in paragraph 2.
Amendment 270 #
Proposal for a regulation
Article 4 – paragraph 3 – subparagraph 2
Article 4 – paragraph 3 – subparagraph 2
Those implementingdelegated acts shall be adopted in accordance with the examination procedure referred to in Article 27(3).
Amendment 276 #
Proposal for a regulation
Article 5 – paragraph 2 a (new)
Article 5 – paragraph 2 a (new)
2a. The Union list shall be made available to the public 12 months after this Regulation enters into force. The Union list shall be published on the Commission website and in the Official Journal of the European Union.
Amendment 285 #
Proposal for a regulation
Article 6 – paragraph 1 – point c
Article 6 – paragraph 1 – point c
(c) where it is intended to replace another food, it does not differ from that food in such a way that its normal consumption would be nutritionally disadvantageous for the consumer. In the case of diverging opinions among the scientific studies referred to in point (a), a conclusion shall be drawn taking into account the opinion of the EFSA.
Amendment 292 #
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
No later than …2312 months after the entry into force of this Regulation, 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 conditions. __________________ 23 Publications Office: please insert date: 24 months after the date of entry into force of this Regulation.
Amendment 295 #
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
No later than … 23 the Commission shall, by means of an implementing delegated 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 conditions, subject to objections from a Member State. __________________ 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 7 – paragraph 2
Article 7 – paragraph 2
That implementingdelegated act shall be adopted in accordance with the advisory procedure referred to in Article 27(2).
Amendment 324 #
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 – points d a to d i (new)
Article 9 – paragraph 1 – subparagraph 2 – points d a to d i (new)
(da) the adverse effects and health incidents already identified by the health authorities concerning this novel food, specifying the date, the number and type of people affected and their symptoms; (db) the allergenic potential, with particular regard to the molecular structure of the novel food; (dc) the target population of the novel food, specifying, in particular, whether it might be consumed by children; (dd) contraindications and restrictions, with reasons; (de) the current state of the category into which the novel food falls, specifying in particular the products used until now and their faults and advantages for the sector and for consumers; (df) the advantages of the novel food, particularly for consumers; (dg) where the novel food is an ingredient, the preparations in which it may be incorporated and its interactions with the other ingredients of these preparations; (dh) the possibility of obtaining this novel food through an ‘organic’ process; (di) unfavourable scientific data concerning the novel food, where such data exists.
Amendment 334 #
Proposal for a regulation
Article 9 – paragraph 3
Article 9 – paragraph 3
3. The procedure for authorising the placing on the market within the Union of a novel food and updating the Union list as provided for in Article 8 shall end with the adoption of an implementing delegated act in accordance with Article 11.
Amendment 349 #
Proposal for a regulation
Article 10 – paragraph 1 – subparagraph 2 – point b d (new)
Article 10 – paragraph 1 – subparagraph 2 – point b d (new)
(bd) whether a novel food, which is intended to replace another food, does not differ from that food in such a way that its normal consumption would be nutritionally disadvantageous for the consumer.
Amendment 361 #
Proposal for a regulation
Article 11 – paragraph 1 – subparagraph 2
Article 11 – paragraph 1 – subparagraph 2
That implementingdelegated act shall be adopted in accordance with the examination procedure referred to in Article 27(3).
Amendment 364 #
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
Amendment 381 #
Proposal for a regulation
Article 13 – paragraph 2 – point e
Article 13 – paragraph 2 – point e
(e) where applicable, the conditions of use and specific labelling requirements, which do not mislead the consumer.
Amendment 384 #
Proposal for a regulation
Article 13 – paragraph 2 – points e a and e b (new)
Article 13 – paragraph 2 – points e a and e b (new)
(ea) the adverse effects and health incidents already identified by the health authorities concerning this traditional food, specifying the date, the number and type of people affected and the symptoms; (eb) the allergenic potential, with particular regard to the molecular structure of the traditional food and existing data;
Amendment 389 #
Proposal for a regulation
Article 14 – paragraph 4
Article 14 – paragraph 4
4. Where no reasoned safety objections are made in accordance with paragraph 2all Member States and the EFSA have approved the application submitted with the notification, within the time-limit laid down in that paragraph 2, 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 397 #
Proposal for a regulation
Article 16 – paragraph 2 – point a
Article 16 – paragraph 2 – point a
(a) whether the history of safe food use ifood has been attested by the EFSA, in terms of its composition and third countrye conditions of its substantiated by reliable data submitted by the applicant in accordance with Articles 13 and 15use, as safe for human health and the environment;
Amendment 401 #
Proposal for a regulation
Article 16 – paragraph 2 – point b
Article 16 – paragraph 2 – point b
Amendment 412 #
Proposal for a regulation
Article 17 – paragraph 1 – subparagraph 1 – introductory part
Article 17 – paragraph 1 – subparagraph 1 – introductory part
Within three months of the date of publication of EFSA's opinion, the Commission shall submit to the Committee referred to in Article 27(1) a draft implementingdelegated act to authorise the placing on the market within the Union of the traditional food from a third country and to update the Union list, taking into account the following:
Amendment 418 #
Proposal for a regulation
Article 19 – title
Article 19 – title
Amendment 419 #
Proposal for a regulation
Article 19 – paragraph 1 – introductory part
Article 19 – paragraph 1 – introductory part
By ...…25 the Commission shall adopt implementingdelegated acts concerning: __________________ 25 Publications Office: please insert date: 24 months after the date of entry into force of this Regulation.
Amendment 424 #
Proposal for a regulation
Article 19 – paragraph 2
Article 19 – paragraph 2
Those implementingdelegated acts shall be adopted in accordance with the examination procedure referred to in Article 27(3).
Amendment 431 #
Proposal for a regulation
Article 22 – paragraph 4 – subparagraph 2 – point e
Article 22 – paragraph 4 – subparagraph 2 – point e
(e) wthe re applicable, the analysis method(s)sults of studies carried out to demonstrate the safety of the novel food.
Amendment 433 #
Proposal for a regulation
Article 22 – paragraph 4 – subparagraph 2 – points e a to e d (new)
Article 22 – paragraph 4 – subparagraph 2 – points e a to e d (new)
(ea) known risks and restrictions on use; (eb) the methods of analysis; (ec) the scientific literature on which the opinion is based; (ed) toxicological data.
Amendment 439 #
6. Where an applicant withdraws, or has withdrawn, its application, the Commission, the Member States and EFSA shall not disclose confidential information, including information the confidentiality of which is the subject of disagreement between the Commission and the applicantother than that used to demonstrate the safety of the novel food.
Amendment 448 #
Proposal for a regulation
Article 23 – paragraph 2 – point b
Article 23 – paragraph 2 – point b
(b) any prohibition or restriction based on scientific data and imposed by anyin a third country in which the novel food is placed on the market. On the basis of this information, the EFSA opinion shall be updated within six months, taking into account the scientific data used to impose the prohibition or restriction.