52 Amendments of Eleonora EVI related to 2013/0435(COD)
Amendment 101 #
Proposal for a regulation
Recital 4
Recital 4
(4) Foods which are intended to be used for technological purposes and genetically modified food should 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 and Directive 2001/18/EC, 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 1333/200812 of the European Parliament and of the Council, 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 116 #
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 clarified 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 is applied to that food or when foods 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, which account for not less than 10% of the food by weight or volume, as calculated by adding together the percentages present in the individual ingredients. __________________ 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 126 #
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 250 years as a part of the customary diet within a large partof the majority 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 134 #
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 food or where the food contains or consists of ‘engineered nanomaterials’, as defined in Article 2(2)(t) of Regulation (EU) No 1169/2011, which account for not less than 10% of the food by weight or volume, as calculated by adding together the percentages present in the individual ingredients, the food should not be considered to be traditional.
Amendment 139 #
Proposal for a regulation
Recital 16
Recital 16
(16) The determination of whether a food was used for human consumption to a significant degree within the Union before 15 May 1997 should be based on information submitted by food business operators and, where appropriate, supported by other by information available in the Member States. Food business operators should consult Member States if they are unsure of the status of the food they intend to place on the market. When there is no information or insufficient information available on human consumption before 15 May 1997, a simple and transparent procedure, involving the Commission, the Member States and food business operators, should be established for collecting such information. Implementing powers should be conferred on the Commission to specify the procedural steps of such consultation processthe food in question must be considered as a novel food.
Amendment 154 #
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 provide for a faster and simplified procedure to update the Union list on a case-by-case basis 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 conferred on the Commission in that respect.
Amendment 156 #
Proposal for a regulation
Recital 20
Recital 20
(20) Criteria for the evaluation of the safety risks arising from novel foods should also be laid down. In order to ensure the harmonised scientific assessment of novel foods, such assessments should be carried out under a transparent and inclusive procedure by the European Food Safety Authority (‘EFSA’), in consultation with Member State health authorities, after stakeholder groups have been consulted.
Amendment 161 #
Proposal for a regulation
Recital 21
Recital 21
(21) As regards the possible use of nanomaterials for food use, EFSA considered in its opinion of 6 April 201121 on Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain that limited information is available in relation to aspects of nanotoxicokinetics and toxicology of engineered nanomaterials and that existing toxicity testing methods may need methodological modifications. In order to better assess the safety of nanomaterials for food use, the Commission is developing test methods which take into account specific characteristics of engineered nanomaterials. __________________ 21In view of the current gaps in toxicological knowledge and measurement methodologies, the precautionary principle should be applied in order to restrict human exposure to nanomaterials. __________________ 21 EFSA Journal 2011; 9(5):2140. EFSA Journal 2011; 9(5):2140.
Amendment 176 #
Proposal for a regulation
Recital 27
Recital 27
(27) In order to ensure uniform conditions for the implementation of this Regulation with regard to updating the Union list concerning the adding of a traditional food from a third country where no reasoned safety objections have been expressed, implementing powers should be conferred on the Commission.
Amendment 191 #
Proposal for a regulation
Article 1 – paragraph 2 – point a
Article 1 – paragraph 2 – point a
(a) genetically modified foods falling within the scope of Regulation (EC) No 1829/2003 and Directive 2001/18/EC;
Amendment 207 #
Proposal for a regulation
Article 2 – paragraph 2 – point a – point i
Article 2 – paragraph 2 – point a – point i
i) food to which a new production process not used for food production within the Union before 15 May 1997 is applied, where that production process 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 levelpresence of undesirable substances;
Amendment 227 #
Proposal for a regulation
Article 2 – paragraph 2 – point a – point ii
Article 2 – paragraph 2 – point a – point ii
ii) food containing or consisting of "engineered nanomaterials", as defined in Article 2(2)(t) of Regulation (EU) No 1169/2011, which account for not less than 10% of the food by weight or volume, as calculated by adding together the percentages present in the individual ingredients;
Amendment 244 #
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 250 years in the customary diet of a large partthe majority of the population of a third country, prior to a notification referred to in Article 13;
Amendment 264 #
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, food 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 1997.
Amendment 274 #
1. The Commission shall establish and update a Union list of novel foods authorised to be placed on the market within the Union in accordance with Articles 6, 7 and 8 ("the Union list"). That list, together with the reasons for the relevant decisions, shall be freely available to the public for consultation.
Amendment 280 #
Proposal for a regulation
Article 6 – paragraph 1 – point a
Article 6 – paragraph 1 – point a
a) it does not, on the basis of the scientific evidence available, pose a safety risk to human health;
Amendment 286 #
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 differs from that food in such a way that its normal consumption would be nutritionally disadvantageous for the consumer in nutritional, health, environmental and social terms.
Amendment 296 #
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 public 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 OJ: please insert date: 24 months after the entry into force of this Regulation.
Amendment 301 #
Proposal for a regulation
Article 8 – paragraph 1 – introductory part
Article 8 – paragraph 1 – introductory part
1. The Commission shall authorise a novel food and update the Union public list in accordance with the rules laid down in:
Amendment 302 #
Proposal for a regulation
Article 8 – paragraph 2 – introductory part
Article 8 – paragraph 2 – introductory part
2. The authorisation of a novel food and updating of the Union public list provided for in paragraph 1 shall consist of one of the following:
Amendment 303 #
Proposal for a regulation
Article 8 – paragraph 2 – point a
Article 8 – paragraph 2 – point a
a) adding a novel food to the Union public list;
Amendment 304 #
Proposal for a regulation
Article 8 – paragraph 2 – point b
Article 8 – paragraph 2 – point b
b) removing a novel food from the Union public list;
Amendment 306 #
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 restrictions associated with the inclusion of a novel food on the Union list.public list. (This amendment applies to the text as a whole. If it is adopted, corresponding changes will need to be made throughout.)
Amendment 308 #
Proposal for a regulation
Article 8 – paragraph 3 – introductory part
Article 8 – paragraph 3 – introductory part
3. The entry for a novel food in the Union list provided for in paragraph 2 shall include where relevant:
Amendment 312 #
Proposal for a regulation
Article 8 – paragraph 3 – point b
Article 8 – paragraph 3 – point b
Amendment 321 #
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 – point b
Article 9 – paragraph 1 – subparagraph 2 – point b
b) the detailed chemical composition of the novel food;
Amendment 322 #
c) scientific evidence demonstrating that the novel food does not pose a safety risk to human health or the environment;
Amendment 338 #
Proposal for a regulation
Article 9 – paragraph 4 – subparagraph 2
Article 9 – paragraph 4 – subparagraph 2
Amendment 342 #
Proposal for a regulation
Article 10 – paragraph 1 – subparagraph 2 – introductory part
Article 10 – paragraph 1 – subparagraph 2 – introductory part
In assessing the safety of novel foods, EFSA shall, where appropriate, consider the following:
Amendment 350 #
Proposal for a regulation
Article 10 – paragraph 4
Article 10 – paragraph 4
4. Where the additional information referred to in paragraph 3 is not sentprovided to EFSA within the additional period referred to in that paragraph, it shall finalise its opinion on the basis of the information already provided to itsuspend the evaluation procedure.
Amendment 352 #
Proposal for a regulation
Article 10 – paragraph 5 – subparagraph 1
Article 10 – paragraph 5 – subparagraph 1
Where applicants submit additional information on their own initiative, they shall send it to the Commission, to the Member States and to EFSA.
Amendment 376 #
Proposal for a regulation
Article 13 – paragraph 2 – point b
Article 13 – paragraph 2 – point b
b) its detailed chemical composition;
Amendment 379 #
Proposal for a regulation
Article 13 – paragraph 2 – point d
Article 13 – paragraph 2 – point d
d) documented scientific data demonstrating the history of safe food use in a third country;
Amendment 386 #
Proposal for a regulation
Article 14 – paragraph 2
Article 14 – paragraph 2
2. Within four months from the date on which the valid notification is forwarded by the Commission in accordance with paragraph 1, a Member State or EFSA may submit to the Commission rheasoned safetylth safety and environmental and social impact objections, based on scientific evidencedata, to the placing on the market within the Union of the traditional food concerned.
Amendment 393 #
Proposal for a regulation
Article 14 – paragraph 5 – subparagraph 1
Article 14 – paragraph 5 – subparagraph 1
Where reasoned safety or environmental and social impact objections, based on scientific evidencedata, are submitted to the Commission in accordance with paragraph 2, the Commission shall not authorise the placing on the market of the traditional food concerned nor update the Union list.
Amendment 395 #
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
The application provided for in Article 14(5) shall include, in addition to the information already provided in accordance with Article 13, documented data relating to the reasoned safety objections submitted in accordance with Article 14(5).
Amendment 400 #
Proposal for a regulation
Article 16 – paragraph 2 – point a
Article 16 – paragraph 2 – point a
(a) whether the history of safe food use in a third country is substantiated by reliable independent scientific data submitted by the applicant in accordance with Articles 13 and 15;
Amendment 405 #
Proposal for a regulation
Article 16 – paragraph 2 – point b b (new)
Article 16 – paragraph 2 – point b b (new)
(bb) the overall environmental and social impact of producing, processing, storing and transporting the food.
Amendment 406 #
Proposal for a regulation
Article 16 – paragraph 5
Article 16 – paragraph 5
5. Where the additional information referred to in paragraph 4 is not sentprovided to EFSA within the additional period referred to in that paragraph, it shall finalise its opinion on the basis of the information already provided to itsuspend the evaluation process.
Amendment 416 #
Proposal for a regulation
Article 17 – paragraph 2 – subparagraph 2
Article 17 – paragraph 2 – subparagraph 2
Amendment 417 #
Proposal for a regulation
Article 17 – paragraph 3
Article 17 – paragraph 3
3. The applicant may withdraw its application referred to in Article 15 at any time before the adoption of EFSA's opinion referred to in Article 16, thereby terminating the procedure for authorising a traditional food from a third country and updating the Union list. In such cases, the applicant shall bear the costs incurred by the EFSA in processing the application.
Amendment 426 #
Proposal for a regulation
Article 20 – paragraph 2
Article 20 – paragraph 2
2. Where the additional information referred to in paragraph 1 is not received within the extended period referred to in that paragraph, the Commission shall act on the basis of the information already providedsuspend the authorisation process.
Amendment 427 #
Proposal for a regulation
Article 21
Article 21
Amendment 430 #
Proposal for a regulation
Article 22 – paragraph 4 – subparagraph 2 – point d
Article 22 – paragraph 4 – subparagraph 2 – point d
(d) a summarthe entirety of the studies submitted by the applicant;
Amendment 432 #
Proposal for a regulation
Article 22 – paragraph 4 – subparagraph 2 – point e
Article 22 – paragraph 4 – subparagraph 2 – point e
(e) where applicable, the analysisthe analysis materials and method(s).
Amendment 435 #
Proposal for a regulation
Article 22 – paragraph 4 – subparagraph 2 – point e f (new)
Article 22 – paragraph 4 – subparagraph 2 – point e f (new)
(ef) information on the detailed chemical composition and health and environmental safety of the food;
Amendment 436 #
Proposal for a regulation
Article 22 – paragraph 4 – subparagraph 2 – point e g (new)
Article 22 – paragraph 4 – subparagraph 2 – point e g (new)
(eg) any prohibition or restriction imposed in respect of the food by a third country.
Amendment 440 #
Proposal for a regulation
Article 22 – paragraph 6
Article 22 – paragraph 6
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 applicant, with the exception of health and environmental safety information.
Amendment 444 #
Proposal for a regulation
Article 23
Article 23
Amendment 458 #
Proposal for a regulation
Article 25 – paragraph 1 – introductory part
Article 25 – paragraph 1 – introductory part
1. Where a novel food is authorised and included in the Union list based on proprietary scientific evidence or scientific data that are granted data protection as provided for in Article 24(1), the entry of a novel food in the Union list shall indicate, in addition to the information referred to in Article 8(3) and Article 22(4):
Amendment 476 #
Proposal for a regulation
Article 29 – paragraph 2 – point b
Article 29 – paragraph 2 – point b
(b) If no reasonedhealth or environmental safety objections are made by a Member State or EFSA within four months from the date of receipt of the application or of the notification referred to in point (a), the food may continue to be placed on the market until a final decision on the application or notification has been taken in accordance with Article 11, 14 or 17.
Amendment 477 #
Proposal for a regulation
Article 29 – paragraph 2 – point c
Article 29 – paragraph 2 – point c
(c) If reasonedhealth or environmental safety objections are made by a Member State or EFSA, the Commission shall take an interim suspension decision on the placing on the market of the food within the Union within fourtwo months of the date of receipt of such objections.