Activities of Pavel POC related to 2013/0435(COD)
Plenary speeches (1)
Novel foods (debate) CS
Shadow reports (1)
PDF (1 MB) DOC (928 KB)
Amendments (44)
Amendment 97 #
Proposal for a regulation
Recital 2
Recital 2
(2) A high level of protection of human health and of consumers’ interests, of the environment and animal welfare, and the effective functioning of the internal market should be assured in the pursuit of Union food policies, whilst ensuring transparency. At all times, moreover, the precautionary principle as laid down in 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 1 a, should be applied. ____________ 1a OJ L 31, 1.2.2002, p. 1.
Amendment 105 #
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 existingmaintained and where appropriate updated by adding new relevant categories withand 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 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 115 #
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 . __________________ 16Regulation (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 119 #
Proposal for a regulation
Recital 8 a (new)
Recital 8 a (new)
(8a) Food with a new or intentionally modified primary molecular structure, food containing, consisting of, or produced from micro-organism, fungi or algae, food derived from tissue culture or cell culture, food containing, consisting of, isolated or produced from plants or animals or their parts, except for animals and plants obtained by traditional propagating or breeding practices, and having a history of safe food use within the Union market, should be considered as novel food as defined in this Regulation
Amendment 123 #
Proposal for a regulation
Recital 10 a (new)
Recital 10 a (new)
(10a) Food derived from cloned animals has been regulated under Regulation (EC) No 258/1997. It is crucial that no legal ambiguity emergences as regards the placing on the market of food from animal clones and/or their descendants. Until specific legislation on food derived from cloned animals and their descendants enters into force, this food should fall under the scope of this Regulation on the condition that, while placed on the market within the Union, it is appropriately labelled for the final consumer.
Amendment 127 #
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 large part of the population of the countryset out in the scientific and technical guidance to be given by the European Food Safety Authority (‘EFSA’). The history of safe food use should not include non-food uses or uses not related to normal diets.
Amendment 137 #
Proposal for a regulation
Recital 15
Recital 15
Amendment 148 #
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 delegated 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.
Amendment 155 #
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 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 conferrThe power to adopt acts in accordance with Article 290 TFEU should therefore be delegated ton the Commission, in that respecorder to update the list.
Amendment 178 #
Proposal for a regulation
Recital 27
Recital 27
(27) In order to ensure uniform conditions for the implementation of this RegulationThe Commission should be empowered to adopt delegated acts, in accordance with Article 26 a 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 182 #
Proposal for a regulation
Recital 28
Recital 28
(28) The implementing powers relating to the definition of ‘novel food’, the consultation process for determination of novel food status, other updates of the Union list, the drafting and presentation of applications or notifications for the inclusion of foods in the Union list, the arrangements for checking the validity of applications or notifications, and confidentiality treatment and transitional provisions, should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council22 . __________________ 22 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
Amendment 184 #
Proposal for a regulation
Recital 28 b (new)
Recital 28 b (new)
(28b) In order to supplement or amend certain elements of this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of the definition of ‘novel food’, of the authorisation of a novel food and of a traditional food from a third country, of establishing and updating the Union list, and of adopting transitional measures. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council.
Amendment 192 #
Proposal for a regulation
Article 1 – paragraph 2 – point c
Article 1 – paragraph 2 – point c
Amendment 198 #
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 under at least one of the following categories:
Amendment 202 #
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 primary molecular structure;
Amendment 203 #
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 consisting of, isolated from or produced from animals or their parts, except for animals obtained by traditional breeding practices which have been used before 15 May 1997 and the food from those animals has a history of safe food use within the Union market;
Amendment 204 #
Proposal for a regulation
Article 2 – paragraph 2 – point a – point -i b (new)
Article 2 – paragraph 2 – point a – point -i b (new)
(-ib) food containing, consisting of, or produced from microorganisms, fungi or algae;
Amendment 205 #
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, isolated from or produced from plants, except for plants obtained by traditional propagating practices and having a history of safe food use within the Union market, where those practices do not give rise to significant changes in the composition or structure of the food affecting their nutritional value, metabolism or level of undesirable substances;
Amendment 210 #
Proposal for a regulation
Article 2 – paragraph 2 – point a – point i b (new)
Article 2 – paragraph 2 – point a – point i b (new)
(ib) food derived from cloned animals and/or their descendants, subject to Article 29 a (new);
Amendment 218 #
Proposal for a regulation
Article 2 – paragraph 2 – point a – point i j (new)
Article 2 – paragraph 2 – point a – point i j (new)
(ij) food derived from tissue culture or cell culture
Amendment 225 #
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 1169/2011resulting from or affected by intentional changes in the particle size, shape or structure, or in the particle size distribution, through any technology that reduces them to nanoscale;
Amendment 231 #
Proposal for a regulation
Article 2 – paragraph 2 – point a – point iii – indent 2
Article 2 – paragraph 2 – point a – point iii – indent 2
– such substances contain or consist of ‘engineered nanomaterials’ as defined in Article 2(2)t of Regulation (EU) No 1169/2011result from or affected by intentional changes in the particle size, shape or structure, or in the particle size distribution, through any technology that reduces them to a nanoscale;
Amendment 233 #
Proposal for a regulation
Article 2 – paragraph 2 – point a – point iii – indent 2 a (new)
Article 2 – paragraph 2 – point a – point iii – indent 2 a (new)
- a new source or starting material has been used, for a single form or for mixtures of vitamins, minerals and other substances used in accordance with Directive 2002/46/EC, Regulation (EC) No 1925/2006 or Regulation (EU) No 609/2013;
Amendment 245 #
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 large part of the population of a third country, prior to a notification referred to in Article 13;
Amendment 252 #
Proposal for a regulation
Article 3 – title
Article 3 – title
Amendment 254 #
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
Amendment 257 #
Proposal for a regulation
Article 3 – paragraph 2
Article 3 – paragraph 2
Amendment 291 #
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. __________________ 23 Publications Office: please insert date: 24 months after the entry into force of this Regulation.
Amendment 300 #
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)6 a.
Amendment 328 #
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 336 #
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 implementingdelegated act in accordance with Article 11 and 26 a.
Amendment 354 #
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 implementinga draft delegated act updating the Union list taking account of:
Amendment 363 #
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)6 a.
Amendment 366 #
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
Amendment 380 #
Proposal for a regulation
Article 13 – paragraph 2 – point d
Article 13 – paragraph 2 – point d
(d) documented data demonstrating the history of safe food use in a third country, as set out in the EFSA guidelines;
Amendment 411 #
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 implementinga draft delegated 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 415 #
Proposal for a regulation
Article 17 – paragraph 1 – subparagraph 2
Article 17 – paragraph 1 – subparagraph 2
That implementingdelegated act shall be adopted in accordance with the examination procedure referred to in Article 27(3)6 a.
Amendment 422 #
Proposal for a regulation
Article 19 – paragraph 1 – point a
Article 19 – paragraph 1 – point a
(a) the contents, drafting and presentation of the notification provided for in Article 13 and of the application provided for in Article 14(5), based on EFSA guidelines;
Amendment 460 #
Proposal for a regulation
Chapter 6 – title
Chapter 6 – title
Penalties and committee proceduregeneral provisions
Amendment 463 #
Proposal for a regulation
Article 26 c (new)
Article 26 c (new)
Article 26c Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 3, Article 9(3), Article 11(1), Article 17(1) and Article 29(3) shall be conferred on the Commission for a period of seven years from ...*. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the seven-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council oppose such extension no later than three months before the end of each period. 3. The delegation of power referred to in Article 3, Article 9(3), Article 11(1), Article 17(1) and Article 29(3) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 3, Article 9(3), Article 11(1), Article 17(1) and Article 29(3) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of the act to the European Parliament and the Council or if, before the expiry of that period, The European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. _______________ *OJ: please insert the date of entry into force of this Regulation.
Amendment 472 #
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).
Amendment 479 #
Proposal for a regulation
Article 29 – paragraph 3
Article 29 – paragraph 3
3. The Commission may, by means of implementingdelegated acts, adopt transitional measures for the application of paragraphs 1 and 2. Those implementingdelegated acts shall be adopted in accordance with the examination procedure referred to in Article 27(3)6 a.
Amendment 482 #
Proposal for a regulation
Article 29 a (new)
Article 29 a (new)
Article 29a Until specific legislation on food derived from cloned animals and their descendants enters into force, this food while placed on the market within the Union shall be accompanied by the following information for the final consumer: "Food derived from cloned animals/ descendants of cloned animals." In the case of pre-packed food, this food information shall be provided by means of a label. In all other cases, this food information shall be provided by other accompanying material.
Amendment 483 #
Proposal for a regulation
Article 29 b (new)
Article 29 b (new)
Article 29b Reporting Five years after its entry into force, the Commission shall report to the European Parliament and to the Council about the implementation of this Regulation, addressing in particular the impact of the new simplified procedure on traditional foods from third countries.