Activities of José BOVÉ related to 2013/0435(COD)
Plenary speeches (1)
Novel foods (debate) FR
Shadow opinions (1)
OPINION on the proposal for a regulation of the European Parliament and of the Council on novel foods
Amendments (101)
Amendment 15 #
Proposal for a regulation
Recital 2
Recital 2
(2) A high level of protection of human health and of consumers’ interests, environmental friendliness, and the effective functioning of the internal market should be asensured in the pursuit of Union food policies, whilst ensuring transparency. Furthermore, and in all instances, 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 must apply.
Amendment 21 #
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, consumer health and the environment. 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 22 #
Proposal for a regulation
Recital 9
Recital 9
(9) When there is a significant change in the production process of a substance that has been used in accordance with Directive 2002/46/EC, Regulation (EC) No 1925/2006 or Regulation (EU) No 609/2013, or a change in particle size of such a substance, for example through nanotechnology, it may haveit has an impact on food and thereby on food safety, consumer health and the environment. Therefore, that substance should be considered a novel food under this Regulation and should be re-evaluated first in accordance with this Regulation and subsequently in accordance with the relevant specific legislation. When there is a change in particle size of that substance, for example through nanotechnology, it should be banned.
Amendment 25 #
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, in accordance with rules established by the EFSA. 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 diets.
Amendment 28 #
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, the food should not be considered to be traditional.
Amendment 31 #
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, thus requiring the use of clear and precise labelling. 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, and as regards health, less advantageous for the consumer. The safety of novel foods shall be assessed on the basis of the precautionary principle as defined in Article 7 of Regulation (EC) No 178/2002.
Amendment 34 #
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 35 #
Proposal for a regulation
Recital 21
Recital 21
Amendment 37 #
Proposal for a regulation
Recital 23
Recital 23
Amendment 39 #
Proposal for a regulation
Recital 24
Recital 24
(24) Novel foods are subject to the general labelling requirements laid down in Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers and other relevant labelling requirements in Union food law. In certain cases it may be necessary to provide for aAdditional labelling information should be included, in particular regarding the description of the food, its source or its conditions of use to ensure that consumers are sufficiently informed of the nature of the novel food.
Amendment 45 #
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 and consumer interests, ensuring transparency and prohibiting the placing on the market of foods using nanomaterials.
Amendment 46 #
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, consumer health and the environment. 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. __________________ 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 47 #
Proposal for a regulation
Article 2 – paragraph 2 – point a – point ii
Article 2 – paragraph 2 – point a – point ii
Amendment 48 #
Proposal for a regulation
Article 2 – paragraph 2 – point a – point iii – indent 2
Article 2 – paragraph 2 – point a – point iii – indent 2
Amendment 52 #
Proposal for a regulation
Recital 8 a (new)
Recital 8 a (new)
(8a) Foods with a new or intentionally modified primary molecular structure, foods consisting of, or isolated from, micro-organisms, fungi or algae, new strains of micro-organism with no history of safe use and concentrates of substances that naturally occur in plants should be considered as novel foods as defined in this Regulation.
Amendment 53 #
Proposal for a regulation
Recital 9
Recital 9
(9) When there is a significant change in the production process of a substance that has been used in accordance with Directive 2002/46/EC, Regulation (EC) No 1925/2006 or Regulation (EU) No 609/2013, or a change in particle size of such a substance, for example through nanotechnology, it may haveit has an impact on food and thereby on food safety, consumer health and the environment. Therefore, that substance should be considered a novel food under this Regulation and should be re-evaluated first in accordance with this Regulation and subsequently in accordance with the relevant specific legislation. When there is a change in the particle size of such a substance, for example through nanotechnology, the substance must be prohibited.
Amendment 59 #
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
1. The Commission shall establish, publish 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’).
Amendment 64 #
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 animal and human health;
Amendment 65 #
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 or would have an adverse effect on his health.
Amendment 65 #
Proposal for a regulation
Recital 15
Recital 15
Amendment 66 #
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 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 process should be established for collecting such information.
Amendment 70 #
Proposal for a regulation
Article 8 – paragraph 3 – point b
Article 8 – paragraph 3 – point b
(b) the conditions under which the novel food may be used, in order to avoid, in particular, possible adverse effects on particular groups of the population, considering in particular the appearance of new allergies, the exceeding of maximum intake levels and risks in case of excessive consumption;
Amendment 71 #
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, which implies clear and precise labelling. 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, or have negative effects on their health. The assessment of the safety of a novel food should be based on the precautionary principle as laid down in Article 7 of Regulation (EC) No 178/2002.
Amendment 76 #
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.
Amendment 77 #
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 78 #
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 79 #
Proposal for a regulation
Article 10 – paragraph 3 – subparagraph 3
Article 10 – paragraph 3 – subparagraph 3
Amendment 80 #
Proposal for a regulation
Article 10 – paragraph 4
Article 10 – paragraph 4
4. Where the additional information referred to in paragraph 3 is not sent 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 itEFSA, being unable to formulate an opinion, shall automatically reject the application.
Amendment 82 #
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
Amendment 82 #
Proposal for a regulation
Recital 21
Recital 21
Amendment 88 #
Proposal for a regulation
Recital 22
Recital 22
(22) When a novel food is authorised and included in the Union list, the Commission should have the power to introduce post- market monitoring requirements to monitor the use of the authorised novel food to ensure that the use is within safe limits as established in the safety assessment by EFSA. In any event, food business operators should inform the Commission of any relevant information regarding the food they have placed on the market.
Amendment 89 #
Proposal for a regulation
Recital 23
Recital 23
Amendment 92 #
Proposal for a regulation
Recital 24
Recital 24
(24) Novel foods are subject to the general labelling requirements laid down in Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers and other relevant labelling requirements in Union food law. In certain cases it may be necessary to provideThere is a need for additional labelling information, in particular regarding the description of the food, its source or its conditions of use to ensure that consumers are sufficiently informed of the nature of the novel food.
Amendment 94 #
Proposal for a regulation
Article 16 – paragraph 5
Article 16 – paragraph 5
5. Where the additional information referred to in paragraph 4 is not sent 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 itEFSA, being unable to formulate an opinion, shall automatically reject the application.
Amendment 97 #
Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 1
Article 20 – paragraph 1 – subparagraph 1
Where the Commission or EFSA requests additional information from an applicant on matters concerning risk management, it shall determine, together withhe time limits which it deems necessary and sufficient to enable the applicant, the period within which that information must be providedo provide this information.
Amendment 97 #
Proposal for a regulation
Recital 27
Recital 27
(27) In order to ensure uniform conditions for the implementation of this Regulation wWith 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 powersthe power to adopt delegated acts in accordance with Article 290 TFEU should be conferred on the Commission.
Amendment 98 #
Proposal for a regulation
Article 20 – paragraph 2
Article 20 – paragraph 2
2. Where the additional information referred to in paragraph 1 is not receivforwarded within the extended period referred to in that paragraph, the Commission shall act on the basis of the information already providednew time limits, the Commission shall not give its approval.
Amendment 99 #
Proposal for a regulation
Article 22 – paragraph 1
Article 22 – paragraph 1
Amendment 99 #
Proposal for a regulation
Recital 28
Recital 28
(28) The implementing powers relating to the definition of ‘novel food’, the consultation process for determinrafting and presentation of applications of novel food status, other updates ofr notifications for the inclusion of foods in the Union list, and the drafting and presentation of applications or notifications for the inclusion of foods in the Union list, the arrangements for checking the validity of applicationarrangements for checking the validity of applications or notifications should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council22. The power to adopt delegated acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the authorisation of novel foods and of traditional foods from a third country, the updating of the Union list, and the consultation process for notifications, confidentiality treatment and transitional provdetermination of a novel food status. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commissions, should be exercised in accordance with Regulation (EU) No 182/2011 ofwhen preparing and drawing up delegated acts, should ensure simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and tof 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 101 #
Proposal for a regulation
Recital 28 a (new)
Recital 28 a (new)
(28a) Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules 1 a lays down general rules for the performance of official controls to verify compliance with food law. Therefore, the Member States are to carry out official controls in accordance with Regulation (EC) No 882/2004, in order to enforce compliance with the present Regulation. __________________ 1a OJ L 165, 30.4.2004, p. 1. Corrected version (OJ L 191, 28.5.2004, p. 1). Regulation as last amended by Council Regulation (EC) No 1791/2006 (OJ L 363, 20.12.2006, p. 1).
Amendment 106 #
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 and consumer interests. and prohibiting the placing on the market of foods in which nanomaterials are used,
Amendment 111 #
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, consumer health and the environment. 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. __________________ 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 111 #
Proposal for a regulation
Article 1 – paragraph 2 – point c
Article 1 – paragraph 2 – point c
(c) food falling within the scope of Council Directive XXX/XX/EU on [on the placing on the market of food from animal clones]. Until the date of application of that Directive, no food from cloned animals and/or their descendants shall be placed on the market.
Amendment 112 #
Proposal for a regulation
Article 1 – paragraph 2 a (new)
Article 1 – paragraph 2 a (new)
2a. The purpose of this Regulation is to provide a high level of protection of consumers' interests, and of animal welfare and the environment, while ensuring the effective functioning of the internal market.
Amendment 121 #
Proposal for a regulation
Recital 9
Recital 9
(9) When there is a significant change in the production process of a substance that has been used in accordance with Directive 2002/46/EC, Regulation (EC) No 1925/2006 or Regulation (EU) No 609/2013, or a change in particle size of such a substance, for example through nanotechnology, it may haveit has an impact on food and thereby on food safety, consumer health and the environment. Therefore, that substance should be considered a novel food under this Regulation and should be re-evaluated first in accordance with this Regulation and subsequently in accordance with the relevant specific legislation. Where there is a change in the particle size of such a substance, for example through the use of nanotechnology, the substance shall be prohibited.
Amendment 129 #
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 level of undesirable substances, or where that production process might give rise to ethical concerns;
Amendment 134 #
Proposal for a regulation
Article 2 – paragraph 2 – point a – point ii
Article 2 – paragraph 2 – point a – point ii
Amendment 137 #
Proposal for a regulation
Article 2 – paragraph 2 – point a – point iii – indent 2
Article 2 – paragraph 2 – point a – point iii – indent 2
Amendment 146 #
Proposal for a regulation
Article 3
Article 3
Amendment 153 #
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 1997whether or not a food falls within the scope of this Regulation. With a view to determining that, the Member State shall consult the Commission and the other Member States.
Amendment 158 #
Proposal for a regulation
Recital 21
Recital 21
Amendment 158 #
Proposal for a regulation
Article 4 – paragraph 3 – subparagraph 1
Article 4 – paragraph 3 – subparagraph 1
The Commission may, by means of implementdelegated acts ing actscordance with Article 26 (a), specify the procedural steps of the consultation process provided for in paragraph 2.
Amendment 160 #
Proposal for a regulation
Article 4 – paragraph 3 – subparagraph 2
Article 4 – paragraph 3 – subparagraph 2
Amendment 164 #
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
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’) is laid down in the Annex.
Amendment 168 #
Proposal for a regulation
Article 5 – paragraph 2 a (new)
Article 5 – paragraph 2 a (new)
2a. The Commission shall make the Union list available to the public on its website.
Amendment 170 #
Proposal for a regulation
Article 5 – paragraph 2 b (new)
Article 5 – paragraph 2 b (new)
2b. The Commission shall also make a list of rejected applications publicly available, in order to serve as reference for future applications.
Amendment 171 #
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 independent peer-reviewed scientific evidence available, pose a safety risk to human healthor animal health or the environment;
Amendment 177 #
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 or have a negative impact on his or her health.
Amendment 181 #
Proposal for a regulation
Article 6 – paragraph 1 – point c a (new)
Article 6 – paragraph 1 – point c a (new)
(ca) In the event of doubt, due, for example, to insufficient scientific certainty or lack of data, the precautionary principle shall be applied and the food in question shall not be included in the Union list.
Amendment 183 #
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 listare listed in the Annex to this Regulation, including any existing authorisation conditions. __________________ 23Publications Office: please insert date: 24 months after the entry into force of this Regulation.
Amendment 184 #
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
Amendment 188 #
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 and consumer interests and prohibiting the placing on the market of foods in which nanomaterials are used.
Amendment 192 #
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 194 #
Proposal for a regulation
Article 8 – paragraph 3 – point a a (new)
Article 8 – paragraph 3 – point a a (new)
(aa) the date of entry of the novel food in the Union list;
Amendment 195 #
Proposal for a regulation
Article 8 – paragraph 3 – point a b (new)
Article 8 – paragraph 3 – point a b (new)
(ab) the name and address of the applicant;
Amendment 196 #
Proposal for a regulation
Article 8 – paragraph 3 – point b
Article 8 – paragraph 3 – point b
(b) the conditions under which the novel food may be used, in order to avoid, in particular, possible adverse effects on particular groups of the population, taking into account the emergence of new allergies in particular, the exceeding of maximum intake levels and risks in case of excessive consumption;
Amendment 197 #
Proposal for a regulation
Article 8 – paragraph 3 – point b
Article 8 – paragraph 3 – point b
(b) where relevant, the conditions under which the novel food may be used, in order to avoid, in particular, possible adverse effects on particular groups of the population, the exceeding of maximum intake levels and risks in case of excessive consumption;
Amendment 200 #
Proposal for a regulation
Article 8 – paragraph 3 – point c
Article 8 – paragraph 3 – point c
(c) where relevant, additional specific labelling requirements to inform the final consumer of any specific characteristic or food property, such as the composition, nutritional value or nutritional effects and intended use of the food, which renders a novel food no longer equivalent to an existing food or of implications for the health of specific groups of the population;
Amendment 202 #
Proposal for a regulation
Article 8 – paragraph 3 – point d
Article 8 – paragraph 3 – point d
(d) where relevant, a post-market monitoring requirement in accordance with Article 23.
Amendment 206 #
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 shall forward the application to Member States and make it available to the public on its website.
Amendment 212 #
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 – point c
Article 9 – paragraph 1 – subparagraph 2 – point c
(c) independent, peer-reviewed, publically available scientific evidence demonstrating that the novel food does not pose a safety risk to human health or the environment;
Amendment 219 #
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. The Commission may request EFSA to render its opinion if the update is liable to have an effect on human healthshall forward the valid application to EFSA and request EFSA to render its opinion.
Amendment 222 #
Proposal for a regulation
Article 2 – paragraph 2 – point a – point ii
Article 2 – paragraph 2 – point a – point ii
Amendment 225 #
Proposal for a regulation
Article 9 – paragraph 3
Article 9 – paragraph 3
3. The procedure forCommission shall be empowered to adopt delegated acts, in accordance with Article 26 (a) concerning the authorisingation of the placing on the market within the Union of a novel foods and the updating of the Union list as provided for in Article 8 shall end with the adoption of an implementing act in accordance with Article 11list laid down in the Annex.
Amendment 229 #
Proposal for a regulation
Article 2 – paragraph 2 – point a – point iii – indent 2
Article 2 – paragraph 2 – point a – point iii – indent 2
Amendment 229 #
Proposal for a regulation
Article 10 – paragraph 1 – subparagraph 1
Article 10 – paragraph 1 – subparagraph 1
Amendment 235 #
Proposal for a regulation
Article 10 – paragraph 1 – subparagraph 2 – point b a (new)
Article 10 – paragraph 1 – subparagraph 2 – point b a (new)
(ba) whether the composition of the novel food and the conditions of its use do not pose a risk to animal health and welfare and/or the environment.
Amendment 236 #
Proposal for a regulation
Article 10 – paragraph 1 – subparagraph 2 – point b b (new)
Article 10 – paragraph 1 – subparagraph 2 – point b b (new)
(bb) whether cumulative and synergistic effects might arise, and whether particular groups of the population could be adversely affected.
Amendment 237 #
Proposal for a regulation
Article 10 – paragraph 3 – subparagraph 3
Article 10 – paragraph 3 – subparagraph 3
Amendment 238 #
Proposal for a regulation
Article 10 – paragraph 4
Article 10 – paragraph 4
4. Where the additional information referred to in paragraph 3 is not sent 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 itautomatically reject the application made to it, given that it is unable to adopt a position.
Amendment 240 #
Proposal for a regulation
Article 11 – paragraph 1 – subparagraph 1 – introductory part
Article 11 – paragraph 1 – subparagraph 1 – introductory part
Within nine 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 implementbe empowered to present a draft delegated act ing actcordance with Article 26 (a) updating the Union list taking account of:
Amendment 242 #
Proposal for a regulation
Article 11 – paragraph 1 – subparagraph 2
Article 11 – paragraph 1 – subparagraph 2
Amendment 244 #
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
Amendment 247 #
Proposal for a regulation
Article 12 – paragraph 1 – point a
Article 12 – paragraph 1 – point a
(a) the contents, drafting and presentation of the application referred to in Article 9(1);
Amendment 248 #
Proposal for a regulation
Article 12 – paragraph 1 – point c
Article 12 – paragraph 1 – point c
Amendment 259 #
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 delay to the Member States and to EFSA and shall make it available to the public on its website.
Amendment 261 #
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 reasoned safety objections regarding its compliance with Article 6, based on scientific evidence, to the placing on the market within the Union of the traditional food concerned.
Amendment 264 #
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.
Amendment 266 #
Proposal for a regulation
Article 14 – paragraph 5 – subparagraph 1
Article 14 – paragraph 5 – subparagraph 1
Where reasoned safety objections, based on scientific evidence, 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 270 #
Proposal for a regulation
Article 16 – paragraph 5
Article 16 – paragraph 5
5. Where the additional information referred to in paragraph 4 is not sent 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 itautomatically reject the application made to it, given that it is unable to adopt a position.
Amendment 272 #
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 implementing actbe empowered to submit a draft delegated act in accordance with Article 26 (a) 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 273 #
Proposal for a regulation
Article 17 – paragraph 1 – subparagraph 2
Article 17 – paragraph 1 – subparagraph 2
Amendment 276 #
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);
Amendment 277 #
Proposal for a regulation
Article 19 – paragraph 1 – point d
Article 19 – paragraph 1 – point d
Amendment 279 #
Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 1
Article 20 – paragraph 1 – subparagraph 1
Where the Commission or EFSA requests additional information from an applicant on matters concerning risk management, it shall determine, together withhe period it deems necessary and sufficient for the applicant, the period within which that information must be providedo be able to provide that information.
Amendment 280 #
Proposal for a regulation
Article 20 – paragraph 2
Article 20 – paragraph 2
2. Where the additional information referred to in paragraph 1 is not receivforwarded within the extended period referred to in that paragraph, the Commission shall act on the basis of the information already providednew period laid down, the Commission shall not issue an authorisation.
Amendment 281 #
Proposal for a regulation
Article 22
Article 22
Amendment 282 #
Proposal for a regulation
Article 22 – paragraph 1
Article 22 – paragraph 1
Amendment 292 #
Proposal for a regulation
Article 26 a (new)
Article 26 a (new)
Article 26a 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 Articles 4(1), 9 (3), 11(1), and 17 (1) shall be conferred on the Commission for a period of 7 years after entry into force of this Regulation. The Commission shall draw up a report in respect of the delegation of power not later than 9 months before the end of the 7-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than 3 months before the end of each period. 3. The delegation of power referred to in Articles 4(1), 9 (3), 11(1), and 17 (1) 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 the 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 on 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 Articles 4(1), 9 (3), 11(1), and 17 (1) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of 2 months of notification of that 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 2 months at the initiative of the European Parliament or of the Council.
Amendment 303 #
Proposal for a regulation
Article 29 – paragraph 3
Article 29 – paragraph 3
Amendment 306 #
Proposal for a regulation
Article 30 – paragraph 1
Article 30 – paragraph 1
This Regulation shall not enter into force until Council Directive XXX/XX/EU [on the placing on the market of food from animal clones] is in force. This condition being satisfied, this Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.