Activities of Nicola CAPUTO related to 2013/0435(COD)
Plenary speeches (2)
Novel foods (debate) IT
Novel foods (A8-0046/2014 - James Nicholson) IT
Amendments (118)
Amendment 36 #
Proposal for a regulation
Recital 2
Recital 2
(2) A high level of protection of human health, based on the precautionary principle, and of consumers’ interests and the effective functioning of the internal market should be assured in the pursuit of Union food policies, whilst ensuring transparency.
Amendment 42 #
Proposal for a regulation
Recital 5
Recital 5
Amendment 43 #
Proposal for a regulation
Recital 5 a (new)
Recital 5 a (new)
(5a) This Regulation should apply to foods and food ingredients which fall under the following categories: foods and food ingredients with a new or intentionally modified primary molecular structure; foods and food ingredients consisting of or isolated from micro- organisms, fungi or algae; foods and food ingredients to which has been applied a production process not currently used, where that process gives rise to significant changes in the composition or structure of the foods or food ingredients which affect their nutritional value, metabolism or level of undesirable substances. The list should be kept open in order to keep pace with scientific progress and new products development. If new categories are included, these should be well defined, justified from a safety perspective and assessed on impact.
Amendment 45 #
Proposal for a regulation
Recital 6
Recital 6
(6) In order to ensure continuity with the rules laid down in Regulation (EC) No 258/97, the absence of a use for human consumption to a significant degree, interpreted as available in supermarkets, general food outlets or pharmacies, within the Union before the date of entry into force of that Regulation, namely 15 May 1997, should be maintained as a criterion for a food to be considered as a novel food. A use within the Union should also refer to a use in the Member States irrespective of the date of accession of the various Member States to the Union.
Amendment 56 #
Proposal for a regulation
Recital 10
Recital 10
(10) If, prior to 15 May 1997, a food was used exclusively as, or in, a food supplement, as defined in point (a) of Article 2 of Directive 2002/46/EC, it should be allowed to be placed on the market within the Union after that date for the same use without being considered a novel food for the purposes of this Regulation. However, that use as, or in, a food supplement should not be taken into account for the assessment of whether the food was used for human consumption to a significant degree, interpreted as available in supermarkets, general food outlets or pharmacies, within the Union before 15 May 1997. Therefore, uses of the food concerned other than in, or as, a food supplement should be subject to this Regulation.
Amendment 57 #
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 partraditional foods from third countries should automatically go through a full risk assessment by EFSA at the beginning of the populatiorocedure, even oif the country. The history of safe food use should not include non- food uses or uses not related to normal dietsno reasoned safety objections are presented.
Amendment 63 #
Proposal for a regulation
Recital 13
Recital 13
(13) Food products produced from food ingredients that do not fall within the scope of this Regulation, in particular by changing the ingredients of the food, their composition or amount, should not be considered as novel foods. However, modifications of a food ingredient, such as selective extracts or the use of other parts of a plant, that have so far not been used for human consumption to a significant degree, interpreted as available in supermarkets, general food outlets or pharmacies, within the Union, should fall within the scope of this Regulation.
Amendment 69 #
Proposal for a regulation
Recital 16
Recital 16
(16) The determination of whether a food was used for human consumption to a significant degree, interpreted as available in supermarkets, general food outlets or pharmacies, 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.
Amendment 75 #
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 The initial Union list of authorised 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, which constitutes a key element, should be annexed to this Regulation and the list should be updated by means of delegated acts.
Amendment 79 #
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 shouldDelegated powers, in accordance with Article 290 TFEU, should therefore be conferred on the Commission in that respecorder to update the Union list.
Amendment 81 #
Proposal for a regulation
Recital 20
Recital 20
(20) Criteria for the evaluation of the safety risks arising from novel foods should also be clearly defined and laid down. In order to ensure the harmonised scientific assessment of novel foods, such assessments should be carried out by the European Food Safety Authority (‘EFSA’). EFSA, whose assessments should be undertaken in a transparent manner, should set up a network with Member States and the Advisory Committee on Novel Foods and Processes (ACNFP). Any novel characteristic that may have an impact on health should be assessed on an individual basis.
Amendment 84 #
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. The assessment of nanomaterials in food or food ingredient should include details of the composition, nutritional value, metabolism, intended use, the level of microbiological and chemical contaminants, studies into the potential for toxic, nutritional and allergenic effects and details of the manufacturing process used to process the food or food ingredient. When carrying out the scientific safety assessment, consumer concerns and ethical issues should also be considered. __________________ 21 EFSA Journal 2011;9(5):2140.
Amendment 93 #
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 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. Materials that give rise to ethical concerns, as in current Regulation (EC) No 258/97, should also be indicated on the label in order to allow the consumers to make informed choices.
Amendment 98 #
Proposal for a regulation
Recital 2
Recital 2
(2) A high level of protection of human health, based on the precautionary principle, and of consumers’ interests and the effective functioning of the internal market shouldneed to be assured in the pursuit of Union food policies, whilst ensuring transparency.
Amendment 98 #
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 CommissionThe initial Union list of traditional food from a third country should be annexed to this Regulation and the list should be updated by means of delegated acts.
Amendment 100 #
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 102 #
Proposal for a regulation
Recital 5
Recital 5
Amendment 109 #
Proposal for a regulation
Recital 5 a (new)
Recital 5 a (new)
(5a) This Regulation should apply to foods and food ingredients which fall under the following categories: foods and food ingredients with a new or intentionally modified primary molecular structure; foods and food ingredients consisting of or isolated from micro- organisms, fungi or algae; foods and food ingredients to which has been applied a production process not currently used, where that process gives rise to significant changes in the composition or structure of the foods or food ingredients which affect their nutritional value, metabolism or level of undesirable substances. The list should be kept open in order to keep pace with scientific progress and new products development. If new categories are included, these should be well defined, justified from a safety perspective and assessed on impact.
Amendment 110 #
Proposal for a regulation
Recital 6
Recital 6
(6) In order to ensure continuity with the rules laid down in Regulation (EC) No 258/97, the absence of a use for human consumption to a significant degree, interpreted as available in supermarkets, general food outlets or pharmacies, within the Union before the date of entry into force of that Regulation, namely 15 May 1997, should be maintained as a criterion for a food to be considered as a novel food. A use within the Union should also refer to a use in the Member States irrespective of the date of accession of the various Member States to the Union.
Amendment 114 #
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 117 #
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, interpreted as available in supermarkets, general food outlets or pharmacies, within the Union before 15 May 1997 irrespective of the date of accession of the various Member States to the Union and includes in particular:
Amendment 118 #
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) foods and food ingredients with a new or intentionally modified primary molecular structure;
Amendment 119 #
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) foods and food ingredients consisting of or isolated from micro-organisms, fungi or algae;
Amendment 120 #
Proposal for a regulation
Article 2 – paragraph 2 – point a – point i c (new)
Article 2 – paragraph 2 – point a – point i c (new)
(ic) foods and food ingredients to which a production process not currently used has been applied, where that process gives rise to significant changes in the composition or structure of the foods or food ingredients which affect their nutritional value, metabolism or level of undesirable substances;
Amendment 122 #
Proposal for a regulation
Recital 10
Recital 10
(10) If, prior to 15 May 1997, a food was used exclusively as, or in, a food supplement, as defined in point (a) of Article 2 of Directive 2002/46/EC, it should be allowed to be placed on the market within the Union after that date for the same use without being considered a novel food for the purposes of this Regulation. However, that use as, or in, a food supplement should not be taken into account for the assessment of whether the food was used for human consumption to a significant degree, interpreted as available in supermarkets, general food outlets or pharmacies, within the Union before 15 May 1997. Therefore, uses of the food concerned other than in, or as, a food supplement should be subject to this Regulation.
Amendment 127 #
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, determined after full risk assessment, in the composition or structure of the food which affect its nutritional value, the way it is metabolised or the level of undesirable substances;
Amendment 128 #
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 country. The history of safe food use should not include non-food uses or uses not related to normal diets. Traditional foods from third countries should automatically go through a full risk assessment by EFSA at the beginning of the procedure, even if no reasoned safety objections are presented.
Amendment 133 #
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 135 #
Proposal for a regulation
Recital 13
Recital 13
(13) Food products produced from food ingredients that do not fall within the scope of this Regulation, in particular by changing the ingredients of the food, their composition or amount, should not be considered as novel foods. However, modifications of a food ingredient, such as selective extracts or the use of other parts of a plant, that have so far not been used for human consumption to a significant degree, interpreted as available in supermarkets, general food outlets or pharmacies, within the Union, should fall within the scope of this Regulation.
Amendment 141 #
Proposal for a regulation
Recital 16
Recital 16
(16) The determination of whether a food was used for human consumption to a significant degree, interpreted as available in supermarkets, general food outlets or pharmacies, 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.
Amendment 145 #
Proposal for a regulation
Article 2 – paragraph 2 – subparagraph 2 (new)
Article 2 – paragraph 2 – subparagraph 2 (new)
The list of foods and food ingredients shall be kept open in order to keep pace with scientific progress and new products development. If new categories are included, these shall be well defined, justified from a safety perspective and assessed on impact.
Amendment 147 #
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 listThe initial Union list of authorised novel foods, which constitutes a key element, should be annexed to this Regulation and the list should be updated by means of delegated acts.
Amendment 147 #
Proposal for a regulation
Article 3 – title
Article 3 – title
Amendment 148 #
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 implementingdelegated acts, whether or not a particular food falls within the definition of novel food, as laid down in Article 2(2)(a).
Amendment 149 #
Proposal for a regulation
Article 3 – paragraph 2
Article 3 – paragraph 2
Those implementingdelegated acts shall be adopted in accordance with the examination procedure referred to in Article 27(31a new).
Amendment 152 #
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 shouldDelegated powers, in accordance with Article 290 TFEU, shall therefore be conferred on the Commission in that respecorder to update the Union list.
Amendment 152 #
Proposal for a regulation
Article 4 – paragraph 1 – subparagraph 1 (new)
Article 4 – paragraph 1 – subparagraph 1 (new)
Food business operators cannot apply for novel food status and a health claim at the same time in order to avoid overlapping assessments. The novel food product shall be considered safe before EFSA evaluates a health claim.
Amendment 157 #
Proposal for a regulation
Recital 20
Recital 20
(20) Criteria for the evaluation of the safety risks arising from novel foods should also be clearly defined and laid down. In order to ensure the harmonised scientific assessment of novel foods, such assessments should be carried out by the European Food Safety Authority (‘EFSA’). EFSA, whose assessments should be undertaken in a transparent manner, should set up a network with Member States and the Advisory Committee on Novel Foods and Processes (ACNFP). Any novel characteristic that may have an impact on health should be assessed on an individual basis.
Amendment 159 #
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 160 #
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. The assessment of nanomaterials in food or food ingredient should include details of the composition, nutritional value, metabolism, intended use, the level of microbiological and chemical contaminants, studies into the potential for toxic, nutritional and allergenic effects and details of the manufacturing process used to process the food or food ingredient. When carrying out the scientific safety assessment, consumer concerns and ethical issues should also be considered. __________________ 21 EFSA Journal 2011;9(5):2140.
Amendment 161 #
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(31a new).
Amendment 163 #
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
1. The Commission shall establish and update aA 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 annexed to this Regulation.
Amendment 170 #
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 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. Materials that give rise to ethical concerns, as in current Regulation (EC) No 258/97, should also be indicated on the label in order to allow the consumers to make informed choices.
Amendment 177 #
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 CommissionThe initial Union list of traditional food from a third country shall be annexed to this Regulation and the list shall be updated by means of delegated acts.
Amendment 181 #
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 182 #
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
Amendment 185 #
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
That implementinge delegated acts shall be adopted in accordance with the advisory procedure referred to in Article 27(21a new).
Amendment 200 #
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, interpreted as having been made available in supermarkets, general food outlets or pharmacies, within the Union before 15 May 1997 irrespective of the date of accession of the various Member States to the Union and includes in particular:
Amendment 204 #
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 1
Article 9 – paragraph 1 – subparagraph 1
The procedure forCommission shall be empowered to adopt delegated acts, in accordance with Article 27 (1a new), concerning the authorisingation of the placing on the market within the Union of a novel food and the 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 applicantwhich shall be annexed to this Regulation.
Amendment 208 #
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, determined after full risk assessment, in the composition or structure of the food which affect its nutritional value, the way it is metabolised or the level of undesirable substances;
Amendment 212 #
Proposal for a regulation
Article 2 – paragraph 2 – point a – point i d (new)
Article 2 – paragraph 2 – point a – point i d (new)
(id) foods and food ingredients with a new or intentionally modified primary molecular structure;
Amendment 217 #
Proposal for a regulation
Article 2 – paragraph 2 – point a – point i i (new)
Article 2 – paragraph 2 – point a – point i i (new)
(ii) foods and food ingredients consisting of or isolated from micro-organisms, fungi or algae;
Amendment 220 #
Proposal for a regulation
Article 2 – paragraph 2 – point a – point i l (new)
Article 2 – paragraph 2 – point a – point i l (new)
(il) foods and food ingredients to which has been applied a production process not currently used, where that process gives rise to significant changes in the composition or structure of the foods or food ingredients which affect their nutritional value, metabolism or level of undesirable substances;
Amendment 223 #
(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. A threshold of 10%, as recommended by EFSA, should be considered for food related applications;
Amendment 226 #
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 acts in accordance with Article 11.
Amendment 230 #
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 are 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. A threshold of 10%, as recommended by EFSA, should be considered for food related applications;
Amendment 231 #
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 and in accordance with the precautionary principle, consider the following:
Amendment 233 #
Proposal for a regulation
Article 10 – paragraph 1 – subparagraph 2 – point b
Article 10 – paragraph 1 – subparagraph 2 – point b
(b) whether the composition of the novel food and the conditions of its use do not pose a safety risk to human health in the Union, taking account of vulnerable consumers or particular groups of consumers.
Amendment 239 #
Proposal for a regulation
Article 11 – paragraph 1 – subparagraph 1 – introductory part
Article 11 – paragraph 1 – subparagraph 1 – introductory part
Amendment 240 #
Proposal for a regulation
Article 2 – paragraph 2 – point a a (new)
Article 2 – paragraph 2 – point a a (new)
(aa) The list of foods and food ingredients shall be kept open in order to keep pace with scientific progress and new products development. If new categories are included, these shall be well defined, justified from a safety perspective and assessed on impact;
Amendment 241 #
Proposal for a regulation
Article 11 – paragraph 1 – subparagraph 1 – point c
Article 11 – paragraph 1 – subparagraph 1 – point c
Amendment 243 #
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(31a new).
Amendment 245 #
Proposal for a regulation
Article 12 – title
Article 12 – title
Amendment 246 #
Proposal for a regulation
Article 12 – paragraph 1 – introductory part
Article 12 – paragraph 1 – introductory part
By …24 at the latest, the Commission shall adopt implementingdelegated acts concerning: __________________ 24 Publications Office: please insert date: 24 months after the date of entry into force of this Regulation.
Amendment 249 #
Proposal for a regulation
Article 12 – paragraph 2
Article 12 – paragraph 2
Those implementingdelegated acts shall be adopted in accordance with the examination procedure referred to in Article 27(31a new).
Amendment 251 #
Amendment 255 #
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
Amendment 256 #
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, including legitimate factors such as ethical concerns, which do not mislead the consumer.
Amendment 258 #
Proposal for a regulation
Article 3 – paragraph 2
Article 3 – paragraph 2
Those implementingdelegated acts shall be adopted in accordance with the examination procedure referred to in Article 27(31a).
Amendment 260 #
Proposal for a regulation
Article 4 – paragraph 1 – subparagraph 1 (new)
Article 4 – paragraph 1 – subparagraph 1 (new)
Food business operators shall not apply for novel food status and a health claim at the same time in order to avoid overlapping assessments. Until EFSA evaluates a health claim, the novel food product shall be considered safe.
Amendment 262 #
Proposal for a regulation
Article 14 – paragraph 3
Article 14 – paragraph 3
3. The Commission shall inform the Member States, EFSA and the applicant of the outcome of the procedure referred to in paragraph 2. Even if no reasoned safety objections are presented, traditional foods from third countries shall automatically go through a full risk assessment by EFSA at the beginning of the procedure.
Amendment 263 #
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, after a convincing full risk assessment by EFSA, the placing on the market within the Union of the traditional food concerned and update without delay the Union list.
Amendment 267 #
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 267 #
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, assessed on the basis of scientific guidelines and criteria that shall be clarified, is substantiated by reliable data submitted by the applicant in accordance with Articles 13 and 15;
Amendment 269 #
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(31a).
Amendment 271 #
Proposal for a regulation
Article 17 – paragraph 1 – subparagraph 1 – introductory part
Article 17 – paragraph 1 – subparagraph 1 – introductory part
Amendment 273 #
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
1. The Commission shall establish and update aA 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 annexed to this Regulation.
Amendment 278 #
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(31a new).
Amendment 286 #
Proposal for a regulation
Article 22 – paragraph 8 – subparagraph 2
Article 22 – paragraph 8 – subparagraph 2
Those implementingdelegated acts shall be adopted in accordance with the examination procedure referred to in Article 27(31a new).
Amendment 290 #
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
Amendment 293 #
Proposal for a regulation
Article 27 – title
Article 27 – title
Amendment 294 #
Proposal for a regulation
Article 27 – paragraph 1
Article 27 – paragraph 1
Amendment 295 #
Proposal for a regulation
Article 27 – paragraph 1 a (new)
Article 27 – paragraph 1 a (new)
Amendment 296 #
Proposal for a regulation
Article 27 – paragraph 2 – subparagraph 1
Article 27 – paragraph 2 – subparagraph 1
Amendment 297 #
Proposal for a regulation
Article 27 – paragraph 2 – subparagraph 2
Article 27 – paragraph 2 – subparagraph 2
Amendment 299 #
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
That implementinge delegated acts shall be adopted in accordance with the advisory procedure referred to in Article 27(21a).
Amendment 299 #
Proposal for a regulation
Article 27 – paragraph 3 – subparagraph 1
Article 27 – paragraph 3 – subparagraph 1
Amendment 300 #
Proposal for a regulation
Article 27 – paragraph 3 – subparagraph 2
Article 27 – paragraph 3 – subparagraph 2
Amendment 304 #
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(31a new).
Amendment 307 #
Proposal for a regulation
Annex (new)
Annex (new)
Union List of authorised novel foods and list of traditional foods from third countries
Amendment 315 #
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 1
Article 9 – paragraph 1 – subparagraph 1
The procedure forCommission shall be empowered to adopt delegated acts, in accordance with Article 27 (1a), concerning the authorisingation of the placing on the market within the Union of a novel food and the 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 applicantwhich shall be annexed to this Regulation.
Amendment 330 #
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. The Commission mayshall request EFSA to render it's opinion if the update is liable to have an effect on human health.
Amendment 335 #
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 acts in accordance with Article 11.
Amendment 343 #
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 and in accordance with the precautionary principle, consider the following:
Amendment 344 #
Proposal for a regulation
Article 10 – paragraph 1 – subparagraph 2 – point b
Article 10 – paragraph 1 – subparagraph 2 – point b
(b) whether the composition of the novel food and the conditions of its use do not pose a safety risk to human health in the Union, taking account of vulnerable consumers or particular groups of consumers.
Amendment 357 #
Proposal for a regulation
Article 11 – paragraph 1 – subparagraph 1 – introductory part
Article 11 – paragraph 1 – subparagraph 1 – introductory part
Amendment 358 #
Proposal for a regulation
Article 11 – paragraph 1 – subparagraph 1 – point c
Article 11 – paragraph 1 – subparagraph 1 – point c
Amendment 362 #
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(31a).
Amendment 369 #
Proposal for a regulation
Article 12 – title
Article 12 – title
Amendment 370 #
Proposal for a regulation
Article 12 – paragraph 1 – introductory part
Article 12 – paragraph 1 – introductory part
By …24 at the latest, the Commission shall adopt implementingdelegated acts concerning: __________________ 24 Publications Office: please insert date: 24 months after the date of entry into force of this Regulation.
Amendment 374 #
Proposal for a regulation
Article 12 – paragraph 2
Article 12 – paragraph 2
Those implementingdelegated acts shall be adopted in accordance with the examination procedure referred to in Article 27(31a).
Amendment 382 #
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, including legitimate factors such as ethical concerns, which do not mislead the consumer.
Amendment 388 #
Proposal for a regulation
Article 14 – paragraph 3
Article 14 – paragraph 3
3. The Commission shall inform the Member States, EFSA and the applicant of the outcome of the procedure referred to in paragraph 2. Even if no reasoned safety objections are presented, traditional foods from third countries shall automatically go through a full risk assessment by EFSA at the beginning of the procedure.
Amendment 391 #
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, after a convincing full risk assessment by EFSA, the placing on the market within the Union of the traditional food concerned and update without delay the Union list.
Amendment 398 #
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, assessed on the basis of scientific guidelines and clear criteria, is substantiated by reliable data submitted by the applicant in accordance with Articles 13 and 15;
Amendment 408 #
Proposal for a regulation
Article 17 – paragraph 1 – subparagraph 1 – introductory part
Article 17 – paragraph 1 – subparagraph 1 – introductory part
Amendment 425 #
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(31a).
Amendment 442 #
Proposal for a regulation
Article 22 – paragraph 8 – subparagraph 1
Article 22 – paragraph 8 – subparagraph 1
The Commission may, by means of implementingdelegated acts, adopt detailed rules on the implementation of paragraphs 1 to 6.
Amendment 443 #
Proposal for a regulation
Article 22 – paragraph 8 – subparagraph 2
Article 22 – paragraph 8 – subparagraph 2
Those implementingdelegated acts shall be adopted in accordance with the examination procedure referred to in Article 27(31a).
Amendment 464 #
Proposal for a regulation
Article 27 – title
Article 27 – title
Amendment 465 #
Proposal for a regulation
Article 27 – paragraph 1
Article 27 – paragraph 1
Amendment 466 #
Proposal for a regulation
Article 27 – paragraph 1 a (new)
Article 27 – paragraph 1 a (new)
1a. 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 delegation of power 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 date of entry into force of this Regulation. 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 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 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 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 from the 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 two months at the initiative of the European Parliament or of the Council.
Amendment 467 #
Proposal for a regulation
Article 27 – paragraph 2 – subparagraph 1
Article 27 – paragraph 2 – subparagraph 1
Amendment 468 #
Proposal for a regulation
Article 27 – paragraph 2 – subparagraph 2
Article 27 – paragraph 2 – subparagraph 2
Amendment 470 #
Proposal for a regulation
Article 27 – paragraph 3 – subparagraph 1
Article 27 – paragraph 3 – subparagraph 1
Amendment 473 #
Amendment 480 #
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(31a).
Amendment 486 #
Proposal for a regulation
Article 30 a (new)
Article 30 a (new)
Article 30 a Annex Union list of authorised novel foods and list of traditional foods from third countries.