Activities of Oreste ROSSI related to 2011/0156(COD)
Plenary speeches (2)
Food intended for infants and young children and food for special medical purposes (debate)
Food intended for infants and young children and food for special medical purposes (debate)
Amendments (58)
Amendment 8 #
Proposal for a regulation
Title
Title
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on food intended for infants and young children and on food for special medical purposes and foodstuffs for people intolerant to gluten(presented by the Commission pursuant to Article 114 of the Treaty on the Functioning of the European Union)(Text with EEA relevance)
Amendment 17 #
Proposal for a regulation
Recital 15
Recital 15
(15) A limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment; such categories of food are vital for the management of certain conditions and/or are essential to maintain the intended nutritional adequacy for certain well-established vulnerable groups of the population. Those categories of food include infant formulae and follow-on formulae, processed cereal-based food and baby food and food for special medical purposes, and food for people intolerant to gluten. Experience has shown that the provisions laid down in Commission Directive 2006/141/EC, Commission Directive 2006/125/EC, as well as Commission Directive 1999/21/EC, and Commission Regulation (EC) No 41/2009 ensure the free movement of such food in a satisfactory manner, while ensuring a high level of protection of public health. It is therefore appropriate that this Regulation focuses on the general compositional and information requirements for infant formula and follow-on formulae, processed cereal-based food and baby food for infants and young children and to food for special medical purposes, and food for people intolerant to gluten taking into account Commission Directive 2006/141/EC, Commission Directive 2006/125/EC and Commission Directive 1999/21/EC, and Commission Regulation (EC) No 41/2009.
Amendment 20 #
Proposal for a regulation
Recital 16
Recital 16
(16) To ensure legal certainty, definitions laid down in Commission Directive 2006/141/EC, Commission Directive 2006/125/EC and Commission Directive 1999/21/EC, and Commission Regulation (EC) No 41/2009 should be transferred to this Regulation. However, the definitions of infant formulae and follow-on formulae, processed cereal-based food and baby food, and food for special medical purposes, and food for people intolerant to gluten should be regularly adapted taking into account technical and scientific progress and relevant developments at international level, as appropriate.
Amendment 30 #
Proposal for a regulation
Recital 19
Recital 19
(19) This Regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula, follow-on formula, processed cereal-based food and baby food, and food for special medical purposes, and food for people intolerant to gluten, taking into account Commission Directive 2006/141/EC, Commission Directive 2006/125/EC and Commission Directive 1999/21/EC, Commission Regulation (EC) No 41/2009. In order to adapt the definitions of infant formula, follow-on formula, processed cereal-based food and baby food, and food for special medical purposes, and food for people intolerant to gluten laid down in this Regulation taking into account technical and scientific progress and relevant developments at international level, to lay down the specific compositional and information requirements with respect to the categories of food covered by this Regulation, including for additional labelling requirements to, or derogations from, the provisions of Directive 2000/13/EC and for the authorisation of nutrition and health claims, 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. It is of particular importance that the Commission carries 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 33 #
Proposal for a regulation
Recital 20
Recital 20
(20) It is appropriate to establish and update a Union list of vitamins, minerals, amino acids and other substances that may be added for specific nutritional purposes to infant formula, follow-on formula, processed cereal-based food and baby food, and food for special medical purposes, and food for people intolerant to gluten, taking into account Regulation 953/2009, Commission Directives 2006/141/EC and 2006/125/EC, subject to certain criteria laid down in this Regulation. Given the fact that the adoption of the list implies the application of criteria set out in this Regulation, implementing powers should be conferred on the Commission in that respect. Those powers should be exercised in accordance with 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. The Commission should adopt immediately applicable implementing acts updating the Union list, where, in duly justified cases relating to public health, imperative grounds of urgency so require.
Amendment 37 #
Proposal for a regulation
Recital 26
Recital 26
(26) Currently, the statements ‘gluten-free’ and ‘very low gluten’ may be used for food intended for particular nutritional uses and for food for normal consumptiofor specialised nutrition intended for people intolerant to gluten under the rules specified in article 3 of Commission Regulation (EC) No 41/2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten. Such statements could be construed as nutrition claims, as defined in Regulation (EC) No 1924/2006. For the sake of simplification, those statements should be regulated solely by Regulation (EC) No 1924/2006 and comply with requirements therein. It is necessary that technical adaptations pursuant to Regulation (EC) No 1924/2006, incorporating the nutrition claims ‘gluten-free’ and ‘very low gluten’ and their associated conditions of use as regulated under Regulation (EC) No 41/2009 be completed prior to the entry into application of this RegulationIn addition, the statement ‘gluten-free’ may be used for foodstuffs for normal consumption and other food for specialised nutrition suitable for people intolerant to gluten under the rules specified in article 4 of Commission Regulation (EC) No 41/2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten which do not allow the use of the statement ‘very low gluten’ for these foods. Such food for specialized nutrition intended for people intolerant to gluten shall be maintained in this Regulation, as providing such safe food intended for people intolerant to gluten and informing coeliacs about the absence of gluten is vital to the management of the disease. This is in line with the international standard for food for special dietary use for persons intolerant to gluten (CODEX STAN 118-1979 revised in 2008). Also the conditions of use of the claim ‘gluten-free’ for food for normal consumption should be maintained in Regulation (CE) No 41/2009.
Amendment 43 #
Proposal for a regulation
Article 1 – paragraph 1 – introductory part
Article 1 – paragraph 1 – introductory part
1. This Regulation establishes compositional and information requirements for the following categories of food for specialized nutrition:
Amendment 46 #
Proposal for a regulation
Article 1 – paragraph 1 – point c a (new)
Article 1 – paragraph 1 – point c a (new)
(c a) food for people intolerant to gluten
Amendment 50 #
Proposal for a regulation
Article 2 – paragraph 2 – point h a (new)
Article 2 – paragraph 2 – point h a (new)
(h a) ‘food for people intolerant to gluten’ means foodstuffs for particular nutritional uses which are specially produced, prepared and/or processed to meet the special dietary needs of people intolerant to gluten
Amendment 57 #
Proposal for a regulation
Title
Title
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on food intended for infants and young children and, on food for special medical purposes and on foodstuffs for people intolerant to gluten
Amendment 58 #
Proposal for a regulation
Title
Title
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on food intended for infants and young children and on, food for special medical purposes and other food for specialised nutrition
Amendment 64 #
Proposal for a regulation
Recital 7
Recital 7
(7) Directive 2009/39/EC foresees that specific provisions could be adopted regarding the two following specific categories of food falling within the definition of foodstuffs for particularspecialised nutritional uses: ‘food intended to meet the expenditure of intense muscular effort, especially for sportsmen’ and ‘food for persons suffering from carbohydrate metabolism disorders (diabetes)’. With regard to food intended to meet the expenditure of intense muscular effort, no successful conclusion could be reached to date as regard the development of specific provisions due to widely diverging views among Member States and stakeholders concerning the scope of the specific legislation, the number of sub- categories of the food to be included, the criteria for establishing composition requirements and the potential impact on innovation in product development, the mandatory information for the safe use of food intended to meet the expenditure of intense muscular effort, and the potential impact on innovation in product development. There is a genuine need for harmonisation of the category of food intended to meet the expenditure of intense muscular effort, especially for sportsmen. Harmonisation will remove barriers to free movement of this category of food, while providing sportsmen a high level of safety and guaranteeing the absence of doping substances, the latter being considered as a priority by the European Commission in its communication on Sports of 18th January 2011. As regards special provisions for food for persons suffering from carbohydrate metabolism disorders (diabetes), a Commission report9 concludes that the scientific basis for setting specific compositional requirements is lacking.
Amendment 65 #
Proposal for a regulation
Article 9 – paragraph 4
Article 9 – paragraph 4
4. TParagraph 3 shall not prevent the dissemination of any useful information or recommendations with reference to the categories of food referred to in Article 1 (1) may be made exclusively byexclusively intended for persons having qualifications in medicine, nutrition, pharmacy or other professionals responsible for maternal and child health care.
Amendment 67 #
Proposal for a regulation
Recital 13
Recital 13
(13) Therefore, the concept of ‘foodstuffs for particular nutritional uses’ should be abolished andspecialised nutrition' should be maintained but strictly limited to products that can demonstrate their unique ability to fulfil the specific nutritional needs of vulnerable groups of the population, which otherwise could not be placed on the market using current Union acts and where harmonisation ensures the free movement of such food in a satisfactory manner. Directive 2009/39/EC should be replaced by the present act. To simplify its application and to ensure consistency throughout the Member States, the present act should take the form of a Regulation.
Amendment 68 #
Proposal for a regulation
Recital 15
Recital 15
(15) A limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment; such categories of food are vital for the management of certain conditions and/or are essential to maintain the intended nutritional adequacy for certain well-established vulnerable groups of the population. Those categories of food include infant formulae and follow-on formulae, processed cereal-based food and baby food and, food for special medical purposes, and foods for people intolerant to gluten. Experience has shown that the provisions laid down in Commission Directive 2006/141/EC, Commission Directive 2006/125/EC, as well as Commission Directive 1999/21/EC, and Commission Regulation 41/2009 ensure the free movement of such food in a satisfactory manner, while ensuring a high level of protection of public health. It is therefore appropriate that this Regulation focuses on the general compositional and information requirements for infant formula and follow-on formulae, processed cereal- based food and baby food for infants and young children and to, food for special medical purposes, and foods for people intolerant to gluten, taking into account Commission Directive 2006/141/EC, Commission Directive 2006/125/EC and Commission Directive 1999/21/EC, and Commission Regulation (EC) No 41/2009.
Amendment 69 #
Proposal for a regulation
Recital 15
Recital 15
(15) A limited number of categories of food constitutes the sole source of nourishment of certain groups of the population or represent a partial source of nourishment; such categories of food are vital for the management of certain conditions and/or are essential to maintain the intended nutritional adequacy for certain well-established vulnerable groups of the population. Those categories of food include infant formulae and follow-on formulae, processed cereal-based food and baby food and, food for special medical purposes, food intended for weight reduction and control, and food intended to meet the expenditure of intense muscular effort. Experience has shown that the provisions laid down in Commission Directive 2006/141/EC, Commission Directive 2006/125/EC, Commission Directive 1999/21/EC, as well as Commission Directive 1999/2196/8/EC ensure the free movement of such food in a satisfactory manner, while ensuring a high level of protection of public health. It is therefore appropriate that this Regulation focuses on the general compositional and information requirements for infant formula and follow-on formulae, processed cereal-based food and baby food for infants and young children and to, food for special medical purposes, food intended for weight reduction and control, and food intended to meet the expenditure of intense muscular effort, taking into account Commission Directive 2006/141/EC, Commission Directive 2006/125/EC and, Commission Directive 1999/21/EC. and Commission Directive 96/8/EC. In addition, the concept of 'specialised nutrition' should be maintained and strictly limited to products that demonstrate their unique ability to fulfil the specific nutritional needs of vulnerable groups of the population, which otherwise could not be placed on the market using current Union acts.
Amendment 71 #
Proposal for a regulation
Article 10 – paragraph 2 – introductory part
Article 10 – paragraph 2 – introductory part
2. Subject to the general requirements of Articles 7 and 9 and taking into account Directive 2006/141/EC, Directive 2006/125/EC and Directive 1999/21/EC, and Regulation (EC) No 41/2009 as well as any technical and scientific progress, the Commission shall be empowered to adopt delegated Regulations, for foods covered under Article 1(1) no later than [2 years after the date of the entry into force of this Regulation], in accordance with Article 15, with respect to the following:
Amendment 76 #
Proposal for a regulation
Recital 16
Recital 16
(16) To ensure legal certainty, definitions laid down in Commission Directive 2006/141/EC, Commission Directive 2006/125/EC and, Commission Directive 1999/21/EC, and Commission Regulation 41/2009 should be transferred to this Regulation. However, the definitions of infant formulae and follow-on formulae, processed cereal-based food and baby food, and food for special medical purposes, and foods for people intolerant to gluten should be regularly adapted taking into account technical and scientific progress and relevant developments at international level, as appropriate.
Amendment 80 #
Proposal for a regulation
Recital 16
Recital 16
(16) To ensure legal certainty, definitions laid down in Commission Directive 2006/141/EC, Commission Directive 2006/125/EC and, Commission Directive 1999/21/EC and Commission Directive 96/8/EC should be transferred to this Regulation. However, the definitions of infant formulae and follow-on formulae, processed cereal-based food and baby food, and food for special medical purposes, food intended for weight reduction and control, and food intended to meet expenditure for intense muscular effort should be regularly adapted taking into account technical and scientific progress and relevant developments at international level, as appropriate.
Amendment 88 #
Proposal for a regulation
Recital 19
Recital 19
(19) This Regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula, follow-on formula, processed cereal-based food and baby food, and food for special medical purposes, and foods for people intolerant to gluten, taking into account Commission Directive 2006/141/EC, Commission Directive 2006/125/EC and, Commission Directive 1999/21/EC, Commission Regulation (EC) No 41/2009. In order to adapt the definitions of infant formula, follow-on formula, processed cereal-based food and baby food, and food for special medical purposes, and foods for people intolerant to gluten laid down in this Regulation taking into account technical and scientific progress and relevant developments at international level, to lay down the specific compositional and information requirements with respect to the categories of food covered by this Regulation, including for additional labelling requirements to, or derogations from, the provisions of Directive 2000/13/EC and for the authorisation of nutrition and health claims, 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. It is of particular importance that the Commission carries 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 91 #
Proposal for a regulation
Article 17 – paragraph 2
Article 17 – paragraph 2
Amendment 94 #
Proposal for a regulation
Recital 19
Recital 19
(19) This Regulation should provide the criteria for the establishment of the specific compositional and information requirements for infant formula, follow-on formula, processed cereal-based food and baby food, and food for special medical purposes, food intended for weight reduction and control, and food intended to meet expenditure of intense muscular effort, taking into account Commission Directive 2006/141/EC, Commission Directive 2006/125/EC and, Commission Directive 1999/21/EC and Commission Directive 96/8/EC. In order to adapt the definitions of infant formula, follow-on formula, processed cereal-based food and baby food, and food for special medical purposes, food intended for weight reduction and control, and food intended to meet the expenditure of intense muscular effort laid down in this Regulation taking into account technical and scientific progress and relevant developments at international level, to lay down the specific compositional and information requirements and the process for placing on the market of food resulting from scientific and technological innovations with respect to the categories of food covered by this Regulation, including for additional labelling requirements to, or derogations from, the provisions of Directive 2000/13/EC and for the authorisation of nutrition and health claims, 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. It is of particular importance that the Commission carries 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 98 #
Proposal for a regulation
Recital 19 a (new)
Recital 19 a (new)
(19a) Whereas food controlled by this Regulation is specialised food distinguishable from foodstuffs intended for normal consumption, and which is governed by specific compositional criteria and which is required to provide additional mandatory labelling information to foodstuffs intended for normal consumption, it is appropriate to provide derogations, where appropriate, to those mandatory labelling requirements laid down in Regulation (EU) No 1169/2011.
Amendment 101 #
Proposal for a regulation
Recital 20
Recital 20
(20) It is appropriate to establish and update a Union list of vitamins, minerals, amino acids and other substances that may be addedsubstances that may be added for specific nutritional purposes to infant formula, follow-on formula, processed cereal-based food and baby foods, and food for special medical purposes, and foods for people intolerant to gluten, taking into account Regulation (EC) No. 953/2009, Commission Directives 2006/141/EC and 2006/125/EC, subject to certain criteria laid down in this Regulation. Given the fact that the adoption of the list implies the application of criteria set out in this Regulation, implementing powers should be conferred on the Commission in that respect. Those powers should be exercised in accordance with 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. The Commission should adopt immediately applicable implementing acts updating the Union list, where, in duly justified cases relating to public health, imperative grounds of urgency so require.
Amendment 102 #
Proposal for a regulation
Recital 20
Recital 20
(20) It is appropriate to establish and update a Union list of vitamins, minerals, amino acids and other substances that may be addedsubstances that may be added for specific nutritional purposes to infant formula, follow-on formula, processed cereal-based food and baby food, and food for special medical purposes and food intended for weight reduction and control, taking into account Regulation 953/2009, Commission Directive 2006/141/EC and Commission Directive 2006/125/EC, subject to certain criteria laid down in this Regulation. Given the fact that the adoption of the list implies the application of criteria set out in this Regulation, implementing powers should be conferred on the Commission in that respect. Those powers should be exercised in accordance with 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. The Commission should adopt immediately applicable implementing acts updating the Union list, where, in duly justified cases relating to public health, imperative grounds of urgency so require.
Amendment 112 #
Proposal for a regulation
Recital 26
Recital 26
(26) Currently, the statements ‘'gluten-free’' and ‘'very low gluten’' may be used for food intended for particular nutritional uses and for food for normal consumptios for specialised nutrition intended for people intolerant to gluten under the rules specified in article 3 of Commission Regulation (EC) No 41/2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten. Such statements could be construed as nutrition claims, as deIn addition, the statement 'gluten-free' may be used for foodstuffs for normal consumption and other foods for specialised nutrition suitable for people intolerant to gluten under the rules specifined in Regulation (EC) No 1924/2006. For the sake of simplification, those statements should be regulated solely by Regulation (EC) No 1924/2006 and comply with requirements therein. It is necessary that technical adaptations pursuant to Regulation (EC) No 1924/2006, incorporating the nutrition claims ‘gluten-free’ and ‘very low gluten’ and their associated conditions of use as regulated under Regulation (EC) No 41/2009 be completed prior to the entry into application ofarticle 4 of Commission Regulation (EC) No 41/2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten which do not allow the use of the statement 'very low gluten' for these foods. Such foods for specialized nutrition intended for people intolerant to gluten shall be maintained in this Regulation, as providing such safe foods intended for people intolerant to gluten and informing coeliacs about the absence of gluten is vital to the management of the disease. This is in line with the international standard for foods for special dietary use for persons intolerant to gluten (CODEX STAN 118-1979 revised in 2008). Also the conditions of use of the claim "gluten- free" for foods for normal consumption should be maintained in thise Regulation (CE) 41/2009.
Amendment 117 #
Proposal for a regulation
Recital 27
Recital 27
Amendment 121 #
Proposal for a regulation
Article 1 – paragraph 1 – introductory part
Article 1 – paragraph 1 – introductory part
1. This Regulation establishes compositional and information requirements for the following categories of food for specialised nutrition:
Amendment 122 #
Proposal for a regulation
Article 1 – paragraph 1 – introductory part
Article 1 – paragraph 1 – introductory part
1. This Regulation establishes compositional and information requirements for the following categories of food for specialised nutrition:
Amendment 126 #
Proposal for a regulation
Article 1 – paragraph 1 – point a
Article 1 – paragraph 1 – point a
(a) infant formula and follow-on formula for infants in good health;
Amendment 130 #
Proposal for a regulation
Article 1 – paragraph 1 – point c a (new)
Article 1 – paragraph 1 – point c a (new)
(ca) food for people intolerant to gluten.
Amendment 131 #
Proposal for a regulation
Article 1 – paragraph 1 – point c a (new)
Article 1 – paragraph 1 – point c a (new)
(ca) food for people intolerant to gluten.
Amendment 139 #
Proposal for a regulation
Article 1 – paragraph 1 – point c b (new)
Article 1 – paragraph 1 – point c b (new)
(cb) food intended for weight reduction and control;
Amendment 140 #
Proposal for a regulation
Article 1 – paragraph 1 – point c c (new)
Article 1 – paragraph 1 – point c c (new)
(cc) food intended to meet the expenditure of intense muscular effort.
Amendment 142 #
Proposal for a regulation
Article 1 – paragraph 1 a (new)
Article 1 – paragraph 1 a (new)
1a. This Regulation establishes rules for the placing on the market of other food for specialised nutrition.
Amendment 149 #
Proposal for a regulation
Article 2 – paragraph 2 – point a a(new)
Article 2 – paragraph 2 – point a a(new)
(aa) 'food for specialised nutrition' means foodstuffs which, owing to their special composition or manufacturing process, are clearly distinguishable from foodstuffs for normal consumption, which are suitable for their claimed nutritional purposes and which are marketed in such a way as to indicate such suitability.
Amendment 151 #
Proposal for a regulation
Article 2 – paragraph 2 – point g – point ii
Article 2 – paragraph 2 – point g – point ii
Amendment 162 #
Proposal for a regulation
Article 2 – paragraph 2 – point h a (new)
Article 2 – paragraph 2 – point h a (new)
(ha) 'food intended for weight reduction and control' means food specially formulated, when used as instructed by the manufacturer, to replace the whole or part of the total daily diet: (i) for use in energy-restricted diets for weight reduction. They are divided in two categories: – products presented as a replacement for the whole of the daily diet (low calorie diet and very low calorie diet); – products presented as a replacement for one or more meals of the daily diet (meal replacement); (ii) for weight control (products presented as a dish or part of a meal or light meal or snack).
Amendment 166 #
Proposal for a regulation
Article 2 – paragraph 2 – point h a (new)
Article 2 – paragraph 2 – point h a (new)
(ha) 'food intended to meet the expenditure of intense muscular effort' means food specially formulated and presented to meet the expenditure of intense muscular effort, especially for sportsmen.
Amendment 170 #
Proposal for a regulation
Article 2 – paragraph 3
Article 2 – paragraph 3
3. The Commission shall be empowered to adopt delegated acts in accordance with Article 15 to adapt the definitions of ‘'infant formula’', ‘'follow-on formula’', ‘'processed cereal-based food’' and ‘'baby food’ and ‘', 'food for special medical purposes’', and 'food for people intolerant to gluten' taking into account technical and scientific progress and relevant developments at international level, as appropriate.
Amendment 171 #
Proposal for a regulation
Article 2 – paragraph 3
Article 2 – paragraph 3
3. The Commission shall be empowered to adopt delegated acts in accordance with Article 15 to adapt the definitions of ‘infant formula’, ‘follow-on formula’, ‘processed cereal-based food’ and ‘baby food’ and, ‘food for special medical purposes’, 'food intended for weight reduction and control' and 'food intended to meet the expenditure of intense muscular effort', taking into account technical and scientific progress and relevant developments at international level, as appropriate.
Amendment 174 #
Proposal for a regulation
Article 3
Article 3
Food referred to in Article 1(1) and 1(1a) may be placed on the market only if it complies with the provisions of this Regulation.
Amendment 182 #
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. Where it is evident that a food referred to in Article 1(1) and 1(1a) is likely to constitute a serious risk to human health and that such risk cannot be contained satisfactorily by means of measures taken by the Member State(s) concerned, the Commission on its own initiative or at the request of a Member State, shall without delay take any appropriate interim emergency measures, including measures restricting or prohibiting the placing on the market of the food concerned, depending on the gravity of the situation. Those measures shall be adopted by means of implementing acts in accordance with the examination procedure referred to in Article 14(2).
Amendment 184 #
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
1. Food referred to in Article 1(1) shall comply with any requirement of Union law applicable to food, save as regards changes made to them to ensure their conformity with the definitions given in Article 1.
Amendment 186 #
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
1. The composition of food referred to in Article 1(1) and 1(1a) shall be such that it is appropriate to satisfy the specific nutritional needs of, and it is suitable for the persons to whom it is intended, in accordance with generally accepted scientific data.
Amendment 188 #
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. Food referred to in Article 1(1) and 1(1a) shall not contain any substance in such quantity as to endanger the health of the persons to whom they are intended.
Amendment 193 #
Proposal for a regulation
Article 9 – paragraph 3
Article 9 – paragraph 3
3. The labelling, presentation and advertising of food referred to in Article 1(1) and 1(1a) shall provide adequate consumer information and must not be misleading and shall not attribute properties to such products for the prevention, treatment or cure of human disease, or imply such properties.
Amendment 198 #
Proposal for a regulation
Article 9 – paragraph 4
Article 9 – paragraph 4
4. TParagraph 3 shall not prevent the dissemination of any useful information or recommendations with reference to the categories of food referred to in Article 1 (1) may be made exclusively byexclusively intended for persons having qualifications in medicine, nutrition, pharmacy or other professionals responsible for maternal and child health care. Or. en (See Directive 2009/39/EC, Article 8(2).)
Amendment 207 #
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
1. Food referred to in Article 1(1) and 1(1a) must comply with the requirements of Article 7 and composition and information requirements provided in Article 9.
Amendment 208 #
Proposal for a regulation
Article 10 – paragraph 2 – introductory part
Article 10 – paragraph 2 – introductory part
2. Subject to the general requirements of Articles 7 and 9 and taking into account Directive 2006/141/EC, Directive 2006/125/EC and, Directive 1999/21/EC and Regulation (EC) No 41/2009, as well as any technical and scientific progress, the Commission shall be empowered to adopt delegated Regulations, for foods covered by Article 1(1) no later than [2 years after the date of the entry into force of this Regulation], in accordance with Article 15, with respect to the following:
Amendment 209 #
Proposal for a regulation
Article 10 – paragraph 2 – introductory part
Article 10 – paragraph 2 – introductory part
2. Subject to the general requirements of Articles 7 and 9 and taking into account Directive 2006/141/EC, Directive 2006/125/EC and, Directive 1999/21/EC and Directive 96/8/EC as well as any technical and scientific progress, the Commission shall be empowered to adopt delegated Regulations for foods covered by Article 1(1), no later than [2 years after the date of the entry into force of this Regulation], in accordance with Article 15, with respect to the following:
Amendment 220 #
Proposal for a regulation
Article 10 – paragraph 2 – point e a (new)
Article 10 – paragraph 2 – point e a (new)
(ea) the process for the placing on the market of food referred to in Article 1(1) resulting from scientific and technological innovations which do not comply with the rules as to composition laid down by the delegated regulations;
Amendment 223 #
Proposal for a regulation
Article 10 – paragraph 2 – point f a (new)
Article 10 – paragraph 2 – point f a (new)
(fa) the requirements for information to be provided on recommendations for appropriate use of the foods referred to in Article 1(1).
Amendment 226 #
Proposal for a regulation
Article 10 – paragraph 2 – subparagraph 1a (new)
Article 10 – paragraph 2 – subparagraph 1a (new)
Due to the additional specific requirements on mandatory information to be provided on labels of certain foods referred to in Article 1(1) of this Regulation, the Commission may, if appropriate, establish by means of the delegated regulations referred to in paragraph 2, derogations from the minimum font size and other legibility requirements established in Article 13(2) of Regulation (EU) No 1169/2011;
Amendment 268 #
Proposal for a regulation
Article 17 – paragraph 2
Article 17 – paragraph 2
Amendment 269 #
Proposal for a regulation
Article 17 – paragraph 2
Article 17 – paragraph 2
Amendment 276 #
Proposal for a regulation
Article 18
Article 18
Food not complying with this Regulation but complying with Directives 2009/39/EC and 96/8/EC, Regulations (EC) No 41/2009 and (EC) No 953/2009, and labelled prior to [2 years after the date of the entry into forceapplication of this Regulation] may continue to be marketed after that date until stocks are exhausted.
Amendment 277 #
Proposal for a regulation
Article 18 – paragraph 1 a (new)
Article 18 – paragraph 1 a (new)
Regulation (EC) No 1169/2011 shall apply to food referred to in Article 1(1) 3 years after the date of the entry into force of the delegated regulations referred to in Article 10(2) of this Regulation.