24 Amendments of Gianni PITTELLA related to 2011/0156(COD)
Amendment 32 #
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 foodstuffs 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 foodstuffs 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. 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 under current Union legislation.
Amendment 39 #
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 foodstuffs 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 45 #
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 foodstuffs 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. 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 foodstuffs 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 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 49 #
Proposal for a regulation
Recital 19 a (new)
Recital 19 a (new)
(19a) Whereas foods controlled by this Regulation are specialised foods distinguishable from foodstuffs intended for normal consumption, and which are governed by specific compositional criteria and which are 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 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers. ________________ 1 OJ L 304, 22.11.2011, p. 18.
Amendment 53 #
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 foodstuffs for people intolerant to gluten, taking into account Regulation (EC) No 953/2009, and 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 58 #
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 CommissionArticle 3 of 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. In 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 specified in Article 4 of Regulation (EC) No 41/2009 which do not allow the usake 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 Regulationthe statement ‘very low gluten’ for these foods. Such foods for specialized nutrition intended for people intolerant to gluten should 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).
Amendment 68 #
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 foods for specialised nutrition:
Amendment 71 #
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 76 #
Proposal for a regulation
Article 1 – paragraph 1 – point c a (new)
Article 1 – paragraph 1 – point c a (new)
(ca) foodstuffs for people intolerant to gluten;
Amendment 93 #
Proposal for a regulation
Article 2 – paragraph 2 – point h a (new)
Article 2 – paragraph 2 – point h a (new)
(ha) ‘foodstuffs 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 104 #
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 ‘foodstuffs for people intolerant to gluten’ taking into account technical and scientific progress and relevant developments at international level, as appropriate.
Amendment 107 #
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
Food referred to in Article 1(1) and (2) may be placed on the market only if it complies with the provisions of this Regulation.
Amendment 111 #
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 (2) 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 114 #
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
1. The composition of food referred to in Article 1(1) and (2) 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 116 #
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. Food referred to in Article 1(1) and (2) shall not contain any substance in such quantity as to endanger the health of the persons to whom they are intended.
Amendment 118 #
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 (2) 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 123 #
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, and pharmacy or other professionals responsible for maternal and child health care.
Amendment 127 #
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
1. Food referred to in Article 1(1) and (2) must comply with the requirements of Article 7 and composition and information requirements provided in Article 9.
Amendment 131 #
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 referred to in 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 137 #
Proposal for a regulation
Article 10 – paragraph 2 – point f a (new)
Article 10 – paragraph 2 – point f a (new)
(fa) 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 139 #
Proposal for a regulation
Article 10 – paragraph 2 – point f b (new)
Article 10 – paragraph 2 – point f b (new)
(fb) the requirements for information to be provided on recommendations for appropriate use of the foods referred to in Article 1(1).
Amendment 146 #
Proposal for a regulation
Article 17 – paragraph 2
Article 17 – paragraph 2
Amendment 151 #
Proposal for a regulation
Article 18 – paragraph 1
Article 18 – paragraph 1
1. 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 [25 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 153 #
Proposal for a regulation
Article 18 – paragraph 1 a (new)
Article 18 – paragraph 1 a (new)
1a. Regulation (EU) No 1169/2011 on shall apply to food referred to in Article 1(1) from ...*. ________________ * OJ Please insert date: three years after entry into force of the delegated Regulations referred to in Article 10(2) of this Regulation.