Activities of Elisabetta GARDINI 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 (41)
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 23 #
Proposal for a regulation
Title 1
Title 1
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on food intended for infants and young children and on, foods 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 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 33 #
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.
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 38 #
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 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 44 #
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 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 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 52 #
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 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 54 #
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 56 #
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 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. 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 use of the 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 puersuant to Regulation (EC) No 1924/2006, incorporatingons intolerant to gluten (CODEX STAN 118- 1979 revised in 2008). Also the nutrconditions of use of the 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 Regulationfor foods for normal consumption should be maintained in the Regulation (EC) No 41/2009.
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 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 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 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 77 #
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 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
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 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 103 #
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 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 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 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 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 130 #
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 145 #
Proposal for a regulation
Article 17 – paragraph 2
Article 17 – paragraph 2
Amendment 153 #
Proposal for a regulation
Article 2 – paragraph 2 – point g – point ii
Article 2 – paragraph 2 – point g – point ii
Amendment 163 #
Proposal for a regulation
Article 2 – paragraph 2 – point h a (new)
Article 2 – paragraph 2 – point h a (new)
(ha) '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 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 200 #
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 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 229 #
Proposal for a regulation
Article 10 – paragraph 2 a (new)
Article 10 – paragraph 2 a (new)
2a. Without prejudice to the criteria for certain contaminants levels laid down in Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs, the microbiological criteria laid down in Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs shall apply to milk-based drinks intended for young children currently on the market during the transition period laid down in Article 18 of this Regulation.
Amendment 230 #
Proposal for a regulation
Article 10 – paragraph 2 b (new)
Article 10 – paragraph 2 b (new)
Amendment 268 #
Proposal for a regulation
Article 17 – paragraph 2
Article 17 – paragraph 2