REPORT on the 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

26.4.2012 - (COM(2011)0353 – C7‑0169/2011 – 2011/0156(COD)) - ***I

Committee on the Environment, Public Health and Food Safety
Rapporteur: Frédérique Ries

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

on the 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

(COM(2011)0353 – C7‑0169/2011 – 2011/0156(COD))

(Ordinary legislative procedure: first reading)

The European Parliament,

–   having regard to the Commission proposal to Parliament and the Council (COM(2011)0353),

–   having regard to Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7‑0169/2011),

–   having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–   having regard to the reasoned opinion submitted, within the framework of the Protocol (No 2) on the application of the principles of subsidiarity and proportionality, by the Italian Senate, asserting that the draft legislative act does not comply with the principle of subsidiarity,

–   having regard to the opinion of the European Economic and Social Committee of 26 October 2011[1],

–   having regard to Rule 55 of its Rules of Procedure,

–   having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinions of the Committee on Industry, Research and Energy and the Committee on the Internal Market and Consumer Protection (A7-0059/2012),

1.  Adopts its position at first reading hereinafter set out;

2.  Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Amendment  1 Proposal for a regulation Title
Text proposed by the Commission	Amendment
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	Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on food intended for infants and young children, on food for special medical purposes, on food for people intolerant to gluten and on food intended for use in low and very low calory diets
Justification
Some essential guarantees that are offered in the current dietetic Framework Directive (2009/39/EC) and under its relevant Vertical Directives have been removed in this proposal to the detriment of vulnerable consumers. These consumers require foods that are specially formulated to provide specialised nutrition and to help them in the dietary management of specific conditions. It is therefore necessary to re-introduce the concept of food intended for specialised nutrition. This is aligned with the current Codex standard for foods for special dietary uses (146-1985).
Amendment  2 Proposal for a regulation Recital 2
Text proposed by the Commission	Amendment
(2) The free movement of safe and wholesome food is an essential aspect of the internal market and contributes significantly to the health and well-being of citizens, and to their social and economic interests.	(2) The safety of food, especially when it is intended for vulnerable groups, such as infants, young children and persons with special diseases, is an essential prerequisite for the free movement of such persons and the proper functioning of the internal market.
Justification
The focus needs to be shifted: if we are to expect the internal market to work properly, we cannot afford to disregard the health of the more vulnerable members of society.
Amendment  3 Proposal for a regulation Recital 2 a (new)
Text proposed by the Commission	Amendment
	(2a) In this context, given that the relevant Union law has been drawn up to ensure that no food is placed on the market if it is dangerous, any substances that are liable to be harmful to the health of the groups of the population concerned should be excluded from the composition of categories of foods covered by this Regulation.
Justification
The current EU legislation must not allow the presence of pesticide residues in formulae for infants under the age of 12 months or children under the age of 3. Early exposure to such toxic products may prove to have irreversible effects. There is an urgent need to apply the principle of prohibiting the use of pesticides in products of animal origin such as milk, but also to impose more stringent checks.
Amendment  4 Proposal for a regulation Recital 3
Text proposed by the Commission	Amendment
(3) Directive 2009/39/EC of the European Parliament and of the Council of 6 May 2009 on foodstuffs intended for particular nutritional uses lays down general rules on the composition and preparation of such foods that are specially designed to meet the particular nutritional requirements of the persons to whom they are intended. The majority of the provisions laid down in that Directive date back to 1977 and should therefore be reviewed.	(3) Directive 2009/39/EC of the European Parliament and of the Council of 6 May 2009 on foodstuffs intended for particular nutritional uses lays down general rules on the composition and preparation of such foods that are specially designed to meet the particular nutritional requirements of the persons to whom they are intended. The majority of the provisions laid down in that Directive date back to 1977 and fail to address the difficulty experienced by consumers in making an informed choice between dietetic foods, fortified foods, foods bearing claims and foods for normal consumption. The interaction between that legislation and Union law adopted more recently, such as Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements, Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods, Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and other substances to food and 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, is a further factor making it necessary to thoroughly overhaul Directive 2009/39/EC.
Justification
The rapporteur shares the Commission’s view that the framework directive on foodstuffs for particular nutritional uses needs to be thoroughly overhauled. Operators have taken advantage of the variety of laws available to them to market similar products under different names.
Amendment  5 Proposal for a regulation Recital 6 a (new)
Text proposed by the Commission	Amendment
	(6a) Having regard to the Council Resolution of 18 June 1992 on the marketing of breast-milk substitutes in third countries by Community-based manufacturers1.
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	1 OJ C 172, 8.7.1992, p. 1.
Amendment  6 Proposal for a regulation Recital 7
Text proposed by the Commission	Amendment
(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 particular 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 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. As regards special provisions for food for persons suffering from carbohydrate metabolism disorders (diabetes), a Commission report1 concludes that the scientific basis for setting specific compositional requirements is lacking.	(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 particular 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 as regards the development of specific provisions due to widely diverging views among Member States and stakeholders concerning the scope of the specific legislation. Nevertheless, the undertaking made by the Commission in Directive 2009/39/EC to recognise the nutritional requirements of sportspeople should still apply, as supported by EFSA scientific opinions on claims relevant to active individuals, and the report of the Scientific Committee on Food of 28 February 2001 on composition and specification of food intended to meet the expenditure of intense muscular effort, especially for sportsmen. Therefore, the Commission should assess, not later than 1 July 2015, the need to review general food law in this regard.
Amendment  7 Proposal for a regulation Recital 7 a (new)
Text proposed by the Commission	Amendment
	(7a) The Commission report of 26 June 2008 on food for persons suffering from carbohydrate metabolism disorders (diabetes) concludes that the scientific basis for setting specific compositional requirements is lacking. This Regulation is therefore not the appropriate legal framework for that category of food. According to the Commission, it is more important, as regards persons with diabetes, to consider the quantity and model of food absorbed. This conclusion is in no way contrary to the establishment of an Union-wide strategy comprehensively targeting diabetes (Type 1 and Type 2), which affects more than 32 million Union citizens. Those figures, which are expected to increase by 16% by 2030 as a result of the obesity epidemic and the ageing of the European population, therefore merit careful consideration at Union level, including in the area of research and development.
Justification
This Regulation is not the appropriate legal framework for examining the whole range of aspects of the important issue of diabetes at EU level.
Amendment  8 Proposal for a regulation Recital 11 a (new)
Text proposed by the Commission	Amendment
	(11a) There is therefore a need to remove differences in interpretation and to tackle difficulties for Member States and operators in combining the different pieces of food legislation, by simplifying the regulatory environment. This would ensure that similar products are treated in the same way across the Union and would create a more level playing field for all operators across the internal market, especially SMEs.
Amendment  9 Proposal for a regulation Recital 14
Text proposed by the Commission	Amendment
(14) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety establishes common principles and definitions for Union food law in order to ensure a high level of health protection and the effective functioning of the internal market. It establishes the principles of risk analysis in relation to food and establishes the structures and mechanisms for the scientific and technical evaluations which are undertaken by the European Food Safety Authority (hereinafter referred to as 'the Authority'). Therefore, certain definitions laid down in that Regulation must also apply in the context of the present Regulation. Moreover, for the purpose of this Regulation, the Authority should be consulted on all matters likely to affect public health.	(14) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety establishes common principles and definitions for Union food law in order to ensure a high level of protection of human health and consumers' interest, while ensuring the effective functioning of the internal market. It establishes the principles of risk analysis in relation to food, sets out that pursuant to the precautionary principle provisional risk management measures can be adopted, and establishes the structures and mechanisms for the scientific and technical evaluations which are undertaken by the European Food Safety Authority (hereinafter referred to as 'the Authority'). Therefore, certain definitions laid down in that Regulation must also apply in the context of the present Regulation. Moreover, for the purpose of this Regulation, the Authority should be consulted on all matters likely to affect public health.
Justification
The precautionary principle, considered as a provisional risk management measure, forms part of the general principles set out in the general legislation on food of 28 January 2002.
Amendment  10 Proposal for a regulation Recital 14 a (new)
Text proposed by the Commission	Amendment
	(14a) Where a risk to life or health exists, whether immediate or in the long term, but scientific uncertainty persists, the precautionary principle should apply to ensure a high level of health protection, taking into account cumulative toxic effects and the particular health sensitivities of the particularly vulnerable groups of the population specified in this Regulation.
Justification
Linked with amendment 9.
Amendment  11 Proposal for a regulation Recital 15
Text proposed by the Commission	Amendment
(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. 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 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, taking into account Commission Directive 2006/141/EC, Commission Directive 2006/125/EC and Commission Directive 1999/21/EC.	(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, food for special medical purposes, food for people intolerant to gluten and food for use in low calorie diets (LCD) and very low calorie diets (VLCD). 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 ensure the free movement of such food in a satisfactory manner, while ensuring a high level of protection of public health. VLCD products are currently not covered by Commission Directive 96/8/EC but solely by Directive 2009/39/EC. 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, food for special medical purposes, food for people intolerant to gluten and food intended for use in low calorie diets (LCD) and very low calorie diets (VLCD), while taking into account Commission Directive 2006/141/EC, Commission Directive 2006/125/EC and Commission Directive 1999/21/EC.
Amendment  12 Proposal for a regulation Recital 16
Text proposed by the Commission	Amendment
(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 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 should be regularly adapted taking into account technical and scientific progress and relevant developments at international level, as appropriate.	(16) To ensure legal certainty, definitions laid down in Commission Directive 2006/141/EC, Commission Directive 2006/125/EC, Commission Directive 1999/21/EC, Commission Regulation (EC) No 41/2009 and Commission Directive 96/8 should be transferred to this Regulation. However, the definitions of infant formulae and follow-on formulae, processed cereal-based food and baby food, food for special medical purposes, food for people intolerant to gluten and food intended for use in low calorie diets (LCD) and very low calorie diets (VLCD) should be regularly adapted taking into account technical and scientific progress and relevant developments at international level, as appropriate.
Amendment  13 Proposal for a regulation Recital 16 a (new)
Text proposed by the Commission	Amendment
	(16a) According to the WHO recommendations, low-birth weight infants should be fed their mother's own milk. Nonetheless, low birth-weight infants and pre-term infants often have special nutritional requirements which cannot be met by the mother's own milk or standard infant formulae. Food for such infants should comply with rules applicable to food for special medical purposes, when this kind of food is chosen as the most appropriate formula, taking into account the specific medical situation of the infant. Formula intended for low birth weight or pre-term infants should in any event comply with the requirements of Directive 2006/141/EC.
Amendment  14 Proposal for a regulation Recital 17
Text proposed by the Commission	Amendment
(17) It is important that ingredients used in the manufacture of the categories of food covered by this Regulation are appropriate to satisfy the nutritional requirements of, and are suitable for the persons to whom they are intended and that their nutritional adequacy has been established by generally accepted scientific data. Such adequacy should be demonstrated through a systematic review of the available scientific data.	(17) It is important that ingredients used in the manufacture of the categories of food covered by this Regulation are appropriate to satisfy the nutritional requirements of, and are suitable for the persons to whom they are intended and that their nutritional adequacy has been established by generally accepted scientific data. Such adequacy should be demonstrated through a systematic and independent review of the available scientific data.
Justification
The scientific data on the nutritional adequacy of the special food must be not only systematic, but also based on independent evaluation, to guarantee the high reliability and general acceptance of such data.
Amendment  15 Proposal for a regulation Recital 17 a (new)
Text proposed by the Commission	Amendment
	(17a) It is important that pesticides, maximum residue levels for which are authorised by Directive 2006/141/EC and Directive 2006/125/EC and which do not satisfy the safety conditions set out in Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market1 be banned from the market and that they not be used in the production of food covered by this Regulation.
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	1 OJ L 309, 24.11.2009, p. 1.
Justification
Cadusafos, which is a member of the organophosphate family of chemicals, has been banned in the territory of the EU since 2008. It must therefore be deleted from the list of the five active substances for which the maximum content of pesticide residue or metabolites in formulae for infants and children under three is fixed. Fipronil, the harmful effects of which have been pointed out by a number of national health authorities, should also be withdrawn.
Amendment  16 Proposal for a regulation Recital 17 b (new)
Text proposed by the Commission	Amendment
	(17b) Maximum residue levels of pesticides set out in relevant Union law, in particular Regulation (EC) No 396/2005 of the Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin1, should apply without prejudice to specific provisions set out in this Regulation and the delegated acts adopted in accordance with this Regulation.
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	1 OJ L 70, 16.3.2005, p. 1.
Amendment  17 Proposal for a regulation Recital 17 c (new)
Text proposed by the Commission	Amendment
	(17c) However, given the vulnerable nature of infants and young children, severe limitations on pesticide residues are required in infant formula and follow-on formula and food for infants and young children. Specific maximum residue levels for such products are set in Commission Directive 2006/141/EC and Commission Directive 2006/125/EC. Particular attention should be paid to pesticides containing substances classified as specifically hazardous to human health.
Amendment  18 Proposal for a regulation Recital 17 d (new)
Text proposed by the Commission	Amendment
	(17d) At all stages of the food production chain, food businesses and food business operators, as defined in Regulation (EC) No 178/2002, should ensure that the food covered by this Regulation comply with the requirements of food law in general and of this Regulation in particular.
Justification
The principle of liability of all actors of the food production chain has to be emphasized in this Regulation.
Amendment  19 Proposal for a regulation Recital 18
Text proposed by the Commission	Amendment
(18) General labelling requirements are laid down in Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the law of the Member States relating to labelling, presentation and advertising of foodstuffs1. Those general labelling requirements should, as a general rule, apply to the categories of food covered by this Regulation. However, this Regulation should also provide for additional requirements to, or derogations from, the provisions of Directive 2000/13/EC, where necessary, in order to meet the specific objectives of this Regulation.	(18) General labelling requirements are laid down in Regulation (EU) No 1169/2011. Those general labelling requirements should, as a general rule, apply to the categories of food covered by this Regulation. However, this Regulation should also provide for additional requirements to, or derogations from, the provisions of Regulation (EU) No 1169/2011, where necessary, in order to meet the specific objectives of this Regulation.
Justification
Since the adoption of the Commission’s proposal for a Regulation on food intended for infants and young children and on food for special medical purposes, Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the law of the Member States relating to labelling, presentation and advertising of foodstuffs has been replaced by 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.
Amendment  20 Proposal for a regulation Recital 19
Text proposed by the Commission	Amendment
(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, taking into account Commission Directive 2006/141/EC, Commission Directive 2006/125/EC and Commission Directive 1999/21/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 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.	(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, food for special medical purposes, food for people intolerant to gluten and food intended for use in low calorie diets (LCD) and very low calorie diets (VLCD), taking into account Commission Directive 2006/141/EC, Commission Directive 2006/125/EC and Commission Directive 1999/21/EC. In order to lay down the specific compositional and information requirements with respect to the categories of food covered by this Regulation, 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.
Justification
It is not appropriate to allow for delegated acts for the updating of the definitions, as the definitions are an essential part of the Regulation which should only be allowed to be changed by the ordinary legislative procedure. The establishment and updating of the list is an act of general application to supplement or amend certain non-essential elements of the legislative act. Moreover the conditions laid down in Article 11(1) are very open. Therefore delegated acts should be applied.
Amendment  21 Proposal for a regulation Recital 19 a (new)
Text proposed by the Commission	Amendment
	(19a) The Commission should, after consulting the European Food Safety Authority, clarify the status of milk intended for children between 12 and 36 months which are currently regulated by different legal acts of the Union , such as Regulation (EC) No 178/2002, Regulation (EC) No 1925/2006, Directive 2009/39/EC, and Regulation (EC) No 1924/2006, and submit a report to the European Parliament and the Council assessing whether further legislative action is required, at the latest 1 year after the date of the entry into force of this Regulation. If appropriate the report should be accompanied by a legislative proposal.
Amendment  22 Proposal for a regulation Recital 20
Text proposed by the Commission	Amendment
(20) It is appropriate to establish and update a Union list of vitamins, minerals, amino acids and other substances that may be added to infant formula, follow-on formula, processed cereal-based food and baby food, and food for special medical purposes, 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.	(20) It is appropriate to establish and update a Union list of vitamins, minerals and other substances that may be added to infant formula, follow-on formula, processed cereal-based food and baby food, food for special medical purposes and food for use in energy-restricted diets, subject to certain criteria laid down in this Regulation. The list should be adopted taking due account of the specific dietary habits of the groups of the population concerned and should take into account and replace the lists set out in Directives 2006/141/EC and 2006/125/EC, and Commission Regulation (EC) No 953/2009 of 13 October 2009 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses1, which does not apply to liquid or solid formula for infants and young children Given the fact that the adoption and updating of the list is a measure of general application to supplement or amend certain non-essential elements of this Regulation, 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 in that respect.. The Commission should adopt immediately applicable delegated acts updating the Union list, where, in duly justified cases relating to public health, imperative grounds of urgency so require.
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	1 OJ L 269, 14.10.2009, p. 9.
Justification
While the Commission’s idea of aiming at a simplified and consolidated model for a single positive list of vitamins, minerals and other nutritional substances is to be supported, it is equally important to specify its content in order to preserve the specific dietary habits of each category. An added nutriment may be good for a sick person, but not necessarily for a new-born baby.
Amendment  23 Proposal for a regulation Recital 21
Text proposed by the Commission	Amendment
(21) At present, pursuant to the Opinion of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) on the risk assessment of products of nanotechnologies, dated 19 January 2009, there is inadequate information on the risks associated with engineered nanomaterials and existing test methods may not be sufficient to address all of the issues arising in relation to engineered nanomaterials. Therefore, engineered nanomaterials should not be included in the Union list for the categories of food covered by this Regulation, until an evaluation by the Authority is carried out.	(21) At present, pursuant to the Opinion of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) on the risk assessment of products of nanotechnologies, dated 19 January 2009, there is inadequate information on the risks associated with engineered nanomaterials and existing test methods may not be sufficient to address all of the issues arising in relation to engineered nanomaterials. Taking account of that scientific opinion and in view of the particular sensitivity of the vulnerable groups for whom foods covered by this Regulation are intended, engineered nanomaterials should not be included in the Union list for the categories of food covered by this Regulation as long as their safety, based on adequate and sufficient test methods, their nutritional value and their suitability for the persons for whom the food is intended have not been demonstrated by the Authority.
Justification
Based on AM 21 by the Rapporteur. Nanomaterials can only be assessed by specific test-methods.
Amendment  24 Proposal for a regulation Recital 22
Text proposed by the Commission	Amendment
(22) In the interests of efficiency and legislative simplification, there should be a medium-term examination of the question whether to extend the scope of the Union list to other categories of food governed by other specific Union legislation.	(22) In the interests of legislative simplification and a clear desire to support innovation, there should be a medium-term examination of the question whether to extend the scope of the Union list to other categories of food governed by other specific Union legislation. Such an extension should be decided by the European Parliament and the Council in accordance with the ordinary legislative procedure, on the basis of an evaluation by the Authority.
Justification
Linked to Amendment 17: any future decision to extend the list to other food categories should be taken subject to the expert assessment of the EFSA and under appropriate democratic scrutiny.
Amendment  25 Proposal for a regulation Recital 26 a (new)
Text proposed by the Commission	Amendment
	(26a) Labelling indicating ‘lactose free’ and ‘very low lactose content’ is currently not covered by Union law. Those indications are, however, important for people who are intolerant to lactose. The Commission should therefore clarify their status under general food law.
Amendment  26 Proposal for a regulation Recital 27
Text proposed by the Commission	Amendment
(27) ‘Meal replacement for weight control’ and ‘total diet replacement for weight control’ are considered as food for particular nutritional uses and are governed by specific rules adopted under Directive 96/8/EC. However, more and more food intended for the general population has appeared on the market carrying similar declarations which are presented as health claims for weight control. In order to eliminate any potential confusion between food marketed for weight control and in the interests of legal certainty and coherence of Union legislation, such 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 health claims referring to the body weight control for food presented as ‘total diet replacement for weight control’ and as ‘meal replacement for weight control’ and associated conditions of use as regulated under Directive 96/8/EC be completed prior to the entry into application of this Regulation.	(27) ‘Meal replacement for weight control’ and ‘total diet replacement for weight control’ are currently considered as food for particular nutritional uses and are governed by specific rules adopted under Directive 96/8/EC, while foods intended for very low calorie diets (VLCD) are governed by Directive 2009/39/EC only. However, more and more food intended for the general population has appeared on the market carrying similar declarations which are presented as health claims for weight control.
	Against the background of the growing number of food products containing generic claims and the risk of disorders in dietary habits arising from certain unsupervised diets, the European Food Safety Authority regularly carries out scientific assessments of health claim applications relating to meal replacement. The assessment carried out by the Authority does not cover the safety of compositional criteria put forward by the operator applying for the use of a claim or certain labelling methods. Specific provisions are therefore needed in this Regulation on food intended for use in energy-restricted diets for weight reduction. Such provisions are an important nutrition and health safety tool for people seeking to lose weight.
	In order to eliminate any potential confusion between food marketed for weight control and in the interests of legal certainty and coherence of Union legislation, while protecting the most vulnerable, such statements on food intended for the general population should be regulated by Regulation (EC) No 1924/2006 and comply with requirements therein, with the exception of foods intended for use in low calorie diets (LCD) and very low calorie diets (VLCD), which should comply with this Regulation. It is necessary that technical adaptations pursuant to Regulation (EC) No 1924/2006, incorporating the health claims referring to the body weight control for food presented as ‘total diet replacement for weight control’ and as ‘meal replacement for weight control’ and associated conditions of use as regulated under Directive 96/8/EC be completed prior to the entry into application of this Regulation.
Amendment  27 Proposal for a regulation Recital 27 a (new)
Text proposed by the Commission	Amendment
	(27a) In order to ensure a high level of consumer protection, adequate procedures for oversight, in respect of both hygiene and composition, both before and after foods are placed on the market, should be established at Member State level.
Amendment  28 Proposal for a regulation Recital 27 b (new)
Text proposed by the Commission	Amendment
	(27b) Pursuant to Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules1, Member States should conduct inspections on the compliance of undertakings with this Regulation and the delegated acts adopted pursuant thereto, following a risk-based approach.
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	1 OJ L 165, 30.4.2004, p. 1.
Amendment  29 Proposal for a regulation Recital 29
Text proposed by the Commission	Amendment
(29) Adequate transitional measures are necessary to enable food business operators to adapt to the requirements of this Regulation.	(29) The Commission should take adequate measures to ensure legal certainty between entry into force and application of this Regulation and provide the assistance and up-to-date information necessary to the food business operators to enable them to adapt to the requirements of this Regulation.
Justification
Account must be taken of the fact that the regulatory adjustments resulting from this proposal may create a legal vacuum, albeit during a transitional period.
Amendment  30 Proposal for a regulation Recital 29 a (new)
Text proposed by the Commission	Amendment
	(29a) To ease access of small and medium-sized enterprises (SMEs) to the market which in some sectors, for example baby food and medical food, appear to be dominated by a few large companies, the Commission should, in close cooperation with concerned stakeholders, adopt guidelines to help undertakings, in particular SMEs, to comply with the requirements laid down in this Regulation and thus facilitate competitiveness and innovation.
Justification
The European Union has to think small first and should facilitate, although with appropriate legal provisions, the access for SMEs to the internal market.
Amendment  31 Proposal for a regulation Recital 29 b (new)
Text proposed by the Commission	Amendment
	(29b) In order to facilitate market access for operators – especially SMEs – wishing to sell foods resulting from scientific and technological innovations, the Commission, in close cooperation with the relevant stakeholders, should adopt guidelines on the procedure for placing such food on the market on a temporary basis.
Amendment  32 Proposal for a regulation Recital 29 c (new)
Text proposed by the Commission	Amendment
	(29c) A procedure should be laid down which allows food resulting from scientific and technological innovations to be placed on the market on a temporary basis in order that proper benefit may be derived from the fruits of industry research pending the amendment of the specific directive concerned. However, in the interests of consumer health protection, marketing authorisation may be granted only after the European Food Safety Authority has been consulted.
Justification
It is important – to enable them to respond as effectively as possible to the specific nutrition needs of vulnerable groups of people – that manufacturers in the sector should have optimal guidance on the steps to be followed. The groups concerned could thus benefit swiftly from relevant technical and scientific progress.
Amendment  33 Proposal for a regulation Article 1 - paragraph 1 – introductory part
Text proposed by the Commission	Amendment
1. This Regulation establishes compositional and information requirements for the following categories of food:	1. This Regulation, complementing Union law on food, establishes compositional and information requirements for the following categories of food:
Justification
Your rapporteur takes the view that substitute meals replacing all or part of a person's daily food intake (meeting nutritional needs in terms of vitamins, minerals, protein, essential fatty acids, fibre, etc.) should continue to be the subject of specific legislation. This is the best way of retaining some control over the composition of the foods in question and of ensuring that there is no confusion with the aspects linked to the health claims made for foodstuffs (Regulation (EC) No 1924/2006).
Amendment  34 Proposal for a regulation Article 1 – paragraph 1 – point c
Text proposed by the Commission	Amendment
(c) food for special medical purposes.	(c) food for special medical purposes, including formula intended for low birth-weight and pre-term infants.
Amendment  35 Proposal for a regulation Article 1 – paragraph 1 – point c a (new)
Text proposed by the Commission	Amendment
	(ca) food for people intolerant to gluten.
Justification
Regulation (EC) No 41/2009, which came into force on 1 January 2012, sets out provisions for labelling and composition for products for people intolerant to gluten. It would therefore be logical to maintain these specific rules by including them in this proposal for a regulation, which covers all the categories of food for specific nutritional purposes intended for vulnerable groups, such as sufferers of coeliac disease.
Amendment  36 Proposal for a regulation Article 1 – paragraph 1 – point c b (new)
Text proposed by the Commission	Amendment
	(cb) foods intended for use in low calorie diets (LCD) and very low calorie diets (VLCD).
Amendment  37 Proposal for a regulation Article 1 - paragraph 2
Text proposed by the Commission	Amendment
2. This Regulation provides the rules for the establishment and update of a Union list of vitamins, minerals and other substances that can be added to the categories of food referred to in paragraph 1.	2. This Regulation provides the rules for the establishment and updating of a clearly defined Union list of vitamins, minerals and other substances that can be added to the categories of food referred to in paragraph 1 for a specific nutritional purpose.
Justification
It is important to make clear that this regulation concerns foods which are intended to meet a range of very specific dietary needs and which account for only 1 to 2 % of the European food market. Paragraph 3 reproduces verbatim Article 7(2) of the proposal for a regulation, dealing with introductory provisions, which has been deleted.
Amendment  38 Proposal for a regulation Article 1 - paragraph 2 a (new)
Text proposed by the Commission	Amendment
	2a. The requirements laid down in this Regulation shall prevail over any other conflicting requirement of Union law applicable to food.
Justification
It is important to make clear that this regulation concerns foods which are intended to meet very specific and clearly defined nutritional needs and which account for only 1 to 2 % of the European food market. Paragraph 3 reproduces verbatim Article 7(2) of the proposal for a regulation, dealing with introductory provisions, which has been deleted.
Amendment  39 Proposal for a regulation Article 2 – paragraph 1 – point a
Text proposed by the Commission	Amendment
(a) the definitions of ‘food’ and ‘placing on the market’ set out in Articles 2 and 3(8) of Regulation (EC) No 178/2002;	(a) the definitions of 'food', 'retail' and 'placing on the market' set out in Articles 2 and 3(7) and 3(8) of Regulation (EC) No 178/2002;
Amendment  40 Proposal for a regulation Article 2 – paragraph 1 – point b
Text proposed by the Commission	Amendment
(b) the definitions of 'labelling' and 'pre-packaged foodstuff' in points (a) and (b) of Article 1(3) of Directive 2000/13/EC;	(b) the definitions of ‘prepacked food’ and 'labelling' set out in points (e) and (j) of Article 2(2) of Regulation (EU) No 1169/2011;
Justification
Alignment to the recently adopted Regulation (EU) No 1169/2011 on food information to consumers, which replaces Directive 2000/13/EC.
Amendment  41 Proposal for a regulation Article 2 – paragraph 1 – point d a (new)
Text proposed by the Commission	Amendment
	(da) the definition of 'engineered nanomaterial' set out in point (t) of Article 2(2) of Regulation (EU) No 1169/2011.
Justification
As engineered nanomaterials are referred to both in the Commission proposal (Recital 21) and in several amendments, it is appropriate to add the definition.
Amendment  42 Proposal for a regulation Article 2 – paragraph 2 – point h
Text proposed by the Commission	Amendment
(h) 'food for special medical purposes' means food intended for the dietary management of patients to be used under medical supervision. It is intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary food or certain nutrients contained therein, or with other medically-determined nutrient requirements, whose dietary management cannot be achieved only by modification of the normal diet.	h) ‘food for special medical purposes’ means food intended for the dietary management of patients to be used under medical supervision. It is intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary food or certain nutrients contained therein, or with other medically-determined nutrient requirements, whose dietary management cannot be achieved only by modification of the normal diet. Foods for special medical purposes also include formula intended for low birth-weight and pre-term infants, which also have to comply with the requirements of Directive 2006/141.
Amendment  43 Proposal for a regulation Article 2 – paragraph 2 – point h a (new)
Text proposed by the Commission	Amendment
	(ha) 'Formula intended for low birth weight and pre-term infants' means a food specifically developed to meet the medically-determined nutrient requirements of infants who are born prematurely or at a low birth weight.
Amendment  44 Proposal for a regulation Article 2 – paragraph 2 – point h b (new)
Text proposed by the Commission	Amendment
	(hb) 'food for people intolerant to gluten' means foodstuffs for particular nutritional uses which are specially produced, prepared or processed to meet the special dietary needs of people intolerant to gluten;
Justification
Some essential guarantees that are offered in the current dietetic Framework Directive (2009/39/EC), in particular those concerning “food for people intolerant to gluten” have been removed from the scope of the proposed revision to the detriment of those suffering from Coeliac disease. These foods for particular nutritional uses are recognized at international level by the recently revised Codex Standard 118-1979 rev 2008 for foods for special dietary use for persons intolerant to gluten.
Amendment  45 Proposal for a regulation Article 2 – paragraph 2 – point h c (new)
Text proposed by the Commission	Amendment
	(hc) ‘gluten’ means a protein fraction from wheat, rye, barley, oats or their crossbred varieties and derivatives thereof and which is insoluble in water and 0.5 M sodium chloride solution;
Justification
Some essential guarantees that are offered in the current dietetic Framework Directive (2009/39/EC), in particular those concerning “food for people intolerant to gluten” have been removed from the scope of the proposed revision to the detriment of those suffering from Coeliac disease. These foods for particular nutritional uses are recognized at international level by the recently revised Codex Standard 118-1979 rev 2008 for foods for special dietary use for persons intolerant to gluten.
Amendment  46 Proposal for a regulation Article 2 – paragraph 2 – point h d (new)
Text proposed by the Commission	Amendment
	(hd) 'food intended for use in low calorie diets (LCD)' and 'food intended for use in very low calorie diets (VLCD)' means specifically formulated food which, when used as instructed by the manufacturer, replaces the total daily diet.
	VLCD products contain between 400 and 800 kcal per day.
	LCD products contain between 800 and 1200 kcal per day.
Amendment  47 Proposal for a regulation Article 2 – paragraph 2 – subparagraph 1 a (new)
Text proposed by the Commission	Amendment
	Foods for special medical purposes within the meaning of point (h) of the first subparagraph fall into one of the following three categories:
	(i) nutritionally complete foods with a standard nutrient formulation which, used in accordance with the manufacturer's instructions, may constitute the sole source of nourishment for the persons for whom they are intended;
	(ii) nutritionally complete foods  with a nutrient-adapted formulation specific for a disease, disorder or medical condition which, used in accordance with the manufacturer's instructions, may constitute the sole source of nourishment for the persons for whom they are intended;
	(iii) nutritionally incomplete foods with a standard formulation or a nutrient-adapted formulation specific for a disease, disorder or medical condition which are not suitable to be used as the sole source of nourishment.
Amendment  48 Proposal for a regulation Article 2 - paragraph 3
Text proposed by the Commission	Amendment
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' taking into account technical and scientific progress and relevant developments at international level, as appropriate.	deleted
Justification
Linked to Amendment 13 to recital 16. Parliament and the Council must be able to exercise democratic scrutiny over the definitions laid down in Article 2, which are fundamental to this proposal for a regulation.
Amendment  49 Proposal for a regulation Article 3
Text proposed by the Commission	Amendment
Food referred to in Article 1(1) may be placed on the market only if it complies with the provisions of this Regulation.	1. Food referred to in Article 1(1) may be placed on the market only if it complies with the provisions of this Regulation and Union law applicable to food.
	2. Food imported into the Union for the purpose of being placed on the market shall comply with the applicable provisions of Union food law. Food exported or re-exported from the Union for the purpose of being placed on the market in a third country shall comply with the applicable provisions of Union food law, save if specific circumstances in the importing country, linked, for example, to climate or topography, justify a different composition and a different market preparation.
	3. Food referred to in Article 1(1) may only be placed on the market in the form of pre-packed food.
	4. Member States may not restrict or forbid the placing on the market of food which complies with this Regulation, for reasons related to their composition, manufacturing, presentation or labelling.
Justification
It is essential that the same safety and quality rules should be laid down for food imported into the Union as for food intended for export, as specified, for example, in Articles 11 and 12 of the General Food Law Regulation of 28 January 2002. To make the text more coherent, the provisions governing 'pre-packaged food' and 'free movement of goods' have been combined in the article headed 'placing on the market'.
Amendment  50 Proposal for a regulation – amending act Article 3 - paragraph 1 a (new)
Text proposed by the Commission	Amendment
	1a. In order to enable food referred to in Article 1(1) and resulting from scientific and technological progress to be placed on the market rapidly, the Commission may, after consulting the European Food Safety Authority, adopt delegated acts in accordance with Article 15 authorising, for a two-year period, the placing on the market of foodstuffs which do not comply with the rules on composition laid down by this Regulation and by the delegated regulations adopted pursuant to this Regulation for food referred to in Article 1(1).
Justification
The current legislation contains an innovation clause providing for an accelerated procedure under EFSA supervision. Although it is used only rarely, such a procedure must be retained in the proposal under consideration here.
Amendment  51 Proposal for a regulation Article 4
Text proposed by the Commission	Amendment
Article 4	deleted
Pre-packaged food
Food referred to in Article 1(1) shall only be allowed on the retail market in the form of pre-packaged food.
Justification
It is essential that the same safety and quality rules should be laid down for food imported into the Union as for food intended for export, as specified, for example, in Articles 11 and 12 of the General Food Law Regulation of 28 January 2002. To make the text more coherent, the provisions governing 'pre-packaged food' and 'free movement of goods' have been combined in the article headed 'placing on the market'.
Amendment  52 Proposal for a regulation Article 5
Text proposed by the Commission	Amendment
Article 5	deleted
Free movement of goods
Member States may not, for reasons related to their composition, manufacturing, presentation or labelling, restrict or forbid the placing on the market of food which complies with this Regulation.
Justification
It is essential that the same safety and quality rules should be laid down for food imported into the Union as for food intended for export, as specified, for example, in Articles 11 and 12 of the General Food Law Regulation of 28 January 2002. To make the text more coherent, the provisions governing 'pre-packaged food' and 'free movement of goods' have been combined in the article headed 'placing on the market'.
Amendment  53 Proposal for a regulation Article 6 a (new)
Text proposed by the Commission	Amendment
	Article 6a
	Precautionary principle
	Where, following an assessment of available scientific information, there are reasonable grounds for concern for the possibility of adverse effects but scientific uncertainty persists, provisional risk management measures may be adopted that are necessary to ensure a high level of protection of the vulnerable groups of the population for whom the food referred to in Article 1(1) is intended.
Justification
It is important to incorporate a provision based on the precautionary principle into the regulation, which is aimed at a particularly vulnerable group of consumers: newborns, infants, sick people and the obese.
Amendment  54 Proposal for a regulation Article 6 b (new)
Text proposed by the Commission	Amendment
	Article 6b
	Oversight
	The national competent authorities shall ensure that an adequate system of oversight is put in place to ensure that market operators comply with this Regulation and with the relevant health requirements.
Amendment  55 Proposal for a regulation Article 7 - paragraph 2
Text proposed by the Commission	Amendment
2. The requirements laid down in this Regulation shall prevail over any other conflicting requirement of Union law applicable to food.	deleted
Justification
For the sake of legal clarity, this article has been deleted and its provisions incorporated into Articles 1 and 3 of the proposal.
Amendment  56 Proposal for a regulation Article 8 a (new)
Text proposed by the Commission	Amendment
	Article 8a
	Food for normal consumption
	In the labelling, presentation and advertising of food for normal consumption the following shall be prohibited:
	(a) the use of the expression ‘specialised nutrition’, either alone or in conjunction with other words, to designate such food;
	(b) all other markings or any presentation likely to give the impression that the food belongs to one of the categories referred to in Article 1(1) .
Justification
To avoid misleading the consumer, there is a need to maintain a provision similar to that in Article 2.2.b of the current Framework Directive ensuring that only products compliant with the regulation can be presented as covering the specific needs of the targeted populations. Vulnerable consumers require proper labelling in order to receive adequate information about the composition of these specific foods. A clear distinction must be made between foods for labelling nutrition and foodstuffs for normal consumption.
Amendment  57 Proposal for a regulation Article 9 – paragraph 1
Text proposed by the Commission	Amendment
1. The composition of food referred to in Article 1(1) shall be such that it is appropriate to satisfy the nutritional needs of, and it is suitable for the persons to whom it is intended, in accordance with generally accepted scientific data.	1. The composition of food referred to in Article 1(1) shall be such that it is appropriate to satisfy the nutritional needs of, and it is suitable for the persons to whom it is intended, in accordance with generally accepted peer-reviewed and independently evaluated scientific data and medical opinion.
Justification
See justification for AM 1.
Amendment  58 Proposal for a regulation Article 9 – paragraph 3
Text proposed by the Commission	Amendment
3. The labelling, presentation and advertising of food referred to in Article 1(1) shall provide adequate consumer information and must not be misleading.	3. The labelling, presentation and advertising of food referred to in Article 1(1) shall be accurate, clear and easy to understand for consumers and must not be misleading. It shall not attribute properties to such products for the prevention, treatment or cure of human disease, or imply such properties.
Amendment  59 Proposal for a regulation Article 9 – paragraph 3 a (new)
Text proposed by the Commission	Amendment
	3 a. The labelling of infant formula and follow-on formula shall not include pictures of infants, nor shall it include other pictures or text which may idealise the use of the product. Graphic representations for easy identification of the product and for illustrating methods of preparation shall, however, be permitted. Directive 2006/141/EC shall be amended accordingly.
Amendment  60 Proposal for a regulation Article 9 – paragraph 4
Text proposed by the Commission	Amendment
4. 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 by persons having qualifications in medicine, nutrition, pharmacy or other professionals responsible for maternal and child health care.	4. The dissemination of any useful information or recommendations with reference to the categories of food referred to in points (a), (b) (c) and (ca) of Article 1 (1) may be made exclusively to persons having qualifications in medicine, nutrition or pharmacy. Additional information disseminated by healthcare professionals to the final consumer shall only be of a scientific and factual nature and shall not contain advertising.
Amendment   61 Proposal for a regulation Article 9 – paragraph 4 a (new)
Text proposed by the Commission	Amendment
	4a. In order to ensure efficient official monitoring, food business operators shall notify the competent authority of each Member State in which they place on the market food referred to in Artciel 1(1), by forwarding it a model of the product's label.
Amendment  62 Proposal for a regulation Article 9 – paragraph 4 b (new)
Text proposed by the Commission	Amendment
	4b. The use of pesticides in agricultural products intended for the production of food referred to in Article 1(1) shall be restricted as far as possible, without prejudice to Directive 2006/125/EC and Directive 2006/141/EC.
Amendment  63 Proposal for a regulation Article 9 – paragraph 4 c (new)
Text proposed by the Commission	Amendment
	4c. Specific provisions relating to food referred to in Article 1(1)that lay down limitations on the use of or that ban certain pesticides shall be updated regularly, with particular attention being paid to pesticides containing active substances, safeners or synergists classified under Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures1 as mutagen category 1A or 1B, carcinogen category 1A or 1B, toxic for reproduction category 1A or 1B, considered to have endocrine-disrupting properties that may cause adverse effects in humans, or pesticides approved as 'candidate for substitution' pursuant to Article 24 of Regulation (EC) No 1107/2009.
	______________
	1 OJ L 353, 31.12.2008, p. 1.
Amendment  64 Proposal for a regulation Article 10 – paragraph 2 – introductory part
Text proposed by the Commission	Amendment
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 as well as any technical and scientific progress, the Commission shall be empowered to adopt delegated Regulations, 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:	2. Subject to the general requirements of Articles 7 and 9, and to the specific requirements of Articles 10a and 10b, and taking into account Directive 2006/141/EC, Directive 2006/125/EC and Directive 1999/21/EC as well as any technical and scientific progress, in particular the results of risk evaluations and the precautionary principle as referred to in Article 6(1), the Commission shall be empowered to adopt delegated acts 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  65 Proposal for a regulation Article 10 – paragraph 2 – point b a (new)
Text proposed by the Commission	Amendment
	(ba) 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 composition requirements laid down pursuant to point (a);
Amendment  66 Proposal for a regulation Article 10 – paragraph 2 – point c
Text proposed by the Commission	Amendment
(c) the specific requirements on labelling, presentation and advertising of food referred to in Article 1(1), including the authorisation of nutrition and health claims thereof;	(c) the specific requirements on labelling, presentation and advertising of food referred to in Article 1(1); those requirements shall include the specific related rules already in force for food referred to in Article 1(1);
2. It is important to retain the single, specific provisions contained in the legislation on infant and follow-up formulas.
Amendment  67 Proposal for a regulation Article 10 – paragraph 2 – point c a (new)
Text proposed by the Commission	Amendment
	(ca) the requirements for information to be provided on recommendations for appropriate use of food referred to in Article 1(1).
Amendment   68 Proposal for a regulation Article 10 – paragraph 2 – point f a (new)
Text proposed by the Commission	Amendment
	(fa) A requirement for post-market monitoring in order to verify whether the specific requirements are being complied with.
Amendment  69 Proposal for a regulation Article 10 – paragraph 3 – subparagraph 1
Text proposed by the Commission	Amendment
3. Subject to the requirements of Articles 7 and 9 and taking into account relevant technical and scientific progress, the Commission shall update the delegated Regulations mentioned in paragraph 2 in accordance with Article 15.	3. Subject to the requirements of Articles 7 and 9, and the specific requirements of Articles 10a and 10b, and taking into account relevant technical and scientific progress, the results of new risk assessments and the precautionary principle as referred to in Article 6(1), the Commission shall update the delegated acts mentioned in paragraph 2 of this Article in accordance with Article 15.
Justification
'Delegated acts' is the agreed standard wording to be used in provisions of this kind
Amendment  70 Proposal for a regulation Article 10 a (new)
Text proposed by the Commission	Amendment
	Article 10a
	Food for people intolerant to gluten
	In addition to the requirements of Article 9, food intended for people intolerant to gluten consisting of or containing one or more ingredients made from wheat, rye, barley, oats or their crossbred varieties which have been especially processed to reduce gluten, shall contain a level of gluten not exceeding 100 mg/kg in the food as sold to the final consumer.
	Food intended for people intolerant to gluten sold to the final consumer which contain a level of gluten not exceeding 100 mg/kg may be labelled ‘very low gluten content’.
	Food intended for people intolerant to gluten sold to the final consumer which contain a level of gluten not exceeding 20 mg/kg may be labelled ‘gluten free’.
	Food intended for people intolerant to gluten shall also comply with the following criteria:
	– they shall provide roughly the same amount of vitamins and mineral salts as the foodstuffs they are replacing,
	– they shall be prepared with special care, in compliance with good manufacturing practice (GMP), to avoid gluten contamination,
	– where the terms ‘very low gluten content’ or ‘gluten free’ are used, they shall appear in proximity to the name under which the product is marketed.
Justification
There should be a specific article setting out the main provisions in the current Regulation (EC) No 41/2009 on composition and labelling in order to address the dietary needs of people who are intolerant to gluten.
Amendment  71 Proposal for a regulation Article 10 b (new)
Text proposed by the Commission	Amendment
	Foods intended for use in low calorie diets and very low calorie diets
	1. LCD and VLCD products shall comply with the compositional requirements set out in the Annex to this Regulation.
	2. All individual components making up LCD and VLCD products, as sold, shall be contained in a single package.
	3. The name under which LCD and VLCD products are sold shall be:
	(a) for VLCD products,
	'Total diet replacement for use in very low calorie diets';
	(b) for LCD products,
	'Total diet replacement for use in low calorie diets'
	4. The labelling of LCD and VLCD products shall bear, in addition to those provided for in Chapter IV of Regulation (EU)No 1169/2011, the following mandatory particulars:
	(a) the available energy value expressed in kJ and kcal, and the content of proteins, carbohydrates and fat, expressed in numerical form, per specified quantity of the product ready for use as proposed for consumption;
	(b) the average quantity of each mineral and each vitamin for which mandatory requirements are stipulated in paragraph 5 of the Annex to this Regulation, expressed in numerical form, per specified quantity of the product ready for use as proposed for consumption;
	(c) instructions for appropriate preparation, when necessary and a statement as to the importance of following those instructions;
	(d) if a product, when used as instructed by the manufacturer, provides a daily intake of polyols in excess of 20 g per day, there shall be a statement to the effect that the food may have a laxative effect;
	(e) a statement on the importance of maintaining an adequate daily fluid intake;
	(f) a statement that the product provides adequate amounts of all essential nutrients for the day;
	(g) a statement that the product should not be used for more than three weeks without medical advice;
	5. The labelling, advertising and presentation of LCD and VLCD products concerned shall not make any reference to the rate or amount of weight loss which may result from their use.
Amendment  72 Proposal for a regulation Article 10 c (new)
Text proposed by the Commission	Amendment
	Article 10c
	Access for SMEs to the internal market
	The Commission shall, in close cooperation with all stakeholders and the Authority, adopt appropriate guidelines and provide technical guidance to enable undertakings, in particular small and medium-sized enterprises, to comply with the requirements laid down in this Regulation and assist them in the preparation and presentation of the application for scientific assessment. The Commission shall be empowered to adopt delegated acts in accordance with Article 15 in order to adopt those guidelines.
Amendment  73 Proposal for a regulation Article 11 - paragraphs 1 and 2
Text proposed by the Commission	Amendment
1. Vitamins, minerals, amino acids and other substances may be added to food referred to in Article 1(1), provided that such substances meet the following conditions:	1. Taking account of Directives 2006/141/EC and 2006/125/EC and Regulation (EC) No 953/2009, the Commission shall, no later than [2 years after the date of entry into force of this Regulation] establish a Union list of vitamins, minerals and other substances which may be added to each category of food referred to in Article 1(1) ('the Union list').
a) they do not, on the basis of the scientific evidence available, pose a safety concern to the health of the consumer; and
b) they are available for use by the human body.
2. No later than [2 years after the date of the entry into force of this Regulation], the Commission shall establish and subsequently update a Union list of permitted substances that meet the conditions of paragraph 1, by means of implementing Regulations. The entry of a substance in the Union list shall include a specification of the substance, and, where appropriate, specify the conditions of use and the applicable purity criteria. Those implementing Regulations shall be adopted in accordance with the examination procedure referred to in Article 14(2). On duly justified grounds of extreme urgency relating to emerging health risks, the Commission shall adopt immediately applicable implementing acts updating the Union list in accordance with Article 14(3).
	2. Vitamins, minerals, amino acids and other substances may be added to food referred to in Article 1(1), provided that such substances meet the following conditions:
	a) they do not, on the basis of the generally accepted and peer-reviewed scientific evidence available, pose a safety concern to the health of the consumer;
	b) they are available for use by the human body;
	(ba) they are suitable for the nutritional use for which they are intended;
	(bb) they have, on the basis of generally accepted scientific evidence, a nutritional or physiological effect.
	2a. For substances referred to in paragraph 2 that are engineered nanomaterials, the following additional conditions shall apply:
	(a) the condition in point (a) of paragraph 2 has been demonstrated on the basis of adequate test methods; and
	(b) their nutritional value and the suitability for the persons for whom they are intended has been shown.
	3. The Commission shall be empowered to adopt delegated acts in accordance with Article 15 in order to establish the Union list..
(Paragraph 1 of the Commission text has become paragraph 2 and paragraph 2 of the Commission text has become paragraph 1, with modifications.)
Justification
It is essential that, in addition to being safe and absorbable by the human body, enriched foods should offer consumers nutritional added value. This is particularly important if, as in the context of this proposal for a regulation, the persons primarily affected are newborns or hospital patients, for whom this type of food is often vital. In addition, and in order to prevent a legal vacuum being created, it is important to draw a distinction between the current list of substances and the list which will probably be updated in two years' time.
Amendment  74 Proposal for a regulation Article 11 – paragraphs 3, 4 and 5
Text proposed by the Commission	Amendment
	Article 11a
	Updating of the Union list
3. The entry of a substance in the Union list referred to in paragraph 2 may be initiated either on the initiative of the Commission or following an application. Applications may be made by a Member State or by an interested party, who may also represent several interested parties (hereinafter referred to as the applicant). Applications shall be sent to the Commission, in accordance with paragraph 4.	1. The entry of a substance in the Union list may be initiated either on the initiative of the Commission or following an application. Applications may be made by a Member State or by an interested party, who may also represent several interested parties (the 'applicant'). Applications shall be sent to the Commission, in accordance with paragraph 2.
	1a. The applicant shall submit an application to the Commission. The Commission shall acknowledge receipt in writing within 14 days of its receipt.
4. The application shall include:	2. The application shall include:
(a) the name and the address of the applicant;	(a) the name and the address of the applicant;
(b) the name and a clear description of the substance;	(b) the name and a clear description of the substance;
(c) the composition of the substance;	(c) the composition of the substance;
(d) the proposed use of the substance and conditions thereof;	(d) the proposed use of the substance and conditions thereof;
(e) a systematic review of the scientific data and appropriate studies performed following generally accepted expert guidance on the design and conduct of such studies;	(e) a systematic review of the scientific data and appropriate peer-reviewed studies performed following generally accepted expert guidance on the design and conduct of such studies;
(f) scientific evidence demonstrating the quantity of the substance which does not endanger the health of the persons to whom it is intended and its suitability for the intended uses;	(f) scientific evidence demonstrating the quantity of the substance which does not endanger the health of the persons to whom it is intended and its suitability for the intended uses;
(g) scientific evidence demonstrating that the substance is available for use by the human body;	(g) scientific evidence demonstrating that the substance is available for use by the human body and has a nutritional or physiological effect;;
(h) a summary of the content of the application.	(h) a summary of the content of the application.
5. When a substance is already included in the Union list and there is a significant change in the production methods, or there is a change in particle size, for example through nanotechnology, the substance prepared by those new methods shall be considered as different substance and the Union list shall be modified accordingly before it can be placed on the Union market.	3. When a substance is already included in the Union list and there is a significant change in the production methods, or there is a change in particle size, for example through nanotechnology, the substance prepared by those new methods or with a change in particle size shall be considered as a different substance which is not included in the list and which shall require a separate application.
	4. If a substance that is on the Union list no longer meets the conditions referred to in Article 11(2) and (2a), the Commission shall decide to remove that substance from the Union list.
	5. The entry for a substance in the Union list shall include:
	- a specification of the substance
	- where appropriate, a specification of the conditions of use, and
	- where appropriate, a specification of the applicable purity criteria.
	6. The Commission shall be empowered to adopt delegated acts in accordance with Article in order to update the Union list.. Where, in the case of emerging health risks, imperative grounds of urgency so require, the procedure provided for in Article 16 shall apply to delegated acts adopted pursuant to this paragraph.
Justification
Since the Regulation will only apply after 2 years after the entry into force it seems that the Commission first shall establish a list (Article 11) which then could be updated on the initiative of the Commission or following an application (Article 11a). Concerning this updated list, it is good sense to set up provisions not only for addition of substances but also for deletion of certain substances in the specific foodstuff.
Nanomaterials can only be assessed by specific test-methods. It should therefore only be possible to include substances in the list which have been proven as safe.
Amendment  75 Proposal for a regulation Article 12 – paragraph 2 – point v a (new)
Text proposed by the Commission	Amendment
	(va) any scientific data gathered from animal testing for the assessment of the safety of the substance.
Amendment  76 Proposal for a regulation Article 13
Text proposed by the Commission	Amendment
General confidentiality clause	General transparency and confidentiality clause
13. The Commission, the Authority and the Member States shall, in accordance with Regulation (EC) No 1049/2001, take the necessary measures to ensure appropriate confidentiality of the information received by them under this Regulation, except for information which must be made public if circumstances so require in order to protect human health, animal health or the environment.	13. The Commission, the Authority and the Member States shall, in accordance with Regulation (EC) No 1049/2001, guarantee the broadest possible access to documents and, in particular, shall assist members of the public with, and inform them about, the procedures for submitting applications for access to documents. They shall also take the necessary measures to ensure appropriate confidentiality of the information received by them under this Regulation, except for information which must be made public if circumstances so require in order to protect human health, animal health or the environment.
Justification
More transparent Community procedures and easier public access to documents are essential.
Amendment  77 Proposal for a regulation Article 15 - paragraph 2
Text proposed by the Commission	Amendment
2. The delegation of power referred to in Articles 2(3) and 10 of this Regulation shall be conferred for an indeterminate period of time from the (*) [(*) Date of entry into force of the basic legislative act or from any other date set by the legislator.]	2. The delegation of power referred to in Articles 10(2) and (3), 10c, 11(3) and 11a(6) shall be conferred for a period of 5 years from the 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 five year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Justification
As regards delegated acts, and with a view to maintaining legal consistency between Community acts, this amendment reproduces the wording of Regulation (EU) No 1169/2011 on the provision of food information to consumers.
It is not appropriate to allow for delegated acts for the updating of the definitions, as they are an essential part of the Regulation which should only be allowed to be changed by the ordinary legislative procedure. The establishment and updating of the list is an act of general application to supplement or amend certain non-essential elements of the legislative act.
Amendment  78 Proposal for a regulation Article 15 - paragraph 3
Text proposed by the Commission	Amendment
3. The delegation of powers referred to in Articles 2(3) and 10 of this Regulation may be revoked at any time by the European Parliament or by the Council. A decision of revocation 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.	3. The delegation of powers referred to in Articles 10(2) and (3), 10c, 11(3) and 11a(6) of this Regulation may be revoked at any time by the European Parliament or by the Council. A decision of revocation 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.
Justification
Strengthened democratic scrutiny is essential in connection with the definitions laid down in Article 2(3), given that this is an area where, for more obviously technical reasons linked to the composition of products and the dissemination of information about them and to the specific provisions to assist SMEs, the delegation of powers to the Commission can be justified more easily.
Amendment  79 Proposal for a regulation Article 15 – paragraph 5
Text proposed by the Commission	Amendment
5. A delegated act adopted pursuant to Articles 2(3) and 10 of this Regulation shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of 2 months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 2 months at the initiative of the European Parliament or the Council.	5. A delegated act adopted pursuant to Articles 10(2) and (3), 10c, 11(3) and 11a(6) of this Regulation shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of 2 months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 2 months at the initiative of the European Parliament or the Council.
Justification
It is not appropriate to allow for delegated acts for the updating of the definitions, as the definitions are an essential part of the Regulation which should only be allowed to be changed by the ordinary legislative procedure. The establishment and updating of the list is an act of general application to supplement or amend certain non-essential elements of the legislative act. Moreover the requirements laid down in Article 11(1) are very open. Therefore delegated acts should be applied.
Amendment  80 Proposal for a regulation Article 16 a (new)
Text proposed by the Commission	Amendment
	Article 16a
	Food for people intolerant to lactose
	At the latest 1 year after entry into force of this Regulation the Commission shall present a report, if appropriate accompanied by a legislative proposal, to clarify the status of labelling indications of 'lactose free' and 'very low lactose content' under general food law.
Amendment  81 Proposal for a regulation Article 16 b (new)
Text proposed by the Commission	Amendment
	Article 16b
	Milks intended for young children
	By ... [ 1 year after the date of the entry into force of this Regulation], the Commission shall, after consulting the European Food Safety Authority, submit a report to the European Parliament and to the Council assessing the need for special provisions regarding the composition and labelling of milks intended for young children between one and three years. This report shall consider the nutritional needs, the pattern of consumption, the nutritional intake and the levels of exposure to contaminants and pesticides of these young children. The report shall also consider whether these milks have any nutritional benefits when compared to a normal diet for a child who is being weaned. In the light of the conclusions of that report, the Commission shall either:
	(a) decide that there is no need for special provisions regarding the composition and labelling of milks intended for young children; or
	(b) submit, if appropriate, in accordance with the ordinary legislative procedure and on the basis of Article 114 of the TFEU, any appropriate legislative proposal.
	Prior to the preparation of the above Commission report the milks intended for young children between one and three years shall continue to fall within the scope of the relevant Union legislation such as Regulation (EC) No 178/2002, Regulation EC No 1925/2006 and Regulation (EC) No1924/2006;
Amendment  82 Proposal for a regulation Annex (new)
Text proposed by the Commission	Amendment
	Compositional requirements for LCD and VLCD products
	These specifications refer to LCD and VLCD products ready for use, marketed as such or reconstituted as instructed by the manufacturer.
	1. Energy
	1.1. The energy provided by a VLCD product shall not be less than 1680 kJ (400 kcal) and shall not exceed 3360 kJ (800 kcal) for the total daily ration.
	1.2. The energy provided by a LCD product shall not be less than 3360 kJ (800 kcal) and shall not exceed 5040 kJ (1200 kcal) for the total daily ration.
	2. Protein
	2.1. The protein contained in LCD and VLCD products shall provide not less than 25 % and not more than 50 % of the total energy of the product. In any event the amount of protein of these products shall not exceed 125 g.
	2.2. Point 2.1 refers to a protein the chemical index of which is equal to that of the FAO/WHO (1985) reference protein set out in table 2. If the chemical index is lower than 100 % of the reference protein, the minimum protein levels shall be correspondingly increased. In any event the chemical index of the protein shall at least be equal to 80 % of that of the reference protein.
	2.3. The ‘chemical index’ shall mean the lowest of the ratios between the quantity of each essential amino acid of the test protein in and the quantity of each corresponding amino acid of the reference protein.
	2.4. In every event, the addition of amino acids is permitted solely for the purpose of improving the nutritional value of the proteins, and only in the proportions necessary for that purpose.
	3. Fat
	3.1. The energy derived from fat shall not exceed 30 % of the total available energy of the product.
	3.2. The linoleic acid (in the form of glycerides) shall not be less than 4,5 g.
	4. Dietary fibre
	The dietary fibre content of LCD and VLCD products shall not be less than 10 g and shall not exceed 30 g for the daily ration.
	5. Vitamins and minerals
	The LCD and VLCD products shall provide for the whole of the daily diet at least: 100 % of the amounts of vitamins and minerals specified in Table 1.
TABLE 1
Vitamin A (µ RE) 700 Vitamin D (µ) 5 Vitamin E (mg-TE) 10 Vitamin C (mg) 45 Thiamin (mg) 1,1 Riboflavin (mg) 1,6 Niacin (mg-NE) 18 Vitamin B6 (mg) 1,5 Folate (µ) 200 Vitamin B12 (µ) 1,4 Biotin (µ) 15 Pantothenic acid (mg) 3 Calcium (mg) 700 Phosphorus (mg) 550 Potassium (mg) 3 100 Iron (mg) 16 Zinc (mg) 9,5 Copper (mg) 1,1 Iodine (µ) 130 Selenium (µ) 55 Sodium (mg) 575 Magnesium (mg) 150 Manganese (mg) 1
Table 2
AMINO ACID REQUIREMENT PATTERN (1)
g/100 g protein Cystine + methionine 1,7 Histidine 1,6 Isoleucine 1,3 Leucine 1,9 Lysine 1,6 Phenylalanine + tyrosine 1,9 Threonine 0,9 Tryptophan 0,5 Valine 1,3 (1) World Health Organisation. Energy and protein requirements. Report of a Joint FAO/WHO/UNU Meeting. Geneva: World Health Organisation, 1985. (WHO Technical Report Series, 724).

• [1]  OJ C 24, 28.1.2012, p. 119.

EXPLANATORY STATEMENT

1. Background

The first piece of European legislation dealing with dietetic foods was a directive adopted back in 1977. That directive was subsequently amended several times and then consolidated in a framework directive based on the concept of ‘foodstuffs intended for particular nutritional uses’, which was adopted in 2009.

Thirty-four years later, following a comprehensive review of the legislation in force in this extremely competitive sector (which accounts for between 1 and 2% of the overall market), the Commission has reached the following stark conclusion: both consumers and controlling authorities are finding it hard to distinguish between foodstuffs for normal consumption and foodstuffs intended for specific population groups. The Commission provides a number of specific examples (muscle-building protein bars for sportspersons, food supplements for pregnant women, calcium- and vitamin D-enriched foods suitable for older people and slimming products).

The impact assessment highlights a number of reasons for this confusing situation, including disparities in the interpretation and implementation of the framework directive in the Member States, administrative constraints, compositional and labelling changes, innovation, competitiveness, price and consumer protection and information. There is therefore a clear need for the legislation on foodstuffs intended for specific population groups to be recast.

2. Abolition of the concept of ‘dietetic food’: a key aspect of the proposal for a regulation

Following the consultations with Member States begun in 2007, the Commission submitted this proposal for a regulation on food intended for infants and young children and on food for special medical purposes in June 2011. The new regulation will repeal the following pieces of legislation:

· Directive 2009/39/EC on foodstuffs intended for particular nutritional uses (recasting the 1989 framework directive);

· Directive 92/52/EEC on infant formulae and follow-on formulae intended for export to third countries;

· Directive 96/8/EC on foods intended for use in energy-restricted diets for weight reduction;

· Commission Regulation (EC) No 41/2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten.

A desire for simplification lies behind this overhaul of the legislation, as is illustrated by the establishment of a single list of substances that may be added to the foods covered by the proposal (the ‘Union list’). Care must, however, be taken to ensure that this consolidation does not pave the way for an increase in the number of vitamins, minerals and other substances added to these highly specific foodstuffs.

3. Rapporteur's remarks

Scope of the regulation

The Commission has rightly chosen to confine the scope of this regulation to a limited number of foods for particular nutritional uses. Infants, children under three years of age and people for whom a special diet is vital on medical grounds clearly require special attention and uniform treatment within the EU. The rapporteur shares the Commission’s view that that the current legal framework should be maintained for these vulnerable population groups.

So what happens to the other types of foodstuff that are not, or are no longer, covered by a ‘tailor-made’ legal framework? The Commission’s abolition of the concept of ‘dietetic food’ will have an impact on other pieces of legislation currently in force, foremost among them being Directive 96/8/EC on foods intended for use in energy-restricted diets for weight reduction. Your rapporteur takes the view that substitute meals replacing all or part of a person's daily food intake (meeting nutritional needs in terms of vitamins, minerals, protein, essential fatty acids, fibre, etc.) should continue to be the subject of specific legislation. This is the best way of retaining some control over the composition of the foods in question and of ensuring that there is no confusion with the aspects linked to the health claims made for foodstuffs (Regulation (EC) No 1924/2006).

Conversely, foodstuffs intended for sportspersons should not be included in the new regulation’s scope. There are objective difficulties in defining exactly what constitutes a ‘sportsperson’ and in distinguishing between a food for intense muscular effort and what might be considered a stimulant or doping agent. Given that, generally speaking, they are not intended to meet special dietary needs, sports-related foods should therefore be covered by the general food provisions (Regulation (EC) No 178/2002 of 28 January 2002).

The EU’s 32 million diabetics also require special attention, but this should not necessarily take the form of specific food legislation. The Commission’s approach in this area – which is in keeping with the views expressed by diabetes associations – should therefore also be endorsed. In this connection, attention should be drawn to the alarming projections for 2030, by which time the incidence of diabetes is expected to have increased by 16% by 2030, owing in particular to endemic obesity and the ageing of the population in the EU.

Including very low calorie diets for obese patients

The idea is to bring very low calorie diet products (VLCDs) within the regulation’s scope by including them in the definition of food for special medical purposes. Unlike many other kinds of weight-loss diet (generally between 800 and 1200 kcals/day), very low calorie diets (between 400 and 800 kcals/day) must be of strictly limited duration (in general, no more than four weeks) and must not be embarked upon without proper medical authorisation and supervision, owing to the possibility of side-effects.

Legal cover for people with a food intolerance

Another of the key aspects of this proposal is the incorporation of Regulation (EC) No 41/2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten into the legislative framework for nutrition and health claims made on foods (Regulation (EC) No 1924/2006).

The rapporteur does not agree with the Commission’s approach in this matter, because it does not provide a suitable legal framework for people with a gluten intolerance or one of the other common food intolerances. There are a number of reasons for this, the first being the fact that, in its present form, Regulation (EC) No 1924/2006 still makes no provision for nutritional profiles, which may be seen as the ‘DNA’ of foodstuffs and are of decisive importance in determining whether or not a claim may be made for a given foodstuff. The second reason stems indirectly from the fact that Regulation (EC) No 1924/2006 is based on the principle of exhaustive lists, meaning that anything that is not specifically included in the lists is banned. Accordingly, unless the Commission adds the statement ‘lactose-free’ – which is of essential importance to people with a lactose intolerance (more common in the Mediterranean countries than in Northern Europe) to the annex to Regulation (EC) No 1924/2006, there is every reason to believe that use of that statement would be banned.

With a view to clarifying this grey area, the rapporteur considers that it would be more appropriate to incorporate the rules governing statements relating to gluten and lactose into the new Regulation (EU) No 1169/2011 on food labelling. Article 36 of this cross-cutting regulation already provides for the possibility of laying down criteria relating to information on the presence of products causing allergies.

Faster, less costly procedures

It is essential for the notification procedure (which is faster and less costly) to continue to be the standard procedure, with marketing authorisations being granted at national level and there being an option to supplement this procedure with additional rules on labelling and composition. It is also only logical for stricter rules than those applying under the prior authorisation procedure based on an opinion delivered by the EFSA to be maintained for claims relating to foods for infants and children between the ages of one and three (Annex IV to Directive 2006/141/EC).

Other key aspects: facilitating market access for SMEs and stimulating innovation

Facilitating access by SMEs to the internal market is one of the key strands of the Europe 2020 strategy launched by the Commission. However, this statement of intent must be followed up by the inclusion in every legislative proposal of provisions specifically designed to make it easier for SMEs to gain such access. This is particularly important in view of the fact that both EU and world markets for foods for particular nutritional uses are dominated by a very small number of industrial groups. This is why the rapporteur considers that the new regulation should do more than ‘not impact disproportionately on small businesses’ (as the Commission puts it in its impact assessment and its comments relating to Objective 4: Small Businesses and Innovation) and should have a genuinely positive impact on SMEs, which form a dynamic, job-creating sector of the EU economy.

No pesticides in foods intended for vulnerable population groups

The current legislation is unsatisfactory. EU lawmakers need to require industry to ensure that the products it places on the market for infants and young children contain no pesticides or other toxic substances. That is the thinking behind the amendments which establish the principle of a ban on pesticides in foods for particular nutritional uses while accepting that some traces of chemicals may be accidentally present. This is because, given that the environment is contaminated by various pesticides, pesticide residues may, unfortunately, be found in some products.

4. Preliminary conclusions

The rapporteur agrees with the Commission that the legislation on foodstuffs for particular nutritional uses needs to be thoroughly overhauled and that the concept of ‘dietetic food’, which in most cases means very little from a nutritional point of view, should be done away with. She nonetheless considers that industry and the vulnerable population groups that are the subject of this regulation should be afforded greater legal certainty. This must necessarily involve regular democratic scrutiny by Parliament of the definitions of foods intended for infants, children under the age of three and people with certain medical conditions, for whom a special diet is of vital importance, and of the rules governing the composition of such foods. This simplified but more protective legal framework must apply to imported and exported foods alike and makes it easier for the precautionary principle to be applied. If we are to expect the internal market to work properly, we cannot afford to disregard the health of the more vulnerable members of society.

5. Legislative footprint

Your rapporteur is grateful for the explanations provided by the Commission through DG SANCO, as well as for the many suggestions made by the shadow rapporteurs, the Polish Presidency of the Council, the future Danish Presidency and representatives of the Belgian and French Governments. She would also like to express her thanks for the proposals put forward by: the food-sector companies Nestlé, Danone and Unilever; the manufacturers of foods for particular nutritional uses the European Dietetic Food Industry Association (IDACE), the Medical Nutrition International Industry (MNI), the European Specialist Sports Nutrition Alliance (ESSNA) and the European Natural Soyfoods Manufacturers Association (ENSA); and the European Consumers’ Organisation (BEUC) and the UK organisation Baby Milk Action. Special thanks must go to Parliament’s lawyer-linguists, who have helped to ensure that the policy proposals set out in this report are legally sound.

OPINION of the Committee on Industry, Research and Energy (10.2.2012)

for the Committee on the Environment, Public Health and Food Safety

on the proposal for a regulation of the European Parliament and of the Council on food intended for infants and young children and food for special medical purposes
(COM(2011)0353 – C7‑0169/2011 – 2011/0156(COD))

Rapporteur: Hannu Takkula

SHORT JUSTIFICATION

The issue of food intended for those with particular nutritional needs (hereinafter ´Parnuts food´) has been a focus area within the European Union's legislation, reflecting a clear market demand for a secure and healthy food supply. Once a niche market, the Parnuts food sector has grown significantly over the recent years, causing a lack of clarity when trying to distinguish between general foods and foods intended for specific groups of people. These developments are taken into account in the proposed legislative framework and therefore the draftsperson strongly favours the objectives of this proposal.

General remarks

Despite some previous attempts at harmonisation, vast differences still exist between national laws relating to Parnuts food. These differences place obstacles in the way of the free movement of goods, create unnecessary regulatory burdens for companies operating within the food business sector and ultimately hinder the functioning of the internal market.

The draftsperson believes that similar products must be treated the same way across the European Union, ensuring appropriate consumer information and allowing free movement and equal conditions of competition for goods. Rules which have become unnecessary, contradictory and potentially conflicting must be abolished, and the protection of the most vulnerable groups of the population and those with special nutritional needs must be guaranteed. A common legal system for Parnuts foods, as proposed by the Commission, must therefore be welcomed as a major step towards improved safety and clarity for consumers as well as producers.

The draftsperson believes that it is of critical importance that all foods intended for infants and young children, as well as foods for special medical purposes be covered by a thorough and standardised prior authorisation process. In order to ensure safety and efficacy, this shall be undertaken by an independent body on the basis of up-to-date scientific information (and research).

This proposal concentrates the notification responsibilities and authorisation procedures of Parnuts foods onto the European Commission, which will remove several existing market barriers. In this context, the draftsperson welcomes the introduction of the "Union list of permitted substances" (Article 11), which combines the currently existing (three separate) lists into a single one, thus creating greater clarity in this particular area. In order to guarantee a smooth transition process, the draftsperson calls upon the Commission for a timely establishment and regular updating of this list, as well as for a streamlined process for entries to this list (as mentioned in Article 11(3)).

Several amendments tabled in the ITRE Committee highlighted the need to include in the text of the draft Regulation additional product groups, namely milk based drinks intended for young children and food for persons intolerant to gluten. The draftsperson believes that the issue of the inclusion of other foods for special nutritional purposes should be carefully analysed within the ENVI Committee in the framework for the public health issues.

Research and innovation aspects

The draftsperson believes that improved EU legislation in the field of special foods must be complemented by investments in research and innovation, as these will also lead to the development of new and enhanced practices, products and processes. In this context, the draftsperson also draws attention to the fact that the health and safety aspects of foods are included in the Food Security chapter of the Union´s Horizon 2020 Research and Innovation Programme and further efforts of interconnected research and innovation activities in the Parnuts food sector must also be strongly supported.

The legal modifications suggested in the Commission´s proposal, such as the exclusion of diabetic food, low-gluten food and sports food, as well as the introduction of the Union´s list, should not, in any case, hinder innovation. However, as our scientific knowledge in the Parnuts food sector continues to improve, flexible procedures must be maintained to foster further research and innovation in these areas.

Small and Medium-sized enterprises (SMEs)

The draftsperson wishes to ensure that any changes to the legislative management of foods currently covered by the Parnuts food framework directive do not have a disproportional effect on SMEs, nor shall they diminish transparency and/or place unnecessary burdens on food business operators. Current data indicates that the Parnuts food sector is dominated by SMEs, and it has shown substantial growth over the past years. The draftsperson is concerned with the existing large variation in the legislative burden between the Member States and believes that streamlined regulation combined with simplification measures will be advantageous for the entire market segment.

AMENDMENTS

The Committee on Industry, Research and Energy calls on the Committee on the Environment, Public Health and Food Safety, as the committee responsible, to incorporate the following amendments in its report:

Amendment  1 Proposal for a regulation Recital 2
Text proposed by the Commission	Amendment
(2) The free movement of safe and wholesome food is an essential aspect of the internal market and contributes significantly to the health and well-being of citizens, and to their social and economic interests.	(2) In order to guarantee the health and well-being of citizens, the safety of food products represents an essential requirement to their free circulation in the internal market, which, in turn, benefits European competitiveness by allowing a larger home market for companies.
Amendment  2 Proposal for a regulation Recital 2 a (new)
Text proposed by the Commission	Amendment
	(2a) This Regulation aims at ensuring the safety of food products placed on the market and addressed to vulnerable groups of the population such as infants, young children and people affected by particular illnesses. To ensure that the health of these people receives a high level of protection it is vital that a certain number of potentially dangerous substances or substances recognised as dangerous are not included in the composition of these products or in the composition of their container.
Amendment  3 Proposal for a regulation Recital 7
Text proposed by the Commission	Amendment
(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 particular 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 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. As regards special provisions for food for persons suffering from carbohydrate metabolism disorders (diabetes), a Commission report concludes that the scientific basis for setting specific compositional requirements is lacking.	(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 particular 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 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. With a view to the proper functioning of the internal market this category of food should be governed by Regulation (EC) No 1924/2006 and should meet the requirements laid down in that Regulation. As regards special provisions for food for persons suffering from carbohydrate metabolism disorders (diabetes), a Commission report concludes that the scientific basis for setting specific compositional requirements is lacking.
Justification
An appropriate regulatory framework for food for sportsmen enhances legal certainty and avoids there being a large number of national laws, which may disrupt the proper functioning of the internal market.
Amendment  4 Proposal for a regulation Recital 15
Text proposed by the Commission	Amendment
(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. 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 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, taking into account Commission Directive 2006/141/EC, Commission Directive 2006/125/EC and Commission Directive 1999/21/EC.	(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, milk-based drinks intended for young children, food for special medical purposes. Experience has shown that the provisions laid down in Directive 2006/141/EC, Directive 2006/125/EC, Directive 1999/21/EC, Regulation (EC) No 41/2009, as well as Directive 96/8/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 , milk-based drinks intended for young children, food for special medical purposes, taking into account Directive 2006/141/EC, Directive 2006/125/EC, Directive 1999/21/EC, Directive 96/8/EC and 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 using current Union acts.
Justification
It is necessary to re-introduce the concept of food intended for specialised nutrition. This inclusion will establish criteria to protect young children with respect to nutritional and food safety requirements specific to the age group, for example limits for the addition of nutrients, microbiological hazards and contaminants. Failure to include these products will result in these products being regulated as general foods and subject to the nutritional and purity criteria laid down for the adult population which are not always appropriate for children aged 12-36 months.
Amendment  5 Proposal for a regulation Recital 17
Text proposed by the Commission	Amendment
(17) It is important that ingredients used in the manufacture of the categories of food covered by this Regulation are appropriate to satisfy the nutritional requirements of, and are suitable for the persons to whom they are intended and that their nutritional adequacy has been established by generally accepted scientific data. Such adequacy should be demonstrated through a systematic review of the available scientific data.	(17) It is important that ingredients used in the manufacture of the categories of food covered by this Regulation are appropriate to satisfy the nutritional requirements of, and are suitable for the persons to whom they are intended and that their nutritional adequacy has been established by generally accepted scientific data. Such adequacy should be demonstrated through a systematic and independent review of the available scientific data.
Justification
The scientific data on the nutritional adequacy of the special food must be not only systematic, but also based on independent evaluation, to guarantee the high reliability and general acceptance of such data.
Amendment  6 Proposal for a regulation Recital 17 a (new)
Text proposed by the Commission	Amendment
	(17a) To update the list of banned substances, the Authority and the national authorities competent in the matter are to perform a regular assessment on the basis notably of new data and scientific and statutory developments in the Member States or internationally.
Amendment  7 Proposal for a regulation Recital 19
Text proposed by the Commission	Amendment
(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, taking into account Commission Directive 2006/141/EC, Commission Directive 2006/125/EC and Commission Directive 1999/21/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 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.	(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, milk-based drinks intended for young children and food for special medical purposes, taking into account Directive 2006/141/EC, Directive 2006/125/EC, Directive 1999/21/EC, Directive 96/8/EC and Regulation (EC) No 41/2009. In order to adapt the definitions of infant formula, follow-on formula, processed cereal-based food and baby food, milk-based drinks intended for young children, and food for special medical purposes 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. A clear and time-efficient procedure with due regard for consumer health protection should also be ensured to enable the foodstuff resulting from scientific and technological innovations to be placed on the market rapidly.
Justification
It is necessary to re-introduce the concept of food intended for specialised nutrition. This would ensure that the strictest safety specifications with regard to nutrition, microbiological hazards, pesticides and contaminants, colourings and sweetening agents govern these products. Failure to include these products within the scope will result in these products being regulated as general foods and subject to the nutritional and purity criteria laid down for the adult population which are not appropriate for children aged 12-36 months.
Amendment  8 Proposal for a regulation Recital 26
Text proposed by the Commission	Amendment
(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 consumption under the rules specified in 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 Regulation.	(26) Currently, the statements ‘gluten-free’ and ‘very low gluten’ may be used for food for specialised nutrition intended for people intolerant to gluten under the rules specified in Article 3 of Regulation (EC) No 41/2009 . Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers1 provides for the adoption by the Commission of implementing acts regulating voluntary information on the possible and unintentional presence in food of a substance causing allergies or intolerances. For reasons of coherence and simplification of the legal framework, implementing powers should be conferred on the Commission under Regulation (EU) No 1169/2011 to adopt implementing acts regulating voluntary information on the absence or reduced presence in food of substances causing intolerances, such as gluten and lactose, repealing Regulation (EC) No 41/2009. It is necessary that Regulation (EU) No 1169/2001 is amended to that effect and that the required implementing provisions be adopted by the Commission prior to the entry into application of this Regulation. The implementing act concerned should maintain on the foods in question the statements 'gluten-free' and 'very low gluten' and their associated conditions of use as specified in Article 4 of Regulation (EC) No 41/2009, which does not allow the use of the statement "very low gluten" for these foods, as well as an indication of the persons for whom the foods are intended, as currently regulated under Regulation (EC) No 41/2009, and hence provide for the same level of consumer protection. Such foodstuff for specialised nutrition intended for people intolerant to gluten should 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)
	____________________
	1 OJ L 304, 22.11.2011, p. 18.
Justification
People intolerant to gluten must have a regulatory framework tailored to their specific needs.
Amendment  9 Proposal for a regulation Recital 27 a (new)
Text proposed by the Commission	Amendment
	(27a) In order to ensure a high level of consumer protection, adequate procedures for oversight, in respect of both hygiene and composition, both before and after foods are placed on the market, should be established at Member State level.
Amendment  10 Proposal for a regulation Recital 29
Text proposed by the Commission	Amendment
(29) Adequate transitional measures are necessary to enable food business operators to adapt to the requirements of this Regulation.	(29) The Commission should take adequate measures to ensure legal certainty during the transition to the implementation of this Regulation and provide the assistance and up-to-date information to the food business operators necessary to enable them to adapt to the requirements of this Regulation.
Justification
Account must be taken of the fact that the regulatory adjustments resulting from this proposal may create a legal vacuum, albeit during a transitional period.
Amendment  11 Proposal for a regulation Recital 29 a (new)
Text proposed by the Commission	Amendment
	(29a) A procedure should be laid down which allows foodstuffs resulting from scientific and technological innovations to be placed on the market on a temporary basis in order that proper benefit may be derived from the fruits of industry research pending the amendment of the specific directive concerned. However, on the grounds of consumer health protection, marketing authorisations may be granted only after the Authority has been consulted.
Justification
It is important – to enable them to respond as effectively as possible to the specific nutrition needs of vulnerable groups of people – that manufacturers in the sector should have optimal guidance on the steps to be followed. The groups concerned could thus benefit swiftly from relevant technical and scientific progress.
Amendment  12 Proposal for a regulation Recital 29 b (new)
Text proposed by the Commission	Amendment
	(29b) In order to facilitate market access for operators – especially small and medium-sized enterprises – wishing to sell foods resulting from scientific and technological innovations, the Commission, in close cooperation with the relevant stakeholders, should adopt guidelines on the procedure for placing such foods on the market on a temporary basis.
Amendment  13 Proposal for a regulation Article 2 – paragraph 2 – point g – point ii
Text proposed by the Commission	Amendment
(ii) milk intended for young children;	deleted
Justification
Milk Based Drinks Intended for Young Children, are specifically designed, nutrient dense products, which contribute to young children’s nutritional needs from 12-36 months. Excluding these products from the Regulation will result in reduced food safety measures, non-specific nutritional composition and a lack of harmonization across EU Member States. As a result, these products will be regulated as general foods, thus subject to the nutritional and safety criteria laid down for adults, which are not appropriate for children aged 12-36 months.
Amendment  14 Proposal for a regulation Article 6 a (new)
Text proposed by the Commission	Amendment
	Article 6a
	Oversight
	The national competent authorities shall ensure that an adequate system of oversight is put in place to ensure that market operators comply with this Regulation and with the relevant health requirements.
Amendment  15 Proposal for a regulation Article 9 – paragraph 1
Text proposed by the Commission	Amendment
1. The composition of food referred to in Article 1(1) shall be such that it is appropriate to satisfy the nutritional needs of, and it is suitable for the persons to whom it is intended, in accordance with generally accepted scientific data.	1. The composition of food referred to in Article 1(1) shall be such that it is appropriate to satisfy the nutritional needs of, and it is suitable for the persons to whom it is intended, in accordance with generally accepted and independently evaluated scientific data and medical opinion.
Justification
See justification for AM 1.
Amendment  16 Proposal for a regulation Article 9 – paragraph 3
Text proposed by the Commission	Amendment
3. The labelling, presentation and advertising of food referred to in Article 1(1) shall provide adequate consumer information and must not be misleading.	3. The labelling, presentation and advertising of food referred to in Article 1(1) must not be misleading and shall:
	(a) provide clear and adequate consumer information; and,
	(b) be based on the advice of independent persons with qualifications in medicine, nutrition or pharmacy, taking into account the specific needs of the persons for whom the food is intended, using scientific data validated by the Authority.
Amendment  17 Proposal for a regulation Article 9 – paragraph 3 a (new)
Text proposed by the Commission	Amendment
	3a. In the labelling, presentation and advertising of foodstuffs for normal consumption, the following shall be prohibited:
	(a) the use of the words "specialised nutrition", either alone or in conjunction with other words, to designate those foodstuffs;
	(b) all other markings or any presentation likely to give the impression that one of the products referred to in Article 1(1) and (2) is involved.
Justification
There is a need to maintain a provision similar to that in Article 2.2.b of the current Framework Directive ensuring that only products compliant with the regulation can be presented as covering the specific needs of the targeted populations. A clear distinction must be made between foods for labelling nutrition and foodstuffs for normal consumption. Only normal foodstuffs with approved nutrition or health claims should be able to communicate on their suitability for specific conditions.
Amendment  18 Proposal for a regulation Article 9 – paragraph 4
Text proposed by the Commission	Amendment
4. 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 by persons having qualifications in medicine, nutrition, pharmacy or other professionals responsible for maternal and child health care.	4. Responsibility for disseminating any useful information or recommendations with reference to the categories of food referred to in Article 1(1) shall lie exclusively with persons having qualifications in medicine, nutrition, pharmacy or other professionals responsible for maternal and child health care and shall be based on scientific data that can be independently verified.
Justification
Any information on these categories of food disseminated by passive means (e.g. via the internet) must be drawn up by qualified professionals and be based on verifiable scientific data.
Amendment  19 Proposal for a regulation Article 10 – paragraph 2 – introductory part
Text proposed by the Commission	Amendment
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 as well as any technical and scientific progress, the Commission shall be empowered to adopt delegated Regulations, 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:	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 as well as any technical and scientific progress, in particular the results of risk evaluations and the precautionary principle, 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  20 Proposal for a regulation Article 10 – paragraph 2 – point b a (new)
Text proposed by the Commission	Amendment
	(ba) the specific compositional limitations of the packaging of the food referred to in Article 1(1);
Justification
The Commission should be given the power to control or ban substantiates in the packaging of infant and children foods which might have an effect on a product before it is consumed, e.g. the use of BPA in the tin can lining of infant formula containers which could leak into the product.
Amendment  21 Proposal for a regulation Article 10 – paragraph 2 – point c a (new)
Text proposed by the Commission	Amendment
	(ca) the derogations from the minimum font size due to the additional specific requirements on mandatory information to be provided on labels of certain foods referred to in Article 1(1) and other legibility requirements, established in Article 13(2) of Regulation (EU) No 1169/2011;
Justification
The specific labelling provisions applying to these groups of products will be reviewed and recast in the form of delegated acts. It is appropriate at that point in time to consider the specific consumer information needs and legibility requirements applicable to these products, which may necessitate derogation from minimum font size and certain other legibility criteria set for general foods.
Amendment  22 Proposal for a regulation Article 10 – paragraph 2 – point d a (new)
Text proposed by the Commission	Amendment
	(da) the process for the placing on the market of foods 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;
Justification
Foods falling within the scope of this regulation are required to provide substantial additional information to that required by general food labelling provisions in order to ensure their safe use. The specific labelling provisions applying to these groups of products will be reviewed and recast in the form of delegated acts. It is appropriate at that point in time to consider the specific consumer information needs and legibility requirements applicable to these products, which may necessitate derogation from minimum font size and certain other legibility criteria set for general foods.
Amendment  23 Proposal for a regulation Article 10 – paragraph 2 – point f a (new)
Text proposed by the Commission	Amendment
	(fa) the requirements for information to be provided on recommendations for appropriate use of the foods referred to in Article 1(1).
Justification
Foods falling within the scope of this regulation are required to provide substantial additional information to that required by general food labelling provisions in order to ensure their safe use.
Amendment  24 Proposal for a regulation Article 10 – paragraph 3 – subparagraph 1
Text proposed by the Commission	Amendment
3. Subject to the requirements of Articles 7 and 9 and taking into account relevant technical and scientific progress, the Commission shall update the delegated Regulations mentioned in paragraph 2 in accordance with Article 15.	3. Subject to the requirements of Articles 7 and 9 and taking into account relevant technical and scientific progress, the results of new risk assessments and the precautionary principle, the Commission shall update the delegated Regulations mentioned in paragraph 2 of this Article in accordance with Article 15.
Amendment  25 Proposal for a regulation Article 10 – paragraph 3 – subparagraph 1 a (new)
Text proposed by the Commission	Amendment
	In order to enable foodstuffs intended for particular nutritional uses and resulting from scientific and technological progress to be placed on the market rapidly, the Commission may, after consulting the Authority, adopt delegated acts in accordance with Article 15 authorising for a two-year period the placing on the market of foodstuffs which do not comply with the rules as to composition laid down by this Regulation and by the delegated regulations for groups of foodstuffs referred to in Article 1(1).
Justification
The innovation clause provided for in Directive 2009/39 on foodstuffs intended for particular nutritional uses must be reinserted. This procedure, which is rarely used at present, should be facilitated to ensure that consumers can benefit as soon as possible from suitable products.
Amendment  26 Proposal for a regulation Article 10 a (new)
Text proposed by the Commission	Amendment
	Article 10a
	Milk intended for young children
	By the end of the transition period defined in Article 18(1), the Commission shall, after consulting the Authority, submit a report to the European Parliament and to the Council on the desirability of special provisions regarding the composition and labelling of milk-based drinks intended for young children in regard to the nutritional needs, the pattern of consumption, the nutritional intake and the levels of exposure to contaminants and pesticides of young children taking into account the different legislation that governs normal food and food intended for infants and young children. In the light of the conclusions of that report, the Commission shall either:
	(a) decide that there is no need for special provisions regarding the composition and labelling of milk-based drinks intended for young children;
	(b) submit, in accordance with the procedure laid down in Article 114 TFEU, any appropriate proposals for amendments to this Regulation; and amend the relevant delegated acts to include the special provisions concerned, in accordance with Article 15.
Justification
Milk Based Drinks Intended for Young Children are currently present on the European market as per the provisions laid down in Framework Directive 2009/39/EC.However, there is a lack of consensus across EU members states on how such products should be regulated. To continue to provide a high level of protection for a group of particularly vulnerable consumers it would therefore be useful to have EFSA’s scientific opinion on the desirability to include specific compositional and labelling requirements for these products in the Commission’s delegated acts
Amendment  27 Proposal for a regulation Article 11 – paragraph 2
Text proposed by the Commission	Amendment
2. No later than [2 years after the date of the entry into force of this Regulation], the Commission shall establish and subsequently update a Union list of permitted substances that meet the conditions of paragraph 1, by means of implementing Regulations. The entry of a substance in the Union list shall include a specification of the substance, and, where appropriate, specify the conditions of use and the applicable purity criteria. Those implementing Regulations shall be adopted in accordance with the examination procedure referred to in Article 14(2). On duly justified grounds of extreme urgency relating to emerging health risks, the Commission shall adopt immediately applicable implementing acts updating the Union list in accordance with Article 14(3).	2. No later than 6 months after the date of the entry into force of this Regulation, the Commission shall establish and subsequently update a Union list of permitted substances that meet the conditions of paragraph 1, by means of implementing Regulations. The entry of a substance in the Union list shall include a specification of the substance, and, where appropriate, specify the conditions of use and the applicable purity criteria. Those implementing Regulations shall be adopted in accordance with the examination procedure referred to in Article 14(2). On duly justified grounds of extreme urgency relating to emerging health risks, the Commission shall adopt immediately applicable implementing acts updating the Union list in accordance with Article 14(3).
Amendment  28 Proposal for a regulation Article 15 – paragraph 2
Text proposed by the Commission	Amendment
2. The delegation of power referred to in Articles 2(3) and 10 of this Regulation shall be conferred for an indeterminate period of time from the (*) [(*) Date of entry into force of the basic legislative act or from any other date set by the legislator.]	2. The power to adopt delegated acts referred to in Articles 2(3) and 10 shall be conferred on the Commission for a period of five years starting from the date of entry into force of this Regulation. The Commission shall submit a report on the delegation of power no later than six months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment  29 Proposal for a regulation Article 18 – paragraph 1 a (new)
Text proposed by the Commission	Amendment
	1a. 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 foodstuffs1, the microbiological criteria laid down in Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs2 shall apply to milk-based drinks intended for young children currently on the market during the transition period laid down in paragraph 1.
	________________
	1 OJ L 364, 20.12.2006, p. 5.
	2 OJ L 338, 22.12.2005, p. 1.
Amendment  30 Proposal for a regulation Article 18 a (new)
Text proposed by the Commission	Amendment
	Article 18a
	Amendment to Regulation (EU) No 1169/2011
	In Article 36(3) of Regulation (EU) No 1169/2011, the following point is inserted:
	“(aa) information on the possible absence or reduced presence in foods of substances that can cause intolerance, such as gluten;”.
Justification
People intolerant to gluten must have a regulatory framework tailored to their specific needs.
Amendment  31 Proposal for a regulation Article 18 b (new)
Text proposed by the Commission	Amendment
	Article 18b
	Food intended to meet the expenditure of intense muscular effort
	No later than 1 July 2015, the Commission shall submit a report to the European Parliament and the Council assessing the need to harmonise the composition and labelling of food intended to meet the expenditure of intense muscular effort. The Commission may accompany this report with proposals to amend the relevant Union legislation.
Justification
The Commission should submit a report on the need to harmonise provisions on the composition and labelling of food intended to meet the expenditure of intense muscular effort, with due regard for requirements relating to consumer protection and the operation of the internal market.

PROCEDURE

Title	Food intended for infants and young children and food for special medical purposes
References	COM(2011)0353 – C7-0169/2011 – 2011/0156(COD)
Committee responsible        Date announced in plenary	ENVI 5.7.2011
Committee(s) asked for opinion(s)        Date announced in plenary	ITRE 5.7.2011
Previous rapporteur(s)	Corinne Lepage
Discussed in committee	12.1.2012
Date adopted	6.2.2012
Result of final vote	+: –: 0:	42 11 1
Members present for the final vote	Gabriele Albertini, Amelia Andersdotter, Josefa Andrés Barea, Jean-Pierre Audy, Ivo Belet, Maria Da Graça Carvalho, Giles Chichester, Pilar del Castillo Vera, Dimitrios Droutsas, Christian Ehler, Vicky Ford, Norbert Glante, Robert Goebbels, András Gyürk, Jacky Hénin, Kent Johansson, Romana Jordan, Krišjānis Kariņš, Béla Kovács, Philippe Lamberts, Marisa Matias, Judith A. Merkies, Jaroslav Paška, Vittorio Prodi, Herbert Reul, Michèle Rivasi, Jens Rohde, Paul Rübig, Amalia Sartori, Salvador Sedó i Alabart, Britta Thomsen, Patrizia Toia, Evžen Tošenovský, Ioannis A. Tsoukalas, Claude Turmes, Marita Ulvskog, Kathleen Van Brempt, Alejo Vidal-Quadras
Substitute(s) present for the final vote	Antonio Cancian, António Fernando Correia De Campos, Françoise Grossetête, Cristina Gutiérrez-Cortines, Jolanta Emilia Hibner, Yannick Jadot, Seán Kelly, Bernd Lange, Werner Langen, Marian-Jean Marinescu, Zofija Mazej Kukovič, Morten Messerschmidt, Vladko Todorov Panayotov, Mario Pirillo, Silvia-Adriana Ţicău
Substitute(s) under Rule 187(2) present for the final vote	Michael Theurer

OPINION of the Committee on the Internal Market and Consumer Protection (15.2.2012)

for the Committee on the Environment, Public Health and Food Safety

on the 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
(COM(2011)0353 – C7‑0169/2011 – 2011/0156(COD))

Rapporteur: Iliana Ivanova

SHORT JUSTIFICATION

Objectives of the proposal

The Commission proposal revises the rules on foodstuffs intended for particular nutritional uses, as laid down in Framework Directive 2009/39/EC and its implementing acts. After more than thirty years of application, the substantive provisions of the Directive do no longer respond to the needs of consumers and to the latest developments in the market. Furthermore, discussions with Member States and stakeholders have revealed difficulties in implementing the Framework Directive, in particular with regards to more recent pieces of EU legislation, such as Regulation (EC) No 1924/2006 on nutrition and health claims on foods (Claims Regulation) and Regulation (EU) No 1169/2011 on food information for consumers.

The Commission proposes to revise the Framework Directive by abolishing the general rules on dietetic foods, but to maintain some of the rules for specific foods adopted under the Framework.

General comments

The Rapporteur for opinion welcomes the proposal of the Commission and supports the general approach, maintaining the vertical Directives for infant formula, baby food and medical food under a new Framework Regulation, which provide a high level of protection to a group of vulnerable consumers, and abandoning the concept of dietetic food, which may mislead consumers and has led to market fragmentation.

The Rapporteur anticipates that the proposed simplification of the existing legal framework will reduce the administrative burden on companies, especially SMEs, and will further stimulate free movement of these goods. She expects that the reform will foster innovation in this segment of the food sector, which is one of the most competitive in the European industry.

Gluten

The Commission proposes to consider food for celiac people as normal food and proposes to withdraw Regulation (EC) No 41/2009. Instead, the Commission proposal suggests regulating this specific type of foods under the Nutrition and Health Claims Regulation. The Rapporteur realizes the importance of the topic and considers it more appropriate to regulate this category of foods under the new Regulation on food information for consumers, while maintaining the existing conditions as regards composition and labelling of the products, and hence the same standard of health protection as today.

Milk intended for young children

The so-called "growing milks" target young children in the age group of one to three years old and constitute a growing market in many Member States. No specific substantive rules are laid down for these products, which are today sometimes, but not always, notified to national authorities under Framework Directive 2009/39/EC as "foods for particular nutritional uses". The Rapporteur supports the Commission in its proposal to have these milks regulated solely under the Nutrition and Health Claims Regulation, but invites the Commission to examine the desirability of special provisions regarding the composition and labelling of such milks.

Foods for sportspeople

Currently, no specific rules exist on composition or labelling for foods for sportspeople. Today, these foods are considered as "dietetic foods". The Commission acknowledges that a specific directive might hinder innovation in the sector, and proposes to include this category of foods in the Nutrition and Health Claims Regulation. The Rapporteur fully supports Commission's approach, since it will definitely bring more legal clarity and reinforce consumers' awareness and protection.

Slimming foods and very low calorie diets (VLCDs)

The Rapporteur shares the Commission's view that Directive 96/8/EC on slimming foods should be repealed, and that the same substantive rules should be maintained under the Nutrition and Health Claims Regulation.

In view of the health risks they entail, the Rapporteur is concerned that there are currently no specific rules at EU level on the composition, labeling and use of so-called very low calorie diets ("VLCDs"), which correspond to total diet replacements under 800 kcal. VLCDs should be made available under medical supervision only and should be regulated under Commission Directive 1999/21/EC on dietary foods for special medical purposes.

Delegated acts

The Commission should be empowered to lay down, by means of delegated acts, rules concerning specific composition and information requirements for food intended for infants and young children and medical food. However, the Rapporteur disagrees that the Commission should be empowered to amend the definitions of 'infant formula', 'baby food', 'food for special medical purposes', etc., since these concern essential elements of the basic legislative act and should therefore remain within the realm of the legislator.

Innovation

Taking into account relevant technical and scientific progress, the Commission should be empowered to speedily update the delegated acts adopted pursuant to this Regulation. This should foster innovation in the sector concerned.

AMENDMENTS

The Committee on the Internal Market and Consumer Protection calls on the Committee on the Environment, Public Health and Food Safety, as the committee responsible, to incorporate the following amendments in its report:

Amendment  1 Proposal for a regulation Recital 2
Text proposed by the Commission	Amendment
(2) The free movement of safe and wholesome food is an essential aspect of the internal market and contributes significantly to the health and well-being of citizens, and to their social and economic interests.	(2) The guarantee of safe and wholesome food products is an essential aspect of the internal market and contributes significantly to the health and well-being of citizens, particularly of vulnerable consumer groups, such as infants and young children, and to the social and economic interests of citizens. A better harmonization of rules will stimulate the free movement of goods and thus contribute to releasing the true potential of the internal market.
Amendment  2 Proposal for a regulation Recital 7
Text proposed by the Commission	Amendment
(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 particular 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 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. As regards special provisions for food for persons suffering from carbohydrate metabolism disorders (diabetes), a Commission report concludes that the scientific basis for setting specific compositional requirements is lacking. (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 particular 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 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. With a view to improving the functioning of the internal market and enhancing consumer protection, while stimulating innovation, ‘foods for sportspeople' should henceforth be regulated under general food law, such as Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods1, Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods2, Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers3,and Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements4 and comply with requirements therein. As regards special provisions for food for persons suffering from carbohydrate metabolism disorders (diabetes), a Commission report concludes that the scientific basis for setting specific compositional requirements is lacking.   ________   1 OJ L 404, 30.12.2006, p. 9.   2 OJ L 404, 30.12.2006, p. 26.   3 OJ L 304, 22.11.2011, p. 18.   4 OJ L 183, 12.7.2002, p. 51.
Justification
'Foods for sports people' are currently considered "foods for particular nutritional purposes". However, no specific compositional or labelling requirements are laid down for them at EU level, and the notification system results in a high administrative burden and unequal market conditions in the EU. To foster innovation and to contribute to a well-functioning internal market, ‘foods for sports people’ should be regulated under Regulation (EC) No 1924/2006 and other acts of general food law. Once a nutrition or health claim is authorized by EFSA, it can be used by other companies (particularly SMEs).
Amendment  3 Proposal for a regulation Recital 11 a (new)
Text proposed by the Commission	Amendment
	(11a) Hence there is a need to remove differences in interpretation and to tackle difficulties for Member States and operators in combining the different pieces of food legislation, by simplifying the regulatory environment. This would ensure that similar products are treated in the same way across the Union and would create a more level playing field for all operators across the internal market, especially SMEs.
Amendment  4 Proposal for a regulation Recital 15
Text proposed by the Commission	Amendment
(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. 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 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, taking into account Commission Directive 2006/141/EC, Commission Directive 2006/125/EC and Commission Directive 1999/21/EC.	(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. 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 ensure the free movement of such food in a satisfactory manner, while ensuring a high level of protection of public health and consumers’ interests. 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, taking into account Commission Directive 2006/141/EC, Commission Directive 2006/125/EC and Commission Directive 1999/21/EC. In this context, as for all food, any substances that are liable to be harmful to the health of the categories concerned should be excluded from the composition of categories of foods covered by this Regulation.
Amendment  5 Proposal for a regulation Recital 16
Text proposed by the Commission	Amendment
(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 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 should be regularly adapted taking into account technical and scientific progress and relevant developments at international level, as appropriate.	(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 should be transferred to this Regulation.
Justification
See amendment 18.
Amendment  6 Proposal for a regulation Recital 18
Text proposed by the Commission	Amendment
(18) General labelling requirements are laid down in Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the law of the Member States relating to labelling, presentation and advertising of foodstuffs. Those general labelling requirements should, as a general rule, apply to the categories of food covered by this Regulation. However, this Regulation should also provide for additional requirements to, or derogations from, the provisions of Directive 2000/13/EC, where necessary, in order to meet the specific objectives of this Regulation.	(18) General labelling requirements are laid down in Regulation (EU) No 1169/2011. Those general labelling requirements should, as a general rule, apply to the categories of food covered by this Regulation. However, this Regulation should also provide for additional requirements to, or derogations from, the provisions of Regulation (EU) No 1169/2011, where necessary, in order to meet the specific objectives of this Regulation.
Justification
Since the adoption of the Commission’s proposal for a Regulation on food intended for infants and young children and on food for special medical purposes, Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the law of the Member States relating to labelling, presentation and advertising of foodstuffs has been replaced by 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.
Amendment  7 Proposal for a regulation Recital 19
Text proposed by the Commission	Amendment
(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, taking into account Commission Directive 2006/141/EC, Commission Directive 2006/125/EC and Commission Directive 1999/21/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 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.	(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, taking into account Commission Directive 2006/141/EC, Commission Directive 2006/125/EC and Commission Directive 1999/21/EC. In order 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 Regulation (EU) No 1169/2011 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 to the Council.
Justification
Subsequent to Article 290 of the TFEU, "a legislative act may delegate to the Commission the power to adopt non-legislative acts of general application to supplement or amend certain non-essential elements of the legislative act". The adaptation of the definitions, however, concerns an essential element of the legislative act and should not be the subject of a delegation to the Commission. See also Amendment 18.
Amendment  8 Proposal for a regulation Recital 19 a (new)
Text proposed by the Commission	Amendment
	(19a) Taking into account relevant technical and scientific progress, the Commission should be empowered to update the delegated acts adopted pursuant to this Regulation. This should foster innovation in the sector of food intended for infants and young children and food for special medical purposes, which must not occur at the expense of food safety.
Justification
The Rapporteur for opinion supports the Commission’s proposal to introduce a more simplified innovation procedure, which allows for updating the relevant delegated acts in case technical or scientific progress is demonstrated by a market operator.
Amendment  9 Proposal for a regulation Recital 26
Text proposed by the Commission	Amendment
(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 consumption under the rules specified in 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 Regulation.	(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 consumption under the rules specified in Commission Regulation (EC) No 41/2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten. Regulation (EU) No 1169/2011 provides for the adoption by the Commission of implementing acts regulating voluntary information on the possible and unintentional presence in food of a substance causing allergies or intolerances. For reasons of coherence and simplification of the legal framework, the Commission should be granted a mandate under Regulation (EU) No 1169/2011 to also adopt implementing acts regulating voluntary information on the absence or reduced presence in food of substances causing intolerances, such as gluten and lactose, and to withdraw Regulation (EC) No 41/2009. It is necessary that Regulation (EU) No 1169/2011 is amended to that effect and that the required implementing acts be adopted by the Commission prior to the entry into application of this Regulation. The implementing act concerned should maintain the statements 'gluten-free' and 'very low gluten' on food and their associated conditions of use as currently regulated under Regulation (EC) No 41/2009, and hence provide for the same level of consumer protection.
Justification
The Commission proposes to consider food for celiac people as normal food, to withdraw Regulation (EC) No 41/2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten and to regulate the statements concerned under the Claims Regulation. The Rapporteur for opinion, however, prefers regulating the statements 'gluten-free' and 'very low gluten' under the Regulation on Food information for consumers, which already provides for the adoption of specific rules to indicate the presence of substances that cause allergy or intolerance.
Amendment  10 Proposal for a regulation Recital 27 a (new)
Text proposed by the Commission	Amendment
(27a) There are currently no specific rules at Union level harmonising the composition, labelling and use of ‘milks intended for young children’, i.e. milks promoted as being particularly suited for children between one and three years old. Some of these milks are currently being notified by market players as ‘foods for particular nutritional purposes’ under Directive 2009/39/EC, whereas others are not. Moreover, while several of these milks are being marketed as ‘growing milks’, sound scientific evidence demonstrating the added health or nutritional value of these milks over normal milk is lacking. This situation causes obstacles to the functioning of the internal market and entails unequal levels of consumer protection across the Union. In order to remedy this situation, ‘milks intended for young children’ should be regulated under general food law, such as Regulation (EC) No 1924/2006, Regulation (EC) No 1925/2006, Regulation (EU) No 1169/2011 and Directive 2002/46/EC and comply with requirements therein. Furthermore, the Commission should, after consulting the European Food Safety Authority, present to the European Parliament and to the Council a report on the desirability of special provisions regarding the composition and labelling of milks intended for young children, and propose measures accordingly.
Amendment  11 Proposal for a regulation Recital 27 b (new)
Text proposed by the Commission	Amendment
	(27b) There are currently no specific rules at Union level on the composition, labelling and use of so-called "Very Low Calorie Diets" (VLCDs), which correspond to total diet replacements under 800 kcal. In view of the health risks they entail, VLCDs should be made available under medical supervision only and should be regulated under Commission Directive 1999/21/EC.
Justification
Other than for meal replacements of 200-400 kcal and total diet replacements (low calorie diets or “LCDs”) of 800-1200 kcal, there are currently no specific rules at EU level on the composition, labelling and use of VLCDs. Whereas the previous categories should henceforth be regulated under the Nutrition and Health Claims Regulation, VLCDs should be regulated under Commission Directive 1999/21/EC on dietary foods for special medical purposes, for reasons of the health risks they entail.
Amendment  12 Proposal for a regulation Recital 27 c (new)
Text proposed by the Commission	Amendment
	(27c) Pursuant to Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules1, Member States should conduct inspections on the compliance of undertakings with this Regulation and the delegated acts adopted pursuant thereto, following a risk-based approach.
	____________________
	1 OJ L 165, 30.4.2004, p. 1.
Amendment  13 Proposal for a regulation Recital 29 a (new)
Text proposed by the Commission	Amendment
	(29a) To ease access of small and medium-sized enterprises (SMEs) to the market which in some sectors, for example baby food and medical food, appear to be dominated by few large companies, the Commission should, in close cooperation with concerned stakeholders, adopt guidelines to help undertakings, in particular SMEs, to comply with the requirements laid down in this Regulation and thus facilitate competitiveness and innovation,
Amendment  14 Proposal for a regulation Article 1 – paragraph 1 – point a
Text proposed by the Commission	Amendment
(a) infant formula and follow-on formula;	(a) infant formula and follow-on formula for infants in good health;
Amendment  15 Proposal for a regulation Article 1 – paragraph 1 – point b
Text proposed by the Commission	Amendment
(b) processed cereal-based food and baby food for infants and young children;	(b) processed cereal-based food and baby food for infants and young children in good health;
Amendment  16 Proposal for a regulation Article 2 – paragraph 1 – point b
Text proposed by the Commission	Amendment
(b) the definitions of 'labelling' and 'pre-packaged foodstuff' in points (a) and (b) of Article 1(3) of Directive 2000/13/EC;	(b) the definitions of ‘prepacked food’ and 'labelling' in points (e) and (j) of Article 2(2) of Regulation (EU) No 1169/2011;
Justification
Alignment to the recently adopted Regulation (EU) No 1169/2011 on food information to consumers, which replaces Directive 2000/13/EC.
Amendment  17 Proposal for a regulation Article 2 – paragraph 2 – point h
Text proposed by the Commission	Amendment
(h) ‘food for special medical purposes’ means food intended for the dietary management of patients to be used under medical supervision. It is intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary food or certain nutrients contained therein, or with other medically-determined nutrient requirements, whose dietary management cannot be achieved only by modification of the normal diet.	(h) ‘food for special medical purposes’ means food intended for the dietary management of patients to be used under medical supervision. It is intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary food or certain nutrients contained therein, or with other medically-determined nutrient requirements, whose dietary management cannot be achieved only by modification of the normal diet. Food for special medical purposes also includes Very Low Calorie Diets (VLCDs), which correspond to a total diet replacement under 800 kcal.
Amendment  18 Proposal for a regulation Article 2 – paragraph 3
Text proposed by the Commission	Amendment
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' taking into account technical and scientific progress and relevant developments at international level, as appropriate.	deleted
Justification
Subsequent to Article 290 of the Treaty on the functioning of the European Union, "a legislative act may delegate to the Commission the power to adopt non-legislative acts of general application to supplement or amend certain non-essential elements of the legislative act". The adaptation of the definitions, however, concerns an essential element of the legislative act and should not be the subject of a delegation to the Commission.
Amendment  19 Proposal for a regulation Article 3 – paragraph 1 a (new)
Text proposed by the Commission	Amendment
	In the labelling, presentation and advertising of foodstuffs for normal consumption the following shall be prohibited:
	(a) the use of the expression ‘specialised nutrition’, either alone or in conjunction with other words, to designate those foodstuffs;
	(b) all other markings or any presentation likely to give the impression that one of the products referred to in Article 1 is involved.
Justification
The aim here is to include a clause that appears in Directive 2009/39/EC to prevent giving the impression that a food that meets only one requirement can be used for the people or diets covered by this regulation.
Amendment  20 Proposal for a regulation Article 4 – title
Text proposed by the Commission	Amendment
Pre-packaged food	Prepacked food
Justification
Alignment to the recently adopted Regulation (EU) No 1169/2011.
Amendment  21 Proposal for a regulation Article 4
Text proposed by the Commission	Amendment
Food referred to in Article 1(1) shall only be allowed on the retail market in the form of prepackaged food.	Food referred to in Article 1(1) shall only be allowed on the retail market in the form of prepacked food.
Justification
Alignment to the recently adopted Regulation (EU) No 1169/2011.
Amendment  22 Proposal for a regulation Article 9 – paragraph 3
Text proposed by the Commission	Amendment
3. The labelling, presentation and advertising of food referred to in Article 1(1) shall provide adequate consumer information and must not be misleading.	3. The labelling, presentation and advertising of food referred to in Article 1(1) shall provide adequate consumer information, must not be misleading, shall not attribute properties to such products for the prevention, treatment or cure of human disease, or imply such properties, and must be based on scientific data validated by the European Food Safety Authority.
Amendment  23 Proposal for a regulation Article 9 – paragraph 4
Text proposed by the Commission	Amendment
4. 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 by persons having qualifications in medicine, nutrition, pharmacy or other professionals responsible for maternal and child health care.	4. The drawing up and dissemination of any useful information or recommendations with reference to the categories of food referred to in Article 1 (1) may be made exclusively by persons having qualifications in medicine, nutrition, pharmacy or other professionals responsible for maternal and child health care and must be based on scientific data that can be independently verified.
Amendment  24 Proposal for a regulation Article 10 – paragraph 1
Text proposed by the Commission	Amendment
1. Food referred to in Article 1(1) must comply with the requirements of Article 7 and composition and information requirements provided in Article 9.	deleted
Justification
Unnecessary repetition of Articles 7 and 9.
Amendment  25 Proposal for a regulation Article 10 – paragraph 2 – introductory part
Text proposed by the Commission	Amendment
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 as well as any technical and scientific progress, the Commission shall be empowered to adopt delegated Regulations, 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:	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 as well as any technical and scientific progress, the Commission shall be empowered to adopt delegated acts, 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:
Justification
'Delegated acts' is the agreed standard wording to be used in provisions of this kind
Amendment  26 Proposal for a regulation Article 10 – paragraph 3 – subparagraph 1
Text proposed by the Commission	Amendment
3. Subject to the requirements of Articles 7 and 9 and taking into account relevant technical and scientific progress, the Commission shall update the delegated Regulations mentioned in paragraph 2 in accordance with Article 15.	3. Subject to the requirements of Articles 7 and 9 and taking into account relevant technical and scientific progress, the Commission shall update the delegated acts mentioned in paragraph 2 in accordance with Article 15.
Justification
'Delegated acts' is the agreed standard wording to be used in provisions of this kind
Amendment  27 Proposal for a regulation Article 10 a (new)
Text proposed by the Commission	Amendment
	Article 10a
	Milks intended for young children
	By ...*, the Commission shall, after consulting the European Food Safety Authority which should notably carry out an exhaustive and independent review of existing scientific literature, present to the European Parliament and to the Council a report on the desirability of special provisions regarding the composition and labelling of milks intended for young children with regard to the nutritional needs, the pattern of consumption, the nutritional intake and the levels of exposure to contaminants and pesticides of young children taking into account the different legislation that governs normal foods and foods intended for infants and young children.
	In the light of the conclusions of that report, the Commission shall either:
	(a) decide that there is no need for special provisions regarding the composition and labelling of milks intended for young children;
	(b) present, in accordance with the procedure laid down in Article 114 TFEU, any appropriate legislative proposals.
	______________
	*OJ: please insert the date: 2 years after entry into force of this Regulation.
Justification
Several national health authorities seem to doubt the added value of so-called ‘growing milks’ or ‘toddler milks’, and/or consider them to be too rich in sugar, flavours or minerals, whereas a small number of associations of health professionals have supported the intake of such milks as part of the daily diet of toddlers. It would therefore be useful to have EFSA’s scientific opinion on the desirability to include specific compositional and labelling requirements for these milks in the Commission’s delegated acts on follow-on formulae or baby food.
Amendment  28 Proposal for a regulation Article 11 – paragraph 2
Text proposed by the Commission	Amendment
2. No later than [2 years after the date of the entry into force of this Regulation], the Commission shall establish and subsequently update a Union list of permitted substances that meet the conditions of paragraph 1, by means of implementing Regulations. The entry of a substance in the Union list shall include a specification of the substance, and, where appropriate, specify the conditions of use and the applicable purity criteria. Those implementing Regulations shall be adopted in accordance with the examination procedure referred to in Article 14(2). On duly justified grounds of extreme urgency relating to emerging health risks, the Commission shall adopt immediately applicable implementing acts updating the Union list in accordance with Article 14(3).	2. No later than [2 years after the date of the entry into force of this Regulation], the Commission shall establish and subsequently update a Union list of permitted substances that meet the conditions of paragraph 1, by means of implementing acts. The entry of a substance in the Union list shall include a specification of the substance, and, where appropriate, specify the conditions of use and the applicable purity criteria. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 14(2). On duly justified grounds of extreme urgency relating to emerging health risks, the Commission shall adopt immediately applicable implementing acts updating the Union list in accordance with Article 14(3).
Amendment  29 Proposal for a regulation Article 18 a (new) Regulation (EU) No 1169/2011 Article 36 – paragraph 3 – point a a (new)
Text proposed by the Commission Amendment   Article 18a   Amendment to Regulation (EU) No 1169/2011   In Article 36, paragraph 3, of Regulation (EU) No 1169/2011, the following point is inserted:   “(aa) information on the possible absence or reduced presence in foods of substances that can cause intolerance, such as gluten and lactose;”.
Justification
The Commission proposes to consider food for celiac people as normal food, to withdraw Regulation (EC) No 41/2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten and to regulate the statements concerned under the Claims Regulation. The Rapporteur for opinion prefers regulating the statements 'gluten-free' and 'very low gluten' under the Regulation on Food information for consumers, which already provides for the adoption of specific rules to indicate the presence of substances that cause allergy or intolerance.
Amendment  30 Proposal for a regulation Article 18 b (new)
Text proposed by the Commission	Amendment
	Article 18b
	Technical guidance for SMEs
	The Commission, in close cooperation with all stakeholders and the European Food Safety Authority, shall make available appropriate technical guidance and tools to assist food business operators, in particular SMEs, in the preparation and presentation of an application for scientific assessment to the European Food Safety Authority, and, more generally, to comply with the requirements laid down in this Regulation.

PROCEDURE

Title	Food intended for infants and young children and food for special medical purposes
References	COM(2011)0353 – C7-0169/2011 – 2011/0156(COD)
Committee responsible        Date announced in plenary	ENVI 5.7.2011
Committee(s) asked for opinion(s)        Date announced in plenary	IMCO 5.7.2011
Discussed in committee	20.12.2011
Date adopted	6.2.2012
Result of final vote	+: –: 0:	35 1 4
Members present for the final vote	Pablo Arias Echeverría, Adam Bielan, Jürgen Creutzmann, Cornelis de Jong, Christian Engström, Vicente Miguel Garcés Ramón, Evelyne Gebhardt, Mikael Gustafsson, Małgorzata Handzlik, Iliana Ivanova, Philippe Juvin, Edvard Kožušník, Kurt Lechner, Toine Manders, Hans-Peter Mayer, Franz Obermayr, Phil Prendergast, Mitro Repo, Heide Rühle, Matteo Salvini, Andreas Schwab, Peter Skinner, Emilie Turunen, Michael Theurer, Róża Gräfin von Thun und Hohenstein, Gino Trematerra, Bernadette Vergnaud
Substitute(s) present for the final vote	Raffaele Baldassarre, Frank Engel, Marielle Gallo, Ildikó Gáll-Pelcz, Liem Hoang Ngoc, María Irigoyen Pérez, Constance Le Grip, Emma McClarkin, Antonyia Parvanova, Olga Sehnalová, Laurence J.A.J. Stassen, Marc Tarabella, Wim van de Camp

PROCEDURE

Title	Food intended for infants and young children and food for special medical purposes
References	COM(2011)0353 – C7-0169/2011 – 2011/0156(COD)
Date submitted to Parliament	20.6.2011
Committee responsible        Date announced in plenary	ENVI 5.7.2011
Committee(s) asked for opinion(s)        Date announced in plenary	ITRE 5.7.2011	IMCO 5.7.2011
Rapporteur(s)        Date appointed	Frédérique Ries 30.8.2011
Discussed in committee	20.12.2011
Date adopted	29.2.2012
Result of final vote	+: –: 0:	62 0 0
Members present for the final vote	János Áder, Elena Oana Antonescu, Pilar Ayuso, Paolo Bartolozzi, Sandrine Bélier, Sergio Berlato, Lajos Bokros, Martin Callanan, Nessa Childers, Yves Cochet, Chris Davies, Esther de Lange, Anne Delvaux, Bas Eickhout, Edite Estrela, Jill Evans, Karl-Heinz Florenz, Elisabetta Gardini, Gerben-Jan Gerbrandy, Matthias Groote, Françoise Grossetête, Cristina Gutiérrez-Cortines, Satu Hassi, Jolanta Emilia Hibner, Dan Jørgensen, Christa Klaß, Jo Leinen, Peter Liese, Kartika Tamara Liotard, Zofija Mazej Kukovič, Linda McAvan, Radvilė Morkūnaitė-Mikulėnienė, Miroslav Ouzký, Vladko Todorov Panayotov, Gilles Pargneaux, Andres Perello Rodriguez, Mario Pirillo, Pavel Poc, Frédérique Ries, Anna Rosbach, Kārlis Šadurskis, Daciana Octavia Sârbu, Carl Schlyter, Horst Schnellhardt, Richard Seeber, Theodoros Skylakakis, Bogusław Sonik, Claudiu Ciprian Tănăsescu, Anja Weisgerber, Åsa Westlund, Glenis Willmott, Sabine Wils
Substitute(s) present for the final vote	Cristian Silviu Buşoi, Vicky Ford, Gaston Franco, Riikka Manner, Vittorio Prodi, Giancarlo Scottà, Kathleen Van Brempt, Anna Záborská, Andrea Zanoni
Substitute(s) under Rule 187(2) present for the final vote	Hynek Fajmon
Date tabled	26.4.2012