# C_2012024EN.01011901.xml

| 28.1.2012 | EN | Official Journal of the European Union | C 24/119 |
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28.1.2012

EN

Official Journal of the European Union

C 24/119

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Opinion of the European Economic and Social Committee 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) 353 final — 2011/0156 (COD)

2012/C 24/26

Rapporteur: Ms Madi SHARMA

Ms Madi SHARMA

On 5 July 2011 the European Parliament and the Council decided to consult the European Economic and Social Committee, under Articles 114 of the Treaty on the Functioning of the European Union, 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

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) 353 final — 2011/0156 (COD).

The Section for Agriculture, Rural Development and the Environment, which was responsible for preparing the Committee's work on the subject, adopted its opinion on 6 October 2011.

At its 475th plenary session, held on 26 and 27 October 2011 (meeting of 26 October), the European Economic and Social Committee adopted the following opinion by 141 votes and 6 abstentions.

1.   Conclusions and recommendations

Conclusions and recommendations

| 1.1 | The Committee praises the Commission for its comprehensive review of existing food legislation and recognises that it is difficult to clarify the distinction between foods intended for the general population and foods intended for specific groups. This lack of clarity makes the interpretation, application and enforcement of the current legislation difficult, particularly for Member States and civil society. |
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1.1

The Committee praises the Commission for its comprehensive review of existing food legislation and recognises that it is difficult to clarify the distinction between foods intended for the general population and foods intended for specific groups. This lack of clarity makes the interpretation, application and enforcement of the current legislation difficult, particularly for Member States and civil society.

| 1.2 | The Commission has conducted an in-depth impact assessment and associated consultations to address its objectives of coherence, simplification and harmonisation of the internal market. The impact analysis has reviewed issues such as administrative burdens, reformulation and labelling, innovation, competitiveness, prices, consumer protection and information, potential employment and small business consequences and social wellbeing. |
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1.2

The Commission has conducted an in-depth impact assessment and associated consultations to address its objectives of coherence, simplification and harmonisation of the internal market. The impact analysis has reviewed issues such as administrative burdens, reformulation and labelling, innovation, competitiveness, prices, consumer protection and information, potential employment and small business consequences and social wellbeing.

| 1.3 | It is essential that the current definition of ‘foods for special medical purposes’ is maintained in order to differentiate them from foods for general consumption, and to ensure the inclusion in their formulation of vital ingredients, such as amino acids and oligo-peptides. |
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1.3

It is essential that the current definition of ‘foods for special medical purposes’ is maintained in order to differentiate them from foods for general consumption, and to ensure the inclusion in their formulation of vital ingredients, such as amino acids and oligo-peptides.

| 1.4 | Furthermore, the EESC believes that formulae for premature infants, who are an extremely vulnerable group, often in a poor state of health, should be included in the category of nutritionally complete foods with standard nutrient formulation. |
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1.4

Furthermore, the EESC believes that formulae for premature infants, who are an extremely vulnerable group, often in a poor state of health, should be included in the category of nutritionally complete foods with standard nutrient formulation.

| 1.5 | The current application of the framework legislation, as recognised by the Commission, is leading to the distortion of trade in the internal market due to uneven interpretation and enforcement across the Member States. It is hoped that the proposed new Regulation will correct this distortion, without any adverse effects for employment or SMEs within the sector and will enable continued innovation. |
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1.5

The current application of the framework legislation, as recognised by the Commission, is leading to the distortion of trade in the internal market due to uneven interpretation and enforcement across the Member States. It is hoped that the proposed new Regulation will correct this distortion, without any adverse effects for employment or SMEs within the sector and will enable continued innovation.

| 1.6 | All products for human consumption are currently protected under EU legislation on Food Safety, Labelling and Claims, supported by EFSA (the European Food Safety Authority). The new proposal will support the harmonisation of EU rules in the field of food safety and consumer protection, removing any duplication and ambiguity. The principle of subsidiarity will be respected by allowing Member States to apply national rules when justified in the interest of public health protection. |
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1.6

All products for human consumption are currently protected under EU legislation on Food Safety, Labelling and Claims, supported by EFSA (the European Food Safety Authority). The new proposal will support the harmonisation of EU rules in the field of food safety and consumer protection, removing any duplication and ambiguity. The principle of subsidiarity will be respected by allowing Member States to apply national rules when justified in the interest of public health protection.

| 1.7 | The EESC urges the Commission to review growth preparations for infants of 12 to 36 months under rigorous scientific assessments. There are currently conflicting scientific conclusions, and the public requires clear guidance and information. |
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1.7

The EESC urges the Commission to review growth preparations for infants of 12 to 36 months under rigorous scientific assessments. There are currently conflicting scientific conclusions, and the public requires clear guidance and information.

| 1.8 | The EESC believes that the new legislation should retain the current legal provision (Article 8(2) of Directive 2009/39/EC of the European Parliament and of the Council of 6 May 2009 on foodstuffs intended for particular nutritional uses) enabling information on foodstuffs for particular nutritional uses and their correct use to be communicated to health professionals, so that they are able to provide consumers and patients with proper information and recommendations. |
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1.8

The EESC believes that the new legislation should retain the current legal provision (Article 8(2) of Directive 2009/39/EC of the European Parliament and of the Council of 6 May 2009 on foodstuffs intended for particular nutritional uses) enabling information on foodstuffs for particular nutritional uses and their correct use to be communicated to health professionals, so that they are able to provide consumers and patients with proper information and recommendations.

| 1.9 | The EESC calls on the Commission to ensure that there is no distortion in the field of sports food, which has a European retail market estimated to be worth EUR 2 357 million, and an annual growth rate of 7 %. In the broader context of food safety and labelling, the EESC also urges the Commission to consider the introduction, in future legislation, of warning statements on food products whose nutrient profiles (particularly in the case of sports products and slimming/diet control products) could have an adverse effect, if taken over long periods or in unadvisable quantities. |
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1.9

The EESC calls on the Commission to ensure that there is no distortion in the field of sports food, which has a European retail market estimated to be worth EUR 2 357 million, and an annual growth rate of 7 %. In the broader context of food safety and labelling, the EESC also urges the Commission to consider the introduction, in future legislation, of warning statements on food products whose nutrient profiles (particularly in the case of sports products and slimming/diet control products) could have an adverse effect, if taken over long periods or in unadvisable quantities.

| 1.10 | The EESC recognises that due to the current economic, social and cultural diversity in Europe, it may not be possible for all population groups to receive all the nutrients needed for a healthy life, and this has led to the development of fortified foods, alongside which the Commission has developed advertising and labelling rules. In this respect, the EESC strongly supports current EU legislative and implementing measures, which will ensure that all voluntary claims made on food products are clear, accurate and substantiated. These claims must not be misleading so that final consumers can make informed choices and, in the case of foods for special medical purposes, so that qualified medical, nutritional and pharmacological staff can have adequate information about their nutritional content and correct usage. |
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1.10

The EESC recognises that due to the current economic, social and cultural diversity in Europe, it may not be possible for all population groups to receive all the nutrients needed for a healthy life, and this has led to the development of fortified foods, alongside which the Commission has developed advertising and labelling rules. In this respect, the EESC strongly supports current EU legislative and implementing measures, which will ensure that all voluntary claims made on food products are clear, accurate and substantiated. These claims must not be misleading so that final consumers can make informed choices and, in the case of foods for special medical purposes, so that qualified medical, nutritional and pharmacological staff can have adequate information about their nutritional content and correct usage.

| 1.11 | Finally, the EESC endorses the continued requirement, as laid out in the Commission Proposal Recital, for a Rapid Alert System for Food and Feed (RASFF) to be implemented in the case of food crises that could affect consumers anywhere in Europe. |
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1.11

Finally, the EESC endorses the continued requirement, as laid out in the Commission Proposal Recital, for a Rapid Alert System for Food and Feed (RASFF) to be implemented in the case of food crises that could affect consumers anywhere in Europe.

2.   Background

Background

| 2.1 | The free movement of safe and wholesome food is an essential aspect of the internal market and contributes significantly to the health and wellbeing of citizens. In this context, EU food legislation has been developed to ensure that ‘food shall not be placed on the market if it is unsafe’. This requirement concerns both its physical content and labelling provisions. |
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2.1

The free movement of safe and wholesome food is an essential aspect of the internal market and contributes significantly to the health and wellbeing of citizens. In this context, EU food legislation has been developed to ensure that ‘food shall not be placed on the market if it is unsafe’. This requirement concerns both its physical content and labelling provisions.

| 2.2 | The Dietetic Foods Framework Directive (Directive 2009/39/EC) was adopted in 1977 to address the fact that ‘differences between national laws relating to foodstuffs for particular nutritional uses impede their free movement, [and] may create unequal conditions of competition’. The terms from the definition of ‘foods for special medical purposes’ have been retained within the proposal, ensuring their differentiation from normal foods and the inclusion in their formulation of essential ingredients. The ‘common definition on dietetic foods’ drawn up under ‘the general provisions and common labelling rules’ states that dietetic foods have three major characteristics:






  — | they are special and distinguishable from normal foods (composition or manufacturing process); |
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2.2

The Dietetic Foods Framework Directive (Directive 2009/39/EC) was adopted in 1977 to address the fact that ‘differences between national laws relating to foodstuffs for particular nutritional uses impede their free movement, [and] may create unequal conditions of competition’. The terms from the definition of ‘foods for special medical purposes’ have been retained within the proposal, ensuring their differentiation from normal foods and the inclusion in their formulation of essential ingredients. The ‘common definition on dietetic foods’ drawn up under ‘the general provisions and common labelling rules’ states that dietetic foods have three major characteristics:

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they are special and distinguishable from normal foods (composition or manufacturing process);

| — | they are intended for specific groups of the population and not for the general population; |
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they are intended for specific groups of the population and not for the general population;

| — | they satisfy the particular nutritional requirements of the persons for whom they are intended. |
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they satisfy the particular nutritional requirements of the persons for whom they are intended.

| 2.3 | Examples of dietetic foods, as defined in the Dietetic Foods Framework Directive, are foods intended for infants or young children, for people suffering from intolerance to gluten or for special medical purposes, where a ‘suitability statement for the particular nutritional use’ must be indicated on the packaging. For a number of these groups (infant formulae, processed cereal-based foods and baby food, food intended for use in energy-restricted diets, food for medical purposes and food for people intolerant to gluten), specific legislation has already been laid down for compositional and labelling rules. However, for sports foods, foods for persons with diabetes and foods for lactose intolerant people, no specific rules have been laid down. |
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2.3

Examples of dietetic foods, as defined in the Dietetic Foods Framework Directive, are foods intended for infants or young children, for people suffering from intolerance to gluten or for special medical purposes, where a ‘suitability statement for the particular nutritional use’ must be indicated on the packaging. For a number of these groups (infant formulae, processed cereal-based foods and baby food, food intended for use in energy-restricted diets, food for medical purposes and food for people intolerant to gluten), specific legislation has already been laid down for compositional and labelling rules. However, for sports foods, foods for persons with diabetes and foods for lactose intolerant people, no specific rules have been laid down.

| 2.4 | In 2007, the Commission began a consultation process with the Member States on the Framework Directive on dietetic foods. Since then, further consultations have been held with the Member States, inter-service steering groups (SANCO, AGRI, ENTR, RTD, TRADE and the Secretariat-General), and industry and consumer groups, and an external consultancy report has been prepared. |
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2.4

In 2007, the Commission began a consultation process with the Member States on the Framework Directive on dietetic foods. Since then, further consultations have been held with the Member States, inter-service steering groups (SANCO, AGRI, ENTR, RTD, TRADE and the Secretariat-General), and industry and consumer groups, and an external consultancy report has been prepared.

| 2.5 | Following these consultations, the Commission has tabled the present Proposal for a Regulation on food intended for infants and young children and on food for special medical purposes. The proposed Regulation will repeal the following directives:






  — | Directive 2009/39/EC on foodstuffs intended for particular nutritional uses (Recast Framework Directive, 1989); |
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2.5

Following these consultations, the Commission has tabled the present Proposal for a Regulation on food intended for infants and young children and on food for special medical purposes. The proposed Regulation will repeal the following directives:

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Directive 2009/39/EC on foodstuffs intended for particular nutritional uses (Recast Framework Directive, 1989);

| — | Directive 92/52/EEC on infant formulae and follow-on formulae intended for export to third countries; |
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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; |
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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. |
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Commission Regulation (EC) No 41/2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten.

| 2.6 | The action now proposed by the Commission is to simplify and clarify the legal requirements applying to only a limited number of categories of foods and establish a single list of substances that may be added to the foods (‘Union list’) covered by this proposal. In particular, it:






  — | abolishes the concept of dietetic foods; |
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2.6

The action now proposed by the Commission is to simplify and clarify the legal requirements applying to only a limited number of categories of foods and establish a single list of substances that may be added to the foods (‘Union list’) covered by this proposal. In particular, it:

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abolishes the concept of dietetic foods;

| — | provides a new general framework law with a clear and defined scope of application, covering only a few well-defined categories of foods that have been identified as essential for certain, well-established groups of consumers with specific nutritional needs; |
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provides a new general framework law with a clear and defined scope of application, covering only a few well-defined categories of foods that have been identified as essential for certain, well-established groups of consumers with specific nutritional needs;

| — | maintains specific measures for these essential categories of foods; |
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maintains specific measures for these essential categories of foods;

| — | lays down general rules as regards the composition and labelling applying to these categories of foods; |
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lays down general rules as regards the composition and labelling applying to these categories of foods;

| — | removes differences in interpretation and difficulties for Member States and operators in applying different items of food legislation by simplifying the regulatory environment; |
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removes differences in interpretation and difficulties for Member States and operators in applying different items of food legislation by simplifying the regulatory environment;

| — | removes the burdens associated with the notification procedure; |
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removes the burdens associated with the notification procedure;

| — | ensures that similar products are treated in the same way across the Union; |
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ensures that similar products are treated in the same way across the Union;

| — | removes rules that have become unnecessary, inconsistent and potentially conflicting; |
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removes rules that have become unnecessary, inconsistent and potentially conflicting;

| — | establishes a single legal measure for substances that can be added to the foods covered by this proposal. |
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establishes a single legal measure for substances that can be added to the foods covered by this proposal.

| 2.7 | Emergency procedures, as listed in Article 6 of the Commission Proposal, are foreseen in situations where food covered by this proposal constitutes a serious risk to human health. |
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2.7

Emergency procedures, as listed in Article 6 of the Commission Proposal, are foreseen in situations where food covered by this proposal constitutes a serious risk to human health.

Brussels, 26 October 2011.

The President of the European Economic and Social Committee

Staffan NILSSON

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