# C_2008224EN.01008101.xml

| 30.8.2008 | EN | Official Journal of the European Union | C 224/81 |
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30.8.2008

EN

Official Journal of the European Union

C 224/81

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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 novel foods and amending Regulation (EC) No XXX/XXXX (common procedure)

COM(2007) 872 final — 2008/0002 (COD)

(2008/C 224/18)

On 30 January 2008, the Council decided to consult the European Economic and Social Committee, under Article 95 of the Treaty establishing the European Community, on the

Proposal for a Regulation of the European Parliament and of the Council on novel foods and amending Regulation (EC) No XXX/XXXX (common procedure).

Proposal for a Regulation of the European Parliament and of the Council on novel foods and amending Regulation (EC) No XXX/XXXX (common procedure).

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 29 April 2008. The rapporteur was Mr Espuny Moyano.

At its 445th plenary session, held on 28 and 29 May 2008 (meeting of 29 May), the European Economic and Social Committee adopted the following opinion by 71 votes to one with two abstentions.

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| 1.1 | The EESC considers an update of legislation on novel foods to be necessary and appropriate, as this would achieve greater food safety and legal certainty, and thus endorses the Commission proposal, although a number of suggestions should be taken into account. |
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1.1

The EESC considers an update of legislation on novel foods to be necessary and appropriate, as this would achieve greater food safety and legal certainty, and thus endorses the Commission proposal, although a number of suggestions should be taken into account.

| 1.2 | The Committee supports the creation of a web page containing the ‘whitelist’ of authorised foods that can be consulted by consumers and businesses but wishes to draw the Commission's attention to the importance of this page being easy to find amongst the mass of Commission pages and of it giving clear explanations, to ensure that it is genuinely useful. |
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1.2

The Committee supports the creation of a web page containing the ‘whitelist’ of authorised foods that can be consulted by consumers and businesses but wishes to draw the Commission's attention to the importance of this page being easy to find amongst the mass of Commission pages and of it giving clear explanations, to ensure that it is genuinely useful.

| 1.3 | Because the regulation makes a distinction between two categories of novel foods (according to whether or not they originate in an EU Member State), the EESC suggests that the whitelist of authorised foods be divided into two parts, so that it is easier to access and understand by consumers and operators alike. |
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1.3

Because the regulation makes a distinction between two categories of novel foods (according to whether or not they originate in an EU Member State), the EESC suggests that the whitelist of authorised foods be divided into two parts, so that it is easier to access and understand by consumers and operators alike.

| 1.4 | The EESC considers that businesses' efforts in the field of R+D+I should be safeguarded by the authorities through the adequate protection of the data they provide and respect for the intellectual property of these data. |
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1.4

The EESC considers that businesses' efforts in the field of R+D+I should be safeguarded by the authorities through the adequate protection of the data they provide and respect for the intellectual property of these data.

| 1.5 | In the Committee's view, the deadline for evaluation (before 1 January 2015) lies too far in the future. |
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1.5

In the Committee's view, the deadline for evaluation (before 1 January 2015) lies too far in the future.

| 1.6 | The EESC considers that the phrase ‘that has not been used for human consumption to a significant degree ...’ is too ambiguous and could lead to error, confusion and dubious practices. |
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1.6

The EESC considers that the phrase ‘that has not been used for human consumption to a significant degree ...’ is too ambiguous and could lead to error, confusion and dubious practices.

| 1.7 | The EESC notes that there is no system or deadline for the revision of the list. It therefore proposes that the regulation establish a procedure for its revision as and when necessary. |
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1.7

The EESC notes that there is no system or deadline for the revision of the list. It therefore proposes that the regulation establish a procedure for its revision as and when necessary.

| 1.8 | The Committee wonders whether the deadline set by the EFSA for evaluation, where necessary, will be adequate. |
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1.8

The Committee wonders whether the deadline set by the EFSA for evaluation, where necessary, will be adequate.

2.   Gist of the Commission proposal

| 2.1 | The original European regulations on novel foods date back to 1997. With the passing of time, it has become clear that some aspects of these regulations need to be updated and amended. |
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2.1

The original European regulations on novel foods date back to 1997. With the passing of time, it has become clear that some aspects of these regulations need to be updated and amended.

| 2.2 | The aim is to improve the efficiency, transparency and application of an authorisation system that should ensure the safety of novel foods and include a procedure for scientific assessment by the EFSA (the European Food Safety Authority), thus reducing the administrative burden on businesses and enabling them to be more competitive. |
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2.2

The aim is to improve the efficiency, transparency and application of an authorisation system that should ensure the safety of novel foods and include a procedure for scientific assessment by the EFSA (the European Food Safety Authority), thus reducing the administrative burden on businesses and enabling them to be more competitive.

| 2.3 | The Commission proposal lays down harmonised rules for the placing of novel foods on the market in the EU with a view to ensuring a high level of human health and consumers' protection, whilst ensuring the effective functioning of the internal market. |
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2.3

The Commission proposal lays down harmonised rules for the placing of novel foods on the market in the EU with a view to ensuring a high level of human health and consumers' protection, whilst ensuring the effective functioning of the internal market.

| 2.4 | The regulation will not apply to food additives, flavourings, extraction solvents, enzymes, vitamins and minerals or genetically modified food and feed, because specific procedures already exist for these products. |
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2.4

The regulation will not apply to food additives, flavourings, extraction solvents, enzymes, vitamins and minerals or genetically modified food and feed, because specific procedures already exist for these products.

| 2.5 | The proposal considers ‘novel food’ to mean:






  — | food that has not been used for human consumption to a significant degree within the Community before 15 May 1997; |
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2.5

The proposal considers ‘novel food’ to mean:

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food that has not been used for human consumption to a significant degree within the Community before 15 May 1997;

| — | food of plant or animal origin, when a non-traditional breeding technique not used before 15 May 1997 is applied to the plant or animal; and |
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food of plant or animal origin, when a non-traditional breeding technique not used before 15 May 1997 is applied to the plant or animal; and

| — | food to which a new production process not used before 15 May 1997 is applied, where that production process gives rise to significant changes in the composition of the food which affect its nutritional value, metabolism or level of undesirable substances. |
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food to which a new production process not used before 15 May 1997 is applied, where that production process gives rise to significant changes in the composition of the food which affect its nutritional value, metabolism or level of undesirable substances.

| 2.6 | The proposal also contains definitions of basic concepts such as ‘traditional food from a third country’ and ‘history of safe food use’. |
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2.6

The proposal also contains definitions of basic concepts such as ‘traditional food from a third country’ and ‘history of safe food use’.

| 2.7 | It lays down that only novel foods included in the Community list of novel foods may be placed on the market and only if they meet the following conditions:






  — | they do not, on the basis of the scientific evidence available, pose a safety concern; |
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2.7

It lays down that only novel foods included in the Community list of novel foods may be placed on the market and only if they meet the following conditions:

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they do not, on the basis of the scientific evidence available, pose a safety concern;

| — | they do not mislead the consumer; |
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they do not mislead the consumer;

| — | they are not nutritionally disadvantageous for the consumer in cases where it is intended to replace a traditional food. |
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—

they are not nutritionally disadvantageous for the consumer in cases where it is intended to replace a traditional food.

| 2.8 | These conditions will also apply to the inclusion in the Community list of both novel foods produced by new breeding methods or new production processes and to traditional foods from third countries considered to be novel foods. In both cases, novel foods must observe the applicable rules and adhere to the established procedure (which involves the Commission, the EFSA and the Member States). |
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2.8

These conditions will also apply to the inclusion in the Community list of both novel foods produced by new breeding methods or new production processes and to traditional foods from third countries considered to be novel foods. In both cases, novel foods must observe the applicable rules and adhere to the established procedure (which involves the Commission, the EFSA and the Member States).

| 2.9 | The Commission will, where appropriate (in cooperation with the EFSA), provide tools and technical guidance to operators — and especially to SMEs — in the process of applying for authorisation. |
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2.9

The Commission will, where appropriate (in cooperation with the EFSA), provide tools and technical guidance to operators — and especially to SMEs — in the process of applying for authorisation.

| 2.9.1 | Again where appropriate, the Commission may, for food safety reasons and following the opinion of the EFSA, impose a requirement for post-market monitoring (Article 11). |
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2.9.1

Again where appropriate, the Commission may, for food safety reasons and following the opinion of the EFSA, impose a requirement for post-market monitoring (Article 11).

| 2.10 | The proposal aims to ensure that the right to data protection is respected (Article 12) and establishes that the national authorities will lay down the corresponding framework for penalties applicable to infringements of Community provisions (Article 13). |
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2.10

The proposal aims to ensure that the right to data protection is respected (Article 12) and establishes that the national authorities will lay down the corresponding framework for penalties applicable to infringements of Community provisions (Article 13).

| 2.11 | The Commission will be assisted by the Standing Committee on the Food Chain and Animal Health (SCFCAH) and, lastly, a deadline is set for submitting the assessment of this Regulation's implementation (2015) with a view to making any changes that might be needed. |
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2.11

The Commission will be assisted by the Standing Committee on the Food Chain and Animal Health (SCFCAH) and, lastly, a deadline is set for submitting the assessment of this Regulation's implementation (2015) with a view to making any changes that might be needed.

3.   General comments

3.1   Centralising evaluation and authorisation procedures

| 3.1.1 | The proposal puts forward a centralised framework for assessing and authorising novel foods, which would be carried out by the EFSA (scientific assessment) and the European Commission (authorisation). This model, involving assessment by the EFSA (Article 10), should help to standardise the safety of novel foods in the EU, simplify the procedures to be followed by businesses and speed up the pace of authorisations for novel foods in Europe. In short, the proposal indirectly stimulates businesses' investment and interest in developing novel foods. |
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3.1.1

The proposal puts forward a centralised framework for assessing and authorising novel foods, which would be carried out by the EFSA (scientific assessment) and the European Commission (authorisation). This model, involving assessment by the EFSA (Article 10), should help to standardise the safety of novel foods in the EU, simplify the procedures to be followed by businesses and speed up the pace of authorisations for novel foods in Europe. In short, the proposal indirectly stimulates businesses' investment and interest in developing novel foods.

3.2   The need for a centralised procedure for authorising novel foods that ensures their safety and simplifies authorisation procedures for novel foods

| 3.2.1 | With the publication of the Regulation on novel foods and novel food ingredients in 1997, Community law acquired the new instrument it needed to ensure the free movement of safe food products. |
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3.2.1

With the publication of the Regulation on novel foods and novel food ingredients in 1997, Community law acquired the new instrument it needed to ensure the free movement of safe food products.

| 3.2.2 | The passing of time and the regulation's implementation have highlighted a number of aspects that need to be improved in order to ensure a high level of public health protection and wellbeing and the free movement of goods and to establish efficient authorisation mechanisms that help businesses to innovate. |
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3.2.2

The passing of time and the regulation's implementation have highlighted a number of aspects that need to be improved in order to ensure a high level of public health protection and wellbeing and the free movement of goods and to establish efficient authorisation mechanisms that help businesses to innovate.

| 3.2.3 | The proposal sets out two authorisation procedures, to be selected according to the type of novel food in question: a procedure for traditional foods from third countries that producers wish to place for the first time on the EU market and a procedure for novel foods produced by non-traditional breeding techniques or by new production processes. |
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3.2.3

The proposal sets out two authorisation procedures, to be selected according to the type of novel food in question: a procedure for traditional foods from third countries that producers wish to place for the first time on the EU market and a procedure for novel foods produced by non-traditional breeding techniques or by new production processes.

| 3.2.4 | With regard to the former (Article 8), there is a need to simplify the existing authorisation procedure, which validates the safety of such products on the basis of a history of safe food use over a period of time (one generation) in third countries and on the basis of proof that such food has not been used for human consumption to a significant degree within the European Union before 15 May 1997. This notification procedure to a large extent simplifies the requirements that traditional foods from third countries have until now had to meet to in order to be placed on the market in the European Union. |
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3.2.4

With regard to the former (Article 8), there is a need to simplify the existing authorisation procedure, which validates the safety of such products on the basis of a history of safe food use over a period of time (one generation) in third countries and on the basis of proof that such food has not been used for human consumption to a significant degree within the European Union before 15 May 1997. This notification procedure to a large extent simplifies the requirements that traditional foods from third countries have until now had to meet to in order to be placed on the market in the European Union.

| 3.2.5 | With regard to foods in the latter category (novel foods produced by non-traditional breeding techniques or by new production processes), which are the focus of the R&D carried out by the EU's food industry, the requirement is for a single safety assessment by the EFSA and a procedure (Article 19) that is clear, straightforward and effective and which helps to speed up the hitherto lengthy authorisation procedures. Nevertheless, despite the importance of this aspect, the proposal does not fully develop the procedure to be followed in such cases, in that it refers to the common authorisation procedure for additives, enzymes and flavourings. Referring to this authorisation procedure (which has not yet been adopted in the EU) looks to be an interesting proposal, but its scope does not appear to have been considered in sufficient detail. |
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3.2.5

With regard to foods in the latter category (novel foods produced by non-traditional breeding techniques or by new production processes), which are the focus of the R&D carried out by the EU's food industry, the requirement is for a single safety assessment by the EFSA and a procedure (Article 19) that is clear, straightforward and effective and which helps to speed up the hitherto lengthy authorisation procedures. Nevertheless, despite the importance of this aspect, the proposal does not fully develop the procedure to be followed in such cases, in that it refers to the common authorisation procedure for additives, enzymes and flavourings. Referring to this authorisation procedure (which has not yet been adopted in the EU) looks to be an interesting proposal, but its scope does not appear to have been considered in sufficient detail.

| 3.2.6 | Centralising the assessment and authorisation of novel foods (involving the EFSA and the European Commission) is essential, but a simple, clear, effective, detailed procedure with deadlines also needs to be established (along the lines of the notification procedure for traditional foods from third countries) to authorise novel foods produced by non-traditional breeding techniques or by new production processes, which lie at the heart of innovation in the food industry. |
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3.2.6

Centralising the assessment and authorisation of novel foods (involving the EFSA and the European Commission) is essential, but a simple, clear, effective, detailed procedure with deadlines also needs to be established (along the lines of the notification procedure for traditional foods from third countries) to authorise novel foods produced by non-traditional breeding techniques or by new production processes, which lie at the heart of innovation in the food industry.

| 3.2.7 | This procedure could be included in the proposal or could refer to another regulation. In both cases, however, the proposal should contain all of the details needed to ensure that the operator is familiar with the procedures to follow in order to obtain the appropriate authorisations. |
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3.2.7

This procedure could be included in the proposal or could refer to another regulation. In both cases, however, the proposal should contain all of the details needed to ensure that the operator is familiar with the procedures to follow in order to obtain the appropriate authorisations.

| 3.2.8 | The proposal should be sufficiently clear and comprehensive as to enable operators to apply it, although this does prevent the Commission from drawing up relevant guidelines at a later date (Article 9). |
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3.2.8

The proposal should be sufficiently clear and comprehensive as to enable operators to apply it, although this does prevent the Commission from drawing up relevant guidelines at a later date (Article 9).

3.3   Community lists

| 3.3.1 | The initiative to draw up lists of novel foods (Articles 5, 6 and 7) will help to improve consumer information and provide operators with greater legal certainty. The list-based model is by no means new, since the use of such lists has become increasingly common (for example, the Regulation on nutrition and health claims and the Regulation on the addition of vitamins and minerals to foods, amongst others). Where traditional foods from third countries are concerned, the model appears to be quite thoroughly developed in the proposal, in terms of the list content and publication on DG SANCO's website, but the same cannot be said of other novel foods (it is not known whether the list will be published on DG SANCO's website, ...). It would be useful for this to be clarified. |
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3.3.1

The initiative to draw up lists of novel foods (Articles 5, 6 and 7) will help to improve consumer information and provide operators with greater legal certainty. The list-based model is by no means new, since the use of such lists has become increasingly common (for example, the Regulation on nutrition and health claims and the Regulation on the addition of vitamins and minerals to foods, amongst others). Where traditional foods from third countries are concerned, the model appears to be quite thoroughly developed in the proposal, in terms of the list content and publication on DG SANCO's website, but the same cannot be said of other novel foods (it is not known whether the list will be published on DG SANCO's website, ...). It would be useful for this to be clarified.

3.4   Protection of intellectual property

| 3.4.1 | Developing novel foods requires considerable commitment to and investment in R&D on the part of businesses and they therefore require not only straightforward, swift and economically feasible procedures; knowledge and developments must also be protected to ensure that competitiveness does not suffer. No clear definition is provided for the scope of the data protection to which, according to the proposal, businesses will be entitled (it refers only to authorisations, what becomes of applications that are ultimately rejected, etc.). |
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3.4.1

Developing novel foods requires considerable commitment to and investment in R&D on the part of businesses and they therefore require not only straightforward, swift and economically feasible procedures; knowledge and developments must also be protected to ensure that competitiveness does not suffer. No clear definition is provided for the scope of the data protection to which, according to the proposal, businesses will be entitled (it refers only to authorisations, what becomes of applications that are ultimately rejected, etc.).

| 3.4.2 | Providing the future regulation with a tool such as data protection will help to give businesses some security as regards the economic and human resources they channel into new projects. They will see data protection as a tool that affords them the protection they need to continue innovating and to become increasingly competitive, given the ever-more demanding nature of both the market and consumers. |
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3.4.2

Providing the future regulation with a tool such as data protection will help to give businesses some security as regards the economic and human resources they channel into new projects. They will see data protection as a tool that affords them the protection they need to continue innovating and to become increasingly competitive, given the ever-more demanding nature of both the market and consumers.

Brussels, 29 May 2008.

The President

of the European Economic and Social Committee

Dimitris DIMITRIADIS

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