11.5.2010   

EN

Official Journal of the European Union

CE 122/38

(1)

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, as well as to their social and economic interests. Differences between national laws, regulations and administrative provisions concerning the safety assessment and authorisation of novel foods may hinder their free movement, thereby creating unfair conditions of competition.

(2)

A high level of protection of human health should be assured in the pursuit of Union policies. Due attention should be given, where appropriate, to the protection of the environment and to animal welfare.

(3)

The Union's rules on novel foods were established by Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (3) and by Commission Regulation (EC) No 1852/2001 of 20 September 2001 laying down detailed rules for making certain information available to the public and for the protection of information submitted pursuant to European Parliament and Council Regulation (EC) No 258/97 (4). For the sake of clarity, Regulation (EC) No 258/97 and Regulation (EC) No 1852/2001 should be repealed and Regulation (EC) No 258/97 should be replaced by this Regulation. Commission Recommendation 97/618/EC of 29 July 1997 concerning the scientific aspects and the presentation of information necessary to support applications for the placing on the market of novel foods and novel food ingredients and the preparation of initial assessment reports under Regulation (EC) No 258/97 of the European Parliament and of the Council (5) should therefore become obsolete as regards novel foods.

(4)

In order to ensure continuity with Regulation (EC) No 258/97, the absence of a use for human consumption to a significant degree within the Union before the date of application of Regulation (EC) No 258/97, namely 15 May 1997, should be kept as the criterion for a food to be considered as novel. A use within the Union refers to a use in the Member States irrespective of the date of their accession to the European Union.

(5)

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 (6) applies. The existing definition of novel food should be clarified and updated by replacing the existing categories with a reference to the general definition of food in that Regulation.

(6)

It should also be clarified that a food is to be considered as novel when a production technology which was not previously used for food production in the Union is applied to that food. In particular, emerging technologies in breeding and food production processes which have an impact on food, and thus might have an impact on food safety, should be covered by this Regulation. Novel food should therefore include foods derived from animals produced by non-traditional breeding techniques and from their offspring, foods derived from plants produced by non-traditional breeding techniques, foods produced by new production processes which might have an impact on food, and foods containing or consisting of engineered nanomaterials. Foods derived from new plant varieties or animal breeds produced by traditional breeding techniques should not be considered as novel foods. Furthermore, it should be clarified that foods from third countries which are novel in the Union can be considered as traditional only when they are derived from primary production as defined in Regulation (EC) No 178/2002, whether they are processed or unprocessed (e.g. fruit, jam, fruit juice). However, foods thus obtained should neither include foods produced from animals or plants to which a non-traditional breeding technique was applied or foods produced from the offspring of such animals, nor foods to which a new production process is applied.

(7)

However, in the light of the opinion of the European Group on Ethics in Science and New Technologies, established by Commission Decision of 16 December 1997, issued on 16 January 2008 and of the opinion of the European Food Safety Authority adopted on 15 July 2008, techniques for the cloning of animals, such as somatic cell nuclear transfer, have specific characteristics such that this Regulation cannot address all the issues of cloning. Therefore, food produced from animals obtained by using a cloning technique and from the offspring thereof should be subject to a report submitted by the Commission to the European Parliament and the Council, followed, if appropriate, by a legislative proposal. If specific legislation is adopted, the scope of this Regulation should be adapted accordingly.

(8)

Implementing measures should be adopted to provide for criteria to facilitate the assessment of whether a food was used for human consumption to a significant degree within the Union before 15 May 1997. If, prior to that date, a food was used exclusively as, or in, a food supplement, as defined in Directive 2002/46/EC (7), it should be allowed to be placed on the market within the Union after that date for the same use without being considered a novel food. However, that use as, or in, a food supplement should not be taken into account for the assessment of whether the food was used for human consumption to a significant degree within the Union before 15 May 1997. Therefore, uses of the food concerned other than in, or as, a food supplement should be authorised in accordance with this Regulation.

(9)

The use of engineered nanomaterials in food production might increase with the further development of technology. In order to ensure a high level of protection of human health, free movement of goods and legal certainty for manufacturers, it is necessary to develop a uniform definition for engineered nanomaterial at international level. The Union should endeavour to reach an agreement on a definition in appropriate international fora. Should such an agreement be reached, the definition of engineered nanomaterial in this Regulation should be adapted accordingly.

(10)

Food products produced from food ingredients that do not fall within the scope of this Regulation, in particular by changing the ingredients of the food, their composition or amount, should not be considered a novel food. However, modifications of a food ingredient, e.g. selective extracts or the use of other parts of a plant, that have so far not been used for human consumption within the Union, should still fall within the scope of this Regulation.

(11)

The provisions of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (8) should apply where, taking into account all its characteristics, a product may fall both within the definition of ‘medicinal product’ and within the definition of a product covered by other Union legislation. In this respect, a Member State, if it establishes in accordance with Directive 2001/83/EC that a product is a medicinal product, should be able to restrict the placing on the market of such product in accordance with Union law. Moreover, medicinal products are excluded from the definition of food as established by Regulation (EC) No 178/2002 and should not be subject to this Regulation.

(12)

Novel foods authorised under Regulation (EC) No 258/97 should maintain their novel food status but authorisation should be required for any new uses of such foods.

(13)

Foods which are intended for technological uses or which are genetically modified should not fall within the scope of this Regulation. Therefore, genetically modified food falling within the scope of Regulation (EC) No 1829/2003 (9), food used solely as additives falling within the scope of Regulation (EC) No 1333/2008 (10), flavourings falling within the scope of Regulation (EC) No 1334/2008 (11), enzymes falling within the scope of Regulation (EC) No 1332/2008 (12) and extraction solvents falling within the scope of Directive 2009/32/EC (13) should not be covered by this Regulation.

(14)

The use of vitamins and minerals is governed by specific sectoral food laws. The vitamins and minerals falling within the scope of Directive 2002/46/EC, 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 foods (14) and Directive 2009/39/EC of the European Parliament and of the Council of 6 May 2009 on foodstuffs intended for particular nutritional uses (recast) (15) should therefore be excluded from the scope of this Regulation. However, those specific legal acts do not deal with cases where authorised vitamins and mineral substances are obtained by production methods or using new sources that were not taken into account when they were authorised. Therefore, pending the amendment of those specific legal acts, such vitamins and mineral substances should not be excluded from the scope of this Regulation when the production methods or new sources give rise to significant changes in the composition or structure of the vitamins or minerals which affect their nutritional value, how they are metabolised or the level of undesirable substances.

(15)

Novel foods, other than vitamins and minerals, intended for particular nutritional uses, for food fortification or as food supplements, should be assessed in conformity with this Regulation. They should also remain subject to the rules provided for in Directive 2002/46/EC, in Regulation (EC) No 1925/2006, in Directive 2009/39/EC, and in the specific Directives referred to in Directive 2009/39/EC and in Annex I thereto.

(16)

The determination of whether a food was used for human consumption to a significant degree within the Union before 15 May 1997 should be based on information submitted by food business operators and, where appropriate, supported by other information available in the Member States. When there is no or insufficient information available on human consumption before 15 May 1997, a simple and transparent procedure, involving the Commission, the Member States and any parties concerned, should be established for collecting that information.

(17)

Novel foods should be placed on the market within the Union only if they are safe and do not mislead the consumer. In addition, where the novel food is intended to replace another food, it should not differ from that food in a way that would be nutritionally disadvantageous for the consumer.

(18)

It is necessary to apply a harmonised centralised procedure for safety assessment and authorisation that is efficient, time-limited and transparent. With a view to further harmonising different procedures for the authorisation of food, the safety assessment of novel foods and their inclusion in the Union list should be carried out in accordance with the procedure laid down in Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (16), which should be applicable whenever it is not specifically derogated from by this Regulation. Upon receipt of an application for authorisation of a product as a novel food, the Commission should assess the validity and applicability of the application. The authorisation of a novel food should also take into account other factors relevant to the matter under consideration, including ethical, environmental, animal welfare factors and the precautionary principle.

(19)

Criteria for the evaluation of the potential risks arising from novel foods should also be laid down. In order to ensure the harmonised scientific assessment of novel foods, such assessments should be carried out by the European Food Safety Authority (‘the Authority’).

(20)

At present, there is inadequate information on the risks associated with engineered nanomaterials. In order to better assess their safety the Commission, in cooperation with the Authority, should develop test methodologies which take into account specific characteristics of engineered nanomaterials.

(21)

In order to simplify procedures, applicants should be allowed to present a single application for foods regulated under different sectoral food laws. Regulation (EC) No 1331/2008 should therefore be amended accordingly. As a consequence of the entry into force of the Treaty of Lisbon on 1 December 2009, the European Union has replaced and succeeded the European Community, and the word ‘Community’ should be replaced by ‘Union’ throughout that Regulation.

(22)

If traditional foods from third countries are included in the list of traditional foods from third countries, they should be allowed to be placed on the market within the Union, under conditions that correspond to those for which the history of safe food use has been demonstrated. As regards the safety assessment and management of traditional food from third countries, their history of safe food use in their country of origin should be taken into account. The history of safe food use should not include non-food uses or uses not related to normal diets.

(23)

Where appropriate and based on the conclusions of the safety assessment, post-market monitoring requirements for the use of novel foods for human consumption should be introduced.

(24)

The inclusion of a novel food in the Union list of novel foods or in the list of traditional foods from third countries should be without prejudice to the possibility of evaluating the effects of the overall consumption of a substance which is added to, or used for the manufacture of that food, or of a comparable product in accordance with Regulation (EC) No 1925/2006.

(25)

Under specific circumstances, in order to stimulate research and development within the agri-food industry, and thus innovation, the newly developed scientific evidence and proprietary data provided in support of an application for inclusion of a novel food in the Union list should be protected. That data and information should not be used to the benefit of a subsequent applicant, during a limited period of time, without the agreement of the prior applicant. The protection of scientific data provided by one applicant should not prevent other applicants from seeking the inclusion in the Union list of novel foods on the basis of their own scientific data.

(26)

Novel foods are subject to the general labelling requirements laid down in Directive 2000/13/EC (17) and, where necessary, to the nutritional labelling requirements laid down in Directive 90/496/EEC (18). In certain cases it might be necessary to provide for additional labelling information, in particular regarding the description of the food, its source or its conditions of use. Therefore, when a novel food is included in the Union list or in the list of traditional foods from third countries, specific conditions of use or labelling obligations may be imposed, which might, inter alia, relate to any specific characteristic or food property, such as composition, nutritional value or nutritional effects and intended use of the food, or to ethical considerations or implications for the health of specific groups of the population.

(27)

Regulation (EC) No 1924/2006 (19) harmonises the provisions in the Member States which relate to nutrition and health claims. Therefore, claims regarding novel foods should only be made in accordance with that Regulation.

(28)

The European Group on Ethics in Science and New Technologies may be consulted, where appropriate, with a view to obtaining advice on ethical issues regarding the placing on the market within the Union of novel foods.

(29)

Novel foods placed on the market within the Union under Regulation (EC) No 258/97 should continue to be placed on the market. Novel foods authorised in accordance with Regulation (EC) No 258/97 should be included in the Union list of novel foods established by this Regulation. In addition, applications submitted under Regulation (EC) No 258/97 before the date of application of this Regulation should be transformed into an application under this Regulation where the initial assessment report provided for under Regulation (EC) No 258/97 has not yet been forwarded to the Commission, as well as in all cases where an additional assessment report is required in accordance with that Regulation. Other pending requests submitted under Article 4 of Regulation (EC) No 258/97 before the date of application of this Regulation should be processed under the provisions of Regulation (EC) No 258/97.

(30)

Regulation (EC) No 882/2004 (20) lays down general rules for the performance of official controls to verify compliance with food law. The Member States should be requested to carry out official controls in accordance with that Regulation, in order to enforce compliance with this Regulation.

(31)

Requirements in respect of the hygiene of foodstuffs as laid down in Regulation (EC) No 852/2004 (21) apply.

(32)

Since the objective of this Regulation, namely laying down harmonised rules for the placing of novel foods on the market within the Union, cannot be sufficiently achieved by the Member States and can therefore be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.

(33)

The Member States should lay down the rules on penalties applicable to infringements of the provisions of this Regulation and should take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive.

(34)

The measures necessary for the implementation of this Regulation should be adopted in accordance with Articles 5 and 7 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (22).

(35)

In particular, the Commission should be empowered to clarify certain definitions in order to ensure a harmonised implementation of these provisions by the Member States on the basis of relevant criteria, including the definition of ‘engineered nanomaterial’, taking into account the technical and scientific developments, and the non-traditional animal breeding technique that includes techniques used for asexual reproduction of genetically identical animals not used for food production within the Union before 15 May 1997. Furthermore, the Commission should be empowered to adopt any appropriate transitional measures and to update the list of traditional foods from third countries and the Union list.

(36)

In addition, the Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union in respect of the criteria according to which foods may be considered as having been used for human consumption to a significant degree within the Union before 15 May 1997. It is of particular importance that the Commission consult experts in the preparatory phase in accordance with the commitment of the Commission undertaken in the Communication of 9 December 2009 on the implementation of Article 290 of the Treaty on the Functioning of the European Union,

(a)

foods when and in so far as they are used as:

(b)

foods falling within the scope of Regulation (EC) No 1829/2003.

(a)

‘novel food’ means food that was not used for human consumption to a significant degree within the Union before 15 May 1997, including:

(b)

‘offspring’ means an animal produced by a traditional breeding technique, where at least one of its parents is an animal produced by a non-traditional breeding technique;

(c)

‘engineered nanomaterial’ means any intentionally produced material that has one or more dimensions of the order of 100 nm or less or that is composed of discrete functional parts, either internally or at the surface, many of which have one or more dimensions of the order of 100 nm or less, including structures, agglomerates or aggregates, which may have a size above the order of 100 nm but retain properties that are characteristic of the nanoscale.

Properties that are characteristic of the nanoscale include:

(d)

‘traditional food from a third country’ means novel food, other than the novel food under sub-points (i) to (iv) of point (a), derived from primary production, with a history of food use in any third country, such that the food in question has been and continues to be part of the customary diet for at least 25 years in a large part of the population of the country;

(e)

‘history of safe food use in a third country’ means that the safety of the food in question is confirmed with compositional data and from experience of use and continued use for at least 25 years in the customary diet of a large part of the population of a country.

(a)

it does not, on the basis of the scientific evidence available, pose a safety concern to the health of the consumer;

(b)

it does not mislead the consumer;

(c)

if it is intended to replace another food, it does not differ from that food in such a way that its normal consumption would be nutritionally disadvantageous for the consumer.

(a)

the name and description of the food,

(b)

its composition,

(c)

its country of origin,

(d)

documented data demonstrating the history of safe food use in any third country,

(e)

where applicable, the conditions of use and specific labelling requirements,

(f)

a summary of the content of the application.

(a)

the history of safe food use in any third country is substantiated by the quality of data submitted by the interested party; and

(b)

the composition of the food and, where applicable, the conditions of its use, do not pose a health risk to consumers in the Union.

(a)

consider whether the food is as safe as food from a comparable food category already existing on the market within the Union or as safe as the food that the novel food is intended to replace;

(b)

take into account the history of safe food use.

(a)

any new scientific or technical information which might influence the evaluation of the safety in use of the novel food;

(b)

any prohibition or restriction imposed by the competent authority of any third country in which the novel food is placed on the market.

(a)

newly developed scientific evidence and/or scientific data was designated as proprietary by the applicant at the time the first application was made (proprietary scientific data);

(b)

the prior applicant had exclusive right of reference to the proprietary scientific data at the time the first application was made; and

(c)

the novel food could not have been authorised without the submission of the proprietary scientific data by the prior applicant.

(a)

the date of entry of the novel food in the Union list;

(b)

the fact that the entry is based on proprietary newly developed scientific evidence and/or proprietary scientific data protected in accordance with this Article;

(c)

the name and address of the applicant;

(d)

the fact that the novel food is authorised for placing on the market within the Union only by the applicant specified in point (c), unless a subsequent applicant obtains authorisation for the food without reference to the proprietary scientific data designated as such by the prior applicant.

(a)

the Union list referred to in Article 7(1) and the list of traditional foods from third countries referred to in Article 7(2), on a single dedicated page of the Commission website;

(b)

the summaries of the applications submitted under this Regulation;

(c)

the findings of the consultations referred to in Article 4(3).

1.

The title is replaced by the following:

2.

In Article 1, paragraphs 1 and 2 are replaced by the following:

‘1.   This Regulation lays down a common procedure for the assessment and authorisation (hereinafter referred to as the “common procedure”) of food additives, food enzymes, food flavourings and source materials of food flavourings and of food ingredients with flavouring properties used or intended for use in or on foodstuffs and novel foods (hereinafter referred to as the “substances or products”) which contributes to the free movement of food within the Union and to a high level of protection of human health and to a high level of consumer protection, including the protection of consumer interests. This Regulation shall not apply to smoke flavourings falling within the scope of Regulation (EC) No 2065/2003 of the European Parliament and of the Council of 10 November 2003 on smoke flavourings used or intended for use in or on foods (28).

2.   The common procedure shall lay down the procedural arrangements for updating the lists of substances and products the marketing of which is authorised in the Union pursuant to Regulation (EC) No 1333/2008, Regulation (EC) No 1332/2008, Regulation (EC) No 1334/2008 and Regulation (EU) No …/2010 of the European Parliament and of the Council of … on novel foods (29) (hereinafter referred to as the “sectoral food laws”).

3.

In Article 1(3), Article 2(1) and (2), Article 9(2), Article 12(1) and Article 13 the words ‘substance’ and ‘substances’ are replaced by ‘substance or product’ or ‘substances or products’ as appropriate.

4.

The title of Article 2 is replaced by the following:

‘Union list of substances or products’.

5.

The following paragraph is added to Article 4:

‘3.   A single application relating to a substance or product may be made to update the different Union lists regulated under the different sectoral food laws in so far as the application complies with the requirements of each of the sectoral food laws.’.

6.

The following sentence is inserted at the beginning of Article 6(1):

‘In the case of scientific grounds for safety concerns, additional information concerning risk assessment shall be identified and requested from the applicant.’.

7.

In Article 7, paragraphs 4, 5 and 6 are replaced by the following:

‘4.   The measures, designed to amend non-essential elements of each sectoral food law, with the exception of novel foods, relating to the removal of a substance from the Union list, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3).

5.   On grounds of efficiency, the measures designed to amend non-essential elements of each sectoral food law, with the exception of novel foods, inter alia, by supplementing it, relating to the addition of a substance to the Union list and for adding, removing or changing conditions, specifications or restrictions associated with the presence of the substance on the Union list, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(4).

6.   With exception of novel foods and on imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 14(5) for the removal of a substance from the Union list and for adding, removing or changing conditions, specifications or restrictions associated with the presence of a substance on the Union list.

7.   The measures relating to the removal, the adding of a product covered by the Regulation on novel foods to the Union list and/or for adding, removing or changing conditions, specifications or restrictions associated with the presence of such product on the Union list shall be adopted in accordance with the regulatory procedure referred to in Article 14(2).’.

8.

The term ‘Community’ shall be replaced by ‘Union’.