(1)

In implementing Union policy and having regard to the Treaty on the Functioning of the European Union (TFEU), a high level of protection of human health and consumer protection should be guaranteed and also a high level of animal welfare and environmental protection. At all times, moreover, the precautionary principle as laid down in 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 (3), should be applied.

(2)

A high level of human health protection should be assured in the pursuit of Union policies and should be given priority over the functioning of the internal market .

(3)

Article 13 TFEU clarifies that the Union and the Member States are to pay full regard to the welfare requirements of animals when formulating and implementing policies, since animals are sentient beings.

(4)

The standards laid down in Union legislation must be applied to all foods placed on the market within the Union, including foods imported from third countries.

(5)

The European Parliament called on the Commission, in its resolution of 3 September 2008 on the cloning of animals for food supply (4), to submit proposals prohibiting for food supply purposes (i) the cloning of animals, (ii) the farming of cloned animals or their offspring, (iii) the placing on the market of meat or dairy products derived from cloned animals or their offspring and (iv) the importing of cloned animals, their offspring, semen and embryos from cloned animals or their offspring, and meat or dairy products derived from cloned animals or their offspring.

(6)

The Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) adopted on 28–29 September 2005 an opinion which concluded that there were ‘major gaps in the knowledge necessary for risk assessment. These include nanoparticle characterisation, the detection and measurement of nanoparticles, the dose-response, fate, and persistence of nanoparticles in humans and in the environment, and all aspects of toxicology and environmental toxicology related to nanoparticles’. Furthermore, the SCENIHR opinion concluded that ‘existing toxicological and eco-toxicological methods may not be sufficient to address all of the issues arising in relation to nanoparticles’.

(7)

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 (5) 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 (6). 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 (7) should therefore become obsolete as regards novel foods.

(8)

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.

(9)

▐ The existing definition of novel food should be clarified, with an explanation of the criteria for novelty, and updated by replacing the existing categories with a reference to the general definition of food in ▐ Regulation (EC) No 178/2002 .

(10)

Foods with a new or intentionally modified primary molecular structure, foods consisting of, or isolated from, micro-organisms, fungi or algae, new strains of micro-organism with no history of safe use and concentrates of substances that naturally occur in plants should be considered as novel foods as defined in this Regulation.

(11)

It should also be clarified that a food should be considered as novel when a production technology which was not previously used for the production of foods to be marketed and consumed 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 plants and animals, produced by non-traditional breeding techniques, and ▐ foods modified by new production processes, such as nanotechnology and nanoscience, which might have an impact on food ▐. Foods derived from new plant varieties, or from animal breeds produced by traditional breeding techniques, should not be considered as novel foods. ▐

(12)

The cloning of animals is incompatible with Council Directive 98/58/EC of 20 July 1998 concerning the protection of animals kept for farming purposes (8), point 20 of the Annex of which states that natural or artificial breeding procedures which cause, or are likely to cause, suffering or injury to any of the animals concerned must not be practised. Food from cloned animals or their descendants must therefore not be placed on the Union list.

(13)

▐ The European Group on Ethics in Science and New Technologies, established by Commission Decision of 16 December 1997, stated in its Opinion (No. 23) of 16 January 2008 on ethical aspects of animal cloning for food supply that it ‘does not see convincing arguments to justify the production of food from clones and their offspring’. The Scientific Committee of the European Food Safety Authority (the ‘Authority’) concluded in its Opinion of 15 July 2008 on animal cloning (9) that ‘the health and welfare of a significant proportion of clones … have been found to be adversely affected, often severely and with a fatal outcome’ .

(14)

Foods derived from cloned animals and their descendants should, however, be excluded from the scope of this Regulation. They should be dealt with in a specific regulation, adopted under the ordinary legislative procedure, and should not be subject to the common authorisation procedure. Before the date of application of this Regulation, the Commission should present a corresponding legislative proposal. Pending the entry into force of a regulation on cloned animals, a moratorium should be imposed on the placing on the market of foods manufactured from cloned animals or their descendants.

(15)

Implementing measures should be adopted to provide for further criteria in order 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 ▐ a food was used exclusively as, or in, a food supplement, as defined in 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 (10), prior to that date , it can be placed on the market ▐ after that date for the same use without being considered as a novel food. However, that use as, or in, a food supplement should not be taken into account for the assessment of whether it was used for human consumption to a significant degree within the Union before 15 May 1997. Therefore, other uses of the food concerned, namely other than ▐ food supplement uses, have to be authorised in accordance with this Regulation.

(16)

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, ▐ it is necessary to develop a uniform definition for engineered nanomaterials .

(17)

Test methods currently available are not adequate for assessing the risks associated with ▐ nanomaterials. Non-animal test methods for testing nanomaterials should be developed as a matter of urgency .

(18)

Only nanomaterials entered in a list of approved substances should be present in food packaging, accompanied by a limit on migration into or onto the food products contained in such packaging.

(19)

Reformulated food products produced from existing food ingredients available on the market within the Union, in particular those reformulated by changing the composition or amounts of those food ingredients , should not be considered as novel food. ▐

(20)

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 (11) 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.

(21)

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.

(22)

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 (12), food used solely as additives falling within the scope of Regulation (EC) No 1333/2008 (13), flavourings falling within the scope of Regulation (EC) No 1334/2008 (14), enzymes falling within the scope of Regulation (EC) No 1332/2008 (15) and extraction solvents falling within the scope of Directive 2009/32/EC (16) should not be covered by this Regulation.

(23)

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 (17) 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) (18) 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.

(24)

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.

(25)

The Commission should establish a simple and transparent procedure for cases in which it does not have information ▐ on human consumption before 15 May 1997 . The Member States should be involved in this procedure. The procedure should be adopted no later than …  (19).

(26)

Novel foods should be placed on the market within the Union only if they are safe and do not mislead the consumer. The assessment of their safety should be based on the precautionary principle as laid down in Article 7 of Regulation (EC) No 178/2002. In addition, they should not differ from the food that they are to replace in any way that would be nutritionally disadvantageous for the consumer.

(27)

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 (20), 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.

(28)

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 Authority.

(29)

Ethical and environmental aspects must be considered as part of the risk assessment during the authorisation procedure. Those aspects should be assessed by the European Group on Ethics in Science and New Technologies and the European Environment Agency respectively.

(30)

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.

(31)

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.

(32)

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.

(33)

The inclusion of a novel food in the Union list of novel foods ▐ 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 Article 8 of Regulation (EC) No 1925/2006.

(34)

In specific circumstances, in order to stimulate research and development within the agri-food industry, and thus innovation, it is appropriate to protect the investment made by innovators in gathering the information and data provided in support of an application under this Regulation. 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 not be used to the benefit of another applicant during a limited period of time, without the agreement of the first 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. In addition, the protection of scientific data should not prevent transparency and access to information relating to the data used in the safety assessment of novel foods. Intellectual property rights should, nevertheless, be respected.

(35)

Novel foods are subject to the general labelling requirements laid down in Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to labelling, presentation and advertising of foodstuffs  (21). 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, the inclusion of a novel food in the Union list may be subject to specific conditions of use or labelling obligations .

(36)

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  (22) 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. Where an applicant wishes a novel food to carry a health claim that needs to be authorised in accordance with Article 17 or 18 of Regulation (EC) No 1924/2006 and the novel food and health claim applications both include requests for the protection of proprietary data, the periods of data protection should start together and run concurrently, where the applicant so requests.

(37)

The European Group on Ethics in Science and New Technologies should be consulted in specific cases with a view to obtaining advice on ethical issues regarding the use of new technologies and the placing on the market ▐ of novel foods.

(38)

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 , in relation to which the initial assessment report provided for under Article 6(3) of that Regulation ▐ has not yet been forwarded to the Commission and in relation to which an additional assessment report is required in accordance with Article 6(3) or 6(4) of that Regulation before the date of application of this Regulation, should be considered as applications under this Regulation. When required to give an opinion, the Authority and the Member States should take into account the outcome of the initial assessment. Other ▐ 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.

(39)

Regulation (EC) 882/2004 (23) 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.

(40)

Requirements in respect of the hygiene of foodstuffs as laid down in Regulation (EC) No 852/2004 (24) apply.

(41)

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.

(42)

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.

▐

(43)

▐ The Commission should be empowered to adopt delegated acts in accordance with Article 290 TFEU 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 , in respect of the determination of whether a type of food falls within the scope of this Regulation, the adjustment and adaptation of the definition of ‘engineered nanomaterial’ to technical and scientific progress and in line with definitions subsequently agreed at international level, rules on how to proceed in cases in which the Commission has no information about use of a food for human consumption before 15 May 1997, as well as in respect of rules for the application of Article 4(1) and Article 9 and the update of the Union list . It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level ,

(a)

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

(b)

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

(c)

foods derived from cloned animals and their descendants. Before … (25), the Commission shall present a legislative proposal to prohibit the placing on the market in the Union of foods derived from cloned animals and their descendants. The proposal shall be forwarded to the European Parliament and the Council.

(a)

‘novel food’ means ▐:

▐

(b)

‘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:

(c)

‘cloned animals’ means animals produced by means of a method of asexual, artificial reproduction with the aim of producing a genetically identical or nearly identical copy of an individual animal;

(d)

‘descendants of cloned animals’ means animals produced by means of sexual reproduction, in cases in which at least one of the progenitors is a cloned animal;

(e)

‘traditional food from a third country’ means a natural non-engineered novel food ▐ with a history of food use in a third country, meaning that the food in question was, for at least 25 years before … (26), and continues to be, part of the normal diet ▐ in a large part of the population of the country;

(f)

‘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 and of animals, which implies that cumulative and synergistic effects as well as possible adverse effects on particular groups of the population will be taken into account in the risk assessment ;

(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 ;

(d)

the opinion of the European Environment Agency, which shall be published no later than the day of the publication of the Authority’s assessment, concerning the extent to which the production process and normal consumption have a harmful impact on the environment, is taken into account in the risk assessment;

(e)

the opinion of the European Group on Ethics in Science and New Technologies, which shall be published no later than the day of the publication of the Authority’s assessment, concerning the extent to which there are ethical objections, is taken into account in the risk assessment;

(f)

a novel food that may have any adverse effects on particular groups of the population will be authorised only where specific measures preventing such adverse effects have been implemented;

(g)

it is not derived from a cloned animal or its descendants;

(h)

maximum intake levels of the novel food as such or as part of another foodstuff or categories of foodstuffs will be laid down, where required in the interests of safe use;

(i)

cumulative effects of novel foods that are used in different foodstuffs or categories of foodstuffs have been assessed .

(a)

a specification of the food ;

(b)

the intended use of the food;

(c)

the conditions of use ;

(d)

where appropriate, additional specific labelling requirements to inform the final consumer;

(e)

the date of entry of the novel food in the Union list and the date of receipt of the application;

(f)

the name and address of the applicant;

(g)

the date and results of the last inspection according to the monitoring requirements laid down in Article 12;

(h)

the fact that the entry is based on newly developed scientific evidence and/or proprietary data protected in accordance with Article 14;

(i)

the fact that the novel food may only be placed on the market by the applicant specified in point (f), unless a subsequent applicant obtains authorisation for the food without prejudice to the proprietary data of the original applicant .

(a)

the novel food is equivalent to existing foods, in terms of composition, how it is metabolised and level of undesirable substances, or

(b)

the novel food consists of, or contains, food previously approved for food use in the Union, and the new intended use can be expected not to significantly increase the intake of consumers, including consumers in vulnerable groups,

(a)

consider whether the novel food , irrespective of whether or not it is intended to replace a food ▐ already existing on the market , poses any risk of harmful or toxic effects to human health, while also taking into account the implications of any new characteristics ;

(b)

take into account , for traditional food from a third country, 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 ▐ data at the time the prior application was made;

(c)

the novel food could not have been authorised without the submission of the proprietary ▐ data by the prior applicant; and

(d)

the scientific data and other information was designated as proprietary by the prior applicant at the time the prior application was made .

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 an assessment and authorisation procedure (hereinafter the “common procedure”) for food additives, food enzymes, food flavourings and sources of food flavourings ▐ used or intended for use in or on foodstuffs and novel foods (hereinafter the “substances or products”) which contributes to the free movement of foods within the Union and to a high level of protection of human health and ▐ protection of consumer interests. ▐

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 …/… of the European Parliament and of the Council of … on novel foods … (33)  (35) (hereinafter the “sectoral food laws”).

▐

3)

In Article 1(3), Article 2(1) and (2), Article 9(2), Article 12(1) and Article 13 the word ‘substance’ or ‘substances’ is replaced by ‘substance or product’ or ‘substances or products’ ▐.

4)

The title of Article 2 is replaced by the following:

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)

The term ‘Community’ shall be replaced by ‘Union’ throughout the text.