# CE2010117EN.01023601.xml

| 6.5.2010 | EN | Official Journal of the European Union | CE 117/236 |
| --- | --- | --- | --- |

6.5.2010

EN

Official Journal of the European Union

CE 117/236

---

Wednesday 25 March 2009Novel foods ***I

P6_TA(2009)0171

European Parliament legislative resolution of 25 March 2009 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)0872 – C6-0027/2008 – 2008/0002(COD))

2010/C 117 E/46

(Codecision procedure: first reading)

The European Parliament,

The European Parliament

having regard to the Commission proposal to the European Parliament and the Council (COM(2007)0872),

having regard to Article 251(2) and Article 95 of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament (C6-0027/2008),

having regard to Rule 51 of its Rules of Procedure,

having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinions of the Committee on the Internal Market and Consumer Protection and the Committee on Agriculture and Rural Development (A6-0512/2008),

| 1. | Approves the Commission proposal as amended; |
| --- | --- |

1.

Approves the Commission proposal as amended;

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

2.

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

| 3. | Instructs its President to forward its position to the Council and Commission. |
| --- | --- |

3.

Instructs its President to forward its position to the Council and Commission.

---

Wednesday 25 March 2009Position of the European Parliament adopted at first reading on 25 March 2009 with a view to the adoption of Regulation (EC) No .../2009 of the European Parliament and of the Council on novel foods, amending Regulation (EC) No 1331/2008 and repealing Regulation (EC) No 258/97

P6_TC1-COD(2008)0002

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission ║,

Having regard to the opinion of the European Economic and Social Committee (1),

Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),

Whereas:

| (1) | In implementing Community policy and having regard to the Treaty establishing the European Community, 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. |
| --- | --- |

(1)

In implementing Community policy and having regard to the Treaty establishing the European Community, 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 Community policies
  and should be given priority over the functioning of the internal market
  . |
| --- | --- |

(2)

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

| (3) | Article 13 of the Treaty on the Functioning of the European Union clarifies that the Union and the Member States shall pay full regard to the welfare requirements of animals when formulating and implementing policies, since animals are sentient beings. |
| --- | --- |

(3)

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

| (4) | The standards defined in Community legislation must be applied to all foods placed on the Community market, including foods imported from third countries. |
| --- | --- |

(4)

The standards defined in Community legislation must be applied to all foods placed on the Community market, 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. |
| --- | --- |

(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 are ‘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 concludes that ‘existing toxicological and eco-toxicological methods may not be sufficient to address all of the issues arising in relation to nanoparticles’. |
| --- | --- |

(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 are ‘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 concludes that ‘existing toxicological and eco-toxicological methods may not be sufficient to address all of the issues arising in relation to nanoparticles’.

| (7) | Community 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 should be repealed and replaced by this Regulation. The present Regulation should include measures currently governed by Regulation (EC) No 1852/2001. |
| --- | --- |

(7)

Community 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 should be repealed and replaced by this Regulation. The present Regulation should include measures currently governed by Regulation (EC) No 1852/2001.

| (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 Community before the date of application of Regulation (EC) No 258/97, namely 15 May 1997, should be kept as a criterion for a food to be considered as novel.
  A use within the Community refers to a use in the Member States, irrespective of the date of their accession to the European Union. |
| --- | --- |

(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 Community before the date of application of Regulation (EC) No 258/97, namely 15 May 1997, should be kept as a criterion for a food to be considered as novel.
  A use within the Community 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 ║. |
| --- | --- |

(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 as well as concentrates of substances that naturally occur in plants should be considered as novel foods as defined in this Regulation. |
| --- | --- |

(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 as well as 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 it is applied a production technology which was not previously used. 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 animal breeds produced by traditional breeding techniques, should not be considered as novel foods. |
| --- | --- |

(11)

It should also be clarified that a food should be considered as novel when it is applied a production technology which was not previously used. 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 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 (7), 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 Community list. |
| --- | --- |

(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 (7), 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 Community list.

| (13) | 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. |
| --- | --- |

(13)

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.

| (14) | The European Group on Ethics in Science and New Technologies 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 (EFSA) concluded in its Opinion of 15 July 2008 on animal cloning (8) 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)

The European Group on Ethics in Science and New Technologies 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 (EFSA) concluded in its Opinion of 15 July 2008 on animal cloning (8) 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’.

| (15) | 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. |
| --- | --- |

(15)

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.

| (16) | 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 codecision procedure, and not be subject to the common authorisation procedure. Before the date of application of this Regulation, the Commission should put forward 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 and their descendants. |
| --- | --- |

(16)

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 codecision procedure, and not be subject to the common authorisation procedure. Before the date of application of this Regulation, the Commission should put forward 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 and their descendants.

| (17) | ▐ Implementing measures should be adopted to provide for
  further
  criteria in order to facilitate the assessment of whether a food has been used for human consumption to a significant degree within the Community before 15 May 1997. If a food has been 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
   (9), 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 has been used for human consumption to a significant degree within the Community before 15 May 1997. Therefore, other uses of the food concerned, i.e. other than food supplement uses, have to be authorised in accordance with this Regulation. |
| --- | --- |

(17)

▐ Implementing measures should be adopted to provide for
  further
  criteria in order to facilitate the assessment of whether a food has been used for human consumption to a significant degree within the Community before 15 May 1997. If a food has been 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
   (9), 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 has been used for human consumption to a significant degree within the Community before 15 May 1997. Therefore, other uses of the food concerned, i.e. other than food supplement uses, have to be authorised in accordance with this Regulation.

| (18) | Reformulated food products produced from existing food ingredients available on the Community market, in particular those reformulated by changing the composition or amounts of those food ingredients, should not be considered as novel food. |
| --- | --- |

(18)

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

| (19) | 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 (10) 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 Community legislation. In this respect, a Member State may, where it establishes in accordance with Directive 2001/83/EC that a substance is a medicinal product, restrict the placing on the market of such a product in accordance with Community law. |
| --- | --- |

(19)

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 (10) 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 Community legislation. In this respect, a Member State may, where it establishes in accordance with Directive 2001/83/EC that a substance is a medicinal product, restrict the placing on the market of such a product in accordance with Community law.

| (20) | 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. |
| --- | --- |

(20)

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.

| (21) | Foods which are intended for technological uses or which are genetically modified should not fall within the scope of this Regulation
  as long as these foods are covered by a safety evaluation and approval according to other Community legislation
  . Therefore, food used solely as additives falling within the scope of Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives
   (11), flavourings falling within the scope of Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods
   (12), extraction solvents falling within the scope of Council Directive 88/344/EEC of 13 June 1988 on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients (13), enzymes falling within the scope of Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes
   (14) and genetically modified food falling within the scope of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (15) should be excluded from the scope of this Regulation. |
| --- | --- |

(21)

Foods which are intended for technological uses or which are genetically modified should not fall within the scope of this Regulation
  as long as these foods are covered by a safety evaluation and approval according to other Community legislation
  . Therefore, food used solely as additives falling within the scope of Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives
   (11), flavourings falling within the scope of Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods
   (12), extraction solvents falling within the scope of Council Directive 88/344/EEC of 13 June 1988 on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients (13), enzymes falling within the scope of Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes
   (14) and genetically modified food falling within the scope of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (15) should be excluded from the scope of this Regulation.

| (22) | The use of vitamins and minerals is governed by specific sectoral food laws. The vitamins and minerals falling within the scope of Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses (16), Directive 2002/46/EC ║ and 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) should therefore be excluded from the scope of this Regulation. |
| --- | --- |

(22)

The use of vitamins and minerals is governed by specific sectoral food laws. The vitamins and minerals falling within the scope of Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses (16), Directive 2002/46/EC ║ and 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) should therefore be excluded from the scope of this Regulation.

| (23) | 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 the safety criteria and requirements applicable to all novel foods. At the same time they should remain subject to the rules provided for in Directive 89/398/EEC and in the specific Directives referred to in Article 4(1) thereof and in Annex I thereof, in Directive 2002/46/EC and in Regulation (EC) No 1925/2006. |
| --- | --- |

(23)

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 the safety criteria and requirements applicable to all novel foods. At the same time they should remain subject to the rules provided for in Directive 89/398/EEC and in the specific Directives referred to in Article 4(1) thereof and in Annex I thereof, in Directive 2002/46/EC and in Regulation (EC) No 1925/2006.

| (24) | 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 six months after the entry into force of this Regulation. |
| --- | --- |

(24)

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 six months after the entry into force of this Regulation.

| (25) | Novel foods should be placed on the Community market 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. |
| --- | --- |

(25)

Novel foods should be placed on the Community market 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.

| (26) | 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 authorisation procedures of food, the safety assessment of novel foods and their inclusion in the Community 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 (18).
  The approval of novel foods should also take into account other factors relevant to the matter under consideration, including ethical factors. |
| --- | --- |

(26)

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 authorisation procedures of food, the safety assessment of novel foods and their inclusion in the Community 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 (18).
  The approval of novel foods should also take into account other factors relevant to the matter under consideration, including ethical factors.

| (27) | In order to avoid animal testing, testing on vertebrate animals for the purposes of this Regulation should be undertaken only as a last resort. This Regulation should ensure that testing on vertebrate animals is minimised and that double-testing is avoided, and should promote the use of non-animal test methods and intelligent testing strategies. Existing results from tests on vertebrate animals should be shared in the process of developing novel foods. Moreover, in accordance with Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes (19), tests on vertebrate animals must be replaced, restricted or refined. Implementation of this Regulation should, where possible, be based on the use of appropriate alternative testing methods. Not later than seven years after the entry into force of this Regulation., the Commission should review the rules on the data protection of results from tests on vertebrate animals and, where necessary, change those rules. |
| --- | --- |

(27)

In order to avoid animal testing, testing on vertebrate animals for the purposes of this Regulation should be undertaken only as a last resort. This Regulation should ensure that testing on vertebrate animals is minimised and that double-testing is avoided, and should promote the use of non-animal test methods and intelligent testing strategies. Existing results from tests on vertebrate animals should be shared in the process of developing novel foods. Moreover, in accordance with Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes (19), tests on vertebrate animals must be replaced, restricted or refined. Implementation of this Regulation should, where possible, be based on the use of appropriate alternative testing methods. Not later than seven years after the entry into force of this Regulation., the Commission should review the rules on the data protection of results from tests on vertebrate animals and, where necessary, change those rules.

| (28) | Criteria for the evaluation of the potential risks arising from novel foods should also be laid down. In order to ensure a harmonised scientific assessment of novel foods, such assessments should be carried out by the European Food Safety Authority (‘the Authority’)
  in cooperation with the Member States’ authorities
  . |
| --- | --- |

(28)

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

| (29) | Ethical and environmental aspects must be considered as part of the risk assessment during the authorisation procedure. These aspects should be assessed by the European Group on Ethics in Science and New Technologies and the European Environment Agency respectively. |
| --- | --- |

(29)

Ethical and environmental aspects must be considered as part of the risk assessment during the authorisation procedure. These 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. |
| --- | --- |

(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.

| (31) | 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. |
| --- | --- |

(31)

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.

| (32) | The inclusion of a novel food in the Community 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. |
| --- | --- |

(32)

The inclusion of a novel food in the Community 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.

| (33) | Under 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 Community 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 Community 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. |
| --- | --- |

(33)

Under 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 Community 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 Community 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.

| (34) | 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 (20). 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 Community list may be subject to specific conditions of use or labelling obligations. |
| --- | --- |

(34)

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 (20). 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 Community list may be subject to specific conditions of use or labelling obligations.

| (35) | 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 (21) 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. |
| --- | --- |

(35)

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 (21) 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.

| (36) | As regards the safety assessment and management of traditional food from third countries, their history of safe use in the third 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. If Member States
  and/or
  the Authority have not presented any reasoned safety objections, based on scientific evidence, for example information on adverse health effects, it
  will
  be permissible to place the food on the Community market after notification of the intention to do so,
  provided that there are no ethical objections. |
| --- | --- |

(36)

As regards the safety assessment and management of traditional food from third countries, their history of safe use in the third 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. If Member States
  and/or
  the Authority have not presented any reasoned safety objections, based on scientific evidence, for example information on adverse health effects, it
  will
  be permissible to place the food on the Community market after notification of the intention to do so,
  provided that there are no ethical objections.

| (37) | The European Group on Ethics in Science and New Technologies (EGE) established by Commission Decision of 16 December 1997(SEC(97) 2404) should
  be consulted
  in justified 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. |
| --- | --- |

(37)

The European Group on Ethics in Science and New Technologies (EGE) established by Commission Decision of 16 December 1997(SEC(97) 2404) should
  be consulted
  in justified 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 Community market 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 Community 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
  an application
  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. |
| --- | --- |

(38)

Novel foods placed on the Community market 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 Community 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
  an application
  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) | Since the objectives of the action to be taken cannot be achieved by the Member States and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. 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 those objectives. |
| --- | --- |

(39)

Since the objectives of the action to be taken cannot be achieved by the Member States and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. 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 those objectives.

| (40) | 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. |
| --- | --- |

(40)

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.

| (41) | The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (22). |
| --- | --- |

(41)

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

| (42) | In particular, power should be conferred on the Commission to establish the criteria under which foods may be considered as having been used for human consumption to a significant degree within the Community before 15 May 1997. Since those measures are of general scope and are designed to supplement this Regulation by the addition of new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. |
| --- | --- |

(42)

In particular, power should be conferred on the Commission to establish the criteria under which foods may be considered as having been used for human consumption to a significant degree within the Community before 15 May 1997. Since those measures are of general scope and are designed to supplement this Regulation by the addition of new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

| (43) | Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (23) lays down general rules for the performance of official controls to verify compliance with food law. Therefore, ║ Member States are to carry out official controls in accordance with Regulation (EC) No 882/2004, in order to enforce compliance with this Regulation, |
| --- | --- |

(43)

Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (23) lays down general rules for the performance of official controls to verify compliance with food law. Therefore, ║ Member States are to carry out official controls in accordance with Regulation (EC) No 882/2004, in order to enforce compliance with this Regulation,

HAVE ADOPTED THIS REGULATION:

Chapter I

Introductory provisions

Article 1

Subject matter

This Regulation lays down harmonised rules for the placing of novel foods on the market in the Community with a view to ensuring a high level
  of protection
  of human
  life and
  health,
  animal health and welfare, the environment and the interests of consumers
  whilst ensuring
  transparency and
  the effective functioning of the internal market
  and stimulating innovation within the agri-food industry.

Article 2

Scope

1.   This Regulation shall apply to the placing of novel foods on the market in the Community.

2.   This Regulation shall,
  unless otherwise provided for,
  not apply to:

| (a) | foods when and insofar as they are used as:






  (i) | food additives falling within the scope of Regulation (EC) No
  1333/2008
  ; |
| --- | --- | --- |

(a)

foods when and insofar as they are used as:

(i)

food additives falling within the scope of Regulation (EC) No
  1333/2008
  ;

| (ii) | food flavourings falling within the scope of Regulation (EC) No
  1334/2008
  ; |
| --- | --- |

(ii)

food flavourings falling within the scope of Regulation (EC) No
  1334/2008
  ;

| (iii) | extraction solvents used in the production of foodstuffs and falling within the scope of ║ Directive 88/344/EEC; |
| --- | --- |

(iii)

extraction solvents used in the production of foodstuffs and falling within the scope of ║ Directive 88/344/EEC;

| (iv) | food enzymes falling within scope of Regulation (EC) No
  1332/2008
  ; |
| --- | --- |

(iv)

food enzymes falling within scope of Regulation (EC) No
  1332/2008
  ;

| (v) | vitamins and minerals falling within the scope of Directive 89/398/EEC, Directive 2002/46/EC or Regulation (EC) No 1925/2006,
  except for vitamin and mineral substances already approved which are obtained by production methods or using new sources that were not taken into account when they were authorised under specific legislation, where these production methods or new sources give rise to significant changes referred to in Article 3(2)(a)(iii). |
| --- | --- |

(v)

vitamins and minerals falling within the scope of Directive 89/398/EEC, Directive 2002/46/EC or Regulation (EC) No 1925/2006,
  except for vitamin and mineral substances already approved which are obtained by production methods or using new sources that were not taken into account when they were authorised under specific legislation, where these production methods or new sources give rise to significant changes referred to in Article 3(2)(a)(iii).

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

(b)

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

| (c) | foods derived from cloned animals and their descendants. Before ... (24), the Commission shall present a legislative proposal to prohibit the placing on the market in the Community of foods derived from cloned animals and their descendants. The proposal shall be forwarded to the European Parliament and the Council. |
| --- | --- |

(c)

foods derived from cloned animals and their descendants. Before ... (24), the Commission shall present a legislative proposal to prohibit the placing on the market in the Community of foods derived from cloned animals and their descendants. The proposal shall be forwarded to the European Parliament and the Council.

3.
     
  Notwithstanding paragraph 2, this Regulation shall apply to food additives, food enzymes, flavourings and certain food ingredients with flavouring properties to which a new production process not used before 15 May 1997 is applied that gives rise to significant changes in the composition or structure of the food, such as engineered nanomaterials.

4.   Where necessary, it may be determined in accordance with the
  regulatory
  procedure
  with scrutiny
  referred to in
  Article 20(3)
  whether a type of food falls within the scope of this Regulation.
  Where a novel food is capable of having an effect on the human body comparable to that of a medicinal product, the Commission shall seek an opinion of the European Medicines Agency (EMEA) on whether it falls under Regulation (EC) No 726/2004 of the European Parliament and of the Council (25).

Article 3

Definitions

1.   For the purposes of this Regulation, the definitions laid down in Regulation (EC) No 178/2002 shall apply.

2.   The following definitions shall also apply:

| (a) | ‘novel food’ means:






  (i) | food that was not used for human consumption to a significant degree within the Community before 15 May 1997;
  ▐ |
| --- | --- | --- |

(a)

‘novel food’ means:

(i)

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

▐

| (ii) | food of plant or animal origin when to the plant and animal is applied a non-traditional breeding technique not used before 15 May 1997,
  with the exception of foods derived from cloned animals and their descendants
  ; |
| --- | --- |

(ii)

food of plant or animal origin when to the plant and animal is applied a non-traditional breeding technique not used before 15 May 1997,
  with the exception of foods derived from cloned animals and their descendants
  ;

| (iii) | 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 or structure of the food which affect its nutritional value, metabolism or level of undesirable substances; |
| --- | --- |

(iii)

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 or structure of the food which affect its nutritional value, metabolism or level of undesirable substances;

| (iv) | food containing or consisting of engineered nanomaterials not used for food production within the Community before 15 May 1997.



  The use of a food exclusively as, or in, a food supplement shall not be sufficient to show whether it was used for human consumption to a significant degree within the Community before 15 May 1997. However, where a food was used exclusively as, or in, a food supplement prior to that date, it may be placed on the Community market after that date for the same use without being considered as a novel food. Further criteria for assessing if a food was used for human consumption to a significant degree within the Community before 15 May 1997, which are designed to amend non-essential elements of this Regulation, inter alia by supplementing it, may be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 20(3); |
| --- | --- |

(iv)

food containing or consisting of engineered nanomaterials not used for food production within the Community before 15 May 1997.

| (b) | ‘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 has been,
  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; |
| --- | --- |

(b)

‘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 has been,
  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;

| (c) | ‘history of safe food use’ 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 30 years
  in the
  customary
  diet of a large part of the population of a country; |
| --- | --- |

(c)

‘history of safe food use’ 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 30 years
  in the
  customary
  diet of a large part of the population of a country;

| (d) | ‘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)

‘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;

| (e) | ‘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)

‘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;

| (f) | ‘engineered nanomaterial’ means any intentionally produced material that has one or more dimensions of the order of 100 nm or less or 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 to the nanoscale.



  Properties that are characteristic to the nanoscale include:









  (i) | those related to the large specific surface area of the materials considered and/or |
| --- | --- | --- |

(f)

‘engineered nanomaterial’ means any intentionally produced material that has one or more dimensions of the order of 100 nm or less or 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 to the nanoscale.

(i)

those related to the large specific surface area of the materials considered and/or

| (ii) | specific physico-chemical properties that are different from those of the non-nanoform of the same material. |
| --- | --- |

(ii)

specific physico-chemical properties that are different from those of the non-nanoform of the same material.

3.
     
  In view of the various definitions of nanomaterials published by different bodies at international level and the constant technical and scientific developments in the field of nanotechnologies, the Commission shall adjust and adapt point ( f) of paragraph 2 to technical and scientific progress and with definitions subsequently agreed at international level. That measure, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 20(3).

Article 4

Collection of information regarding the classification of a novel food

1.   The Commission
  shall
  collect information from the Member States and/or from food business operators
  or any other interested party
  to determine
  whether a food falls within the scope of this Regulation. Member States, business operators and other interested parties shall transmit to the Commission information on the
  extent a food has been used for human consumption within the Community before 15 May 1997.

2.
     
  The Commission shall publish those data and the conclusions drawn from the data collection and the non-confidential data supporting it.

3.
     
  Implementing measures on how to proceed in cases in which the Commission has no information about use for human consumption before 15 May 1997, which are designed to amend non-essential elements of this Regulation, inter alia by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 20 (3) not later than ... (27).

4.   Implementing measures for the application of paragraph 1, which are designed to amend non-essential elements of this Regulation, inter alia by supplementing it, may be adopted in accordance with the regulatory procedure with scrutiny referred to Article 20(3).

Chapter II

Requirements and inclusion in the Community list of novel foods

Article 5

Community list of novel foods

Only novel foods included in the Community list of novel foods (‘the Community list’) may be placed on the market.
  The Commission shall keep and publish the Community list on a publicly accessible page intended for that purpose on the website of the Commission.

Article 6

Prohibition of non-compliant novel foods

Novel foods shall not be placed on the market if they do not comply with the provisions of this Regulation.

Article 7

Conditions for inclusion in the Community list

1.
     A novel food may be included in the Community list only if it meets the following conditions:

| (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; |
| --- | --- |

(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 ▐; |
| --- | --- |

(b)

it does not mislead the consumer ▐;

| (c) | in the case where 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; |
| --- | --- |

(c)

in the case where 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 concerning the extent to which the production process and normal consumption have a harmful impact on the environment shall be taken into account in the assessment; |
| --- | --- |

(d)

the opinion of the European Environment Agency concerning the extent to which the production process and normal consumption have a harmful impact on the environment shall be taken into account in the assessment;

| (e) | the opinion of the European Group on Ethics in Science and New Technologies, concerning the extent to which there are ethical objections, shall be taken into account in the assessment; |
| --- | --- |

(e)

the opinion of the European Group on Ethics in Science and New Technologies, concerning the extent to which there are ethical objections, shall be taken into account in the 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; |
| --- | --- |

(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) | maximum intake levels of a 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; |
| --- | --- |

(g)

maximum intake levels of a 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;

| (h) | cumulative effects of novel foods that are used in different foodstuffs or categories of foodstuffs have been assessed. |
| --- | --- |

(h)

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

2.
     
  Foods to which production processes have been applied that require specific risk assessment methods (e.g. foods produced using nanotechnologies) may not be included in the Community list until such specific methods have been approved for use, and an adequate safety assessment on the basis of those methods has shown that the use of the respective foods is safe.

3.
     
  A novel food may be included in the Community list only if the competent authority has submitted an opinion establishing that the food is not harmful to health.

Foods from cloned animals or their descendants shall not be placed on the Community list.

4.
     
  In the event of doubt, due, for example, to insufficient scientific certainty or lack of data, the precautionary principle shall be applied and the food in question shall not be included in the Community list.

Article 8

Content of the Community list

1.   The Community list shall be updated in accordance with the procedure laid down in Regulation (EC) No 1331/2008 and the Commission shall publish it on a dedicated page of its website
  .

2.   The entry of a novel food in the Community list shall include:

| (a) | a specification of the food; |
| --- | --- |

(a)

a specification of the food;

| (b) | the intended use of the food; |
| --- | --- |

(b)

the intended use of the food;

| (c) | the conditions of use; |
| --- | --- |

(c)

the conditions of use;

| (d) | the date of entry of the novel food in the Community list and the date of receipt of the application; |
| --- | --- |

(d)

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

| (e) | the name and address of the applicant; |
| --- | --- |

(e)

the name and address of the applicant;

| (f) | the date and results of the last inspection according to the monitoring requirements laid down in Article 13; |
| --- | --- |

(f)

the date and results of the last inspection according to the monitoring requirements laid down in Article 13;

| (g) | the fact that the entry is based on newly developed scientific evidence and/or proprietary data protected in accordance with Article 15; |
| --- | --- |

(g)

the fact that the entry is based on newly developed scientific evidence and/or proprietary data protected in accordance with Article 15;

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

(h)

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

3.
     
  Post-marketing monitoring shall be required for all novel foods. All novel foods which have been allowed onto the market shall be reviewed after five years and whenever more scientific evidence becomes available. In the context of the monitoring, special attention should be paid to the categories of the population with the highest dietary intakes.

4.
     
  In the cases referred to in Article 2 (3) the common procedure shall be employed irrespective of the previous use or authorisation of the substance to which a standard production process was applied.

5.
     
  Where a novel food contains a substance which may pose a risk to human health in the event of excessive consumption, it shall require approval for use within maximum limits in certain foods or food categories.

6.
     
  All ingredients present in the form of nanomaterials shall be clearly indicated in the list of ingredients. The names of such ingredients shall be followed by the word ‘nano’ in brackets.

7.
     
  Products produced from animal fed with genetically modified feeding stuffs must be labelled with the words ‘produced from animal fed with genetically modified feeding stuffs’.

8.   
  The updating of the Community list shall be decided in accordance with the regulatory procedure with scrutiny referred to in Article 20(3).

║

9.   Before the expiry of the period referred to in Article 15, the Community list shall be updated to amend non-essential elements of this Regulation in accordance with the regulatory procedure with scrutiny referred to in Article 20(3) so that, provided that the authorised food still meets the conditions laid down in this Regulation, the specific indications referred to in point (g) of paragraph 2 of this Article, are no longer included.

10.
     
  For the purposes of updating the Community list through entry of a novel food, where the novel food does not consist of or contain food subject to data protection according to Article 15 and:

| (a) | the novel food is equivalent to existing foods, in composition, metabolism and level of undesirable substances, or |
| --- | --- |

(a)

the novel food is equivalent to existing foods, in composition, metabolism and level of undesirable substances, or

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

(b)

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

the notification procedure referred to in Article 10 of this Regulation shall apply mutatis mutandis, by way of derogation from Article 7 (3) of Regulation (EC) No 1331/2008.

Article 9

Labelling of novel foods and novel food ingredients

Without prejudice to the provisions and requirements of Directive 2000/13/EC, all specific data on novel foods shall be indicated and labelled to ensure proper consumer information:

| (a) | all new foods placed on the market shall be sold with clearly distinctive, precise and easily legible labelling indicating that they are novel foods; |
| --- | --- |

(a)

all new foods placed on the market shall be sold with clearly distinctive, precise and easily legible labelling indicating that they are novel foods;

| (b) | all the characteristics or properties of novel foods such as their composition, nutritional value and proper use, shall appear clearly, precisely and in an easily legible and comprehensible manner on their packaging; |
| --- | --- |

(b)

all the characteristics or properties of novel foods such as their composition, nutritional value and proper use, shall appear clearly, precisely and in an easily legible and comprehensible manner on their packaging;

| (c) | the presence of a novel food or novel ingredient replacing a material or ingredient in a food, whether or not the food is replaced by a novel food, must be stated clearly, precisely and in an easily legible and comprehensible manner on the labelling. |
| --- | --- |

(c)

the presence of a novel food or novel ingredient replacing a material or ingredient in a food, whether or not the food is replaced by a novel food, must be stated clearly, precisely and in an easily legible and comprehensible manner on the labelling.

Where a novel food contains a substance which may pose a high risk to human health in the event of excessive consumption, the consumer must be informed of this by means of clear, precise and easily legible labelling on the packaging of the food.

Article 10

Traditional food from a third country

1.   A food business operator intending to place a traditional food from a third country on the market in the Community shall notify it to the Commission, indicating the name of the food, its composition and country of origin.

The notification shall be accompanied by documented data demonstrating the history of safe food use in
  any
  third country.

2.   The Commission shall forward the notification including the demonstration of history of safe food use referred to in paragraph 1 without delay to the Member States and the Authority
  and make it publicly available on its website.

3.   Within four months from the date on which the notification provided for in paragraph 1 is forwarded by the Commission according to paragraph 2, a Member State and the Authority may inform the Commission that they have justified safety objections, based on scientific evidence, to the placing on the market of the traditional food concerned.

In that case, the food shall not be placed on the market in the Community and Articles 5 to 8 shall apply. The notification as referred to in paragraph 1 of this Article shall be considered as an application referred to in Article 3(1) of ║ Regulation (EC) No 1331/2008.
  Alternatively, the applicant may choose to withdraw the notification.

The Commission shall inform the food business operator concerned accordingly
  without undue delay and in a demonstrable manner
  within
  no more than
  five months from the date of the notification provided for in paragraph 1.

4.   If no justified safety objections, based on scientific evidence, have been raised and no information thereof has been communicated to the food business operator concerned in accordance with paragraph 3, the traditional food may be placed on the market in the Community after five months from the date of the notification in accordance with paragraph 1.

5.   The Commission shall publish a list of traditional foods from third countries that may be placed on the market in the Community in accordance with paragraph 4 on a dedicated page of the Commission’s website.
  This page shall be accessible from and linked to the page on the Community list of novel foods referred to in Article 5.

6.   
  Before ... (28),
  detailed rules for the implementation of this Article, designed to amend non-essential elements of this Regulation, inter alia by supplementing it,
  shall
  be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 20(3).

Article 11

Technical guidance

Without prejudice to the provisions of Article 9(1) (a) of Regulation (EC) No 1331/2008 and before ... (28),
  the Commission shall, where appropriate, in close cooperation with the Authority,
  the food business operators and small and medium-sized enterprises
  make available technical guidance and tools to assist food business operators and especially small and medium-sized enterprises in preparing and submitting applications under 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 (29) shall be available for use by applicants until replaced by revised technical guidance issued in accordance with this Article.

The technical guidance and tools shall be published, not later than ... (30), on a publicly accessible page intended for that purpose on the website of the Commission.

Article 12

Opinion of the Authority

In assessing the safety of novel foods, the Authority shall,
  on the basis of the requirements specified in Article 6:

| (a) | consider whether
  the
  new
  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; |
| --- | --- |

(a)

consider whether
  the
  new
  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. |
| --- | --- |

(b)

take into account for traditional food from a third country, the history of safe food use.

In the event of ethical objections, an opinion shall be sought, over and above the safety assessment, from the European Group on Ethics in Science and New Technologies (EGE).

Article 13

Obligations on the food business operators

1.   The Commission
  shall
  impose for food safety reasons and following the opinion of the Authority, a requirement for post-market monitoring.
  This monitoring shall take place five years after the date of inclusion of a novel food in the Community list and take into account food safety aspects as well as animal health and welfare aspects and the environmental impact. Special attention shall be paid to the categories of the population with the highest dietary intakes.

The monitoring requirements shall also apply to novel foods already on the market, including those approved under the simplified procedure (‘notification’) laid down in Article 5 of Regulation (EC) No 258/97.

Member States shall appoint competent authorities that will be responsible for the post-marketing monitoring.

2.   The producer
  and food business operator
  shall forthwith inform the Commission of:

| (a) | any new scientific or technical information which might influence the evaluation of the safety in use of the novel food; |
| --- | --- |

(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. |
| --- | --- |

(b)

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

All food business operators shall notify the Commission and the competent authorities of the Member State in which they operate of any health problem of which they have been informed by consumers or consumer protection organisations.

The Member State’s competent authority shall report to the Commission within three months of the completion of an inspection. The Commission shall submit a report to the European Parliament and the Council no later than a year after the expiry of the five-year period referred to in paragraph 1.

3.
     
  In order to avoid animal testing, testing on vertebrate animals for the purposes of this Regulation shall be undertaken only as a last resort. The use of non-animal tests and intelligent testing strategies shall be promoted.

Article 14

European Group on Ethics and new Technologies

Where appropriate, the Commission may, on its own initiative or at the request of a Member State, consult the European Group on Ethics and new Technologies on ethical questions relating to science and new technologies of major ethical importance.

The Commission shall make that opinion of the European Group on Ethics and new Technologies available to the public.

Chapter III

General provisions

Article 15

Data protection

1.
     At the request of the applicant, supported by appropriate and verifiable information included in the application dossier, newly developed scientific evidence and proprietary scientific data provided to support the applications may not be used for the benefit of another application for a period of five years from the date of the inclusion of the novel food in the Community list
  unless the subsequent applicant has agreed with the prior applicant that such data and information may be used, and where:

| (a) | the scientific data and other information has been designated as proprietary by the prior applicant at the time the prior application was made; and |
| --- | --- |

(a)

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

| (b) | the prior applicant had exclusive right of reference to the proprietary data at the time the prior application was made; and |
| --- | --- |

(b)

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

| (c) | the novel food could not have been authorised without the submission of the proprietary data by the prior applicant. |
| --- | --- |

(c)

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

2.
     
  Data from research projects partly or completely paid by the EC and/or public institutions and risk studies or data related to risk studies, like feeding studies, shall be published together with the application and shall be freely available for use by other applicants.

3.
     
  In order to avoid the repetition of studies involving vertebrates, reference by a subsequent applicant to studies on vertebrates and other studies that may prevent animal testing shall be allowed. The owner of the data may claim adequate compensation for the use of the data.

Article 16

Harmonised data protection

Notwithstanding the authorisation of a novel food pursuant to Articles 7 and 14 of Regulation (EC) No 1331/2008 or authorisation of a health claim pursuant to Articles 17, 18 and 25 of Regulation (EC) No 1924/2006, the data concerning the authorisation and the publication of the authorisation in the Official Journal shall be identical and the data protection periods shall run concurrently where authorisation is sought for a novel food and for a health claim relating to that food, and where data protection pursuant to the provisions of both Regulations is warranted and requested by the applicant.

Article 17

Inspection and control measures

In order to enforce compliance with this Regulation, official controls are to be carried out in accordance with Regulation (EC) No 882/2004.

Article 18

Penalties

The Member States shall lay down the rules on penalties applicable to infringements of the provision of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission
  within 12 months
  at the latest and shall, without delay, notify it of any subsequent amendment affecting them.

Article 19

Privileges of Member States

1.
     
  Where a Member State, as a result of new information or a reassessment of existing information, has detailed grounds for considering that the use of a food or a food ingredient complying with this Regulation endangers human health or the environment, that Member State may either temporarily restrict or suspend the trade in and use of the food or food ingredient in question in its territory. It shall immediately inform the other Member States and the Commission thereof, giving the grounds for its decision.

2.
     
  The Commission, in close cooperation with EFSA, shall examine the grounds referred to in paragraph 1 as soon as possible and shall take the appropriate measures. The Member State which took the decision referred to in paragraph 1 may maintain it until those measures have entered into force.

Article 20

Committee

1.   The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health, set up by Article 58 of Regulation (EC) No 178/2002 ║.

2.   Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply having regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3.   Where reference is made to this paragraph, Article 5a (1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

Article 21

Review

1.
     No later than ... (31) and in the light of experience gained, the Commission shall forward to the European Parliament and to the Council a report on the implementation of this Regulation and in particular of
  Articles 10 and 15
  , accompanied, where appropriate, by any proposals.

2.
     
  No later than ... (32) the Commission shall forward to the European Parliament and to the Council a report on all aspects of food produced from animals obtained by using a cloning technique and from their descendants followed, where appropriate, by any legislative proposals.

The report and any proposal shall be made accessible to the public.

Chapter IV

Transitional and final provisions

Article 22

Repeal

Regulation (EC) No 258/97 shall be repealed with effect from the date of application of this Regulation.

Article 23

Establishment of the Community list

By ... (33) at the latest, the Commission shall establish the Community list by entering
  in this list
  novel foods
  which are
  authorised under Regulation (EC) No 258/97
  and which fall within the scope of this Regulation pursuant to Articles 2 and 3 thereof
  , including any existing authorisation conditions, as appropriate.

Article 24

Transitional measures

║ Any request for placing a novel food on the market submitted to a Member State under Article 4 of 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 before ...
   (34) shall be considered as an application under this Regulation.
  Other requests submitted under Articles 3(4), 4 and 5 of Regulation (EC) No 258/97 before ... (34) shall be processed under the provisions of Regulation (EC) No 258/97.

▐

Article 25

Amendments to Regulation (EC) No 1331/2008

Regulation (EC) No 1331/2008 is amended as follows:

| (1) | The title is replaced by the following: |
| --- | --- |

(1)

The title is replaced by the following:

| (2) | In Article 1, paragraph 1, first sentence is replaced by the following:
  ‘1.   This Regulation lays down a common assessment and authorisation procedure (hereinafter referred to as 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 referred to as the “substances or products”), which contributes to the free movement of foods within the Community and to a high level of protection of human health and protection of consumers’ interests.’. |
| --- | --- |

(2)

In Article 1, paragraph 1, first sentence is replaced by the following:

‘1.   This Regulation lays down a common assessment and authorisation procedure (hereinafter referred to as 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 referred to as the “substances or products”), which contributes to the free movement of foods within the Community and to a high level of protection of human health and protection of consumers’ interests.’.

| (3) | In Article 1, paragraph 2 is replaced by the following:
  ‘2.   The common procedure shall set the procedural arrangements for updating the lists of substances and products the marketing of which is authorised in the Community pursuant to Regulation (EC) No 1333/2008, Regulation (EC) No 1332/2008, Regulation (EC) No 1334/2008 and Regulation (EC) No .../2009 of the European Parliament and of the Council of ... on novel foods (hereinafter referred to as the “sectoral food laws”).’ |
| --- | --- |

(3)

In Article 1, paragraph 2 is replaced by the following:

‘2.   The common procedure shall set the procedural arrangements for updating the lists of substances and products the marketing of which is authorised in the Community pursuant to Regulation (EC) No 1333/2008, Regulation (EC) No 1332/2008, Regulation (EC) No 1334/2008 and Regulation (EC) No .../2009 of the European Parliament and of the Council of ... on novel foods (hereinafter referred to as the “sectoral food laws”).’

| (4) | In Article 1 paragraph 3, Article 2 paragraphs 1 and 2, Article 9 paragraph 2, Article 12 paragraph 1 and Article 13 the word ‘substance’ or ‘substances’ is replaced by ‘substance or product’ or ‘substances or products’. |
| --- | --- |

(4)

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

| (5) | The title of Article 2 is replaced by the following:

  ‘Community list of substances or products’. |
| --- | --- |

(5)

The title of Article 2 is replaced by the following:

‘Community list of substances or products’.

| (6) | In Article 4 the following paragraph is added:
  ‘3.   A single application relating to a substance or product may be made to update the different Community 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)

In Article 4 the following paragraph is added:

‘3.   A single application relating to a substance or product may be made to update the different Community 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.’.

| (7) | The following sentence is inserted at the beginning of Article 6, paragraph 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 following sentence is inserted at the beginning of Article 6, paragraph 1:

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

Article 26

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from ... (35).

However, Article 23 shall apply from ... (36).

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at ║,

For the European Parliament

The President

For the Council

The President

---

(1)  
  OJ C 224, 30.8.2008, p. 81
  .

1

OJ C 224, 30.8.2008, p. 81

(2)  Position of the European Parliament of 25 March 2009.

2

Position of the European Parliament of 25 March 2009

(3)  

  OJ L 31, 1.2.2002, p. 1.

3

OJ L 31, 1.2.2002, p. 1.

(4)  
  Texts adopted, P6_TA(2008)0400.

4

Texts adopted, P6_TA(2008)0400.

(5)  OJ L 43, 14.2.1997, p. 1. ║

5

(6)  OJ L 253, 21.9.2001, p. 17.

6

(7)  

  OJ L 221, 8.8.1998, p. 23.

7

OJ L 221, 8.8.1998, p. 23.

(8)  
  The EFSA Journal (2008)767, p. 32.

8

The EFSA Journal (2008)767, p. 32.

(9)  
  OJ L 183, 12.7.2002, p. 51
  .

9

OJ L 183, 12.7.2002, p. 51

(10)  

  OJ L 311, 28.11.2001, p. 67.

10

OJ L 311, 28.11.2001, p. 67.

(11)  
  OJ L 354, 31.12.2008, p. 16
  .

11

OJ L 354, 31.12.2008, p. 16

(12)  
  OJ L 354, 31.12.2008, p. 34
  .

12

OJ L 354, 31.12.2008, p. 34

(13)  OJ L 157, 24.6.1988, p. 28. ║

13

(14)  
  OJ L 354, 31.12.2008, p. 7
  .

14

OJ L 354, 31.12.2008, p. 7

(15)  OJ L 268, 18.10.2003, p. 1. ║

15

(16)  OJ L 186, 30.6.1989, p. 27. ║

16

(17)  OJ L 404, 30.12.2006, p. 26.

17

(18)  
  OJ L 354, 31.12.2008, p. 1
  .

18

OJ L 354, 31.12.2008, p. 1

(19)  

  OJ L 358, 18.12.1986, p. 1.

19

OJ L 358, 18.12.1986, p. 1.

(20)  OJ L 109, 6.5.2000, p. 29. ║

20

(21)  OJ L 404, 30.12.2006, p. 9.

21

(22)  OJ L 184, 17.7.1999, p. 23. ║

22

(23)  OJ L 165, 30.4.2004, p. 1. ║

23

(24)  
  Six months after the date of publication of this Regulation.

24

Six months after the date of publication of this Regulation.

(25)  

  OJ L 136, 30.4.2004, p. 1.

25

OJ L 136, 30.4.2004, p. 1.

(26)  
  Six months after the date of publication of this Regulation.

26

Six months after the date of publication of this Regulation.

(27)  
  Six months after the date of entry into force of this Regulation.

27

Six months after the date of entry into force of this Regulation.

(28)  
  Six months after the date of publication of this Regulation.

28

Six months after the date of publication of this Regulation.

(29)  

  OJ L 253, 16.9.1997, p. 1.

29

OJ L 253, 16.9.1997, p. 1.

(30)  
  Six months after the date of entry into force of this Regulation.

30

Six months after the date of entry into force of this Regulation.

(31)  
  Three years and six months after the date of publication of this Regulation.

31

Three years and six months after the date of publication of this Regulation.

(32)  
  One year after the date of entry into force of this Regulation.

32

One year after the date of entry into force of this Regulation.

(33)  Six months from the date of entry into force of this Regulation.

33

Six months from the date of entry into force of this Regulation.

(34)  Six months after the date of publication of this Regulation.

34

Six months after the date of publication of this Regulation.

(35)  Six months after the date of publication of this Regulation.

35

Six months after the date of publication of this Regulation.

(36)  The date of entry into force of this Regulation.

36

The date of entry into force of this Regulation.

---