RECOMMENDATION FOR SECOND READING on the Council position at first reading for adopting a regulation of the European Parliament and of the Council on novel foods, amending Regulation (EC) No 1331/2008 and repealing Regulation (EC) No 258/97 and Commission Regulation (EC) No 1852/2001

10.5.2010 - (11261/3/2009 – C7-0078/2010 – 2008/0002(COD)) - ***II

Committee on the Environment, Public Health and Food Safety
Rapporteur: Kartika Tamara Liotard

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

on the Council position at first reading for adopting a regulation of the European Parliament and of the Council on novel foods, amending Regulation (EC) No 1331/2008 and repealing Regulation (EC) No 258/97 and Commission Regulation (EC) No 1852/2001

(11261/3/2009 – C7‑0078/2010 – 2008/0002(COD))

(Ordinary legislative procedure: second reading)

The European Parliament,

–   having regard to the Council position at first reading (11261/3/2009 – C7‑0078/2010),

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

–   having regard to Article 251(2) and Article 95(1) of the EC Treaty, pusuant to which the Cimmission submitted the proposal to Parliament (C6-0027/2008),

–   having regard to its position at first reading[1],

–   having regard to the Communication from the Commission to the European Parliament and the Council entitled 'Consequences of the entry into force of the Treaty of Lisbon for ongoing interinstitutional decision-making procedures' (COM(2009)0665)

–   having regard to Article 294(7) and Article 114(1) of the Treaty on the Functioning of the European Union,

-    having regard to the opinion of the European Economic and Social Committee of 29 May 2008[2],

–   having regard to Rule 66 of its Rules of Procedure,

–   having regard to the recommendation for second reading of the Committee on the Environment, Public Health and Food Safety (A7‑0152/2010),

1.  Adopts the position at second reading hereinafter set out;

2.  Instructs its President to forward its position to the Council, to the Commission and to the national parliaments.

Amendment  1 Council position – amending act Recital 1
Council position	Amendment
(1) The free movement of safe and wholesome food is an essential aspect of the internal market and contributes significantly to the health and well-being of citizens, as well as to their social and economic interests. Differences between national laws, regulations and administrative provisions concerning the safety assessment and authorisation of novel foods may hinder their free movement, thereby creating unfair competition conditions.	(1) In implementing Union policy and having regard to the Treaty on the Functioning of the European Union, 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 safety1, should be applied.
	1 OJ L 31, 1.2.2002, p. 1.
Justification
EP first reading amendment 1.
Amendment  2 Council position – amending act Recital 2
Council position	Amendment
(2) A high level of protection of human health should be assured in the pursuit of Union policies. Due attention should be given, where appropriate, to the protection of the environment and to animal welfare.	(2) A high level of human health protection should be assured in the pursuit of Union policies and should be given priority over the functioning of the internal market.
Justification
EP first reading amendment 2.
Amendment  3 Council position – amending act Recital 2 a (new)
Council position	Amendment
	(2a) 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.
Justification
EP first reading amendment 3.
Amendment  4 Council position – amending act Recital 2 b (new)
Council position	Amendment
	(2b) The standards defined in Union legislation must be applied to all foods placed on the market within the Union, including foods imported from third countries.
Justification
EP first reading amendment 4.
Amendment  5 Council position – amending act Recital 2 c (new)
Council position	Amendment
	(2c) The European Parliament called on the Commission, in its resolution of 3 September 2008 on the cloning of animals for food supply1, 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.
	1 OJ C 295 E, 4.12.2009, p. 42.
Justification
EP first reading amendment 5.
Amendment  6 Council position – amending act Recital 2 d (new)
Council position	Amendment
	(2d) 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’.
Justification
EP first reading amendment 6.
Amendment  7 Council position – amending act Recital 3
Council position	Amendment
(3) The Union's rules on novel foods were established by Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients 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 . For the sake of clarity, Regulation (EC) No 258/97 and Regulation (EC) No 1852/2001 should be repealed and Regulation (EC) No 258/97 should be replaced by this Regulation. Commission Recommendation 97/618/EC of 29 July 1997 concerning the scientific aspects and the presentation of information necessary to support applications for the placing on the market of novel foods and novel food ingredients and the preparation of initial assessment reports under Regulation (EC) No 258/97 of the European Parliament and of the Council should therefore become obsolete as regards novel foods.	(3) The Union's rules on novel foods were established by Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients1 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 258/972. For the sake of clarity, Regulation (EC) No 258/97 should be repealed and replaced by this Regulation. This Regulation should include measures currently governed by Regulation (EC) No 1852/2001 and that Regulation should be repealed.
Justification
Recital 3 from the Commission document.
Amendment  8 Council position – amending act Recital 5
Council position	Amendment
(5) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety applies. The existing definition of novel food should be clarified and updated by replacing the existing categories with a reference to the general definition of food in that Regulation.	(5) 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.
Justification
EP first reading amendment 8.
Amendment  9 Council position – amending act Recital 5 a (new)
Council position	Amendment
	(5a) Foods with a new or intentionally modified primary molecular structure, foods consisting of, or isolated from, micro-organisms, fungi or algae, new strains of micro-organism with no history of safe use and concentrates of substances that naturally occur in plants should be considered as novel foods as defined in this Regulation.
Justification
EP first reading amendment 9.
Amendment  10 Council position – amending act Recital 6
Council position	Amendment
(6) It should also be clarified that a food is to be considered as novel when a production technology which was not previously used for food production in the Union is applied to that food. In particular, emerging technologies in breeding and food production processes which have an impact on food, and thus might have an impact on food safety, should be covered by this Regulation. Novel food should therefore include foods derived from animals produced by non-traditional breeding techniques and from their offspring, foods derived from plants produced by non-traditional breeding techniques, foods produced by new production processes which might have an impact on food, and foods containing or consisting of engineered nanomaterials. Foods derived from new plant varieties or animal breeds produced by traditional breeding techniques should not be considered as novel foods. Furthermore, it should be clarified that foods from third countries which are novel in the Union can be considered as traditional only when they are derived from primary production as defined in Regulation (EC) No 178/2002, whether they are processed or unprocessed (e.g. fruit, jam, fruit juice). However, foods thus obtained should neither include foods produced from animals or plants to which a non-traditional breeding technique was applied or foods produced from the offspring of such animals, nor foods to which a new production process is applied.	(6) It should also be clarified that a food should be considered as novel when a production technology which was not previously used for the production of foods to be marketed and consumed is applied to that food. In particular, emerging technologies in breeding and food production processes, which have an impact on food and thus might have an impact on food safety, should be covered by this Regulation. Novel food should therefore include foods derived from plants and animals, produced by non-traditional breeding techniques, and foods modified by new production processes, such as nanotechnology and nanoscience, which might have an impact on food. Foods derived from new plant varieties, or animal breeds produced by traditional breeding techniques, should not be considered as novel foods.
Justification
Recital 6 from the Commission document.
Amendment  11 Council position – amending act Recital 6 a (new)
Council position	Amendment
	(6a) The cloning of animals is incompatible with Council Directive 98/58/EC of 20 July 1998 concerning the protection of animals kept for farming purposes1, point 20 of the Annex of which states that natural or artificial breeding procedures which cause, or are likely to cause, suffering or injury to any of the animals concerned must not be practised. Food from cloned animals or their descendants must therefore not be placed on the Union list.
	1 OJ L 221, 8.8.1998, p. 23.
Justification
EP first reading amendment 11.
Amendment  12 Council position – amending act Recital 7
Council position	Amendment
(7) However, in the light of the opinion of the European Group on Ethics in Science and New Technologies, established by Commission Decision of 16 December 1997, issued on 16 January 2008 and of the opinion of the European Food Safety Authority adopted on 15 July 2008, techniques for the cloning of animals, such as somatic cell nuclear transfer, have specific characteristics such that this Regulation cannot address all the issues of cloning. Therefore, food produced from animals obtained by using a cloning technique and from the offspring thereof should be subject to a report submitted by the Commission to the European Parliament and the Council, followed, if appropriate, by a legislative proposal. If specific legislation is adopted, the scope of this Regulation should be adapted accordingly.	(7) The European Group on Ethics in Science and New Technologies, stablished by Commission Decision of 16 December 1997, stated in its Opinion (No. 23) of 16 January 2008 on ethical aspects of animal cloning for food supply that it ‘does not see convincing arguments to justify the production of food from clones and their offspring’. The Scientific Committee of the European Food Safety Authority (EFSA) concluded in its Opinion of 15 July 2008 on animal cloning1 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’.
	1 The EFSA Journal (2008)767, p.32.
Justification
EP first reading amendment 12.
Amendment  13 Council position – amending act Recital 7 a (new)
Council position	Amendment
	(7a) 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.
Justification
EP first reading amendment 13.
Amendment  14 Council position – amending act Recital 7 b (new)
Council position	Amendment
	(7b) Foods derived from cloned animals and their descendants should, however, be excluded from the scope of this Regulation. They should be dealt with in a specific regulation, adopted under the ordinary legislative procedure, and 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.
Justification
EP first reading amendment 14.
Amendment  15 Council position – amending act Recital 8
Council position	Amendment
(8) Implementing measures should be adopted to provide for criteria to facilitate the assessment of whether a food was used for human consumption to a significant degree within the Union before 15 May 1997. If, prior to that date, a food was used exclusively as, or in, a food supplement, as defined in Directive 2002/46/EC , it should be allowed to be placed on the market within the Union after that date for the same use without being considered a novel food. However, that use as, or in, a food supplement should not be taken into account for the assessment of whether the food was used for human consumption to a significant degree within the Union before 15 May 1997. Therefore, uses of the food concerned other than in, or as, a food supplement should be authorised in accordance with this Regulation.	(8) Implementing measures should be adopted to provide for further criteria in order to facilitate the assessment of whether a food was used for human consumption to a significant degree within the Union before 15 May 1997. If a food was used exclusively as, or in, a food supplement, as defined in Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements1, prior to that date, it can be placed on the market after that date for the same use without being considered as a novel food. However, that use as, or in, a food supplement should not be taken into account for the assessment of whether it was used for human consumption to a significant degree within the Union before 15 May 1997. Therefore, other uses of the food concerned, namely other than food supplement uses, have to be authorised in accordance with this Regulation.
	1 OJ L 183, 12.7.2002, p. 51.
Justification
EP first reading amendment 15.
Amendment  16 Council position – amending act Recital 9
Council position	Amendment
(9) The use of engineered nanomaterials in food production might increase with the further development of technology. In order to ensure a high level of protection of human health, free movement of goods and legal certainty for manufacturers, it is necessary to develop a uniform definition for engineered nanomaterial at international level. The Union should endeavour to reach an agreement on a definition in appropriate international fora. Should such an agreement be reached, the definition of engineered nanomaterial in this Regulation should be adapted accordingly	(9) The use of engineered nanomaterials in food production might increase with the further development of technology. In order to ensure a high level of protection of human health, it is necessary to develop a uniform definition for engineered nanomaterials.
Amendment  17 Council position – amending act Recital 10
Council position	Amendment
(10) Food products produced from food ingredients that do not fall within the scope of this Regulation, in particular by changing the ingredients of the food, their composition or amount, should not be considered as novel food. However, modifications of a food ingredient, e.g. selective extracts or the use of other parts of a plant, that have so far not been used for human consumption within the Union, should still fall within the scope of this Regulation.	(10) Reformulated food products produced from existing food ingredients available on the market within the Union, in particular those reformulated by changing the composition or amounts of those food ingredients, should not be considered as novel food.
Justification
Recital 8 from Commission document.
Amendment  18 Council position – amending act Recital 13
Council position	Amendment
(13) Foods which are intended for technological uses or which are genetically modified should not fall within the scope of this Regulation. Therefore, genetically modified food falling within the scope of Regulation (EC) No 1829/2003 , food used solely as additives falling within the scope of Regulation (EC) No 1333/2008, flavourings falling within the scope of Regulation (EC) No 1334/2008, enzymes falling within the scope of Regulation (EC) No 1332/2008 and extraction solvents falling within the scope of Directive 2009/32/EC should not be covered by this Regulation.	(13) 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 Union 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 additives1, 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 foods2, extraction solvents falling within the scope of Directive 2009/32/EC of the European Parliament and of the Council of 23 April 2009 on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients (recast)3, 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 enzymes4 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 feed5 should be excluded from the scope of this Regulation.
	1 OJ L 354, 31.12.2008, p. 16.
	2 OJ L 354, 31.12.2008, p. 34.
	3 OJ L 141, 6.6.2009, p. 3.
	4 OJ L 354, 31.12.2008, p. 7.
	5 OJ L 268, 18.10.2003, p. 1.
Justification
EP first reading amendment 17.
Amendment  19 Council position – amending act Recital 15
Council position	Amendment
(15) Novel foods, other than vitamins and minerals, intended for particular nutritional uses, for food fortification or as food supplements, should be assessed in conformity with this Regulation. They should also remain subject to the rules provided for in Directive 2002/46/EC, in Regulation (EC) No 1925/2006, in Directive 2009/39/EC, and in the specific Directives referred to in Directive 2009/39/EC and in Annex I thereto.	(15) Novel foods, other than vitamins and minerals, intended for particular nutritional uses, for food fortification or as food supplements, should be assessed in conformity with 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 2009/39/EC and in the specific Directives referred to in Article 4(1) thereof and Annex I thereto, in Directive 2002/46/EC and in Regulation (EC) No 1925/2006.
Justification
Recital 12 from the Commission document..
Amendment  20 Council position – amending act Recital 16
Council position	Amendment
(16) The determination of whether a food was used for human consumption to a significant degree within the Union before 15 May 1997, should be based on information submitted by food business operators and, where appropriate, supported by other information available in the Member States. When there is no or insufficient information available on human consumption before 15 May 1997, a simple and transparent procedure, involving the Commission, the Member States and any parties concerned, should be established for collecting that information.	(16) 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
Justification
EP first reading amendment 18.
Amendment  21 Council position – amending act Recital 17
Council position	Amendment
(17) Novel foods should be placed on the market within the Union only if they are safe and do not mislead the consumer. In addition, where the novel food is intended to replace another food, it should not differ from that food in a way that would be nutritionally disadvantageous for the consumer.	(17) Novel foods should be placed on the market within the Union only if they are safe and do not mislead the consumer. The assessment of their safety should be based on the precautionary principle as laid down in Article 7 of Regulation (EC) No 178/2002. In addition, they should not differ from the food that they are to replace in any way that would be nutritionally disadvantageous for the consumer.
Justification
EP first reading amendment 19.
Amendment  22 Council position – amending act Recital 19 a (new)
Council position	Amendment
	(19a) Ethical and environmental aspects must be considered as part of the risk management 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.
Justification
This amendment re-establishes partially the EP first reading amendment 23.
Amendment  23 Council position – amending act Recital 20
Council position	Amendment
(20) At present, there is inadequate information on the risks associated with engineered nanomaterials. In order to better assess their safety the Commission, in cooperation with the Authority, should develop test methodologies which take into account specific characteristics of engineered nanomaterials.	(20) 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.
Amendment  24 Council position – amending act Recital 22
Council position	Amendment
(22) If traditional foods from third countries are included in the list of traditional foods from third countries, they should be allowed to be placed on the market within the Union, under conditions that correspond to those for which the history of safe food use has been demonstrated. As regards the safety assessment and management of traditional food from third countries, their history of safe food use in their country of origin should be taken into account. The history of safe food use should not include non-food uses or uses not related to normal diets.	(22) As regards the safety assessment and management of traditional food from third countries, the EU rules in force 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 market within the Union after notification of the intention to do so, provided that there are no ethical objections.
Justification
EP first reading amendment 28.
Amendment  25 Council position – amending act Recital 24
Council position	Amendment
(24) The inclusion of a novel food in the Union list of novel foods or in the list of traditional foods from third countries should be without prejudice to the possibility of evaluating the effects of the overall consumption of a substance which is added to, or used for the manufacture of that food, or of a comparable product in accordance with Regulation (EC) No 1925/2006.	(24) The inclusion of a novel food in the Union list of novel foods should be without prejudice to the possibility of evaluating the effects of the overall consumption of a substance which is added to, or used for the manufacture of that food, or of a comparable product in accordance with Article 8 of Regulation (EC) No 1925/2006.
Justification
Recital 19 from the Commission document.
Amendment  26 Council position – amending act Recital 25
Council position	Amendment
(25) Under specific circumstances, in order to stimulate research and development within the agri-food industry, and thus innovation, the newly developed scientific evidence and proprietary data provided in support of an application for inclusion of a novel food in the Union list should be protected. That data and information should not be used to the benefit of a subsequent applicant, during a limited period of time, without the agreement of the prior applicant. The protection of scientific data provided by one applicant should not prevent other applicants from seeking the inclusion in the Union list of novel foods on the basis of their own scientific data.	(25) 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 Union list should not be used to the benefit of another applicant during a limited period of time, without the agreement of the first applicant. The protection of scientific data provided by one applicant should not prevent other applicants from seeking the inclusion in the Union list of novel foods on the basis of their own scientific data. In addition, the protection of scientific data should not prevent transparency and access to information relating to the data used in the safety assessment of novel foods. Intellectual property rights should, nevertheless, be respected.
Justification
EP first reading amendment 25.
Amendment  27 Council position – amending act Recital 26
Council position	Amendment
(26) Novel foods are subject to the general labelling requirements laid down in Directive 2000/13/EC and, where necessary, to the nutritional labelling requirements laid down in Directive 90/496/EEC . In certain cases it might be necessary to provide for additional labelling information, in particular regarding the description of the food, its source or its conditions of use. Therefore, when a novel food is included in the Union list or in the list of traditional foods from third countries, specific conditions of use or labelling obligations may be imposed, which might, inter alia, relate to any specific characteristic or food property, such as composition, nutritional value or nutritional effects and intended use of the food, or to ethical considerations or implications for the health of specific groups of the population.	(26) 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 foodstuffs1. In certain cases it might be necessary to provide for additional labelling information, in particular regarding the description of the food, its source, or its conditions of use. Therefore, the inclusion of a novel food in the Union list may be subject to specific conditions of use or labelling obligations.
	1 OJ L 109, 6.5.2000, p. 29.
Justification
Recital 21 from the Commission document.
Amendment  28 Council position – amending act Recital 27
Council position	Amendment
(27) Regulation (EC) No 1924/2006 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.	(27) Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods2 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.
	2 OJ L 404, 30.12.2006, p. 9.
Justification
EP first reading amendment 27.
Amendment  29 Council position – amending act Recital 28
Council position	Amendment
(28) The European Group on Ethics in Science and New Technologies may be consulted, where appropriate, with a view to obtaining advice on ethical issues regarding the placing on the market within the Union of novel foods.	(28) The European Group on Ethics in Science and New Technologies (EGE) should be consulted in specific cases with a view to obtaining advice on ethical issues regarding the use of new technologies and the placing on the market of novel foods.
Justification
EP first reading amendment 29.
Amendment  30 Council position – amending act Recital 29
Council position	Amendment
(29) Novel foods placed on the market within the Union under Regulation (EC) No 258/97 should continue to be placed on the market. Novel foods authorised in accordance with Regulation (EC) No 258/97 should be included in the Union list of novel foods established by this Regulation. In addition, applications submitted under Regulation (EC) No 258/97 before the date of application of this Regulation should be transformed into an application under this Regulation where the initial assessment report provided for under Regulation (EC) No 258/97 has not yet been forwarded to the Commission, as well as in all cases where an additional assessment report is required in accordance with that Regulation. Other pending requests submitted under Article 4 of Regulation (EC) No 258/97 before the date of application of this Regulation should be processed under the provisions of Regulation (EC) No 258/97.	(29) Novel foods placed on the market within the Union under Regulation (EC) No 258/97 should continue to be placed on the market. Novel foods authorised in accordance with Regulation (EC) No 258/97 should be included in the Union list of novel foods established by this Regulation. In addition, applications submitted under Regulation (EC) No 258/97, 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.
Justification
EP first reading amendment 89.
Amendment  31 Council position – amending act Recital 30
Council position	Amendment
(30) Regulation (EC) No 882/2004 lays down general rules for the performance of official controls to verify compliance with food law. The Member States should be requested to carry out official controls in accordance with that Regulation, in order to enforce compliance with this Regulation.	(30) 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 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.
Justification
Recital 30 from the Commission document.
Amendment  32 Council position – amending act Recital 34
Council position	Amendment
(34) The measures necessary for the implementation of this Regulation should be adopted in accordance with Articles 5 and 7 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission1.	deleted
OJ L 184, 17.7.1999, p. 23.
Amendment  33 Council position – amending act Recital 35
Council position	Amendment
(35) In particular, the Commission should be empowered to clarify certain definitions in order to ensure a harmonised implementation of these provisions by the Member States on the basis of relevant criteria, including the definition of "engineered nanomaterial", taking into account the technical and scientific developments, and the non-traditional animal breeding technique that includes techniques used for asexual reproduction of genetically identical animals not used for food production within the Union before 15 May 1997. Furthermore, the Commission should be empowered to adopt any appropriate transitional measures and to update the list of traditional foods from third countries and the Union list.	deleted
Amendment  34 Council position – amending act Recital 36
Council position	Amendment
(36) In addition, the Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union in respect of the criteria according to which foods may be considered as having been used for human consumption to a significant degree within the Union before 15 May 1997. It is of particular importance that the Commission consult experts in the preparatory phase in accordance with the commitment of the Commission undertaken in the Communication of 9 December 2009 on the implementation of Article 290 of the Treaty on the Functioning of the European Union.	(36) The Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union in respect of the criteria according to which foods may be considered as having been used for human consumption to a significant degree within the Union before 15 May 1997, in respect of the determination of whether a type of food falls within the scope of this Regulation, the adjustment and adaptation of the definition of "engineered nanomaterial" to technical and scientific progress and in line with definitions subsequently agreed at international level, rules on how to proceed in cases in which the Commission has no information about use of a food for human consumption before 15 May 1997, as well as in respect of rules for the application of Article 4(1) and Article 11 and the update of the Union list. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level.
Amendment  35 Council position – amending act Article 1
Council position	Amendment
This Regulation lays down harmonised rules for the placing of novel foods on the market within the Union with a view to ensuring a high level of protection of human health and consumers' interests, whilst ensuring the effective functioning of the internal market, taking into account, where appropriate, the protection of the environment and animal welfare.	This Regulation lays down harmonised rules for the placing of novel foods on the market within the Union 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.
Justification
EP first reading amendment 30.
Amendment  36 Council position – amending act Article 2 - paragraph 2
Council position	Amendment
2. This Regulation shall not apply to:	2. This Regulation shall, unless otherwise provided for, not apply to:
(a) foods when and in so far as they are used as:	(a) foods when and insofar as they are used as:
(i) food additives falling within the scope of Regulation (EC) No 1333/2008;	(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 2009/32/EC;	(iii) extraction solvents used in the production of foodstuffs and falling within the scope of Directive 2009/32/EC ;
(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 respective scope of Directive 2002/46/EC, Regulation (EC) No 1925/2006 or Directive 2009/39/EC, except for vitamin and mineral substances already authorised, which are obtained by production methods or using new sources that were not taken into account when they were authorised under specific legislation, where those production methods or new sources give rise to the significant changes referred to in point (iii) of Article 3(2)(a) of this Regulation.	(v) vitamins and minerals falling within the scope of Directive 2002/46/EC, Regulation (EC) No 1925/2006 or Directive 2009/32/EC, 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;
Justification
EP first reading amendment 91.
Amendment  37 Council position – amending act Article 2 - paragraph 2 - point b a (new)
Council position	Amendment
	(ba) foods derived from cloned animals and their descendants. Before ...*, 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.
	* Six months after the date of entry itfo force of this Regulation.
Justification
EP first reading amendment 91.
Amendment  38 Council position – amending act Article 2 - paragraph 2 a (new)
Council position	Amendment
	(2a) 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.
Justification
EP first reading amendment 91.
Amendment  39 Council position – amending act Article 2 – paragraph 2 b (new)
Council position	Amendment
	(2b) Where necessary and taking into account the scope defined in this Article, the Commission may determine, by means of delegated acts in accordance with Article 21 and subject to the conditions of Articles 22 and 23, 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 may 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 of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency1, and therefore not under this Regulation.
	1 OJ L 136, 30.4.2004, p. 1.
Justification
EP first reading amendment 91.
Amendment  40 Council position – amending act Article 3 - paragraph 2 - point a - introductory part and point i
Council position	Amendment
(a) "novel food" means food that was not used for human consumption to a significant degree within the Union before 15 May 1997, including:	(a) "novel food" means:
(i) food of animal origin, when a non‑traditional breeding technique not used for food production within the Community before 15 May 1997 is applied to the animal and food derived from the offspring of these animals;	(i) food that was not used for human consumption to a significant degree within the Union before 15 May 1997;
Justification
EP first reading amendments 92 and 35.
Amendment  41 Council position – amending act Article 3 - paragraph 2 - point a - point ii
Council position	Amendment
(ii) food of plant origin, when a non-traditional breeding technique not used for food production within the Union before 15 May 1997 is applied to the plant, if that non-traditional breeding technique applied to a plant gives rise to significant changes in the composition or structure of the food, which affect its nutritional value, how it is metabolised or the level of undesirable substances;	(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;
Justification
EP first reading amendments 92 and 35.
Amendment  42 Council position – amending act Article 3 - paragraph 2 - point a - point v
Council position	Amendment
(v) traditional food from a third country; and	deleted
Amendment  43 Council position – amending act Article 3 - paragraph 2 - point a - point vi
Council position	Amendment
(vi) food ingredients used exclusively in food supplements within the Union before 15 May 1997, if they are to be used in foods other than food supplements. However, if a food has been used exclusively as, or in, a food supplement prior that date, it may be placed on the market within the Union after that date for the same use without being considered a novel food;	deleted
Amendment  44 Council position – amending act Article 3 - paragraph 2 - point b
Council position	Amendment
(b) "offspring" means an animal produced by a traditional breeding technique, where at least one of its parents is an animal produced by a non-traditional breeding technique;	deleted
Amendment  45 Council position – amending act Article 3 - paragraph 2 - point c a (new)
Council position	Amendment
	(ca) "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;
Justification
EP first reading amendments 92 and 35.
Amendment  46 Council position – amending act Article 3 - paragraph 2 - point c b (new)
Council position	Amendment
	(cb) "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;
Justification
EP first reading amendments 92 and 35.
Amendment  47 Council position – amending act Article 3 - paragraph 2 - point d
Council position	Amendment
(d) "traditional food from a third country" means novel food, other than the novel food under sub-points (i) to (iv) of point (a), derived from primary production, with a history of food use in any third country, such that the food in question has been and continues to be part of the customary diet for at least 25 years in a large part of the population of the country;	(d) "traditional food from a third country" means a natural non-engineered novel food with a history of food use in a third country, meaning that the food in question was, for at least 25 years before ...* , and continues to be, part of the normal diet in a large part of the population of the country;
	* Six months after the date of entry into force of this Regulation.
Justification
EP first reading amendments 92 and 35.
Amendment  48 Council position – amending act Article 3 - paragraph 2 - point e
Council position	Amendment
(e) "history of safe food use in a third country" means that the safety of the food in question is confirmed with compositional data and from experience of use and continued use for at least 25 years in the customary diet of a large part of the population of a country.	(e) ''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;
Justification
EP first reading amendments 92 and 35.
Amendment  49 Council position – amending act Article 3 – paragraph 3
Council position	Amendment
3. The Commission may adopt further criteria to clarify the definitions in sub-points (i) to (iv) of point (a), and in points (c), (d) and (e) of paragraph 2 of this Article in accordance with the regulatory procedure referred to in Article 19(2).	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 (c) of paragraph 2 of this Article to technical and scientific progress, and in line with definitions subsequently agreed at international level, by means of delegated acts in accordance with Article 21 and subject to the conditions of Articles 22 and 23.
Justification
EP first reading amendment 92 and 35.
Amendment  50 Council position – amending act Article 4 - title
Council position	Amendment
Procedure for determination of novel food status	Collection of information regarding the classification of a novel food
Justification
EP first reading amendment 40.
Amendment  51 Council position – amending act Article 4 - paragraph 1
Council position	Amendment
1. Food business operators shall verify the status of the food they intend to place on the market within the Union with respect to the scope of this Regulation.	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 was used for human consumption within the Union before 15 May 1997.
Justification
EP first reading amendment 40.
Amendment  52 Council position – amending act Article 4 - paragraph 2
Council position	Amendment
2. In case of doubt, food business operators shall consult the relevant competent authority for novel foods as defined in Article 15 of Regulation (EC) No 1331/2008 on the status of the food in question. On request from the relevant competent authority, food business operators shall submit information concerning the extent to which the food in question was used for human consumption within the Union 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.
Justification
EP first reading amendment 40.
Amendment  53 Council position – amending act Article 4 – paragraph 3
Council position	Amendment
3. Where necessary, the competent authority may consult other competent authorities and the Commission concerning the extent to which a food was used for human consumption within the Union before 15 May 1997. Replies to any such consultation shall also be transmitted to the Commission. The Commission shall summarise the replies received and communicate the result of the consultation to all competent authorities.	3. In order to ensure the completeness of information regarding the classification of novel foods, the Commission shall, not later than...*, adopt rules on how to proceed in cases in which the Commission has no information about the use of a food for human consumption before 15 May 1997 by means of delegated acts in accordance with Article 21 and subject to the conditions of Articles 22 and 23.
	* Six months after the date of entry into force of this regulation.
Justification
EP first reading amendment 40.
Amendment  54 Council position – amending act Article 4 – paragraph 4
Council position	Amendment
4. The Commission may adopt implementing measures for paragraph 3 of this Article in accordance with the regulatory procedure referred to in Article 19(2).	4. The Commission may adopt detailed rules on the application of paragraph 1, in particular as regards the type of information to be collected from Member States and/or from food business operators, by means of delegated acts in accordance with Article 21 and subject to conditions of Articles 22 and 23.
Justification
Article 4(2) from the Commission document.
Amendment  55 Council position – amending act Article 5
Council position	Amendment
Article 5	deleted
Interpretation decisions
Where necessary, it may be decided in accordance with the regulatory procedure referred to in Article 19(2) whether a type of food falls within the scope of this Regulation.
Amendment  56 Council position – amending act Article 5 a (new)
Council position	Amendment
	Article 5a
	Union list of novel foods
	Only novel foods included in the Union list of novel foods (''the Union list'') may be placed on the market. The Commission shall keep and publish the Union list on a publicly accessible page intended for that purpose on the website of the Commission.
Justification
EP first reading amendment 41.
Amendment  57 Council position – amending act Article 6
Council position	Amendment
No person shall place on the Union market a novel food if it does not comply with this Regulation.	Novel foods shall not be placed on the market if they do not comply with the provisions of this Regulation.
Justification
EP first reading amendment 42.
Amendment  58 Council position – amending act Article 7
Council position	Amendment
Article 7
Lists of novel foods
1. The Commission shall maintain a Union list of authorised novel foods other than traditional foods from third countries (hereinafter "the Union list"), which will be published in accordance with Article 2(1) of Regulation (EC) No 1331/2008.	deleted
2. The Commission shall establish and maintain a list of traditional foods from third countries authorised pursuant to Article 11(5) of this Regulation, which shall be published in the C series of the Official Journal of the European Union.
3. Only novel foods included in the Union list or in the list of traditional foods from third countries may be placed on the market within the Union.
Amendment  59 Council position – amending act Article 8 - point a
Council position	Amendment
(a) it does not, on the basis of the scientific evidence available, pose a safety concern to the health of the consumer;	(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;
Justification
EP first reading amendment 43.
Amendment  60 Council position – amending act Article 8 - point c
Council position	Amendment
(c) if it is intended to replace another food, it does not differ from that food in such a way that its normal consumption would be nutritionally disadvantageous for the consumer.	(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.
Justification
EP first reading amendment 45.
Amendment  61 Council position – amending act Article 8 – point c a (new)
Council position	Amendment
	(ca) the opinion of the European Environment Agency, which shall be published no later than the day of the publication of the EFSA assessment, concerning the extent to which the production process and normal consumption have a harmful impact on the environment, is taken into account in the risk management;
Justification
This amendment re-establishes partially the EP first reading amendment 47.
Amendment  62 Council position – amending act Article 8 – point c b (new)
Council position	Amendment
	(cb) the opinion of the European Group on Ethics in Science and New Technologies, which shall be published no later than the day of the publication of the EFSA assessment, concerning the extent to which there are ethical objections, is taken into account in the risk management;
Justification
This amendment re-establishes partially the EP first reading amendment 48.
Amendment  63 Council position – amending act Article 8 - point c c (new)
Council position	Amendment
	(cc) 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;
Justification
EP first reading amendment 49.
Amendment  64 Council position – amending act Article 8 – point c d (new)
Council position	Amendment
	(cd) it is not derived from a cloned animal or its descendants.
Justification
Parliament's 1st reading report specifically endorsed future legislation to prohibit these foods being placed on the EU market. This amendment would ensure that these foods are not placed on the market before such legislation is presented.
Amendment  65 Council position – amending act Article 8 - point c e (new)
Council position	Amendment
	(ce) 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;
Justification
EP first reading amendment 49.
Amendment  66 Council position – amending act Article 8 - point c f (new)
Council position	Amendment
	(cf) cumulative effects of novel foods that are used in different foodstuffs or categories of foodstuffs have been assessed.
Justification
EP first reading amendment 49.
Amendment  67 Council position – amending act Article 8 - paragraph 1a (new)
Council position	Amendment
	1a. Foods to which production processes have been applied that require specific risk assessment methods (for example, foods produced using nanotechnologies) may not be included in the Union 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.
Justification
EP first reading amendment 50.
Amendment  68 Council position – amending act Article 8 - paragraph 1 b (new)
Council position	Amendment
	1b. A novel food may be included in the Union list only if the competent authority has submitted an opinion establishing that the food is not harmful to health.
Justification
EP first reading amendment 51.
Amendment  69 Council position – amending act Article 8 - paragraph 1 c (new)
Council position	Amendment
	1c. 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 Union list.
Justification
EP first reading amendment 52.
Amendment  70 Council position – amending act Article 9 – paragraph 1
Council position	Amendment
1. The Union list shall be updated in accordance with the procedure laid down in Regulation (EC) No 1331/2008 and, where applicable, in accordance with Article 16 of this Regulation.	1. The Commission shall update the Union list, inter alia in cases of data protection referred to in Article 16, in accordance with the procedure laid down in Regulation (EC) No 1331/2008. By way of derogation from paragraphs 4 to 6 of Article 7 of Regulation (EC) No 1331/2008, the Regulation updating the Union list shall be adopted by means of delegated acts in accordance with Article 21 and subject to the conditions of Articles 22 and 23. The Commission shall publish the Union list on a dedicated page of its website.
Justification
Article 7(4) form the Commission document.
Amendment  71 Council position – amending act Article 9 - paragraph 2
Council position	Amendment
2. The entry for a novel food in the Union list shall include a specification of the food, and, where appropriate, specify the conditions of use, additional specific labelling requirements to inform the final consumer, and/or a post-market monitoring requirement and, where applicable, the information referred to in Article 16(4).	2. The entry of a novel food in the Union list shall include:
	(a) a specification of the food;
	(b) the intended use of the food;
	(c) the conditions of use;
	(d) where appropriate, additional specific labelling requirements to inform the final consumer;
	(e) the date of entry of the novel food in the Union list and the date of receipt of the application;
	(f) the name and address of the applicant;
	(g) the date and results of the last inspection according to the monitoring requirements laid down in Article 14;
	(h) the fact that the entry is based on newly developed scientific evidence and/or proprietary data protected in accordance with Article 16;
	(i) 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 prejudice to the proprietary data of the original applicant.
Justification
EP first reading amendment 54 and Article 7(3), point (b) from the Commission document.
Amendment  72 Council position – amending act Article 9 - paragraph 2 a (new)
Council position	Amendment
	2a. 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.
Justification
EP first reading amendment 55.
Amendment  73 Council position – amending act Article 9 - paragraph 2 b (new)
Council position	Amendment
	2b. In the cases referred to in Article 2 (2) (a) the procedure shall be employed irrespective of the previous use or authorisation of the substance to which a standard production process was applied.
Justification
EP first reading amendment 56.
Amendment  74 Council position – amending act Article 9 - paragraph 2 c (new)
Council position	Amendment
	2c. 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.
Justification
EP first reading amendment 57.
Amendment  75 Council position – amending act Article 9 - paragraph 2 d (new)
Council position	Amendment
	2d. 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.
Justification
EP first reading amendment 90.
Amendment  76 Council position – amending act Article 9 - paragraph 2 e (new)
Council position	Amendment
	2e. Products produced from animals fed with genetically modified feeding stuffs must be labelled with the words ‘produced from animal fed with genetically modified feeding stuffs’.
Justification
EP first reading amendment 6.
Amendment  77 Council position – amending act Article 9 – paragraph 2 f (new)
Council position	Amendment
	2f. Before the expiry of the period referred to in Article 16(1), the Union list shall be updated in accordance with paragraph 1 of this Article so that, provided that the authorised food still meets the conditions laid down in this Regulation, the specific indications referred to in point (h) of paragraph 2 of this Article, are no longer included.
Justification
Article 7(4) form the Commission document.
Amendment  78 Council position – amending act Article 9 – paragraph 2 g (new)
Council position	Amendment
	2g. For the purposes of updating the Union 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 16 and:
	(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 Union, and the new intended use can be expected not to significantly increase the intake of consumers, including consumers in vulnerable groups,
	then the notification procedure referred to in Article 11 of this Regulation shall apply mutatis mutandis, by way of derogation from paragraph 1 of this Article.
Justification
EP first reading amendment 86.
Amendment  79 Council position – amending act Article 9 a (new)
Council position	Amendment
	Article 9a
	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 as set out below 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;
	(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.
	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.
Justification
EP first reading amendment 62.
Amendment  80 Council position – amending act Article 10
Council position	Amendment
Article 10	deleted
Content of the list of traditional foods from third countries
1. The list of traditional foods from third countries shall be updated in accordance with the procedure laid down in Article 11.
2. The entry for a traditional food from a third country in the list of traditional foods from third countries shall include a specification of the food, and, where appropriate, specify the conditions of use and/or additional specific labelling requirements to inform the final consumer.
Amendment  81 Council position – amending act Article 11
Council position	Amendment
Procedure for including a traditional food from a third country in the list	Traditional food from a third country
1. By way of derogation from the procedure laid down in Article 9(1) of this Regulation, an interested party referred to in Article 3(1) of Regulation (EC) No 1331/2008, who intends to place on the market within the Union a traditional food from a third country, shall submit an application to the Commission.	1. A food business operator intending to place a traditional food from a third country on the market in the Union shall notify this to the Commission, indicating the name of the food, its composition and country of origin.
The application shall include: (a) the name and description of the food, (b) its composition, (c) its country of origin, (d) documented data demonstrating the history of safe food use in any third country, (e) where applicable, the conditions of use and specific labelling requirements, (f) a summary of the content of the application.
The application shall be made in accordance with the implementing rules referred to in paragraph 7 of this Article.	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 valid application referred to in paragraph 1 without delay to the Member States and the Authority.	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 six months of receipt of an application, the Authority shall give its opinion. Whenever the Authority seeks supplementary information from the interested party, it shall, after consulting the interested party, lay down a period within which that information shall be provided. The six-month time limit shall be automatically extended by this additional period. The supplementary information shall be made available to the Member States and the Commission by the Authority.	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 a - 9 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. In order to prepare its opinion the Authority shall verify that: (a) the history of safe food use in any third country is substantiated by the quality of data submitted by the interested party; and (b) the composition of the food and, where applicable, the conditions of its use, do not pose a health risk to consumers in the Union. The Authority shall forward its opinion to the Commission, the Member States and the interested party.	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 Union after five months from the date of the notification in accordance with paragraph 1.
5. Within three months of the Authority giving its opinion, the Commission shall, in accordance with the regulatory procedure referred to in Article 19(2), update the list of traditional foods from third countries, taking account of the opinion of the Authority, any relevant provisions of Union law and any other legitimate factors relevant to the matter under consideration. The Commission shall inform the interested party accordingly. If the Commission decides not to proceed with an update of the list of traditional foods from third countries, it shall inform the interested party and the Member States accordingly, indicating the reasons for not considering the update justified.	5. The Commission shall publish a list of traditional foods from third countries that may be placed on the market in the Union 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 Union list of novel foods referred to in Article 5a.
6. At any stage of the procedure the interested party may withdraw its application.	6. In order to ensure smooth functioning of the notification procedure provided for in this Article, the Commission shall, before ...*, adopt detailed rules on the application of this Article by means of delegated acts in accordance with Article 21 and subject to the conditions of Articles 22 and 23.
7. By ..…, the Commission shall adopt detailed rules for the implementation of this Article in accordance with the regulatory procedure referred to in Article 19(2).
* OJ: please insert date: 2 years after the entry into force of this Regulation.	* Six month after the date of entry into force of this Regulation
Justification
Article 8 from the Commission document and EP first reading amendments 63-68.
Amendment  82 Council position – amending act Article 12
Council position	Amendment
Without prejudice to the provisions under point (a) of Article 9(1) of Regulation (EC) No 1331/2008 and by .…, the Commission shall, where appropriate, in close cooperation with the Authority and after consultation with interested parties, make available technical guidance and tools to assist interested parties in preparing and submitting applications under this Regulation; in particular, food business operators, especially small and medium-sized enterprises.	Without prejudice to the provisions of Article 9 a (1) (a) of Regulation (EC) No 1331/2008 and before ...*, 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 Council26 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 ...**, on a publicly accessible page intended for that purpose on the website of the Commission.
	* Six months after the date of entry into force of this Regulation.
	26 OJ L 253, 16.9.1997, p. 1.
	** Six months after the date of entry into force of this Regulation.
Justification
EP first reading amendment 69.
Amendment  83 Council position – amending act Article 13 – introductory part
Council position	Amendment
In assessing the safety of novel foods, where appropriate, the Authority shall, in particular:	In assessing the safety of novel foods, the Authority shall, on the basis of the requirements specified in Article 6:
Justification
EP first reading amendment 70.
Amendment  84 Council position – amending act Article 13 - point a
Council position	Amendment
(a) consider whether the food is as safe as food from a comparable food category already existing on the market within the Union or as safe as the food that the novel food is intended to replace;	(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;
Justification
EP first reading amendment 71.
Amendment  85 Council position – amending act Article 13 - point b
Council position	Amendment
(b) take into account the history of safe food use.	(b) take into account for traditional food from a third country, the history of safe food use.
Justification
Article 10b from the Commission document.
Amendment  86 Council position – amending act Article 13 - paragraph 1a (new)
Council position	Amendment
	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).
Justification
EP first reading amendment 74.
Amendment  87 Council position – amending act Article 14 - title and paragraph 1
Council position	Amendment
Special obligations on food business operators	Obligations on the food business operators
1. The Commission may, for food safety reasons and following the opinion of the Authority, impose a requirement for post-market monitoring. The food business operator placing the food on the market within the Union shall be responsible for fulfilling the post marketing requirements specified in the entry of the food concerned in the Community list of novel foods.	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 Union list .
Justification
EP first reading amendment 75.
Amendment  88 Council position – amending act Article 14 - paragraph 1 a (new)
Council position	Amendment
	1a. 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.
Justification
EP first reading amendment 75.
Amendment  89 Council position – amending act Article 14 - paragraph 1 b (new)
Council position	Amendment
	1b. Member States shall appoint competent authorities that will be responsible for the post-marketing monitoring.
Justification
EP first reading amendment 75.
Amendment  90 Council position – amending act Article 14 - paragraph 2 - introductory part
Council position	Amendment
2. The producer shall forthwith inform the Commission of:	2. The producer and food business operator or the authority shall forthwith inform the Commission of:
Justification
EP first reading amendment 75.
Amendment  91 Council position – amending act Article 14 - paragraph 2 - subparagraph 1 a (new)
Council position	Amendment
	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.
Justification
EP first reading amendment 75.
Amendment  92 Council position – amending act Article 14 - paragraph 2 - subparagraph 1 b (new)
Council position	Amendment
	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.
Justification
EP first reading amendment 75.
Amendment  93 Council position – amending act Article 15
Council position	Amendment
European Group on Ethics in Science and New Technologies	European Group on Ethics and New Technologies
The Commission, on its own initiative or at the request of a Member State, may consult the European Group on Ethics in Science and New Technologies, with a view to obtaining its opinion on ethical questions relating to science and new technologies of major ethical importance.	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, with a view to obtaining its opinion on ethical questions relating to science and new technologies of major ethical importance.
The Commission shall make this opinion available to the public.	The Commission shall make that opinion of the European Group on Ethics and new Technologies available to the public.
Justification
EP first reading amendment 76.
Amendment  94 Council position – amending act Article 16 - paragraph 1 - introductory part
Council position	Amendment
Authorisation procedure in cases of data protection	Data protection
1. On request by the applicant, supported by appropriate and verifiable information included in the application dossier, newly developed scientific evidence and/or scientific data supporting the application may not be used for the benefit of another application during a period of five years from the date of the inclusion of the novel food in the Union list without the agreement of the prior applicant. This protection shall be granted where:	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 Union list unless the subsequent applicant has agreed with the prior applicant that such data and information may be used, and where:
Justification
EP first reading amendment 77.
Amendment  95 Council position – amending act Article 16 - paragraph 1 - point a
Council position	Amendment
(a) newly developed scientific evidence and/or scientific data was designated as proprietary by the applicant at the time the first application was made (proprietary scientific data);	(a) the scientific data and other information has been designated as proprietary by the prior applicant at the time the prior application was made;
Justification
EP first reading amendment 77.
Amendment  96 Council position – amending act Article 16 - paragraph 1 - point b
Council position	Amendment
(b) the prior applicant had exclusive right of reference to the proprietary scientific data at the time the first 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
Justification
EP first reading amendment 77.
Amendment  97 Council position – amending act Article 16 - paragraph 1 - point c
Council position	Amendment
(c) the novel food could not have been authorised without the submission of the proprietary scientific 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.
Justification
EP first reading amendment 77.
Amendment  98 Council position – amending act Article 16 - paragraph 1 a (new)
Council position	Amendment
	1a. Data from research projects partly or completely paid by the Union 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.
Justification
EP first reading amendment 77.
Amendment  99 Council position – amending act Article 16 - paragraph 1 b (new)
Council position	Amendment
	1b. 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.
Justification
EP first reading amendment 87.
Amendment  100 Council position – amending act Article 16 - paragraph 3
Council position	Amendment
3. By way of derogation from Article 7(5) of Regulation (EC) No 1331/2008, the updating of the Union list with a novel food, other than traditional food from third countries, shall be decided in accordance with the regulatory procedure referred to in Article 19(2) of this Regulation in cases where proprietary scientific data are protected in accordance with this Article. In this case, the authorisation shall be granted for the period specified in paragraph 1 of this Article.	deleted
Amendment  101 Council position – amending act Article 16 - paragraph 4
Council position	Amendment
4. In the cases referred to in paragraph 3 of this Article, the entry of a novel food in the Union list shall indicate, in addition to the information referred to in Article 9(2) of this Regulation:	deleted
(a) the date of entry of the novel food in the Union list;
(b) the fact that the entry is based on proprietary newly developed scientific evidence and/or proprietary scientific data protected in accordance with this Article;
(c) the name and address of the applicant;
(d) the fact that the novel food is authorised for placing on the market within the Union only by the applicant specified in point (c), unless a subsequent applicant obtains authorisation for the food without reference to the proprietary scientific data designated as such by the prior applicant.
Amendment  102 Council position – amending act Article 16 - paragraph 5
Council position	Amendment
5. Before the expiry of the period referred to in paragraph 1 of this Article, the Commission shall update the Union list in accordance with the regulatory procedure referred to in Article 19(2) so that, provided that the authorised food still meets the conditions laid down in this Regulation, the specific indications referred to in paragraph 4 of this Article are no longer included.	deleted
Amendment  103 Council position – amending act Article 16 a (new)
Council position	Amendment
	Article 16a
	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 of the European Union 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.
Justification
EP first reading amendment 80.
Amendment  104 Council position – amending act Article 17
Council position	Amendment
Article 17	deleted
Information to the public
The Commission shall make available to the public:
(a) the Union list referred to in Article 7(1) and the list of traditional foods from third countries referred to in Article 7(2), on a single dedicated page of the Commission website; (b) the summaries of the applications submitted under this Regulation; (c) the findings of the consultations referred to in Article 4(3).
The Commission may adopt the implementing measures for this Article, including arrangements for making public the outcome of the consultations under point (c) of the first paragraph of this Article, in accordance with the regulatory procedure referred to in Article 19(2).
Amendment  105 Council position – amending act Article 17 a (new)
Council position	Amendment
	Article 17 a 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.
Justification
EP first reading amendment 81.
Amendment  106 Council position – amending act Article 18
Council position	Amendment
Member States shall lay down the rules on penalties applicable to infringements of the provisions 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. Member States shall notify those provisions to the Commission by … and shall notify it without delay of any subsequent amendment affecting them.	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 by ... * and shall, without delay, notify it of any subsequent amendment affecting them.
	* 12 months from the entry into force of this Regulation
Justification
EP first reading amendment 82.
Amendment  107 Council position – amending act Article 18 a (new)
Council position	Amendment
	Article 18a 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.
Justification
EP first reading amendment 83.
Amendment  108 Council position – amending act Article 19
Council position	Amendment
Article 19	deleted
Committee procedure
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.
Justification
No need for comitology committee provisions since all comitology procedures have been aligned to delegated act procedures.
Amendment  109 Council position – amending act Article 21
Council position	Amendment
1. The power to adopt the delegated acts referred to in Article 20 shall be conferred on the Commission for a period of five years following the entry into force of this Regulation. The Commission shall make a report in respect of the delegated powers at the latest six months before the end of the five-year period. The delegation of power shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 22.	1. The power to adopt the delegated acts referred to in Articles 2(2b), 3(3), 4(3), 4(4), 9(1), 11(6) and 20 shall be conferred on the Commission for a period of five years following the entry into force of this Regulation. The Commission shall make a report in respect of the delegated powers at the latest six months before the end of the five-year period. The delegation of power shall be automatically extended for periods of an identical duration, unless the European Parliament or the Council revokes it in accordance with Article 22.
2. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.	2. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
3. The power to adopt delegated acts are conferred on the Commission subject to the conditions laid down in Articles 22 and 23.	3. The power to adopt delegated acts are conferred on the Commission subject to the conditions laid down in Articles 22 and 23.
Amendment  110 Council position – amending act Article 22
Council position	Amendment
1. The delegation of power referred to in Article 20 may be revoked at any time by the European Parliament or by the Council.	1. The delegation of power referred to in Articles 2(2b), 3(3), 4(3), 4(4), 9(1), 11(6) and 20 may be revoked at any time by the European Parliament or by the Council.
2. The institution which has commenced an internal procedure for deciding whether to revoke the delegation of power shall inform the other institution and the Commission at the latest one month before the final decision is taken, stating the delegated powers which could be subject to revocation and the reasons for a revocation.	2. The institution which has commenced an internal procedure for deciding whether to revoke the delegation of power shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated powers which could be subject to revocation and possible reasons for a revocation.
3. The decision of revocation shall put an end to the delegation of the powers specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union.	3. The decision of revocation shall put an end to the delegation of the powers specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union.
Amendment  111 Council position – amending act Article 23
Council position	Amendment
1. The European Parliament or the Council may object to the delegated act within a period of three months from the date of notification.	1. The European Parliament or the Council may object to a delegated act within a period of two months from the date of notification.
	At the initiative of the European Parliament or the Council this period shall be extended by two months.
2. If, on expiry of that period, neither the European Parliament nor the Council has objected to the delegated act, or if, before that date, the European Parliament and the Council have both informed the Commission that they have decided not to raise objections, the delegated act shall enter into force on the date stated therein.	2. If, on expiry of that period, neither the European Parliament nor the Council has objected to the delegated act it shall be published in the Official Journal of the European Union and shall enter into force at the date started therein.
	The delegated act may be published in the Official Journal of the European Union and enter into force before the expiry of that period if the European Parliament and the Council have both informed the Commission of their intention not to raise objections.
3. If the European Parliament or the Council objects to the delegated act, it shall not enter into force. The institution which objects shall state the reasons for objecting to the delegated act.	3. If the European Parliament or the Council objects to a delegated act, it shall not enter into force. The institution which objects shall state the reasons for objecting to the delegated act.
Amendment  112 Council position – amending act Article 24 - paragraph 1
Council position	Amendment
1. By ...* and in the light of experience gained, the Commission shall submit to the European Parliament and to the Council a report on the implementation of this Regulation and in particular of Articles 3, 11 and 16, accompanied, where appropriate, by any legislative proposals.	1. No later than ...* 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 11 and 16, accompanied, where appropriate, by any proposals.
* Five years after the date of entry into force of this Regulation	* Three years and six months after the date of entry into force of this Regulation.
Justification
EP first reading amendment 93.
Amendment  113 Council position – amending act Article 24 - paragraph 2
Council position	Amendment
2. By …*, the Commission shall submit 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 offspring, followed, where appropriate, by any legislative proposals.	2. No later than ...* 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.
* One year after the date of entry into force of this Regulation	* Three years and six months after the date of entry into force of this Regulation.
Justification
EP first reading amendment 93.
Amendment  114 Council position – amending act Article 27 - paragraph 1
Council position	Amendment
1. Any request for placing a novel food on the market within the Union submitted to a Member State under Article 4 of Regulation (EC) No 258/97 before …… shall be transformed into an application under this Regulation if an initial assessment report provided for under Article 6(3) of Regulation (EC) No 258/97 has not yet been forwarded to the Commission, and in cases where the additional assessment report is required in accordance with Article 6(3) or (4) of Regulation (EC) No 258/97.	1. 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 ... shall be considered as an application under this Regulation.
Other pending requests submitted under Article 4 of Regulation (EC) No 258/97 before …… shall be processed under the provisions of that Regulation.	Other requests submitted under Articles 3(4), 4 and 5 of Regulation (EC) No 258/97 before ... shall be processed under the provisions of Regulation (EC) No 258/97.
Justification
EP first reading amendment 88.
Amendment  115 Council position – amending act Article 27 - paragraph 2
Council position	Amendment
2. The Commission may, in accordance with the regulatory procedure referred to in Article 19(2), adopt appropriate transitional measures for the application of paragraph 1 of this Article.	deleted
Amendment  116 Council position – amending act Article 28 - point 2 Regulation (EC) No 1331/2008 Article 1 - paragraphs 1 and 2
Council position Amendment "1. This Regulation lays down a common procedure for the assessment and authorisation (hereinafter referred to as the "common procedure") of food additives, food enzymes, food flavourings and source materials of food flavourings and of food ingredients with flavouring properties used or intended for use in or on foodstuffs and novel foods (hereinafter referred to as the "substances or products") which contributes to the free movement of food within the Union and to a high level of protection of human health and to a high level of consumer protection, including the protection of consumer interests. This Regulation shall not apply to smoke flavourings falling within the scope of Regulation (EC) No 2065/2003 of the European Parliament and of the Council of 10 November 2003 on smoke flavourings used or intended for use in or on foods. "1. This Regulation lays down an 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 Union and to a high level of protection of human health and protection of consumers' interests. 2. The common procedure shall lay down the procedural arrangements for updating the lists of substances and products the marketing of which is authorised in the Union pursuant to Regulation (EC) No 1333/2008, Regulation (EC) No 1332/2008, Regulation (EC) No 1334/2008 and Regulation (EU) No …/… of the European Parliament and of the Council of … on novel foods (hereinafter referred to as the "sectoral food laws"). 2. The procedure shall set the procedural arrangements for updating the lists of substances and products the marketing of which is authorised in the Union pursuant to Regulation (EC) No 1333/2008, Regulation (EC) No 1332/2008, Regulation (EC) No 1334/2008 and Regulation (EC) No .../2009 of the European Parliament and of the Council of ... on novel foods (hereinafter referred to as the "sectoral food laws")."
Justification
Article 19, points 2 and 3 from Commission document.
Amendment  117 Council position – amending act Article 28 - point 3 Regulation (EC) No 1331/2008 Article 1 paragraph 3, Article 2 paragraphs 1 and 2, Article 9 paragraph 2, Article 12 paragraph 1 and Article 13
Council position Amendment 3) In Article 1(3), Article 2(1) and (2), , Article 9(2), Article 12(1) and Article 13 the words "substance" and "substances" are replaced by "substance or product" or "substances or products" as appropriate. 3. 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'.
Justification
Article 19, point 4 from Commission document.
Amendment  118 Council position – amending act Article 28 - point 7 Regulation (EC) No 1331/2008 Article 7 - paragraphs 4, 5 and 6
Council position Amendment 7) In Article 7, paragraphs 4, 5 and 6 are replaced by the following: deleted "4. The measures, designed to amend non-essential elements of each sectoral food law, with the exception of novel foods, relating to the removal of a substance from the Union list, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3).   5. On grounds of efficiency, the measures designed to amend non-essential elements of each sectoral food law, with the exception of novel foods, inter alia, by supplementing it, relating to the addition of a substance to the Union list and for adding, removing or changing conditions, specifications or restrictions associated with the presence of the substance on the Union list, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(4).   6. With exception of novel foods and on imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 14(5) for the removal of a substance from the Union list and for adding, removing or changing conditions, specifications or restrictions associated with the presence of a substance on the Union list.   7. The measures relating to the removal, the adding of a product covered by the Regulation on novel foods to the Union list and for adding, removing or changing conditions, specifications or restrictions associated with the presence of such product on the Union list shall be adopted in accordance with the regulatory procedure referred to in Article 14(2).".
Amendment  119 Council position – amending act Article 29 - Paragraph 3
Council position	Amendment
However, Articles 26, 27 and 28 shall apply from …**. Furthermore, by way of derogation from the second paragraph of this Article and by way of derogation from the second paragraph of Article 16 of Regulation (EC) No 1331/2008, applications may be made in accordance with this Regulation as from …** for the authorisation of food referred to in point (iv) of Article 3(2)(a) of this Regulation, where such food is already on the market within the Union at that date.	However, Article 26 shall apply from ...**.
Justification
Article 20 from Commission document.

• [1]  Texts adopted, 25.3.2009, T6(2009)0171.
• [2]  OJ C 224, 30.8.2008, p. 81.

EXPLANATORY STATEMENT

I. Background

As part of the framework to improve and bring coherence to Community legislation from "farm to fork" the Commission announced in the White Paper on Food Safety its intentions to examine the application of the novel food legislation and to make the necessary adaptations to the existing legislation in the light of the conclusions of the report on the implementation of the Regulation (EC) No 258/97 on novel foods and novel ingredients and pursuant to the regulatory framework of Directive 90/220/EEC.

In accordance with these commitments, the proposal of the COM on Novel Food 14.01.2008 (COM 2007 (872)) aims to ensure food safety, protect human health and secure the functioning of the internal market for food. The proposal aims to regulate the placing on the market of novel foods and foods from third countries. Furthermore, it lays down rules for authorisation, supervision, labelling and use of novel foods.

II. First Reading in EP

On 25 March 2009, the European Parliament adopted by 658 votes to 15, with 11 abstentions, a legislative resolution amending, under the first reading of the co-decision procedure, the proposal for a regulation on novel food.

The main amendments were as follows:

Purpose: 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.

Scope: MEPs intend to exclude foods derived from cloned animals and their offspring from the scope of this Regulation. Before the date of application of this Regulation, the Commission should put forward a corresponding legislative proposal on foods derived from cloned animals and their descendants. This proposal shall be presented to the European Parliament and the Council. This Regulation shall apply to food additives, food enzymes, flavourings and certain food ingredients with flavouring properties to which is applied a new production process not used before 15 May 1997, which give rise to significant changes in the composition or structure of the food such as engineered nanomaterials. Where a novel food can have 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) whether it falls under Regulation (EC) No 726/2004.

Definitions: MEPs have introduced the definition of “cloned animals”, “descendants of cloned animals” and “engineered nanomaterial”. 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 these definitions to technical and scientific progress and with definitions subsequently agreed at international level.

Other amendments adopted in first reading covered the collection of information regarding the classification of a novel food, the prohibition of non-compliant novel foods, the conditions for the entry of novel foods in the Community list, Information, Monitoring, Labelling, traditional food from a third country, use of non-animal tests and intelligent testing strategies, data protection as well as inspection and control measures.

III. Second Reading

The position of the Council at first reading on novel food was adopted on 15 March 2010.

The Council has taken on board some elements of the first reading in Parliament. However, the most important amendments of the first reading have not been taken into consideration in an appropriate manner by the Council, particularly in view of the issue of cloned animals in food and feed.

Your rapporteur respects the first reading position of the European Parliament as much as possible in her second reading report, as the first reading position was adopted by a very large majority. Almost all of the amendments adopted in the first reading have been reinstated.

PROCEDURE

Title	Novel foods (common procedure)
References	11261/3/2009 – C7-0078/2010 – 2008/0002(COD)
Date of Parliament’s first reading – P number	25.3.2009                     T6-0171/2009
Commission proposal	COM(2007)0872 - C6-0027/2008
Date receipt of common position announced in plenary	25.3.2010
Committee responsible        Date announced in plenary	ENVI 25.3.2010
Rapporteur(s)        Date appointed	Kartika Tamara Liotard 27.2.2008
Discussed in committee	7.4.2010
Date adopted	4.5.2010
Result of final vote	+: –: 0:	49 2 3
Members present for the final vote	János Áder, Elena Oana Antonescu, Kriton Arsenis, Pilar Ayuso, Paolo Bartolozzi, Sandrine Bélier, Sergio Berlato, Martin Callanan, Nessa Childers, Chris Davies, Esther de Lange, Bas Eickhout, Karl-Heinz Florenz, Elisabetta Gardini, Gerben-Jan Gerbrandy, Julie Girling, Françoise Grossetête, Satu Hassi, Jolanta Emilia Hibner, Karin Kadenbach, Christa Klaß, Jo Leinen, Corinne Lepage, Peter Liese, Kartika Tamara Liotard, Radvilė Morkūnaitė-Mikulėnienė, Miroslav Ouzký, Vladko Todorov Panayotov, Gilles Pargneaux, Andres Perello Rodriguez, Sirpa Pietikäinen, Mario Pirillo, Pavel Poc, Vittorio Prodi, Frédérique Ries, Anna Rosbach, Oreste Rossi, Daciana Octavia Sârbu, Horst Schnellhardt, Richard Seeber, Theodoros Skylakakis, Catherine Soullie, Anja Weisgerber, Glenis Willmott, Sabine Wils
Substitute(s) present for the final vote	Matthias Groote, Jiří Maštálka, Bill Newton Dunn, Bart Staes, Michail Tremopoulos, Thomas Ulmer, Marita Ulvskog
Substitute(s) under Rule 187(2) present for the final vote	George Sabin Cutaş, Francesco Enrico Speroni