COMMON POSITION (EC) No 25/95 adopted by the Council on 23 October 1995 with a view to adopting Regulation (EC) No . . ./95 of the European Parliament and of the Council concernnig novel foods and novel food ingredients
Date: 1995-10-23
Institutions: Council of the European Union
Subjects: biotechnology, food inspection, foodstuffs legislation, genetically modified organism, human nutrition, marketing













EUR-Lex - 51995AG1130(01) - EN






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51995AG1130(01)

COMMON POSITION (EC) No 25/95 adopted by the Council on 23 October 1995 with a view to adopting Regulation (EC) No . . ./95 of the European Parliament and of the Council concernnig novel foods and novel food ingredients  


Official Journal C 320 , 30/11/1995 P. 0001 





COMMON POSITION (EC) No  25/95adopted by the Council on 23 October 1995with a view to adopting Regulation (EC) No . . ./95  of the European Parliament and of the Council concernnig novel foods and novel food  ingredients(95/C 320/01)THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN  UNION, Having regard to the Treaty establishing the European Community and in particular Article 100a  thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the Economic and Social Committee (2), Acting in accordance with the procedure laid down in Article 189b of the Treaty (3), Whereas, differences between national laws relating to novel foods or food ingredients could hinder  the free movement of foodstuffs; whereas they may create conditions of unfair competition, thereby  directly affecting the functioning of the internal market; Whereas, in order to protect public health, it is necessary to ensure that novel foods and novel  food ingredients are subject to a single safety evaluation through a Community procedure before  they are placed on the market within the Community; whereas in the case of novel foods and novel  food ingredients which are substantially equivalent to existing foods or food ingredients a  simplified procedure should be provided for; Whereas food additives, flavourings for use in foodstuffs and extraction solvents are covered by  other Community legislation and should therefore be excluded from the scope of this Regulation; Whereas appropriate arrangements should be made for the placing on the market of novel foods and  novel food ingredients derived from plant varieties subject to the provisions of Council Directive  70/457/EEC of 29 Sepember 1970 on the common catalogue of varieties of agricultural plant species  (4) and Council Directive 70/458/EEC of 29 September 1970 on the marketing of vegetable seed (5); Whereas risks to the environment may be associated with food or food ingredients which contain or  consist of genetically modified organisms; whereas Council Directive 90/220/EEC of 23 April 1990 on  the deliberate release into the environment of genetically modified organisms (6) has specified  that, for such products, an environmental risk assessment must always be undertaken to ensure  safety for the environment; whereas, in order to provide for a unified Community system for  assessment of a product, provisions must be made under this regulation for a specific environmental  risk assessment, which in accordance with the procedures of Article 10 of Directive 90/220/EEC must  be similar to that laid down in that Directive, together with the assessment of the suitability of  the product to be used as a food or food ingredient; Whereas the Scientific Committee for Food instituted by Decision 74/234/EEC (1) should be consulted  on any question relating to this Regulation which may have an effect on public health; Whereas Council Directive 89/397/EEC of 14 June 1989 on the official control of foodstuffs (2) and  Council Directive 93/99/EEC of 29 October 1993 on the subject of additional measures concerning the  official control of foodstuffs (3) apply to novel foods or food ingredients; Whereas, without prejudice to the other requirements in Community legislation relating to the  labelling of foodstuffs, additional specific requirements on labelling should be laid down; whereas  these requirements must be subject to precise provisions in order to ensure that the necessary  information is available to the consumer; whereas defined population groups, associated with well  established practices regarding food should be informed when the presence in a novel food of  matters which are not present in the existing equivalent foodstuff gives rise to ethical concerns  as regards those population groups; whereas, with respect to labelling, information to the consumer  on the presence of an organism which has been genetically modified within the meaning of Directive  90/220/EEC, where it does not correspond solely to a modification of its agricultural  characteristics, constitutes an additional requirement applicable to the foods and foodstuffs  referred to in this Regulation; Whereas, in respect of this Regulation, provision should be made for a procedure instituting close  cooperation between Member States and the Commission within the Standing Committee on Foodstuffs  set up by Decision 69/414/EEC (4), HAVE ADOPTED THIS REGULATION: Article 11. This Regulation concerns the placing on the market within the  Community of novel foods or novel food ingredients. 2. This Regulation shall apply to the placing on the market within the Community of foods and food  ingredients which have not hitherto been used for human consumption to a significant degree within  the Community and which fall under the following categories: (a) foods and food ingredients containing or consisting of genetically modified organisms within  the meaning of Directive 90/220/EEC; (b) foods and food ingredients produced from, but not containing, genetically modified organisms; (c) foods and food ingredients with a new or intentionally modified primary molecular structure; (d) foods and food ingredients consisting of or isolated from micro-organisms, fungi or algae; (e) foods and food ingredients consisting of or isolated from plants and food ingredients isolated  from animals, except for foods and food ingredients obtained by traditional propagating or breeding  practices and which have a history of safe food use; (f) foods and food ingredients to which has been applied a production process not currently used,  where that process gives rise to significant changes in the composition or structure of the foods  or food ingredients which affect their nutritional value, metabolism or level of undesirable  substances. 3. Where necessary, it may be determined in accordance with the procedure laid down in Article 13  whether a type of food or food ingredient falls under paragraph 2 of this Article. Article 2This Regulation shall not apply to: (a) food additives falling within the scope of Council Directive 89/107/EEC of 21 December 1988 on  the approximation of the laws of the Member States concerning food additives authorized for use in  foodstuffs intended for human consumption (5); (b) flavourings for use in foodstuffs, falling within the scope of Council Directive 88/388/EEC of  22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use  in foodstuffs and to source materials for their production (6); (c) extraction solvents used in the production of foodstuffs, falling within the scope of Council  Directive 88/344/EEC of 13 June 1988 on the approximation of the laws of he Member States on  extraction solvents used in the production of foodstuffs and food ingredients (1). Article 31. Foods and food ingredients falling within the scope of this Regulation must not: - constitute a danger for the consumer, - mislead the consumer, - differ from foods or food ingredients which they are intended to replace in such a way that their  normal consumption would be nutritionally disadvantageous for the consumer. 2. For the purpose of placing the foods and food ingredients falling within the scope of this  Regulation on the market within the Community, the procedures laid down in Articles 4, 6, 7 and 8  shall apply on the basis of the criteria defined in paragraph 1 of this Article and the other  relevant factors referred to in those Articles. However, in the case of foods or food ingredients referred to in this Regulation derived from plant  varieties subject to Directives 70/457/EEC and 70/458/EEC, the authorization decision referred to  in paragraph 7 of this Regulation shall be taken in accordance with the procedures provided for in  those Directives, provided they take account of the assessment principles laid down in this  Regulation and the criteria set out in paragraph 1 of this Article, with the exception of the  provisions relating to the labelling of such foods or food ingredients, which shall be established,  pursuant to Article 8, in accordance with the procedure laid down in Article 13. 3. Paragraph 2 shall not apply to the foods and food ingredients referred to in Article 1 (2) (b)  where the genetically modified organism used in the production of the food or food ingredient has  been placed on the market in accordance with this Regulation. 4. By way of derogation from paragraph 2, the procedure laid down in Article 5 shall apply to foods  or food ingredients referred to in Article 1 (2) (b), (d) and (e) which, on the basis of the  scientific evidence available and generally recognized or on the basis of an opinion delivered by  one of the competent food assessment bodies mentioned in Article 4 (3) are substantially equivalent  to existing foods or food ingredients as regards their composition, nutritional value, metabolism,  intended use and the level of undesirable substances contained therein. Where necessary, it may be determined in accordance with the procedure laid down in Article 13  whether a type of food or food ingredient falls under this paragraph. Article 41. The person responsible for placing on the Community market (hereinafter 'the  applicant') shall submit a request to the Member State in which the product is to be placed on the  market for the first time. At the same time, he shall transmit a copy of the request to the  Commission. 2. An initial assessment as provided for in Article 6 shall be carried out. Following the procedure referred to in Article 6 (4), the Member State referred to in paragraph 1  shall inform the applicant without delay: - that he may proceed with placing the food or food ingredient on the market, where the additional  assessment referred to in Article 6 (3) is not required and that no reasoned objection has been  presented in accordance with Article 6 (4), or- that, in accordance with Article 7, an  authorization decision is required. 3. Each Member State shall notify to the Commission the name and address of the food assessment  bodies responsible in its territory for preparing the initial assessment reports referred to in  Article 6 (2). 4. Before the date of entry into force of this Regulation, the Commission shall publish  recommendations concerning the scientific aspects of: - the information necessary to support an application and the presentation of such information, - the preparation of the initial assessment reports provided for in Article 6. 5. Any detailed rules for implementing this Article shall be adopted in accordance with the  procedure laid down in Article 13. Article 5In the case of the foods or food ingredients referred to in Article 3 (4), the  applicant shall notify the Commission of the placing on the market when he does so. Such  notification shall be accompanied by the relevant details provided for in Article 3 (4). The  Commission shall transmit to Member States a copy of that notification within 60 days and, at the  request of a Member State, a copy of the said relevant details. The Commission shall publish each  year a summary of those notifications in the 'C' series of the Official Journal of the European  Communities. Article 61. The request referred to in Article 4 (1) shall contain the necessary information,  including a copy of the studies which have been carried out and any other material which is  available to demonstrate that the food or food ingredient complies with the criteria laid down in  Article 3 (1), as well as an appropriate proposal for the presentation and labelling, in accordance  with the requirements of Article 8, of the food or food ingredient. In addition, the request shall  be accompanied by a summary of the dossier. 2. Upon receipt of the request, the Member State referred to in Article 4 (1) shall ensure that an  initial assessment is carried out. To that end, it shall either notify the Commission of the name  of the competent food assessment body responsible for preparing the initial assessment report, or  ask the Commission to arrange with another Member State for one of the competent food assessment  bodies mentioned in Article 4 (3) to prepare such a report. The Commission shall forward to the Member States without delay a copy of the summary provided by  the applicant and the name of the competent body responsible for carrying out the initial  assessment. 3. The initial assessment report shall be drawn up within a period of three months from receipt of  a request meeting the conditions laid down in paragraph 1, in accordance with the recommendations  referred to in Article 4 (4), and shall decide whether or not the food or food ingredient requires  additional evaluation as referred to in Article 7. 4. The Member State concerned shall without delay transmit the report of the competent food  assessment body to the Commission which shall circulate it to the other Member States. Within a  period of 60 days from the date of circulation of the report by the Commission, a Member State or  the Commission may make comments or present a reasoned objection to the marketing of the food or  food ingredient concerned. The comments or objections may also concern the presentation or  labelling of the food or food ingredient. Comments or objections shall be forwarded to the Commission, which shall circulate them to Member  States within the period of 60 days referred to in the first subparagraph. The applicant shall, where a Member State asks for it, provide a copy of any pertinent information  appearing in the request. Article 71. Where an additional assessment is required in accordance with Article 6 (3) or an  objection is raised in accordance with Article 6 (4), an authorization decision shall be taken in  accordance with the procedure laid down in Article 13. 2. The decision shall define the scope of the authorization and shall establish, where  appropriate: - the conditions of use of the food or food ingredient, - the designation of the food or food ingredient, and its specification, - specific labelling requirements as referred to in Article 8. 3. The Commission shall without delay inform the applicant of the decision taken. Decisions shall  be published in the Official Journal of the European Communities. Article 81. Without prejudice to other requirements of Community law concerning the labelling of  foodstuffs, the following additional specific labelling requirements shall apply, to ensure that  the consumer is informed of: (a) any characteristic or food property such as: - composition, - nutritional value or nutritional effects, - intended use of the food, which renders a novel food or food ingredient significantly different from an equivalent existing  food or food ingredient. In such case, the labelling must mention the characteristics or properties modified, accompanied by  an indication of the method by which that characteristic or property was obtained; (b) the presence in the novel food or food ingredient of material which is not present in an  existing equivalent foodstuff, and which may have implications for the health of certain sections  of the population; (c) the presence in the novel food or food ingredient of material which is not present in an  existing equivalent foodstuff, and which may give rise to ethical concerns; (d) the presence of a genetically modified organism within the meaning of Directive 90/220/EEC  where, according to a decision adopted in accordance with the procedure laid down in Article 13 of  this Regulation, it does not correspond solely to modification of its agricultural  characteristics. 2. In the absence of an existing equivalent food or food ingredient, appropriate provisions shall  be adopted where necessary in order to ensure that consumers are adequately informed of the nature  of the food or food ingredient. 3. Any detailed rules for implementing this Article, including those for the definition of the  agricultural characteristics referred to in point (d) of paragraph 1, shall be adopted in  accordance with the procedure laid down in Article 13. Article 91. Where a food or food ingredient falling within the scope of this Regulation contains  or consists of a genetically modified organism within the meaning of Article 2 (1) and (2) of  Directive 90/220/EEC, the information required in the request for placing on the market mentioned  in Article 6 (1) shall be accompanied by: - a copy of the written consent, if any, from the competent authority, to the deliberate release of  the genetically modified organisms for research and development purposes provided for in Article 6  (4) of Directive 90/220/EEC, together with the results of the release(s) with respect to any risk  to human health and the environment, - the complete technical dossier supplying the relevant information requested in Article 11 of  Directive 90/220/EEC and the environmental risk assessment resulting from this information; the  results of any investigations performed for the purposes of research and development or, where  appropriate, the decision authorizing the placing on the market provided for in part C of Directive  90/220/EEC. Articles 11 to 18 of Directive 90/220/EEC shall not apply to food or food ingredients which contain  or consist of genetically modified organisms. 2. In the case of food or food ingredients falling within the scope of this Regulation containing  or consisting of genetically modified organisms, the decision mentioned in Article 7 shall respect  the environmental safety requirements laid down by Directive 90/220/EEC to ensure that all  appropriate measures are taken to avoid adverse effects on human health and the environment which  might arise from the deliberate release of genetically modified organisms. During the process of  evaluating requests for the placing on the market of products containing or consisting of  genetically modified organisms, the necessary consultations will be held by the Commission or the  Member States with the bodies set up by the Community or the Member States in accordance with  Directive 90/220/EEC. Article 10Detailed rules for the protection of the information provided by the applicant shall  be adopted in accordance with the procedure laid down in Article 13. Article 11The Scientific Committee for Food shall be consulted on any matter falling within the  scope of this Regulation likely to have an effect on public health. Article 121. 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 shall examine the grounds referred to in paragraph 1 as soon as possible within  the Standing Committee for Foodstuffs; it shall take the appropriate measures in accordance with  the procedure laid down in Article 13. The Member State which took the decision referred to in  paragraph 1 may retain it until the measures have entered into force. Article 131. Where the procedure defined in this Article is to be implemented, the Commission  shall be assisted by the Standing Committee for Foodstuffs, hereinafter referred to as the  'Committee'. 2. Matters shall be referred to the Committee by the Chairman, either on his own initiative or at  the request of the representative of a Member State. 3. The representative of the Commission shall submit to the Committee a draft of the measures to be  taken. The Committee shall deliver its opinion on the draft within a time limit which the Chairman  may lay down according to the urgency of the matter. The opinion shall be delivererd by the  majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is  required to adopt on a proposal from the Commission. The votes of the representatives of the Member  States within the Committee shall be weighted in the manner set out in that Article. The Chairman  shall not vote. 4. (a) The Commission shall adopt the measures envisaged if they are in accordance with the opinion  of the Committee. (b) If the measures envisaged are not in accordance with the opinion of the Committee, or if no  opinion is delivered, the Commission shall, without delay, submit to the Council a proposal  relating to the measures to be taken. The Council shall act by a qualified majority. If, on the expiry of a period of three months from the date of referral to the Council, the Council  has not acted, the proposed measures shall be adopted by the Commission. Article 14No later than five years from the date of entry into force of this Regulation 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 accompanied, where appropriate, by any  suitable proposals. Article 15This Regulation shall enter into force 12 months following the day of its publication  in the Official Journal of the European Communities. This Regulation shall be binding in its entirety and directly applicable in all  Member States. Done at . . . For the European ParliamentThe PresidentFor the CouncilThe President(1) OJ  No C 190, 29. 7. 1992, p. 3. (2) OJ No C 108, 19. 4. 1993, p. 8. (3) Opinion of the European Parliament (not yet published in the Official Journal). Council Common  Position of . . . (not yet published in the Official Journal) and Decision of the European  Parliament of . . . (not yet published in the Official Journal). (4) OJ No L 225, 12. 10. 1970, p. 1. Directive as last amended by Directive 90/654/EEC (OJ No L  353, 17. 12. 1990, p. 48). (5) OJ No L 225, 12. 10. 1970, p. 7. Directive as last amended by Directive 90/654/EEC (OJ No L  353, 17. 12. 1990, p. 48). (6) OJ No L 117, 8. 5. 1990, p. 15. Directive as last amended by Directive 94/15/EC (OJ No L 103,  22. 4. 1994, p. 20). (1) OJ No L 136, 20. 5. 1974, p. 1. (2) OJ No L 186, 30. 6. 1989, p. 23. Directive as last amended by Directive 93/99/EC (OJ No L 290,  24. 11. 1993, p. 14). (3) OJ No L 290, 24. 10. 1993, p. 14. (4) OJ No L 291, 19. 11. 1969, p. 9. (5) OJ No L 40, 11. 2. 1989, p. 27. Directive as last amended by Directive 94/34/EC (OJ No L 237,  10. 9. 1994, p. 1). (6) OJ No L 184, 15. 7. 1988, p. 61. Directive as last amended by Directive 91/71/EEC (OJ No L 42,  15. 2. 1991, p. 25). (1) OJ No L 157, 24. 6. 1988, p. 28. Directive as last amended by Directive 94/52/EC (OJ No L 331,  21. 12. 1994, p. 10). STATEMENT OF THE COUNCIL'S REASONS I. INTRODUCTION1. On 7 July 1992 the Commission  submitted to the Council a proposal for a Regulation on this subject, based on Article 100a of the  Treaty (1). 2. In response to the European Parliament's opinion, delivered on 27 October 1993 (2), the  Commission submitted an amended proposal to the Council (3). 3. The Economic and Social Committee delivered its opinion on 23 February 1993 (4). 4. On 23 October 1995 the Council adopted a common position on the amended proposal in accordance  with the procedure laid down in Article 189b (2) of the Treaty. II. OBJECTIVE5. The objective of the proposal is to introduce assessment criteria and procedures  for the marketing in the Union of novel foods, i.e. foodstuffs which have not hitherto been used  for human consumption to a significant degree. The proposal is of considerable importance Union-wide for technical progress in the agri-foodstuffs  sector, for the proper operation of the internal market and for consumer protection and  information. III. ANALYSIS OF THE COMMON POSITION6. In general terms, the text has been extensively revised  during discussions. The wording of the common position reflects the European Parliament's wishes on  a number of important points broadly indicated below. All of the amendments to the original  proposal which were approved by the Council have been accepted by the Commission. 7. The scope (European Parliament amendments 14, 15 and 29) has been extended and specified more  clearly in Article 1 (2) in comparison with the original proposal. However, the Council and the  Commission were unable to include part of amendment 15, taking the view that additives are already  covered by specific Community provisions and should therefore be excluded from the scope of the  prospective Regulation. In line with European Parliament amendments 19 and 30, the general criteria for the assessment of  products are included in the enacting terms (in Article 3 (1)). The Council also found a need to make clearer the relationship between this text and the Community  provisions on seeds, particularly as regards assessment procedures and labelling rules (see Article  3 (2)). 8. The common position has considerably improved the provisions concerning the procedures in  Articles 4 to 7 for the marketing of products coming within its scope (amendments 18, 20 and 21).  The main points are as follows: (a) a clearer and more specific breakdown of tasks between the Member States and the Commission as  compared with the original proposal; (b) wider publication of the results of decisions taken (see Articles 5 and 7), in response to the  European Parliament opinion (amendment 24); (c) clear, detailed requirements for the preparation and presentation of the documentation to be  submitted to the authorities regarding products coming within the scope (Article 6); (d) clearer indication of the cases in which the Member States or the Commission may present a  reasoned objection to the marketing of a product (Article 6 (4)); (e) greater clarification of the procedure for taking a formal decision to authorize the marketing  of products as well as clarification of the scope of such decisions (Article 7). 9. As regards labelling requirements (amendment 22), the Council has decided on a number of rules  (Article 8) under which the consumer is to be informed systematically of: - differences in respect of the characteristics or food properties of a novel food compared with a  conventional product; in such cases the method used to obtain the characteristics or properties in  question is to be stated for the consumer's information, - the presence in the product of material which is not present in the equivalent existing product  and which may have implications for the health of certain sections of the population, e.g.  allergens, - the presence in the product of material which is not present in the equivalent existing product  and which may give rise to ethical concerns for specific population groups with established  practices regarding food, - the presence of a genetically modified organism not corresponding solely to modification of  agricultural characteristics. In laying down these rules, the Council felt it very important that they should be complete, that  the information given to the consumer should be useful and that the rules should be amenable to  effective checking by the appropriate authorities. 10. The Council has taken into account amendment 17 concerning independent experts. 11. The Council has accepted the principle of amendments 54 and 55 concerning the protection of  information supplied in the course of the procedures laid down by the Regulation (see Article 10). 12. The Council has accepted the aim of amendment 45 - to confirm that the general foodstuffs  control system is applicable to the products in question - and has included it in a recital. 13. In the case of amendment 58, the Council is setting the entry into force of the Regulation 12  months after its publication in the Official Journal to enable the Commission and the Member States  to take the measures necessary to give effect to it. 14. All in all, three years after the submission of the original proposal, having accepted the  European Parliament amendments taken up by the Commission and having also taken into consideration  European Parliament concern on other points, the Council considers it has finally struck the right  balance between the differing views which have been expressed for some while on the matter,  particularly as regards key points such as: - the scope, - marketing procedures, - labelling. (1) OJ No C 190, 29. 7. 1992, p. 3. (2) OJ No C 315, 22. 11. 1993, p. 139. (3) OJ No C 16, 19. 1. 1994, p. 10. (4) OJ No C 108, 19. 4. 1993.