EUROPEAN PARLIAMENT ***I REPORT. Session document. FINAL A5-0198/2001 Par1. 31 May 2001

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1 EUROPEAN PARLIAMT 1999 Session document May 2001 FINAL A5-0198/2001 Par1 ***I REPORT on the proposal for a European Parliament and Council regulation laying down the general principles and requirements of food law, establishing the European Food Authority, and laying down procedures in matters of food (COM(2000) 716 C5-0655/ /0286(COD)) Part 1: draft legislative resolution Committee on the Environment, Public Health and Consumer Policy Rapporteur: Phillip Whitehead RR\ doc PE

2 Symbols for procedures * Consultation procedure majority of the votes cast **I Cooperation procedure (first reading) majority of the votes cast **II Cooperation procedure (second reading) majority of the votes cast, to approve the common position majority of Parliament s component Members, to reject or amend the common position *** Assent procedure majority of Parliament s component Members except in cases covered by Articles 105, 107, 161 and 300 of the EC Treaty and Article 7 of the EU Treaty ***I Codecision procedure (first reading) majority of the votes cast ***II Codecision procedure (second reading) majority of the votes cast, to approve the common position majority of Parliament s component Members, to reject or amend the common position ***III Codecision procedure (third reading) majority of the votes cast, to approve the joint text (The type of procedure depends on the legal basis proposed by the Commission) PE /195 RR\ doc

3 CONTTS Page PROCEDURAL PAGE...4 LEGISLATIVE PROPOSAL...6 DRAFT LEGISLATIVE RESOLUTION...93 EXPLANATORY STATEMT...94 The opinions will be published separately in Part 2. RR\ doc 3/195 PE

4 PROCEDURAL PAGE By letter of 29 November 2000 the Commission submitted to Parliament, pursuant to Article 251(2), 37, 95, 133, and 152(4) of the EC Treaty, the proposal for a European Parliament and Council regulation laying down the general principles and requirements of food law, establishing the European Food Authority, and laying down procedures in matters of food (COM(2000) /0286 (COD)). At the sitting of 11 December 2000 the President of Parliament announced that she had referred this proposal to the Committee on the Environment, Public Health and Consumer Policy as the committee responsible and the Committee on Budgets, the Committee on Legal Affairs and the Internal Market, the Committee on Industry, External Trade, Research and Energy, the Committee on Agriculture and Rural Development, and the Committee on Fisheries for their opinions (C5-0655/2000). At the sitting of 18 January 2001 the President of Parliament announced that she had also referred the proposal to the Committee on Budgetary Control, for its opinion. The Committee on the Environment, Public Health and Consumer Policy appointed Phillip Whitehead rapporteur at its meeting of 9 January The committee considered the Commission proposal and draft report at its meetings of 10 and 24 April and 28 and 29 May At the last meeting it adopted the draft legislative resolution by 40 votes to 0, with 2 abstentions. The following were present for the vote: Caroline F. Jackson, chairman; Guido Sacconi, Alexander de Roo and Ria G.H.C. Oomen-Ruijten, vice-chairmen; Phillip Whitehead, rapporteur; Maria del Pilar Ayuso González, Jean-Louis Bernié(for Jean Saint-Josse), Hans Blokland, David Robert Bowe, John Bowis, Philip Bushill-Matthews (for Martin Callanan), Dorette Corbey, Chris Davies, Jillian Evans (for Patricia McKenna), Carlo Fatuzzo (for Per- Arne Arvidsson), Anne Ferreira, Karl-Heinz Florenz, Laura González Álvarez, Robert Goodwill, Eija-Riitta Anneli Korhola, Hans Kronberger, Bernd Lange, Torben Lund, Jules Maaten, Minerva Melpomeni Malliori, Maria Martens (for Avril Doyle), Emilia Franziska Müller, Rosemarie Müller, Riitta Myller, Giuseppe Nisticò, Béatrice Patrie, Marit Paulsen, Frédérique Ries, Karin Scheele, Horst Schnellhardt, Inger Schörling, Jonas Sjöstedt, Renate Sommer (for Marialiese Flemming), María Sornosa Martínez, Bart Staes (for Hiltrud Breyer), Catherine Stihler, Charles Tannock (for Christa Klaß), Nicole Thomas-Mauro, Marianne L.P. Thyssen (for Peter Liese), Antonios Trakatellis, Roseline Vachetta. The opinions of the Committee on Budgets, the Committee on Budgetary Control, the Committee on Legal Affairs and the Internal Market, the Committee on Industry, External Trade, Research and Energy, the Committee on Agriculture and Rural Development and the Committee on Fisheries are published separately in Part 2 of this report. The report was tabled on 31 May PE /195 RR\ doc

5 The deadline for tabling amendments will be indicated in the draft agenda for the relevant part-session. RR\ doc 5/195 PE

6 LEGISLATIVE PROPOSAL Proposal for a European Parliament and Council regulation laying down the general principles and requirements of food law, establishing the European Food Authority, and laying down procedures in matters of food (COM(2000) 716 C5-0655/ /0286(COD)) The proposal is amended as follows: Text proposed by the Commission 1 Amendments by Parliament Amendment 1 TITLE Proposal for a regulation of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Authority, and laying down procedures in matters of food safety Proposal for a regulation of the European Parliament and of the Council 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 (This amendment applies throughout the text) This reiterates the position adopted in the European Parliament resolution on the Commission s White Paper on Food Safety (A5-0272/2000, on 25 October 2000). Food safety should be the Authority s primary concern. Amendment 2 Recital 3 (3) The free movement of food within the Community can be achieved only if food safety requirements do not differ significantly from Member State to Member State. (3) The free movement of food within the Community can be achieved only if food safety requirements do not differ significantly from Member State to Member State. These requirements should also apply to food and feed imported from third 1 OJ C 96, , p.247. PE /195 RR\ doc

7 countries. In the interests of consumer protection, the same standards must be imposed on imported goods as apply to food and feed produced in the EU. Amendment 3 Recital 6 (6) In this regard, water is ingested as other foods, thereby contributing to the overall exposure of a consumer to ingested substances, including chemical and microbiological contaminants. It should therefore be considered to be food, without prejudice to the requirements established in Council Directives 80/778/EEC [12] and 98/83/EC [13] on the quality of water intended for human consumption. (6) In this regard, water is ingested directly or indirectly as other foods, thereby contributing to the overall exposure of a consumer to ingested substances, including chemical and microbiological contaminants. It should therefore be considered to be food, without prejudice to the requirements established in Council Directives 80/778/EEC [12] and 98/83/EC [13] on the quality of water intended for human consumption. The formulation proposed by this amendment is more explicit. Amendment 4 Recital 9 (9) Experience has shown that it is necessary to adopt measures aimed at guaranteeing that only safe food is placed on the market and at ensuring that systems exist to identify and respond to food safety problems in order to ensure the proper functioning of the internal market and to protect human health. (9) Experience has shown that it is necessary to adopt measures aimed at guaranteeing that only safe food is placed on the market and at ensuring that systems exist to identify and respond to food safety problems in order to ensure the protection of human health and consequently the proper functioning of the internal market. RR\ doc 7/195 PE

8 This amendment does not disagree with recital 9 but rewords the Commission text so that the protection of human health is stressed foremost. Amendment 5 Recital 11 (11) In order to ensure the safety of food, it is necessary to consider all aspects of the food production chain as a continuum because each element may have a potential impact on food safety. (11) In order to ensure the safety of food, it is necessary to consider all aspects of the food production chain as a continuum, from the inputs used in agriculture, through the feeding of animals to the sale of foodstuffs to individuals and the catering industry, because each element may have a potential impact on food safety. The Food Authority must be able to monitor the entire food chain. Amendment 6 Recital 12 (12) Experience has shown that for this reason it is necessary to consider the production, manufacture, and distribution of feed given to food-producing animals, since the inadvertent or deliberate contamination of feed, and adulteration or fraudulent or other bad practices in relation to it, may give rise to a direct or indirect impact on food safety. (12) Experience has shown that for this reason it is necessary to consider the production, manufacture, transport and distribution of feed given to foodproducing animals, since the inadvertent or deliberate contamination of feed, and adulteration or fraudulent or other bad practices in relation to it, may give rise to a direct or indirect impact on food safety. Transport under appropriate conditions is essential to the quality and hygiene of feed and should be stipulated PE /195 RR\ doc

9 Amendment 7 Recital 17 (17) It is recognised that scientific risk assessment alone cannot, in some cases, provide all the information on which a riskmanagement decision should be based, and that other factors relevant to the matter under consideration should legitimately be taken into account including societal, economic, ethical and environmental factors and the feasibility of controls. (17) It is recognised that scientific risk assessment alone cannot, in some cases, provide all the information on which a riskmanagement decision should be based, and that other factors relevant to the matter under consideration should legitimately be taken into account including societal, economic, traditional, ethical and environmental factors and the feasibility of controls. To the factors provided for in this recital traditional is also proposed, since there are certain foods produced in accordance with traditional methods, which are important to certain localities, and should therefore be taken into consideration. Amendment 8 Recital 18 (18) The precautionary principle has been invoked to ensure health protection in the Community, thereby giving rise to barriers to the free movement of food. By adopting a uniform basis throughout the Community, the possibility of an improper use of this principle is diminished. (18) The precautionary principle has been invoked to ensure health protection in the Community, thereby giving rise to barriers to the free movement of food. By adopting a uniform basis throughout the Community, the possibility of an improper use of this principle is diminished. In the interests of consumer protection, the precautionary principle must also apply to food and feed imported from third countries. Measures taken on the basis of the precautionary principle must apply both to goods produced in the EU and food and feed imported from third countries, in order to ensure compliance with European standards. In this way, distortions of competition can be prevented. RR\ doc 9/195 PE

10 Amendment 9 Recital 22 (22) A food business operator is best placed to devise a safe system for supplying food and ensuring that the food it supplies is safe; thus, he should have primary legal responsibility for ensuring food safety. Although this principle exists in some Member States and areas of food law, in other areas, this is either not explicit or else responsibility is assumed by the competent authorities of the Member State, through the control activities they carry out. Such disparities are liable to create barriers to trade and distort competition between food business operators in different Member States. (22) A food business operator is best placed to devise a safe system for supplying food and ensuring that the food it supplies is safe; thus, s/he should have primary legal accountability for ensuring food safety. Although this principle exists in some Member States and areas of food law, in other areas, this is either not explicit or else responsibility is assumed by the competent authorities of the Member State, through the control activities they carry out. Such disparities are liable to create barriers to trade and distort competition between food business operators in different Member States. The food operator should not merely have legal responsibility but accountability Amendment 10 Recital 22a (new) (22a) In the light of recent food safety scandals, illegal practices that have the potential to endanger consumer safety need to be reported. Employees and external inspectors should therefore have the reassurance that any concerns they may have should not be detrimental to their employment. To reflect the amendments proposed by the rapporteur to Article 14 (2) and Article 15 (2). PE /195 RR\ doc

11 Amendment 11 Recital 29 a (new) (29 a) Recognises the role of SMEs in maintaining the cultural diversity of food throughout the EU and underlines the need to ensure necessary measures to support their capacity to comply with new safety and hygiene rules. It is important to make reference to Small and Medium Enterprises. It is noted that 30% of the sector's 2.6 million workers are employed in SMEs. New rules should not be at the expense of traditional and local products which are often sustained in production by SMEs. Amendment 12 Recital 32 The Authority should take on the role of an independent scientific point of reference and in so doing should assist in ensuring the smooth functioning of the internal market. It may be called upon to give opinions on contentious scientific issues, thereby enabling Member States to take informed risk-management decisions necessary to ensure food safety whilst helping avoid the fragmentation of the internal market through the adoption of unjustified or unnecessary obstacles to the free movement of food. The Authority should take on the role of an independent scientific point of reference and in so doing should assist in ensuring the smooth functioning of the internal market. It may be called upon to give opinions on contentious scientific issues, thereby enabling Member States to take informed risk-management decisions necessary to ensure food safety and food hygiene whilst helping avoid the fragmentation of the internal market through the adoption of unjustified or unnecessary obstacles to the free movement of food. Safety alone without hygiene is restrictive. Food should have two basic characteristics, (a) be healthy and (b) be safe. RR\ doc 11/195 PE

12 Amendment 13 Recital 33 (33) The Authority's role as an independent scientific point of reference means that a scientific opinion may be requested not only by the Commission, but also by the European Parliament and the Member States or a competent national body. Steps should also be taken to help avoid conflicting scientific opinions and, in the event of conflicting scientific opinions between several scientific bodies, procedures should be in place to solve the conflict or provide the risk managers with a transparent basis of scientific information. (33) The Authority's role as an independent scientific point of reference means that a scientific opinion may be requested not only by the Commission, but also by the European Parliament and the Member States or a competent national body not only before but also during the legislative process. Steps should also be taken to help avoid conflicting scientific opinions and, in the event of conflicting scientific opinions between several scientific bodies, procedures should be in place to solve the conflict or provide the risk managers with a transparent basis of scientific information. Each body involved in the legislative process and which has a significant influence on it must be able and prepared to submit its own proposals for amendments for examination by the Authority as the independent scientific point of reference. Amendment 14 Recital 34 (34) The Authority should be an independent source of information and risk communication in order to improve consumer confidence. (34) The Authority should be an independent source of information and risk communication in order to improve consumer confidence. Therefore the link between risk assessment and risk management should be strengthened. To reflect the principle set by the proposed amendment to Article 22 (c a) (new). PE /195 RR\ doc

13 Amendment 15 Recital 35 (35) A system for rapid alert already exists in the framework of Council Directive 92/59/EEC of 29 June 1992 on general product safety. The scope of the existing system includes food and industrial products but not feed. Recent food crises have demonstrated the need to set up an improved and broadened rapid alert system covering food and feed. This revised system should be operated by the Authority. The system should not cover the early exchange of information in the event of a radiological emergency established in Council Decision 87/600/Euratom. (35) A system for rapid alert already exists in the framework of Council Directive 92/59/EEC of 29 June 1992 on general product safety. The scope of the existing system includes food and industrial products but not feed. Recent food crises have demonstrated the need to set up an improved and broadened rapid alert system covering food and feed. This revised system should be operated by the Authority. with ultimate responsibility resting with the Commission. The system should not cover the early exchange of information in the event of a radiological emergency established in Council Decision 87/600/Euratom. To reflect the principle set by the proposed amendment to Article 50. Amendment 16 Recital 39 a (new) (39 a). The EFSA will contribute on the basis of its opinions, to the Community's role in the development and establishment of international food safety standards and trade agreements with the objective of promoting free world trade in food products which meet internationally agreed and acceptable safety standards. This reiterates the position taken in the opinion (PE ) of the ITRE Committee on the Commission's White Paper on Food Safety. RR\ doc 13/195 PE

14 Amendment 17 Recital 41 (41) It is necessary to ensure that there is effective monitoring of the Authority by the various Community institutions involved, and for this purpose its Management Board should include four representatives appointed by the European Parliament, four by the Council, and four by the Commission. The Management Board should have the necessary powers to establish the budget, check its implementation, draw up internal rules, adopt financial regulations, appoint members of the Scientific Committee and Scientific Panels and appoint the Executive Director. deleted The composition of the Management Board is modified by an amendment to Article 24, paragraph 1. Amendment 18 Recital 42 (42) it is necessary to build up a relationship of confidence and transparency with the general public, and therefore the Management Board should include four representatives of consumers and industry; (42) it is necessary to build up a relationship of confidence and transparency with the general public, and therefore the Management Board should include people with experience of food and feed production, processing and retailing, and as food consumers; The number should not be limited to a particular figure and those appointed should not be PE /195 RR\ doc

15 seen as representatives of any particular interest, but rather should have between them a wide range of relevant experience. Amendment 19 Recital 49 (49) The establishment of the Authority should enable Member States to become more closely involved in scientific procedures; there should therefore be close cooperation between the Authority and the Member States for this purpose. In particular, the Authority should be able to assign certain tasks to organisations in the Member States. (49) The establishment of the Authority should enable Member States to become more closely involved in scientific procedures; there should therefore be close cooperation between the Authority and the Member States for this purpose. In particular, the Authority should be able to assign certain tasks to authorised competent organisations in the Member States. Specifies organisations having competence or the competence for the assignment referred to. Amendment 20 Recital 50 (50) It is necessary to ensure that a balance is struck between the use of national organisations carrying out tasks for the Authority and the need to ensure for the purposes of overall consistency that such tasks are carried out in line with the criteria established for such tasks for the Authority. Existing procedures for the allocation of scientific tasks to the Member States, in particular with regard to the evaluation of dossiers presented by industry for the authorisation of certain substances, products or procedures, should be reexamined within a year to take into account (50) It is necessary to ensure that a balance is struck between the use of national authorised competent organisations carrying out tasks for the Authority and the need to ensure for the purposes of overall consistency that such tasks are carried out in line with the criteria established for such tasks for the Authority. Existing procedures for the allocation of scientific tasks to the Member States, in particular with regard to the evaluation of dossiers presented by industry for the authorisation of certain substances, products or procedures, should be re-examined within RR\ doc 15/195 PE

16 the establishment of the Authority and the new facilities it offers a year to take into account the establishment of the Authority and the new facilities it offers. However, such scrutiny should remain at least as stringent as current processes. Specifies organisations having competence or the competence for the assignment referred to. The EFSA may become an alternative source of validation but it should not be seen as a more permissive one. Amendment 21 Recital 51 (51) The independence of the Authority and its role in informing the public mean that it should be able to communicate autonomously in the fields falling within its competence, its purpose being to provide objective, reliable and easily understandable information. However, the Commission remains fully responsible for communicating risk management measures; the appropriate information should therefore be exchanged between the Authority and the Commission. (51) The independence of the Authority and its role in informing the public mean that it should be able to communicate autonomously in the fields falling within its competence, its purpose being to provide objective, reliable and easily understandable information, including all recommendations to risk managers. To reflect the principle set by the proposed amendment to Article 39 (3). Amendment 22 Recital 51a (new) (51a) The Commission remains fully responsible for communicating risk management measures; the appropriate information should therefore be exchanged PE /195 RR\ doc

17 between the Authority and the Commission. (see wording of Recital 51, second part) For reasons of clarity. Amendment 23 Recital 54 (54) The Authority should be financed by the Community budget. however, in the light of experience acquired, in particular with regard to the processing of authorisation dossiers presented by industry, the possibility of fees should be examined within three years after the entry into force of the Regulation. The Community budgetary procedure remains applicable as far as any subsidies chargeable to the general budget of the Communities are concerned; moreover, the auditing of accounts should be undertaken by the Court of Auditors. (54) The Authority should be financed by the Community budget. The Community budgetary procedure remains applicable as far as any subsidies chargeable to the general budget of the Communities are concerned; moreover, the auditing of accounts should be undertaken by the Court of Auditors. To reflect the proposed amendment to Article 44. Amendment 24 Recital 56 (56) Recent food safety incidents have demonstrated the need to establish appropriate measures in emergency situations ensuring that all foods, whatever (56) Recent food safety incidents have demonstrated that the Commission has been unable to react in an effective and expedient manner and that there is a clear RR\ doc 17/195 PE

18 their type and origin, should be subject to common measures in the event of a serious risk to human health. Such a comprehensive approach to emergency food safety measures should allow effective action to be taken and avoid artificial disparities in the treatment of food representing a serious risk to human health. need to establish appropriate measures in emergency situations ensuring that all foods, whatever their type and origin, should be subject to common measures in the event of a risk to human health. Such a comprehensive approach to emergency food safety measures should facilitate effective action to be taken and avoid artificial disparities in the treatment of food representing a risk to human health. (Part of this amendment ("serious risk") applies throughout the text) Whilst accepting that there is no such thing as zero risk, the precautionary principle requires risk to be quantified wherever it is perceived, and not only by the more drastic criteria. Amendment 25 Recital 57 (57) Recent food crises have also shown the benefits to the Commission of having properly adapted, more rapid procedures for crises management. These organisational procedures should make it possible to improve coordination of effort and to determine the most effective measures on the basis of the best scientific information; therefore, revised procedures should take into account the Authority's responsibilities and should provide for its scientific and technical assistance in the event of a food crisis. (57) Recent food crises have also shown the benefits to the Commission of having properly adapted, more rapid procedures for crises management. These organisational procedures should make it possible to improve coordination of effort and to determine the most effective measures on the basis of the best scientific information; therefore, revised procedures should take into account the Authority's responsibilities and should provide for its scientific and technical assistance in the form of advice in the event of a food crisis. The advisory as opposed to regulatory nature of the authority should be clearly expressed and stressed. Amendment 26 Article 1, paragraph 1 PE /195 RR\ doc

19 1. This Regulation provides the basis for the assurance of a high level of protection of human life and health and consumers interest in relation to food, whilst ensuring the effective functioning of the internal market. It establishes common principles, definitions and responsibilities, a strong science base, efficient organisational arrangements and procedures to underpin decision-making in matters of food safety. 1. This Regulation provides the basis for the assurance of a high level of protection of human health and consumers interest in relation to food, whilst ensuring the effective functioning of the internal market geared towards quality and diversity in the supply of food, without therefore penalising typical or traditional products. It establishes common principles, definitions and responsibilities, a strong science base, efficient organisational arrangements and procedures to underpin decision-making in matters of food safety and food quality. The expression protection of human life may lead to misunderstandings and is already included in the expression protection of human health. It must also be emphasised that the internal market must be made to work effectively and at the same time a European food model must be developed which is based on food quality, diversity and safety and which does not therefore penalise typical or traditional products, as is often the case. Food quality and food safety are the two major objectives of the new authority and of European food law. Amendment 27 Article 1(3) 3. This Regulation shall apply to all stages of production and distribution of food and feed. It shall not apply to primary production for private domestic use or to the domestic preparation, handling or storage of food for domestic consumption. 3. This Regulation shall apply to all stages of production, processing and distribution of food and feed, whether produced within the EU or imported. It shall not apply to primary production for private domestic use or to the domestic preparation, handling or storage of food for domestic consumption. Processing is also part of the food chain. In the interests of consumer protection, the same standards must be imposed on imported goods as apply to food and feed produced in the EU. RR\ doc 19/195 PE

20 Amendment 28 Article 2, paragraph 2 It includes drink, chewing gum and any substance intentionally incorporated into the food during its manufacture, preparation or treatment. It includes water, without prejudice to the requirements of Directives 80/778/EEC and 98/83/EC. It includes drink, chewing gum, food supplements and any substance intentionally incorporated into the food during its manufacture, preparation or treatment and still present in it. It includes water, without prejudice to the requirements of Directives 80/778/EEC and 98/83/EC. Questions with regard to classification often arise in the case of these products. The clear inclusion in the definition of food or food supplement should help to solve many of these problems. Amendment 29 Article 2, paragraph 3, point (d) (d) medicinal products within the meaning of Council Directive 65/65/EEC (d) substances or products used only as medicinal products within the meaning of Council Directive 65/65/EEC The definition proposed by the Commission is not suitable for resolving issues relating to the distinction between foodstuffs and medicinal products, as it does not contain any criteria on which to base relevant decisions. This amendment is based on the wording of the Codex Alimentarius ('but does not include cosmetics or tobacco or substances used only as drugs'). The main purpose of the consumption of a substance or product serves as the criterion for drawing the distinction: medicinal product if the purpose is medicinal; foodstuff if the purpose is nutritional or if consumption is for enjoyment. Amendment 30 Article 3, paragraph -1a (new) PE /195 RR\ doc

21 (-1a) 'final consumer' means the ultimate consumer of a foodstuff who does not use the food as part of any food business operation or activity; The proposal for a regulation does not contain a definition of this term. Amendment 31 Article 3, paragraph 1 1. food law means the laws, regulations and administrative provisions governing food in general, and food safety in particular, in the Community; it covers all stages of production and distribution of food, and also feed where feed may have an adverse effect on food safety; 1. food law means the laws, regulations and administrative provisions governing food in general, and food safety in particular, whether at Community or national level; it covers all stages of production and distribution of food, and also feed where feed may have an adverse effect on food safety; Clarification. Amendment 32 Article 3, paragraph 2 (2). 'food business means any undertaking, whether for profit or not and whether public or private, carrying out any of the activities related to the stages of production and distribution of food; (2). 'food business means any undertaking, whether for profit or not and whether public or private, carrying out any of the activities related to all stages of production and distribution of food; The provisions of Chapters I & II also need to apply to storage and distribution, which can RR\ doc 21/195 PE

22 also contribute to hazards in food presented for human consumption. See amendment to Article Amendment 33 Article 3(2a) (new) 'ingredient' means any substance, including additives, used in the manufacture or preparation of a food product which is still present, even if in modified form, in the finished product. This amendment is in the interests of supplying a set of definitions that is as clear and comprehensive as possible. Amendment 34 Article 3 (4) 4. feed or feedingstuff means products of vegetable or animal origin in their natural state, fresh or preserved, and products derived from industrial preparation thereof, intended for oral feeding to food-producing animals; 4. feed product means products of vegetable or animal origin in their natural state, fresh or preserved, and products derived from industrial preparation thereof, for use in feeding animals; This amendment applies throughout the text) Feed products also include feed additives which are not feed. Amendment 35 Article 3, paragraph 5 PE /195 RR\ doc

23 (5). feed business means any undertaking whether for profit or not and whether public or private, carrying out any operation of production, manufacture, processing, storage or distribution of feed including any agricultural producer producing, processing or storing feed for feeding to food animals on his own holding; (5). feed business means any undertaking whether for profit or not and whether public or private, carrying out any operation of production, manufacture, processing, storage, transport and distribution of feed including any agricultural producer or other producers which farm animals for feed, including fish farmers, producing, processing or storing feed for feeding to food animals on the holding of that undertaking; : The provisions of Chapters I & II also need to apply to transport, which can also contribute to hazards in food presented for human consumption..clearly provisions on animal feed must include fish farmers. Amendment 36 Article 3, paragraph 7 (7) retail trade means the handling and/or processing of food and its storage at the point of sale or delivery to the final consumer, and includes mass catering operations, factory canteens, institutional catering, restaurants and other similar food service operations, shops, supermarket distribution centres and wholesale outlets; (7) "retail trade" means the handling and/or processing of food and its storage at the point of sale or delivery to the final consumer, and includes shops, supermarket distribution centres and wholesale outlets; The wording of Article 3(7) is modified in order to allow for a clear distinction to be made between the different characteristics of retail trade and the food service sector. As it stands, the original formulation does not make this distinction with adequate clarity. Amendment 37 Article 3, paragraph 7 a (new) (7 a). "food service" means the handling and/or processing of food and its storage at RR\ doc 23/195 PE

24 the point of sale or delivery to the final consumer, and includes mass catering operations, factory canteens, institutional catering, restaurants and other similar food service operations. The wording of Article 3(7) is modified in order to allow for a clear distinction to be made between the different characteristics of retail trade and the food service sector. As it stands, the original formulation does not make this distinction with adequate clarity. Amendment 38 Article 3, paragraph 8 (8). placing on the market means the holding of food or feed for the purpose of sale, including offering for sale or any other form of transfer, whether free of charge or not, to third parties, and the sale and other forms of transfer themselves; (8). placing on the market means the placing in circulation or holding of food or feed for the purpose of sale, including offering for sale or any other form of transfer, whether free of charge or not, to third parties, and the distribution, sale and other forms of transfer themselves; The provisions of Chapters I & II also need to apply to distribution, which can also contribute to hazards in food presented for human consumption. Amendment 39 Article 3 (9) 9. official control means any inspection, verification audit, sampling, laboratory examination or analysis or other means of performing controls by the competent authority of the Member States or their agents or by the services of the Commission with a view to ensuring compliance with food law and to protecting 9. official control means any inspection, verification audit, sampling, laboratory examination or analysis or other means of performing controls by the competent authority of the Member States or their agents or by the services of the Commission with a view to ensuring compliance with food law and to protecting PE /195 RR\ doc

25 human health and consumer interests; human and animal health and consumer interests; Official control should also extend to the protection of animal health. Amendment 40 Article 3, paragraph risk management means the process, distinct from risk assessment, of weighing policy alternatives in consultation with interested parties, considering risk assessment and other legitimate factors, and, if need be, selecting appropriate prevention and control options; 13. risk management means the process, following on from risk assessment, of weighing policy alternatives after consideration of the scientific conclusions drawn from the process of risk assessment in consultation with interested parties, and selecting appropriate prevention and control options; This is a more precise definition which is important when it comes to allocating responsibilities to the European Food Authority. Amendment 41 Article 3, paragraph 16 (16) 'traceability' means the ability to trace a food, feed, food-producing animal or ingredient, through all stages of production distribution ; (16) 'traceability' means the ability with the objective of food safety to trace a food, feed, food-producing animal or ingredient, through all stages of production distribution including retail sale; The point of this amendment is to clarify that the principle of traceability is food safety. RR\ doc 25/195 PE

26 Amendment 42 Article 3, paragraph 17 (17). all stages of production and distribution means all stages from and including the primary production of a food, up to and including its sale or supply to the final consumer and, where relevant to food safety, the production, manufacture and distribution of feed; (17). all stages of production, processing and distribution means all stages from and including the primary production of a food, up to and including its storage, transport, sale or supply to the final consumer and, where relevant to food safety, the production, manufacture, storage, transport and distribution of feed; The provisions of Chapters I & II also need to apply to storage and transport, which can also contribute to hazards in food presented for human consumption. Processing is also part of the food chain. Amendment 43 Article 3, paragraph 18 (18). unfit for human consumption or contaminated means that the food is unacceptable for human consumption according to its intended use, for reasons of contamination, whether by extraneous matter or otherwise, or through putrefaction, deterioration or decay; (18). unfit for human consumption means that the food is unacceptable for human consumption, where putrefaction, deterioration or decay would cause harm to human health; The definition suggested by the Commission is considered to be too vague and open to a wide interpretation. See amendment to Article 3.18 a (new). Amendment 44 Article 3, paragraph 18a (new) (18a) 'contaminated' means that the food is unacceptable for human consumption PE /195 RR\ doc

27 for reasons of pollution by extraneous matter above levels that are approved as safe. The definition suggested by the Commission in Article 3, paragraph 18 is considered to be too vague and open to a wide interpretation, and does not cover the term 'contaminated'. It should also relate to safe levels approved under other legislation. Amendment 45 Article 3, paragraph 19 (19) primary production means the production, rearing or growing of primary products up to and including harvesting, milking and farmed animal production prior to slaughter. It also includes hunting and fishing. (19) primary production means the production, rearing or growing of primary products up to and including harvesting, milking and farmed animal production prior to slaughter. It also includes hunting and fishing and the harvesting of wild products for commercial purposes. Amendment 12 to Article 3, paragraph 19 is withdrawn in favour of this new amendment to cover a wider range of products. Amendment 46, Article 3, paragraph 19a (new) (19a) 'marketing' means holding, displaying and offering for sale, selling, delivering or any other form of placing on the market in the Community; RR\ doc 27/195 PE

28 The proposal for a regulation does not contain a definition of this term. Amendment 47 Article 4, initial paragraph This Chapter shall relate to all stages of the production and distribution of food and to feed produced for, or fed to, food-producing animals. This Chapter shall relate to all stages of the production, processing and distribution of food and to feed produced for, or fed to, food-producing animals and importation and exportation of foods and feed products. Processing is also part of the food chain. The scope of the proposal should be defined more clearly and should include importation and exportation of foods and feed products. Amendment 48 Article 4, paragraph 2 The general principles laid down in Articles 5 to 8 shall form a general framework of a horizontal nature to be followed when new measures are established. The general principles laid down in Articles 5 to 8 shall form a general framework of a horizontal nature in respect of food law in general. The draftsman welcomes the principles laid down. They should in future be applied both when new measures are established and in applying existing provisions. Amendment 49 Article 5, paragraph 1 Food law shall pursue one or more of the general objectives of the protection of Food law shall pursue one or more of the general objectives of the protection of PE /195 RR\ doc

29 human life, health or safety, the protection of consumers interests, and other objectives, including, where appropriate, the protection of the environment, the protection of animal health, life and welfare and the protection of plant health and life. human life, health or safety, the protection of consumers interests, and other objectives, including, where appropriate, measures to combat food fraud, the protection of the environment, the protection of animal health, life and welfare and the protection of plant health. Criminal networks involved in food fraud aimed at defrauding the Community budget, Community consumers and the outside world are being discovered in spheres such as dairy products, meat, oil and wine, but the European institutions seem incapable of making an adequate response to it. Because of the scale of the fraud, measures to combat it must be conducted in an integrated way, be treated as a priority and be one of the priorities of the new European Food Authority. Animal health and welfare and plant health are the correct terms to be used within the context of this Regulation, in relation to the protection of human life. Amendment 50 Article 5, paragraph 1(a) (new) 1a. Food law is one of the instruments available to the Community for developing the European food model on the basis of the principles of quality, diversity and safety. It is in the interests both of consumers and of producers that a European food model based on the principles of quality, diversity and safety should be developed. The future food law should therefore constitute one of the instruments to be adopted by the Community for the purposes of achieving that objective. Amendment 51 Article 5 2 a (new) RR\ doc 29/195 PE

30 (a) Seeks to ensure that the same regulations in respect of chemical and antibiotic use, are applied to aquaculture products imported into the EU, as are applied to community produced products. Currently, aquaculture products from outwith the EU can be sold within the EU, despite having been exposed to medicines, chemicals and antibiotics unlicensed in the community. Amendment 52 Article 5, paragraph 3 3. Where international standards exist or their completion is imminent, they shall be taken into consideration in the development or adaptation of food law, except where such standards or relevant parts would be an ineffective or inappropriate means for the fulfilment of the legitimate objectives of food law or there is a scientific justification, or where they would result in a different level of protection than the one determined as appropriate in the Community. 3. Where international standards exist or their completion is imminent, they shall be complied with in the development or adaptation of food law, except where they would result in a lower level of protection than the one determined as appropriate in the Community. International standards should be met so long as this will not result in lowering standards. Amendment 53 Article 6, paragraph 1 1. Food law shall aim to achieve a high level of health protection, and shall be based on risk analysis except where this is 1. Food law shall aim to achieve a high level of health protection, and shall be based on risk analysis except where such PE /195 RR\ doc

31 not appropriate to the circumstances or the nature of the measure. measures are intended to correct and eliminate misleading information and harmful packaging. The definition suggested by the Commission is considered to be too vague and open to a wide interpretation. The Commission make it clear in the Explanatory Memorandum that a risk analysis procedure is not needed to prove that information is misleading and/or packaging is harmful to the consumer. Amendment 54 Article 6, paragraph 3 3. Risk management shall take into account the results of risk assessment, and in particular, the opinions of the European Food Authority established in Article 21, and other factors as legitimate to the matter under consideration. 3. Risk management shall take into account the results of risk assessment, and in particular, the opinions of the European Food Authority established in Article 21, and other international legitimate factors relevant for the health protection of consumers. In order to ensure that other factors are taken into account in a consistent manner worldwide, it is suggested to introduce the Codex wording when defining 'other factors'. Amendment 55 Article 7, paragraph 1 1. In those specific circumstances where, following an assessment of available pertinent information, a risk to health is identified but scientific uncertainty persists, provisional risk management measures necessary to ensure the high level of health protection chosen in the Community may be adopted, pending further scientific information for a more comprehensive risk 1. In those specific circumstances where, following an assessment of available pertinent information, a risk or potential risk to health, either from products from Member States or from imports from third countries, is identified but scientific uncertainty persists, provisional risk management measures necessary to ensure the high level of health protection chosen in RR\ doc 31/195 PE

32 assessment. the Community shall be adopted by the appropriate public authorities, pending further scientific information for a more comprehensive risk assessment. The Commission Communication of 2 February 2000 on the precautionary principle (COM(2000)1 final), which was endorsed by the European Parliament on 14 December 2000, includes well-defined criteria for the adoption of the most appropriate course of action in cases of scientific uncertainty. Hence there is no reason for adding further criteria which, moreover, would be poorly defined or formulated. Amendment 56 Article 7, paragraph 2 2. Measures adopted on the basis of paragraph 1 shall be proportionate and no more restrictive of trade than is required to achieve the high level of health protection chosen in the Community, regard being had to technical and economic feasibility and other factors regarded as legitimate in the matter under consideration. The measures shall be reviewed within a reasonable period of time, depending on the nature of the risk to life or health identified and the type of scientific information needed to clarify the scientific uncertainty and to conduct a more comprehensive risk assessment. 2. Measures adopted on the basis of paragraph 1: (a) shall presuppose consideration of the benefits and the costs stemming from action or inaction; (b) must be proportionate to the level of protection sought; (c) must not, when they are implemented, cause discrimination; (d) must be consistent with measures which have already been adopted in similar situations and using similar approaches; (e) must be reconsidered and, if necessary, modified on the basis of the results of scientific research and monitoring of the impact which they produce. The Commission Communication of 2 February 2000 on the precautionary principle (COM(2000)1 final), which was endorsed by the European Parliament on 14 December 2000, PE /195 RR\ doc