Select Committee on European Scrutiny Eighth Report


EIGHTH REPORT

The European Scrutiny Committee has made further progress in the matter referred to it and has agreed to the following Report:—

GENERAL PRINCIPLES AND REQUIREMENTS OF FOOD LAW

(21886)
14174/00
COM(00) 716

Draft 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.


Legal base: Articles 37, 95, 133 and 152(4)(b) EC; co-decision (Articles 95 and 152), consultation (Article 37); qualified majority voting
Document originated: 8 November 2000
Forwarded to the Council: 30 November 2000
Deposited in Parliament: 11 December 2000
Department: Health
Basis of consideration: EM of 21 January 2001
Previous Committee Report: None; but see (20875) 5761/00: HC 23-x (1999-2000), paragraph 2 (1 March 2000)
To be discussed in Council: June 2001
Committee's assessment: Legally and politically important
Committee's decision: For debate on the Floor of the House (with the draft Council Regulation and Directive on food hygiene recommended for debate on 17 January 2001)

Background

  1.1  In the last few years, the Commission has issued two major documents dealing with the general principles governing food law in the Community. First, a Green Paper in April 1997[10] sought to launch a public debate by examining how the existing legislation was meeting the needs of producers and consumers. It identified a number of basic goals, such as the need to ensure a high level of public heath and safety for the consumer, that legislation is based primarily on scientific evidence and risk assessment, and that primary responsibility for food safety is placed on industry, producers and suppliers. It also said that, while risk assessment may be delegated to scientific bodies, the responsibility for risk management at Community level should remain with the Council, Commission and European Parliament.

  1.2  This document was followed in January 2000 by a White Paper,[11] which made it clear that the Commission regards providing the Community with the highest possible standards of food safety as a key policy priority, and that, in order to achieve this, every link in the production chain must be as strong as the others. It concluded that, whilst the present system had generally functioned well, there needed to be a comprehensive and integrated approach to food safety, and that, although this did not mean the Community should be exclusively responsible, all aspects of the subject needed to be addressed at Community level.

  1.3  The White Paper addressed a number of more specific issues. These included the guiding principles of food safety (covering such matters as the sectoral coverage, the interface between the Community and the Member States, the importance of wider considerations, such as those affecting the environment, and the need for the responsibilities of all concerned to be clearly defined); the need for comprehensive and effective food safety monitoring and surveillance systems, integrating all the present information sources; the adequacy of the present arrangements for obtaining quality scientific advice; the need for an extensive legislative programme to provide a more coherent framework; and the need for improvements in such areas as internal and external controls and the provision of information to consumers. However, the central feature in the White Paper was the proposal for the establishment of an independent European Food Authority (EFA), which would give effect to the general principles and requirements of food law, and so contribute to a high level of health protection and improved consumer confidence, whilst maintaining a clear separation of responsibilities between it and other Community bodies for risk assessment and risk management.

The current proposal

  1.4  The present document addresses the establishment of a European Food Authority and the need for agreed common principles underlying Community food legislation as envisaged in the White Paper, but it also proposes certain procedural changes; introduces a mediation procedure in cases of dispute between Member States; and sets up a Commission Standing Committee on Food Safety and Animal Health.

Chapter I: Scope and definitions

  1.5  The Commission states that the aim of the proposal is to provide a common comprehensive basis for food law, establishing the common principles underlying it, defining common terms, and creating a general framework for food law. In particular, it notes that, although definitions of food exist at an international level in Codex Alimentarius and within most Member States, no such definition exists in Community law. It therefore seeks to make good that omission by proposing that food should be defined as any substance which is intended to be, or is reasonably expected to be, ingested by humans, thus ensuring that substances (such as palm oil), which may find their way into different industry sectors, are handled with the same care until it is clear that they will not become a food. In addition to raw materials and ingredients, the definition also includes all water[12] intended for human consumption. The term "food law" is also defined, but in a way which includes all measures relating to materials and substances in contact with food, to practices on the farm, and also to animal feed given to food-producing animals, where there may be a direct or indirect impact on food safety.

Chapter II: General objectives of food law

  1.6  The Commission says that the proposal establishes the over-arching principles of food law. It sees the primary objectives as ensuring the effective functioning of the internal market, and providing a high level of protection for human health, safety and consumer interests, based on an integrated approach from the farm to the final consumer (as in its recent proposal[13] recasting the Community's food hygiene provisions). This would include measures applicable on the farm, and, where directly or indirectly relevant to food safety, to feed businesses; and, where necessary, it would cover animal or plant health and the protection of the environment. The Commission also envisages that food law would deal with other consumer interests relating to deceptive practices, the adulteration of food, and the need for any information provided to be accurate.

  1.7  The proposal then addresses a number of more specific aspects as follows:

— Principles of risk analysis

  1.8  The proposal establishes the principles of risk analysis, and the structures and mechanisms relating to the necessary scientific and technical evaluation, which it says will in the main be undertaken by the EFA. It emphasises the need for risk assessment, management and communication, and for any measures taken both to be underpinned by strong, independent and objective science, and to take into account such considerations as feasibility, socio-economic effects and environmental impact.

— The precautionary principle

  1.9  The Commission recalls its Communication[14] on this subject last year, and points to the validity of this approach, where there are reasonable grounds for concern that an unacceptable level of risk to health exists, but where the supporting information may not be sufficient to enable a comprehensive assessment to be made. It also says that such measures have to comply with the normal principles of non-discrimination and proportionality, and need to be reviewed within a reasonable period.

— Traceability

  1.10  The Commission suggests that recent food scares, such as those involving BSE and dioxins, have demonstrated the prime importance for consumer protection of identifying at all stages of production and distribution the origin of feed, food (including ingredients) and food sources, both in enabling food to be withdrawn and in providing accurate information on implicated products. The proposal requires food and feed businesses, including importers, to have in place systems enabling them to identify both those supplying them foods, feed and food-producing animals, and those to whom they have supplied such products. Provision would also be made for this information to be made available on request to the competent authorities.

— Responsibilities

  1.11  The Commission points out that, in some areas of European food law, notably dealing with hygiene, the primary responsibility for ensuring compliance rests with the food business, backed up by adequate and effective Member State controls. It proposes that this principle should be extended to all food law, and that there should be a general review to establish whether the principle has been respected, or whether Community legislation has unnecessarily taken responsibility away from business by prescribing how a given objective has to be achieved rather than fixing the objective.

— Food and feed safety

  1.12  The Commission says there is no over-arching principle in European food law for only safe food to be placed on the market, although such a principle does exist in several Member States. This proposal aims to fill that gap by establishing a requirement that food should not be potentially injurious to health, or unfit for consumption or contaminated, such that it would be unreasonable for it to be consumed in the way intended. The potentially injurious nature of food would take into account its likely use, the information provided to the consumer, and any processing or subsequent handling to which it would be subject, though the Commission is at pains to stress that processing does not abrogate the need to ensure that safety is considered all along the supply chain.

  1.13  Other aspects dealt with in this context include the need to consider, not just acute effects, but also those circumstances (for example, relating to prions) where a long incubation period is involved; those foods marketed for particularly sensitive consumers; and foods which may not strictly be injurious, but which it would not be reasonable to expect to be used for human consumption. There would be a general obligation on all food businesses to ensure that the food they put on the market complies with the principles of safety at all stages under their control, and to inform the authorities where a food (including any imported) is considered to be unsafe: but, provided a business ensures that a food complies with the specific provisions applicable to it, it would be deemed to have met its responsibilities.

— International obligations and trade in foods

  1.14  The proposal acknowledges the Community's commitments to its international obligations under the World Trade Organisation (WTO), to the development of international technical standards for foods, and to use these wherever possible to promote free trade in safe and wholesome foods. However, it notes that WTO members may require higher health standards where risk assessment shows these to be necessary, and it comments that the Community has a vital interest in ensuring its high standards of food law are widely accepted internationally.

— Principle of transparency

  1.15  The proposal stresses the need for the greater involvement of stakeholders at all stages in the development of food law, and for mechanisms to increase consumer confidence in food law, which it sees as an essential part of a successful food policy.

Chapter III: The European Food Authority (EFA)

  1.16  The Commission recalls the general role which the White Paper on Food Safety envisaged for the EFA (and which is summarised in paragraph 1.3 above). The proposal sets out in more detail how these aims might be achieved.

— Mission and tasks

  

  1.17  The Commission says that, if the EFA is to take a comprehensive view, it must have a broad mandate, covering not just food safety and certain aspects of nutrition, but also plant and animal health and animal welfare; its competence should extend to all matters having a direct or indirect impact on consumer health and safety, and should cover all stages from primary production to the final consumer. It should also take into account environmental risk, and provide scientific opinions on genetically modified organisms (though the Commission says that, where a GMO is not intended for human or animal consumption, the Authority's remit should not extend beyond the provision of opinions). At the same time, advice on nutrition and health will need to be coordinated by the Commission and Member States to avoid confusing the public.

  1.18  More specifically, the Authority's tasks will be:

    —  to provide the Community and Member States with the best possible scientific opinions;

    —  to promote the harmonisation of risk assessment methodologies;

    —  to provide scientific and technical support to the Commission;

    —  to commission scientific studies necessary for the accomplishment of its mission;

    —  to collect and analyse relevant scientific and technical data;

    —  to identify emerging risks with a view to reducing or preventing them;

    —  to establish a network of organisations operating in relevant fields;

    —  to operate a rapid alert system for food and feed;

    —  to provide scientific assistance in the Commission's crisis management procedures for food safety;

    —  to provide scientific assistance to improve co-operation between the Community, applicant countries, international organisations and third countries;

    —  to provide assistance in communicating nutritional issues; and

    —  to ensure that the public and interested parties receive rapid and reliable information.

— Organisation

  1.19  The Commission stresses the need to facilitate the involvement of the EFA's many and diverse stakeholders, to ensure its independence from external pressures, and to provide for transparency and democratic accountability. It has therefore proposed that the Authority should have a Management Board which includes four representatives appointed by the Council of Ministers, four by the Commission, four by the European Parliament, and four representatives of consumers and industry designated by the Commission. Its functions would include ensuring that the Authority performs the tasks assigned to it, adopting the Authority's annual work programme, and adopting its annual budget. The Commission also believes that there should be an Advisory Forum comprising representatives of the analogous Member States bodies, which it suggests should ensure that the Authority makes the best use of Member States' expertise.

  1.20  The proposal also envisages a radical restructuring of the six independent scientific committees[15] which advise the Commission on matters to be covered by the EFA. In order to reflect the current emphasis on a farm-to-table approach, and also to ensure greater scientific coherence in related areas and to anticipate future needs, these would be replaced by eight permanent panels,[16] each with its own sphere of competence, and a scientific committee which would provide general co-ordination and deal with issues falling within the competence of several of the panels, or none of them. The proposal also seeks to address the lack of capacity, highlighted in the White Paper, of the existing committees to address the increasing number and urgency of the issues put before them. It would do this by providing members with administrative and scientific support, using both in-house expertise and the support of the Member States in preparatory work.

— Scientific opinions

  1.21  At present, the role of the scientific committees is to advise the Commission, but it is now proposed that the European Parliament, the Member States or their competent bodies should be able to seek scientific opinions from the EFA, except in areas where consultation with the Authority is obligatory under Community law (where the right would be confined to the Commission). The extension of this right would, however, be subject to establishing a clear set of rules and criteria for such requests, so as to avoid overload, needless duplication, and distraction from priority tasks: these rules would be the subject of a further Commission proposal, following consultation with the EFA. In addition, the EFA would be able to issue opinions on its own initiative.

— Conflicting scientific opinions

  1.22  The Commission observes that differences of scientific opinion can complicate both risk management and communication. However, although it does not envisage that the EFA should be the final and binding arbitrator in such cases, the proposal gives the Authority an important role in anticipating conflicts, bringing the parties together, and identifying and agreeing the basis for differences of opinion; and it adds that, even if the EFA is unable by this means to resolve a conflict, the procedure would provide the Commission itself with a transparent basis on which to develop risk management proposals. In any event, it says that, where conflicting opinions arise, those concerned should work with the Authority to resolve the conflict. A similar approach would apply where the difference arises between the Authority and a national body, but, in that event, there would be consultation with the proposed Advisory Forum.

— Scientific and technical support

  1.23  The Commission says that, in addition to independent scientific opinions, it needs substantial on-line assistance on a wide range of matters which would not fall within the scope of the scientific committee and permanent scientific panels. It proposes that the EFA would provide such support by various means, including in-house expertise, external contracts with industry and research bodies, and Member State networks, but that, because of the potential pressure on resources, this would have to be provided as part of an agreed annual work programme.

— Scientific studies

  1.24  The Commission recalls that the White Paper identified the need for the EFA to have its own budget to undertake independent scientific studies where necessary. However, it comments that it is essential to make best use of existing resources and to develop synergies through appropriate consultation, and that such studies should have a relatively high degree of focus and be of short-term duration.

— Information and data collection

  1.25  The Commission says that the absence of a centralised mechanism for gathering and analysing information at Community level on food health and safety matters is a major weakness in current procedures, and in particular that information on food consumption, composition and the levels of potentially harmful substances is essential if the EFA is to evaluate nutrient intake and dietary exposure, especially for vulnerable groups. The proposal would give the Authority powers to collect and analyse such data, and would place on Member States an obligation to transmit relevant data to it.

— Identification of emerging risks

  1.26  The Commission says that early warning of emerging risks or newly identified concerns will allow preventive rather than curative measures to be taken, and that the EFA should therefore be able to identify and monitor emerging risks in liaison with Member States, international bodies and third countries.

— Networks of organisations in the same field

  1.27  The Commission observes that the establishment of an effective network of organisations operating in the same fields as the Authority will provide the mechanism by which expertise can be combined in the common interests of the Community, and give the EFA an overall capacity comparable with bodies such as the US Food and Drug Administration. It therefore proposes that the Authority should draw up a list of competent organisations designated by the Member States which could undertake, on a repayment basis, various tasks on its behalf, particularly in evaluating information submitted by industry in support of requests for Community- level authorisation of products and processes. At the same time, the Commission says that it will be essential to avoid the currently wide differences in the extent of the preparatory work undertaken by the Member States, and to ensure that all scientific evaluations meet the necessary standards of quality and independence. In addition, because this is a complex area, the Commission says it will publish, within 12 months of the Regulation coming into force, an inventory of the various systems of scientific support relevant to the EFA, accompanied by "appropriate proposals".

— Independence, transparency and confidentiality

  1.28  The Commission believes that acceptance of the EFA will depend crucially on it establishing a culture of independence and transparency at all levels of its operation. It therefore proposes that there should be a series of obligations on the Management Board, members of the scientific committee, scientific panels, and the Advisory Forum designed to ensure that the EFA's advice is "both truly and visibly independent". Some of the Management Board meetings would be held in public, and stakeholders would be able to observe some of the Authority's activities. Also, opinions of the scientific committee and panels, including minority opinions, would be published as soon as possible after their adoption. These provisions would be qualified by the need not to divulge confidential information, unless this is necessary to protect public health.

— Communication

  1.29  The White Paper highlighted the importance of direct and open communication with consumers, and the proposal will give the EFA the right of initiative to communicate on subjects within its competence, which the Commission says will provide an important, additional safeguard. It adds that, although it will itself remain responsible for the communication of risk-management decisions, it is important that there is an exchange of information between it and the EFA to ensure a coherent overall message. The public information work of the EFA will also need to be "carefully orchestrated" with the Member States and other interested parties.

— Access to information

  1.30  The Commission observes that, notwithstanding transparency demands, constraints inevitably arise from legitimate commercial confidentiality and from legislation governing the protection of personal information. It therefore proposes that the Management Board should adopt any additional internal rules needed to cover these points.

— Fees

  1.31  The Commission says that, unlike the system adopted by the European Medicines Evaluation Agency (EMEA), it is not intended to levy fees for the work of the EFA, at least during its initial period of operation. However, it proposes to issue a report on the possibility of charging fees, particularly for work on the Community authorisation of commercial products, with three years of the operation of the EFA.

Chapter IV: Rapid alert system

  1.32  The Commission says a rapid alert system already exists within the General Product Safety Directive under which Member States must notify it of measures which restrict the placing on the market of products posing a risk, and that these must be notified to other Member States. However, it notes that this system is limited to consumer products, including food, but does not cover animal feed. It believes there is an urgent need to separate food from other consumer goods, and to set up a broadened rapid alert system for entire food and feed chain, with the EFA being responsible for its operation. For serious risks to health, this would involve mandatory notification by Member States of measures taken in relation to food or feed, including rejections at the Community's borders, with the emphasis being placed on those actions requiring rapid intervention.

  1.33  The Commission also says that recent events have demonstrated the importance of establishing clearly defined operational procedures allowing it to manage food crises effectively, and it proposes new mechanisms to ensure optimum coordination and to strengthen the Community's overall capacity, including the establishment of a crisis unit within the Commission, in which the EFA would participate. The Commission also sets out the action to be taken in emergency situations which constitute a serious risk to human health. These include the suspension of the placing of the food in question on the market, and the laying down of special conditions.

Chapter V: Committee and mediation procedures

  1.34  The final Chapter of the proposal covers a number of diverse, but nonetheless important, matters.

  1.35  It would provide for the introduction of a Committee for Food Safety and Animal Health covering all relevant regulatory activities with a direct or indirect impact on the food chain. It says this will foster greater harmony of approach, whilst providing flexibility to manage problems affecting several sectors. It also establishes a mediation procedure enabling the Commission to ask for the opinion of the Authority on contentious scientific issues if a Member State considers that another Member State has taken measures which are either incompatible with the proposed Regulation or likely to affect the operation of the Single Market. It says this procedure will be of particular value where there is a conflict involving differences of scientific opinion.

  1.36  On the management and funding of the Authority, the Commission points out that it will need to have a sufficient number of high quality and specialised staff to ensure the effective operation of the scientific committee and the eight panels, and manage the various Member State networks underpinning the Authority's work. Personnel are also required for information-gathering networks, technical support to the Commission, communication and general administrative support. It suggests that this implies an Authority staff of around 340, when it is fully functional (some five years after the adoption of the proposed Regulation). It says that this will need to be reviewed after three years, but that the staff likely at that stage would be around 255. It compares these figures with the 570 staff of the UK's Food Standards Agency devoted only to food safety and the 850 people employed by the US Food and Drug Administration. The authority's staff would be subject to the same conditions as those of the Commission, and would include a "relatively small" number seconded from it to ensure an efficient transfer of expertise.

  1.37  As regards the Authority's budget, the Commission considers that there would be start-up costs of roughly 9 million euros for the first year, with an annual expenditure of some 67 million euros once it is fully operational - a figure which it again compares with the 136 million euros budget of the Food Standards Agency. In the meantime, the present financial assessment is for expenditure of 44 million euros by the third year, at which point the figures would be reviewed in the light of experience. The Commission further proposes that the Authority should be financed by a subsidy from the Community, and that it will need to put in place an appropriate set of rules and controls to ensure the "highest level of financial Control". The Authority's Management Board would be entitled to adopt these, subject to the approval of the Commission, but the Authority would ultimately be subject to the supervision of the Court of Auditors.

The Government's view

  1.38  In her Explanatory Memorandum of 21 January 2001, the Parliamentary Under-Secretary of State at the Department of Health (Ms Gisela Stuart) says that the Government is considering whether the legal base proposed provides an adequate basis for establishing the Authority, but that it has still to examine whether the proposal is consistent with the principle of subsidiarity, given the increase envisaged in the Commission's competence and in the harmonisation of national measures.

  1.39  So far as the policy implications are concerned, the Minister says that the Government broadly supports the proposal to establish the EFA, albeit with reservations about its remit, and in particular the lack of clarity about its involvement in risk management. She adds that there are also questions to be raised over how the Authority will function in certain areas, such as crisis management, the rapid alert system, and dossier assessment, as well as the provisions for its management and accountability, the accessibility and transparency of its procedures, and the involvement of consumers. However, subject to further discussion of these issues, she welcomes the proposal to set up a central body which could play an active role in the development of a more coherent and modern approach to food safety issues at Community level, and says that the Government also attaches importance to the proposed arrangements for the EFA to network with national agencies.

  1.40  On the general food law provisions and other elements of the proposal, the Minister says that these raise complex issues, which may considerably extend Community and Commission competence, and have "significant" implications for UK food law. She also believes that the interface with other Community legislation needs to be considered, and she suggests that there will therefore need to be detailed consideration and the fullest consultation. In particular, she says that the general food law provisions might be much better suited to a Directive, which would allow Member States a degree of flexibility over implementation, though she notes that the Commission is keen to maintain all the proposed measures within one Regulation. She also makes the point that many of the issues in this part of the proposal have no direct bearing on the setting up of the EFA, and will inevitably delay that process if retained as part of a single package.

  1.41  The Minister has attached to her Explanatory Memorandum a partial Regulatory Impact Assessment, but, as she herself points out, it is difficult quantify the benefits of the proposal in that it relates in the main to general principles, and any information on its costs will emerge only as part of the consultation process referred to above. She has, therefore, undertaken to provide a further Regulatory Impact Assessment once more information is available.

Conclusion

  1.42  As will be apparent from the contents of our Report, this is a major document, which moreover touches upon an important area of public policy, both in general terms and as regards the establishment of a European Food Authority. It is also clear that, although the Government broadly supports what is proposed, it has a number of reservations relating to the legal base and functions of the Authority, the subsidiarity implications, the impact on UK food law generally of the proposed extension of Community and Commission competence in this area, and whether it would preferable for any new Community measures to be incorporated in a Directive rather than a Regulation. In addition, pending completion of the Government's consultation exercise, there remain considerable uncertainties over the potential costs and benefits involved.

  1.43  We would expect the Government to address these points further in an Explanatory Memorandum, but we think it right to make clear now our view that this is a document which should be debated, even though we recognise that there must necessarily be some uncertainty at this stage over the timing. We also believe that the issues raised by the document are of sufficient importance to warrant a debate on the Floor of the House, rather than in European Standing Committee. If timing considerations permit, we would in that event think it sensible for such a debate to cover as well the Commission's proposals[17] on food hygiene, which we considered on 17 January and recommended for debate in European Standing Committee C.



10   (18083) 8150/97; see HC 155-ii (1997-98), paragraph 1 (22 July 1997). Back

11   (20875) 5761/00; see headnote to this paragraph. Back

12  The Commission says that this is without prejudice to the requirements of Council Directives 80/778/EEC and 98/83/EC on the Quality of Water Intended for Human Consumption. Back

13  (21499) 10427/00; see HC 28-iii (2000-01), paragraph 1 (17 January 2001). Back

14  (21005) 6055/00; see HC 23-xiii (1999-2000), paragraph 28 (5 April 2000). Back

15  The Scientific Steering Committee (SSC); the Scientific Committee on Food (SCF), the Scientific Committee on Animal Nutrition (SCAN), the Scientific Committee on Plants (SCP), the Scientific Committee on Veterinary measures relating to Public Health (SCVPH), and the Scientific Committee on Animal Health and Welfare (SCAHAW). Back

16  On food additives and flavourings; on additives used in animal feed; on plant protection products; on genetically modified organisms; on dietetic products, nutrition and allergies; on biological hazards; on contaminants in the food chain; and on animal health and welfare. Back

17  (21499) 10427/00. Back


 
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