At the request of the secretary of the committee, we are making a presentation on the hygiene package as a whole rather than on the specific regulation. The background to this hygiene package and these regulations is that in its White Paper on Food Safety of 12 January 2000, the European Commission set out its plans for a proactive new food policy to modernise existing legislation into a more coherent and transparent set of rules, reinforcing controls from the farm to the table and increasing the capability of the scientific advice system so as to guarantee a high level of human health and consumer protection.
The strategic priorities of the White Paper were to create a European food safety authority; to consistently implement a farm to table approach in food legislation; and to establish the principles that feed and food operators should have primary responsibility for food safety, that member states need to ensure surveillance and control of these operators, and that the Commission shall test the performance of member states' control capacities and capabilities through audits and inspections.
In July 2000 the EU Commission published proposals to consolidate, update and simplify existing Community legislation on food hygiene. For the most part, many of the proposals already existed in EU legislation, which had evolved in a more fragmented sector by sector way over the previous 30 years or so. In all, 17 directives dating back to 1964 were to be revised under five proposals, which became known as the hygiene package. These related to hygiene of foodstuffs on page 1; specific rules for food and animal origin on page 2; official control on products of animals origin intended for human consumption on page 3; animal health rules governing the production, placing on the market and importation of products of animal origin intended for human consumption on page 4; and repeal or amendment of certain directives regarding food hygiene on page 5. The annex to my statement gives fuller details of those items.
The basic principles underlying the Commission's proposals were as follows. The first principle is the introduction of a "farm to table" approach towards food hygiene policy. Up to this there was no systematic and all embracing hygiene regime covering all food in all sectors, but rather a patchwork of rules for specific sectors and types of produce with gaps notably at primary production level.
A second important principle underpinning these proposals is that food business operators are given primary responsibility for the safety of the food they produce. This principle is facilitated by the development of hazard analysis and critical control point, HACCP, systems and is in line with internationally accepted procedures. HACCP systems can take into account the variety of different operations, both in terms of products and scale and provide operators with the flexibility to adapt "own checks" control systems to the specific requirements of their operation. Although it was proposed that general hygiene rules would be extended to cover hygiene at farm level and would operate on a risk analysis basis, it was not proposed at this time to have a formal implementation of HACCP at the primary production level.
A third key principle is the traceability of all food and food ingredients. To achieve this, the registration of all food businesses and appropriate record keeping was proposed. Producers would also have to put in place procedures for the withdrawal of product from the market in the event of it presenting a serious risk to consumer health. The proposals recognised the need for flexibility in a number of areas, particularly regarding traditional food production, food businesses in remote islands, mountain areas and other geographically isolated areas, and the implementation of HACCP systems in small and medium enterprises.
Council agreement was reached during Ireland's Presidency of the European Union in April 2004 on the hygiene package with the exclusion of H4, which was finalised in 2002. Annex 1 gives a summary of the hygiene package. On the second page of the annex, reference is made to the feed and food regulation and the feed hygiene regulation. These were also agreed during the Irish Presidency. The reason for including these in our discussions is that while H3 sets out the official controls that apply to the production of animal products only, the regulation on official food and feed controls is an overarching regulation which provides for the carrying out of official controls at any of the stages of production, processing and distribution of feed or food and of animals and animal products. It also provides for the submission of a multi-annual control plan.
In essence, the hygiene package substituted a more simplified system of legislation for the production of safe food for the myriad of regulations that are currently in place. The parts of the package are cross-referenced to ensure all aspects of food safety are considered. The regulations cover a number of areas and the main issues include the following. All food and feed premises must be either registered or approved, from farms through to retail premises. While no specific requirements for registration exist, any existing list of registered premises may be used for the purposes of these regulations. As food of animal origin can present a more serious risk to consumers, such premises must be approved rather than registered.
The onus is on food business operators, FBOs, to make the application for either registration or approval but competent authorities must put procedures in place to allow FBOs to apply for approval of their premises. Approval may be given if establishments meet all the requirements of the regulations on foot of an on-site inspection. There is provision for conditional approval for up to six months under certain conditions provided there is no food hygiene risk. Provisions are also made for existing approved premises or premises, which did not previously require approval, to continue in operation until an inspection takes place. Once its premises are approved, a food business operator may market its products throughout the EU, which represents a change from what currently applies.
While all premises are included in these requirements, specific provision is made for small businesses, for establishments using traditional methods and for those operating in geographically constrained areas. A section on small businesses is contained and I will deal later with those derogations, etc. Member states must maintain up-to-date lists of approved establishments and make them available to other member states and to the public.
Food business operators must put in place, implement and maintain a permanent procedure or procedure based on the HACCP principals. This requirement does not apply to primary production, domestic preparation, storage, etc., of food for private consumption or the direct supply of small quantities of primary products to the final consumer or local retailer. Food business operators are to provide evidence of compliance to the competent authority. Detailed rules for implementation of the above are to be agreed on an EU-wide basis. As these regulations do not come into force until January 2006, there is time for those rules to be made yet.
While member states are to encourage the development of national guides to good practice for hygiene and for the application of HACCP principles, the guides themselves must be prepared by the business sector involved in consultation with parties who might be affected, including competent authorities, consumer groups, etc. This may be done under the aegis of a national standards institute. Member states then have to assess the guides to ensure they meet the requirements of the regulation and forward compliant guides to the European Commission.
Guides to good practice drawn up under existing Council Directive 93/43/EEC on the hygiene of foodstuffs shall continue to apply if compatible with the objectives of the hygiene package. Competent authorities are to include assessment of practices on HACCP in any audits carried out on premises. The direct supply by producers of small quantities of primary products to final consumers or local retail establishments directly supplying final consumers is excluded from the regulations. However, member states must establish rules under national law for such trade. The rules should ensure the achievement of the objectives of the regulations.
Derogations may be granted from the requirements of annex 2 of regulation 852/2004 for small businesses, particularly in respect of the HACCP requirements. That may be done at EU level, rather than national level. National measures may be introduced adapting the requirements of annex 2 of the regulation with the aim of enabling the continued use of traditional methods at all stages of the production, processing or distribution of food or accommodating the needs of food businesses situated in regions that are subject to special geographical constraints. The European Commission and other member states must be notified of any such measures. A procedure is in place for the acceptance or otherwise of the national measures, which cannot stand alone without approval.
I mentioned earlier that primary producers will be brought under food legislation in a systematic way for the first time. Such producers will be required to be registered. They will not have to meet any specific conditions to be registered, other than to apply for registration. I have mentioned that primary producers are excluded from the HACCP requirements. Specific hygiene requirements which are laid down will be included in guides to good hygiene practice for primary producers. However, certain primary producers of feed — those who produce feed on farms — will be required to implement a HACCP programme. The requirements apply to the transport, storage and handling of primary products at the place of production, the transport of live animals or products of plant origin and transport operations to deliver primary products from place of production to an establishment.
The main specific requirements which have to be met by operators are to keep facilities used in connection with primary production clean and, where necessary, disinfected; to keep clean and, where necessary, disinfect, equipment, containers, crates and vehicles; to ensure the cleanliness of animals going for slaughter; to ensure that staff handling foodstuffs are in good health and undergo training of health risks; to store and handle waste and hazardous substances to prevent contamination; to report suspected outbreaks of contagious diseases to the competent authority; to use feed additives, veterinary medicinal products, plant protection products and biocides correctly; and to keep records of the nature and origin of feed fed to animals, veterinary medicinal products or other treatments given to animals, the use of plant protection products and biocides, the occurrence of diseases or pests and the results of any relevant analyses carried out on samples taken from animals or plants.
The competent authority is charged with encouraging the development of national guides to good hygiene practice in the interests of such practice. Guides should be developed and disseminated by food business sectors in consultation with interested parties which may be substantially affected, such as competent authorities and consumer groups. The same procedure of approval also applies to the guides.
The issue of advance notification of slaughterhouse operators is a new one. Slaughterhouse operators may not accept animals for slaughter if they have not requested and received the relevant food safety information provided in the records kept by farmers at least 24 hours before the arrival of the animals at the slaughterhouse. A list of the relevant information is included in the regulation. There are derogations in certain circumstances from the need for the receipt of some of the information. However, some information must be given in respect of animals.
There are no major changes from the existing regulations relating to primary milk producers. Provision is made, however, for the use of raw milk of healthy animals from reactor herds in cheese that has a maturation of at least two months.
Training is another issue for farmers and food business operators, who must instruct or train food handlers in food hygiene issues relating to their work. They have to ensure that those involved in developing or maintaining HACCP systems or operating guides have adequate training. Operators must ensure that there is compliance with national legislation on training requirements for people working in certain food sectors. Competent authorities can appoint only those veterinarians who have passed a test, which must be arranged by the competent authority, on specific issues referred to in the regulation.
Veterinarians must undergo practical training for a probationary period of at least 200 hours. The training should refer particularly to the auditing of food safety management systems. Continuing education activities should also be provided where necessary. Veterinarians who are already appointed must have adequate knowledge of the subjects referred to in the regulation. Competent authorities can appoint only those official auxiliaries who have undergone and passed a specific test. Such people must prove they have at least 500 hours of theoretical training, as well as at least 400 hours of practical training covering specific issues listed in the regulation, if they are to be eligible. Auxiliaries who have already been appointed must have adequate knowledge of the subjects referred to in the regulation.
The regulations make feed and food business operators who import feed and food responsible for complying with the requirements of the regulations. There are no major changes in the requirements for the import of animal products. Such food must come from an approved establishment in an approved country and be accompanied by a veterinary certificate. Animal products must be imported through a border inspection post. The importer must give prior notification of import. Some 24 hours' notice of import is required under the existing regulations, but no time period is provided in the new regulations. It is a matter for the members states to decide.
The regulations also provide for the making of safeguard provisions if imports of particular products from certain countries might be a danger to public or animal health. In the case of imports of food and feed of non-animal origin, member states will have to designate particular points of entry which have access to appropriate control facilities for different types of feed and food. Importers will be required to give prior notification of such imports. The regulations set out the procedures for dealing with products which are rejected for import. Fees must be charged for imports of animal products regarding the inspections which are carried out. Minimum levels are laid down in the regulation. The fees may be charged for imports of other food and feed. If the minimum level is not charged, the method of calculation of the fee levels must be published.
Each competent authority must ensure that it has, or has access to, adequate laboratory capacity, suitably qualified staff, proper facilities and equipment. Controls may be delegated to laboratories which operate to the same standards as official laboratories, in which case the competent authority must audit the laboratories as necessary. The competent authority must designate laboratories that may conduct analysis of samples taken during official controls, but only to officially accredited laboratories. The accreditation may relate to individual tests or a group of tests. The EU community reference laboratories will be responsible for specific tasks for feed, food and animal health. Member states must designate one or more national reference laboratories for each community reference laboratory.
I have outlined the main provisions of the regulation, but I wish to speak about consultation and implementation. The Departments and the official agencies consulted widely while the proposals were under negotiation. We are satisfied that the regulations represent a balance between the need for food safety and the needs of food business operators. The hygiene package is a consolidation of existing controls, to a large degree, with some new additions. It should not have any significant impact on the competitiveness of the Irish food industry.
The Department of Agriculture and Food has undertaken a scoping exercise to identify how best to approach the implementation of the hygiene package before entering into discussions with other Departments and agencies. A number of Departments and agencies are involved, including the Department of Health and Children, the Department of Communications, Marine and Natural Resources and the FSAI. It is essential to take a co-ordinated implementation approach to these regulations if food safety is to be ensured and the food industry is not to be unduly disrupted.
Further consultation with stakeholders is essential in the period leading up to the implementation of the hygiene package, especially as Ireland pressed for flexibility during the negotiation of the proposals. We intend to avail fully of the provisions in this area. Accordingly, we will consult with all interested parties with a view to ensuring that flexibility provisions are fully utilised to protect our food industry and traditional producers while avoiding compromising overall hygiene standards.
