Scottish Government

INFORMAL DRAFT RIA - 16/4/02

UPDATED PARTIAL REGULATORY IMPACT ASSESSMENT:

1. Introduction - Title of the Proposed Provision

European Commission proposals for the consolidation and simplification of EU food hygiene legislation

1.1 The draft instrument contains five linked proposals intended to replace existing food hygiene requirements in the European Union. In the United Kingdom, four of the proposals are the responsibility of the Food Standards Agency (2000/178 (COD), 2000/179 (COD), 2000/180 (COD) and 2000/182 (COD)). The fourth proposal (2000/0181 (CNS)), which relates to animal health rules, is the responsibility of DEFRA and is not the subject of this RIA. Details on the subject matter and purpose of the proposals are at Annex A.

2. Purpose and intended effect of the measures

i) The issues and objectives

Issue

2.2 The earliest of the current legislation dates back over 35 years. Most of it tends now to reflect an outdated understanding of, and approach to, food safety management in the interests of public health. In general it has involved a highly prescriptive approach although the general food hygiene directive adopted in 1993 reflects a more modern risk based approach, overtly based on the application of hazard analysis principles.

2.3 The current legislation exhibits inconsistencies in approach and a degree of duplication. Its numerous amendments make the directives difficult for food businesses to interpret, and also to enforce. Legislation has not kept pace with change and innovation in food technology and processing, and consequently the current prescriptive controls no longer address adequately the potential food hygiene risks. These factors have resulted in criticism from both industry and enforcement authorities about the extent and complexity of existing food hygiene legislation. Concern has also been expressed over perceived inconsistent application between Member States. For these reasons, the UK has for some time been urging the European Commission to come forward with proposals to update and simplify this legislation. The proposals as issued would hold implications for around 800,000 businesses in the UK.

Objective

2.4 The primary objective is to improve and modernise the existing EU legislative framework covering food hygiene. The European Commission has stated its primary motivation is the need to ensure a high level of health protection. This accords with UK Government policy. The proposals would introduce more risk based and flexible procedures better matched to the needs of individual businesses.

2.5 The proposals are intended to achieve three broad aims. The first is the introduction of a "farm to fork" approach to food safety covering primary production through to the retail and catering level. Such an approach has been advocated in independent reports (Pennington (see paragraph 2.7)), by the Advisory Committee on the Microbiological Safety of Food (ACMSF) and in the international context by the Codex Alimentarius Commission and World Health Organisation (WHO).

2.6 The second aim is the ability to trace food and food ingredients. Compulsory registration of all food businesses is being proposed, and food businesses will be allocated a unique registration number (which may be one already used for other purposes) which must accompany all food to its final destination. This is integral to a "farm to fork" approach to food safety. Registration has been a requirement for most UK food businesses since 1991. The traceability elements contained in the proposals are expected to be removed following the introduction of traceability requirements in the recently introduced Council regulation (178/2002) on the General Principles of Food Law.

2.7 The third aim is to place responsibility for safe production of food clearly on food producers, not enforcement authorities. This would be facilitated by moving away from prescriptive legislation towards a more risk-based approach requiring the application of Hazard Analysis and Critical Control Points (HACCP) principles. This rests comfortably with one of the recommendations of the Pennington Report, accepted by Government, into the E.coli 0157 outbreak in central Scotland, which was that, "The Government should seek to have HACCP enshrined in the review and consolidation of the vertical EU Directives". Information on the background to HACCP and its current status in the UK is included at Annex C.

2.8 The need for food hygiene legislation is generated by the risk to consumers of illness or death from pathogenic microorganisms, which can occur in or cross-contaminate food at all stages from production to consumption. For 2000, it is estimated that the total number of cases of foodborne disease in the country (referred to hereafter as Indigenous Foodborne Disease (IFD)) in England and Wales was 1,338,772 of which, 368,516 visited a GP and 970,256 did not. It is estimated that 480 cases resulted in death. The cost of IFD to the UK is estimated to be in excess of £1.4 billion per year. Legislation must, therefore, be targeted to minimise the risk of food poisoning. It does so by prescribing conditions under which food is produced that will prevent, eliminate or acceptably control pathogen contamination of food. The application of a HACCP approach across the whole of the food chain is widely regarded as crucial to the management of food safety as it ensures that the procedures in place minimise risk to the consumer. The present position in relation to food poisoning incidence in England and Wales is outlined at Annex D.

3. Options

3.5 Option (d) would be to negotiate legislation, the adoption and application of which would be flexible and pragmatic. This would allow for full application of HACCP where appropriate, but would also allow for the development of generic HACCP-based food safety management systems. For example, guides could be developed for convenience stores just dealing in ready wrapped foods for display in a chiller cabinet. This would be to the advantage of many small businesses by avoiding unnecessary burdensome application in circumstances which do not demand it. Such an approach is borne out by the findings of the FSA's Task Force report on the "burdens of food regulations on small food business", and is the approach the FSA has pursued in negotiations to date, according with existing Government Policy.

3.8 For all options other than maintaining the status quo an important consideration is the need for realistic and practical implementation dates for the new requirements. They must allow for business to put in place the necessary procedures. They must also allow time for authorities and industry to develop relevant guidance literature, training and advice.

4. Benefits

To the UK as a Whole:

4.1 The most significant benefit of the measures would be the simplification of hygiene legislation in a way that would lead to its better application and enforcement than is the case with the present raft of prescriptive controls. Improved understanding of hazard-analysis based requirements by stakeholders would be expected to result in greater public health assurances, reduction in the incidence of food poisoning, and, in turn, greater consumer confidence. In addition, the existence of documentation on the controls in place in food businesses should provide increased evidence for enforcement authorities that controls are in place and being applied. The precise effect the modernised approach would have on the level of food poisoning is difficult to measure, notably given the high degree of uncertainty surrounding food poisoning statistics. Against this background, two related pieces of work carried out on behalf of the FSA provide information on which to base an understanding. First, work on the cost of indigenous foodborne disease (see report at Annex D) in England and Wales found that the estimated total cost of indigenous foodborne disease in 2000 was £1,292 million. This was made up from the basic costs to the health service, loss of earnings etc. £164 million and the costs of pain grief and suffering £1,126 million. If, therefore, it is possible to reduce the number of cases of foodborne illness the potential savings are substantial. An assumption must be made as to the possible level of that reduction (see paragraph 5.16) but a 1% reduction brings about consequent savings of £12.9 million per year. If applied to the UK as a whole in line with the ratio of populations, these figures indicate costs of £1,456 million and savings of £14.6 million per 1% reduction in illness per year.

4.3 The benefits indicated in paragraph 4.1 and 4.2 would be shared between the individuals affected, consumers, food businesses, business generally, the NHS and enforcers. Other real benefits would result for both consumers and food businesses which are difficult to quantify in pure monetary terms. These benefits are set out in Annex H. In terms of the options set out in section 3, only option (c) and (d) would deliver the benefits identified above. Option (a) would maintain the status quo, and options (b) and (e) would not change current practice to the extent where significant improvement on the current situation could be expected.

To enforcement authorities

4.4 The proposals will simplify and greatly reduce the volume of EU legislation that controls food hygiene, and will do much to rectify anomalies that have made interpretation and enforcement difficult. Because HACCP systems lend themselves to audit, and should not require constant supervision to safeguard public health, enforcement resources could become freer to focus efforts where most needed. Legislation would be aligned more closely with the enforcement authorities' risk-based approach to official controls. This would allow them to target their resources more effectively; e.g. certain enterprises may be identified as low-risk through a HACCP-based approach, and therefore visited less frequently. There will be a need for enforcers to undertake an educational role in this respect. There would also be a benefit to enforcement authorities from any reduction in food poisoning incidence resulting from the introduction of the proposals in reducing the number of post incident investigations. There is an ongoing, constructive dialogue between the FSA and enforcement bodies on these questions.

1. Compliance Costs for Business, Charities, and Voluntary Organisations

i) Overview

5.1 There are over 600,000 food business establishments in the United Kingdom, covering catering, retail, manufacturing and distribution. In addition, there are some 200,000 primary producers, including farms and fishing vessels. The majority of these businesses will be affected by these proposals to some extent.

5.2 The main additional business cost of implementing these proposals will be associated with the introduction of verification and documentation of a HACCP-based system. Implementation of the hazard analysis requirements of the existing regulations is variable throughout the UK and corresponding data are limited. Central and local government bodies do not routinely collect this information. For this reason, a questionnaire was sent to UK food authorities in September 2001 seeking information on the numbers of businesses operating HACCP based controls, including documented and undocumented systems. The results of the survey are summarised in Annex E. The main findings are that about 20 per cent of food businesses (excluding the majority of agricultural holdings and fishing vessels) operate a documented HACCP system and a further 45 per cent operate an undocumented system. This equates to approximately 390,000 (of the total 600,000) food businesses applying a hazard analysis system (documented or undocumented). If the retail and catering sectors were complying with current legislative requirements for hazard analysis, this would mean that in excess of 490,000 premises would be complying with the major part of the proposed requirements (See Annex F for information on the current legislative requirement by sector). This non-compliance is a concern for the FSA, and is currently being addressed by a major food hygiene campaign. This will raise awareness and, in turn, compliance levels. The FSA's HACCP strategy, aiming to ensure that 30% of businesses have documented HACCP in place by 2004, is also addressing non-compliance. The implementation of this strategy will result in the provision of training and guidance for food businesses and will go a long way to preparing UK business for the new requirements. Indeed, it should reduce the burdens for business estimated in this RIA.

5.3 The nature of the individual businesses affected range from low-risk one-person businesses selling wrapped confectionery, through to major businesses manufacturing high-risk products and employing hundreds of people. Given this, compliance costs will potentially vary greatly dependant on the nature and sector of the business, existing food safety management systems and the present level of compliance. Indications are that most major retailers and most large food manufacturers have generally satisfactory HACCP systems in place. Smaller food businesses may have much reduced awareness of HACCP systems. Even so, for the vast majority of small businesses new record keeping requirements will be minimal, and many businesses will already be doing at least some of what is necessary, such as recording temperature monitoring.

5.4 Research undertaken on behalf of the FSA (summary at Annex I) indicates costs for the retail and catering sectors combined in the region of £170 million, £165 million of which would be annual costs and £5 million one-off costs. The findings are very significant as the two sectors are the largest in terms of numbers and, combined, account for about 565,000 of the total 600,000 food businesses in the UK, excluding primary producers. The hypotheses underpinning these figures are, of course, open to critique and resulting estimates may be on the high side, but they represent an honest attempt to assess costs. The research took into account the fact that many of the larger enterprises in the sectors concerned, such as the major supermarket chains, already have in place systems that will mean they fully comply with the new requirements.

5.5 Since the proposals were issued, Commission Decision 2001/471/EC has been introduced which requires the implementation of HACCP principles and microbiological testing in fresh meat and poultry meat slaughterhouses, cutting plants and cold stores. This will affect approximately 1,400 establishments in the UK and mean, in effect, that there will be little, if any, additional burden placed on this sector by these proposals.

5.6 In the remainder of the food manufacturing, production and processing sectors any additional burdens should be minimal. Under the existing general food hygiene directive 93/43, many operators should be implementing at least the first five of the HACCP principles. In most sectors covered by specific vertical Directives own check systems are required. Own checks should be carried out with some form of record keeping, and so the proposals should involve little change to existing practice. However, if it is assumed that there may be some additional requirements around record keeping it is possible to estimate the costs involved by applying the average costs for the catering and retail sectors to the remaining manufacturing, production and processing sectors. Excluding the retail and catering businesses and slaughterhouses, as mentioned in paragraph 5.5 above, there remain approximately 33,500 food businesses. If the average of the costs for all businesses is assumed to be the same as the average for the total number of retail and catering businesses, as in paragraph 5.4 above, the costs per business would be in the region of £300 per year. The total cost would therefore be approximately £10 million. However, work carried out on behalf of the FSA ( Annex I) puts the additional costs in the food processing sector at approximately £1 million per year. A mid-range estimate of £5 million per year, has been taken for the summary, and we would envisage further work to develop the RIA in this area.

5.7 The costs of the requirement for HACCP training of food business operators have been factored into the estimates for applying HACCP in food businesses generally.

5.8 Work on the requirement for broad systems of traceability has already been undertaken as part of the RIA on the proposed regulation laying down the general principles of food law (GFL). The large majority of those who responded to the consultation welcomed the general requirement for traceability and the reason for its introduction. In most cases traceability systems are already in place.

ii) Specific Issues

Impact on Primary Producers

5.9 In contrast to midstream food businesses which will be required to apply HACCP principles fully, primary producers would only be required to identify and monitor hazards to food safety and to prevent, eliminate or reduce these to an acceptable level. As with other food businesses, primary producers would have to be registered with Competent Authorities and withdraw food found to be a risk to consumer health. In practice, the requirements are expected to entail relatively modest change to current practice for most businesses. Various assurance schemes cover the majority of primary production in the UK, including, 80% of all cereals, oilseeds and pulses, 70% of all fruit, vegetables and salads, 85% of all dairy cows and chickens and 90% of British pig farms. Under some of these schemes, at least at a generic level, hazards are identified and action put in place to address them. Relatively minor change to some of these schemes would make them compatible with the aims of the proposals. Under current legislation primary producers are required to identify and control hazards, e.g. under veterinary and pesticides residues and zoonoses legislation.

5.10 Research carried out ( Annex I), on behalf of the FSA, into the effects of the proposals on primary production estimates the total additional costs involved as being in the region of £27 million per year. These costs were calculated on the basis of costs being shared between, in excess of, 146,000 farm businesses in the UK. The research considered the effects on a range of business types and sizes. It did not consider the effects on the fishing or the game/hunting industries. The cost of adopting hazard analysis ranged from £94 for a very small beef or sheep farm to £620 per year for a large horticultural producer (the total figure also included an element for the adoption of traceability measures). Costs for the fishing sector have been estimated by attributing to the number of fishing vessels and fish farms the average costs to other primary producers. The result is an estimate of costs for the fishing sector of £1.5 million, although this is likely to be an overestimate as the number of vessels will certainly exceed the number of businesses. It is possible to attribute costs in a similar way for the c.200 game farms in the UK resulting in costs in the region of £40,000.

Registration of Food Businesses

5.11 Under the proposals all food businesses will have to be registered with the competent authorities. In most sectors, this will not impose an additional or new burden as the existing Food Premises (Registration) Regulations 1991 (Great Britain legislation) require premises used as food businesses to be registered with local authorities if they are not otherwise registered or approved under commodity specific rules. This applies with only limited exemptions. Most primary producers and premises controlled by voluntary organisations or charities are among the exemptions, and they will be affected by the new proposals. The proposals allow for existing forms of registration to be used where feasible, which will minimise any additional burden. In the case of agricultural primary production, for example, consideration could be given to using registration systems already in place, such as the Integrated Administration and Control System.

Impact on Charities and Voluntary Organisations

5.12 Charities and voluntary organisations will be affected by the proposals to some extent. Organisations that give out food, e.g. Shelter and Crisis at Christmas, would be covered by the legislation. They would need to be registered as food businesses and would have to apply HACCP principles. A number of charitable organisations were included in the original consultation, including the National Federation of Women's Institutes and the Townswomen's Guild, but no comments were received from them. Further information is required on the costs and benefits to charity and voluntary organisations, and the FSA intend to further seek their views.

iii) Costs and Benefits - Available Evidence

5.13 Some 800,000 businesses in total are affected by this proposal and on the basis of the foregoing estimates, total compliance costs are put at around £200 million per year, with an additional £5 million one-off costs.

5.14 Evidence gathered to date suggests that the costs of complying with the additional HACCP requirements would not be overly burdensome to individual businesses. Averaged out over the entire industry costs are around £250 per business annually. Notably, the report of the "Task Force on the burdens of food regulations on small food business" (paragraph 16) found that "the HACCP approach should be an important way for businesses to minimise regulatory burdens and costs" (See Annex J for further information on the report). In no instance is it believed that increased burdens will be of the magnitude to deter new entry into the industry or to bring about the closure of businesses. Neither would any particular foodstuffs be affected more than others by the proposals.

5.15 The benefits likely to arise from introduction of proposals along the lines of option (d) can be best estimated from research carried on behalf of the FSA. First, a reduction in the incidence of foodborne illness of between 1% and 5% (an estimated outcome foreseen by enforcement experts consulted) resulting in benefits in the region of £14.6 to £73.0 million. Second, additional benefits resulting from a "willingness to pay" among consumers for safer food of between £500 and £1000 million per year.

5.16 Options (a) and (b) would be neutral in terms of costs and benefits as they would perpetuate the status quo.

5.17 Option (c) would likely double, at least, the compliance costs for most sectors, with the exception of primary production, and would be particularly burdensome on SME's. It could, as a rough estimate, increase the total compliance costs to in excess of £350 million per year, and substantially increase the one-off costs to business in setting up HACCP systems. No specific research has been undertaken to cost this scenario, however all the researchers involved in costing these proposals agree the cost effect outlined above.

6. Results of Consultation

6.1 Thorough consultation with interested parties both internal and external was initiated in July 2000. This included issuing approximately 2000 consultation packs, supported by an initial draft RIA, to the interested organisations, representative bodies and individuals identified. It included industry, consumers, scientific, enforcement and trade representatives. It also involved posting the consultation documents on the Food Standards Agency (FSA) web-site. Some 150 responses to the consultation have been received and taken into consideration. A summary of the comments received has been drafted and will be posted on the FSA web-site shortly. In the main, responses were favourable to the intention and philosophy of the proposals. Individual respondents made a number of comments both of substance and detail, which the Agency is taking into account. The consultation process will continue throughout the course of the negotiations. Larger business interests, both in the manufacturing and retail sectors, were generally welcoming of the proposals. Most were already utilising HACCP methods or what they considered to be even more stringent techniques, and demanded similar of their suppliers. They welcomed the use of guides to good practice. It was pointed out that food hygiene risks were not dependent on the size of business. A number also stressed the importance of flexibility in the application of provisions. They also called for consistent application across the EU.

6.2 Enforcement bodies, such as the Local Authorities Coordinating Body on Food and Trading Standards (LACOTS), the Chartered Institute of Environmental Health (CIEH) and the Royal Environmental Health Institute Scotland (REHIS) expressed support for the introduction of HACCP in all food businesses, and believe that carefully considered implementation of the seven principles would improve food safety and raise consumer confidence. They consider that HACCP, once fully and effectively implemented, will lead to increased effectiveness for enforcement by focusing activity on a business' responsibility to manage food safety, allowing enforcers to effect change to poor work practices by challenging the risk assessments.

7. Results of Consultation with Small Businesses "The Litmus Test"

7.1 During the consultation we received responses from a number of small and medium-sized businesses (SMEs), or their representative organisations. In addition, in conjunction with the Small Business Service (SBS), the FSA are visiting and talking to a number of SMEs operating at various stages of the food chain. At the end of March 2002, four small retail businesses had been visited which sold fresh, chilled and preserved foods. They all baked part prepared bread and pastries and one cooked meat on the premises. These visits were arranged with the co-operation of the Rural Shops Alliance and took place in rural areas of Sussex and Kent. All of the businesses were registered with the Local Authority (LA), or the LA was aware that they were operating. All received visits by Environmental Health Officers. All found these visits helpful, as a source of information and advice, and even suggested that they be more frequent. Although the businesses lacked knowledge of the HACCP system, they had identified hazards and took action to control them. Food was temperature controlled, checked and, in most cases, records kept. The businesses regarded the proposals as reasonable and proportionate. In no case, did the business consider the burdens imposed by the proposals unreasonable, nor did they consider that the proposals carried any undue cost implications. The most common response was that the requirements concerned measures that the business would undertake in any case as part of normal operations. In this respect, all accepted that the financial consequences of a food poisoning incident being attributed to a food business could be very serious, and indeed threaten its existence. All of the businesses indicated benefits to their operation in terms of improved access to information and training. Employing good food hygiene practice was also recognised as a means of building and safeguarding the reputation of the business in the community. In terms of how the businesses would like to see the proposals implemented, they encouraged the FSA to provide small businesses with simple, straightforward and easy to access information on the main food hygiene messages. Such information is a major part of the FSA HACCP strategy independent of these proposals. It is intended to continue with further consultation and visits to SME's in other sectors with the SBS to gain further understanding of their views.

8. Other Costs

8.1 In terms of enforcement, the FSA would expect any costs and benefits to be closely balanced. Any initial requirement for additional training of enforcers should be offset by medium to longer-term improvements in efficiency. Through the FSA's strategy for wider implementation of HACCP, it is planned to maximise the role of local authorities in helping businesses apply centrally developed guidance in a practical way. Enhanced guidance and further Agency training will be provided to help enforcers assess the effectiveness of HACCP based controls which have been put in place or are planned. The strategy includes a number of initiatives intended to support more consistent and effective HACCP enforcement, and maximise the local authority role in advising and supporting food businesses. This work should go a long way to smoothing the transition in the duties of enforcement authorities demanded by the proposals.

8.2 Research carried out on behalf of the FSA has provided different and varying results on the costs to enforcement agencies of the introduction of the proposals. In one case ( Annex G) it estimated minimal increased costs for enforcers of £118,000 whereas a second project ( Annex I) indicated much higher costs in the region of £32.5 million. The second project report recognised that the estimate was based on a paucity of information and that there may have been an incentive for Local Authorities to generously estimate the size of additional costs. For this reason, the second scenario may represent an overestimate. The FSA would expect the major part of any burden to be offset by targeting resources more effectively and by support planned by the FSA independent of these proposals. It is accepted, however, that there may be some additional costs in terms of training enforcement officers as envisaged in Annex G and so a cost has been indicated in the summary of £0.2 million. Further work will be undertaken to inform this question.

1. Summary and Recommendations

2. 9.1 The best available evidence suggests that there are likely to be financial implications for most sectors of the food chain as discussed at earlier points in this RIA. At present, these are still to be fully assessed, but costs to business across all of the sectors affected are likely to be in the region of £200 million per year. There are likely to be one-off costs in the retail and catering sectors of approximately £5 million for additional training required in certain businesses. Additional costs to enforcement authorities are likely to amount to approximately £0.2 million per year, although estimates vary widely on this area. The ongoing consultation process should enable us to gain a clearer understanding of the implications and these will be kept under review.

   9.2 The likely benefits arising from the proposals are difficult to quantify in strictly monetary terms, but it is possible to gain an indication of the global figures from the work undertaken to date. In basic foodborne disease reduction terms the likely savings are thought to be in the region of £14.6 to £73.0 million per year assuming that implementation of the requirements of the proposals by food businesses results in a 1% to 5% reduction in food poisoning incidents. There are additional benefits arising in terms of "willingness to pay" by consumers as outlined in paragraph 4.2 in the region of £425 million per year.

   9.3 The recommendation would be to pursue option (d) (paragraph 3.5). It would introduce HACCP-based risk management throughout the food chain (with the exception of primary production) in a flexible and pragmatic manner. Option (a) and (b) are considered to be unrealistic, and option (c) is considered to bring with it undue burdens with no demonstrable offsetting benefits. Option (e) would not change the current situation to any great extent and would not bring about any significant improvement in terms of food safety.

   9.4 Although the summary (TABLE 1) below indicates that the total benefits identified are greater than costs, it should be noted that the major part of the costs fall to business, whereas benefits are more widespread across society. However, option (d) is justified on the basis of the paramount importance of protecting public health. The proposals, introduced in a flexible and pragmatic manner, would provide the opportunity to improve the safety of food in a concrete way. The implementation of HACCP principles has been promoted by the FSA (and earlier by DH and MAFF) independent of the EU proposals. The costs outlined in this RIA are expected to be significantly reduced by the implementation of the FSA HACCP strategy now underway. The first benefits of that strategy are expected in advance of the new EU legislation being implemented.

   TABLE 1 - Food Hygiene Legislation RIA - Summary of Annual Costs and Benefits (£million)

   		Option a	Option b	Option c	Option d	Option e
   Costs	Primary production	0	0	29	29	0
   	Retail & Catering*	0	0	330	165	0
   	Production and processing	0	0	10	5	0
   	Enforcement	0	0	0.2	0.2	0
   Benefits	Disease reduction	0	0	14.6 - 73.0	14.6 - 73.0	0
   	Willingness to pay	0	0	425	425	0

   * An additional one-off cost of £5 million was identified for this sector.

3. Competition Filter

4. 10.1 The competition filter requirements have been studied and the FSA consider that the proposals are unlikely to have a negative competitive impact. The new legislation will apply equally to all new and existing businesses.

5. Monitoring and Evaluation
6. 1. The intention is to follow up this assessment with further research and consultation. The draft Regulatory Impact Assessment will be updated on an ongoing basis in the light of the continuing consultations.

12. Timetable

ANNEX A

PROPOSALS TO SIMPLIFY AND CONSOLIDATE EU FOOD HYGIENE LEGISLATION

Draft instruments concerning 5 linked proposals.

2000/0178 (COD)

2000/0179 (COD)

2000/0180 (COD)

2000/0181 (CNS)

2000/0182 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on the hygiene of foodstuffs

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

laying down specific hygiene rules for food of animal origin

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

laying down detailed rules for the organisation of official controls on products of animal origin intended for human consumption

Proposal for a

COUNCIL REGULATION

laying down the animal-health rules governing the production, placing on the market and importation of products of animal origin intended for human consumption

Proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

repealing certain Directives on the hygiene of foodstuffs
and the health conditions for the production and placing on the market
of certain products of animal origin intended for human consumption,
and amending Directives 89/662/EEC and 91/67/EEC

PROPOSAL 1 for a Regulation of the European Parliament and of the Council on the hygiene of foodstuffs

1. This proposal applies to the production of all foodstuffs (including products of animal origin). It would extend the existing principles embodied in Council Directive 93/43/EEC, namely:

• the paramount concern to protect human health,
• the use of HACCP principles (but not necessarily HACCP per se) to identify, control and monitor critical food safety points in food businesses,
• the possibility of adopting microbiological criteria and temperature control measures in accordance with scientifically accepted principles,
• the development of codes of good hygiene practice,
• the monitoring of food hygiene by the competent authorities of the Member States,
• the obligation on food business operators to ensure that only foodstuffs not harmful to human health are placed on the market.

2. The proposal would introduce a requirement for all food business operators (other than primary producers) to operate a full documented food safety management system based on HACCP principles. HACCP stands for Hazard Analysis and Critical Control Points and is a structured food safety management system that is widely regarded as the most effective approach to preventing food safety problems. It involves the systematic assessment of all the procedures involved in a food operation and the identification of those that are critical to the safety of the product. Application of HACCP principles will identify Critical Control Points (CCPs) together with control measures, critical limits, monitoring procedures and corrective actions for each CCP. Documentation would be required to provide an audit trail.

3. The proposal seeks to ensure good hygiene practice throughout the food chain, starting with primary production in order to provide a farm to fork approach to food safety. Primary producers, while not subject to the full application of HACCP principles, would be required to monitor hazards to food safety and to eliminate or reduce these to an acceptable level. The proposal provides that methods of doing so should be addressed in guides to good practice in combination with those already required under existing relevant legislation.

4. With the aim of improving traceability, the proposal would require:

• the registration of food businesses by the competent authority and the allocation of a registration number to each of them. In certain cases, where the competent authority wished to have assurances about compliance of food businesses with the hygiene rules prior to starting-up such business, the prior approval of the food business concerned would be required. Food businesses (except those operating at retail level) would have to identify foodstuffs they produce with their number; and

• that food businesses ensure that adequate procedures were in place to withdraw food from the market where such food presented a risk to the health of the consumer; must immediately inform the competent authority when a product had been withdrawn for that reason; and must keep adequate records which would enable them to identify the supplier of ingredients and foods used in their operation.

The definition of "food business" in the proposal would mean that these requirements applied as appropriate to primary producers.

5. The proposals would allow a certain flexibility in applying controls to small to medium sized enterprises (SMEs), especially those situated in regions with special geographical constraints (mountains, remote islands etc), and for the manufacture of traditional products. This proposal would allow Member States to grant certain derogations for SMEs, subject to European Commission "approval", as long as the overall objective of food hygiene were not compromised.

6. The proposal would require that imports into the EU would need to adhere to (at least) equivalent standards.

PROPOSAL 2 for a Regulation of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin

7. The legislation laying down public health controls in this area is currently embodied in food-sector specific Directives. These have been made over the last 35 years and naturally reflect the understanding of, and approach to, public health issues at the time they were made. In general this has meant the adoption of a detailed, prescriptive approach with specific standards laid down for e.g. the construction of premises, hygiene measures and production processes. Whilst these specific rules have proved reasonably successful in protecting public health, it is now recognised by the European Commission that they are unnecessarily burdensome, inconsistent, complicated and contain repetitions of similar or identical requirements. This has led to differences in interpretation and problems in both implementation and enforcement.

8. The proposal aims to reduce and rationalise the detailed prescriptive requirements applying to products of animal origin. Certain derogations for SMEs serving the local market or those situated in regions with particular supply constraints are proposed, subject to the need to ensure food safety.

PROPOSAL 3 for a Regulation of the European Parliament and of the Council laying down detailed rules for the organisation of official controls on products of animal origin intended for human consumption

9. The detailed proposals for official controls on products of animal origin covers such issues as qualifications of inspectors, frequency of inspections, detailed procedures for both ante and post-mortem meat inspection and record keeping. The existing controls would remain largely unchanged in the proposed regulation. There would be provision for some relaxation of the current requirements for veterinary supervision in licensed meat premises.

10. The European Commission's Explanatory Memorandum notes its intention to make a separate proposal on the modernisation of ante and post-mortem meat inspection procedures once scientific assessments have been completed.

PROPOSAL 4 for a Council Regulation laying down the animal-health rules governing the production, placing on the market and importation of products of animal origin intended for human consumption

11. This proposal deals with animal-health rules and is therefore the responsibility of DEFRA.

PROPOSAL 5 for a Directive of the European Parliament and of the Council repealing certain Directives on the hygiene of foodstuffs and the health conditions for the production and placing on the market of certain products of animal origin intended for human consumption, and amending Directives 89/662/EEC and 91/67/EEC.

12. This measure would repeal the existing EU legislation which the suite of proposals would replace, subject to a saving pending EU implementing rules in the case of temperature requirements and microbiological standards for products of animal origin. This measure would also amend other related legislation consequentially.

Annex B

EXISTING EU FOOD HYGIENE LEGISLATION

Council Directive 64/433/EEC of 26 June 1964, on health conditions for the production and marketing of fresh meat, as last amended by Directive 95/23/EC.

Council Directive 71/118/EEC of 15 February 1971, on health problems affecting the production and placing on the market of fresh poultry meat, as last amended by Directive 97/79/EC.

Council Directive 77/96/EEC of 21 December 1976 on the examination for trichinae (trichinella spiralis) upon importation from third countries of fresh meat derived from domestic swine, as last amended by Directive 94/59/EC.

Council Directive 77/99/EEC of 21 December 1976 on health problems affecting the production and marketing of meat products and certain other products of animal origin, as last amended by Directive 97/76/EC.

Commission Directive 89/362EEC of 26 May 1989 on general conditions of hygiene in milk production holdings.

Council Directive 89/437/EEC of 20 June 1989 on hygiene and health problems affecting the production and the placing on the market of egg products as last amended by Directive 96/23/EC.

Council Directive 91/492/EEC of 15 July 1991, laying down the health conditions for the production and the placing on the market of live bivalve molluscs, as last amended by Directive 97/79/EC.

Council Directive 91/493/EEC of 22 July 1991, laying down the health conditions for the production and placing on the market of fishery products, as last amended by Directive 97/79/EC.

Council Directive 91/495/EEC of 27 November 1990, concerning public health and animal health problems affecting the production and placing on the market of rabbit meat and farmed game meat, as last amended by the act of accession of Austria, Finland and Sweden.

Council Directive 92/45/EEC of 16 June 1992 on public health and animal health problems relating to the killing of wild game and the placing on the market of wild game meat, as last amended by Directive 97/79/EC.

Council Directive 92/46/EEC of 16 June 1992, laying down the health rules for the production and placing on the market of raw milk, heat-treated milk and milk-based products, as last amended by Directive 96/23/EC.

Council Directive 92/48/EEC of 16 June 1992 laying down the minimum hygiene rules applicable to fishery products caught on board certain vessels in accordance with Article 3(1)(a)(i) of Directive 91/493/EEC.

Council Directive 92/118/EEC laying down animal health and public health requirements governing trade in and imports into the Community of products not subject to the said requirements laid down in specific Community rules referred to in Annex A(I) to Directive 89/662/EEC and, as regards pathogens, to Directive 90/445/EEC, as last amended by Directive 97/79/EC.

Council Directive 93/43EEC of 14 June 1993 on the hygiene of foodstuffs.

Council Directive 94/65EC of 14 December 1994 laying down the requirements for the production and placing on the market of minced meat and meat preparations.

Annex C

Hazard Analysis and Critical Control Points (HACCP)

Background to HACCP

1. HACCP is a system of food safety assurance based on the prevention of food safety problems. HACCP is internationally accepted by governments and the food industry alike as the system of choice in the management of food safety in food businesses. It provides a documented, structured approach to ensuring food safety and places a requirement on food businesses to manage and control hazards inherent in their food handling and production process. It is proportionate and flexible and offers the best protection to consumers when implemented effectively. In line with modern thinking on a wide variety of matters, it is a risk-based system. Wider application of effective HACCP based controls is considered as key to the FSA achieving its wider food borne disease targets. HACCP has gained world-wide acceptance and there is a clear international trend to adopt it as the preferred approach to food safety. The UK has also been one of the leading advocates of Hazard Analysis and Critical Control Points (HACCP) in the EU.

2. Increasing uptake of HACCP was confirmed as Government policy when accepting the recommendations of the Pennington Report into the 1997 E.coli outbreak in Scotland. Indeed, the need to overhaul European hygiene legislation was a specific recommendation of the Pennington Report that was accepted by Government. In addition, HACCP is promoted by the main international bodies with an interest in this field, e.g. the WHO and the Codex Alimentarius Commission. In recent years a clear international trend has developed to adopt a HACCP approach to food safety.

3. The FSA has set itself a publicly declared Service Delivery Agreement target for 30 per cent of food businesses to be operating documented HACCP based controls by April 2004. The target is aimed at complementing and assisting wider Agency action to reduce food-borne disease by 20 per cent by April 2006. The FSA has a number of initiatives currently in place to further this target and is in the process of developing an overall strategy for wider implementation of HACCP.

Current Status of HACCP and Hazard Analysis in the UK

4. For the vast majority of the businesses affected by the proposals, the application of certain HACCP principles is not a new requirement. In most areas of food production the law requires that the main elements of HACCP should be being applied already. Since the implementation of the general food hygiene directive in 1995, food businesses including retail and catering businesses (by far the biggest two sectors in terms of numbers of businesses affected), have been required to analyse and control hazards on the basis of applying five of the seven HACCP principles. In addition, many of the sector specific hygiene directives require manufacturers to operate 'own checks', based on HACCP principles. What is new in the proposals as they apply to all food businesses is the requirement to verify that the procedures in place actually work. Businesses operating under general food hygiene law, and some sector specific law, will also have to keep documentary records of the procedures in place. Regardless of the present legal requirements, many businesses that are applying the five principles of HACCP will actually be keeping documentary records for their own purposes. The proposals will remove a degree of prescriptive detail contained in the current legislation and so will mean a reduced compliance burden for some sectors of the industry. For example, in the case of slaughterhouses, the proposals make no additional requirements of operators, but do clarify what is required of all food businesses as opposed to what is specific to slaughterhouses. Annex E provides an overview of HACCP uptake by the main sectors. Annex F provides an overview of the current legislative requirement to have hazard analysis systems in place.

5. The proposals seek to ensure good hygiene practice throughout the food chain, starting with primary production. While not subject to a full, documented HACCP-based procedure, primary producers will be required to monitor possible hazards to food safety and to prevent, eliminate or reduce these to an acceptable level.

Annex D

THE COST OF INDIGENOUS FOODBORNE DISEASE (England and Wales)

Introduction

The aim of food safety regulations is to ensure the production of safe food and reduce the incidence of foodborne disease. The benefits of any new food safety regulation are mainly any consequent reduction in indigenous foodborne illness, i.e. illness due to food consumed within the country. The economic savings due to the reduction in indigenous foodborne illness therefore measures the benefits of the new regulation.

This note provides an estimate of the total economic cost of foodborne illness at a baseline year, the year 2000. Any proportionate reduction in foodborne illness attributed to the new regulations can then be estimated using this benchmark.

The amount of indigenous foodborne disease

In a recent paper submitted for publication researchers at PHLS Communicable Disease Surveillance Centre (CDSC estimates) estimate the number of cases of Indigenous Foodborne Disease (IFD) in England and Wales in 1992, 1995 and 2000. This information is available classified by foodborne pathogen (16 bacteria, 3 parasites, 3 viruses and those of unknown origin) and for each pathogen there are estimates of the total number of cases, cases presented to a GP, hospital admissions, hospital bed days and deaths (data in table1, Appendix 2).

The CDSC estimates are based on data from routinely available surveillance data, special survey data (including the IID Study discussed below), hospital episode statistics and National Statistics mortality data. Adjustment to the data were made to reflect available estimates on the proportion of total disease, by pathogen, confirmed in laboratory tests and included in the surveillance data. A further adjustment was made to deduct foodborne disease imported through foreign travel.

For the purpose of costing the effectiveness of any change in UK food safety legislation the relevant measure it is the indigenous foodborne disease level and not all foodborne illness. In estimating the cost of indigenous foodborne disease the CDSC estimates will be used as a base for the quantity and outcome of foodborne illness in the year 2000 and these quantities will be matched by a price vector based on available estimates on the cost of such disease, taking into account the outcomes of such illness.

The cost of foodborne disease

The cost of illness, including foodborne disease, can be assumed to comprise two main components: (i) the actual, out of pocket, costs of the illness to individuals, employers and the NHS and (ii) the additional monetary value to individuals of the pain, grief and suffering due to the disease. Information on actual costs is based on data collected from individuals and includes expenses of ill individuals and their cares, lost output and the costs to the NHS. Estimates of the monetary value individuals attribute to the pain, suffering and grief due to illness are based on studies of individuals' willingness to pay (WTP) to reduce the risk of death or of getting ill.

(i) Actual price/cost of illness

A source of information on the actual cost of all intestinal illness is available from the relatively recent Report of The Study of Infectious Intestinal Disease in England (IID study). This comprehensive study includes survey data collected between August 1993 and January 1996 (centred in 1994/5). The study includes estimates of the actual costs of all IID for a long but not complete list of intestinal diseases, for example Listeria is missing and though the number of cases of Listeria is small, 194 cases estimated in 2000, the mortality rate is high, 68 deaths in 2000. The costs are for all IID, including both foodborne diseases and those transmitted in other ways. To utilise these estimates in the RIA, an assumption is made that the average cost of foodborne disease is similar to that of all IID.

The design of the IID Study was complex and aimed to answer a range of questions including estimates of the total number and proportion in the population suffering from IID, the proportion that present to GP and the proportion where the infectious organism is identified. Costs of IID were estimated from samples of individuals and provide details on the financial burdens incurred by the NHS, individuals and employers.

The IID study collected information on individual for a period of 6 months and does not include information on long-term consequences of IID. The study does not provide information on cases of permanent incapacity due to the illness nor does it include any cases of death. Estimates of the actual costs based on this data are therefore likely to be biased downward.

For the RIA we would ideally want an estimate of the total cost of illness at some base date and a breakdown of the costs by foodborne organism. Such a breakdown would allow monitoring or estimating the cost of reducing specific sources of foodborne disease due to the introduction of the new legislation. However, such detailed estimates are not available. The IID study only includes details of costs for a few pathogens and it is not possible to estimate the cost of total IFD by adding up the costs of illness attributed to each of the pathogens. The estimates below are, by necessity, based on the average cost estimates for all IID for two groups, patients who visit a GP and patients who do not visit a GP.

The costs in the IID study were centred in 1994/5 and to apply them to estimate the costs of IFD in the year 2000 the costs are uprated using appropriate price indices.

Estimate of actual cost of IFD, England and Wales 2000

Table 1 in Annex 1 presents the CDSC estimates of Indigenous Foodborne Disease in 1995 and 2000. The estimated total number of cases of IFD in 2000 was 1,338,772 of these 368,516 visited a GP and 970,256 did not.

For the 368,516 cases who visited a GP the actual cost of illness is based on the on the GP control component in the IID Study. This component is a sample of 1652 individuals with intestinal disease who visited their doctor and is considered to be the more accurate source of information in the IID Study for this group.

For the 970,256 individuals who suffered from IFD in 2000 and did not visit their doctor the only source of information on costs is from the population or community component in the IID Study. This component is a smaller sample of 397.

Costs in the IID Study were classified into three categories: costs to the NHS including GP, laboratory and hospital costs, direct personal cost and costs of lost output which were estimated by lost earnings. For our purpose, of estimating the cost of illness in 2000, each of these components has to be uprated by a suitable price index from 1994/5, taken as Q4 1994, to mid 2000.

For the NHS cost the price index used is the NHS Composite Inflation Index (see Annex 3 for information on uprating factors) produced by DOH. This index includes the prices of both primary and secondary NHS care and is considered to be the most appropriate of available health care price indices. The direct personal costs borne by the ill person and their carers are uprated by the RPI index excluding housing costs between Q4 1994 and Q2 2000. Lost earnings are uprated by the rise in the Average Earnings Index between Q4 1994 and Q2 2000.

The estimated total actual costs in 2000 of those who suffered IFD and visited a doctor are estimated as £123 million in 2000 prices and for those who did not visit a doctor the total cost are estimated as £41 million (detailed calculations are in Annex 1). The estimated overall total actual cost is £164million in 2000. As explained above, the estimate of total actual costs is based on study that followed individuals for a period of six months and do not include the cost of cases of long term illness. The total estimate of actual cost is therefore likely to be biased downward.

The actual, out of pocket, costs do not include the monetary value of pain, grief and suffering due to illness, injury and death. Such costs are usually included in Cost/Benefit analysis and RIAs of government policy, and to these we turn next.

(ii)Monetary value of pain, grief and suffering due to IFD, England and Wales 2000

Monetary value for pain, grief and suffering are included in RIAs produced by Department for Transport Local Government and the Regions (DTLR) and the Health and Safety Executive (HSE). Such values are part of the estimates of the cost of road accidents and illness due to work. The basis for estimates of the cost of pain grief and suffering is the measurement of individuals' willingness to pay (WTP) to reduce the risk of premature death due to road accidents.

For example, consider a safety improvement expected to reduce the number of premature deaths in a year by one in a population of 100,000. Each person's risk of dying is thus reduced by an average of 1 in 100,000. Assume people are prepared to pay (on average) £50 extra a year to effect the safety improvement. For each death prevented there are a 100,000 people willing to pay £50, or a total of £5 million: the Value of Fatality Prevention (VFP) is £5 million.

There are practical difficulties involved in determining appropriate values and the value used here is the one formally adopted by DTLR (formerly DETR) and also used, with some modifications, by HSE. This VFP is based on a major empirical study and was subjected to public consultation. The final figure chosen by DTLR is towards the bottom end of the potential range suggested by the research.

The VPF, and related values for preventing casualties of varying severity, are updated annually and published by DTLR. The latest one is for 2000 (HEN 2000) where the estimate of the VPF is £1,144,890 in June 2000 prices. This is the sum of lost output (£393.580) medical and ambulance cost (£670) and human cost (£750, 640).

The HSE uses the WTP element of the DTLR estimates of the VPF to derive an estimate of the monetary value of pain, grief and suffering in the case of death. This is calculated as the human cost component of the VPF plus 80% of the lost output component and yields (detailed calculations in Appendix 1) an estimate for the monetary value of pain, grief and suffering in a case of death in 2000 of £1,065,504 (June 2000 prices). HSE add this cost to independent estimates of actual, out of pocket, costs to individuals, employers, the NHS and other costs central and local government to estimate the total cost of a fatality due to work accident or illness.

HSE also produces estimates of the cost of pain, grief and suffering for 'minor cases of ill health', defined as those ill for up to 7 days, for 'other cases of ill health', defined as those ill for more than 7 days, and for 'permanently incapacitating ill health'. The costs for minor and other illness is derived using the 'standard gamble' approach, a variant of the WTP approach, where individuals are asked what they are willing to pay to reduce the risk of varying severity of illness or injury . The latest published estimates are for Q3 1999 and these are uprated to Q2 2000 by the rate of increase of nominal GDP per capita between the two periods (see appendix 1 for detailed calculations).

The estimated monetary values of pain, grief and suffering for the four levels of severity of illness, uprated to mid 2000 are:

1. Minor illness of up to 7 days £155

2. Illness lasting more than 7 days £1,960

3. Permanently incapacitating ill health £188,870

4. Death £1,065,504

Matching quantities on the number of cases of IFD occurring at each level of severity of illness utilises the estimates by PHLS/CDSC, information from the IID Study on the duration of intestinal illness and a few additional assumptions.

The CDSC paper provides information on the total number of IFD cases and a breakdown into those cases presenting to a GP (368,516) and those not visiting a GP (970,256). The IID Study estimates that 97% of those not seeing a GP are ill for up to 7 days and 3 % for longer than 7 days. For those who do see a GP it is estimated that close to 60% are ill for up to 7 days while 40% are ill for longer than 7 days.

There is no information on the number of cases that become permanently disables due to IFD but CDSC estimate that there were 480 cases of deaths due to IFD in the year 2000. A conservative assumption is added that the number of cases of permanent disablement is the same, 480.

In the calculations of costs it is also reasonably assumed that all cases resulting in permanent disability or death consulted a GP.

The monetary value of pain, grief and suffering from IFD is estimated at a total of £1,126 million, the (rounded) sum of:

£145.9 million for cases that do not see a GP and ill for up to 7 days;

£ 57.1 million for cases that do not see a GP and ill for more than 7 days;

£ 34.3 million for cases that see a GP and ill for up to 7 days;

£287.9 million for cases that see a GP and ill for more than 7 days;

£ 90.7 million for cases of permanent disability;

£511.4 million for cases of death;

(Detailed calculations of the above estimates are provided in Appendix 1.)

The estimated total cost of IFD in England and Wales is the sum of (i) the estimated actual, out of pocket, cost of £164 million and (ii) the monetary value of pain, grief and suffering due to such illness of £1,126 million, a total of £1,290 million in the year 2000.

The average cost per case is £1,290 / 1,338,772 = £964 per case.

Assuming that the incidence and outcome of IFD is the same in Scotland and Northern Ireland as in England and Wales, the estimated total cost of IFD can be scaled up to UK level, by the ratio of the population in UK to that in England and Wales. The estimated total cost of IFD in the UK in 2000 is £1,456 million.

Adak G.K., Long S.M., O'Brien S.J. (Paper submitted for publication 2002) Trends in Indigenous Foodborne Disease and Deaths, England and Wales - 1992 to 2000.

A Report of the Study of Infectious Intestinal Disease in England (2000) Food Standards Agency, HMSO.

Source of information see (i) above.

There are estimates of the average costs of cases of Salmonella (£606), Campylobacter (£315), Enterovir E. coli (£214), C. difficili (£287), Rotavirus (£164) and SRSV (£177) in 1994/5 prices.

Advise by Dr J Roberts, the economist on the IID study team.

Quoted from HSE document GAP 23: Regulatory Impact Assessment -Policy Appraisal and Evaluation. Version: 3 ^rd version, January 2001.

Though the HSE has not formally endorses any single VPF figure.

For further details refer to GAP 23 above and to HSE Book published by HMSO (1999), The Costs to Britain of workplace accidents and work-related ill health in 1995/6.

DTLR Highways Economic Notes No1: 2000.

It is relevant to note that while the HSE uses this statistical value of life for most death cases, for death due to work related cancer a value double this estimate is used to reflect the particular aversion of people (the dread factor) to this illness.

See HSE The cost to Britain of workplace accidents (reference in viii above) pages 32 & 33 and Appendix 4 pages 77 & 78.

Source GAP 23, January 2001, reference iii above.

See paragraph 10 in HEN2000, reference vi above for method of uprating WTP estimates.

Data from the Population Component of the IID Study matching diagram A4.48, provided by Dr J Roberts.

Same as xiv to match diagram A4.44.

Appendix 1: Calculations of cost of illness in 2000

Actual cost of illness

Additional monetary value of pain, grief and suffering

(i) Total number of IFD cases in 2000 1,338,772

of which: visited GP 368,516

did not visit GP 970,256

For those visiting a GP the average cost of illness is based on the estimated cost in the PG control component of the IID Study (see Table 8.7. IID). Costs are centred in 1994/5 and uprated with appropriate indices to mid 2000. The average cost comprise of:

NHS costs = GP £44.80 + Hospital £17.82 = £80.44 * 1.206 (NHS composite inflation index 1994/5 to mid 2000. See Appendix 3 for data and uprating factor) = £97.0

Direct personal cost £15.21 * 1.1355 (RPI excluding housing 1944Q4 to 2000Q2) = £17.3

Lost earnings of ill person and carers £139.97 +£35.98 = £175.95 * 1.253 (Average Earnings Index 1994Q4 to 2000Q2) = £220.5

Average actual cost for those visiting a GP = £334.8

Total cost for those visiting a GP £334.8 * 368,516 = £ 123 million.

For those not visiting a GP the average cost of illness is based on the cost in the Population/community component in the IID Study (see Table 8.7). The average cost comprise of:

Direct cost £3.72 * 1.1355 (RPI) = £4.22

Lost earnings £17.21 + £13.38 = £30.59 * 1.253 (AEI) = £38.33

Average cost for those not visiting a GP = £42.55

Total actual cost for those not visiting a GP £42.55 * 970,256 =£41million

Total actual cost for all cases of IFD £123 + £41 =£164million

(ii) Additional monetary value of pain, grief and suffering based on estimates of values by DTLR as used by HSE to add monetary value for pain, grief and suffering to actual cost of work related illness and death.

HSE uses four classifications of the severity of illness: minor illness lasting up to 7 days, other illness lasting more than 7 days, permanent disability and death.

For death the estimates of the monetary value of pain, grief and suffering used in this paper are taken from components of the cost of fatality for June 2000 published by DTLR in the Highways Economic Notes No1: 2000. The components of Human costs and Lost output are combined, using the formulae used by HSE:

Value of pain etc. in case of death = Human cost + 0.8 * Lost output = £750,640 + 0.8* £393,580 = £1,065,504 in June 2000.

The monetary value of pain grief and suffering of permanent disability, other ill health and minor illness are taken from the latest published estimates for the third quarter of 1999 by HSE (GAP23: Regulatory Impact Assessment - Policy Appraisal and Evaluation, 3 ^rd Version, January 2001). These estimates are uprated from Q3 1999 to Q2 2000 by the nominal growth of GDP between the two periods, an addition of 3.15%. (No correction is made for change in population since the period is short.)

The monetary values of pain grief a suffering for various severity of illness are:

Minor illness in Q3, 1999 £150 * 1.0315 = £155 in Q2, 2000;

Other illness in Q3, 1999 £1,900 *1.0315 = £1,960 in Q2, 2000;

Permanent incapacitating ill health Q3, 1999 £183,100 * 1.0315= £ 188,870 in Q2, 2000.

Quantities of illness of various severities have to be matched to the above estimates of costs per case. Quantities estimates are based on the CDSC estimates of the total number of IFD in the year 2000 (data in Appendix 2).

The CDSC researchers estimate that there were 480 cases of death from IFD in 2000.

There is no information on the number of cases of permanent incapacity. An assumption is made that the number of cases of permanent incapacitating IFD is of a similar scale to that of fatality, 480 cases in 2000. There is some evidence from the US for a few pathogens on the level of very long-term illness and this suggests that our assumption is reasonable and may be conservative.

There are in total 1,338,772 of cases of IFD in 2000 (CDSC estimates).

Of this total 368,516 see a GP and 970,256 don't see a GP.

Using information collected in the IID Study, these totals are divided into cases that are ill for up to 7 days and those that are ill for longer than 7 days:

For those not seeing a GP 97% are ill for up to 7 days and 3% for longer (population component, diagram A4.48, data provided by authors).

For those presenting to a GP some 60% are ill for up to 7 days and 40% are ill for longer (GP component, diagram A4.44, data provided by authors).

Applying these proportions we get:

Cases not seeing a GP and ill for up to 7 days 970, 256 * 0.97 = 941,148

Cases not seeing a GP ill for longer than 7 days 970,256 * 0.03 = 29,108

Cases seeing a GP and ill for up to 7 days 368,516 * 0.6 = 221,110

Case seeing a GP and ill for longer than 7 days 368,516 * 0.4 = 147,406

Assuming that all cases of death and permanent incapacity see a GP and are ill for longer than 7 days, we deduct 960 (=480+ 480) from the last category to yield:

Cases seeing a GP and ill for longer than 7 days, net 147,406-960 = 146,446.

Multiplying quantities by prices, costs, we get the following monetary values in year 2000 for pain, grief and suffering for the various categories of IFD illness:

Mortality 480 cases * £1, 065,504 = £511.4 million

Permanent disability 480 cases * £188,870 = £90.7 million

Not presenting to GP, up to 7 days illness 941,148 cases * £155 = £145.9 million

Not presenting to GP, more than 7 days illness 29,108 cases * £1,960 = £57.1 million

Presenting to GP, up to 7 days illness 221,110 cases * £ 155 = £34.3 million

Presenting to GP, more than 7 days illness 146,446 * £1,960 = £287.0 million

Total = £1,126.4 million

The estimated total cost of IFD in England and Wales is the sum of (i) the estimated actual, out of pocket, cost of £164 million and (ii) the monetary value of pain, grief and suffering due to such illness of (rounded) £1,126 million, a total of £1,290 million in the year 2000.

The average cost per case is £1,290 / 1,338,772 = £964 per case.

To scale the estimates of total cost of indigenous foodborne disease in England and Wales to the UK level an assumption is added that the number and outcome of cases of IFD in Scotland and Northern Ireland is similar to that in England and Wales. The UK costs can then be calculated scaling up the costs in England and Wales by the ratio of their population to the UK population, a ratio of 1.129 in 1999, the latest available data (source: Social Trends 2001 Table 1.1)

The estimates total cost of IFD in the UK in 2000 is:

1,290 million * 1,129 =1,456 million

Appendix 2

Appendix 3: Data and uprating factors

NHS Composite Inflation

Estimates of annual inflation increase of NHS total costs, percentages. Source: DOH

Increase from 1994/5, when data from the IID Study is centred to the latest available year 1999/00 and an assumed addition of 2% from the middle of 1999/00 (September/October) to mid 2000.

Base year 1994/5 % increase Index (1994/5=100)

1995/6 3.7 103.7

1996/7 2.9 106.7

1997/8 2.1 108.9

1998/9 3.9 113.2

1999/00 4.5 118.3

Adding 2% for the period mid 1999/00 to mid 2000 the index is120.6.

The uprating factor between 1994/5 and mid 2000 is 1.206.

Retail Price Index excluding housing

Source: National Statistics StatBase. Dataset Name:rpi1 Index of all items excluding housing (CHAZ), Quarterly series (update 12/2/02).

Index in 1994 4 142.4

Index in 2000 2 161.7

Uprating factor between the two periods 161.7/142.4 = 1.1355.

Average Earnings Index

Source: National Statistics StatBase. Dataset Name: aei. Average Earnings Index for the Whole Economy, s.a. (LNMQ), Quarterly series (update 13/2/02).

Index in 1994 Q4 98.3

Index in 2000 Q2 123.2

Uprating factor between the two periods 123.2/98.3 = 1.253.

Gross domestic product (GDP) at market prices

Source: National Accounts Table A1. GDP at market prices, s.a. £ million.

1999 Q3 224,686

2000 Q2 231,773

Uprating factor between the two periods 231,773/224,686 = 1.0315.

Annex E

HACCP and Hazard Analysis Uptake by Food Business Sector

N.B. This information was drawn from the results of a questionnaire sent to UK food authorities in September 2001 seeking local information on the number of businesses operating HACCP based controls. The above estimates must be indicative only, as they are more based on local authorities' perceptions rather than objective assessments and records.

(1) Having HACCP in place means applying all 7 principles, including the 6 ^th and 7 ^th, which require establishing procedures to verify that the system is working effectively and documentation of all procedures and records.

Annex F

Current Legislative Requirement to have a HACCP or Hazard Analysis System in Place by Sector

Current Legislative Requirement

* Commission Decision 201/471/EC requires the implementation of HACCP principles and microbiological testing in fresh meat and poultry meat slaughterhouses, cutting plants and cold stores by June 2002, and for smaller plants, June 2003.

N.B. The requirements outlined above refer to the legislative position flowing from the current EU Directives. Those Directives will be repealed (detailed in Annex A) and replaced by the implementation of the legislation that is the subject of the proposals under consideration.

Annex G

Work to inform the preparation of a Regulatory Impact Assessment

Verification and documentation of HACCP - Catering and Retail Sectors

Executive Summary

This project examines the financial impact of the EU proposal to apply from 2004, verification and documentation procedures related to HACCP, in catering and retail businesses.

Methodology:

a telephone survey of trade, enforcement, educational and other interests, to assess the response, level of support or opposition to the proposal;

an assessment of food business costs in terms of time required for training, verification and documentation, using three businesses on which hypothetical calculations were based; and

an estimate of the benefits of improved food safety.

The cost assessment is subject to uncertainty. Annual expenditure requirements of £103 million in the catering sector and £67 million in the retail sector have been estimated. A one-off training-time expenditure of £118,000 for local authority EHO's, is also estimated.

The food safety benefits are potentially large: in the region of £500 to £1000 million, or even more on some assumptions. These figures are based on what consumers would be willing to pay and are much larger than implied by DOH estimates of cost savings from reduced infectious intestinal disease (IID): about £2 to £5 million for each 1% reduction.

1. INTRODUCTION

The project remit was to examine the implications for the catering and retail food sectors of verification and documentation of the HACCP proposals. The Food Safety (General Food Hygiene) Regulations 1995 imposed the first five principles of HACCP on food businesses in the UK. Therefore the extra, anticipated costs, involves the necessity for verification and documentation procedures and enforcement by EHO's.

2. THE FSA STRATEGY

The FSA strategy for the wider implementation of HACCP and the FSA action plan, aims to achieve documented HACCP implementation in 30% of UK food businesses by April 2004. The extra cost implications arising from this have also been considered.

3. ASSESSING HACCP APPLICATION - CATERING/RETAIL SECTORS

3.1 Views of trade associations, local authority organisations, academic, professional bodies and individuals were sought on the EU proposal. Although in general there were no specific or strongly expressed views opposing the future increased HACCP requirements, there were concerns regarding documentation.

3.2 Overall, there was no serious criticism of the proposal to require verification and documentation procedures, but emphasis was placed on the need to balance the requirements and enforcement aspects with the scale of business operations.

3.3 Calculations were made of notional and relative costs of applying verification and documentation requirements in three SME's. The figures used were hypothetical, but based on actual businesses from examination of research projects in the earlier BO2 Programme, and after discussion with catering and professional experts situated in the area of the three businesses. They considered figures after payment of VAT and NI. The calculations were also examined by independent HACCP and training experts, who judged them as reasonable.

4. VERIFICATION AND DOCUMENTATION ESSENTIALS

4.1 It is presumed that if future legislation requires application of HACCP as defined by Codex, a HACCP Plan or similar document will be required for each business. Flow and decision tree charts will most likely need to be optional, depending on each food producing operation.

4.2 The Department of Health publication "Assured Safe Catering" identifies in Appendix 4, the critical points in SME's where daily monitoring, verification checks and the record of such checks, are necessary. This guidance will likely be enhanced by initiatives in the FSA strategy for HACCP.

5. ASSESSMENT OF THE COST OF THE LEGISLATION CHANGE

5.1 Local authority EHO time costs

Looking ahead to 2006, an estimated provision is required for the training time necessary for one officer from each authority to acquire the necessary expertise of a HACCP specialist. An estimate of £118,000 is made in this respect. No extra enforcement costs are anticipated.

5.2 Costs for the Catering and Retail sectors

The cost assessment required relates to 380,198 catering and 187,147 retail businesses, the application of verification and documentation requirements of HACCP from 2004, and the time needs for staff training.

5.3 The estimates of costs are based on figures for 3 SME's in the catering and retail sectors, referred to in paragraph 3.3, although some adjustments have been made to make them more typical of the average business. The costs are the ongoing daily costs and the start up costs of training and putting system in place. The latter element is very small.

5.4 The ongoing costs are more substantial, but even so for some businesses are likely to be modest. Most food retailing SME's sell only pre-prepared food for which the only checking required relates to temperatures of storage and display. Also for some caterers, the time costs will be small. For the smaller less complicated catering business and retailers it is assumed that 15 minutes each day is required and for the larger catering business, a little over 30 minutes, at around £10 per hour.

5.5 The total calculated costs to the catering and retail sectors of verification and documentation of HACCP is estimated at £170 million annually, equivalent to 0.4% of turnover.

6. BENEFITS

6.1 In the Department of Health's study of IID, the average cost per case was put at £79 in 1994/95 prices (say £100 at present prices) and the total cost of food borne IID was estimated at between £190 million and £550 million. On this basis, each 1% reduction in IID would save costs of £1.9 to £5.5 million.

6.2 These estimates of costs per case of IID were extremely narrowly based. They counted only the very direct costs of each incident in isolation: costs to the NHS, costs to employers in lost production and the small amount of expenses incurred by the individuals concerned. They did not make any allowance for suffering and inconvenience borne by IID victims or their close relatives, or for the risk adversity of consumers.

6.3 Benefits of avoiding the risk of IID are shown, and can be measured by willingness to pay (WTP) studies. These indicate that the benefits to consumers of reduced risk of IID could be very large: in the region of £500 to £1,000 million, or possibly much more if the risk of food poisoning was reduced to the lowest possible level.

Annex H

Benefits to Consumers and Food Businesses

To Consumers:

1. First and foremost, consumers of food will benefit from increased food safety as a result of enhanced hygiene controls outlined above. Notably, the WHO has stated that the main benefit of the implementation of HACCP will be the reduction of the risk of food-borne disease.

2. The second main benefit to the consumer will be increased consumer confidence in the food supply, which is reflected in the perceived benefits from "willingness to pay" outlined above. Improved food safety standards should reduce the potential for consumer complaints and wastage.

3. The WHO argues that application of HACCP can improve the quality of life for consumers, in terms of both health and socio-economic factors. The Consumers' Association has welcomed the proposals and argue that HACCP should ensure a higher level of food safety, and that HACCP should be viewed as a tool for food producers to use to ensure that they are providing safer food.

To Food Business Operators:

4. The proposal should remove much of the outdated and unnecessary controls on production processes thereby allowing some cost savings. The benefits of the HACCP approach include:

• a single, systematic risk-based approach to all aspects of food safety from raw materials through to final product use;

• movement from solely retrospective end product testing towards a preventative approach, in turn leading to reduced product losses;

• capacity to identify areas of concern where failure has not yet been experienced, making it particularly useful for new operations and products;

• a business focussed, flexible approach aimed at preventing problems occurring and therefore protecting reputations of businesses;

• focusing technical resources into critical parts of the food production process;

• application of HACCP techniques can also bring direct benefits in terms of new and additional orders for the business (as demonstrated in the Cardiff study);

• in requiring that third countries exporting food to the EU conforms to the same or equivalent standards, the proposals may aid business by helping to crate a level playing field and driving out substandard competition;

• food businesses will also benefit directly, as all other members of the population, by reduced foodborne illness among the staff working in those businesses;

• the potential to reduce the costs of official supervision and inspection in fresh meat plants (assistants as well as Official Veterinarians may be permitted to carry out some inspections), as HACCP systems lend themselves to audit and therefore do not require constant supervision; and,

• introduction via directly applicable regulations, would ensure a uniform approach to HACCP across the EU and so facilitate trade in foodstuffs.

Annex I

ADAS CONSULTING LTD

FSA Project Code: B18004

PROPOSALS TO CONSOLIDATE AND SIMPLIFY EU FOOD HYGIENE LEGISLATION: WORK TO INFORM THE PREPARATION OF A REGULATORY IMPACT ASSESSMENT

The main costs will be additional compliance by firms operating in the food chain from primary producer to final consumer. The main benefit will be less illness among consumers caused by food.

The cost benefit analysis (CBA) seeks to estimate the total of society's additional costs and benefits arising from the proposed new EU regulations. As is convention in CBA, transfer costs have been ignored. For example, if enforcement bodies raised charges for their work, this would be a transfer from businesses in the food chain to enforcers. The total costs and benefits to society as a whole would not change. Hence our calculations do not investigate the distribution of costs and benefits between the different economic agents. In practice the market would be likely to transfer much of the additional costs borne by businesses to consumers through higher food prices.

The following page shows a simple diagram (Table 1) that summarises the possible costs and benefits of food safety regulation. An important notion when identifying costs and benefits is causality. In the diagram below causality runs from left to right. It is only changes in costs and benefits caused by the new EU Regulation which should be costed.

The impact of the new regulations on businesses in the food chain are now considered in turn, and then the impact on consumers. The food businesses considered in this study were farmers and growers, and food processors. Other studies have considered the impact on other primary producers (e.g. fishing) and caterers/retailers. In addition the new regulations will affect regulators and enforcers. The FSA and Local Authorities are the institutions with the regulation and enforcement functions.

Table 1. Simple Model of Potential Costs and Benefits of New EU Food Safety Regulations

The estimate of the cost to farmers is calculated on an assumption of 146,430 farm businesses in the UK derived from data on VAT registrations. The mix of farm types and sizes have been based on statistics from the Agriculture Departments of the UK based on the annual agricultural census returns.

About 65,000 farms, mainly the larger ones, were in Produce Assurance schemes and these produce the largest volumes of products. A key assumption in calculating the cost to farms of the new EU regulation is whether farm assurance schemes will satisfy their new obligations under the proposed EU regulation. It is assumed that farm assurance schemes will meet nearly all the requirements of the new EU regulation leaving assured farms to make an expenditure of a balance of only 5% of the cost which will be incurred by non-assured farms. For the remaining 71,000 farms the costs of compliance have been estimated by ADAS specialists for a farm business with two full time persons. Very small farm business are assumed to incur a cost of 50% of the two man business, small farms to incur a cost of 75% of two man businesses, large farms to incur a cost of 150% of two man businesses.

In this study the costs of meeting the expected requirements for traceability and for the adoption of hazard analysis principles for food safety were estimated separately and these are shown in Table A4.5.(a) - (c). Costs of adopting hazard analysis ranged from £94 for a very small beef and sheep farm to £620 per year for a large horticultural producer. The details are shown in Table 4. The cost of £20.69 million per year is composed of £0.94 million for assured farms and £19.74 million for non-assured farms. The costs of including traceability are shown in Table A6.1, Appendix 6.

There are calculated to be about 14,000 food processors. After excluding those in sectors where the new EU regulation will not add to the legislative requirements there were about 6,500 small processors employing less than 50 employees. Larger businesses were generally considered to be already complying with the new proposals, due to customer pressure. ADAS specialists estimate the compliance cost per business at £120 per year for adopting traceability measures and £504 per year for adopting full HACCP, totalling £624 per year. The compliance cost for HACCP is calculated at £0.99m. per year. The costs of including traceability are shown in Table A6.1, Appendix 6.

The quantitative evidence of the cost of enforcement of the new regulation is not substantial because at the time of completion of this draft report replies had only been received from four local authorities, one in Wales and three in England.

There are no data sources on the total manpower or cost of food hygiene work carried out local authorities in the UK. The FSA is now receiving information on Food Service plans from each Local Authority but this only becomes available as audits are carried out and this is not yet complete.

In the ADAS consultation, four local authorities covering a population of 1.195 million people devoted 6,900 person days to food hygiene. Raising this figure to the total population of the UK (which takes no account of differences between the nature of work in different types of authority) gives an estimate of 1,500 person years per year engaged in food hygiene work. The grades of staff employed in this work will vary from relatively junior technical staff to senior managers. ADAS has used a total cost per person year (to cover salary, employer's national insurance, pension costs, office accommodation, expenses and any support staff not included in the 1,500 man years) of £35,000 as the average cost across all grades. The implied expenditure on food hygiene enforcement is therefore £53 million per year.

In the responses from the four local authorities their expectations were for very little change in non-staff cash expenditure, but for one-off cost of implementation of 50% of current staff time, and ongoing costs of 50% of staff time to enforce the new regulation. Annualising the one-off cost by the method used for primary producers and processors, plus the recurrent costs, gives an additional total annualised cost of £32.5 million per year.

The cost estimate reported above clearly needs to be made more robust by getting more responses from Local Authorities. Account also needs to be taken of any incentive for Local Authorities to generously estimate the size of additional costs. These estimates probably reflect a worst case scenario as viewed from the Enforcement Officers' perspective. It has not been possible to accurately estimate the split in costs between the enforcement of traceability and of HACCP, but the bulk of costs would be associated with the latter.

It has been claimed that consumers would benefit from having more confidence in buying food if there were greater assurances about food safety and less cause for 'media scares'. Whilst these claims may be true it would be necessary to use a willingness to pay methodology to estimate these benefits and this has not been done in the CBA presented here.

Consumers would be the main beneficiaries of a reduction in the incidence of Infectious Intestinal Disease (IID). The cost of IID was £676.9 million in England in 1995. To adjust this to 2002 prices and for the UK, based on population, the total becomes £975.3 million. These costs are based on the resource costs of IID, not willingness to pay.

The cost calculated in the report (1994/95 figures) per organism was:

Table 2. Cost per organism (IID Report)

The IID report includes organisms (e.g. viruses) where person to person transmission is common. If one assumes 90% of the Salmonella, Campylobacter and E. coli costs were attributable to foodborne transmission, and 50% of the remaining cases to foodborne transmission, the total cost of foodborne disease in the UK in 2002 is estimated as £594 million per year

The reduction in foodborne disease which the new regulation might assist is very uncertain, but an estimate of 5% is used in this document which would generate a benefit of £29.72 million per year.

The benefits of avoiding the costs of deaths from food poisoning have not been included in this calculation since these were excluded from the IID costing. However these should in principle be added to the FSA's final RIA. An alternative means of calculating benefits would be to cost the willingness of consumers to pay higher costs for 'safer' food, and in the consultants' opinion this is likely to increase value of benefits.

The costs and benefits described above are summarised in Table 3.

Table 3. Summary of Costs of Adopting Hazard Analysis/HACCP and Benefits

The costs exceed the benefits with total costs of £ 54.18 million per year (excluding caterers and retailers) and total benefits of £29.72 million per year.

Annex J

Costs and benefits - Further Background Evidence

1. There will be compliance costs for implementation of this proposal for SMEs (Small and Medium Enterprises). However, evidence gathered to date suggests that the costs of complying with the additional HACCP requirements would not be that great or overly burdensome. Notably, the report of the "Task Force on the burdens of food regulations on small food business" (paragraph 16) found that "the HACCP approach should be an important way for businesses to minimise regulatory burdens and costs". In no instance is it believed that increased burdens will be of the magnitude to deter new entry into the industry or to bring about the closure of businesses. Neither would any particular foodstuffs be affected more than others by the proposals.

2. Of the 30 businesses interviewed for the Task Force study, 29 were small businesses. Coverage was wide in terms of activity and location. A HACCP plan was in place in 25 of the businesses while the remaining 5 had a HACCP approach to food safety, identifying and controlling hazards but without a documented plan. Seven of the businesses had a documented HACCP plan without a legal obligation to do so. Costs were identified on the basis of the additional costs to the business of HACCP and/or other food safety regulations other than what the business would do if the regulations did not exist. It emerged that the costs of HACCP are, in most cases, negligible or small and in no business were the costs considered by the business to endanger its viability. In only four businesses with a HACCP plan were the costs significant, three in the meat trade and one where there were serious problems with food safety generally. In this context it is useful to note that one of the Task Force conclusions was that reviewing and simplifying existing HACCP plans could in some cases reduce existing running costs of HACCP.

3. University of Wales Institute research on the "Evaluation of barriers to the use of food hygiene management systems throughout the UK food industry" included a postal survey of 254 SME's in food manufacturing, catering and retail and a detailed case study of eight businesses with data on costs and benefits. The eight businesses comprised five independent small businesses, one of medium size and part of a multinational and two small plants part of a bigger group. It found that the non-recurring total value of time and money spent on HACCP implementation, with one exception was between 3% and 17% of one-week turnover of the business. The changes in direct costs of ongoing hygiene management as a direct result of HACCP implementation, as a percentage of weekly turnover, amounted to substantially less than 1 per cent in five of the businesses and 2.3% in one business. In one case there was not sufficient data to calculate the percentage of running costs and in another the researchers calculated a decrease of 28% in costs as weekly turnover was substantially increased as a result of introducing HACCP. The study also found that even where businesses were not applying a full HACCP system, most did apply some of its principles. The system could not therefore be called a totally new requirement nor were all the costs additional and due to new regulations. For example, caterers did apply hazard analysis in 37% of cases, identified critical control points in 43%, had documentation in 63% and verification in 65% of cases without being legally obliged to do so.

1. A Regulatory Impact Assessment was produced on "The Food Safety (General Food Hygiene) (Butchers' Shops) Amendment Regulations 2000". It found that the costs of implementation of HACCP in butchers' shops varied from £0 to £500 for those just selling raw meat, to £1,000 to £5,000 for premises manufacturing and selling a range of cooked meats alongside raw meat. This provides an indication of the costs involved for one industry sector. However, these figures are likely to be higher than for many sectors affected given the relatively higher risks involved in the meat sector (see results of Task Force in paragraph 6.2 where higher costs were almost exclusively in the meat trade). It is also probable that in a number of cases examined the business was starting from having no hazard analysis in place, whereas most businesses should be applying the first five principles of HACCP already.

5. It should be borne in mind that for the studies above the cost identified were in the main relating to one-off start up costs, and not ongoing running costs. It is also true that in some cases costs were included for equipment purchase, such as freezers, which do not, in fact relate to the costs of HACCP, but rather the proper running of the business as required under existing legislation.