17.3.2006   

EN

Official Journal of the European Union

C 65/141

1.1

The new food-hygiene legislation (1), which came into force on 20 May 2004, seeks to ensure a high level of consumer-protection as regards the safety of food products by pursuing an integrated approach covering the whole of the food chain (‘from farm gate to plate’). The application of uniform principles is also designed to ensure the smooth operation of the internal market.

1.2

The key principle underlying the new legislation is that food business operators have to assume full responsibility for ensuring their products pose no health hazard. This is to be ensured by means of the observance of fundamental, specific hygiene standards and the application of the principles of risk analysis systems (HACCP (2)).

1.3

The new food hygiene legislation comprises several regulations:

1.4

In order to ensure that Regulations (EC) 852/2004 and 853/2004 are applied as uniformly as possible, the following guidance documents have been drawn up by the Directorate-General for Health and Consumer Protection (SANCO). They are in the nature of recommendations and are addressed to the food businesses themselves and to the local authorities:

1.5

As part of the EU legislative procedure, the European Economic and Social Committee (EESC) inter alia issued opinions (3) on 28/29 March 2001 on Regulations 852/2004, 853/2004 and 854/2004, which were adopted in 2004. In its opinions, the EESC expressly endorsed the new Regulations and their underlying principles.

1.6

In drawing up this own-initiative opinion, the EESC is seeking to set in train an appraisal to determine whether the new food hygiene rules make the best possible contribution — from the standpoint of the coherence of the objectives and measures — towards promoting the politically-desirable goal of sustainable development in rural areas. Small, artisanal and/or traditional processing businesses are of particular importance for the economic development of these areas. Frequent experience shows, however, that in the last few years there has been a sharp decline in structures of this kind, especially in the areas of meat and milk processing and marketing. It has often been suggested by those affected and by the competent authorities that high EU hygiene requirements are responsible for this structural change.

1.7

In the light of this, it needs to be established whether the EU is in fact directly or indirectly responsible for structural change prompted by hygiene requirements. This of course in no way calls into question the essential objective, that of preventing risks to human health. What does need to be asked, however, is whether differentiated requirements are needed, and whether the necessary flexibility exists in seeking to achieve all the objectives set by the EU (hygiene and creation and safeguarding of jobs).

1.8

This opinion will examine the new food hygiene provisions to determine whether:

1.9

As the specific hygiene rules set out in Regulations 853/2004 and 854/2004 cover exclusively food products of animal origin, the appraisal will focus on the impact on food businesses dealing in these products. Processors of products of plant origin (e.g. bakers, cake makers etc) and other animal products (e.g. fish), which are also covered by the new hygiene rules (Regulation 852/2004), are thus not considered.

1.10

With this opinion the EESC is seeking to stimulate a debate on food safety standards and the related issue of sustainable development in rural areas. In this context, the Committee takes the view that the goals of consumer protection, the maintenance of cultural diversity, the safeguarding of fair competition and the maintenance and increase in the number of jobs in rural areas are objectives of equal importance which need to be reconciled with each other.

2.1

Regulation (EC) 178/2002 lays down the general principles and requirements of food law, including food safety procedures, with a view to improving both the operation of the internal market and the free movement of food products and animal feed. Furthermore, the alignment at EU level of food law concepts, principles and procedures, which hitherto were still, to a large extent, marked by a national approach, should ensure a high level of consumer protection.

2.2

Regulation (EC) 852/2004 on food hygiene gives concrete expression to the objectives of Regulation 178/2002 and sets out basic rules governing the hygienic production of all food products. This Regulation applies to all stages of the production, processing and marketing of food products. It also covers primary agricultural production. In contrast to ‘food businesses’, primary agricultural producers are (still) not obliged to apply procedures based on HACCP principles but they have to comply with the principles set out in Annex I. All food businesses do, however, have to be registered and comply with the general food hygiene rules of Annex II of the Regulation. The procedures for the registration of businesses will be laid down by the national authorities on the basis of Article 31 of Regulation 882/2004.

2.3

All food businesses have to comply with the following hygiene rules:

2.4

The following are not covered by the Regulation:

2.5

The new food hygiene legislation does not set out detailed rules in respect of the criteria listed in point 2.3 above (e.g. type of microbiological criteria, scale of sampling and type of analyses). A draft separate Regulation on microbiological criteria for food products, on the basis of Article 4 of Regulation (EC) 852/2004, already exists, however.

2.6

In view of the fact that food products of animal origin may give rise to a number of special risks, two specific regulations have been introduced covering these products, namely:

2.7

Food businesses working with food products of animal origin must:

2.8

Products and procedures not covered by Regulation 853/2004. In addition, the following products and procedures are not covered by the Regulation:

2.9

Point 3.5 of SANCO guidance document 1514/2005 rev. 1 states that the retail trade shall be excluded from the scope of Regulation 853/2004 and fall within the scope of Regulation 852/2004 only when it means (a) direct marketing or (b) small-scale, regional and limited supply of products of animal origin to other institutions. It is left to the Member States to lay down general rules for the retail trade.

2.10

The new food hygiene legislation attaches particular importance to flexibility:

3.1

Many EU Member States continue to have a broad range of food businesses. The processing of agricultural raw materials and the production of food products can take place in a variety of enterprises: large businesses organised on an industrial scale and geared towards the international markets; small food businesses geared to a greater extent (but not exclusively!) to supplying regional markets; and micro-enterprises. Micro-enterprises can readily be linked to agricultural enterprises, from both an organisational and spatial standpoint.

3.2

The structure of food businesses and the volume of processing which they carry out are generally linked to specific production processes. The range of such production processes is broad, extending from industrial-scale/mass production processes to artisanal and traditional processes. The transitions between the respective levels of production are not clearly defined.

3.3

The text set out below will focus mainly on small food businesses and micro-enterprises which employ, to a greater extent, artisanal and/or traditional production processes.

3.4

A second area of emphasis will comprise food businesses engaged in processing meat products (including meat from poultry and other small animals) and milk; meat and milk are important sectors in respect of added value for agricultural products in many EU Member States and specific hygiene rules have been laid down covering these sectors (see also point 1.9). These rules apply, specifically and above all, to regional slaughterhouses, butchers carrying out their own slaughtering and processing operations, regional dairies, small-scale commercial cheese dairies, farm-based cheese dairies and Alpine dairies.

3.5

There is a majority of small food businesses in most EU Member States and they therefore play an important role in providing employment. Small businesses include artisanal businesses. These are often located in inner city areas and provide a high degree of product and cultural diversity and often — a factor which should not be overlooked — provide jobs for ethnic minorities. Particular attention should, however, be paid to food businesses which are engaged in the production and processing stages and are also closely linked, to a greater or lesser extent, to agricultural primary producers or commodity producers. Many of these businesses are based in rural areas. In some cases they play an important part in safeguarding and creating employment, especially in rural and often structurally weak areas.

3.5.1

Examples: In Europe there are more than 150 000 independent butchers, with about one million employees. In Germany alone there are at present approximately 18 000 butchery businesses (or 29 000 butcher's shops, including branches) providing employment for approximately 168 000 people. 15 % of those businesses continued to carry out their own slaughtering, whilst 10 % of the businesses had their own livestock slaughtered in slaughterhouses. Other centres of the butchery business are Spain, with some 35 400 independent butchers (including branches) and some 70 000 employees, and France, with just under 35 000 butchers and over 55 000 employees.

3.5.2

In the last few years there has been a trend towards buying meat in large supermarkets and discount stores. The EESC stresses, however, the importance of small-scale businesses, which cannot be measured purely in terms of sales figures (4).

3.5.3

There are a large number of small firms in the dairy sector too. Thus, in Germany, as a result of the expansion of organic milk production, over 500 new farm-based cheese dairies have been set up in the last few years, thereby generating some 1 500 new jobs. This figure is bolstered by the new jobs which have been created in organic dairies and commercial organic cheese dairies. Unfortunately no European data are available on this.

3.6

In the context of Agenda 2000, both the European Commission and EU Member States stressed the need not only to enhance the competitiveness of EU agriculture on the world market but also to focus on quality. With this aim in view, the multifunctional character of agriculture (also known as the ‘European agricultural model’) is to be maintained and promoted. This expression implies that this is a form of agriculture which, inter alia, supplies high-quality products thereby safeguarding jobs and creating new jobs. This strategy of increasing added value in rural areas is indissolubly linked to the maintenance and further development of the downstream sector of food processing. Protected designations of origin also contribute to this quality policy.

3.7

The EU policy on food quality is to be implemented, in future, inter alia, by means of the European Agricultural Fund for Rural Development (EAFRD) Regulation (‘Diversification Axis’) and by means of the action programme for organic farming.

3.8

Small food businesses, and in particular, small artisanal food processors, are of strategic importance in connection with this quality policy. These small food businesses are the very businesses which can help to promote diversity by, for example, providing consumers with a high level of product diversity. Growing demand in this sector points to the fact that consumers are increasingly valuing such diversity and underlines the fact that traditional artisanal production methods are indissolubly linked to high product quality. These production methods are also part of our cultural heritage. These food businesses have, for decades, demonstrated that they are able to produce products which are safe.

3.9

The EESC is therefore pleased to note that, compared with the existing rules, the new regulations make provision for a higher level of flexibility. The adoption of a flexible approach offers new opportunities to small food businesses operating in the field of artisanal and traditional food processing. The new uniform approval procedure will in future make it possible for them to participate in cross-border trade. But these opportunities must also be exploited by the Member States.

3.10

This flexibility does, however, also involve risks for small food businesses. Businesses which were previously only registered must now meet the higher standards of the approval procedure. Furthermore, some specific hygiene measures set out in Regulation 853/2004 lay down requirements which are clearly more demanding than those applying hitherto. This applies in particular to the related microbial control requirements.

3.11

The laying down of hygiene objectives rather than rigid requirements and the related flexibility clauses make it possible to tailor the shaping of the HACCP concept (in line with Regulation 852/2004) and the approval procedures to the specific risks posed by various kinds of business and their production processes.

3.12

This flexibility is of key importance for maintaining a diverse range of food businesses in Europe, as hygiene risks and the corresponding hygiene requirements are in some cases closely linked with the respective specific production, processing and distribution systems. Small, artisanal food businesses having a mainly local and regional distribution network present, to a certain extent, food safety risks of a different order than those which arise in the case of large food businesses organised on an industrial scale and having national and international distribution networks. It is thus clear that, in the case of large food businesses employing many workers, having high production volumes and limited areas of responsibility, traceability and quality-management systems, batch-marking and sophisticated spatial planning arrangements and input-related microbiological analyses do make sense. In the case of small food businesses, in which responsibility rests with a small number of workers and which are frequently not involved in intra-Community trade, simple concepts are usually sufficient, such as sample checks on cold temperatures or cooking temperatures, or visual inspection (cooked sausages). Traditional and proven checks have their place here. More stringent technical or organisational requirements do not result in improved hygiene but may be costly and time-consuming.

3.13

One example of the transfer of measures, which in the industrial context are both effective and necessary, to the craft domain is the requirement of Directive 64/433/EC for the use of. sterilisers. In the case of processing line slaughter, where the line typically moves at high speed, there is no time to sterilise knives, if for instance they cut into an abscess. A steriliser at every workplace in the cutting area enables workers to take new, sterile knives without stopping the line. The work of independent butchers is different. A single animal is cut by one person. There is always enough time to take a new, sterile knife, if required. And to this end it is sufficient to ensure that there is an adequate supply of knives sterilised the previous evening. A steriliser at each workplace is not needed. The revision of SANCO paper No 1514 of 8 September 2005 is a reaction to this objection raised by the EESC; point 5.3 states that in small abattoirs a sufficient number of knives, disinfected before slaughter, will suffice.

3.14

In other words, if hygiene standards and safety requirements are based predominantly on the risks inherent in present-day mainstream production techniques, i.e. industrial-scale processing and global-level trade and then applied to artisanal structures, there is always a danger that products produced using artisanal and traditional procedures will be placed at a competitive disadvantage. Such products will then be denied access to the market, partly directly and partly indirectly (by virtue of increased costs).

3.15

A request is made in the paragraphs below for concepts of hygiene to be geared to specific procedures and structures; this call is not made only in order to ensure equal opportunities as regards market access. The objective is rather, and in particular, to maintain and promote innovation in rural areas. By way of example, one of the most important innovations of the last few decades was the development and expansion of organic agriculture. In the absence of both the existing and the newly secured freedom, the revival of the exploitation of traditional food processing procedures could not have taken place. In future, too, there is therefore a need to continue to provide freedom for regional specialities, artisanal and traditional procedures, special forms of processing, special qualities of product and special means of marketing and at the same time to guarantee the consumer a uniform and high level of food safety.

4.1

Some Member States had taken advantage of the possibility provided for under the ‘old’ legislation to make a distinction between ‘registered’ and ‘authorised’ enterprises operating in the meat- and milk- processing sectors. ‘Registered’ enterprises were not allowed to take part in intra-Community trade, without this ban having to be justified on grounds of differing hygiene standards. Point 3.4 of SANCO guidance document 1513/2005 rev. 1 of 8 September 2005 specifically calls on the Member States to allow direct marketers, who are excluded from the scope of Regulations 852/2004 and 853/2004, to engage in cross-border trade in border areas. Thus businesses in border areas are being offered new market opportunities.

4.2

Regulation 852/2004 calls for the application of the concept of Hazard Analysis and Critical Control Point (HACCP) to food safety procedures. The mandatory introduction of the HACCP concept is to be welcomed; bringing about maximum product safety on the basis of a small number of controls — which are as effective as possible — carried out at the correct points is an approach which chimes with artisanal tradition. SANCO guidance document 1555/2005 of 30 August 2005 puts forward guidelines for adapting the HACCP concepts to different types of enterprise. Corresponding guidelines for good hygiene practice have been drawn up in the individual Member States. These can facilitate the application of HACCP in small food businesses, as the carrying-out of own risk analyses can in some cases be dispensed with.

4.3

Whether or not HACCP principles will thus prove beneficial to artisanal food businesses, too, will depend upon the way in which national HACCP guidelines are framed. If too much importance is attached to documentation and extensive checklists, the use of this instrument can easily force costs upwards without raising safety standards.

4.4

The HACCP concept involves carrying out microbiological controls; the criteria and scope of these controls have yet to be determined (Article 4). The form of the new regulation on microbiological criteria will have a decisive influence on the costs involved in cases where enterprises carry out their own controls. This regulation will play a part in determining whether or not small food businesses can operate competitively in future since such enterprises have to distribute the costs over much smaller volumes of processed products and sales than is the case with large food businesses. The proposed rule whereby, in the case of smaller abattoirs, cutting plants or butchery enterprises, the frequency of checks on minced meat can be adjusted in line with the volume of production is to be welcomed. All other enterprises must take weekly samples.

4.5

As a result of the adoption of a flexible approach, considerable discretionary powers will be given not only to Member States themselves but also, and in particular, to regional veterinary authorities responsible for approving food businesses. There are already at the present time considerable differences in the application of hygiene rules, in particular in those areas classified by veterinary officers as areas of risk, such as: the artisanal slaughtering of poultry; farm-based cheese dairies; and the production of raw milk products.

4.6

In many EU Member States the processing of milk for cheese production is an important source of farm incomes. Experience in Poland before and after accession has shown that veterinary authorities initially banned the establishment of farm-based cheese dairies, allegedly in order to comply with ‘EU requirements’. They were unsure how to deal with the ‘new’ ideas and wanted to ‘play it safe’, on the assumption that what does not exist cannot cause (hygiene) problems. Clearly however, it is not the EU but national and regional authorities which carry the responsibility for such decisions.

4.7

Many detailed provisions set out in the old EU legislation covering the processing of milk will now disappear. The new regulation offers small and artisanal food businesses, in particular, new opportunities. They can secure recognition of ‘alternative procedures’. These are not, however, specifically defined in the Regulation.

4.8

There is therefore a fully justified fear that some Member States are applying a much ‘stricter’ interpretation of the regulations and one which is more unfavourable to small food business, than was intended by the EU.

4.9

Example 1: In Germany the initial drafts have been prepared for a general administrative regulation (approval procedure in accordance with Article 31 of Regulation 882/2004). This requires — as in the past — type approval for the approval of pasteurisation facilities and sterilisation centrifuges. Businesses using other equipment or procedures would bear the burden of proof and the cost of having their own inspections carried out.

4.10

Example 2: In eastern European Member States like the Czech Republic, Poland, Slovenia and the Baltic States processes took place when adapting national laws to the acquis communautaire similar to those noted in the new German Länder after reunification. Not only did economic problems lead to massive structural change and corresponding job losses in dairies and abattoirs, but the interests of large-scale processors, which wanted to see increased use of their plants, often influenced the approval process.

4.11

The EU is therefore called upon to pay attention to the question of maintaining fair competition in the individual Member States by ensuring that the scope for interpretation granted in respect of traditional and regional quality products can also utilised by the authorities to the benefit of local, small food businesses.

4.12

Regulation 853/2004 contains a number of clearly-defined conditions which go far beyond the conditions hitherto applicable to small food businesses operating in the meat sector; these conditions will also have a detrimental effect on the trend as regards costs and will thus have a damaging impact on small food businesses. The most important of these conditions are as follows:

4.13

Under the new Regulation, all slaughtering enterprises have to provide waiting pens  (5). This requirement would also apply to butchers, even if in small abattoirs the animals are not held for long and if overall they only slaughter a small number of animals each week. This rule in principle makes it necessary for small businesses to carry out a considerable investment without bringing any recognisable hygiene benefits. It is therefore welcome that the revised version of the SANCO/1514/2005 guidance document picks up on this problem. Point 5.2 stresses that small abattoirs are not to be obliged to maintain sophisticated or extensive infrastructures or feeding and watering facilities.

4.14

Separate rooms must be made available for slaughtering and meat cutting. If these operations are not carried out at the same time, the same room could be used for both these activities without jeopardising safety status. Moreover, if this is the case, the premises will have time to dry. This will improve their hygiene status. It will also reduce the investment required of small businesses. Exemption from the second room requirement where there is a sufficient gap between slaughter and meat cutting, and provided the premises are cleaned appropriately, should therefore be included in a revised version of the guidelines.

4.15

A new requirement has been introduced whereby, in future, small artisanal enterprises, too, which hitherto had the status of ‘registered enterprise’ must now maintain a temperature of 12°C in meat-cutting rooms or else introduce alternative procedures. Quite apart from the fact that working at 12oC poses problems, this will give rise to additional investment and refrigeration costs for small businesses. It would be quite sufficient to require that the meat to be cut be removed from the refrigeration room in portions.

4.16

The new temperature and inspection provisions in respect of minced meat set out in Regulation (EC) 853/2004 are particularly problematic as minced meat is a product of major economic importance, also in the case of micro-enterprises and small meat-processing enterprises. In Germany at least, these businesses have in the past been classified ‘merely’ as ‘registered enterprises’ and they have therefore had to comply with the national rules on minced meat, which prescribe a temperature of 4°C. As, in future, there will only be EU-authorised enterprises, artisanal meat-processing enterprises will also have to comply with the strict temperature requirements (2°C) set out in the new Regulation (6). As long as businesses are producing fresh minced meat and selling it only on the day of production (as the old rules required) there is no hygiene advantage to be derived from lower temperatures. As old plant cannot simply be adapted to lower temperatures and moreover defrosting systems will be required, businesses will have to invest in new refrigeration equipment. Another feature of the new regulation which poses problems for the competitiveness of artisanal businesses is the fact that it allows the mincing of frozen meat. This will only encourage more price dumping.

4.17

A further new requirement is that artisanal meat enterprises will be obliged to carry out microbiological inspections of minced meat even if these enterprises sell or flash-freeze the minced meat on the very day of production (7). This results in a considerable cost burden without any recognisable advantage as regards food hygiene. The required frequency of checks is still open. The draft regulation merely states that small businesses will be exempted from the requirement for weekly checks (see points 4.18 — 4.20 below).

4.18

The regulation on microbiological standards is currently being drawn up; the form taken by this regulation will be of particular importance to the future competitiveness of small food businesses. There needs to be a sensible correlation between the degree and scope of sampling and the level of production of the enterprises concerned and there is a need to ensure that this sampling is statistically meaningful.

4.19

In the past abattoirs were required to carry out annual microbiological inspections of carcasses for microbial load and spoiling agents (enterobacteriaceae) and to carry out appropriate inspections of equipment, walls etc ten times a year. The planned increased in the required frequency of inspections will impose significant additional costs on small businesses (for minced meat see point 4.16).

4.20

A further factor to be borne in mind is that the small volumes of production give rise not only to statistical problems but also to problems in respect of the quantities which have to be taken away for testing. This factor has been highlighted by the ‘Conféderation Générale de l'Alimentation en Détail (CGAG)’, the French trade organisation representing retail food traders. The CGAD points out that, if the planned rate of testing were to be maintained, this would result in a situation whereby, in particular cases, there would be no more products left to be offered for sale, quite apart from the costs involved.

5.1

The EESC welcomes the flexibility of the new regulations. They offer new opportunities to traditional and/or artisanal and regional food businesses.

5.2

The EESC points out, however, that the degree of leeway allowed by the proposals carries a degree of risk for artisanal food businesses, as both national governments and local authorities may be able to interpret the rules in a way which is disadvantageous to these firms. Experience with the implementation of EU directives suggests that this may happen. It should be left up to the firms themselves to decide how they achieve the hygiene objectives. This is also stressed in point 4 of the SANCO 1513/2005/rev. 1 guidance document of 8 September 2005. The Commission must therefore ensure that the guidelines are appropriately publicised in the Member States.

5.3

The EESC sees a need to amend specific aspects of the regulations:

5.3.1

Artisanal individual slaughter should be recognised as a traditional process. This applies to all national amendments based on Article 13(4) of Regulation (EC) 852/2004, Article 10(4) of Regulation (EC) 853/2004 and Article 17(4) of Regulation (EC) 854/2004.

5.3.2

The facilities used by the retail trade for the preparation and/or cutting of large quantities of food of animal origin destined for other retailers should, without exception, be included in the scope of Regulation 853/2004 (8).

5.3.3

With regard to buildings (Annex III to Regulation (EC) 853/2004), account should be taken of the recommendations of SANCO 1514, point 5.2, that craft enterprises which do their own slaughtering should not necessarily have to provide waiting pens and that only simple feeding and watering facilities need be provided.

5.3.4

The requirement for an additional room (Chapter II, paragraph 2(c)) should be waived if there is a clear separation in time of slaughter and cutting.

5.3.5

Requirements for the temperature of cutting rooms should be waived if the meat, as in artisanal enterprises, is removed from the cold store and cut in portions.

5.3.6

In the case of artisanal meat processors, the requirement for minced meat to be chilled to 2°C (Section V, Chapter III, paragraph 2(c)) should be dropped, and instead the old German requirement for registered enterprises (4°C provided that produce is fresh and that it is sold only on the day of production) used. Moreover, the frequency of microbiological inspections of minced meat in businesses which produce only small quantities and which either flash-freeze or sell it on the day of production should be geared to the quantity of minced meat actually produced (Regulation (EC) 852/2004, Chapter II, Article 4(3)(a)).

5.3.7

The EESC also proposes that a comparative study be drawn up in order to 1) analyse the implementation of the regulation in various Member States which differ in relation to the structure of their artisanal food businesses, and 2) draw up proposals for improving the competitive position of artisanal food businesses. The availability to small food businesses of initial and further training facilities should in particular also be looked into. The systems for publicising Commission guidelines should also be looked at to ensure that small businesses are sufficiently informed about the degree of flexibility available to them.