REPORT FROM THE COMMISSION on the second series of visits by Commission representatives to the Member States pursuant to Article 5 of Council Directive 93/99/EEC with a view to evaluating the national systems for the official control of foodstuffs

TABLE OF CONTENTS

1. introduction

2. development of the official control of foodstuffs since the initial visits

2.1 control structures

2.2 HACCP in firms, guide on good hygiene practices: training and activities of the control authorities

2.3 accreditation of analysis laboratories

2.4 registration and authorisation of establishments

2.5 staff resources

3. controls of imported foodstuffs of non-animal origin

3.1 controls at entry points

3.2 controls of foodstuffs for sale

3.3 self-monitoring by importers and verification by the control authorities

4. conclusions

4.1 development of official controls

4.2 controls of imported foodstuffs of non-animal origin

Report FROM THE COMMISSION on the second series of visits by Commission representatives to the Member States pursuant to Article 5 of Council Directive 93/99/EEC with a view to evaluating the national systems for the official control of foodstuffs

1. INTRODUCTION

Article 5 of Council Directive 93/99/EEC on the subject of additional measures concerning the official control of foodstuffs provides that the Commission shall monitor and evaluate the equivalence and effectiveness of official food control systems operated by the competent authorities of the Member States.

Following the initial visits which led to a report being drawn up in 1997, it was decided that the second series of visits would focus on updating the information gathered during the initial visits and examining the special subject of controls on imported foodstuffs of non-animal origin.

The Directives on the official control of foodstuffs (89/397/EEC and 93/99/EEC) were the principal basis of the search for information.

Precise information was provided by the food control services on the following areas:

I. developments since the initial visits with regard to the official control of foodstuffs;

II. control of imported foodstuffs of non-animal origin.

The visits took place between February 1998 and March 1999 and usually lasted a week in each Member State. They were carried out by two Commission officials (from DG XXIV - Consumer Policy and Consumer Health Protection) accompanied in most cases by a national expert from a State other than the host State, selected from lists supplied by the Member States.

Preliminary information was obtained from the Member States on the areas mentioned above through a questionnaire addressed to the Permanent Representations.

All the visits were organised on the same lines, viz.:

I. initial meeting with the competent central authority; visit to the central laboratories;

II. meeting with regional and local control authorities (depending on the country's administrative structure); visit to ports, airports, road border posts and laboratories, visit to importers;

III. final appraisal meeting with the competent authorities;

IV. drawing up of a draft report submitted to the competent authorities of the Member State concerned;

V. report published on DG XXIV's Internet site. The conclusions of the reports on each country are annexed to the present document.

The information was collected during the meetings and visits on the basis of a questionnaire for use by Commission officials.

The visits were facilitated by the full collaboration of all the authorities involved

2. DEVELOPMENT OF THE OFFICIAL CONTROL OF FOODSTUFFS SINCE THE INITIAL VISITS

The observations relate to different aspects of official control dealt with in the report on the initial visits.

2.1. Control structures

Although half the Member States had not carried out any substantial reorganisation of their food control authorities, the other Member States introduced the following key changes designed to reallocate, coordinate and amalgamate existing control authorities and improve their performance:

I. bringing the monitoring of the different food sectors within one ministry;

II. reinforcing cooperation between ministries at central, regional and local level;

III. setting up a new single food control body amalgamating the existing services;

IV. setting up a food safety agency whose main task is to evaluate control bodies and assess risks;

V. transferring responsibility for food control from local authorities to central authorities.

2.2. HACCP in firms, guide on good hygiene practices: training and activities of the control authorities

The report on the initial visits indicated that there had been a delay in the implementation by firms of the HACCP system for food safety.

During the second series of visits, it was evident that some progress had been made in this area, albeit to a limited extent.

The HACCP training of control officials continues to be a priority for the Member States, which have organised courses in this regard. In some Member States, these courses are nevertheless limited to basic principles while other Member States have organised specific multidisciplinary courses relating to different branches of the food industry.

The fact that several Member States have been late in transposing Directive 93/43/EEC on the hygiene of foodstuffs into national law, including the Directive's provisions on HACCP, explains to some extent the delay in the implementation of the HACCP system by firms.

The information gathered still shows that large firms have made more progress with regard to implementing the system and that this is also often the case in catering establishments and large-scale distributors. On the other hand, it is acknowledged that small and medium-sized enterprises and, in particular, the retail sector have made less progress in this regard.

The Member States are making progress at different rates with regard to drawing up guides on good hygiene practices, seen as an important instrument for implementing the HACCP system.

So far, the control authorities do not in general appear to be penalising firms for failing to implement the HACCP system.

2.3. Accreditation of analysis laboratories

More progress has been made in some Member States than in others with regard to the laboratory accreditation process. The deadline of 1 November 1998 laid down in Directive 93/99/EEC for the accreditation of all official control laboratories has been met by several Member States; in other Member States, only some laboratories have been accredited and the process was under way in others.

2.4. Registration and authorisation of establishments

Improvements have been noted in this area, particularly in one Member State where authorisation is now required for all establishments dealing with foodstuffs, as well as in other Member States where computerised lists of establishments are progressively being introduced.

2.5. Staff resources

At least one country has recruited supplementary control staff, while another has amalgamated services and thus made additional controllers available.

On the other hand, budget restraints have prevented some countries from increasing staff levels, in spite of their limited numbers.

3. CONTROLS OF IMPORTED FOODSTUFFS OF NON-ANIMAL ORIGIN

It became evident from the initial visits that three different methods were used by the Member States for conducting these controls:

I. controls at entry points into the European Union;

II. controls of these foodstuffs on the market;

III. application of the principle whereby the importer is primarily responsible for controlling foodstuffs, with the checking of self-monitoring by importers.

3.1. Controls at entry points

This method has been adopted in its entirety by five Member States (and in part by a sixth). It does not rule out controls of imported foodstuffs once they are for sale, nor does it rule out controls conducted on importers' premises.

It involves close cooperation between the food control services and the customs services, the latter being responsible themselves for controls in a Member State.

In two Member States, where the control of foodstuffs is organised on a regional basis, responsibility for controls at borders has remained within the remit of the Ministry of Health, which has installed peripheral health control points (in one Member State, these include border veterinary inspection posts). In the other two Member States, the decentralised services of one ministry (agriculture) or two ministries (agriculture and finance, according to the type of foodstuffs concerned) are responsible for these controls.

In all five countries, controls are conducted because importers (or their representatives) are required to submit to the control authorities an import declaration for foodstuffs (except for the Member State in which the customs authorities are responsible for controls), in order to acquire an authorisation (or refusal) as a result of the control. This authorisation is then required from the customs authorities so that they can release the goods for free circulation.

Although in three countries an import declaration is required for all foodstuffs, this does not appear to be the case for cereals, alcoholic beverages in the fourth country and materials in contact with foodstuffs in the fifth.

The obligation on the part of importers to provide an import declaration leads to systematic document controls and, to a varying degree, to visual checks accompanied, where necessary, by the taking of samples and laboratory tests. The decisions relating to the inspection/sampling/tests are based on a risk analysis taking account of inspection data (concerning the product, the manufacturer, the country of origin and the importer) which come from the national services as well as from the Community's rapid alert system.

Depending on the country concerned and the inspection posts, inspection rates (visual checks) vary between 35% and 100%, and the rates of sampling for tests (or simple examinations) between 4% and 25%. Between 0.5% and 1% of goods, taking all declared goods as a whole, are refused entry in the various countries. The differences which have been recorded may be linked, to some degree, to the number of staff at the inspection posts, which, in some cases, is considered insufficient. Moreover, the cost of inspections and tests is usually borne by the official authorities (a modest set fee is nevertheless charged in one country).

As a result of the risk analysis already mentioned, which forms part of the controls, all the countries concerned have set inspection priorities linked to certain criteria which are quite closely related in the various Member States. In addition to the obligations resulting from Community legislation (concerning specific foodstuffs such as Iranian pistachios), most of the countries have made the testing of nuts for aflatoxins one of their main priorities (sampling rates nevertheless vary according to the type of nut concerned - most attention being paid to groundnuts - between the Member States and sometimes between the inspection posts). To a lesser extent, the countries concerned have focused on the testing of coffee and apple juice for mycotoxins and on the identification of pesticide residues in fruit and vegetables (this control does not mean that the release of the product is suspended at the first opportunity until the laboratory results are obtained, unlike the other controls).

The visits showed that in three countries inspections and sampling were not, in most cases, conducted under satisfactory conditions which allowed the goods to be viewed properly, protected from bad weather or representative samples to be taken. In fact, most controls are conducted on the quays (where containers are stored) and relate to those items which are immediately accessible when the container is opened. Even in the country where staff are also responsible for border veterinary inspection posts, controls are also conducted on the quays; in another country, the equipment at these inspection posts (where separate facilities have been installed) are used but the containers are only unloaded completely as a last resort. On the other hand, controls in two countries, in agreement with the customs authorities, are conducted on the importers' premises under better conditions, after the containers have been unloaded. In one of the two countries, this option is subject to certain conditions, however, which means that it is not employed systematically.

The fact that controls are conducted at entry points does not rule out the possibility that, following document or visual controls, inspections or controls of foodstuffs with regard to their conformity with the legislation (such as labelling) are conducted at the place of final destination by the competent controlling authority according to an entry pass system. However, the expertise of the competent authority at the place of destination and the information it possesses may not always be of the same quality as those of the authorities at the entry points.

There is a varying degree of communication between the various border inspection posts depending on the country concerned. One country has the most advanced information available, as it has installed a computer system linking the central service with all the inspection posts. All the alert messages concerning products and the characteristics of refused products are fed into the system, thereby making it possible to screen all import applications.

The customs services work with the food control authorities to the extent that they require an authorisation from these authorities in order to release products for free circulation. It does not appear, however, that they intervene on their own initiative in order to suspend the release of a product in keeping with Article 2 of Council Regulation (EEC) No 339/93 on checks for conformity with the rules on product safety in the case of products imported from third countries, except in the country where the customs services are themselves responsible for controls. The customs services justify this situation primarily by referring to their inadequate in-depth expertise and the lack of specific food safety information from the control authorities. The control authorities do not have access to computerised customs declaration systems or computerised systems used for messages reporting ship (or aircraft) manifests for foodstuffs. One country is taking steps to allow such access.

Foodstuffs which enter a country under the external transit procedure and are destined for a Member State other than the State of the point of entry are not in principle checked by the authorities at the point of entry.

3.2. Controls of foodstuffs for sale (market controls)

The visits showed that among the seven Member States (and in particular the eighth Member State mentioned also in point 3.1) which primarily use this method, four nevertheless conduct, albeit to a lesser extent, targeted checks of some imported foodstuffs at entry points.

In several Member States, such market controls on foodstuffs for sale are primarily conducted on importers' premises and on wholesale markets.

Targeted checks at entry points preferably involve an agreement to have been concluded between the control authorities and the customs services for the specific foodstuffs (in addition to existing agreements concerning checks which have become compulsory as a result of specific Community decisions); an agreement of this kind has been reached in three countries, while in a fourth the agreement has been concluded between importers and food control authorities. The foodstuffs targeted generally consist of those mentioned in point 3.1; i.e. mainly nuts (particularly groundnuts, but samples of these are taken less frequently than for countries which concentrate controls on entry points), but also dried figs, which are tested for aflatoxins; in one country, paprika from one source is checked for aflatoxins and wild mushrooms from Eastern Europe are checked for radioactivity. Checks for pesticide residues are also conducted on fruit and vegetables. One of the four countries has made it compulsory for importers wishing to import foodstuffs considered to pose a risk (nuts, dried figs, and in particular, powdered coconut and powdered cocoa (tested for salmonella)) to obtain a permit from the control authorities. To obtain this they must, among other things, submit certificates of analysis for aflatoxins conducted in the exporting country or bacteriological analyses (for salmonella) conducted when the goods are imported.

Apart from the cooperation mentioned above, the customs services of Member States which prefer to carry out checks on foodstuffs already on the market do not appear to intervene on their own initiative under Regulation (EEC) No 339/99, with regard to imported foodstuffs of non-animal origin, for the same reasons as mentioned above. The food control authorities do not have access to the computerised customs declaration and manifest reporting systems for foodstuffs. However, in one country referred to also in point 3.1, the Ministry of Trade and Industry has launched an initiative, which is, however, confined to ports, to allow access to such information with a view to improving the flow of goods and decision-making in the field of health controls.

3.3. Self-monitoring by importers and verification by the control authorities

The principle whereby the importer is primarily responsible for checking foodstuffs has been adopted as the mainstay of control arrangements in two Member States.

This principle nevertheless does not rule out official controls carried out on imported products (in one country, these controls are conducted on goods for sale with information being sent back to the competent control authorities at the importer's place of establishment and, in the other, in the importers' warehouses). Specific campaigns for conducting checks on products can also be organised.

Both Member States recognise, however, that self-monitoring is being implemented progressively by importers at different rates; they may be induced to do so by consumers' or professional associations' requirements. The local control authorities in one of the two countries have made it known that they would like to receive more substantial assistance from the central authority in order to assess self-monitoring by importers.

The customs services of the two countries concerned do not appear to intervene on their own initiative under Regulation (EEC) No 339/93 with regard to imported foodstuffs of non-animal origin, for the same reasons as mentioned in 3.1. The control authorities do not have access to the computerised customs declaration and manifest reporting systems for foodstuffs. In one of the two countries, however, the customs services forward import statistics to the central control authorities every three months.

It was also possible during the visits to gather information on self-monitoring by importers in the other Member States. It would appear that in many Member States controls of this kind already form part of commercial transactions by large firms. However, the methods used for the analyses and the frequency with which such analyses are conducted vary from one firm to another; the analyses are often limited to consignments at the beginning of the harvest season, and from new exporters and non-member countries. The principle of trust often comes into play. The introduction of HACCP systems has been patchy, as the range of risks is in most cases only partly covered due to the lack of a comprehensive risk analysis. The initiative launched in one Member State by an association of importers and distributors of fruit and vegetables to organise and supervise the self-monitoring required from its members was judged to be a positive development. On the other hand, it would appear that the self-monitoring carried out by firms which import smaller volumes of goods is usually very limited. In this regard, the delay in drawing up guides on good hygiene practices for imported foodstuffs, which would serve as an important tool for self-monitoring in this sector, is most regrettable.

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The table below shows the methods used by each Member State when conducting controls of imported foodstuffs of non-animal origin.

>TABLE>

XX= Primary method

X = Secondary method

- = Method not used

The table does not take account of compulsory checks at entry points provided for in specific Commission decisions (e.g. Iranian pistachios).

4. CONCLUSIONS

The visits in the Member States focussed on two main areas, from which the following conclusions may be drawn:

4.1. Development of official controls

The visits showed that progress still needs to be made by firms in the food sector (particularly small and medium-sized enterprises) with regard to setting up HACCP systems and that this is an issue which should be resolved as a matter of priority by the Member States.

So far, the accreditation of official control laboratories has not been given the same degree of attention in all the Member States.

The evaluation visits laid down in Article 5 of Council Directive 93/99/EEC should be pursued along the lines mentioned in the 1997 report on the initial visits.

4.2. Controls of imported foodstuffs of non-animal origin

Three main approaches have been adopted by the Member States: official controls at entry points, controls of food for sale and official checks of self-monitoring by importers, although these approaches are not mutually exclusive.

Controls conducted at points of entry are undoubtedly the most reliable method when it comes to food safety, as they prevent foodstuffs which do not conform to the Directive from being released for free circulation throughout the European Union. However, due to different situations noted in the Member States the following proposals may be made concerning the way in which such controls are carried out:

- In view of the risks posed by products of non-animal and of animal origin, the instructions concerning controls for importing both types of product should be brought closer together to form a general control framework for foodstuffs involving the following arrangements in particular:

- It is essential that the food control authorities work together with the customs services, as the latter are responsible for releasing goods for free circulation after receiving the necessary declarations, especially in the context of Council Regulation (EEC) No 339/93. The control authorities should possibly be given access to the computerised customs declaration and manifest reporting systems for foodstuffs.

- Physical checks and laboratory tests should be conducted on the basis of a list of priority foodstuffs drawn up according to a risk analysis (which already exists in several Member States), without excluding the other foodstuffs. A list of this kind would be compiled from notifications sent via the rapid alert system for foodstuffs and resulting from checks of this kind as well as from the results of national and Community control programmes. Notifications could be transmitted by computer to all the control authorities at entry points. The conformity checks already conducted at entry points on products to which quality standards apply pursuant to Commission Regulation (EEC) No 2251/92 on quality inspection of fresh fruit and vegetables could, where appropriate, be used as an opportunity for taking samples.

- Physical checks and sampling should be carried out under satisfactory conditions which allow investigations to be conducted correctly and representative samples to be taken. Importers' storage facilities would seem to provide the best conditions for this. The consent of the customs services should be sought, however, so that the products can be transferred to these facilities under customs control, in line with procedures applicable to the entry of goods into the customs territory. The transfer of foodstuffs to the final destination after samples have been taken and before the results have been obtained cannot be ruled out, provided that the competent control authorities take action at the final destination.

- The official control authorities of exporting non-member countries should provide guarantees that the foodstuffs concerned comply with Community quality standards. The relevant authorities should be contacted at official level in this regard and, where necessary, certain foodstuffs should be certified. It should also be possible for Commission staff to conduct appraisal missions for official control systems in non-member countries.

The implementation of these recommendations would, however, require Community legislation currently in force to be strengthened as part of the process currently under way to simplify the rules on hygiene and food controls.

The surveillance by the control authorities of safety procedures implemented by importers is still an important element of food control. The visits have shown how much still needs to be done in many cases on this subject. The registering of importers should be a prerequisite for all Community States.

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REPORT

results of the second visit to evaluate the official foodstuffs control system in the united kingdom by the european commission foodstuffs assessment team 02 - 06 February 1998

CONCLUSIONS

1. New developments concerning legislation and policy on food control since the initial assessment visit of the Commission.

Several changes have occurred, many of them following the Pennington report. Consumer Protection is now the main goal of the Government. A joint group combining the food services of both the Ministry of Agriculture, Fisheries and Food and the Department of Health (JFSSG) has been established, as a first step towards the creation of the Food Standards Agency foreseen for late 1999. This organisation would be an independent body reporting to Department of Health Ministers and would have the power to audit food safety enforcement in local authorities.

Several codes of practice have been amended or issued in order to strengthen food safety and controls and improve information (notably of the consumer). The Imported Food Regulations have been revised.

2. Food import control

The Imported Food Regulations constitute the basic legislation. Specific regulations are in place for the control of aflatoxins in certain products. The other regulations in the area of import control relate to food additives, colours and labelling.

The controls, though not systematic, are supposed to be based on risk analysis, mainly at the discretion of each control authority using its own experience and the information disseminated.

Although a system for food import control has been in place for at long time, the controls may not be evenly applied throughout the country, depending on the authority in charge and some other factors:

- The controls under the responsibility of the Port Health Authorities (Seaports) seem to give satisfactory guarantees. The personnel is well trained and informed. The system for the collation of information on incoming products seems satisfactory and is being facilitated and enhanced by the use of an electronic system set up by the trade and used also by the customs. The premises used for control are part of the veterinary border inspection posts. The Association of Port Health Authorities (APHA) plays an important role via the dissemination of useful information on controls.

- The controls under the responsibility of the Airport Health Authorities, which themselves have personnel just as qualified as the Port Health Authorities and are members of APHA, are unfortunately hindered by some factors linked to trade and to the transmission of data. In the absence of a computerised system (in place only for customs) for the collation of information before arrival and in the absence of a notification obligation, the Health Authorities are not aware of the arrival of many products, which consequently are not controlled by them. An important proportion of these products go to Enhanced Remote Transit Sheds (ERTS) outside the airport and possibly outside the Port Health enforcement area.

- Products not controlled at the ports or airports of entry may be controlled inland at the place of destination under the deferred examination regime. This system is easier to monitor for Port Health Authorities than for Airport Health Authorities, because, as previously mentioned, many products are not notified to Airport Health Authorities. The Commission team was not able to assess the import controls (including their funding) performed by an inland local authority.

- The costs of chemical analyses (charged by the Public Analyst laboratories) may be a determining factor in the controls. However, bacteriological examinations are free up to a certain number of samples. The control budget for each control authority is funded partly by central government and the rest by local taxes, each local authority being free to decide how the money will be spent.

Official controls of imported goods are free of charge for the importers.

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REPORT

RESULTS OF THE SECOND VISIT TO EVALUATE THE OFFICIAL FOODSTUFFS CONTROL SYSTEM IN SPAIN BY THE EUROPEAN COMMISSION FOODSTUFFS ASSESSMENT TEAM

23 - 27 February 1998

5. CONCLUSIONS

Royal Decree 1418/1986, which specifies the functions of the Ministry of Health and Consumer Affairs as regards health controls at borders, together with the Ministry of Health and Consumer Affairs Order of 20 January 1994 constitute the basic legislation for health controls on imported food products. Community legislation (both horizontal and vertical) is also applied, as are national health regulations relating to products where there is no harmonised legislation at EU level.

Materials in contact with foodstuffs are not covered by the controls. It is hoped to include them, as well as bulk products, when the Order of 20 January 1994 is amended.

The system of import controls applies to all types of foodstuffs, whether they are of animal origin or not, and the checks themselves are carried out by the same staff and with the same facilities as those available to the services responsible for health controls at borders. The existing facilities at border inspection posts (BIPs) are not used for inspecting products of non-animal origin. These inspections are carried out on containers in the open air, which means it is difficult to have access to the whole load and the product may deteriorate. The control services are free to establish their own priorities even though the main determining factor is the existence of alerts and previous refusals.

Control staff are well trained and systematically receive all relevant information (circulars, instructions, etc.) and legislation (both national and EU legislation). The computerised SISAEX system is a very useful tool for permanent communication between the various control units and the central departments. SISAEX is used to establish a number of priorities (alerts) and filters (refusals), thus enabling checks to be more uniform. The system, which has been operating for four years, is now being improved and extended (to set sampling levels).

Given the large amount of products to be checked, there may not be enough staff (15 inspectors are being recruited).

The accreditation of the laboratories involved in border health checks is now under way, although it would appear that in some cases this will take longer than planned.

From what we observed, import checks are carried out in a uniform manner at all the border inspection posts. The fact that such checks take place at the border is a positive factor. Existing links with the customs authorities make it easier to carry out checks in the proper way since products cannot be released until the border health control authorities have given their approval. In this way, any decision by the customs authorities depends on a decision concerning health aspects.

The Spanish authorities pointed out that, since the EU has no harmonised system of public health control and consumer protection concerning imported foodstuffs of non-animal origin, the fact that these checks are carried out systematically by Spain means that such products are being diverted to countries where there are no border controls.

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report results of the second visit to evaluate the official foodstuffs control system in belgium

by the european Commission foodstuffs assessment team

23 - 27 March 1998

CONCLUSIONS

1. Update since 1996 (legislation, policy, IGDA activities)

Several changes concerning the legislation and the policy for food control (non-veterinary products) in Belgium have occurred since the initial Commission visit in 1996.

The transposition of Directive 93/43/EEC made HACCP compulsory in food establishments. Guides to good hygiene practice have been sent to the IGDA by several professional organisations for assessment.

The requirement for all food establishments to be approved is seen as a positive element, increasing the degree of control over establishments and improving compliance with hygiene standards. Nevertheless, many establishments have not met the deadline for submitting a request for approval. A priority ranking for visits to establishments yet to be approved should be established according to the risk they present. This should also be done for routine visits.

The recruitment of 40 new controllers with a "BAC+3" degree represents an important advance for food control, allowing the number of controls in establishments to be tripled. The new staff have received in-house training. Nevertheless, in spite of the staff increase, two years will be necessary to perform the inspections to meet the requests for approval by establishments.

A continuing professional education programme is provided, in collaboration with other ministerial services, while the quality manual of the IGDA, available to all staff members, is continuously updated.

The accreditation of testing laboratories is progressing, with 20 accredited at the moment (including the Institut scientifique de la santé publique - Louis Pasteur).

2. Role of other control services

- Municipalities

5 big cities (as mentioned in 1996), as well as 20 smaller ones, perform hygiene controls in food retail and catering premises. Their controllers (except for the Laboratoire intercommunal de Bruxelles) are not entitled to take samples but the help and expertise of the IGDA (or the IEV) may be requested if necessary.

Relations between the IGDA and the municipalities are being strengthened: the municipal controllers are invited to the training courses organised by the IGDA and the municipalities are asked to collaborate in food poisoning declarations and investigations and in providing information for the rapid alert system for food. Nevertheless, the standards for the recruitment of controllers do not conform to those applied by the IGDA, and the IGDA quality manual does not apply to the municipalities, which retain a degree of autonomy.

- Ministry of Agriculture

It runs a control programme for nitrate and pesticide residues in fruit and vegetables (more at the production level) and will start with an import programme in 1998, while the IGDA runs a programme for pesticide residues and nitrate in foods on the market (auctions, wholesalers, importers, processors and retailers). An agreement has been concluded between the Ministry of Agriculture and the IGDA concerning inspection in the dairy and egg sectors.

- Ministry of Economic Affairs

Its agents perform controls on the labelling of foodstuffs, in collaboration with the IGDA.

- Institut d'expertise vétérinaire (IEV)

In collaboration with the IGDA, its controllers perform inspections in butcher shops.

An agreement has been reached between the IEV and the IGDA concerning the inspection of meat product establishments.

The requirement for recruitment with a "BAC+3" degree does not apply yet to the IEV controllers but is planned.

3. Food Import Control

3. a) Activities of the IGDA

The IGDA does not place a particular emphasis on the control of imported foodstuffs at their point of entry. These are more liable to fall under the general control of foodstuffs on the market.

Controls at import are limited to those imposed by specific Community decisions (pistachio nuts from Iran, fruit and vegetables from East Africa) and to some specific products (pistachio and groundnuts, herbs and spices, dried figs) under a FLEP Import Control Programme started in 1995, which importers at the port of Antwerp have to declare in advance to the IGDA. Nevertheless, the number of samples taken of these specific products for analysis (aflatoxins, salmonella) is limited (a total of 5 in 1997, and 5 out of 71 consignments of 192 containers for the first 10 weeks of 1998). The staff responsible for these import controls have to undertake many other food control tasks in their respective districts, which could be a reason for the limited number of import controls.

3. b) Role of the customs service

The customs service has a key role in import controls. Under the Royal Decree of 9 February 1981 on the supervision of the import of foodstuffs and under Regulation EEC No 339/93, the customs service may inform the IGDA about any suspicion regarding a particular foodstuff. Nevertheless, it would seem that very few cases are reported by the customs to the IGDA (there are more communications for cosmetics).

The adoption of Community decisions on specific food import controls gives rise to customs service instructions from the central service to the border posts, with some delay in the case of the last Commission decision on fruit and vegetables from East Africa.

The efficiency of the collaboration between the customs service and the IGDA would be enhanced if the IGDA had access to the computerised SATBEL system, giving it a more thorough knowledge of imported foods and more opportunity to perform controls. Access for the customs service to the IGDA's Videotex and Infana Systems would in turn strengthen communication. The transmission of the rapid alert system notifications concerning imported foodstuffs to the customs service would allow tighter import control at the points of entry.

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REPORT

RESULTS OF THE SECOND VISIT TO EVALUATE

THE OFFICIAL FOODSTUFFS CONTROL SYSTEM IN

THE NETHERLANDS

BY THE EUROPEAN COMMISSION FOODSTUFFS ASSESSMENT TEAM

20 - 24 April 1998

CONCLUSIONS

1. Update since 1995:

An important restructuring of the inspection services is under way and should be effective from 1st September 1998, when both inspection departments of the Ministry of Health, the IGB and the Veterinary Inspectorate VI, merge together to form the IW&V, which will cover the whole food chain. The number of regional offices (including inspection and laboratory activities) will be reduced to five (two of them will have to be established), each one with a specialisation. The benefit of this merger should be synergy from both existing departments, with the availability of more controllers for inspections and the creation of specific multidisciplinary inspection teams for large, more complex food establishments. Teams will also be set up in each office to maintain scientific contacts with universities, draw up reports of programmes and develop methods of analyses for the 5 laboratories.

The accreditation in February 1998 of the whole network of food testing laboratories (13 sites) under the IGB by the Dutch accreditation body STERLAB, with the Quality Assurance department of the IGB performing second-party auditing, should be regarded as a particularity of the Dutch system, which in any event has met the deadline imposed by Directive 93/99/EEC.

The progress of the implementation of the HACCP system in food establishments (with the exception of smaller establishments selling directly to the consumer, including the hotel and catering sector, which should follow the specific hygienic codes of practice already approved by the Minister of Health) is closely followed by the IGB. Progress is rather slow, with 23% of the companies visited not having started to develop a food safety plan; moreover, HACCP certificates granted by certification bodies to food establishments have been found to be unsatisfactory by the IGB. Official warnings are sent by the IGB to companies that have not started to prepare a food safety plan.

2. Food import control

The IGB does not put a particular emphasis on the control of imported foodstuffs at their point of entry; they are more liable to fall under the general control of foodstuffs on the market. The 2 main points of entry into the Netherlands for foodstuffs from third countries, the port of Rotterdam and the airport of Amsterdam, were visited by the Commission assessment team. This allowed a satisfactory overview of the procedures in place.

The controls by the IGB at the points of entry are limited to a few selection profiles based on a risk analysis, including the obligations resulting from Community decisions (pistachio nuts from Iran, fruit and vegetables from East Africa), established by the authority responsible for the point of entry. In Rotterdam, the profiles originated from a FLEP import control programme initiated in 1995 and concern mostly nuts from some specific countries. At Amsterdam airport, on top of the controls for Vibrio cholerae, samples of fruit and vegetables are taken twice a month to test for the presence of pesticide residues (10% of results so far over the MRL). Except for pistachio nuts, sampled products are usually not held back.

Collaboration with the customs service is necessary in order to perform these controls, as no declaration from the importers to the IGB is required. Agreements have been reached between the customs service at the points of entry and the IGB, under which the Rotterdam IGB is informed of all declarations for products meeting the selection profiles. A decision on whether or not to control has to be given within three hours. At Amsterdam airport, the IGB is informed, upon request, of the arrival of fruit and vegetables by the customs service. Products entering with a T1 declaration are not controlled.

It would seem that no suspicion concerning food consignments is ever reported by the customs services to the IGB. The customs informed the Commission assessment team of some difficulties related to the CN codes for imported foodstuffs and to the possibilities of changing the destination of a product (from an animal feed to a foodstuff). The assessment team considers that access by the IGB to the computerised system of the customs service for declarations would give it a better grip on import control.

The visits revealed a shortage of personnel for food import control (considering in particular the fact that the sampling of nuts in Rotterdam is already performed in accordance with the forthcoming Commission Directive). It was stated that controls are always performed under cover, in warehouses.

The visit to a fruit and vegetable importer did not reveal the existence of an HACCP plan, including guarantees for imported products.

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REPORT

RESULTS OF THE SECOND VISIT TO EVALUATE THE OFFICIAL FOODSTUFFS CONTROL SYSTEM IN DENMARK BY THE EUROPEAN COMMISSION FOODSTUFFS ASSESSMENT TEAM

27 - 30 April 1998

CONCLUSIONS

The Commission assessment team highly appreciated the spirit of co-operation of the Government of Denmark, its central as well as its local officials, in enabling the mission to Denmark to proceed successfully. The visit was well organised and all information requested was duly made available without any reservation.

It was particularly appreciated that, although public transport and several services were hampered by a general strike, all visits were duly organised with no delays.

1. STRUCTURE

A fundamental amendment has been introduced since the last assessment mission of May 1996. Whereas food control used to come under the Ministry of Health, it now comes under the new Ministry of Food, Agriculture and Fisheries. We were informed of the establishment of the new Veterinary and Food Administration (VFA) in 1997.

However, further structural changes are planned. A proposal has been presented to parliament. This would give more power to the central services. It could bring a more harmonised approach to food control.

The flow of information and instructions between central and local authorities is sometimes delayed. Commission Decision 98/116/EEC of 4 February 1998 (cholera: sampling on import of fruit and vegetables airfreighted into the EU from Kenya, Uganda, Mozambique and Tanzania) took a long time to reach the local authorities. The central services forwarded the above-mentioned Decision, as implemented in Danish legislation, on 8 April 1998. The date of entry into force was 21 April 1998. The preamble to Commission Decision 98/116/EEC had not been taken up by the Danish implementation, thereby deleting the reference to airfreighted foodstuffs (10-day clause). More guidance from the central to the local authorities would have been helpful.

2. AFLATOXINS - PISTACHIOS SHIPPED OR CONSIGNED FROM IRAN

On 8 September 1997, Commission Decision 97/613/EC introduced an initial ban on the import of pistachios and pistachio products from Iran. On 11 December 1997, the ban was amended by Commission Decision 97/830/EC, introducing the concept of certification by the Iranian authorities. Implementation at Danish national level of the initial ban was duly carried out by the VFA at central level.

Implementation of the second Decision (97/830/EEC) took 5 weeks (13 January 1998). During the visit, Århus LMK local control unit said, however, that it had not been informed about certification by the Iranian authorities, as communicated in the letter of 13 January 1998. The entry into force at Danish national level was first mentioned on 1 February 1998. We welcome however the later communication containing the additional guidance note of 7 April 1998, giving extra information to all concerned.

During the visit by the Glostrup inspector to a local storage company, four pallets of 1000 kg of pistachio nuts from Iran and well over 1000 kg of unlabelled pistachio nuts of unknown origin were found to be stored in a haphazard condition. They had been at the premises for the last 6 months, i.e. after the embargo on pistachio nuts from Iran had come into effect. No sampling had since been carried out, although the Glostrup unit had called known importers of this commodity. Shared responsibility between different local control units compounded the problem.

It was unclear from the visit to a large wholesaler whether, upon bringing the pistachio nuts into Denmark from the Netherlands, the retailer was compelled to inform the food control authorities of this event. Clearly, goods imported into the EU through another Member State and brought into free circulation are regarded as foodstuffs coming from another Member State in accordance with the principles of the internal market.

3. AUTO CONTROL / HACCP / IMPORT CONTROL

During the first assessment of May 1996, it was felt that further training in the application of the principles of auto-control to the range and type of premises covered by the Hygiene of Foodstuffs Directive 93/43/EEC was necessary.

In particular, it was considered that the inspectors should play a role in the evaluation of auto-controls in catering and retail premises, although the assessment team appreciated that detailed information on these types of premises would be produced.

Since then, a series of auto-control codes have been developed by industry. Codes for supermarkets and fish retailers are about to be adopted by the VFA. Other sectors such as food transportation, bakeries, restaurants and public catering (hospitals, schools, etc.) are being developed.

During the period 1996-1997, a number of HACCP training courses were organised. During 1998, a further 7 two-day courses were to be held.

Out of a grand total of 700 potential trainees, 350 have already been HACCP-trained.

Nevertheless, the training of the staff in HACCP during a two-day course is not enough to cover this complicated matter. More time should be spent on practice and case studies. When the staff of the local control units have to deal with the auto-control systems of large enterprises, they will need specialist training requiring a considerable investment in time and budgetary resources.

Directive 93/43/EEC on the hygiene of foodstuffs was implemented at national Danish level in 1995. A joint consolidated set of regulations, encompassing five food hygiene Directives, was to be published by VFA in the course of 1998. The local LMK control unit at Århus stated that, for several years, they had scheduled a budget for the implementation of HACCP. Although several requests had been made to central level, the local control units as well as the trade companies are still waiting for proper guidance on this subject from the central authorities.

The philosophy of the Danish food control services is based on the system of auto-control rather than on border control of imported products. It thus relies on the responsibility of the importer, who has to establish a proper auto-control system.

During the different visits, however, it became clear that only a tiny minority had already implemented an approved system of auto-control. It is up to the central food control service to provide guidance to make the Danish system of import control through auto-control fully effective.

The Danish customs service seems not to be involved on a routine basis in the official control of imported foodstuffs of non-animal origin. Council Regulation (EEC) No 339/93 of 8 February 1993, on checks for conformity with the rules on product safety in the case of products imported from third countries, provides in its Article 2 that if, in the context of checks which they carry out in respect of goods declared for release for free circulation, the customs authorities find that a product or batch of products display certain characteristics which would give rise to a serious doubt as to the existence of a serious and immediate risk to health or safety in the event of that product being used under normal and foreseeable conditions, they shall suspend the release of the product and notify the national authority responsible for monitoring the market. These provisions were implemented in Danish legislation by Circular Letter No. 144 of 14 September 1995.

The central authorities receive import data that are 3 months old; while the local units only receive information once a year. These figures therefore only give information on what has happened in the past but not on what is happening at the moment. Nevertheless, the customs service can be asked to notify the food control authorities before release for free circulation or if certain products (identified by their CN codes) are imported. An on-line service between customs services and control authorities, possibly limited to specific products or product categories based on KN/CN codes, would vastly improve this situation. The handling of cases such as the cholera-East Africa case would require close and swift co-operation between customs and food control to be fully effective.

4. LABORATORIES - ACCREDITATION

The laboratories visited in Glostrup and Århus were found to be well equipped. Ample staff levels with sufficient training and expertise to carry out the food control analyses (chemical and microbiological) were encountered.

30 out of 32 official laboratories have already achieved accreditation EN 45001. The other are expected to be granted accreditation in the near future. This is a very positive situation.

The Glostrup chemical laboratory, however, is currently only accredited for environmental analyses and not for food control analyses. Glostrup is waiting for the announced restructuring of the food control services at central and local level before the investment can be made by local authorities. Where food control analyses are concerned, they are only handling about 100 analyses a year.

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REPORT

RESULTS OF THE SECOND VISIT TO EVALUATE THE OFFICIAL FOODSTUFFS CONTROL SYSTEM IN ITALY

BY THE EUROPEAN COMMISSION FOODSTUFFS ASSESSMENT TEAM

11-15 MAY 1998

CONCLUSIONS

1. Update since 1995 (legislation, policy)

Since the initial visit, several pieces of legislation on food control (including hygiene) have been promulgated, mainly to transpose Community Directives.

- The aim of the Presidential Decree of 14 July 1995 is to guide the regions in drawing up annual food control programmes, recommending a minimum frequency of inspections for various food establishments, the minimum number of samples from all establishments and in the context of import controls (5%, except in suspect cases) and the priorities for analysing various foodstuffs. The criteria are scheduled to be reviewed every three years.

- The Legislative Decree of 26 May 1997, No 156, transposed Directive 93/99/EEC, including the requirement for the accreditation of food testing laboratories. It would appear that the accreditation process is experiencing some delay in the majority of laboratories, and there is some controversy about the appointment of official accreditation bodies (SINAL being the only one at present). (Update: as of 12 May 1999, the Istituto Superiore di Sanità is the official accreditation body; however, previous accreditations remain valid.)

- The Legislative Decree of 26 May 1997, No 155, transposed Directive 93/43/EEC and should be mandatory as of 26 May 1998 for all food establishments (except for market places, for which the implementation date was December 1998). This delay in implementation would explain the slow progress in introducing the HACCP system in food establishments (except in large companies, which would now be well advanced). One region has published a guide to the HACCP system for establishments. A number of guides to good hygiene practice have been prepared by professional associations in the food sector, some of which are still being assessed by the Ministry of Health.

2. Import controls

Controls on imported foodstuffs primarily take place at the point of entry into Italy and are performed by a network of 33 branch offices (USMA) which are under the Ministry of Health. A study is under way to coordinate these offices with the veterinary inspection posts. There is also the possibility of transferring imported products to the final place of destination under health bond, where they are controlled by the competent local authority (ASL).

The controls form also part of general food controls on the market.

The clearance procedure for imported foodstuffs is based on the presentation to the customs authorities of a document ("Nulla Osta Sanitario") issued by the Ministry of Health's branch offices. In many places, customs declarations are still processed in paper form, but electronic forwarding is starting to become established.

In addition to the mandatory controls resulting from Community Decisions, some priorities for analysing foodstuffs have been determined centrally on the basis of previous experience and of information provided by the EU rapid alert system: these are essentially analyses for aflatoxins in nuts (dry hard-shelled fruit); in some cases, 100% of peanuts and pistachios are sampled and analysed, whatever their origin. Pesticides in fruit and vegetables and microbiological analyses are also covered to a lesser extent, in so far as checks are also performed on the market.

Communication between Office V of the Ministry of Health at central level and the branch offices includes the forwarding of Community legislation, specific decisions on imports, notifications from the EU rapid alert system and information on consignments rejected and destroyed by the offices which is redistributed to the other Ministry of Health branch offices. It was noted that the Commission Decisions concerning the import of pistachio nuts from Iran were quickly forwarded to the offices, while Commission Decision 98/116/EC concerning checks for Vibrio cholerae on fruit and vegetables from East African countries suffered delays.

The site visits have enabled observation of the implementation of procedures determined at central level, with some variations relating to the percentage of visual examination of foodstuffs, the percentage of samples of nuts taken for aflatoxins analysis, the number of samples per consignment and relationships with the customs authorities, in so far as cooperation between customs and control authorities did not appear to be at the same level in all places visited. The variations noted may lead to an imbalance in the pressure of official controls, which was pointed out by economic operators. Moreover, staffing was not considered sufficient, particularly in Venice, given the number of tasks and the geographical area to be covered.

The procedures for health checks on containers (in the open, by "tail inspection") do not provide easy access to all the contents of the consignment, nor do they ensure an adequate level of hygiene, since the contents may deteriorate owing to the weather conditions. It was noted that sampling could in some cases take place in customs warehouses, allowing for more efficient control, but that there were usually no provisions for allowing official controls to be carried out in the importer's warehouses, where conditions for inspection and sampling would be better. The official analyses have to be performed in official laboratories specifically assigned to the USMA, which may lead to delays in obtaining the analytical results.

Information gathered during the visit showed that the operation of HACCP systems by importers, particularly the smaller ones, still required major improvement.

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REPORT

RESULTS OF THE SECOND VISIT TO EVALUATE

THE OFFICIAL FOODSTUFFS CONTROL SYSTEM IN FRANCE

BY THE EUROPEAN COMMISSION FOODSTUFFS ASSESSMENT TEAM

2 - 5 June 1998

CONCLUSIONS

1. Updating of the 1996 report

1.1 Bill for the creation of a Food Health Safety Agency

The bill is nearing completion. Four public bodies are to be created, including the Food Sanitary Safety Agency, attached to the Ministries of Agriculture, the Economy and Health, and responsible for evaluating all three ministries' monitoring services and for risk assessment. However, it will have no direct powers as regards food control.

1.2 Role of the Ministry of Health in food control

Besides evaluating health hazards, health monitoring and organising one-off surveillance programmes, the control activities mainly concern drinking water (exclusive responsibilities) and, to a lesser degree, the hygiene of premises used by restaurants and bakeries/confectioners.

1.3 Progress in introducing HACCP (Hazard Analysis - Critical Control Points) in establishments and guides on Good Hygiene Practices

Statistics are not yet available concerning the implementation of HACCP by the establishments. The agents of the monitoring services (DGCCRF and DGAL) are receiving HACCP training.

Decrees transposing Directive 93/43/EEC on the hygiene of foodstuffs have since been published, each for a specific food sector. They prescribe the use of HACCP principles and compliance with a guide on good hygiene practices or the application of safety procedures specific to the establishment. For the moment the absence of HACCP has not led to complaints being filed, except in the case of hygiene deficiencies.

Food professionals are making good progress in preparing guides on good hygiene practices and 11 have already been validated by the authorities, who are encouraging their adoption.

1.4 Progress in laboratory accreditation

Currently, many DGCCRF laboratories are accredited by COFRAC for essential determinations. The number of working laboratories is to be reduced, with analyses being concentrated in certain laboratories. The time limits (which are still excessive in some cases) for performing the analyses will be shortened.

2. Controls at importation

2.1 DGCCRF activities

The DGCCRF services are the services responsible for import controls pursuant to Council Directive 89/397/EEC.

The DGCCRF does not generally perform controls at the place of importation. Rather, it is responsible for two types of surveillance:

- controls in the general context of monitoring products on the market, at the distribution stage, supplemented by information which, if necessary, is sent to the DGCCRF regional services where the importer is based;

- controls of import firms as regards compliance with quality and safety requirements (self-monitoring). Evaluation of progress made in self-monitoring is part of the annual activity plan for the DGCCRF in 1998.

Besides, the DGCCRF may investigate food imports in the context of its scheduled quarterly surveys. The supervisory authorities also collaborate on a cross-border basis in monitoring food imports.

The DGCCRF is the body responsible for checking the conformity of fruit and vegetables pursuant to Regulation (EEC) No 2251/92 on quality inspection; these controls are performed systematically at the importation stage. In connection with these controls samples are taken wuith a view to detecting pesticide residues as provided for in the European legislation, according to an established plan. However, the time limits for obtaining the analysis results are felt to be excessive. In the same context, certain labelling and radioactivity controls are carried out, but they do not concern other contaminants (bacteriological, chemical).

At the time of the Community mission the importation of Iranian pistachios was still prohibited in France. Controls on imports of vibrio cholerae in respect of East African fruit and vegetables had been mandated by an administrative order issued more than two months after the adoption of Decision 98/116/EEC.

2.2 Role of the customs authorities

It seems that the customs authorities are not involved in detecting foodstuffs which may present serious health hazards (as provided for by Council Regulation No 339/93), their involvement being limited to cases in which a specific document (mainly veterinary or plant health documents or quality certificates) is required.

In monitoring food imports, it might be useful for the DGCCRF to have access to the customs authorities' SOFI database, which contains all the relevant data.

2.3 Self-monitoring by importers

The fruit and vegetable import firms selected for the visit had already introduced self-monitoring with an eye in particular to the market in one of the Member States, in response to pressure from purchasers, notably as regards the conditions under which imported food is produced and including analyses of pesticide residues. The Federation of Fruit and Vegetable Importers has been urging its members to introduce such self-monitoring systems.

However it seems that this concept is relatively new for importers and that the DGCCRF is encouraging the progressive implementation of self-monitoring, while buyers' rquirements also play a role.

A self-monitoring agreement has already been signed between the Federation of Food Importers and the DGCCRF, notably for fruit and vegetable preserves; however, these self-monitoring arrangements do not cover all the main health risks.

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REPORT

REsults of the second visit to evaluate The official foodstuffs control system in Luxembourg by the European commission foodstuffs assessment team

29 June - 2 July 1998

conclusions

The number of people involved in controls is inadequate to cover all the tasks assigned to them in the legislation. The probable figure of 3500 establishments and the need to introduce the HACCP system highlight this lack of staff. The inclusion of the motorised units from the Customs and Excise Service in the control of foodstuffs seems very positive; however, specific training must be continued and stepped up if this reinforcement of food control is to be effective.

Training for inspectors is still needed, in particular with regard to the HACCP system. The limited number of staff prevents inspectors from being absent for long periods in order to follow training courses. The long periods of training under the Karolus programme are also preventing Luxembourg inspectors from participating in this programme.

The introduction of the HACCP system in companies is quite limited, the system having been introduced in only a few large companies. In the specific case of the establishment visited, structural and hygiene improvements were necessary before a self-monitoring system could be considered.

Because of the involvement of various bodies in the official control of foodstuffs (DIS, LNS, motorised units, revenue offices), it seems necessary to improve coordination between them in order to avoid overlapping or shortcomings in the control system. This coordination would also make it possible to define priorities (list of establishments classified according to the level of health risk, control or approval of establishments prior to their opening).

Since the visit in 1996, an improvement in cooperation between the customs services and the control services has been observed.

In the case of the LNS, the problem of staff shortages in relation to the tasks it is required to perform is still present. The accreditation procedure will not be completed by the November 1998 deadline. In view of the growing sophistication of analyses, the budget seems inadequate to cover the whole range of analyses required. Owing to the lack of staff, training and retraining are inadequate.

Import controls at the Cargocentre are based on quality and visual checking of residues. Analytical back-up should be envisaged.

The interest shown by the staff at the Croix de Gasperich customs centre was considered to be very positive. Special training in the field of foodstuffs and analytical back-up should be considered.

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REPORT

RESULTS OF THE SECOND VISIT TO EVALUATE THE OFFICIAL FOODSTUFFS CONTROL SYSTEM IN SWEDEN

BY THE EUROPEAN COMMISSION'S FOODSTUFFS ASSESSMENT TEAM

21 - 25 September 1998

CONCLUSIONS

1. Update since 1996

No significant changes have occurred in the Swedish food control system since the initial Commission visit in 1996, responsibilities being shared between the National Food Administration (NFA) and the 288 municipalities.

Nevertheless, changes are envisaged and are expected to be implemented by a government bill presented to the Swedish Parliament in 1999 which would result in the possibility of cooperation on food control between municipalities. The responsibility for import controls of foodstuffs would be transferred from the municipalities to the state, while the fees for food controls would rise (charges for resampling). Food establishments' in-house control systems would be exempted from approval by the food control authorities.

The NFA is making progress with its three-year programme of auditing the municipal authorities, and also with a training course for these authorities which includes the HACCP concept.

Progress with implementing the HACCP system in companies seems to be far more advanced in large industrial establishments than in the restaurant/retail sector.

The guides to good hygiene practices in use in Sweden have been issued either by the NFA (six of them, relating mainly to the retail sector and products of animal origin) or by European professional organisations (in the industrial sectors).

All official food control laboratories, which are privately owned, have received EN 45001 accreditation.

2. Food import controls

The control of imported foods of non-animal origin combines several means:

· It falls primarily under the general official control of foodstuffs on the market, performed by the local authorities.

· Selection of certain profiles, based on risk analysis, leading to the imposition of import permits by the NFA.

· Specific official controls required by Commission decisions (pistachio nuts from Iran; fruit and vegetables from East Africa).

· Official sampling programme for pesticide residues in imported fruit and vegetables, cereals, cereal products and oilseeds, the samples being taken at importers' premises.

· Register of importers kept by the NFA.

· In-house controls, based on HACCP, put in place by importers and supervised by the NFA or local authorities.

The on-the-spot visits allowed the Commission's assessment team to obtain a more precise view of these different means of control:

· Commission decisions requiring specific controls at the place of entry are communicated by the NFA to the customs service, which must inform the competent local food control authority of the arrival of the foodstuffs concerned. Such information exchange was observed at the Stockholm Arlanda airport.

· The imposition of import permits concerns peanuts (and peanut butter), brazil nuts, dried figs, coconut flakes, cacao powder, products containing soya protein, and spring water. Permits are linked to the presentation of satisfactory certificates of analysis for aflatoxins for some products or the need for an analysis (salmonellae, aflatoxins) by the local food control authority at the point where the product is declared to customs. The customs authorities are aware of these requirements and act accordingly in checking import permits and informing the competent food control authority.

· The pesticide residue control programme, covering imported foodstuffs, is a well-balanced programme based on criteria relating to the consumption and origin of products and past experience with them. The establishment of a black-list of exporters represents an efficient preventive measure.

· The requirement for importers to be registered with the NFA is a positive factor allowing transmission of information and supervision by the NFA or local authorities.

· Cooperation between the customs and the food control authorities is effective in the specific cases mentioned above. The register of importers is transmitted to the customs service (quarterly updates). Outside the field of cooperation, however, it seems that no cases of suspicion concerning imported foodstuffs are reported by customs to the food control authorities. Communication to the customs service of the black-list of exporters involved in pesticide residue violations could strengthen the grip on import controls. The same applies to access for the food control authorities to the customs service's computerised system for imported goods.

· The in-house controls of the two importers selected for the visit were quite sophisticated, but it appeared that not all health aspects (hazards) were covered in the HACCP system, in respect of the analyses performed. It would seem, however, that such controls are far less extensive in the case of small importers (ethnic foods particularly), the implementation of HACCP principles being problematic.

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RESULTS OF THE SECOND VISIT TO EVALUATE THE OFFICIAL FOODSTUFFS CONTROL SYSTEM IN FINLAND

BY THE EUROPEAN COMMISSION'S FOODSTUFFS ASSESSMENT TEAM

28 September - 2 October 1998

CONCLUSIONS

1. Updating the 1996 report

· The assessment team noted the possibility of an amalgamation between the NFA and the National Veterinary Research Institute.

· The assessment team was informed that a joint group had been founded in 1997, combining the NFA and provincial and municipal authorities, to improve the flow of documentation and information. We noted that feedback may bypass the provincial level. This lack of information and guidance (e.g. HACCP) could result in food controls being applied in different ways at municipal level (see 1996 EU report, page 21, paragraph 6).

· For the second year running a testing and cooperation agreement between the NFA and the customs administration is being implemented. However, there is still a potential risk of duplication between customs laboratory sampling on the one hand and market control sampling at municipal level on the other hand.

· The forwarding throughout Finland of messages from the Rapid Alert System has been noted with interest. Conversely, however, feedback and input from Finland could be improved. For instance, messages concerning excessive levels of ochratoxine in coffee beans detected by the customs laboratory never seem to be passed on to the European Commission.

1.1 Progress in introducing HACCP (Hazard Analysis - Critical Control Points) in establishments and guides to good hygiene practices

· The assessment team welcomes the training organised and coordinated by the NFA concerning HACCP. However, there is no evidence to show that all the staff concerned have received proper guidance regarding HACCP ("total number of food controllers unlisted").

· Experience acquired by some municipal environmental units (Helsinki) could be of use to other municipalities if coordinated centrally (NFA).

· Article 5 of the Food Hygiene Directive (93/43/EEC) requires Member States to encourage the development of guides to good hygiene practice. No developments have taken place since the last evaluation visit in September 1996.

1.2 Progress in laboratory accreditation

· Municipal environmental laboratories are allowed to carry out both official and private laboratory analyses. This might lead to a situation in which the same laboratory acts in an official capacity whilst also providing advisory services for the same food business operators. This may jeopardise the independence of the municipal environmental health unit.

· The same remark is applicable to the customs laboratory, which offers guidance to private customers (importers) on in-house controls and is prepared to carry out pre-assessments of new products introduced onto the Finnish market (for the benefit of the importer). This also may lead to a conflict of interests.

· Considerable progress has been made in the accreditation of recognised food control laboratories, and Finland will meet the deadline of 1 November 1998 laid down in Articles 3 and 9 of Council Directive 93/99/EEC on the subject of additional measures concerning the official control of foodstuffs.

2. Import Controls

2.1 Role of the customs authorities

· The procedure applied by the customs authorities on the arrival of foodstuffs of non-animal origin in Finland is well organised. The draft sampling manual in use at Sompasaari port will need further development, requiring the adoption of inspection procedures. The manual will have to be distributed to all points of entry.

· The sampling procedures applied at present by the customs laboratory make provision only for a closed (and unsealed) counter-sample. No safeguard measures are listed to preserve the integrity of the sample itself.

2.2 Self-monitoring by importers

· The information given by the environmental health unit of Helsinki City on the implementation of in-house control plans indicates that more than half the food business operators have submitted such a plan. No assessment of the quality of these plans has been carried out, though Helsinki City intends to complete such an assessment by mid-1999. Its environmental health unit appears to be aware of the number of food establishments, keeps inspection records on computer and maintains a constant watch over the application of foodstuffs legislation.

· The assessment team has noted, as a result of a questionnaire sent out by the NFA, through the provincial authorities, to the municipal level, that a success rate of 64% (national average) has been achieved in the application of in-house control plans. However, in 1999, phase 2 of the survey will have to establish the quality of the in-house control plans submitted at municipal level.

· The initiatives taken by some of the larger Finnish food business operators concerning the provisions of Article 3 of Directive 93/43/EEC testify to their willingness to implement the Finnish concept of in-house control plans.

· Formal enforcement action is seldom taken, since the preferred way of dealing with infringements is the educational approach (this is similar to the findings of the 1996 visit to the municipal units of Hämeenlinna and Ilomantsi).

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REPORT

RESULTS OF THE SECOND VISIT TO EVALUATE THE OFFICIAL FOODSTUFFS CONTROL SYSTEM IN THE FEDERAL REPUBLIC OF GERMANY BY THE EUROPEAN COMMISSION'S FOODSTUFFS ASSESSMENT TEAM

19 - 23 October 1998

CONCLUSIONS

1. Update since 1995:

Both Directive 93/99/EEC on the subject of additional measures concerning the official control of foodstuffs and Directive 93/43/EEC on the hygiene of foodstuffs have been transposed into German law. The transposition of Directive 93/43/EEC led to the replacement of 16 different federal state laws by one single food hygiene regulation. Nevertheless, Article 3 of Directive 93/43/EEC on HACCP did not enter into force in Germany until August 1998, which would partly explain the lack of awareness and the delay in implementing the HACCP system in certain parts of the food sector.

It has been mentioned that large concerns and supermarkets have made considerable progress in implementing quality management systems including HACCP, with customer and market requirements playing a significant role. On the other hand, it was noted that progress with HACCP implementation is much slower in small and medium-sized businesses (e.g. retail sector).

The help provided for the implementation of HACCP by guides to good hygiene practice, which include HACCP principles, remains limited, as only two guides have been produced. However, several guides for different sectors are being assessed by the food control authorities (in the federal states) and should constitute valuable tools at a later date.

The German authorities consider that the duty of care long imposed on companies in the food sector under German law already in a certain way covers the HACCP requirement.

For their part, the food control authorities in the federal states have given priority to continuing training programmes for their officials covering the HACCP system and its assessment, through the organisation of pilot projects (for particular food sectors) as part of integrated training courses (teamwork).

The Commission's assessment team was informed of the growing use of risk analysis by the official food control authorities in determining their inspection priorities, with a view to the more efficient use of staff resources within the constraints of the available budget.

The transposition of Directive 93/99/EEC has led to rapid progress in the accreditation of official testing laboratories. Two official accreditation bodies have been created, each of which is responsible for eight federal states. Accreditation is based on groups of tests. According to the information received, all official laboratories in Germany should have received accreditation by 1 November 1998, the deadline specified in Directive 93/99/EEC. A regulation on the accreditation of private laboratories used for official counter-sample analysis has been submitted to the Bundesrat for approval.

2. Food import controls:

Checks are in the hands of each federal state. The emphasis - rather than on checking imported foodstuffs at their point of entry - tends to be on the general monitoring of foodstuffs on the market, in particular at wholesale markets.

Nevertheless, certain specific foodstuffs must be checked at their point of entry, pursuant to Commission decisions (pistachio nuts from Iran, fruit and vegetables from East Africa) or Federal Health Ministry regulations, on the basis of a risk analysis, with involvement of the customs authorities, and in accordance with section 48 of the Foodstuffs and Commodities Act (mushrooms from Eastern Europe have been systematically checked for radioactivity since 23 July 1998, and paprika from Turkey has had to be presented to the food control authorities for checking for aflatoxins since 1994).

Apart from official checks, the German authorities emphasised the important role played by importers through their own checks, as part of their duty of care.

Site visits to Frankfurt am Main (airport), Hamburg (port) and Frankfurt an der Oder (border post, road transport) allowed the Commission's assessment team to obtain detailed information on the various checks, including the activities of the customs services.

The visit to Hamburg port confirmed its leading role in the import of pistachio nuts from Iran into Europe. The Hygiene Institute is the official food control authority responsible for the release of these pistachio nuts on the basis of satisfactory laboratory results. The very heavy workload may result in analysis being carried out by private laboratories instead of the Hygiene Institute. The Commission's assessment team is concerned by the fact that the accuracy of analysis results from a number of private laboratories has been questioned by the Hygiene Institute, as a result of significantly lower levels of aflatoxins being recorded by those laboratories. An inquiry has been started with a view to withdrawing the accreditation of one of the private laboratories.

The visit to the Frankfurt an der Oder border post revealed the major efforts being made by the local food control authorities as regards radioactivity checks on mushrooms from Eastern Europe prior to import. These have led to a significant fall in the number of rejected consignments.

The visit to Frankfurt am Main airport found that only the compulsory checks on fruit and vegetables from East Africa are performed there; official sampling for pesticide residues in imported fruit and vegetables takes place at the central market rather than the point of entry. During the visit the Commission's assessment team was also informed about the activities of one of the two associations of German fruit and vegetable wholesalers/importers. Those activities were seen as positive, in that importers are responsible for carrying out their own checks. A programme for sampling and analysis for residues is run by the association, which has close contacts with the Federal Health Ministry.

Importers and wholesalers, like other food industry concerns, should implement an HACCP system, and it is the responsibility of the food control authorities to inspect and evaluate compliance with the duty of care and application of HACCP systems. Little progress seems to have been made by importers of foodstuffs in general to implement HACCP as part of their duty of care. It was explained to the team, however, that sampling is undertaken by importers, especially in the case of new suppliers and new third countries.

Cooperation between the customs services and the food control authorities seems to be limited to the above-mentioned compulsory checks at the point of entry. The Commission's assessment team was informed that not a single case of suspicion concerning food consignments had been reported by the customs services to the food control authorities, in accordance with Regulation (EEC) No 339/93 concerning conformity checks on imported products. The assessment team feels that the efficiency of import checks would be increased if the food control authorities had access to the computerised system used by the customs services for the processing of declarations.

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REPORT

RESULTS OF THE SECOND VISIT TO EVALUATE

THE OFFICIAL FOODSTUFFS CONTROL SYSTEM IN PORTUGAL

BY THE EUROPEAN COMMISSION FOODSTUFFS ASSESSMENT TEAM

16 - 20 November 1998

CONCLUSIONS

1. Update since 1997

1.1 Competent authorities

The same three Ministries of Agriculture, Economy and Health and their corresponding regional administrative units, as well as municipal authorities, remain competent for food control, with a redistribution of sectors.

Organic Laws governing the Ministry of Agriculture and its Regional Directorates have been adopted with a view to defining the responsibilities of the various departments, but there is still no list of official positions within the Ministry and recruitment is still blocked, with resulting staff shortages (particularly evident in Porto), compensated to some extent by the involvement of staff from the central office in campaigns in the regions.

An increasing emphasis has been put on co-ordination between Ministries (including the Customs services of the Ministry of Finance), via regular meetings promoted at central level by the DGCFQA of the Ministry of Agriculture and the transmission of EU rapid alert system notifications. The same applies to co-ordination between the DGCFQA and the Regional Directorates of the Ministry of Agriculture.

According to Resolution 104/98, a working group within the Ministries concerned should be created soon with a view to examining within six months the possibility of redistributing responsibilities in food control and setting up an agency.

1.2 Progress of HACCP in food premises and guides to good hygiene practice; listing of establishments

Directive 93/43/EEC on the hygiene of foodstuffs was not transposed in Portugal until 1998, and a transition period of one year (ending in March 1999) has been granted for the enforcement of the requirement for HACCP implementation. As a consequence, implementation is still minimal in small and medium-sized enterprises, while in the large industries sector more progress has been made. The number of sectors for which guides to good hygiene practice have been prepared is limited so far to 5.

Food controllers have already received basic training in HACCP, but more specific preparation (relating to different sectors) is still needed.

The responsibility of the relevant department within the DGCFQA and the Regional Directorates for the enforcement of the HACCP requirement in food premises has yet to be clarified.

The listing of food establishments is still incomplete. To improve this situation, the legislation concerning the licensing of premises in Portugal is in the process of being amended in order to simplify and harmonize the procedures at central and regional levels. Provisions concerning the registration of premises selling directly to consumers will be published soon.

1.3 Progress of the accreditation of official laboratories

The central laboratory of the DGCFQA and the laboratory of the Port Wine Institute have so far been accredited. The accreditation of individual tests is applied in Portugal. Preparatory work has started in the regional laboratories of the Ministry of Agriculture. The laboratories of the other Ministries have not yet been accredited.

2. Import controls

2.1 Role of the official authorities

Controls on imported foodstuffs of non-animal origin in Portugal combine controls at import (performed by the Ministry of Agriculture, with the co-operation of the Customs services) and market controls (performed by the Ministries of Economy - IGAE - and Agriculture).

Controls at the points of entry are prescribed by an Ordinance for an exhaustive official list of products (but not including cereals and alcoholic beverages) prepared by the Ministry of Agriculture - DGCFQA - and communicated to the Customs services. This list is updated with the inclusion of Community Decisions on compulsory controls (pistachio nuts from Iran, with the omission, however, of the Decision concerning analyses for Vibrio cholerae on fruit and vegetables from East Africa, no imports of which had, in any case, taken place during the period of validity of the Decision). Notifications via the EU rapid alert system for food are communicated by the DGCFQA to the Customs services. Visits on the spot found a satisfactory degree of co-operation between the food control and Customs services. It would seem, in any case, that Customs services do not play a role in the detection of products which may present a serious risk for health (pursuant to Council Regulation (EEC) n° 339/93). The DGCFQA does not have access to the Customs import services' computerized system.

The controls at import are based on a risk analysis and may be limited to documentary checks (which are systematic) or include physical checks (with possible sampling for analyses) on specific products such as dried fruit and nuts (for aflatoxins), grated coco nuts (for salmonella), canned fruit and vegetables (for additives), pulses and dried fruit (for parasites), taking into account the country of origin, the importers' records and the rapid alert system notifications. The physical checks are not systematic (except in Porto) but have been facilitated by the conclusion of a recent agreement between the Agriculture and Customs services which allows inspection at the importer's premises, under certain conditions, due to the unsatisfactory inspection facilities in the harbours. This agreement allows the containers to be unloaded, resulting in a satisfactory examination of the products. It was admitted, in Porto, that prior to that agreement no samples were taken from imported products at their point of entry.

2.2 Own-checks performed by importers - implementation of HACCP

The visits to the three importers showed the implementation of own-checks on imported foodstuffs to be inconsistent. Some privates analyses were performed on some products by two of them and certificates of analyses for pistachio nuts and peanuts (for aflatoxins) required by one of them, but the third did not carry out any laboratory tests or require any form of certificate (analyses being performed by the purchasers). Confidence in the exporters and the opinion that the official controls should prevail seem to play a major role.

Implementation of an HACCP system had been initiated by one importer only and the other two appeared to be unaware of the requirement.

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REPORT

Results of the second visit to evaluate the official food control system in the republic of Ireland by the European Commission foodstuffs assessment team

18 January / 22 January 1999

CONCLUSIONS

1. Update since 1996.

1.1 New developments in legislation and policy on food control since the initial assessment visit by the Commission

There has been a fundamental change since the last assessment visit in March 1996. The Irish government has established the Food Safety Authority of Ireland (FSAI). This new FSAI came into formal existence in January 1999. FSAI will co-ordinate the food-related work of all the agencies (50) involved in food control.

The main remarks made in the last report were that the central authority was not in a position to monitor the effectiveness of the local services (8 Health Boards), no guidance was available for officials carrying out inspections and there was a need for improved setting of priorities. Now, with the FSAI in place and a food quality assurance system having been launched by three Regional Health Boards (quality manual system, standard operating procedures), this situation is set to improve. Nevertheless, due to the recent creation of the FSAI, a definitive assessment of future food control in Ireland will only be possible after the co-operation agreement between the different departments has been implemented at operational level. A future visit will be necessary to assess the functioning of the FSAI.

The flow of information and instructions between central and local authorities can be slow. Commission Decision 98/116/EEC of 4 February 1998 on cholera sampling on import of fruit and vegetables entering the EU from Kenya, Uganda, Mozambique and Tanzania appears not to have been communicated to the regions.

Of particular note is the current work on setting up a single food control body for Ireland as a whole.

1.2 Laboratory accreditation

The laboratories visited in Cork and Limerick were found to be well equipped, with sufficient training and expertise to carry out the food control analyses (chemical and microbiological).

The 11 official laboratories already have EN 45001 accreditation. This is a very positive situation. The Commission team has noted that the Irish authorities have put a lot of effort and resources into improving conditions and equipment in laboratories. However, it seems that the workload is increasing faster than the staff resources can cope with. There is still room for improvement in co-ordination between laboratories and the central authorities on the sampling programme.

1.3 HACCP training

Ongoing training is being provided for staff. All EHO's have received an HACCP course, and an auditing course for 50% of inspectors is planned for 1999.

Directive 93/43 on the hygiene of foodstuffs has been implemented since 1 April 1998, although it transpired during the inspection visit that only a tiny minority already have an approved self-monitoring system. Implementation of the HACCP system in companies is apparently far more advanced in large industrial establishments than in small and medium-sized businesses. Local authorities are drawing up an auditing plan for businesses.

2. Food import control

Because of the location and size of the country, the importation of non-animal food products into Ireland is limited in both variety and quantity. Even if there is already close co-operation between the customs and port health authorities, this relationship should be formalised.

Harmonised procedures should be brought in as one of the new responsibilities of the FSAI, perhaps by means of a service contract with the customs authorities.

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REPORT

RESULTS OF THE SECOND VISIT TO EVALUATE THE OFFICIAL FOODSTUFFS CONTROL SYSTEM IN THE FEDERAL REPUBLIC OF AUSTRIA BY THE EUROPEAN COMMISSION FOODSTUFFS ASSESSMENT TEAM

08 - 12 February 1999

CONCLUSIONS

1. Update since 1997.

There has been no change since 1997 concerning the competences for food law implementation and enforcement in Austria, or coordination between the Federal Chancellery and the administrations of the Federal States.

Since the initial visit, Directive 93/43/EEC on the hygiene of foodstuffs has been transposed into Austrian law. Article 3 on HACCP only came into force in Austria on 1 March 1999, which explains the lack of awareness and the delay in implementing the HACCP system in some food sectors.

It was mentioned that the industrial and catering sectors are advanced in the implementation of HACCP principles, the requirements of clients and the market playing a role. On the other hand, progress on HACCP implementation is much slower in the small and medium-sized enterprises (e.g. the retail sector). The trade associations do, however, promote the adoption of HACCP by their members.

The help given on the implementation of HACCP by guides to good hygiene practice, which include HACCP principles, is limited for the moment, as only one guide has been established. Three others are, however, currently being assessed by the Federal Chancellery and should be valuable tools later on.

Since 1997, training courses on HACCP in the food sector have been organised by the Federal Chancellery on a yearly basis for inspectors working in the Federal States; some Federal States have also taken this initiative. Although these courses combine lectures and visits to establishments, the Commission assessment team considers that they should include more practical workshops.

All official food-testing laboratories have already been accredited or are in the process of receiving the final accreditation after a favourable audit. Two accreditation bodies have accredited the Federal laboratories, while a single body has accredited the Federal State and Municipal laboratories. The principle of accreditation of groups of tests has been applied.

Budgetary restrictions or political priorities do not always allow the recruitment by Federal States of a sufficient number of food inspectors to meet the targets of the coordinated annual inspection, and sampling plans drawn up by the Federal Chancellery for each Federal State. Consequently, priorities have to be given to certain food sectors to remedy this situation.

2. Food import control

The controls are in the hands of the Federal States, which follow the procedures established by the Federal Chancellery and may also adopt special measures independently. Except for the obligations resulting from Commission Decisions (monitoring of pistachio nuts from Iran and, previously, of fruit and vegetables from East Africa), no particular emphasis is put on the control of imported foodstuffs at their point of entry. It is considered preferable for these controls to be carried out at the importers' and wholesalers' premises, which is considered as the most effective system; they form part of the general market controls on foodstuffs within the annual sampling plans, and vary according to the season.

Commission Decisions on compulsory import controls are communicated by the Federal Chancellery to the customs authorities, which incorporate them into their regulations, using a computerised system available to all customs posts. Pistachio nuts from Iran have so far entered only in transit to other Member States, but recently they have started to be imported directly into Austria; this has led to difficulties for the official laboratories in performing the compulsory analyses for aflatoxins in reasonable time. On the other hand, checks for Vibrio cholerae on fruit and vegetables from East Africa have been performed.

Two Federal States apply special control priorities on imported products for the moment: nuts for aflatoxin contamination in the Land of Vienna, and mushrooms from Belarus for radioactivity at one importer in the Land of Styria. No other import control priority has been mentioned.

Visits on the spot in Vienna (airport + wholesale market), Nickelsdorf (land-border, truck transport), Graz (laboratory + importer) and Spielfeld (land-border, truck transport) allowed the Commission assessment team to obtain detailed information on the various controls, including the participation of the Customs Department. An important part of the sampling on imported foodstuffs is linked to the plan for the detection of pesticide residues in fruit and vegetables. In this field, it would seem that in the event of excessive pesticide residue levels being detected, the powers of detention by the control authorities of a future consignment of the same origin are limited.

Importers and wholesale companies, as other food business operators, are expected to implement an HACCP system and it is the responsibility of the food control authorities to inspect and evaluate the results from the duty of care and HACCP systems. The requirement for the importers of foodstuffs in general, as food business operators, to implement HACCP within their duty of care, seems so far to have made limited progress. The point was made that importers would take samples anyway, especially at the beginning of the production season and in the case of new suppliers and new third countries.

Co-operation between the Customs services and the food control authorities seems usually to be limited to the above-mentioned compulsory checks at the point of entry. It is apparently rare that any suspicion concerning food consignments is communicated by the Customs services to the food control authorities, as laid down in Regulation (EEC) N° 339/9