Report on the initial visits by the Commission's services 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 foodstuffs
-*«ï8Pr COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, 11. 02. 1998 COM(1998) 37 final REPORT ON THE INITIAL VISITS BY THE COMMISSION'S SERVICES 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 (presented by the Commission) 1. INTRODUCTION 2. THE GENERAL SITUATION 2. 1 2. 2 2. 3 2. 4 2. 5 2. 6 2. 7 2. 8 2. 9 CONTROL STRUCTURES STAFF TRAINING BUDGET-HUMAN RESOURCES PRIORITIES REGISTRATION AND AUTHORISATION OF ESTABLISHMENTS FREQUENCY OF CONTROLS POWERS OF THE CONTROL AUTHORITIES SHORTCOMINGS IN CONTROLS CONTROL OF IMPORTED FOOD 2. 10 INFORMATION OF CONTROL OFFICIALS - CONSUMER INFORMATION 2. 11 TRAINING OF FOOD SECTOR WORKERS 2. 12 2. 13 EVALUATION OF THE CONTROL SERVICES ANALYSIS LABORATORIES 3. RECOMMENDATIONS 3. 1 3. 2 3. 3 ADDITIONAL INFORMATION AND UPDATES IN-DEPTH STUDY OF CERTAIN TOPICS EVALUATION OF CONTROL ACTIVITIES ON THE GROUND, IN THE COMPANY OF THE OFFICIALS 3 4 4 5 6 6 7 8 8 8 9 9 10 10 10 11 11 11 11 REPORT ON THE INITIAL VISITS BY THE COMMISSION'S SERVICES 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 the effectiveness of the systems for the official food control systems operated by the competent authorities in the Member States. To this end an inspection body was created by the Commission, initially attached to the Directorate-General for Industry and later transferred to the Directorate-General for Consumer Policy and Consumer Health Protection. The officials of this service have been designated to carry out these controls. The purpose of the visits was to obtain an accurate picture of the work and responsibilities of the competent authorities. 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 major domains: I. legal powers in matters relating to food control, notably the power to take appropriate measures in the event of health hazards; II. III. IV. V. policy, education and adoption of priorities in regard to official control; details on the resources allocated to the food control system (budget, staff, equipment); relations between the central authorities and the authorities implementing the controls; measures taken to ensure that central legislation and policies are correctly implemented on the ground. The visits took place between February 1995 and June 1997. They lasted a week in each Member State. They were carried out by two Commission officials accompanied in most cases by a national expert from a State other than the host State, selected from the lists supplied by the Member States. Prior details on the above-mentioned domains had been supplied by the Member States via a questionnaire addressed to the Permanent Representations. All the visits were organised on the- same lines, viz. : I. II. initial meeting with the competent central authority; visit to the central laboratories; meeting with regional and local authorities (depending on the country's administrative structure); visit to control units and laboratories; III. final evaluation meeting with the competent authorities and presentation of a report; IV. official transmission of the report to the Permanent Representation of the country visited. The information was collected during the meetings and visits on the basis of a questionnaire for use by the Commission officials. The visits were facilitated by the full collaboration of all the authorities involved. These visits should be considered as the initial phase of the controls provided for in Article 5 of Directive 93/99/EEC, with a view to understanding and evaluating the official control systems. They should give rise to additional visits on certain themes discussed in this report. 2. THE GENERAL SITUATION Food produced in the Community is subject to official control to ensure protection of public health, consumers and fair competition. Food control in the Member States is carried out independently of the food's place of origin within the Community. Controls are also carried out at all stages of production, storage and distribution. 2. 1 Control structures Depending on the country's political and administrative structure, two systems exist: I. II. powers to legislate and carry out controls exercised by one or more ministries with control units at regional or department level; powers to legislate exercised by one or more ministries or a national agency, and powers to carry out controls exercised by the regional or municipal authorities, whereby the central authorities play a coordinating role. The powers to carry out certain controls, notably those concerning imports, are sometimes retained by the central authorities. In certain Member States the services are currently being reformed (transfer or reallocation of responsibilities). It should be noted that in several countries the larger municipalities exercise control on their territory using their own services. In most cases it was not possible to look into the operation of these services. The distribution of powers between several ministries sometimes leads to the risk of ambiguities as to responsibilities (with absence of controls in certain sectors or overlapping powers with redundant controls in others). This means that better coordination between these ministries is required. In certain cases collaboration between ministries has been observed. Investment of regional or local authorities with control responsibilities makes the need for coordination from the central and regional authorities all the greater. 2. 2 Staff training According to the information received it seems that in most countries there is a two-tier recruitment system for personnel " on the ground" , depending on the nature of the control tasks: I. II. university graduates: chemists, food chemists, "environmental health officers", engineers, doctors, pharmacists, veterinary surgeons: for the career of "inspector", generally responsible for controlling industry-level establishments, secondary (or intermediate) education supplemented by vocational training of variable duration depending on the country concerned, provided by institutes or academies or by the administration itself, and followed by practical training: for the career of "controller", generally responsible for inspecting the retail trade or restaurants and for taking samples. In at least three countries which have a food police force, police officers are recruited also. In quite a number of countries the level of recruitment seems to have been unique for a number of years, viz. secondary education followed by an environmental health officer diploma obtained after three or four years study in a university institute specialised in environmental sciences. This training pattern explains why as a rule staff are not responsible for food control alone but also for other environmental domains. It seems that not all countries have precise requirements as to basic training. There is a need for additional information in this area, notably on the content of vocational training (subjects taught, practical tuition). Continuing training, while available in all the Member States, is more widespread in some than in others. It is provided both by the ministries and by the regional authorities. The main topic seems to be HACCP (Hazard analysis and critical control points) in the undertakings, where certain countries have made more progress than others. In several countries the controllers have stated that until now they have been inadequately schooled in this area. A more in-depth study of the topics addressed in continuing training is desirable, mainly with a view to pooling information between Member States. The exchanges of officials between Member State administrations in the field of the internal market (Karolus Programme) seem to be appreciated, by allowing knowledge and a reflexion concerning the control systems. 2. 3 Budget -human resources Depending on the country, funds are provided by national, regional- or local authorities or by a combination thereof. Except for special cases controls are generally free of charge but certain countries charge fees for health approvals (agréments sanitaires), for the taking of samples and analyses, for inspections or for a combination of these activities. It is difficult to compare the inspection budgets in the different Member States. This is because the calculations do not always take the same elements into consideration and because the controllers' activities are not normally confined to food inspections alone. In most cases the authorities visited acknowledged that they were short of staff. Additional information on human resources in all countries is required. 2. 4 Priorities the In most countries the central authorities or committees of regional authorities lay down priorities, notably taking into account the results of controls performed by implementing authorities, coordinated European programmes and the opinions of scientific committees. The role played by the implementing authorities in laying down central priorities varies from country to country. There were many cases of delays in the transmission of the results of controls by the implementing authorities to the central or regional authorities: these delays may adversely affect the definition of priorities. They also lead to delays in transmitting the Member States' food control statistics to the Commission. Consideration of the risks, provided for in Community legislation (Directive 93/43/EEC) on the hygiene of foodstuffs), is one of the criteria for selecting priorities and is applied more consistently in some Member States than in others. The priorities take the form of annual inspection and sampling plans, targeted actions, monthly campaigns and coordinated European programmes. Besides the central priorities - issued in the form of instructions or recommendations depending on the country's administrative system - priorities adapted to regional or local needs are determined in all countries. The visits revealed that catering establishments (notably in nurseries, schools and retirement homes) are a priority control area in the Member States. Some countries have developed and adopted a risk evaluation system in planning controls of establishments on the basis of several criteria for determining the risk level and the frequency of controls. This system requires sophisticated information technology and the prior registration of all establishments. It looks as though it will be developed in all the Member States in the near or not so near future and will replace the traditional and more subjective systems, based on the controllers' own experience with the establishments, their personal hunches and familiarity with. the socio economic structure of the regions, including the at-risk trades. 2. 5 Registration and authorisation of establishments Member States differ considerably in regard to the registration and authorisation of establishments. In most Member States, health approval (agrément sanitaire) is required (following submission of a dossier to the control authorities and an inspection visit from these authorities) for industrial plants or for certain categories, while a health authorisation (autorisation sanitaire) is necessary (issued by the control authorities) for retail establishments (fixed or itinerant), for catering establishments, import businesses, etc. But such requirements do not seem to exist in all countries, or they are just in the process of being introduced. Failing these obligations, an inventary and an adequate control of these establishements can not be ensured. Depending on the country's administrative structure: I. II. the central authorities (one of the ministries) or the regional authorities deliver the health approvals; this approach makes for greater uniformity; the local authorities (including the municipalities) deliver the health authorisations and, the health approvals, which may adversely affect uniformity. in certain countries, Some progress has been noted in certain countries or local units where information technology has been used to inventory all the establishments and their particulars and inspection reports, and also to transmit the lists to the other control authorities. On the other hand, other services visited acknowledged that they cannot keep tabs on all the establishments which have to be controlled (notably in the catering sector). A more in-depth study of this dossier will be required. 2. 6 Frequency of controls Risk assessment, mentioned at 2. 4, is one of the criteria applied in determining the frequency of controls. This criterion is most developed in countries that have introduced a computerised system in planning their controls. In most countries the central authorities recommend or prescribe a frequency which may range from once monthly for the production of perishable foodstuffs to once every two years for the storage of preserved foods. However, the visits and the control statistics have shown that, largely because of manpower shortages, it has not been possible to meet the objectives in several countries and that as a result there are considerable differences in "control pressure" between Member States. " 2. 7 Powers of the control authorities The visits showed that in all countries the officials responsible for controls had the necessary powers to enforce the rules and to take appropriate action in the event of health hazards, accompanied by police powers in certain countries. The powers to confiscate insanitary food are not always invested in the authority responsible for the control but sometimes too in the health authority, which must issue an opinion. The same applies to decisions to destroy confiscated food, which in certain countries is a prerogative of the courts, and to the closure of insanitary establishments, where in certain countries the decision must be confirmed by the health authority or by a municipal authority. In all countries, infringements - depending on their severity -may bring warnings, cautions, and administrative or penal sanctions in their wake. However - while several countries tend more to a punitive approach - others put the focus on education, except in the case of severe infringements. The educational approach is designed to correct errors and this is reflected in the statistics on infringements. The general trend seems to be in the educational direction. 2. 8 Shortcomings in controls (1) HACCP in the undertakings As in the case of HACCP training of inspectors, the introduction of the system into the undertakings is behind schedule to a varying extent in all the Member States (however, a few States envisage its general introduction in 1997), according to the declarations received from the control authorities and a number of punctual visits carried out. Small firms, catering establishments and above all retail stores (where HACCP is almost non-existent in the EU) trail far behind the leading industrial firms. Certain Member States are considering enforcing guides of good conduct instead of HACCP for the retail trade. However, preparation of these guides of good conduct is not equally advanced in all the Member States. In certain Member States with an education-oriented approach to control, the officials help in the preparation of HACCP systems in small undertakings and businesses. However, this assistance may clash with their role as supervisors. The delay in implementing HACCP means in fact that there has been failure to comply with the requirements of Directive 93/43/EEC on the hygiene of foodstuffs. (2) Other topics In numerous Member States controls of chemical risks - notably as regards additives, contaminants and materials in contact with food - have proven inadequate. 2. 9 Control of imported food There are considerable differences between the Member States, mainly because they apply different systems, viz. : I. II. III. control at Community entry points, whereby the degree of collaboration with the customs authorities differs from country to country: there may be systematic document controls or controls limited to certain foodstuffs, with batches being analysed at random or in the event of suspicion only, in respect of certain foodstuffs or for all foodstuffs; control of food once it has been placed on the market, on the same basis as EC-produced food; application of the principle that liability lies primarily with the importer, with verification of the internal control systems (notably HACCP) established by the importer in order to check whether the imported food complies with Community and national provisions. As a result "control pressure" in respect of imported food differs from country to country', and in certain cases leads to a laxer treatment of imported food than Community food. This dossier should be the subject of a more in-depth study on the ground. 2. 10 Information of control officials - consumer information The level of information of officials - notably as regards legislation and changes in the law, case law, inspection and. sampling procedures (sometimes with a breakdown by type of establishment and foodstuff) - varies from one country to another. The same applies to food safety information for consumers. A more in-depth study of these areas would be desirable with a view mainly to pooling information between Member States. 2. 11 Training of food sector workers In certain countries, food sector workers must have received vocational training. In some countries the control authorities are involved in training in the field of worker hygiene, notably by organising courses or conferences or publishing brochures. More information is needed on this topic. 2. 12 Evaluation of the control services While in certain countries performance evaluation of the control services by the central authorities is limited - sometimes for constitutional reasons - to examining the control statistics provided by these services, other countries have introduced an audit system, currently at internal level. This system is being developed in parallel with quality assurance in the administration. These trends should be followed up. 2. 13 Analysis laboratories The official controls generally rely on public laboratories, but private laboratories are also involved. The laboratory accreditation process provided for in Directive 93/99/EEC is more developed in some countries than in others, with the result that in some cases it is doubtful whether the deadline of 1 November 1998 can be met. The accreditation bodies are generally private organisations and in many cases laboratories are accredited on a sector of activity basis. Some countries have opted for approval of isolated tests, others for approval of batteries of tests. In many countries the laboratories perform private analyses as well as official ones, which means that conflicts of interest are not totally ruled out. The role played by the laboratories in determining control priorities varies from country to country. 10 3. RECOMMENDATIONS The results of the first round of visits indicate that, in compliance with Article 5 of Directive 93/99/EEC, these visits should be continued with a view to obtaining additional information and to investigating in greater depth certain aspects in several domains, with an eye to a more thorough assessment of the control systems, notably at grass roots level: 3. 1 Additional information and updates I. II. III. powers and activities of certain ministries, services and coordination committees; activities of the municipalities in certain countries; progress in laboratory accreditation. All major changes in the administrative structure of a country's control services should give rise to a new evaluation mission. 3. 2 In-depth study of certain topics I. II. III. IV. V. 3. 3 I. II. III. IV. V. training of control officials, continuing training; information and instructions provided by the control authorities to their officials; consumer information; evaluation of the control services by the national or regional authorities; authorisation and registration of the establishments subject to controls; training of food sector workers. Evaluation of control activities on the ground, in the company of the officials control of imported food; control of HACCP in the undertakings; controls relating to additives, contaminants, materials in contact with food; controls in priority sectors such as catering establishments;, control procedures relating to undertakings and taking of food samples. 11 Hence as from January 1998 it is planned to organise a one-week visit to each Member State with a view to evaluating control activities on the ground, besides obtaining additional information and studying certain subjects in greater depth. Moreover, it should be possible to organise urgent missions at any moment, notably in the following cases: I. II. to accompany control officials in visits to establishments affected by a rapid alert and, possibly, other establishments in the same sector; to follow up the adoption of a safeguard clause concerning a third country, in application of Article 10 of Directive 93/43/EEC on the hygiene of foodstuffs. 12 ISSN 0254-1475 COM(98) 37 final DOCUMENTS EN 03 10 17 15 Catalogue number : CB-CO-98-061-EN-C ISBN 92-78-30822-6 Office for Official Publications of the European Communities L-2985 Luxembourg \6