EFTA SURVEILLANCE AUTHORITY GOODS DIRECTORATE Doc. No: 01-4328-D Ref. No: VET 604.400.002 FINAL REPORT FROM A MISSION CARRIED OUT BY THE EFTA SURVEILLANCE AUTHORITY TO NORWAY FROM 26 FEBRUARY TO 2 MARCH 2001 FOR THE PURPOSE OF ASSESSING THE APPLICATION OF COUNCIL DIRECTIVE 77/99/EEC, COUNCIL DIRCTIVE 94/65/EC, AND OTHER ACTS RELATING TO MEAT PRODUCTS, MINCED MEAT, MEAT PREPARATIONS AND PROCESSED CASINGS Please note that comments from the Norwegian Authorities to factual errors have been included in bold, italic print in the body of the report. Comments providing additional information or expressing their view on particular issues are included as footnotes in bold, italic print. Page 2 of 21 Contents Page 1 Introduction 4 2 Objectives of the mission 4 3 Legal basis for the mission 5 4 Background 5 4.1 Reference to previous missions 5 4.2 Production and trade information 5 5 Legislation 6 6 Main findings 7 6.1 The competent authorities 6.1.1 Organisation of SNT 6.1.2 Organisation of KNT 6.1.3 Co-ordination between SNT and KNT 6.1.4 Independence and resources 6.1.5 Recruitment and training 6.1.6 Prioritisation of controls / Reporting procedures 7 6.2 Veterinary supervision of meat product, minced meat and meat preparation establishments 6.2.1 Approval procedure and suspension / withdrawal of approval of establishments 6.2.2 Control in the establishment 6.2.2.1 Central level 6.2.2.2 Local level 6.2.2.3 Health marking 6.2.3 Veterinary supervision of own-check systems and staff training programmes 10 6.3 Visit to meat product establishments 6.3.1 Structure and layout 6.3.2 Installation and equipment 6.3.3 Maintenance and cleaning 6.3.4 Operational hygiene 6.3.5 Traceability 14 6.4 Certificates and trade documents 16 6.5 Residues 16 Page 3 of 21 7 Conclusions 16 7.1 The competent authority 16 7.2 Veterinary supervision of meat product, minced meat and meat preparation establishments 17 7.3 Visit to meat product establishments 18 7.4 Certificates and trade documents 19 7.5 Residues 19 8 Recommendations to the competent authority of Norway 19 9 Addendum to the mission report 20 Page 4 of 21 1 Introduction The mission to Norway took place from 26 February to 2 March 2001. The mission team comprised one inspector from the EFTA Surveillance Authority1 and one observer from the Food and Veterinary Office of the European Commission. An opening meeting was held on 26 February with the Competent Authority (CA), which is the Norwegian Food Control Authority (SNT). A representative from the Ministry of Health and Social Affairs was also present. The Authority’s inspector confirmed the objectives of and the itinerary for the mission. The Norwegian representatives submitted additional information required for the satisfactory completion of the mission. The mission team was accompanied throughout the mission by representatives from SNT and representatives from the Local Food Control Authorities (KNT). During the visit of the casings establishment and one meat product plant a representative from the Ministry of Health and Social Affairs was present. In each establishment a summary of the observations made by the Authority during the visit was presented, on which the representatives from the CA as well the establishment had an opportunity to comment. A final meeting was held on 2 March 2001 at SNT in Oslo where the Authority’s inspector presented the main findings and conclusions of the mission to the SNT’s representatives and a representative from the Ministry of Health and Social Affairs who took note of them. 2 Objectives of the mission The main objective of the mission was to check the application by the Norwegian Competent Authority of the requirements laid down in the Council Directives 77/99/EEC, 94/65/EC and 92/118/EEC and other acts relating to meat products, minced meat, meat preparations and processed casings. During the mission the following sites were visited (table 1): Food processing establishments Meat product plants Number Comments 2 Meat product plant producing products with a meat content of less than 10% Casing establishment Temperature controlled stores 1 With integrated cutting plants, both approved also for the production of minced meat for the national market. No other production. 1 2 No comment. Integrated in the establishments. 1 Hereinafter called the Authority Page 5 of 21 3 Legal basis for the missions The legal basis for the mission is laid down in point 6.1.4 of Chapter I of Annex I to the EEA Agreement on health problems affecting intra-Community trade in meat products (Council Directive 77/99/EEC) as amended by Council Directive 92/118/EEC, the Act referred to in point 6.1.6 of Chapter I of Annex I to the EEA Agreement laying down the requirements for the production and placing on the market of minced meat and meat preparations (Council Directive 94/65/EC) and the Act referred to in part 1.2.74 of Chapter I of Annex I to that Agreement, laying down certain detailed rules concerning on-the-spot checks carried out in the veterinary field by Commission experts in the Member States (Commission Decision 98/139/EC). In addition an assessment was made on the application of the requirements laid down in the act referred to in point 1.1.9 of Chapter I of Annex I to the EEA Agreement, laying down the certification of animals and animal products (Council Directive 96/93/EC).2 4 Background for the mission 4.1 Reference to previous mission The Authority carried out two missions in the same field in 1997, which included visits to 11 meat processing plants located throughout Norway. This was the first mission on meat products, minced meat and meat preparations where a more detailed assessment of the performance of the CA was undertaken. It was the first time that a casing establishment was visited. In December 2000 a mission concerning fresh meat (Council Directive 64/433/EEC) had been carried out. In this report reference will be made to the final report from that mission (Doc. No. 01-1794-D3), which will be available to the public on the Authority’s homepage. 4.2 Production and trade information In the answer to the Authority’s pre-mission questionnaire, the Norwegian CA submitted the following statistical information for 1999: Norway imported altogether 1323 tons of meat products, minced meat and meat preparations from the EU (mainly Denmark and Sweden) and some third countries (mainly Brazil and Argentina). Altogether 1155 tons of meat products, minced meat and meat preparations were produced for the EEA market. The main countries of destination were Sweden, Belgium, Spain, Denmark and France. 2 The Norwegian Authorities informed in their comments to the draft report that Council Directive 96/93/EC is now implemented into Norwegian legislation. See addendum. 3 Hereafter referred to as the fresh meat report. Page 6 of 21 For the national market 223153 tons of meat products, minced meat and meat preparations were produced. 5 Legislation Council Directive 77/99/EEC has been applicable to Norway since 1 January 1994. Council Directive 96/65/EC has been applicable to Norway since 1 January 1999. Council Directive 92/118/EC has been applicable to Norway since 1 July 1994. In an answer to the pre-mission questionnaire the Authority was informed that the relevant EC-Directives, which are included in the EEA Agreement, relating to meat products, minced meat and meat preparations have been transposed into Norwegian law as follows: Council Directive 77/99/EEC on health problems affecting intra-Community trade in meat products: - Lov om kjøttproduksjon (Meat production act), LOV 1997-01-10. - Forskrift om hygiene ved produksjon og frambud m.v. av kjøttprodukter og enkelte andre produkter av animalsk opprinnelse (Regulations on the hygienic production and placing on the market etc. of meat products and some other products of animal origin), FOR 1995-04-06 353 and amended 1998-12-23 1473. - Forskrift om identifikasjonsmerking av næringsmiddelpartier (Regulations on the lot identification of food), FOR 1993-12-21 1384 and amended 1997-01-15 75. Council Directive 94/65/EC laying down the requirements for the production and placing on the market of minced meat and meat preparations: - Lov om kjøttproduksjon (Meat production act), LOV 1997-01- 10. - Forskrift om krav til kvernet kjøtt og tilberedt kjøtt og hygiene ved produksjon m.v. (Regulations laying down the requirements for the production etc. of minced meat and meat preparations), FOR 1998-12-12 1470 and amended 1999-10-17 1190. - Forskrift om identifikasjonsmerking av næringsmiddelpartier (Regulations on the lot identification of food), FOR 1993-12-21 1384 and amended 1997-01-15 75. The following Norwegian regulations are applicable both to meat products and meat preparations (and minced meat), thus transposing parts of both Directives: - Forskrift om kjøttråvarer og kjøttprodukter (Regulation on raw materials and meat products), FOR 1983-02-18 150 and amended 1996-02-18 199. - Forskrift om produkter framstilt av blandinger av findelte animalske råvarer eller blandinger av findelte animalske og vegetabilske råvarer (Regulations on products produced from mixtures of minced animal raw materials or mixtures of minced animal and vegetable raw materials), FOR 1983-02-18 151 and amended 1996-02-18 200. Page 7 of 21 - - - - Forskrift om merking m.v. av næringsmidler (Regulations on the labelling etc. of foodstuffs), FOR 1993-12-21 1385 and amended 1996-02-18 200. Forskrift om internkontroll for å oppfylle næringsmiddellovgivningen (Regulations on in-house control, based on risk analysis, to meet the requirements of the food control act), FOR 1994-12-15 1187 and amended 1997-11-12 1240. Forskrift om vannforsyning og drikkevann m.m. (Regulations on water supply and drinking water etc.), FOR 1995-01-01 68. Forskrift om maksimumsgrenser for restmengder av veterinæpreparater i næringsmidler av animalsk opprinnelse (Regulations on maximum residue limits for veterinary medicine in foodstuffs of animal origin), FOR 1996-10-10 997 and amended 2000-10-20 1069. Forskrift om kontrolltiltak for restmengder av visse stoffer i animalske næringsmidler, produskjonsdyr og fisk for å sikre helsemessig trygge næringsmidler (Regulations on control measures relating to amounts of residues of certain substances found in foods of animal origin, production animals and fish, aimed at ensuring food safety), FOR 200-01-27 65. Forskrift om delegering av myndighet på næringsmiddelområdet til det kommunale og interkommunale næringsmiddeltilsyn (Regulations on the delegation of powers concerning the food control, transferred to the municipal and inter-municipal food control authorities), FOR 2000-02-17 251. Finally Council Directive 96/93/EC relating to the certification of live animals and animal products has not been transposed into Norwegian legislation.4 During transport within the EEA area meat products, minced meat and meat preparations have to be accompanied by a commercial document providing information according to the Norwegian Regulation of 25 April 1994 no.320 on meat inspection and the placing on the market of fresh meat. The same regulation lays down that meat products, which are produced from raw material coming from a slaughterhouse situated in a restricted area/ region, have to be accompanied by a health certificate. The Authority’s comments regarding certification are to be found under point 6.4. 6 Main findings 6.1 The competent authorities The separation of competences is described under point 6.1 in the fresh meat report. The Ministry of Health and Social Affairs deals with the legislation on meat products, minced meat and meat preparations. The Ministry of Health and Social Affairs has delegated the responsibility for the official control to be carried out with regard to safety and quality of meat products, minced meat and meat preparations to the Norwegian Food Control Authority (Statens 4 The Norwegian Authorities informed in their comments to the draft report that Council Directive 96/93/EC is now implemented into Norwegian legislation. See comment to the legal basis in the addendum. Page 8 of 21 næringsmiddeltilsyn/SNT) although it remains financially and administratively responsible for it (Myndighetsoverføring til SNT m.v. of 29 April 1988 no.312). In turn, SNT has delegated certain responsibilities to 81 Local Food Control Authorities (kommunale næringsmiddeltilsyn/KNTs), which are, inter alia, responsible for the supervision, inspection and the control of meat products, minced meat and meat preparations. This is formalised in regulations on the delegation of powers concerning food control transferred to the municipal and inter-municipal food control authorities of 17 February 2000 no.251 (Forskrift om delegering av myndighet på næringsmiddelområdet til det kommunale og interkommunale næringsmiddeltilsyn). In addition to be responsible for drafting regulations relating to official food control, SNT issues instructions and administrative provisions describing how the KNTs should perform the delegated tasks. 6.1.1 Organisation of SNT The organisation of SNT is described under point 6.1.1 in the fresh meat report. 6.1.2 Organisation of KNT The organisation of KNT is described under point 6.1.2 in the fresh meat report. The Official Veterinarians (OVs) and the inspectors present in the meat product, minced meat and meat preparation establishments are employed by KNT. 6.1.3 Co-ordination between SNT and KNT In order to ensure a harmonised control system of supervision throughout the country SNT organises annual seminars where both local and central authorities must be present. In addition SNT stated that the intention was to audit the KNTs regularly, as further illustrated under point 6.1.6 concerning reporting. Finally the SNT can withdraw the delegation of competences given to a KNT but the dismissal of an OV or an inspector can only be done by the KNT he/she belongs to. 6.1.4 Independence and resources The official veterinarians and the inspectors in Norway are employed as civil servants by the public services in order to carry out the control according to the requirements laid down in Council Directives 77/99/EEC and 94/65/EC. An official control performed by an OV or an inspector is financed by the SNT. In SNT seven full time and one part time staff member are dealing with the control and supervision of meat product, minced meat and meat preparation establishments as well as with the implementation of regulations in this field. The same staff has also the responsibility for the fresh meat area. Page 9 of 21 The KNTs have 158 veterinary officers and approximately 70 inspectors inspecting plants for meat products, minced meat, meat preparations and poultry meat. During the inspection the following observations were made: At the central and local level the staff was competent and motivated despite a heavy workload especially at the central level and in one of the KNTs visited. Due to various administrative obligations the veterinary officers, designated to the specific geographical areas of SNT, were unable to perform the inspections necessary to ensure conformity with the Council Directives 77/99/EEC and 94/65/EC. In one KNT the inspections, required by the Directives, could not be performed due to a shortage of staff. 6.1.5 Recruitment and training The OVs are recruited by SNT based on recommendations made by the KNTs and it is foreseen by SNT that they participate once a year in a two-day training course about relevant legislation and subjects related to the daily supervision performed by them. The inspectors work on behalf of the SNT but KNT recruits them. The following observations were made during the inspection: There are no minimum requirements drawn up by SNT for the qualification requested when the KNTs are recruiting inspectors to supervise establishments. The KNTs have no uniform and no written requirements for the staff they recruit in order to let them supervise establishments. There are no formal procedures for the training of inspectors. They have a different professional background, which can range from a former pastry-cook to a food scientist. There is no routine established by SNT to ensure that all OVs and inspectors join the yearly training courses. One of the KNTs, despite adequate funding, had a shortage of staff due to recruitment problems. 6.1.6 Prioritisation of controls / Reporting procedures The prioritisation of controls is done by the SNT based on an annual report and a quarterly report received from the KNTs. SNT does not assess the actual performance of the various KNTs but performs audits on all of their tasks although not on a regular basis. SNT receives information if a KNT issues formal notices requiring establishments to rectify observed deficiencies within specified deadlines. The KNTs decided upon the frequency of supervision performed in each establishment and receives payment accordingly. The establishments are supposed to be classified in different categories according to guidelines issued by SNT and the frequency of supervision shall be accordingly. Page 10 of 21 The following observations were made during the inspection: The above-mentioned quarterly reports are concerned with budgetary matters. The annual reports contain only a description of the tasks performed (e.g. number of letters written, number of samples taken). Except for one KNT visited, the OVs or the inspectors wrote reports, listing deficiencies detected in an establishment. The reports were sent to the establishment concerned and to the relevant KNT. However, these reports were not forwarded to SNT. Except for one KNT visited, the OVs or the inspectors carried out an annual revision covering all of their tasks in the relevant establishments. These reports were not forwarded to SNT. The frequency of the inspections carried out varied significantly between the individual KNTs; no standardized risk assessment was performed. The approach in the prioritisation adopted by the KNTs varied considerably from drawing up a clear plan for the implementation of controls to working on a more ad hoc basis, reacting to circumstances as they developed. There were no reports from SNT about audits, performed in the four KNTs visited. No information was received about the supervision performed by SNT of establishments approved in accordance with Council Directive 94/65/EC. 6.2 Veterinary supervision of meat product, minced meat and meat preparation establishments 6.2.1 Approval procedure and suspension / withdrawal of approval of establishments SNT is the competent authority for the approval of establishments producing and marketing meat products, minced meat, meat preparations and processed casings in accordance with the Council Directives 77/99/EEC and 94/65/EC. SNT and KNT have established routines for the approval of establishments, which are the same as described for the fresh meat establishments in the fresh meat report. No establishments approved for the production of meat products, minced meat or meat products have had their approval withdrawn in 2000. Information was received in the answer to the pre-mission questionnaire, that in Norway establishments are approved for the production of meat products without an industrial structure or production capacity. Approvals for the production for the national market only are granted by the KNTs alone without consulting the SNT, however the procedure is the same as for EEA approvals. The approval for the national market can be withdrawn by the KNTs. Information was submitted in the answer to the pre-mission questionnaire, that SNT authorises the production and placing on the market of minced meat to be sold in Norway Page 11 of 21 only. The nature of these derogations granted is a reduced frequency of microbiological testing (§8 of regulation of 17 October 1999 no. 1190 laying down the requirements for the production etc. of minced meat and meat preparations) and that the production of minced meat can take place in the same room as where cutting of fresh meat takes place (§11 and §18 of the before mentioned regulation). The following observations were made during the inspection: No list of establishments approved in accordance with Council Directive 94/65/EC has been submitted to the Authority. The latest list submitted to the Authority in May 1999, about establishments approved in accordance with Council Directive 77/99/EEC, was already outdated while being transmitted as it included an establishment closed since 1997. The list of establishments submitted to the Authority in May 1999 is not in accordance with Commission Directive 83/201/EEC as establishments, approved for the production of meat products with a meat content of less than 10%, are not mentioned with the figure 8 followed by a hyphen in front of their approval number.5 No information was received during the mission what the criteria are to assess whether an establishment or a category of establishments are under the provisions of Article 9 of Council Directive 77/99/EEC (establishments manufacturing without an industrial structure or production capacity). The above-mentioned derogations granted for the production of minced meat for the national market are not based on particular habits of consumption e.g. with regard to the raw material used or the recipe. No information was received whether derogations for production and placing on the market of meat preparations to be sold on the national territory only are granted in order to take account of particular habits of consumption. There was no information received, how the CA ensures that meat products, approved for the EEA market, and minced meat, approved for the national market only, are not mixed up in the establishments if both productions are taking place in the same facilities. SNT had not visited the establishments, inspected during this mission, prior to approval. Two out of four establishments were approved although they did not have all the rooms required in Council Directive 77/99/EEC. The other two establishments visited were also missing facilities, although to a smaller extend. See also 6.3.1. 6.2.2 Control in the establishment 6.2.2.1 Central level It was stated in the opening meeting that each year SNT intends to audit six to eight KNTs. These audits cover all fields of activities in the KNTs (including e.g. dairies and The Norwegian Authorities submitted information that these establishments can be identified by “an x in the column labeled M<10” in the list annexed as attachment no.1 to the comments to the draft report. See comment to 6.2.1 in the addendum. 5 Page 12 of 21 fish establishments approved for the national market only) and one of the activities is specifically scrutinised each year. An audit takes two to three days. Newly approved establishments and establishments, which have undergone major alterations, were stated to be prioritised by SNT when inspecting establishments. In practice all inspections prior to approval are performed by the KNTs, however SNT’s inspections of KNTs are not prioritised in SNT’s yearly inspection programme. The following observations were made during the inspection: No inspections immediately following an approval or a major alteration had been carried out in the establishments visited. None of the establishments visited had been inspected by SNT on a routine basis with regard to their compliance with Council Directive 77/99/EEC. Although SNT had received information from one of the KNTs visited, that due to a shortage of staff they could not fulfil their obligations concerning the supervision of meat product establishments, no action from SNT had been taken. No special guidelines or requirements for the supervision of establishments, producing EEA approved meat products and non-EEA approved minced meat in the same facilities, were issued by SNT. 6.2.2.2 Local level OVs or inspectors belonging to the local KNT supervise the establishments on the spot. SNT has issued detailed guidelines on how the establishments are to be supervised. The responsibilities of the OVs and the inspectors include the supervision of the establishment’s own check system, the participation in staff training programmes related to operational hygiene and the regularly reporting to the establishment’s management (see 6.1.6). SNT requires that all official samples taken by the OV and the inspectors have to be analysed in accredited laboratories. The Norwegian Metrology and Accreditation Service (NA) grants the accreditation exclusively for particular analysis. Four different KNTs were visited. The following observations were made during the inspection: As described in point 6.1.6, the supervision of the establishments was not homogeneous. In all establishments visited it was noted that the quality of the supervision is closely linked to the activity, organisation and personal skills of the local service, which was in general very motivated. In one of the KNTs (not the one mentioned under 6.2.2.1) a shortage of veterinarians was observed. It was stated that it is common practise that non-veterinarians supervise the cutting plants in this KNT. In all establishments deficiencies found by the mission team had not been identified by the official services. In all KNTs deficiencies in the supervision of the establishment’s own check systems (see 6.2.3) and the health marks (see 6.2.2.3) were observed. Page 13 of 21 There is no list of laboratories approved or recognised by the CA. 6.2.2.3 Health marking In the answer to the pre-mission questionnaire the Authority received information that no procedures are established how the printing of labels and wrapping material bearing the health mark should be supervised. The OVs and the inspectors are responsible to control the use of health marks in the establishment. This includes labels on the wrapping material in case that the health marks appear on it. Meat products, minced meat and meat preparations in consumer packages are to be labelled according to the regulation of 23 May 1999 no. 1496 on the labelling of foodstuffs. According § 23 of the regulation of 23 May 1999 no. 1190, laying down the requirements for the production etc. of minced meat and meat preparations, products from establishments, approved for the national production only, are obliged to be labelled with a square shaped health mark. It was stated in the opening meeting, that health marks shall not be printed on cartons, packages and plastic tape in a way that they are not destroyed once the package is opened. The following observations were made during the inspection: The health mark was not applied in such a way to a label fixed to the packaging or was not printed in such way on the packaging, that it would be destroyed when the packaging is opened. It was printed on plastic tape used as packaging material and sprayed on cartons. In one establishment meat products bearing an incorrect health mark were observed. In one establishment unidentified meat was observed in the freezer store as well as unidentified meat and fat in the store for raw material. In one establishment only the pallets covered with a plastic tape were bearing the health mark but the, ready to be sold, single packages were unmarked. In all establishments the health marks were printed out by the establishment and not numbered. They were perceived and stored like commercial labels.6 6.2.3 Veterinary supervision of own check systems and staff training programmes In the answer to the pre-mission questionnaire it was stated, that all establishments approved under the Council Directives 77/99/EEC and 94/65/EC have an own check system as this is a key-criteria, which has to be presented before an approval is granted by the KNTs. All establishments visited had own check systems in place. In all places evidence of veterinary supervision was present. However, a number of hygiene deficiencies observed during this inspection had not been detected neither by the own check system nor during veterinary supervision. The following observations were made during the inspection: 6 The Norwegian Authorities commented that there is no legal requirement to number the health marks in order to facilitate the supervision performed by the official inspector. See comment to 6.2.2.3 in the addendum. Page 14 of 21 6.3 The presented own check system varied significantly from being self-made to being based on classical HACCP principles. In all cases difficulties in the identification of critical control points, the set up of critical limits and definition (and the documentation) of corrective actions were observed. No written evidence was found for the performed review of the programmes. The CA had a limited role in the development of the own check system. Not all controls of the own check system, carried out by the local OVs or inspectors, were documented. There was a lack of written evidence for the follow-up of corrective actions by the CA. Visit to meat product establishments7 6.3.1 Structure and layout In two out of four establishment visited the facilities were generally good. The following observations were made during the inspection: Two of the establishments visited received approval, although they were lacking several rooms required in Council Directive 77/99/EEC (e.g. a separate room for slicing), thus operations which should be confined to closed rooms took place in open areas. In the same two establishments the layout and the structures did not permit a clear separation between clean and unclean parts of the establishments, thus contamination could not be precluded. These two establishments had been approved for the production of EEA approved meat products and minced meat for the national market although the layout did not permit a clear separation between the two types of production. 6.3.2 Installation and equipment The following observations were made during the inspection: In all establishments meat, which was no longer intended for human consumption, was kept in containers that were not designated for that purpose. In three establishments the waste-water was not hygienically ducted into drains at all locations. The system of location of goods in the storage areas did not provide a clear separation between meat products approved for the EEA market and non-EEA approved meat products. 3 The detailed findings, related to the individual establishments, were submitted to the CA in a working document. Page 15 of 21 6.3.3 Maintenance and cleaning In two out of four establishments visited the maintenance and cleaning was generally satisfactory. The following observations were made during the inspection: In one establishment visited several deficiencies concerning maintenance and cleaning were observed in the establishment’s older parts. In one establishment, which just started production in new facilities, there were some deficiencies observed in the maintenance. In all except one establishment not all rooms were included in the cleaning plans. 6.3.4 Operational hygiene In all establishments some deficiencies were found, including the following: Unused packaging material was not stored so that it was protected from dust and contamination. The conditions for the storage of ingredients were not satisfactory as either the designated storage areas were turned into multi-purpose areas or the ingredients were stored outside the designated storage. In all establishments, except the casing plant, it was observed that exposed and packed products were partly stored together. 6.3.5 Traceability The traceability was satisfactory in the casing plant and in the meat products plant producing meat products with less than 10% meat content. It was stated in the answer to the pre-mission questionnaire that incoming and outgoing meat has to be identified as a critical control point in the establishment’s own check system. The OVs and the inspectors have also to focus on this. The following observations were made during the inspection: In two meat product plants the traceability ended when the raw material entered production. Both plants produce EEA approved meat products and minced meat approved for the national market in the same facilities. However, it was stated that only EEA approved raw material is used for the production. As described under 6.2.2.3 several unidentified products were observed in these establishments, which leads to concern as these plants were producing for the EEA market and the national market, thus using raw material with a possibly different hygiene status. In one establishment non-EEA approved meat was observed in the freezer store although the establishment is only approved for the production of EEA approved meat products. In two establishments the intake of raw material was not identified as a critical control point and no planned sampling was performed. Page 16 of 21 6.4 Certificates and trade documents The Authority was informed in the answer to the pre-mission questionnaire that the commercial document which accompanies meat intended for trade within the EEA, must contain the same information as provided on the health mark. The following observations were made during the inspection: The date of freezing was not always mentioned on the commercial documents accompanying frozen meat products. 6.5 Residues According to the answer to the pre-mission questionnaire, there is a monitoring programme developed in accordance with Council Directive 96/23/EC. A summary of the results for 1999 was transmitted. In 1999 the Authority carried out a special mission with regard to residues, which will be followed up. 7 Conclusions 7.1 The competent authority 7.1.1 The competent authority is independent, but the number of staff on central and local level was found to be insufficient in relation the responsibilities delegated to them and the lack of co-ordinated surveillance programmes between SNT and KNT is an obstacle to the effective functioning of the supervision of establishments. 7.1.2 There are no minimum requirements for the qualification of inspectors drawn up by SNT or the KNTs, thus a homogenous quality of supervision of EEA approved establishments might not be guaranteed.8 7.1.3 The required participation of staff in training courses was not enforced by SNT, thus adequate training could not be guaranteed.9 7.1.4 The prioritisation of control done by SNT is based on reports from KNTs, which do not contain information relevant to the CA’s obligation to supervise EEA approved establishments. 8 The Norwegian Authorities commented that they consider that there are no legal requirements in the Council Directives 77/99/EEC and 94/96/EC for the minimum qualification of official inspectors. See comment to 7.1.3 in the draft report. In the light of this comment attention is drawn to Art. 8 (2) of Council Directive 94/65/EC. 9 The Norwegian Authorities commented that they arrange seminars on annual basis compulsory for KNT leaders and chief veterinary personal. See comment to 7.1.4 in the addendum. Page 17 of 21 7.1.5 The prioritisation of control done by the different KNTs was not done in a uniform way, thus a homogenous control of the establishments could not be guaranteed. 7.1.6 The established reporting procedure does not guarantee that information from the KNTs, which is relevant for the supervision of EEA approved establishments, is submitted to SNT. 7.2 Veterinary supervision of meat product, minced meat and meat preparation establishments 7.2.1 A list of establishments approved in accordance with Council Directive 94/65/EC for minced meat and meat preparations has not been submitted to the Authority, thus it was impossible during this mission to check whether the CA fulfils its obligations originating from this Directive. 7.2.2 The list of establishments approved in accordance with Council Directive 77/99/EEC submitted to the Authority is not in compliance with the EEArequirements and outdated, which reduces the effective surveillance by the CA and the Authority. 7.2.3 The criteria adopted to assess whether an establishment or a category of establishments are covered by the provisions of Article 9 of Council Directive 77/99/EEC have not been communicated to the Authority.10 7.2.4 The derogations granted for the production of minced meat for the national territory only, are not based on particular habits of consumption as required in Council Directive 94/65/EEC. 7.2.5 The routines for the approval of establishments were not in compliance with Council Directive 77/99/EEC as establishments not fulfilling the requirements were approved by SNT. 7.2.6 The KNTs had recommended establishments for approval, which were not in compliance with Council Directive 77/99/EEC. 7.2.7 SNT grants approvals based on inspection reports from the KNTs. However, the surveillance of the KNTs is not prioritised by SNT. 10 The Norwegian Authorities commented by submitting, as attachment no.2 to their comment on the draft mission report, a letter from SNT to the Norwegian Ministry of Health and Social Affairs including the notification documents (Form 1) and a table of correspondence for Council Directive 94/65/EC. See addendum. Page 18 of 21 7.2.8 For none of the establishments visited written evidence was available showing that they had been inspected by SNT although some had recently undergone major alterations. Thus, the SNT’s system for the prioritisation of control was not followed. 7.2.9 SNT grants approval for the production of meat products, approved for the EEA market, and the production of minced meat, approved for the national market only, to establishments, which carry out both kinds of production in the same facilities. During the mission no special emphasis from the CA concerning the supervision of these establishments, working with raw material with a possibly different hygiene status, could be noted, which leads to a major concern. 7.2.10 The supervision of own check systems needs further improvement in order to fulfil the EEA-requirements. The same deficiencies were noted in different KNTs. Thus, it is necessary to intensify the staff training programmes accordingly. 7.2.11 There was no list of laboratories approved or recognised by the CA as required by Council Directives 77/99/EEC and 94/65/EC. 7.2.12 The OVs and inspectors were not in control of the health marks as they were not printed or reprinted under the authorisation by the CA as required in Council Directive 77/99/EEC. 7.3 Visit to meat product establishments 7.3.1 Significant problems in relation to structure and layout were identified in two establishments, in particular with regard to the separation of goods approved for the EEA market and goods approved for the national market only. 7.3.2 The installations and equipment were in general satisfactory, apart from the system of location of goods in the storage areas. In none of the establishments visited was a clear separation provided between goods approved for the EEA market and minced meat approved for the national market only. 7.3.3 The maintenance was satisfactory in most establishments. 7.3.4 Some deficiencies were noted with regard to cleaning and operational hygiene. It was especially noted that exposed and packed products were stored together. 7.3.5 The traceability in the plants producing goods approved for the EEA market and goods approved for the national market only in the same facilities needs to be improved. Page 19 of 21 7.4 Certificates and trade documents An improvement is needed concerning the content of the commercial documents in order to ensure full compliance with Council Directive 77/99/EEC. 7.5 Residues No deficiencies were noted during this mission. However this subject is covered by special missions from the Authority and was therefore not evaluated in depth. 8 8.1 Recommendations to the competent authority of Norway The Norwegian Authority should notify the Authority of written evidence of the corrective action relevant to the points mentioned in Chapter 7, except 7.3.1, within two months after receiving the final report. 8.2.1. The Norwegian Authorities should notify the Authority of written evidence of the corrective action relevant to point 7.3.1 in detail within six months after receiving the final report. Page 20 of 21 9 Addendum to the mission report The Norwegian Authorities informed the Authority in a letter dated 26 April 2001 about their comments on the factual content of the report. The full text of this letter is annexed except the two attachments. Attachment no.1 is a “list of Norwegian establishments approved for meat products (cf. Council Directive 77/99/EEC) per 4th of May 1999”. Attachment no.2 is a letter from SNT to the Norwegian Ministry of Health and Social Affairs submitting the notification documents (Form 1) and a table of correspondence for Council Directive 94/65/EC, which has been implemented as FOR 1998-12-12 1470 (see point 5 in the final report) into Norwegian law. CONCERNING MISSION TO NORWAY 26 February – 2 March 2001 – APPLICATION OF COUNCIL DIRECTIVE 77/99/EEC and 94/65/EC Reference is made to inspections made during the mission to Norway 26 February to 2 March 2001. The mission was made to verify the uniform application of Council Directive 77/99/EEC and 94/65/EC. After the inspection the Norwegian Authorities received a draft report and was given the opportunity to comment on the factual content of the report. The following comments are hereby addressed to Efta Surveillance Authority in regard to the draft report received: 3 Legal basis for the mission SNT would like to inform Efta Surveillance Authority that all of Council Directive 96/93/EC is now implemented into Norwegian legislation. 5 Legislation – comments regarding point 2 last sentence Ref. draft report: Council Directive 94/65/EC laying down the requirements for the production and placing on the market of minced meat and meat preparations: Forskrift om identifikasjonsmerking av næringsmidler (Regulations on the lot identification of food. This regulation is also applicable to the production of meat products and meat preparations. 6.2.1 Approval procedure and suspension/withdrawal of approval of establishments – point 3 Ref. draft report: The list of establishments submitted to the Authority in May 1999 is not in accordance with Commission Directive 83/201/EEC as establishments, approved for the production of meat products with a meat content of less than 10%, are not mentioned with a figure 8 followed by a hyphen in front of their approval number. Page 21 of 21 Establishments producing meat products with a meat content of less than 10% are given an approval number starting with 8-, hence identifying the activity. Such establishments do usually also produce other meat based products. Therefore they are also given an approval number identifying this other activity (the same number lacking the 8- in front). When lists of approved establishments are sent ESA, the only number identifying the establishment is the number without the 8 in the front. Despite this the ”< 10% activity” can be identified by an x in the column labelled M<10 (see list attachment no.1). 6.2.2.3 Health marking – point 5 Ref. draft report: In all establishments the health mark were printed out by the establishment and not numbered. They were perceived and stored like commercial labels. As far as the Norwegian Authorities consider, Directive 77/99/EEC and 94/65/EC do not require the establishments to number the health marks to be used in order to facilitate the supervision/control performed by official inspectors. 7.1.2 Comments regarding the competent authority Ref.draft report: 7.1.3 There are no minimum requirements for the qualification of inspectors drawn up by SNT or the KNTs, thus a homogenous quality of supervision of EEA approved establishments may not be guaranteed. As far as the Norwegian Authorities consider, Directive 77/99/EEC and 94/65/EC do not contain legal requirements defining the minimum qualification levels for official inspectors performing supervisory/control activities on behalf of the competent authority. As competent authority, SNT has developed detailed guidelines (Tilsynsveilederen) specifying how the tasks of supervision are to be performed. These guidelines are also developed in order to facilitate calibration/homogeneity of the supervision/control performed by individual official inspectors. 7.1.4 Ref. Draft report: The required participation of staff training courses was not enforced by SNT, thus adequate training could not be guaranteed. SNT arrange seminars on an annual basis, where KNT leaders and chief veterinary personnel are obliged to be present. During these seminars overall principles regarding supervision/control activities in meat producing establishments are in focus. 7.2.3 Ref. draft report: The criteria adopted to assess whether an establishment or category of establishment are covered by the provisions of Article 9 of council Directive 77/99/EEC have not been communicated to the Authority. Please see letter of 25.02.99 ref 98/00349/PSK/cso verifying the notification of implementation (attachment no.2). We kindly ask ESA to take into consideration the comments made by the Norwegian Food Control authority in regard to the received draft report.