Final Report from The

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FINAL REPORT FROM THE

EFTA SURVEILLANCE AUTHORITY MISSION TO

NORWAY 20-24 NOVEMBER 2000

FOR THE PURPOSE OF ASSESSING THE APPLICATION OF

COUNCIL DIRECTIVE 91/493/EEC

Please note that comments by the Norwegian Authorities have been included in the report in underlined italic.

Contents

Page

1

Introduction

3

2

Objectives of the mission

3

3

Legal basis for the mission

3

4

Information on trade

4

5

Legislation

4

6

Main findings

6.1Competent Authorities

6.1.1Competent Authorities – division of tasks

6.1.2Competent Authorities – organisation

6.2Approval and suspension/withdrawal of approval of establishments, laboratories, vessels etc

6.3Official supervision of establishments and vessels

6.4Laboratory visited

6.5Factory vessel visited

6.6Establishments visited

6.6.1General conditions related to premises

6.6.2General conditions related to equipment

6.6.3General conditions related to hygiene and production

6.6.4General conditions related to the own checks system

6.6.5Official supervision

5

5

5

6

7

7

8

9

10

10

11

12

1212

13

14

7

Conclusions

15

8

Recommendations to the competent authorities of Norway

16

1Introduction

The mission took place in Norway from 20 to 24 November 2000. In addition to the inspector from the EFTA Surveillance Authority[1], one inspector from the EU Commission, Food and Veterinary Office (FVO) participated as an observer.

An opening meeting was held on Monday 20 November with the Competent Authorities (the Directorate of Fisheries/Fiskeridirektoratet and the Norwegian Food Control Authority/Statens Næringsmiddeltilsyn (SNT)). At this meeting, held in Fiskeridirektoratet in Bergen, the two directorates added information to their reply to the Authority’s pre-mission questionnaire. The parties also agreed to the draft mission itinerary forwarded to the Authority in beforehand.

Throughout the mission, two representatives from Fiskeridirektoratet accompanied the inspection team in addition to representatives from its different regional offices. Furthermore, representatives from SNT accompanied the inspection team for two days and representatives from the Municipal Food Control Authority/det Kommunale Næringsmiddeltilsynet (KNT) accompanied the inspection team the day one establishment, approved by KNT, was visited.

A final meeting was held in Fiskeridirektoratet on Friday 24 November, in which the inspection team presented orally the conclusions of the mission. During this meeting representatives from the SNT also participated. The Competent Authorities agreed to the conclusions.

2Objectives of the mission

The main objective of the mission was to check the application by the Norwegian Competent Authorities of the requirements laid down in Council Directive 91/493/EEC.

The Authority has performed several missions to Norwegian fishery establishments since 1995. However, this was the first mission where a more detailed assessment of the performance of the Competent Authorities was done. In addition to four fish-processing establishments a laboratory and a factory vessel were visited.

3Legal basis for the mission

The legal basis for the mission is laid down in point 1 of Article 8 of the Act referred to in part 6.1.8 of Chapter I of Annex I to the EEA Agreement, laying down the health conditions for the production and placing on the market of fishery products (Council Directive 91/493/EEC[2]), and in 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).

4Information on trade

As part of the reply to the Authority’s pre-mission questionnaire, the Norwegian Authorities forwarded statistics for 1999 (approximates and preliminary figures) regarding the Norwegian production and export of fishery products. According to these figures the total volume of exported fish and fishery products for 1999 was approximately 2.079.000 tons. The main species exported related to quantity, were herring (539.000 tons), salmon (338.000 tons), mackerel (306.000 tons) and cod (170.000 tons) respectively. Included in the total export volume is also 210.000 tons of fishmeal/fish oil.

The main market was the European Union (1.015.000 tons) out of which 291.000 tons were exported to Denmark, 161.000 tons to Great Britain, 120.000 tons to France and 102.000 tons to Germany. The by far largest markets outside the European Union are Japan (283.000 tons), Russia (164.000 tons) and Poland (157.000 tons).

Divided into products, Norway in 1999 exported 516.000 tons of frozen fish, 400.000 tons of fresh/frozen herring, 371.000 tons of fresh fish, 97.000 tons of frozen filet, 62.000 tons of clipfish and 55.000 tons of salted fish.

For salmon, the largest farmed species in Norway, the main market for fresh fish was the European Union (approximately 84% of the total export of fresh salmon) out of which approximately 28% was exported to Denmark, 23% to France and 9% to Germany. The second largest market was Japan (approximately 9%). For frozen salmon the largest market was Japan (33%), followed by Taiwan (11%), Russia (11%) and EU (10%).

5Legislation

The Authority performed a conformity assessment of the relevant national legislation in January 1997. As Chapter II of the Directive (Imports from third countries) became part of the EEA Agreement for Norway on 1 January 1999, a new notification of full implementation of the Directive was notified to the Authority on 15 April 1999.

The Directive is implemented by Act No. 12 of 28 May 1959 on Quality Control of Fish and Fishery Products, Food Act No. 3 of 19 May 1933 and Quality Regulations of 14 June 1996 relating to Fish and Fishery Products.

Council Directive 92/48/EEC of 16 June 1992 laying down the minimum hygiene rules applicable to fishery products caught on board certain vessels in accordance with Article 3(1)(a)(i) of Directive 91/493/EEC is also implemented by Act No. 12 of 28 May 1959 on Quality Control of Fish and Fishery Products and Quality Regulations of 14 June 1996 relating to Fish and Fishery Products. The Authority was notified on 20 October 1994 that the Directive was fully implemented into the said Norwegian Act and Regulation. The Authority performed a conformity assessment of the notified Norwegian legislation in January 1997.

The acts have been applicable to Norway since 1 July 1994.

6Main findings

6.1Competent Authorities

The Ministry of Agriculture, the Ministry of Fisheries and the Ministry of Health and Social Affairs lay down Norwegian food safety and quality legislation. They administer several acts including the Quality Control Act on Fish and Fishery products. The Ministry of Fisheries is professionally, financially and administratively responsible for Fiskeridirektoratet, whilst the Ministry of Agriculture is financially and administratively responsible for SNT. Other responsibilities bearing on SNT’s activities are shared among the Ministry of Agriculture, the Ministry of Fisheries and the Ministry of Health and Social Affairs.

6.1.1Competent Authorities – division of tasks

The responsibility for official controls according to the Norwegian legislation implementing the EEA legislation on safety and quality of fish and fishery products is divided between Fiskeridirektoratet and SNT. This is laid down in Article 5 of the Act No. 12 of 28 May 1959 on Quality Control of Fish and Fishery Products.

This division of tasks between the two directorates implies that establishments producing both for export and for the domestic market and transport of such products are under the responsibility of Fiskeridirektoratet and that establishments producing fishery products solely for the domestic market are under the responsibility of SNT.

Because of the revised EEA Agreement, the Quality Regulations of 14 June 1996 relating to Fish and Fishery Products was amended in December 1998. This regulation requires that import of any fishery products from the EEA have to be notified in advance to the competent authority (Fiskeridirektoratet or SNT/KNT) having supervision of the first consignee in Norway.

SNT has, by document 17 February 2000 No. 251 delegated the above-mentioned competence to the 95 municipal food control authorities (KNT). However, when having received such delegation, the KNTs act directly on behalf of SNT and economical resources are provided by SNT according to standardised specifications. SNT has also established routines for regular supervision of the KNTs.

Finally, regulations banning import of certain fish and fishery products, reflecting necessary immediate response to hygienic conditions in exporting countries, are issued by SNT.

6.1.2Competent Authorities – organisation

Fiskeridirektoratet is divided into five departments. Its Department of Quality, Control and Regional Management, is the one enforcing the laws and regulations regarding handling, processing and distribution of fishery products. Included are also establishments that purchase fish first-hand from fishermen for the domestic market. The other four departments of Fiskeridirektoratet are the Department of Legal Matters and Fishing Activity, the Department of Fisheries Economics, the Department of Aquaculture and the Institute of Nutrition.

The Department of Quality, Control and Regional Management is divided into four divisions; the Division of Control and Surveillance, the Division of Quality and Environment, the Division of Industrial Development and Coastal Planning, and the Central Laboratory. From 1 January 2001 however, the Central Laboratory will be organised in the same department as the Institute of Nutrition.

At the time of the visit, twelve persons were working in the Division of Quality and Environment, out of which five were advisers and five were specialist executive officers. However, three of the advisers are only working on veterinary issues related to import of animal products from third countries.

Furthermore, Fiskeridirektoratet has nine regional offices, each, among others, manned with a Regional Director and a Head of Section (Section of Supervision). Te number of inspectors differs from three to 18. In addition most of the regional offices also have one executive officer and one veterinarian. The duties of the inspectors include quality control, veterinary border control, control of resources (landings of fish and quota outtake) and other control activities.

Fiskeridirektoratet aims at spending 50% of the time available on control on inspections of establishments. However, according to information provided by Fiskeridirektoratet during the visit, the border control of products coming from third countries has taken extensive resources from the other duties during most of this year.

Finally, Fiskeridirektoratet has three regional laboratories that are administratively organised as a section under the regional offices in Troms, Nordland and Møre og Romsdal.

SNT is divided into three departments (Department of Administrative Affairs, Department of Food Law and International Affairs and Department of Food Control and Food Law Enforcement). Each of the departments is divided into three sections where section 2 in the Department of Food Control and Food Law Enforcement is the relevant one for authorisation of fish establishments.

In order to ensure harmonisation of the system the Director General from both Fiskeridirektoratet and SNT have an annual meeting. In addition, a working group with representatives from the two directorates has been established and meetings are held 2-3 times a year. Finally, joint training courses are held for relevant staff on a regular basis.

6.2Approval and suspension/withdrawal of approval of establishments, laboratories, vessels etc.

6.2.1Approval of establishments, laboratories, vessels etc.

Fiskeridirektoratet is the competent authority for approval of establishments producing fishery products for export and for establishments producing both for export and for the domestic market.

The criteria for approval are laid down in the Norwegian Quality Regulations relating to Fish and Fishery Products. After a regional office has received an application for approval, the local inspector inspects the establishment. The Division of Quality and Environment has prepared a standard form to be used in this process. The results of the inspection are reported to the regional office by using a checklist in the application form. If recommended by the regional office, the application is forwarded to the Division of Quality and Environment, which evaluates it and in case of positive outcome, issues the approval. This procedure is also used for the approval of factory vessels.

According to information provided by Fiskeridirektoratet there are three different types of approval. One for establishments approved before 1996, a temporary approval for all establishments approved after 1996 and an upgraded approval for establishments that meet all the requirements of the Directive and where the own checks system has been assessed by Fiskeridirektoratet with a positive outcome. At the time of the visit 255 out of 706 establishments had temporary approvals.

Fiskeridirektoratet registers freezer vessels in a separate register. The registration is based on a positive outcome of an inspection by the local inspectors and a recommendation for registration by the regional office.

The local KNTs are approving establishments producing fishery products solely for the domestic market. An approval is based on the same regulation as for establishments approved by Fiskeridirektoratet. However, SNT and KNT have issued a separate questionnaire that the establishment fills in and forwards to the local KNT as part of the application form. Based on the information in the checklist an inspector from KNT inspects the establishment. KNT receives an approval number from SNT and in case of a positive outcome of the inspection, KNT issues the approval. According to information provided by SNT as a reply to the Authority’s pre-mission questionnaire, only establishments, which fulfill all legal requirements, are approved.

At the time of the visit, 29 KNTs had establishments approved for production, transport or marketing of fishery products. The production quantities in most of these establishments are small compared to the establishments approved by Fiskeridirektoratet.

According to information provided by Fiskeridirektoratet, all vessels and establishments in Norway are either registered or approved. There are no non-approved/non-registered vessels or establishments. Furthermore, there are no auction markets/wholesale markets in Norway.

The number of establishments and factory vessels approved by Fiskeridirektoratet and SNT/KNT in accordance with the Directive is given in Table I. The number of freezer vessels registered by Fiskeridirektoratet is given in the same table.

Table INumber of establishments, factory and freezer vessels approved by Fiskeridirektoratet
and SNT/KNT in accordance with Council Directive 91/493/EEC

The number of fishing vessels in compliance with Council Directive 92/48/EEC is 12.948, according to information provided by Fiskeridirektoratet.

There are no landing sites approved as such in Norway. However, the landing sites are linked to certain categories of approval. Thus, a total of 580 establishments with the approval code 01 are also approved for landing of fish. In addition, shrimps and other shellfish can be landed at establishments with the approval codes 10 and/or 23.

SNT informs Fiskeridirektoratet of any changes in the approval status of establishments under its responsibility. Fiskeridirektoratet updates the lists of approved establishments and vessels continuously. However, the Authority does not receive these updated lists on a regular basis.

Although SNT has established guidelines for use of laboratories, neither Fiskeridirektoratet nor SNT had approved any of the laboratories used for the purposes laid down in the Directive, including the establishments’ own laboratories and private laboratories.

During the visit, the list of disinfectants approved by Fiskeridirektoratet was submitted. However, routines for approval of detergents and similar substances were not established.

6.2.2Suspension/withdrawal of approval of establishments and vessels

Procedures for suspension/withdrawal of approval/registration of establishments/vessels are established in both Fiskeridirektoratet and SNT/KNT. These are based on the requirements laid down in the Quality Regulations of 14 June 1996 relating to Fish and Fishery Products.

When minor deficiencies are revealed, the regional offices issue a written decision where the establishments are given a time limit to remedy the deficiencies. If the establishment fails to comply with requirements of the decision, the approval might be partly or fully withdrawn by Fiskeridirektoratet. Furthermore, a draft regulation giving Fiskeridirektoratet a legal basis to impose a fine on establishments that fail to remedy the deficiencies is prepared and is foreseen to enter into force in the spring 2001.

In case of major deficiencies, the regional offices have the possibility to stop the production until the deficiencies are remedied. In case where deficiencies risk public health the regional offices have the power to stop production immediately.

According to information submitted by Fiskeridirektoratet a total of 63 approvals had been withdrawn in 2000 by the time of the visit. Out of these 63, nine approvals were withdrawn because of lack of follow-up after inspections by the competent authorities. The majority of the other withdrawals were because of change in ownership or of normal termination of production.

Similar routines as for Fiskeridirektoratet are established within SNT/KNT. The KNTs have the power to temporarily stop production or withdraw approval of an establishment, depending on the nature of the deficiencies. In addition, KNTs have the legal basis for imposing a fine on establishments that fail to remedy minor deficiencies. The fine involves the imposition of daily penalty, which is to run until KNT takes the view that the deficiencies identified have been satisfactorily remedied. Furthermore, SNT has also the legal basis for taking action against establishments that are not in compliance with the requirements of the Directive.

6.3Official supervision of establishments and vessels

Fiskeridirektoratet inspects the establishments and factory vessels in connection with the approvals, by spot-checks during landings and by regular inspections according to the nature of the establishments, type of processing, activity etc. However, the frequency of inspections of approved establishments and vessels is not formalised. During the visits to the establishments the inspection team was informed that inspections could be as frequent as once a week.

The inspections can normally be divided into three categories, one related to facilities and equipment, one to inspections of documents and finally one related to the assessment of the own checks system. For these categories Fiskeridirektoratet has prepared different kinds of inspection forms. During each inspection the relevant form is filled in and the representatives of the establishment always receive a copy of this form. However, reports from the inspections are not always issued, but the inspection forms create the basis for a monthly report to the Department of Quality, Control and Regional Management in Fiskeridirektoratet.