Brussels, 3 February 2003 Doc. no: 03-554-D Ref. no: VET 604.300.002 GENDA: 2569

FINAL REPORT

EFTA SURVEILLANCE AUTHORITY MISSION TO

ICELAND

16 – 25 SEPTEMBER 2002

REGARDING THE APPLICATION OF COUNCIL DIRECTIVE 91/492/EEC AND COUNCIL DIRECTIVE 91/493/EEC

Please note that comments from the Icelandic Directorate of Fisheries have been included in the report in underlined italic.

______Rue de Trèves 74, B-1040 Brussels, tel: (+32)(0)2 286 18 11, fax: (+32)(0)2 286 18 00, www.eftasurv.int Page 2

Contents Page

1 Introduction 4

2 Objectives of the mission 4

3 Legal basis for the mission 5

4 Legislation 5

5 Information on production 6

6 Information on trade 7

7 Previous mission 8

8 Main findings 9 8.1 Competent Authorities - General 8.1.1 Fiskistofa – Organisation 9

8.2 Inspection Bodies 10

8.3 Delegation of control tasks to Inspection Bodies 10

8.4 Laboratories 11

8.5 Approval and supervision/withdrawal of approval of 12 vessels, auction markets and fishery products establishments

8.6 Classification and monitoring of molluscs production 13 8.6.1 Classification of production areas 13 8.6.2 Monitoring of the microbiological quality of bivalve 13 molluscs 8.6.3 Monitoring of phytoplankton situation 13 8.6.4 Monitoring of biotoxins 14 8.6.5 Monitoring of chemical contaminants 14 8.6.6 Viral contamination 14 8.6.7 Public health control and monitoring of production 15

8.7 Health control and monitoring of production conditions of 15 fishery products

8.8 Official supervision 15 8.8.1 Supervision of auction markets and fishery 15 products establishments 8.8.2 Supervision of harvesting and processing of molluscs 16 Page 3

8.9 Laboratories visited 17 8.9.1 Regional laboratory 17 8.9.2 National laboratory 18

8.10 Auction markets visited 20

8.11 Fishery products establishments visited 21 8.11.1 Conditions related to the own-checks system 21 including HACCP 8.11.2 Conditions related to premises 22 8.11.3 Conditions related to equipment 22 8.11.4 Conditions related to hygiene, production and storage 23

9 Final meeting 24

10 Conclusions 24

11 Recommendations to Iceland 27

Annex I Comments from the Icelandic Directorate of Fisheries to the draft report. Page 4

1 Introduction

The mission took place in Iceland from 16 to 25 September 2002. The inspection team comprised two inspectors from the EFTA Surveillance Authority (hereinafter referred to as the Authority).

An opening meeting was held on Monday 16 September 2002 with the Competent Authority (the Directorate of Fisheries/Fiskistofa). At this meeting, held at Fiskistofa in Reykjavík, representatives of Fiskistofa added information to the reply to the Authority’s pre-mission questionnaire. The representatives also informed the inspection team that it would not be possible to visit any factory vessel during the mission. Consequently, this point on the mission itinerary earlier forwarded to the Authority was replaced by a meeting with representatives of Fiskistofa. At this meeting, held on 24 September, a particular emphasis was put on Fiskistofa's follow-up of the Authority's conclusions and recommendations from the last mission.

Finally, at a meeting held in Reykjavík on 17 September, Fiskistofa provided additional information related to the Icelandic application of Council Directive 91/492/EEC.

Throughout the mission two representatives of Fiskistofa accompanied the inspection team. In addition, representatives of the respective Inspection Bodies were present in all the establishments visited during the mission.

A final meeting was held in Reykjavík on 25 September at which the inspection team orally presented the main findings and conclusions of the mission.

2 Objectives of the mission

The main objective of the mission was to assess Fiskistofa's application of the requirements laid down in Council Directive 91/492/EEC and Council Directive 91/493/EEC.

Moreover, an assessment of the actions taken by Fiskistofa in order to follow up the conclusions and recommendations of the previous mission was also carried out.

During the mission the following number of Inspection Bodies, laboratories, auction markets and fishery products establishments were visited:

Inspection Bodies 1

Laboratories National/reference 1 Regional 1

Establishments and auction markets Fishery product establishments 5 Auction markets 2 Page 5

Additionally, a boat used for harvesting and transport of molluscs was visited at the quayside.

3 Legal basis for the mission

The legal basis for the mission was:  Article 6 (1) of the Act referred to in point 6.1.10 of Chapter I of Annex I to the EEA Agreement: Council Directive 91/492/EEC of 15 July 1991 laying down the health conditions for the production and the placing on the market of live bivalve molluscs (OJ L 268, 24.9.1991, p 1).

 Article 8 (1) of the Act referred to in point 6.1.8 of Chapter I of Annex I to the EEA Agreement: Council Directive 91/493/EEC of 22 July 1991 laying down the health conditions for the production and the placing on the market of fishery products (OJ L 268, 24.9.1991, p. 15).

4 Legislation

The main Icelandic law regulating the production and placing on the market of fishery products and bivalve molluscs is Lög nr. 55/1998 um meðferð, vinnslu og dreifingu sjávarafurða (Act No 55 of 10 June 1998 on handling, processing and distribution of fishery products).

In addition to implementing the general provisions of Council Directive 91/492/EEC, Council Directive 91/493/EEC and Council Directive 92/48/EEC1, the Act also creates the legal basis for a number of regulations implementing the specific requirements laid down in these directives and other relevant EEA legislation.

Council Directive 91/492/EEC is implemented in the following Icelandic Regulation enacted by the Ministry of Fisheries:

 Reglugerð nr. 260/1999 um veiðar, meðferð, vinnslu og dreifingu lifandi samloka (Regulation No 260/1999 of 30 April 1999 on fishing, handling, processing and distribution of live bivalve molluscs.)

Council Directive 91/493/EEC is implemented in the following Icelandic regulations enacted by the Ministry of Fisheries:

 Reglugerð nr. 260/1999 um veiðar, meðferð, vinnslu og dreifingu lifandi samloka (Regulation No 260/1999 of 30 April 1999 on fishing, handling,

1 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 (OJ L 187, 7.7.1992, p. 41). Page 6

processing and distribution of live bivalve molluscs.)

 Reglugerð nr. 233/1999 um hollustuhætti við meðferð, vinnslu og dreifingu sjávarafla og fiskafurða (Regulation No 233/1999 of 9 April 1999 on health conditions for the handling, processing and distribution of fishery products.)

 Reglugerð nr. 558/1997 um innra eftirlit með framleiðslu sjávarafurða (Regulation No 558/1997 of 10 October 1997 on own checks.)

Council Directive 92/48/EEC is implemented in the following Icelandic Regulation enacted by the Ministry of Fisheries:

 Reglugerð nr. 233/1999 um hollustuhætti við meðferð, vinnslu og dreifingu sjávarafla og fiskafurða (Regulation No 233/1999 of 9 April 1999 on health conditions for the handling, processing and distribution of fishery products.)

Council Directive 98/83/EC2 is implemented in the following Icelandic Regulation enacted by the Ministry for the Environment:

 Reglugerð nr. 536/2001 um neysluvatn (Regulation No 536/2001 of 28 June 2001 on water intended for human consumption.)

All the main acts have been applicable to Iceland since 1994. The Authority performed a conformity assessment of the notified Icelandic legislation in 1997. In the spring 2002 the Authority performed a conformity assessment of the national measures notified as implementing Council Directive 98/83/EC.

Council Directive 79/923/EEC of 30 October 1979 on the quality required of shellfish waters has not been made part of the EEA Agreement. However, representatives of Fiskistofa informed the inspection team that some parts of the Directive are applied in Iceland.

Although incorporated into the EEA Agreement, Commission Decision 98/139/EC3 has not been made applicable to Iceland. However, the Authority follows the procedures of that act.

5 Information on production

The number of establishments, factory vessels, freezer vessels and auction markets approved by Fiskistofa in accordance with Council Directive 91/492/EEC and Council Directive 91/493/EEC, the number of fishing vessels complying with the requirements of Council Directive 92/48/EEC and the number of landing sites are given in table I.

2 Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (OJ L 330, 5.12.1998, p. 32). 3 Commission Decision 98/139/EC of 4 February 1998 laying down certain detailed rules concerning on-the- spot checks carried out in the veterinary field by Commission experts in the Member States (OJ L 38, 12.2.1998, p. 10). Page 7

Table I

Establishments4 approved by Fiskistofa 748 Approved factory vessels 40 Approved freezer vessels 22 Approved auction markets 31 Fishing vessels 1690 Landing sites 68

Fiskistofa has approved no dispatch centres or purification centres.

At the time of the visit molluscs were mainly harvested on the north and west coast of Iceland. Three areas were classified according to the US standards for production of Ocean quahog (Arctica islandica) on the north coast, while wild scallops (Clamys islandica) are harvested on the west coast. Ocean quahog and red abalone (Haliotis rufescens) are harvested all year, while scallops are harvested between September and February.

6 Information on trade5

As part of the reply to the Authority’s pre-mission questionnaire, Fiskistofa forwarded statistics prepared by Statistics Iceland for 2000 and 2001 regarding the Icelandic production and export of fishery products and bivalve molluscs.

According to these figures, the total volume of exported marine products for 2001 was approximately 780.000 tons. The main species exported related to quantity were capelin (330.000 tons, out of which 300.000 tons registered as fish meal/fish oil), herring (71.000 tons, out of which 34.000 tons registered as fish meal/fish oil), 116.000 tons of cod, 48.000 tons of redfish and 20.000 tons of flatfish, 27.000 tons of shrimps and 630 tons of scallops.

Split into different products, some 63.000 tons of salted and/or dried fish were exported during 2001, out of which 47.000 tons were placed on the EEA market. Out of 13.000 tons of fresh, chilled or iced fish fillets, 9.000 tons were during 2001 placed on the EEA market.

Furthermore, 18.000 tons out of a total export of 92.000 tons of whole frozen fish and 57.000 tons out of a total export of 77.000 tons of frozen fish fillets were placed on the EEA market. Of the total production of shrimps 26.000 tons were placed on the EEA market and more than 500 tons out of a total production of 600 tons of frozen scallops were placed on the EEA market.

4 Total number of approvals issued by Fiskistofa. Fiskistofa defines an establishment as a unit producing a certain category of products. Consequently, the premises of one establishment can have more than one approval number. 5 The figures reproduced are extracts and rounded. Page 8

Finally, out of a total production of 337.000 tons of fish meal and fish oil Norway received approximately 116.000 tons, United Kingdom 75.000 tons and Denmark 70.000 tons.

7 Previous mission

The Authority has performed several missions to Icelandic fishery establishments since 1995. However, the previous mission on fishery products, carried out from 9 to 13 October 2000, was the first mission where a more detailed assessment of the performance of the competent authority was included in the itinerary. The final report from that mission is available at the Authority’s Homepage on the Internet: http://www.eftasurv.int/

In addition to comments from Fiskistofa included in the report from the mission in 2000, the Authority received a letter dated 31 May 2001 from the Icelandic Mission to the European Union containing information from Fiskistofa on the measures taken within the time limits set out in the final report.

In that letter it was, inter alia, stated that:  Establishments and auction markets are obliged to perform organoleptic checks on every batch of fish received.  Fiskistofa would write a letter to the laboratories were they would formally be approved as required in Article 6 of Directive 91/493/EEC.  Fiskistofa had reaffirmed with the Inspection Bodies the demands that are placed on the establishments regarding storage facilities and the responsibilities regarding cross contamination of products.  Fiskistofa had reaffirmed with the Inspection Bodies the demands that are placed on the establishments regarding disposal of waste.  It is clearly stated in the Icelandic regulations that every employee has to have a health certificate.  Fiskistofa had reaffirmed with the Inspection Bodies the demands that are placed on the establishments regarding icing and drainage of melt water.

Furthermore, as part of the follow-up of the Authority's mission in 2000 Fiskistofa sent on 18 May 2001 a letter to the establishments visited during the mission in October 2000. Additionally, on 18 May 2001 letters were also sent to the Inspection Bodies in which the deficiencies contained in the Authority's report were linked to the inspection item number set out in the Inspection Manual. The respective Inspection Bodies also received copies of the letters sent to the establishments.

In its reply to the Authority's letter of 4 July 2002 containing the pre-mission questionnaire, Fiskistofa informed that all the establishments addressed in the letters of May 2001 submitted plans for improvement to Fiskistofa. Fiskistofa approved these plans. Furthermore, Fiskistofa also informed that according to the Icelandic surveillance system, the Inspection Bodies are responsible for the regular inspections of the establishments. Page 9

8 Main findings

8.1 Competent Authorities The Ministry of Fisheries enacts the Icelandic legislation implementing EEA acts related to handling, processing and distribution of marine products and on control of import of fishery products. Fiskistofa is the competent authority for the enforcement of this legislation.

The Ministry for the Environment enacts the Icelandic legislation implementing EEA acts on, inter alia, water intended for human consumption. Hollustuvernd ríkisins/the Environmental and Food Agency of Iceland is the competent authority for the enforcement of this legislation. Additionally, Hollustuvernd ríkisins is also responsible for, inter alia, the approval of detergents, disinfectants and similar substances as referred to in the EEA acts related to marine products.

Finally, involved in the enforcement of legislation related to food safety is also the Office of the Chief Veterinarian, which operates under the responsibility of the Ministry of Agriculture.

Based on the Food Law No. 93/1995, the Director General of Fiskistofa constitutes together with the Chief Veterinary Officer and the Director of the Office of Food of the Environmental and Food Agency, the Food Council. The Council has no legal authority, but it, inter alia, co-ordinates the food control in Iceland and gives comments to the Ministries on draft legislation.

During the mission the inspection team was informed that a process had been initiated in order to evaluate the organisation of the competent authorities responsible for the enforcement of legislation related to, inter alia, food safety in Iceland. Conclusions from the process were not available at the time of the visit.

8.1.1 Fiskistofa – Organisation Being located in Reykjavík, with no regional or local level, Fiskistofa operates on a national level. According to the organization chart provided by Fiskistofa as a reply to the Authority's pre-mission questionnaire, four Departments are organized directly under the Director General. Additionally, the Deputy Director of Fiskistofa is leading three different Departments, and a Quality Manager is leading the Quality Control Department and the Border Inspection Department.

The Quality Control Department is the department relevant for enforcing the laws and regulations regarding handling, processing and distribution of fishery products. The Department consists of six senior staff members and five inspectors. According to information provided by Fiskistofa the staff performing official control has not changed for several years.

The Border Inspection Department is, inter alia, responsible for the control of import of fishery products from third countries.

For the performance of inspections of vessels, auction markets and fish establishments, Fiskistofa has recognised two Inspection Bodies: Nýja skoðunarstofan and Sýni Page 10

skoðunarstofa.

8.2 Inspection Bodies The legal basis for recognition by Fiskistofa of Inspection Bodies are the provisions laid down in the Icelandic Regulation No. 450/1997 on surveillance framework and working methods of accredited inspection bodies in the fish industry, and in particular Article 12 thereof.

In order to be recognised by Fiskistofa an Inspection Body must, inter alia, be accredited and operate in accordance with the European Standard ÍST EN 45004:1995 on General criteria for the operation of various types of bodies performing inspection.

The two Inspection Bodies currently operating in Iceland were both recognised by Fiskistofa in 1998. The recognitions are valid for five years.

According to information provided by Fiskistofa the Inspection Bodies are accredited by both the Icelandic Metrology and Accreditation Service and by SWEDAC (the Swedish Board for Accreditation and Conformity Assessment) as Type A Inspection Bodies (providing "third party" services as defined in Point 4.2.1 of the ÍST EN 45004:1995).

One of the Inspection Bodies has five inspectors and one senior staff, whilst the other has two inspectors and one senior staff. According to information provided by Fiskistofa the senior staff of the Inspection Bodies to some extent perform inspections. However, not all the inspectors are inspecting full time.

The Inspection Bodies are private law subjects and inspection fees are collected directly from the approved fishing vessels, factory vessels, auction markets and establishments that they inspect. The fees are determined by the two Inspection Bodies without any involvement by Fiskistofa.

8.3 Delegation of control tasks to Inspection Bodies Recognised Inspection Bodies are performing inspections of approved fishing vessels, factory vessels, auction markets and fishery establishments on behalf of Fiskistofa. These inspections include checks on hygiene, premises, equipment and own checks systems.

Fiskistofa has issued an inspection manual, which is regularly updated. The manual, together with a model for the inspection reports and the Icelandic Regulation No 450/1997 create the basis for the inspections carried out by the inspectors of the Inspection Bodies. The outcome of the inspections are notified to Fiskistofa, normally on a weekly basis, but immediately if serious deficiencies are revealed.

As no legal competence has been delegated from Fiskistofa to the Inspection Bodies, it is only Fiskistofa that has the competence to adopt decisions where the establishments are given time limits for rectification of deficiencies. Furthermore, it is only Fiskistofa that has the legal competence to withdraw approvals or instruct an establishment to stop production. Consequently, inspectors from Fiskistofa do follow-up inspections of vessels, Page 11

auction markets and establishments where the Inspection Bodies have revealed serious deficiencies. These inspections create the basis for any legal actions taken by Fiskistofa. Normally, the inspectors of the Inspection Bodies, through their routine inspections, check the establishment's compliance with the content of the legal actions taken by Fiskistofa.

Fiskistofa is responsible for the co-ordination and follow-up of the Inspection Bodies. In order to harmonize the inspections, Fiskistofa performs common inspections, comparison inspections and evaluations of findings. Additionally, regular meetings are arranged between Fiskistofa and the Inspection Bodies.

When carrying out common inspections, the inspector of the Inspection Body is inspecting and the inspector from Fiskistofa comments on his performance. When carrying out comparison inspections, an inspector from Fiskistofa inspects an establishment shortly after an inspection by the Inspection Body. Following the latter Fiskistofa also issues an inspection report, which is sent to both the establishment and to the relevant Inspection Body. The results of these inspections are discussed in meetings where the inspectors of the Inspection Bodies are present.

Finally, annual seminars are arranged for the inspectors of both Fiskistofa and the Inspection Bodies. At these seminars the conclusions from evaluations of the content of the inspection reports from all inspections including those performed by inspectors from Fiskistofa are presented and discussed.

8.4 Laboratories Although Fiskistofa has been notified to the Authority as being the competent authority when it comes to application of the Icelandic legislation implementing EEA legislation related to production and placing on the market of live bivalve molluscs and fishery products, Fiskistofa informed in its reply to the Authority's pre-mission questionnaire that designation of national reference laboratories as it follows from Council Decision 93/383/EEC6 as amended, and Council Decision 1999/313/EC7, is not the responsibility of Fiskistofa.

For the approval of laboratories involved in the official laboratory analysis required by Directive 91/492/EEC, Directive 91/493/EEC and Directive 98/83/EC and for the examination of samples taken as part of the establishments own-checks systems, Fiskistofa informed in the reply to the Authority's pre-mission questionnaire that the main criterion is that the methods used for such analysis have to be accredited.

Furthermore, it was informed that results of analysis are only accepted from accredited laboratories. Seven laboratories were listed, four of which are branches/regional laboratories to the national laboratory having its main office in Reykjavík.

By an amendment to the Food Law No 93/1995, that entered into force as of 2002, laboratories are instructed to notify the competent authorities of positive results of, inter

6 Council Decision of 14 June 1993 on reference laboratories for the monitoring of marine biotoxins (93/383/EEC). 7 Council Decision of 29 April 1999 on reference laboratories for monitoring bacteriological and viral contamination of bivalve molluscs (1999/313/EC). Page 12

alia, certain bacteria. However, information on the situation regarding relevant zoonotic agents in Iceland was not available at the time of the visit.

8.5 Approval and suspension/withdrawal of approval of vessels, auction markets and fishery products establishments The establishments must meet all requirements concerning appropriate facilities, equipment and sanitation procedures and have documented an own checks system based on HACCP principles before being approved. Additionally, in order for Fiskistofa to assess an application for approval, a representative of the establishment must have signed a contract with one of the Inspection Bodies.

After having assessed the application and inspected the facilities of the establishment with a favourable outcome, Fiskistofa issues the approval certificate and updates the list of approved establishments. A letter is also issued to the contracted Inspection Body, which initiates regular inspections of the establishment.

Similar procedures are followed for approval of factory vessels. For the approval of freezer vessels, the contracted Inspection Body carries out the inspection of the vessel and submits the report to Fiskistofa. If necessary, a second inspection by the Inspection Body is carried out before Fiskistofa issues the approval certificate.

The system established in Iceland for issuing approval numbers is not linked to each establishment but to the different types of production. The approval numbers are linked to each establishment as a legal entity, to the location of the production facility and to the type of product concerned. Consequently, one establishment can have more than one approval number linked to the same production facilities.

The list of approved establishments, vessels and auction/wholesale markets is continuously updated by Fiskistofa and made available on its homepage on the Internet: http://www.fiskistofa.is/dirfish/.

Suspension or withdrawal of approvals or registrations of establishments/vessels can be based on a report from the Inspection Body, from Fiskistofa's own inspectors and/or on a notification from the management of the establishment.

If an inspection from the Inspection Body reveals a serious deficiency, inspectors from Fiskistofa visit the establishment and if the situation is verified, a written warning is issued. If the deficiencies have not been rectified within the time limit set, the approval is withdrawn. Fiskistofa issues a new approval only after an inspection has revealed that the deficiencies have been rectified or at least a plan for corrective action has been prepared and approved by Fiskistofa.

During 2000 11 approvals were withdrawn, three because of deficiencies related to facilities, six because of different hygienic deficiencies, and finally two because of lack of corrective action by the management of the establishments.

Five out of seven withdrawals of approvals during 2001 were because of hygienic reasons, one was because of use of decomposed raw material and lack of qualified staff in Page 13

management, whilst the last was due to lack of corrective action of deficiencies revealed during inspections.

Up to the time of the mission, two approvals had been withdrawn during 2002.

8.6 Classification and monitoring of molluscs production 8.6.1 Classification of production areas The harvesting areas in Iceland are divided into six main areas each having its own number: Vestfirðir (1), Norðurland (2), Austfirðir (3), Suðurland (4), Faxaflói (5) and Breiðafjörður (6). Each of these main areas is divided into sub areas and a further subdivision of the areas is also used. Consequently each production area has a unique four-digit number. Additionally, each main area is identified by a two-letter code used as a prefix to the unique four-digit identification number.

Fiskistofa has so far not classified any of the production areas according to the requirements laid down in Directive 91/492/EEC. However, four areas have been classified according to the shellfish sanitation program of the US Food and Drug Administration. These four areas are used for harvesting of Ocean quahog (Arctica islandica) for the US market only.

According to the information contained in Fiskistofa's reply to the Authority's pre-mission questionnaire the classification of production areas according to Directive 91/492/EEC is being discussed.

8.6.2 Monitoring of the microbiological quality of bivalve molluscs In its reply to the Authority's pre-mission questionnaire Fiskistofa informed that samples for the monitoring of microbiological quality of bivalve molluscs are taken of live shellfish four times a year.

Samples are taken under adverse conditions at stations that best reflect the conditions in the area. Each sample consists of 50-60 shells from each station. The analysing methods are the five-tube, three-dilution MPN test or other bacteriological test of comparable accuracy.

8.6.3 Monitoring of phytoplankton situation On behalf of Fiskistofa, the Icelandic Marine Research Institute does regular monitoring of the phytoplankton situation on a monthly basis from May to October. Both sampling and analyses are carried out by the Institute, which also evaluates the results and sends reports to Fiskistofa. The co-operation between the institute, the national laboratory for monitoring marine biotoxins and Fiskistofa was not formalised.

In the monitoring period the Institute checks a series of potentially toxin producing algae species, inter alia, Pseudo-nitzschia delicatissima, P. fraudulenta, P. pseudodelicatissima, P. pungens and P. seriata, Alexadrium minutum, A. ostenfeldii and A. tamarense, Dinophysis acuminata, D. acuta and D. norvegica, Gonyaulax grindleyi, Gymnodinium spp., Gyrodinium spp., Phalochroma rotundatum, Prorocentrum spp. and Hetrerosigma akashiwo. Page 14

Action limits are established for Alexandrium spp. (> 50.000/litre), Dinophysis spp. (> 100-500/litre) and Pseudo-nitzchia spp. (>500.000/litre).

The frequency for intensive monitoring and the criteria for switching from intensive sampling to periodic monitoring are under review. However, the existing programme for intensive monitoring includes, inter alia, increased sampling frequency, number of sampling points and toxicity testing of bivalve molluscs.

8.6.4 Monitoring of biotoxins According to information provided by Fiskistofa in its reply to the Authority's pre-mission questionnaire, monitoring of marine biotoxins is done by weekly sampling from each production area between May and October and every two weeks between November and April. In the period from May to October the samples are analysed for Paralytic Shellfish Poison (PSP), Diarrhetic Shellfish Poison (DSP) and Amnesic Shellfish Poison (ASP), whilst the samples taken from November to April are only analysed for PSP.

Samples are taken under adverse conditions at stations that best reflect the conditions in the area. One sample consists of 50 to 60 live shells in different sizes. The species monitored are Ocean quahog. When the guidance levels for algae are exceeded, samples of blue mussels are collected and tested for the relevant toxin.

Potential toxin producing algae are observed in harvesting areas around Iceland, in particular in the period from May until October. A surveillance strategy established by Fiskistofa is based on three premises:  A contingency plan is activated when levels of PSP, DSP or ASP exceeds the limits set out in Directive 91/492/EEC.  A potential problem is based on particular levels of toxigenic organisms during certain seasons or other conditions as established by background surveillance such as strange behaviour of birds or aquatic animals.  Routine monitoring of marine biotoxins is activated when background surveillance indicates that an actual or potential biotoxin problem exists.

8.6.5 Monitoring of chemical contaminants Monitoring of pollution in Iceland is organised as part of the OSPAR (the Convention for the Protection of the Marine Environment of the North-East Atlantic) and the AMAP programme (Arctic Monitoring and Assessment Programme) of the Nordic Council. However, Fiskistofa is not involved in setting priorities for monitoring of contaminants.

In production areas, heavy metals and organic pollutants are monitored every second year and one sample is analysed prior to opening of a new production area.

During the mission the inspection team revealed a possible incorrect implementation of Commission Regulation (EC) No 466/2001 of 8 March 2001 setting maximum levels for certain contaminants in foodstuffs.

8.6.6 Viral contamination According to information contained in Fiskistofa's reply to the Authority's pre-mission questionnaire there is no surveillance of possible viral contamination of bivalve molluscs Page 15

in Iceland.

8.6.7 Public health control and monitoring of production According to Fiskistofa's reply to the Authority's pre-mission questionnaire official checks are not performed on final products in order to check compliance with the requirements as laid down in Directive 91/492/EEC. However, according to the Icelandic legislation the establishments are obliged to perform internal checks.

8.7 Health control and monitoring of production conditions of fishery products According to information provided in Fiskistofa's reply to the Authority's pre-mission questionnaire neither Fiskistofa nor the Inspection Bodies are performing any organoleptic checks, parasite checks, chemical checks or microbiological checks on a regular basis.

However, according to the Icelandic legislation establishments must do organoleptic checks on every batch and have a procedure for checking parasites. Furthermore, if results of organoleptic checks are not conclusive, the producer can use chemical methods to check the quality of the raw material. Finally, microbiological samples must be taken from cooked crustaceans and bivalve molluscs.

8.8 Official supervision 8.8.1 Supervision of auction markets and fishery products establishments According to information provided by Fiskistofa all fishery products establishments shall be inspected four times per year. The inspection team observed that one of the establishments visited during the mission had been inspected three times in sixteen months. However, Fiskistofa had visited the establishment in June this summer. A report from the latter was not available.

In one of the establishments visited several samples of final products had been positive for Salmonella since late 1999. Samples had been taken from the products on a regular basis and products had been put on the market when the analysis showed negative results. Products positive for Salmonella were stored in a freezer store in the establishment. At the time of the visit the source of contamination of the products had not been revealed.

However, according to copies of relevant documents provided by Fiskistofa, inter alia, letters of November 1999, Fiskistofa had banned export of the products until the source of the contamination had been revealed and necessary measures to assure the quality of the products had been taken. Moreover, following an inspection carried out in January 2001 by an inspector from Fiskistofa, Fiskistofa had re-approved the establishment without having taken full account of the content of the letters of November 1999.

One of the establishments visited had two valid approval documents with two different dates for one production. In Fiskistofa's files reference was given to other dates than the dates indicated on the documents.

In one of the establishments visited major alterations, including installation of new machinery, had taken place after the approval of the establishment. However, Fiskistofa had not re-approved the establishment and any assessment by Fiskistofa of the revised own-checks system, including the HACCP plan, could not be documented. Page 16

In order to follow-up the deficiencies revealed during the last mission by the Authority, the establishments visited had issued plans for corrective action. Fiskistofa had approved the plans. During this mission one establishment was re-visited. In this establishment the inspection team observed that no deadline for implementation of the corrective actions had been agreed. Furthermore, when visiting this establishment during the last mission, the inspection team commented on, inter alia, the design and layout, in particular related to the facilities for storage of final products. The situation was still the same when the inspection team visited the establishment during this mission and Fiskistofa could not provide any information on follow-up of this point.

Checklists have been prepared for use by the inspectors of the Inspection Bodies when inspecting approved establishments and vessels. The inspectors mark the checklist and add written comments only when deficiencies are revealed.

During the last two years major changes had been done to the equipment in two of the establishments visited. However, from the inspection reports available it was not possible to verify whether the inspectors had assessed the establishments revised own-checks systems.

During the mission representatives from Fiskistofa provided statistical information regarding the findings following inspections by the inspectors of the Inspection Bodies and following inspections by the inspectors of Fiskistofa. According to this information the inspectors from the Inspection Bodies in general have fewer remarks than the inspectors of Fiskistofa.

The inspection team was also informed that all the points on the checklist are checked during every inspection and that one inspection by inspectors of the Inspection Bodies normally takes less than three hours.

As part of the preparation for the mission inspectors from Fiskistofa had visited three of the establishments shortly before the mission. An inspector from the Inspection Body had also recently inspected one of these establishments. In this establishment the inspector from Fiskistofa had noted twice the number of deficiencies noted by the inspector from the Inspection Body.

Finally, the inspection team was informed that the inspectors of the Inspection Bodies have calibrated thermometers and check the thermometers in the establishments. However, these checks could not be documented.

8.8.2 Supervision of harvesting and processing of molluscs During the mission one boat used for harvesting and transport of molluscs was visited at the quayside.

After harvesting and during transport to the processing establishment the molluscs are stored on board the boat in shell stocks with a maximum capacity of 1600 kg of shells. The shells can be kept on board the boat for more than 30 hours before being landed at the processing establishment. During transport at sea the shells are stored in seawater. Page 17

According to information provided by the owner of the boat, it is inspected twice a year. However, no inspection reports were available at the time of the visit.

In the establishment the shells are stored in a cold store for up to three days before being processed. The shells are not kept in water during storage on shore. The inspection team observed that shells were also stored in smaller containers piled on top of each other with direct contact between the shells in these containers.

After an initial process for opening the shells, cocking is taking place under high temperature and pressure before further processing. The inspection team observed a high percentage of damaged shells stored. A representative of the establishment informed that also damaged shells – sometimes up to 50% of the amount harvested – are used in the production.

Representatives of Fiskistofa informed the inspection team that the competent authority had not evaluated the methods for harvesting, transport and storage of molluscs.

8.9 Laboratories visited Two laboratories were visited during the mission, one national laboratory and one regional laboratory, the latter being a branch of the national laboratory visited. Representatives from Fiskistofa confirmed that designation of national reference laboratories and notification thereof to the Authority, as required in Decision 93/383/EEC as amended, and Decision 1999/313/EC, had not been done.

Moreover, as a follow-up of the Authority's report from the mission in 2000, Fiskistofa informed in its letter of May 2001 (Chapter 7 of this report) that a letter would be written to the laboratories where they would formally be approved as required in Article 6 of Directive 91/493/EEC. Before the final meeting on 25 September 2002, the inspection team received copies of letters to three of the laboratories dated 24 September 2002. In these letters Fiskistofa, by referring to Article 6 of Directive 91/493/EEC, approved the laboratories.

Approval of laboratories as required in Chapter IV of the Annex to Council Directive 91/492/EEC could not be documented.

8.9.1 Regional laboratory The regional laboratory visited, being a branch of the national laboratory in Reykjavík, is an official laboratory organised under the Ministry of Fisheries. The number of staff is six, out of which two are working part time.

At the time of the visit the regional laboratory could not provide a copy of the letter in which Fiskistofa approves the laboratory.

SWEDAC accredited the laboratory according to the EN 45001 standard in 1997. It obtained accreditation for specific chemical and microbiological analyses during 1999 and some chemical methods were added to the accreditation in February 2001.

The accreditation comprises analysis of samples of potable water, seawater, fish meal, fish and shellfish. The variables analysed are water and salt, total plate count, total and faecal Page 18

coliforms, Stahphylococcus aureus, Listeria, Salmonella, Sulphite-reducing clostridia and enterobacteriaceae. The laboratory also performs other non-accredited analyses. However, a list of these was not available at the time of the visit.

In addition to tests organised internally, the laboratory participates in comparative tests three times a year organised by the Swedish National Food Administration/ Livsmedelverket.

Parts of the facilities for storage of samples were shared with another laboratory. However, the analysing equipment was clearly separated from the other laboratory and the access to the laboratory was restricted.

A sampling instruction, issued by the laboratory, is always sent to the persons taking samples. The producers take the majority of the samples analysed at the laboratory. In addition to samples of products, which constitute the majority of samples received, the laboratory also receives water samples from fish establishments.

Samples are transported either by car or plane in order to arrive at the laboratory on the same day. As a service for the establishments, the inspectors of the Inspection Bodies sometimes deliver samples of both products and water to the laboratories. Normally, the Inspection Bodies also want copies of the results of the samples that have been delivered by their inspectors.

Samples are kept in fridges and analysis is initiated the same day as the samples arrive at the laboratory.

It is possible to trace back the samples through the analysing process. However, the staff performing the analysis normally know the owners of the samples. The representative of the laboratory informed the inspection team that these procedures would be improved in order to assure anonymity of the samples.

The inspection team was informed that procedures for notification to the competent authorities of positive results as laid down in the Food Act No 93/1995 have been established, however not formalised between the laboratory and Fiskistofa. It should be pointed out that a formalisation between the individual laboratories and the Directorate is not necessary as this requirements is laid down in Law. It should also be noted that the Food Council has sent the laboratories detailed guidelines on how to implement this requirement.

8.9.2 National laboratory The national laboratory, organised under the Ministry of Fisheries, was accredited by SWEDAC in co-operation with the Icelandic Metrology and Accreditation Service in 1997.

The national laboratory is the only laboratory in Iceland monitoring marine biotoxins. At the time of the visit it was still to be decided whether other laboratories in addition to the national laboratory should take part in the monitoring of bacteriological and viral contamination of bivalve molluscs. Page 19

The representative of the laboratory informed the inspection team that the central laboratory had been designated as the national reference laboratory for both the monitoring of marine biotoxins and of bacteriological and viral contamination of bivalve molluscs. However, this had not been formalised.

Consequently, despite being designated as a national reference laboratory, it had so far not been involved in the process organised by Fiskistofa for establishing a system for monitoring marine biotoxins and bacteriological and viral contamination of bivalve molluscs.

Moreover, the representative of the laboratory also informed the inspection team that the laboratory had not established any contact with the European Community reference laboratories for the monitoring of marine biotoxins and for the monitoring of bacteriological and viral contamination of bivalve molluscs. Consequently, the laboratory had not been taking part in any of the activities organised by the European Community reference laboratories.

Additionally, the representative of the laboratory also informed the inspection team that there was hardly any contact between the national laboratory and national reference laboratories in other countries within the EEA and the laboratory had so far not participated in any comparative tests related to marine biotoxins.

Comparative tests between the laboratories performing microbiological analyses were not organised nationally. Participation in comparative test organised by laboratories outside Iceland was based on direct contact between each of the Icelandic laboratories and the laboratories organising such tests.

The inspection team was informed by the representative of the laboratory that the laboratory was not accredited for the methods used for analysing samples for marine biotoxins. Furthermore, initiation of a process for accreditation was depending on the extension of the monitoring programme to be established by Fiskistofa. Moreover, Fiskistofa had accepted the results from the analyses performed at the laboratory. This was contrary to the information provided by Fiskistofa in its reply to the Authority's pre- mission questionnaire and confirmed to the inspection team during the mission.

According to information provided by the representative of the laboratory no samples were analysed for mouse bioassay during 1998, 2000 and 2001. However, as part of a separate project carried out during 1999, between 20 and 30 samples were analysed for DSP, several with a positive result. Samples had not been analysed for the ASP toxin complex since 1996.

The inspection team was informed that although the laboratory received samples for analysis on a regular basis, up to the time of the visit only three samples had been analysed in 2002. One of the samples was positive for PSP. The laboratory uses the AOAC (Association of Analytical Communities) method (1995) for detection of the PSP toxin complex. Supplementary analytical chemical methods are not performed.

The representative of the laboratory informed the inspection team that the limited number of samples analysed this year was due to re-organisation of the laboratory and lack of Page 20

staff. Representatives of Fiskistofa informed the inspection team that they had just recently been aware of this situation.

Based on sampling guidelines prepared by the laboratory and submitted to Fiskistofa, samples are taken both by representatives of establishments and by Fiskistofa. Samples arrive at the laboratory either on the same day as sampled or the day after. When samples are received on Fridays they are stored in a freezer over the weekend. Consequently, samples can sometimes be up to four days old before the analysing process is initiated. Samples with insufficient labelling making it impossible to trace back the samples were observed in one freezer. Anonymity of the samples through the analysing process could not be assured.

When analysing samples for marine algae toxins, the laboratory prepares the samples before being sent to another laboratory in Reykjavík, which is performing the mouse bioassay. The samples are stored in a fridge overnight and the mice are injected in the morning the day after. Results of the bioassays are communicated by phone to the national laboratory, which thereafter informs Fiskistofa, normally also by phone. Formalisation of these procedures could not be documented.

The laboratory performing the mouse bioassay, being the main laboratory for animal science in Iceland, is the only laboratory in Iceland having a licence for using animals for experimental and other scientific purposes. A representative from the laboratory informed the inspection team that the laboratory most probably would be accredited in the beginning of 2003. However, it was not likely that the mouse bioassay would be included in the accreditation.

The inspection team was informed that the national laboratory issues an annual report, which also contains information about the activities in the four branches. However, the report does not contain any information on results of samples related to bivalve molluscs.

8.10 Auction markets visited During the mission two auction markets approved by Fiskistofa were visited, one at the east coast and one at the west coast of Iceland.

One of the auction markets visited was approved for gutting, and gutting was taking place at the time of the visit, although the facilities were not in compliance with the requirements of Directive 91/493/EEC. There was, inter alia, no separation between clean and contaminated parts of the facilities.

The inspection team observed that a forklift was used for road transport of unprotected fish in containers from boats at the quayside to the auction market, a distance of approximately 300 meters. One forklift was used both outside and inside the auction market.

Finally, the inspection team was informed that samples for controlling the quality of potable water were taken once a year and that samples for checking the quality of the products were neither taken by the staff at the market nor by Fiskistofa/the Inspection Bodies. Page 21

At the second auction market visited, the inspection team was informed that the ice machine was out of order and that it had difficulties in receiving ice produced elsewhere. One container intended for use as a cold store was placed in the auction hall. However, this was not in use at the time of the visit.

The inspection team observed that a forklift was used both outside and in the auction hall. Crates with fish, several containing fish without ice, were placed directly on the floor. One of the crates was dated three days before the visit. The inspection team was informed that the date was most probably indicating the date of catch.

Finally, crates and containers used for storage and transport of fish were cleaned at a temperature of 48-49 °C.

8.11 Fishery products establishments visited During the mission five fishery products establishments were visited, three at the north coast, one at the east coast and one at the west coast of Iceland.

The first establishment visited was approved for production of frozen products and the second establishment was approved for production of frozen products and pre- cocked/ready to eat products. The third establishment was approved for production of shellfish. The fourth establishment was approved for production of frozen products whilst the fifth establishment was approved for production of frozen products, fresh products and for salting.

The Authority visited one establishment that was also visited during the mission carried out in 2000. In this establishment it was observed that only some of the deficiencies marked during the last visit had been remedied. It was, inter alia, observed that facilities for storage of final products were still not in compliance with the requirements of Directive 91/493/EEC.

8.11.1 Conditions related to the own-checks system including HACCP Although an own-checks system was present in all establishments visited, the inspection team observed several deficiencies in all the systems. In four of the establishments the end products were just partly described and the intended use had not been identified. Moreover, the identification of potential hazards was either incomplete or not available and the risk analysis was either incomplete or not performed. In at least two of the establishments critical limits were not established for all of the critical control points.

In one establishment the frequency for monitoring of temperature was not indicated in the plan and no corrective action was included in the plan for this point. Furthermore, according to the Icelandic legislation the temperature in the final product at the end of processing shall be below 8 °C. However, the establishment had set a limit of 10 °C.

In one establishment training of staff was not included in the own-checks system. However, the inspection team was informed that the staff had participated in relevant training. Page 22

Finally, in three of the establishments procedures for corrective action and for verification of the plan, were either incomplete or missing and in at least one establishment the own- checks system had not been revised.

In most of the establishments visited none of the deficiencies revealed during the mission had been commented on in the latest inspection reports issued by the Inspection Bodies.

8.11.2 Conditions related to premises In at least two establishments the size of the working areas were not sufficient and the design and layout could not preclude contamination of the products. Separation between clean and contaminated parts of the premises were not distinct, in particular between the changing rooms and the production area.

Most of the premises of the establishments visited were in an acceptable state of repair. However, this was not the case for parts of the reception area for raw material in at least two of the establishments. The maintenance of parts of the production area in at least one establishment was not sufficient and in at least two of the establishments some of the doors to the outside were not closing tightly.

Furthermore, in one of these establishments there was not a clear separation between the reception area for raw materials and the area for heading. Additionally, in the latter headed fish was transported outside in containers with lid for further processing in adjoining facilities.

Instead of permanent facilities for storage of final products one establishment used freezer containers placed outside the production facilities. The temperature charts for theses containers were not possible to control and the temperature in the containers could not be verified.

In three establishments a separate area for cleaning of equipment, inter alia, containers used for storage and transport of raw material, was not designated and cleaning of containers was taking place close to the production line, sometimes during processing.

Furthermore, in two establishments the walls of the freezing machinery were not sealed off to the ceiling in the production area. Dust and dirt was observed on top of these mezzanines, which were not easy to clean.

Finally, the inspection team observed that a variable amount of waste and wastewater was accumulating on the floor in the production area in all the establishments visited.

8.11.3 Conditions related to equipment In the establishments visited the instruments and working equipment were corrosion resistant and easy to clean and disinfect. However, in one of the establishments some of the machinery was not well maintained. Furthermore, in three of the establishments several of the conveyer belts were in a pore state of repair. Page 23

One of the establishments used its own truck for transport of both raw material and final products. However, adequate facilities for cleaning and disinfecting the means of transport were not available in the establishment. Moreover, representatives of Fiskistofa informed the inspection team that the competent authorities had not officially authorized other adequate facilities for cleaning and disinfecting means of transport.

8.11.4 Conditions related to hygiene, production and storage In the reception area for raw material in one of the establishments visited the door to the outside was left open during production. In the same area products were kept in brine in containers without lid.

In another of the establishments one large pallet of frozen final products was left outside the establishment. The representative of the establishment informed the inspection team that the products could be kept there for up to thirty minutes.

The inspection team observed that in at least two of the establishments the procedures for staff entering from contaminated to clean parts of the facilities were not always respected.

At the time of the visit to one of the establishments the temperature in the freezer store was observed to be -8 °C. Additionally, the freezer store was used for storage of both exposed and packed products.

In three of the establishments medical certificates were not required upon recruitment, neither for permanent staff nor for seasonal workers. Necessary measures to prevent persons liable to contaminate fishery products from handling such products were insufficient in four of the establishments. However, in one establishment the staff had to issue an own statement and in another establishment health certificates were required although it was not laid down in the own checks system.

In all the establishments samples of drinking water were normally taken once or twice a year. In at least two of the establishments the inspection team was informed that the number of samples taken was based on the requirements in the national legislation, not on an internal evaluation. None of the establishments received on a regular basis information on the quality of the water from the supplier. In one of the establishments the last sample had been positive for E. coli. Corrective action related to both the quality of the water and to the products could be documented.

In two places the inspection team observed filling of ice in plastic tubs under open air and temporary storage of exposed ice in tubs on the quayside. Additionally, tubs were piled on top of each other allowing direct contact between the contaminated outside of the tubs and the ice in the tubs below. Furthermore, the inspection team observed transport of ice from the producer to establishments in tubs under open air without protection from contamination.

In one establishment the inspection team observed storage of raw material in plastic tubs without drainage of melt water. The inspection team was informed that raw material could be kept in a mixture of ice and water for up to two days. In the same establishment the inspection team observed that ice was re-used for products intended for further processing in another establishment. These products were temporarily stored in tubs without drainage Page 24

of melt water. Temporary storage and transport of the products to the other establishment was done in a poorly cleaned container without cooling device.

In two of the establishments the inspection team observed that walls, floors and/or equipment in the production area were hosed with water while exposed products were on the conveyer belts. Additionally, in one of the establishments static water was used for washing of headed fish.

Furthermore, in one establishment mechanically recovered fish flesh was stored in tubs in a cold store overnight and sometimes over the weekend before further processing. Additionally, as no information was available on the tubs, tracing back the products was not possible.

Packaging materials were in at least two establishments stored together with spare parts for the equipment used in production. The rooms for storage of packaging materials were dusty and wrapping and packaging materials were not always sufficiently covered during storage and in one establishment also during transport.

Finally, according to representatives from one of the establishments visited, products received from one auction market were often both insufficiently iced and labelled.

9 Final meeting

A final meeting was held on Wednesday 25 September 2002 with representatives of the Ministry of Fisheries and Fiskistofa. At the meeting the inspection team presented orally the main findings and the conclusions of the mission. The representatives of Fiskistofa agreed to the findings and the conclusions. It was on the contrary clearly stated by the representatives of the Directorate that due to the very short time available, this final meeting could only be viewed as an opertunity for the Authority to read out its findings. No significant discussion could take place and no conclusions could be drawn at the reading of findings by the Authority. At the meeting it was agreed that the remaining information requested by the inspection team during the mission could be forwarded to the Authority before 4 October 2002.

10 Conclusions

10.1 Application of Council Directive 91/492/EEC The relevant provisions of Council Directive 91/492/EEC were not applied on production and harvesting of scallops (Clamys islandica).

10.2 Notification of designation of national reference laboratory according to Commission Decision 93/383/EEC Iceland has not notified the EFTA Surveillance Authority of the designation of the national reference laboratory for monitoring of marine biotoxins as laid down in Article 5a of Commission Decision 93/383/EEC. Page 25

10.3 Designation and notification of national reference laboratory according to Commission Decision 1999/313/EEC Iceland has not designated a national reference laboratory for monitoring of viral and bacteriological contaminations of bivalve molluscs and informed the EFTA Surveillance Authority thereof, as laid down in Article 1 of Commission Decision 1999/313/EC.

10.4 Approval of laboratories Fiskistofa had not approved one of the laboratories visited which was used for analysing samples as required in Article 6 of Council Directive 91/493/EEC and Point IV(3) of Chapter IV of the Annex to Council Directive 91/492/EEC.

10.5 Follow-up of the conclusions of visits by the EFTA Surveillance Authority The follow-up by Fiskistofa of the conclusions of visits by the EFTA Surveillance Authority needs improvements to be in accordance with the requirements of Directive 91/493/EEC and in particular Paragraph 2 of Point 1 of Article 7 thereof since deficiencies reported after a visit in 2000 were still not remedied.

10.6 Follow-up of findings of official inspections Routines for follow-up of findings of official inspections must be improved in order to be in accordance with the requirements of Council Directive 91/493/EEC and in particular Article 7 thereof.

10.7 Public health monitoring of production of molluscs The public health control system for monitoring of production of molluscs was not fully in compliance with the requirements laid down in Chapter VI of the Annex to Council Directive 91/492/EEC, and the system was not formalised.

10.8 Classification of production areas for bivalve molluscs A procedure for classification of production areas complying with the requirements of Council Directive 91/492/EEC, and in particular Article 5(2)(a) and Chapter I of the Annex thereto was not established.

10.9 Evaluation of methods for harvesting, transport and handling of live bivalve molluscs Fiskistofa could not document an evaluation of the harvesting methods, transport and handling of live bivalve molluscs, in order to check if they cause excessive damage to the shells or tissues or result in additional contamination of the product, as referred to in Point 1 and Point 3 of Chapter II, Point 5 of Chapter VI, and Chapter IX of the Annex to Council Directive 91/492/EEC.

10.10 Registration documents Procedures regarding registration documents and/or permanent transport authorisations as laid down in Point 6 of Chapter II of the Annex to Council Directive 91/492/EEC were not established. Page 26

10.11 Health control and monitoring of production conditions The arrangements for health control and monitoring of production conditions, as referred to in Point I of Chapter V of the Annex to Council Directive 91/493/EEC, were not sufficient to document that all the checks had been carried out.

10.12 Health control and monitoring of production conditions Special checks as required in Point II of Chapter V of the Annex to Council Directive 91/493/EEC could not be documented.

10.13 Approval of fishery products establishments The routines for approval of establishments were not always in compliance with the requirements of Council Directive 91/493/EEC and in particular Points 1 and 3 of Article 7, since, inter alia, some of the approval documents did not reflect the establishments compliance with the requirements of the Directive.

10.14 The establishments own-checks system The own-checks systems in the establishments visited were not in compliance with the requirements of Article 6 of Council Directive 91/493/EEC and with Commission Decision 94/356/EEC, since identification of hazards were incomplete or missing in all establishments visited. Furthermore, relevant information such as a description of the products, identification of the intended use of the products, analysis of risks and procedures for corrective action and verification were not always available.

10.15 Training of inspection staff The training of inspection staff of Fiskistofa and of the Inspection Bodies authorized to assess the own-checks system of the establishments needs to be improved in order to assure compliance with the requirement of Article 7 of Commission Decision 94/356/EC. 10.16 Medical certificates Medical certificates of the health status of new employees were not always required contrary to what is laid down in Point II(B)(2) of Chapter III of the Annex to Council Directive 91/493/EEC.

10.17 Documentation of the quality of the water supply The quality of the water supply within the meaning of Council Directive 98/83/EC and as referred to in Chapter III of the Annex to Council Directive 91/493/EEC could not always be assured and documented.

10.18 Size, design and layout of fishery products establishments and auction markets The size, design and/or layout was not always in accordance with the requirements of Council Directive 91/493/EEC, in particular Point I of Chapter III of the Annex, since contamination of the products could not always be precluded and clean and contaminated parts of the buildings could not always be separated. Furthermore, premises such as storage facilities for final products were not always sufficient.

10.19 Maintenance of fishery products establishments and equipment Parts of the premises and parts of the equipment in some of the establishments visited were not in an acceptable state of repair, contrary to what is laid down in Chapter III of the Page 27

Annex of Council Directive 91/493/EEC.

10.20 Production hygiene The production was not always in accordance with the requirements of Council Directive 91/493/EEC, in particular Chapter IV and VIII of the Annex, since products were sometimes stored under conditions not allowing drainage of melt water, re-icing of products not carried out as often as necessary, ice was re-used, mechanically recovered fish flesh not quickly frozen or incorporated in products for freezing, and frozen products not kept at the temperatures required. Furthermore, the production, storage and transport of ice could not always guarantee a quality of the ice within the definitions of Council Directive 98/83/EC.

10.21 Collection of wastewater Collection of wastewater was often not in accordance with the requirements, in particular Chapter III of the Annex of Council Directive 91/493/EEC, since wastewater was not collected around the working machines.

10.22 Collection of waste Waste was not always collected and transported away from the production area on a regular basis in suitable containers as required in Chapter IV of the Annex to Council Directive 91/493/EEC.

10.23 Storage of packaging materials Storage of packaging materials was not always in accordance with the requirements, in particular Point 4 of Chapter VI of the Annex to Council Directive 91/493/EEC, since it was not stored protected from dust and contamination.

11 Recommendations to Iceland

11.1 Notification of corrective action and a plan for completion of measures The Icelandic Authorities should notify to the EFTA Surveillance Authority within two months after receiving the final report, written evidence of the corrective actions taken and a plan for corrective measures and actions, including a timetable for completion of measures still outstanding at that time, relevant to all the conclusions under Chapter 10 of this report.

A particular focus should be put on:

11.2 Council Directive 91/492/EEC Procedures should be established in order to assure that the provisions of Directive 91/492/EEC are also made applicable to all relevant species including production of scallops.

Procedures should be established in order to assure compliance with Directive 91/492/EEC in particular regarding the classification of the production areas and the monitoring of the production. The public health control and monitoring of the production of bivalve molluscs should comprise all the points set out in Chapter VI of the Annex to the Directive including, inter alia, sampling for laboratory tests of end products. Page 28

Procedures to assure traceability of bivalve molluscs throughout the control chain should be established and applied.

Procedures for the evaluation of the methods for harvesting, transport and handling of live bivalve molluscs should be established and applied both during the approval process and during follow-up inspections of approved establishments.

11.3 Competent Authority The process for approval of establishments should be improved in order to assure that only establishments complying with the requirements of Directive 91/492/EEC and Directive 91/493/EEC are approved. The deficiencies observed by the inspection team in the establishments visited and, if necessary, similar deficiencies in other approved establishments should be rectified accordingly.

The procedures for inspections of establishments approved in accordance with Council Directive 91/492/EEC and Council Directive 91/493/EEC should be improved, in particular for the documentation of the content of the official inspections, follow-up of the conclusions following inspections by the Authority, previous inspections by inspectors of the Inspection Bodies and documentation of the results of such inspections.

In the training of inspection staff further emphasis should be put on the own-checks system.

11.4 Laboratories The measures to be put in place related to the application of Directive 91/492/EEC, Directive 91/493/EEC, Decision 93/383/EEC and Decision 1999/313/EC must ensure a proper functioning of the laboratory activity in Iceland, including co-operation with, and follow-up by Fiskistofa.

A national reference laboratory as referred to in Commission Decision 1999/313/EC should be designated. The notification thereof to the Authority should comprise information relevant to Article 2 of the Decision in addition to a list of other national laboratories responsible for the analysis referred to.

Iceland should notify the Authority of the national reference laboratory referred to in Commission Decision 93/383/EEC and the measures adopted in order to assure compliance with the Decision.

Procedures for approval of laboratories carrying out analysis referred to in Council Directive 91/492/EEC and Council Directive 91/493/EEC must be established.