EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL

Directorate F - and Veterinary Office

DG (SANCO)/7335/2004– MR final

FINAL REPORT OF A MISSION

CARRIED OUT IN LITHUANIA

FROM 27 SEPTEMBER TO 1 OCTOBER 2004

IN ORDER TO

ASSESS THE CONTROL MEASURES IN PLACE FOR IMPORT CONTROLS ON PRODUCTS OF PLANT ORIGIN

28/01/05 - 36692

TABLE OF CONTENTS

1. INTRODUCTION...... 5 2. OBJECTIVES OF THE MISSION ...... 5 3. LEGAL BASIS FOR THE MISSION...... 6 4. BACKGROUND...... 6 4.1. Overview of previous missions regarding import controls...... 6 4.2. Background to present mission ...... 6 4.3. Public health information ...... 7 5. MAIN FINDINGS...... 9 5.1. General Observation...... 9 5.2. Legislation ...... 10 5.3. Competent Authorities in charge of the import control system ...... 11 5.4. Statistical information on import controls of relevant products...... 13 5.5. Import Procedures...... 13 5.6. ...... 15 5.7. 3-MCPD ...... 17 5.8. Residues...... 18 5.9. Irradiated ...... 18 5.10. Sudan dyes...... 18 5.11. RASFF Communication ...... 18 5.12. Follow up...... 19 6. CONCLUSIONS...... 19

7. CLOSING MEETING...... 21

8. RECOMMENDATIONS ...... 22

2 EXECUTIVE SUMMARY

The mission was carried out as part of series of missions to major importing Member States to assess controls at import of products of plant origin and compliance with certain Commission Decisions. In pursuit of these objectives the mission team visited the Central Competent Authorities: the State Food and Veterinary Service (SFVS) and the customs authorities. Additionally visits were made to local authorities, to an official control laboratory, one importer of nuts and two authorised points of import.

Although not all relevant legislation was transposed at the time of the mission, the mission team was subsequently informed that all remaining legislation has recently been transposed.

The division of responsibilities between authorities is clear. The competent authorities for the import procedure are the SFVS and the Department of Customs. Communication within the relevant bodies is good. However, communication between customs and SFVS was not seen as enough.

The import procedure demonstrated is well defined, based on a written agreement between the two competent authorities, the SFVS and Department of Customs. At the BIPs a documentary check takes place and then all consignments are supervised by the SFVS inspectors before being released to the market. There is an adequate system in place regarding RASFF.

The Lithuanian authorities perform a level of control in conformance with the frequencies established in Commission Decisions. However, certain deficiencies were noted at the laboratory where no suitable equipment is available to achieve complete homogenisation of the samples for the analysis of . Only one result is provided for each consignment sampled and results are not corrected for recovery. Analysis for mycotoxins, , Sudan I and IV and 3-MCPD are undertaken at the National Veterinary Laboratory in Vilnius. Development of methods for analysis for 3-MCPD and Sudan I and IV is not yet complete and there is not yet capability for analysis of irradiated food.

There are deficiencies in the content of the inspection visits as they basically focus on hygiene prerequisites and autocontrol, in respect of aflatoxins, was not assessed.

In conclusion, there is a clear definition of responsibilities between the competent authorities responsible for import controls of food of plant origin but there is not enough communication between SFVS and customs. Analytical capability in some areas is being developed. The mission team has identified deficiencies in relation to the preparation of the samples for the analysis of aflatoxins and the reporting of results.

Some follow up to recommendations from previous reports was also made by the mission team. Work is in progress to address all the outstanding issues.

The report makes a number of recommendations to the competent authorities to make improvements to the current system.

3 Abbreviations and Special Terms Used In the Report

BIP Border Inspection Post BTSVS Border and Transport State Veterinary Service CSFVS County State Food and Veterinary services DON Deoxynivalenol FAPAS Food Analysis Performance Assessment Scheme FVO Food and Veterinary Office GC/MS Gas Chromatography/ Mass Spectrometry HACCP Hazard Analysis and Critical Control Point HPLC High Performance Liquid Chromatography 3-MCPD 3-Monochloro-1, 2-propandiol MRL Maximum Residue Levels NVL National Veterinary Laboratory OTA Ochratoxin A RASFF Rapid Alert System for Food and Feed SFVS State Food and Veterinary Service SOP Standard Operating Procedure TARIC Tarif Intégré de la Communauté (Integrated tariff of the Community)

4 1. INTRODUCTION

The mission took place in Lithuania from 27 September to 1 October 2004. The mission team comprised 2 inspectors from the Food and Veterinary Office (FVO). This mission was combined with a mission to evaluate the implementation of controls on hygiene of foodstuffs.

The mission was undertaken as part of the FVO's planned mission programme, and in agreement with the State Food and Veterinary Service (SFVS).

The mission team was accompanied during the whole mission by representatives from the central competent authority, the SFVS.

An opening meeting was held on the 27th September 2004 at the premises of the SFVS in the presence of all competent authorities. At the meeting, the itinerary for the mission was finalised and confirmed by the mission team.

2. OBJECTIVES OF THE MISSION

The objectives of the mission were:

-To assess the control measures for imported products of plant origin intended for free circulation within the European Union, in relation specifically to mycotoxins, pesticide residues, irradiated food and 3-MCPD levels and in addition to assess the extent of monitoring of foodstuffs treated with ionising radiation, as required by Directive 1999/2/EC1 of the Parliament and Council.

-To monitor compliance with Commission Decisions imposing special conditions on the import of certain products concerning contamination and for the presence of sudan dye in chilli products.

-Additionally, the team followed up on action taken by the competent authorities in relation to recommendations made in last visit within the scope of this mission, in particular report number 9248/2003 from 15 to 19 September 2003.

In pursuit of these objectives, the visits were carried out in accordance with the itinerary agreed between the SFVS and the FVO and were as follows:

1 OJ L 66 of 13 March 1999, p. 16

5 COMPETENT AUTHORITY VISITS Comments Competent authority Central 2 Meeting at the SFVS in the presence of representatives of the National Veterinary Laboratory, National Nutrition Centre, Ministry of Health, Ministry of Agriculture and Customs Local/Port 2 Border Inspection Posts at Medininkai and Malku ilankos

Regional 2 Vilnius City and Klapeida City State Food and Veterinary Service LABORATORY VISITS Comments Official Control Laboratory 1 National Veterinary Laboratory PREMISES VISITS Comments Processing Premises 1 Importer and packager of nuts in Vilnius (50 FTE employees)

3. LEGAL BASIS FOR THE MISSION

The mission was carried out under the general provisions of Community legislation, (the Treaty of the European Community, in particular Articles 10, 152,153 and 211) and other general provisions of Community legislation, specifically:

- Council Directive 89/397/EEC2 of 14 June 1989 on the official control of foodstuffs,

- Council Directive 93/99/EEC3 of 29 October 1993 on additional measures concerning the official control of foodstuffs.

4. BACKGROUND

4.1. Overview of previous missions regarding import controls.

This report is the 14th in a series of missions to Member States with similar objectives. The final reports of these missions are or will be available on the DG Health and Consumer Protection Internet site:

(http://europa.eu.int/comm/food/fs/inspections/fnaoi/reports/contaminants/index_en. html)

This is the first FVO mission concerning import controls on products of plant origin since the accession of Lithuania to the EU. Prior to accession the FVO carried out a number of missions in the framework of the accession preparations, in order to assist and monitor progress with the adoption of the relevant EU legislation.

4.2. Background to present mission

There have been an increasing number of rapid alert messages notified in the Rapid Alert System for Food and Feed (RASFF) within the European Union related to products containing mycotoxins, pesticide residues and 3-MCPD.

2 OJ L 186 of 30 June 1989, p. 23 3 OJ L 290 of 24 November 1993, p. 14 6 In 2003 there were over 500 RASFF messages for mycotoxins. In 2002 there were over 250 RASFF messages for mycotoxins, and in 2001 a total of 186. Implicated products included peanuts and peanut products, pistachios, hazelnuts, Brazil nuts, almonds, dried fruits (figs, apricots), spices, coffee products and cereals.

As well as a general obligation for Member States to undertake random analysis of products, there are specific conditions imposed in Commission Decisions over products from certain third countries where the risk is considered greater. These specific conditions relate to mycotoxin contamination. There is an additional Commission Decision imposing conditions over the import of hot chilli and chilli products following the presence of the unauthorised colorant sudan I-IV.

In 1999 the Commission received the first notification of excessive levels of 3- MCPD in soy sauce imported from third countries, particularly Asia. This was followed by a large number of alerts in 2000, 15 in 2001, 10 in 2002 and 20 in 2003.

There are only a small number of rapid alerts related to pesticide residues in products imported to the Community, predominately in dried products such as teas and herbs. However the extent of monitoring of these products is unknown, and there are very large quantities of these products entering through European ports.

At present the import of irradiated foodstuffs into the EU is only allowed from five irradiation plants approved for export to the EU in the context of Directive 1999/2/EC. The level of imported products is not known.

Between the adoption of the Commission Decision on sudan I in June 2003 and the date of the mission, there had been over 200 alerts and additional information notifications pertaining to the finding of sudan dyes in a wide range of products.

4.3. Public health information

Mycotoxins

Mycotoxins are naturally occurring metabolites produced by certain species of moulds (e.g. Aspergillus spp, Fusarium spp) which develop at high temperatures and humidity levels and may be present in a large number of foods. This group of includes a number of compounds of varying toxicity and frequency in food. The mould may occur on the growing crop or after harvesting during storage or processing. Whilst the moulds can be considered plant infection the ingestion of the can result in disease in animals or humans. Some of the mycotoxins are known to be carcinogenic.

In addition sampling plays a crucial part in the precision of the determination of the levels of mycotoxins, which are very heterogeneously distributed in a consignment. Therefore, in Commission Directives, a sampling procedure and general criteria were fixed to ensure that laboratories in charge of the analysis use methods of analysis with comparable levels of performance.

7 3-MCPD

3-MCPD is one of a group of chemical contaminants known as chloropropanols. It is known to be carcinogenic in animals at relatively low levels.

For safety reasons it is recommended that 3-MCPD should be limited in foods to ensure that this threshold of intake is not exceeded and furthermore be limited to levels which are as low as reasonably achievable (ALARA).

3-MCPD is a contaminant, which is known to be formed during the industrial processing of foodstuffs, in particular during the acid hydrolysis of vegetable protein (to produce acid-HVP) using concentrated hydrochloric acid. The contaminant was originally identified in acid-HVP; which is used as an ingredient to flavour savoury products such as soups, stock cubes, snacks and sauces. It was then identified in soy sauce and similar savoury sauces that are produced with the addition of HVP as a flavour enhancer to shorten the traditional fermentation process: “compound” sauces. Particular problems were identified in imported sauces from a number of Asian countries, including China, Hong Kong, Vietnam and Thailand.

The maximum level for 3-MCPD in soy sauce is established in Commission Regulation (EC) No 466/20014, as 0.02 mg/kg. Sampling methods and methods of analysis are established in Commission Directive 2001/22/EC5.

Pesticides

A pesticide is any substance intended to be active in the control or elimination of pests, which are all organisms affecting plant health, including competitive weeds. The term also sees wider use and incorporates plant growth regulators. Their use generally may result in the presence of residues in the crop or subsequently produced products.

To limit this risk of food being contaminated a number of MRL (Maximum Residue Levels) are established in European legislation. More than 17000 of these levels have been established in various commodities for a total of 133 pesticide active substances. In addition where there is no harmonised Community MRL, Member States may set MRL at a national level to protect consumer’s health.

Member States must establish national monitoring programmes to ensure that food conforms to these MRL. In addition to these national programmes co-ordinated European monitoring has been established. The results of the co-ordinated programme are available on the Directorate-General Health and Consumer Protection Internet site:

http://europa.eu.int/comm/food/fs/inspections/fnaoi/reports/annual_eu/index_en.html

4 OJ L 77 of 16 March 2001, p. 1 5 OJ L 77 of 16 March 2001, p. 14 8 Irradiation

Directive 1999/2/EC of the European Parliament and Council lays down the conditions applicable to the imports of foodstuffs treated with ionising radiation from a third country. It requires the facility irradiating such products to be approved by the Community and to appear on an official list. There are currently five Community approved premises in third countries.

The Directive also requires Member States to report yearly to the Commission results of controls carried out in their approved irradiation facilities (for list of approved facilities in the Member States see OJ, C 38/17, 12.2.2002) and at the product marketing stage. On the basis of this information, the Commission has to publish a report in the Official Journal. The first report covering the period of 20.9.2000 to 31.12.2001 was published in the Official Journal of the European Communities on the 23rd October 2002.6

Sudan dyes

Sudan I-IV is a dye not authorised for food use by Council Directive 94/36/EC7 on colours for use in foodstuffs, and a suspected genotoxic . In May 2003 notification was received from France of the colorant in imported chilli products indicating adulteration that could constitute a serious health risk. This resulted in Commission Decision 2003/460/EC8 in June 2003 requiring all consignments of chilli to be received with an analysis certificate demonstrating the absence of Sudan I.

This Decision was then updated by Commission Decision 2004/92/EC9. The original measures were extended to curry powder and to additional controls on Sudan II, III and IV.

Member States are required to check consignments of chilli and chilli products presented for importation. Such consignments must be accompanied by an analytical report demonstrating the absence of Sudan I-IV. Where such reports are not available, Member States must detain the consignment. They shall also include random sampling and analysis of these products, for importation or already on the market, in order to verify the absence of the chemical substances mentioned.

5. MAIN FINDINGS

5.1. General Observation

Lithuania has physical external borders with Russian Federation (Kaliningrad) and Belarus and internal borders with Poland and Latvia.

6 OJ C 255 of 23 of October 2002, p. 2 7 OJ L 237 of 10 September 1994, p. 13 8 OJ L 154 of 21 June 2003, p. 114 9 OJ L 27 of 30 January 2004, p. 52 9 For the purpose of import of products of plant origin for which Commissions Decision on special conditions on the import applies, the competent authorities have nominated 12 Border Inspection Posts (BIPs). They include 5 road, 3 seaport, 1 airport and 3 railway crossings, as established by Commission Decision 2004/428/EC10.

5.2. Legislation

Legislation within the context of this mission is drafted by the Ministry of Health.

At the time of the mission, Commission Directives 2003/121/EC11 and 2004/43/EC12 amending Directive 98/53/EC13 laying down sampling methods and the methods of analysis for the official control of the levels for certain contaminants in foodstuffs, had not been transposed. This was also the case for the sampling Directive for patulin (Commission Directive 2003/78/EC14) and tin (Commission Directive 2004/16/EC15). However, after the mission the Lithuanian authorities informed the mission team that all of them have recently been transposed by Order No.V-706 amending Order No. V-778 of the Ministry of Health approving sampling and analysis methods for determining levels of contaminants in food products. A copy of this legislation was provided but complete compatibility was not checked.

All relevant Commission Decisions must be applicable from the date of publication in the Official Journal. However, the Lithuanian legal system requires their incorporation into national legislation to be enforced. This didn’t create a significant delay for their practical application.

All Commission Decisions within the scope of the mission (imposing special conditions on the import of certain products from China, Egypt, Turkey, Brazil and Iran and also on emergency measures regarding chilli and chilli products), were transposed on 7 May of 2004.

10 OJ L 154 of 30 April 2004, p. 13 11 OJ L 332 of 19 December 2003, p. 38 12 OJ L 113 of 20 April 2004, p. 14 13 OJ L 201 of 17 July 1998, p. 93 14 OJ L 203 of 12 August 2003, p. 40 15 OJ L 42 of 13 February 2004, p. 16 10 5.3. Competent Authorities in charge of the import control system

The structure of relevant competent authorities is summarised in the following table.

Levels

Central Regional Local Competencies

Institutions

State Food Policy and Communication with external Veterinary bodies Service RASFF contact point Operation of laboratories

County and Development of inspection Cities State programmes Food and Veterinary services

District State Implementation of programmes Food and through inspection on the market Veterinary and at points of import. services

Ministry of National Drafting food legislation Health Nutrition Centre

Ministry of Department of 10 regional Application of customs law at Finance Customs offices points of import.

5.3.1. State Food and Veterinary Service

The main competent authority for import controls of products of plant origin is the State Food and Veterinary Service (SFVS). It is under the direct control of the government and the director reports directly to the prime minister.

The SFVS is the sole institution responsible for food control in Lithuania and for developing policy, enforcement and communicating with international bodies and also the Commission.

Within the central administration of the SFVS (headquarters) there are 7 departments, the Food Department and the Risk and Quality Management Department being the most relevant to the scope of this mission. The food inspection activities are under the Food Department and the Risk and Quality Management Department is responsible for risk assessment and for the management of the Rapid Alert System for Food and Feed (RASFF).

11 The central administration of the SFVS is organised in 5 subordinate institutions: State Inspection of Veterinary Preparations, Food and Veterinary Audit Service, National Veterinary Laboratory (NVL), Border and Transport State Veterinary Service (BTSVS) and the County State Food and Veterinary services (CSFVS).

The subordinate institutions of direct relevance are the NVL, the BTSVS, and the CSFVS.

The BTSVS is in charge of the management of the 12 Border Inspection Posts (BIPs) ensuring that all foodstuffs coming from third countries are checked according to the procedure for the control of the safety and quality of non-animal origin foods imported into Lithuania (Order No.B1-411 of 30 April 2004).

The NVL is responsible for carrying out foodstuff analysis. Its involvement and functions are described in chapter 5.6.2.

Lithuania is divided by 10 counties and 4 cities and the counties are also divided by 34 districts. The CSFVS covers from three to six districts or cities. They are responsible for the co-ordination and analysis performed by the districts in their area of competence. The cities are at the same level as the counties.

The District and the City SFVS, which employ together 182 inspectors, implement the inspection programmes and are responsible for the regular control of relevant foodstuffs.

5.3.2. Ministry of Health

The National Nutritional Centre of the Department of Health is responsible for drafting legislation.

5.3.3. Ministry of Finance- Department of Customs

The Department of Customs is subordinate to the Ministry of Finance. It is divided into 10 regional customs offices and is responsible for applying the customs procedures for imported goods. They decide which goods require further checks at BIPs before they could be cleared to the market and they also have the final responsibility of the products detained by the local inspectors (from the City or District SFVS).

Communication

In general, there is good communication between the services of the SFVS. Communication is mainly via electronic mail and there are also periodical meetings and working groups with the participation of all levels of responsibility. All SFVS officers have access to an intranet including legislation and RASFF information.

Communication between customs and the BIPs takes place basically by means of documents. The local inspectors have also contact with customs in relation to the detained consignments before releasing them onto the market. However, no further communication exists and there is no connection between the database systems of the two organisations.

12 5.4. Statistical information on import controls of relevant products

The pre-mission questionnaire contained some statistical information on the volumes of imported products. More data was provided during the mission. The mission team was informed by the competent authorities that the sources of the data are the BIPs. In both cases, there were discrepancies between the data provided by Lithuanian authorities and the data available from Eurostat, (see below). This aspect was communicated to the competent authorities during the mission, but no explanation or reason was given to the mission team. However, the SFVS expressed their concern and the intention to find a solution.

In general the imported volumes of products subject to special import conditions were low. Figures indicated that no increase in volumes of the listed food commodities in the few months prior accession could be identified.

Product (Tonnes) 2002 2003 2004 (January to July)

Hazelnuts-Turkey 700 573 306

Pistachios-Iran 551 981 186

Peanuts-China 3041 3315 1153

(Source: information from Eurostat)

Product (Tonnes) 2002 2003 2004 (January to July)

Hazelnuts-Turkey 287 340 440

Pistachios-Iran 155 112 312

Peanuts-China 1965 1831 5564

(Source: information from Lithuanian authorities)

No chilli powder and related products (TARIC code 0904209000) or soy sauce and related sauces (TARIC code 21031000) have been imported after accession.

The competent authority was not able to inform the mission team about imports for irradiated products.

5.5. Import Procedures

The control of imported non-animal food from third countries is carried out in accordance with Order No. B1-411. The competencies for import products are established in Order No. 1253 of 9 of October of 2003.

After arrival, consignments of food of non-animal origin are first checked by customs. Submission of associated documents (in voices and quality certificates) takes place and they decide if the consignment needs to be sent to the BIP for further checks.

13 This decision is made according to the list of products annexed to the Order No. B1- 411. This list contains the name and code of the products that require authorisation of the BIP authorities prior being released.

At the BIPs the inspectors undertake a documentary check and systematically stamp the documents indicating that the sale is prohibited without the authorisation of the food control authority. Only when the commodity is specified in the list of sensitive foods approved by Order No.V-259 of 22 April 2004, information related to the consignment (BIP of origin, code of importer, date of entry and destination) is entered in a computer database (intranet). On the basis of this information the inspectors decide which consignments need to be checked.

The list of sensitive foods includes 25 different commodities. They are identified by name and by TARIC code and there is also indication of the hazard associated to each commodity.

After the documentary checks at BIPs, an authorisation is given by customs and the product is stored in the customs or importer warehouses until the local food inspectors from SFVS examine the consignment and make a decision on the acceptance of the product.

The information regarding imported consignments is checked twice a day by inspectors to see how many consignments they need to control and where they are located. With that information, and after a special requirement by the importer, the local inspectors perform always a documentary and a physical check of all imported consignments.

As a general rule, a sampling analysis takes place in 10% of the imported consignments unless specific Commissions Decisions indicate a higher frequency of control. The inspector decides if samples are necessary or the product can be released for free circulation. A draft guidance document was shown to the mission team on quality procedures on duties and responsibilities of the SFVS inspectors concerning sampling on imported products.

All SFVS inspectors receive updated information of RASFF notifications from the Risk and Quality Management Department from the SFVS.

Pending the availability of analytical results, the product is detained in customs or importers warehouses under customs responsibility and under SFVS local inspector’s supervision.

Once analysed, the inspectors subsequently inform the importers and customs of the result. The product is released or, in case of non- conforming products, the importer decides on the alternative course of action.

Importers are given 10 days to make a decision about the final destination of the consignment. Documents showing effective re-export to the country of origin were shown to the mission team.

The mission team was informed that importers have a legal right to request a second instance analysis, but the appeal procedure has not been used in Lithuania to date.

14 5.6. Mycotoxins

5.6.1. Sampling and Import Procedures

The mission team was unable to observe a sampling procedure of imported products in practice as none arrived during the mission, but a simulation was organised. The observed procedure was as follows:

Documentation including certificates from the country of origin is checked by the city SFVS inspector.

A decision as to whether to sample is made on the basis of the frequency dictated by Commission Decisions and additional criteria such as the RASFF information received by mail from the FSVS. The figures can be seen in the table under section 5.6.3.

Where sampling is deemed necessary the container is fully unloaded at a commercial warehouse under customs’ supervision.

The distribution of the sampling is not calculated in accordance with the guidance established in Commission Directive 98/53/EC.

Samples were taken from varying places of the sacks using metal sampling tools. Each incremental sample of approximately 300g is placed into a bag and weighed. Then the aggregate sample of 30 Kg is made up by uniting and mixing these samples. The content of the aggregate sample is mixed by hand to create a homogenous sample. The 30Kg sample is then sealed and submitted with relevant documentation to the laboratory.

Several certificates of products from third countries were shown to the mission team and in one case a consignment was accepted without an appropriate health certificate. The consignment was sampled and analysed for aflatoxins and found not in conformance with the maximum levels established by Commission Regulation 466/2001/EC. The consignment was re-exported to the country of origin and the case was communicated to the European Commission via RASFF.

5.6.2. Laboratory Performance

Most of the analyses are undertaken in the National Veterinary Laboratory (NVL) located in Vilnius. It employs 120 staff. The department of chemistry analyses all relevant foodstuffs samples.

The laboratory is accredited to ISO 17025 by the German accreditation body DAP (Deutsches Akkreditierungssstem Prüfwesen GmbH) for a list of 13 analytical methods for pesticides and mycotoxin determination.

Currently 3 other branches of this laboratory are established in the country performing foodstuff analysis without accreditation. However, it is planned to achieve accreditation in 2005 and to continue the re-structuring of foodstuffs laboratories.

The laboratory undertakes routine analysis for a range of mycotoxins, including determination of aflatoxins by Enzyme Linked Immunosorbent Assay (ELISA).

15 Immuno ferment assay is used for the determination of other mycotoxins (OTA, zearalenone and deoxynivalenol in grain and also patulin in juice).

Determination of Sudan I and IV in Spices using HPLC and determination of 3- MCPD in soy sauce using Gas Chromatography/Mass Spectometry (GC/MS), were described as in process of validation and preparation for accreditation.

Samples of generally 30 Kg are received from the inspectors of SFVS, in opaque bags but this sample is not divided in 3 subsamples of 10 Kg in the laboratory, as required in Commission Directive 98/53/EC.

A lack of adequate grinding equipment to achieve complete homogenisation of the 10kg subsample was noted by the mission team. In addition, for each sample analysed, only one result is provided instead of three. The results are not corrected for recovery or analytical uncertainty, and this uncertainty is not stated in the result. Some analyses reports were examined and in some cases the result is given only for total aflatoxins. There is no SOP available for sample preparation.

The results of the samples are sent directly to the inspectors. In the case of non conformities they are also sent to the Food Department and the Risk and Quality Management Department. Traceability was demonstrated for the sample examined during the visit. Participation in international proficiency tests FAPAS was noted, and results examined from July 2004 for analysis indicated good performance.

5.6.3. Action in the event of non-compliance

The following figures for imports and samples were provided for 2004:

Commodity Origin No. Samples Non Consignments (frequency of Conformance sampling)

Pistachios Iran 4 4 (100) 1

Peanuts Egypt 1 1 (100) -

Peanuts China 16 3 (18.7) -

Hazelnuts Turkey 7 2 (28.6) -

(Source: SFVS)

The usual action for products contaminated by mycotoxins is the rejection of the consignment. The importer has 10 days to decide the final destination of the product. This 10 days period and the destination of the product are under SFVS supervision. Documents showing effective re-export to the country of origin were shown to the mission team.

No situation was identified of non-compliant foods of plant origin being diverted to animal feed.

16 5.6.4. Control at visited premises

The mission team visited one establishment where the sampling simulation took place as explained in chapter 5.6.1.

The company is specialised in import, export, distribution and packaging of nuts, (pistachios, peanuts, hazelnuts, almonds and cashews), dried fruits, and edible seeds. They import nuts from third countries. Approximately 50 employees are working in this company.

In addition to the controls by the competent authorities, the company undertakes sampling and analysis of imported products. This includes aflatoxin analysis at a private laboratory.

City SFVS inspectors visit the premises once or twice a year and sampling is carried out by two inspectors that come to the establishment when consignments arrive.

The inspection covers generally a range of hygiene pre-requisites and incoming documents are also checked. The company had implemented procedures based on HACCP principles but these were not assessed by the inspector.

Last August a consignment of pistachios from Iran arrived at the visited premises via Germany and was sampled by the inspectors on the 19th of the same month. The analytical results, which were issued on the 25th, were not in compliance with the legal requirements and the 26th a communication was sent to the company. The company had 10 days to decide the destination of the consignment and they decided to send it back to origin. On the same date the notification was sent to the European Commission through the RASFF network by the SFVS.

5.7. 3-MCPD

5.7.1. Sampling and Import Procedures

Imports on soy sauce and related sauces (TARIC code 21031000) do not occur in Lithuania and the control for 3-MCPD takes place on the marketplace. According to the Lithuanian food contamination monitoring programme for 2004, 3 samples of soy sauce are foreseen. One sample has been unfavourable up to the time of the mission.

5.7.2. Laboratory Performance

The analyses for 3-MCPD are undertaken by the NVL. The method used is GC/MS for which validation is on-going.

5.7.3. Action in the event of non-compliance

In cases of non-compliance the products are withdrawn from sale and destroyed.

17 5.8. Pesticide Residues

The Order of the Minister of Health No. 773 of 24 December 2003 (HN 54:2003) which transposes relevant EU Directives concerning MRLs of pesticides in foodstuffs of plant origin, including the most recent amendments, was published on 26 March of 2004.

Competence at the point of import for pesticide residue control is also with SFVS. Controls of products that are imported from third countries are undertaken at wholesale centres by the SFVS inspectors.

In the monitoring plan for food contamination for 2004 it is planned to test 266 samples for Pesticides from both domestic and imported foodstuffs. Up to now 230 samples have been analysed with no unfavourable results.

The NVL has validated methods for the detection of 91 pesticides in foodstuffs of plant origin. Work is in progress in this area.

5.9. Irradiated Foods

5.9.1. Sampling and Import Procedures

The competent authority for imports of foodstuffs exposed to ionising irradiation, for import is the SFVS. There are at present no controls at import but it is planned to start the sampling for such products by the end of this year.

The mission team was informed that the SFVS inspectors performed inspections in 380 establishments selling aromatic herbs, spices and flavourings and did not find any product identified as treated with ionising irradiation.

5.9.2. Laboratory Performance

The responsible laboratory will be the NVL. Methods for the analysis of irradiated foodstuffs using Direct Epifluorescent Filter Tecnique (DEFT) and Aerobic Plate Count (APC) were introduced last July and are being developed at present. It is foreseen to be accredited at the end of this year.

5.10. Sudan dyes

No chilli or chilli products have been imported into Lithuania after accession. However market checks have taken place. 11 Samples were analysed and 4 of these have been found containing Sudan I and IV.

In cases of non-compliance the products are withdrawn from sale and destroyed.

Analysis is undertaken at the NVL. The method used is HPLC which currently is in the process of validation and preparation for accreditation.

5.11. RASFF Communication

The Department of Risk and Quality Management within the SFVS is the national contact point for RASFF notifications.

18 The operation of the RASFF is based on Resolution No. 439 of 2 April 2002 of the Government of the Republic of Lithuania approving the procedure for the application of measures to restrict products from being placed on the market.

The department of Risk and Quality management assess and selects notifications received from the European Commission and also from county and city offices. Information is in general processed by means of e-mail and/or fax transmissions.

Twice a week all services involved receive updated information of relevant notifications within the scope of the mission. This information is taken into account when a decision on sampling is made.

The mission team examined two files and the SFVS adequately demonstrated the traceability of a rejected consignment to the notified RASFF message in an acceptable time-frame.

5.12. Follow up

The mission team followed up a number of issues related to missions conducted as part of the accession process. Following these missions, recommendations were made with regard to, amongst other things, the transposition of certain legislation, uptake of autocontrol systems based on HACCP, inspection frequencies, development of RASFF network, GMOs controls. Response to the outstanding issues was handed to the mission team which shows that work is in progress to address all these issues.

6. CONCLUSIONS 6.1. Legislation

At the moment of the mission, legislation on sampling for tin and patulin was identified as not being transposed and also the two last amendments of the Directive 98/53/EC. However, the mission team was informed after the mission that all remaining legislation had been transposed.

Commission Decisions need to be transposed into Lithuanian legislation to be enforced but no significant delay was identified.

6.2. Competent Authorities in charge of the import control system

The competent authorities are well defined and the division of responsibilities is well delineated. The FSVS is responsible for the enforcement while the MH is responsible for producing legislation.

Adequate communication pathways are established within the SFVS. The mission team has identified a lack of effective communication between SFVS and Customs Department.

6.3. Statistical information on import controls of relevant products

Problems in data collection were identified. Data of imports provided by the competent authority are not compatible with Eurostat data.

19 Volumes of products entering are relatively low. No increase has been noted immediately prior to accession in May 2004 (according Eurostat).

6.4. Import Control Procedures

Import controls are carried out in accordance a clear procedure described in Order No. B1-411 of 30 April 2004.

6.5. Mycotoxins

6.5.1. Sampling and Import Procedures

The mission team saw a sampling procedure and was considered as adequate except for the distribution of the sampling frequency that was not calculated according the guidance established in section 4.1 of the Annex I of the Directive 98/53/EC.

The frequency of sampling was in compliance with the frequency set out in relevant Commission Decisions.

6.5.2. Laboratory Performance

Analyses within the scope of this mission are undertaken at the NVL in Vilnius. It is accredited to ISO 17025 for an acceptable range of methods.

Reliability of analytical results is compromised because no adequate equipment for grinding the samples and achieving complete homogenisation is available as required by Commission Directive 98/53/EC.

There is no SOP available for sample preparation.

Results are not corrected for recovery and uncertainty, and the rate is not reported on the analytical report.

6.5.3. Action in the event of non-compliance

The SFVS adequately supervises non-complying lots.

6.5.4. Control at visited premises

The establishment visited was inspected in accordance with the established frequency by the inspector. The inspection was focused on hygiene prerequisites and the assessment of the potential food hazard associated with the business was not performed as required in article 8.2 of Commission Directive 93/43/CE.

6.6. 3-MCPD

Control is undertaken on the marketplace as direct imports do not occur. 3 samples were taken this year with one non-favourable result. Method validation is ongoing.

6.7. Pesticide Residues

Control on imported products takes place at import and on the marketplace. 20 6.8. Irradiated Foods

There are currently no controls at import and no validated analytical method but it is foreseen to start before the end of the year.

6.9. Sudan I-IV

No chilli or chilli products have been directly imported into Lithuania. 11 Samples have been taken at market place with 4 unfavourable results. The analytical method for the analysis of Sudan I-IV is not fully validated.

6.10. RASFF Communications

The RASFF communication system was demonstrated as effective, using given examples.

6.11. Follow up

The mission team received information in relation to actions undertaken in response to recommendations made in previous reports, which demonstrated that work is in progress to address all the outstanding issues.

6.12. Overall Conclusion

There is a clear definition of responsibilities between the competent authorities responsible for import controls of food of plant origin and the control procedure for importing food is well defined but there is not enough communication between SFVS and customs. Analytical capability in some areas is still developing. The mission team identified deficiencies regarding the preparation of the samples for the analysis of aflatoxins and the reporting of the results.

7. CLOSING MEETING

A closing meeting was held on the 1st October with representatives of the competent authorities. The main observations and initial conclusions of the mission were presented by the mission team. The representatives of the competent authorities accepted the specific observations and initial conclusions presented during that meeting with no comments.

21 8. RECOMMENDATIONS

8.1. To the Competent Authorities of Lithuania

The competent authorities of Lithuania should address the conclusion stated above in section 6, in order to improve the official control system of imported foodstuffs, and in particular:

1. Ensure that sample preparation for the analysis of aflatoxins complies with Commission Directive 98/53/EC.

2. Ensure inspection of premises handling at risk products are carried out to assess potential food hazards associated with the business, specifically controls on aflatoxins.

3. Proceed towards full validation of analytical methods for irradiated foods, sudan dyes, 3-MCPD and mycotoxins.

4. Ensure that analytical results are reported adjusted for recovery/uncertainty or stating the rate of recovery and uncertainty.

5. Include controls of imported products being exposed to ionising irradiation.

Written assurances should be forwarded to the European Commission with regard to the above recommendations within two months of receipt of the final translated mission report. The Competent Authority should provide detailed information on the actions that will be taken and propose deadlines by which these actions will be completed.

ADDENDUM

In their response to the draft report, the Lithuanian CA did not submit any comments, and actions to be taken in response to the recommendations made in the report were not indicated yet.

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