EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL

Transcription

1 EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office DG(SANCO)/9141/2003 MR Final FINAL REPORT OF A MISSION CARRIED OUT IN AUSTRIA FROM 23/06/03 TO 26/06/03 IN ORDER TO EVALUATE OFFICIAL CONTROL SYSTEMS ON FOODS CONSISTING OF OR PRODUCED FROM GENETICALLY MODIFIED ORGANISMS (GMO). Please note that factual errors in the draft report have been corrected in bold, italic type. Clarifications provided by the Austrian authorities are given as footnotes, in bold, italic, type, to the relevant part of the report. 23/10/

2 TABLE OF CONTENTS 1. INTRODUCTION OBJECTIVES OF THE MISSION LEGAL BASIS FOR THE MISSION BACKGROUND MAIN FINDINGS Legislation Competent authorities Pre-marketing assessment of GMO food Controls of GMO food Deliberate release of GMO Controls of GMO foods Activities carried out by BMGF Activities carried out by the Länder food inspection services Activities carried out at the Border Inspection Posts (BIP) Laboratories Institute for Food Analysis and Quality Control in Kärnten Institute for Food Control Vienna CONCLUSIONS Legislation Competent authorities Controls of GMO food Laboratories CLOSING MEETING RECOMMENDATIONS...18 To the competent authorities of Austria ADDENDUM

3 Executive Summary GMO food control activities in Austria are well established, particularly in the light of Austria being a significant producer of organic food products. The Federal Ministry for Health and Women (BMGF) is the central competent authority in Austria with competence for drafting legislation for GMO food control. They are also responsible for planning of inspection and sampling activities in cooperation with the food inspection services of the regions. The regional authorities are responsible for the enforcement of Austrian food law. The Austrian Food Safety Agency is responsible for novel food assessment before marketing. The agency incorporates 5 Institutes for Food Control, which are concerned with GMO food analysis. The BMGF is the competent authority in the area of deliberate release of GMO in the environment (Directive 2001/18/EC). Austria has several national provisions on GMO foods in addition to EU legislation. They include GMO free labelling and a threshold of 0.1% GMO traces for organic food products. Directive 2001/18/EC has not yet been transposed but the Austrian Gene Technology Act is being revised to incorporate its requirements. Food inspectors from the regional food inspection services carry out inspection and sampling activities for GMO food control. Targeted action plans are produced every year by the BMGF in co-operation with the regional authorities for GMO food control, in addition the BMGF circulate instructions. There is regular contact between the BMGF and the regional services. The food control inspectors have regular informal contact with laboratory staff with regard to sampling instructions and follow up activities. The mission team participated in an inspection visit of an organic soya product company. The laboratories visited are accredited according to ISO The regional laboratories carry out screening methods to identify the presence of GMO in food. The Institute of Food Control Vienna is competent to carry out quantification of GMO in a range of food matrices. 3

4 ABBREVIATIONS & SPECIAL TERMS USED IN THE REPORT AGES BIP Austrian Agency for Health and Food Safety (Österreichische Agentur für Gesundheit und Ernährungssicherheit) Border Inspection Post BMBWK Federal Ministry for Education, Science and Culture (Bundesministerium für Bildung, Wissenschaft und Kultur) BMLFUW BMGF BGBI DNA EU FVO GM GMO HACCP IRMM MS PCR Federal Ministry for Agriculture, Forestry Environment and Water Management (Bundesministerium für Land- und Forstwirtschaft, Umwelt und Wasserwirtschaft) Federal Ministry for Health and Women (Bundesministerium für Gesundheit und Frauen) Austrian Official Gazette (Bundesgesettesblatt) Deoxyribonucleic acid European Union Food and Veterinary Office Genetically Modified Genetically Modified Organism(s) Hazard analysis and critical control points Institute for Reference Materials and Measurements Member State Polymerase Chain Reaction 4

5 1. INTRODUCTION The mission took place in Austria from 23/06/03 to 26/06/03. The mission team comprised 2 inspectors from the Food and Veterinary Office (FVO), and 1 Member State expert. The mission was undertaken as part of the FVO's planned mission programme. The inspection team was accompanied during the whole mission by a representative from the central competent authority, the Austrian Federal Ministry for Health and Women (BMGF). An opening meeting was held on 23 June 2003 with the representatives of the BMGF, the Ministry of Agriculture, Forestry, Environment and Water Management (BMLFUW), the Austrian Agency for Health and Food Safety (AGES), and representatives of the laboratories and regions to be visited. At this meeting, the inspection team confirmed the objectives of the mission and the itinerary was confirmed. 2. OBJECTIVES OF THE MISSION The objective of the mission was to evaluate the official control systems for foods containing, consisting of or produced from genetically modified organisms (GMO foods). The scope of the mission covered Regulation (EC) 258/97 1 on novel foods and novel foods Ingredients, that defines the framework for safety and pre-marketing approval of novel foods, including all foods containing, consisting or produced from GMO. This regulation also provides that certain GMO-derived foods and ingredients should be specifically labelled for consumer s information. The scope of the mission also covered the labelling requirements of foodstuffs derived from two GMO (one soya bean and one maize) authorised in the Community prior to the entry into force of the Regulation (EC) 258/97. Labelling requirements for these products were introduced by Council Regulation (EC) 1139/98 2. This Regulation has been amended by Commission Regulation (EC) 49/ introducing a tolerance threshold of 1% for the adventitious presence of authorised GMO materials. The labelling applies to products destined as such to the final consumer or mass caterers. Labelling of foodstuffs and ingredients containing 1 Regulation (EC) No. 258/97of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (OJ L 43, , p.1) 2 Council Regulation (EC) No. 1139/98 of 26 May 1998 concerning the compulsory indication of the labelling of certain foodstuffs produced from genetically modified organisms of particulars other than those provided for in Directive 79/112/EEC (OJ L 159, , p.4) 3 Commission Regulation (EC) No. 49/2000 of 10 January 2000 amending the above mentioned Council Regulation (EC)1139/98 (OJ L 6, , p.13) 5

6 additives or flavourings derived from GMO is required under the Commission Regulation (EC) 50/ This was the first mission undertaken to Austria for this purpose. It formed part of a wider series of missions to Member States evaluating control systems and operational standards in this sector. In pursuit of this objective, the following sites were visited and meetings took place: MEETING WITH NATIONAL COMPETENT AUTHORITIES Federal Ministry for Health and Women Comments Responsible for drafting legislation. Competent authority for deliberate release into the environment of GMO. Austrian Agency for Health and Food Safety Responsible for novel food assessment before marketing. Combines the laboratories for food safety including GMO food analysis. MEETING WITH REGIONAL COMPETENT AUTHORITIES Food control inspection service Kärnten Food control inspection service Niederösterreich Comments Responsible for Food Act implementation and control of GMO food. Responsible for Food Act implementation and control of GMO food LABORATORY VISITS Institute for Food Analysis and Quality Control in Kärnten (regional laboratory) Institute of Food Control Vienna (central laboratory) Comments Laboratory involved in GMO food analysis Laboratory involved in GMO food analysis INSPECTION VISITS Comments 1 manufacturer of soya bean products Establishment under the control of Niederösterreich food inspection service 4 Commission Regulation (EC) No. 50/2000 of 10 January 2000 on the labelling of foodstuffs and food ingredients containing additives and flavourings that have been genetically modified or have been produced from genetically modified organisms (OJ L 6, , p.15) 6

7 3. LEGAL BASIS FOR THE MISSION The mission was carried out under the provisions of the Treaty of the European Community (in particular Articles 10, 152,153 and 211) and in agreement with the Austrian Federal Ministry for Health and Women (BMGF). In addition Regulation (EC) 258/97 foresees a monitoring role for the Commission in the application of the Regulation, its impact on health and consumer information and the functioning of the internal market. 4. BACKGROUND Before the Regulation (EC) 258/97 on novel foods took force in May 1997, products from two genetically modified plants were authorised for food use on the European market. This was by means of the labelling of the finished products (Roundup Ready -soya beans and Bt-176-maize; Commission Decisions 96/281/EC 5 and 97/98/EC 6 ). Labelling of foodstuffs derived from these plants, genetically modified soya bean and maize, was introduced by Council Regulation (EC) 1139/98. However, foodstuffs need no labelling if neither DNA nor protein resulting from the genetic modification is present. The regulation was amended (by Commission Regulation (EC) 49/2000) to address the problem of adventitious presence of GMO material in food. Operators are not obliged to label if the presence of GMO material in the final product is below a threshold (1% GMO material in a given ingredient) and due to adventitious mixing (therefore some evidence of avoiding GMO sources has to be provided by the producers). The Roundup Ready -soya bean is not cultivated in the EU but is widely imported. Although the main use of soya bean is for feed, soya bean derivatives are also present in many processed food products. According to data from Eurostat Austria imported about 2500 tonnes of soya bean grains in 2001 and 640 t in 2002 from third countries (representing 4.4% of total import into EU in 2001). Austria also imported around 34 tonnes of soya bean flour and meal in 2001 and 2.4 t in The main exporters of soya bean are Brazil, USA, Paraguay and Argentina. There are no genetically modified crops cultivated in Austria. Austria imports maize (grains), soya beans and oil seed rape from third countries. Data supplied (see table below) gives figures for the import of these crops into Austria for 2001 and 2002 but includes figures for crops from other Member States. The principal countries for imports of soya beans, maize and oil seed rape (breakdown of data by crop not available) includes Argentina, Croatia and many Candidate Countries such as Slovak Republic, Czech Republic, Slovenia, Hungary and Poland. Between 10,000 and 70,000 tonnes are imported annually from each of these countries. Volumes of imports from Brazil are low and have decreased 5 OJ L 107, , p.10 6 OJ L 31, , p. 69 7

8 dramatically in the two years for which figures are available (2,641t in 2001 and 253t in 2002). Austrian imports (tonnes x 1000): Year Soya Maize Oil seed rape Total including MS Total less MS Data supplied by: Austrian response to Pre-mission questionnaire Under the Regulation (EC) 258/97 on novel foods, no products consisting of or containing live GMO are so far authorised. Thirteen products deriving from genetically modified plants are approved in Europe as being substantially equivalent 7 : oil deriving from 7 varieties of genetically modified oilseed rape, oil from 2 GM cottonseeds and food and food ingredients deriving from 4 genetically modified maize varieties. Following the de facto moratorium in Europe, no GMO was approved in Europe since October On the other hand, in North and South America as well as in China, several genetically modified varieties of maize and of soya bean are cultivated and derived products are likely to be imported into Europe. 5. MAIN FINDINGS 5.1. Legislation Austria has national legislation on food produced from GMO in addition to the EU Regulations 258/97 and 1139/98 as amended by Commission Regulations 49/2000 and 50/2000. This includes specific provisions to restrict GMO content in organic food to less than 0.1%, instructions for sampling for GMO food and guidelines for using "GMO free" claims, the latter is given in the Austrian Codex Alimentarius. The Austrian Gene Technology Act entered into force in January 1995 and was amended in 1998 and in It regulates the main aspects of biotechnology and genetic engineering: contained use of GMOs, deliberate release of GMOs into the environment, the placing on the market of products that contain GMOs and the application of biotechnology in human medicine. Furthermore the act lays down the rules for the establishment of an Advisory Board on Gene-technology and its three scientific committees, for strict liability for damages due to genetic engineering and punishment for offences against the law. 7 application of the simplified procedure of Article 5 of Regulation (EC) 258/97 8

9 Austria has a register of products containing GMOs (Gentechnikregister) which is continuously updated with the list of products, which have been approved under Council Directive 90/220/EEC 8 following procedures of Article 13. In three cases of the placing on the market of GM maize, Austria has issued a ban for the import of these products. The measures were taken in accordance with Article 16 of Council Directive 90/220/EEC and led to the publication of three ordinances banning GM maize varieties: BGBI. II Nr. 45/1997 (Bt 176), BGBI. II Nr. 175/1999 (Mon 810) and BGBI. II Nr. 120/2000 (T25). The Seed and Gene Technology Ordinance (BGBI. II Nr. 59/1998) prescribes a mandatory labelling for products that contain GMOs or consist of both modified and non-modified organisms. This regulation does not apply to "novel foods", pharmaceuticals and products that are only destined for contained use or scientific purposes. An Ordinance on GM seed (BGBI. II Nr. 478/2001) was passed by the Federal Ministry for Agriculture, Forestry, Environment and Water Managment (BMLFUW), which prescribes mandatory labelling for all GM seed varieties covered by Council Directive 90/220/EEC. Furthermore the latter Ordinance sets thresholds for accidental contamination of conventional seed with GM seed. The feed - GMO Threshold Value Ordinance (BGBI. II Nr. 394/2001) sets a threshold of 1% in respect of the GMO maize products prohibited in Austria, namely BT 176, MON 810 and T25. While it is not included in the objectives of the mission, it was noted that transposition of Directive 2001/18/EC 9 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC, is under the responsibility of the Federal Ministry for Health and Women (BMGF) and is not yet complete. The Austrian Gene Technology Act is currently under revision to incorporate Directive 2001/18/EC and is expected to be finalised in Autumn This Directive should have been transposed by 17 October Competent authorities Pre-marketing assessment of GMO food The Austrian Agency for Health and Food Safety (AGES) is the competent body in Austria to carry out assessment of novel foods under the terms of the Regulation (EC) 258/97. The Agency was founded on the basis of the Austrian Food Safety Act in 2002 (BGBI. II Nr. 63/2002). It combines the expertise from the BMLFUW agricultural research laboratories with that of the BMGF laboratories for food safely 8 Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of GMOs (OJ L117, ,p.15) now repealed by directive (EC) 2001/18 on 17 October Directive 2001/18/EC of the European Parliament and of the Council of the 12 March 2001 on the deliberate release into the environment of GMOs and repealing Council directive 90/220/EEC (OJ L 106, , P. 0001), as ammended. 9

10 and public health. There are 1050 staff in the AGES of which 6 to 7 are involved in the evaluation of novel foods and GM food analysis. There were no applications so far to request authorisation for a novel food in Austria. After receiving the summary of an initial assessment report prepared by another Member State, the AGES evaluate the document in collaboration with the experts of the Institute of Food Control Vienna. The latter Institute (Department of Toxicology, Novel Foods) is responsible for drafting reports and opinions with regard to Article 6 of the Regulation (EC) 258/97 and their opinions are sent to the European Commission. The BMLFUW is responsible for the Novel Seed Directive 98/95/EC 10 (as transposed by BGBI. II Nr. 39/2000 and BGBI. II Nr. 478/2001) and is also responsible for GM controls on feed imports Controls of GMO food The BMGF (formerly known as the Federal Ministry of Social Security and Generations) is responsible for drafting legislation and the planning of inspection and sampling activities but has no role in food inspection per se. There are 2 people in BMGF who work part time in the area of GM food. The inspection of GM foods falls within the competence of the regions (Länder), each region (Land) is responsible for enforcing national legislation. There is no regional legislation produced for GM food control. The implementation of official controls on foodstuffs is undertaken by the food inspection service (Organe der Lebensmittelaufsicht) in each Land. These controls include the annual inspection programme and targeted sampling activities for GMO food, which are organised and planned at central level by the BMGF in co-operation with the food inspection services of the 9 Länder authorities in Austria Deliberate release of GMO The Federal Ministry for Education, Science and Culture (BMBWK) is the competent authority for the deliberate release of GMOs at scientific highereducation establishments or scientific institutions run by the federal government. Otherwise, the BMGF is the competent authority in the area of deliberate release of GMO in the environment (Directive 2001/18/EC of the European Parliament and of the Council). The BMGF carries out the assessment of notifications concerning GMO release under part B of Council Directive 90/220/EEC. To do this BMGF consults with experts from the Institute for Food Control Vienna (Department of Biochemical Analysis), the Federal Environment Office and other federal departments, after contacting the competent committee of the Austrian Gene Technology Commission. There are 5-8 people in BMGF working part time in the area of environmental release. No consents have been given by the Austrian authorities for deliberate release of GMO into the environment for research and development purposes or for any other purpose than for placing on the market (part B of Council Directive 90/220/EEC). There were 5 applications under Part B of Council Directive 90/220/EEC, 4 of 10 Council Directive 98/95/EC of 14 December 1998 (OJ L 25, , p.1) 10

11 which were withdrawn due to public objections and the fifth was stopped by the BMGF for legal reasons. There are no genetically modified crop varieties cultivated in Austria Controls of GMO foods Activities carried out by BMGF The BMGF do not undertake or participate in GMO food controls. When the planned activities are agreed with the Länder inspection services the BMGF circulates the annual inspection programme and targeted action plans to all Länder specifying the number of samples and inspections to be undertaken in each Land. Formal meetings between the BMGF and the Länder authorities for food control take place at least twice per year where activities are planned and results are discussed. The minutes and agenda were supplied to the mission team for both meetings held in 2002 but there was no mention of GMO food control in either meeting. However, there was evidence of regular communication of instructions and sampling plans to the Länder authorities for GMO food control. The Commission Recommendation of 25 January concerning a co-ordinated programme for the official control of foodstuffs for 2002 suggested control for the labelling of genetically modified foodstuffs. Based on this recommendation, the BMGF has established a national programme consisting of 189 samples of food products deriving from maize or soya bean. The BMGF specified the number of inspection samples to be taken in each Land for the purpose of this recommendation. The results of this co-ordinated programme have been communicated to the European Commission Activities carried out by the Länder food inspection services The food inspection service of the Länder implement the targeted action plans, labelling controls and follow-up of suspect samples as part of GM food control activities. The targeted action is planned in advance in co-operation with the BMGF, which specifies the number of samples to be taken in each Land. The sampling plan is then published and circulated by fax or mail to all the Länder. It is up to the Land food inspection service to subdivide the number of samples assigned to that Land between the relevant municipalities (Gemeinden) and chartered towns or local authorities Control activities carried out in the Land of Kärnten Kärnten has 550,000 inhabitants of whom two-thirds are in central Kärnten and onethird is located in remote parts of the region. The surface area is approximately 9,500 km 2 and has borders with Slovenia and Italy. The Health care division of the Kärntner Land authorities is divided into two departments legal and technical. The latter department is subdivided into several technical units concerned with health 11 O J L 026, 30/01/2002 P (2002/66/EC) 11

12 care, one of which is the food inspection unit. There are two local authorities in Kärnten, these are Klagenfurt and Villach. The total number of food inspectors in Kärnten is 21, 11 are regional inspectors, 6 are based in the local authority of Klagenfurt and 4 in Villach. Each inspector specialises in various food sectors. One senior inspector in Kärnten is involved in the control of GM food. The basic qualification is high school graduation and a 3-month training programme is provided centrally by BMGF along with on the job training. A small part of the BMGF training is in novel foods and GMOs, approximately half a day. The senior inspector has participated in additional training at regional level in Kärnten in GMO food in 1995 (half-day course) and courses of one-day duration in both 1996 and Also in 1998 a gene technology seminar was organised by the inspection service to provide information to the public. Inspections are conducted using a detailed checklist for GMO food control. The checks include the company's types of ingredients (maize or soya bean) and whether GMO products are used. The inspector also verifies if the company looks for GMO free certificates from their suppliers. There are 30 companies in Kärnten which use maize or soya beans in their production and these companies are usually selected for the targeted action plans. All samples taken in this region are sent for analysis to the regional laboratory, the Kärntner Institute for Food Analysis and Quality Control. A new system, which is not yet fully operational in Kärnten, is being introduced with specific software for inspectors to facilitate report writing and monitoring of food control inspections using laptop computers. There are 2 motorway BIPs in Kärnten that are under the control of the customs authorities. The food inspectors are not routinely informed about food imports, which could contain GMO. The only contact with the customs authorities with regard to food control is relating to specific Commission Decisions (for example, on imports of peanuts from various third countries) which are not within the scope of this mission. The inspection and sampling activities in Kärnten for recent years are summarised in the following table: Year No. Samples GMO Action positive for RR soya (0.15%) Notification given producer out-side of region, relevant Land was notified Bt176 maize (<0.05%) Notification given To be analysed Data supplied by Food inspection services of Kärnten (samples taken were for the targeted action plans and the Commission Recommendation of January 2002) Control activities carried out in the Land of Niederösterreich The region of Niederösterreich has 1.7 million inhabitants, covers a surface area of about 20,000 km² and has borders with the Czech Republic and the Slovak Republic. The regional government, the Landesregierung of Niederösterreich is divided into 9 groups, of which one is Health and Social Affairs where the department for food control belongs. There are six sub-departments (outposts), the inspectorates are related to territorial areas of Niederösterreich, the total number of 12

13 inspectors is 40. There are 9 in the central office, 24 between the 6 outposts and for the two local authorities there are 4 in St. Pölten and 3 in Wiener Neustadt. The local authorities are under the supervision of the head of the department for food control. The food inspectors in Niederösterreich have as basic qualification technical and scientific knowledge from high school graduation level. They participate in the 3- month training at BMGF but have no training at regional level in GMO food control. Inspection activities are initiated by the annual inspection program (in cooperation with the Länder) and by targeted programs issued by the BMGF. A few additional inspection and sampling activities take place on own initiative as followup to previous findings or in cases of suspicion. The inspectors are advised to inspect food producers, importers and retailers and are asked to conduct documentary controls for traceability. Any findings of approved GMO s in raw materials or foodstuffs which are not in compliance with the provisions for labelling of GMO foodstuffs are reported to the regional government which issues written warnings and follow-up sampling is performed. Austrian law does not allow the inspectors to seize products because of a breach of GMO national labelling rules, however due to strong public opinion the companies concerned voluntarily withdraw the products in question from the market. All official samples taken in Niederösterreich are sent for analysis in the Institute of Food Control Vienna. In 2001 a total of 12 samples from Niederösterreich were analysed, none of them were positive for the presence of GMO. In samples from Niederösterreich were analysed, 1 sample contained 0.2 +/- 0.06% GMO but was not rejected officially because of measurement uncertainty and it was below 1% GMO. Details of sampling activities for the outpost of Baden are provided in the following table (number of organic samples out of total): Year No. Samples Positive for GMO Action (0) 2 Legal proceedings (2) 0 4 were follow up (7) 1 borderline 0.2 +/- 0.06% (14) To be analysed To facilitate the inspection performance and for documentation purposes a new system has been introduced recently. The inspectors use laptop computers and specific software which allows for consistency in reporting and follow-up of each inspection visit. As in Kärnten the food inspectors in Niederösterreich are not routinely informed about food imports, which could contain GMO Inspection visit The mission team accompanied the responsible inspector on a visit to a major organic soya food producer in the outpost of Baden. The operation started in

14 The HACCP concept was introduced in 2000 with the support of a private consulting company. The main incoming raw materials are organic soya beans, which originate from EUcountries and are supplied by a single source company in lot sizes of 15 t. The soya beans are milled and by a combination of different coagulation and separation steps soya milk and soya cake are produced. Dependent on the final product further processing takes place. Certificates for GMO-free products are requested for each batch of products supplied by the company and the inspector checks these. Sampling is undertaken according to the Austrian official sampling instructions or in some cases after consulting the Food Control Institute Vienna. The inspector had noted deficiencies regarding the premise layout and general hygiene as documented in previous inspection visits and dates have been agreed with the company for corrective action to take place. Every inspection is finalised by a meeting to inform the company about findings and of further procedures to be taken. A report is printed and handed over only on request of the company or in cases where the inspector deems it necessary. No checklist is routinely used Activities carried out at the Border Inspection Posts (BIP) The Customs authorities are responsible for controls at BIPs. The customs authorities notify the food inspection service of the relevant Land where there are imports with regard to specific Commission Decisions (for example, on imports of peanuts from various third countries) and for organic food imports. There is no routine inspection of imported food for GMOs or novel foods. Inspection of imported feed is the responsibility of BMLFUW. In Austria samples from feed were taken and analysed in the years 2000 to 2003 specifically for GMO analysis. A summary of results on checks carried out on feeds imported into, moved to or produced in Austria is presented in the following table: Feed samples analysed for GMO maize content: Year No. Samples Positive for GM maize Above 1% GM maize to date In the absence of Community threshold values for GM feeds, feed testing for GMO content in Austria has so far been based mainly on national regulations, cf. BGBl. II No 45/1997 (BT 176), BGBl. II No 175/1999 (MON 810) and BGBl. II No 120/2000 (T 25). All the feed samples of GM maize events banned in Austria under these national regulations, which were positive, were of less than 1% GMO. 14

15 The threshold set in Austrian legislation for specific GMO events in maize feed is 1% so no further action was required Laboratories There are 4 Federal laboratories for food analysis, which have been integrated into the AGES including the Institute for Food Control Vienna. There are 2 regional laboratories, one of which is the Institute for Food Analysis and Quality Control in Kärnten. Samples are sent to a laboratory based on geographical location. All 6 laboratories are involved in GMO food controls for initial screening analysis but only the Institute for Food Control Vienna undertakes analysis for quantification of GMO in food. AGES plans to establish centres of competence for various areas of analysis however, it is not yet decided if GMO food analysis is to be centralised into a centre of competence. A working group on GMO analysis has been set up since 2000 (known as ARGE-GVO) and has facilitated better communication between all laboratories in Austria concerned with GMO food analysis Institute for Food Analysis and Quality Control in Kärnten In the laboratory there are 26 employees, of these one scientist and one technician undertake GMO analyses. The scientist is well qualified and set up the laboratory in 1997 when work with GMO analyses was initiated. Up to 2001 the scientist worked full time in the area of GMO food analysis but since then she is also responsible for the microbiology sector and spends about 20% of her time on GMO food analysis. In 1998 the laboratory received accreditation according to ISO The scope of the accreditation covers screening by PCR of the CaMV35S promoter and of the nos terminator from Agrobacterium tumefaciens. The specific detection of the authorised Roundup Ready -soya bean, Bt176 maize, Bt11 maize and MON810 maize are included in the accreditation. In addition the maize event T25 can also be detected, but lies outside the scope of accreditation. The laboratory performs GMO analyses of all kinds of food matrices from raw materials to finished products. Both official and private samples are analysed. The reference materials are provided either from the Institute of Reference Materials and Measurements (IRMM) or from other official laboratories in Austria. Positive samples for the presence of genetically modified material are either sent to the Institute for Food Control Vienna or to a private accredited laboratory for quantification. The laboratory participates mostly in nationally organised ring tests about once per year in order to test a method. The laboratory is well equipped with two conventional PCR machines and the layout of the rooms is appropriate. 12 In their response to the draft report the Austrian Authorities noted that imports of soya or soya meal into Austria are rare (Austria does not have any seaports or extraction plants). Imports, and hence import checks and customs clearance, take place via Germany or Italy. Soya meal is then forwarded to Austria under intra-community circulation. All feed imports into Austria are recorded by specially trained customs bodies using an import check document. Soya meal is therefore sampled directly at feed establishments. 15

16 The number of official samples analysed in recent years are summarised in the following table: Year No. Samples No. Positive for GMO Results not available yet Institute for Food Control Vienna The institute employs approximately 100 people and consists of 12 departments. The Department of Biochemical Analysis is the actual department carrying out the analysis of GMO food but other departments are also involved at various stages from reception of the sample to the release of results. One scientist and two technicians are working part time in the area of GMO detection and quantification. The scientist is well qualified and has some publications in scientific journals on GMO food detection methods. The department is accredited since 1998 according to ISO Accreditation is by both the Austrian Ministry for Economic Affairs (which is the Austrian National Accreditation Authority) and AKS Hannover (German accreditation body). The accreditation is in an open scope for "molecular biology procedures", individual methods are not accredited. The laboratory is using methods for the qualitative detection of the authorised genetically modified soya bean Roundup Ready and the authorised maize varieties Bt176, Bt11, MON810 and T25. In addition Liberty-Link rapeseed, CaMV and genetically modified potatoes can also be detected. For quantification of GMO content commercially available kits are used for soya and maize. In the case of maize the CaMV 35S promoter is used as a GM target for quantification. All kinds of matrices are analysed, from raw materials to finished products. The majority of samples analysed are from official controls. Reference materials used are either from the IRMM or have been made available from bio-companies. The laboratory has participated in several validation studies, and participates in proficiency testing schemes at least once per year however these are mostly national proficiency tests. The laboratory is well equipped and the layout of the rooms is appropriate. The following table provides a summary of the number of positive samples quantified in recent years: Year No. Samples No. > 1% GMO (1 st half) 8 Not available 16

17 These samples were positive for the presence of GMO, however many of them had less than 1% GMO (threshold established in Regulation (EC) 49/2000) but greater than the 0.1% tolerance level for organic food established in Austrian law. There is regular informal communication between the inspection service of the Länder and the laboratory to clarify sampling instructions for GMO food and where follow up samples might be required. 6. CONCLUSIONS 6.1. Legislation (1) Apart from the existing EU legislation, Austria has additional provisions on foods containing, consisting of or produced from genetically modified organisms (GMO) including provisions on GM labelling, for GM traces in organic food and instructions for sampling GMO food. (2) Directive 2001/18/EC should have been transposed by 17 October 2002, is not yet transposed in the national legislation Competent authorities (3) The division of tasks among the relevant competent authorities is well organised and structured for GMO food, novel food assessment, deliberate release in to the environment and novel seed Controls of GMO food (4) The control activities for GMO food are ongoing in Austria for several years. The BMGF efficiently and effectively plans and organises inspection and sampling activities in GMO food in co-operation with the regional food inspection authorities. (5) Communication between the BMGF and the regional food inspection service of the Länder is well established. (6) There is little formal training in GMO food control at central level and there is variation in the amount of training provided in GMO food control at regional level. This is not in line with EU legislation on Official Control 13. (7) There is variation between the Lander in the use of checklists. (8) Inspection and sampling activities in the Länder are well organised and a new system of documenting these activities is currently being established which will greatly improve consistency in reporting and follow-up of control activities. 13 Council Directive 93/99/EEC of 29 October 1993 on the subject of additional measures concerning the official control of food stuffs (OJ L p. 14) 17

18 (9) Communication between the food inspection services of the Länder and the customs authorities for food imports is limited. However the BMLFUW controls on feed (including imports of feed) for GMO are well established Laboratories (10) There are 4 Federal laboratories incorporated into the AGES of which one undertakes analysis for quantification of GMO food that is the Institute for Food Control Vienna. (11) There are 2 regional laboratories for food control in Austria and they undertake analysis of GMO food for identification of the GM event. (12) All 6 laboratories are accredited but participation in international proficiency tests is limited. 7. CLOSING MEETING A closing meeting was held on 26 June 2003 with the representatives of BMGF, the AGES and representatives of the Länder authorities and the laboratories visited. The BMLFUW were unavailable to attend the closing meeting. At this meeting, the main findings and conclusions of the mission were presented by the FVO inspection team. The Austrian competent authorities accepted these findings and conclusions. 8. RECOMMENDATIONS To the competent authorities of Austria (1) The competent authorities of Austria should consider including GMO food control training and guidelines for regional level training in GMO, during the centrally organised food control training programme, in order to harmonise the training level of food inspectors for GMO according to Council Directive 93/99/EEC Article 2. (2) The competent authorities concerned with the Institute of Food Control Vienna should consider extending their participation in international proficiency testing schemes according to Council Directive 93/99/EEC Article 3.2 (b). An action plan in response to these recommendations should be forwarded to the Commission within two months of the dispatch of the final translated report. This action plan should clearly set out the manner and deadline by which the competent authorities will address these recommendations. 9. ADDENDUM In their response to the draft report the Austrian Authorities stated that they will forward an action plan to address the recommendations within 2 months of the dispatch of the final translated report. 18

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