SUMMARY RECORD OF THE STANDING COMMITTEE ON THE FOOD CHAIN AND ANIMAL HEALTH HELD ON 20 MARCH 2007 IN BRUSSELS

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SUMMARY RECORD OF THE STANDING COMMITTEE ON THE FOOD CHAIN AND ANIMAL HEALTH HELD ON 20 MARCH 2007 IN BRUSSELS (Section Biological Safety of the Food Chain) (Section Genetically Modified Food and Feed and Environmental Risk) President: Eric Poudelet All the Member States were present. 1. Examination and possible opinion on a draft Commission Decision on the withdrawal from the market of Bt176 (SYN-EV176-9) maize and its derived products 2. Examination and possible opinion on a draft Commission Decision on the withdrawal from the market of Ms1xRf1 (ACS-BNØØ4-7xACS-BNØØ1-4) hybrid oilseed rape and its derived products 3. Examination and possible opinion on a draft Commission Decision on the withdrawal from the market of Ms1xRf2 (ACS-BNØØ4-7xACS-BNØØ2-5) hybrid oilseed rape and its derived products 4. Examination and possible opinion on a draft Commission Decision on the withdrawal from the market of Topas 19/2 (ACS-BNØØ7-1) oilseed rape and its derived products 5. Examination and possible opinion on a draft Commission Decision on the withdrawal from the market of products derived from GA21xMON810 (MON- ØØØ21-9xMON-ØØ81Ø-6) maize A general discussion took place on the 5 draft decisions that are similar but related to different products. The draft Decisions were already presented and discussed during the previous meeting of the Standing Committee on 2 March 2007 (Section Genetically modified food and feed and environmental risks). Questions were raised regarding the tolerance for the adventitious or technically unavoidable presence of traces of the GMO in food and feed products. In particular, it was questioned whether the tolerance at a level of 0.9% and for a period of 5 years were appropriate. The draft Decisions are based on a series of considerations that have to be taken into account: the concerned products are at the present time fully authorised and these measures are not related to safety concerns but to the end of their period of authorisation and of their commercialisation, the seeds for cultivation have to be actively recalled from the market and the tolerance for traces is only valid for food and feed products, on the basis of the information available a period of time of 5 years appears to be reasonable to allow the traces of GMO to progressively disappear from the food and feed chain (although the experience in this respect is limited and that some delegations questioned

whether a shorter or a longer period of time would not be more appropriate), the level of 0.9% corresponds to the threshold in place for traceability and labelling of GMOs. Regarding processed oil from oilseed rape that were initially notified in accordance with Article 5 of Regulation (EC) No 258/97 on the basis of its substantial equivalence with oil produced from non genetically modified oilseed rape, it was clarified that the threshold is related to the raw material (the grains) from which the oil is produced. In refined oil produced from oilseed rape, DNA and protein are not present. The products subject to this decision will be maintained in the Community Register on GM Food and Feed in a separate category. The Austrian delegation made a declaration as follows: Österreichische Erklärung zum Beschluss über die Marktrücknahme von 5 GVO Österreich begrüsst grundsätzlich die Tatsache, dass diese Produkte auch rechtlich endgültig vom Markt genommen werden sollen. Festzuhalten ist, dass bezüglich vier dieser Produkte (GV-Mais BT176 und drei genetisch veränderte Rapslinien), die von der Europäischen Kommission genehmigt wurden, auch nationale Schutzmassnahmen in Anspruch genommen wurden. Mais GA21XMON 810 verfügt bisher noch über keine EU-rechtliche Zulassung. Österreich vertritt die Ansicht, dass für das Auslaufen dieser Produkte eine Übergangsfrist von drei Jahren mit einem tolerierbaren Grenzwert von 0.5% für unbeabsichtigte und technisch unvermeidbare Verunreinigungen die sachadäquatere Lösung wäre, dies auch im Hinblick auf die vergleichbare Regelung in Art. 47 der VO (EG) 1829/2003. Österreich hat sich aus diesen Gründen der Stimme enthalten. After the discussion, the draft Decisions were submitted to a vote. Vote: Favourable opinion (294 votes in favour, 3 MS abstained). 6. Exchange of views on a draft Commission Regulation implementing Regulation (EC) No 2160/2003 as regards a Community target for the reduction of the prevalence of certain Salmonella serotypes in broilers (Legal basis: Regulation (EC) No 2160/2003) (Right of scrutiny of the European Parliament) (SANCO/467/2007) (KDS) This proposal aims at setting a Community target for the reduction of the prevalence of Salmonella Enteritidis and Salmonella Typhimurium in flocks of broilers. It is based on the comparable information provided by a baseline study on the prevalence of the concerned Salmonella serotypes in broilers in the Member States. The proposal also lays down a testing scheme to verify the progress on the achievement of the target. Almost all Member States were in favour of the target of 1 % or less of broiler flocks remaining positive by 31 December 2011. Spain stressed the difficulty of reaching such a target for Member States where the prevalence is high. The Commission showed confident that with strong political will this objective can be achieved.

The proposal will be further discussed at a working group meeting on 11 April and presented for vote at the 24-25 April 2007 SCFCAH. 7. Exchange of views on a draft Commission Decision on a harmonised monitoring of antimicrobial resistance in Salmonella in poultry and pigs, and Campylobacter in broilers (Legal basis: Directive 2003/99/EC) (Right of scrutiny of the European Parliament) (SANCO/431/2007) (KDS) Due to the public health risk posed by antimicrobial resistance it is necessary to collect comparable data from all Member States on the antimicrobial resistance occurrence in zoonotic agents. In accordance with the report of 20 February 2007 adopted by the Task Force on Zoonoses Data Collection of the European Food Safety Authority (http://www.efsa.europa.eu/fr/science/monitoring_zoonoses/reports/ej96_amr1.html), this proposal lays down a harmonised monitoring scheme of antimicrobial resistance in Salmonella in fowl (Gallus gallus), turkey and pigs, and Campylobacter in broilers. It also foresees a financial contribution from the Community to cover the costs for 170 samples per animal population and zoonotic agent up. The maximum amount per sample still has to be determined after further discussion. 8. Exchange of views on a draft Commission Decision amending Annex IV to Council Directive 90/539/EEC as regards health certificates for intra-community trade in poultry and hatching eggs (SANCO/443/2007) (KDS) This proposal combines both animal health and public health requirements by including information on the testing for certain zoonoses and zoonotic agents into the health certificates for intra-community trade in poultry and hatching eggs. It also introduces TRACES system requirements to those model certificates. The Commission took note of some delegations' comments and proposed to further discuss the draft at the next working group meeting on 11 April. 9. Exchange of views on a draft Commission Decision amending Commission Decision 2006/696/EC laying down a list of third countries from which poultry, hatching eggs, day-old chicks, meat of poultry, ratites and game birds, eggs and egg products and specified pathogen-free eggs may be imported into and through the Community and the applicable veterinary certification conditions, and amending Decisions 93/342/EEC, 2000/585/EC and 2003/812/EC, as regards public health requirements (Legal basis: Regulation (EC) No 2160/2003) (Right of scrutiny of the European Parliament) (SANCO/582/2007 Rev. 1) (KDS) This proposal aims at amending the list of third countries authorised for import by the Member States with regard to certain poultry and eggs so as to remove Bulgaria and Romania further to their Accession to the European Union on 1 January 2007. Furthermore Canada, Israel, Tunisia and the United States have submitted their programmes for the control of Salmonella in breeding flocks of Gallus gallus, which have been found to provide sufficient guarantees as those provided for in Regulation (EC) No 2160/2003. Other countries did not submit any control programmes. The list of third countries authorised for import of live breeding animals and hatching eggs should be amended accordingly.

Authorised third countries should also certify effective application of their control programmes as well as the use of antimicrobials and vaccines as Salmonella control methods. Appropriate model veterinary certificates should therefore be amended to include the date of the last testing and results and to specify control methods. The model health certificates should already include amendments as regards the import of laying hens and broilers of Gallus gallus along with the date of application. The Commission will submit this proposal for a technical vote at the 24-25 April 2007 SCFCAH meeting. The formal vote is planned to occur in September after a 60-days delay for SPS notification. 10. Exchange of views on a draft Commission Decision concerning a financial contribution from the Community towards a baseline survey on the prevalence of Campylobacter in broilers and of Campylobacter and Salmonella in broiler carcasses to be carried out in the Member States (SANCO/3969/2006) (SD/KDS) Due to the high number of Salmonella and Campylobacter cases in humans and the importance of broilers and broiler meat as source of infection, it is necessary to carry out a survey starting 1 January 2008 in order to collect comparable date on the prevalence of Campylobacter in broilers and of Campylobacter and Salmonella in broiler carcasses in the Member States. Technical specifications have been prepared by scientific experts and the Community Reference Laboratory for Campylobacter for a baseline study on a harmonised monitoring of Campylobacter in broiler flocks. Similarly the opinion of the European Food Safety Agency of 16-17 October 2006 proposes technical specifications for a co-ordinated monitoring programme for Salmonella and Campylobacter in broiler meat. (http://www.efsa.europa.eu/en/science/monitoring_zoonoses/reports/zoon_report_ej92_bro ilermeat.html) This proposal defines the financial contribution from the Community for implementing specific requirements of the survey as provided for in the annexed technical specifications. The Member States will be granted the financial contribution under the condition that they provide necessary information within specific time limits. The delegations expressed various comments, particularly on the technical aspects. 11. Exchange of views on a draft Commission Regulation amending Annexes I, III, VII and X to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards specific definitions, surveillance and eradication of transmissible spongiform encephalopathies in ovine and caprine animals and sampling and laboratory analysis methods and repealing Commission Decision 2003/100/EC (Legal basis: Regulation (EC) 999/2001) (Right of scrutiny of the European Parliament) (SANCO/3622/2006 Rev. 6) (See point 6 of the 18 January and point 3 of the 21 February 2007 SCFCAH's) (JOV) The opinion of the European Food Safety Authority of 8 March 2007 (http://www.efsa.europa.eu/en/science/biohaz/biohaz_opinions/ej466_tse_ovicap.html) concludes that to date there is no evidence for an epidemiological or molecular link between classical and/or atypical scrapie and TSEs in humans. The BSE agent is the only TSE agent identified as zoonotic. However, in view of their diversity, it is currently not possible to exclude transmissibility to humans of other animal TSE agents. The current discriminatory tests as described in the EC legislation to be used for discrimination

between scrapie and BSE appear, up to now, to be reliable for the differentiation of BSE from classical and atypical scrapie. The Commission presented a new draft which was revised on the basis of the discussions from the working group meeting of 12 March, and clarified the changes made. The Commission will carefully examine the views of the EFSA before presenting the proposal for vote. Member States were requested to send any further comments in writing before the April committee. 12. Exchange of views on a draft Commission Regulation amending Annexes II, V and IX to Regulation (EC) No 999/2001 of the European Parliament and of the council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies as regards the determination of the BSE status and categorisation of countries, specified risk materials and the importation into the Community of live animals and products of animal origin (SANCO/3748/2006 Rev. 5) (KVD) The classification in 3 categories of Member States and third countries according to their BSE risk status as established in Regulation (EC) No 999/2001 should be adjusted to the new categorisation adopted by the World Organisation for Animal Health (OIE) in May 2005. Annexes II, V, VI, VIII and IX should therefore be amended to adjust to the new categorisation system, which will apply from 1 July 2007. After having replied to the comments from some delegations, the Commission informed the committee that a technical vote will be taken at the 11-12 April SCFCAH (Animal Health and Animal Welfare section). 13. Exchange of views on a draft Commission Decision providing a derogation to the United Kingdom to use the hides from bovine animals born before 1 August 1996 for the production of leather (Legal basis: Regulation (EC) 999/2001) (Right of scrutiny of the European Parliament) (SANCO/654/2007 Rev. 1) (MP) Due to Bovine Spongiform Encephalopathy risk, it is prohibited to place on the market products derived from bovine animal born or reared within the UK before 1 August 1996. This applies also to hides prepared for the use of leather production since cattle born before August 1996 are considered to be BSE cohort animals because the cattle identification system in the UK was insufficient at that time. On 12 March the UK provided a rigorous protocol on the use of hides in leather production which requires strict channelling of hides from abattoirs to tannery and meets the requirements of the European Food Safety Authority opinion of 18 May 2006 (http://www.efsa.europa.eu/etc/medialib/efsa/science/biohaz/biohaz_opinions/1575.par.00 03.File.dat/biohaz_op_ej367_cohort_hides_tech_purposes_en.pdf) on cohort hides processing. The British delegate presented the main points of the protocol to the committee and replied to further concerns from some Member States. The Commission intends to lift the current restriction on hides further to the guarantees demonstrated. It will submit the current proposal for vote at the 24-25 April SCFCAH meeting.

14. Miscellaneous Exchange of views on a draft Commission Regulation amending Regulation (EC) No 2076/2005 laying down transitional arrangements for the implementation of Regulations (EC) No 853/2004, (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/2004 (SANCO/936/2007 Rev. 1) (ACR/TC) In order to avoid disruption of trade and any administrative difficulties at points of entry into the Community due to the late adaptation of third country certification system to the new Community certification regime introduced by Regulation (EC) No 2074/2005, the Commission proposed that the use of certificates issued under the previous regime and signed before 1 May 2007, is allowed for imports into the Community until 30 June 2007. A similar arrangement is also provided for fish oil, for which the use of certificates issued under the previous certification regime and signed before 31 October 2007, is allowed until 31 December 2007. Furthermore, it is intended to simplify the certification procedures form certain third countries from which imports of live bivalve molluscs and fishery products are authorised during the transitional period. The Commission will submit the proposal for vote at the 22 March 2007 SCFCAH, Animal health and animal welfare section.