SANCO D1(2007)D/412302 SUMMARY RECORD OF THE STANDING COMMITTEE ON THE FOOD CHAIN AND ANIMAL HEALTH HELD IN BRUSSELS ON 5 OCTOBER 2007 SECTION TOXICOLOGICAL SAFETY OF THE FOOD CHAIN President : Mrs Patricia Brunko All member States were represented, except Bulgaria and Czech Republic 1. Discussion and possible opinion on a draft Commission Decision amending Decision 2002/840/EC as regards the list of approved facilities in third countries for the irradiation of foods (SANCO/1114/2007) Additional information was given on the follow-up by the Competent Authorities of Thailand on the recommendations in the FVO report and to the questions raised at the SCOFCAH meeting of 20 July 2007. The Commission clarified that the decision concerns the approval of the facilities in general. The vote was taken. The Committee expressed a favourable opinion by qualified majority. 2. Discussion and possible opinion on a draft Commission Decision imposing an increased frequency of controls on peanuts and derived products originating from Brazil due to contamination risks of these products by aflatoxins (SANCO/2842/2007) In 2005 and 2006 an increasing number of notifications through the Rapid Alert System for Feed and Food (RASFF) indicated that the EU-maximum levels for aflatoxins were regularly exceeded in peanuts and derived products from Brazil. An inspection mission was carried out by the FVO in Brazil from 25 April to 4 May 2007 in order to assess the control systems in place to prevent aflatoxin contamination in peanuts intended for export to the Community. That mission revealed that the system for control of peanuts exported to the European Union is in place but not fully implemented. Therefore the current system does not fully ensure that peanuts exported to the European Community comply with or are at least equivalent to the relevant requirements as regards aflatoxins. In the interest of public health, the import of peanuts and derived products into the Community from Brazil should be subjected to increased frequency of sampling and analysis for aflatoxin levels by the competent authority of the importing Member State, prior to release onto the market.
Article 15 (5) of the Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules 1 provides that a list of products shall be drawn up that is, on the basis of a known or emerging risk, to be subject to an increased level of official control. The measures referred to in Article 15(5) of that Regulation will not apply before 2008. For the protection of public health it is appropriate to impose increased frequency of controls as regards aflatoxins in peanuts from Brazil without delay. For the time being, no health certificate issued by the competent authorities of Brazil is required for the import of peanuts and derived products from Brazil. The text was submitted for vote and the Committee expressed a favourable opinion by qualified majority. 3. Discussion and possible opinion on a draft Commission Decision approving the pre-export checks carried out by the United States of America on peanuts and derived products thereof as regards the presence of aflatoxins (SANCO/2013/2007- rev 2) The United States of America has submitted to the Commission in April 2005 an application for obtaining an approval of the pre-export checks performed by the competent authorities of the United States of America on the aflatoxin contamination in peanuts and derived products intended for export to the European Community. An inspection mission was carried out by the FVO in the United States of America from 18 to 22 September 2006 to assess the control systems in place to prevent aflatoxin contamination levels in peanuts and derived products and to verify that preexport checks for these products exported to the European Community ensure that these products comply with Community requirements. From the findings of the mission, it was concluded that the United States of America have a well defined control system for aflatoxins in peanuts and the system of laboratory approval appears to result in well performing laboratories. The competent authorities of the United States of America have committed and taken action to address the minor deficiencies observed. Taking into account that a Community audit has shown that the controls carried out prior to dispatch are sufficiently effective and efficient to replace or reduce the physical checks at import to ensure that the foodstuffs comply with the Community legislation on aflatoxins, the draft Decision proposes to grant approval of pre-export checks carried out by the United States of America on peanuts and derived products ensuring compliance with the Community maximum levels of aflatoxins. Member States are required by Article 16 (2) of Regulation (EC) No 882/2004 to adjust the frequency of physical checks on imports to the risk associated with different categories of food and taking into account, among other things, the guarantees provided by the competent authorities of the third country of origin of the 1 OJ L 139; 30.4.2004, p. 1. Corrigendum published in OJ L 226, 25.6.2004, p. 3. Regulation as last amended by Council Regulation (EC) No 1791/2006 (OJ L 363, 20.12.2006, p. 1).
food in question. Systematic pre-export checks carried out under the authority of the USDA in conformity with the Community approval in accordance with Article 23 of Regulation 882/2004 provide to the Member States' authorities strong guarantees. As a consequence, Member States should reduce the frequency of physical checks performed on those commodities to a level appropriate to those guarantees. Comments were made as regards the future possibility of electronic certification, administrative burden related to the splitting of a consignment, the documentary check and as regards the certificate. The comments were taken into account in the text submitted for vote. The Committee expressed a favourable opinion by qualified majority. 4. Contamination of guar gum, originating from India, by pentachlorophenol and dioxins: update of the situation Guar gum powder is extracted from the guar bean. The food grade guar gum powder is used as a gelling, thickening and binding agent in a very wide range of foodstuffs such as jams, jellies, fruit spreads, ice cream, soft drinks, puddings. India produces about 80% of the world's total production of guar beans, concentrated in the regions neighbouring Pakistan. The Rapid Alert System for Food and Feed (RASFF) received on 24 July 2007 a notification from the competent authorities of Switzerland concerning a finding of a contamination by dioxins and pentachlorophenol (PCP) in guar gum originating from India; a company in Switzerland supplied nine Member States with this contaminated guar gum. The contamination by dioxins is linked to the presence of PCP but the pathway of contamination is still unclear. There is normally no reason to find dioxins in guar gum and therefore no maximum level has been established for dioxins in guar gum intended for food. By analogy with the maximum level for dioxins in vegetable oils and the maximum level established for products of plant origin intended for animal feed, Member States have been advised to consider levels above 0.75 pg dioxins/g guar gum as unacceptable contamination and these batches cannot be used for production of food (and feed). For PCP, a fungicide no longer used in food production, the maximum residue level is the limit of quantification i.e. 0.01 mg/kg product for all foods. In addition to tracing and blocking of identified contaminated batches of guar gum following information disseminated through the RASFF, the Member States were asked to detain, sample and analyse for the presence of PCP and dioxins all batches of guar gum originating from the Indian company from which the identified contaminated batches of guar gum originated from, and to sample and analyse for the presence of PCP and dioxins batches of guar gum from other suppliers in India.
In case contaminated guar gum was already used in food products, these food products have to be withdrawn from the market in case they are not compliant with EUlegislation. The highest level of dioxins found in guar gum is 738 pg dioxins/g, although most contaminated batches of guar gum contain levels in the range of 12-80 pg dioxins/g. Batches of guar gum not affected by this contamination incident contained levels of dioxins significantly below 0.75 pg dioxins /g guar gum. As regards PCP, the highest level of PCP in guar gum found is 80 mg PCP/kg, although most contaminated batches of guar gum contain levels in the range of 0.1 to 3 mg PCP/kg product. Batches of guar gum not affected by this contamination incident contained levels of PCP below or in the range of 0.01 mg PCP/kg guar gum. All guar gum which was found contaminated and not yet used has been withdrawn from the market. Also all non-compliant intermediate and finished foodstuffs have been withdrawn. An FVO mission to India concerning this contamination incident took place early October (ongoing at the moment of the meeting). The Committee agreed that the abovementioned reference points of action for dioxins and PCPs were the appropriate levels to apply to protect public health and to distinguish products affected by the contamination incident from products not affected by the contamination incident. The Committee agreed furthermore that there was no need to keep a very high level of official control. It was stressed that such a contamination could occur again and that it is therefore very important to point out to the food business operators their legal responsibility to take the necessary measures to avoid that contaminated guar gum can enter the food chain and contaminated food is put on the market, in accordance with the provisions of the General Food Law. Referring to the recent contamination incident, analytical results have shown that in case the guar gum contains a level of PCP lower than 0.01 mg/kg, it can be assumed that the level of dioxins will be below the level of 0.75 pg dioxins/g guar gum. This assumption of compliance as regards dioxins when no PCP can be quantified is however not applicable to foods produced with contaminated guar gum. The reason is that such foods can contain dioxins from other sources and maximum levels for dioxins are in most cases expressed on fat basis while for PCP on product basis. It was agreed that the issue would be discussed again once the outcome of the FVO mission to India is available 5. Draft Commission Regulation on recycled plastic materials and articles intended to come into contact with food and amending Commission Regulation (EC) No 2023/2006 : for information
Content and background of the draft regulation on recycled plastic to come into contact with food were presented to Member States. The measure will cover recycled plastics from mechanical recycling and will introduce an authorisation procedure for those recycling processes that produce recyclate intended for food contact use. The draft will be presented for possible opinion in a forthcoming meeting of the section. 6. Translation in relation with the use of E385-EDTA (Annex IV to Directive 95/2/EC) : divergences in different language versions Member States agreed that divergences observed in different language versions in the section defining the uses of E 385 (Annex IV to Directive 95/2/EC) result from a mistranslation of the English term legumes, most probably the original version. They all agreed that the narrowed term used in some countries should be retained and that it is possible to interpret the different language versions in a uniform manner despite the wider term used by other Member States (i.e. légume in French). They agreed with the COM that the only option is to correct this mistranslation via comitology once the forthcoming Regulation on food additives will be adopted. 7. Request for EFSA to undertake a review of a study examining the effect of mixtures of certain additives on children's behaviour : for information The Commission updated the Committee on the action which had been taken following the publication of the study funded by the UK Food Standards Agency examining the effect of mixtures of certain colours and a preservative on children's behaviour. As soon as the study was published the Commission requested the European Food Safety Authority (EFSA) to assess the results of the study and provide an opinion on the findings taking into account any other available scientific evidence in the area. The Commission asked EFSA to examine the study with some urgency and asked if they could give an opinion by the end of the year or at the latest by the 28 th February 2008. EFSA have subsequently indicated that they will examine the study in depth with the help of additional scientists and clinicians with expertise in child psychology and behaviour, allergy and analysis of clinical trials and they expect to complete their assessment by the end of January 2008. The Committee agreed that it was appropriate to await the assessment from EFSA before considering any further action. 8. A.O.B. Nanotechnology : the Commission noted that despite all the newspaper articles relating to application of nanotechnology in food, the only area where an application for EU-approval has so far been received relates to food contact materials. The Commission informed the Committee that EFSA has been requested to give an initial scientific opinion relating to the risks arising from nanoscience and nanotechnologies on food and feed safety and the environment (opinion by 31 March 2008). Furthermore, the Commission shortly reminded the Committee about the necessity to evaluate new products should they fall under pre-market approval.
A delegation raised the issue that in the Risk Information System applied by the custom authorities the description of the food products and the nature of hazard/risk is not very well defined. The absence of very detailed well defined food products and nature of risks creates problems as it does not permit to identify the risk products and to target the controls. A better cooperation between the Risk Information System managed by DG TAXUD with the RASFF system managed by SANCO would improve the situation significantly. The representative of the Commission indicated that there is already cooperation but that he would examine to which extent this can be further elaborated to address the raised problem. Eric POUDELET, Acting Director (signed)