European Food Safety Authority Parma, 6 May 2006 EFSA/CONTAM/410 MINUTES OF THE 16TH PLENARY MEETING OF THE SCIENTIFIC PANEL ON CONTAMINANTS IN THE FOOD CHAIN (CONTAM) HELD ON 3 TO 5 APRIL 2006 IN PARMA (ADOPTED BY WRITTEN PROCEDURE ON 29 APRIL 2006) PARTICIPANTS Panel Members: Jan Alexander, Herman Autrup, Denis Bard 1, Diane Benford, Angelo Carere, Jean-Pierre Cravedi, Alessandro di Domenico, Johanna Fink-Gremmels, Roberto Fellini, John Gilbert, Niklas Johansson, Jirí Ruprich, Josef Schlatter (chair), Dieter Schrenk, Greet Schoeters, Agneta Oskarsson, Rolaf van Leeuwen (vice-chair), Philippe Verger (vicechair) 2. EFSA Ulla Bertelsen (Assistant Scientific Co-ordinator CONTAM Panel), Tlaitmass Bounou (Administrative matters CONTAM Panel), Claudia Heppner (Scientific Co-ordinator CONTAM Panel), Helen Kinghan (Science Department). European Commission Frans Verstraete (DG Health and Consumer Protection), Michael Walsh (DG Health and Consumer Protection), Walther Quasigroch (DG Health and Consumer Protection) 1. WELCOME AND APOLOGIES FOR ABSENCE The chair of the Panel opened the meeting and welcomed the participants for the last meeting of the CONTAM Panel in the current composition. Apologies for absence were received from the following CONTAM Panel members: Lucio Guido Costa and Philippe Grandjean. 1 Only present on 4 to 5 April 2006 2 Only present on 3 to 4 April 2006 contam_minutes_16th_plenmeet.doc Page 1 of 8
2. ADOPTION OF THE AGENDA The proposed agenda was adopted without modifications. 3. DECLARATIONS OF INTEREST Josef Schlatter and Philippe Verger declared that they were members of the FAO/WHO Joint Expert Committee on Food Additives (JECFA) in 2001 where ochratoxin A was discussed. Johanna Fink-Gremmels, Josef Schlatter and Diane Benford declared that they participated in an ILSI workshop on ochratoxin A on 29-30 July 2005 in Vienna. These declarations were not seen as causing any conflict of interests. 4. OCHRATOXIN A IN FOOD. DRAFT OPINION The chair of the working group (WG) on ochratoxin A introduced the draft opinion. The Panel adopted this opinion subject to incorporation of changes as suggested during the discussions. The chair of the Panel expressed his appreciation for this opinion to the WG and thanked the members of the WG for their work. 5. PERFLUOROOCTANE SULFONATE (PFOS) AND ITS SALTS. DRAFT OPINION The chair of the WG on PFOS introduced the draft opinion. During the discussion the Panel members proposed a number of revisions and the following main points for revising the draft opinion were recommended in order to adopt the opinion in the near future: i) A clear separation within the opinion on PFOS and PFOA is needed, or to consider issuing one opinion per substance. ii) The exposure section should point out that occurrence data were primarily covered fish, as well as addressing the major uncertainties in the exposure assessment. iii) For the risk characterisation a further reflection is needed with respect to what kind of health based guidance value, if any, should be established. The chair of the Panel expressed his appreciation for the work carried out so far by the WG. 6. MATTERS ARISING SINCE THE PREVIOUS MEETING The chair of the working group on undesirable substances in animal feed (section: persistent organic pollutants) (USAF-POPs) informed the Panel, that a revision to the opinion from 7 July 2005 3 on endosulfan as an undesirable substance had to be carried out. This was necessary because the only study of oral toxicity of endosulfan in fish listed in the original opinion was found to be actually a study 3 Updated opinion from 7 April 2006 available at URL http://www.efsa.eu.int/science/contam/contam_opinions/1025/contam_op_ej234_endosulfan_en_updated2 1.pdf contam_minutes_16th_plenmeet.doc Page 2 of 8
with endosulfan exposure of fish via water. Furthermore, two additional toxicity studies on endosulfan in fish feed were made available to the Panel. Therefore, the following items have been changed: i) Section 5.2, 1 st paragraph has been replaced by 2 new paragraphs; ii) conclusions, heading adverse effects in animals, bullet point on fish has been replaced as follows: Fish show high sensitivity to endosulfan exposure via water. Oral exposure studies have shown effects on thyroxin level and thyroid hormone metabolism at dietary concentration of 100 µg/kg (Nile tilapia), and ultrastructural alterations of the liver and intestinal tract at dietary concentration of 0.5 µg/kg (common carp). These effects were subtle, possibly adaptive, and were not considered to represent adverse effects. iii) Reference list was updated. 7. FEEDBACK FROM THE SCIENTIFIC COMMITTEE (SC) The chair reported back from the previous Scientific Committee meeting held in February 2006. The minutes of this meeting can be found on the EFSA web page 4. 8. GENERAL INFORMATION FROM EFSA The scientific co-ordinator informed the Panel on the following items: Membership in Scientific Committee/Panel at EFSA The Members of the Panel were informed that overall 874 applications were received. The applications of the experts were assessed using eligibility criteria as well as scientific selection criteria. A standardized scoring form was used to evaluate all potential candidates. In addition to the scientific criteria, the availability of the experts was also considered. A random subset of 65 applicants was additionally evaluated by three external senior EU risk assessors. The scoring of these experts was in line with the EFSA scoring. A shortlist was put together and sent on a confidential basis on 28 March 2006 to the members of the advisory forum asking for feedback. The Management Board (MB) will meet on 11 of May 2006 to nominate the experts for the term 2006 to 2009. Management Board meeting At the last MB meeting which was held on 29 of March 2006 in London, the EFSA annual report 2005 was adopted. The report will be available in the near future once the proposed revisions have been included in the document. 4 Available at URL: http://www.efsa.eu.int/science/sc_commitee/sc_meetings/1344_en.html contam_minutes_16th_plenmeet.doc Page 3 of 8
The chair of the Scientific Committee (SC) presented a paper on the functioning of the SC and Panels. The MB appreciated this paper and encouraged EFSA to implement the changes which can already be done. Some proposals however, such as a splitting of the AFC and CONTAM Panel into three Panels would require further discussions within EFSA. The MB is still awaiting the report from the European Parliament for Catherine Geslain-Lanéelle to proceed with the appointment of the new executive director of EFSA. 9. GENERAL INFORMATION FROM THE COMMISSION SERVICES ON MATTERS RELATING TO CONTAM The Service within the European Commission (EC) responsible for legislation introduced Michael Walsh, the new person appointed responsible for the relationship with EFSA, in particular on matters concerning the CONTAM Panel. Walther Quasigroch, currently on a placement with the DG Health and Consumer Protection, was also introduced. An overview of recent changes to EU legislation on contaminants in feed and food was provided. Contaminants in food - Establishment of maximum levels for the sum of dioxins and dioxin-like PCBs in food 5 and new action levels for dioxin-like PCBs 6. - Merging of all EU provisions on sampling for the control of mycotoxins (aflatoxins, ochratoxin A, patulin and fusarium-toxins) in food into one Commission Regulation 7. - Consolidating Regulation (EC) 466/2001 establishing maximum levels for contaminants in food, which has been already 18 times amended since 2001. It is expected that this consolidation will be finalised by July 2006. - Merging of the five specific Commission Decisions with special measures as regards some products of certain third countries due to unacceptable amounts of aflatoxins into one Commission Decision. The adoption by the Commission of this Decision is expected in May 2006. - The provisions as regards sampling and methods of analysis for dioxins and dioxin-like PCBs are currently reviewed, in particular as regards the sampling of fish. 5 Commission Regulation (EC) 199/2006 of 3 February 2006 available at URL http://europa.eu.int/eurlex/lex/lexuriserv/site/en/oj/2006/l_032/l_03220060204en00340038.pdf 6 Commission Recommendation 2006/88/EC of 6 February 2006 available at URL http://europa.eu.int/eurlex/lex/lexuriserv/site/en/oj/2006/l_042/l_04220060214en00260028.pdf 7 Commission Regulation (EC) 401/2006 of 23 February 2006 available at URL http://europa.eu.int/eurlex/lex/lexuriserv/site/en/oj/2006/l_070/l_07020060309en00120034.pdf contam_minutes_16th_plenmeet.doc Page 4 of 8
Contaminants in feed - Based upon the respective EFSA opinions, the provisions in Directive 2002/32/EC as regards camphechlor 8, lead, cadmium and fluorine 9 in animal feed has been amended. - Establishment of maximum levels for the sum of dioxins and dioxin-like PCBs in feed and new action levels for dioxin-like PCBs 10. - Measures as recommendation (increased monitoring and orientation values) related to mycotoxins such as zearalenone, ochratoxin A, fumonisins, and deoxynivalenol in feed are close to adoption. - It is foreseen that a recommendation will be issued by the Commission to monitor the presence of ergot alkaloids such as ergometrine, ergotamine, ergosine, ergocristine, ergocryptine and ergocornine in animal feed following the EFSA opinion on ergot as undesirable substance in animal feed. - Discussions are ongoing on amendments to the current provisions on endosulfan, endrin, aldrin/dieldrin and hexachlorocyclobenzene following EFSA opinions on these undesirable substances. Non-legislative activities: A joint EC/CIAA workshop on acrylamide was held on 16 to 17 March 2006 in Brussels, focussing on analytics, formation pathways, mitigation, home cooking, and risk assessment considerations. Break-out sessions in the area of potato products, cereal products, coffee and home cooking were organised at the second day of the workshop. A joint EC/JRC/EFSA workshop on furan in food: state-of the art on analytics and considerations for a scientific information database is planned to be held on 19 May 2006 in Brussels. Representatives from the Member States will be invited to this workshop in order to discuss the most appropriate format to collect data on furan to facilitate the risk assessment. A brief summary was given on the recent Belgium contamination case where elevated dioxin levels in pig fat were found. The source of contamination was the presence of elevated levels of dioxins in hydrochloric acid used as a processing aid to produce gelatine for human consumption from pig bones with fat intended for animal feeding as by product. The gelatine was found not to be contaminated by dioxins at significant levels. Belgium was asked to give at the occasion of an Expert 8 Commission Directive 2005/86/EC of 5 December 2005 available at URL http://europa.eu.int/eurlex/lex/lexuriserv/site/en/oj/2005/l_318/l_31820051206en00160018.pdf 9 Commission Directive 2005/87/EC of 5 December 2005 available at URL http://europa.eu.int/eurlex/lex/lexuriserv/site/en/oj/2005/l_318/l_31820051206en00190024.pdf 10 Commission Directive 2006/13/EC of 3 February 2006 available at URL http://europa.eu.int/eurlex/lex/lexuriserv/site/en/oj/2006/l_032/l_03220060204en00440053.pdf contam_minutes_16th_plenmeet.doc Page 5 of 8
Committee meeting mid April 2006 more details on the way of production of hydrochloric acid, resulting in such levels of dioxins. The US FDA re-opening probe related to formation of benzene in soft drinks due to interaction between benzoic and ascorbic acid and findings within Europe was discussed at the Standing Committee on 31 March 2006. 10. WORK PROGRAMME 10.1. Official requests to EFSA The Panel was informed that EFSA has received three new requests which fall within the mandate of the CONTAM Panel. Two requests from the Commission concern undesirable substance in animal feed (nitrite and mercury). These requests were accepted and the working group on USAF-heavy metals will be re-activated. One request was receive by Germany (Bundesinstitute für Risikobewertung, BfR) with regard to alternative methods to the mouse bioassay for routine shellfish toxin testing. As this request will need some reflection on the terms of reference it was proposed that a small group of Panel members will meet to discuss this in more detail, and to prepare draft terms of reference, to be reviewed by the Panel at its next meeting. The Panel was also informed that the Belgium government (Federal Overheidsdienst Volksgezondheid, Veiligheid van de Voedselketen en leefmilieu) did contacted EFSA following a publication in the Lancet oncology 11 asking to reconsider the current PTWI of 7 µg/kg body weight for cadmium. EFSA welcomed the additional data on lung cancer, but did not have the view that these data would lead to revision of the current PTWI due to the fact that the data provided in this study did not allow the establishment of a dose-response relationship. EFSA also noted the large uncertainty in the reported data and the limited number of individuals surveyed in this study compared to the environmental epidemiological studies from Japan considered in the latest evaluation in 2004 by JECFA 12. 11 Nawrot, T., Plusquin, M., Hogervorst, J., Roels, H.A., Celis, H., Thijs, L. Vangronsveld, J., Van Hecke, E. and Staessen, J.A. 2006. Environmental exposure to cadmium and risk of cancer: a prospective population-based study. Lancet Oncol 7: 119-126. 12 Available at URL http://www.inchem.org/documents/jecfa/jecmono/v52je22.htm contam_minutes_16th_plenmeet.doc Page 6 of 8
10.2. Update on undesirable substances in animal feed (section: persistent organic pollutants) The chair of the WG informed the Panel, that the work for the remaining opinions on hexachlorobenzene and DDT are progressing very well, and that the work on chlordane and heptachlor will start soon. 10.3. Update on undesirable substances in animal feed (section: natural plant products) The assistant scientific co-coordinator informed the Panel that a WG meeting scheduled for March had to be cancelled, but a new meeting is foreseen in May. It was also reported that an expert on gossypol has joined the WG. 10.4. Update on undesirable substances in animal feed section coccidiostats The scientific co-ordinator informed the Panel that the WG had its first meeting in March, were the general structure of the opinion and the distribution of tasks were discussed. A next meeting is scheduled for the beginning of July 2006. Industry provided data on the safety on non-target animal species for six coccidiostats, and the data submission for the five remaining coccidiostats is scheduled for mid April. A dialog with the industry representatives who submitted data is foreseen at one of the next WG meetings. 10.5. Update on hormone residues in bovine meat and meat products The assistant scientific co-ordinator informed the Panel that a first meeting of the WG took place in January 2006. The structure of the opinion was discussed and the need for additional experts was identified. A second meeting of this WG is scheduled in July 2006. 11. Presentation: Report from the Norwegian Scientific Committee for food safety: Fish and seafood consumption in Norway benefits and risks. A Panel member presented a report 13 from the Norwegian Scientific Committee for food safety (VKM) Fish and seafood consumption in Norway benefits and risks which was issued on 28 March 2006. The Panel welcomed very much this presentation. 13 English summary of the report is available at URL http://www.vkm.no/eway/default.aspx?pid=0&oid=- 2&trg= new& new=-2:16530; English translation of the responses to questions posed in the mandate is available at URL http://www.vkm.no/eway/default.aspx?pid=0&oid=-2&trg= new& new=- 2:16531 contam_minutes_16th_plenmeet.doc Page 7 of 8
12. CONTAM Plenary meeting dates 2006 The next meeting, which will be the inauguration of the new CONTAM Panel, is planned to take place on 12 to 14 June 2006. 13. Any other business The chair of the CONTAM Panel and the Secretariat on behalf of EFSA thanked the Panel members for their excellent support over the last 3 years. contam_minutes_16th_plenmeet.doc Page 8 of 8