Food Standards Agency
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Minutes of the meeting held on Thursday 20 November 2003 in Conference Room 5, Aviation House.
Professor Mike Gasson
Professor Philip Dale
Miss Jill Brand
Professor Ruth Chadwick
Dr Hilary Close
Professor Jim Dunwell
Professor Gary Foster
Professor Alan Malcolm
Dr Clive Meredith
Professor Ian Rowland
Dr Anthony Williams
Dr Clair Baynton
Dr Sandy Lawrie
Mr Colin Ross
Ms Frances Cleaver
Ms Kate Halliwell
Dr Chris Jones
Dr Sonia Molnar
Ms Michelle Gardner
Members are required to declare any personal interest in matters under discussion. Where Members have a particularly close association with any item, the Chairman will limit their involvement in the discussion. In cases where an item is to be discussed in their absence, a Member may make a statement before leaving.
1. Apologies and announcements.
1.1 Apologies were received from Dr John Fowler, Professor John Warner, Mr Neville Craddock, Dr Peter Lund, and from observers from FSA Scotland, Wales and Northern Ireland (Mrs Elspeth MacDonald, Mr Phil Morgan, and Mr Gerry McCurdy).
1.2 The Chairman welcomed Professor Gary Foster who was very recently appointed to the Committee and was attending his first meeting. The Chairman also welcomed Dr Sonia Molnar to the Secretariat.
1.3 The Chairman reminded Members of the need to announce any commercial interests in the business of the Committee, prior to the discussions on each item.
2. Minutes of the sixty-second meeting: DRAFT/ACNFP/62/MIN
Members agreed that, subject to the correction of two typographical errors and one minor change, the minutes were a true record of the 62nd meeting of the ACNFP held on Wednesday 17 September 2003.
3. Matters Arising
3.1 Deerhorn Powder
Members were informed that the Agency had written to the European Commission on 20 October 2003 with its reasoned objection to this novel food application. This product had been unanimously rejected by all member states.
The Committee was informed that the Agency had written to the European Commission on 20 October 2003 with its reasoned objection to this novel food application. The application had been referred to the Nutrition Panel of the European Food Safety Authority (EFSA).
3.3 Unsaponifiable matter of palm oil
Members were informed that the Agency had written to the European Commission on 20 October 2003 with its reasoned objection to this novel food application. The Secretariat reported that the company had withdrawn their application.
3.4 Herbicide-tolerant rice line LLRICE62 (deliberate release)
Members were informed that their comments had been forwarded to the Department for Environment Food and Rural Affairs (Defra) on 20 October 2003.
4. Diacylglycerol oil: further data – ACNFP/63/1
This novel food application was made via the Netherlands and the Dutch initial opinion had been discussed at the Committee's meeting in March 2003. While the Committee had no major concerns over the product, they highlighted various areas where clarification and/or further information was required to support the statements made in the dossier.
The applicant had produced an additional dossier of information to address the questions raised by the UK and by other member states. They had subsequently provided further information on the resin component of the immobilised enzyme preparation used in the manufacture of the modified oil.
The Committee confirmed that the new information adequately addressed their earlier questions. They were still however concerned about the potential presence of allergens and sought confirmation of the levels of protein in the final product.
The Secretariat agreed to seek a response from the applicant on this point before passing the Committee's final views to the European Commission.
5. Isomaltulose: ACNFP/63/2
Members were asked to consider a new application that the UK Competent Authority had received for the use of this novel disaccharide in a range of foodstuffs. The application had been placed on the Agency's website for public consultation with a deadline of 5 December 2003. The Committee was therefore asked to give a provisional opinion, subject to their consideration of any further comments that might be received from the public consultation.
Prior to discussion of this item Professor Rowland noted that his department was receiving funding for two research projects from the applicant company, neither of which involved isomaltulose. The Committee agreed that Professor Rowland should be able to take part in the discussion of this item.
The Committee considered that the toxicity studies supplied were sufficient to demonstrate the safety of the product. However it noted that the potential intake by young children was higher that for adults (on a body weight basis) and that children also have a higher incidence of fructose intolerance. The Committee requested further information on this issue.
Members were concerned that the target market and the exact function of the novel ingredient were unclear, and that its inclusion in certain products might lead to an increase in energy intake. The Committee noted that isomaltulose was less sweet than other sugars and was concerned that the consumer should not be misled into thinking that products with reduced sweetness also contained less energy. These concerns were intensified by the proposal to use isomaltulose in both reduced energy and high energy foods.
Members also identified a possible polymorphism for isomaltulose metabolism in the population, based on the limited data available from a study on 8 healthy ileostomists. Members suggested that malabsorption resulting from such a polymorphism might explain the adverse gastrointestinal effects that were observed in some children and not others.
The Secretariat agreed to contact the company to request further information on the points raised by the Committee.
6. Lycopene from Blakeslea trispora: ACNFP/63/3
Members were asked to consider this Novel Food application to incorporate lycopene produced from Blakeslea trispora into dietary supplements and a range of foodstuffs. The application had been made via the UK Competent Authority and had been placed on the Agency's website for public consultation with a deadline of 5 December 2003. The Committee was therefore asked to give a provisional opinion, subject to their consideration of any further comments that might be received from the public consultation.
The Committee was generally satisfied with the toxicological safety data provided by the applicant. Clarification was requested on the significance of the altered incidence of hyaline droplet nephropathy in one of the toxicity studies. Members also sought clarification whether similar tests conducted on the B. trispora biomass used in the production of beta-carotene raised any additional concerns.
Members also considered that the applicant should demonstrate the absence of anaerobic organisms, specifically Clostridium species, and noted that the application dossier did not address the exposure to residual solvents that would result from consumption of lycopene in capsule form.
The Secretariat agreed to contact the company to request further information on the points raised by the Committee.
7. Post Market Monitoring Feasibility Study: ACNFP/63/4
The Committee were invited to consider the outcome of a recently-completed study that examined the feasibility of conducting nutritional surveillance using commercially available sources of food purchase data, and to consider what further steps might be taken towards developing an effective monitoring system for different types of novel foods.
This topic had also been discussed at the Committee's open meeting on the previous day.
The Committee considered post market monitoring to be a potentially useful tool but noted that there were a number of difficulties associated with the collection of meaningful information for such a study. There was a wide divergence in both lifestyle and diet among the UK population and it might be expected that there would be variations in the manifestation of unexpected adverse effects. These presented significant obstacles to the detection of subtle effects related to novel foods that typically would form a small percentage of the diet.
The Committee recommended that the likely sensitivity of any proposed monitoring should be assessed before any further studies were commissioned, bearing in mind that any unexpected long-term effects might be small and cumulative.
Members considered that alternatives to population-based monitoring may be more effective, such as studies designed to test specific hypotheses or a formal system for collecting reports of adverse reactions to novel foods.
The Secretariat agreed to draft a statement reflecting the Committee's consideration of the study for the next meeting.
8. Forward look: ACNFP/63/5
This paper provided members with information on dossiers that are awaiting evaluation under the procedures for novel foods and for releases of GMOs to the environment. The paper invited Members to propose any additional topics for inclusion in future agendas and requested members' views on three possible issues for future consideration:
Following discussion Members agreed to consider the criteria for decisions relating to the substantial equivalence of novel foods at future meetings. The Committee also assented to the setting up of a joint sub-group with the Scientific Committee on Nutrition, and a sub-group of members to discuss approaches to the assessment of GM hybrids and other issues related to molecular characterisation of GMOs.
9. Items for Information
9.1 EU update: ACNFP/63/6
This paper provided an update on EU issues that are relevant to the work of the Committee. These included novel food applications, and new EU regulations on GM food and feed and on the traceability and labelling of GM food. The paper also contained minutes of the 4 July 2003 and 2 October 2003 meetings of the European Food Safety Authority (EFSA) Scientific Panel on Genetically Modified Organisms.
10. Any other business
10.1 ACNFP open meeting
Members were invited to discuss the open meeting that was held in Aviation House on the previous day (19 November 2003).
The Committee believed that the open meeting had been successful and provided stakeholders with a good opportunity to voice their opinions and concerns. While initial feedback from the audience had been generally positive Members suggested that a meeting evaluation form should be circulated to all attendees in order to assess their perception of the event.
The Committee agreed that the smaller group sessions had been productive. The broad, approachable questions had facilitated wider discussion and the smaller groups encouraged those who were otherwise apprehensive about contributing to the proceedings. However it would have been beneficial to have separate rooms for breakout groups.
During the meeting a number of questions fell within the remit of either the Advisory Committee on Releases to the Environment (ACRE) or the Food Standards Agency. The Committee suggested that the Secretariat should develop the current mechanism for addressing any questions that are outside the remit of the Committee. The Secretariat noted that they had recorded all such questions and would ensure that they were dealt with appropriately. Members considered that it would be useful for a representative of ACRE and an Agency Board member to be present at future open meetings.
The Secretariat agreed to circulate a meeting evaluation form and to produce a Secretary's note of the meeting.
11. Date of next meeting
The next meeting of the Committee was scheduled for Wednesday 4 February 2004, in Aviation House.