Food Standards Agency
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Notes for the meeting of the Committee at 10.30am on 22 November in conference room 5, Aviation House, Kingsway, London
Professor Mike Gasson
Ms Jill Brand
Ms Jayam Dalal
Professor Gary Foster
Professor Stephen Holgate
Professor Alan Malcolm
Dr Clare Mills
Professor Peter Shewry
Professor John Warner
Dr Paul Brantom
Professor Ruth Chadwick
Mr Neville Craddock
Professor Harry Flint
Professor Peter Lund
Dr Clair Baynton
Ms Sarah Hardy (Food Allergy Team - Item 5)
Ms Alison Asquith (Minutes)
Ms Azuka Aghadiuno
Ms Shuhana Begum
Dr Chris Jones
Dr Sandy Lawrie (ACNFP Secretary)
Mrs Narriman Looch
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
Five members had sent apologies for non-attendance and written comments from several of these were tabled at the meeting. Apologies were also received from observers from FSA Scotland, Wales and Northern Ireland (Mrs Elspeth MacDonald, Mr Phil Morgan and Mr Gerry McCurdy)
The Chairman thanked Ms Jill Brand, Professor Ruth Chadwick, Mr Neville Craddock, Professor Alan Malcolm and Professor Peter Lund, whose terms end on 31 December, for their positive contributions to the work of the Committee.
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 84th meeting DRAFT/ACNFP/84/Min
Subject to one amendment being made, Members agreed that the minutes were a true record of the 84th meeting of the ACNFP held on Thursday 20 September
3. Matters Arising
The Secretariat provided the following update on items arising from the previous meeting:
ITEM 3: Astaxanthin-rich oleoresin from H. pluvialis algae
The Secretariat was awaiting further information from the applicant on issues that were raised during the public consultation on this application. Once this is available, a draft opinion will be presented for discussion at a future meeting of the Committee.
ITEM 8: Cold water dispersible lycopene from B. trispora
The Food Standards Agency wrote to the European Commission on 17 October indicating that this application should undergo an additional assessment.
ITEM 9. Calcium L-methylfolate
The Food Standards Agency wrote to the European Commission on 8 October agreeing with the Irish initial assessment report on this application, with the proviso that use of this ingredient in infant formula and follow-on formula would require further assessment.
4. Phosphated Distarch Phosphate (PDP) ACNFP/85/1
The application had been discussed by the Committee in September and November 2005 and in July and September 2007. The Committee was asked to consider the text of the draft opinion and in particular the sections concerning allergenicity, labeling and the overall discussion and conclusion.
The Committee’s primary concern had been the potential for this ingredient to give rise to gastro-intestinal (GI) intolerance in young children, who would be the highest consumers (by body weight). The data provided by the applicant regarding GI intolerance were obtained from studies on healthy adults, which were not directly applicable to young children who may have a different gut microflora.
Members had previously indicated that clear labelling could ensure that consumers were adequately informed about the potential for the product to elicit GI intolerance. Members considered the labelling proposal in the draft opinion and concluded that, on the basis that the available data on GI intolerance were not necessarily applicable to children, it was not possible to say that intolerance would only occur if ‘excessive’ quantities of the ingredient were consumed. Members agreed that in all other respects the labelling should be consistent with that currently used for foods containing polyols.
The Secretariat agreed to amend the draft opinion as suggested by the Committee and to circulate the text on labelling to all Members for final comment. The overall opinion would be cleared by Chairman's action prior to it going to public consultation.
5. Kiwiberry Concentrate ACNFP/85/2
The Committee considered this application at the July and September 2007 meetings when allergencity had been highlighted as the key issue of concern. As it appeared unlikely that there would be any further data on this issue, the Committee was asked to consider whether the remaining uncertainties in this area prevented them from completing the risk assessment. The Committee was also asked to consider the effectiveness and implications of the risk management options, including the possible restriction of food categories and the provision of information to health professionals and allergy support groups.
The Committee noted that kiwi allergy is of increasing concern in the UK and some other EU member states. It also noted that the UK population was increasingly susceptible to allergic diseases. This was highlighted in a House of Lords Science and Technology Committee Report in September 2007 .
The Committee noted that kiwiberry is, on the basis of taxonomy and a limited in vitro analysis, likely to be allergenic to individuals who are currently react to green kiwi fruit and were concerned about the absence of in vivo studies to determine the likelihood of allergic responses to the unprocessed kiwiberry fruit and the heat-treated kiwiberry concentrate.
In the absence of these data, and in view of the potentially serious consequences of cross-reactivity in individuals previously sensitised to green kiwi fruit, the Committee was of the view that it was not possible to conclude their risk assessment of this novel ingredient. In view of this Members did not offer a view on the adequacy of the proposed risk management options. The Secretariat agreed to convey the Committee's conclusions to the applicant and, if no further data were available, to draft a formal opinion.
6. Beta-Glucan rich extracts from Lentinus edodes (Shiitake mushroom) ACNFP/85/3
The Committee had previously considered and rejected an application for an opinion on substantial equivalence between this product and an existing beta-glucan product that is derived from a different part of the same mushroom species. The applicant had now submitted a full application for authorisation of their mycelial extract as a novel food ingredient, for use in food supplements and a number of other food categories . The Committee was asked to consider whether the available data were adequate to determine whether the novel ingredient complied with the criteria for acceptance of a novel food and if not, to identify what further data should be provided.
Members advised that the applicant had not adequately characterised the components present in the product and that a full proximate analysis should be carried out. Members also requested evidence to support the statement that there was no effect of scale-up on the composition of the product, in order to confirm that data based on pilot scale fermentation systems could be used in the risk assessment.
Members also advised that the available animal studies showed that the product caused inflammatory effects, which would be expected in beta-glucan rich extracts, but the applicant had not provided the original data sets to enable the Committee to review these studies in detail. The Committee noted that the levels of lentinan, the primary beta-glucan present in the product, were significantly lower in the novel food ingredient than those found in Shiitake mushrooms themselves.
Members also noted that a clinical study had been carried out on elderly people, but this may have limited relevance to the population as a whole.
The Secretariat agreed to obtain further information on these points from the applicant, for discussion at the next meeting.
7. Phytosterols ACNFP/85/4
The Food Standards Agency received a request from Naturis for an opinion on substantial equivalence of a phytosterol ingredient manufactured in the USA, compared to phytosterols currently marketed by Archer Daniels Midland (ADM). The Committee was asked to consider whether it was content to agree that substantial equivalence has been established and, if not, what additional information the applicant should supply in order to demonstrate equivalence.
The Committee noted that no information was provided on the production process used by the US manufacturer of the sterols and it was not possible to determine the validity of the applicant’s statement that the “process is very close to the one described in the SCF Opinion and ADM novel food application”. Members also noted that the phytosterol ingredient contains 95% total sterols and asked for information on the composition of the remaining 5%.
The Secretariat agreed to contact the applicant and obtain the necessary information for the next meeting of the committee.
8. Open Meeting ACNFP/85/5
At the September meeting the Committee had agreed to defer the open meeting from November to April. The Committee was asked whether it was content with the proposed format of the open meeting and to suggest topics which should be covered.
The Committee agreed the proposed format of the meeting and suggested a number of topics. The Secretariat agreed to present the detailed arrangements for the open meeting for final agreement at the next meeting.
9. Review of Novel Foods Regulation
This item was not discussed.
10. Items for Information
10.1 EFSA Advisory Forum meeting on GMO risk assessment ACNFP85/7
The Committee raised concerns about the centralisation of risk assessments which make it difficult for applicants representing small companies to seek advice on applications prior to submitting them. It also raised concerns about the centralising of EFSA as difficulties travelling to Parma could discourage the best experts from participating in EFSA's Scientific Panels.
11. Any Other Business
The Secretary reported that interviews had taken place for new members, to replace those whose terms of appointment expire at the end of 2007, and the successful candidates would be appointed in time to attend the next meeting.
The Chair provided feedback from the Annual meeting of the Food Standards Agency’s advisory committee Chairs, which had taken place at the end of October. This meeting had covered a range of topics including two new scientific advisory committees that are due to being work in 2008, a General Advisory Committee on Science, to be chaired by Professor Colin Blakemore, and a Social Science Research Committee. On research funding, the Committee noted the overlap between the Agency's interests and those of other funding bodies such as the MRC and BBSRC, and the value of maintaining good links with those bodies.
12. Date of next meeting
The next meeting was scheduled for 31 January 2008, in Aviation House.