ACNFP Secretariat
Food Standards Agency
Room 515b Aviation House
125 Kingsway
London WC2B 6NH
Tel: +44 (0)20 7276 8595
Fax: +44 (0)20 7276 8564
acnfp@foodstandards.gsi.gov.uk
Notes for the meeting of the Committee at 9.30am in Conference room 5 Aviation House, Kingsway, London
Professor Peter Shewry – Chairman
Dr Paul Brantom
Professor Andrew Chesson
Ms Jayam Dalal
Professor Harry Flint
Dr Paul Haggarty
Professor John Mathers
Dr Clare Mills
Mrs Gillian Pope
Professor Christopher Ritson
Mr Kevin Swoffer
Apologies: Professor Michael Bushell
Professor Gary Foster
Professor Mike Gasson
Professor Stephen Holgate
Professor John Warner
FSA Assessor: Clair Baynton
Secretariat: Ms Azuka Aghadiuno
Misss Alison Asquith (Minutes)
Ms Shuhana Begum
Dr David Jefferies
Dr Chris Jones
Dr Darren Key
Dr Sandy Lawrie - ACNFP Secretary
Miss Nathalie Shapiro
Dr Manisha Upadhyay
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. In the absence of Mike Gasson, Peter Shewry agreed to chair the meeting. Apologies were also received from observers from FSA Scotland, FSA Wales and Northern Ireland (Mrs Elspeth MacDonald, Mr Phil Morgan and Mr Gerry McCurdy).
The Chairman welcomed Nathalie Shapiro who has recently joined the Secretariat on the administration team whilst Sandeep Virdee is on maternity leave
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 91st meeting DRAFT/ACNFP/91/Min
Subject to minor amendments members agreed that the minutes were a true record of the 91st meeting of the ACNFP held on Thursday 20 November 2008.
3. Matters Arising
The Secretariat provided the following update on items arising either following the previous meeting or in the previous meeting:
Item 3 Extranet
The development of the Agency's extranet is currently on hold. The Secretariat will discuss with the FSA's IT security officer whether ACNFP papers can be provided to members on compact discs.
Item 4 Phosphated Distarch Phosphate
The opinion has not yet been finalised but it will be circulated to Members for their final clearance in the next few days.
Item 5 Touchi (Black Bean) extract
The applicant provided the missing information, as requested by the Committee, and the draft opinion was issued for public comment. As there were no responses the opinion was forwarded to the Commission as the basis of the UK's initial assessment of this ingredient.
Item 6: Draft EFSA Opinion on Nanotechnology
The FSA submitted comments based on the discussions by both ACNFP and COT. The final version of the EFSA opinion is expected to be issued in the next 2-3 weeks.
Item 7: CLA-rich oil
The Commission is forwarding this application for EFSA for advice on the objections and other questions raised by the UK and other Member States.
Item 9: Reproduction studies in mice with GM maize
The Committee's observations on this report were circulated to the Commission, EFSA and other Member States. The Austrian authors have provided some initial comments on the points raised by the Committee. They have also responded to some of the points raised by EFSA's GMO Panel, who considered this report at their meeting in December. The Austrian authorities are considering whether further details of the work can be circulated to EFSA and other Member States (on a confidential basis) prior to publication in the scientific press.
4. Review of Open Event on Novel Foods
The Committee considered that the previous day's Open Event was a good one and that the right topics had been selected for discussion.
The discussion group on intake levels queried whether the ACNFP should consider higher levels of consumption than the 97.5th percentile currently used when evaluating the safety of products. However, consumption at the top end of the distribution is unlikely to be maintained over a sustained period and therefore it was not considered necessary to evaluate for this volume of consumption.
The discussion group on intake levels also highlighted the weak data on food consumption in the European Union (EU) as a whole and the need for an EU-wide database. The Committee agreed that there was a lack of data across the EU and that there was a need for contemporary data to bring it up to date. It considered the UK’s NDNS programme, which the FSA sponsors was amongst the best and in future will take the form of a rolling survey. EFSA recognises the need for better data across the EU and is working on a pan-European database. It will take several years before it is available. In the meantime EFSA is aiming to have some methological and coded data for all member states to access.
A discussion group on labelling suggested that a list of novel foods which have been authorized together with their labeling requirements be published. The Secretariat agreed to include the list in an information paper to be presented to the Committee at its next meeting.
The ethical remit of the ACNFP was questioned during the open discussion. The Committee’s ethicist agreed to draft a discussion paper for the committee. This will include the ethics of testing on children to determine both the benefits and risks of certain foods consumed by children.
The Committee requested that the secretariat collate feedback obtained from delagates. It also asked that the next open event should include a report on the actions taken from the previous event.
Action: Secretariat
5. Isomalto-oligosaccharides ACNFP/91/1
The Committee was asked to consider this application from Bioneutra Inc. to the UK Competent Authority for the approval of Isomalto-oligosaccharides (IMO) as a novel food ingredient.
One public comment was received during the 21 day consultation period and this provided data showing that two other IMO preparations (not Bioneutra’s) were fully absorbed and altered serum insulin levels. The Committee considered this comment and the associated data as part of their assessment of the novel ingredient.
The Committee requested that given the variability in the composition of IMO preparations from different sources, data from tolerance studies and absorption studies using Bioneutra’s own IMO preparation would be required.
The Committee considered that the applicant should consider the effects of their IMO preparation on blood glucose/insulin levels and should provide relevant data, particularly if the novel ingredient is absorbed to a significant degree.
The Committee was concerned that, if there is significant absorption, the novel ingredient may have the potential to mislead diabetics who might consume the product because they have perceived it to be a prebiotic dietary fibre rather than a mixture of carbohydrates that may be largely or fully absorbed. It also noted that the applicant’s proposed product label would need to be amended in line with EU legislation to state that the product is “derived from a source of wheat”.
The Secretariat agreed to obtain further information from the applicant on these points.
Action: Secretariat
6. Astaxanthin (Parry Nutraceuticals) ACNFP/92/2
The Committee was asked to consider whether an application made by Parry Nutraceuticals for an opinion on whether their astaxanthin-rich oleoresin extracted from H. pluvialis is substantially equivalent to an existing product from Cyanotech.
The Committee considered it was impossible to make an assessment using the data presented by the applicant from batches produced in different years, given that the manufacturing process has changed during that period.
The Committee also sought clarification on the criteria for substantial equivalence and the secretariat agreed to circulate the existing guidance for discussion at a future meeting.. It also agreed to obtain further information from the applicant to improve the quality of the data.
Action: Secretariat
7. Astaxanthin (Bioreal AB) ACNFP/92/3
The Committee considered the Finnish Competent Authority’s (CA) initial opinion on this application for authorisation of astaxanthin-rich extract as a novel food ingredient.
The Committee was concerned that evidence from rat studies indicated that astaxanthin accumulates in the eye to the same extent as canthaxanthin and concluded that further studies on food safety aspects of astaxanthin should be concluded. The Committee considered that long term exposure and the potential for accumulation of astaxanthin in tissues need to be examined further.
The Committee was not satisfied with the applicant’s proposal to label products with a statement that they are only intended for healthy adults and not for consumption by children or pregnant women. The Committee noted that adults may still regard themselves as healthy whilst still taking medication to manage their conditions and a number of women may not know they are pregnant until after the critical stages of development that take place in early pregnancy. The consumption of astaxanthin by at-risk groups therefore needs to be considered further.
The Committee considered that astaxanthin residues in food, resulting from its use in animal feed, were considered acceptable on the basis that it is a normal constituent of wild fish. However, its use as a food ingredient would lead to increased levels of intake and the data indicated a toxicological concern. The Committee noted that the available data were not sufficient to establish an acceptable daily intake..
The Secretariat agreed to transmit the Committee’s comments to the European Commission as part of the UK's formal response to the Finnish opinion.
Action:Secretariat
8. New Publications Relevant to the Safety of GM Foods: ACNFP/92/4
The Committee considered 3 published papers comparing the effects of GM and non GM crops. The papers were on the following:
1. A long term (24 month) proteomic and ultrastructural study on the effects of GM soya on liver ageing in rats;
2. A three generation study on the effects of GM Bt corn on various biochemical and histopathological parameters in rats;
3. A study of the gut and peripheral immune response to GM maize MON810 in mice.
The Committee considered the papers were not definitive. The studies were broad observational studies and therefore appeared to have no clear goals. There was a lack of comparability between the GM and non GM feed given to the rats which would add to the difficulty in interpreting the results. The Committee considered the results in all three papers were inconclusive and could not draw any conclusions about their significance caused by the transgenes.
The Committee noted also that papers 1 and 2 had no protection against false positives. Also, the results were interpreted solely in terms of differences introduced by genetic modification, with no allowance for other factors such as mycotoxins, some of which were above the legally allowed level for food. The third study was better designed but the Committee was concerned that differences may have been misinterpreted as changes.
Action: Secretariat
9. 2008 Annual report/Review of SACS Guidance ACNFP/92/5
The Committee was asked to comment by post on a first draft of its 2008 Annual Report and to consider a self assessment questionnaire. Comments received will form the basis of a discussion at the next Committee meeting.
Action: Members, Secretariat
10. Items for Information
EU update ACNFP/92/6
Update on other Scientific Advisory Committees ACNFP92/8
11 Any other business
The Committee noted that the FSA used to have special events for consumer representatives on FSA advisory committees. The consumer representatives on the committee considered these were a useful means of sharing information about activities on all of the committees, which were of interest to consumer representatives and asked if the FSA had any plans to continue these events.
The Committee raised the issue of ethnic and religious population subgroups which may have particular dietary habits. Members noted that research into cultural aspects of diets may be of particular interest to the Economic and Social Research Council.
12 Date of next meeting
The next meeting was scheduled to be held on 29 April 2009