Professor Peter Shewry – Chairman
Dr Paul Brantom
Professor Michael Bushell
Professor Andrew Chesson
Ms Jayam Dalal
Professor Harry Flint
Professor Gary Foster
Dr Clare Mills
Mrs Gillian Pope
Professor Christopher Ritson
Professor John Warner
Apologies Professor Mike Gasson
Dr Paul Haggarty
Professor Stephen Holgate
Professor John Mather
Mr Kevin Swoffer
FSA Assessor Clair Baynton
Secretariat Ms Azuka Aghadiuno
Misss Alison Asquith (Minutes)
Ms Shuhana Begum
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 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 92nd meeting DRAFT/ACNFP/92/Min
Subject to minor amendments members agreed that the minutes were a true record of the 92nd meeting of the ACNFP held on Thursday 19 February 2009
3. Matters Arising
The Secretariat provided the following update on items arising either following the previous meeting or in the previous meeting:
Postal Consultation: Licorice Root Extract (Glavonoid) ACNFP/P93/1
The European Commission timetable did not allow this application to be taken to the 93rd meeting. The Committee was therefore consulted by post and its written comments were compiled into a short report that was sent to the Commission. The Committee was concerned over the potential for effects on blood coagulation, particularly in sensitive individuals including patients undergoing anti-coagulant therapy, and for oestrogen-like effects. Other concerns were raised about the potential to exceed the recommended intake levels and the consumption of products by children.
On the basis of this advice, the Agency had written to the European Commission objecting to the authorisation of this novel ingredient.
Extranet The Food Standards Agency’s IT section was testing an encryption system for CDs, which should be available to be trialled at the Committee’s July meeting.
Phosphated Distarch Phosphate The Committee’s opinion was finalised by post and submitted to the European Commission on 27 April.
Draft EFSA Opinion on Nanotechnology The EFSA statement on nanotechnology was published on 5 March and would be presented in a paper to the next meeting
Astaxanthin (Bioreal AB) The UK opinion, based on the Committee’s advice, was forwarded to the Commission on 25 March.
Meetings of consumer representatives serving on scientific committees No further information was available for the Committee.
4. Cis-9 Cetyl Myristoleate Rich Complex ACNFP93/1
The Committee considered the Italian Competent Authority’s (CA) initial opinion on this application for authorisation of a cis-9 cetyl myristoleate rich complex as a novel food ingredient.
The Committee agreed with the Italian CA that the toxicological data were poor and queried whether the novel ingredient was being marketed as a medicine or food. The Committee was concerned that one form of the product contained significant quantities of myristic acid esters which could contribute to an increase in cholesterol. This was of particular concern as the product would be targeted at individuals with arthritic conditions who may also be elderly and overweight and should not consume products which could increase cholesterol levels.
The Committee also highlighted the atherogenic effect of myristic acid and the applicant’s reference to interactions with steroids and immunosuppressant drugs, which may be being taken by the target population.
The Secretariat agreed to write to the Commission reflecting the Committees discussion.
5. Sardine Peptide Product. ACNFP/93/2
The Committee considered the Finnish Competent Authority’s (CA) initial opinion on this application for authorisation of a sardine peptide product (SPP) as a novel food ingredient.
The Committee's main concern related to the animal studies presented in the dossier. The Committee’s view was that a 28 day feeding study was not sufficient to provide reassurance on the safety of sardine peptide product, particularly as it showed some marginal effects which should have been followed up in further investigations, such as a 90-day study. This concern formed the basis as to why the Committee was unable to agree with the positive opinion of the Finnish CA.
The Committee agreed with the Finnish CA that the novel ingredient was unlikely to cause an allergic reaction except to those who already have an allergy to fish. The Committee stated that the previous history of consumption of sardine meat was of limited relevance to the risk assessment of SPP given that SPP is a highly processed product.
The Committee noted that there may be potential for SPP to interfere with medication (such as ACE inhibitors) likely to be taken by hypertensive individuals. Additionally, the Committee was concerned that hypertensive individuals may consume foods containing SPP in favour of prescribed medication to control their blood pressure.
The Committee stated that as sardine peptide product is on the Japanese market, it would have been useful if the applicant had provided information about reports of adverse reactions and post-market monitoring.
The Committee discussed written comments submitted in advance of the meeting by absent memberswhich were tabled at the meeting. The comments highlighted the possibility of immunological reactions in fish-allergic individuals and drew attention to a published study on cat peptides which indicated that peptides, such as those in SPP, might have the potential to generate a Th2 T cell response leading to IgE responses if the intact protein is then ingested. It was the view of members at the meeting that this was applicable only for larger peptides than those present in SPP.
The Committee questioned the applicant’s proposed intake estimate of 0.6g SPP per portion for all products and considered that consumption of some products such as confectionery could lead to higher intake levels. The Committee also questioned the estimated daily intake values proposed by the applicant and expressed concern that some of the products categories would be particularly attractive to children.
The Committee questioned the conclusion of the Finnish CA that SPP is unlikely to alter the absorption of captopril or other ACE inhibitors, noting that high doses of valine-tyrosine may inhibit absorption of ACE inhibitors.
The Secretariat agreed to write to the Commission reflecting the Committee’s discussion
6. Chitin-Glucan ACNFP/93/3
The Committee considered the Belgian Competent Authority’s (CA) initial opinion on this application for authorisation of chitin-glucan, extracted from the fungus Aspergillus niger, as a novel food ingredient.
The Committee noted that there were numerous literature reports of A. niger allergy following spore inhalation. The Committee therefore considered that there was a significant risk of oral allergy as the novel ingredient contained significant quantities of protein. In this regard the Committee considered that it was misleading to call the product hypoallergenic did not accept the applicant’s view that it was not possible to characterise the proteins present. The Committee also noted that the source fungus is not generally consumed in the diet and in view of this the applicant should carry out a thorough investigation of the allergenic potential of the novel ingredient including an appropriate analysis of the protein component.
The Secretariat agreed to write to the Commission reflecting the Committee’s discussion.
7. 2008 Annual Report/Review of SACs Guidelines ACNFP/93/4
The Committee considered the revised draft of its 2008 annual report, which has been amended following the Committee's comments in February, and discussed its self assessment against the Food Standards Agency's Good Practice Guidelines for scientific advisory committees.
The Committee was content with the draft 2008 Annual Report and the self assessment of the guidelines subject to minor amendments. The Committee agreed that the self-assessment was a useful reflection of the Committees processes.
The Secretariat agreed to incorporate the amendments into the draft Annual Report and self assessment and to publish the Annual Report.
8. Guidance on Substantial Equivalence ACNFP/93/5
Following the Committee's recent discussions on the criteria for acceptance of requests for opinions on substantial equivalence, the Secretariat proposed revisions to the guidelines that the Committee had drawn up in March 2005 The Committee considered the Secretariats proposals and agreed them subject to minor amendments.
The Secretariat agreed to incorporate the amendments into the guidelines and publish the revised document.
9. Items for Information
9.1 Open Event ACNFP/93/6
The Committee noted the feedback and agreed that specific comments on small discussion groups would be considered when planning the next open event.
9.2 EU Update ACNFP/93/7
9.3 Novel Food Notifications ACNFP/93/8
9.4 Update on Scientific Advisory Committees ACNFP/93/9
9.5 Labelling Requirements for Novel Foods. ACNFP/93/10
The Committee noted the other information papers listed above, without comment.
10. Any other business
The Committee was invited to attend a workshop to be held on 24 June by the Food Standard Agency’s General Advisory Committee on Science. Some members had already volunteered to attend the workshop. Other members were encouraged to inform the Secretariat if they wished to attend.
11. Date of next meeting
The next meeting is scheduled for Thursday 2 July 2009 in Aviation House.