ACNFP minutes: 13 March 2003

Minutes of the meeting held on Thursday 13 March 2003, in Conference Room A, Aviation House.

Present

Chairman:
Professor Janet Bainbridge

Members:
Professor Phil Dale
Professor Peter Aggett
Miss Jill Brand
Professor Ruth Chadwick
Dr Hilary Close
Mr Neville Craddock
Professor James Dunwell
Dr John Fowler
Dr John Heritage
Professor Peter Lund
Professor Alan Malcolm
Dr Clive Meredith
Professor Ian Rowland
Professor John Warner

Secretariat:
Dr Sandy Lawrie
Dr Jane Cockram
Dr Sharn Bowen
Ms Ruth Dadswell
Mr Mark Boden
Ms Iulia Young
Mr Adam Hardgrave (Minutes)
Ms Azuka Aghadiuno

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 Professor Mac Johnston, Dr Clair Baynton (FSA Assessor), and Mrs Elspeth MacDonald, Mr Phil Morgan, and Mr Gerry McCurdy (Observers from FSA Scotland, FSA Wales and FSA Northern Ireland).

1.2 Members were informed that this was to be the last meeting for Professor Peter Aggett, who is an ex-officio member by virtue of his membership of the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT), which comes to an end on 31 March. The Chairman thanked Professor Aggett for his invaluable contributions over many years with the Committee.

1.3 The Chairman introduced Azuka Aghadiuno as a new member of the Secretariat.

1.4 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. Draft Minutes of the fifty-eighth meeting - DRAFT/ACNFP/58/MIN
Members agreed that, subject to one minor change, the minutes were a true record of the 58th meeting of the ACNFP held on 14 November 2002.

3. Matters Arising
3.1 Gene Transfer - ACNFP/59/1
The Committee was asked to consider whether the work commissioned by the Food Standards Agency (or other published work on gene transfer) had addressed its original concerns on the presence of antibiotic resistance markers and potential for gene transfer. The Committee was also asked to consider whether further work is required in this area and to identify any remaining issues that need to be addressed.

Members suggested that a review of all the recent work carried out on gene transfer would be helpful, although they recognised the difficulty of such an exercise. It was noted that a similar exercise is already being carried out as part of the Science Review that is part of the Government's GM Public Debate.

Members noted that there was insufficient information to allow quantitative estimates of gene transfer and also commented on the relative lack of information on gene transfer in environments other than the gut flora. Members agreed to send further written comments to the Secretariat.

4. Diacylglycerol oil (Enova Oil) - ACNFP/59/2
Diacylglycerol (DAG) oil is a novel food ingredient, which is prepared from vegetable oils using an immobilised enzyme preparation. The resulting product contains a high proportion of 1,3-diacylglycerols and is intended for use as a replacement for conventional cooking oils.

A paper summarising the key elements of this application had been sent to Members by post in February, along with the initial assessment report from the Dutch Competent Authority and the applicant's dossier. Members had been asked to consider if they agreed with the opinion of the Dutch authorities that the product should be authorised, or if they wished to raise any comments.

Members had broadly agreed with the Dutch CA opinion and their comments were used to prepare a draft UK opinion, which the Committee was now asked to consider.

Members felt that specific data on the presence of protein in the final oil should have been included in the dossier, rather than accepting assumptions made by the company. They also questioned the assessment of the enzyme preparation, since the relevant data were not included in the original application.

The Committee was asked to consider the possibility that the starting material for manufacture of DAG-oil could be GM-derived, i.e. authorised oil extracted from GM crops, and whether this type of starting material was adequately covered by the evaluation.

Members felt that this would not present any additional concerns as long as the GM crops were authorised for food use. However, they reiterated the need for evidence to support statements made in the dossier regarding the presence of protein in the final oil.

The Secretariat agreed to modify the draft UK opinion in light of these comments and clear it by Chairman's action.

5. Odontella aurita - ACNFP/59/3
The Committee was asked to consider a notification under article 5 of regulation (EC) 258/97 to market a marine microalga Odontella aurita as a novel food.

The notification was made on the basis of an opinion from the French Competent Authority that O.aurita is substantially equivalent to a range of macroalgae (or seaweed) which are authorised for food use under French regulations. These algal species have a significant history of consumption and are taxonomically distinct from O.aurita. The opinion on substantial equivalence was based on the broad compositional analysis of the relevant species.

O.aurita is intended to be used in soup, crackers, various fish products and as a food supplement, with an estimated average consumption of approximately 2g/week. Although described in some of the documentation as a flavouring ingredient, its primary use is as a source of polyunsaturates and trace elements.

The Committee was asked if it had any concerns regarding the marketing of this alga and if it was happy to accept that this microalga can be regarded as "substantially equivalent" to a range of taxonomically distinct seaweeds.

The Committee noted that microalgae are very different from seaweed and concluded that this product should therefore not have been submitted as an Article 5 notification. Instead, its safety should be assessed according to the standard novel Foods Decision Tree.

Members reported that the data included in the dossier were inadequate to make a reasonable judgement of allergenicity, as they related to contact hypersensitivity (a type 4 allergic reaction) and were of limited relevance to consumption of the product (which could elicit a type 1 IgE allergic response).

Members concluded that more information would be required on toxicity, allergenicity, HACCP and the intended use of the product in order to allow a proper safety assessment. The assessment should also address specific concerns related to the potential intake of iodine and silicates associated with the product.

Members noted that the company had stated its intention to build a purification plant to ensure that arsenic levels were maintained within acceptable limits and advised that this should be a mandatory condition of authorisation.

The Secretariat agreed to write to the Commission raising the Committee's concerns on this application.

6. Increasing the openness of the ACNFP - ACNFP/59/4
Although the Committee already complied with most of the recommendations on openness in the FSA's March 2002 Report on the Review of Scientific Committees, it was now asked to consider how to implement Recommendation 26:

'all Committees should move to a position where they conduct as much of their business as possible in open sessions'.

The Secretariat pointed out that the ACNFP differs from most other committees that advise the Agency since much of its work involves assessment of dossiers that often contain commercially sensitive information. The Secretariat had therefore proposed draft guidelines for the handling of items that involve restricted information in open session. Members were asked to consider the document and whether they were content in principle to hold open meetings.

Members agreed that holding meetings in public would be challenging, but were not opposed to the idea. Members noted that most of the discussions they normally have on applications could be held in public, particularly as more information on applications is now published on the FSA website. They discussed the handling of confidential data and agreed that such discussions should be held in two parts, with a closed session either before or after the open meeting. The minutes would clearly reflect this separation.

The Secretariat was asked to redraft the guidelines document in line with Members' suggestions, for consideration at the next meeting. The Committee would then be in a position to hold its first public meeting in July.

7. Factsheet - ACNFP/59/5
The ACNFP Secretariat issues a corporate brochure to interested parties, outlining the work of the Committee, its membership and its functions. A new factsheet describing the ACNFP's links with other advisory committees had been revised following suggestions made at the 58th meeting. The Committee was asked to consider the redrafted fact sheet and to suggest any final amendments.

Members agreed that, subject to minor changes (the addition of the ACNFP's remit and a key), the factsheet should go forward for production. The Secretariat agreed to make the changes requested and would clear the final factsheet through Chairman's action.

8. Items for information
8.1 EU Update - ACNFP/59/6
The Committee was provided with an information paper covering recent EU activity on issues relevant to the Committee's work. Members found this paper very useful and requested that it become a regular item on future agendas.

8.2 Update on applications dealt with by post:
Maize line NK603 (novel food application)
Maize line NK603 (deliberate release application)
Oilseed rape line GT73 (deliberate release application)

The Secretariat provided an update on three dossiers that had been dealt with by post since the last meeting and informed that Committee the relevant postal papers will be made available on the website alongside the normal agenda papers. In each case, the Committee had been asked to advise on initial opinions prepared by other Member States. UK responses to these three applications would be submitted later in the month, in accordance with the timescales set out in Regulation 258/97 (novel foods) and Directive 2001/18 (deliberate release).

8.3 Assessments of Novel Foods and Deliberate Releases of GMOs - ACNFP/59/7
This paper contained information on dossiers that have entered the systems for authorisation of novel foods and for approval for environmental releases of GMOs, and which are likely to be presented to the Committee for evaluation at some point. The paper also gave a brief explanation of the new procedures for environmental releases, which came into force late last year under directive 2001/18/EC, replacing those originally established under directive 90/220/EEC.

Members agreed that this paper would help in the construction of a forward work plan for the Committee. Members agreed to contact the Secretariat with any other issues they wished to appear on the work plan.

9. Any other business
9.1 Annual Report
A draft of the Committee's Annual Report for 2002 had been distributed to Members for comment during January/February and had been finalised by Chairman's action at the end of February. The report had now gone to the printers and was expected to be published shortly after Easter.

10. Date of the next meeting
The next meeting is scheduled for Thursday 22 May 2003, in Aviation House.