ACNFP minutes: 23 September 2004

Minutes of the meeting held on 23 September 2004 in Conference Room 5, Aviation House, 125 Kingsway, London.

Present

Chairman:
Professor Mike Gasson

Members:
Miss Jill Brand
Dr Hilary Close
Mr Neville Craddock
Professor Jim Dunwell
Professor Gary Foster
Dr Peter Lund
Professor Alan Malcolm (Items 1-6)
Dr Clive Meredith
Dr Anthony Williams

FSA Assessor:
Dr Clair Baynton

Secretariat:
Dr Sandy Lawrie
Mr Colin Ross
Ms Michelle Gardner
Ms Kate Halliwell
Dr David Jefferies
Dr Chris Jones
Dr Sonia Molnar
Ms Annie-Laure Robin

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
Apologies were received from John Warner, Phil Dale, Ruth Chadwick, Ian Rowland, John Fowler and from observers from FSA Scotland, 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 sixty-seventh meeting
DRAFT/ACNFP/67/MIN

Subject to one minor textual change, Members agreed that the minutes were a true record of the 67th meeting of the ACNFP held on Thursday 22 July 2004.

3. Matters Arising (including postal consultations)
3.1 Insect resistant GM maize line MON 863: ACNFP 68/P/1
Following the discussion at the July meeting, the committee reviewed the complete dossier of information provided in support of this novel food application by post and Members provided written comments to the Secretariat. As Professor Gasson was a member of the scientific panel on GMOs responsible for drafting the European Food Safety Authority (EFSA) opinion on this application he did not contribute to the postal consultation.

The outcome of this postal consultation is summarised in the following paragraphs.

Members noted that the molecular characterisation of MON 863 maize was generally satisfactory but was incomplete in one respect, as it left open the question whether any genes in the maize genome have been disrupted by the insertion event. The available data do not rule out the possibility that the inserted DNA was first coupled with mitochondrial DNA during the process of incorporation of the insert into the maize genome. This uncertainty had been acknowledged in the initial opinion from the German assessment body and more recently by EFSA's scientific panel on GMOs. These bodies concluded that this did not represent a safety concern and they advised that MON 863 maize is equivalent to conventional maize and is unlikely to have an adverse effect on human or animal health.

The Committee discussed this issue at length and stressed that complete characterisation of the insertion site should normally be provided for all GMOs, as indicated in the draft guidelines for safety assessment that were recently published by EFSA. In the case of MON 863 maize, the Committee concluded that the uncertainty about the insertion of mitochondrial DNA during the genetic modification was unlikely to influence the safety of food products derived from the maize.

The Committee took account of the other data showing that MON 863 maize exhibits no phenotypic differences other than the intended insect resistance traits, when compared with parental maize lines.

The Committee also noted the results of a 90-day toxicity study in rats and feeding studies in other animals. These studies were additional to the minimum data requirements for assessment of GM foods and did not identify any potential hazards. While providing some reassurance of safety, these studies did not provide evidence of a complete absence of risk. Nevertheless, taking the data as a whole, the Committee agreed with the conclusions reached by the EFSA panel.

4. ACNFP fact heet on Antibiotic Resistance Markers: ACNFP/68/1
At its May 2004 meeting the Committee considered the EFSA GMO panel's opinion on the use of antibiotic resistance genes as marker genes in genetically modified (GM) plants. Following discussions on this item Members suggested that the ACNFP factsheet on the use of antibiotic resistance markers in GM plants should be updated to reflect the comments of the Committee. Members were therefore asked to consider a draft revised factsheet.

Members suggested a number of changes and requested that they be incorporated into a revised draft for the next meeting.

5. ACNFP factsheet on cholesterol lowering foods: ACNFP/68/2
At its July 2004 meeting the Committee considered a draft revised factsheet on cholesterol lowering foods. Members suggested that the document could be made more accessible by reducing the amount of technical detail. Members were therefore invited to comment on an amended draft factsheet.

Members suggested a number of further changes and requested that they be incorporated into a revised draft for the next meeting.

6. ACNFP open meeting: ACNFP/68/3
Following discussions at the Committee's July meeting Members were asked to finalise the programme for the open meeting to be held on 24 November 2004.

Subject to a minor change in the running order, Members agreed with the proposed programme for the meeting and identified Members to introduce case studies and to chair each of the sessions.

The Secretariat advised Members that they would publicise the meeting and begin working on relevant papers.

7. Any other business
The Secretariat informed Members of its intention to meet with the Advisory Committee on Releases to the Environment (ACRE) to discuss the assessment of GM hybrids.

Following the identification of a selection of Members to attend this meeting, the Secretariat agreed to liaise with ACRE to identify a suitable date.

7.1 Postal consultation: Lycopene-rich extract from tomatoes
The Secretariat advised the Committee that this application for use of a tomato extract as a novel food ingredient had been received and was posted on the website for public comment. Members were informed that papers relating to this postal consultation would be circulated in due course, once the Secretariat had clarified certain issues.

8. Items for information
8.1 EU update: ACNFP/68/5
This paper provided a routine update on EU issues of relevance to the work of the Committee. These included an update on current novel food applications, the implementation of EC Regulation 1829/2003 (on GM food and feed), and applications for authorisation of GM food and feed under Regulation 1829/2003.

The paper also provided details of recent meetings of the European Food Safety Authority (EFSA) Scientific Panels.

8.2 Safety of genetically engineered foods: ACNFP/68/6
This paper summarised the recommendations of a report on identifying and assessing unintended effects of genetically engineered foods on human and animal health, produced on behalf of the Institute of Medicine and the National Research Council of the National Academies of the USA. The Secretariat noted that this report raised no new issues that were not addressed in the EU evaluation of GM foods.

8.3 Update on substantial equivalence notifications: ACNFP/68/7
This paper provided members with information on a series of notifications received via the European Commission for noni juice and phytosterols to be marketed in the EU.

9. Date of next meeting
The next meetings of the Committee were scheduled for Wednesday 24 November (open meeting) and Thursday 25 November 2004, in Aviation House.