ACNFP minutes: 22 July 2004

Minutes of the meeting held on Thursday 22 July 2004 in Conference Room 5, Aviation House, 125 Kingsway, London.

Present

Chairman:
Professor Mike Gasson

Members:
Professor Philip Dale
Professor Ruth Chadwick (Items 1-8)
Dr Hilary Close
Mr Neville Craddock
Professor Gary Foster
Dr John Fowler
Professor Ian Rowland
Professor John Warner

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

Observers:
Claire Pitcher (Defra)

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 Jim Dunwell, Professor Alan Malcolm, Dr Anthony Williams, Dr Peter Lund, Miss Jill Brand, Dr Clive Meredith and from observers from FSA Scotland, Wales and Northern Ireland (Mrs Elspeth MacDonald, Mr Phil Morgan, and Mr Gerry McCurdy).

1.2 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 66th meeting
DRAFT/ACNFP/66/MIN

Members agreed that, subject to the correction of two typographical errors, the minutes were a true record of the 66th meeting of the ACNFP held on Thursday 27 May 2004.

3. Matters Arising
3.1 GM potato clone EH92-52
The Secretariat informed the Members that the Agency had relayed the Committee's comments on this deliberate release notification to Defra on 28 May 2004.

3.2 Astaxanthin-rich extract from Haematococcus pluvialis
The secretariat informed Members that the Committee's draft opinion was published for public comment in early June and that no comments were received. The Agency therefore issued a positive opinion to the applicant, indicating that this extract can be regarded as substantially equivalent to the existing algal product.

3.3 Antibiotic resistance genes as marker genes in genetically modified plants
Following discussion at the May meeting, and a subsequent exchange of views by email concerning the need for two or three categories of resistance gene, the Secretariat had circulated a draft letter reflecting the views of the Committee for Members' comments. The Secretariat informed the Committee that this letter would be finalised and sent to EFSA, after incorporating Members' final drafting suggestions.

3.4 Draft guidance document for the risk assessment of genetically modified plants and derived food and feed
The Secretariat informed the Committee that its views on EFSA's draft guidance document were sent to the Secretary of the GMO panel on 7 June 2004.

3.5 Phytosterols (Triple Crown AB)
Following the May meeting the Secretariat circulated information to Members confirming that the cholesterol-lowering effect of phytosterols occurs equally in individuals with normal and elevated blood cholesterol levels. The deadline for public comments on the company's application was 14 June 2004, and no comments were received. Members agreed the text of a draft opinion on substantial equivalence by email, and this was published for public comment with a deadline of 26 July 2004.

Phytosterol esters (Cognis GmbH)
The deadline for public comments on the company's application was 14 June 2004, and no comments were received. The Agency issued a positive opinion on 16 July 2004, confirming that phytosterol esters manufactured by Cognis can be regarded as substantially equivalent to those currently on the market in yellow fat spreads and certain other products. This conclusion was based primarily on commercial documentation showing that Cognis GmbH supplied the same phytosterol esters for use in the products that are currently on the market. The Agency's letter to the company was therefore not accompanied by a formal opinion from the Committee. Cognis subsequently notified the European Commission of its intention to market their ingredient.

Saskatoon berries
The Agency wrote to the applicant on 10 June 2004, confirming that saskatoon berries are not regarded as substantially equivalent to blueberries. The Committee was advised that the applicant has chosen not to proceed with a full application for novel food authorisation at this stage.

Noni Juice from Hawaii
The Committee's draft opinion on substantial equivalence between this product and the juice from Tahiti that is already on the EU market was published for public comment with a deadline of 13 June. Members were advised that the comments received did not raise any new issues and that the final opinion was formally conveyed to the applicant on 16 July 2004.

Glucosamine from Aspergillus niger
Members were informed that the company provided the Secretariat with the results of an additional analysis of their product, demonstrating the absence of low molecular weight peptides. The Committee's draft opinion on the substantial equivalence of this product and glucosamine extracted from shellfish was updated to reflect this conclusion and was published for public comment on 21 July 2004, with a deadline of 31 July 2004.

4. Insect protected genetically modified maize MON 863: ACNFP/67/1
Following reasoned objections from member states (MS), the Commission asked EFSA for an opinion on an application for authorisation of the maize line MON 863 and the hybrid line MON 863 x MON 810 under article 4 of regulation (EC) No. 258/97. The UK raised reasoned objections against the hybrid line but not MON 863. EFSA's Scientific Panel on GMOs had no concerns regarding the MON 863 line, in agreement with the original Committee assessment at the ACNFP meeting in July 2003.

The opinion of the EFSA panel regarding MON 863 was considered at the May 2004 meeting of the ACNFP. At this meeting the Committee expressed concern that new data presented to EFSA on the flanking sequences of the MON 863 insert was insufficient to allow the site of insertion in the maize genome to be completely identified. Members were invited to consider the response from the applicant to their request for further sequence data.

The Chairman declared a conflict of interest as he had been closely involved in the EFSA Panel's discussions on this maize line, and left the meeting room while this item was discussed.

The applicant had not provided any additional data but highlighted technical difficulties in obtaining and interpreting additional sequence data, referring the Committee to its detailed response to EFSA on this point. Members acknowledged the difficulties in providing the additional information they had requested but were still of the opinion that it would be feasible to obtain these data.

The Committee concluded that uncertainty about the insertion point should be considered in the context of all the other data on this maize line. As these data were not in front of the Committee at this meeting, and because other Members with GM expertise were not present, the Committee deferred further discussion on this item.

5. Research Forward Look: ACNFP/67/2
The Food Standards Agency's Novel Foods Division currently funds two extensive research programmes (G01/G02) that underpin the safety assessment of GM and novel foods. The Division is currently in the process of considering priorities for commissioning future research in these areas and had held a research review meeting on 13 July. A draft report of the priorities identified at this review was circulated to Members prior to the meeting. The Committee was invited to consider the work that had been carried out in the G01 and G02 programmes in order to suggest priorities for future research.

Members agreed with the ideas discussed in the research review meeting and suggested additional areas of research including: polymorphisms; the validity of health effects attributed to probiotics and prebiotics; phytosterol intakes in non-target groups; and detection methods, other than those based on DNA or protein, for oils, starches, and sugars derived from GM crops.

6. Noni Juice: ACNFP/67/3
At the May 2004 meeting Members considered an application for an opinion on equivalence of Noni juice (juice of the fruit of Morinda citrifolia L) grown on a number of Pacific Islands. Members raised a number of questions and requested further information from the applicant. The applicant had provided additional information to address the questions of the Committee.

The Committee was generally satisfied with the clarification of the fermentation process but considered that the new compositional data required clarification. Members noted that there was a large variation in levels of amino acids and that these were consistently higher in the case of matured noni. It was not stated whether these figures included amino acids in the form of proteins. The Committee therefore requested further information regarding the differences seen for amino acids together with a detailed description of the analytical methods.

In the light of a comment received during the public consultation on this application the Committee requested that analyses be carried out on a range of products in order to provide reassurance that mycotoxins will not be present in the final product. Members also requested information on any quality assurance procedures that might be in place.

The Secretariat agreed to contact the applicant to request further information on the points raised by the Committee.

7. ACNFP factsheet on cholesterol lowering foods: ACNFP/67/4
Members were invited to comment on the draft update of the cholesterol lowering foods factsheet.

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

8. ACNFP open meeting: ACNFP/67/5
The Committee was asked to consider the details and proposed agenda for the ACNFP open meeting to be held on 24 November 2004.

Members agreed with the proposed format and agenda for the meeting. However, the Committee suggested that it might be beneficial to have a short introductory presentation on the GM Food and Feed Regulation and the role of the European Food Safety Authority (EFSA). Members also agreed that part of the meeting should comprise smaller "breakout" groups to provide more opportunity for attendees to put their points across.

The Secretariat agreed to finalise the agenda and identify Members to chair each of the sessions. Subject to the Committee's final agreement the Secretariat advised Members that they would publicise the meeting and begin working on relevant papers.

9. Items for information
9.1 EU update: ACNFP/67/6
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 and the implementation of EC Regulations 1829/2003 (on GM food and feed) and 1830/2003 (on traceability and labelling).

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

10. Any other business
There was no further business.

11. Date of next meeting
The next meeting of the Committee was scheduled for Thursday 23 September 2004, in Aviation House.