ACNFP minutes: 30 March 2005

Minutes of the meeting held on 30 March 2005 in Conference Room 5, Aviation House, 125 Kingsway, London.

Present

Chairman:
Professor Mike Gasson

Members:
Miss Jill Brand
Professor Ruth Chadwick
Dr Hilary Close
Mr Neville Craddock
Professor Jim Dunwell
Professor Gary Foster
Professor Stephen Holgate
Dr Peter Lund
Professor Alan Malcolm
Dr Clive Meredith
Professor Ian Rowland
Professor Peter Shewry

Secretariat:
Dr Sandy Lawrie - Secretary
Mrs Alison Dyson - Minutes
Ms Michelle Gardner
Ms Kate Halliwell
Dr David Jefferies
Dr Chris Jones
Dr James Ridsdale
Ms Annie-Laure Robin
Mr Colin Ross

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 Tony Williams and John Fowler. Written comments submitted by Dr Williams were tabled at the meeting. Apologies were also received from Clair Baynton and observers from FSA Scotland, Wales and Northern Ireland (Mrs Elspeth MacDonald, Mr Phil Morgan, and Mr Gerry McCurdy).

The Chairman welcomed Professor Stephen Holgate and Professor Peter Shewry who had been recently appointed to the Committee.

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 seventieth meeting
DRAFT/ACNFP/70/MIN

Members agreed that the minutes were a true record of the 70th meeting of the ACNFP held on Wednesday 26 January 2005.

3. Matters Arising
Fruit juice and nectars with added phytosterols

Following the January meeting the Secretariat circulated a revised draft opinion on this application for Members' comments, after which it was issued for public consultation. A number of comments were received and, where relevant, these were incorporated into the opinion before it was finalised by Chairman's action. The Secretariat further noted that the opinion would be forwarded to the Commission shortly.

4. Plant sterol enriched rice drink
ACNFP/71/1

The Committee was asked to consider the Finnish Competent Authority's opinion on an application submitted by Teriaka for authorisation of a plant sterol-enriched rice drink as a novel food.

Members noted that the applicant's plant sterol ingredient (Diminicol®) was the same as that approved for other food uses, except that the sterols in this application were to be mixed with sunflower oil rather than other edible oils. The Committee also drew attention to the absence of efficacy data directly attributing the lowering of blood cholesterol to the consumption of this specific product, but concluded that the effect was likely to be similar to that of other approved plant sterol-enriched drink products.

Members also queried the applicant's statement in Annex 1 of the application, that 'vegetable oil sterols are GMO free as verified with PCR test'. The Committee was concerned that this claim could be misleading given that there are no approved GM sources of sunflower oil.

The Committee confirmed that they agreed with the Finnish Competent Authority's positive opinion and noted that the product must be labelled in accordance with Regulation (EC) No 608/2004, which applies to all foods with added plant sterols. The Secretariat agreed to draft the UK response to the Finnish Competent Authority's opinion accordingly.

One Member sought clarification on the potential effects of added sterols in individuals with the genetic condition phytosterolaemia. The Secretariat agreed to report back on this point at the next meeting.

5. Tagatose
ACNFP/71/2

The Committee was asked to consider an application submitted by Bioresco on behalf of Arla Food Ingredients, Denmark for the authorisation of D-tagatose as a novel food ingredient. The Secretariat noted that following discussions with the Commission and other Member States, it had been agreed that D-tagatose should be regarded as a novel food ingredient and not as a food additive (sweetener). Members had not had a great deal of time to consider this application and in view of this, and the large amount of toxicological data that accompanied the dossier, the Secretariat asked for initial views and invited members to submit more detailed comments by post.

Members highlighted the potential for accidental consumption by consumers with milk allergies who follow a milk-free diet. The Secretariat assured members that, according to the EU-wide legislative framework for the labelling of allergens, D-tagatose would have to be additionally labelled as being derived from milk.

The Committee further noted that D-tagatose could be used in a wide range of foodstuffs and expressed concern about the potential for over consumption, particularly by children and diabetics. Members also drew attention to the possible absence of human data regarding the effect of absorption and noted that the applicant had provided intake data obtained from a US study as opposed to a study carried out within the EU. The Secretariat agreed to look into these points, and contact the applicant as necessary.

The Secretariat indicated that they would await any further comments from Members and, if there were not points requiring clarification by the applicant, would draft an opinion for consideration at the May meeting.

6. Food use of 1507 maize - further data
ACNFP/71/8

The Committee initially reviewed the food uses of 1507 maize under Regulation 258/97 in early 2004. At that time the Committee requested further data on both the specificity of expression of the novel genetic material, and potential allergenicity. As this application dossier was not sufficiently advanced when Regulation 1829/2003 on GM food and feed came into force in April 2004, the dossier was re-presented for consideration under the new regulation. The transferred application, which included the applicant's response to the concerns previously raised by the ACNFP, had been evaluated by the European Food Safety Authority (EFSA). EFSA had now issued a positive opinion and the Committee was asked to confirm whether its earlier questions had been answered satisfactorily.

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 discussion. Dr Peter Lund chaired the Committee's discussions on this item.

The Committee noted the applicant's explanation of the additional protein band that appears in the Western blot that had been carried out to demonstrate the presence of the insecticidal Cry1F protein and requested sight of the unpublished technical report submitted to EFSA as part of the application. Members were also interested in any further information the applicant could provide to confirm the identity of the additional band.

Members confirmed that the additional data provided by the applicant addressed their other concerns. The Secretariat agreed to contact the applicant to request this additional information concerning the Western blot.

7. Noni juice from Mi GmbH
ACNFP/71/3

The Committee was asked to consider an application from Mi GmbH Switzerland and Mi EU Ltd, for an opinion on the equivalence of their noni juice to the GSE Vertrieb product already approved for sale in the EU.

The Committee advised that the applicant had provided insufficient data for the assessment of this application and requested more detailed compositional analysis.

The Secretariat agreed to contact the applicant to request this additional information.

8. Lycopene-rich oleoresin from tomato
ACNFP/71/4

At its November 2004 and January 2005 meetings the Committee had considered an application from Lycored for an opinion on oleoresin derived from lycopene-rich tomatoes to be used in a range of foodstuffs, including bread, juices and dairy products. At the January 2005 meeting 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 remained concerned about the possible over-consumption of the oleoresin by children as result of it being used in foodstuffs such as ice-cream, cakes or biscuits. During their consideration of the draft opinion Members also noted that carotenoids pass into breast milk and requested information on the potential transfer of lycopene to breast-fed infants.

Members had previously requested expert advice from the animal pathologist concerning the increased lung weights of female rats in the semi-chronic toxicity study. The Secretariat had obtained an assessment by a member of the Committee on Toxicity which concluded that this finding was not indicative of a target organ toxic effect but was related to the increase in overall body weight in the rodents. The Committee accepted this advice.

The Committee was informed that new analytical data on protein content for the lycopene rich-oleoresin had been requested but this had yet to be provided.

The Secretariat agreed to present an updated draft of the Committee's opinion once the applicant had provided information on the points raised above.

9. Items for Information
9.1 EU Update: ACNFP/71/5

This paper provided Members with an update on novel food applications under (EC) 258/97, other EU issues relevant to the work of the Committee, and details of recent meetings of the European Food Safety Authority (EFSA) Scientific Panels.

9.2 Update paper on novel foods research: ACNFP/71/6
This paper provided members with an update on the Agency's research programme for novel foods.

In July 2004, the Committee had been asked to consider priorities for commissioning future research by the Novel Foods, Additives and Supplements Division, to underpin the safety of GM and novel foods.

Members noted that the Agency's recently published research requirements document had not included all of the areas that they had regarded as a high priority, but anticipated that they might be included in a future document.

9.3 Nanotechnology
This paper provided Members with information on the Government's response to the Royal Society/Royal Academy of Engineers report Nanoscience and Nanotechnology: Opportunities and Uncertainties.

10. Any other business
There was no further business.

11. Date of next meeting
The next meeting of the Committee was scheduled for Thursday 19 May 2005, in Aviation House.