ACNFP minutes: 25 November 2004

Minutes of the meeting held on 25 November 2004 in Conference Room 5, Aviation House, 125 Kingsway, London.

Present

Chairman:
Professor Mike Gasson

Members:
Professor Philip Dale
Miss Jill Brand
Professor Ruth Chadwick
Mr Neville Craddock
Professor John Fowler
Professor Alan Malcolm
Dr Clive Meredith
Professor Ian Rowland
Professor John Warner

FSA Assessor:
Dr Clair Baynton

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

Observers:
Dr Reggie Vas - National Food Authority Sweden

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 Hilary Close, Tony Williams, Jim Dunwell, Peter Lund and Gary Foster. Written comments submitted by these Members were tabled at the meeting. Apologies were also received from observers from FSA Scotland, Wales and Northern Ireland (Mrs Elspeth MacDonald, Mr Phil Morgan, and Mr Gerry McCurdy).

The Chairman welcomed Mrs Alison Dyson to the Secretariat.

The Chairman noted that Professors John Warner and Philip Dale would reach the end of their terms of appointment in December and that this would be their last meeting. The Chairman thanked them for their contribution to the Committee throughout their membership.

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 68th meeting
DRAFT/ACNFP/68/MIN

Subject to the addition of further text under Matters Arising, Members agreed that the minutes were a true record of the 68th meeting of the ACNFP held on 23 September 2004.

3. Matters Arising
There were no matters arising.

4. Fruit juices (inc. Tomato juice) and nectars with added phytosterols: ACNFP/69/1
Members were asked to consider an application from Coca Cola Services s.a., for the authorisation of fruit juices and fruit nectars with added phytosterols as novel foods.

Prior to discussion of this item Professor Rowland declared a non-personal, non-specific personal interest and informed the Committee that his department carries out unrelated research on behalf of Cargill, the company that manufactures the phytosterol ingredient. The Chairman concluded that he should remain.

The Secretariat indicated that they were not seeking the Committee's view on the safety of the phytosterol ingredient as an opinion on equivalence had already been provided. However, Members were asked to comment on the proposed use of phytosterols in fruit juices and nectars.

The Committee indicated that although additional reassurance was offered by the requirements of phytosterol labelling regulation 608/2004, they remained concerned about potential consumption by 'at risk' groups, particularly children and teenagers. Members were of the opinion that the potential for inappropriate consumption was greater with a product of this type than with a low fat spread made with added phytosterols. The Committee further drew attention to the proposed sale of the phytosterol containing fruit juices in 250ml containers, and indicated that such products could be particularly attractive to children.

The Committee therefore asked whether the product would be marketed in a way that distinguished it from similar products without added phytosterols.

Members discussed the addition of phytosterols production as micro-sized particles and requested additional clarification as to the exact nature and size of the particles and whether these presented any safety concerns. The Committee also noted the comments received during the public consultation, particularly those of the Margarine & Spreads Association regarding the relative contribution of butter and spreads to fat intake by UK consumers.

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

5. Lycopene oleoresin from tomatoes (Lyc-O-Mato®): ACNFP/69/2
Members were asked to consider 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. The applicant is already marketing this oleoresin in the EU as an ingredient for food supplements and as a food colorant (E61Od).

The Committee noted that the applicant had provided information on previous human exposure to tomatoes and tomato products, but not the oleoresin. Members considered that the data provided were insufficient to support the application and specifically highlighted the lack of data regarding the potential intake by children.

Members expressed concerns about the use of the oleoresin in foodstuffs such as ice cream, cakes or biscuits, and indicated that the potential health benefits provided by the addition of the oleoresin would be compromised by the presence of sugar and fats in such products. Members suggested that healthy eating patterns could therefore be unnecessarily disrupted.

The Committee reviewed the safety data on the product and was informed that the SCF had previously accepted the use of tomato oleoresin as a food colour. The Committee noted that the SCF opinion of 10 December 1987 was based on a limited evaluation that did not include formal toxicological studies. Members advised that skin irritation studies should be repeated with the recent batches of the oleoresin and also asked for information on skin sensitisation. The Committee noted the increased lung weights of female rats in the semi-chronic toxicity study and requested a detailed report of the histopathological analyses.

Additionally, the Committee requested that the applicant should provide data on the level of tomatin in the oleoresin, and examine the potential allergenicity of the oleoresin through the analysis of its protein content by an appropriate method.

The Chairman asked Members whether they had any concerns regarding the size of the lycopene particles in the oleoresin. The Committee did not express any concerns and indicated that the particles would disperse when ingested.

The application dossier had been placed on the Agency's website for a 21-day public consultation. One response was received which included a total of 13 comments on Lycored's application. Members agreed in general with the responses proposed by the Secretariat to these different points as outlined in the meeting paper. However, Members requested that the Secretariat should forward three comments to the applicant related to: (i) consumption of tomato oleoresin by male teenagers, (ii) estimate of consumption in kg/body weight, focusing on infants and (iii) effect of lycopene consumption on children.

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

6. ACNFP factsheet on Antibiotic Resistance Markers: ACNFP/69/3
At its September 2004 meeting the Committee considered a draft revised factsheet on the use of antibiotic resistance markers in GM plants. Members had suggested a number of changes and requested that they be incorporated into a revised factsheet. The Committee was therefore invited to comment on the redrafted factsheet.

Subject to the incorporation of further minor changes, Members indicated that they were content with the factsheet. The Secretariat informed the Committee that the final text would be cleared by Chairman's action following the incorporation of Members' comments.

7. ACNFP factsheet on cholesterol lowering foods: ACNFP/69/4
At its meeting in September 2004 the Committee considered a draft revised factsheet on cholesterol lowering foods. Members had suggested a number of changes and requested that they be incorporated into a revised factsheet. The Committee was therefore invited to comment on the redrafted factsheet.

Subject to the incorporation of further minor changes, Members indicated that they were content with the factsheet. The Secretariat informed the Committee that the final text would be cleared by Chairman's action following the incorporation of Members' comments.

8. Genetically Modified oilseed rape events Ms8, Rf3 and Ms8xRf3: ACNFP/69/5
At its March 2004 meeting the Committee had considered a favourable opinion (with limited scope) from the Belgian CA under the Deliberate Release Directive (EC) No. 2001/18. This concerned a notification for import, cultivation, and processing of oilseed rape genetically modified for the presence of transformation events Ms8, Rf3 and Ms8xRf3 hybrids.

On the basis of the data provided the Committee was unable to exclude the possibility of human health problems associated with pollen from these lines. These concerns were outlined in a letter to ACRE on 29 March 2004. The applicant has now withdrawn its request for cultivation but nevertheless had provided additional information to address the concerns of the Committee.

Amino acid query sequences translated from the nucleotide sequence data from the gene insertion site, the flanking sequences, and the plant DNA junctions were used to look for homologies with known allergens at the whole protein and the 8 amino acid epitope level. No translated sequences showed any significant homology with known toxins or allergens and none of the sequences showed identity with known allergenic epitopes.

The applicant also carried out a Western blot analysis of the presence or absence of introduced gene products. The results show that there was a low but detectable level of the PAT protein in pollen. However, the Committee agreed that the presence of the PAT protein does not present any toxic or allergenic risk.

The Committee was satisfied that the additional data provided had addressed their concerns.

9. Any Other Business
9.1 ACNFP Open Meeting

Members discussed the ACNFP open meeting which had taken place on Wednesday 24 November. The meeting was well attended and Members noted that early feedback on the day had been positive. The Committee noted the comments raised by attendees, particularly those relating to nanotechnology and the evaluation of traditional foods from countries outside the EU.

The Secretariat agreed to distribute a questionnaire to all attendees to obtain further feedback.

10. Items for Information
10.1 EU Update: ACNFP/69/6

This paper provided an update on novel food applications under (EC) 258/97 and details of recent meetings of the European Food Safety Authority (EFSA) Scientific Panels.

10.2 GM Food and Feed Regulation: ACNFP/69/7
This tabled paper explained the procedures for assessment and authorisation of food products obtained from genetically modified organisms (GMOs), according to EU legislation that came into force in April 2004.

11. Date of next meeting
The next meeting of the Committee was scheduled for Wednesday 26 January 2005, in Aviation House.