ACNFP Minutes 3 April 2008

Notes for the meeting of the Committee at 9.30am on 3 April in conference room 5, Aviation House, Kingsway, London

Present:

Professor Mike Gasson - Chairman
Dr Paul Brantom
Professor Michael Bushell
Professor Andrew Chesson
Ms Jayam Dalal
Professor Harry Flint
Professor Gary Foster
Dr Paul Haggarty
Professor John Mathers
Dr Clare Mills
Mrs Gillian Pope
Professor Christopher Ritson
Professor Peter Shewry

Apologies
Professor Stephen Holgate
Mr Kevin Swoffer
Professor John Warner

Observer
Professor Colin Blakemore

FSA Assessor
Dr Clair Baynton

FSA Observer
Sarah Hardy (Item 10)
Karen McCallum-Smith

Secretariat
Ms Alison Asquith - Minutes
Ms Azuka Aghadiuno
Ms Shuhana Begum
Dr Chris Jones
Dr Sandy Lawrie - ACNFP Secretary
Mrs Narriman Looch
Dr Manisha Upadhyay

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

The Chairman welcomed Andrew Chesson, who was attending his first meeting, and also Colin Blakemore, Chairman of the Food Standards Agency's General Advisory Committee on Science.

Two members had sent apologies for non-attendance. Apologies were also received from observers from FSA Wales and Northern Ireland (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 86th meeting DRAFT/ACNFP/86/Min

Subject to one amendment being made, Members agreed that the minutes were a true record of the 86th meeting of the ACNFP held on Thursday 31 January.

3. Matters Arising

The Secretariat provided the following update on items arising from the previous meeting.

ITEM 4: PDP

The Secretariat advised that a draft opinion incorporating the comments of the Committee would be placed on the Agency’s website for public comment in due course.

ITEM 8: Alpha–Cyclodextrin

The Secretariat agreed to send a letter to the applicant expressing the Committees views.

ITEM 9: EFSA Opinion on Cloned Animals

The Secretariat had submitted the Committee's views on the draft opinion to EFSA.

4. Review of Workshop on Novel Foods

The Committee considered that the workshop had been a success. Members commented that the time allocated to the discussion groups had been too short and this should be taken into account in planning any future events of this type. Also, a longer question and answer session would allow delegates' questions to be allocated to the relevant experts on the Committee.

The Secretariat agreed to take the Committee's comments into consideration when planning the next workshop.

Action: Secretariat

5. Phytosterols ACNFP/87/1

The Committee considered this application in November 2007 and January 2008. Members were asked to consider further information provided by the applicant in response to the questions raised at the Committee’s meeting in January 2008 on this request for an opinion on equivalence.

The Committee was informed that there was an error in the paper and the last sentence of paragraph 4 should read "… authorised in the EU for general use as an extraction solvent in the manufacture of food with a maximum residue limit of 1 mg/kg ".

The Committee was content with the information regarding the method used to determine residual solvents and recommended that sufficient monitoring should take place to ensure that the level of hexane residues does not exceed the maximum limit set in the EU.

The Committee remained concerned about the absence of compositional data to demonstrate what constituents make up the remaining 5% of the preparation not accounted for by phytosterols. The Committee considered that the use of different mixtures of vegetable oils to produce phytosterols could generate different constituents each time. The Committee noted that the existing ADM product is derived from a mixture of edible vegetable oils (including soybean) whereas the applicant’s product is derived solely from soybeans. Members were therefore not able to agree that it would be reasonable to assume that the other components seen in the applicant’s phytosterol are also present in existing phytosterol preparations

The Committee again requested evidence to support the applicant's statement detailing the individual minor constituents of the preparation.

The Secretariat agreed to obtain further information on these points from the applicant and to amend the draft opinion. The revised draft opinion would be circulated to Members for final comments before being published for a 10-day public consultation.

Action: Secretariat

6. DHA (Docosahexaenoic Acid) ACNFP/87/2

The Committee considered this application to extend the authorisation of DHA-rich oil from Schizochytrium sp. in January 2008. It was asked to consider further information provided by the applicant in response to its earlier concerns.

The Committee was broadly content with the additional information provided by the applicant.

The Committee concluded that there were some uncertainties as to the effect of long term dietary exposure to high levels of polyunsaturated fatty acids such as DHA, but it was of the view that this was a generic issue that did not apply solely to this ingredient. The Committee indicated that this issue should be further investigated at UK or EU level.

The Secretariat agreed to draft an Opinion for consideration at the next meeting.

Action: Secretariat

7. Beta-Glucan rich extract of Letinus edodes ACNFP/87/3

The Committee had previously considered this product on a number of occasions. The applicant had first submitted a request for an opinion on equivalence with an existing mushroom extract and, when this was rejected, a full application was made. The Committee was asked to consider additional data provided by the applicant in response to the questions raised at the November meeting.

The Committee considered that the data provided remained insufficient to conclude the safety assessment. It was particularly concerned about the possibility that the novel ingredient may contain secondary metabolites derived from the fermentation, which could be unsafe. The Committee therefore sought reassurance from the applicant that unidentified compounds contained in the product would not affect its safety. Such reassurance could be gained by the provision of additional safety studies carried out under OECD guidelines.

The Secretariat agreed to write to the applicant and advise them of the concerns of the Committee.

Action: Secretariat

8. D-Ribose ACNFP/87/4

The Committee was asked to consider this full new application for D-Ribose. D-Ribose is a naturally occurring 5-carbon sugar with the approximate sweetness of glucose and it is synthesised endogenously by the pentose phosphate pathway. The application was for D-Ribose synthesised by fermentation and the applicant was not proposing to use the novel ingredient solely for its sweetening properties, but considered that the novel ingredient has an energy recovery function and that the exogenous supplementation of ribose allows the cell to bypass the rate-limiting steps of the pentose phosphate pathway, providing a precursor for ATP and nucleotide synthesis.

The Committee considered that the stated metabolic effects were implausible as the novel ingredient’s contribution to energy recovery was insignificant when compared with the body’s ability to synthesise ATP.

The Committee noted that the toxicity reports did not suggest any abnormal effects. However, they were concerned that developmental studies showed that the novel ingredient could affect ossification and growth rate, which would be a concern as the novel ingredient was to be used in a wide range of products that might be consumed by pregnant women.

The Committee was also concerned that the administration of ribose can lower glucose levels, possibly as a consequence of insulin secretion. The Committee questioned the intake data, particularly in the 11-18 age group. The Committee considered that teenagers may take a significant amount of the novel ingredient through sports drinks, energy bars etc The Committee was also concerned about possible increases in uric acid levels as the applicant's post market analysis highlighted gout as one of the adverse reactions.

The Committee noted that the very low levels of protein found in the product suggested that allergenicity is unlikely to be a problem, but sought further background on the presence of known allergens in the source organism. Although the applicant had reported that the genomic sequence of the source species had been established, it was not clear whether this information was relevant to the strain used for ribose production.

The Secretariat agreed to write to the applicant seeking further information on these points.

Action:Secretariat

9. Annual Report ACNFP/87/5

The Committee was asked to consider the text of the 2007 Annual Report and to review its working practices after considering the FSA’s Good Practice Guidelines.

The Committee had one substantive comment on the Annual Report and agreed to provide any other detailed comments by post. The Committee considered that the FSA’s Good Practice Guidelines reflected the Committee’s current working practices.

Action: Committee

10 Kiwiberry Concentrate ACNFP/87/6

The Committee had considered this application on three occasions during 2007 when allergenicity was highlighted as the key issue of concern. At the November meeting, the Committee concluded that the in vitro allergenicity studies carried out by the applicant were insufficient to complete the safety assessment of the novel ingredient, as they did not accurately reflect the likely extent of cross-reactivity amongst individuals who are currently allergic to green kiwi (A. deliciosa). The applicant had now asked the Committee to consider its likely response to the results of a proposed in vivo study which they would carry out to provide the necessary data to enable the Committee to complete their safety assessment.

The Committee considered that they could not comment on the in vivo study until it was completed but confirmed that they sought information on the relationship between kiwi fruit and kiwiberry allergy, as it was possible that people could be allergic to one but not the other. The Committee could not rely solely on the in vitro studies that had been carried out previously to determine the possibility of cross reactivity. Members recognised that there was a possibility that an in vivo study would identify subjects who reacted to the kiwiberry, but this would not preclude the product from gaining a favourable opinion in the future.

The Secretariat agreed to draft a formal response to the applicant.

Action: Secretariat

11 Items for Information

The Committee noted the following information papers:

11.1 EU update ACNFP/87/7
11.2 Update on G03 Research Programme ACNFP/87/8
11.3 Update on the General Advisory Committee on Science (GACS) ACNFP/87/9
11.4 Update on other Scientific Advisory Committees ACNFP/87/10

12 Any other business

The Secretariat reported that the joint subgroup of the ACNFP and SACN, which is looking at approaches to the nutritional assessment of novel foods, would resume work in the next few months. As members of the original subgroup have recently retired from the ACNFP, and therefore were no longer eligible to serve on the subgroup. The subgroup gives applicants guidance on how to undertake nutritional assessments of novel foods. Three members volunteered to serve on the Subgroup.

Jayam Dalal reported that the FSA had set up a group whose members have a common interest in Indian Culture and in linking it with the work of the Agency. The group was due to hold its second meeting in Neasden Temple on 22 April 2008.

The Chairman thanked Narriman Looch for all her hard work as part of the Secretariat, particularly in the organisation of the April open meeting, and wished her well in her new post in the Agency.

Date of next meeting

The next meeting was scheduled to be on 4 June at Aviation House.