ACNFP minutes: 20 July 2006

Minutes of the meeting held on 20 July 2006 in Conference Room 5, Aviation House, 125 Kingsway, London.

Present

Chairman:
Professor Mike Gasson

Members:
Professor Ruth Chadwick
Mr Neville Craddock
Professor Jim Dunwell
Professor Gary Foster
Dr John Fowler
Professor Stephen Holgate
Dr Peter Lund
Professor Clive Meredith
Professor Ian Rowland
Professor Peter Shewry
Dr Anthony Williams

Secretariat:
Ms Alison Asquith
Ms Suhana Begum
Mrs Alison Dyson - Minutes
Dr David Jefferies
Dr Sandy Lawrie - ACNFP Secretary
Dr Sonia Molnar
Ms Annie-Laure Robin
Mrs Michelle Young

FSA Assessor:
Dr Clair Baynton

Observers:
Mr Clifton Gay – FSA

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 Jill Brand and Alan Malcolm. Apologies were also received from observers from FSA Scotland, Wales and Northern Ireland (Mrs Elspeth MacDonald, Mr Phil Morgan, and Mr Gerry McCurdy).

1.2 The Chairman welcomed Alison Asquith who will join the secretariat in August.

1.3 Members noted this was the final meeting for Professor Dunwell, Dr Fowler and Professor Meredith whose term of appointment end at the end of August. The Chairman thanked them for their contributions.

1.4 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 seventy-seventh meeting
DRAFT/ACNFP/77/MIN

Members agreed that the minutes were a true record of the 77th meeting of the ACNFP held on Wednesday 17 May.

3. Matters Arising

There were no matters arising.

4. Noni juice produced by Leap of Faith Farms
ACNFP/78/1

At the May meeting the Committee had confirmed it was satisfied with the additional information provided by the applicant but wished to ratify the wording of the sections on botanical identity of the noni fruit used and the shelf life and stability of the dried product. Members were invited to consider the revised text of the draft opinion on equivalence.

The Committee confirmed that subject to two textual changes they were content with the text of the opinion.

The Secretariat would arrange the draft opinion to be published on the ACNFP website for a 10 day publication before finalising any changes with the Chairman.

5. Ice Structuring Protein from GM yeast
ACNFP/78/2
ACNFP/78/2 - Addendum

Prior to the discussion of this item Mr Neville Craddock notified the Committee that in the past he had collaborated with one of the individuals named on the application, but not with respect to the subject of this application. The Committee agreed this was indirect interest and he was permitted to remain for the discussion of this item.

The Committee were asked to consider an application for the approval of an ice structuring protein preparation as a novel food ingredient. The applicant intends to use the novel ingredient in ice cream and other edible ice products to increase their nutrition profiles, organoleptic properties and stability.

The Committee asked for further explanation of the variability between batches of the ISP preparation, including the extent and pattern of glycosylation.

Members considered the potential allergenicity of the protein preparation and requested expert advice on the significance of homologies in the amino acid sequences of the ISP and proteins from Aspergillus niger. The Committee also requested further details of the sequence analyses conducted by the applicant in 2005. Members also requested that a study be carried out using an animal sensitisation model, noting that the arguments against such a study appeared to be outdated.

It was suggested that that using cod allergic individuals in Phase I of the assessment of the allergic potential of the ISP preparation may not be representative of the entire fish allergic population, in which case a wider panel of fish-allergic subjects should be studied.

The Committee confirmed that they were broadly content with the toxicological data provided but requested clarification on two points. Members noted that a concentrated version of the ISP preparation was used in the 90 day subchronic rat study and requested additional information on the preparation of the test material for compositional comparison with the novel ingredient. The Secretariat had received comments from the Independent Science Panel suggesting a need to conduct studies to test long-term inflammation in both young and older animals. The Committee requested expert advice on this point.

During the discussion on GM yeast the Committee requested sight of the available data on the molecular characterisation of the insert, including the analysis of the insert flanking sequences. Members also requested protein analysis data of the yeast with its non-GM counterpart.

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

6. Astaxanthin
ACNFP/78/3
ACNFP/78/3 - addendum

Members were asked to consider an application made by Cyanotech Corporation for an opinion on substantial equivalence of their astaxanthin-rich extract compared with the existing whole-algal product marketed by Astacarotene.

The applicant intends to market its extract as an ingredient to be used in hard and soft gelatine capsules and tablets to manufacturers of human dietary supplements.

Members noted that the applicant had failed to address possible differences between the proportions of esterified and non-esterified astaxanthin in the two products. The Committee requested the applicant demonstrate substantial equivalence by providing compositional data to show the levels of free and esterified astaxanthin in both products

One comment received following the public consultation had raised concerns that the production method could be prone to contamination resulting in the presence of toxin producing micro organisms. Members requested details of any quality assurance procedures that are in place to prevent contamination of the algal culture. The Committee requested additional information to demonstrate the absence of toxins during the production process including the potential impact of seasonal variations on levels of toxins.

The Secretariat agreed to contact the applicant to seek additional information on the points raised by the Committee.

7. Phytosterol food ingredient Cardiabeat
ACNFP/78/4

Prior to the discussion of this item Mr Craddock declared a non-personal, non-specific interest and informed the Committee that he had acted as a consultant for another company who had submitted an application for a phytosterol ingredient. The Chairman concluded that he should remain.

The Committee was asked to consider an initial opinion from the Dutch Competent Authority (CA) on an application submitted by Enzymotec Ltd, for the authorisation of a phytosterol food ingredient for use as a novel food ingredient.

The Committee confirmed it agreed with the Dutch assessment and was content for authorisation to be granted.

The Agency, as the UK Competent Authority, will send a formal reply to the Commission reflecting the Committee's conclusion.

8. Allanblackia seed oil

The Committee was asked to consider an initial opinion from the German Competent Authority (CA) on an application for the authorisation of allanblackia seed oil for use as a novel food ingredient. The applicant intends to use the ingredient in the manufacture of spreads at a level of up to 20%, as a substitute for palm oil or palm kernel oil.

The Committee noted the inclusion of a sustainable agriculture programme in the application but expressed concern that Allanblackia stuhlmanii, one of the sources of the novel food ingredient, is included in the Conservation of Nature and Natural Resources (IUCN) red list of threatened species . The Committee noted that the applicant did not identify the species used to obtain the oil samples used in the toxicological tests. It was also unclear whether the samples subjected to chemical analysis were representative of the full diversity of Allanblackia species found in the different areas of Africa from which the oil might be harvested.

Members noted that the applicant had not offered an explanation for the decrease in the white blood cells in the rats fed allanblackia seed oil compared with the control group during the toxicity study. The Committee recommended that this product be labelled as Allanblackia seed oil.

The Secretariat agreed to draft a response to the Commission reflecting the concerns of the Committee.

9. Alpha-cyclodextrin
ACNFP/78/6

At the November 2005 meeting, Members considered an opinion from the Belgian Competent Authority on the application for authorisation of alpha-cyclodextrin as a novel food ingredient. The Committee had raised a number of concerns and the applicant had provided reasoned arguments in response.

The Committee stated it was content that the information provided by the applicant satisfactorily addressed the effect of the NI consumption in the diabetic population. Members were content that the product would be labelled in line with the labelling Directives 2001/13/EC and 90/496/EC.

The Committee agreed with the applicant that at the present time there was no pan-European food consumption database to provide intake data but requested that consumption estimates be obtained from the UK National Dietary and Nutrition Survey database. Members confirmed they would await sight of these data before finalising their decision on this issue.

Members were satisfied with the applicant's explanation that the metabolic fate of the product was expected to be similar to that of similar ingredients. The Committee noted that the rate of metabolism of the NI would have an impact on gas production and GI intolerance, and recommended that the applicant conduct an in vitro study to compare the fermentation rate of the product with products of similar composition such as inulin.

Members were not satisfied that the applicant had addressed their concerns regarding the use of the term 'dietary fibre' in the labelling of such a product. The Committee remained concerned that the novel ingredient could be nutritionally disadvantageous if it was marketed as an alternative to natural dietary fibres.

The Secretariat indicated it would draft a response reflecting Members' comments for clearance by Chairman's action.

10. Italian research on sub-cellular effects of GM Soya
ACNFP/78/7

The Committee was invited to consider a series of papers published by Italian researchers which examined the differences between the cells from mice given genetically modified (GM) and non-GM soya. Members were asked to identify any conclusions that could be drawn regarding the safety of GM herbicide-resistant soya.

Members noted that the papers did not state the origin of the GM and non-GM soya used in the feeding studies. There were no details of whether the soya had been grown in a field or under controlled conditions and whether or not the GM and non-GM soya were grown, handled and processed under similar conditions. It was also not clear whether the soya used in the control and GM experiments had a similar genetic background.

The Committee was unable to determine whether or not the GM and non-GM soya crops had been treated with the herbicide glyphosate, although the authors had suggested that differences in residual levels of glyphosate might be responsible for the observed differences.

The Committee also requested data on the nutritional equivalence of the two diets and as well as confirmation on whether or not the same experimental animals were used in each study.

The Secretariat agreed to contact the author of the studies for clarification on these points and to report back to the Committee.

11. Date of next meeting

The next meeting is scheduled for Thursday 21 September 2006, in Aviation House.