ACNFP Minutes: 20 September 2007

Minutes for the meeting of the Committee at 10.30am on 20 September in Conference Room 5 Aviation House, Kingsway, London

Present:

Professor Mike Gasson – Chairman
Professor Ruth Chadwick
Mr Neville Craddock
Ms Jayam Dalal
Professor Harry Flint
Professor Gary Foster
Professor Stephen Holgate
Dr Clare Mills
Professor Peter Shewry

Apologies Miss Jill Brand
Dr Paul Brantom
Dr Peter Lund
Professor Alan Malcolm
Professor John Warner

FSA Observers Ms Sarah Hardy (Food Allergy Team – Item 7)

Secretariat Ms Alison Asquith - Minutes
Ms Shuhana Begum
Dr Chris Jones
Dr Sandy Lawrie – ACNFP Secretary
Ms Narriman Looch

1. Apologies and announcements
Five members had sent apologies for non-attendance and written comments from several of these were tabled at the meeting. Apologies were also received from the Assessor (Clair Baynton) and observers from FSA Scotland, FSA Northern Ireland and FSA Wales (Elspeth MacDonald, Gerry McCurdy and Phil Morgan)

The Chair welcomed Narriman Looch who had joined the Secretariat on secondment for a year.
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 83rd meeting DRAFT/ACNFP83/MIN
Members agreed that, subject to one minor amendment being made, the minutes were a true record of the 83rd meeting of the ACNFP held on Wednesday 18 July 2007.

3. Matters Arising
The Secretariat provided the following update on items arising from the previous meeting:

ITEM 3: Glucosamine from Aspergillus niger
The Committee had been satisfied with the explanation provide by the applicant company, concerning the potential presence of chloropropanols arising from the acid hydrolysis stage of the manufacturing process. The Committee’s draft opinion was amended accordingly and the final text was cleared by Chairman’s action. The opinion was submitted to the European Commission on 17 September.

ITEM 4: Ice Structuring Protein from GM Yeast
The final amendments to the Committee’s opinion and the explanatory note had been cleared by Chairman’s action and the opinion had been submitted European Commission. The opinion and accompanying explanatory note have been published on the ACNFP website.

ITEM 6: Astaxanthin-rich oleoresin from H.pluvialis algae
The Secretariat was awaiting further information from the applicant on issues that had been raised during the public consultation on this application. A draft opinion would be presented for consideration at a future meeting of the Committee, once these issues had been addressed.

4. Antarctic Krill Oil ACNFP84/1
The Committee considered the Finnish Competent Authority’s (CA) initial opinion on this application for authorisation of Antarctic krill oil as a novel food ingredient in March 2007. The Committee raised a number of comments and concerns and these had formed the basis of the UK’s response to the CA’s opinion. Several other Member States had also raised objections. The Committee was asked to consider the applicants response to the points raised by the UK and by other Member States.

The Committee was content with the applicant's response to its concerns about intake levels, Food Hygiene Regulations and history of consumption. The applicant had also responded to the Committee's questions about the environmental impact of fishing for krill, which were acknowledged to be outside the remit of the novel foods regulation. The Committee reiterated its concerns about allergenicity, noting that the novel food ingredient had a high protein level compared with, for example, refined vegetable oils. The Committee therefore recommended that the novel ingredient should be labelled as not suitable for people with a shellfish allergy. The Secretariat noted the Committees comments which will be used to form the Food Standards Agency’s position in future discussions on this novel ingredient at meetings of the Standing Committee on the Food Chain and Animal Health

5. Beta Glucan Rich Extract from Lentinus edodes ACNFP84/2
The Committee had discussed this application in November 2006 (by post) and at the 17 January and 22 March meetings as well as by post. The Committee was asked to review all the information provided by the applicant in order to determine whether all the issues raised by Members had been answered and to conclude whether substantial equivalence had been demonstrated.

Neville Craddock provided clarification of the indirect interest he had declared at previous meetings in connection with this application, when he notified the Committee that he was working with a company on a potential competitor product. He advised the Committee that he had not worked on that product for a period of at least a year and his indirect interest had therefore lapsed.

The Committee was of the view that, whilst there was a credible scientific rationale for equivalence of fungal mycelia to fruiting bodies was credible, the compositional data provided by the applicant were insufficient and they had failed to demonstrate equivalence. Members were therefore of the view that there was insufficient information to demonstrate that the novel ingredient was substantially equivalent to its existing counterpart. They agreed that there appeared to be no particular safety concerns with the novel food.

The Secretariat agreed to write to the applicant.

6. Phosphated Distarch Phosphate (PDP) ACNFP84/3
The application was discussed by the Committee in September and November 2005 and in July 2007. The Committee was asked to consider further information from the applicant about potential gastrointestinal intolerance in high level consumers, specifically children. It was also asked to comment on the proposed new name of the ingredient and to comment on the text of the draft opinion.

The Committee was content that the new proposed name “resistant (modified) (maize) starch” appeared to be in line with EU labelling requirements. Members had previously indicated their concern that the consumption of this novel ingredient by young children might give rise to gastrointestinal intolerance. Members agreed that the provision of an advisory label would be beneficial but did not accept the applicant's proposal that this should be limited to products containing greater than 15g per serving and which were marketed solely at children. Members were of the view that most of the proposed products (e.g. pizza bases, tinned pasta) would be consumed by young children even if they were marketed for the general population. They also questioned the validity of a 15g limit as this figure was derived from limited studies carried out on healthy adults. The Committee advised that labelling in line with current labelling for polyols be used on all products containing the novel ingredient, unless further studies were carried out to demonstrate the extent to which the novel ingredient was tolerated in young children.

The Committee agreed to defer commenting on the draft opinion to the next meeting.

7. Kiwiberry Concentrate ACNFP84/4
The Committee considered this application at the July 2007 meeting when allergenicity was highlighted as the key issue of concern. The Committee was asked to consider further information supplied by the applicant about the intended use of the novel ingredient in different food categories and labelling.

The Committee reiterated their concern about allergenicity and noted that, contrary to the impression given in the applicant's response, allergy to kiwi fruit is emerging as a significant allergen across Europe. Members were particularly concerned that the novel ingredient is proposed for use in a large number of products that would not be expected to containing kiwi fruit products. They noted that the study reported by the applicant had identified a single case of cross-reactivity, based on tests using serum from individuals with existing kiwi fruit allergy, but this screening test did not prove that such individuals would actually cross-react to kiwiberry products on oral exposure. In these circumstances, it would be inappropriate to apply a precautionary statement about kiwi allergy to the wide range of products in which the novel ingredient was to be used as this would result in significant, and possibly unnecessary, restriction of choice. The Committee therefore indicated that additional studies should be carried out in order to determine the likely extent of the allergenicity. The Secretariat agreed to liaise with the applicant and with allergy experts on the Committee to determine whether any additional studies could be carried out in order to better inform the safety assessment of the ingredient.

8. Cold water dispersable lycopene from Blakeslea trispora ACNFP85/5
This was a new application submitted to the UK authorities for for the use of cold water dispersible lycopene derived from the fungus Blakeslea trispora as a novel food ingredient.

The Committee had delivered a positive opinion in 2004 on lycopene from Blakeslea trispora, from the same manufacturer but formulated in an oil suspension. This had resulted an in EU-wide authorisation being granted to the applicant in October 2006, covering a range of uses of their product. The new application was essentially an extension of the use of the same ingredient, but in an alternative formulation that permits its addition to a range of different foodstuffs where the vegetable oil suspension form could not be used.
Two further novel food applications for the use of other lycopene, from other sources (a lycopene-rich oleoresin from tomatoes and a synthetic lycopene product) were under examination at EU level, following questions and concerns raised by some member states.
Given that the European Food Safety Authority (EFSA) is currently evaluating lycopene from all sources as part of a review of the safety assessment of a number of food colours, the Committee agreed that the UK opinion should conclude that an additional assessment is required, and an authorisation should be considered only when the EFSA review is completed.

The Secretariat agreed to write to the European Commission indicating that the application should undergo an additional assessment.

9. Calcium L-methylfolate ACNFP84/6
The Irish competent authority has issued an initial assessment report on this substance, which is intended for use as a source of dietary folate. The safety and acceptability of this ingredient has already been assessed by EFSA, and member states have agreed unanimously that it should be added to the list of permitted sources of folate in supplements and in parnuts foods. The use of this ingredient is subject to the novel food regulation and is therefore required to be authorised as a novel food ingredient before it can be used.

The Committee agreed that Calcium L-methylfolate meets the criteria for acceptance as a novel food ingredient. However, as the use of this ingredient in infant formula is not covered by the existing risk assessments, this use should only be authorised once it has been specifically evaluated by EFSA.

The Secretariat will send a response on this application to the European Commission.

10. Open Meetings (oral update)
The Committee agreed that the open meeting due to take place on 21 November should be postponed to Wednesday 2 April due to difficulties in finding suitable accommodation, combined with a temporary staff shortage in the Secretariat.

11. Items for Information
11.1 EU Update ACNFP84/9

11.2 EFSA Statement on the fate of recombinant DNA or proteins in GM feed ACNFP84/10
The Committee noted the statement from EFSA on a review of the available information concerning the transfer of GM material (DNA and protein) from GM plant material from animal feed into farm animals and animal-derived food products.

11.3 EFSA guidance document for the risk assessment of GM plants containing stacked transformation events ACNFP84/11
The Committee noted the guidance document published by EFSA which sets out the information required when assessing plants that contain two or more stacked events.

11.4 The effect of GM soya on newborn rats ACNFP84/12
The Committee noted the article recently published in Nature Biotechnology on the feeding studies conducted by Dr Irina Ermakova, which have been claimed to demonstrate toxicity of GM soya in newborn rats. In this article, Dr Ermakova stated that her research is being submitted for publication in the peer-reviewed literature and the Secretariat would keep the Committee informed of any further developments.

12. Any Other Business
The Medical Research Council’s (MRC) November programme includes a review of immunology. This will examine the state of immunology in the UK. Professor Stephen Holgate will forward views in response to the MRC’s consultation.

Jayam Dalal informed the Committee she would be facilitating a meeting to discuss how the FSA involves ethnic communities when sending messages about the preparation and cooking food and she invited any interested Committee members to attend.

The Secretary informed the Committee that EFSA was having a meeting with national experts on the safety of food and feed to discuss the current approaches used by EFSA and member states when assessing GM products.

13. Date of next meeting
The next meeting was scheduled for Thursday 22 November in Aviation House.