ACNFP
THE ADVISORY COMMITTEE ON NOVEL FOODS AND PROCESSES
ACNFP Secretariat
Food Standards Agency
Room 515b Aviation House
125 Kingsway
London WC2B 6NH
Tel: +44 (0)20 7276 8595
Fax: +44 (0)20 7276 8564
acnfp@foodstandards.gsi.gov.uk
ACNFP minutes: 24 November 2005
Minutes of the meeting held on 24 November 2005 in Conference Rooms A&B, 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 Stephen Holgate
Professor Ian Rowland
Professor Alan Malcolm (items 1-8)
Dr Clive Meredith
Professor Peter Shewry
Dr Tony Williams
Secretariat:
Ms Azuka Aghadiuno
Mrs Alison Dyson - Minutes
Ms Michelle Gardner
Dr David Jefferies
Dr Chris Jones
Dr Sandy Lawrie - ACNFP Secretary
Dr Sonia Molnar
Dr Trudy Netherwood (items 8-13)
Ms Annie-Laure Robin
Mr Colin Ross
FSA Assessor:
Dr Clair Baynton
Observer:
Ms Anna Ashelford - Food Standards Agency (items 8-9)
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 Gary Foster, John Fowler and Peter Lund. Written comments from Peter Lund 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 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 73rd meeting
DRAFT/ACNFP/73/MIN
Subject to one minor textual correction, Members agreed that the minutes were a true record of the 73rd meeting of the ACNFP held on Thursday 29 September.
3. Matters Arising
Item 3.4 - Tagatose
The UK's initial opinion was distributed in September and the 60-day comment period has now expired. Once the UK has received confirmation from the Commission that there are no objections, the UK will issue a confirmatory letter to the applicant.
Item 5 - Clinoptilolite
The Secretariat informed the Committee that the draft negative opinion it had considered at the September meeting had been redrafted to reflect the Committee's detailed comments and would be issued for public consultation shortly.
Item 6 - Zeaxanthin
The Committee had considered an initial assessment report prepared by the Dutch Competent Authority on this application at its September meeting. Members were advised that the UK opinion on this initial assessment report, reflecting the points raised by Members, was forwarded to the European Commission on 13 October.
Item 7 - Phytosterols from Prima Pharm
The Secretariat indicated that a draft opinion on this application had been circulated for Members' comments, following which it would be issued for public consultation.
Item 8 - Draft EFSA guidelines for the risk assessment of genetically modified micro-organisms
At the September ACNFP meeting Members provided detailed comments on this draft EFSA guidance document, which had been issued for public consultation in July. The Secretariat advised the Committee that its comments, together with those of the Advisory Committee on Releases to the Environment (ACRE), had formed the basis of the UK's 3 October response to this consultation.
4. Phosphated distarch phosphate
ACNFP/74/1
At its meeting in September the Committee considered an application from National Starch Food Innovation (UK) for the approval of its novel food ingredient, phosphated distarch phosphate (PDP). The Committee had raised a number of questions and the applicant had provided additional data for Members' consideration.
The Committee had previously requested further information on the effects of consumption by 'at risk' groups, particularly diabetics and people with irritable bowel syndrome (IBS). Members were of the view that the predicted beneficial effects of the consumption of PDP by diabetics could not be reliably inferred by reference to an in vitro study on the Englyst digestion evaluation of high amylose RS4-fibre and regular maize starch. The Committee therefore suggested that the applicant use in vivo data to show the effect of consumption of PDP by diabetics and determine the glycaemic index of the product. With regard to consumption of PDP by individuals with IBS, Members noted that while fibre and other similar substances may alleviate constipation, such substances might also exacerbate other symptoms of IBS such as bloating and diarrhoea.
The Committee was of the view that the additional data provided by the applicant did not adequately address its concerns about the potential for gastrointestinal (GI) intolerance in high level consumers as the tests were carried out using different resistant starches (type 2 or 3). Members also noted that the applicant had not provided any fermentability data on resistant starch type 4.
While the Committee was content with the amended levels of incorporation of the novel ingredient, it noted that the estimated high level intake by children remains higher on a body weight basis than the high level intake level examined by Pieters et al (1971), using adult subjects. Members therefore considered that the data provided did not offer any additional reassurance that high level consumption of PDP by children would not give rise to GI intolerance.
The Committee remained concerned about the potential allergenicity of the product to individuals allergic to maize, but noted the applicant's intention to identify the source of PDP by including 'maize' as part of the name of the ingredient. However, Members were of the view that the term 'starch fibre' was likely to confuse consumers and indicated that an alternative name should be used. The Committee also considered the marketing of the novel ingredient as a source of dietary fibre and noted that any claims would need to comply with general food labelling legislation.
The Secretariat agreed to contact the applicant to seek additional information on the points raised by the Committee.
5. Alpha-cyclodextrin
ACNFP/74/2
The Committee was asked to consider an opinion from the Belgian Competent Authority (CA) on an application from Bioresco, acting on behalf of Wacker Chemic GmbH, for authorisation of alpha-cyclodextrin as a novel food ingredient. Alpha-cyclodextrin is a non-reducing cyclic saccharide produced by the action of cyclodextrin glucosyltransferase (CGTase) on hydrolysed starch. The applicant proposes to market the ingredient as a source of dietary fibre.
The Committee considered diabetics to be a group of sensitive consumers requiring special consideration for any novel carbohydrate ingredient and was concerned that the data provided by the applicant referred only to studies from 1923 and 1927 on a very small number of type-1 diabetics. The Committee considered that additional evidence is required to determine the effect of the novel ingredient on diabetics.
Members also requested clarification of the consumption estimates provided by the applicant, which indicated the mean and high level consumption of alpha-cyclodextrin to be 11.4 and 19.8 g/day. However, other estimates indicate that 38g of the novel ingredient could be consumed from a single large portion of one food (bread).
Members discussed a possible interaction with alcohol and were concerned about the potential for high level consumption of the product by children aged between 2-5 years.
Finally, Members were concerned that the use of the term 'dietary fibre' on the label of products containing the novel ingredient could mislead the consumer.
The Secretariat indicated that a draft response reflecting Members' comments would be cleared by the Committee by post, for inclusion in the UK's formal response to the initial assessment report.
6. Arachidonic acid-rich fungal oil
ACNFP/74/3
The Committee was asked to consider an initial opinion from the Dutch Competent Authority on an application for authorisation of arachidonic acid-rich oil derived from the fungus Mortierella alpina as a novel food ingredient. The applicant proposes to market the ingredient for use in infant formula only.
The Secretariat informed the Committee that the Dutch authorities had accepted this application in 1999, and had requested that the applicant provide additional studies in order to gain additional reassurance that the oil would be safe for continuous consumption by infants. The applicant had since provided a two-generation study.
As this paper had been provided to the Committee at short notice, the Secretariat indicated that it was only seeking initial comments at the meeting and invited Members to submit written comments by post in the two weeks following the meeting.
The Committee had no substantive comments at this stage but requested that the Secretariat investigate the possible presence of allergens.
7. Phytosterols
ACNFP/74/4
Prior to the discussion Neville Craddock declared a direct interest in this application and left the room for the duration of the Committee�s discussion on this item.
The Committee was asked to consider a request made to the UK Competent Authority for an opinion on substantial equivalence between phytosterols manufactured by DDO Processing and those currently marketed by Forbes Medi Tech.
Members indicated that they were satisfied that the proposed upper limit of 87% for beta-sitosterol did not rule out consideration of this application under the simplified (substantial equivalence) procedures.
As this paper had been provided to the Committee at short notice, Members were invited to submit any further comments by post after the meeting. The Secretariat indicated that it would then draft an initial opinion for consideration at the Committee's January 2006 meeting.
8. Effect of GM soya on newborn rats
ACNFP/74/8
The Food Standards Agency asked the Committee to consider a report provided by Dr Irina Ermakova which contained the results from a preliminary study conducted in Russia on the offspring of rats given flour from genetically modified (herbicide-tolerant) soya beans. The report showed that pups born to rats given the GM soya flour had reduced growth and increased mortality compared with those born to rats given non-GM soya flour or a control group given no soya.
The Committee stated that it was not possible to draw any conclusions from the results of this study as it lacked essential detailed information concerning the composition of the test materials. Members also indicated that there were a number of possible explanations for the results of this preliminary study, apart from the GM and non-GM origin of the test materials. The Committee further noted that the study had not been quality-controlled through the normal peer-review process for scientific publications.
Additionally, the Committee also drew attention to the fact that the study's conclusions were not consistent with those described in a peer-reviewed paper published in 2004. This paper reported the results of a well-controlled study in which mice were fed on diets containing 21% GM herbicide-resistant soya beans and followed through up to four generations. This study did not show any adverse effect of the GM soya.
The Committee agreed to issue a statement outlining its comments on this report, indicating that it would consider any further information that could be obtained and will review the position if a full report of the study is published in the peer-reviewed literature.
9. Structure and immunogenicity of bean alpha-amylase inhibitor expressed in peas
ACNFP/74/9
The Food Standards Agency asked the Committee to comment on this paper which was recently published by the Commonwealth Scientific and Industrial Research Organisation (CSIRO) in the Journal of Agricultural and Food Chemistry. The paper detailed the immunological effects in mice exposed to peas genetically modified to contain the bean protein alpha-amylase inhibitor-1. Genetically modified peas expressing this protein were found to elicit a variety of immunological responses that were not seen with the native form of the protein, extracted from beans.
The Committee stated that plant proteins are likely to differ in structure when expressed in different species and that it was therefore not surprised by the results. Members noted that differences in the expressed proteins are identified and investigated routinely during the commercial development of GM crops. The Committee also emphasised that the risk assessment of GM proteins is based on the form that is present in the GM plant and it is only possible to use data derived from other expression systems if the equivalence of the proteins is clearly demonstrated.
Finally, Members indicated that the standard risk assessment of GM foods, carried out in line with guidelines issued by the European Food Safety Authority in the EU, would identify any differences in post-translational modification and that any such alterations would trigger additional requirements for toxicity and allergenicity assessments.
Members noted that EFSA's GMO panel has established a sub-group to consider issues related to allergenicity assessment and invited the Secretariat to investigate whether and how the Committee could contribute to this work.
10. Open meetings
The Secretariat provided an oral update and reported that it was still considering practical details arising from the proposal to conduct future ACNFP meetings in open session on a trial basis. The Secretariat informed Members that a paper would be presented at the Committee's January 2006 meeting.
11. Items for information
EU Update: ACNFP/74/5
This paper provided a routine overview of progress on EU issues of relevance to the Committee.
Update on applications for authorisation under the GM food and feed regulation EC/1829/2003: ACNFP/74/6
This paper provided an update on the status of the 22 applications for GM food and feed products currently being assessed under the GM food and feed regulation EC/1829/2003.
SACN paper on novel carbohydrates and 'fibre': ACNFP/74/7
Members were provided with a copy of this paper on novel carbohydrates, which had been discussed by the Scientific Advisory Committee on Nutrition (SACN) at its 19 October meeting. The Committee was also informed that SACN intends include a review of current advice on carbohydrates in its work programme.
12. Any other business
The Chairman provided an oral update on a workshop hosted by the Royal Society that he had attended on 30 September. The aim of this workshop was to examine the role that social science plays in the risk assessment process for foods and it involved the discussion of two recent case studies. A report of the workshop is to be published by the Royal Society and the ACNFP Secretariat agreed to circulate this to the Committee when it is available.
13. Date of next meeting
The next meeting of the Committee was scheduled for Wednesday 25 January 2006, in Aviation House.
Following its discussions at this meeting, the Committee issued a statement on the effect of GM soya on newborn rats.