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: 29 September 2005
Minutes of the meeting held on 29 September 2005 in Conference Room 4, Aviation House, 125 Kingsway, London.
Present
Chairman:
Professor Mike Gasson
Members:
Professor Ruth Chadwick
Dr Hilary Close
Mr Neville Craddock
Professor Jim Dunwell
Professor Gary Foster
Dr John Fowler
Professor Stephen Holgate
Dr Peter Lund
Professor Alan Malcolm
Dr Clive Meredith
Professor Peter Shewry
Dr Tony Williams
Secretariat:
Mrs Alison Dyson - Minutes
Ms Michelle Gardner
Dr David Jefferies
Dr Chris Jones (Items 1-7)
Dr Sandy Lawrie - ACNFP Secretary
Ms Annie-Laure Robin
FSA Assessor:
Dr Clair Baynton
Observers:
Dr Louise Ball - Defra
Dr Kate Morley - Defra
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 Ian Rowland and Jill Brand. 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 Louise Ball and Kate Morley from the Department for Environment Food and Rural Affairs, who were attending the meeting as observers.
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-second meeting
DRAFT/ACNFP/72/MIN
Members agreed that the minutes were a true record of the 72nd meeting of the ACNFP held on Thursday 19 May.
3. Matters Arising (including postal consultations)
Plant sterol enriched rice drink
At the May meeting Members were informed that the European Commission had asked the European Food Safety Authority (EFSA) Dietetics Nutrition and Allergy Panel for an opinion on two scientific papers on the potential risks associated with elevated plasma levels of phytosterols. Members were informed that the panel's conclusions had been noted in the Committee�s EU Update paper (ACNFP/73/8).
Lycopene-rich oleoresin from tomato
The Committee was informed that the draft opinion on this application was issued for public consultation following the May meeting and no comments were received. The UK's initial opinion on this application was forwarded to the Commission on 30 June for distribution to the Competent Authorities in other member states. The 60-day period for comment by other member states would expire on 8 October.
Noni juice from Mi GmbH
The Committee was advised that the draft opinion on equivalence between this product and the GSE Vertrieb product already on the EU market had been published for comment following the May meeting. The Secretariat noted that the comments received did not raise any new issues and the UK's opinion on equivalence was sent to the applicant on 24 June.
Tagatose: ACNFP/73P/1A
When Members considered the draft opinion on this application at the Committee's May meeting, concerns were raised regarding the proposed advisory labelling for high-level single dose consumption. Members noted that the proposal to label if more than 15 grams was consumed as a single dose was determined on the basis of studies carried out in healthy adult subjects and requested reassurance that this threshold was equally applicable to young children. In response to this request the applicant submitted a number of related studies and the Committee reviewed these by post in July.
Members concluded that the data did not demonstrate unequivocally that the use of adult studies could be used to predict the potential gastrointestinal effects in young children. The applicant does not intend the ingredient to be used in foods specially manufactured for young children but it is likely that they will consume general foods that contain D-tagatose, particularly soft drinks. To take account of consumption by young children, and because of evidence that poorly-absorbed compounds may exert a greater laxative effect when taken in liquid form, the Committee proposed that the advisory labelling should apply additionally to all beverages containing more than 1% tagatose.
The Secretariat indicated that the draft opinion on this application was issued for public consultation at the end of July. No comments were received and the UK's initial opinion on this application was forwarded to the Commission on 15 August for distribution to the Competent Authorities in other member states. The 60-day period for comment by other member states would expire on 12 November.
Codex Intergovernmental Task Force on Foods Derived from Biotechnology: ACNFP/73P/1B
In August the Committee was asked to consider the proposed work programme of this recently re-formed Codex Task Force. Comments were particularly sought on the relative importance of the various issues proposed by the European Commission and any significant uncertainties in the science that might limit the success of the proposed projects within the allotted timescale.
Members considered that the proposed activities were sensible and were generally content with the prioritisation of the issues. However, it was suggested that item 5 (Food safety issues specific to staple food crops for developing countries) could be given a higher priority, and that the issues related to item 3 (GM plants expressing pharmaceutical or other bioactive substances) could be addressed through the provision of guidance on biopharming. In relation to item 3, it was further noted that minimising the risk to consumers from accidental contamination of the food supply with bioactive plant products was a crop segregation and traceability issue, rather than a scientific one.
The Committee welcomed the inclusion of a proposal related to the safety assessment of GM hybrids (item 4) but highlighted the absence of any proposal examining possible improvements to the methodologies of the current safety tests. Members also noted that the definition of "modern biotechnology" used by Codex excludes cloning and tissue culture, although these techniques are also of interest.
The Committee noted that there was considerable commercial interest in the modification of non-food plants for the production of pharmaceuticals and other substances. Such systems, involving contained growth facilities, are subject to different regulatory controls than GM crops intended for food and feed. Techniques, such as transient expression systems, are also being developed in this area and may fall outside the current definition of biotechnology.
While the Committee suggested that it was unlikely that all of the proposed issues could be tackled within the allotted 4-year timeframe, Members did not identify any significant uncertainties that might limit the success of any individual projects.
The Secretariat reported that the Codex Task Force met on 19-23 September and agreed to establish two initial projects, on the safety assessment of GM animals and on nutritionally modified GM crops. The latter would include crops of importance to developing countries. These project proposals are subject to formal endorsement at the next meeting of the Codex Alimentarius Commission, which oversees the work of all the Codex Committees and Task Forces.
4. Phosphated distarch phosphate
ACNFP/73/2
The Committee was asked to consider an application from National Starch Food Innovation (UK) for the approval of its novel ingredient, phosphated distarch phosphate (PDP). Members noted that this modified starch is an approved food additive (E1413) used as a thickening agent in products such as gravies and sauces. The applicant proposes to use the novel ingredient as a source of fibre in a range of bakery products, where it would partially replace ingredients such as flour.
The Secretariat had received one set of comments during the public consultation which were tabled at the meeting. These comments centred on the interpretation of novel food and food additive legislation and questioned whether PDP required authorisation for the uses proposed by the applicant. The Secretariat indicated that this was a legal point that does not fall within the Committee's remit and the Agency would respond directly to the correspondent.
The Committee expressed concern that the toxicological data provided was based upon doses lower than the proposed intake levels and that data from human studies should be provided to support the proposed uses of the ingredient, particularly as there are reports that consumption of modified starches can have adverse gastrointestinal effects. Members also noted that the proposed levels of incorporation of the novel ingredient were higher than foods containing this ingredient currently on the market in Australia.
Members noted that the dossier did not consider "at risk" groups such as diabetics, people suffering with Irritable Bowel Syndrome (IBS), and children, and requested that the applicant consider the effects of the novel ingredient on these groups. The Committee was also of the view that the issue of allergenicity had not been addressed and requested that the applicant provide further information.
The Committee was additionally concerned that labelling the product as a source of dietary fibre could mislead the consumer as many nutritionists consider that the beneficial effects of dietary fibre are associated only with fibre polysaccharides from plant cell walls. The Secretariat agreed to obtain expert nutritional advice on the labelling of the novel ingredient and to report back at the Committee�s next meeting.
Finally, Members raised a general concern about the effects of long-term consumption of poorly absorbed/digested carbohydrates, given that these are increasingly consumed for their perceived health benefits over conventional food ingredients.
5. Clinoptilolite
ACNFP/72/2
Members had considered Euremica's application for the authorisation of clinoptilolite at the Committee's February 2004 meeting, when a number of safety concerns had been raised. Following the meeting, the Secretariat had contacted the applicant to request further information on the points raised by the Committee. However, no response had been received and the company had later confirmed that it did not intend to provide any further data. The Secretariat had therefore drafted a formal negative opinion for Members' consideration.
In addition to providing detailed comments on the draft, the Committee raised concerns over the difference in particle sizes reported for the clinoptilolite tested in the toxicological studies and the product described by the applicant.
Attention was also drawn to a paper by Martin-Kleiner et al (2001), not mentioned in the application dossier, which reported on the effect of clinoptilolite on hematopoiesis and serum chemistry in mice.
The Secretariat agreed to redraft the relevant paragraphs of the opinion in advance of it being issued for public consultation.
6. Zeaxanthin
ACNFP/73/4
The Committee was asked to consider the initial opinion from the Dutch Competent Authority (CA) on an application from Bioresco for the novel food ingredient zeaxanthin. The Dutch CA had no safety concerns over the proposed intake levels but were unable to complete the safety assessment due to the absence of a list of proposed food uses. The Secretariat noted that the Dutch CA had highlighted the need for additional assessment for zeaxanthin, and that the dossier is likely to be referred to the European Food Safety Authority (EFSA).
Members agreed that it was not possible to complete the safety assessment without a list of proposed food uses. In addition, the Committee raised concerns about the slight deterioration of the product during its shelf life as this could mislead consumers with respect to the quantity of zeaxanthin in the product being purchased. Members also noted that the applicant had not considered the effect of consuming zeaxanthin as a food supplement on "at risk" groups such as the elderly and high-end users.
Members drew attention to the chronic study in monkeys, which found no crystal formation in the eyes of animals given high doses of zeaxanthin, but revealed unexpected findings described as "polarising structures". The Committee requested that this issue be evaluated further to determine whether there are implications, especially for the high user group.
The Secretariat agreed to draft a response to the Commission reflecting these points, to ensure that they would be taken into account when the dossier was referred to EFSA.
7. Phytosterols from Prima Pharm
ACNFP/73/5
Prior to the discussion on this item Neville Craddock declared a non-specific personal interest and informed the Committee that he was currently advising a company on a possible application for authorisation of a similar product. The Chairman concluded that he should remain.
The Committee was asked to consider a request from Prima Pharm for an opinion on the equivalence of their phytosterol products to those currently marketed by Teriaka.
Members noted that Prima Pharm intend to obtain their phytosterols from the French company DRT and that details of DRT's tall oil-derived sterols were contained in the original novel food application from Teriaka. However, since gaining approval Teriaka has decided not to use DRT's products.
The Committee confirmed that it was satisfied that the evidence provided demonstrated substantial equivalence.
The Secretariat indicated that it would draft an initial opinion and circulate the document for Members' comments, following which the opinion will be issued for public consultation.
8. Draft EFSA guidelines for the risk assessment of genetically modified micro-organisms
ACNFP/73/6
As Professor Gasson was a member of the Scientific Panel on GMOs responsible for drafting this document, Dr Peter Lund chaired the Committee�s discussions on this item.
The European Food Safety Authority (EFSA) had issued an open consultation on its guidance document for the risk assessment of genetically modified microorganisms (GMMs) on 15 July. The Committee was invited to provide comments for inclusion in the UK's response to this consultation. The document had also been circulated to the Advisory Committee on Releases to the Environment, whose comments would also be included in the response.
The Committee drew attention to the issue of the transfer of antibiotic resistance markers (ARMs) from GMOs to microorganisms. Members suggested that this issue should be specifically discussed in section II of the document, with a comparison of the relative probability of gene transfer from GMMs and from GM plants, in order to support and explain the recommendation about the use of ARMs.
Members also noted that although socioeconomic and ethical considerations are outside the scope of the guidance, they are of great concern to some consumers and should not be dismissed. The Committee therefore suggested that the guidelines should acknowledge these concerns before explaining why they are not addressed as part of EFSA's risk assessment process for GMOs.
The Committee further noted that, as with the current GM plant guidelines, and the review paper provided in ACNFP/73/10, the discussion section on allergenicity is restricted to IgE mediated reactions, although this is not the only mechanism for individuals to have adverse reactions to food. Members also indicated that substances present in food may modulate immune responses without themselves being allergens.
Members agreed that the methods used to remove and/or kill live GMMs will be a critical factor in the assessment and each applicant will need to demonstrate that the methods used, and the detection method used to provide confirmation, are appropriate for the organism in question. In particular, the problem of viable but non-culturable organisms needs to be addressed, since it is well established that estimates of viable counts can be very significantly distorted (by several orders of magnitude) by the methods chosen for cultivation.
Finally, the Committee noted that there was limited experience with risk assessment of GMMs and derived products, and suggested that the guidelines would need to be reviewed at periodic intervals in the light of practical experience.
The Committee made further minor comments on the text and the Secretariat indicated that it would incorporate Members' comments into the UK's response to this consultation.
9. EFSA GMO Panel safety assessment of GM maize hybrids
ACNFP/73/7
As Professor Gasson was a member of the Scientific Panel on GMOs responsible for drafting the European Food Safety Authority (EFSA) opinions on these applications, Dr Peter Lund chaired the Committee's discussions on this item.
The Committee was asked to consider the EFSA GMO Panel opinions on applications for authorisation of grain and grain-derived food ingredients from maize hybrid lines MON863 x NK603, MON863 x MON 810 and MON863 x MON810 x NK603, under Regulation (EC) No. 1829/2003.
In July 2004 Members considered the EFSA GMO Panel opinions on applications for authorisation of food ingredients derived from MON863 x MON 810 maize hybrids in the context of an earlier application under the novel foods regulation. At that time the Committee had some concerns, primarily based on the fact that these were the first GM hybrids to be evaluated by EFSA. The Committee advised that it was necessary to consider the potential for interactions in the hybrid plants and noted that this evaluation would set a precedent for future hybrid dossiers. Additionally, Members considered that the data provided did not address potential allergenicity.
EFSA had since adopted its guidelines for the risk assessment of GM plants and derived food and feed which considers these general questions. The Committee was therefore asked if it agreed with the GMO Panel's opinions and in particular the strategy used to assess the safety of hybrids, given its previous comments.
The Committee confirmed that it agreed with the GMO Panel opinions.
10. Items for information
EU Update: ACNFP/73/8
This paper provided a routine overview of progress on EU issues of relevance to the Committee.
A generic approach to the safety assessment of micro-organisms used in food/feed and the production of food/feed additives: ACNFP/73/9
This paper provided members with an update on the above opinion, which was published by the European Food Safety Authority (EFSA) Scientific Committee in June 2005, and a summary of the next steps for the guidelines.
Assessment of potential allergenicity - paper from Nature Immunology: ACNFP/73/10
This paper, recently published in Nature Immunology, provided an overview of the assessment of allergenicity of GM crops and derived foods.
Update on substantial equivalence notifications: ACNFP/73/11
This paper provided Members with an update on a series of notifications received via the European Commission. Members' attention was drawn to the notification for Argan oil as the Committee had previously questioned the basis for a similar notification for this product in 2002.
11. Any other business
The Secretariat informed the Committee there were no plans to hold an annual open meeting this year. However, the Secretariat indicated that it is exploring options for conducting future ACNFP meetings in open session and agreed to report back to the Committee.
Members were informed that the Agency had put out a call for a research project to be undertaken on phytosterols and phytosterol products, but were yet to receive any formal response.
12. Date of next meeting
The next meeting of the Committee was scheduled for Thursday 24 November 2005, in Aviation House.