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: 22 March 2006
Minutes of the meeting held on 22 March 2006 in Conference Room 5, Aviation House, 125 Kingsway, London.
Present
Chairman:
Professor Mike Gasson
Members:
Ms Jill Brand
Professor Jim Dunwell
Professor Gary Foster
Dr Peter Lund
Professor Alan Malcolm (items 1-8)
Dr Clive Meredith
Professor Ian Rowland
Professor Peter Shewry
Dr Tony Williams
Secretariat:
Ms Azuka Aghadiuno
Ms Shuhana Begum
Mrs Alison Dyson - Minutes
Ms Michelle Gardner
Dr David Jefferies
Dr Sandy Lawrie - ACNFP Secretary
Ms Annie-Laure Robin
Mr Colin Ross
FSA Assessor:
Dr Clair Baynton
Observer:
Mr Neil Aitken - COMS (items 6 & 8)
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 Hilary Close, Neville Craddock, Stephen Holgate, Ruth Chadwick and John Fowler. Written comments from Hilary Close 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 seventy-fifth meeting
DRAFT/ACNFP/75/MIN
Members agreed that the minutes were a true record of the 75th meeting of the ACNFP held on Wednesday 25 January.
3. Matters Arising
Phosphated distarch phosphate
At the January meeting the Secretariat informed the Committee that it had written to the applicant to request additional information on the points raised by Members in November 2005. The Secretariat advised the Committee that the applicant was working on their response.
Effect of GM soya on newborn rats
The Secretariat reported that the Chairman had written to GM Free Cymru taking account of the points raised by the Committee at the January meeting. The Chairman had received three further emails from GM Free Cymru but that a reply to these new messages had been deferred pending the receipt of additional detailed comments that the organisation intends to submit.
Phytosterols produced by DDO processing
The Secretariat reported that it had received further comments from the applicant on the interpretation of the analytical data on their phytosterol product, but that these had arrived too late for consideration at the meeting. As this was the only outstanding issue in relation to this application, the Secretariat indicated it would seek Members' views on the new information by email.
4. Noni juice produced by Leap of Faith Farms
ACNFP/76/1
At its meeting in January the Committee considered a request for an opinion on substantial equivalence between noni juice products produced by Leap of Faith Farms compared with an approved noni juice. The Committee had raised a number of questions and the applicant had provided additional data for Members' consideration.
The Committee noted that the applicant had not offered any new compositional data to confirm the equivalence of the existing Tahitian product and the equivalent Panamanian product. Members also expressed concern that the applicant had not provided any information on the botanical identity of the fruits used for juice production in Panama.
The Committee further noted that the applicant had not supplied any new data to satisfy its concerns regarding the stability of the dehydrated form of the applicant's product. Members were particularly concerned about the lack of information to support the quoted shelf life and noted that it was impossible to compare the stability of the product to other dried products. The Committee additionally stated that the compositional data on the reconstituted juice could not be assessed without a fuller description of the test material, including information on the storage conditions, and details of the length of time between drying and reconstitution.
Members noted that the European Food Safety Authority (EFSA) was currently considering literature reports of a possible link between hepatitis and the consumption of noni juice. The Secretariat noted that these considerations were relevant to all noni products and agreed to report back to the Committee once EFSA's conclusions had been published.
The Secretariat agreed to contact the applicant to request further information to address the Committee's outstanding concerns.
5. Zeaxanthin
ACNFP/76/2
At the September 2005 meeting, Members considered an opinion from the Dutch Competent Authority on an application for authorisation of zeaxanthin as a novel food ingredient. The Committee had raised a number of concerns and the applicant had provided reasoned arguments in response.
Members were content that the information provided by the applicant had satisfactorily demonstrated the stability of the ingredient in a number of food matrices. The Committee also stated that it was satisfied that the data supplied adequately demonstrated that the establishment of a group acceptable daily intake for zeaxanthin and lutein had considered 'at risk' groups. However, Members repeated their concerns about the lack of information on the intended food uses and levels of incorporation, and reiterated their view that this information was necessary to conclude the safety assessment.
The Committee further noted that the applicant had not provided any new data to explain the "polarising structures" observed in the eyes of tested animals and therefore maintained its original concerns. The Secretariat confirmed that it would seek further specialist advice on this point following the meeting.
Members wished to record that they had not discussed the applicant's argument that zeaxanthin could be considered a 'conditionally essential nutrient' that plays an indispensable function in the human eye as this was not relevant to the safety assessment.
The Secretariat informed Members that a formal response to the information from the applicant was not required and that the Committee's comments would be taken into account by the Food Standards Agency in EU discussions on authorisation of zeaxanthin.
6. Nanotechnology
ACNFP/76/3
Members were asked to consider this paper which provided an update on various activities in relation to nanotechnology, and to comment on a draft outline of a public information document on nanotechnology in relation to food.
The Committee noted the joint COT/COC/COM statement on nanomaterial toxicology and the Institute of Food Science and Technology (IFST) statement on nanotechnology, and agreed that it was essential to maintain an integrated Government approach to any issues related to nanotechnology. Members also reiterated their view that it was important to engage the public by inviting comments on areas of concern in relation to the application of nanotechnology to food.
The Committee supported the idea of a public information document but suggested that the proposed outline was too technical and that it was vital to provide clear definitions for all the terminology. Members also suggested that if the document was published on the Agency's, website links could be provided to existing material on nanotechnology, such as the Royal Society report or the IFST statement.
The Secretariat indicated that the Agency would consider the Committee's comments when publishing any public information on nanotechnology.
7. EFSA Opinions on maize-germ oil and rapeseed oil high in unsaponifiable matter
ACNFP/76/4
The Committee was invited to consider two positive opinions from EFSA on vegetable oil products high in unsaponifiable matter, and to consider whether the issues raised when the Committee first reviewed these products in 2002 had been addressed. These issues related to the product specification, limiting daily intake and labelling.
Members noted that the applicant had provided further detailed information on the product specification and confirmed that this satisfied their earlier concerns.
Members also remained concerned about the lack of information on how the intake levels could be achieved in practice and the absence of any data on intakes for different age groups. The Committee further noted that the EFSA opinion did not include any consideration of the labelling of the products containing the oils.
The Committee concluded that it agreed with the EFSA opinion in that there were no specific safety concerns, but maintained its original concerns over limiting daily intake and labelling. Although not directly relevant to the assessment of the proposed level of intake of the two novel ingredients, the Committee continued to question the approach taken in the initial assessment, where the intake limit was set as a multiple of the recommended daily intake for vitamin E and not on the basis of a scientific risk assessment.
8. Allergenicity testing of GM foods
ACNFP/76/5
In February, Friends of the Earth sent the Agency a copy of its report on allergy risks associated with GM. The Committee was asked to consider this report and its recommendations.
Members acknowledged that the science of allergenicity of all foods is still developing and that the current guidelines for the safety assessment of GM foods have evolved from the previous Scientific Committee on Food guidelines and the 2001 WHO/FAO consultation documents. The Committee also noted that the current guidelines take account of scientific developments and practical experience during the intervening period and that it was incorrect to suggest that evolution of the guidelines have resulted in a less rigorous approach to the allergenicity assessment of GM foods.
Members indicated that the hypothesis that allergenic proteins were likely to be resistant to digestion was not always supported by evidence gained from later studies. As a result less weight is placed on pepsin digestion tests. The Committee also noted that the use of screening tests using human serum is only recommended in cases where there is evidence to suggest a cross-reaction with existing allergens. It would not be feasible to design a routine screening test for all known human allergies, given that many of these allergies are quite rare and that the human serum samples needed for such tests are limited in their availability.
The Committee further noted that the possibility of using animal models to predict the allergenicity of new proteins is being investigated and that animal tests could be incorporated into the safety assessment process in future, but only if the models can be validated as useful predictors of human sensitisation reactions.
The Committee noted the comments in the report regarding the altered protein structures obtained in different expression systems, as demonstrated in the recent Australian work on transgenic peas, and referred to the previous discussion on this issue at the meeting in November 2005.
The Committee noted that the Friends of the Earth report suggested that scientific uncertainties in GM risk assessments should require the strict application of the precautionary principle, and that GM products should no longer be marketed. Members were of the view that this was ultimately a risk management decision, but noted that logically such an approach would also prevent the marketing of many foods introduced to the UK market without any formal safety assessment, including traditional foods from other countries and new (non-GM) crop varieties.
The Secretariat indicated that the Agency would reply to Friends of the Earth outlining the Committee's comments on the report.
9. Review of novel processing techniques
ACNFP/75/8
The Committee agreed to revisit this paper at its next meeting.
10. Items for information
EU Update: ACNFP/76/6
This paper provided a routine overview of progress on EU issues of relevance to the Committee.
Royal Society/FSA Workshop - social science insights for risk assessment: ACNFP/76/7
This paper provided Members with a copy of the draft report of this Royal Society/FSA Workshop which took place on 30 September. The final version of the report would be published on the Royal Society's website.
11. Any other business
(a) Application for authorisation of noni leaf
The Secretariat reported that the Commission had recently circulated the Belgian Competent Authority's initial opinion on an application submitted by Morinda Inc for authorisation of the leaves of Morinda citrifolia L (noni) as a novel food ingredient in a large variety of products (including a Tahitian noni leaf tea). This initial opinion had been received shortly before the meeting and was emailed to Members for information.
The Secretariat reported that the date of the formal distribution of documents by the Commission would allow sufficient time for this application to be considered at the Committee's next meeting, before the end of the 60-day period for responses.
(b) Staff changes in the Agency
The Secretariat reported that Jon Bell was retiring as Chief Executive of the Agency at the end of March and that his successor would be appointed later in the year. An interim Chief Executive, John Harwood, would take over the management of the Agency during this period.
The Committee was also advised that Andrew Wadge (Director of the Agency's Food Safety Policy Group) had recently been appointed as interim Chief Scientist for the Agency, taking over from Jon Bell and pending the appointment of the next (permanent) Chief Executive.
(c) Governance of science
The Secretariat reported that a recent meeting of the Chairs of the scientific committees that advise the Agency had undertaken to develop a best practice guide, which would describe the processes by which the committees develop the opinions and reports that are presented to the Agency Board. A draft of this document will be presented to the Committee for discussion at a future date.
(d) ACNFP appointments
The Secretariat informed the Committee that it was in the process of seeking four new committee members and that an advertisement had recently been published in Nature, and on the Agency and ACNFP websites.
12. Date of next meeting
The next meeting is scheduled for Wednesday 17 May 2006, in Aviation House.