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: 4 February 2004
Minutes of the meeting held on Wednesday 4 February 2004 in Conference Rooms A & B, Aviation House, 125 Kingsway, London.
Present
Chairman:
Professor Mike Gasson
Members:
Professor Philip Dale
Miss Jill Brand
Dr Hilary Close
Professor Jim Dunwell
Professor Gary Foster
Professor Alan Malcolm
Dr Clive Meredith (items 5 - 16)
Professor Ian Rowland
Professor John Warner (items 4 - 16)
Dr Anthony Williams
FSA Assessor:
Dr Clair Baynton
Secretariat:
Dr Sandy Lawrie
Mr Colin Ross
Ms Frances Cleaver
Ms Michelle Gardner
Ms Kate Halliwell
Dr Chris Jones
Dr Sonia Molnar
Ms Annie-Laure Robin
Observers:
Dr Louise Ball (DEFRA)
Ms Anna Ashelford (FSA - COMS)
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 Professor Ruth Chadwick, Mr Neville Craddock, Dr John Fowler, Dr Peter Lund, and from observers from FSA Scotland, Wales and Northern Ireland (Mrs Elspeth MacDonald, Mr Phil Morgan, and Mr Gerry McCurdy).
1.2 The Chairman welcomed Ms Annie-Laure Robin to the Secretariat.
1.3 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 sixty-third meeting
DRAFT/ACNFP/63/MIN
Members agreed that the minutes were a true record of the 63rd meeting of the ACNFP held on Thursday 20 November 2003.
3. Matters Arising
3.1 Diacylglycerol oil
The Secretariat reported that the applicant had provided results of more sensitive protein analyses of the modified oil, which satisfied the Committee's allergy experts on this point. The Agency wrote to the Commission in January stating that the UK Competent Authority had no further objections to this novel food application.
3.2 Forward Look
The Secretariat reported that the work of the GM Sub-Group would commence by email in the next few weeks. The membership of the joint ACNFP/SACN sub-group looking into the nutritional assessment of novel foods had been confirmed and two meetings were arranged for 25 March and the beginning of June.
4. Lycopene from Blakeslea trispora: ACNFP/64/1
This novel food application was submitted to the UK Competent Authority and was discussed at the Committee's meeting in November 2003. The Committee had raised a number of concerns and requested further information from the applicant. The applicant had provided additional information to address these issues and the Secretariat had drafted an initial opinion for Members' consideration.
The Committee confirmed that the new information adequately addressed their earlier questions. However Members drew attention to the labelling paragraph in the draft initial opinion. The Committee considered that consumers might wish to avoid products containing fungal products and suggested that the source of the lycopene should be indicated by appropriate labelling.
The Secretariat agreed to redraft the relevant paragraph of the initial opinion. A final draft will be circulated for Members' approval and the opinion would be finalised after a short public consultation.
5. Isomaltulose: ACNFP/64/2
This novel food application was submitted to the UK Competent Authority and was discussed at the Committee's meeting in November 2003. The Committee had raised a number of concerns and requested further information from the applicant. The applicant had provided additional information to address these issues and the Secretariat had drafted an initial opinion for Members' consideration.
Prior to discussion of this item Professor Rowland noted that his department was receiving funding for two research projects from the applicant company, neither of which involved isomaltulose. The Committee agreed that Professor Rowland should be able to take part in the discussion of this item.
Members concluded that the applicant had sufficiently addressed their concerns regarding the higher relative consumption of isomaltulose by children. The Committee was also content that the applicant had provided sufficient evidence of the low levels of heavy metals in the product and that there was no polymorphism for isomaltulose metabolism.
The Committee reiterated their concerns regarding the labelling of the product, noting that the term 'reduced sweetness' could mislead the consumer into thinking that the product contained less energy. Members requested a programme of post-market monitoring to assess whether the 'reduced sweetness' claim would cause an increase in energy intake amongst consumers.
The Secretariat agreed to redraft the initial opinion to reflect the views of the Committee. A final draft will be circulated for Members' approval and the opinion would be finalised after a short public consultation.
6. Cliniptilolite: ACNFP/64/3
Members were asked to consider this Novel Food application for approval to market cliniptilolite as a food supplement. The application had been made via the UK Competent Authority and had been placed on the Agency's Website for public consultation with a deadline of 2 February 2004. No comments had been received.
Members concluded that the applicant had provided insufficient evidence to demonstrate the safety of this product and requested further human studies. The Committee also noted that the protein present in the product must be characterised to assess the potential for allergenicity. Members were also concerned that the product might affect the absorption and activity of some medicines, nutrients (such as beta-carotene) and gut hormones and requested further data in these areas.
Members noted that the toxicity studies provided by the applicant were primarily acute studies, often with non-oral administration, but it is anticipated that the product will be consumed orally on a chronic basis. The Committee therefore requested chronic oral intake studies. Members also commented that the studies provided by the applicant were presented with insufficient detail to assess the results.
Members indicated that the high intake of silicon could cause problems with crystalluria, particularly in people with existing kidney problems, and also drew attention to the possibility of consumers being misled by the proposed labelling.
The Secretariat agreed to contact the company to request further information on the points raised by the Committee.
7. Genetically modified maize line NK603: ACNFP/64/4
Prior to discussion of this item Professor Gasson informed the Committee that he was a member of the scientific panel that had prepared the European Food Safety Authority (EFSA) opinion on this application. Professor Gasson withdrew from the meeting for the course of discussions on this item and passed the Chair to Professor Dale.
Members were invited to consider the opinion from EFSA's Scientific Panel on GMO's on the herbicide tolerant GM maize line NK603, and to consider whether they wished to revise their earlier opinion on the acceptability of this maize line in the light of the receipt of new information from the applicant. The Committee confirmed that they were satisfied with the EFSA opinion and that the data provided by the applicant raised no new safety concerns.
8. Maize 1507: ACNFP/64/5
Members were asked to consider the initial opinion from the Dutch Competent Authority for Maize 1507, an insect resistant and herbicide resistant GM maize line. The Committee considered Maize 1507 in September 2003 under Directive 2001/18 for the deliberate release into the environment of GMO's.
The Committee was unable to agree with the positive initial opinion of the Dutch Competent Authority and raised a number of concerns regarding the specificity of expression of novel genetic material and the toxicological information. Members requested a detailed analysis to explain the behaviour of the CRY1F protein in a test system where it appeared as two separate bands.
Members also considered that the cross reactivity in healthy pollen grains with PAT antisera was poorly explained and suggested that these experiments should be repeated using pre-absorbed antisera to remove cross-reactivity, with the possibility of using a better source of polyclonal or a monoclonal antisera or specific phage display antisera. This could also be backed up by Northern or RT-PCR experiments on RNA from wild type and transgenic pollen. The Committee also requested details of the three allergens that were reported to display homology with CRY 1F.
The Secretariat agreed to reflect these points in the formal UK response to the Commission.
9. Hawaiian noni juice: Further data - ACNFP/64/6
At the July 2003 meeting, Members considered an application from Neways, Inc for an opinion on the equivalence of noni juice (juice of the fruit of Morinda citrifolia L) grown in Hawaii under Article 5 of EC Regulation 258/97. Members raised a number of issues and requested further information from the applicant.
The applicant had produced additional information to address these issues but the Committee considered that its concerns had not been completely addressed and requested further analytical compositional data with respect to samples of the applicant's own product.
The Secretariat agreed to contact the applicant to request this further information.
10. DHA-rich oil from Ulkenia sp.: ACNFP/64/7
Members were asked to consider a positive opinion on equivalence from the German Competent Authority (CA) on DHA-rich oil derived from Ulkenia sp. with the comparable product obtained from another algal source, Schizochytrium sp.. Based on this opinion, the former oil had been notified as a novel food under article 5 of EC Regulation 258/97 and could now be marketed across the EU.
The Committee was unable to agree with the opinion of the German CA and considered that the information summarised in the opinion did not appear to be sufficient to support the substantial equivalence of the two products.
The Committee asked for clarification on the number of samples assessed for the comparison of the average fatty acid levels between DHA-rich oil from Ulkenia sp. and the existing DHA-rich oil, and requested that these levels be compared statistically in order to ascertain whether they are significantly different. Members also asked for an indication of the source for the daily intake limit of 0.5g of DHA per day for children aged 4-9 years. The Committee also questioned the premise that oils from two different algal species, neither of which has a history of food use, could be judged to be of equivalent safety based solely on an analysis of known lipid constituents.
The Secretariat agreed to seek clarification from the German CA on these points.
11. Chia (Salvia hispanica L): ACNFP/64/13
This novel food application was submitted to the UK Competent Authority and was discussed at the Committee's meeting in July 2003. The Committee had raised a number of questions and requested further information from the applicant.
Prior to discussions on this application Professor Rowland declared a conflict of interest as he had provided advice to the applicant on this product and left the room for this item. Professor Warner and Dr Meredith informed the Committee that they had some indirect involvement with the design and execution of certain studies and the Chairman concluded that they should remain.
The applicant provided additional information to answer the Committee's questions but Members considered that the applicant did not adequately address their concerns relating to potential cross reactivity and the request for further allergenicity studies. The applicant suggested that they would be unable to carry out further allergenicity testing to determine cross reactivity between Chia and other seeds, such as sesame or mustard, due to the difficulty in finding a sufficient number of suitable subjects. However the allergenicity experts on the Committee considered that allergenicity studies were possible, while acknowledging that such studies might entail significant cost.
Members noted that the applicant's labelling proposal would minimise the risk associated with cross-reactivity between components of Chia and other seed allergens, but was potentially unfair to consumers with seed allergies since this cross-reactivity might not exist. Additionally the Committee examined the hazard analysis from harvest to storage and considered the information supplied to be insufficient as it failed to take account moisture levels during transport and and did not indicate the monitoring that would be put in place to ensure the controls were being effectively applied.
The Secretariat agreed to draft a response to the applicant outlining the Committee's response to the additional information.
12. ACNFP Annual Report 2003: ACNFP/64/8
Members had been provided with a draft copy of the 2003 ACNFP Annual Report and were asked to provide substantive comments at the meeting. The Committee confirmed that no significant changes were required and agreed to forward minor drafting points to the Secretariat in writing.
The Secretariat informed the Committee that the Annual Report would be cleared by Chairman's action following the receipt of Members' comments.
13. Substantial equivalence: ACNFP/64/9
This tabled paper provided Members with a draft guidance document for the assessment of substantial equivalence.
The Committee agreed to forward comments to the Secretariat, who would present a revised version for further discussion or agreement at the Committee's next meeting.
14. Items for information
14.1 ACNFP open meeting feedback: ACNFP/64/11
Following the ACNFP open meeting on 19 November 2003 the Secretariat circulated an evaluation form to the 34 attendees. This paper provided Members with information on the nine responses received.
14.2 EU update: ACNFP/64/12
This paper provided an update on EU issues that are relevant to the work of the Committee. These included progress with novel food applications and a proposal for new EU legislation on nutrition and health claims. The paper also contained minutes of recent meetings of the European Food Safety Authority (EFSA) Scientific Panels on Genetically Modified Organisms, and on Dietetic Products, Nutrition and Allergies.
14.3 Post market monitoring of novel foods: ACNFP/64/10
This paper updated Members on the recently completed feasibility study on post-market monitoring of novel foods in the form of an information paper that was presented to the Food Standards Agency board in December.
15. Any other business
The Secretariat and Members confirmed that there was no further business.
16. Date of next meeting
The next meeting of the Committee was scheduled for Thursday 25 March 2004, in Aviation House.