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Professor J Bainbridge - Chairman
Professor P Aggett
Dr M Gasson
Dr J Heritage
Professor D Ledward
Professor I Rowland
Mrs E Russell
Dr N Simmons
Professor F Woods
Mrs S Hattersley
Dr C Baynton
Dr R Evans
Dr A Sewart
Ms T Boshier
Dr S Rowles
Mr A Hardgrave - Minutes
Mr K Hussein
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 Dale, Professor Sanders, Professor Sewell, Professor Walker, Professor Warner, Mr G McCurdy (FSA NI), Mr B Greig (FSA Scotland), Mrs J Whinney (FSA Wales) Dr J Bell and Mr N Tomlinson.
1.2 The Committee was informed that Dr Bell was recently promoted to the post of Deputy Chief Executive and Director of Food Safety Policy in the Food Standards Agency. In future he will not be attending the meetings of the ACNFP on a regular basis. Members congratulated him on his promotion and wished him every success in his new post.
1.3 The Committee was also informed that Mr Nick Tomlinson had been promoted to Head of the Novel Foods Division and would now be the FSA Assessor to the ACNFP. Members congratulated Mr Tomlinson on his promotion.
1.4 The Committee was informed that Dr Rhodri Evans would be leaving the Secretariat shortly, to take up a new post on promotion in the Food Additives Branch. Members congratulated him on his promotion and thanked him for his work with the ACNFP.
1.5 The Chairman welcomed Kamran Hussein, a summer student, who attended the meeting to assist with minute taking.
1.6 Sue Hattersley apologised on behalf of the Secretariat for the late dispatch of papers for the meeting. Delays were partly due to work pressures and the short gap between this meeting and the last, as well as to the late arrival of some papers from the Commission in relation to the applications considered under the 60 Day procedures (High Pressure Processing and Bt 11 Maize).
1.7 Finally, the Committee was reminded of the need to declare any commercial interests in the items under discussion.
2. Minutes of the 45th Meeting of the ACNFP ACNFP/45/MIN
The Committee agreed that, subject to two minor changes, the minutes were a true record of the 45th meeting held on 18 May 2000.
3. Matters Arising
At its 41st meeting (13 July 1999) the Committee considered the novel food status of Lyprinol, an oil derived from the freeze-dried powdered form of the New Zealand Green Lipped Mussel. The Committee considered that this was a novel food but that its status needed to be confirmed by the European Commission. Meanwhile, Members requested further information on production quality controls, likely intakes and potential changes in fatty acid composition.
The Company had provided additional data for the 45th meeting that offered some reassurance, however it was not clear what specific controls were used for the protection against pathological bacteria in the mussels used in production, and on the fatty acid composition of the oil.
Members queried whether these concerns would also be relevant to a similar product that is currently marketed in the UK. The Committee was informed that as this similar product had been on sale prior to 1997 it fell outside the remit of the EC Novel Food Regulations. Nevertheless, if safety concerns of possible relevance to this product were raised in the course of the consideration of Lyprinol they could be referred to the Committee on Toxicity of chemicals in Food, Consumer Products and the Environment (COT) for its views.
The Committee requested that the Secretariat write again to the company and request further data to address their concerns.
3.2 Revised Specification of Myco-protein
At its last meeting the Committee considered a request from Marlow Foods for an alteration to the specification for Myco-protein, in terms of the levels of RNA present in the final product. It had been agreed that this alteration to the RNA-reduction step in the post-fermentation processing of myco-protein did not mean that the material produced in this way constituted a novel food, while recognising that this decision was ultimately for the EC Standing Committee for Foodstuffs. However, Members had asked that further data be provided regarding the intake by vegetarians before a final decision on the acceptability of the revised specification could be made.
The company provided some further data for scrutiny by the Committee, however this did not include detailed data on intakes by vegetarians.
The initial limit on RNA in the specification for myco-protein had been set to restrict purine intake. Given that other sources of protein in the diet that would be replaced by myco-protein also contained purines, the Committee requested that the Secretariat seek further data on the intakes of purines from these other protein sources. The Committee agreed to reconsider the revised specification for Myco-protein, in the context of overall purine intake, at a future meeting.
3.3 Taste Trials
Members considered revised guidelines on the conduct of taste trials at their 45th meeting and suggested a number of amendments that could be made to improve the paper. The paper was referred back to Members for final clearance to go out to consultation.
Members agreed that subject to one minor change the paper was now ready to go out to consultation. It was suggested that when going out to consultation, in addition to those on its accompanying list of consultees, the paper should be sent to the Nutrition Society, the Board of Social Responsibility at the Church of England and to the Food Science Departments of all the Major Universities.
The Secretariat agreed to make the change and send the paper out to consultation.
4. Trehalose ACNFP/46/3
This was the first application to the ACNFP for an initial opinion on a novel food to be handled under the new openness procedures agreed in December 1999. The application dossier, minus any sections deemed to be commercially confidential, was placed on the ACNFP website for public comment on 25 May, the first day of the 90-day evaluation period.
The application related to a sugar, Trehalose, obtained from food grade starch using a novel enzymatic process. The process uses four enzymes that have not been evaluated by the FAC, however, the application dossier stated that a subsequent purification step in the production process should remove all proteinaceous material from the final product.
Members noted that the source organism used to produce two of the enzymes used in Trehalose production did not have a history of food use. It was agreed that further evidence was needed to provide reassurance that this organism could not produce toxins under the conditions of the fermentation process, used to produce the two enzymes, that might be carried through into the final food ingredient. Members therefore sought clarification regarding the quality controls for the production of the enzyme preparations, and the batch to batch purity of the Trehalose product.
The Committee was also concerned that diabetics would not be aware that Trehalose was a ready source of glucose. Members therefore suggested that it should be a requirement of any clearance that an indication would be given on the packaging that Trehalose-containing products are a source of glucose.
The Secretariat agreed to write to the company regarding these aspects of the dossier, and to distribute any additional information to the Committee for consideration.
A draft opinion will then be circulated to Members by post for comment and agreement, and will be placed on the ACNFP website allowing for a short period of Public consultation. The Opinion will then be forwarded to the European Commission.
5. High Pressure Processing
The French Competent Authority had evaluated an application from Danone for the high pressure processing of fruit based preparations and given a favourable opinion. The Committee was asked to comment on the summary of the application and French initial opinion and to consider whether they agreed with the proposed approval.
The Committee sought clarification of a number of points regarding the specifications of the food preparation, quality assurance testing and the process controls. They concluded that in order to protect against botulism, the approval for the use of high pressure treated fruit preparations should be limited only to final products whose characteristics conformed to the recommendations given in the Report on Vacuum Packaging and Associated Processes published by the UK Advisory Committee on the Microbial Safety of Food (ACMSF), as amended.
The Committee generally agreed with the opinion of the French Competent Authority and was content for clearance to be given for the fruits listed when processed in the manner described in the application dossier only.
The Secretariat will draft a letter for circulation to members, expressing the Committee's views to the European Commission. Once approved this letter will be forwarded to the Commission and placed on the ACNFP website.
6. Novartis BT11 Sweet Maize ACNFP/46/5
The Netherlands Competent Authority had evaluated an application from Novartis for approval of fresh and processed food products derived from GM sweet maize (Bt11), that had been modified to confer insect resistance, and given a favourable opinion. The Committee was asked to comment on the application, and to consider whether they agreed with the Netherlands favourable opinion, or whether the Committee had any concerns or questions that they felt had not been addressed in the dossier.
The ACNFP recognised it had previously considered Bt 11 field maize and considered it to be equivalent to the unmodified field maize except for the intentionally introduced genes. In carrying out its safety assessment the Committee focussed on the consumer safety aspects of the processed products from the GM maize. The Committee had concluded that the processed products from the inbred and hybrid GM maize lines derived from Bt11 were safe for use in food. Clearance was given in 1997 for Bt11 field maize and conventional crosses derived from it. The Bt11 sweet maize had been obtained by conventional crossing with the Bt11 field maize, however, Bt11 sweet maize may be sold unprocessed. The Committee raised a number of queries on the data submitted to the Netherlands Competent Authority.
The applicant had submitted digestibility and acute oral toxicity studies on the Cry 1A protein expressed in E. coli rather than the protein expressed in the sweet maize. Other in vivo studies were based on studies in tomato. The recent FAO WHO report, on safety aspects of genetically modified foods of plant origin, recognised the merits of testing material derived from analogous systems however it stressed the need to demonstrate that such material is biochemically and functionally equivalent to that produced in the genetically modified food.
Studies relating to expression of the PAT protein were carried out in field maize rather than on the sweet maize. Although the Committee accepted that the protein was the same as in the field maize there was no indication of the expression levels of the PAT protein in the sweet maize. The data collected on sweet maize examined herbicide tolerance to indicate the presence of the pat gene rather than looking at the levels of PAT protein in the kernels.
The quality of the molecular biology data was questionable, particularly as additional unaccountable bands appeared on the Southern Blots and the applicant has been asked to provide clarification.
The Committee agreed to forward any further comments to the Secretariat who will produce a letter to the European Commission with the Committee's views. This letter will be placed on the website in due course.
7. ITEMS FOR INFORMATION
7.1 Feedback on the R&D workshop held on 14th and 15th June in Oxford.
Members were informed that a successful R&D workshop had been held in Oxford on 14th and 15th June. The workshop included reports on existing projects and an opportunity for helpful discussions of possible areas of future research. Areas of potential future research discussed included risk analysis of GM foods and functional foods including probiotics and preboitics.
It is expected that the Food Standards Agency will go out to tender for future projects in September. Members were asked to send in any suggestions for future R&D projects or comments to the Secretariat by the end of July.
7.2 Updates on previous applications to the ACNFP
The Committee was updated as to the progress of previous applications seen by the ACNFP. In short the Zeneca Tomato, Salatrim, Nangi Nuts and Radicchio rosso and green hearted chicory applications are all with the SCF.
The Stevia application has been rejected by the SCF and stevioside is not a permitted sweetener under EC Food Additive legislation.
The phytosterols dossier was voted on at the last Standing Committee for Foodstuffs meeting and Members of that Committee agreed to approve the application.
7.3 Irradiation Consultation
Members were informed that comments are sought on the Food Irradiation Provisions (England) Regulation 2000, which will implement two EC Directives on food irradiation. The consultation pack was issued on 24th May and all responses are due by 19 July. All Member States have until September 2000 to implement the EC Directives.
8. Any other Business
8.1 FSA Board Meeting
The Committee was informed that the Food Standards Agency Board had discussed GM food issues at their last open meeting, held in Glasgow on 22nd June. The outcome of the Board meeting was set out in the statement issued on the FSA website.
8.2 ACNFP Discussion System.
Members commented that they were continuing to have problems with the ACNFP discussion system. The Secretariat agreed to investigate these problems and to look into the possibility of a web based system. In the meantime the Secretariat agreed to set up an e-group and to act as postmaster to Committee emails.
9. Date of next meeting
The next ACNFP meeting is scheduled for 16 November 2000.