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These minutes are subject to confirmation by the Committee at its next meeting.
MINUTES OF THE FORTY-EIGHTH MEETING OF THE ADVISORY COMMITTEE ON NOVEL FOODS AND PROCESSES, HELD 25 January 2001 AT ERGON HOUSE, LONDON
Professor J Bainbridge - Chairman
Professor P Dale
Professor M Gasson
Dr J Herritage
Rev Professor M Reiss
Mrs E Russell
Professor T Sanders
Professor H Sewell
Professor F Woods
Mr N Tomlinson
Ms C Wood (FSA Scotland)
Mrs S Hattersley
Dr C Baynton
Dr J Cockram
Dr C Jones
Miss R Dadswell
Mr A Hardgrave - Minutes
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 I Rowland, Dr N Simmons, Professor J Warner, Mr G McCurdy (FSA NI) and Mrs J Whinney (FSA Wales).
1.2 The Committee congratulated former Committee Member Professor Peter Aggett on his award of an OBE in the New Years Honours List.
1.3 The Committee welcomed Miss Ruth Dadswell to the Committee Secretariat.
1.4 Membership - The Committee was informed that interviews had taken place on the 15th December 2000, to fill the 4 vacancies on the Committee. A submission recommending certain appointments was forwarded to the FSA Chairman Sir John Krebs on 19 January 2001.
1.5 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 Forty-seventh meeting ACNFP/47/MIN
The Committee agreed that the minutes were a true record of the 47th meeting held on 16th November 2000.
3. Matters Arising
3.1 Echium Oil
Members were informed that the Secretariat had written to the company outlining the concerns expressed at the last meeting and detailing the further information required. The Company has indicated that it would be providing additional information shortly. The Commission has been informed of the resulting delay in producing the initial opinion on this application.
3.2 Draft ACNFP Annual Report ACNFP/48/1
The Committee considered the first draft of the 2000 ACNFP Annual Report and subject to some minor amendments was happy with its content.
The Secretariat agreed to amend the report and clear the final text through the Chairman. It is planned that the report will be published by Easter 2001. After publication the report will be placed on the ACNFP webpage.
Members requested that the report be advertised by way of a fact sheet in the ACNFP corporate brochure and that the Chair would also be available to respond to any media interest.
4. Phytosterols ACNFP/48/2
The Committee was asked to consider the summary application and initial assessment report of the Finnish Competent Authority on the use of phytosterols in frankfurters, cheese and yoghurt.
The Finnish Competent Authority evaluated an application from Valio for plant sterol enriched frankfurters, sausage, yoghurt and cheese products, and gave them a favourable opinion, which was then circulated to other Member States.
The Committee was unable to agree with the initial opinion of the Finnish Competent Authority.
Members were interested to note that unlike previous applications for the use of phytosterols, this application was for a crystalline product not an ester and queried whether the product would be dissolved in a fat phase. Members were concerned that no data were provided on the long-term effect on fat-soluble vitamin and caratenoid absorption, they also noted that no data were presented for vitamins D and K.
The Committee noted that, like similar products on the market, the company suggests 2-3 portions of the product should be consumed per day. Members were concerned at the effect of cumulative plant sterol uptake from a range of foodstuffs with raised plant sterol levels, and felt that intake data should be provided. It would be relatively easy for the consumer to ingest more than 2-3 portions a day, particularly as yellow fat spreads, cheese, yoghurts and snack bars containing plant sterols are already on the market. The Committee also queried whether the intake calculations presented, based on Finnish diets, would be predictive of consumption in the UK.
It was also noted that other Competent Authorities are currently assessing a wide range of plant sterol enriched foodstuffs. It was suggested that one way forward would be to set sale levels of intake for extreme consumers, or to specify certain food products that should not contain these ingredients. Furthermore, better education about what these products do would be helpful for consumers, together with information on the identity of all similar products.
In summary the Committee was unable to agree with the initial opinion of the Finnish Competent Authority. The Committee recognised that some of their concerns might have been addressed in the full application dossier. However, despite repeated requests to the applicant the complete dossier had still not been provided. The Committee requested that further data be sought on the long term effect on fat soluble vitamins and caratenoid absorption and the effect of cumulative plant sterol uptake from a range of foodstuffs containing raised amounts of plant sterols.
The Secretariat agreed to write to the Finnish Competent Authority and the Company again requesting the full application dossier, and will copy the letter to the European Commission. In addition the Secretariat will write to the European Commission setting out the UK concerns regarding this particular application and also voicing concerns about the cumulative effect of consuming phytosterols present at raised levels in a range of foodstuffs.
5. Research and Development ACNFP/48/3
The Committee was asked to comment on the final reports for 4 completed R&D projects:
1. G01001 - Regulation and targeting of transgene expression in fruit crops.
2. FS0212 - Causes of instability in transgenic plants.
3. CSA2915 - The effect of background genotype on transgenes; and
4. FS3023 - Development of methods to predict the allergenic potential of genetically modified foods and new protein products.
Some Members were particularly interested in receiving the full report on the fourth project (FS3023) which they felt could be useful in the future work of the Committee.
Members also discussed the peer review process and wondered if any of the work would be published in scientific journals prior to being deposited in the FSA Library. Many of the Members expressed an interest in receiving the full reports, which fell within their area of expertise, and being involved in the review process in future.
Members agreed to write to the Secretariat with any further comments on the reports and the Secretariat agreed to send Members a spread sheet of all existing R&D projects funded by the FSA, in order that they can express an interest in receiving relevant reports in future. The Secretariat also agreed to explore how the commissioned research could be peer reviewed
6. GM enzyme ACNFP/48/4
The Committee considered the genetic modification aspects of an application from the company DSM Gist for the powdered and micro granulated forms of an endoxylanse preparation derived from GM Aspergillus niger strain XYL-2 and its future progeny on behalf of the Committee on Toxicology of Chemicals in Food, Consumer Products and the Environment (COT).
Safety assessments of enzyme products classed as processing aids, are conducted by COT under a voluntary scheme before they are used. This preparation will be used as an ingredient of enzymatic processing aids in the bread baking industry and in the preparation of other baked goods.
The Committee was asked in particular to evaluate the information and data provided in the dossier with respect to the genetic modification and any food safety implications arising from this. This advice will be forwarded to the COT to be taken into account as part of their overall evaluation of the safety of this enzyme.
The Committee was content with the application but wished to bring to COT's attention the following points:
- Data are required to show that there is no residual enzyme activity or source of allergenicity in the final food, although it was noted that the same enzyme produced from the unmodified source organism was already being used. This modification only increased the yield of the enzyme from the source organism whereas the amount of enzyme used in bread making would not change.
- Claims made within the dossier regarding the genetic stability of the organism require further support.
- Although many micro-organisms produce mycotoxins, Aspergillus niger does not. However, it was possible that the modification might inadvertently activate normally silent (inactive) DNA resulting in mycotoxin production. This possibility would need to be excluded by the safety data provided.
The Secretariat agreed to forward the Committees advice to COT regarding this application.
7. Monsanto Soya ACNFP/48/5
The Committee was asked to consider a letter from Belgian Government scientists and further information from Monsanto on the Monsanto Soya bean line 40-3-2.
Members agreed that there was still some uncertainty regarding the origin of the DNA fragment that had been identified. However the DNA had been present in the line during the original safety assessment. Members recommended that the Secretariat ask Monsanto to provide data demonstrating that this DNA is 'silent' and does not result in the production of a novel protein.
The Secretariat will forward the Committees requests to DETR (the lead department).
8. Items for information
8.1 Updates on previous applications and the latest Competent Authority meeting (Oral update)
Members were informed that the last Competent Authority meeting had been held on 9th January 2001 at which High Pressure Processing was discussed. A draft decision has been prepared on the Danone application and this will now go to the Standing Committee on Foodstuffs.
Members were also informed that the trehalose application is due to be discussed at the next Competent Authority meeting in March. A number of Member States do not consider trehalose to be a novel food, but rather a sweetener, and its status will therefore be discussed.
Finally Members were updated on the EC's discussion paper on the tracebility and labelling of GMO's and products derived from them.
9. General Discussion
9.1 Topics for an ACNFP open meeting.
Members agreed that is was important that they hold an open meeting in 2001.
It was agreed that at this open meeting a number of generic issues could be discussed, such as High Pressure Processing technology and the Novel Food regulation, as well as possible GM issues. It was proposed that the meeting could consist of a discussion of the topics, with an opportunity for members of the public to express their views.
Members agreed to put forward any other possible topics for discussion. The Secretariat agreed to look at dates and venues, and to report back to the Committee at its next meeting with proposals.
9.2 General discussion on GM issues.
The Committee discussed a number of possible generic GM issues that could be developed for discussion at an open meeting, including:
- Guidance for the presentation of molecular data necessary to support applications for the placing on the market of novel foods and novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and Council. - Members noted the need to bear in mind the dynamism of the whole genome and background changes when assessing the implication of changes arising from genetic modification.
- The implications of Biolistic Techniques in GM Modification for food safety assessments
- The Molecular Characteristics of GM plants, including guiding principles on the information that was required, which should be considered within the context of the changes that occur with conventional plant breeding and natural re-arrangements.
10. Any other business.
Members were provided with copies of 2 papers for the next Codex Ad Hoc Intergovernmental Taskforce on foods derived from Biotechnology meeting due to be held on 25-29 March 2001:
1. Consideration of proposed draft guidelines for the conduct of safety assessment of foods derived from plants obtained through modern biotechnology.
2. Consideration of proposed draft general principles for the risk analysis of foods derived from modern biotechnology.
Members were also provided with a copy of the EU-US Biotechnology consultative forum- final report.
Members agreed to forward any comments on these papers to the Secretariat.
11. Date of next meeting
The next ACNFP meeting is scheduled for 14 March 2001.