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: 20 November 2008
Notes for the meeting of the Committee at 10.30am on 20 November in Conference Rooms 3 & 4, Aviation House, Kingsway, London
Present:
Professor Andrew Chesson – Chairman
Dr Paul Brantom
Professor Harry Flint
Professor Gary Foster
Dr Paul Haggarty
Professor Stephen Holgate
Professor John Mathers
Dr Clare Mills
Mrs Gillian Pope
Professor John Warner
Apologies:
Professor Michael Bushell
Ms Jayam Dalal
Professor Mike Gasson
Professor Christopher Ritson
Professor Peter Shewry
Mr Kevin Swoffer
FSA Observer:
David Gott (item 7)
Elaine Stone
Paul Willetts (item 8)
FSA Assessor:
Clair Baynton
Secretariat: Ms Azuka Aghadiuno
Ms Alison Asquith
Ms Shuhana Begum
Dr Chris Jones
Dr Darren Key
Dr Sandy Lawrie - ACNFP Secretary
Dr Manisha Upadhyay
Ms Sandeep Virdee - 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
Six members had sent apologies for non-attendance. In the absence of Mike Gasson, Andrew Chesson agreed to chair the meeting. Apologies were also received from observers from FSA Scotland, FSA 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 90th meeting DRAFT/ACNFP/90/Min
Subject to two minor amendments, Members agreed that the minutes were a true record of the 90th meeting of the ACNFP held on Tuesday 16 September 2008.
3 Matters Arising
The Secretariat provided the following update on items arising from the previous meeting.
Item 4 (beta-glucan-rich extract from Lentinus edodes): the Committee's draft opinion had been issued for public consultation and no comments were received. The opinion had been made final and was sent to the European Commission as the basis of the UK's initial assessment.
Item 6 (D-ribose). The Secretariat tabled the letter that had been sent to the applicant setting out the Committee's outstanding concerns about this product. The applicant had asked the Secretariat whether the Committee required additional mechanistic studies on the interaction between ribose and glucose metabolism, in addition to a new study on reproductive toxicity. Members confirmed that they did not.
Items 7, 8 and 9 (Conjugated linolenic acid, synthetic lycopene and policosanol): the Secretariat confirmed that the Committee's comments had been forwarded to the Commission.
Item 12 (use of Extranet): there had been no further progress on the development of an Extranet system. The Secretariat would examine the possibility of providing an archive of committee papers for each meeting on CD-ROM.
Action: Secretariat
4. Phosphate Distarch Phosphate ACNFP/91/1
The Committee considered the two outstanding issues that had been raised during the final consultation on their draft opinion, regarding phosphorus levels and the need for an advisory statement highlighting potential GI intolerance in children .
The Committee accepted that the guidance for dietary management of renal patients had previously been misreported as 'phosphate' rather than 'phosphorus', and that the corrected values meant that any increase in phosphorus intake from the consumption of this novel ingredient (NI) would be negligible. The Committee therefore agreed that there was no need for renal patients to be informed of the presence of phosphorus in the NI.
The Committee rejected the applicant's view that it was unduly precautionary for all products containing the NI to carry a warning about possible laxative effects in young children. The Committee stated they could not ignore the lack of relevant studies in children particularly as many of proposed food categories such as tinned pasta and biscuits would be attractive to the young.
The Committee was also of the view that, as these food categories are very likely to be consumed by young children, it would not be unreasonable for the applicant to seek ethical approval to carry out a non-invasive in vivo study in this age group to investigate potential intolerance. Members rejected the applicant's suggestion that a programme of post launch monitoring could be carried out to determine the extent of any GI intolerance on the basis that it would be extremely difficult to obtain meaningful data.
The Secretariat agreed to alter the opinion to reflect the discussion, and advised that as the draft had undergone two separate public consultations, the final text would be circulated to the Committee for final clearance prior to publication.
Action: Secretariat
5. Touchi (Black Bean) Extract ACNFP/91/2
The Committee considered this application for the authorisation of Touchi (Black Bean) extract as a novel food ingredient in July and September 2008. It was asked to consider further information provided by the applicant in response to its request for a better analysis to demonstrate the similarity of the proteins in Touchi extract and black bean sauce from the September meeting. It was also invited to consider the text of the draft opinion.
Members were satisfied that the HPLC traces provided indicated proteins in Touchi extract and black bean sauce were similar however this was subject to confirmation of various experimental details.
The Secretariat agreed to request further information from the applicant on the method used for HPLC analysis (including sample preparation and UV wavelengths) and on the labelling of the chromatograms.
The Secretariat agreed to revise the draft opinion to reflect members' comments and, once the experimental details had been confirmed, to issue the document for public consultation.
Action: Secretariat
6. Draft EFSA Opinion on Nanotechnology ACNFP/91/3
Andrew Chesson informed the Committee that, as Chair of EFSA's FEEDAP Panel, he was a member of the EFSA Scientific Committee that had issued this draft opinion and that he would therefore not take part in this discussion.
Members drew attention to the recently-published report on new materials, from the Royal Commission on Environmental Pollution. This report had highlighted the limited availability of data on ingested nanomaterials and stressed the need to evaluate materials based not only on size but also on their functionality. Public understanding of nanomaterials was a prerequisite for effective risk communication.
Members also noted that most work to date has been on inorganic nanomaterials and carbon nanotubes, whereas many of the potential food applications were "bio-nanomaterials" such as micelles. It would be valuable to consider the potential risks from "new" nanomaterials in the context of those occur naturally in food and the environment. Also, the interaction of nanoparticles with macromolecules in foods was potentially important, as the resulting complexes could enhance their absorption.
Members agreed that the EFSA document was valuable but there were apparent contradictions about the adequacy of current approaches to risk assessment, as set out in different sections of the opinion. It would also be useful to prioritise the long list of recommendations and to explain what is driving the development of nanotechnologies in relation to food and food ingredients, since this would give an appreciation of type of applications that come to market.
The Secretariat agreed to relay the Committee's comments to EFSA, together with those of other FSA Committees.
7. Conjugated Linoleic Acid (CLA) – Rich Oil ACNFP/91/4
Paul Haggarty informed the Committee that a group in his Institute was carrying out industry-research on CLA and that he had not previously reported this as he had only recently become aware of this work. The Committee agreed that this did not represent a conflict of interests and did not prevent him from taking part in this item.
The Committee considered the Irish Competent Authority’s (CA) initial opinion on this application for CLA-rich oil derived from safflower oil as a novel food ingredient in July 2008. The Committee raised a number of comments and concerns and these had formed the basis of the UK’s response to the CA’s opinion. Several other Member States had also raised objections. The Committee noted that the concerns were, in many cases, similar to those raised by the Committee. The Committee was asked to consider the applicant's response to the points raised by the UK and by other Member States.
The Committee was not satisfied with the applicant's response to its concerns about intake of the novel ingredient, stability/oxidative stress and animal studies.
The Committee reiterated its concerns about intakes, noting that the estimated intake for children is similar to adults but the proportion consumed in relation to body weight is substantially higher. Children are therefore likely to be overexposed to the novel ingredient considering the wide range of food products it is intended to be used in. The Committee noted that the EFSA report referenced in the applicant's response appeared to confirm the recommendations from COMA (Committee on the Medical Aspects of Food and Nutrition Policy).
In relation to this issue, Members raised a general question on whether the balance of isomers in CLA products is of concern. The Committee also noted the Scientific Advisory Committee on Nutrition (SACN) report ‘Update on Trans Fatty Acids and Health 2007’ which considered recent evidence regarding the health effects of trans fatty acids (TFA) including CLA. The review endorses the current recommendation set by COMA (1994), that the average TFA intake should not exceed 2% of food energy.
The Committee was also not satisfied with the applicant’s response regarding oxidative stress and noted that the evidence presented indicated that oxidative stress increased with ingestion of the novel ingredient. In terms of product stability the Committee was of the view that the comparison with vegetable oils, such as safflower oil from which the ingredient is sourced, was incorrect as these oils contain natural antioxidants e.g. tocopherols. The Committee reiterated its concerns that appropriate anti-oxidants need to be used to ensure the stability of the product.
The Committee noted that the applicant continued to put a low weighting on animal studies and therefore its original comments should stand.
The Secretariat noted that the Committee's comments will be used to inform the Food Standards Agency’s position in future EU discussions on the authorisation of this novel ingredient.
Action:Secretariat
8. Emerging Technologies ACNFP/91/5
The Committee was invited to consider a recent review of emerging technologies for food processing, which had been carried out by the Food Processing Faraday Partnership on behalf of the Food Standards Agency, and to identify any topics requiring detailed consideration.
The Committee noted the increasing interest in modifying the composition of food and suggested that nutritional knowledge was lagging behind the ability to derive new ingredients with postulated beneficial effects. Any proposed benefits and the associated health or nutrition claims were not evaluated in the EU as part of the novel food procedures. This was in contrast to the approach taken in New Zealand, where safety and claims are examined together. This raised the question whether new foods and processes might be examined on the balance of risks and benefits, rather than solely on the basis of risk.
The Committee noted the increased emphasis on ingredients derived from fungi and algae, which was already seen in recent novel food applications and underlined the need to have appropriate expertise among the Committee membership for the assessment of such products and of their production methods.
Finally the Committee noted that the development of new plant varieties by conventional (non-GM) plant breeding was being accelerated by the application of new technologies, and that the introduction of new varieties could lead to step changes in the composition of crops.
Action: Secretariat
9. Reproduction studies in mice with GM Maize NK603MON810 ACNFP/91/6
The Committee considered a report on three long term reproduction studies in mice whose diets contained 33% of maize flour from a GM source (NK603 x MON810), a non-GM source related to the NK603 line (ISO), or an unrelated non-GM source (REF).
The Committee observed that the report described what had been done and what results were obtained but it did not go into the level of detail that was needed to make a full evaluation, as would be required when carrying out a risk assessment on a new GM food.
Although the three test materials used in these studies were reported to be "substantially equivalent" this was not tested statistically and the results of the nutrient analyses were reported only as single values. Among these figures there appeared to be differences in some micronutrients that could be important for reproductive performance (iron and zinc).
Although it is a general principle that safety tests should be conducted on materials that are representative of what is consumed (as food and/or feed), it was notable that the maize meal used in these studies was not heat-treated, which would be the case for commercial maize products used as food or feed. The multi-generation study was of a conventional design but used an outbred mouse strain, which meant that the analysis was complicated by possible genetic differences in the successive generations due to inbreeding.
The Committee noted that the report highlighted differences in reproductive performance between the GM and ISO groups in the continuous breeding study. This is not a type of study that is used in Europe and most experience with this methodology is in the USA, where it has been used in the National Toxicology Program. The current study differs from the standard protocol in that the pups remained with their parents until weaning. This means that each subsequent litter was conceived during the lactation phase of the previous reproductive cycle. Although the authors reported a reduction in the number of litters in the GM group compared to the ISO group, they did not carry out any further investigations into the possible causes. They also did not report any results from examination of the offspring.
The Committee noted that the statistical treatment of the results was simplistic and should be reviewed. The Committee also noted that it was not valid (in the multi-generation study) to compare the GM group with a pooled control consisting of the ISO and REF groups, since the latter two groups were shown to be significantly different.
The treatment groups in the long term feeding study were relatively small (10 animals of each sex) which would have limited the ability to detect possible differences. An assessment of the power of this study would have been helpful.
In conclusion, the Committee was satisfied that the observations were correctly reported and that there were differences in some parameters. However, it was not possible to draw any conclusions about cause and effect or to assess the significance of these differences for human or animal health, for the reasons set out above.
10 ACNFP Open Event ACNFP/91/7
Members considered the proposed programme for the annual ACNFP open event to be held on the afternoon of 18 February 2009.
The Committee agreed the topics for discussion and the opening presentations. Post marketing surveillance was proposed as a possible additional topic. The Committee agreed that it could be included either in the discussion on estimating and controlling intake levels of novel food or in the presentation on novel foods and how they are handled across the European Union.
Three members of the Committee agreed to volunteer as chairs for the small discussion groups and to give short presentations on the specific topics.
11. Items for Information
Update on other Scientific Advisory Committees ACNFP/91/10
FDA Guidelines for the assessment of GM Animals ACNFP/91/11
The Committee noted these information papers without comment. The Secretariat informed the Committee that the information paper ACNFP/91/8 (on EU developments) would be distributed by post after the meeting and the information item on novel food notifications was deferred to the next meeting.
12 Any other business
None
13 Date of next meeting
The next meeting was scheduled to be on 19 February 2009