ACNFP Minutes: 10 February 2010

Notes of the meeting of the Committee at 10.30am in Conference Room 5, Aviation House, Kingsway, London

Present:

Professor Peter Gregory Chairman
Dr Paul Brantom
Professor Michael Bushell
Ms Jayam Dalal
Dr Paul Haggarty
Professor Stephen Holgate
Professor Harry Flint
Professor Peter Meyer
Professor Clare Mills
Mrs Gillian Pope
Professor Christopher Ritson
Professor Peter Shewry
Mr Kevin Swoffer
Professor John Warner

Apologies: Professor Andrew Chesson
Professor John Mathers

Secretariat: Miss Alison Asquith
Ms Shuhana Begum
Dr Chris Jones
Dr Darren Key
Dr Sandy Lawrie - ACNFP Secretary
Dr Manisha Upadhyay
Mrs 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
Two members had sent apologies for non-attendance. Apologies were also received from the FSA Assessor (Alison Gleadle) and from observers from FSA offices in 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 95th meeting DRAFT/ACNFP/95/Min
Subject to minor amendments members agreed that the minutes were a true record of the 95th meeting of the ACNFP held on Thursday 26 November 2009.

3. Matters Arising and Postal Consultations
The Secretariat reported back on matters arising from the 95th meeting and on the consultation on the EFSA draft opinion on allergenicity testing of GM foods, which was circulated in December for the Committee to consider by post (paper ACNFP/96P/1). Members’ comments had been incorporated into a formal response submitted via the EFSA website.

The Committee noted that there are no definitive methods for predicting allergenic potential of new substances and that this has implications for novel foods as well as GM foods. Members suggested that it would be useful to draw up a short statement on its approach to the allergenicity assessment of novel foods.

4. Bee Venom for addition to honey ACNFP/96/1
The Committee was asked to further consider the text of the draft opinion and conclude whether it is content to approve venom as a novel ingredient. The application had previously been discussed by the Committee in September and November 2009. Members are asked to specially consider whether the uncertainty over sensitisation represents a risk that is greater or lesser than that from products that are accepted as part of the existing diet.

The Committee noted that honey contains venom. However, this product has significantly higher levels.

The Committee expressed some concern about the concept of deliberately adding a toxic substance to food, particularly as the data from the clinical study did not provide convincing evidence that bee venom has any clear benefits.

The Committee’s main concerns with this application related to potential allergenicity. While it was felt that strong warning labelling could protect individuals who are already sensitised to bee stings/bee products, the Committee remained concerned that there may be a possibility that bee venom may cause allergic reactions in individuals who are not aware they are allergic to bee stings or bee products, and that oral consumption of bee venom may have the potential to sensitise non-venom allergic individuals to bee stings. Relating to these two points, the Committee stated that it could not be certain that there was no risk to consumers as any potential risk could not be quantified. The Secretariat agreed to amend the initial opinion and circulate it to the Committee as a postal consultation.

Action: Secretariat to amend initial opinion, to be cleared by post prior to public consultation

5. Magnolia Bark Extract ACNFP/96/2
The Committee initially considered this application at the September and November meetings and had two outstanding concerns relating to this application. The Committee requested that the applicant provides further data to demonstrate the absence of protein in magnolia bark extract (MBSE) preparations. The Committee stated that the Bradford assay method was not an appropriate method for protein detection for this purpose and requested the applicant uses a more specific detection method such as mass spectrometry. The Committee highlighted the need for such data to be obtained from an accredited laboratory. Members also had concerns about the gender-specific, statistically significant increases in blood total bilirubin levels (TBBL) observed during the 90 day rodent study and requested a copy of the original study report to investigate this further.

The Committee was informed that the applicant is carrying out additional protein analysis data which the Secretariat agreed to circulate upon receipt. The Committee was satisfied that the 90 day rodent feeding study contained all relevant data and that the observed increases in TBBL were not dose-related. The Committee stated that increases in TBBL levels in the treatment group were deemed significant because TBBL levels in the control group were aberrantly low rather than as a result of any dose-related effect.

Members also discussed whether cholestasis may be a reason for the observed increases in TBBL in females. Members discussed the seriousness of this disease during pregnancy (cholestasis during pregnancy can increase the risk of foetal death). However, based on reviewing the original study report, the Committee agreed that the observed increases in TBBL in females were not of toxicological concern and were not attributable to cholestasis.

The Committee noted that the dossier describes studies showing that magnolol and honokiol may have pharmacological effects on gastrointestinal function in humans, but the applicant states that exposure to magnolol and honokiol from MBSE-containing mints or gum is limited so such effects would not be expected. The Committee was unable to assess the validity of this argument without information on levels in the GI tract of the compounds tested in the relevant studies and how these relate to exposure to MBSE from confectionery and requested that the applicant provides this information.
The Committee was asked to review the text of the draft initial opinion and suggest any amendments.

The Secretariat agreed to request further information from the applicant and to incorporate this information into the draft opinion for review at the next meeting.

Action: Secretariat to request information from applicant

6. Phosphated Distarch Phosphate ACNFP/96/3
Phosphated distarch phosphate is a chemically modified resistant starch derived from high amylose vegetable starch. The Committee had issued a positive opinion for phosphate distarch phosphate (from maize) in 2009 and this new application, considered for the first time at the November meeting, concerned the use of phosphate distarch phosphate (from wheat), also as a source of fibre in a range of low moisture foods.

The Committee was asked to consider whether the concerns raised at the November meeting, related to the stability of the product and the relevance of the intake assessment, were adequately addressed by the additional information provided by the applicant.

The Committee accepted the applicants’ intention to modify their proposed food categories and level of incorporation to replicate those proposed by a previous applicant meant that a new intake assessment was not required because the assessment carried out by the previous applicant applies would now also apply to their product. It was possible that the entry to the market of a second company producing the same ingredient would result in more widespread use, possibly at a lower price, but the intake assessment based on “worst case” consumption scenarios remained valid.

The Committee was not satisfied with the additional information provided in relation to the stability of the product and requested that the applicant provide further data to demonstrate that the physico-chemical structure of the starch does not alter over time and indicated that the use of infrared spectroscopy could be considered in this regard. The Secretariat agreed to seek this information from the applicant, as well as information on particle size.

Action: Secretariat to seek information from applicant

7. Chia Seed (The Chia Company) ACNFP/96/4
The Committee were asked whether it is content to agree the substantial equivalence has been established between the chia seed from The Chia Company and the authorised chia that is currently marketed in the EU. The Committee was also asked what additional information the applicant should supply in order to demonstrate equivalence.

The Committee were generally content with this application with only two issues requiring clarification. Firstly, the Committee requested more information on the variety of chia seed grown in Australia in order to see how it differs from the South American variety that is currently on the market. Secondly, the Committee asked for more detailed information on the growing conditions in Australia, compared with the conditions for cultivation of the South American product.

Action: Secretariat to request information from applicant

8. REV-7 Chewing Gum Base ACNFP/96/5
The Committee initially considered this application in Summer 2009. At this time the Committee did not agree with the positive opinion issued by the Dutch CA and concluded that additional information was required before the assessment of the safety of the NI could be concluded. Concerns related to a significant underestimation of the consumption of chewing gum (and as a consequence the novel ingredient) and a lack of human studies to determine its fate during transit through the human gastrointestinal (GI) tract. Members also expressed concern that the new ingredient would not be identified on food labels.

The Committee was asked to consider additional information provided by the applicant in response to each of these concerns. Members accepted that the in vitro study carried out by the applicant addressed questions related to transit through the GI tract if the gum was swallowed, but requested clarification as to the extent to which this study was being relied upon to support the safety of the product. Members therefore sought confirmation that the other safety studies carried out by the applicant were adequate.

The Committee accepted that the there was no legal requirement to indicate the presence of this type of ingredient on the label of chewing gum products, but their view was that the applicant’s proposed name “REV-7” to be inadequate if it were to appear on food labels.

The Secretariat agreed to forward the safety studies to toxicologists on the Committee for review, and to ask the applicant to consider an alternative, more descriptive, name for the ingredient.

Action: Secretariat to forward studies to toxicologists and to ask applicant to reconsider name

9. Yeast beta-glucans ACNFP/96/6
The Committee was asked to consider a positive initial opinion from the Irish Competent Authority (CA) on an application submitted by Biothera Incorporated, for the authorisation of two insoluble (BWGP and WGPD) and one soluble (WGPS) yeast beta-glucan preparations as novel food ingredients.

The novel ingredients are derived from the cell wall of baker’s yeast, Saccharomyces cerevisiae, which has a long history of safe use in the production of bread, beer and wine. The ingredients are intended to be used as food supplements and food ingredients.

The Committee was asked whether it agreed with the Irish CA’s positive opinion, that yeast beta-glucans be granted authorisation as a novel food ingredient.

The Committee considered that a proper definition of the ingredients was required. In particular it noted that no information on the composition of the soluble product was provided, and there may be significant differences in this form due to the solubilisation steps involved in the production process.

The Committee noted that the safety data presented in the application were not clearly cross-referenced to the correct product. As there are likely to be significant differences between 1,3 and 1,4 beta-glucans, more information was required on which products the safety data corresponds to.

The Committee requested further information on the immunostimulatory effects of the ingredients and whether they have significant effects on the gut flora.

The Committee also noted some inconsistencies between the information reported by the Irish CA and the information presented in the application dossier.

The Secretariat agreed to transmit the Committee’s comments to the European Commission as part of the UK's formal response to the Irish opinion.

Action: Secretariat to request information from applicant and to transmit Committee’s comments to the European Committee

10. House of Lords Science and Technology Committee Report on Nanotechnologies in food ACNFP/96/7
The House of Lords select committee announced this inquiry in February 2009 and gathered written and oral evidence from a range of interested parties. The inquiry covered a wide range of topics regarding the current and future use of nano-technologies in relation to food.

The Committee noted the report and suggested that the Food Standards Agency should take the lead on any research requirements that are specific to food, as food research does not feature high on the priorities of the Research Councils.

11. Open Meeting ACNFP/96/8
The Committee was asked to review the format and programme for the annual ACNFP workshop which is to be held on 21 April 2010.

The Committee agreed the format and the topics to be discussed in the meeting. The Secretariat agreed to proceed with the organisation of the meeting and would contact individual members directly about specific topics.

Action: Secretariat to proceed with open meeting arrangements

12. Items for information

12.1 EU Update ACNFP/96/9

12.2 Update on Scientific Advisory Committees ACNFP/96/10

12.3 Novel Food Notifications ACNFP/96/11

12.4 Effects of Three GMOs (MON810, MON863 and NK603) on the Health of Mammals ACNFP/96/12

12.5 Food Standards Agency’s Protective Marking System ACNFP/96/13

On paper ACNFP/96/12, the Committee commented that the nutrient composition of animal diets can be a critical factor in feeding trials, particularly those involving a high proportion of the test material. There appeared to be some confusion over assessing the significance of any differences that are observed in these types of studies and there was a role for advisory committees in explaining this more clearly to the public.

The Committee noted the other information papers without comment.

13. Any other business
Three members reported on an event hosted by the Government Office of Science and the Food Standards Agency for non-specialist (lay) members of Government’s scientific advisory committees, which they had found to be interesting and worthwhile.

The Members and Secretariat agreed to set up a small working group regarding guidance for applicants on methods for protein analysis.

Action: Secretariat to work with Members in order to set up working group

The Committee and Secretariat also suggested to consider a planning day to examine work that the Committee wish to undertake.

Action: Secretariat to liaise with Chairman re planning day

14. Date of next meeting
The next meeting was scheduled for Thursday 22 April 2010 in Aviation House.