Food Standards Agency
2nd floor Aviation House
London WC2B 6NH
Tel: +44 (0)20 7276 8596
Fax: +44 (0)20 7276 8513
Notes of the meeting of the Committee which took place at 10:30am in conference room 5, Aviation House, 125 Kingsway, London
Professor Peter Gregory – Chairman
Dr Paul Brantom
Professor Mike Bushell
Ms Jayam Dalal
Dr Paul Haggarty
Professor Peter Meyer
Professor Clare Mills
Mrs Gillian Pope
Professor Christopher Ritson
Professor Andrew Chesson
Professor Harry Flint
Professor Stephen Holgate
Professor John Mathers
Professor Peter Shewry
Professor John Warner
Ms Azuka Aghadiuno
Ms Alison Asquith – Minutes
Ms Shuhana Begum
Dr Chris Jones
Dr Sandy Lawrie – ACNFP Secretary
Dr Manisha Upadhyay
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. Apologies were also received from the FSA Assessor (Mr Terry Donohoe) and observers from FSA offices in Scotland, Wales and Northern Ireland (Ms Alison Taylor, Ms Hilary Neathey 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.
The Chairman announced that he had recently changed jobs following the amalgamation of the Scottish Crop Research Institute with the Macaulay Land Use Research Institute. His new dual role is as Chief Executive of East Malling Research and Professor of Global Food Security at the University of Reading.
2. Minutes of the 101st meeting DRAFT/ACNFP/101/Min
Subject to minor amendments the Committee agreed the minutes were a true record of the 101st meeting of the ACNFP held on Wednesday 9 February 2011
3. Matters Arising and Postal Consultations
Postal paper ACNFP/102/P1: The Committee was consulted by post on an application for authorisation of wheat bran extract and an initial assessment report that was prepared by the Belgian authorities. Members’ comments were passed to the European Commission concerning
• labelling (allergy/intolerance and to highlight possible problems with individuals with IBS) and
• biological effect (whether the product, which is intended for use as a prebiotic, would exhibit the same properties as other prebiotics)
The latter point could only be resolved by the provision of additional studies but, as these would be to determine efficacy rather than safety, the UK did not lodge a formal objection. Labelling will be considered when the product comes up for a decision on authorisation.
The Secretariat reported on the following actions following the previous meeting:
Item 5, Dihydrocapsiate: The Committee’s opinion was sent to European Commission for review by other MS
Item 7, gamma-Cyclodextrin (CD): Members had commented on additional information that was circulated by post and the FSA wrote to the Commission setting out the Committee’s one outstanding concern, which related to the potential for gamma-CD to compromise the intake of fat soluble vitamins (Vitamin D).
Item 8, Phosphated distarch phosphate: FSA had not yet written to EFSA about the difference in views in respect of potential Gastrointestinal effects in children.
Item 11, EFSA guidance on risk assessment of nanomaterials: Comments were submitted to EFSA and have been taken into account in their final revision of the guidelines, which was published on 10 May.
Item 12, Protein guidance: The document was revised and cleared by Members by post. It will be published shortly on the website acnfp.food.gov.uk
Action: the Secretariat to write to EFSA about phosphated distarch phosphate
4. Taxifolin ACNFP/102/1
The Committee considered this application over a number of meetings in 2010 and 2011. The Committee considered the applicant’s response to issues raised during the public consultation on this novel ingredient in relation to the presence of saponins, quality control procedures and whether there were appropriate controls in place to monitor for, and control, the presence of mycotoxins.
The Committee was content with the response from the applicant in relation to saponins and quality controls procedures that they employ. The Committee accepted that the quality control procedures for both the raw material and the final product meant that it was unlikely that mycotoxins would be present. A small study carried out by the applicant showed the absence of aflatoxins in the final product and Members were of the view that it would be prudent if the final product was regularly tested to confirm the absence of relevant mycotoxins.
Action: The Secretariat will clear the initial opinion through Chairman’s action prior to a public consultation
5. Phosphate Distarch Phosphate ACNFP/102/2
The Committee had considered this product during 2009 and 2010 and was asked to consider a response from the applicant regarding their outstanding questions about product stability.
The Committee agreed with the applicant’s response and thanked the applicant for providing information that was clear and unambiguous and that specifically addressed the Committee’s concerns.
Action: the Secretariat to update the draft opinion and clear it through Chairman’s action prior to a public consultation
6. Rooster Comb Extract ACNFP/102/3
The Committee considered this application in February 2011. The Committee was asked to consider the response from the applicant to a number of concerns raised by the Committee at that meeting.
The Committee was content that the novel ingredient was safe. It was concerned that procedures had been carried out properly and therefore sought confirmation that the egg allergic patient sera had been collected with due ethical approval systems in place. The Committee was also content with the applicant’s explanation of the calculation of a safety factor based on the “human equivalent dose”. It questioned whether the 60kg quoted was the average body weight of a UK citizen. It was informed that 60kg is generally used as the average adult weight in the world population and this provides a degree of conservatism when applied to European populations.
The Committee was content with the microbiological data. The Committee considered that, although the data indicated that intake might exceed the proposed ADI, this was based on a worst case scenario and was unlikely. It considered that there was a need for a better assessment of intake if the novel ingredient is to be used in a wider range of products.
The Committee was concerned that the labeling would not be specific enough for vegetarians, noting that vegetarian diets are more common in the UK than in some other member states. Consumers would not expect to see animal products in milk products and products should carry a prominent statement such as “not suitable for vegetarians”.
The Committee was concerned that the health claims for healthy joints may be misleading as there was no evidence that this ingredient would lead to this outcome.
The Committee noted that a number of respondents to the consultation on this dossier had been concerned about animal welfare issues. The Committee asked for confirmation that the combs were removed from chickens which had been raised and slaughtered for human consumption. If so, it could be satisfied that the procedures for obtaining the combs would not affect the welfare of the birds adversely.
Action: The Secretariat will produce a draft initial opinion to be considered at the next meeting
7. EPA and DHA rich oil from algae (Schizochyrium sp) ACNFP102/4
The Committee first considered this application in February 2011. The Committee was asked to consider the applicant’s response to concerns raised by the Committee at that meeting in relation to high dose supplements that were targeted at pregnant women and nursing mothers, and to potential microbiological contamination during fermentation.
The Committee noted the potential benefit of this type of product for maintaining adequate intakes of long chain omega-3 fatty acids, as an alternative to fish oils.
The Committee considered however that the applicant had not fully addressed its concerns in relation to the consumption of high doses of DHA and EPA by pregnant women and nursing mothers. In particular the Committee requested that the applicant consider studies which link intake of fish oil to increased gestation periods.
Members were partially reassured by the applicant’s response in regard to Cyanobacteria but asked for confirmation whether light was excluded from the fermentation process. Members also advised that testing for Cyanobacteria should be included in the quality control strategy.
Action: the Secretariat to ask the applicant for additional information and then draft an initial opinion
8. Chia Seed (Additional use) ACNFP/102/5
The Committee was asked to consider an application from The Chia Company, to extend the use of their chia seeds in foods other than bread.
The Committee accepted that chia seeds would only be incorporated into products where seeds were commonly usually found, namely breakfast cereals (e.g. muesli), biscuits and other baked products and fruit, nut and seed mixtures (sprinkles).
The Committee recognized that individuals with seed allergies may not always avoid these products but did not think there was a substantial risk from extending the use of chia seeds, particularly if this was accompanied by communication with “at risk” groups. The Committee therefore considered that the applicant should fulfill its positive commitment to contact patient groups.
The Committee noted that the applicant’s intake estimates did not include children and also recalled the discussion on under-reporting in food consumption surveys from the previous meeting.
The Committee stressed that a positive opinion on the extension of use would not imply endorsement of any health benefits attributed to consumption of the seeds.
Action: the Secretariat to draft an initial opinion for the next meeting
9. Novel Sources of Selenium and Zinc. ACNFP/102/06
The committee was asked to note that zinc L-pidolate has previously been cleared by EFSA as a source of zinc and that selenitetriglycerides will be evaluated in due course by EFSA as a source of selenium.
As new sources of vitamins and minerals undergo parallel authorisation procedures under sector-specific legislation and under the novel foods regulation, they are inevitably evaluated by EFSA before an authorisation can be granted in the EU. To avoid duplication of effort, national authorities for novel foods usually rely on the centralised assessment that is carried out under the other legislation, so that novel food authorisation is based on an EFSA opinion rather than a detailed opinion from one or other member state. In this case, the Polish competent authority for novel foods had carried out a national assessment and the Committee was invited to highlight any specific concerns they would like to bring to EFSA’s attention about selenitetriglycerides, in the light of the Polish report. The Committee highlighted the need to assess the bioavailability of this new source of selenium and whether this formulation with triglycerides altered its distribution and accumulation within the body, for example in adipose tissue. These questions had not apparently been considered by the Polish assessors.
The Secretariat agreed to pass these comments on to EFSA as part of the UK’s response to the initial opinion.
Action: the Secretariat to transmit the Committee’s comments to EFSA
10. Recent notifications ACNFP/102/07
The Committee was asked to consider two recent opinions from other EU Member States on (substantial) equivalence where the basis for the comparison was a similar product obtained from another species, and whether, in the light of these opinions, it wished to review its guidance on the submission of requests for opinions on equivalence in the UK. One of the opinions was a comparison between squid oil and tuna oil, the other a comparison between sugar cane fibre and bamboo fibre.
The Committee considered that in both cases the taxonomic differences were too great to allow a meaningful comparison. The Committee did not see any need to update its existing guidelines, which state that the novel and existing products should be derived from closely related species in order to demonstrate substantial equivalence. The Secretariat noted that this issue was expected to be discussed at EU level over the coming months and that this may necessitate a future review.
Action: the Secretariat will take forward the Committee’s views in discussions with other Member States
11. EU novel foods regulation ACNFP/102/08
The Committee was asked to note the outcome of EU negotiations on the proposals to update the EU novel foods regulation.
The Committee noted the EU’s legislative bodies had been unable to reach agreement on updating the EU novel foods regulation and considered that a new proposal would stand more chance of success if the issues related to animal cloning are treated separately.
Action: the Secretariat to keep the Committee informed of any new negotiations
12. ACNFP Advice ACNFP/102/09
The Committee was asked to consider a table setting out the Committee’s advice for a number of novel food applications between 2008 and 2010, alongside the eventual outcome of the applications. The table had been developed in response to a request by members for an overview of how the Committee’s recent advice has been implemented.
The Committee noted that the Secretariat intended to update this information annually and commented that it was a useful paper. The Secretariat confirmed that the paper would be put on the Committee’s website and could be referred to in future open events.
The Committee asked why, on occasions, the UK abstained rather than voting against a proposal. The Secretariat explained that as the decisions were taken by qualified majority the net effect of abstaining was the same as voting against, as it was the strength of the favourable vote which was important. A vote against authorisation might be appropriate where there was evidence that a novel ingredient presented a risk to consumers, while abstaining would be appropriate where there was insufficient proof of safety.
The Committee also noted the number of pending decisions and asked whether applications were ever withdrawn and whether ACNFP advice was reflected in the final authorisation decisions.
The Secretariat explained that there were various reasons why applications remained pending, for example complex risk management decisions or awaiting additional information from an applicant. The Secretariat agreed to look at ways to incorporate additional information into the table, and possibly including ACNFP advice from previous years.
The Committee noted that withdrawn products would be included in future versions of the table.
Action: the Secretariat to update the table for the next meeting
13. Items for Information:
13.1 EU Update ACNFP/102/10
The Committee noted this information paper without comment.
13.2 Update on Scientific Advisory Committees (SACs) ACNFP/102/11
The Chairman reported on the General Advisory Committee on Science (GACS) meeting which took place in early March, when he had given a presentation on the work of the ACNFP.
14. Any other business
The Chairman reflected on his appraisal discussion with the FSA’s Chief Scientist, Dr Andrew Wadge. The Chairman reported that Dr Wadge had encouraged the Committee to discuss generic issues in its meetings as well as routine applications for novel foods.
The Chairman fed back comments made by ACNFP Members via their appraisal questionnaires. Two common themes had emerged: Members asked that papers be sent out at least 10 days before each meeting, and they praised the excellent support provided by the Secretariat.
Action: Members who had not yet completed it were reminded to complete the self-assessment questionnaire
15. Date of next meeting
The next meeting was scheduled for Thursday 7 July 2011 in Aviation House