Advisory Committee on Novel Foods and Process. Draft minutes of the 154th Meeting held on the 7th of September 2022
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These minutes are subject to confirmation by the Committee.
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.
Minutes of the 154th meeting of the Advisory Committee on Novel Foods and Processes, held on 7th of September at Broadway House, London and as a hybrid meeting on Teams.
Dr Camilla Alexander-White
Dr Anton Alldrick
Ms Alison Austin
Dr Mark Berry
Dr Dimitris Charalampopoulos
Professor Susan Fairweather-Tait
Professor Paul Fraser
Dr Hamid Ghoddusi
Dr Andy Greenfield
Professor Wendy Harwood
Professor Huw Jones
Dr Ray Kemp
Dr Elizabeth Lund
Professor Harry McArdle
Mrs Rebecca McKenzie
Professor Clare Mills
Dr Lesley Stanley
Prof Hans Verhagen
Dr Maureen Wakefield - Member
Ms Claire Nicholson - Science Council
Mr Paul Tossell - Head of Radiological, GM, Novel Foods & Radiological Protection
Mr Peter Quigley - Deputy Director, Regulatory Services
Mr Chris Stockdale - Head of GM Policy
Mr Hoa Chang - FSA GM Policy Advisor
Ms Gemma Jones - FSA Novel Food Policy Advisor
Mr Takbeer Ahmed - FSA GM Policy Advisor
Mr Shaun Jacobs - FSA Senior Policy Advisor
Ms Alison Asquith - FSA Senior Policy Advisor
Ms Sophie Burder - FSA Policy Advisor
Ms Monique Van Tonder - FSA Policy Advisor
Mr Donal Griffin - Head of Regulated Products Risk Assessment (Feed and GM)
Ms Louise Carey - FSA Communications
Ms Melissa Bookbinder - FSA Communications
Observers Devolved administration
Ms Alexia Sully Karlis - Policy, FSA Wales
Mr Andrew Dodd - Policy, FSA Wales
Ms Hannah Reid - Policy, FSA Wales
Ms Siobhan Watt - Food Standards Scotland
Mr Joshua Evans - Food Standards Scotland
Ms Krystle Boss - Food Standards Scotland
Ms Svetlozara Chobanova - Food Standards Scotland
Ms Colleen Mulrine - Policy, FSA NI
Mr Patrick McCurdie - Policy Development Support
Mr Mike Ellis - Defra Representative and ACRE Secretariat
Mr Martin Cannell - Defra Representative and ACRE Secretariat
Mr Pete Lund - ACRE Representative
Mrs Ruth Willis - Technical Secretary
Mrs Priscilla Wanjiru - Science Secretariat
Dr Karin Heurlier - Science Secretariat
Dr Rachael Oakenfull - Science Secretariat
Mr Will Smith - Science Secretariat
Mrs Afielia Choudhry - Science Secretariat
Dr Andrew Hudson - Science Secretariat
Mr Matt Hall - Science Secretariat
Dr Johann Trotter - Science Secretariat
Dr Annalisa Leone - Science Secretariat
Mr Rhys Williams - Science Secretariat
Ms Katie Schultz - Science Secretariat
Mr Ben Haynes - Science Secretariat
Mr Nathan Allen - Science Secretariat
Mrs Jenny Lika - Science Secretariat
Miss Victoria Balch - Administrative Secretariat
Ms Carol Scott - Administrative Secretariat
1. Apologies and Announcements
This was a hybrid meeting held in London with Members attending both in-person and online. Dr Maureen Wakefield and Claire Nicholson the Science Council observer sent their apologies.
The Chair welcomed the Members, representatives from the FSA, the observers from the devolved administrations and the Secretariat team.
The Chair gave a special welcome to Professor Bruce Whitelaw as it was his first ACNFP meeting.
2. Meeting Minutes for the 153rd Meeting
The Committee discussed the minutes of the 153rd meeting. Now that these have been agreed they will be circulated to members for information and placed on the website.
3. Matters Arising from the last meeting.
- The Committee reviewed a traditional food application for Tetradenia riparia (Iboza). A summary of the points raised and the Committee’s views were subject to a 10-day consultation and no comments were received. The summary has been updated with the consultation information and the final version circulated to members and risk managers in the countries of the UK.
- Two dossiers were considered for the first time, a mixture of Lacto-N-fucopentaose I (LNFP-I) and 2'-fucosyllactose (2' FL) (LNFP-I/2'-FL) and; the oligosaccharide 3-Fucosyllactose. Clarification was also sought on an aspect of the composition in both applications and the applicants have responded. It is expected the response will be brought back for consideration at the next meeting.
- An application continues to be reviewed for ‘Mung Bean Protein’. The applicant has sought further advice on the approach to assessing allergenicity and the Secretariat are working with the Committee experts on a response. Members also as a result of the item had made strong recommendations for additional work and research on the allergic potential of new foods in particular legumes. These have been shared with the relevant teams in FSA and the Committee will receive further updates on progress in due course.
- The draft opinions for Barley Rice Protein and Cetylated Fatty Acids were reviewed by the Committee. These opinions will be the first opinions to be developed by the Committee since the UK’s departure from the EU and so there is a particular focus on ensuring the right depth of information and style is achieved. Revised draft opinions that have taken account of members comments are presented for Committee input under items 4 and 5.
- The Members also reviewed the response from the applicant providing further information on Calcidiol. Further information was sought on identity, production process and proposed use to address information gaps.
- A Science Council member reported on the work of the Science Council’s group on Food Safety and Net Zero Carbon. A number of areas relevant to the ACNFP and their future assessment work were highlighted and will be taken on board as part of the Committees horizon scanning activities.
4. Barley Rice Protein – RP19
This dossier was considered by the Committee for the fourth time in the 153rdACNFP meeting in June this year. No further requests were made for information and the Secretariat were asked to prepare a draft output in the form of an opinion for review which was considered intersessionally.
Members made further detailed comments on the draft. Additional queries on composition and nutritional information and how these were presented were raised and these will be raised with the applicant for clarification.
The Committee requested a refined version of the draft opinion to be presented for review prior to the next meeting.
Action: The Secretariat to request further information from the applicant.
The Secretariat to refine the draft opinion for ACNFP input and agreement.
5. Cetylated fatty acids - RP 200
The dossier was first considered by the Committee in November 2021. A subsequent request for information was reviewed by Members in June 2022. Following this meeting, the Committee requested the Secretariat draft a summary opinion on the risk assessment for cetylated fatty acids as a novel food.
The Committee reviewed the draft outcome opinion and suggested a number of changes for the Secretariat to take on board. These comments were aligned to Members discussions on the content and layout for all outcome publications in the future.
The Committee considered the style and format of the summary opinions for novel foods, as this would be one of the first outputs by the Committee since leaving the EU. The ACNFP remarked that the summary opinion should explain how the Committee reached their conclusions independently, without direct reference to other authorities. Members also agreed that the NOAEL and margin of safety (MOS) should be presented, but further explanation on the values for the MOS and body weight that are used to determine the safe intake level for a novel food, was required.
Members raised questions for the Secretariat on the process for finalising the opinions and their publication. It was explained that they will be FSA and FSS opinions but the role of the Committee in the assessment would be clearly explained.
Action: The Secretariat to revise the draft summary opinion
6. Magnesium-L-threonate – RP956
The Committee reviewed this new novel food application, but only conducted a preliminary assessment at this stage. This is a new and large dossier, and this provided an early opportunity to comment on any gaps in information and will provide sufficient time between this meeting and the next for the ACNFP members to fully appraise the information shared. A more detailed evaluation of this novel food application would be considered at the next ACNFP meeting in November 2022.
Members in reviewing the production process remarked that the applicant had not provided sufficient detail concerning key steps in the manufacturing process. In addition, further information was also sought on the control measures and the raw material specifications.
The Committee reviewed the proposed use for the novel food as a food supplement with reference to an example copy of the labelling. Members noted that this included statements concerning improved cognitive function in consumers. While any health claim would be for consideration by DHSC, clarification was considered to be needed on the intended use for this food supplement by UK consumers to assess exposure and use. Exposure and how this relates to the toxicological data was highlighted as an area for detailed consideration at the next meeting.
The applicant provided a report evaluating the dissociation of magnesium-L-threonate in aqueous solution under different pH conditions. The results presented did not convincingly demonstrate that the novel food is a highly dissociable salt. Further evidence clarifying the implications for absorption and metabolism of the novel ingredient was needed.
The Committee reviewed the nutritional information and remarked that there was no discussion concerning the use of the novel food and the potential impact on serum calcium levels in consumers. The applicant was asked to provide information on this.
7. Update on the Joint subgroup of the Committee on Toxicity (COT) and Advisory Committee on Novel Foods and Process (ACNFP) on CBD and hemp derived products.
The Committee was updated on the work of the CBD subcommittee. The first meeting of the ACNFP/COT subcommittee was held on 27th July 2022 and considered the toxicology datasets collated for CBD isolate applications and ultimately concluded that a list of toxicological uncertainties must be tackled before opinions on the safety of CBD isolates can be made.
The next meeting will be held on Wednesday 28th September and the main topic of discussion will be an in-depth review of the data on CBD isolates and synthetic CBD products. By using a refined but detailed table format, the Secretariat hopes to prompt further discussion amongst the subcommittee members. This will inform the next steps to support the review of dossiers in this group by the ACNFP.
The Secretariat to carry out further discussions that facilitate drafting of the opinion.
8.Update on the subcommittee of the ACNFP on products of genetic technology for food and feed (PGT)
The first PGT Subcommittee meeting in July saw the initial opinions for applicants RP188, RP212 and RP652 (GM renewals) being reviewed and a recommendation made to draft outcome opinions. The meeting also included a workshop on precision breeding to inform the scientific underpinning for regulation in this area. The second meeting held in August saw a two parts precision breeding workshop to further consider the issues and develop thinking. The progress achieved in these discussions was shared with members and formed the basis for the ACNFP workshop on the topic.
9. Workshop on Precision Bred Organisms
Professor Bruce Whitelaw declared financially benefiting from a University of Edinburgh Commercialisation Licence with Genus plc regarding PRRSV-resistant pigs; this was noted, and it was agreed that when discussing this particular case study, Professor Whitelaw would be present but only to answer questions on the case.
A workshop on Precision Bred Organisms was held, building on the readout from the second ACNFP PGT2 update. As a result, a statement on the outcomes of the workshop is being drafted.
Action: The Secretariat to draft the outcomes of the Workshop of Precision Bred Organisms for publication
14. Items for Information
14.1 Novel Food Policy Update - Written
The Committee was provided with a written update on the issues under consideration regarding novel foods.
14.2 GM Policy Update - Oral
The Committee was provided with an oral update on the issues under consideration regarding GM.
14.3 SACS Update - Written
The Committee was provided with a written update on the activities of the different SACs.
Date of next meeting
The next meeting is scheduled for 16th November 2022. It will be a hybrid meeting at on teams and in London.