ACNFP meeting minutes: 20 November 2013

Notes of the meeting of the Committee which took place in Conference Room 5 Aviation House, 125 Kingsway, London

Present:

Professor Peter Gregory – Chairman
Professor Michael Bushell
Dr Susan Duthie
Mrs Nichola Lund
Professor Harry McArdle
Professor George Macfarlane
Professor John Mathers
Dr Rohini Manuel
Professor Peter Meyer
Professor Clare Mills
Ms Claire Nicholson
Dr Camilla Pease
Professor Christopher Ritson

Apologies:
Professor Andrew Chesson
Mr Simon Flanagan
Dr Carina Venter

Secretariat:
Ms Alison Asquith – Minutes
Dr David Jefferies
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

Three members had sent apologies for non-attendance. No written comments from these members were received before the meeting. Apologies were received from the FSA Assessor and observers from the FSA offices in Scotland, Wales and N.Ireland.

The Chairman informed the Committee that Professor Chesson was retiring from the Committee due to time pressures, having taken on additional work with the European Food Safety Authority.

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 112th meeting DRAFT/ACNFP/112/Min

The Committee agreed that subject to minor amendments the minutes were a true record of the 112th meeting of the ACNFP held on Thursday 12 September 2013.

3. Matters Arising and Postal Consultations

Matters arising from the 112th meeting:

The Secretariat confirmed that the Committee’s comments on item 11 (milk products treated with Bacteroides xylanisolvens) had been sent to the European Commission on 25 September.
Synthetic Resveratrol (paper ACNFP/113/P1)

The Committee considered this paper by correspondence during October 2013, when they reviewed the Irish Competent Authority’s Initial Assessment Report on synthetic resveratrol. As a result of Members’ comments, the UK submitted reasoned objections to this opinion citing concerns over:

• Lack of information about the current production process
• Potential interference with drug metabolism
• Failure to take account of certain publications on the safety of this resveratrol
• Suitability for children
• Lack of information on adverse reporting from areas where the product has already been marketed

4. Buglossoides Oil ACNFP/113/1

The Committee considered a draft opinion following its review of the applicant’s response to concerns raised at its September and June meetings when it reviewed this application for the authorisation of refined Buglossoides Oil as a novel ingredient.

The Committee agreed the wording in the draft opinion subject to some amendments. The Committee stated nonetheless, that neither the novel ingredient nor its source has a history of consumption anywhere in the world and as such recommended that the applicant should ensure that reports of adverse reactions are closely monitored after the product is introduced to the market, in order to identify any unexpected effects.

Before completing its opinion, the Committee would therefore like to see details of how the applicant intends to monitor adverse effects once foods containing the novel ingredient are launched in the EU, for example, how data will be collected and monitored by the applicant in a way that enables early detection of any unexpected reactions to the novel ingredient.

Action: Secretariat to update and publish the draft opinion for a 10 day public consultation

5. 1-Methylnicotinamide Chloride (1-MNA) ACNFP 113/2

The Committee discussed the applicant’s response to concerns raised at the June meeting, together with the conclusions of a sub-group of ACNFP toxicologists and nutritionists who had examined the implications of various treatment-related changes that were observed in the 90-day feeding study.

The sub-group did not agree with the interpretation provided by the applicant and indicated that the presence of liver lesions and other findings were a cause for concern. The Committee agreed with the conclusions of its sub-group and with its suggestion that a follow up 90 day animal study should carried out to investigate these observations in more detail. The Committee advised that this study should also consider potential bone mineral changes.

The Committee was not satisfied with the information provided in regard to the effect of 1-MNA supplementation on the metabolism of niacin. The Committee advised that the response described the relevant pathways in a qualitative manner but did not consider the quantitative aspects of the kinetics of metabolism. The Committee therefore requested that appropriate investigations are carried out to determine whether the proposed level of consumption of 1-MNA is likely to have a significant effect on niacin metabolism. This study should also take into account the effect of 1-MNA supplementation on high doses of niacin which are used for the treatment of cholesterolaemia. Members noted that mathematical modelling of metabolic pathways and metabolic interactions is now available and this might be one way of addressing this question.

Action: The Secretariat to ask for further information from the applicant.

6. D-beta-hydroxybutyrate ester ACNFP/113/3

The Committee reviewed the applicant’s response to concerns raised at its meeting in September.

The Committee accepted that the component parts of the ester are not mutagenic and that there are no structural alerts for ketone esters. However the Committee did not regard this to offer conclusive reassurance that D-beta-hydroxybutyrate ester is not mutagenic. The Committee noted that mutagenicity and genotoxicity studies are relatively straightforward to perform and are routinely carried out for novel foods, and requested that these are carried out for this novel food.

The Committee did not agree with the applicant’s view that the proposed intake of D-beta-hydroxybutyrate ester was akin to that seen during certain physiological conditions where carbohydrate intake is restricted and remained of the view that the in vivo production of ketone bodies is of limited relevance to modern consumers. In regard to the applicant’s suggestion that statistically significant changes in certain clinical chemistry parameters were not clinically significant, the Committee also noted that the relatively low margin of safety from the animal studies was not confirmed by an appropriate human study. In view of this the Committee concluded that the significance of changes in the clinical chemistry parameters ought to be confirmed in a longer term study and the Committee toxicologists agreed to provide additional information regarding a suitable study to the Secretariat following the meeting.

The Committee noted that the novel ingredient is intended to be targeted at a particularly small subset of the population (high performance athletes) who would only use products containing D-beta-hydroxybutyrate ester during sustained periods of intense muscular activity. However, the Committee remained concerned that this limited use is at odds with information on the applicant’s website and asked that the applicant provides information to reassure it that D-beta-hydroxybutyrate ester would not be widely incorporated into mainstream sports supplements. The Committee noted that, if D-beta-hydroxybutyrate ester has no conceivable benefit to the wider population, wider availability could be misleading to the consumer.

Action: Secretariat to ask for further information from the applicant

7. DHA rich algal oil from the microalgae Schizochytrium ACNFP/113/4

The Committee reviewed and accepted the applicant’s response to questions raised at its meeting in September about the extraction process and regarding the specific strain used in the production of the novel ingredient.

The Committee highlighted the absence of good quality taxonomic information on production strains of alga and microorganisms that are used in the production of novel foods as a potential area of concern. The Secretariat agreed to look into this issue, with a view to the Committee issuing guidance to assist applicants. The Committee also sought clarification from the applicant on an apparent inconsistency in the analytical results of mycotoxins and agreed the draft opinion subject to this and other amendments.

Action: Secretariat to update and publish the draft opinion for a 10 day public consultation

8. D- Ribose ACNFP/113/5

The Committee had considered an application for the authorisation of D-Ribose as a novel food ingredient on a number of occasions in 2008 and 2009 when the assessment was suspended. In June 2013 the Committee confirmed to the applicant that it did not see the need for additional animal experiments at this stage and would review the situation when the applicant submitted an updated dossier.

The Committee reviewed the applicant’s revised dossier and was generally content with the information provided. The Secretariat agreed to obtain specialist advice on the results from the developmental toxicity study, where the applicant reported minor variations in the offspring of the top dose group.

The Committee noted that the novel ingredient altered glucose metabolism when taken at a high dosage under fasting conditions, but was satisfied that concern was addressed by ensuring that D-ribose is only proposed for addition to foods that contain other carbohydrate energy sources. It recommended labelling ‘not to be taken on an empty stomach’ as a warning against possible hypoglycemic effects for food supplements containing D-ribose.

The Committee noted that the method used to assess the protein content of the ingredient (the Bradford assay) is not itself sufficient to demonstrate the absence of proteins and peptides at levels that could be allergenic. The Committee also sought further information about the performance characteristics of the method that is used to determine the purity of the ingredient.

Action: Secretariat to seek advice from a developmental toxicologist and to draft an initial opinion for the next meeting

9. Phytosterol Esters: Extension of Use ACNFP/112/6

The Committee considered the applicant’s response to concerns raised at the previous meeting about the increase in exposure to phytosterol oxidation products (POPs) if consumers used margarine and the liquid margarine products with added phytosterol esters for cooking and baking purposes.

Dr Camilla Pease informed the Committee that she had worked on similar products at Unilever between 2000 and 2010, however she has not been involved with these or similar products since leaving Unilever’s employment in 2010.

The Committee was broadly happy with the response from the applicant and commented on the text of a draft opinion. Before finalising the opinion, Members requested that the Secretariat circulate further background information about POPs, including a summary of the studies that resulted in the setting of a NOAEL figure when this issue was first discussed in 1999-2000.

Action: Secretariat to update the Initial Opinion and provide background information to Committee members.

10. Chia Seeds (Supernutrients) ACNFP/113/7

The Committee was asked whether it agreed that substantial equivalence had been established between chia seeds produced by Supernutrients and chia seeds currently marketed by the Chia Company.

The Committee noted that the evidence provided by the applicant was very clear and well-presented, and was content that substantial equivalence had been established.

Action: The public to be consulted on the application and the secretariat to draft an opinion

11. Sporopollenin Shells from Club Moss ACNFP/113/9

The Committee reviewed the applicants response to concerns raised at its February meeting about this application for the authorisation of sporopollenin shells from club moss (Lycopodium clavatum) as a novel ingredient.

The Committee accepted the preparation process at the laboratory scale and requested more information on how this would be scaled up for bulk production.

The Secretariat informed the Committee that detailed specifications will be provided by the applicant in time for the next meeting. The Committee requested that the specifications should include details of the molecular structure of sporopollenin, not only its physical characteristics and elemental composition.

The Committee again expressed concern relating to the possible effects that these small particles may have when they are in a food matrix, in terms of inhalation effects of dry particles and effects on the gut and immune system, and sought further reassurance on these points.

The Committee also requested more information relating to the range of ingredients intended to be encapsulated into sporopollenin shells. The Committee remarked that the applicant’s response highlighted that the bioavailability of vitamin D is increased 2.2 fold as a result of encapsulation into sporopollenin shells, but the applicant has not considered the nutritional and safety consequences of this. It was unclear whether similar changes in bioavailability will occur in other applications, and how manufacturers will be able to ensure the safety and nutritional quality of products formulated with sporopollenin shells.

The Committee also sought evidence to support the suggestion that all ingested sporopollenin shells are egested unchanged, minus their contents. In this context, the Committee questioned the suitability and limits of detection of the methods used to test for the presence of sporopollenin shells in urine, faeces, blood and gut.

The Committee was content with the information the applicant provided relating to sustainability.

Action: Secretariat to ask for further information from the applicant

12. Possible Transfer of DNA from Food to Human Blood ACNFP/113/10

The Committee considered a recent article that reports the potential presence of plant derived DNA sequences in human blood samples.

The Committee agreed that this was a very interesting paper and that the results required confirmation. Members made a number of comments in relation to the results of the study, which were obtained using next generation sequencing, a relatively new high throughput method of DNA sequencing that generates very large numbers of DNA sequences and corresponding sequence information:

(a) Of the foreign DNA fragments identified, plant sequences seemed to be overrepresented and it was unclear why so few bacterial and mammalian sequences were found. Dietary intake did not seem to be the most likely explanation as a number of the plant species identified, such as Arabidopsis, are not consumed as part of the human diet.
(b) It was also unclear why the authors had not attempted to clone some of the longer plant DNA fragments, as this could have confirmed the indirect evidence that these fragments are in the 10 Kilobase range.
(c) The Committee were divided on the question of whether DNA contamination issues could explain the results of the study and it was only one of a number of possible explanations of the results.

The Secretariat agreed to keep the Committee informed of further work that might help to clarify this point.

13. Items for Information
13.1 EU Update ACNFP/113/11
13.2 Update on Scientific Advisory Committees (SACs) ACNFP/113/12

The Committee noted item 13.1 without comment.

Under item 13.2 the Chair updated the Committee on the last GACS meeting held on 8 October.

14. Any Other Business

Members received further information on arrangements for the open event which took place after the meeting.
15. Date of next meeting

The next meeting was scheduled for Wednesday 12 February in Aviation House.