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Notes of the meeting of the Committee which took place at 10:30am in Conference Room 5, Aviation House, 125 Kingsway, London
Professor Peter Shewry – Acting Chairman
Dr Paul Brantom
Professor Michael Bushell
Professor Andrew Chesson
Ms Jayam Dalal
Dr Paul Haggarty
Professor John Mathers
Mrs Gillian Pope
Professor Christopher Ritson
Apologies: Professor Harry Flint
Professor Stephen Holgate
Dr Clare Mills
Mr Kevin Swoffer
Professor John Warner
FSA Chair: Lord Rooker (Items 7- 11)
Secretariat: Miss Alison Asquith (Minutes)
Ms Shuhana Begum
Dr Chris Jones
Dr Darren Key
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
Five members had sent apologies for non-attendance. Apologies were also received from observers from FSA offices in Scotland, Wales and Northern Ireland (Mrs. Elspeth MacDonald, Mr. Phil Morgan and Mr. Gerry McCurdy).
Clair Baynton has moved to Nutrition Division and her role as assessor was taken over by Alison Gleadle. Dr Gleadle sent her apologies for this meeting.
A new Chairman, Professor Peter Gregory, and a new expert in molecular biology, Professor Peter Meyer have been appointed. Their terms will start on 1 December 2009.
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 94th meeting DRAFT/ACNFP/94/Min
Members agreed to provide written comments on the draft minutes following the meeting.
3. Matters Arising
The Secretariat provided the following update on items arising from the previous meeting:
Provision of ACNFP documents on compact disk
The Secretariat reported that there was no further information on the provision of secure compact disks, as this was still under development by the Agency’s IT department.
4. Bee Venom for addition to honey ACNFP/95/1
The Committee was asked to consider the text of a draft opinion for the authorisation of bee venom for addition to honey. The application had previously been discussed by the Committee in September.
The Committee considered that the novel ingredient should not lead to an increase in the daily intake of sugar and people consuming this novel ingredient should make compensatory changes to the rest of their diet. The novel ingredient should therefore be seen as a replacement for sugar in the overall diet.
The Committee recommended that the novel ingredient was labelled so that consumers are made aware of the possibility of life threatening allergic reactions if the product is consumed by those who are allergic to bee stings. This risk was highlighted by a case of anaphylactic shock following the consumption of the ingredient in New Zealand. The Committee had no data on the incidence of bee sting allergy in the population of New Zealand to compare with the incidence of allergic reactions in the UK or the EU. The Committee considered that the labelling should be strong and clear, providing a warning of a serious reaction for people with bee sting allergies so they can avoid the novel food ingredient.
The Committee did not reach an overall conclusion on the acceptability of this product, in advance of hearing further advice from members of the Committee who are experts in allergenicity, particularly in relation to the possibility that oral doses of bee allergens might sensitise consumers to venom in bee stings. The Secretariat agreed to amend the draft opinion by incorporating the points raised in the meeting by the Committee.
5. Magnolia Bark Extract ACNFP/95/2
The Committee initially considered this application for the authorisation of supercritical carbon dioxide extract of magnolia bark as a novel food ingredient in September 2009. The applicant had now provided further information in response to earlier comments.
The Committee was not satisfied that the new data on the absence of protein in the novel ingredient was reliable, and suggested the use of a more precise assay such as mass spectrometry. The Committee was also concerned that the applicant did not provide sufficient data to explain the raised levels of bilirubin seen in female rats in a 90 day feeding study. The applicant presented data from a recent publication but the Committee asked to see the original study report containing data on individual animals before drawing any conclusions from these findings.
The Committee noted the claims made legally in the USA on anti-microbial effects of the extract would not be legal in Europe as it is not permitted to make medical claims about food in the EU.
The Secretariat agreed to request further information from the applicant and to draft an opinion for the next meeting.
6. Phosphated Distarch Phosphate ACNFP/95/3
The Committee was asked to consider this application from MGP Ingredients to the UK competent authority for the approval of phosphated distarch phosphate (PDP) as a novel food ingredient.
The Committee was concerned about the potential for high levels of intake as the applicant was planning to add the novel food ingredient to a large range of products. As with the previous application for a similar ingredient, the Committee considered that it could be misleading to call the novel ingredient “fibre” and was concerned that it may compete with other different sources of natural starches. As a consequence consumers would reduce their intakes of other sources of dietary fibre.
The Committee noted that it was necessary to consider the total intake of PDP, by including the intake of this novel ingredient together with other products on the market. The highest predicted intakes should not exceed the intakes that have been tested in human studies. As with the previous application, the Committee was concerned that it was difficult to predict the possible GI intolerance in children.
The Secretariat agreed to draft an opinion for the next meeting and to request further information from the applicant on the estimated total intake of PDP.
7. Sucromalt ACNFP/95/4
The Committee considered the Dutch Competent Authority’s (CA) initial opinion on this application for authorisation of Sucromalt as a novel food ingredient.
The Committee sought a clear statement from the applicant on the particular benefits of this novel food to consumers and why they wanted to put it in food. It was concerned that as this novel ingredient was a type of sugar it could lead to diabetics unwittingly increasing their intake of sugar. The Committee advised that products containing sucromalt should be labelled as “equivalent to sucrose” [or not suitable for diabetics]. The Committee noted there were problems with nutrition labelling when products contained different types of sugar as they are not listed individually. Current labelling requirements lead to only monosaccharides being declared and in the case of this novel ingredient this could affect the “traffic light” labelling, for example moving it from amber to green.
The Committee endorsed the views of the Dutch CA on the toxicology situation and were therefore content with the safety of the novel ingredient.
The Secretariat agreed to seek further information from the applicant and to write to the Commission reporting on the Committee’s conclusions.
8. Zeaxanthin ACNFP/95/5
The Committee considered a new proposal for the use level of Zeaxanthin as a novel food ingredient, following an opinion from the European Food Safety Authority (EFSA).
The Committee agreed with EFSA’s observation that, on the basis of the available data, it was not possible to assess whether additional zeaxanthin at the proposed level of use would increase the risk of lung cancer in heavy smokers, as reported for beta-carotene.
The Committee was not persuaded by the arguments put forward by the applicant but considered that the proposal to limit intake to 2mg per day was acceptable and reduced the safety concerns. It considered that a further assessment would be required if Zeaxanthin was used in such a way that intake levels were increased.
The Secretariat noted that the Agency would draw on the Committee’s advice during any future discussions on the authorisation of zeaxanthin.
9. Glucosamine from Aspergillus niger ACNFP/95/6
The Committee considered an opinion by EFSA on this application for authorisation of Glucosamine from Aspergillus niger as a novel food ingredient.
The Committee noted glucose metabolism is affected by glucosamine. It also noted that the risk due to consumption of glucosamine is negligible compared with the overriding risk to undiagnosed diabetics of unregulated sugar consumption. It considered the number of diabetics who had not been diagnosed was increasing in the population. It was concerned that EFSA had suggested labelling as the way to alleviate the risk to this group as undiagnosed diabetics would not be aware that they should be monitoring their consumption of sugars. The Committee considered the possible risk of consuming glucosamine could push possible diabetics to become diabetic.
The Secretariat agreed to report the Committee’s concerns to EFSA.
10. Items for Information
10.1 EU Update ACNFP/95/7
10.2 Update on Scientific Advisory Committees ACNFP/95/8
The Committee noted the information papers listed above.
11. Any other business
The Chair of the Food Standards Agency, Lord Rooker, introduced himself to the Committee and highlighted the importance of independent scientific advice to the Agency.
Jayam Dalal noted the FSA’s consultative group on faith groups have signed up to a cross government faith group. She informed the Committee that the Agency would arrange a meeting with faith groups. She noted that the FSA had arranged a meeting with industry to discuss faith groups’ concerns, which included labelling issues.
12. Date of next meeting
The next meeting was scheduled for Wednesday 10 February 2010 in Aviation House.