Professor Peter Gregory – Chairman
Dr Paul Brantom
Professor Mike Bushell
Professor Harry Flint
Professor John Mathers
Professor Peter Meyer
Professor Clare Mills
Professor Christopher Ritson
Professor Peter Shewry
Professor John Warner
Professor Andrew Chesson
Ms Jayam Dalal
Dr Paul Haggarty
Professor Stephen Holgate
Mrs Gillian Pope
Mr Terry Donohoe
Department of Health
Dr Alison Tedstone (Item 4)
Mr Mark Bush (Items 1-4)
Miss Rufina Acheampong (Items 1-4)
Mr Jon Elliott (Items 1-4)
Dr Joseph Shavila (Items 1-4)
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
Five members had sent apologies for non-attendance. Apologies were also received from observers from FSA offices in Scotland, Wales and Northern Ireland (Ms Alison Taylor, Ms Hilary Neathey and Mr Gerry McCurdy).
The Secretary reported the resignation from the Committee of Mr Kevin Swoffer, whose work commitments made it increasingly difficult for him to attend ACNFP meetings. The resulting vacancy would be advertised in due course.
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 Committee congratulated Professor Holgate on his receiving a CBE in the Queen’s New Year Honours.
2. Minutes of the 100th meeting DRAFT/ACNFP/100/Min
The Committee agreed the minutes were a true record of the 100th meeting of the ACNFP held on Thursday 25 November 2010.
3. Matters Arising and Postal Consultations
The Secretariat reported back on matters arising from the 100th meeting. The outcome of two postal consultations undertaken during December and January were summarized. The two consultations were:
• EFSA Draft Guidance on GM plant comparators (postal paper ACNFP/101P/1)
• EFSA Updated Guidance on risk assessment of GM microorganisms and their food and feed (postal paper ANFP/101/P/2).
The comments received from Committee Members had been collated and fed in to EFSA as part of the UK’s response to these consultations.
4. Under-reporting in the National Diet and Nutrition Survey (NDNS) ACNFP/101/1
Dr Tedstone from the Department of Health’s Nutrition Division introduced this item. The question of intake estimation had been raised in a previous ACNFP meeting in the course of a novel food evaluation, where it was pointed out that estimates prepared on the basis of data from the National Diet and Nutrition Survey (NDNS) could be inaccurate, as there is significant under-reporting of food consumption in this type of survey.
The question of under-reporting was identified some time ago in the nutrition area, and studies had shown that the energy content of an individual’s reported diet did not correspond to energy expenditure as measured by other means (doubly-labelled water). However, attempting to make corrections to the data would lead to more uncertainty.
The Committee thanked the Department of Health for their useful paper.
A European wide survey is not close to being undertaken. The data collected by the European Food Safety Authority is variable. Data from a nutrition survey at a European level would not be useful as different countries have different levels of resources.
The Department of Health reported that habitual intake levels differed from intake levels over a period of 7 days. Consumption of some foods may also be under-reported as a result of lack of capture depending on the number of days of the week the survey is undertaken. Mis-reporting also occurs in ethnobiological studies where data is poorer than for a national survey.
The Committee considered whether there should be more post market monitoring on novel foods, in cases where there was uncertainty about the way that certain ingredients or about consumption of relevant foods by specific groups of the population, such as children and teenagers. The Committee was concerned that adequate margins of safety were unclear when “child-friendly” foods were targeted by manufacturers producing novel carbohydrate rich snack foods and also that the issue of cumulative exposure to novel foods with similar effects was difficult to address. The DH officials advised there was less under-reporting in children and more in adolescents, and agreed with the Committee that it was difficult to determine margins of safety properly for example because portion sizes differ.
The Committee considered that the NDNS data might be strengthened by using biomarkers to confirm the completeness of food diaries. DH reported that the NDNS is looking at biomarkers but that more work was needed and they would not be used in the near future
5. Synthetic Dihydrocapsiate (oral report)
The Committee considered this application in September and November 2010. The Committee was given an oral update on the public consultation on the initial opinion, which had not raised any new issues. It was content that the assessment of this novel ingredient was complete and a favourable UK initial opinion would be forwarded to the European Commission.
The Secretariat will forward the UK opinion to the European Commission
6. Taxifolin ACNFP/101/3
The Committee considered this application in September and November 2010. The Committee was asked to consider comments from the public consultation on this application before finalising its opinion.
In the light of a previous response received by the applicant the Committee raised a general point about the use of non-EU accredited laboratories and whether this could affect the quality and reliability of analytical data.
After considering the public comments, the Committee requested further data on the levels of saponins in the product and how this compares to the saponin content of existing foods such as soya. The Committee also asked about quality control procedures that were employed on each of the batches of the novel ingredient and also whether there were any checks carried out in relation to mycotoxins, as the tree stumps used to obtain the novel ingredient might subject to fungal decay. Members agreed various amendments to the text of its draft opinion, subject to resolving these remaining issues.
Action: The Secretariat will seek further additional information from the applicant.
7. Gamma-cyclodextrin ACNFP101/4
The Committee considered the Irish Competent Authority’s initial opinion on this application for authorisation of gamma-cyclodextrin as a novel food ingredient by postal consultation in September 2010. The Committee was asked to consider the response from the applicant to a number of concerns that had been raised by Members during this consultation.
The Committee noted that its concerns about labelling had not been addressed by the applicant.
The Committee considered that it was difficult to assess the safety of the novel food ingredient with the current state of knowledge. It considered it couldn’t make a judgement on whether the ingredient was beneficial or detrimental and it would be necessary to look at dietary survey comparisons. The Committee advised that there was insufficient information to assess the consequences of interactions with lipophillic substances including fat-soluble vitamins. Although the applicant had suggested that the novel ingredient may be useful for diabetics, it has only tested on healthy adults. The Committee also considered that further information was needed about the intended use and expected intake of the novel ingredient. The Secretariat noted the Committee’s concerns and reported that the applicant had provided additional information to other Member States which may address some of these.
The Committee was satisfied that its concerns about the intestinal fate of the ingredient had been answered.
Action: The Secretariat agreed to circulate additional information to the Committee by post regarding the concerns raised.
8. Phosphated Distarch Phosphate ACNFP/100/5
The Committee had considered EFSA’s opinion on this application for authorisation of phosphated distarch phosphate as a novel food ingredient, at its previous meeting in February 2011. As differing views were expressed on the mandatory labelling of this novel ingredient, in respect of gastrointestinal effects in children, the Committee was asked to consider whether such a label is necessary.
The Committee agreed with EFSA that resistant starch helps to reverse acute disease states such as cholera and diarrhoea. However, if resistant starch is added to foods there is evidence of laxation in normal individuals. The Committee noted that the studies referenced by EFSA were not of the same starches as the novel ingredient and it was not correct to assume that if one type of resistant starch had no side effects then all the others would be the same. It therefore confirmed that it would be advisable to inform consumers of the potential GI effects of this ingredient and advised that the label might read “may cause altered bowel habits”
Action: The Secretariat will inform EFSA of the Committee’s views
9. Rooster Combs Extract ACNFP/101/05
The Committee was asked to consider an application from the Spanish company Bioiberica to the UK competent authority for the approval of Rooster [cockerel] comb extract rich in sodium hyaluronate as a novel food ingredient.
The Committee was concerned about possible allergic reactions in people who are allergic to egg proteins. The Committee considered it was not to just indicate the possibility of allergic reactions through precautionary labelling and requested the applicant performed more analysis to determine whether antibodies to egg proteins would cross-react with the proteins in the novel ingredient. The committee also noted that the current rules on allergen labelling refers to hens and therefore may cause confusion if it is applied to a product from cockerels.
The Committee noted that the novel food ingredient was intended for use in a wide range of foods including those available to children. The Committee therefore requested consumption levels of the novel ingredient for both children and adults. The Committee also requested justification of the applicant’s approach to calculating a safety margin between the doses used in animal trials and the estimated human intake, which had been based on a publication by Reagan and Shaw (2007).
The Committee considered that the microbiological analyses should be reported in more detail and should include appropriate controls.
The Committee was concerned that consumers may be misled by the addition of the novel ingredient, which is an animal product, to dairy products that are otherwise regarded as suitable for vegetarians
Action: The Secretariat to ask the applicant for additional information
10. EPA and DHA rich algal oil ACNFP/101/06
The Committee was asked to consider this application from Martek Biosciences for the approval of an oil rich in polyunsaturated fatty acids, obtained from the microalga Schizochytrium sp.
The Committee was generally content with the data and considered that the toxicological studies were well conducted with appropriate controls and the data were of good quality. The Committee noted that the novel ingredient had potential sustainable and environmental benefits as it was a substitute for fish oils which could help reduce fish catches.
The Committee requested further information on the potential contamination of the product with toxic cyanobacteria. The Committee was also concerned that tests had not been carried out on pregnant and lactating women, a particular target group for high dose supplements containing the novel ingredient .
Action: The Secretariat to ask the applicant for additional information
11. EFSA Guidance on Risk Assessment on Nanoscience and Nanotechnologies to Food and Feed ACNFP/101/07
The Committee was asked to consider draft guidance to applicants and risk assessors on carrying out risk assessment of food and feed produced using nanotechnologies. The guidance went out to consultation on 14 January and the consultation period ends on 25 February. The guidance was also being reviewed by the Food Standards Agency’s (FSA) Committee on Toxicology (COT) and advice from both committees would form the basis of the Agency’s response to the consultation.
The Committee noted that Table 1 was useful. It noted that there was no evidence that EFSA had examined other international developments, for example in Japan and USA, although this was part of the original mandate. The EFSA guidance did not reflect the European policy of reducing animal testing and asked if EFSA had considered alternatives, for example distinguishing where nano products differ from the non-nanoforms and devising appropriate tests. The Committee also advised that the proposed framework should not be too prescriptive, as it may become rapidly outdated.
The Committee was concerned there was no reference to allergenicity of nanomaterials derived from proteins as there is evidence that the physical form of a protein may affect its digestibility and its allergenic potential.
Action: The combined views of COT and the ACNFP would be forward to EFSA in the FSA’s response.
12. Protein Guidance ACNFP/101/08
The Committee is asked to consider the final draft of the document on Protein Guidance.
The Committee agreed the text of the guidance subject to some amendments.
Action: The Secretariat will finalise the guidance which will be cleared by the Committee by email.
13. Open Meeting Feedback and 2011 workshop. ACNFP/101/09
The Committee was asked to consider feedback from the ACNFP open event held in November 2010 and to consider the timing of the next open event. Members were also asked to consider how more of their discussions could be held in open session.
The Committee considered that the next open event should be held in Autumn and that its format and topics for discussion should be discussed further in May.
The Committee sought further advice on the percentage of its meeting which could be opened up as, under the Novel Foods Regulations, there are legal constraints to holding discussions on applications in an open session.
14. Items for Information:
14.1 EU Update ACNFP/101/10
14.2 Novel Food notifications ACNFP/101/11
14.3 Update on Meat and Milk from Cloned Cattle
and their progeny ACNFP/101/12
The Committee noted these information papers without comment.
15. Any other business
The Chair noted that he would shortly be meeting the Agency’s Chief Scientist for a routine annual review and asked members to complete a questionnaire by email.
Action: Members to complete the self-assessment questionnaire
16. Date of next meeting
The next meeting was scheduled for Thursday 12 May 2011 in Aviation House