Professor Peter Gregory Chairman
Ms Jayam Dalal
Dr Paul Brantom
Professor Mike Bushell
Professor Andrew Chesson
Dr Paul Haggarty
Professor Stephen Holgate
Professor John Mathers
Professor Peter Meyer
Dr Clare Mills
Mrs Gillian Pope
Professor Christopher Ritson
Mr Kevin Swoffer
Professor Harry Flint
Professor Peter Shewry
Professor John Warner
Ms Azuka Aghadiuno
Ms Alison Asquith –Minutes
Ms Shuhana Begum
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. Apologies were also received from observers from FSA offices in Scotland, Wales and Northern Ireland (Ms Alison Taylor, Mr Phil Morgan and Mr Gerry McCurdy).
The Chair noted that Darren Key had left the ACNFP secretariat to take up a temporary post in another part of the FSA.
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 97th meeting DRAFT/ACNFP/97/Min
Subject to minor amendments members agreed that the minutes were a true record of the 97th meeting of the ACNFP held on Thursday 22 April 2010.
3. Matters Arising and Postal Consultations
The Secretariat reported back on matters arising from the 97th meeting.
Item 6 - : Magnolia Bark Extract:
No comments were received on the draft Opinion during the recent public consultation. The opinion would therefore be finalised and submitted to the European Commission.
Item 11 - Committee on Toxicity’s (COT) development of an approach to handling uncertainty:
COT has published a paper -TOX/2010/19 on its website which was discussed at its meeting on 22 June. The paper can be located at http://cot.food.gov.uk/cotmtgs/cotmeets/cotmeet2010/cotmeet22jun2010/cot...
The Secretariat summarised the responses to the two postal consultations that took place after the April meeting:
Phosphatidyl serine (postal paper ACNFP/98/P1)
Only one comment was received from Members and this was not substantive. The UK had sent a nil return to the European Commission’s request for comments and objections
Lactoferrin (postal paper ACNFP/98/P2)
The Committee confirmed that its concerns over a previous application for lactoferrin still applied. The Agency had relayed this to the European Commission.
4. Licorice root extract ACNFP/98/1
The Committee considered the Belgian Competent Authority’s initial opinion in April 2009. The Committee was asked to consider further information received from the applicant in response to a number of comments and concerns which had been raised by the Committee.
The Committee questioned the average licorice intake level as it seemed very high for the UK, but accepted that consumption is significantly higher in some other European countries. The Committee also questioned the evidence for the claim that the novel ingredient was comparable to existing licorice extracts, as the applicant had not provided data on how the production process changes the composition of the product.
The Committee considered that their concerns about children’s intake levels had not been answered. This was particularly relevant as it was intended to add the novel ingredient to yoghurt and fruit drinks which were widely consumed by children. The Committee noted that the novel ingredient would not be suitable for children under 12.
The Committee also considered that the applicant had not addressed their concerns on haematological effects. It was particularly concerned that when the novel ingredient was consumed there was prolongation of PT (prothrombin time) and APTT (activated partial thromboplastin time). This was a significant concern, even although the effect was reversible and values rapidly returned to normal once consumption had stopped.
The Committee agreed that its concerns on oestrogen receptors had been addressed by the applicant.
The Committee’s comments will inform the UK’s position in future discussions regarding this novel ingredient at meetings of the Standing Committee on the Food Chain and Animal Health.
5. Phosphated Distarch Phosphate ACNFP/98/2
The Committee previously considered this application in September and November 2009 and in February 2010. In February the Committee requested that the applicant provide additional information to reassure Members that the product remained stable for the duration of its shelf life. The applicant had questioned the need for additional studies, pointing out that a previous application for a similar product which had not provided detailed stability data, but had relied upon compliance with a European starch industry standard.
The Committee understood the rationale for the applicant’s question but as it dealt with ingredients that, by their nature, were new there was a strong possibility that new issues of concern could emerge. The Committee might therefore need to ask for more information than they had requested for previous applications. In the case of this product it considered that there was greater awareness that processing and shelf life of ingredients can affect their chemical properties and it concluded that the additional information it requested following the February 2010 meeting was still required.
Action: Secretariat to ask the applicant for additional information
6. Guar Gum ACNFP98/3
The Committee considered the French Competent Authority’s initial opinion on this application for authorization of Guar Gum as a novel food ingredient.
Professor Paul Brantom confirmed he did not have an interest in the company BIBRA which had prepared a report that was included in the application. Whilst he had been previously employed by BIBRA, he was not associated with the company involved in the current application, which was a new company that had started up following the demise of the original BIBRA.
The Committee noted that, although it is stated in the application dossier that the guar plant has no history of consumption in the EU, guar beans are consumed in the UK by the Indian community. However, the Committee was not aware of consumption of guar gum derived from the beans.
The Committee recognized there was a possibility that the novel ingredient may cause obstructions in the GI tract (oesophageal and intestinal obstruction) as it will swell significantly on exposure to water. Members shared the French authorities’ concern that some consumers may eat the cereal component of the proposed cereal/dairy bi-component product without mixing with the dairy component and stressed that such products should be clearly labelled so that the cereal component is not consumed on its own. The committee advised there was little risk in consuming the product provided this risk was addressed.
Action: The Secretariat to transmit the Committee’s comments to the European Commission
7. Conjugated Linoleic Acid (CLA) ACNFP/98/4
The Committee considered two opinions from the European Food Safety Authority (EFSA) on two separate applications for CLA-rich oils, which had initially been assessed by the Irish and Spanish Competent Authorities. The Committee had considered the two opinions in July 2008 and September 2008 respectively.
The Committee confirmed that their previous concerns had not been satisfactorily resolved.
The Committee agreed with EFSA’s conclusion that the long term effects of CLA intake on insulin sensitivity had not been adequately addressed. The Committee considered that a study longer than eight weeks was necessary to address its concerns that people might be put at risk of developing type 2 diabetes if they consumed this novel ingredient. The Committee considered that both animal and human studies should be considered when evaluating the effects of CLA. The Committee also agreed with EFSA that the products were unsuitable for type 2 diabetics, noting the high prevalence of type 2 diabetes in the UK and the fact that many cases are undiagnosed. It recommended that food containing CLA-rich oils, if authorised, should carry a warning label that it should not be taken by diabetics and those at risk of diabetes, by pregnant women or by children or babies.
The Committee re-iterated its concern about oxidative effects of high level intake of polyunsaturated fatty acids (PUFA) at the arterial wall, which had led the Committee on Medical Aspects of Food and Nutrition Policy (COMA) to recommend an upper limit of 10% for the ratio of PUFA to total fat intake. Consumption of the recommended amounts of CLA-rich oil would significantly increase PUFA intakes. The EFSA opinion confirmed that this issue has not been addressed by the applicants.
The Committee expressed disappointment that EFSA had not considered the implications of CLA consumption by children and also noted that the intake estimates reported in the EFSA opinions did not take account of the total intake of CLA from all sources. One member observed that surveys of food consumption may underestimate real rates of consumption, as judged by energy balance studies, and that this could lead to underestimation of the intake of added components such as CLA.
The Committee could not therefore agree with EFSA’s conclusion that the safety of these ingredients has been demonstrated (for limited periods of exposure), given the significant uncertainties over oxidative stress and effects on glucose control (in non-diabetic subjects), combined with the lack of data on the stability of CLA in food products.
From a risk management perspective, the the Committee questioned how it would be possible to implement advice that a novel ingredient was safe for a period of six months continuous exposure but safety beyond this had not been established. Whilst recognizing that risk management issues were outside the remit of the Committee, it noted that advice in this format may cause practical difficulties for risk managers.
Action: The Secretariat will draft a letter to EFSA seeking a response to the Committee’s reservations. The letter to be cleared by the Committee.
8. New Techniques of Genetic Modification ACNFP 98/5
The Committee considered the techniques detailed in the Advisory Committee on Releases to the Environment (ACRE) draft report entitled “New Techniques used in plant breeding”. The ACRE report is in response to a Brussels working group addressing the question of whether new techniques, now being employed or under development, result in a genetically modified organism (GMO) as defined in European Union (EU) legislation.
The Committee agreed with the thrust of the ACRE report that a decision needed to be made as to whether in future it was the ‘process’ or the ‘product of genetic modification (GM) that was regulated. EU legislation currently defines GM as a process or technique whereas many countries define it as a product and the definition of GM needs to be rethought so it is consistent with state of the art techniques of GM. The Committee agreed that the product shouldn’t be analysed on the basis of the technology. All ethical issues identified by the Committee were concerned with the product rather than the technology.
The Committee considered that epigenetic changes had less potential to be of concern than current methods of genetic modification as mutations arising from epigenetic effects are fewer.. It considered it was arguable whether, contrary to popular belief, transgenesis is more dangerous than cisgenesis, e.g. changing the spatial or temporal pattern of endogenous gene expression.
The Committee commented that a rigorous risk assessment was required before GMO’s could be placed on the market whereas products derived from traditional cross breeding techniques required no risk assessment even though allergenicity levels may be altered or toxic compounds expressed. The Secretariat agreed to keep the Committee informed as to future drafts of the ACRE report and any outputs that arise from the Commission working group ahead of discussions by EU Member States in Brussels.
Action: The Secretariat will provide feedback on the Committees comments following further consultation.
9. ACNFP Guidelines for low-level Protein Analysis ACNFP/98/6
The Committee reviewed a draft guidance note regarding the detection of proteins in novel foods, which was prepared by the Protein Sub-group, a working group of the ACNFP. The guidance note was intended to assist applicants with the provision of appropriate information on the presence of proteins in novel ingredients.
The Committee thanked the members of the Sub-group for their input into the draft guidance. It noted that the draft guidance aimed to help applicants identify the appropriate methods fo protein detection, quantification and identification when seeking authorisation for novel foods.
The Committee agreed that all products should be evaluated on a case by case basis and that the technique used for the protein analysis should based on optimal performance rather than availability.
The Committee also viewed the decision tree approach to be very useful as made it clear the importance of critical review of the methods employed.
Action: The Secretariat and members of the Sub-group will update the draft guidance note prior to review at the Committee’s September meeting.
10. Preparation for Horizon Scanning Meeting Oral Update
The Committee considered the format and potential speakers for a forthcoming fact finding meeting on nanotechnology, to be held in November.
The Committee considered that the objective of the meeting should be clearly set out so that the meeting’s success would be measurable. It agreed that the main objective was that the Committee would be better informed on nanotechnology and able to deal with any future issues related to nanomaterials The Committee was particularly interested in the effect of nanoparticles in the gut and where nanotechnology may be applied in the future in food.
The Committee was of the view that discussions would be more useful than lengthy presentations, providing more opportunity to question invited experts. It would be useful to be given papers in advance of the meeting including key discussion points so that there was a focus. It also considered it helpful if they could see the UK Nanotechnology Strategy, which had been published by the Government in March 2010.
The Committee was informed there would be a debate the following week in the House of Lords on the House of Lords Science and Technology Committees report on Nanotechnologies and Food. It was suggested that an organisation which had given evidence to the enquiry should be invited to speak to the Committee as the people giving evidence had shown they were very knowledgeable. Some organisations, such as Unilever, had experience in engagement with the public as well as with food applications and the Committee and Secretariat suggested additional experts who might join this meeting.
The Committee considered whether labelling issues should be discussed at a separate meeting in the evening but concluded that a discussion which should include all members of the Committee may be difficult over dinner and it would be better to concentrate on one topic during the Horizon Scanning meeting.
Action: The Secretariat will continue with arrangements for the Horizon Scanning meeting.
11. Items for Information
11.1 EU Update ACNFP/98/8
11.2 SAC Update ACNFP/98/9
11.3 Update on G03 research programme ACNFP/98/10
11.4 Improving engagement across SAC secretariats ACNFP/98/11
The Committee noted these information papers without comment.
12. Any other business
The Committee was given an update on the FSA’s engagement with a representative Hindu group which was founded following a visit of FSA officials to a Temple. The Committee was informed that a Chair for a meeting with the catering industry had been identified. The FSA would bring others into the group. The FSA had reaffirmed that it was committed to engage with various communities, such as the Indian community, to take forward food issues which were specific to that community.
The Committee was reminded about the new FSA policy on refunding travel and other expenses. The Committee asked the Secretariat to note that they would need early notice of events, particularly those outside the normal ACNFP meeting times, in order to take advantage of the cheapest fares.
Members were invited to stay after the meeting for a presentation on nanomaterials by a representative from Food Standards Australia New Zealand, who was visiting the Food Standards Agency.
13. Date of next meeting
The next meeting was scheduled for Thursday 23 September 2010 in Aviation House