Food Standards Agency
Room 3B Aviation House
London WC2B 6NH
Tel: +44 (0)20 7276 8595
Fax: +44 (0)20 7276 8513
Minutes of the meeting held on 25 January 2006 in Conference Room 5, Aviation House, 125 Kingsway, London.
Professor Mike Gasson
Professor Ruth Chadwick
Mr Neville Craddock
Professor Jim Dunwell
Professor Gary Foster
Dr John Fowler
Professor Stephen Holgate
Dr Peter Lund
Professor Alan Malcolm
Dr Clive Meredith
Professor Ian Rowland
Dr Tony Williams
Ms Azuka Aghadiuno
Mrs Alison Dyson - Minutes
Ms Michelle Gardner
Dr David Jefferies
Dr Chris Jones
Dr Sandy Lawrie - ACNFP Secretary
Ms Annie-Laure Robin
Mr Colin Ross
Dr Clair Baynton
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
Apologies were received from Jill Brand, Hilary Close and Peter Shewry. Apologies were also received from observers from FSA Scotland, Wales and Northern Ireland (Mrs Elspeth MacDonald, Mr Phil Morgan, and Mr Gerry McCurdy).
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 74th meeting
Subject to five minor textual corrections, Members agreed that the minutes were a true record of the 74th meeting of the ACNFP held on Thursday 24 November 2005.
3. Matters Arising
The Committee was informed that the Agency had received final confirmation from the European Commission that no objections were received from other Member States during the 60-day comment period. The Agency therefore wrote to the applicant on 14 December 2005, informing them that D-Tagatose may now be marketed in the EU. The Secretariat noted that this was the first time that a novel food application has been authorised without at least one Member State raising formal objections.
The Secretariat informed the Committee that the draft opinion on this application was issued for public consultation on 30 November 2005. No comments were received and the final negative UK opinion was sent to the European Commission on 5 January 2006.
Phytosterols from Prima Pharm
The Committee's draft positive opinion on this application was issued for public consultation on 30 November 2005. No comments were received and the UK's opinion on equivalence was sent to the applicant on 20 December 2005.
Phosphated distarch phosphate
The Committee was informed that following the discussion at the November meeting the Secretariat wrote to the applicant to request additional information on the points raised by Members. The Secretariat noted that the applicant was unable to provide this additional information for consideration at the meeting but that it was expected that it would be received in time for consideration at the Committee's next meeting in March.
At its November meeting the Committee considered an initial assessment report on this application prepared by the Belgian Competent Authority. The Committee was informed that the UK opinion on this initial assessment report, reflecting the points made by Members, was forwarded to the European Commission on 2 December 2005.
Arachidonic acid-rich fungal oil
The Committee considered an initial assessment report prepared by the Dutch Competent Authority on this application at its November meeting. Members provided initial comments at the meeting, but were invited to submit any further substantive comments by post as the paper had been provided to the Committee at short notice. The Secretariat indicated that no further comments were received and the UK's response was sent to the European Commission on 24 January.
3a. Effect of GM soya on newborn rats
The Committee considered two emails from the organisation GM Free Cymru, which invited the Committee to withdraw or substantially revise its recent statement on the effect of GM soya on newborn rats, which concluded that the available information from a recent study conducted by the Russian scientist Dr Irina Ermakova was insufficient to allow any conclusions to be drawn.
Members noted that the emails were based on the premise that the Committee had considered Dr Ermakova's study to be invalid because the results were contradicted by a published paper (Brake and Evenson, 2004). In fact this was not the case and the statement reflected the view that it was not possible to draw any conclusions from the Ermakova study because there was insufficient information about the experimental conditions. It was clearly indicated that ACNFP would consider any further information that can be obtained.
The ACNFP statement drew attention to a published study involving mice fed GM soya. In addition to reporting the results of specific investigations into testicular development, the paper included information on the same basic reproductive parameters reported by Dr Ermakova (i.e. litter sizes, survival of the offspring and growth rates). The 2004 report indicated no adverse effects in the group fed GM soya, which was fed to the mice over four generations. While this information was relevant for readers of the statement, the paper had not influenced Members' opinion of Dr Ermakova's research.
Members also confirmed that they regarded the Brake and Evenson study as 'well-controlled' because it contained both negative and positive controls. The GM soya and control diets were designed to ensure that the basic nutritional needs of the animals were met and the two diets were virtually identical in their macronutrient and micronutrient composition, thus minimizing any confounding effects of differences in nutrient intake. Also, it was not correct to suggest that the Committee had accepted the conclusions reported by these authors solely because of the peer review process, as the Committee had only referred to this study after a detailed reading of the published paper.
Members did not agree with the suggestion from GM Free Cymru that recent literature reports raise 'major concerns' over health effects of GM soya and therefore considered it inappropriate to advise the Food Standards Agency to commission urgent research in this area.
The Committee noted the reference in the emails to an extract from a report by the Royal Commission on Environmental Pollution (RCEP), which contained recommendations on the transmission of scientific advice from advisory committees to Government Ministers. While these recommendations had been made in the specific context of the RCEP's consideration of risks associated with crop spraying, the Committee agreed that the same principles apply to all areas of scientific advice.
A separate email from The Soil Association raised questions arising from the December statement about the role of peer review during the safety assessment of GM foods. A reply had been sent by the Secretariat.
4. Noni juice produced by Leap of Faith Farms
The Committee considered a request made to the UK Competent Authority for an opinion on substantial equivalence between noni juice products produced by Leap of Faith Farms compared with an approved noni juice.
The applicant intended to produce the juice in a number of forms, including a fresh juice, a concentrated juice, and a juice made from a reconstituted powder. The Secretariat drew attention to the fact that the dried noni product will only be sold to consumers as a reconstituted juice and that it therefore differed from the dried noni product currently undergoing a full assessment in Germany.
Although the Committee was generally satisfied that the evidence provided demonstrated substantial equivalence, Members requested further information on the rehydration process, including its effect on the composition of the product, and on the shelf life of the powder. Members also noted that they would normally expect to see a larger amount of analytical data on composition.
The Secretariat agreed to contact the applicant to request additional information on the points raised by the Committee, and to prepare a draft opinion reflecting the Committee's views for the next meeting.
5. Phytosterols produced by DDO Processing
Neville Craddock declared a direct interest in this application and left the room for the duration of the Committee's discussion on this item.
Following the Committee's initial consideration of this application at its November meeting, a set of comments had been received during the public consultation. These comments concerned the analytical method used to determine the composition of the phytosterols; the higher beta-sitosterol level compared with the existing product; the lack of data on the actual solvent residues; and the lack of data on the levels of other impurities.
At its meeting in November the Committee had confirmed that it was content that the higher level of beta-sitosterols was acceptable. In relation to the comment on the lack of data on the level of impurities, the Secretariat informed Members that the Scientific Committee on Food (SCF) had previously identified concerns over potential impurities in tall oil phytosterols. The SCF concluded that these concerns were best addressed by ensuring a purity level of above 99%, which was the case for both DDO's ingredient and the Forbes Medi-Tech ingredient to which equivalence is being claimed.
The applicant had been asked to respond to the comments relating to the solvent residues and the analytical method. The Secretariat indicated that following receipt of the applicant's response, it was seeking further advice on the legal status of the use of heptane in the manufacture of the phytosterols product. Members noted that the residues of heptane were very low (<0.1 mg/kg) and that residue levels of 5000 mg/kg were accepted for use in the manufacture of pharmaceuticals. The Committee concluded that the residues were unlikely to present a safety concern.
The Committee noted that the additional information provided by the applicant on their method for analysing the composition of the ingredient now indicated that the sitosterol levels were lower than reported in the original application and requested an explanation for this difference.
The Secretariat agreed to contact the applicant to seek further information on the question raised by the Committee and to revise the draft opinion for possible finalisation at the next meeting.
6. Chia seed
Ian Rowland declared a direct interest in this application and left the room for the duration of the Committee's discussion on this item. Clive Meredith indicated that his previous employer had conducted certain studies on chia, which the Committee had considered during the initial evaluation of this novel food dossier. The Chairman concluded that he should remain.
The Committee had issued a positive opinion on this application in April 2004. However, when the European Commission circulated this opinion to other Member States for comment, some of them raised reasoned objections on the basis of insufficient toxicological information, allergenicity, and the presence of anti-nutrients.
The European Food Safety Authority (EFSA) was therefore asked by the Commission to review the application and to address the concerns raised by Member States. In November 2005, EFSA issued an unfavourable opinion on the safety of whole chia seed and ground whole chia as novel ingredients.
The Committee had already considered the issue of allergenicity at length during its assessment and had concluded that appropriate labelling would control any risks associated with cross-reactivity. Members were asked whether they agreed that there was a need for additional toxicity information and whether additional studies were required to investigate the potential presence of toxins and anti-nutrients.
Members noted that EFSA had considered additional data which had not been available when the Committee carried out its initial assessment, including three published studies into the effects of diets containing up to 30% chia seed on the performance of laying hens. They accepted EFSA's overall conclusion, that further data were needed to conclude the risk assessment, although they questioned whether all of the studies requested by EFSA would be necessary, given that exposure to chia seed would be limited by its use in one type of food.
7. Nordic Council report on novel plant foods
The Food Standards Agency invited the Committee to comment on certain proposals related to the risk assessment and risk management of novel plant foods, drawn up by a Working Group established under the Nordic Council. The report from the Nordic group focused on the situation where food plants with a traditional history of food use outside the EU are proposed for introduction to the EU.
The Committee discussed the two-stage evaluation process proposed by the report but indicated that it would need to see more closely worked examples before any conclusions could be drawn on its feasibility. Members also noted that the report did not describe any interface with scientific experts (e.g. EFSA) in the first stage of the process and that a non-scientific administrator might not be best placed to determine the type of risk assessment required for a novel food, especially when considering issues such as potential allergenicity. The Committee stated that extreme care would need to be taken to ensure that the introduction of any new procedures did not reduce the current high level of consumer protection provided by the existing evaluation framework.
The Committee noted the Nordic group's recommendation that 90-day feeding studies should be a routine part of the evaluation scheme for this type of novel food, but asked to see the detailed background papers before commenting on this issue.
The Committee agreed to revisit some of the other issues raised by the report at a future meeting.
8. Codex guidance on foods derived from GM animals
When the re-formed Codex Alimentarius Task Force on Foods Derived from Modern Biotechnology met in September 2005, it agreed to begin work on guidelines for the safety assessment of foods derived from GM animals. It is intended that these will complement current guidelines on the assessment of GM plants and GM microorganisms, which were adopted by Codex in 2003. To help the UK prepare for discussions on this topic, the Committee was invited to consider a working draft of the guidelines and to advise on any additional topics that need to be considered.
Members suggested that unintended changes in hormone levels and the potential for gene transfer would need to be included in the list of issues relevant to the assessment of products from GM animals. The Committee also suggested that the possible role of new technologies such as proteomics and genomics in the evaluation should be considered.
The Secretariat indicated that it would keep the Committee informed of progress on this activity.
9. ACNFP annual report 2005
Members had been provided with a draft copy of the 2005 ACNFP annual report and were asked to provide substantive comments at the meeting. The Committee confirmed that no significant changes were required and agreed to forward minor drafting points to the Secretariat in writing.
The Secretariat informed the Committee that the report would be cleared by Chairman's action following the receipt of Members' comments.
10. Review of novel processing techniques
The Committee was asked to provide comments on two recent reviews of novel processing techniques commissioned by the Food Standards Agency in 2004/5 and to identify any topics that required further consideration. As there was limited time for discussion, Members agreed to revisit some of the issues raised by the report in more detail at the next meeting.
One Member observed that the report did not recognise the general obligations placed on the food industry to control the quality and safety of its products. Members also noted that some of the processes had been in use for some time and fell outside the scope of the novel foods regulation.
11. Items for information
This paper provided a routine overview of progress on EU issues of relevance to the Committee.
Update on G03 research programme
This paper provided members with an update on the Agency's research programme for novel foods.
12. Any other business
The Secretariat informed Members of a new EU-funded website on GMOs which can be found at www.gmo-compass.org. The stated aim of this website is to provide consumer-oriented information on all aspects of GMOs, including food safety.
13. Date of next meeting
The next meeting of the Committee was scheduled for Wednesday 22 March 2006, in Aviation House, London.