ACNFP
THE ADVISORY COMMITTEE ON NOVEL FOODS AND PROCESSES
ACNFP Secretariat
Food Standards Agency
Room 515b Aviation House
125 Kingsway
London WC2B 6NH
Tel: +44 (0)20 7276 8595
Fax: +44 (0)20 7276 8564
acnfp@foodstandards.gsi.gov.uk
ACNFP Minutes: 31 January 2008
Notes for the meeting of the committee at 10.30am on 31 January in conference room 5, Aviation House, Kingsway, London
Present:
Professor Mike Gasson - Chairman
Professor Stephen Holgate
Professor Peter Shewry
Professor John Warner
Dr Clare Mills
Dr Paul Brantom
Professor Harry Flint
Professor Michael Bushell
Professor John Mathers
Ms Gillian Pope
Professor Christopher Ritson
Mr Kevin Swoffer
Dr Paul Haggarty
Apologies:
Ms Jayam Dalal
Professor Andrew Chesson
Professor Gary Foster
FSA Assessor:
Dr Clair Baynton
FSA Observor
Ms Gill Fine
Secretariat
Ms Alison Asquith
Ms Azuka Aghadiuno
Ms Shuhana Begum
Dr Chris Jones
Dr Sandy Lawrie - ACNFP Secretary
Ms Narriman Looch - Minutes
Dr Manisha Upadhyay
1. Apologies and announcements
The Chairman welcomed new members Michael Bushell, John Mathers, Gillian Pope, Christopher Ritson, and Kevin Swoffer, who were appointed to the Committee in January 2008, and also Paul Haggarty who was the new cross-member with the Scientific Committee on Nutrition.
The Chair also welcomed Manisha Upadhyay who had recently joined the Secretariat as a Higher Scientific Officer.
Three members had sent apologies for non-attendance and apologies were also received from observers from FSA Scotland, Wales and Northern Ireland (Ms Elspeth MacDonald, Mr Phil Morgan and Mr Gerry McCurdy).
The Chair introduced Gill Fine ,the FSA’s Director of Consumer Choice and Dietary Health, who welcomed the new members to the Committee.
The Secretariat agreed to circulate an updated contacts list for all members.
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.
ACTION Secretariat
2. Minutes of the 85th meeting DRAFT/ACNFP/85/Min
Members agreed that the minutes were a true record of the 85th meeting of the ACNFP held on Thursday 22 November 2007.
3. Matters Arising
The Secretariat provided the following update on items arising from the previous meeting
ITEM 5: Kiwiberry concentrate
At the previous meeting the Committee was of the view that it was not possible to conclude their risk assessment of this novel ingredient due to the absence of in vivo allergenicity studies. The committee will be updated with progress on this before or at the next meeting
ITEM 6: Beta-Glucan rich extracts from Lentinus edodes assessment.
The Secretariat agreed to obtain further information from the applicant on points raised by the Committee at the previous meeting. This had been delayed due to a number of outstanding administrative issues that had now been resolved.
4. Phosphated Distarch Phosphate (PDP) ACNFP/86/1
John Mathers declared an indirect commercial interest as his department has received research project funding from National Starch, but not on this product. The Committee agreed that he should remain for the discussion of this item.
This application had previously been discussed by the ACNFP on a number of occasions. The draft opinion was published for public comment in December and four responses were received, two of which raised substantive points regarding phosphorous consumption in individuals undergoing renal dialysis. and the definition of fibre The Committee was asked to consider the comments received during the public consultation and the applicant's response, and to finalise the text of the opinion.
The Committee agreed that the phosphorous content of the ingredient was a cause for concern among individuals who were trying to control their intake levels. As such individuals would have serious renal problems they asdvised that the term should be included in the name. It recommended that a suitable name could be “resistant phosphated (maize) starch”.
The Committee also recommend that consideration should be given for a mechanism to inform the appropriate renal dialysis support groups of the introduction of the Novel food ingredient and any food products that may contain it.
The Committee reiterated their concerns that consumers might be misled if the novel food ingredient were to replace other fibre products which have more demonstrable health benefits.
In view of the significant nature of these amendments to the draft opinion, the Committee agreed that it should be issued for further public comment once the amendments are made.
Action: Secretariat
5. Phytosterols ACNFP/86/2
Members were asked to consider further information provided by the applicant in response to the questions raised at the Committee’s meeting in November 2007 on this request for an opinion on equivalence.
The Committee was broadly content with the information provided however requested further information regarding the production process and data on the composition of the phytosterol ingredient.
The Committee noted in the supplementary information provided that the solvent is removed at high temperature under vacuum and each lot is tested for loss on drying to determine residual solvents. The Committee requested clarification as to whether this method was appropriate for determining levels of residual solvent. The applicant had provided a list of individual constituents making up the remaining 5% of the preparation not accounted for by phytosterols and Committee requested the evidence to support this list.
The Secretariat agreed to obtain further information on these points from the applicant and would circulate the revised draft opinion to Members for final comments before publishing it for a 10-day public consultation.
Action: Secretariat
6. Astaxanthin rich oleoresin from Haematococcus pluvialis algae ACNFP/86/3
The Committee considered this application for an opinion on substantial equivalence in July 2007 and was generally satisfied that the oleoresin produced by the applicant was equivalent to that produced by Valensa, subject to any responses to the public consultation on the application dossier.
The public consultation raised two issues which the Secretariat had relayed to the applicant. Members were asked to consider the information provided by the applicant in response, concerning, Information on the stability of the oleoresin extract and the possible presence of DPA (diphenylamine) as a contaminant in batches of the algal meal.
The Committee was content with the applicants response regarding DPA contamination and agreed that the opinion should include information on the levels found in batches of the algal meal, which were very low and close to the limit of detection.
Members asked to review the detailed results from the stability study as the results had only been provided in summary. Members also requested information on the proposed shelf life of the product and a clearer idea of what the maximum acceptable stability changes were.
The Secretariat agreed to obtain further information on these points from the applicant and would circulate the revised draft opinion to Members for final comments before publishing it for a 10-day public consultation.
Action: Secretariat
7. DHA (Docosahexaenoic Acid)-rich Algal Oil ACNFP/86/5
The Committee was asked to consider this application for the extension of use of a DHA-rich algal oil from microalgae of the species Schizochytrium.
The Committee first considered an application for the authorisation of this ingredient in 2001 and issued a favourable initial opinion in June 2002. The product was authorised in 2003 in a limited range of food products.
The Committee was asked if the data provided by the applicant were adequate to determine whether the request for an extension of use of the ingredient complies with the criteria for acceptance under the novel food regulation.
Members recognised that intakes of polyunsaturated fatty acids were generally considered to be too low in the UK and the population's dietary needs could not easily be met from traditional foods and food ingredients.
The Committee noted that there were reports in the literature indicating that DHA and other long chain omega-3 fatty acids can increase gestation time and may also have adverse effects on the immune system and on blood clotting time. The Committee therefore requested further information these possible effects. Members also highlighted that the applicant's consumption estimates did not take food supplements into account and that this information was required in order to get a full understanding of the likely levels of consumption.
The Secretariat agreed to obtain further information on these points for discussion at the Committee’s next meeting.
Action: Secretariat
8. Alpha-Cyclodextrin ACNFP/86/6
In 2007 the European Food Safety Authority had published its opinion on the use of alpha-cyclodextrin as a novel food ingredient. The Committee was asked if the further assessment carried out by EFSA fully addressed its earlier concerns on the safety of this substance.
The Committee previously advised that 2 of its original 5 concerns had been answered by the applicant and discussion focussed on the remaining 3 points, namely the applicability of the estimated intakes, based on US data, to the UK situation; the designation of this novel carbohydrate as a source of fibre; and potential gastrointestinal intolerance in children.
The Committee was satisfied by information provided by the Secretariat which showed the intake estimates based on US food consumption data were not markedly different to estimated based on UK data. They noted that the definition of fibre was currently under consideration, as noted in its draft opinion on phosphated distarch phosphate.
The Committee was of the view that EFSA's conclusion, that the fermentation of carbohydrates in the gut was a harmless process, was too simplistic and ignored the serious consequences of fermentation for example in Irritable Bowel Syndrome sufferers. The Committee reiterated its earlier concern over potential gastrointestinal intolerance in young children, noting that unexplained childhood diarrhoea is an increasing problem in hospital clinics. The committee therefore concluded that the further assessment carried out by EFSA did not address its concerns about GI intolerance.
The Committee expressed a general concern that soluble fibre intake may increase significantly as new products come onto the market.
The Secretariat agreed to draft a response to the applicant incorporating the points raised by the Committee
Action: Secretariat
9. EFSA Opinion on Cloned Animals ACNFP/86/7
In view of increasing interest within the livestock industry in the use of cloned animals, particularly in the USA, EFSA had been asked by the European Commission to consider the implications of animal cloning. Having set up a special expert group to consider the relevant issues, EFSA issued a draft report in January 2008 for public comment.
Based on its evaluation of the available evidence, EFSA had proposed that food products derived from healthy clones, or from their offspring, were not expected to introduce any new food safety risks. The draft report also addressed the potential impact on animal health and welfare and on the environment, which are not within the remit of the ACNFP.
The Committee was asked to consider EFSA's draft report with a view to providing formal written comments to EFSA.
The Committee concluded that EFSA had provided a thorough analysis of the available literature was good but limitations in the data left many questions unanswered. For example, the Committee noted the lack of studies on levels of known allergens and the lack of studies on animals kept in different conditions, noting that stress and environmental factors can have a large impact on epigenetics. The age of the new technology has meant that no tests have been carried out beyond the F1 generation.
The Committee also suggested that the use of cloning could potentially have a much more marked effect on genetic diversity compared with other assisted breeding techniques.
The Secretariat agreed to submit the Committee's comments to EFSA.
ACTION: Secretariat
10 Open Meeting ACNFP/86/8(tabled)
The Committee was asked to consider an outline programme for the open meeting which was planned for 2 April 2008.
The Committee agreed the proposed format of the meeting and suggested topics for discussion.
11 Revision of the Novel Food Regulation ACNFP/86/9
The Commission had recently published a draft regulation which it proposed should replace the existing novel food regulation EC 258/97. The Agency advised that it will soon be carrying out a formal public consultation on this proposal and it would welcome initial comments from the Committee.
The Committee raised concerns regarding the definition proposed for ‘traditional food’. A one-generation history of consumption outside the EU (approximately 25 years) was an arbitrary figure and should not be the sole factor in deciding the safety of a new product. The Committee noted that their recent consideration of baobab fruit pulp, a traditional food from Africa, had included an assessment of allergenic potential and an investigation of any potential toxic effects and that such issues should be considered in any future consideration of traditional foods. The Committee was also concerned that the definition of traditional foods may be too vague and that there should be additional explanation of what these products might be.
The Committee were concerned that the proposed centralised assessment system would not draw on the existing expertise developed in Member States.
The Secretariat agreed to keep the Committee informed of progress with this new legislation and might need to seek comment on specific issues that arise during the negotiations, particularly in relation to risk assessment.
12 Items for information
12.1 EU update ACNFP/86/10 (tabled)
12.2 Update on other Scientific Advisory Committees ACNFP/86/11(tabled)
These papers were noted by the Committee without comment. An update on GM food and feed applications would be circulated at a later date.
13 Any other business
There was no other business.
14 Date of next meeting
The next meeting was scheduled for 3 April, to be held in Aviation House.