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: 19 May 2005
Minutes of the meeting held on 19 May 2005 in Conference Room 5, Aviation House, 125 Kingsway, London.
Present
Chairman:
Professor Mike Gasson
Members:
Miss Jill Brand
Dr Hilary Close
Professor Jim Dunwell
Professor Gary Foster
Dr John Fowler
Professor Alan Malcolm
Dr Clive Meredith
Professor Ian Rowland
Professor Peter Shewry
Dr Tony Williams
Secretariat:
Mrs Alison Dyson - Minutes
Ms Michelle Gardner
Ms Kate Halliwell
Dr David Jefferies
Dr Chris Jones
Dr James Ridsdale
Ms Annie-Laure Robin
Mr Colin Ross
FSA Assessor:
Dr Clair Baynton
Observer:
Mr Tamio Takemoto - Japanese Ministry of Agriculture, Forestry and Fisheries
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 Peter Lund, Neville Craddock, Ruth Chadwick and Stephen Holgate. Written comments submitted by Dr Lund were tabled at the meeting. Apologies were also received from Sandy Lawrie and observers from FSA Scotland, Wales and Northern Ireland (Mrs Elspeth MacDonald, Mr Phil Morgan, and Mr Gerry McCurdy).
The Chairman welcomed Mr Tamio Takemoto from the Japanese Ministry of Agriculture, Forestry and Fisheries, who was attending the meeting as an observer.
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 seventy-first meeting
DRAFT/ACNFP/71/MIN
Members agreed that the minutes were a true record of the 71st meeting of the ACNFP held on Wednesday 30 March 2005.
3. Matters Arising
Fruit juices and nectars with added phytosterols
The Secretariat informed Members that the UK's initial opinion on this application had been forwarded to the Commission on 12 April.
Plant sterol enriched rice drink
At the March meeting the Secretariat agreed to provide Members with clarification on the potential effects of added plant sterols in individuals with the rare genetic condition phytosterolaemia (also known as sitosterolaemia). The Secretariat confirmed that plant sterol-enriched foods are not suitable for individuals who suffer from sitosterolaemia. Commission Regulation 608/2004 requires that all foods with added plant sterols must be clearly labelled with the statement "with added plant sterols", in the same field of vision as the name under which the product is sold. There is no requirement for a warning targeted specifically at consumers suffering from sitosterolaemia.
Sitosterolaemia is a recessive condition and the Secretariat reported that consumption of plant sterols by heterozygotes, who carry one copy of the defective gene and one copy of the normal gene, has also been investigated. Two studies cited by the Scientific Committee on Food in 2003 showed that intakes of 3g of added sterols per day "equally affected or minimally increased" plasma levels of sitosterol in heterozygotes, compared to healthy controls. While these studies did not provide any evidence of possible effects associated with a small increase in plasma phytosterols, the SCF noted that no precise data on the incidence of sitosterolaemia are available - although the condition is known to be very rare - and more information on the possible long-term effects of exposure to higher intakes of plant sterols is required.
Finally, the Secretariat informed the Committee that the European Commission has recently asked the European Food Safety Authority (EFSA) Dietetics Nutrition and Allergy Panel for an opinion on two scientific papers on potential risks associated with elevated plasma levels of phytosterols. The Secretariat will report on the Panel�s conclusions when they are available.
4. Additional uses of DHA-rich oil from the microalga Ulkenia sp.
ACNFP/72/1
The Committee was asked to consider the German Competent Authority's initial opinion on an application from Nutrinova to extend the range of food uses of its novel ingredient DHA-rich algal oil derived from the microalga Ulkenia.sp.
Members noted that the German Competent Authority had not provided an explanation for the maximum intake level of 1.5 grams/day of DHA. The Committee also raised concerns about the estimated daily intake of DHA in pre-school children and noted that the extrapolation of these data resulted in high intakes in adults.
Members were reassured by the announcement that EFSA is to consider this application.
5. Tagatose
ACNFP/72/2
At its March meeting members considered an application by Bioresco, on behalf of Arla Foods, for the approval of D-tagatose as a novel food ingredient and were invited to submit detailed comments by post. The Secretariat had drafted an opinion to reflect Members' comments.
Members noted that all the studies on laxative effects associated with a high level of consumption of tagatose were carried out in adults and requested information on the doses that might cause similar effects in young children. One member expressed concern about the possible cumulative effects of tagatose with complex carbohydrates.
Members suggested some minor drafting points to the draft opinion and the Secretariat agreed to incorporate these changes into a revised draft for consideration at the July meeting, along with the applicant's response to the question about laxative effects in children.
6. Lycopene-rich oleoresin from tomato
ACNFP/72/3
At its November 2004, January and March 2005 meetings the Committee had considered an application from Lycored for an opinion on oleoresin derived from lycopene-rich tomatoes to be used in a range of foodstuffs, including bread, juices and dairy products.
At its January meeting the Committee had requested new analytical data on the protein content of the product. These data had now been received and Members were satisfied that the applicant had confirmed that there was no safety risk.
At its March meeting Members had requested information on the potential transfer of lycopene to breast-fed infants. The Committee was content with the additional data and was satisfied that the applicant had confirmed that the risk from the potential transfer of lycopene to breast-fed infants was minimal.
The Committee considered a draft opinion and a final version, reflecting the changes made by the Committee, would be cleared by Chairman's action prior to being issued for public consultation.
7. Noni juice from Mi GMBH
ACNFP/72/4
At its meeting in March the Committee considered a request from Mi GmbH Switzerland and Mi EU Ltd, for an opinion on the equivalence of their noni juice to the GSE Vertrieb product. The Committee had raised a number of questions and had requested further analysis data from the applicant. The applicant had provided this additional data and the Secretariat had drafted an initial opinion for Members' consideration.
Members noted the variation of lactic acid levels in the additional analysis data provided but indicated that this was not a significant safety issue. The Committee therefore confirmed that it was satisfied that sufficient evidence had been provided to demonstrate substantial equivalence.
Members suggested a number of minor changes to the text of the draft initial opinion. The Secretariat agreed to redraft the relevant paragraphs of the opinion and circulate the document for Members' comments, following which the opinion will be issued for public consultation.
8. 1507 maize
ACNFP/72/5
At the March meeting Members discussed the EFSA opinion on 1507 maize in relation to the specific points that the Committee had raised when it reviewed the dossier in 2004. The Committee had requested sight of the internal technical report by Evans (1998) to support the explanation for the size of the Cry1F protein bands on Western blots. The applicant had provided a copy of this report together with other data that were relevant to the Committee's question. The Committee was asked to consider this additional information and indicate whether it had any outstanding concerns regarding this aspect of the 1507 maize dossier.
As Professor Gasson was a member of the Scientific Panel on GMOs responsible for drafting the European Food Safety Authority (EFSA) opinion on this application he did not contribute to the discussion. Professor Jim Dunwell chaired the Committee's discussions on this item.
The Committee confirmed that it was content with the additional information provided by the applicant and that it had no further concerns.
9. Items for information
EU Update: ACNFP/72/6
This paper provided an update on novel food applications under (EC) 258/97 and other EU issues relevant to the work of the Committee.
Accidental cultivation of Bt10 maize in the USA: ACNFP/72/7
This paper provided Members with the background to action taken in the EU following the detection of the unauthorised transformation event Bt10 in commercial maize in the US.
10. Any other business
There was no further business.
11. Date of next meeting
The next meeting of the Committee was scheduled for Wednesday 27 July 2005, in Aviation House.