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: 27 May 2004
Minutes of the meeting held on Thursday 27 May 2004 in Conference Room 5, Aviation House, 125 Kingsway, London.
Present
Chairman:
Professor Mike Gasson
Members:
Professor Philip Dale
Miss Jill Brand
Professor Ruth Chadwick (items 1-9)
Dr Hilary Close
Mr Neville Craddock
Professor Jim Dunwell
Professor Gary Foster
Dr John Fowler
Dr Peter Lund (items 3-12)
Professor Alan Malcolm (Items 1-6)
Dr Clive Meredith
Professor Ian Rowland
Professor John Warner (items 3-9)
Dr Anthony Williams (items1-6)
FSA Assessor:
Dr Clair Baynton
Secretariat:
Dr Sandy Lawrie
Mr Colin Ross
Ms Frances Cleaver
Ms Michelle Gardner
Ms Kate Halliwell
Dr David Jefferies
Dr Chris Jones
Dr Sonia Molnar
Ms Annie-Laure Robin
Observers:
Steven Hill (DEFRA) (items 1-6)
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
1.1 Apologies were received from observers from FSA Scotland, Wales and Northern Ireland (Mrs Elspeth MacDonald, Mr Phil Morgan, and Mr Gerry McCurdy).
1.2 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 65th meeting
DRAFT/ACNFP/65/MIN
Members agreed that, subject to the correction of two typographical errors and one minor change, the minutes were a true record of the 65th meeting of the ACNFP held on Thursday 25 March 2004.
3. Matters Arising
3.1 Annual Report
The Secretariat informed Members that the annual report would be published in June.
3.2 Leaf extracts from lucerene
The Secretariat reported that the Committee's comments had been forwarded to the European Commission.
3.3 GM oilseed rape events MS8 and RF3, and MS8 x RF3 Hybrids
The Secretariat informed Members that their concerns and comments were relayed to DEFRA and noted that the UK's formal response on this notification had been forwarded to the European Commission.
3.4 Chia
The Secretariat noted that they had received no responses from the public consultation on the draft opinion and that the final opinion had been submitted to the European Commission.
3.5 Substantial Equivalence
The Committee was informed that the guidelines had been revised according to comments made at the 25 March 2004 meeting and by email thereafter. The final version will be cleared by Chairman's action and made available to prospective applicants via the Committee's web pages.
3.6 Lycopene from Blakeslea trispora
The Secretariat confirmed that the final opinion on this novel food application was submitted to the Commission and has been distributed to Member States.
3.7 Postal consultations
(i) GM Potato clone EH92-52
The Committee was asked to consider a notification from BASF for deliberate release (including cultivation) of a potato clone genetically modified for altered starch composition.
The Committee was concerned that full analysis of the flanking regions on either side of the insertion site had not been provided (as this would be required for crops destined to enter the food chain). Although a thorough identification preservation system is outlined in the dossier the Committee considered that there is still the potential for contamination in the human food chain, in particular, the possibility of volunteers which can persist for many years in subsequent crops.
The Committee noted the applicant's introductory statement that 'EH92-527-1 is not intended for direct human consumption and the derived starch will only be used in non-food applications'. Nevertheless, the Committee considered it important to remind the applicant that growers of this potato clone must be made aware of their obligations to ensure that neither the crop nor any of its by-products, including products recovered from the effluent of the starch extraction process, should enter the human food chain. If this were the case, a separate assessment would need to be conducted under Regulation 1829/2003.
The Secretariat agreed to reflect these points in the Food Standards Agency's formal response to Defra.
(ii) Astaxanthin-rich extract from Haematococcus pluvialis: ACNFP/66P/1
At the 25 March 2004 meeting Members considered an application from US Nutra for an opinion on the equivalence of an astaxanthin product extracted from Haematococcus pluvialis under Article 3(4) of EC Regulation 258/97. The Secretariat had drafted an initial opinion for Members' consideration.
Members drew attention to the human study investigating the immune boosting effect of oleoresin included in the application dossier, and suggested that it should be noted that it was an unpublished eight-week trial and did not contribute to the safety assessment of the product.
The Committee also noted that the applicant proposes to sell capsules containing 5mg of astaxanthin while the product currently on the market contains 4mg. In order for usage to be 'substantially equivalent' to the existing product, Members considered that the daily consumption of the new astaxanthin preparation should not exceed current levels. The Committee therefore concluded that companies wishing to sell capsules containing US Nutra astaxanthin oleoresin should limit the level of incorporation to 4mg, in line with astaxanthin levels found in existing similar products.
The Secretariat agreed to revise the text of the initial opinion to reflect Members' comments and noted that the opinion would be finalised after a short public consultation.
4. Antibiotic resistance genes as marker genes in genetically modified plants: ACNFP/66/1
Members were asked to consider the European Food Safety Authority's (EFSA) GMO panel's opinion on the use of antibiotic resistance genes as marker genes (ARMs) and whether they wished to amend the Committee's existing advice on ARMs.
Members considered the relevance of the classification of antibiotic resistance genes by their biological distribution and suggested that EFSA needed to take greater account of the wider clinical use of antibiotics. The Committee considered that it was important to note that clinical uses vary throughout the world and may change over time. Members also noted that gene transfer is very rare but suggested that the prevalence of natural resistance was the major factor that should be considered when assessing the risk associated with such transfer.
The Committee concluded that the ACNFP fact sheet regarding the use of antibiotic resistance markers in GM plants should be updated to reflect these points.
The Secretariat agreed to forward the Committee's comments to EFSA and update the ACNFP fact sheet.
5. Draft guidance document for the risk assessment of genetically modified plants and derived food and feed: ACNFP/66/2
The EFSA GMO panel published a draft guidance document for the risk assessment of genetically modified plants and derived food and feed on 7 April 2004. Members were asked to consider the draft guidance document to determine whether it satisfactorily addressed areas that had been previously identified by the Committee as requiring further review.
The ACNFP Secretary informed the Committee that a consultation meeting was held on the draft guidance document on 25 May 2004, and noted that the GMO panel would consider all comments received and publish them on the EFSA website.
Members suggested that the draft guidance document was unfortunately lacking in specific advice on allergenicity testing, particularly regarding the number of sera to be screened with respect to cross-reactivity and the length of amino acid sequences to be used in homology searches. The Committee also drew attention to a lack of clarity regarding the use of the term 'hybrid' and indicated that the examination of hybrids between different GM lines should go beyond molecular characterisation.
The Secretariat agreed to forward Members' comments to EFSA.
6. Insect protected genetically modified maize MON 863 and MON 863 X MON 810: ACNFP/66/3
Members were asked to consider the EFSA GMO panel's opinion on an application for authorisation of grain and grain-derived food ingredients from GM insect-resistant maize line MON 863 and maize hybrid line MON863xMON 810 under the Novel Foods Regulation (EC) 258/97.
Prior to discussion of this item Professor Gasson informed the Committee that he was a member of the scientific panel on GMOs and had been responsible for drafting the European Food Safety Authority (EFSA) opinion on this application. Professor Gasson withdrew from the meeting for the course of discussions on this item and passed the Chair to Professor Dale.
The Committee noted that additional details on the flanking sequences were insufficient for adequate characterisation of the insertion point. The Committee acknowledged that, on the basis of the other studies on MON863 maize, there was unlikely to be a safety issue but was of the opinion that the ability to describe the insertion point in detail is fundamental to the analysis of any GM plant.
Members therefore considered that the applicant should provide additional data on the sequences of the flanking regions, to determine whether the mitochondrial sequences reported to EFSA had been inserted into the plant genome during the GM transformation and, if so, whether this insertion might have disrupted a functional DNA sequence. Members noted that this issue could be addressed relatively easily using standard sequencing methods.
7(a). Phytosterols: ACNFP/66/4
Members were asked to consider an application for an opinion under Article 3(4) of EC Regulation 258/97, on the equivalence of free phytosterols to be used in milk-type products and yoghurt-type products, compared with phytosterol esters currently used in the same product types.
The Committee suggested that the sterol composition should be checked to ensure that the product complies with the Scientific Committee on Food (SCF) approval. Members also questioned whether the proposed labelling met all the requirements of Regulation (EC) No 608/2004 concerning the labelling of foods and food ingredients with added phytosterols.
Before arriving at a view on equivalence, Members requested information regarding the differences of effect between sterols and sterol esters, particularly in relation to their effect on individuals with normal blood cholesterol levels.
The Secretariat agreed to seek further clarification from the applicant on the points raised.
7(b). Phytosterols: ACNFP/66/5
Members were asked to consider an application for an opinion under Article 3(4) of EC Regulation 258/97 on the equivalence of phytosterol esters intended for use in a specified range of products, comparable to phytosterol esters currently used in milk and yoghurt-type products, and yellow fat spreads.
The Committee informed the Secretariat that they were satisfied with the information provided by the applicant. The Secretariat noted that this was the first application for a UK opinion on substantial equivalence that relied on commercial information to demonstrate that the applicant's product was the same one that was already on the market. In such cases, the Food Standards Agency would be primarily responsible for responding to applicants and it would continue to seek the Committee's advice on any relevant scientific or technical issues.
8. Saskatoon berries: ACNFP/66/6
Members were asked to consider an application for an opinion under Article 3(4) of EC Regulation 258/97, on the equivalence of saskatoon berries (Amelanchier alnifolia), comparable with blueberries.
The Committee acknowledged that while saskatoon berries have a history of consumption in Canada and do not appear to present any safety concerns, they could not be considered substantially equivalent to blueberries as the species are unrelated and their phytochemical compositions are completely different. These berries could not therefore be considered under the simplified procedure for novel foods, which applies only to products that are substantially equivalent to an existing food, and would have to be assessed under the standard procedure described in Article 4 of the Regulation.
The Secretariat agreed to forward the Committee's comments to the applicant.
9(a). Matured Noni: ACNFP/66/7
Members were asked to consider an application for an opinion under Article 5 of (EC) Regulation 258/97 on noni juice (juice of the fruit of Morinda citrifolia L) comparable to the Morinda noni product approved for sale in the EU.
The Committee advised that the applicant had provided insufficient data for the assessment of this application and requested more detailed compositional analysis. Members requested a greater number of samples to allow a satisfactory data comparison and requested further information on the fermentation that takes place in the maturation process.
The Secretariat agreed to contact the applicant and request further information.
9(b). Noni Juice: ACNFP/66/8
At the 16 July 2003 and 4 February 2004 meetings Members had considered an application for an opinion on the equivalence of Noni juice (juice of the fruit of Morinda citrifolia L) grown in Hawaii under Article 5 of EC Regulation 258/97. Members had raised a number of concerns and requested further information from the applicant. The applicant had provided additional information to address the questions of the Committee and the Secretariat had drafted an initial opinion for Members' consideration.
The Committee concluded that the new compositional data provided by the applicant, taken together with the information provided in the original request, provided sufficient evidence of substantial equivalence and, subject to one minor change, they were content that the draft initial opinion accurately reflected Members' views.
The Secretariat informed the Committee that the opinion would be published on the Agency's website for a short period of public consultation before being finalised.
10. Glucosamine from Aspergillus niger: ACNFP/66/12
This request for an opinion on substantial equivalence was submitted to the UK Competent Authority and was discussed at the 25 March 2004 meeting. The applicant had provided additional information to address the questions raised by the Committee.
Prior to discussions on this application Professor Rowland declared a non-personal, non-specific interest and informed the Committee that his department carries out research on behalf of other companies owned by the applicant's parent company. The Chairman concluded that he should remain.
Members noted that the applicant had not satisfactorily answered the Committee's query regarding the SDS page gel and requested further information to address the potential presence of potentially allergenic peptides.
Members confirmed that the remaining information provided sufficient evidence to address the questions of the Committee and agreed that, subject to the resolution of the above query, the draft initial opinion was an accurate record of the Committee's discussions on this application.
The Secretariat agreed to seek clarification on the Committee's remaining query.
11. Items for information
11.1 EU update: ACNFP/66/9
This paper provided and update on EU issues that are relevant to the work of the Committee. These included an updates on current novel food applications, EC Regulations 1829/2003 (on GM food and feed) and 1830/2003 (on traceability and labelling), and European enlargement.
The paper also contained details of recent meetings of the European Food Safety Authority (EFSA) Scientific Panels.
11.2 Notification of two Noni juice products: ACNFP/66/10
This paper provided Members with information regarding two notifications circulated by the European Commission concerning the marketing of noni juice products.
11.3 Update on current novel food applications: ACNFP/66/11
This paper provided Members with information on the status of applications currently progressing through the novel food authorisation process.
12. Any other business
The Secretary informed the Committee that the ACNFP and SACN sub-group on approaches to the nutritional assessment of novel foods had held their first meeting on 25 March 2004. A further meeting was being arranged for July when the Group would discuss draft guidance.
13. Date of next meeting
The next meeting of the Committee was scheduled for Thursday 22 July 2004, in Aviation House.