Food Standards Agency
2nd floor Aviation House
London WC2B 6NH
Tel: +44 (0)20 7276 8596
Fax: +44 (0)20 7276 8513
Minutes of the meeting held on Thursday 25 March 2004 in Conference Room 5, Aviation House, 125 Kingsway, London.
Professor Mike Gasson
Professor Philip Dale
Miss Jill Brand
Professor Ruth Chadwick
Dr Hilary Close
Mr Neville Craddock
Professor Jim Dunwell
Dr John Fowler
Dr Peter Lund
Professor Alan Malcolm
Professor Ian Rowland
Professor John Warner (items 3 - 14)
Dr Anthony Williams
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
Dr Steven Hill (DEFRA) (items 1-7)
Dr Claire Pitcher (DEFRA) (items 1-7)
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 Professor Gary Foster, Dr Clive Meredith, from Dr Clair Baynton (FSA assessor) and from observers from FSA Scotland, Wales and Northern Ireland (Mrs Elspeth MacDonald, Mr Phil Morgan, and Mr Gerry McCurdy).
1.2 The Chairman welcomed Dr David Jefferies to the Secretariat.
1.3 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 sixty-fourth meeting
Members agreed that the minutes were a true record of the 64th meeting of the ACNFP held on Wednesday 4 February 2004.
3. Matters Arising
The Secretariat reported that the concerns of the Committee had been relayed to the applicant.
3.2 Maize 1507
The Committee was informed that the UK's formal response was sent to the Commission on 5 February 2004. The Secretariat noted that this application will be overtaken by the new GM food and feed regulation which comes into effect on 18 April 2004.
3.3 DHA-rich oil from Ulkenia sp.
The Committee was informed that the Secretariat had obtained further information on this product from the German Competent Authority (CA):
The Secretariat informed Members that they would write formally to the German CA reflecting the Committee's concerns about drawing conclusions from a basic analysis of nutrients in products from two different algal species, neither of which has a history of food use, and suggesting that substantial equivalence is not the appropriate route for authorisation of this product.
The Secretariat reported that Members' comments on the draft report had been incorporated and the report would be printed shortly.
4. Glucosamine from Aspergillus niger: ACNFP/65/1
Members were asked to consider an application for an opinion under Article 3(4) of EC Regulation 258/97, on the equivalence of Glucosamine hydrochloride (HCl) from Aspergillus niger and comparable existing Glucosamine HCl products derived from shellfish.
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. The Chairman concluded that he should remain.
Members considered that data submitted by the applicant to verify the absence of proteins sized 12 KDa and above was insufficient to prove the product was not potentially allergenic. The allergenicity experts noted that proteins smaller than 12KDa have been known to cause an allergic response in some individuals. Some allergenic proteins are resistant to digestion and would not necessarily be removed by acid hydrolysis. Members noted that shellfish Glucosamine HCl is produced by a similar process and is reported to be capable of causing an allergic response. Members therefore requested confirmation of the absence of proteins below 12KDa.
The Committee also noted that Ochratoxin A is a mycotoxin produced by a small proportion of A.niger strains. Members requested further information to confirm that Ochratoxin A is not found in Glucosamine HCl from A.niger. Members also considered that the product should be clearly labelled as a fungal source.
The Secretariat agreed to seek clarification from the applicant regarding the points raised.
5. Astaxanthin-rich extract from Haematococcus pluvialis: ACNFP/65/2
Members were asked to consider an application for an opinion under Article 3(4) of EC Regulation 258/97, on the equivalence of an Astaxanthin product called Zanthin® extracted from the algae Haematococcus pluvialis. The applicant was of the view that the extracted product should be considered substantially equivalent to H. pluvialis astaxanthin-rich algal meal currently on the market in the EU.
While the Committee acknowledged the nutritional benefits of consuming carotenoids they expressed concern regarding the possibility of over-consumption and requested clarification on the intended use and dosage. Members further noted that high level consumption of ß-carotene in supplements increased the risk of cancer for smokers, but it was not known whether other carotenoids such as lycopene might have a similar effect.
The Committee also drew attention to the absence of detail on the duration of the human study carried out by the applicant and suggested that the statement on BSE should be updated in light of recent BSE cases in the United States.
The Secretariat agreed to seek clarification from the applicant on these points and to circulate a draft initial opinion for Members' comments before the next meeting.
6. Two leaf extracts from lucerne: ACNFP/65/3
Members were asked to consider a negative opinion from the French Competent Authority on an application for authorisation of a protein, mineral and vitamin (PMV) complex and a protein ingredient obtained from lucerne leaves for use as a food supplement and food ingredient respectively.
The Committee endorsed the French initial opinion but noted that heating the PMV complex at 90°C would not exclude the possible presence of bacterial spores in this ingredient. Members also considered that the presence of coumestrol, a phytoestrogen found in lucerne, was of concern due to possible consumption by small children. The Committee further noted that the applicant had not supplied details regarding the control of the suggested daily intake of 2.5g.
Members also questioned whether the lucerne protein ingredient may be subject to the Food Additives Regulations by virtue of its intended use as an emulsifier. The Committee requested further details on the specification of this ingredient.
The Secretariat agreed to draft a formal letter to the Commission highlighting the additional points raised by the Committee.
7. Genetically modified oilseed rape events MS8, RF3 and MS8x RF3 hybrids: ACNFP/65/4
Members were asked to consider a favourable opinion (with limited scope) from the Belgian Competent Authority for genetically modified oilseed rape events Ms8, Rf3 and Ms8xRf3, for import, cultivation and processing under the deliberate release Directive 2001/18/EC. The Department for Environment, Food and Rural Affairs (DEFRA) requested the Committee's views on the molecular characterisation and human health aspects of the application.
The Committee was satisfied that the basic molecular information provided was satisfactory. However, on the basis of the data provided the Committee was unable to exclude the possibility of human health problems associated with these lines.
Members discussed the potential allergenicity of these lines and considered that searching only for DNA sequence similarities using BLAST N was inadequate to ensure that there were no significant homologies with known allergens. The Committee advised that information on protein sequence similarities such as BLAST X should be provided and that, if any homologies were identified from this process, cross-reactivity testing should take place.
The Committee requested Western blot data to indicate the level of the introduced proteins, whether as a result of expression or contamination. Should any of the introduced proteins be expressed in pollen, further reassurance would be necessary to show that they are degraded in honey as this does not always undergo heat treatment.
The Secretariat agreed to reflect these points in the Food Standards Agency's formal response to DEFRA.
8. Chia seed: ACNFP/65/5
This novel food application was submitted to the UK Competent Authority and was discussed at the July 2003 and February 2004 meetings of the Committee. The applicant had provided additional information to address the questions of the Committee and the Secretariat had drafted an initial opinion for Members' consideration.
Prior to discussions on this application Professor Rowland declared a personal and specific conflict of interest as he had provided advice to the applicant on this product and left the room for the duration of discussions on the item. Professor Warner also informed the Committee that he had some indirect involvement with the design and execution of certain studies. The Chairman concluded that he should remain.
Members were generally satisfied with the draft initial opinion but requested some changes to the wording of the labelling paragraph in the conclusion.
The Secretariat agreed to redraft the relevant paragraph and circulate the document for Members' comments before issuing the opinion for public consultation.
9. Noni juice: opinions on substantial equivalence from other Member States: ACNFP/65/6
Members were invited to consider opinions from other Member States on the substantial equivalence of five noni juice products to the noni juice that had been approved as a novel food ingredient in June 2003.
The Committee confirmed that they agreed with the conclusions of the other Member States with regard to the applications submitted by GSE Vertrieb; Svane Trading ApS; Botanical Products International/FM Brenner GmbH; and NCT Nord Trading. However, Members were of the view that the application for approval of a fermented noni juice product submitted by Paracelsus Haus did not appear to meet the necessary criteria. The Secretariat informed the Committee that the Austrian authorities were examining further information on fermented juices and would report back to the next meeting.
10. Substantial equivalence guidelines: ACNFP/65/7
Following the presentation of a draft guidance document at the 4 February 2004 meeting of the Committee the Secretariat presented a revised version for further discussion or agreement.
Members proposed that guidance should be provided on the number of samples that should be analysed in order to assure the Committee that the food or food ingredient being considered was substantially equivalent with respect to its compositional and nutritional value. The Committee further suggested that the guidelines should include a more detailed definition of the scope of the term composition.
The Committee also recommended that usage level should be examined with respect to the intended use of the novel food, and that applications should include details of factors such as harvesting and ripeness.
The Secretariat agreed to incorporate Members' comments and to circulate a revised draft before the next meeting.
11. Lycopene from Blakeslea trispora: ACNFP/65/8
This Novel Food application was submitted to the UK Competent Authority and was evaluated in November 2003. Following discussions at the meeting in February 2004 the secretariat drafted an initial opinion, which was published on the Agency's website for public comment in line with the Committee's openness procedure. The Secretariat confirmed that they had received two comments.
The Committee was asked to consider these comments and advise the Secretariat if they wished to review the text of the initial opinion.
Members agreed to forward comments to the Secretariat.
12. Items for information
12.1 EU update: ACNFP/65/9
This paper provided an update on EU issues that are relevant to the work of the Committee. These included progress with novel food applications and an update on the implementation of EC Regulations 1829/2003 (on GM food and feed) and 1830/2003 (on traceability and labelling).
The paper also contained minutes of recent meetings of the European Food Safety Authority (EFSA) Scientific Panel on Genetically Modified Organisms, together with their opinion on the deliberate release of a genetically modified line of oil seed rape, GT73.
13. Any other business
The Secretariat and Members confirmed that there was no further business.
15. Date of next meeting
The next meeting of the Committee was scheduled for Thursday 27 May 2004, in Aviation House.