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
Guidelines on the conduct of taste trials involving novel foods or foods produced by novel processes
The Advisory Committee on Novel Foods and Processes (ACNFP) is an independent Committee of experts that advises the central authorities responsible, in England, Scotland, Wales and Northern Ireland respectively on any matters relating to novel foods and novel food processes, having regard to the views of relevant expert bodies where appropriate.
2. The EC Novel Foods Regulation (EC 258/97) defines a 'novel' food as a food or food ingredient which has not previously been used for human consumption to a significant degree within the European Community. Amongst the foods covered by this definition are low calorie fat replacers, GM foods and an increasing range of dietary products such as some functional foods. All foods that are deemed novel are required to undergo a rigorous pre-market safety assessment. Pre-market acceptability trials as described by these guidelines are not generally regarded as ‘placing on the market’ within the context of the EC Novel Food Regulation 258/97.
3. In 1991, the ACNFP issued Guidelines (1) on the assessment of novel foods and processes, to assist those wishing to develop and/or market such foods in the UK. Included in those Guidelines is a brief section on human studies, such as taste trials and marketing and acceptability trials.
4. In 1992, the ACNFP published general guidance relating to ethical, as well as safety, criteria for the conduct of taste trials on novel foods or foods produced by novel processes (2).
5. The ACNFP guidelines on the assessment of novel foods and processes (1) were superseded by the EC Novel Foods Regulation (3) which came into force in May 1997 with accompanying guidelines on the provision of information, including that relating to previous human exposure to the novel food or its source (4). Additional guidelines on novel foods and novel food ingredients legislation were produced by the Ministry of Agriculture, Fisheries and Food/Department of Health (5). However, none of these address the issues of taste trials or human studies per se and, therefore, the need for such guidance remains.
6. The Committee is preparing guidelines on the use of human studies in the pre-market safety assessment of novel foods (6). These focus on the circumstances in which such studies might be appropriate and the issues that need to be considered when conducting human studies on novel foods. In view of these, and given that the existing guidelines on taste trials (2) were produced some time prior to the Novel Foods Regulation, it was considered prudent to reconsider and update them at this time.
7. The Committee wishes to stress that these guidelines relate solely to taste trials, and not to exercises related to preliminary marketing/monitored sales, nor to studies designed to assess safety (which are addressed elsewhere (6)). The guidelines are intended for use by those developing novel foods.
General Guidance
8. The ACNFP is of the opinion that, in general, there is no need for protocols for taste trials to be referred to it for consideration provided that certain conditions are met:
(i) Those carrying out the trial are satisfied, after taking suitable professional advice, that it poses no hazard to human health;
(ii) The protocol for the taste trial had been referred to, and cleared by, an independent Ethics Committee (see paragraph10);
(iii) Appropriate records are kept (see paragraph 13);
(iv) If the trial could involve the release of genetically modified organisms into the environment, the appropriate notification and clearance procedures are followed (see paragraph 14).
Assessment of Risk to Human Health
9. In considering whether to proceed with a taste trial, it is necessary to carry out a risk assessment, taking into account the likely levels of intake from a taste trial and the extent of information on the safety of the product. Where there is limited information on the safety of the product, taste trials should not proceed. It is recommended that individuals with known food allergy or intolerances or individuals with gastrointestinal disorders should be excluded from taste trials.
Local Ethics Committees
10. Irrespective of the guidance obtained from this document, any relevant legal requirements relating to the performance of studies on human subjects should be adhered to. Detailed guidance on the legal and ethical considerations of studies in human subjects is available elsewhere (7, 8, 9, 10, 11, 12). One of the prime requirements relates to the need for all research involving healthy volunteers to be approved by an independent Ethics Committee. Such Committees exist within major industrial companies or, alternatively, organisations can refer their research to the local or regional Ethics Committees that already exist at many Universities and Medical Schools for assessment. However, it is recognised that these Ethics Committees produce their own guidance on what products should and should not be referred to them for consideration and such guidance must be borne in mind in any such referral. The UK Government has produced guidelines advising on the structure and function of local research ethics committees (13, 14).
11. Ethics Committees should be able to draw on sufficient technical competence and informed judgment to be able to assess the consequences of participation in the trial, in the context of the welfare of the subject and the objectives of the investigation. However, the Committees also need to accommodate respected lay opinion so as to provide effective representation of community, as well as scientific interests.
12. Other important issues include the method of recruitment of volunteers and the need for full informed written consent. A copy of the explanatory information to be given to volunteers should be submitted to the ethics committee, which should be satisfied that the information is adequate and in a form that would be understood readily by the volunteers. The information supplied to volunteers must include details of any known adverse reactions to the novel food/ingredient. The company conducting the taste trials should also send a letter to the GP’s of the volunteers providing the details of the study.
Records
13. Records should be kept on the conduct of, and results from, taste trials and should include the names and particulars of the individuals involved, including their health status, and also details of the novel food involved in the trial. These records should be retained for 30 years. Any adverse effects reported by the volunteers should be recorded and followed up for a suitable period, with medical investigation if necessary. Classification and reporting of adverse effects is dealt with in a report on Adverse Reactions to Food and Food Ingredients published by the Committee on Toxicity (COT) (15).
Release to the Environment
14. (I) If the production of the novel food has taken place in the UK and involves the contained use of a live genetically modified organism , then the centre will have been notified to the Health and Safety Executive (HSE) under The Genetically Modified Organisms (Contained Use) Regulations 2000.
(ii) If the novel food contains live genetically modified organisms (GMOs) then, under The Genetically Modified Organisms (Contained Use) Regulations 2000, any contained use, including taste trials, must be undertaken in premises that have been notified to HSE. Individual activities such as taste trials will only need to be notified to HSE if, for GM plants and animals, the GMO is more harmful to humans than the non-modified organism. For GM micro-organisms (GMM), the individual activity only requires notification if the GMM is likely to cause adverse effects on humans or the environment. Consequently, it is highly unlikely that individual taste trials would require notification, although the requirement for the premises to be notified must be complied with.
(iii) The Genetically Modified Organisms (Deliberate Release) Regulations 1992 as amended in 1996 and 1997, together with Part VI of the Environmental Protection Act 1990, implement EC Directive on the Deliberate Release into the Environment of Genetically Modified Organisms (90/220/EEC) . They require specific consent for release from the Secretary of State for the Environment in England (or the devolved authorities in Scotland and Wales). Taste trials involving the release of genetically modified organisms, including via waste, will require such consent.
(iv) The contact point for contained use of genetically modified organisms is:
Health and Safety Executive (HSE)
Health Directorate
Room 6.19 Rose Court
2 Southwark Bridge
London SE1 9HS
The contact point for releases of genetically modified organisms to the environment is:
Joint Regulatory Authority
Department of the Environment, Food and Rural
Affairs (DEFRA)
GM Policy and Regulatory Unit
Room 3/G9 Ashdown House
123 Victoria Street
London SW1E 6DE
Other Points
15. The Committee has indicated that where the above conditions are met there is no need, on a routine basis, for protocols for taste trials to be referred to it consideration. However, the Committee is willing to give advice in individual instances, particularly those involving difficult or complex issues.
16. Those seeking further information, or wishing to obtain advice from the Committee should, in the first instance, contact Mrs Sue Hattersley at:
Food Standards Agency
Room 526B
Aviation House
London
WC2B 6NH
References
1. Department of Health “Guidelines on the Assessment of Novel Foods and Processes”. Report on Health and Social Subjects No. 38. HMSO, London, 1991.
2. Advisory Committee on Novel Foods and Processes. "Guidelines on the Conduct of Taste Trials Involving Novel Foods or Foods Produced by Novel Processes". Issued 1992.
3. Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients. Official Journal of the European Communities No L 43/1, 14 February 1997.
4. Commission of the European Communities. "Commission Recommendation of 29 July 1997 concerning the scientific aspects and the presentation of information necessary to support applications for the placing on the market of novel foods and novel food ingredients and the preparation of initial assessment reports under Regulation (EC) No. 258/97 of the European Parliament and of the Council. C(97) 2634 final. Official Journal of the European Communities Vol. 40 L253/1- 46, 16 September 1997.
(Also available on: www.europa.eu.int/eur-lex/en/lif/dat/1997/en-397XO618.html).
5. Ministry of Agriculture, Fisheries and Food/Department of Health. Guidance Notes - Novel Foods and Novel Food Ingredients Legislation. Ministry of Agriculture, Fisheries and Food, June 1999.
6. Advisory Committee on Novel Foods and Processes. Consideration of the Use of Human Studies in the Pre-Market Safety Assessment of Novel Foods. Food Standards Agency, 2000 (currently under consultation).
7. World Medical Association. "Recommendations Guiding Physicians in Biomedical Research Involving Human Subjects". Helsinki, 1964 (as amended).
8. DHSS “Guidelines for the Testing of Chemicals for Toxicity”. Report on Health and Social Subjects, No. 27. HMSO, London, 1982.
9. Forster, H. P., Emanuel, E., & Grady, C. (2001) “The 2000 revision of the Declaration of Helsinki: a step forward or more confusion?” The Lancet 358.
10. Royal College of Physicians. “Research of Healthy Volunteers”. Journal of the Royal College of Physicians. Vol 20, No 4 p243-257, October 1986.
11. Royal College of Physicians “Guidelines on the Practice of Ethics Committees in Medical Research involving Human Subjects.” Third Edition. The Royal College of Physicians of London, August 1996.
12. The Association of the British Pharmaceutical Industry. “Guidelines for Ethical Approval of Human Pharmacology Studies Carried out by Pharmaceutical Companies”, 7 November 1990.
13. Department of Health (DH, 1991b). Circular on local research ethics committees. London: Department of Health, 1991.
14. Research Governance Framework for Health and Social Care, http://www.doh.gov.uk/research/rd3/nhsrandd/researchgovernance/govhome.htm
15. Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) Report on Adverse Reactions to Food and Food Ingredients (2000). Available from the COT Secretariat on request.