Advisory Committee on Novel Foods and Processes

The Advisory Committee on Novel Foods and Processes (ACNFP) is responsible for assessing the safety of novel foods submitted for approval under the EC Novel Foods and Novel Food Ingredients Regulation (258/97). This regulation, which came into effect on 15 May 1997, defines a novel food as food which has not been used for human consumption to a significant degree within the Community and which falls under one of the following six categories.

(a) foods and food ingredients containing or consisting of genetically modified organisms (GMOs) within the meaning of Directive 90/220/EEC;

(b) foods and food ingredients produced from, but not containing, genetically modified organisms;

(c) foods and food ingredients with a new or intentionally modified primary molecular structure;

(d) foods and food ingredients consisting of or isolated from micro-organisms, fungi or algae;

(e) foods and food ingredients consisting of or isolated from plants and food ingredients isolated from animals, except for foods and food ingredients obtained by traditional propagating or breeding practices and having a history of safe food use;

(f) foods and food ingredients to which has been applied a production process not currently used, where that process gives rise to significant changes in the composition or structure of the foods or food ingredients which affect their nutritional value, metabolism or level of undesirable substances.

There is general agreement that ‘human consumption to a significant degree within the Community’ need not have taken place in each Member State. Consideration will need to be given to the quantities consumed and the length of time that the product has been available for consumption. In practice, foods which have been sold in one or more Member States before 15 May will not generally be covered by the Regulation. A number of products, including some GM food ingredients, have already been approved under other Community or national legislation and consumed extensively in the Community. A consequence of this is that food ingredients obtained from the herbicide tolerant GM soya beans and insect resistant maize that were approved for sale under the Deliberate Release Directive 90/220/EEC and which are now on sale in a variety of processed foods would not be regarded as novel foods, although a separate EC regulation 1139/98 requires the labelling of food ingredients containing GM material derived from soya or maize.

Regulation 258/97 does not apply to food additives, flavourings or extraction solvents since these are already covered by existing legislation. Although the Regulation does make it clear that these exemptions only apply if the products are subject to the same level of safety assessment as that required for novel foods.

Procedures

From 15 May, companies wishing to market a novel food in the EU have been required to submit an application to the competent authority in the Member State where they first intend to market their product. They are also required to send a copy of their application to the Commission. Following acceptance of the application, the competent authority is required to complete an initial safety assessment and forward it to the Commission, within 90 days. The Commission then copies it to other Member States for their comments, which have to be made within 60 days. If the initial assessment is favourable and no objections are raised by other Member States, then the product can be marketed. If objections are raised, or if the initial Member State considers that an additional assessment is required, the application will be referred to the EC Standing Committee for Foodstuffs for final agreement, consulting the EC Scientific Committee for Food as necessary. If no agreement is reached there, the matter will be referred to the Council of Ministers.

The Regulation acknowledges that for some novel food ingredients their composition, nutritional value, intended use and level of undesirable substances will be substantially equivalent to conventional food ingredients. For foods and food ingredients that fall into categories outlined in paragraph 6(b), (d) or (e) which are considered to be substantially equivalent to an existing food, companies have the option of notifying the Commission when they first market the product of the Regulation which are considered to be substantially equivalent to an existing food, companies have the option of notifying the Commission when they first market the product. If a company wishes to make use of the simplified procedures, it is required to notify the Commission when the product is first marketed. As part of the notification it needs to provide evidence that the product is substantially equivalent to a conventional food ingredient. This evidence can be based either on the opinion of one Member State’s competent authority or on generally available and recognised scientific evidence. The UK has stated that it will only give an opinion on substantial equivalence to support such a notification in the case of a novel food where an applicant can demonstrate that neither novel protein nor DNA is present in the food ingredient(s) concerned. Where DNA or protein is present in the final product, a full safety assessment will be required before approval for use will be given. The EC and all other member states have approved this approach.

Labelling Provisions

In 1979, Directive 79/112/EEC on the labelling of foodstuffs was introduced. This Directive, which contains extensive food labelling provisions is implemented in Great Britain by the Food Labelling Regulations 1996 made under the Food Safety Act 1990. During negotiations on the novel foods Regulation some Member States felt that more specific labelling provisions were required, particularly for genetically modified foods. The provisions in article 8 of the Regulation were deliberately drafted in such a way that the labelling of novel foods could be considered on a case by case basis. This article provides for special labelling of novel foods supplied to the final consumer in the following situations:

a) For foods and food ingredients obtained from GMOs when, on the basis of a scientific assessment, they are judged not to be equivalent to an existing food.

b) If a novel food contains material which is not present in an existing equivalent foodstuff and which may have implications for the health of some sections of the population. An example would be a protein from a known food allergen source such as peanuts.

c) If a novel food contains material which is not present in an existing equivalent foodstuff and which gives rise to ethical concerns.

d) All foods which contain or consist of GMOs within the meaning of Directive 90/220/EEC. However, in the case of commodity crops such as soya and maize it is recognised that segregation of genetically modified and conventional produce may not be practical. In such circumstances the Regulation recognises that providing information for the consumer identifying that GMOs may be present fulfils the labelling obligation.

An aspect of the labelling provisions in the novel food Regulation that was readily agreed related to the use of labelling to identify any specific safety issues such as allergenicity.

In 1992 the UK Minister of Agriculture, Fisheries and Food appointed a Committee under the chairmanship of the Reverend Dr J Polkinghorne "to consider future trends in the production of transgenic organisms; to consider moral and ethical concerns (other than those related to food safety) that may arise from the use of such organisms and to make recommendations." In its report (MAFF 1993), the Committee recommended that food should be labelled if it contained copies of ethically sensitive genes (human genes or genes of religious significance) or if a plant contained copies of an animal gene. These recommendations are also reflected in the Regulation.

Member States reached agreement in May 1998 on a European Council Regulation which sets detailed rules for the labelling of ingredients derived from GM soya and maize. This Regulation took effect from 1 September 1998 and specifies that any new packaging manufactured for a product which contains GM soya or maize will have to clearly show the words ‘genetically modified’. This Regulation sets a precedent for the labelling of all GM foods sold in the EU.

Safety Assessment of Novel Foods

The UK has had a system for assessing the safety of novel foods in place for many years. The first novel food, mycoprotein, was approved in 1983. The Advisory Committee on Novel Foods and Processes (ACNFP) developed a structured approach to the safety assessment of novel foods in 1991 (Department of Health 1991). This approach, which was subsequently refined in 1994 (ACNFP 1994), uses a series of linked questions to characterise the potential hazard of a novel food.

In toxicological studies it is essential that animals receive a balanced diet; this is very difficult to achieve if a large proportion of the diet is accounted for by one food component. To overcome this and other practical constraints, the ACNFP bases its safety assessment on the concept of substantial equivalence. This concept, which involves the comparison of a novel food with a conventional counterpart, has been developed by the WHO (WHO 1991) and OECD (OECD 1993) to focus the safety assessment on the differences between a novel food and its conventional equivalent.

The WHO concluded that ‘substantial equivalence is established by a demonstration that the characteristics assessed for the GMO, or the specific food product derived there from, are equivalent to the same characteristics of the conventional comparator. The levels and variation for characteristics in the GMO must be within the natural range of variation for those characteristics considered in the comparator and be based upon an appropriate analysis of data’ (FAO 1996).

The concept of substantial equivalence has been used extensively as a tool in assessing the safety of GM foods. In comparing a GM food with a conventional counterpart, consideration is given to both intentional and unintentional effects. A wide range of information is used in this comparison ranging from agronomic data such as crop height, yield, flowering pattern, disease resistance etc. through to compositional data on key nutrients and toxicants. In this context, key nutrients are those food components which may have a major impact on the total diet and include fats, proteins and carbohydrates as well as minerals and vitamins. The comparison can result in one of three conclusions:

1 The GMO or food product obtained from it is substantially equivalent to a conventional counterpart.

2. The GMO or food product obtained from it is substantially equivalent to a conventional counterpart except for a few clearly defined differences.

3. The GMO or food product obtained from it is not substantially equivalent to a conventional counterpart - either because the differences cannot be defined or because there is no existing counterpart to compare it with.

Where a food can be shown to be substantially equivalent, it is considered to be as safe as its counterpart and no further safety assessment is required. Where there are clearly defined differences between the GM food and its conventional counterpart, the safety implications of the differences need to be fully assessed. Where a food is not substantially equivalent, it does not mean that the food is unsafe. However, there would be a need for extensive data to be provided to demonstrate its safety.

Since the novel foods Regulation requires all Member States to consider the safety information provided by an applicant, it is essential that safety assessment procedures are common to all Member States. For this reason, the Commission asked its Scientific Committee for Food to prepare guidelines covering the information needed to support an application and the form in which it should be presented. In addition, the SCF produced guidelines on the way in which Member States should prepare an initial assessment report. These guidelines which were subsequently published by the Commission (Scientific Committee for Food 1997) are based on a decision tree approach that is very similar to the ACNFP’s 1994 guidelines.

When an application contains all the relevant information, the UK will assess the information provided. The food safety assessment will be carried out by the ACNFP who may in turn seek advice from the Food Advisory Committee, the Department of Health’s Committee on Toxicity or the Committee on Medical Aspects of Food Policy.

Where an application is for a food or food ingredient that contains or consists of a GMO, the application will also need to include the relevant information required by article 11 of Directive 90/220/EEC and the environmental risk assessment based on that information. For such applications, MAFF will seek the advice of the Department of the Environment who will in turn seek the advice of the Advisory Committee on Releases to the Environment within the same 90 day deadline.

For applications made through the UK, applicants will be encouraged to continue the practice of depositing the accompanying dossier in the British Library. The completed ACNFP assessments will continue to be published upon completion of the assessment.

Labelling

The UK Government firmly believes that consumers have a right to know if the products they buy contain genetically modified ingredients. If manufacturers are using ingredients that are different from conventional products they should say so. All foods should be labelled where they contain an ingredient which has been genetically modified, or where there is reason to believe that this may be the case, for example when GM and conventional ingredients have not been segregated. However, specific labelling will not be required where, for example, the ingredient has been obtained from a GM plant but does not itself contain modified genetic material and can therefore be considered to be equivalent to an ingredient obtained from a conventional source.

Enforcement

The EC Regulation is directly applicable and legally binding in all Member States. In the UK the novel foods Regulation 258/97 will be enforced by food authorities as defined in the Food Safety Act 1990 and the Food Safety (Northern Ireland) Order 1991. The Novel Foods and Novel Food Ingredient Regulations 1997 (SI 1997/1335), which came into effect on 16 June 1997, makes provisions for the enforcement and execution of the EC Regulation in Great Britain including offences and penalties. Similar regulations will be introduced in Northern Ireland.

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This page was last updated on 7 July 1999