The regulation of novel foods and novel food ingredients in the EU is driven by the degree of substantial equivalence of the novel food to those traditionally used in the European market. Recent examples of novel foods include Argan oil (Almond Kernel oil) and phytosterol esters (Flora pro.active). Here, Andrew Burgess and Stephen Ruckmanis review the factors influencing the equivalence of a food and describe the impact these can have.
We live in a society where people are increasingly conscious about their own health and well being. Consumer trends indicate a desire to move away from the synthetic world to a more anatural' way of life. Perhaps this is nowhere more evident than with foods. Consumers may believe that synthesised chemical materials pose a health hazard where any exposure, particularly ingestion, should be kept to a minimum. These same sentiments are held by parts of society towards food additives, whereas foodstuffs themselves are a different matter.
In Europe, food law is intended to ensure a high level of protection of public health and safety to the consumer and to ensure that legislation is primarily based upon scientific evidence and risk assessment. The prime responsibility for safety is with industry, producers and suppliers. Novel foods are regulated under Regulation (EC) 258/97 concerning novel foods and novel food ingredients. A novel food is defined as any food that had not been consumed to a significant degree within the European Community before 15th May 1997. Novel foods are assessed and broadly categorised as: p Substantially equivalent to a traditional reference food. p Sufficiently similar to a traditional reference food. p Seither substantially equivalent nor sufficiently similar to a traditional reference food.
The emphasis is on safety with the familiar, ie where foods we know and use are trusted and those we have not used before in Europe or are new as food are considered to be of concern until proven otherwise.
Degree of equivalence
An appraisal of how substantially equivalent a novel food is to a traditional food or food component involves an in-depth review of the novel food's specification, production process, history of organism usage and extent to which it will be present in the diet. These features are further reviewed below.
Specification: The analytically derived specification of the novel food is a key detail in assessing the degree and extent of similarity to traditional foods. It is important that all components of the food are identified and quantified taking into account potential variations in production processes. Where relevant, this includes microorganisms and their metabolites from which a novel food is derived. The importance of a reliable, robust and comprehensive analytical specification cannot be overstated. This is the foundation upon which the novel food application is made.
Effect of the production process: The technical description of the production process should be detailed enough to distinguish between novel and existing processes, and to predict any adverse effects in physical, chemical and/or biological changes that may have an impact on the essential nutritional, toxicological and microbiological parameters of the final foodstuff. The goal here is to encompass the whole range of food/process combinations without needing to investigate all possible combinations. This is accomplished is by identifying and focussing on the key changes and differences.
History of organism usage: It is advantageous to thoroughly investigate the degree of novelty of food organisms (and those organisms used in the production process). A critical factor will be whether other members of the same species have been consumed previously as part of the European food supply. Where previous European consumption has not occurred, one should consider whether the food has been consumed in other regions. In this situation, information about these uses could be of advantage. Factors such as how the food is handled and processed should be taken into account as this can influence the nutritional and toxicological properties of a food.
Anticipated intake: The proposed range of uses of a novel food will determine the quantity a person is likely to consume. The higher the anticipated intake the higher the level of concern this attracts. When an application leads to an increase in overall consumption of a novel food (for example by extending the approved uses of a novel food) the safety data needs to be carefully reviewed to ensure that there will not be any adverse effects.
Factors effected by equivalence
If substantial equivalence cannot be established, appropriate preliminary assessments should be conducted into nutritional impact, microbiological safety and safety information.
Nutritional information: It is important to carefully consider the nutritional impact of a novel food by taking into account the maximum consumption level and changes that could be imparted through processing, storage and cooking. Initial investigations to assess nutritional quality (combined toxicological/ awholesomeness' approach) are carried out using animal models, with more complete assessments being conducted using human subjects. The studies conducted should be of a magnitude such that there is sufficient statistical power to detect any adverse effects.
Microbiological safety: In general the source organism of a novel food should be genetically stable, non-pathogenic and should not have an adverse effect on the function of intestinal flora. The analytical food specification generated will have identified and quantified the presence of microorganisms and their metabolites.
Safety information: Where substantial equivalence to a traditional counterpart cannot be established, the safety assessment should be developed on a case-by-case basis. Where the difference to traditional foods comes from identifiable components it is possible to focus the safety testing on those components. The toxicity studies required follow a tiered approach that is influenced by factors such as the extent to which the food is expected to be present in the diet, possible toxicity and allergenic potential of each component of the food and the results of studies already available.
Summary
In Europe, the key function of the regulation of foods is to ensure a high level of protection of public health and to ensure consumer safety. The regulation of novel foods meets this through determining the degree of similarity of a novel food to traditional foods (ie those that are themselves considered safe). The factors that determine similarity include the novel food's specification, production process, history of organism usage and extent to which it will be present in the diet. Where substantial equivalence cannot be established, consideration and potentially further investigations are required into the novel food's nutritional and potential toxicological impact, microbiological safety and safety testing.
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Andrew Burgess is Regulatory Affairs Manager and Stephen Ruckmanis Programme Director with Huntingdon Life Sciences, Huntingdon, Cambridgeshire, UK. www.huntingdon.com
