Novel food notifications and opinions on substantial equivalence
Novel foods are normally placed on the market after submission of a novel food application and subsequent authorisation by the European Commission. Products, which fulfil the conditions of Article 3.4 of the Regulation on novel foods, i.e. are substantially equivalent to a product already on the market, can be placed on the market through a notification procedure. Equivalence can be based on generally recognised and available scientific evidence or on an opinion on substantial equivalence from a competent body.
In practice, it has been very difficult for the applicants to meet the requirement for generally recognised scientific evidence, which would prove substantial equivalence. In fact, the Commission has almost without exception required that an assessment of substantial equivalence by a competent body be attached to the notification.
The Commission maintains a list of novel food notifications.
Content of request for opinion
No exact guidelines have been drawn up on the content of the request for opinion on substantial equivalence. According to Article 4 of the Regulation on Novel Foods (EC) No 258/97, the equivalence of the product with existing foods or food ingredients in terms of composition, nutritional value, metabolism, intended use and level of undesirable substances contained therein must be taken into account when assessing its substantial equivalence.
The Commission recommendation on drafting a novel food application (97/618/EC) also covers the concept of substantial equivalence. The concept of substantial equivalence incorporates the principle that existing foods or ingredients used as foods or ingredients can be used as a basis for comparison when assessing the safety of novel foods or ingredients for human consumption.
The applicant must define the composition of the product analytically and document the comparison of equivalence in the request for opinion. The comparison between the product concerned and the product already on the market must be clearly presented. Otherwise the content of the request depends on the type of the food and the substantial equivalence in question.
In practice, in requests for opinion regarding noni juices for example, the conditions of growth, the origin of the raw material and the processes from harvesting to the final product must be described. The applicant must be able to show that an origin and processes that differ from those used in other noni products do not materially change the characteristics of the product concerning the characteristics listed in the Regulation on novel foods (composition, nutritional value, metabolism, intended use and level of undesirable substances contained therein) compared with products that have already been authorised for the market.
Applicants submitting requests for opinions regarding products fortified with plant sterols must be able to show that the sterol ingredient used is equivalent to products already on the market or those authorised for the market in terms of sterol and/or stanol composition, purity and any foreign substances. Both the sterol composition and other characteristics of the food to be fortified must also be equivalent to products already on the market or those authorised for the market.
The request for opinion should be drafted carefully. If the request for opinion or the comparison of substantial equivalence is deficient or does not contain all the required documents, the request cannot be reviewed.
Coordination authority in Finland is Food Safety Authority Evira
Requests for opinion regarding substantial equivalence can be submitted to a competent authority receiving novel food applications in any EU country. In Finland, the requests for opinion must be submitted to the Finnish Food Safety Authority Evira, which functions as the national coordination authority. Before an official request for opinion is submitted, the applicant should contact the Authority so that any obvious shortcomings in the material can be rectified. Evira does not assess the content of the requests for opinion; it forwards the material to the Novel Food Board in Finland for assessment.
The opinion on substantial equivalence is subject to a fee. By virtue of the Decree of the Ministry of Agriculture and Forestry on the fees chargeable by the Finnish Food Safety Authority (1161/2014) (in Finnish), Evira charges a fee of 1.020 € for the issuance of the opinion on substantial equivalence referred to in the Novel Food Regulation (EC) No 258/97. If the request for opinion is withdrawn or otherwise ceases to have effect before the procedure has been completed, Evira can charge a processing fee, which is half the amount that would otherwise have been charged. The Novel Food Board also charges a fee of 700 € for its opinion on substantial equivalence, as stipulated in the Decree of the Ministry of Agriculture and Forestry on the fees chargeable by the Ministry (868/2012) (in Finnish) (position June 2015).