Establishment of the status of novel food.

 

How do you know if a product is a novel food? A product is not considered a novel food if it has been used commercially for human consumption to a significant degree within the European Union prior to 15 May 1997, date on which the Regulation on novel foods was adopted. It is important to remember that the consumption of the food in another part of the world is not considered when establishing the significant degree of consumption for the food.

There are no complete lists of novel foods or authorised products. The food business operators are responsible for providing safe products which satisfy the applicable food law. With respect to novel foods, the food operator is also responsible for establishing, and if necessary, providing data to demonstrate the consumption history of the product prior to 1997. In the case of ingredients which are not widely known for their use as food, the operator shall verify that they are not considered as novel foods. If it is not possible to establish a history of consumption in food, the products shall be considered as novel foods and therefore would fall under the scope of the Regulation on novel foods.

The status of novel food is always established in cooperation with novel food experts from the EU on the basis of the knowledge and materials available at present. These interpretations at community level are registered in the public Novel Food Catalogue maintained by the European Commission.

To demonstrate the history of consumption, one source of information that may be used is the Novel Food Catalogue of the Commission. This catalogue consists of a list which contains the result of the information exchanged between Member States and the Commission to determine whether a product falls under the scope of the Novel Food Regulation. It is important to remember that the list is not exhaustive.

Other good sources of information, for establishing whether a product has, or does not have, a history of consumption in food and is therefore, or is not, a novel food, include:

  1. EuroFIR-Nettox plant list - NETTOX covers 334 major European food plants (and plant parts) including scientific names, vernacular names in 15 European languages. It was updated and published in 2007. This list is developed in relation to an EU Project. The plants appearing in the list may be considered as not novel food.
  2. Belfrit list: (English). The competent authorities of Belgium, France and Italy, as part of the BELFRIT Project (the initials of the three countries) have created, based on a review of the national lists in accordance with current scientific evidence, a common list of substances and preparations (& botanical) for use in food supplements. The list may still be updated with the introduction of plants, including plants which are in at least one of the countries but which have not yet been approved in the BELFRIT list. French list of plants permitted in food supplements. (Language: French).
  3. Belgian list of plants and plant parts; and list of substances and their novel food status. (Language: Dutch).
  4. German list of plants and plant parts. (Language: English). This list includes consumption in food data for different botanical species and their parts. It is useful for determining the history of consumption in food.
  5. Italian list of plants authorised for use in food supplements (Language: Italian)
  6. Austrian list of plants with history of consumption as food infusion (language: German)
  7. Commercial fungi in Spain.
  8. Authorised or rejected novel foods. These can only be used by the operators in receipt of the authorisations to place the product on the market, whether they have been received by the general procedure or by the simplified procedure. If another food operator wishes to place an authorised novel food on the market, they may be do so under the SIMPLIFIED OR SUBSTANTIAL EQUIVALENCE PROCEDURE.
    1. Novel foods authorised and rejected under the general procedure.
    2. Novel foods authorised by substantial equivalence (article 5 of Regulation (EC) 258/1997.
  9. List of applications for authorisation as novel food.
  10. Algae with a history of consumption in food (language: French).
  11. Other substances other than vitamins, minerals and plants
  1. Biological agents: bacteria, fungi, yeasts: Qualified Presumption of Safety (QPS) approach and work  

Other useful information for assessing plant safety includes the:

In April 2012, the EFSA published the Compendium of botanicals reported to contain toxic, addictive, psychotropic or other substances of concern. The purpose of the Compendium is to assist risk assessors responsible for the evaluation of specific food ingredients in food supplements, to more easily identify the compound (s) of concern on which to focus the assessment. The Scientific Committee of the EFSA considered the botanicals that appear on a negative list or subject to restricted use (for example, establishing a maximum list or admitting certain parts of the plant only) in at least one European Member State.

In addition, this document contains two other annexes, Annex A which lists botanicals for which not enough information on possible substances of concern could be found, or which the information present could not be verified. Annex B lists botanicals for which, although some data were available, the Scientific Committee could not identify substances of concern, or other reasons for the inclusion in the compendium. The EFSA Compendium has no legal or regulatory force pertaining to the legal classification of products or substances.