Procedures for authorisation to place a novel food on the market.
UNTIL 1 JANUARY 2018
Once the condition of novel food has been confirmed, these products must undergo a risk assessment prior to the authorisation to place them on the market applicable throughout the EU.
Regulation (EC) 258/1997 establishes two authorisation procedures for novel foods:
How and where is an application for authorisation presented?
The application for authorisation of a novel food is made before the EU Member State in which the novel food is to be placed on the market for the first time. In Spain the application would be submitted to the AECOSAN.
The application shall contain:
- the necessary information, including a copy of the studies made and any other element to demonstrate that the food or food ingredient satisfies the criteria of not:
- presenting a danger for the consumer;
- misleading the consumer;
- differing from foods or food ingredients which they are intended to replace to such an extent that their normal consumption would be nutritionally disadvantageous for the consumer.
- and the corresponding proposal for presentation and labelling of the food or food ingredient to provide additional information to the end consumer about the description of the food, its origin, composition, conditions of use, in order to ensure that consumers are suitably informed of the nature and safety of the novel food, especially in regard to vulnerable population groups.
- a summary of the dossier.
To assist applicants on how to present this dossier confirming the safety of their product, the European Commission published Commission Recommendation 97/618/EC concerning the scientific information and the safety assessment report which must be presented by the applicant.
Once the application has been accepted, the assessing Member State has 90 days to issue an initial opinion. This opinion is then circulated to all EU Member States and to the Commission, who have a further 60 days to comment or make a reasoned objection. If there are no objections, the novel food will be authorised (or rejected) at the end of the 60 days, in line with the initial opinion. Otherwise a decision on the authorisation will be taken by a vote among Member States at the Standing Committee on the Food Chain and Animal Health. If necessary, the European Food Safety Authority (EFSA) will first be asked for its opinion on any outstanding safety questions.
Decisions to authorise novel foods are directed to one recipient, the applicant for authorisation to place the novel food on the market providing the documentation and studies to support the safety of the product.
This link offers further information on the Assessment of novel foods submitted in Spain for assessment in line with the GENERAL PROCEDURE laid out in Regulation (EC) No 258/97.
The simplified procedure applies exclusively to:
- foods and food ingredients consisting of or isolated from microorganisms, fungi or algae; and
- 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.
The application should show how the food in question is “substantially equivalent” to existing foods or food ingredients as regards its:
- composition,
- nutritional value,
- metabolism,
- intended use and
- level of undesirable substances.
Broadly speaking, there are three types of application for equivalence:
- application in which the existing product is an authorised novel food or,
- application with respect to a product which is very similar to an authorised novel food or,
- application with respect to a product that is considered equivalent to an existing product with a history of consumption in food prior to May 1997.
In this case, the assessment is made by the Competent National Authority (CNA) of the EU Member State before which the substantial equivalence application is presented and once a report from the CNA has been received confirming that the substantial equivalence has been demonstrated, the applicant sends the opinion to the Commission who will have 60 days to forward it to the remaining Member States. The product may be placed on the market from the date of the receipt of the favourable report from the CNA.
Member States have prepared a guidance document to assist food operators on how to present an application for substantial equivalence:
For further information on the types of assessment carried out by the AECOSAN as regards Novel Foods, please see Novel Food Assessment.