To obtain an authorisation to market a new food or food ingredient in accordance with Regulation (EC) No. 258/97, it is necessary to make an application and submit a file with the necessary information to demonstrate the product’s safety.

To request the evaluation of a new food from AECOSAN the following questions must be borne in mind:

What must be submitted? A file demonstrating that your product does not involve any risk to consumers, does not mislead consumers and does not differ from other foods and food ingredients they are intended to replace, such that their normal consumption involves disadvantages for consumers from the point of view of nutrition. It may be submitted in Spanish.

Where must it be submitted? In every European Union country, there is a body appointed to evaluate new foods. In Spain, this body is AECOSAN.

What must the file contain? The file must contain information about the applicant and the new food. Recommendation 97/618/EC established, in accordance with the product type, the aspects that must be addressed: specifications, effects of the production process, history of the organism used as the food source, intake/level of intended uses, data of prior human exposure to the new food or its source and nutritional, microbiological and toxicological information about the new food. It is important that no expenditure is carried out before there is a complete draft file.

Are there guidelines? The European Union has published Recommendation 97/618/EC relating to scientific aspects and the submitting of the necessary information to support the applications for the market launch of new foods and new ingredients.

What analytical data must be submitted? The data depend on the type of product, they may correspond to composition, undesirable substances (contaminants, residues, etc.), toxicological essays, allergenicity tests, etc.

How many analysis results must be submitted? The analysis results of at least three product batches must be submitted; however, more may be necessary depending on their characteristics. Batches must be representative of the product obtained in conditions that represent maximum variability. 

Which laboratories can carry out the required analyses? The analyses will preferentially be carried out by laboratories that are accredited in accordance with ISO/IEC standard 17025 to perform the specific analyses required for the new food. If in any case this is not possible, it must be ensured that the quality of results is adequate, for example, they must be obtained through validated methods and the laboratory has implemented a quality system. The analyses may be carried out in several laboratories. Toxicological essays must comply with good laboratory practices.

How much does the evaluation cost? In accordance with Law 17/2011 of 5 July on Food Safety and Nutrition, the evaluation by AECOSAN of files relating to foods and food ingredients not previously authorised in human food in the European Union is subject to a fee that must be paid when the file is submitted. However, before paying the fee, it is necessary for a valid file to have been prepared.

How long does the process take? The period for carrying out the evaluation once a valid request has been submitted is three months, but the clock stops every time clarifications or supplementary information is requested from the applicant.

What is obtained? AECOSAN will issue a report concluding, or not, that the new food complies with the acceptance criteria established by Regulation (EC) No. 258/97 on new foods and new food ingredients. The report is aimed at the applicant who submitted the file and the European Commission so that the processing provided for in this Regulation is followed.