Regulated food ingredient applications

EFSA carries out the safety evaluation of regulated food ingredients (i.e. those which currently require market authorisation). These comprise chemical substances which are used as food additives, food enzymes, flavourings, smoke flavourings and sources of vitamins and minerals added to food (commonly called nutrient sources). This work includes (1) the evaluation of new substances and (2) the evaluation of new proposed uses for already authorised substances.

Frequently Asked Questions

  1. I have submitted a regulated food ingredient application for safety evaluation by EFSA. How can I check the status of my application?
  2. I am not sure if my substance requires authorisation. Who should I contact?
  3. Is there an official list of all authorised regulated food ingredients?
  4. I am a new applicant. How do I prepare an application?
  5. What happens to my application when EFSA has received it?
  6. How long does EFSA’s evaluation take?
  7. Do I need to pay?
  8. Does EFSA authorise regulated food ingredients?
  9. Short cuts for applicants

  1.  I have submitted a regulated food ingredient application for safety evaluation by EFSA. How can I check the status of my application?

    All applications received and accepted by EFSA are given an application number and assigned an EFSA Question number (e.g. EFSA-Q-2009-12345) in the Register of Questions (ROQ), which describes the status and progress of EFSA’s scientific work. To find an application in the ROQ, click on the ‘Question’ option in the top menu of the ROQ, then in the ‘Question type’ field select ‘Application’ and select the relevant ‘Food sector area’ (for regulated food ingredients you can select one of the following options: ‘Food additives’, ‘Food enzymes’, ‘Flavourings’, ‘Smoke flavourings’ and ‘Nutrient sources’). You can then search using key words or a Question number if you know it. After locating your application, the ‘Status’ column indicates the present stage of the safety evaluation. When a question is ‘Finished’, a scientific opinion has been adopted by the relevant scientific panel and scheduled for publication within a few days. The Panel on Food Additives and Other Nutrient Sources Added to Food (ANS) deals with food additives and nutrient sources added to food while the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) is responsible for food enzymes and flavourings. If the opinion has been published, it is available via the ‘View’ link. Further information: ROQ User Guide

    You can also monitor the progress of an application in the risk assessment phase (i.e. while EFSA is undertaking its evaluation) in the agendas and minutes of the Working Groups of the ANS Panel and of the CEF Panel as well as their Plenary meetings.

  2.  I am not sure if my substance requires authorisation. Who should I contact?

    An overview of the authorisation process for the various categories of regulated food ingredients can be found on the European Commission’s website. If you have any further questions about your substance and especially whether it requires an authorisation, please contact the Directorate-General for Health and Consumers (DG SANCO), European Commission. For food additives, food enzymes and flavourings, the DG SANCO Unit in charge is Unit E3 – Chemicals, Contaminants and Pesticides. For nutrient sources (vitamins, minerals) added to food, the DG SANCO Unit in charge is E4 – Food law, nutrition and labelling. EFSA’s topics in these areas also contain relevant background information.

  3.  Is there an official list of all authorised food ingredients?

    Depending on the category of regulated food ingredient, such lists already exist or are under development. In 2008, harmonised rules on food additives, food enzymes and flavourings were adopted that call for new EU lists of these substances. They are not yet finalised for food enzymes and flavourings. There are existing lists for food additives and nutrient sources, and in the case of smoke flavourings there is a list of valid applications only. Authorisations of new substances and new uses of regulated food ingredients are published in the Official Journal of the European Union.

  4.  I am a new applicant. How do I prepare an application?

    The application procedures and technical requirements for regulated food ingredient authorisations vary under different EU legislation. You can find specific information related to each regulated food ingredient application type as follows:

    Food additives, food enzymes and flavourings – the application procedure for food additives, food enzymes and flavourings is set down in Regulation EC 1331/2008. Further administrative and technical requirements for applications are explained in Regulation EC 234/2011. Applications should be submitted to the European Commission, which has provided a Practical guidance for applicants containing a check list and useful addresses, contact points and relevant documents. EFSA has published scientific guidance documents detailing the requirements for preparing the technical dossiers for applications.

    Smoke flavourings – the application procedure for smoke flavourings differs from other flavourings. The authorisation procedure and administrative steps are set down in Regulation EC 2065/2003. Specific quality criteria for the testing are described in Regulation EC 627/2006. Requirements regarding scientific data needs are specified by EFSA’s scientific guidance documents. Applications should be submitted to a national competent authority of a Member State. EFSA’s topic on smoke flavourings also contains relevant background information.

    Nutrient sources – the application procedure for nutrient sources added to food are set down in Regulation EC 1925/2006 and as amended, with requirements on scientific data needs specified by scientific guidance documents. The currently applicable scientific guidance for nutrient sources is the guidance on submission for safety evaluation of sources of nutrients adopted by the Scientific Committee on Food in 2001.

    For an overview see guidance documents for regulated food ingredients .

  5.  What happens to my application when EFSA has received it?

    Completeness check – during this check, the status of an application in EFSA’s Register of Questions (ROQ) is described as ‘Registration not yet completed’ or ‘Under Consideration’. The procedures for these checks vary for the different kinds of regulated food ingredients:

    • Food additives, food enzymes and flavourings – if the European Commission considers the application applicable and valid, it asks EFSA to verify the suitability of the data and may request a scientific opinion in accordance with Article 12 of Regulation EU 234/2011.

    • Smoke flavourings – an application received by a Member State is forwarded to EFSA within 14 days and EFSA then verifies that the particulars and documents submitted by the applicant are in accordance with Article 7(3) of Regulation EC 2065/2003.

    • Nutrient sources added to food – the European Commission confirms the administrative acceptance of the application before sending it to EFSA.

    Applicants should make every effort to include all information, data and full study reports as requested in the respective guidance documents when they first submit their application.For an overview see guidance documents for regulated food ingredients .

    Valid applications – If the application is considered applicable and valid, EFSA starts its scientific assessment. This is done either by its Panel on Food Additives and Other Nutrient Sources Added to Food, or by the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids. The status in EFSA’s ROQ then changes to ‘In progress’.

  6.  How long does EFSA’s evaluation take?

    EFSA’s scientific panels must endeavour to adopt an opinion within a nine-month period (for food additives, food enzymes and flavourings) and six months (for smoke flavourings) from the date on which EFSA sends confirmation to the European Commission that the information contained in the application is suitable for the risk assessment. There is no legally binding time limit for nutrient sources added to food, rather the time limit is agreed jointly by the European Commission and EFSA on a case-by-case basis. These time limits can be extended during the evaluation process if EFSA requests additional information from the applicant. EFSA’s work ends with the publication of a scientific opinion and the status of the application in EFSA’s Register of Questions is described as ‘Finished’. The European Commission is required to inform the applicant about the status of their application. The Standing Committee for the Food Chain and Animal Health decides whether or not to authorise a substance on the advice of the European Commission. In addition, for food additives, food enzymes and flavourings the European Parliament has the right of scrutiny on the proposed measure.

  7.  Do I need to pay?

    No. Currently, EFSA does not charge a fee for its scientific evaluations. However, this practice is under review by the EU decision-makers.

  8.  Does EFSA authorise regulated food ingredients?

    No. The authorisation of these substances is not within EFSA’s remit. In the European food safety system, scientific risk assessment (the responsibility of EFSA) is done independently from risk management, which includes market authorisation. EFSA’s scientific advice is available in the adopted scientific opinions of the Panel on Food Additives and Other Nutrient Sources Added to Food and the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids . If you require further information on the authorisation of these materials, please contact the European Commission (see Question 2, above).

  9.  Short cuts for applicants

Ask a question about applications

I have carefully checked both the administrative guidance and the technical guidance documents and I still have a question related to my application – what should I do?

 

See also

Food ingredients and packaging

Aspartame homepage

Food supplements homepage

Food Colours homepage

Food Additives homepage

Flavourings homepage

Smoke Flavourings homepage