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?
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 Flavourings (FAF) deals with food additives and nutrient sources added to food while the Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) is responsible for food enzymes and flavourings. If the opinion has been published, it is available via the ‘View’ link.
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 FAF Panel and of the CEP 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 European Commission’s Directorate-General for Health and Food Safety (DG SANTE). For food additives, food enzymes and flavourings, the DG SANTE Unit in charge is Unit E7 Food Improvement Agents. For nutrient sources (vitamins, minerals) added to food, the DG SANTE Unit in charge is E4 – Nutrition, food composition and information. EFSA’s topics in these areas also contain relevant background information.
3. Is there an official list of all authorised food ingredients?
Some lists already exist or are under development depending on the category of regulated food ingredient. 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. What is EFSA’s role with regard to processing aids in the European Union?
EFSA is required to carry out the safety evaluation of food enzymes used as certain processing aids. This work is done by the Panel on Food Contact Materials, Enzymes and Processing Aids (CEP).
Food enzymes used as processing aids are covered by Regulation EC 1332/2008. Member State(s) national provisions apply for the aspects not harmonised by the European Union.
More information can be found in Question 11.
5. 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 EU 234/2011. Applications should be submitted to the European Commission, which has provided 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 is set down in Regulation EC 1925/2006. The currently applicable administrative and scientific guidance documents for nutrient sources are the European Commission guidance on submissions for the safety evaluation of substances added for specific nutritional purposes in the manufacture of food (2006) and 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.
6. Can I group food enzymes under one application?
Yes. Food enzymes may be grouped under one application if the requirements laid down in Article 8(5) of Regulation EU 234/2011 as amended by Regulation EU 562/2012 are met, i.e. they have the same catalytic activity, are processed from the same source material (e.g. at species level) and with a substantially same production process, and have been obtained from:
edible parts of plants or animals intended to be or reasonably expected to be ingested by humans; or
micro-organisms having the status of Qualified Presumption of Safety; or
micro-organisms which have been used in the production of food enzymes that have been evaluated and authorised by the competent authorities in either France or Denmark in accordance with the Scientific Committee on Food guidelines of 1992.
To facilitate fulfilment of criterion (c), the Commission together with the competent authorities of France and Denmark, and the Association of food enzyme producers (AMFEP) have developed a table which lists all the food enzymes complying with that criterion:
Food enzymes EU legislation – European Commission (Table: Food enzymes falling under Article 8(5)(c) of Regulation EU 234/2011)
Grouping of food enzymes is not possible in case of genetically modified organisms or micro-organisms (see Article 8(6) of Regulation EU 234/2011).
7. 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 Panel on Food Additives and Flavourings, or by the Panel on Panel on Food Contact Materials, Enzymes and Processing Aids. The status in EFSA’s ROQ then changes to ‘In progress’.
8. How long does EFSA’s evaluation take?
EFSA’s scientific panels must endeavour to adopt an opinion within nine months (for food additives 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. The nine-month period for risk assessment will apply also for food enzymes once a Union list is established by the European Commission. Until the Union list is established, the time limit for performing the risk assessment for food enzymes is agreed jointly by the European Commission and EFSA. For nutrient sources added to food there is no legally binding time limit, which 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.
9. 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.
10. 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 authorisation of substances, products, claims, processes or organisms for their placing and use on the European Union market. EFSA’s scientific advice is available in the adopted scientific opinions of the Panel on Food Additives and Flavourings and the Panel on Panel on Food Contact Materials, Enzymes and Processing Aids. If you require further information on the authorisation of these materials as well as other administrative or authorisation-related issues, such as import requirements, information on specific brands or products on the market, labelling of foods and food ingredients, etc, please contact the European Commission (see Question 2).
11. Short cuts for applicants
- Application procedure for:
- Food additives, enzymes and flavourings:
- Smoke flavourings: Regulation EC 2065/2003 and Regulation EC 627/2006
- Nutrient sources:
- Food enzymes EU legislation – European Commission (Table : Food enzymes falling under Article 8(5)(c) of Regulation EU 234/2011)
- DG SANTE Food enzymes web section
- Directive 2009/32/EC on extraction solvents used in the production of foodstuffs and food ingredients
- EFSA’s topic on Food Enzymes
- Requirements for technical dossiers: EFSA’s scientific guidance documents
- Status, information and supporting documents about a request: Register of Questions (ROQ); ROQ Tutorial video
- FAF and CEP Panels Working Groups
- FAF and CEP Panels Plenary meetings
- Adopted scientific opinions of FAF and CEP Panels
- EFSA’s topics
- Standing Committee on the Food Chain and Animal Health
- Authorisation process for food ingredients
- Official Journal of the European Union
- Existing lists for food additives, nutrient sources, smoke flavourings and food enzymes
- Contact regarding authorisation: Unit E4 – Nutrition, food composition and information - Directorate-General for Health and Food Safety (DG SANTE)