Decontamination substance applications

In the European Union all substances other than potable water used for the removal of microbial surface contamination of foods of animal origin require prior authorisation. EFSA carries out the safety and efficacy evaluation of these ‘decontamination substances’.

Frequently Asked Questions

  1. I have submitted an application for the safety evaluation of a decontamination substance by EFSA. How can I check the status of my application?
  2. I am not sure if a decontamination substance requires approval. Who should I contact?
  3. Is there an official list of all authorised decontamination substances?
  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 decontamination substances for food of animal origin?
  9. Short cuts for applicants

  1.  I have submitted an application for the safety evaluation of a decontamination substance by EFSA. How can I check the status of my application?

    All applications received 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, 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’ (in this case ‘Food hygiene’). 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 evaluation. When a question is ‘Finished’, an opinion has been adopted by the Panel on Biological Hazards (BIOHAZ) or jointly with the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF). In most cases, the BIOHAZ Panel evaluates the safety of biological substances while the CEF Panel assesses the safety of chemical substances. If the opinion has been published, it is available via the ‘View’ link. Further information: ROQ User Guide.

    While EFSA is undertaking its evaluation, you can further monitor the progress of an application in the agendas and minutes of the specific Working Groups of the BIOHAZ and CEF Panels and of the plenary meetings of the BIOHAZ and CEF Panels.

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

    If you have any questions related to the authorisation of chemical substances used for the removal of microbial surface contamination of foods of animal origin, please contact: Unit G4 – Food, Alert System and Training, Directorate-General for Health and Consumers (DG SANCO), European Commission.

  3.  Is there an official list of all authorised decontamination substances?

    No, there is no official list of authorised decontamination substances. While Regulation EC 853/2004 opens the door for the use of substances other than potable water for removing surface contamination of food of animal origin, at the EU level, no substances other than potable water are currently authorised for this purpose. Some Member States allow alternatives to water for nationally-traded foods only and are required to notify the European Commission about the substances and their uses. If you would like to know more, please contact the European Commission (see Question 2, above).

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

    The legal basis for decontamination substance applications falls under Articles 3 and 12 of Regulation EC 853/2004 on hygiene rules for food of animal origin. All the administrative, technical and scientific requirements for correctly compiling an application are provided in EFSA’s scientific guidance document. Applications should be submitted to the European Commission’s Directorate General for Health and Consumers.

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

    Completeness check – Following receipt of an application, an acknowledgement letter is sent to the applicant and EFSA performs a check to verify its completeness. Within six weeks of receiving the application forwarded by the European Commission, EFSA verifies that the application including the technical dossier submitted by the applicant complies with Regulation EC 853/2004 and the relevant EFSA’s guidance for applicants. During this completeness check, the status of an application in EFSA’s Register of Questions (ROQ) is described as ‘Registration not yet completed’ or ‘Under consideration’.

    Incomplete applications – 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. If some information is missing or incomplete, the applicant is asked to provide the missing information and the status bar in the ROQ reads ‘Waiting for full dossier’ or ‘Additional data request’.

    Valid applications – If the application is complete, it is considered valid and EFSA can start its scientific assessment, which is done by either its Panel on Biological Hazards or its Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids or both. 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 six-month deadline from receiving the mandate from the European Commission and a complete dossier (see ‘completeness check’, see Question 5, above). This time limit can be extended whenever 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 decision whether or not to authorise a decontamination substance is taken by the European Commission on the advice of its Standing Committee for the Food Chain and Animal Health.

  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 decontamination substances for food of animal origin ?

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

  9.  Short cuts for applicants

Ask a question about applications

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

 

See also

Food ingredients and packaging

Animal health and welfare

Biological hazards