Animal by-product treatment applications

In the European Union (EU) some by-products not intended for human consumption may be used for the production of technical or industrial products. Under EU law EFSA provides scientific advice on the safety evaluation of these animal by-product treatments, which are legally known as “alternative methods of use or disposal of animal by-products or their derived products”.

Frequently Asked Questions

  1. I have submitted an application for an animal by-product treatment for evaluation by EFSA. How can I check the status of my application?
  2. I am not sure if my treatment requires approval. Who should I contact?
  3. Where can I find all the approved animal by-product treatments?
  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 animal by-product treatments?
  9. Short cuts for applicants

  1.  I have submitted an application for an animal by-product treatment for evaluation 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’ (i.e. Animal by-products’). 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 EFSA’s Panel on Biological Hazards (BIOHAZ) and is scheduled for publication within a few days. If the opinion is 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 Panel and of the plenary meetings of the Panel.

  2.  I am not sure if my animal by-product treatment requires approval. Who should I contact?

    If you have any questions related to the approval of alternative methods of use or disposal of animal by-products, please contact: Unit G2 – Animal Health, Directorate-General for Health and Consumers (DG SANCO), European Commission.

  3.  Where can I find all the approved animal by-product treatments?

    All approved alternative methods of use or disposal of animal by-products are described in Regulation EC 142/2011. Additional approvals are published in the Official Journal of the European Union in the form of amendments to Regulation EC 142/2011.

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

    The application procedure, including the detailed requirements for the technical dossier, is described under Article 20 of Regulation EC 1069/2009. The standard form for applications is provided in Regulation EC 142/2011 and its subsequent amendments. EFSA also published a statement on the format for applications for new alternative methods for animal by-products. Applications should be submitted to the national competent authority of a Member State. EFSA carries out the risk assessment whilst the European Commission decides whether or not to authorise the alternative method.

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

    Completeness check – Following receipt of an application dossier, 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 a Member State, EFSA verifies that the application dossier submitted by the applicant complies with Regulation EC 1069/2009 and Regulation EC 142/2011. 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’.

    Valid applications – If the application is complete, it is considered valid and EFSA can start its scientific assessment, which is done by its Panel on Biological Hazards. The status in EFSA’s ROQ then changes to ‘In progress’.

  6.  How long does EFSA’s evaluation take?

    Under Article 20 of Regulation EC 1069/2009, EFSA must endeavour to adopt an opinion within a six-month deadline following receipt of a complete dossier (i.e. it is verified as complete). This time limit 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 of the proposed measures within three months of receiving EFSA’s opinion. The decision whether or not to authorise an alternative method of use or disposal of animal by-products is taken by the European Commission on the advice of the 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 animal by-product treatments?

    No. The authorisation of alternative methods 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 authorisations. If you require further information on the authorisation of animal by-product treatments, please contact: Unit G2 – Animal Health, Directorate-General for Health and Consumers (DG SANCO), European Commission. EFSA’s scientific advice is available in the adopted scientific opinions of the BIOHAZ Panel .

  9.  Short cuts for applicants

Ask a question about applications

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

See also

Biological hazards