Biological hazard applications: frequently asked questions

FAQ on animal by-products treatments applications

1. I have submitted an application for an alternative method of use or disposal of animal by-products or derived products 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 minutes of the specific Working Groups of the BIOHAZ Panel and in the agenda and minutes of the plenary meetings of the Panel.

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

If you have any questions related to the authorisation of alternative methods of use or disposal of animal by-products or derived products, please contact: Unit G2 – Animal Health, European Commission’s Directorate-General for Health and Food Safety (DG SANTE) , European Commission.

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

All standard and approved alternative processing methods of use or disposal of animal by-products are described in Regulation EU 142/2011 (Annex IV). Additional approvals are published in the Official Journal of the European Union in the form of amendments to Regulation EU 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 format for applications for alternative methods is provided in Regulation EU 142/2011 (Annex VII) 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 EU 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 alternative animal by-product processing methods 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 authorisations of substances, products, claims, processes or organisms for their placing or use on the European Union market. If you require further information on the authorisation of animal by-product processing methods, as well as other administrative or authorisation related issues, such as import requirements, information on specific brands or products on the market please contact: Unit G2 – Animal Health, European Commission’s Directorate-General for Health and Food Safety (DG SANTE) , European Commission. EFSA’s scientific advice is available in the adopted scientific opinions of the BIOHAZ Panel.

9. Short cuts for applicants

 

FAQ on decontamination substances applications

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 Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) in case of chemical substa In most cases, the BIOHAZ Panel evaluates the safety of biological substances while the CEF Panel assesses the safety of chemical substances. When the opinion has been published, it is available via the ‘View’ link. 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  CEF and BIOHAZ Panels and of the plenary meetings of the CEF and BIOHAZ Panels. 

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

If you have any questions related to the authorisation of  decontamination 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 Food Safety (DG SANTE) , European Commission.

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

No, there is no official list of authorised decontamination substances. Regulation EC 853/2004 provides the legal basis for the use of substances other than potable water for removing surface contamination of food of animal origin, and Regulation EU 101/2013 allows the use of lactic acid to reduce microbiological surface contamination on bovine carcasses. No other substances are currently authorised for this purpose within the EU. 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 guidance on the submission of data for the evaluation of the safety and efficacy of substances for the removal of microbial surface contamination of foods of animal origin intended for human consumption. Applications should be submitted to the European Commission’s Directorate General for Health and Food Safety (DG SANTE).

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 30 working days 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 the relevant working group on decontamination substances either of the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF). ), in case of chemical substances, or of the Panel of Biological Hazards (BIOHAZ), in case of biological substances. The status in EFSA’s ROQ then changes to ‘In Progress’.

6. How long does EFSA’s evaluation take?

The timeline for EFSA’s scientific panels to adopt an opinion is is negotiated with the European Commission, (typically a nine-month deadline) and starts whena dossier is considered complete (see ‘completeness check’, see Question 5). This  deadline can be extended whenever EFSA requests additional information from the applicant. FSA’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, scientific risk assessment (the responsibility of EFSA) is done independently from risk management, which includes authorisations of substances, products, claims, processes or organisms for their placing or use on the European Union market. EFSA’s scientific advice is available in the adopted scientific opinions of the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) and the Panel on Biological Hazards (BIOHAZ). If you require further information on the authorisation of decontamination substances as well as other administrative or authorisation related issues, such as import requirements, information on specific brands or products on the market, please contact the European Commission (see Question 2).

9. Short cuts for applicants