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?
3. Where can I find all the approved animal by-product processing methods?
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?
7. Do I need to pay?
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
- Application procedure for animal by-product treatments: Regulation EC 1069/2009
- Standard format for applications for alternative methods form: Regulation EU 142/2011 (and as amended)
- Requirements for technical dossiers: technical and scientific guidance
- Format for applications for new alternative methods for animal by-products: EFSA Statement
- Status, information and supporting documents about a request:Register of Questions (ROQ); ROQ Tutorial video
- Biological hazards Working groups
- BIOHAZ Plenary meetings
- Adopted scientific opinions of the BIOHAZ Panel
- EU rules on animal by-products
- Official Journal of the European Union
- Standing Committee for the Food Chain and Animal Health
- Contact regarding authorisation: Unit G2 – Animal Health - Directorate-General for Health and Food Safety (DG SANTE)
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 (CEP) in case of chemical substance. In most cases, the BIOHAZ Panel evaluates the safety of biological substances while the CEP 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 CEP and BIOHAZ Panels and of the plenary meetings of the CEP and BIOHAZ Panels.
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?
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 ‘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 and Processing Aids (CEP), 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 negotiated with the European Commission, typically a nine-month deadline and starts when a dossier is considered complete (see ‘completeness check’, Question 5). This deadline can be extended when 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?
8. Does EFSA authorise decontamination substances for food of animal origin?
9. Short cuts for applicants
- 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 and Regulation EU 101/2013 on the use of lactic acid to reduce microbiological surface contamination on bovine carcasses
- Application procedure for decontaminants for food of animal origin: EFSA’s scientific guidance document
- Contact regarding authorisation: European Commission’s Directorate-General for Health and Food Safety
- Status, information and supporting documents about a request: Register of Questions (ROQ); ROQ Tutorial video
- Biological hazards Working groups
- BIOHAZ Plenary meetings
- Food Contact Materials, Enzymes and Processing Aids Working groups
- CEP Plenary meetings
- Contact regarding authorisation: European Commission’s Directorate-General for Health and Food Safety
