The EU Library gathers guidance documents related to food safety and produced by EU national competent organisations and risk assessors.
The EU Library includes entries collected by members of EFSA’s Advisory Forum with the support of the national Focal Points. It will be updated at least annually to ensure the inclusion of any new guidance and updates of existing ones.
Showing 59 documents
Original title:Valutazione del benessere animale nell'allevamento del coniglio - Manuale per l'autocontrollo
Food Domain: Animal Health
Abstract/Summary:ClassyFarm is an IT platform of the Italian Ministry of Health, developed by the Istituto Zooprofilattico Sperimentale della Lombardia e dell'Emilia Romagna "Bruno Ubertini" (IZSLER), with the aim to categorise livestock farms based on their risk in animal welfare, biosecurity, and antimicrobial use.
Within this platform, several data are inserted: in relation to Animal Welfare in rabbits, a guidance and a checklist have been developed for on-farm risk assessment to be run by a farm veterinarian (private practitioner). To guarantee a uniform collection of management-based, resource-based, and animal-based indicators, this guidance has been developed.
The indicators are based on current European and Italian animal welfare legislation and international scientific references, such as the Welfare Quality protocol (2009) and several EFSA Opinions and Guidelines. For each indicator (question), three possible answers have been identified according to three levels of risk:
- Level 1 - High risk: unacceptable or non-compliant condition; some animals may be in stressful situations and exposed to hazards.
- Level 2 - Controlled Risk: compliant condition, where animals benefit at least from the five animal welfare freedoms.
- Level 3 - Low risk: optimal condition, above minimum law requirements, which allows animals to have rewarding positive experiences.
Once the farm veterinarian submits aswers to the Classyfarm Platfor, the system provides scores for non-animal-based and animal-based indicators, breaking them down into three assessment areas (on a 0-100% scale scoring system):
- Area A: Farm management and staff training
- Area B: Facilities and equipment
- Area C: Animal-based measures
- along with a final total score for overall Animal Welfare (0-100%).
For more info: https://www.classyfarm.it/index.php/en/what-en
Original title:Valutazione del benessere animale e della biosicurezza dell'allevamento della bovina da latte: manuale di autocontrollo-ClassyFarm
Food Domain: Animal Health; Animal Welfare; Biological Hazards
Abstract/Summary:"ClassyFarm is an IT platform of the Italian Ministry of Health, developed by the Istituto Zooprofilattico Sperimentale della Lombardia e dell'Emilia Romagna ""Bruno Ubertini"" (IZSLER), with the aim to categorise livestock farms based on their risk in animal welfare, biosecurity, and antimicrobial use. Within this platform, several data are inserted: in relation to Animal Welfare and Biosecurity in dairy cows, a guidance and two checklists (for both loose-housed and tie-stalls housing systems) have been developed for on-farm risk assessment to be run by a farm veterinarian (private practitioner). To guarantee a uniform collection of management-based, resource-based, and animal-based indicators, this guidance has been developed.
The indicators are based on current European and Italian animal welfare legislation and international scientific references, such as the Welfare Quality protocol (2009) and several EFSA Opinions and Guidelines. For each indicator (question), three possible answers have been identified according to three levels of risk:
- Level 1 - High risk: unacceptable or non-compliant condition; some animals may be in stressful situations and exposed to hazards.
- Level 2 - Controlled Risk: compliant condition, where animals benefit at least from the five animal welfare freedoms.
- Level 3 - Low risk: optimal condition, above minimum law requirements, which allows animals to have rewarding positive experiences.
Once the farm veterinarian submits aswers to the Classyfarm Platfor, the system provides scores for non-animal-based and animal-based indicators, breaking them down into three assessment areas (on a 0-100% scale scoring system):
- Area A: Farm management and staff training
- Area B: Facilities and equipment
- Area C: Animal-based measures
- along with a final total score for overall Animal Welfare (0-100%).
For more info: https://www.classyfarm.it/index.php/en/what-en"
Original title:Valutazione del benessere animale del suino da ingrasso in allevamento all'aperto -ClassyFarm
Food Domain: Animal Welfare
Abstract/Summary:"ClassyFarm is an IT platform of the Italian Ministry of Health, developed by the Istituto Zooprofilattico Sperimentale della Lombardia e dell'Emilia Romagna """"Bruno Ubertini"""" (IZSLER), with the aim to categorise livestock farms based on their risk in animal welfare, biosecurity, and antimicrobial use.
Within this platform, several data are inserted: in relation to Animal Welfare of free-ranging fattening pigs , a guidance and a checklist have been developed for on-farm risk assessment to be run by a farm veterinarian (private practitioner). To guarantee a uniform collection of management-based, resource-based, and animal-based indicators, this guidance has been developed.
The indicators are based on current European and Italian animal welfare legislation and international scientific references, such as the Welfare Quality protocol (2009) and several EFSA Opinions and Guidelines. For each indicator (question), three possible answers have been identified according to three levels of risk:
- Level 1 - High risk: unacceptable or non-compliant condition; some animals may be in stressful situations and exposed to hazards.
- Level 2 - Controlled Risk: compliant condition, where animals benefit at least from the five animal welfare freedoms.
- Level 3 - Low risk: optimal condition, above minimum law requirements, which allows animals to have rewarding positive experiences.
Once the farm veterinarian submits aswers to the Classyfarm Platfor, the system provides scores for non-animal-based and animal-based indicators, breaking them down into three assessment areas (on a 0-100% scale scoring system):
- Area A: Farm management and staff training
- Area B: Facilities and equipment
- Area C: Animal-based measures
- along with a final total score for overall Animal Welfare (0-100%).
For more info: https://www.classyfarm.it/index.php/en/what-en"""
Original title:Valutazione del benessere e animale nell'allevamento delle specie bovina e bufalina- Manuale per i Controlli Ufficiali- Classyfarm
Food Domain: Animal Welfare
Abstract/Summary:"ClassyFarm is an IT platform of the Italian Ministry of Health, developed by the Istituto Zooprofilattico Sperimentale della Lombardia e dell'Emilia Romagna ""Bruno Ubertini"" (IZSLER), with the aim to categorise livestock farms based on their risk in animal welfare, biosecurity, and antimicrobial use.
Within this platform, several data are inserted: in relation to Animal Welfare, a guidance and a checklist for bovines and buffaloes farms have been developed for on-farm risk assessment to be run by the Official Veterinarian.
To guarantee a uniform collection of management-based, resource-based, and animal-based indicators, this guidance has been developed, and it is integrated into the official animal welfare checklist, which is structured in sections to verify compliance with current regulatory requirements. The data collected is further combined with information from the National Data Bank, ClassyFarm checklists from farm veterinarians, and return data from slaughterhouses, all contributing to the assessment of the farm's risk level, which can be compared at provincial, regional, and national levels.
The indicators are based on current European and Italian animal welfare legislation and international scientific references, such as the Welfare Quality protocol (2009) and several EFSA Opinions and Guidelines. For each indicator (question), three possible answers have been identified according to three levels of risk:
- Level 1 - High risk: unacceptable or non-compliant condition; some animals may be in stressful situations and exposed to hazards.
- Level 2 - Controlled Risk: compliant condition, where animals benefit at least from the five animal welfare freedoms.
- Level 3 - Low risk: optimal condition, above minimum law requirements, which allows animals to have rewarding positive experiences.
Once the Official Veterinarian submits aswers to the Classyfarm Platfor, the system provides a
document that will contain:
- the critical points found (criteria with non-compliant or insufficient evaluation),
- the overall risk level of the herd, calculated from the ratio of “non-compliant - insufficient, “compliant - acceptable” and “compliant - optimal” observations,
- the risk level for each area (Area A: Farm management and staff training; Area B: Facilities and equipment; Area C: Animal-based measures), expressed according to the observations noted (non-compliant, compliant, optimal, insufficient, improvable).
-any measures and prescriptions adopted,
-the final result of the inspection, along with the owner's or keeper's right to defense.
For more info: https://www.classyfarm.it/index.php/en/what-en""
Original title:Valutazione del benessere animale nell'allevamento del vitello- Manuale per i Controlli Ufficiali- Classyfarm
Food Domain: Animal Welfare
Abstract/Summary:"ClassyFarm is an IT platform of the Italian Ministry of Health, developed by the Istituto Zooprofilattico Sperimentale della Lombardia e dell'Emilia Romagna ""Bruno Ubertini"" (IZSLER), with the aim to categorise livestock farms based on their risk in animal welfare, biosecurity, and antimicrobial use.
Within this platform, several data are inserted: in relation to Animal Welfare, a guidance and a checklist for cattle farms have been developed for on-farm risk assessment to be run by the Official Veterinarian.
To guarantee a uniform collection of management-based, resource-based, and animal-based indicators, this guidance has been developed, and it is integrated into the official animal welfare checklist, which is structured in sections to verify compliance with current regulatory requirements. The data collected is further combined with information from the National Data Bank, ClassyFarm checklists from farm veterinarians, and return data from slaughterhouses, all contributing to the assessment of the farm's risk level, which can be compared at provincial, regional, and national levels.
The indicators are based on current European and Italian animal welfare legislation and international scientific references, such as the Welfare Quality protocol (2009) and several EFSA Opinions and Guidelines. For each indicator (question), three possible answers have been identified according to three levels of risk:
- Level 1 - High risk: unacceptable or non-compliant condition; some animals may be in stressful situations and exposed to hazards.
- Level 2 - Controlled Risk: compliant condition, where animals benefit at least from the five animal welfare freedoms.
- Level 3 - Low risk: optimal condition, above minimum law requirements, which allows animals to have rewarding positive experiences.
Once the Official Veterinarian submits aswers to the Classyfarm Platfor, the system provides a
document that will contain:
- the critical points found (criteria with non-compliant or insufficient evaluation),
- the overall risk level of the herd, calculated from the ratio of “non-compliant - insufficient, “compliant - acceptable” and “compliant - optimal” observations,
- the risk level for each area (Area A: Farm management and staff training; Area B: Facilities and equipment; Area C: Animal-based measures), expressed according to the observations noted (non-compliant, compliant, optimal, insufficient, improvable).
-any measures and prescriptions adopted,
-the final result of the inspection, along with the owner's or keeper's right to defense.
For more info: https://www.classyfarm.it/index.php/en/what-en"
Original title:Valutazione del benessere e animale nell'allevamento delle specie ovina e caprina- Manuale per i Controlli Ufficiali- Classyfarm
Food Domain: Animal Welfare
Abstract/Summary:"ClassyFarm is an IT platform of the Italian Ministry of Health, developed by the Istituto Zooprofilattico Sperimentale della Lombardia e dell'Emilia Romagna ""Bruno Ubertini"" (IZSLER), with the aim to categorise livestock farms based on their risk in animal welfare, biosecurity, and antimicrobial use.
Within this platform, several data are inserted: in relation to Animal Welfare, a guidance and a checklist for goats and sheep farms have been developed for on-farm risk assessment to be run by the Official Veterinarian.
To guarantee a uniform collection of management-based, resource-based, and animal-based indicators, this guidance has been developed, and it is integrated into the official animal welfare checklist, which is structured in sections to verify compliance with current regulatory requirements. The data collected is further combined with information from the National Data Bank, ClassyFarm checklists from farm veterinarians, and return data from slaughterhouses, all contributing to the assessment of the farm's risk level, which can be compared at provincial, regional, and national levels.
The indicators are based on current European and Italian animal welfare legislation and international scientific references, such as the Welfare Quality protocol (2009) and several EFSA Opinions and Guidelines. For each indicator (question), three possible answers have been identified according to three levels of risk:
- Level 1 - High risk: unacceptable or non-compliant condition; some animals may be in stressful situations and exposed to hazards.
- Level 2 - Controlled Risk: compliant condition, where animals benefit at least from the five animal welfare freedoms.
- Level 3 - Low risk: optimal condition, above minimum law requirements, which allows animals to have rewarding positive experiences.
Once the Official Veterinarian submits aswers to the Classyfarm Platfor, the system provides a
document that will contain:
- the critical points found (criteria with non-compliant or insufficient evaluation),
- the overall risk level of the herd, calculated from the ratio of “non-compliant - insufficient, “compliant - acceptable” and “compliant - optimal” observations,
- the risk level for each area (Area A: Farm management and staff training; Area B: Facilities and equipment; Area C: Animal-based measures), expressed according to the observations noted (non-compliant, compliant, optimal, insufficient, improvable).
-any measures and prescriptions adopted,
-the final result of the inspection, along with the owner's or keeper's right to defense.
For more info: https://www.classyfarm.it/index.php/en/what-en""
Original title:Valutazione del benessere animale nell'allevamento della gallina ovaiola- Manuale per i Controlli Ufficiali- Classyfarm
Food Domain: Animal Welfare
Abstract/Summary:"ClassyFarm is an IT platform of the Italian Ministry of Health, developed by the Istituto Zooprofilattico Sperimentale della Lombardia e dell'Emilia Romagna ""Bruno Ubertini"" (IZSLER), with the aim to categorise livestock farms based on their risk in animal welfare, biosecurity, and antimicrobial use.
Within this platform, several data are inserted: in relation to Animal Welfare, a guidance and a checklist for laying hens farms have been developed for on-farm risk assessment to be run by the Official Veterinarian.
To guarantee a uniform collection of management-based, resource-based, and animal-based indicators, this guidance has been developed, and it is integrated into the official animal welfare checklist, which is structured in sections to verify compliance with current regulatory requirements. The data collected is further combined with information from the National Data Bank, ClassyFarm checklists from farm veterinarians, and return data from slaughterhouses, all contributing to the assessment of the farm's risk level, which can be compared at provincial, regional, and national levels.
The indicators are based on current European and Italian animal welfare legislation and international scientific references, such as the Welfare Quality protocol (2009) and several EFSA Opinions and Guidelines. For each indicator (question), three possible answers have been identified according to three levels of risk:
- Level 1 - High risk: unacceptable or non-compliant condition; some animals may be in stressful situations and exposed to hazards.
- Level 2 - Controlled Risk: compliant condition, where animals benefit at least from the five animal welfare freedoms.
- Level 3 - Low risk: optimal condition, above minimum law requirements, which allows animals to have rewarding positive experiences.
Once the Official Veterinarian submits aswers to the Classyfarm Platfor, the system provides a
document that will contain:
- the critical points found (criteria with non-compliant or insufficient evaluation),
- the overall risk level of the herd, calculated from the ratio of “non-compliant - insufficient, “compliant - acceptable” and “compliant - optimal” observations,
- the risk level for each area (Area A: Farm management and staff training; Area B: Facilities and equipment; Area C: Animal-based measures), expressed according to the observations noted (non-compliant, compliant, optimal, insufficient, improvable).
-any measures and prescriptions adopted,
-the final result of the inspection, along with the owner's or keeper's right to defense.
For more info: https://www.classyfarm.it/index.php/en/what-en"
Original title:Valutazione del benessere animale nell'allevamento della specie suina- Manuale per i Controlli Ufficiali- ClassyFarm
Food Domain: Animal Welfare
Abstract/Summary:"ClassyFarm is an IT platform of the Italian Ministry of Health, developed by the Istituto Zooprofilattico Sperimentale della Lombardia e dell'Emilia Romagna ""Bruno Ubertini"" (IZSLER), with the aim to categorise livestock farms based on their risk in animal welfare, biosecurity, and antimicrobial use.
Within this platform, several data are inserted: in relation to Animal Welfare in pig farming, a guidance and a checklist have been developed for on-farm risk assessment to be run by the Official Veterinarian.
To guarantee a uniform collection of management-based, resource-based, and animal-based indicators, this guidance has been developed, and it is integrated into the official animal welfare checklist, which is structured in sections to verify compliance with current regulatory requirements. The data collected is further combined with information from the National Data Bank, ClassyFarm checklists from farm veterinarians, and return data from slaughterhouses, all contributing to the assessment of the farm's risk level, which can be compared at provincial, regional, and national levels.
The indicators are based on current European and Italian animal welfare legislation and international scientific references, such as the Welfare Quality protocol (2009) and several EFSA Opinions and Guidelines. For each indicator (question), three possible answers have been identified according to three levels of risk:
- Level 1 - High risk: unacceptable or non-compliant condition; some animals may be in stressful situations and exposed to hazards.
- Level 2 - Controlled Risk: compliant condition, where animals benefit at least from the five animal welfare freedoms.
- Level 3 - Low risk: optimal condition, above minimum law requirements, which allows animals to have rewarding positive experiences.
Once the Official Veterinarian submits aswers to the Classyfarm Platfor, the system provides a
document that will contain:
- the critical points found (criteria with non-compliant or insufficient evaluation),
- the overall risk level of the herd, calculated from the ratio of “non-compliant - insufficient, “compliant - acceptable” and “compliant - optimal” observations,
- the risk level for each area (Area A: Farm management and staff training; Area B: Facilities and equipment; Area C: Animal-based measures), expressed according to the observations noted (non-compliant, compliant, optimal, insufficient, improvable).
-any measures and prescriptions adopted,
-the final result of the inspection, along with the owner's or keeper's right to defense.
For more info: https://www.classyfarm.it/index.php/en/what-en""
Original title:Beurteilung der Relevanz von Metaboliten im Grundwasser im Rahmen des nationalen Zulassungsverfahrens für Pflanzenschutzmittel
Food Domain: Pesticides
Abstract/Summary:Plant protection products are only authorised if no adverse effect on ground water may be anticipated, i.e., if the predicted concentration of the active substance and its relevant metabolites after application is below the limit value specified in Annex VI of Directive 91/414/EEC. A metabolite is considered relevant, if it has comparable intrinsic properties as the active substance in terms of its pesticidal (biologieal) activity, or if it poses a risk for ground water ecosystems or if it has certain toxicological properties that are considered severe (i.e., classification as "very toxic", "toxic", "carcinogenic", "genotoxic" or "toxic to reproduction"). A detailed description of metabolites that must be subjected to a relevance assessment in the context of national authorisation procedures and the applicable criteria in the stepwise assessment of relevance folIows.
Attribution: Abstract reproduced from Nachrichtenblatt für den Deutschen Pflanzenschutzdienst, 2004, licenced under CC BY 4.0.
https://www.bfr.bund.de/cm/364/guideline-for-the-assessment-of-health-risks.pdf
Original title:Leitfaden für die Bewertung gesundheitlicher Risiken
Food Domain: Contaminants; Biological Hazards; Veterinary…
Abstract/Summary:The German Federal Institute for Risk Assessment (BfR) has the legal mandate to estimate and assess the risks to human health presented by food and animal feed, substances, microorganisms, products and procedures. The BfR also provides information about potential, identified and assessed risks, and recommends measures necessary for risk mitigation or avoidance. In certain circumstances, it is also necessary to assess the benefits of substances, products and procedures. The assessment process is documented and explained in
full. By providing a comprehensive and understandable presentation of the scientific basis of its assessments, the BfR makes an important contribution to risk communication. One aspect of risk communication, among other things, is the exchange of information and scientific opinion concerning risks between all target groups, which include consumers, government, research and public institutions, industry bodies, non-governmental organisations and the media. As a result of this independent scientific assessment, research and clear-cut communication of health risks the BfR actively contributes to the safety of food and feed, products and chemicals. The present ‘Guideline for the assessment of health risks’ serves to implement the theoretical principles mentioned in practice and, therefore, assure the quality of risk assessments and other health statements published by the BfR.
Original title:Valutazione del benessere animale delle galline ovaiole: manuale di autocontrollo- ClassyFarm
Food Domain: Animal Welfare
Abstract/Summary:"ClassyFarm is an IT platform of the Italian Ministry of Health, developed by the Istituto Zooprofilattico Sperimentale della Lombardia e dell'Emilia Romagna ""Bruno Ubertini"" (IZSLER), with the aim to categorise livestock farms based on their risk in animal welfare, biosecurity, and antimicrobial use.
Within this platform, several data are inserted: in relation to Animal Welfare of laying hens, a guidance and a checklist have been developed for on-farm risk assessment to be run by a farm veterinarian (private practitioner). To guarantee a uniform collection of management-based, resource-based, and animal-based indicators, this guidance has been developed.
The indicators are based on current European and Italian animal welfare legislation and international scientific references, such as the Welfare Quality protocol (2009) and several EFSA Opinions and Guidelines. For each indicator (question), three possible answers have been identified according to three levels of risk:
- Level 1 - High risk: unacceptable or non-compliant condition; some animals may be in stressful situations and exposed to hazards.
- Level 2 - Controlled Risk: compliant condition, where animals benefit at least from the five animal welfare freedoms.
- Level 3 - Low risk: optimal condition, above minimum law requirements, which allows animals to have rewarding positive experiences.
Once the farm veterinarian submits aswers to the Classyfarm Platfor, the system provides scores for non-animal-based and animal-based indicators, breaking them down into three assessment areas (on a 0-100% scale scoring system):
- Area A: Farm management and staff training
- Area B: Facilities and equipment
- Area C: Animal-based measures
- along with a final total score for overall Animal Welfare (0-100%).
For more info: https://www.classyfarm.it/index.php/en/what-en"""
https://www.bvl.bund.de/EN/Tasks/04_Plant_protection_products/03_Applicants/04_AuthorisationProcedure/02_ClassificationLabelling/02_Changes/ppp_classif_lab_changes_node.html
Original title:Gefahrstoffrechtliche Einstufung und Kennzeichnung von Pflanzenschutzmitteln, wenn sich die Einstufung von darin enthaltenen Wirkstoffen oder Beistoffen ändert
Food Domain: Pesticides
Abstract/Summary:New information or the first-time adoption of a classification and labelling according to Regulation (EC) No. 1272/2008 (CLP Regulation) may lead to changes in the classification of active substances, safeners, synergists and other ingredients of plant protection products under CLP Regulation (this also applies to the additional EU hazard statements for labelling mentioned in the text).
Original title:Valutazione del benessere animale nell'allevamento del pollo da carne - Manuale per i Controlli Ufficiali- Classyfarm
Food Domain: Animal Welfare
Abstract/Summary:"ClassyFarm is an IT platform of the Italian Ministry of Health, developed by the Istituto Zooprofilattico Sperimentale della Lombardia e dell'Emilia Romagna ""Bruno Ubertini"" (IZSLER), with the aim to categorise livestock farms based on their risk in animal welfare, biosecurity, and antimicrobial use.
Within this platform, several data are inserted: in relation to Animal Welfare, a guidance and a checklist for broiler farms have been developed for on-farm risk assessment to be run by the Official Veterinarian.
To guarantee a uniform collection of management-based, resource-based, and animal-based indicators, this guidance has been developed, and it is integrated into the official animal welfare checklist, which is structured in sections to verify compliance with current regulatory requirements. The data collected is further combined with information from the National Data Bank, ClassyFarm checklists from farm veterinarians, and return data from slaughterhouses, all contributing to the assessment of the farm's risk level, which can be compared at provincial, regional, and national levels.
The indicators are based on current European and Italian animal welfare legislation and international scientific references, such as the Welfare Quality protocol (2009) and several EFSA Opinions and Guidelines. For each indicator (question), three possible answers have been identified according to three levels of risk:
- Level 1 - High risk: unacceptable or non-compliant condition; some animals may be in stressful situations and exposed to hazards.
- Level 2 - Controlled Risk: compliant condition, where animals benefit at least from the five animal welfare freedoms.
- Level 3 - Low risk: optimal condition, above minimum law requirements, which allows animals to have rewarding positive experiences.
Once the Official Veterinarian submits aswers to the Classyfarm Platfor, the system provides a
document that will contain:
- the critical points found (criteria with non-compliant or insufficient evaluation),
- the overall risk level of the herd, calculated from the ratio of “non-compliant - insufficient, “compliant - acceptable” and “compliant - optimal” observations,
- the risk level for each area (Area A: Farm management and staff training; Area B: Facilities and equipment; Area C: Animal-based measures), expressed according to the observations noted (non-compliant, compliant, optimal, insufficient, improvable).
-any measures and prescriptions adopted,
-the final result of the inspection, along with the owner's or keeper's right to defense.
For more info: https://www.classyfarm.it/index.php/en/what-en"
Original title:Valutazione del benessere animale nell'allevamento del coniglio - Manuale per i Controlli Ufficiali- Classyfarm
Food Domain: Animal Welfare
Abstract/Summary:"ClassyFarm is an IT platform of the Italian Ministry of Health, developed by the Istituto Zooprofilattico Sperimentale della Lombardia e dell'Emilia Romagna ""Bruno Ubertini"" (IZSLER), with the aim to categorise livestock farms based on their risk in animal welfare, biosecurity, and antimicrobial use.
Within this platform, several data are inserted: in relation to Animal Welfare, a guidance and a checklist for rabbit farms have been developed for on-farm risk assessment to be run by the Official Veterinarian.
To guarantee a uniform collection of management-based, resource-based, and animal-based indicators, this guidance has been developed, and it is integrated into the official animal welfare checklist, which is structured in sections to verify compliance with current regulatory requirements. The data collected is further combined with information from the National Data Bank, ClassyFarm checklists from farm veterinarians, and return data from slaughterhouses, all contributing to the assessment of the farm's risk level, which can be compared at provincial, regional, and national levels.
The indicators are based on current European and Italian animal welfare legislation and international scientific references, such as the Welfare Quality protocol (2009) and several EFSA Opinions and Guidelines. For each indicator (question), three possible answers have been identified according to three levels of risk:
- Level 1 - High risk: unacceptable or non-compliant condition; some animals may be in stressful situations and exposed to hazards.
- Level 2 - Controlled Risk: compliant condition, where animals benefit at least from the five animal welfare freedoms.
- Level 3 - Low risk: optimal condition, above minimum law requirements, which allows animals to have rewarding positive experiences.
Once the Official Veterinarian submits aswers to the Classyfarm Platfor, the system provides a
document that will contain:
- the critical points found (criteria with non-compliant or insufficient evaluation),
- the overall risk level of the herd, calculated from the ratio of “non-compliant - insufficient, “compliant - acceptable” and “compliant - optimal” observations,
- the risk level for each area (Area A: Farm management and staff training; Area B: Facilities and equipment; Area C: Animal-based measures), expressed according to the observations noted (non-compliant, compliant, optimal, insufficient, improvable).
-any measures and prescriptions adopted,
-the final result of the inspection, along with the owner's or keeper's right to defense.
For more info: https://www.classyfarm.it/index.php/en/what-en"
Original title:Valutazione del benessere animale nell'allevamento del tacchino- Manuale per i Controlli Ufficiali- Classyfarm
Food Domain: Animal Welfare
Abstract/Summary:"ClassyFarm is an IT platform of the Italian Ministry of Health, developed by the Istituto Zooprofilattico Sperimentale della Lombardia e dell'Emilia Romagna ""Bruno Ubertini"" (IZSLER), with the aim to categorise livestock farms based on their risk in animal welfare, biosecurity, and antimicrobial use.
Within this platform, several data are inserted: in relation to Animal Welfare, a guidance and a checklist for turkey farms have been developed for on-farm risk assessment to be run by the Official Veterinarian.
To guarantee a uniform collection of management-based, resource-based, and animal-based indicators, this guidance has been developed, and it is integrated into the official animal welfare checklist, which is structured in sections to verify compliance with current regulatory requirements. The data collected is further combined with information from the National Data Bank, ClassyFarm checklists from farm veterinarians, and return data from slaughterhouses, all contributing to the assessment of the farm's risk level, which can be compared at provincial, regional, and national levels.
The indicators are based on current European and Italian animal welfare legislation and international scientific references, such as the Welfare Quality protocol (2009) and several EFSA Opinions and Guidelines. For each indicator (question), three possible answers have been identified according to three levels of risk:
- Level 1 - High risk: unacceptable or non-compliant condition; some animals may be in stressful situations and exposed to hazards.
- Level 2 - Controlled Risk: compliant condition, where animals benefit at least from the five animal welfare freedoms.
- Level 3 - Low risk: optimal condition, above minimum law requirements, which allows animals to have rewarding positive experiences.
Once the Official Veterinarian submits aswers to the Classyfarm Platfor, the system provides a
document that will contain:
- the critical points found (criteria with non-compliant or insufficient evaluation),
- the overall risk level of the herd, calculated from the ratio of “non-compliant - insufficient, “compliant - acceptable” and “compliant - optimal” observations,
- the risk level for each area (Area A: Farm management and staff training; Area B: Facilities and equipment; Area C: Animal-based measures), expressed according to the observations noted (non-compliant, compliant, optimal, insufficient, improvable).
-any measures and prescriptions adopted,
-the final result of the inspection, along with the owner's or keeper's right to defense.
For more info: https://www.classyfarm.it/index.php/en/what-en"
Original title:Valutazione della biosicurezza negli allevamenti di suini semibradi ad alta capacità-Manuale per i Controlli Ufficiali- Classyfarm
Food Domain: Animal Health; Biological Hazards
Abstract/Summary:"ClassyFarm is an IT platform of the Italian Ministry of Health, developed by the Istituto Zooprofilattico Sperimentale della Lombardia e dell'Emilia Romagna ""Bruno Ubertini"" (IZSLER), with the aim to categorise livestock farms based on their risk in animal welfare, biosecurity, and antimicrobial use.
Within this platform, several data are inserted: in relation to Biosecurity in pig farming, a guidance and a checklist for high-capacity semi-free-range system have been developed for on-farm risk assessment to be run by the Official Veterinarian.
To guarantee a uniform collection of management-based, resource-based, and animal-based indicators, this guidance has been developed, and it is integrated into the official animal welfare checklist, which is structured in sections to verify compliance with current regulatory requirements. The data collected is further combined with information from the National Data Bank, ClassyFarm checklists from farm veterinarians, and return data from slaughterhouses, all contributing to the assessment of the farm's risk level, which can be compared at provincial, regional, and national levels.
The indicators are based on current European and Italian animal welfare legislation and international scientific references, such as the Welfare Quality protocol (2009) and several EFSA Opinions and Guidelines. For each indicator (question), three possible answers have been identified according to three levels of risk:
- Level 1 - High risk: unacceptable or non-compliant condition; some animals may be in stressful situations and exposed to hazards.
- Level 2 - Controlled Risk: compliant condition, where animals benefit at least from the five animal welfare freedoms.
- Level 3 - Low risk: optimal condition, above minimum law requirements, which allows animals to have rewarding positive experiences.
Once the Official Veterinarian submits aswers to the Classyfarm Platfor, the system provides a
document that will contain:
- the critical points found (criteria with non-compliant or insufficient evaluation),
- the overall risk level of the herd, calculated from the ratio of “non-compliant - insufficient, “compliant - acceptable” and “compliant - optimal” observations,
- the risk level for each area (Area A: Farm management and staff training; Area B: Facilities and equipment; Area C: Animal-based measures), expressed according to the observations noted (non-compliant, compliant, optimal, insufficient, improvable).
-any measures and prescriptions adopted,
-the final result of the inspection, along with the owner's or keeper's right to defense.
For more info: https://www.classyfarm.it/index.php/en/what-en""
Original title:Valutazione della biosicurezza negli allevamenti di suini stabulati a bassa capacità-Manuale per i Controlli Ufficiali- Classyfarm
Food Domain: Animal Health; Biological Hazards
Abstract/Summary:"ClassyFarm is an IT platform of the Italian Ministry of Health, developed by the Istituto Zooprofilattico Sperimentale della Lombardia e dell'Emilia Romagna ""Bruno Ubertini"" (IZSLER), with the aim to categorise livestock farms based on their risk in animal welfare, biosecurity, and antimicrobial use.
Within this platform, several data are inserted: in relation to Biosecurity in pig farming, a guidance and a checklist for low-capacity housed system have been developed for on-farm risk assessment to be run by the Official Veterinarian.
To guarantee a uniform collection of management-based, resource-based, and animal-based indicators, this guidance has been developed, and it is integrated into the official animal welfare checklist, which is structured in sections to verify compliance with current regulatory requirements. The data collected is further combined with information from the National Data Bank, ClassyFarm checklists from farm veterinarians, and return data from slaughterhouses, all contributing to the assessment of the farm's risk level, which can be compared at provincial, regional, and national levels.
The indicators are based on current European and Italian animal welfare legislation and international scientific references, such as the Welfare Quality protocol (2009) and several EFSA Opinions and Guidelines. For each indicator (question), three possible answers have been identified according to three levels of risk:
- Level 1 - High risk: unacceptable or non-compliant condition; some animals may be in stressful situations and exposed to hazards.
- Level 2 - Controlled Risk: compliant condition, where animals benefit at least from the five animal welfare freedoms.
- Level 3 - Low risk: optimal condition, above minimum law requirements, which allows animals to have rewarding positive experiences.
Once the Official Veterinarian submits aswers to the Classyfarm Platfor, the system provides a
document that will contain:
- the critical points found (criteria with non-compliant or insufficient evaluation),
- the overall risk level of the herd, calculated from the ratio of “non-compliant - insufficient, “compliant - acceptable” and “compliant - optimal” observations,
- the risk level for each area (Area A: Farm management and staff training; Area B: Facilities and equipment; Area C: Animal-based measures), expressed according to the observations noted (non-compliant, compliant, optimal, insufficient, improvable).
-any measures and prescriptions adopted,
-the final result of the inspection, along with the owner's or keeper's right to defense.
For more info: https://www.classyfarm.it/index.php/en/what-en""
Original title:Valutazione della biosicurezza negli allevamenti di suini semibradi a bassa capacità-Manuale per i Controlli Ufficiali- Classyfarm
Food Domain: Animal Health; Biological Hazards
Abstract/Summary:"ClassyFarm is an IT platform of the Italian Ministry of Health, developed by the Istituto Zooprofilattico Sperimentale della Lombardia e dell'Emilia Romagna ""Bruno Ubertini"" (IZSLER), with the aim to categorise livestock farms based on their risk in animal welfare, biosecurity, and antimicrobial use.
Within this platform, several data are inserted: in relation to Biosecurity in pig farming, a guidance and a checklist for low-capacity semi-free-range system have been developed for on-farm risk assessment to be run by the Official Veterinarian.
To guarantee a uniform collection of management-based, resource-based, and animal-based indicators, this guidance has been developed, and it is integrated into the official animal welfare checklist, which is structured in sections to verify compliance with current regulatory requirements. The data collected is further combined with information from the National Data Bank, ClassyFarm checklists from farm veterinarians, and return data from slaughterhouses, all contributing to the assessment of the farm's risk level, which can be compared at provincial, regional, and national levels.
The indicators are based on current European and Italian animal welfare legislation and international scientific references, such as the Welfare Quality protocol (2009) and several EFSA Opinions and Guidelines. For each indicator (question), three possible answers have been identified according to three levels of risk:
- Level 1 - High risk: unacceptable or non-compliant condition; some animals may be in stressful situations and exposed to hazards.
- Level 2 - Controlled Risk: compliant condition, where animals benefit at least from the five animal welfare freedoms.
- Level 3 - Low risk: optimal condition, above minimum law requirements, which allows animals to have rewarding positive experiences.
Once the Official Veterinarian submits aswers to the Classyfarm Platfor, the system provides a
document that will contain:
- the critical points found (criteria with non-compliant or insufficient evaluation),
- the overall risk level of the herd, calculated from the ratio of “non-compliant - insufficient, “compliant - acceptable” and “compliant - optimal” observations,
- the risk level for each area (Area A: Farm management and staff training; Area B: Facilities and equipment; Area C: Animal-based measures), expressed according to the observations noted (non-compliant, compliant, optimal, insufficient, improvable).
-any measures and prescriptions adopted,
-the final result of the inspection, along with the owner's or keeper's right to defense.
For more info: https://www.classyfarm.it/index.php/en/what-en"
Original title:Valutazione della biosicurezza negli allevamenti di suini stabulati ad alta capacità-Manuale per i Controlli Ufficiali- Classyfarm
Food Domain: Animal Health; Biological Hazards
Abstract/Summary:"ClassyFarm is an IT platform of the Italian Ministry of Health, developed by the Istituto Zooprofilattico Sperimentale della Lombardia e dell'Emilia Romagna ""Bruno Ubertini"" (IZSLER), with the aim to categorise livestock farms based on their risk in animal welfare, biosecurity, and antimicrobial use.
Within this platform, several data are inserted: in relation to Biosecurity in pig farming, a guidance and a checklist for high-capacity housed system have been developed for on-farm risk assessment to be run by the Official Veterinarian.
To guarantee a uniform collection of management-based, resource-based, and animal-based indicators, this guidance has been developed, and it is integrated into the official animal welfare checklist, which is structured in sections to verify compliance with current regulatory requirements. The data collected is further combined with information from the National Data Bank, ClassyFarm checklists from farm veterinarians, and return data from slaughterhouses, all contributing to the assessment of the farm's risk level, which can be compared at provincial, regional, and national levels.
The indicators are based on current European and Italian animal welfare legislation and international scientific references, such as the Welfare Quality protocol (2009) and several EFSA Opinions and Guidelines. For each indicator (question), three possible answers have been identified according to three levels of risk:
- Level 1 - High risk: unacceptable or non-compliant condition; some animals may be in stressful situations and exposed to hazards.
- Level 2 - Controlled Risk: compliant condition, where animals benefit at least from the five animal welfare freedoms.
- Level 3 - Low risk: optimal condition, above minimum law requirements, which allows animals to have rewarding positive experiences.
Once the Official Veterinarian submits aswers to the Classyfarm Platfor, the system provides a
document that will contain:
- the critical points found (criteria with non-compliant or insufficient evaluation),
- the overall risk level of the herd, calculated from the ratio of “non-compliant - insufficient, “compliant - acceptable” and “compliant - optimal” observations,
- the risk level for each area (Area A: Farm management and staff training; Area B: Facilities and equipment; Area C: Animal-based measures), expressed according to the observations noted (non-compliant, compliant, optimal, insufficient, improvable).
-any measures and prescriptions adopted,
-the final result of the inspection, along with the owner's or keeper's right to defense.
For more info: https://www.classyfarm.it/index.php/en/what-en""
Guidelines and procedure for the collection of samples from the encephalon stem surveillance of transmissible spongiform encephalopathies in bovines, buffalo, sheep, goats and deer
Original title:Linea guida e procedura per il prelievo dei campioni di tronco encefalico sorveglianza delle encefalopatie spongiformi trasmissibili in bovini, bufalini, ovini, caprini e cervi
Food Domain: Animal Health; Biological Hazards - EUSR TSE
Abstract/Summary:These guidelines provide useful guidance to Local Health Authority veterinarians regarding brainstem sampling procedures, surveillance for bovine, sheep/goat and cervid TSEs, and biosecurity measures in compliance with the regulatory framework.
Original title:Valutazione del benessere animale e della biosicurezza dell'allevamento della pecora da latte: manuale di autocontrollo-ClassyFarm
Food Domain: Animal Welfare
Abstract/Summary:"ClassyFarm is an IT platform of the Italian Ministry of Health, developed by the Istituto Zooprofilattico Sperimentale della Lombardia e dell'Emilia Romagna ""Bruno Ubertini"" (IZSLER), with the aim to categorise livestock farms based on their risk in animal welfare, biosecurity, and antimicrobial use.
Within this platform, several data are inserted: in relation to Animal Welfare and Biosecurity in dairy sheep, a guidance and a checklist have been developed for on-farm risk assessment to be run by a farm veterinarian (private practitioner). To guarantee a uniform collection of management-based, resource-based, and animal-based indicators, this guidance has been developed.
The indicators are based on current European and Italian animal welfare legislation and international scientific references, such as the Welfare Quality protocol (2009) and several EFSA Opinions and Guidelines. For each indicator (question), three possible answers have been identified according to three levels of risk:
- Level 1 - High risk: unacceptable or non-compliant condition; some animals may be in stressful situations and exposed to hazards.
- Level 2 - Controlled Risk: compliant condition, where animals benefit at least from the five animal welfare freedoms.
- Level 3 - Low risk: optimal condition, above minimum law requirements, which allows animals to have rewarding positive experiences.
Once the farm veterinarian submits aswers to the Classyfarm Platfor, the system provides scores for non-animal-based and animal-based indicators, breaking them down into three assessment areas (on a 0-100% scale scoring system):
- Area A: Farm management and staff training
- Area B: Facilities and equipment
- Area C: Animal-based measures
- along with a final total score for overall Animal Welfare (0-100%).
For more info: https://www.classyfarm.it/index.php/en/what-en"
Original title:Valutazione del benessere animale polli da carne: manuale di autocontrollo- ClassyFarm
Food Domain: Animal Welfare
Abstract/Summary:"ClassyFarm is an IT platform of the Italian Ministry of Health, developed by the Istituto Zooprofilattico Sperimentale della Lombardia e dell'Emilia Romagna ""Bruno Ubertini"" (IZSLER), with the aim to categorise livestock farms based on their risk in animal welfare, biosecurity, and antimicrobial use.
Within this platform, several data are inserted: in relation to Animal Welfare of broilers, a guidance and a checklist have been developed for on-farm risk assessment to be run by a farm veterinarian (private practitioner). To guarantee a uniform collection of management-based, resource-based, and animal-based indicators, this guidance has been developed.
The indicators are based on current European and Italian animal welfare legislation and international scientific references, such as the Welfare Quality protocol (2009) and several EFSA Opinions and Guidelines. For each indicator (question), three possible answers have been identified according to three levels of risk:
- Level 1 - High risk: unacceptable or non-compliant condition; some animals may be in stressful situations and exposed to hazards.
- Level 2 - Controlled Risk: compliant condition, where animals benefit at least from the five animal welfare freedoms.
- Level 3 - Low risk: optimal condition, above minimum law requirements, which allows animals to have rewarding positive experiences.
Once the farm veterinarian submits aswers to the Classyfarm Platfor, the system provides scores for non-animal-based and animal-based indicators, breaking them down into three assessment areas (on a 0-100% scale scoring system):
- Area A: Farm management and staff training
- Area B: Facilities and equipment
- Area C: Animal-based measures
- along with a final total score for overall Animal Welfare (0-100%).
For more info: https://www.classyfarm.it/index.php/en/what-en"""
Original title:Linee guida per la lotta alle encefalopatie spongiformi trasmissibili (TSE) negli allevamenti ovini e caprini
Food Domain: Animal Health; Biological Hazards - EUSR TSE
Abstract/Summary:"The following Guidelines are intended to be a tool that can facilitate the application of the complex regulations governing the management of TSEs in sheep and goats. In the
specific attention has been paid to the surveillance and management of outbreaks.
It should be noted that collaboration with the breeder must always be promoted for the purpose of the prompt reporting, to the competent Local Health Authority, of all cases of animal death and possible finding of clinical symptoms and behavioral alterations referable to the disease. Failure to report the death constitutes a violation of the provisions of Art. 6 of Legislative Decree 136/2022 and therefore the sanctioning measures provided for in by Article 23, paragraph 1 of the same Legislative Decree 136/2022, as explained by the note of the Ministry of Health 0005173-23/02/2023-DGSAF-MDS-P.
Anything not expressly defined in the following guidelines shall be implemented pursuant to current national and European Union regulations."
https://www.aesan.gob.es/AECOSAN/docs/documentos/seguridad_alimentaria/evaluacion_riesgos/informes_cc_ingles/GUIDELINES_PROCESSING_AIDS.pdf
Original title:Líneas directrices del Comité Científico de la Agencia Española de Seguridad Alimentaria y Nutrición (AESAN) sobre la información requerida para realizar la evaluación de coadyuvantes tecnológicos que se pretenden emplear en la elaboración y obtención de alimentos
Food Domain: Other;Processing aids
Abstract/Summary:The processing aids used in food preparation and production processes are regulated in Spain by Royal Decree 773/2023, which also defines them. There is also a specific regulation for the processing aids used in the production process of edible oils, which are regulated by Royal Decree 640/2015. As established in said Royal Decrees, the processing aids that do not appear in Annex I, and that are not referred to in sections 2 and 3 of Article 3, of Royal Decree 773/2023, and the processing aids used in the production process of edible oils that do not appear in Annex I of Royal Decree 640/2015 must be subject, for their approval and inclusion in said annexes, to a risk assessment by the Scientific Committee of the Spanish Agency for Food Safety and Nutrition (AESAN) that establishes the safety of the intended use. In this regard, and in order to specify what information is necessary to evaluate the safety of the use of said processing aids and thus facilitate the submission of the assessment application dossiers, the AESAN Scientific Committee has developed these guidelines that are an amendment of those approved by the AESAN Scientific Committee in 2010, which they replace. They establish a series of guidelines regarding the submission of processing aid assessment applications, in addition to the documentation that must accompany said applications, in the form of a dossier, which will include information regarding: administrative details and general presentation; detailed composition and specifications; stability and reactivity; authorised uses in human food; technological function; toxicological reference values; allergenicity; efficacy; residues and environmental impact.
Original title:Intégration de l’exposome dans les travaux de l’Anses
Food Domain: Animal Health; Animal Welfare; Biological Hazards…
Abstract/Summary:The ANSES guidance “Intégration de l’exposome dans les activités de l’Anses” (2022-METH-0197) explores how the exposome concept—which encompasses the full array of environmental, chemical, biological, physical, psychosocial, and socio-economic influences over an individual’s life—can be integrated into the Agency’s risk assessment and health evaluation activities. The report surveys existing definitions, data sources, methods, and tools relevant to exposome research, and identifies challenges in applying them in regulatory or public health contexts. It emphasizes the need for holistic exposure tracking (multiple sources, multiple pathways, temporal dynamics), incorporation of inter- and intra-individual variability, and dealing with mixtures of stressors. The guidance proposes a roadmap for operationalizing exposome approaches within ANSES: selecting priorities, developing or adapting measurement and modelling tools, ensuring data interoperability, and embedding these approaches in expert assessments. Overall, the document aims to modernize risk evaluation by shifting from single-agent, single-pathway assessments toward more integrated, realistic representations of human exposures over life.
OPINION of the National Agency for Food, Environmental and Occupational Health & Safety on a supporting document for the guidelines of the decree of March 7, 2011 concerning the evaluation of antimicrobial efficacy of processing aids used as decontamination agents for foodstuffs of plant origin
Original title:AVIS de l’Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail relatif à un document d’appui aux lignes directrices de l’arrêté du 7 mars 2011 relatives à l’évaluation de l'efficacité antimicrobienne des auxiliaires technologiques utilisés comme agents de décontamination des denrées d’origine végétale
Food Domain: Food Processing aids
Abstract/Summary:This ANSES guidance document provides updated scientific and technical support for evaluating the antimicrobial efficacy of food Processing aids used as decontamination agents for plant-based food products. The document replaces earlier recommendations and clarifies the requirements for dossiers submitted for authorization under French regulation. It outlines the types of data needed to demonstrate efficacy, including microbiological testing against bacteria, viruses, fungi, and parasites.
Food Domain: Animal Welfare
Abstract/Summary:This guidance document from the Office for Risk Assessment & Research (BuRO) of the Dutch Food and Consumer Product Safety Authority (NVWA) outlines the methodology used for assessing risks to animal welfare. Based on EFSA's framework and aligned with Codex Alimentarius principles, the method includes four key steps: hazard identification, hazard characterisation, exposure assessment, and risk characterisation. It integrates the Welfare Quality® principles to structure welfare-related hazards and consequences, focusing on nutrition, housing, health, and behavior.
https://www.bfr.bund.de/cm/349/guidance-on-uncertainty-analysis-in-exposure-assessment.pdf
Original title:Leitfaden zur Unsicherheitsanalyse in der Expositionsschätzung
Food Domain: Contaminants; Biological Hazards; Veterinary…
Abstract/Summary:This guidance document delineates the procedure recommended by the BfR Committee for Exposure Assessment and Exposure Standardisation and the BfR Committee on Evidence-
based Methods in Risk Assessment for recording, describing and evaluating uncertainties in connection with public health related scientific statements. It primarily refers to the application
of uncertainty analysis in the field of exposure assessment. Since exposure assessment is an essential part of risk assessment, it is recommended that the outlined principles should also
be applied to the risk assessment process as a whole. In principle, this guidance follows the previously published guidance documents of EFSA (EFSA Scientific Committee et al., 2018; IPCS & IOMC, 2008). The development of standardised procedures for uncertainty analysis, especially in the area of hazard characterisation, is currently subject to intensive discussion and considerable collaborative efforts at the international level, so that an update of this guidance may be necessary in the future. The primary purpose of uncertainty analysis is to increase transparency regarding all elements of risk assessment and exposure estimation. In particular, uncertainty analysis should enable consumers, decision-makers and stakeholders to better understand risk assessments and to make their own decisions on a well-founded basis. Therefore, the uncertainty analysis should include the subject and question of the assessment, as well as the definition of the required protection goal. Deficits in knowledge about scenarios, models and parameters must also be described in an appropriate manner. This ensures that risk assessments contribute to informed decision-making under conditions of uncertainty.
Original title:Valutazione del benessere animale e della biosicurezza dell'allevamento della capra da latte: manuale di autocontrollo-ClassyFarm
Food Domain: Animal Health; Animal Welfare; Biological Hazards
Abstract/Summary:"ClassyFarm is an IT platform of the Italian Ministry of Health, developed by the Istituto Zooprofilattico Sperimentale della Lombardia e dell'Emilia Romagna ""Bruno Ubertini"" (IZSLER), with the aim to categorise livestock farms based on their risk in animal welfare, biosecurity, and antimicrobial use.
Within this platform, several data are inserted: in relation to Animal Welfare and Biosecurity in dairy goat, a guidance and a checklist have been developed for on-farm risk assessment to be run by a farm veterinarian (private practitioner). To guarantee a uniform collection of management-based, resource-based, and animal-based indicators, this guidance has been developed.
The indicators are based on current European and Italian animal welfare legislation and international scientific references, such as the Welfare Quality protocol (2009) and several EFSA Opinions and Guidelines. For each indicator (question), three possible answers have been identified according to three levels of risk:
- Level 1 - High risk: unacceptable or non-compliant condition; some animals may be in stressful situations and exposed to hazards.
- Level 2 - Controlled Risk: compliant condition, where animals benefit at least from the five animal welfare freedoms.
- Level 3 - Low risk: optimal condition, above minimum law requirements, which allows animals to have rewarding positive experiences.
Once the farm veterinarian submits aswers to the Classyfarm Platfor, the system provides scores for non-animal-based and animal-based indicators, breaking them down into three assessment areas (on a 0-100% scale scoring system):
- Area A: Farm management and staff training
- Area B: Facilities and equipment
- Area C: Animal-based measures
- along with a final total score for overall Animal Welfare (0-100%).
For more info: https://www.classyfarm.it/index.php/en/what-en"
Food Domain: Biological Hazards; Contaminants; Food Contact…
Abstract/Summary:The document provides a comprehensive framework for assessing health risks from environmental chemical and microbiological exposures. It follows international standards, including EFSA, WHO, and Codex Alimentarius methodologies. Risk assessment steps include hazard identification, hazard characterization, exposure assessment, and risk characterization. It covers both microbiological (e.g., pathogens in food and water) and toxicological (e.g., heavy metals, pesticides) risks. Special topics include endocrine disruptors, nanomaterials, genotoxicity, and non-testing methods like QSAR and TTC. Practical examples include risk assessments for lead and atrazine in drinking water, PAHs in food, and nickel from cookware. The document emphasizes the importance of data quality, transparency, and multidisciplinary collaboration. It provides tools and models for predictive microbiology and chemical exposure estimation. Regulatory frameworks from the EU and international bodies are integrated throughout the guidelines. The aim is to standardize national approaches, improve assessment quality, and support public health protection.
Food Domain: Plant Health
Abstract/Summary:This guidance document from Office for Risk Assessment & Research (BuRO) of the Dutch Food and Consumer Product Safety Authority (NVWA) outlines the methodology for assessing risks associated with phytosanitary hazards. It follows a structured four-step approach: identification of EU quarantine organisms or harmful organisms potentially qualifying as EU quarantine pests, estimation of the likelihood of their introduction and spread in the Netherlands, estimation of their potential impact on commercial cultivation, trade and export, and natural ecosystems, and final risk characterization. The steps in the methodology align with the steps in the International Standard of Phytosanitary Measures No. 11 (ISPM No. 11) for preparing “Pest Risk Analysis for quarantine pests” and also correspond to the framework used by the European and Mediterranean Plant Protection organization (EPPO) for preparing a risk assessment.
Food Domain: Other; Allergens
Abstract/Summary:Food allergens are substances (often proteins) that commonly cause allergic reactions or other hypersensitivity issues. In food safety risk communication, as in this report, food that contains allergenic proteins (e.g., milk) are described as ‘allergens’ even though the specific food actually contains a number of different allergenic proteins. Allergens such as milk, peanut, or egg protein can go undeclared in food products due to mislabelling or contamination. Undeclared allergens can cause severe allergic reactions and a dose–response relationship exists, meaning that more allergic consumers will react if they are exposed to higher doses of the allergen. The symptoms of an allergic reaction vary from mild to severe and can involve one or several organs including the skin, the stomach, and the airways. The most severe symptom is anaphylactic shock, which can be fatal. Globally, peanuts, tree nuts, milk and crustaceans are the most common causes of anaphylaxis, including fatal anaphylactic shock.
Double blind placebo-controlled food challenges (DBPCFC) are the standard method for testing whether an individual is allergic to a food and can also be performed to test at which dose an allergic individual reacts. Data from individual DBPCFC can be used to calculate eliciting doses at the population level. Doses that elicit reactions in one to fifty percent of individuals allergic to milk, peanuts, hazelnuts, eggs, cashew nuts, walnuts, soy, wheat, shrimp, fish or celery, are described in this guide. The interval is collected from scientific publications.
Labelling of allergenic ingredients is regulated in the Food Information Regulation (EU) No 1169/2011. Food allergens are considered hazards in Hygiene regulation (EC) No 852/20049 and food business operators therefore need to assess the risk of allergens and allergen crosscontamination in order to make risk-based decisions and take risk-based measures.
This risk assessment guide offers comprehensive information regarding how the Swedish Food Agency will assess the risk of allergic reactions in a population when the concentration of an undeclared allergen is identified. Food business operators and control authorities may also use the guide to calculate the risk undeclared allergens might constitute. The focus of the guide is on deterministic risk assessment, which offers a point estimate based on analytical results (mg/kg), food consumption data, and eliciting doses. Aspects to consider regarding analytical data, measurement uncertainty, food consumption data (portion sizes), and eliciting doses for different food allergens are included. In addition, the reference doses for food allergens proposed by FAO/WHO expert consultation on reference doses for food allergens (FAO/WHO, 2021) are included. This report does not give advice as per which doses require actions, nor does it advise as to which risk management decision would be most appropriate in any given situation.
Original title:Valutazione del benessere animale delle galline ovaiole-manuale di autocontrollo - ClassyFarm
Food Domain: Animal Welfare
Abstract/Summary:"ClassyFarm is an IT platform of the Italian Ministry of Health, developed by the Istituto Zooprofilattico Sperimentale della Lombardia e dell'Emilia Romagna """"Bruno Ubertini"""" (IZSLER), with the aim to categorise livestock farms based on their risk in animal welfare, biosecurity, and antimicrobial use.
Within this platform, several data are inserted: in relation to Animal Welfare of laying hens, a guidance and a checklist have been developed for on-farm risk assessment to be run by a farm veterinarian (private practitioner). To guarantee a uniform collection of management-based, resource-based, and animal-based indicators, this guidance has been developed.
The indicators are based on current European and Italian animal welfare legislation and international scientific references, such as the Welfare Quality protocol (2009) and several EFSA Opinions and Guidelines. For each indicator (question), three possible answers have been identified according to three levels of risk:
- Level 1 - High risk: unacceptable or non-compliant condition; some animals may be in stressful situations and exposed to hazards.
- Level 2 - Controlled Risk: compliant condition, where animals benefit at least from the five animal welfare freedoms.
- Level 3 - Low risk: optimal condition, above minimum law requirements, which allows animals to have rewarding positive experiences.
Once the farm veterinarian submits aswers to the Classyfarm Platfor, the system provides scores for non-animal-based and animal-based indicators, breaking them down into three assessment areas (on a 0-100% scale scoring system):
- Area A: Farm management and staff training
- Area B: Facilities and equipment
- Area C: Animal-based measures
- along with a final total score for overall Animal Welfare (0-100%).
For more info: https://www.classyfarm.it/index.php/en/what-en"""
Original title:Linee guida in materia di igiene delle carni di selvaggina selvatica
Food Domain: Biological Hazards
Abstract/Summary:The game meat sector has shown a constant increase in supply and demand in recent years. In particular, the preparation of game meat-based dishes in public catering is increasingly found even outside the traditionally dedicated areas. At the same time, there is a significant increase in the number of certain wild animal populations, particularly ungulates. Most of this game can be hunted in accordance with the sector regulations and some species are subject to specific numerical control plans, which may involve different parties, as provided for by Law 157/92 and Law 394/91. Furthermore, in some periods of the year, there is the availability of large quantities of small game meat, both furred and feathered, killed during hunting. Finally, the movements of wild game carcasses or meat carried out directly by hunters, within the EU or outside the EU, must be considered. In such a context of wide availability of game meat, killed by hunting or as part of containment plans implemented by the competent bodies, and of great demand from consumers and restaurateurs, it is necessary to share the reference guidelines for the hygienic production of game meat and for the methods of official control of the same. The special rules on the protection of warm-blooded fauna and animal health are reserved. Since wild game, like other wild animals, is an important tool for assessing the prevalence of parasites and other zoonotic agents, it is also possible to proceed with regular checks on animals classified as indicators. The results of the monitoring carried out on the fauna will be included in the annual report in accordance with Directive 2003/99/EC of the European Parliament and of the Council. As is known, Regulation (EC) No 853/2004, which establishes specific rules on the hygiene of food of animal origin, in Annex III, Section IV, defines precise requirements regarding the placing on the market of wild game meat. The regulation does not apply to primary production for private domestic use as well as "to hunters who supply small quantities of wild game or wild game meat directly to the final consumer or to laboratories attached to retail or local catering establishments supplying the final consumer" (art. 1, co-signature 3, letter e of regulation (EC) 853/2004). The regulation of this last aspect, in application of the principle of subsidiarity, is delegated to the individual Member States. Italy has partially implemented this last provision through the agreement between the Ministry of Health, the Regions and the autonomous Provinces of 9/2/2006, lastly updated and modified with the agreement between the Government, the Regions and the autonomous Provinces relating to "Application guidelines of Regulation no. 852/2004/EC of the European Parliament and of the Council on the hygiene of food products" (Rep. Atti no. 59/CSR of 29 April 2010). These guidelines aim to harmonise the indications relating to the hygiene of the production of wild game meat, as defined in points I and 5 of Annex I to Regulation (EC) no. 853/2004, as well as the related official control activities on the national territory. These guidelines do not apply to farmed game as defined in Annex I, point 1.6 of Regulation (EC) no. 853/2004.
Food Domain: Plant Health
Abstract/Summary:This guidance document from Office for Risk Assessment & Research (BuRO) of the Dutch Food and Consumer Product Safety Authority (NVWA) outlines the methodology for assessing risks associated with phytosanitary hazards in a relatively short time. This method can be used to assess a large number of organisms that do not (yet) occur in the Netherlands in a relatively short time. The method provides an indication of the likelihood of introduction and the potential impact of the organism on cultivation, green spaces, and export. The framework consists of 10 questions, and a score is requested for each question. When assigning a score, a brief explanation with references to the sources consulted is sufficient.
OPINION of the French Agency for Food, Environmental and Occupational Health Safety on a guide for assessing the specific health risk of nanomaterials in products intended for food
Original title:AVIS de l’Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail relatif à un guide d’évaluation du risque sanitaire spécifique aux nanomatériaux dans les produits destinés à l’alimentation
Food Domain: Food Contact Materials; Food Improvement Agents;…
Abstract/Summary:This ANSES guidance document provides a framework for assessing health risks associated with nanomaterials in food products. The document highlights the lack of harmonized regulations and the coexistence of multiple definitions of nanomaterials across different EU legislative texts, which creates confusion. ANSES proposes a structured approach to evaluate potential health risks, including hazard identification, exposure assessment, and toxicological analysis. While the two methodologies developed by EFSA (2018) and ANSES are based on broadly similar risk assessment concepts and methodologies, ANSES proposed specific variations in relation to regulatory definitions, particle size measurements, dissolution properties and hazard identification. This guide is a continuation of the work initiated by ANSES, contributing to the scientific debate and the search for the most appropriate method for assessing the health risks posed by manufactured nanomaterials.
Original title:Linee guida nazionali in materia di protezione di conigli allevati per la produzione di carne.
Food Domain: Animal Welfare
Abstract/Summary:In 2014, the Italian Ministry of Health issued guidelines for the farming of meat rabbits, aiming to guide the production sector toward improved animal management practices. This initiative was taken in light of the fact that, both at the European and national levels, there is currently no specific legislation in force for this species. The only applicable regulatory framework remains Legislative Decree 146/2001 (transposing Directive 98/58/EC), which, however, provides general provisions that are too broad to be effectively applied to rabbits. The purpose of the ministerial guidelines was to offer basic recommendations through a practical tool intended for both farmers and veterinary services responsible for official controls. Following requests from sector associations, the need arose to update these guidelines based on new scientific evidence. To this end, a dedicated working group was established within the Ministry of Health, which also considered the latest scientific opinion published by the European Food Safety Authority (EFSA) on January 9, 2020. The final version of the text underwent an internal review process within the Ministry of Health and was subsequently revised in accordance with the opinion expressed by Section IV of the Higher Health Council on September 16, 2020. The document was then submitted to the Regions and Autonomous Provinces, which issued a favorable opinion on January 20, 2021. The expected impact of these new guidelines (Annex 1), beyond raising awareness among farmers regarding improved and innovative farming and animal management practices compared to previous methods, is to help align the sector with the requirements of both the national and European Union markets. It is therefore hoped that the production sector will take full advantage of this opportunity—not only to reassure consumers but also to be adequately prepared in the event of future national or EU legislative developments, a prospect already advocated by several EU Member States.
Original title:Valutazione del benessere animale e della biosicurezza dell'allevamento del bovino da carne: manuale di autocontrollo- ClassyFarm
Food Domain: Animal Health; Animal Welfare; Biological Hazards
Abstract/Summary:"ClassyFarm is an IT platform of the Italian Ministry of Health, developed by the Istituto Zooprofilattico Sperimentale della Lombardia e dell'Emilia Romagna ""Bruno Ubertini"" (IZSLER), with the aim to categorise livestock farms based on their risk in animal welfare, biosecurity, and antimicrobial use.
Within this platform, several data are inserted: in relation to Animal Welfare and Biosecurity in beef cattles, a guidance and a checklists have been developed for on-farm risk assessment to be run by a farm veterinarian (private practitioner). To guarantee a uniform collection of management-based, resource-based, and animal-based indicators, this guidance has been developed.
The indicators are based on current European and Italian animal welfare legislation and international scientific references, such as the Welfare Quality protocol (2009) and several EFSA Opinions and Guidelines. For each indicator (question), three possible answers have been identified according to three levels of risk:
- Level 1 - High risk: unacceptable or non-compliant condition; some animals may be in stressful situations and exposed to hazards.
- Level 2 - Controlled Risk: compliant condition, where animals benefit at least from the five animal welfare freedoms.
- Level 3 - Low risk: optimal condition, above minimum law requirements, which allows animals to have rewarding positive experiences.
Once the farm veterinarian submits aswers to the Classyfarm Platfor, the system provides scores for non-animal-based and animal-based indicators, breaking them down into three assessment areas (on a 0-100% scale scoring system):
- Area A: Farm management and staff training
- Area B: Facilities and equipment
- Area C: Animal-based measures
- along with a final total score for overall Animal Welfare (0-100%).
For more info: https://www.classyfarm.it/index.php/en/what-en"
https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Feng.mst.dk%2Fmedia%2Fk54dai3p%2Fbird-mammal-scenario-template-v20-1.xlsm&wdOrigin=BROWSELINK
Food Domain: Pesticides
Abstract/Summary:This is a guidance document developed by the Danish EPA for higher tier risk assessment of pesticides for birds and mammals. It has been revised to meet the need for a common strategy within the Northern Zone. The guidance describes species to be included, and the focal species to be used in higher tier risk assessment for each combination of crop and growth stage. The exposure scenarios, particularly the composition of diet to be used for all relevant combinations of focal species, crop and growth stage has been specified in more detail. A calculator tool (Excel spreadsheet) was developed for use in connection with the guidance. The calculator tool is a flexible tool, which complements the EFSA Calculator Tool for Tier 1 risk assessment, providing a range of refinement options for many species required for higher tier risk assessment. It supports regulatory evaluations within the Northern Zone framework, which includes several European countries collaborating on plant protection product authorizations. The template facilitates detailed modeling of exposure scenarios by integrating species-specific data such as body weight, diet composition, and application intervals. It calculates predicted environmental concentrations and compares them with toxicological endpoints like LD50 values to determine risk quotients. It is primarily used by applicants and evaluators to demonstrate compliance with EU Regulation No. 1107/2009, promoting safer pesticide use and protecting wildlife.
Food Domain: Nutrition
Abstract/Summary:The purpose of this report is threefold:
(1) To provide scientific advice to the FSAI to develop guidance for the food industry on safety of vitamins and minerals in food supplements
(2) To provide ULs and highest intakes of vitamins and minerals for population groups in Ireland to allow risk assessments of food supplements on Irish market, and
(3) To outline the method for assessing the safety of food supplements for population groups in Ireland
Food Domain: Pesticides monitoring
Abstract/Summary:Groundwater monitoring is recommended as a higher-tier option in the regulatory groundwater assessment of crop protection products in the European Union. However, to date little guidance has been provided on the study designs. The SETAC EMAG-Pest GW group (a mixture of regulatory, academic, and industry scientists) was created in 2015 to establish scientific recommendations for conducting such studies. This report provides recommendations for study designs and study procedures made by the Society of Environmental Toxicology and Chemistry (SETAC) Environmental Monitoring Advisory Group on Pesticides (EMAG-Pest). Because of the need to assess the vulnerability to leaching in both site selection and extrapolating study results, information on assessing vulnerability to leaching is also a major topic in this report. The design of groundwater monitoring studies must consider to which groundwater the groundwater quality standard is applicable and the associated spatial and temporal aspects of its application, the objective of the study, the properties of the active substance and its metabolites, and site characteristics. This limits the applicability of standardised study designs. The effect of the choice of groundwater to which the water quality guideline is applied on study design is illustrated and examples of actual study designs are presented.
Attribution: Abstract reproduced from Journal of Consumer Protection and Food Safety, 2019, licensed under CC BY 4.0.
Original title:Valutazione del benessere animale nell'allevamento suino dallo svezzamento all'ingrasso - ClassyFarm
Food Domain: Animal Welfare
Abstract/Summary:"ClassyFarm is an IT platform of the Italian Ministry of Health, developed by the Istituto Zooprofilattico Sperimentale della Lombardia e dell'Emilia Romagna """"Bruno Ubertini"""" (IZSLER), with the aim to categorise livestock farms based on their risk in animal welfare, biosecurity, and antimicrobial use.
Within this platform, several data are inserted: in relation to Animal Welfare in pig farming, from the weaning phase to the fattening phase, a guidance and a checklist have been developed for on-farm risk assessment to be run by a farm veterinarian (private practitioner). To guarantee a uniform collection of management-based, resource-based, and animal-based indicators, this guidance has been developed.
The indicators are based on current European and Italian animal welfare legislation and international scientific references, such as the Welfare Quality protocol (2009) and several EFSA Opinions and Guidelines. For each indicator (question), three possible answers have been identified according to three levels of risk:
- Level 1 - High risk: unacceptable or non-compliant condition; some animals may be in stressful situations and exposed to hazards.
- Level 2 - Controlled Risk: compliant condition, where animals benefit at least from the five animal welfare freedoms.
- Level 3 - Low risk: optimal condition, above minimum law requirements, which allows animals to have rewarding positive experiences.
Once the farm veterinarian submits aswers to the Classyfarm Platfor, the system provides scores for non-animal-based and animal-based indicators, breaking them down into three assessment areas (on a 0-100% scale scoring system):
- Area A: Farm management and staff training
- Area B: Facilities and equipment
- Area C: Animal-based measures
- along with a final total score for overall Animal Welfare (0-100%).
For more info: https://www.classyfarm.it/index.php/en/what-en"""
Original title:Valutazione del benessere animale del suino da riproduzione: manuale di autocontrollo-ClassyFarm
Food Domain: Animal Welfare
Abstract/Summary:"ClassyFarm is an IT platform of the Italian Ministry of Health, developed by the Istituto Zooprofilattico Sperimentale della Lombardia e dell'Emilia Romagna """"Bruno Ubertini"""" (IZSLER), with the aim to categorise livestock farms based on their risk in animal welfare, biosecurity, and antimicrobial use.
Within this platform, several data are inserted: in relation to Animal Welfare of breeding pigs, a guidance and a checklist have been developed for on-farm risk assessment to be run by a farm veterinarian (private practitioner). To guarantee a uniform collection of management-based, resource-based, and animal-based indicators, this guidance has been developed.
The indicators are based on current European and Italian animal welfare legislation and international scientific references, such as the Welfare Quality protocol (2009) and several EFSA Opinions and Guidelines. For each indicator (question), three possible answers have been identified according to three levels of risk:
- Level 1 - High risk: unacceptable or non-compliant condition; some animals may be in stressful situations and exposed to hazards.
- Level 2 - Controlled Risk: compliant condition, where animals benefit at least from the five animal welfare freedoms.
- Level 3 - Low risk: optimal condition, above minimum law requirements, which allows animals to have rewarding positive experiences.
Once the farm veterinarian submits aswers to the Classyfarm Platfor, the system provides scores for non-animal-based and animal-based indicators, breaking them down into three assessment areas (on a 0-100% scale scoring system):
- Area A: Farm management and staff training
- Area B: Facilities and equipment
- Area C: Animal-based measures
- along with a final total score for overall Animal Welfare (0-100%).
For more info: https://www.classyfarm.it/index.php/en/what-en"""
Original title:Linee Guida per una sana alimentazione
Food Domain: Nutrition
Abstract/Summary:04-05. This is the Italian reference document on healthy eating, aimed at consumers. It contains a series of dietary advice and recommendations developed by a special scientific committee comprising prestigious scholars from the fields of nutrition and beyond, and is periodically updated. The Italian Guidelines for Healthy Eating are based on the well-known Mediterranean dietary model, which, although not widely followed, is universally recognised as the most effective combination of health and well-being with sensory fulfilment. The priority objective of the Guidelines is to prevent overeating and obesity, a problem that is particularly prevalent among disadvantaged population groups in Italy, especially children. In this revision of the Guidelines, the concept of healthy eating is presented as a means of protecting against chronic degenerative diseases, promoting health and longevity, ensuring social and environmental sustainability, and improving quality of life.
Original title:Valutazione del benessere animale: linee guida per la prevenzione del taglio coda nell'allevamento suino dallo svezzamento all'ingrasso -ClassyFarm
Food Domain: Animal Welfare
Abstract/Summary:"ClassyFarm is an IT platform of the Italian Ministry of Health, developed by the Istituto Zooprofilattico Sperimentale della Lombardia e dell'Emilia Romagna """"Bruno Ubertini"""" (IZSLER), with the aim to categorise livestock farms based on their risk in animal welfare, biosecurity, and antimicrobial use.
Within this platform, several data are inserted: in relation to Animal Welfare and prevention of tail docking application in pig farming, from the weaning phase to the fattening phase, a guidance and a checklist have been developed for on-farm risk assessment to be run by a farm veterinarian (private practitioner). To guarantee a uniform collection of management-based, resource-based, and animal-based indicators, this guidance has been developed.
The indicators are based on current European and Italian animal welfare legislation and international scientific references, such as the Welfare Quality protocol (2009) and several EFSA Opinions and Guidelines. For each indicator (question), three possible answers have been identified according to three levels of risk:
- Level 1 - High risk: unacceptable or non-compliant condition; some animals may be in stressful situations and exposed to hazards.
- Level 2 - Controlled Risk: compliant condition, where animals benefit at least from the five animal welfare freedoms.
- Level 3 - Low risk: optimal condition, above minimum law requirements, which allows animals to have rewarding positive experiences.
Once the farm veterinarian submits aswers to the Classyfarm Platfor, the system provides scores for non-animal-based and animal-based indicators, breaking them down into three assessment areas (on a 0-100% scale scoring system):
- Area A: Farm management and staff training
- Area B: Facilities and equipment
- Area C: Animal-based measures
- along with a final total score for overall Animal Welfare (0-100%).
For more info: https://www.classyfarm.it/index.php/en/what-en"""
Original title:Vadlīnijas antimikrobiālās rezistences attīstības ierobežošanai lauksaimnieciskās ražošanas posmā un veterinārmedicīnas praksē Latvijā
Food Domain: Biological Hazards - EUSR zoonoses and AMR
Abstract/Summary:This Latvian guidance document focuses on limiting the development of antimicrobial resistance (AMR) in agriculture and veterinary practice. It was developed under the AgroBioRes project and integrates international recommendations with national research findings. The document outlines the causes and spread of AMR, emphasizing the risks of improper antibiotic use, such as overuse, incorrect dosing, and lack of diagnosis. It highlights the environmental impact of antibiotic residues and the role of food in transmitting resistant microorganisms. The "One Health" approach is central, recognizing the interconnectedness of human, animal, and environmental health. The guidance provides principles for responsible antibiotic use, including avoiding routine group treatments, ensuring proper animal welfare, and implementing disease prevention strategies. It also discusses the roles of veterinarians, animal owners, and regulators, and includes classifications of antibiotics, resistance mechanisms, and global efforts to combat AMR. The document aims to promote sustainable practices and reduce reliance on antibiotics to preserve their effectiveness for both human and animal health.*
Original title:AVIS de l'Anses relatif aux lignes directrices pour l'évaluation des allégations en alimentation animale - Evaluation des dossiers de preuve des allégations fonctionnelles
Food Domain: Animal Feed
Abstract/Summary:This ANSES Opinion presents guidance for evaluating dossiers that support functional claims about animal feed (i.e. claims that a feed has specific beneficial effects). The document outlines the principles and criteria that competent authorities or experts should apply to assess whether submitted evidence is sufficient, reliable, and biologically plausible. Key elements include: (1) defining the claimed effect precisely; (2) establishing a credible mode of action or causal mechanism; (3) demonstrating effect size, consistency, and reproducibility across studies; (4) assessing the quality, relevance, and internal validity of trials (including controls, randomization, blinding, statistical methods); (5) integrating lines of evidence (in vivo, in vitro, mechanistic) and resolving contradictions; (6) considering dose-response relationships and exposure relevance; and (7) evaluating uncertainties and potential biases. The guidance emphasizes transparency in justifying judgments and the need for dossiers to present all relevant data, including negative studies or anomalies, and to allow assessment of robustness and generalizability of the claimed effect.
OPINION of the French Agency for Food, Environmental and Occupational Health Safety regarding the update of the guidelines for the evaluation of guides to good hygiene practices and the application of HACCP principles
Original title:AVIS de l’Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail relatif à l’actualisation des lignes directrices pour l’évaluation des guides de bonnes pratiques d’hygiène et d’application des principes HACCP (GBPH)
Food Domain: Biological Hazards; Contaminants; Allergens
Abstract/Summary:This ANSES guidance document updates the evaluation framework for guides to good hygiene practices and the application of HACCP principles in the food sector. It aims to ensure that these guides remain aligned with current scientific knowledge, regulatory requirements, and practical realities in food production. The document outlines criteria for assessing the relevance, clarity, and effectiveness of hygiene guides, emphasizing their role in supporting food business operators in managing risks and complying with food safety regulations. It also provides methodological recommendations for drafting and reviewing the guides.
Scientific and technical support note from the French Agency for Food, Environmental and Occupational Health Safety related to "rules for the constitution of applications for authorization of food processing aids and the acceptance of theoretical calculations related to exposure assessment"
Original title:NOTE d’appui scientifique et technique de l’Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail relative aux « règles de constitution des dossiers de demande d’autorisation d’auxiliaires technologiques et l’acceptation des calculs théoriques en lien avec l’évaluation de l’exposition »
Food Domain: Food Processing aids
Abstract/Summary:This ANSES guidance document provides scientific and technical support for preparing application dossiers for the authorization of food processing aids under French regulation. It describes three methods to estimate consumer exposure to residues, degradation products, and reaction by-products. The document outlines a tiered approach to dossier preparation based on usage levels and expected residue concentrations. It details the required administrative, technical, and toxicological data, including substance identity, manufacturing process, technological role, and analytical methods.
Food Domain: Pesticides
Abstract/Summary:Evaluation of data relevance, reliability and contribution to uncertainty is crucial in regulatory health risk assessment if robust conclusions are to be drawn. Whether a specific study is used as key study, as additional information or not accepted depends in part on the criteria according to which its relevance and reliability are judged. In addition to GLP-compliant regulatory studies following OECD Test Guidelines, data from peer-reviewed scientific literature have to be evaluated in regulatory risk assessment of pesticide active substances. Publications should be taken into account if they are of acceptable relevance and reliability. Their contribution to the overall weight of evidence is influenced by factors including test organism, study design and statistical methods, as well as test item identification, documentation and reporting of results. Various reports make recommendations for improving the quality of risk assessments and different criteria catalogues have been published to support evaluation of data relevance and reliability. Their intention was to guide transparent decision making on the integration of the respective information into the regulatory process. This article describes an approach to assess the relevance and reliability of experimental data from guideline-compliant studies as well as from non-guideline studies published in the scientific literature in the specific context of uncertainty and risk assessment of pesticides.
Attribution: Abstract reproduced from Journal of Regulatory Toxicology and Pharmacology, 2017, licensed under (CC BY-NC-ND 4.0).
ANSES methodological guide for the planning of expert assessments, uncertainty analysis, literature review, and evaluation of the weight of evidence
Original title:Guide méthodologique de l’Anses pour la planification des expertises, l’analyse d’incertitude, la revue de la littérature et l’évaluation du poids des preuves
Food Domain: Animal Health; Animal Welfare; Biological Hazards…
Abstract/Summary:This methodological report by ANSES (GT ACCMER) aims to operationalize previous recommendations from GT MER by adapting them into a pragmatic framework for internal use. It offers guidance on planning expert assessments, conducting literature reviews, evaluating the weight of evidence, and analyzing uncertainties systematically in risk evaluation contexts. The document also provides decision criteria for choosing methods proportionate to the complexity, data availability, and stakes of each expertise. Key features include standardized review protocols, dual independent assessments, structured integration of evidence lines, transparent justification of methodological choices, and graded expression of confidence or uncertainty. By embedding these processes into the organisational practices of ANSES and allowing iterative refinement during pilot implementation, the report seeks to enhance consistency, rigour, reproducibility and transparency across the Agency’s expert assessments.
Original title:Prise en compte de l’incertitude en évaluation des risques : revue de la littérature et recommandations pour l’Anses
Food Domain: Animal Health; Animal Welfare; Biological Hazards…
Abstract/Summary:This ANSES guidance (Prise en compte de l’incertitude en évaluation des risques) reviews scientific concepts and methodologies for treating uncertainty within risk assessment, and offers recommendations tailored to ANSES practices. It begins by defining types and sources of uncertainty (e.g. data gaps, model assumptions, variability) and reviews methods (probabilistic models, sensitivity analysis, scenario analysis, expert elicitation, qualitative approaches). It proposes a structured workflow: planning the uncertainty analysis, identifying and characterizing uncertainties in each assessment step, propagating uncertainties through the model, and communicating them transparently. The document emphasizes distinguishing uncertainty from variability, documenting assumptions and choices, expressing confidence levels or degrees of uncertainty, and using both quantitative and qualitative approaches when appropriate. In its annex (“illustrations and updates”), the working group recommends explicitly integrating uncertainty analysis and weight-of-evidence elements into assessments. Overall, the guidance seeks to improve robustness, clarity and consistency in how ANSES deals with uncertainty in scientific assessments.
Evaluation of the weight of evidence at ANSES: critical review of the literature and recommendations at the hazard identification stage
Original title:Évaluation du poids des preuves à l’Anses: revue critique de la littérature et recommandations à l’étape d’identification des dangers
Food Domain: Animal Health; Animal Welfare; Biological Hazards…
Abstract/Summary:This guidance report by ANSES critically reviews existing literature on the “weight of evidence” (WoE) approach as applied in the hazard identification phase of risk assessment, and makes methodological recommendations to harmonize internal practices. It defines key concepts (e.g. line of evidence, WoE, systematic review), proposes a four-step framework (planning, establishment of evidence lines, integration, expression of conclusions), and evaluates ~25 methods from the literature according to criteria of directionality, relevance, and feasibility. The report then compares these with current practices at ANSES and formulates concrete recommendations to improve transparency, reproducibility and consistency in expert assessments. Recommendations include use of formal reading grids, dual independent review, meta-analysis or multicriteria methods where possible, explicit justifications of choices, and graded expression of evidence strength. The document aims to strengthen the credibility and robustness of scientific expertise within ANSES.
OPINION of the National Agency for for Food, Environmental and Occupational Health & Safety on "Recommendations for the development of a good practice guide to ensure animal welfare"
Original title:AVIS de l’Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail relatif à des « Recommandations pour l’élaboration d’un guide de bonnes pratiques pour assurer le bien-être animal »
Food Domain: Animal Welfare
Abstract/Summary:This ANSES Avis provides recommendations for drafting Guides of Best Practices (GBP) to ensure animal welfare. The guidance is intended to help ANSES evaluate such GBP and to assist professionals in producing them. It emphasizes that GBP should be consistent, transparent, and scientifically grounded while remaining practical for intended users and adaptable to evolving knowledge. Animal welfare is defined as a multidimensional state reflected by satisfying physiological and behavioral needs and the ability to cope with environment. The document proposes a template for GBP, covering sections including objectives, scope (species, settings, actors), regulatory foundation, risk/factor analysis, description of recommended practices, control strategies, indicators, glossary, and annexes. Controls are categorized into first-level (operator self-checks), second-level (periodic internal sampling checks), and third-level (external audits or certification). The GBP should include strategies for monitoring, corrective actions, and updates over time. A multi-stakeholder drafting committee is recommended, involving operators, scientists, regulatory bodies, and external experts. The Avis underscores the importance of clarity, readability, and transparency of decision logic; and it encourages periodic revision and evaluation of GBP based on evidence, indicators, and feedback.
Food Domain: Pesticides
Abstract/Summary:Cumulative risk assessment (CRA) is of major importance and one of the biggest challenges for the future as a legal requirement within the EU for active substances used in plant protection products (PPP) and biocidal products (BP). Therefore, it is important to develop a methodology to take into account cumulative and synergistic effects for both active substances and substances of concern (SoC). The implementation of cumulative aspects in regulatory decisions is highly demanded and promoted by EU parliament, EU commission, European Food Safety Authority (EFSA), European Chemicals Agency (ECHA) and national authorities. Based on EFSA’s and ECHA’s work on CRA, the Federal Institute for Risk Assessment (BfR) drafted a concept on how to take cumulative aspects into account in the regulatory context in risk assessments for operators, consumers and other uninvolved third parties. Application of this concept as part of the routine risk assessment for PPP and BP is envisaged as soon as suitable experience has been gained in a testing phase. The BfR draft concept uses dose-addition of individual active substances and SoC as the toxicological standard concept for CRA and proposes a tiered approach. It recommends to start with calculation of a hazard index (HI) for all relevant substances contained in the PPP or BP under consideration. Proceeding to higher tiers is currently foreseen if the HI is larger than 1, i.e., an unacceptable risk cannot be excluded. In higher tiers, the HI should be calculated with respect to common targets and might consider effect-specific NOAEL’s (No Observed Adverse Effect Level) or relative potency factors, if available. Refinements should consider both the toxicity and the exposure part of the CRA and will depend on availability of relevant data. BfR acknowledges the complexity of the refinement work in mixture risk assessment to be done. The exposure assessment for operators, bystanders/residents and workers as well as the acute exposure assessment for consumers rely mainly on the active substances in a PPP or BP under consideration or on combinations of products for which simultaneous use is notified. Chronic consumer exposure assessment needs to take into account all relevant substances contained in the PPP or BP under consideration, but also the residue background of other pesticides in food, which have to be derived from representative food monitoring programmes. A representative food monitoring database is currently being developed. The assessment requires the application of complex probabilistic methods. It is planned that BfR will review the chronic CRA for each active substance and each CAG regularly as soon as all essential monitoring data are available. It is planned to carry out case studies on the impact on regulatory decisions. The paper is intended to promote further discussions of risk assessors, risk managers as well as stakeholders in this area on the applicability of CRA in routine authorisation procedures for PPP and BP and to encourage the flexible use of strategies in CRA.
Attribution: Abstract reproduced from Journal of Consumer Protection and Food Safety, 2014, licensed under CC BY 4.0.
OPINION of the French Agency for Food, Environmental and Occupational Health and Safety relating to the revision of the guidelines for the assessment of risks to humans of the constituents of cleaning products for materials and objects intended for contact with foodstuffs
Original title:AVIS de l’Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail relatif à la révision des lignes directrices pour l'évaluation des risques pour l'homme des constituants des produits de nettoyage des matériaux et objets destinés au contact avec des denrées alimentaires
Food Domain: Food Contact Materials
Abstract/Summary:This ANSES guidance document provides updated scientific and technical support for preparing application dossiers for the authorization of the constituents of cleaning products for FCM. The document replaces earlier recommendations and clarifies the requirements for dossiers submitted for authorization under French regulation. It outlines the types of data needed to demonstrate food safety. It details the required administrative, technical, and scientific data including substance identity, impurities, analytical methods, toxicological data (following a tiered approach base on exposure levels), conditions of use, exposure estimates to residues in food.
Food Domain: GMO
Abstract/Summary:This ANSES guidance opinion presents recommendations for statistically analysing 90-day rat feeding studies used in GMO risk assessment. It reviews common practices—parametric and non-parametric tests, data transformations, mixed models for repeated measures, and equivalence testing—and discusses their strengths and limitations. The document emphasises the importance of identifying and handling outliers, ensuring assumptions (e.g. normality, homoscedasticity), and choosing appropriate models for repeated data (e.g. weight curves). To reduce false negatives, ANSES recommends relaxing the Type I error level (e.g. setting α = 10 %) to increase statistical power, while correcting for multiple comparisons (e.g. via False Discovery Rate). Power analyses are advocated to determine sample sizes or assess post hoc detectability of effects. For many parameters, adequate power may require increasing group sizes from the standard 10 to about 20 animals per sex/group. Equivalence testing is discussed but it is difficult to use these tests for analysing data from toxicological tests on laboratory animals as the results can only be interpreted if a large number of animals per group and per sex. Finally, ANSES advises making raw data available and using graphical representations of effect sizes to enhance transparency and expert interpretation.
Original title:Une méthode qualitative d’estimation du risque en santé animale
Food Domain: Animal Health
Abstract/Summary:This methodological document, titled A qualitative risk assessment method in animal health, presents a structured qualitative approach for estimating risks in veterinary contexts. It frames risk analysis according to the standard phases: hazard identification, risk assessment, risk management, and risk communication. The document proposes a decision-aiding tool using categorical scales (e.g. negligible, low, medium, high) to rate likelihoods and consequences, and to combine them into qualitative risk levels. It emphasizes using expert judgment in a transparent, documented way, integrating epidemiological, biological, and managerial data. The method suggests steps to define the context, identify hazards and pathways, evaluate the probability of occurrence and magnitude of impact, and characterize resulting risk. Uncertainties should be explicitly stated, and assumptions recorded. The guidance also underscores that qualitative approaches should be proportionate to available data and resource constraints, and may serve as a preliminary screening tool before more quantitative analyses. In sum, it offers a pragmatic, transparent framework to support decision-making in animal health when quantitative data are limited.
OPINION of the French Food Safety Agency on the preparation of risk assessment dossiers related to the use of plastic materials treated with ionizing radiation and intended to come into contact with foodstuffs: Guidelines
Original title:AVIS de l’Agence française de sécurité sanitaire des aliments relatif à la constitution des dossiers d’évaluation des risques sanitaires liés à l’emploi de matériaux plastiques traités par rayonnements ionisants et destinés au contact de denrées alimentaires : Lignes directrices
Food Domain: Food Contact Materials
Abstract/Summary:This document provides guidance to applicants submitting applications on FCM treated with ionizing radiation and intended to come into contact with foodstuffs, which are to be evaluated by Anses. It describes the administrative and scientific requirements for the preparation of the dossier submitted for authorization under French regulation.