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 7 documents
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.
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).
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.
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.
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).
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.