Britta Michalski

Human health risk assessment from combined exposure in the framework of plant protection products and biocidal products

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.

Compilation of processing factors and evaluation of quality controlled data of food processing studies

Often, agricultural commodities are not eaten raw but undergo processing operations prior to human consumption. These may significantly affect the residue levels of pesticides contained therein and/or thereon. Due to the physico-chemical properties of the residue, its concentration may decrease or increase in processed fractions compared to the initial concentration in the raw agricultural commodity (RAC). The resulting ratio between processed fraction and RAC is denoted as processing factor (Pf). Information obtained from processing studies may serve for 2 different purposes: to decide on compliance of residues in processed products with legal standards for the RAC, and to refine dietary exposure estimation of humans and livestock with respect to residues in processed products. The German Federal Institute for Risk Assessment (BfR) extracted and compiled the results of several processing studies, the full reports of which had been made available to BfR in the framework of applications either for pesticide authorisation, for the setting of maximum residue levels (MRL), or within the EU active substances approval programme. Each Pf derived from processing studies was reviewed against transparent quality criteria and statements have been made regarding the robustness and reliability of the study results. Compared to the former version, the revised BfR database includes a more extended, more detailed and more trustworthy compilation of more than 6500 processing factors accompanied by relevant information on key parameters of the underlying processing studies.

Dietary burden calculations relating to fish metabolism studies

Abstract Fish farming is increasingly dependent on plant commodities as a source of feed leading to an increased risk for pesticide residues in aquaculture diets and consequently their transfer into aquaculture food products. The European pesticide regulation requires fish metabolism and fish feeding studies where residues in fish feed exceed 0.1 mg kg−1 of the total diet (dry weight basis) to enable the setting of appropriate maximum residue levels in fish commodities. Fish dietary burden calculation is therefore an important prerequisite to decide on further experimental testing as part of the consumer risk assessment. In this review, the different aquaculture production systems are compared with regard to their specific feeding practices and the principles of dietary burden calculation are described.

[Plant protection products and their residues : Aspects of consumer safety in context of the new EU regulations].

The law regulating plant protection products (PPP) in the European Union (EU) was fundamentally revised through the introduction of Regulation (EC) No. 1107/2009 which is due to enter into force on 14 June 2011. EU-wide harmonized maximum residue levels (MRLs) for the active substances of PPP in foods are laid down in Regulation (EC) No. 396/2005 and apply since entry into force of the regulation on 1 September 2008. The goal of both regulations is to strengthen the level of consumer protection. PPP are subject to a strict assessment of active substances, which is regulated at the EU level as well as an authorization procedure in the EU Member States. Prior to application for authorization of a PPP, the active substance(s) it contains must be included in a positive list. Tests regarding the toxicity and residue behavior of PPP must be conducted by the applicant, and the respective documents must be submitted to the authorities for evaluation. Following review of the required data, toxicological threshold values are derived, consumer exposure is assessed, and the risk to health is evaluated. The goal of this evaluation is to ensure that the use of PPP according to good plant protection practice does not have any harmful effects on human health.

Pflanzenschutzmittel und ihre Rückstände, Aspekte der Verbrauchersicherheit im Kontext neuer EU-Verordnungen

The law regulating plant protection products (PPP) in the European Union (EU) was fundamentally revised through the introduction of Regulation (EC) No. 1107/2009 which is due to enter into force on 14 June 2011. EU-wide harmonized maximum residue levels (MRLs) for the active substances of PPP in foods are laid down in Regulation (EC) No. 396/2005 and apply since entry into force of the regulation on 1 September 2008. The goal of both regulations is to strengthen the level of consumer protection. PPP are subject to a strict assessment of active substances, which is regulated at the EU level as well as an authorization procedure in the EU Member States. Prior to application for authorization of a PPP, the active substance(s) it contains must be included in a positive list. Tests regarding the toxicity and residue behavior of PPP must be conducted by the applicant, and the respective documents must be submitted to the authorities for evaluation. Following review of the required data, toxicological threshold values are derived, consumer exposure is assessed, and the risk to health is evaluated. The goal of this evaluation is to ensure that the use of PPP according to good plant protection practice does not have any harmful effects on human health.

Pflanzenschutzmittel und ihre Rückstände

The law regulating plant protection products (PPP) in the European Union (EU) was fundamentally revised through the introduction of Regulation (EC) No. 1107/2009 which is due to enter into force on 14 June 2011. EU-wide harmonized maximum residue levels (MRLs) for the active substances of PPP in foods are laid down in Regulation (EC) No. 396/2005 and apply since entry into force of the regulation on 1 September 2008. The goal of both regulations is to strengthen the level of consumer protection. PPP are subject to a strict assessment of active substances, which is regulated at the EU level as well as an authorization procedure in the EU Member States. Prior to application for authorization of a PPP, the active substance(s) it contains must be included in a positive list. Tests regarding the toxicity and residue behavior of PPP must be conducted by the applicant, and the respective documents must be submitted to the authorities for evaluation. Following review of the required data, toxicological threshold values are derived, consumer exposure is assessed, and the risk to health is evaluated. The goal of this evaluation is to ensure that the use of PPP according to good plant protection practice does not have any harmful effects on human health.

Pflanzenschutzmittel und ihre Rückstände@@@Plant protection products and their residues: Aspekte der Verbrauchersicherheit im Kontext neuer EU-Verordnungen@@@Aspects of consumer safety in context of the new EU regulations

The law regulating plant protection products (PPP) in the European Union (EU) was fundamentally revised through the introduction of Regulation (EC) No. 1107/2009 which is due to enter into force on 14 June 2011. EU-wide harmonized maximum residue levels (MRLs) for the active substances of PPP in foods are laid down in Regulation (EC) No. 396/2005 and apply since entry into force of the regulation on 1 September 2008. The goal of both regulations is to strengthen the level of consumer protection. PPP are subject to a strict assessment of active substances, which is regulated at the EU level as well as an authorization procedure in the EU Member States. Prior to application for authorization of a PPP, the active substance(s) it contains must be included in a positive list. Tests regarding the toxicity and residue behavior of PPP must be conducted by the applicant, and the respective documents must be submitted to the authorities for evaluation. Following review of the required data, toxicological threshold values are derived, consumer exposure is assessed, and the risk to health is evaluated. The goal of this evaluation is to ensure that the use of PPP according to good plant protection practice does not have any harmful effects on human health.