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Unit Toxicology of Products and their Safe Use

The unit assesses whether the health of all persons can be ensured when the product is used as intended. People who may come into contact with plant protection products and biocidal products include operators, workers and unintended third parties such as residents and bystanders, as well as pets and farm animals.

The unit directly implements European regulations and national laws for biocidal and plant protection products. These stipulate the necessity of performing a safety assessment of the application for the evaluation and authorization procedures for pesticides. This is carried out in line with the EU regulations on pesticides (Regulation (EC) No. 1107/2009) and biocides (Regulation (EC) No. 528/2012), as well as with the regulation on Classification, Labelling and Packaging (CLP)(Regulation (EC) 1272/2008).

Key activities

Pesticide products will be assessed with regard to the following main aspects:

• Toxicity of the pesticide products (generally acute oral, dermal and inhalation toxicity, the potential for skin and eye irritation as well as sensitisation);
• Estimation of cumulative effects resulting from mixtures of the active substances and the co-formulants used;
• Determination of the dermal absorption of toxicological relevant substances (e.g. active substances, metabolites, substances of concern) of a pesticide product;
• Determination of the exposure of operators, workers and third parties to toxicologically relevant active substances and substances of concern due to the proposed applications for the products;
• Assessment of the health risk(s) resulting from uses of the products by comparing the estimated exposure with the toxicological reference values;
• Determination of proposals for the classification and labelling concerning toxicological aspects of the pesticide product according to the CLP regulation;
• Stipulation of restrictions on use, personal protection measures or other risk mitigation requirements to ensure the safe handling and application of the products.

Legal basis

The unit directly implements European regulations and national laws for biocidal and plant protection products. These stipulate the necessity of performing a safety assessment of the application for the evaluation and authorization procedures for pesticides. This is carried out in line with the EU regulations on

• pesticides (Regulation (EC) No. 1107/2009) and
• biocides (Regulation (EC) No. 528/2012), as well as with
• regulation on Classification, Labelling and Packaging (CLP)(Regulation (EC) 1272/2008).

Further activities

The unit is involved in the further development of testing methods as well as testing and assessment strategies for application safety. For example, models have been developed for the exposure assessment of professional operators for outdoor applications (Großkopf et al., 2013) as well as applications in greenhouses (Großkopf et al., 2016 and 2020) of plant protection products.

The unit is also involved in the EU harmonisation of the risk assessment of plant protection products and biocidal products (e.g. EFSA Guidance on pesticides exposure assessment of operators, workers, residents and bystanders (EFSA Journal 2014, 12, 3874 and EFSA Journal 2022, 20, 7032); EFSA Guidance on dermal absorption (EFSA Journal 2017, 15, 4873); Ad hoc Working Group - Human Exposure (HEAdhoc) of the European Chemicals Agency (ECHA)).

Additionally, the unit represents the BfR on specific issues in numerous national and international bodies and advises the German government on technical issues relating to the safe use of plant protection products and biocidal products.

The unit also assesses pesticides that may be used for pest control as arranged by the authorities in accordance with Section 18 of the German “protection against infection” law regarding.

The risk classification and assessment system Product Safety-Pesticides (ProSafe-Pesticides) is used for the toxicological evaluation of the pesticide products. This web application was developed to support the cumulative evaluation of pesticides concerning human health (see below About ProSafe-Pesticides).

Relevant publications

Adler-Flindt S, Martin S, 2019. Comparative cytotoxicity of plant protection products and their active ingredients. Toxicology in Vitro, 54, 354–366.
https://doi.org/10.1016/j.tiv.2018.10.020

Bloch D, Marx-Stoelting P, Martin S, 2020. Towards a tiered test strategy for plant protection products to address mixture toxicity by alternative approaches in human health assessment. Pest Management Science, 76, 3326–3332.
https://doi.org/10.1002/ps.6034

European Food Safety Authority (EFSA), 2014. Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment for plant protection products. EFSA Journal 2014, 12(10), 3874.
http://www.efsa.europa.eu/de/efsajournal/pub/3874

European Food Safety Authority (EFSA), 2017. Buist H, Craig P, Dewhurst I, Hougaard Bennekou S, Kneuer C, Machera K, Pieper C, Court Marques D, Guillot G, Ruffo F and Chiusolo A. Guidance on dermal absorption. EFSA Journal 2017, 15(6), 4873.
https://www.efsa.europa.eu/en/efsajournal/pub/4873

European Food Safety Authority (EFSA), 2022. Charistou A, Coja T, Craig P, Hamey P, Martin S, Sanvido O, Chiusolo A, Colas M and Istace E. Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment for plant protection products. EFSA Journal 2022, 20(1), 7032.
https://www.efsa.europa.eu/en/efsajournal/pub/7032

Großkopf C, Mielke H, Westphal D, Erdtmann-Vourliotis M, Hamey P, Bouneb F, Rautmann D, Stauber F, Wicke H, Maasfeld W, Salazar JD, Chester G and Martin S, 2013. A new model for the prediction of agricultural operator exposure during professional application of plant protection products in outdoor crops. Journal für Verbraucherschutz und Lebensmittelsicherheit, 8, 143–153.
https://www.openagrar.de/receive/openagrar_mods_00012668

Großkopf C, Martin S, Mielke H, Hamey P, Mercier T, Bouneb F, Muñoz IA, Machera K, Rautmann D, Erdtmann-Vourliotis M, and Tiramani M, 2016. Joint development of a new Greenhouse Argicultural Operator Exposure Model for hand-held application. BfR Wissenschaft; 01/2016 (ISBN 978-3-943963-36-6).
https://mobil.bfr.bund.de/cm/350/joint-development-of-a-new-greenhouse-agricultural-operator-exposure-model-for-hand-held-application.pdf

Großkopf C, Mielke H, Bloch D, Martin S, 2020. Update of the Greenhouse Agricultural Operator Exposure Model Amendment to Project Report 01/2016. BfR Wissenschaft; 02/2020 (ISBN 978-3-948484-12-5).
https://mobil.bfr.bund.de/cm/350/revision-of-the-greenhouse-agricultural-operator-exposure-model.pdf

Karaca M, Fischer BC, Willenbockel CT, Tralau T, Marx-Stoelting P, Bloch D, 2021. Effects of co-formulants on the absorption and secretion of active substances in plant protection products in vitro. Archives of Toxicology 95, 3205–3221.
10.1007/s00204-021-03140-x

Kurth D, Wend K, Adler-Flindt Sarah, Martin S, 2019. A comparative assessment of the CLP calculation method and in vivo testing for the classification of plant protection products. Regulatory toxicology and pharmacology 101, 79–90.
https://doi.org/10.1016/j.yrtph.2018.11.012

Lichtenberg B, Mischke U, Scherf S, Röver M and Martin S, 2015. Hazard and risk based allocation of safety instructions to operators handling pesticides. Journal für Verbraucherschutz und Lebensmittelsicherheit, 10, 373-384.
https://link.springer.com/article/10.1007/s00003-015-0952-x

Pieper C, Schwebke I, Noeh, I, Uhlenbrock, K, Hübner N, Solecki R, 2014. Antimikrobielle Produkte im Haushalt – eine Betrachtung zu Auswirkungen auf Gesundheit und Umwelt sowie zum Nutzen für den Anwender. Hygiene & Medizin 39, 68-76.
https://www.bfr.bund.de/cm/343/antimikrobielle-produkte-im-haushalt.pdf

Pieper C, Holthenrich D, Schneider H 2014, Gesundheitliche Risiken durch Schädlingsbekämpfungsmittel. Bundesgesundheitsblatt - Gesundheitsforschung – Gesundheitsschutz, 5, 574-584.
https://link.springer.com/article/10.1007/s00103-013-1920-1

Stein B, Michalski B, Martin S, Pfeil R, Ritz V, Solecki R, 2014. Human health risk assessment from combined exposure in the framework of plant protection products and biocidal products. Journal of Consumer Protection and Food Safety 4, 367–376.
https://link.springer.com/article/10.1007/s00003-014-0915-7

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