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Title (Primary) Establishment of a concept for comparative risk assessment of plant protection products with special focus on the risks to the environment. Project No. (FKZ) 3712 67 406. Report No. (UBA-FB) 002256/ENG
Author Altenburger, R.; Gündel, U.; Rotter, S.; Vogs, C.; Faust, M.; Backhaus, T.;
Journal Texte Umweltbundesamt
Year 2017
Department BIOTOX;
Volume 47/2017
Language englisch;
POF III (all) T42;
UFZ wide themes RU3;
Abstract The EU regulation 1107/2009 introduces the substitution principle for the authorisation of plant protection products that contain active substances identified as candidates for substitution. For this novel regulatory principle active substances are flagged at the Commission level as candidates for substitution if they are found to meet a set of human or environmental hazard criteria. At the member state level, subsequently, comparative risk assessment for products is to be carried out if a product is to be authorised that contains a candidate for substitution. Almost one quarter of the active substances that are currently approved for use in plant protection products in the EU can be expected to be flagged as candidates for substitution and many of those will be identified for their persistence, bioaccumulation or aquatic toxicity properties. For Germany about one third of the currently authorised products would fall into the category where, upon reauthorisation, a comparative assessment with alternative products would become necessary. For about 40% of the registered uses there are alternative products which do not contain potential candidates for substitution and all potential candidates for substitution have at least one use where a potential alternative is available. Comparative environmental risk assessment of plant protection products can thus be expected to become a major additional effort in the authorisation process. To perform comparative environmental risk assessment a set of generic criteria is proposed in this report that operationalises the legal benchmark which defines ‘a factor of at least 10 for the toxicity/exposure ratio […] a significant difference in risk’. We suggest carrying out risk comparisons for all different endpoints currently used in environmental risk assessment, while not discriminating a substitution candidate if the alternative products shows a significant increase in any other risk endpoint. For ten case studies it was shown that the current summary authorisation reports principally facilitate conducting a comparative risk assessment along the suggested principles. However, ambiguity in assessments was found where risk estimates were provided as limit values only. To organise the upcoming comparative assessments most efficiently a major resource saving factor would be to store and retrieve risk measures such as TER or HQ values electronically. We recommend establishing new data handling systems, to harmonise assessment procedures, and to achieve consent on decision rules.
ID 19070
Persistent UFZ Identifier https://www.ufz.de/index.php?en=20939&ufzPublicationIdentifier=19070
Altenburger, R., Gündel, U., Rotter, S., Vogs, C., Faust, M., Backhaus, T. (2017):
Establishment of a concept for comparative risk assessment of plant protection products with special focus on the risks to the environment. Project No. (FKZ) 3712 67 406. Report No. (UBA-FB) 002256/ENG
Texte Umweltbundesamt 47/2017
Umweltbundesamt, Dessau-Roßlau, 215 pp.