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Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products (Text with EEA relevance)
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Textual Amendments
F1Words in Annex Pt. 2.B points 2.6.1.2, 2.6.1.3, 2.6.1.4 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(9)(b)(xvii); 2020 c. 1, Sch. 5 para. 1(1)
the medical data and the toxicity, infectivity and pathogenicity studies provided for in part B of the Annex to Regulation (EU) No 544/2011, and the results of the evaluation thereof. Tier 1 tests shall permit an evaluation to be made of a micro-organism with respect to its ability to persist or grow in the host and its ability to cause effects/reactions in the host. Parameters that indicate the absence of ability to persist and multiply in the host, and the absence of ability to produce non-adverse or adverse effects in a host, include rapid and complete clearance from the body, no activation of the immune system, no histopathological changes, and inability to replicate at mammalian body temperatures. These parameters can in some cases be assessed using acute studies and existing human data, and sometimes can only be assessed using repeated dose studies.
Evaluation based on relevant parameters of Tier 1 tests shall lead to an assessment of the possible effects of occupational exposure, taking into account the intensity and duration of exposure, including exposure due to repeated use during practical use.
The toxicity of certain metabolites/toxins can only be assessed, if it has been demonstrated that the test animals are actually exposed to these metabolites/toxins;
other relevant information on the micro-organism, the metabolites/toxins, residual growth medium, contaminants and co-formulants in the plant protection product, such as their biological, physical and chemical properties (e.g. survival of the micro-organism at the body temperature of humans and animals, ecological niche, behaviour of the micro-organism and/or metabolites/toxins during application);
the toxicological studies provided for in part B of the Annex to Regulation (EU) No 545/2011;
other relevant information on the plant protection product as provided for in part B of the Annex to Regulation (EU) No 545/2011, such as:
re-entry periods, necessary waiting periods or other precautions to protect humans and animals,
method of application, in particular spraying,
maximum application rate,
minimum spray application volume,
composition of the preparation,
excess remaining on plants and plant products after treatment, taking into account the influence of factors such as temperature, UV light, pH and the presence of certain substances,
further activities whereby workers are exposed.
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