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Commission Regulation (EU) No 284/2013Dangos y teitl llawn

Commission Regulation (EU) No 284/2013 of 1 March 2013 setting out the data requirements for plant protection products, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Text with EEA relevance)

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10.1.2. Effects on terrestrial vertebrates other than birds U.K.

Possible risks to vertebrate species other than birds shall be investigated except when the test substance is included in plant protection products used, for example, in enclosed spaces and wound-healing treatments where vertebrate species other than birds will experience neither direct nor secondary exposure.

Experimental testing of vertebrates shall only be carried out where the data required for risk assessment cannot be derived from the data generated in accordance with the requirements set out in Section 5 and 7 of Part A of the Annex to Regulation (EU) No 283/2013.

An acute and reproductive risk assessment for terrestrial vertebrates other than birds shall be conducted in accordance with the relevant risk quotient analysis.

10.1.2.1. Acute oral toxicity to mammals U.K.
Circumstances in which required U.K.

If exposure to the formulation is considered possible and the toxicity cannot be predicted on the basis of the data for the active substance, data on the acute oral toxicity of the plant protection product from the mammalian toxicological assessment shall also be considered (see point 5.8 of Part A of the Annex to Regulation (EU) No 283/2013).

10.1.2.2. Higher tier data on mammals U.K.

Higher tier studies on mammals shall be conducted where the first tiers of the risk assessment do not demonstrate that risk is acceptable.

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