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Commission Regulation (EU) No 283/2013Show full title
Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, 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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- Revised 17/11/20141.04 MB
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- Signature words omitted by S.I. 2019/556 reg. 21(4)
- Annex Pt. A s. 8 word omitted by S.I. 2019/556 reg. 21(5)(b)(xiv)
- Annex Pt. A s. 1 point 1.4 word substituted in earlier amending provision S.I. 2019/720, Sch. 2 para. 176(2)(a)(i) by S.I. 2020/1567 Sch. 2 para. 61
- Annex Pt. A s. 1 point 1.4.1 word substituted in earlier amending provision S.I. 2019/720, Sch. 2 para. 176(2)(b) by S.I. 2020/1567 Sch. 2 para. 61
- Annex Pt. B s. 9 words omitted by S.I. 2019/556 reg. 21(5)(c)(vi)
- Art. 1(1) Art. 1 renumbered as Art. 1(1) by S.I. 2019/556 reg. 21(2)(a)
- Art. 1(2) inserted by S.I. 2019/556 reg. 21(2)(b)
Introduction U.K.
1.The relevance of generating toxicity data in animal models with dissimilar metabolic profiles to those found in humans shall be addressed, if such metabolic information is available, and taken into consideration for study design and risk assessment.U.K.
2.All potentially adverse effects found during toxicological investigations (including effects on organs/systems such as the immune system, the nervous system, or the endocrine system) shall be reported. Additional studies may be necessary to investigate the mechanisms underlying effects that could be critical to hazard identification or risk assessment.U.K.
All available biological data and information relevant to the assessment of the toxicological profile of the active substance tested, including modelling, shall be reported.
3.Where available, historical control data shall be provided routinely. The data submitted shall be for endpoints that could represent critical adverse effects, and shall be strain-specific and from the laboratory which carried out the index study. They shall cover a five-year period, centred as closely as possible on the date of the index study.U.K.
4.When preparing a study plan, available data on the test substance, such as its physico-chemical properties (such as volatility), purity, reactivity (such as rate of hydrolysis, electrophilicity) and structure-activity relationships of chemical analogues, shall be taken into account.U.K.
5.For all studies actual achieved dose in mg/kg body weight, as well as in other convenient units (such as mg/L inhalation, mg/cm2 dermal), shall be reported.U.K.
6.The analytical methods to be used in toxicity studies shall be specific for the entity to be measured and shall be adequately validated. The LOQ shall be adequate for the measurement of the range of concentration anticipated to occur in the generation of the toxicokinetic data.U.K.
7.Where, as a result of metabolism or other processes in or on treated plants, in livestock, in soil, in ground water, open air, or as a result of processing of treated products, the terminal residue to which humans will be exposed contains a substance which is not the active substance itself and is not identified as a significant metabolite in mammals, toxicity studies shall, where technically possible, be carried out on that substance unless it can be demonstrated that human exposure to that substance does not constitute a relevant risk to health.U.K.
Toxicokinetic and metabolism studies relating to metabolites and breakdown products shall only be required if toxicity findings of the metabolite cannot be evaluated by the available results relating to the active substance.
8.The oral route shall always be used if it is practical. In cases where exposure of humans is mainly by the gas phase, it can be more appropriate to perform some of the studies via inhalation.U.K.
9.For dose selection, toxicokinetic data such as saturation of absorption measured by systemic availability of substance and/or metabolites shall be taken into consideration.U.K.
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