Commission Regulation (EU) No 544/2011 (repealed)Show full title

[F1 Introduction U.K.

(i) The information provided, taken together with that provided for one or more preparations containing the active substance, must be sufficient to permit an evaluation to be made as to the risks for man, associated with the handling and use of plant protection products containing the active substance, and the risk for man arising from residual traces remaining in food and water. In addition, the information provided must be sufficient to: U.K.

• permit a decision to be made as to whether, or not, the active substance can be approved,

• specify appropriate conditions or restrictions to be associated with any approval,

• classify the active substance as to hazard,

• establish a relevant acceptable daily intake (ADI) level for man,

• establish acceptable operator exposure level(s) (AOEL),

• specify the pictograms, signal words, and relevant hazard and precautionary statements for the protection of man, animals and the environment to be included in packaging (containers),

• identify relevant first aid measures as well as appropriate diagnostic and therapeutic measures to be followed in the event of poisoning in man, and

• permit an evaluation to be made as to the nature and extent of the risks for man, animals (species normally fed and kept or consumed by man) and of the risks for other non-target vertebrate species.

(ii) There is a need to investigate and report all potentially adverse effects found during routine toxicological investigations (including effects on organs and special systems such as immunotoxicity and neurotoxicity) and to undertake and report such additional studies which may be necessary to investigate the probable mechanism involved, to establish Noaels (no observed adverse effect levels), and to assess the significance of these effects. All available biological data and information which are relevant to the assessment of the toxicological profile of the substance tested, must be reported. U.K.

(iii) In the context of the influence that impurities can have on toxicological behaviour, it is essential that for each study submitted, a detailed description (specification) of the material used, as mentioned under point 1.11 of Part A be provided. Tests shall be conducted using active substance of that specification to be used in the manufacture of preparations to be authorised, except where radiolabelled material is required or permitted. U.K.

(iv) Where studies are conducted using an active substance produced in the laboratory or in a pilot plant production system, the studies must be repeated using the active substance as manufactured, unless it can be justified that the test material used is essentially the same, for the purposes of toxicological testing and assessment. In cases of uncertainty, appropriate bridging studies must be submitted to serve as a basis for a decision as to the possible need for repetition of the studies. U.K.

(v) In the case of studies in which dosing extends over a period, dosing shall preferably be done using a single batch of active substance if stability permits. U.K.

(vi) For all studies actual achieved dose in mg/kg body weight, as well as in other convenient units, must be reported. Where dosing via the diet is utilised the test compound must be distributed uniformly in the diet. U.K.

(vii) Where, as a result of metabolism or other processes in or on treated plants, or as a result of processing of treated products, the terminal residue (to which consumers or workers as defined in the Annex to Regulation (EU) No 545/2011 point 7.2.3 of Part A will be exposed) contains a substance which is not the active substance itself and is not identified as a metabolite in mammals, it will be necessary to carry out toxicity studies on these components of the terminal residue unless it can be demonstrated that consumer or worker exposure to these substances does not constitute a relevant risk to health. Toxicokinetic and metabolism studies relating to metabolites and degradation products shall only be conducted if toxicity findings of the metabolite cannot be evaluated by the available results relating to the active substance. U.K.

(viii) The way of administration of the test substance depends on the main exposure routes. In cases where exposure is mainly by the gas phase, it can be more appropriate to perform inhalation studies instead of oral studies.] U.K.

Textual Amendments applied to the whole legislation

F1 Repealed (subject to transitional measures in Arts. 3, 4) by 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.