Commission Regulation (EU) No 544/2011 (repealed)Show full title

1. The information required shall:

1.1.

include a technical dossier supplying the information necessary for evaluating the foreseeable risks, whether immediate or delayed, which the active substance may entail for humans, animals and the environment and containing at least the information and results of the studies referred to below;

1.2.

where relevant, be generated using test guidelines, in accordance with the latest adopted version, referred to or described in this Annex; in the case of studies initiated before the entry into force of the modification of this Annex, the information shall be generated using suitable internationally or nationally validated test guidelines or, in the absence thereof, test guidelines accepted by the competent authority;

1.3.

in the event of a test guideline being inappropriate or not described, or where another one than those referred to in this Annex has been used, include a justification, which is acceptable to the competent authority for the guidelines used. In particular, when reference is made in this Annex to a method laid down in Commission Regulation (EC) No 440/2008(1) which consists in the transposition of a method developed by an international organisation (e.g. OECD), Member States may accept that the required information is generated in accordance with the latest version of that method if at the initiation of the studies the method under Regulation (EC) No 440/2008 has not yet been updated;

1.4.

include, when required by the competent authority, a full description of test guidelines used, except if they are referred to or described in this Annex, and a full description of any deviations from them including a justification, which is acceptable to the competent authority, for these deviations;

1.5.

include a full and unbiased report of the studies conducted as well as full description of them or a justification, which is acceptable to the competent authority where:

• particular data and information which would not be necessary owing to the nature of the product or its proposed uses, are not provided, or

• it is not scientifically necessary, or technically possible to supply information and data;

1.6.

where relevant, have been generated in accordance with the requirements of Council Directive 86/609/EEC(2).

(1)

OJ L 142, 31.5.2008, p. 1.

(2)

OJ L 358, 18.12.1986, p. 1.