Council Directive of 15 July 1991 concerning the placing of plant protection products on the market (91/414/EEC) (repealed)

[F1 [F2 1. General principles U.K.

1.1. Having regard to current scientific and technical knowledge, Member States shall evaluate the information provided in accordance with the requirements of Annex IIB and IIIB and in particular: U.K.

(a)

identify the hazards arising, assess their significance and make a judgement as to the likely risks to humans, animals or the environment; and

(b)

assess the performance in terms of efficacy and phytotoxicity/pathogenicity of the plant protection product for each use for which authorisation is sought.

1.2. The quality/methodology of tests, where there are no standardised test methods, must be evaluated and the following characteristics, when available, of the methods described must be assessed: U.K.

relevance; representativeness; sensitivity; specificity; reproducibility; interlaboratory validations; predictiveness.

1.3. In interpreting the results of evaluations, Member States shall take into consideration possible elements of uncertainty in the information obtained during the evaluation, in order to ensure that the chances of failing to detect adverse effects or of underestimating their importance are reduced to a minimum. The decision-making process shall be examined to identify critical decision points or items of data for which uncertainties could lead to a false classification of risk. U.K.

The first evaluation made shall be based on the best available data or estimates reflecting the realistic conditions of use of the plant protection product. This must be followed by a repeat evaluation, taking account of potential uncertainties in the critical data and of a range of use conditions that are likely to occur and resulting in a realistic worst-case approach, to determine whether it is possible that the initial evaluation could have been significantly different.

1.4. Member States shall evaluate each microbial plant protection product for which an application for authorisation is made in that Member State — the information evaluated for the micro-organism can be taken into account. Member States must take into account the fact that any co-formulants might have an impact on the characteristics of the plant protection product compared to the micro-organism. U.K.

1.5. In evaluating applications and granting authorisations Member States shall consider the proposed practical conditions of use and in particular the purpose of use, the dose, the manner, frequency and timing of applications, and the nature and composition of the plant protection product. Whenever possible Member States shall also take into account the principles of integrated pest control. U.K.

1.6. In the evaluation, Member States shall consider the agricultural, plant health or environmental (including climatic) conditions in the areas of use. U.K.

1.7. Where specific principles in Section 2 provide for the use of calculation models in the evaluation of a plant protection product, those models shall: U.K.

(a)

make a best possible estimation of all relevant processes involved taking into account realistic parameters and assumptions,

(b)

be submitted to an evaluation as referred to in point 1.3.,

(c)

be reliably validated with measurements carried out under circumstances relevant for the use of the model,

(d)

be relevant to the conditions in the area of use,

(e)

be supported with details indicating how the model calculates estimates provided, and explanations of all the inputs to the model and details of how they have been derived.

1.8. The data requirements, specified in Annex IIB and IIIB, contain guidance as to when and how certain information must be submitted and as to procedures that must be followed when preparing and evaluating a dossier. That guidance must be respected.] ] U.K.

Textual Amendments

F1 Substituted by Council Directive 97/57/EC of 22 September 1997 establishing Annex VI to Directive 91/414/EEC concerning the placing of plant protection products on the market.

F2 Inserted by Council Directive 2005/25/EC of 14 March 2005 amending Annex VI to Directive 91/414/EEC as regards plant protection products containing micro-organisms (Text with EEA relevance).