Council Directive of 15 July 1991 concerning the placing of plant protection products on the market (91/414/EEC) (repealed)

[F1 INTRODUCTION U.K.

The information required shall:

1.1. include a technical dossier supplying the information necessary for evaluating efficacy and the foreseeable risks, whether immediate or delayed, which the plant protection product may entail for humans, animals and the environment and containing at least the information and results of the studies referred to below; U.K.

[F2 1.2. where relevant, be generated using test guidelines, according to 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;] U.K.

Textual Amendments

F2 Substituted by Commission Directive 94/79/EC of 21 December 1994 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market.

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 [F2 .] [F3 In particular, when reference is made in this Annex to an EEC Method which consists in the transposal of a method developed by an international organization (e.g. OECD), Member States may accept that the required information is generated according to the latest version of that method if at the initiation of the studies the EEC Method has not yet been updated;] U.K.

Textual Amendments

F3 Inserted by Commission Directive 94/79/EC of 21 December 1994 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market.

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; U.K.

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

• 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 Directive 86/609/EEC. U.K.

2.1. Tests and analyses must be conducted in accordance with the principles laid down in Directive 87/18/EEC where testing is done to obtain data on the properties and/or safety with respect to human or animal health or the environment. U.K.

2.2. Tests and analyses, required under the provisions of Section 6 points 6.2 to 6.7 of this Annex, shall be conducted by official or officially recognized testing facilites or organizations which satisfy at least the following requirements: U.K.

• have at their disposal sufficient scientific and technical staff, having the necessary education, training, technical knowledge and experience for their assigned functions,

• have at their disposal suitable items of equipment required for correct performance of the tests and measurements which it claims to be competent to carry out. This equipment shall be properly maintained and calibrated where appropriate before being put into service and thereafter according to an established programme,

• have at their disposal appropriate experimental fields and, where necessary glasshouses, growth cabinets or storage rooms. The environment in which the tests are undertaken shall not invalide its results or adversely effect the required accuracy of measurement,

• make available to all relevant personnel operating procedures and protocols used for the trials,

• make available, where requested by the competent authority, prior to the commencement of a test, detailed information on it, containing at least its location and the plant protection products included in it,

• ensure that the quality of the work performed is appropriate to its type, range, volume and intended purpose,

• [X1 maintain records of all original observations, calculations and derived data,] calibration records and the final test report as long as the product concerned authorized in the Community.

Editorial Information

X1 Inserted by Corrigendum to Commission Directive 93/71/EEC of 27 July 1993 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Official Journal of the European Communities No L 221 of 31 August 1993).

2.3. Member States shall require that officially recognized testing facilities and organizations, and, where requested, official facilities and organizations: U.K.

• report to the relevant national authority all detailed information necessary to demonstrate that they can satisfy the requirements provided for in point 2.2,

• accept at any time the inspections, which each Member State shall regularly organize on its territory in order to verify the compliance with the requirement as laid down in point 2.2.

[F4 2.4. By way of derogation from point 2.1, Member States may apply the provisions of points 2.2 and 2.3, by extension, to tests and analyses performed on their territory in order to obtain data on the properties and/or safety of the preparations with respect to honey-bees and beneficial arthropods other than bees and actually started on or before 31 December 1999 .] U.K.

Textual Amendments

F4 Substituted by Commission Directive 95/35/EC of 14 July 1995 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance).

[F5 2.5. By way of derogation from point 2.1, Member States may apply the provisions of points 2.2 and 2.3, by extension, to supervised residue trials performed on their territory in accordance with the provisions of Section 8 ‘ Residues in or on treated products, food and feed ’ with plant protection products containing active substances already on the market two years after notification of the Directive and actually started on or before 31 December 1997 .] U.K.

Textual Amendments

F5 Inserted by Commission Directive 95/35/EC of 14 July 1995 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance).

[F6 2.6. By way of derogation from point 2.1, for active substances consisting of micro-organisms or viruses, tests and analyses done to obtain data on the properties and/or safety with respect to other aspects than human health, may have been conducted by official or officially recognised testing facilities or organisations which satisfy at least the requirements under points 2.2 and 2.3 of the introduction of Annex III.] U.K.

Textual Amendments

F6 Inserted by Commission Directive 2001/36/EC of 16 May 2001 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance).

3. The information required shall include the proposed classification and labelling of the plant protection product in accordance with relevant Community Directives. U.K.

4. In individial cases it may be necessary to require certain information as provided for in Annex II, Part A, for formulants. Before such information will be required and before possible new studies have to be performed, all information on the formulant, made available to the competent authority, will be considered, in particular when: U.K.

• the use of the formulant is permitted in food, animal feeding stuffs, medicines or cosmetics in accordance with Community legislation,

  or

• a safety data sheet has been submitted for the formulant in accordance with Council Directive 67/548/EEC.]

Textual Amendments

F1 Substituted by Commission Directive 93/71/EEC of 27 July 1993 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market.