Council Directive of 15 July 1991 concerning the placing of plant protection products on the market (91/414/EEC) (repealed) (c. 414)

[F1 ANNEX VI 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 PART I U.K. UNIFORM PRINCIPLES FOR EVALUATION AND AUTHORISATION OF CHEMICAL PLANT PROTECTION PRODUCTS]

B. EVALUATION U.K.

2. Specific priciples U.K.

2.4. Impact on human or animal health U.K.

2.4.1. arising from the plant protection product U.K.

2.4.1.1. Member States shall evaluate operator exposure to the active substance and/or to toxicologically relevant compounds in the plant protection product likely to occur under the proposed conditions of use (including in particular dose, application method and climatic conditions) using by preference realistic data on exposure and, if such data are not available, a suitable, validated calculation model. U.K.

(a)

This evaluation will take into consideration the following information:

(i)

the toxicological and metabolism studies as provided for in Annex II and the results of the evaluation thereof including the acceptable operator exposure level (AOEL). The acceptable operator exposure level is the maximum amount of active substance to which the operator may be exposed without any adverse health effects. The AOEL is expressed as milligrams of the chemical per kilogram body weight of the operator. The AOEL is based on the highest level at which no adverse effect is observed in tests in the most sensitive relevant animal species or, if appropriate data are available, in humans;

(ii)

other relevant information on the active substances such as physical and chemical properties;

(iii)

the toxicological studies provided for in Annex III, including where appropriate dermal absorption studies;

(iv)

other relevant information as provided for in Annex III such as:

• composition of the preparation,

• nature of the preparation,

• size, design and type of packaging,

• field of use and nature of crop or target,

• method of application including handling, loading and mixing of product,

• exposure reduction measures recommended,

• protective clothing recommendations,

• maximum application rate,

• minimum spray application volume stated on the label,

• number and timing of applications;

(b)

This evaluation shall be made for each type of application method and application equipment proposed for use of the plant protection product as well as for the different types and sizes of containers to be used, taking account of mixing, loading operations, application of the plant protection product and cleaning and routine maintenance of application equipment.

2.4.1.2. Member States shall examine information relating to the nature and characteristics of the packaging proposed with particular reference to the following aspects: U.K.

• the type of packaging,

• its dimensions and capacity,

• the size of the opening,

• the type of closure,

• its strength, leakproofness and resistance to normal transport and handling,

• its resistance to and compatibility with the contents.

2.4.1.3. Member States shall examine the nature and characteristics of the protective clothing and equipment proposed with particular reference to the following aspects: U.K.

• obtainability and suitability,

• ease of wearing taking into account physical stress and climatic conditions.

2.4.1.4. Member States shall evaluate the possibility of exposure of other humans (bystanders or workers exposed after the application of the plant protection product) or animals to the active substance and/or to other toxicologically relevant compounds in the plant protection product under the proposed conditions of use. U.K.

This evaluation will take into consideration the following information:

(i)

the toxicological and metabolism studies on the active substance as provided for in Annex II and the results of the evaluation thereof, including the acceptable operator exposure level;

(ii)

the toxicological studies provided for in Annex III, including where appropriate dermal absorption studies;

(iii)

other relevant information on the plant protection product as provided for in Annex III such as:

• re-entry periods, necessary waiting periods or other precautions to protect humans and animals,

• method of application, in particular spraying,

• maximum application rate,

• maximum spray application volume,

• composition of the preparation,

• excess remaining on plants and plant products after treatment,

• further activities whereby workers are exposed.

2.4.2. Arising from residues U.K.

2.4.2.1. Member States shall evaluate the specific information on toxicology as provided for in Annex II and in particular: U.K.

• the determination of an acceptable daily intake (ADI),

• the identification of metabolites, degradation and reaction products in treated plants or plant products,

• behaviour of residues of the active substance and its metabolites from the time of application until harvest, or in the case of post-harvest uses, until outloading of stored plant products.

2.4.2.2. Prior to evaluating the residue levels in the reported trials or in products of animal origin Member States shall examine the following information: U.K.

• data on the proposed good agricultural practice, including data on application as provided for in Annex III and proposed pre-harvest intervals for envisaged uses, or withholding periods or storage periods, in the case of post-harvest uses,

• nature of the preparation,

• analytical methods and the residue definition.

2.4.2.3. On the basis of suitable statistical models Member States shall evaluate the residue levels observed in the reported trials. This evaluation shall be made for each proposed use and shall take into consideration: U.K.

(i)

the proposed conditions of use of the plant protection product;

(ii)

the specific information on residues in or on treated plants, plant products, food and feed as provided for in Annex III and the distribution of residues between edible and non-edible parts;

(iii)

the specific information on residues in or on treated plants, plant products, food and feed as provided for in Annex II and the results of the evaluation thereof;

(iv)

the realistic possibilities of extrapolating data from one crop to another.

2.4.2.4. Member States shall evaluate the residue levels observed in products of animal origin, taking into consideration the information provided for in Annex III, Part A, point 8.4 and residues resulting from other uses. U.K.

2.4.2.5. Member States shall estimate the potential exposure of consumers through diet and, where relevant, other ways of exposure, using a suitable calculation model. This evaluation will take account, where relevant, of other sources of information such as other authorized uses of plant protection products containing the same active substance or which give rise to the same residues. U.K.

2.4.2.6. Member States shall, where relevant, estimate the exposure of animals, taking into account the residue levels observed in treated plants or plant products intended to be fed to animals.] U.K.

Textual Amendments

F2 Substituted 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).