Council Directive of 15 July 1991 concerning the placing of plant protection products on the market (91/414/EEC) (repealed)

[F1 7. EFFECTS ON HUMAN HEALTH U.K.

For proper evaluation of the toxicity including potential for pathogenicity and infectiveness of preparations sufficient information should be available on acute toxicity, irritation and sensitisation of the micro-organism. If possible, additional information on mode of toxic action, toxicological profile and all other known toxicological aspects of the micro-organism should be submitted. Special attention should be given to co-formulants.

While performing toxicology studies, all signs of infection or pathogenicity should be noted. Toxicology studies should include clearance studies.

In the context of the influence that impurities and other components can have on toxicological behaviour, it is essential that for each study submitted, a detailed description (specification) of the material used, be provided. Tests must be conducted using the plant protection product to be authorised. In particular, it must be clear that the micro-organism used in the preparation, and the conditions of culturing it, are the same for which information and data are submitted in the context of Annex II, Part B.

A tiered testing system will be applied to the study of the plant protection product.

7.1. Basic acute toxicity studies U.K.

The studies, data and information to be provided and evaluated, must be sufficient to permit the identification of effects following a single exposure to the plant protection product, and in particular to establish, or indicate:

• the toxicity of the plant protection product,

• toxicity of the plant protection product relative to the micro-organism,

• the time course and characteristics of the effect with full details of behavioural changes and possible gross pathological findings at post-mortem,

• where possible the mode of toxic action, and

• the relative hazard associated with the different routes of exposure.

While the emphasis must be on estimating the toxicity ranges involved, the information generated must also permit the plant protection product to be classified in accordance with Directive 78/631/EEC. The information generated through acute toxicity testing is of particular value in assessing hazards likely to arise in accident situations.

7.1.1. Acute oral toxicity U.K.

Circumstances in which required U.K.

An acute oral test should always be carried out unless the applicant can justify to the satisfaction of the competent authority that Article 3(2) of Directive 78/631/EEC can be invoked.

Test guideline U.K.

The test must be carried out in accordance with Method B.1 or B.1 bis of Commission Directive 92/69/EEC (1) .

7.1.2. Acute inhalation toxicity U.K.

Aim of the test U.K.

The test will provide the inhalation toxicity to rats of the plant protection product.

Circumstances in which required U.K.

The test must be carried out where the plant protection product:

• is used with fogging equipment,

• is an aerosol,

• is a powder containing a significant proportion of particles of diameter < 50 micrometre (> 1 % on a weight basis),

• is to be applied from aircraft in cases where inhalation exposure is relevant,

• is to be applied in a manner which generates a significant proportion of particles or droplets of diameter < 50 micrometre (> 1 % on a weight basis),

• contains a volatile component at greater than 10 %.

Test guideline U.K.

The test must be carried out in accordance with Method B.2 of Directive 92/69/EEC.

7.1.3. Acute percutaneous toxicity U.K.

Circumstances in which required U.K.

An acute percutaneous test should always be carried out unless the applicant can justify to the satisfaction of the competent authority that Article 3(2) of Directive 78/631/EEC can be invoked.

Test guideline U.K.

The test must be carried out in accordance with Method B.3 of Directive 92/69/EEC.

7.2. Additional acute toxicity studies U.K.

7.2.1. Skin irritation U.K.

Aim of the test U.K.

The test will provide the potential of skin irritancy of the plant protection product including the potential reversibility of the effects observed.

Circumstances in which required U.K.

The skin irritancy of the plant protection product must always be determined, except where the formulants are not expected to be skin irritant or the micro-organism is shown not to be skin irritant or where it is likely, as indicated in the test guideline, that severe skin effects can be excluded.

Test guideline U.K.

The test must be carried out in accordance with Method B.4 of Directive 92/69/EEC.

7.2.2. Eye irritation U.K.

Aim of the test U.K.

The test will provide the potential for eye irritation of the plant protection product, including the potential reversibility of the effects observed.

Circumstances in which required U.K.

The eye irritancy of the plant protection product must be determined, where the formulants are suspected to be eye irritant, except where the micro-organism is eye irritant or where it is likely, as indicated in the test guideline, that severe effects on the eyes may be produced.

Test guideline U.K.

The eye irritation must be determined in accordance with Method B.5 of Directive 92/69/EEC.

7.2.3. Skin sensitisation U.K.

Aim of the test U.K.

The test will provide sufficient information to assess the potential of the plant protection product to provoke skin sensitisation reactions.

Circumstances in which required U.K.

The test must be carried out where the formulants are suspected to have skin sensitising properties, except where the micro-organism(s) or the formulants are known to have skin sensitising properties.

Test guideline U.K.

The tests have to be carried out in accordance with Method B.6 of Directive 92/69/EEC.

7.3. Data on exposure U.K.

The risks for those in contact with plant protection products (operators, bystanders, workers), depend on the physical, chemical and toxicological properties of the plant protection product as well as the type of the product (undiluted/diluted), formulation type, and on the route, the degree and duration of exposure. Sufficient information and data must be generated and reported to permit an assessment of the extent of exposure to the plant protection product likely to occur under the proposed conditions of use.

In the cases where there is particular concern on the possibility of dermal absorption based on the information for the micro-organism available in Annex II, Part B, section 5, or from the information provided for the preparation in the present section of Annex III, Part B, further dermal absorption data can be necessary.

Results from exposure monitoring during production or use of the product must be submitted.

The abovementioned information and data must provide the basis for the selection of appropriate protective measures including personal protective equipment to be used by operators and workers and to be specified on the label.

7.4. Available toxicological data relating to non-active substances U.K.

A copy of the notification and the safety data sheet submitted in the context of European Parliament and Council Directive 1999/45/EC (2) and Commission Directive 91/155/EEC of 5 March 1991 defining and laying down the detailed arrangements for the system of specific information relating to dangerous preparations in implementation of Article 10 of Directive 88/379/EEC (3) must be submitted for each formulant. All other available information should be submitted.

7.5. Supplementary studies for combinations of plant protection products U.K.

Aim of the test U.K.

In certain cases it may be necessary to carry out the studies as referred to under points 7.1 to 7.2.3 for a combination of plant protection products where the product label includes requirements for use of the plant protection product with other plant protection products and/or with adjuvants as a tank mix. Decisions as to the need for supplementary studies must be made on a case-by-case basis, taking into account the results of the acute toxicity studies of the individual plant protection products, the possibility for exposure to the combination of the products concerned and available information or practical experience with the products concerned or similar products.

7.6. Summary and evaluation of health effects U.K.

A summary of all data and information provided under paragraphs 7.1 through 7.5, must be submitted, and include a detailed and critical assessment of those data in the context of relevant evaluative and decision-making criteria and guidelines, with particular reference to the risks for man and animals that may or do arise, and the extent, quality and reliability of the database.]

Textual Amendments

F1 Substituted 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).

(1)

[F1 OJ L 383, 29.12.1992, p. 113 .

(2)

OJ L 200, 30.7.1999, p. 1 .

(3)

OJ L 76, 22.3.1991, p. 35 .]

Textual Amendments

F1 Substituted 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).