Commission Regulation (EU) No 545/2011 (repealed)Show full title

7. Effects on human health

For proper evaluation of the toxicity including potential for pathogenicity and infectiveness of preparations sufficient information shall 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 shall be submitted. Special attention shall be given to co-formulants.

While performing toxicology studies, all signs of infection or pathogenicity shall be noted. Toxicology studies shall 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 Part B of the Annex to Regulation (EU) No 544/2011.

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

7.1. Basic acute toxicity studies

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 1999/45/EC or Regulation (EC) No 1272/2008. 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

Circumstances in which required

An acute oral test shall always be carried only if the applicant cannot justify an alternative approach under Directive 1999/45/EC or Regulation (EC) No 1272/2008, where applicable.

Test method

The test must be carried out in accordance with Method B 1 bis or B 1 tris of Regulation (EC) No 440/2008.

7.1.2. Acute inhalation toxicity

Aim of the test

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

Circumstances in which required

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 method

The test must be carried out in accordance with Method B 2 of Regulation (EC) No 440/2008.

7.1.3. Acute percutaneous toxicity

Circumstances in which required

An acute percutaneous test shall be conducted only if the applicant cannot justify an alternative approach under Directive 1999/45/EC or Regulation (EC) No 1272/2008, where applicable.

Test method

The test must be carried out in accordance with Method B 3 of Regulation (EC) No 440/2008.

7.2. Additional acute toxicity studies

7.2.1. Skin irritation

Aim of the test

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

The skin irritancy of the plant protection product must always be determined, except where the co-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 method

The test must be carried out in accordance with Method B 4 of Regulation (EC) No 440/2008.

7.2.2. Eye irritation

Aim of the test

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

The eye irritancy of the plant protection product must be determined, where the co-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 method

The eye irritation must be determined in accordance with Method B 5 of Regulation (EC) No 440/2008.

7.2.3. Skin sensitisation

Aim of the test

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

Circumstances in which required

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

Test method

The tests have to be carried out in accordance with Method B 6 of Regulation (EC) No 440/2008.

7.3. Data on exposure

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 Section 5 of Part B of the Annex to Regulation (EU) No 544/2011, or from the information provided for the preparation in this Section, 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

Where relevant, the following information shall be submitted for each co-formulant:

(a)

the registration number as referred to in Article 20(3) of Regulation (EC) No 1907/2006;

(b)

the study summaries included in the technical dossier as referred to in Article 10(a)(vi) of Regulation (EC) No 1907/2006; and

(c)

the safety data sheet as referred to in Article 31 of Regulation (EC) No 1907/2006.

All other available information shall be submitted.

7.5. Supplementary studies for combinations of plant protection products

Aim of the test

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

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.