Report of the sub-committee on the environment and health.
Annex 1
Data required for authorisation of pesticides
When application is made for authorisation of pesticides, the applicant must supply the data, with appurtenant analyses, specified in Annexes 5.1 and 5.3 to Ministry of Environment and Energy Order No. 241 of 27 April 1998 on Pesticides. For substances that are new in the EU (i.e. for which application is made after 15 June 1993), the data requirements for the active ingredient have been slightly expanded, and for these pesticides, too, more information is required concerning the formulated products. That is, however, of no relevance in this context because it concerns only a very limited number of substances.
In the environmental area, data are required concerning some of the active ingredient’s physical and chemical properties, its "fate" in soil and water and its toxicity to a number of aquatic and terrestrial organisms.
The minimum information required concerning the active ingredient is listed below.
 | Physical and chemical data (that are of relevance to the environmental risk assessment): solubility in water and organic solvents, vapour pressure, hydrolytic stability and distribution coefficient n-octanol/water. |
| Metabolism and degradation in soil: photolysis on ground surface, rate of degradation in three types of soil under aerobic conditions, metabolism, rate of degradation at two temperatures and at two dosages, dependence of rate of degradation on water content, rate of degradation in sterile soil and under anaerobic conditions, evaporation from soil (calculated on the basis of the physical and chemical properties). |
| Mobility in soil: leaching tests in soil columns with the active ingredient, performed with three different types of soil, leaching tests in soil columns with aged active ingredient, performed in one type of soil, adsorption and desorption tests. |
| Metabolism and degradation in water: BOD value and BOD/COD ratio, adsorption to organic material (plankton and sediment), accumulation in sediment (BOD = Biological Oxygen Demand; COD = Chemical Oxygen Demand). |
| Test for bioaccumulation in aquatic ecosystems if the distribution coefficient n-octanol/water is greater than 1000. |
| Toxic effect on aquatic organisms: acute toxicity in fish (2 species), acute toxicity in daphnia (1 species), reproduction test on daphnia (1 species), acute toxicity in algae. |
| Toxic effect on terrestrial organisms: acute toxicity in worms, effect on soil respiration, effect on ammonification, effect on nitrification, effect on asymbiotic N-fixation and, in some cases, effect on symbiotic N-fixation. |
| Toxic effect on birds: toxicity caused by food intake in species with different food resources (2 species), reproduction test (1 species). |
The following toxicological data for assessment of effects on humans must be provided for the active ingredient:
1) Acute toxicity
Toxicity with a single dose of the substance. Measured as LD50 (the dose needed for half the animals to die). Must be tested in separate tests with swallowing, skin contact and inhalation.
2) Local irritation
Skin irritation, eye irritation and allergenic properties in connection with skin contact must also be investigated.
3) Sub-chronic toxicity
Toxicity with daily dosing for 3-6 months. Two tests are required: one on rats (of 3 months duration ) and one on non-rodents (e.g. dogs) of 3-6 months duration.
4) Chronic toxicity
Toxicity with long-term dosing. Chronic toxicity and carcinogenicity are often combined in the same 2-year test. Two tests are required on different species of mammal. If dogs are more sensitive than rats, a separate 1-year toxicity test on dogs is required.
5) Carcinogenic effect
6) Mutagenicity
The ability of the substance to cause damage to the genetic material. Must be tested in test-tube tests (in vitro) and in animal tests (in vivo). If the substance is found to be positive in the above tests, it must be tested in gametes.
7) Tests on impairment of fertility
Multi-generational tests; the possible ability of the substance to reduce fertility must be tested by feeding with the substance through several generations.
8) Teratogenicity tests
The ability of the substance to damage the foetus during pregnancy must be tested in two species of mammal. The pregnant dam must receive the substance by tube in the most sensitive period of the pregnancy.
9) Neurotoxicity
Particularly for the so-called cholinesterase inhibitors.
10) Toxicity of any metabolites, degradation products and impurities.
11) Metabolism in animals
The substance’s absorption, distribution, degradation and elimination.
12) Toxicity to humans
Experience gained during, for example, production.
The following toxicological data are required for the product:
- Acute oral toxicity
- Acute toxicity through the skin
- Acute toxicity when inhaled
- Skin irritation
- Eye irritation
- Other toxicological data for the product
- Toxicological data for non-active ingredients.
The above data have normally been obtained by means of laboratory tests. In cases in which the laboratory tests indicate that the substance is problematical, supplementary laboratory tests or tests under semi-field or field conditions have in some cases been carried out. Typically, field tests have been carried out concerning degradation of the active ingredient, semi-field tests concerning mobility (lysimeter tests) or mesocosm tests concerning toxicity in aquatic organisms.
The quality of the tests and the relevance of the data to Danish conditions are evaluated before the data are used in the risk assessment.