1.The health hazards of a preparation shall be assessed by one or more of the following procedures:
(a)by a conventional method described in Annex II;
(b)by determining the toxicological properties of the preparation necessary for appropriate classification in accordance with the criteria in Annex VI to Directive 67/548/EEC. These properties shall be determined by means of the methods laid down in Part B of Annex V to Directive 67/548/EEC, unless, in the case of plant protection products, other internationally recognised methods are acceptable in accordance with the provisions of Annexes II and III to Directive 91/414/EEC.
2.Without prejudice to the requirements of Directive 91/414/EEC, only where it can be scientifically demonstrated by the person responsible for placing the preparation on the market that the toxicological properties of the preparation cannot correctly be determined by the method outlined in paragraph 1(a), or on the basis of existing test results on animals, the methods outlined in paragraph 1(b) may be used, provided they are justified or specifically authorised under Article 12 of Directive 86/609/EEC.
When a toxicological property is established by the methods outlined in paragraph 1(b) to obtain new data, the test shall be conducted in compliance with the principles of good laboratory practice provided for in Council Directive 87/18/EEC of 18 December 1986 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances(1) and the provisions of Directive 86/609/EEC, in particular Articles 7 and 12 thereof.
Subject to the provisions of paragraph 3, where a toxicological property has been established on the basis of both the methods outlined in paragraphs 1(a) and (b), the results from the methods outlined in paragraph 1(b) shall be used for classifying the preparation, except in the case of carcinogenic, mutagenic or toxic effects for reproduction for which only the method outlined in 1(a) shall be used.
Any of the toxicological properities of the preparation which are not assessed by the method outlined in paragraph 1(b) shall be assessed in accordance with the method outlined in paragraph 1(a).
3.Furthermore, where it can be demonstrated:
by epidemiological studies, by scientifically valid case studies as specified by Annex VI to Directive 67/548/EEC or by statistically backed experience, such as the assessment of data from poison information units or concerning occupational diseases, that toxicological effects on man differ from those suggested by the application of the methods outlined in paragraph 1, then the preparation shall be classified according to its effects on man,
that, owing to effects such as potentiation, a conventional assessment would underestimate the toxicological hazard, those effects shall be taken into account in classifying the preparation,
that, owing to effects such as antagonism, a conventional assessment would overestimate the toxicological hazard, those effects shall be taken into account in classifying the preparation.
4.For preparations of a known composition, with the exception of those covered by Directive 91/414/EEC, classified in accordance with paragraph 1(b), a new evaluation of health hazard by the methods outlined in either paragraph 1(a) or (b) shall be performed whenever:
changes of composition of the initial concentration, as a weight/weight or volume/volume percentage, of one or more of the dangerous constituents are introduced by the manufacturer, in accordance with the following table:
| Initial concentration range of the constituent | Permitted variation in initial concentration of the constituent |
|---|---|
| ≤ 2,5 % | ± 30 % |
| > 2,5 ≤ 10 % | ± 20 % |
| > 10 ≤ 25 % | ± 10 % |
| > 25 ≤ 100 % | ± 5 % |
changes of composition involving the substitution or addition of one or more constituents, which may or may not be dangerous within the meaning of the definitions set out in Article 2, are introduced by the manufacturer.
This new evaluation will apply unless there is valid scientific justification for considering that a re-evaluation of the hazard will not result in a change of classification.