Article 3Determination of dangerous properties of preparations
1
The evaluation of the hazards of a preparation shall be based on the determination of:
physico-chemical properties,
properties affecting health,
environmental properties.
These different properties shall be determined in accordance with the provisions laid down in Articles 5, 6 and 7.
Where laboratory tests are conducted, they shall be carried out on the preparation as placed on the market.
2
Where the determination of dangerous properties is carried out in accordance with Articles 5, 6 and 7, all dangerous substances within the meaning of Article 2 and in particular those which:
are listed in F1Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures17,
are listed in Elincs in accordance with Article 21 of Directive 67/548/EEC,
are classified and labelled provisionally by the person responsible for the placing on the market in accordance with Article 6 of Directive 67/548/EEC,
are classified and labelled in accordance with Article 7 of Directive 67/548/EEC and are not yet included in Elincs,
are covered by Article 8 of Directive 67/548/EEC,
are classified and labelled in accordance with Article 13 of Directive 67/548/EEC.
shall be taken into consideration in accordance with the provisions laid down in the method used.
3
For preparations covered by this Directive, dangerous substances as referred to in paragraph 2 which are classified as dangerous on the basis of their health and/or environmental effects, whether they are present as impurities or additives, shall be taken into consideration when their concentrations are equal to, or greater than, those defined in the following table unless lower values are given in F1Part 3 of Annex VI to Regulation (EC) No 1272/2008, or in Part B of Annex II to this Directive or in Part B of Annex III thereto, unless otherwise specified in Annex V to this Directive.
Category of danger of the substance | Concentration to take into consideration for | |
|---|---|---|
gaseous preparations% vol/vol | other preparations% w/w | |
Very toxic | ≥ 0,02 | ≥ 0,1 |
Toxic | ≥ 0,02 | ≥ 0,1 |
Carcinogenic Category 1 or 2 | ≥ 0,02 | ≥ 0,1 |
Mutagenic Category 1 or 2 | ≥ 0,02 | ≥ 0,1 |
Toxic for reproduction Category 1 or 2 | ≥ 0,02 | ≥ 0,1 |
Harmful | ≥ 0,2 | ≥ 1 |
Corrosive | ≥ 0,02 | ≥ 1 |
Irritant | ≥ 0,2 | ≥ 1 |
Sensitising | ≥ 0,2 | ≥ 1 |
Carcinogenic Category 3 | ≥ 0,2 | ≥ 1 |
Mutagenic Category 3 | ≥ 0,2 | ≥ 1 |
Toxic for reproduction Category 3 | ≥ 0,2 | ≥ 1 |
Dangerous for the environment N Dangerous for the environment N | ≥ 0,1 | |
Dangerous for the environment ozone | ≥ 0,1 | ≥ 0,1 |
Dangerous for the environment | ≥ 1 | |