Dangerous Preparations Directive
The European chemicals industry manufactures and uses a large number of different chemical products. 90-95% of all chemicals on the European market are preparations - i.e. mixtures of chemical substances. They include industrial chemicals, such as solvents and coatings; petrochemicals, such as fuels and lubricants; agricultural chemicals such as pesticides; consumer products, such as detergents and disinfectants, and many others. Whereas the majority of these chemicals are of low concern for human health or the environment, some of them do have properties which are hazardous to human health and/or the environment.
Two key pieces of EU legislation aim at achieving a high level of protection of human health and the environment from chemicals by requiring the producers of chemicals:
- to identify the intrinsic hazards of the chemicals they manufacture or import (i.e. to "classify" chemicals according to their dangers such as flammability, toxicity, carcinogenicity);
- to label these chemicals according to strict rules (i.e. warnings about the dangers and safety advice);
- and to package them safely.
Directive 67/548/EEC (Dangerous Substances Directive) sets out harmonised EU rules for classification, packaging and labelling of dangerous chemical substances. This Directive is the responsibility of DG Environment.
Directive 1999/45/EC (Dangerous Preparations Directive) extends these rules to dangerous preparations. This directive is the responsibility of DG Enterprise & Industry.
- These "classification and labelling" directives only concern themselves with the assessment of the intrinsic hazards of chemicals. Other EU legislation concerns itself with the tasks of the assessment of risks from chemicals and their control.
- The classification and labelling directives do not cover certain special types of chemicals - such as medicines, cosmetics and foodstuffs - for which stricter control regimes exist.
Directive 1999/45/EC sets out detailed rules on how to classify and label preparations including pesticide and biocides for human health and environmental hazards.
Directive 1999/45/EC has been adapted to technical progress for the first time by Directive 2001/60/EC , following new provisions for substances and preparations established by an adaptation to technical progress of Directive 67/548/EC . Directive 2001/60/EC
- introduces new criteria and a new Risk-phrase (R67) in Annex V to Directive 1999/45/EC for vapours which may cause drowsiness and dizziness;
- introduces new wording for Risk-phrase R40 when it is assigned to carcinogens of category 3 and refers the old wording of Risk-phrase R40 to R68 by amending Annex II to Directive 1999/45/EC;
- gives clearer advice on the classification of preparations for corrosive effects by supplementing Annex II to Directive 1999/45/EC; a preparation with a pH < or = 2 or > or = 11.5 should be classified as corrosive unless additional evidence to demonstrate otherwise is provided - a position paper [48 KB] of preparation with extreme pH values explains how to implement this principle
- introduces a requirement for cement preparations containing chromium (VI) in Annex V to Directive 1999/45/EC to display a warning label that these preparations may cause allergic reactions in certain circumstances.
Directive 1999/45/EC has been adapted to technical progress for the second time by Directive 2006/8/EC *. The changes provided for by the 2nd ATP are the following:
- Annex II is amended the way that preparations containing more than one carcinogenic, mutagenic and/or toxic substance must only be classified and labelled according to their highest risk category (category 1, 2 or 3);
- Annex III is amended by introducing generic concentration limits for preparations containing substances which are very toxic to the aquatic environment (classified as N) and assigned Risk phrases R50 or R50-53 based on the aquatic toxicity of the component(s) of the preparations;
- following an adoption to technical progress of Directive 67/548/EEC, Annex III to Directive 1999/45/EC now only provides for the assignment of the symbol N and the Risk phrase R59 for ozone depleting substances;
- the terminology used to describe the packaging and labelling requirements in Annex for ozone depleting substance V have been harmonised.
* Consolidated version Directive 1999/45/EC