The DSD and the DPD

The Dangerous Substances Directive –DSD – 67/548/EEC

In the 1960s it was recognized that there was a need to ensure the protection of public health, in particular the health of workers handling dangerous substances by the six Member States. This resulted in the adoption of Directive 67/548/EEC in 1967. The Dangerous Substances Directive is permanently updated to take account of the scientific and technical progress in the field of dangerous substances. Until April 2004 it has been amended 9 times and adapted to technical progress 29 times.

The Directive introduced common provisions on the:

classification of dangerous substances, since placing a substance into one or several defined classes of danger characterizes the type and severity of the adverse effects that the substance can cause,
packaging of dangerous substances, since adequate packaging protects from the known danger(s) of a substance,
labeling of dangerous substances, since the label on the packaging informs about the nature of the danger(s) of the substance inside and about the safety measures to apply during handling and use.

Currently there are fifteen classes of danger in Directive 67/548/EEC, such as “explosive”, “very toxic”, “carcinogenic” or “dangerous for the environment”.

The Dangerous Preparations Directive – DPD – 99/45/EC

The objective of the Dangerous Preparation Directive (DPD) is similar to that of the Dangerous Substances Directive (DSD), but with regards to preparations and finished products.

The Dangerous Preparations Directive :

communicates safety properties of finished product formulations by prescribing specific classification and labeling measures for preparations. In addition it can prescribe certain packaging measures.
describes the methodology to assess the safety properties of finished products.
acknowledges the use of certain animal tests and human experience data to reach a particular conclusion on which measures to take

The difference between the DSD and the DPD is that the DSD applies to chemical substances (examples of chemical substances that are biocidal active substances include CMIT and MIT [5-Chloro-2-Methyl-4-Isothiazolin-3-One and 2-Methyl-4-Isothiazolin-3-One], Diuron, Carbendazim, OIT [2-OCTYL-3-ISOTHIAZOLONE], etc.) while the DPD applies to mixtures / formulations (preparations) of chemical substances.

An example of how a DSD mandatory classification of substances can impact on the classification and labelling of a preparation is given below for the 3 biocidal active (substances) CMIT and MIT, Diuron and Carbendazim".

Products containing more than:	Labeling:
15 ppm of CIT/MIT	Irritant R43: May cause sensitization by skin contact
0.25% of Diuron	R52: Harmful to aquatic organisms R53: May cause long-term adverse effects in the aquatic environment
1000 ppm of Carbendazim	R46: May cause heritable genetic damage

Carbendazim labeling changes implies that dry-film biocides containing Carbendazim will have to change their labeling due to DPD. For example a dry-film biocide containing 20% Diuron, 9% Carbendazim and 3% OIT must be labeled with the sentences:

R20/21: Harmful by inhalation and in contact with skin.
R40: Limited evidence of a carcinogenic effect.
R43: May cause sensitization by skin contact.
R46: May cause heritable genetic damage.
R48/22: Harmful: danger of serious damage to health by prolonged exposure if swallowed.
R50/53: Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.
R60: May impair fertility.
R61: May cause harm to the unborn child.