The DSD and the DPD
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
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
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
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:
15 ppm of CIT/MIT
- 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
- 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.