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Dräger Analytical Services
in the light of the new Hazardous Substances Ordinance
The new Hazardous Substances Ordinance [ 1 ], abbreviated in German to GefStoffV, entered into force on 1 January 2005 and supersedes the ordinance issued in 1986. It contains completely new regulations relating to hazardous substance law, and is based on the EC provisions contained in the Hazardous Substances Directive 98/24/EC. Its central focus is to assess toxic, inhalation and dermal risks at the workplace. Physicochemical risks (fire or explosion hazard) are appraised separately. The risk analysis results in a protection concept comprising four stages, from protection class 1 for minor applications involving hazardous substances, to protection class 2 for activities involving hazardous substances with relevant risk, protection class 3 for activities involving toxic substances, and protection class 4 for activities involving the use of substances that are carcinogenic, mutagenic or toxic to reproduction. The result of the risk assessment must be documented.
Dräger Analytical Services, accredited in accordance with § 9 Subsection 6 of the GefStoffV as per EN ISO/IEC 17025 (reg. no. ZLS-P-598/05), provides services intended to enable small and medium-sized enterprises in particular to achieve the requirements of the new Hazardous Substances Ordinance. In this context,
– the necessary information regarding the hazardous substances in use and any associated activities are first identified,
– the next step is to determine the hazard and release groups,
– then the necessary protection classes are ascertained,
– the safety measures necessary to achieve the protection classes are identified,
– and finally the efficacy of the safety measures is checked, e.g. by conducting measurements.
Risk assessment
A risk assessment must be conducted before any activity involving hazardous substances is carried out. The risk assessment must also be performed for existing work processes. In the context of our service package, the risk assessment takes place as follows:
Step 1 Zunächst wird ermittelt, ob die Beschäftigten It is first determined whether workers' activities either involve the use of hazardous substances or generate or release such substances. It is checked which properties of the substances could result in a risk to workers. Not only the routine work process is observed, but also any maintenance work, operational breakdowns, accidents and emergencies which could affect the generation or release of hazardous substances. During the course of this investigation, all substances and preparations which contain hazardous substances are recorded and listed in a hazardous substance registry.
Step 2
To assess the potential risk, information is needed about the hazardous substances present in the processed substances, products and preparations. One important source of information is the Safety Data Sheet which the manufacturer or supplier must provide for every hazardous substance and every hazardous preparation. Without a Safety Data Sheet, it is not possible to perform a risk assessment. The Safety Data Sheet provides information about
  • the substance / preparation designation
  • the manufacturer or supplier
  • the composition / constituents of the substance / preparation
  • possible hazards
  • first aid procedures
  • fire fighting procedures
  • procedures in the event of accidental release
  • handling and storage
  • exposure limit and personal protective equipment
  • physical and chemical properties
  • stability and reactivity
  • toxicology
  • ecology
  • disposal
  • transport
  • regulations (marking, classification of risk and safety phrases)


Information is also included about possible fire and explosion risks which are dealt with separately in the risk assessment.
Step 3
Information is obtained about the activities involving the hazardous substances and the conditions under which they are processed with the aim of checking whether the safety and health of workers is guaranteed. To this end, the nature, scope and duration of exposure are determined and the exposure route is taken into account. A site visit is made to obtain answers to the following questions:
  • Which quantity is processed during each shift?
  • How long is the worker exposed to the hazardous substance?
  • Is any dust generated in the case of solid hazardous substances?
  • At what temperature is the liquid hazardous substance processed?
  • Do the hazardous substances have any contact with the worker's skin?
  • If so, for how long, and can this contact be classified as small- or large-area?
On the basis of the answers to these questions it can be determined whether and to what extent hazardous substances are released and contribute to worker exposure.
Step 4
Once all risks have been identified, the saved information is fully documented and the necessary safety measures are specified in accordance with §§ 8 – 18 GefStoffV.

The individual protection classes describe the safety measures which are necessary for an activity involving hazardous substances in terms of substitute solutions, technology, organization and protective equipment. In the case of activities classified as protection class 2 or above, it needs to be checked whether the substances, preparations or products could be substituted by less hazardous substances or types of use. The protection classes are progressive in nature, with each class also including the safety measures of the lower classes. The protection classes also contain details of checking the efficacy of those safety measures already realized.
Protection class 1:
Regulations pertaining to risk avoidance; activities involving negligible risk Protection class 2:
Basic worker safeguards Protection class 3:
Additional safeguards for extremely hazardous activities Protection class 4:
Supplementary safeguards for substances that are carcinogenic, mutagenic or toxic to reproduction.

If the risk assessment has shown that workers only carry out activities involving hazardous substances marked "Xn", "Xi" and "C" (Table 1) in small quantities and involving short and low levels of exposure, the safety measures provided for by protection class 1 are generally sufficient. The safety measures detailed in § 8 GefStoffV shall be implemented in this case.
If workers carry out activities involving hazardous substances marked "Xn", "Xi" or "C" in relevant quantities or if the workers are exposed to such substances over a longer period, protection class 2 applies. The applicable safety measures are described in §§ 8 and 9 GefStoffV.
In the case of activities involving hazardous substances marked "T" and "T+", at least the safety measures detailed in protection class 3, i.e. those described in §§ 8 to 10 GefStoffV, are necessary.
If substances are processed that are carcinogenic, mutagenic or toxic to reproduction and classified as category 1 (CMRF substances), the safety measures of protection class 4 (§§ 8 to 11 GefStoffV) must be implemented in addition to the safety measures described in classes 1 to 3.
If there is also a risk of fire or explosion, the safety measures described in § 12 GefStoffV must be implemented.
Checking the efficacy of the realized safety measures
The efficacy of the safety measures must be checked at regular intervals to ensure that occupational exposure limit values and biological limit values are met. If the activities are carried out in accordance with a process- or substance-specific criterion as per TRGS 420 [ 2 ], compliance with the occupational exposure limit value can be assumed. In this case, and in the case of activities involving protection class 1 hazardous substances, no measurements are necessary. In this case other methods can be used to check the efficacy of the safety measures. Where substances are used that are carcinogenic, mutagenic or toxic to reproduction (CMRF substances), measurements to check compliance with occupational exposure limit values are compulsory unless the activities are carried out in accordance with a process- or substance-specific criterion in accordance with TRGS 420 [ 2 ]. In all other cases, measurements or other equivalent methods of assessment can be carried out to demonstrate compliance with occupational exposure limit values.
Measurements may only be performed by persons possessing the necessary knowledge and the necessary equipment. Dräger Analytical Services, which is accredited in accordance with § 9 Subsection 6 Gef- StoffV as per EN ISO/IEC 17025 (reg. no. ZLS-P-598/05), fulfils these conditions for the following substance groups

-inorganic gases and vapours
– organic gases and vapours
– isocyanates.
The services on offer including consulting, the risk assessment itself, planning and carrying out of sampling or measurements on site, analysis of the samples in the Dräger Analytical Services laboratory, and an assessment of the results on the basis of existing occupational exposure limit values, presented in the form of a measurement report.
For further information about the services offered by Dräger Analytical Services, please visit our website at www.draeger.com
Karl-Heinz Pannwitz
Dräger Safety AG & Co. KGaA

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Dräger Safety AG & Co. KGaA
Revalstrasse 1
23560 Luebeck, Germany
Tel +49 451 882 0
Fax +49 451 882 2080

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