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Hazardous substances / CMR substances

Substances and mixtures of substances that are toxic, irritant, corrosive, carcinogenic, highly flammable or hazardous to the environment are considered hazardous substances. The hazardousness of a substance or mixture is indicated by hazard symbols or hazard labels as well as by R and S phrases. CMR substances have additional hazard potential.

Differentiation from dangerous goods, pollutants

While the term hazardous substance refers to the dangers involved in the manufacture, processing and use of a substance, dangerous goods labelling is based on transport hazards. In addition to substances, hazardous goods labelling also refers to finished products, such as ammunition, equipment or components. A hazardous substance is therefore not automatically a dangerous good, and vice versa. In the event of an unintentional release or uncontrolled reaction of a hazardous substance, it is referred to as a hazardous substance.

CMR substances

Substances that are carcinogenic, mutagenic or toxic to reproduction have additional hazard potential. They are referred to as CMR substances (carcinogenic, mutagenic and toxic to reproduction), in Germany also as KMR substances (carcinogenic, mutagenic, toxic to reproduction). CMR substances are categorised into three categories, with knowledge of the hazard decreasing from 1 to 3.

  • Category 1: proven from experience in humans
  • Category 2: proven in animals, suspected in humans
  • Category 3: suspected for humans

Based on these categories, CMR substances must be labelled with T for "toxic" or Xn for "hazardous to health". If the carcinogenic, mutagenic or reprotoxic effect of a substance has been proven in humans or in animal experiments, it is classified as category 1 and requires labelling with T if the acute toxicity does not require labelling with T+. If the substance is classified in category 3, it is possibly carcinogenic, mutagenic or toxic to reproduction. In this case, it must be labelled with Xn if there is no acute toxicity that requires labelling with T or T+.

The EU classification system does not provide any information on the potency of the CMR effect. A CMR substance in category 3 can therefore have a highly potent effect, but is not classified in category 1 or 2 due to a lack of sufficiently valid data.

Legal regulations on hazardous substances

The Globally Harmonised System of Classification and Labelling of Chemicals (GHS) is a globally standardised system for the classification of chemicals and their labelling on packaging and in safety data sheets. Regulation (EC) No. 1272/2008, also known as the CLP Regulation, was developed on the basis of this labelling system. It is a slightly modified implementation of the UN model regulations for Europe. According to the CLP Regulation, the classification and labelling of substances has been mandatory since 2012 and the classification of mixtures since 2015.

Hazardous substances legislation refers to the entirety of all regulations intended to protect people and the environment from hazardous substances during storage and use. Within the EU member states, there are European hazardous substances directives that are transposed into national law by the member states. In Germany, the Hazardous Substances Ordinance (GefStoffV) is the legal basis for the implementation of protection for employees.

Dangerous goods legislation covers all international and national regulations for the transport and temporary storage of dangerous goods worldwide and thus forms the basis for national laws, regulations and intergovernmental agreements.

 

Working with hazardous substances

Working with hazardous substances is regulated in the Hazardous Substances Ordinance, and model safety guidelines have been drawn up to help with implementation. In general, the following principles apply: avoid, contain, protect. This means: replace hazardous substances with non-hazardous substances wherever possible and use as few as possible. Separate work areas and use special high-performance filters in the extraction systems. If necessary, employees must also be provided with personal protective equipment free of charge. According to the Hazardous Substances Ordinance, the employer must fulfil a number of obligations, including the following:

  • The most important requirement is the risk assessment. Here, the employer is obliged to carry out an inspection: the company manager must recognise hazards in the company, correctly assess the hazard potential and take protective measures to combat it.
  • Hazardous substances must be labelled and recognisable as such; there is a labelling obligation.
  • The employer is obliged to put up appropriate warning signs and the EC safety data sheet must be openly accessible.
  • Employees who come into contact with hazardous substances must be specially and regularly instructed by means of operating instructions and, depending on the hazardous substance, undergo a regular examination by an occupational or company physician.
  • For the handling or trading of some hazardous substances, proof of expertise is required in the form of an examination of expertise in hazardous substances.

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