Uniform regulations for hazardous substances and mixtures throughout Europe
For safety reasons, hazardous substances and mixtures must be correctly classified and labelled before being placed on the market or used in the workplace. The respective rules can be found in European Regulation (EC) No 1272/2008, the so-called CLP Regulation. It sets uniform standards for all member states for the classification, labelling, and packaging of substances and mixtures.
Until 2008, the regulations on the classification and labelling of hazardous substances and mixtures in the EU were based on two European directives, the Substances Directive (Directive 67/548/EEC) and the Preparations Directive (Directive 1999/45/EC). 1 June 2017 marked the end of the transitional period for the introduction of the CLP Regulation; since then it has not been allowed for containers with the "old" labelling to be placed on the market. However, stocks may still be used up within a company or bear the old labelling under certain conditions if it is ensured that the old and current classification and labelling are understood by workers; see also the regulations in TRGS 201, "Classification and labelling for activities involving hazardous substances".
The UN GHS will also be subject to changes and adaptations in the future. Within the framework of 2-year programmes, current developments are taken up for improvement and are integrated if necessary. This has two practical consequences: on the one hand, the CLP Regulation has to be adapted to the latest technical status of the UN GHS. This is done in each case with the help of a so-called ATP (adaptation to technical progress). On the other hand, many criteria are formulated comparatively openly and require expert knowledge for evaluation. This broadens the system’s scope, but can also cause uncertainty. Assistance with such problems is provided by the REACH-CLP-Biocide Helpdesks of the federal authorities. ECHA offers clarifications and examples related to the classification criteria of the CLP Regulation with its Guidance on the Application of the CLP Criteria.
The provisions of the CLP Regulation have many similarities with the previous legislation, in particular the classification is in principle structured in the same way.
In detail, however, there are quite a few deviations. For example, the change in the hazard pictograms is obvious: in the past, the black symbols were backed by an orange square; today, they are placed on the background of a white rhombus with a red border. The symbols themselves have also been modified.
With classification, substances and mixtures are assigned certain hazard classes and hazard categories based on relevant criteria according to their hazardousness. While the hazard classes indicate the nature of the hazard, the hazard categories are used for grading within the classes. With the publication of Commission Delegated Regulation (EU) 2023/707 on 31 March 2023, the European Commission extended the CLP Regulation by adding four new hazard classes, although these are not based on the UN GHS. The introduction of these hazard classes is regarded as a first important step in the EU’s implementation of the Chemicals Strategy for Sustainability (CSS) published on 14 October 2020.
The new hazard classes added to the CLP Regulation govern the classification and labelling of chemicals that have proven to be of very high concern. These are substances and mixtures
- that, as “endocrine disruptors”, can alter the functions of the endocrine system and consequently, among other things, cause birth defects and developmental and reproductive disorders in human beings and negatively affect animal populations in the environment;
- with “PBT” and “vPvB” properties that are not readily biodegradable in the environment (persistent) and consequently accumulate in living organisms along the whole food chain; it is only possible to reverse the environmental concentration (accumulation) of such chemicals, which are also toxic to aquatic species or can cause severe harm to human health, with some difficulty;
- with “PMT” and “vPvM” properties that are not readily biodegradable in the environment (persistent) and consequently enter the water cycle, including drinking water, and can spread over long distances (mobile); many of these chemicals, which are also toxic to aquatic species or can cause severe harm to human health, are resistant to waste water treatment processes and, unfortunately, drinking water purification processes as well. It has not hitherto been possible to predict how the effects of such chemicals will impact on humans and animals.
With the CLP regulation, the EU currently has seventeen classes for physical hazards, eleven for health hazards and five classes for environmental hazards. Some criteria have been tightened, especially for mixtures. According to the CLP Regulation, for example, irritant or corrosive substances in a mixture trigger the classification of the mixture as hazardous in significantly lower concentrations than before. Details of the classification criteria can be found in Annex I, Parts 2-5 of the CLP Regulation.
Relevant labelling elements are then used to communicate the hazards via the label and the safety data sheet. The labelling includes (where applicable):
- Hazard pictograms
- A signal word (“Danger” or “Warning”)
- Hazard statements (including EUH statements)
- Precautionary statements
- Further details, such as product name, supplier, etc.
The signal word as a labelling element next to the hazard pictogram and should always be taken seriously for an initial assessment of the hazards posed by a substance or mixture: The use of "Danger" on the label indicates particularly serious hazardous properties. Some of the nine pictograms are also new. In particular, GHS08 Health hazard, the so-called "torso", deserves special attention. This pictogram, in combination with the signal word "Danger", signals very serious damage to health with delayed progression. This combination is used, for example, to indicate carcinogenic properties. Overall, the new label contains more information than before, especially when it comes to the allocation of safety information, and can thus appear overloaded. Rules on how to counteract the overload of information can be found in Articles 26-28 of the CLP Regulation and the ECHA Guidance on Labelling and Packaging. Exceptions to labelling and packaging requirements for special or small packaging are facilitated by Article 29 in combination with Annex I, Part 1 of the CLP Regulation, and are specified in the above-mentioned ECHA Guidance.
You can find further help and explanations on the CLP Regulation via the links on this page. You can also order information material, such as the GHS memo card "Hazardous substances compact", which explains the meaning of the new symbols, and posters on the Globally Harmonised System (GHS) in the EU.
For further detailed information please refer to our German Website.