REACH

The name REACH is derived from the following terms and procedures

• Registration
• Evaluation
• Authorisation and
• restriction of Chemicals

which were created in 2006 in Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals.

The REACH Regulation envisages that Member State authorities provide the public and relevant companies with comprehensive information on REACH and its procedures. In Germany, this task is primarily carried out by the REACH-CLP-Biozid Helpdesk based at the Federal Institute for Occupational Safety and Health (BAuA). The European Chemicals Agency (ECHA) also provides information on REACH.

After long and intensive political negotiations, the REACH Regulation was adopted in 2006 at EU level to restructure European chemicals legislation. REACH aims to ensure a high level of protection of human health and the environment from risks arising from chemical substances and mixtures (hereafter collectively referred to as “substances”), ensure free movement of substances on the EU internal market, promote innovations and improve competitiveness. Furthermore, REACH is intended to promote alternative test methods for determining the properties of substances and thus avoid animal testing wherever possible.

REACH is therefore a key instrument for environmental and health protection (for consumers and workers) in the European Union. The activities to implement REACH and the CLP Regulation (Regulation (EC) No 1272/2008) on the classification, labelling and packaging of substances and mixtures build on one another and are interdependent. The CLP Regulation constitutes the second pillar of European chemicals legislation.

The REACH Regulation

• requires manufacturers, importers and downstream users of substances to ensure that these substances do not adversely affect human health or the environment
• requires manufacturers or importers in the context of registration to identify the properties of substances (e.g. toxic, carcinogenic, dangerous for the environment) and to evaluate their health and environmental impacts. To date, almost 23,000 substances have been registered with the ECHA (as of June 2024), further information on registrations is available on the ECHA homepage under registration 
• provides that substances in quantities > 1 tonne per year may only be manufactured or placed on the market on their own, in mixtures or in products if they have been registered under REACH (no data, no market principle)
• requires manufacturers and importers to provide information on hazardous properties as well as the safe use of the substances
• envisages a multi-stage authorisation procedure for substances of very high concern (SVHC)
• contains a process for restricting the manufacture, placing on the market or use of a substance or group of substances with problematic properties where there is an EU-wide unacceptable risk to humans and/or the environment
• requires that commercial users carry out their own safety analysis if they do not comply with the recommendations issued by the manufacturer or importer

To ensure that unacceptable risks from the use of substances of (very high) concern are actually adequately controlled, it is first necessary to know the properties and uses (and thus the exposure) of the substances. A particular focus lies on long-term effects, such as carcinogenic properties or properties that are toxic for reproduction.

Under Title VI, the REACH Regulation envisages two evaluation procedures intended to close knowledge gaps regarding the properties and uses of registered substances. As part of the dossier evaluation (Article 40 et seq. of the REACH Regulation), the ECHA reviews whether the information submitted during registration meets with requirements. For substance evaluation (Article 44 et seq. of the REACH Regulation), a Member State examines whether the use of a substance poses a risk to human health or the environment.

The REACH-CLP-Biozid Helpdesk provides information on its website about this evaluation procedure (in German only).

Further information can be found on the European Chemicals Agency homepage under evaluation.

Thanks to the significantly expanded data base under REACH, it should also be ensured that unacceptable risks arising from the use of substances can be prevented or adequately controlled. To this end, the REACH Regulation envisages corresponding, partially tiered regulatory options, which may be used in accordance with needs and individual cases.

1. Restriction

If the manufacture, placing on the market or use of a substance or group of substances poses an unacceptable risk to human health or the environment across Europe, these may be partially (e.g. in the form of limit values on the concentration of a substance / group of substances in mixtures or products) or completely banned or may be subject to conditions on their use (e.g. labelling, special risk management measures).

The REACH-CLP-Biozid Helpdesk provides information on its website about this restriction procedure (in German only).

Further information can be found on the European Chemicals Agency homepage under restriction.

Under REACH, substances of very high concern (SVHC) are classified as such if they have any of the following characteristics:

• carcinogenicity, mutagenicity or reproductive toxicity (referred to as CMR substances)
• persistent in the environment, bioaccumulative in organisms and toxic (PBT) or 
• very persistent in the environment and very bioaccumulative in organisms (vPvB properties)

In addition, substances of equivalent concern to the aforementioned substances can also be identified as SVHC. This last group can include, for instance, endocrine disrupters or respiratory- or skin‑sensitising substances.

Substances identified as SVHC may also be subject to an authorisation requirement. This is done by including the substance in Annex XIV to the REACH Regulation. The use or placing on the market for use of substances subject to an authorisation requirement is prohibited, but may be authorised upon application by the Commission.

More information can be found on the REACH-CLP-Biozid Helpdesk website under SVHC (German only) and authorisation procedure (German only).

Further information on SVHC and the authorisation procedure can be found on the European Chemicals Agency website under authorisation.