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The REACH Regulation is an EU regulation designed to protect human health and the environment from the risks posed by chemical substances. At the same time, it promotes new testing and research methods for these substances in order to reduce animal testing.
During their manufacture and use, chemical substances can have a serious impact on human health and ecosystems. REACH therefore aims to establish the measures and controls needed to prevent these risks.
Companies that market chemical substances or modified natural substances within the EU are required to comply with the REACH Regulation. This means identifying the hazards and properties of these substances and determining the safest way to use them.
What does the REACH Regulation mean?
REACH stands for Registration, Evaluation, Authorisation and restriction of CHemicals.
It refers to EC Regulation 1907/2006, which entered into force on 1 June 2007. Its main objective is to protect human health and the environment from the risks posed by chemical substances.
What does the REACH Regulation require?
The REACH Regulation requires companies to identify the properties and risks of the chemical substances they manufacture and sell in the EU, and to provide information on how they can be used safely.
This includes obligations such as:
- obtaining a REACH registration number
- notifying the chemical substances contained in products placed on the market
However, not all companies are subject to the same obligations. The requirements depend on the role the company plays in the supply chain.
Who is required to comply with the REACH Regulation?
REACH is a cross-cutting regulation that, to varying degrees, applies to most companies, including businesses that may not appear to be involved in the chemical industry.
| Type of company | How REACH affects them |
|---|---|
| Manufacturers | EU companies that manufacture substances for their own use, sale or export. They generally have the most extensive obligations. |
| Importers | Companies that bring chemical products into the EU or EEA from outside: substances, mixtures and finished products (clothing, electronic devices, plastics, etc.). |
| Downstream users | EU companies that use or handle chemical products. |
| Distributors | Companies that do not use chemical products but are responsible for their storage, distribution and/or supply to third parties. |
| Producers | Companies that manufacture or produce articles in the EU that may contain chemical substances. |
| Only Representatives | EU-based companies appointed exclusively by non-EU companies to handle the procedures required to comply with REACH. |
Companies based outside the EU are not directly required to comply with REACH, including when they export products to the European Union. The obligations fall on EU-based companies importing those products, or on the Only Representatives appointed by non-EU companies.
How is the REACH Regulation enforced?
The ECHA (European Chemicals Agency), established in 2007 and based in Helsinki, is responsible for implementing the REACH legislation. It provides information on chemical substances and manages the reports and information submitted by companies.
However, the ECHA does not have the power to enforce REACH directly. This role is carried out by the competent authorities in each EU Member State.
The regulation requires laboratory testing. In practice:
- companies identify the risks associated with their substances
- they demonstrate to the ECHA that the substances can be used safely
- they provide users with information on how to avoid these risks
At Kaeltia, we help companies determine which sections of the regulation apply, what information needs to be collected, which reports need to be prepared and how to submit the required documentation to the competent authority, with follow-up until the certificate is obtained, where applicable.
An ECHA scientific committee assesses the application and, if the risks cannot be adequately managed, restrictions may be imposed on the use of the substance or it may even be banned completely. The regulation promotes the gradual replacement of the most hazardous substances with safer alternatives.
Substances covered by the REACH Regulation
REACH applies to a wide range of substances, not only those used in industrial processes. They are also found in everyday products such as cleaning products, paints, clothing and electronic devices.
In general, REACH covers substances manufactured or imported into the EU, whether they are placed on the market as individual substances, in mixtures or as part of products and articles. Some substances are excluded from the regulation, such as radioactive substances, waste and substances being transported, in accordance with the exemptions set out in Article 2.
The main categories include:
- Substances subject to authorisation: these are listed in Annex XIV of REACH, and the list can be expanded when necessary.
- SVHC substances: substances of very high concern included in the ECHA Candidate List. These include CMR substances (carcinogenic, mutagenic or toxic to reproduction) and certain phthalates. As of September 2026, the list contains 253 entries.
- Substances used in fertilisers: EU fertilising products are subject to specific REACH+ requirements established alongside Regulation (EU) 2019/1009 (FPR).
For fertilisers:
- With CE marking: REACH+ requirements apply, including the registration of substances and the provision of the necessary information on their safety and use as fertilising products.
- Without CE marking: the product is not considered an EU fertilising product and is subject to the standard REACH requirements, depending on the tonnage manufactured or imported.
What is the CLP Regulation?
While REACH evaluates, authorises and restricts chemical substances, the CLP Regulation deals with the classification, labelling and packaging of chemical substances and mixtures. It uses labelling to identify the properties and potential hazards of each substance and also regulates how they are packaged.
Like REACH, CLP imposes obligations depending on the company’s role in the supply chain. Both regulations are key parts of the European regulatory framework for assessing and managing chemicals and their associated risks.
To help ensure compliance, at Kaeltia Consulting we advise manufacturers, distributors and importers through services such as:
- reviewing and preparing Safety Data Sheets (SDS)
- reviewing labelling and adapting it to the country of export
- reviewing and preparing CLP classifications for chemical substances
- preparing, submitting and monitoring REACH certification dossiers
Discover our biocides service and our fertilisers and biostimulants service.
