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REACH Regulation
What is REACH (Regulation (EC) 1907/2006)
REACH (Regulation (EC) No 1907/2006) is a European Union regulation that aims to protect human health and the environment from the risks posed by chemicals. It entered into force on 1 June 2007 and applies to all chemicals – not only those used in industry, but also those in everyday products such as cleaning products, paints or adhesives. For this reason, REACH has an impact on a wide range of businesses across the European Union.
The REACH Regulation applies to:
manufacturer and importer of chemicals
distributors and downstream users
companies outside the chemical industry that use substances or mixtures
Key elements of REACH
1. Registration
Every company manufacturing or importing a chemical substance in quantities exceeding 1 tonne per year must register it with the European Chemicals Agency (ECHA). Registration includes:
- identification of the substance,
- its properties and uses,
- risk assessment and measures to control them.
The first step is to submit an inquiry, followed by the preparation of the so-called registration dossier. Both are prepared using the IUCLID software tool and sent via the REACH-IT system. The dossier can be submitted individually or jointly with other companies. The principle of "one substance, one registration" applies, which means that all entities must submit the registration together.
Registration applies to substances on their own, to substances contained in mixtures, and in certain cases also to substances in articles (e.g. in products). Exemptions from registration apply, for example, to medicines, food or radioactive substances.
2. Evaluation and authorisation of substances
Rating
The aim of the evaluation is to verify whether there is sufficient information available on the substance for its safe use. It is carried out at two levels:
Evaluation of documentation
is carried out by the ECHA agency, which assesses the completeness of the data, checks its quality and completeness.
Substance evaluation
carried out by individual Member States and assesses substances for which specific concerns have been identified – e.g. carcinogenicity, reproductive toxicity or persistence in the environment.
Three-phase evaluation process:
- 1. Assessment – collection and analysis of available data on the substance.
- 2. Decision – ECHA may request additional information if it is insufficient.
- 3. Follow-up – the decision may require the applicant to submit or obtain further data.
If the evaluation reveals serious risks, the substance may be restricted or made subject to authorisation. In this way, REACH seeks to gradually reduce the presence of the most hazardous substances on the European market.
Authorization
Substances of very high concern (e.g. carcinogenic or persistent substances) are subject to specific authorisation requirements. The aim is to control their use and, where technically and economically feasible, to gradually replace them with safer alternatives.
Restriction
Some substances may be completely banned or only used under specific conditions – typically due to health or environmental hazards.
The restriction may apply not only to the substance itself, but also to the substance contained in a mixture or in an article. All currently applicable restrictions are listed in Annex XVII of the REACH Regulation. The list of restrictions is continuously updated.
The restriction process includes:
- proposal – submitted by any Member State or ECHA,
- dossier – containing the substance identification, description of the proposed restriction and justification and prepared in accordance with Annex XV of REACH
- public consultation – comments from all interested parties
- assessment by RAC and SEAC,
- Commission decision and update of Annex XVII of REACH.
Once a restriction is approved, it becomes binding on all actors in the supply chain – from manufacturers, importers, distributors, downstream users and retailers.
Obligations of companies
The REACH Regulation places the responsibility for the safe management of chemicals on companies themselves. They must ensure that the substances they place on the market or use are properly risk-assessed and used safely.
In practice, they can play the following roles:
Manufacturer
is a company that produces a chemical substance either for its own use or supplies it to third parties.
Importer
purchases chemical substances or mixtures from countries outside the EU/EEA and places them on the EU market.
Downstream user
uses chemical substances or mixtures in production, processing or as part of its business activities.
Non-EU entity
does not have obligations arising directly from REACH. The importer who places substances or mixtures into the customs territory of the Union is responsible for compliance with the regulation.
Safety Data Sheet (SDS) according to REACH
The Safety Data Sheet (SDS) is a key communication tool in the supply chain. Under the REACH Regulation, it serves to communicate information on the risks of chemical substances and mixtures and how to handle them safely.
Every company that places substances classified as hazardous on the market, or substances meeting specific criteria (e.g. PBT, vPvB, substances subject to authorisation), must provide a safety data sheet with its products.
The format and content of the safety data sheet are precisely specified in Annex II to the REACH Regulation. The format of Annex II was last updated by Commission Regulation (EU) 2020/878, which is binding from 1 January 2023 and applies to all newly issued and updated safety data sheets.
The safety data sheet must be provided free of charge, in the language of the country of destination, and in the current version – updating is mandatory whenever information or formal requirements change.
This text is for informational purposes only and does not replace applicable legislation.
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