What is the REACH Regulation?
The REACH Regulation (EC) No 1907/2006 is the cornerstone of European chemicals legislation. The acronym stands for Registration, Evaluation, Authorisation and Restriction of Chemicals.
REACH entered into force on 1 June 2007 and is administered by the European Chemicals Agency (ECHA) in Helsinki. The regulation applies directly in all EU Member States and the EEA (Norway, Iceland, Liechtenstein).
The core principle of REACH is straightforward yet far-reaching: it is not for the authorities to prove that a substance is dangerous — it is for the manufacturer or importer to demonstrate that it is safe. REACH thus reverses the burden of proof and places responsibility for risk management squarely on industry.
Who Needs to Register Under REACH?
The registration obligation applies to three groups of actors:
- Manufacturers: Companies that produce chemical substances in the EU — from a volume of 1 tonne per year per substance.
- Importers: Companies that bring substances (on their own or in mixtures) into the EU from non-EU countries — also from 1 tonne/year.
- Only Representatives: EU-based persons or companies appointed by a non-EU manufacturer to fulfil their registration obligations.
Downstream users such as formulators and industrial end-users do not need to register themselves, but they do have information obligations along the supply chain — particularly concerning safe use.
Tonnage Bands and Data Requirements
The higher the manufactured or imported volume, the more comprehensive the data requirements:
- 1–10 t/year: Basic physico-chemical data, baseline toxicology
- 10–100 t/year: Additional sub-chronic toxicity studies, ecotoxicology
- 100–1,000 t/year: Additional long-term toxicity studies, Chemical Safety Report (CSR)
- >1,000 t/year: Full dossier with long-term animal studies, extended CSR
Substances of Very High Concern (SVHCs)
SVHCs are substances that may have serious effects on human health or the environment. They include:
- CMR substances (Category 1A/1B): Carcinogenic, mutagenic or toxic for reproduction
- PBT substances: Persistent, bioaccumulative and toxic
- vPvB substances: Very persistent and very bioaccumulative
- Endocrine disruptors: Substances with hormonal effects (added in REACH revisions)
SVHCs are placed on the ECHA Candidate List. Companies placing articles containing SVHCs above 0.1% by weight on the market must proactively inform their customers and respond to consumer inquiries within 45 days (Art. 33 REACH).
As of April 2026, the Candidate List contains over 240 entries. ECHA typically updates it twice a year.
The Authorisation List (Annex XIV)
Priority substances from the Candidate List are included in Annex XIV. After the relevant sunset date, these substances may only be used if an authorisation has been granted — requiring proof that risks are adequately controlled or that the socio-economic benefits outweigh the risks.
REACH and the Digital Product Passport
The REACH Regulation and the Digital Product Passport (DPP) complement each other perfectly. While REACH defines the data obligations for chemical substances, the DPP provides the digital framework to make this data transparent and accessible.
The OYSI Digital Product Passport integrates REACH-relevant information directly:
- REACH registration number: Proof of proper registration
- SVHC status: Transparent labeling of whether substances of very high concern are present
- Safety Data Sheet: Direct download of the SDS in all relevant languages
- GHS classification: Automatic integration of all CLP data from the substance database
- Supply chain communication: Exposure scenarios and conditions of use
REACH Compliance in Practice
For companies in the chemical industry, REACH compliance means a series of concrete obligations:
- Pre-registration and registration: Timely submission of the technical dossier to ECHA
- Information sharing: Prepare and maintain Safety Data Sheets (SDS) in accordance with Annex II
- SVHC monitoring: Regular checks of the Candidate List for own substances and supplies
- Observe restrictions: Annex XVII contains use restrictions and bans
- Downstream communication: Inform customers about safe conditions of use
The OYSI chemistry database with over 3,800 substances helps companies manage REACH-relevant data centrally and make it available along the entire supply chain through the Digital Product Passport.
OYSI and REACH Compliance
As a specialized chemical distributor with over 30 years of experience, OYSI GmbH provides comprehensive support for REACH compliance:
- Complete registration data for all distributed substances
- Up-to-date Safety Data Sheets in DE, EN, FR — available at any time via the DPP
- SVHC screening with every Candidate List update
- Automated compliance checks through the DPP platform
Author
Olivier Höfer
Managing Director, OYSI GmbH
OYSI GmbH