REACH Registration Requirement
The European REACH Regulation (Registration, Evaluation, Authorisation, and Restriction of Chemicals) is one of the most far-reaching and comprehensive legal frameworks in the world regarding chemical substances. Its primary aim is to protect human health and the environment from harmful chemical risks. At the same time, REACH encourages the free movement of substances within the EU’s internal market and promotes both innovation and competitiveness. Approximately 84% of chemical substances used on a large scale in the EU fall under this regulation.
For companies that manufacture, import, or use chemicals within the EU, REACH imposes a series of significant obligations. The registration requirement forms the foundation of these obligations.
This article of our Dutch REACH attorneys provide an overview of the registration requirement under the REACH regulation. It refers to the official guidance from the European Chemicals Agency (ECHA), which supports businesses in achieving proper compliance. Additionally, we discuss the role of national supervisory authorities in the Netherlands and the consequences of non-compliance.
What Does the Registration Requirement Under REACH Entail?
The registration requirement obliges manufacturers and importers of chemical substances in the EU to gather extensive information about the properties, hazards, and uses of these substances. This data must be documented in an electronic registration dossier, which is submitted to ECHA via the REACH-IT portal. Our Dutch attorneys often see that parties struggle with the registration requirement under the REACH Regulation.
A substance may only be manufactured or imported in quantities of one tonne or more per year after successful registration. In 2023, more than 92% of registered substances had more than one use, highlighting the necessity of detailed dossier preparation.
A REACH registration dossier typically includes:
- Identification data of the substance
- Production and use conditions
- Risk management measures
- A chemical safety report (CSR) for substances over 10 tonnes per year
Who Is Responsible for Registration Under REACH, and When?
The REACH registration requirement applies to:
- EU manufacturers and importers of substances, either on their own or in mixtures (from one tonne per year)
- EU producers and importers of articles containing substances above one tonne per year, provided these substances are intended to be released during normal use
- Only representatives appointed by non-EU manufacturers to fulfill the registration obligation
Downstream users—companies that only use substances without manufacturing or importing—are exempt from registration but do have other obligations. Since May 2018, every substance falling under REACH must be registered prior to production or import.
A Step-by-Step Plan for Compliance Under the REACH Regulation
According to ECHA’s guidance, the following stepwise approach should be followed:
- Determine Your Role: Are you a manufacturer, importer, only representative, or downstream user?
- Identify the Substance(s): Collect data on chemical identity and composition.
- Assess Registration Needs: Check for exemptions or restrictions (for example, Annex IV/V of the regulation).
- Calculate Annual Volume: Add up all volumes per substance.
- Gather Toxicological and Ecotoxicological Data: Essential for risk assessment.
- Prepare a Dossier in IUCLID Format: Use official tools like IUCLID and REACH-IT.
- Submit the Dossier: Upon successful technical review, you will receive a registration number.
- Keep the Dossier Up to Date: Mandatory upon changes in volume, hazards, or uses.
Key Points and Pitfalls Under REACH
Exemptions and Exceptions
Not all substances require registration. Exemptions apply to substances such as natural minerals, waste, and certain polymers under specific conditions. Only 11% of substances used in the EU are entirely excluded from registration.
Joint Submission of Data Under REACH
The “one substance, one registration” principle obliges companies to cooperate. While this reduces costs and animal testing, discussions about confidentiality and cost-sharing often arise. The opt-out option remains vital for sensitive information.
Confidentiality and Dossier Justification
Sensitive company information can be declared confidential. However, only 38% of confidentiality requests are accepted by ECHA without additional justification.
Dynamic Obligations
A registration dossier is not static. New insights or changed circumstances require immediate updates.
Enforcement and Sanctions
National enforcement authorities in the Netherlands regularly carry out inspections. In 2022, 14% of inspected dossiers resulted in a penalty or warning, often due to insufficient documentation or incomplete information.
Practical Example: The Pitfall of Incorrect Role Definition
In 2021, a medium-sized German paint manufacturer received a fine after importing substances from Switzerland for years without registering as an importer. The company considered itself a downstream user because the supplier provided safety information. However, the regulator determined the legal role was wrongly defined. The result: a €75,000 fine, reputational damage, and temporary production shutdown.
Involved Authorities and Their Role
- ECHA: Manages the registration system, evaluates dossiers, and publishes public data.
- National enforcement authorities in the Netherlands: Monitor compliance, impose fines, and can remove products from the market.
- European Commission: Responsible for policy interpretation and revision of REACH.
Practical Tips for Companies
Preparation Is Essential
- Map out your entire portfolio of substances.
- Clearly establish your REACH role.
- Utilize tools like IUCLID and Chesar.
- Consult industry associations for joint registrations.
- Involve legal and technical teams early.
Common Mistakes and How to Avoid Them
- Incorrect role determination: Review REACH definitions thoroughly.
- Inaccurate substance identification: Use accredited laboratories for analyses.
- Slow dossier management: Set internal deadlines and use checklists.
- Poor confidentiality justification: Clearly document the commercial sensitivity.
- Insufficient documentation: Systematically archive all communication and decisions.
Conclusion
The Registration Requirement Under the REACH Regulation is not a mere administrative formality. It is a strategic prerequisite for market access and risk management in the Netherlands. Now that enforcement is increasing and transparency is more important than ever, companies must proactively and accurately comply with registration obligations under Dutch law.
Companies investing in solid registration dossiers gain not only legal certainty but also enhance their market position. Do not wait for an inspection—anticipate and invest in compliance. Proper REACH registration is not optional; it is a competitive advantage in the Netherlands.
