Introduction.
When considering the export of products to the European market, one of the most frequently discussed regulations is the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. Especially for companies dealing with chemical substances and products containing them, this regulation goes beyond mere legal obligations and can be a key to business continuity. This article provides a comprehensive overview of the basics of the REACH regulation, the companies that are subject to it, the application process, and the risks associated with non-compliance.
What is the REACH Regulation?
The REACH regulation is a comprehensive chemical substance regulation system that came into force in the European Union (EU) in 2007. It aims to minimize the impact of chemical substances on human health and the environment, and requires manufacturers and importers of chemical substances to evaluate their safety and register them with the European Chemicals Agency (ECHA).
- REACH consists of the following four elements
- Registration: Registration with ECHA is required prior to importing or manufacturing more than 1 ton per year of a chemical substance into the EU.
- Evaluation: Scientific assessment of submitted data.
- Authorisation: For Substances of Very High Concern (SVHC), special authorization is required for their use.
- Restriction: The use or sale of a chemical substance is restricted under certain conditions.
Companies subject to the REACH Regulation
We receive many inquiries on a daily basis, but what is often misunderstood is that all companies must be REACH compliant.
In practice, the REACH regulation is only applicable to companies that import more than one ton of the subject substance per year into the EU. Therefore, when exporting products to Europe, if the export volume is less than 1 ton, there is basically no REACH registration obligation.
In principle, the responsibility for registration under REACH rests with importers in the EU. Therefore,
trading company
Local subsidiary of a major company with offices in Europe
In most cases, the target companies are small and medium-sized enterprises (SMEs) and manufacturing companies that ship directly from Japan, and in most cases, they do not need to comply with REACH on their own.
If you understand this point, you can avoid unnecessary anxiety and erroneous investments.
How to apply for the REACH Regulation
To register for REACH, follow these steps
Substance Identification
Clarify chemical structure, composition, impurities, etc.
Joint Submission
Multiple companies can jointly register for the same substance.
The lead registrant compiles the data, and other registrants refer to it for registration.
Preparation of Technical Dossier
Collects information on the safety of substances, conditions of use, and risk assessment.
Prepare Chemical Safety Report (CSR) (as needed)
Required for more than 10 tons/year.
Submission to ECHA
Apply electronically using special software called IUCLID.
Payment of registration fees
Depending on the size of the company and the characteristics of the registered substance, the cost may range from several thousand to several tens of thousands of euros.
Failure to comply with REACH regulations
Failure to comply with the obligations under REACH entails significant risks, including the following
Ban on sales in the European market
Seizure and injunction of exported goods
Termination of contract by business partner / loss of trust
High fines (depending on member country)
Especially in B2B, if unregistered REACH is discovered, it may cause serious damage to the trust relationship with local partners and make it difficult to continue business.
Points to keep in mind when outsourcing compliance with the REACH regulation
Many small and medium-sized enterprises (SMEs) deal with REACH registration by asking their EU representative (Only Representative) to do it for them. However, the following points should be noted
Select an agent with a proven track record (preferably one with a history of ECHA registration)
Ensure that post-registration administration (renewal obligations, notification of regulatory changes, etc.) is covered.
Need to prepare technical information in English
summary
The REACH regulation is a very important regime for companies exporting chemicals or products containing them to the European market. However,
Exports less than 1 ton per year
EU-side importers are responsible
In many cases, depending on conditions such as the following, it may not be necessary to take action. Avoiding unnecessary procedures and identifying necessary measures is the first step toward efficient European business development.
We offer comprehensive support, from determining whether or not your company is REACH compliant in Japanese, to introducing EU representatives, to liaison with ECHA. Please feel free to contact us.