Impact of REACH Regulation on Importers and Distributors

REACH, or Registration, Evaluation, Authorisation and Restriction of Chemicals, is a European Union regulation concerning the safe use of chemicals. Enacted in 2007, it places the responsibility on manufacturers, importers, and downstream users to ensure that chemicals they produce, import, or use do not adversely affect human health or the environment. This article is specifically aimed at overseas distributors and OEM brands who import products containing chemical substances into the European Union (EU) and the European Economic Area (EEA).

Understanding Your Obligations as an Importer under REACH

As an importer, you are responsible for understanding and complying with REACH regulations. This means determining whether the substances in your imported products are subject to registration, evaluation, authorisation, or restriction. Ignorance of REACH is not an excuse; non-compliance can result in significant penalties, including fines, import restrictions, and reputational damage. The core of compliance lies in identifying the substances present in your products and understanding the obligations linked to those substances.

What Constitutes an “Import” under REACH?

Under REACH, “import” means the physical introduction into the customs territory of the European Union. This includes substances on their own, in preparations (mixtures), or in articles. It’s crucial to remember that even if you are not directly involved in the manufacturing process, if you are the entity responsible for bringing the product into the EU, you are considered the importer and bear the associated responsibilities. Furthermore, if you are an Original Equipment Manufacturer (OEM) placing your brand on products manufactured outside the EU, you are likely considered the importer if you are responsible for bringing them into the EU.

Key Obligations for Importers

Your key obligations as an importer under REACH revolve around registration, notification, and communication within the supply chain.

• Registration: If you import a substance on its own or in a preparation in quantities of 1 tonne or more per year, you are generally required to register that substance with the European Chemicals Agency (ECHA). Registration involves providing detailed information about the substance, including its properties, uses, and potential hazards. You may register jointly with other importers of the same substance to share the cost and effort.
• Notification: If your products contain substances on the Candidate List of Substances of Very High Concern (SVHC) in a concentration above 0.1% weight by weight (w/w), you are required to notify ECHA if the total amount of the substance contained in articles produced or imported by you exceeds 1 tonne per year. This notification requirement only applies under certain conditions, such as when the substance is not already registered for that use.
• Communication: You have a responsibility to communicate information about the safe use of your products throughout the supply chain. This includes providing Safety Data Sheets (SDSs) to downstream users for substances and preparations, and providing sufficient information to allow safe use of articles containing SVHCs. This information should include the name of the SVHC, its concentration, and any relevant safe handling instructions.

Authorisation and Restriction under REACH

Beyond registration and notification, REACH also includes provisions for authorisation and restriction, which can significantly impact importers.

Authorisation

Certain Substances of Very High Concern (SVHCs) are placed on Annex XIV of REACH, which subjects them to the authorisation process. If a substance is on Annex XIV, its use is prohibited unless an authorisation has been granted by the European Commission. Importers who wish to continue using a substance subject to authorisation must apply for authorisation demonstrating that the risks associated with its use are adequately controlled or that the socio-economic benefits outweigh the risks and that there are no suitable alternative substances or technologies.

Restriction

Annex XVII of REACH lists substances that are subject to restrictions on their manufacture, placing on the market, or use. These restrictions may apply to specific uses or concentrations of a substance. Importers must ensure that their products comply with any restrictions listed in Annex XVII. Failure to comply with restrictions can lead to enforcement actions and the withdrawal of products from the market.

Navigating the Complexity: Strategies for Compliance

Complying with REACH can be complex, but there are several strategies that importers can employ to navigate the regulatory landscape effectively.

• Know Your Supply Chain: A thorough understanding of your supply chain is essential. Identify all chemical substances present in your products and communicate with your suppliers to obtain the necessary information for registration, notification, or compliance with restrictions.
• Leverage Existing Registrations: If a substance you import is already registered by another entity in your supply chain, you may be able to rely on that registration, provided you have the necessary information and can demonstrate that your use is covered by the registration.
• Join a Substance Information Exchange Forum (SIEF): SIEFs are groups of potential registrants of the same substance who collaborate to share data and prepare a joint registration dossier. Joining a SIEF can significantly reduce the cost and effort associated with registration.
• Utilize ECHA’s Resources: ECHA provides a wealth of information and guidance on REACH compliance, including webinars, manuals, and online tools. Take advantage of these resources to stay informed and ensure compliance.
• Engage with Experts: Consider engaging with REACH consultants or legal experts who can provide tailored advice and support to help you navigate the complexities of REACH and ensure compliance.
• Implement a Robust Compliance Program: Establish a systematic approach to REACH compliance, including processes for identifying chemical substances, assessing risks, and communicating information throughout the supply chain.

The Long-Term Benefits of REACH Compliance

While complying with REACH may seem burdensome, it offers several long-term benefits for importers and distributors. Besides avoiding penalties and maintaining access to the EU market, REACH compliance can enhance your reputation, improve product safety, and drive innovation. By demonstrating a commitment to responsible chemical management, you can build trust with your customers and stakeholders. Furthermore, the drive to find safer alternatives to hazardous substances can lead to the development of innovative and more sustainable products.

Summary

REACH significantly impacts overseas distributors and OEM brands importing into the EU/EEA. Understanding your obligations as an importer is crucial for ensuring compliance and avoiding penalties. Key aspects include registration of substances, notification of SVHCs in articles, communication within the supply chain, and adherence to authorisation and restriction provisions. By implementing robust compliance strategies, leveraging available resources, and engaging with experts, importers can effectively navigate the complexities of REACH and reap the long-term benefits of responsible chemical management.