Are you a non-EU manufacturer aiming to place chemical products on the EU market? Navigating the REACH Regulation can be challenging, as non-EU companies cannot register their chemical substances directly with the European Chemicals Agency (ECHA). 

To legally access the EU market, you must appoint a qualified Only Representative (OR). This EU-based entity handles the REACH duties of your EU importers, reclassifying them as downstream users. This strategic step ensures you maintain control of your REACH registration and compliance obligations while streamlining your supply chain. 

Understanding the Only Representative’s role 

The role of an Only Representative is legally and precisely defined. It’s important to understand what an OR is and what it is not. 

An OR is: 

• A legal entity physically established in the EU/EEA. 

• The holder of your REACH registration on your behalf. 

• Your point of contact with ECHA for all REACH matters. 

• An expert with sufficient background and OR practical experiences to do OR tasks. 

An OR is not: 

• An import/export agent. 

• A logistics or customs broker. 

• Just a consultant. An OR should also be able to handle all REACH duties on behalf of the non-EU manufacturer.  

A step-by-step guide to the OR appointment process 

1. Confirm your REACH obligations

1. • Verify if your substance either on its own, in a mixture or in an article, falls under REACH.
   • Identify the correct tonnage bands.
2. Select a qualified Only Representative
   • Ensure the OR is a legal entity established within the EU/EEA.
   • Assess their expertise in chemistry, toxicology, and EU-REACH regulatory affairs.
   • Check for relevant accreditations or memberships, such as with the Only Representative Organisation (ORO), which can signal credibility.
3. Exchange substance-related information
   • Provide your OR with a complete list of your substances.
   • Share all relevant data, including substance identity, purity, intended uses, and annual tonnage.
   • Supply available safety data sheet, test results, and any previous registration history.
4. Finalize the OR service agreement
   • Ensure the contract clearly defines the scope of OR services, including the duties and responsibilities.
   • Review the cost structure, which typically includes annual fees and any additional charges for consortium costs or dossier updates.
5. The OR initiates the registration process
   • The OR will create and manage a separate REACH-IT account under its name for each non-EU manufacturer that it represents.
   • The OR takes care of the whole REACH registration process including communications with the consortium and ECHA.
6. Ongoing compliance and dossier maintenance
   • The OR manages all post-submission obligations, including dossier updates, tonnage reports, and communication with your EU importers, the consortium and ECHA.

Key benefits of using an Only Representative 

Appointing an OR offers several key advantages for your business: 

• Secured market access: Once having the registration in hand via an OR, a non-EU manufacturer can compliantly export their products to the EU market.  

• Market flexibility: The OR model widens the gate to every EU country. Instead of being dependent on certain EU clients who have REACH registration, owning REACH registration via an OR allows you to actively and smoothly sell products to any EU importers: more clients, more deals and therefore more profits.  

• Centralized service: All REACH regulatory duties are handled by a single contact point who knows what to do, giving you peace of mind for your business matters. 

• Secured confidential information: By registering the substance via an OR, a non-EU supplier can avoid providing confidential business information to clients.  

• Strategic advantage: EU importers prefer to work with non-EU suppliers who have an OR, as it reduces their own REACH regulatory burden. 

By appointing a trusted Only Representative, you can ensure REACH compliance, reduce administrative burden, and focus on expanding your business in the European market. 

Chementors has been acting as an Only Representative for many years. Let us take care of your REACH matters.  

Frequently asked questions about REACH Only Representatives 

1. What is the difference between a REACH Only Representative and an importer?

A REACH Only Representative (OR) is an EU-based legal entity appointed by a non-EU manufacturer. The OR’s primary role is to act as the registrant for the substances being placed on the EU market, taking over the REACH compliance obligations from the importers. An importer, on the other hand, is any EU-based company that physically brings a substance, mixture, or article from outside the EU into the European market. By having an OR appointed by the non-EU supplier, the importer’s legal role under REACH is simplified from that of being a registrant to being a downstream user, reducing their REACH duties. 

2. Can a non-EU manufacturer have multiple Only Representatives?

A non-EU manufacturer must appoint a single Only Representative for each specific substance they wish to register. However, a single OR can represent a manufacturer for multiple substances. This centralizes all registration activities under one entity, which is more efficient and provides better control over the REACH compliance process. 

3. What happens if a non-EU manufacturer sells a product into the EU without an Only Representative?

If a non-EU manufacturer places a substance on the EU market without the required REACH registration, the product is non-compliant and cannot be legally sold. Authorities can request the product to be removed from the market, and the importer may face fines and penalties. This lack of compliance can also damage a company’s reputation and lead to a complete loss of market access.