EU REACH Only Representative Services

Companies outside of Europe need an EU REACH Only Representative (OR) to handle their EU REACH matters.

We are fully qualified and experienced to act as your EU REACH Only Representative for the European market. We offer a comprehensive approach to meet all of your EU REACH registration and Only Representative needs. 

What is a REACH Only Representative?

According to EU REACH Regulation (EC) No. 1907/2006, the registration must be done by EU manufacturers, EU importers, or EU Only Representatives (OR). Non-EU companies cannot make the registration.

Instead, non-EU legal suppliers who manufacture a substance on their own, in mixtures, or articles, formulate a combination, or manufacture a product imported into the EU market, can appoint an EU-based entity as their Only Representative to conduct the registration for their chemicals.

With this model, the Only Representative shall fulfill all REACH obligations of importers, and the importers shall become downstream users in the registration according to the regulation.

Chementors, with a legal entity in Finland, is experienced in acting as Only Representative for companies established outside the EU.

In short, in compliance with Article 8 of the REACH Regulation, a qualified Only representative must be:

A natural person or legal entity found physically in the EU
Has knowledge and know-how to handle information and data required for the registration and manage post-registration requirements

Appointed by a mutual agreement with a non-EU manufacturer, formulator or article producer
Fulfill all REACH obligations for importers

“Non-EU entities cannot do REACH registration. The best choice for them would be appointing an EU-based Only Representative. Chementors offers qualified OR services.“

Benefits of using a REACH Only Representative

Via the Only Representative model, non-EU manufacturers can proactively promote and sell their chemicals to various importers in multiple EU countries instead of passively to a limited number of importers who have already made the REACH registration for the substances.

By having an OR to take care of all REACH legal obligations, time and resources could be saved while access to the EU market for products is simplified and widened. This allows non-EU companies to secure their supply and maintain competitiveness.

This OR practice also brings benefits to importers as their REACH responsibilities would be reduced remarkably. In fact, EU importers usually look for non-EU suppliers who have already registered their substances and are capable of maintaining the REACH compliance matters at all times.

Chementors with a team of competent and experienced experts has been acting as an OR for different non-EU entities. Operating on a one-stop service model, we take care of and handle all REACH obligations.

Common challenges and risks with REACH Only Representatives

As an OR will be the one who processes all required data, handles REACH registration, and manages post-registration obligations, establishing an OR partnership is therefore critical to be sure that the REACH compliance status of the products is well taken care of at all times.

There are some common challenges and risks associated with REACH Only Representatives:

OR is not an EU-based entity as claimed therefore violating the REACH Regulation
OR does not have sufficient qualifications and practical experience to handle a large amount of scientific data and complex regulatory terms & conditions to generate a qualified registration dossier. This could lead to the failure of the registration submission or the penalties from the authority due to incorrect information, therefore delaying and harming trading activities
OR is not capable of following up on post-registration notifications from the authority and consortiums leading to delays in fulfilling post-registration obligations
In case of termination, OR does not cooperate fully in the transfer of the necessary data, documents in its possession and ownership of the pre-registrations and registrations to another Only Representative of the Client’s choice

Choosing a good Only Representative is important. Chementors is a legally compliant and competent OR.

Chementors

Why Chementors as your EU REACH OR?

Chementors, with its headquarters in Finland, is an EU-legal entity. We are also a member of the Only Representative Organization (ORO) and are approved by the REACHReady organization. If you are a non-EU manufacturer, we can legally represent you as an OR for your REACH registration.

Furthermore – The European Chemicals Agency (ECHA) has its headquarters in Helsinki, Finland, where one of our offices and most of our experts are based.

Our REACH team can discuss confidential issues with ECHA experts face-to-face smoothly and efficiently. Another advantage is the possibility of communicating with Finnish experts in their language.

We have several OR customers around the world; please see an example Case Study here. We have also accomplished many REACH registrations for non-EU manufacturers.

We are experts in EU REACH matters and can act as your REACH Only Representative in Europe. Let us help you manage the complex requirements of EU REACH compliance.

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Who needs an Only Representative?

Legal entities established outside the EU who manufacture a substance on its own, in mixtures, or articles, formulate a mix or manufacture an article placed on the EU markets.

Who can be appointed as EU REACH Only Representative?

Legal entities established in the EU who should be competent in chemicals and REACH regulation to handle the whole REACH registration and follow-up process can be appointed as EU REACH Only Representatives.

Our REACH Only Representative services

Chementors’ Only Representative responsibilities are the following:

Accepting the role as an OR following the appointment by the supplier
Setting up a REACH-IT account and submitting a REACH inquiry and REACH registration dossier
Taking official roles in the Substance Information Exchange Forums (SIEFs)/Consortiums
Establishing and agreeing on testing strategies
Determining and agreeing on hazard assessment for each registration
Assessing and agreeing on data gaps
Compiling and agreeing on registration details
Negotiating contractual details
Organizing the preparation/updates of the Chemical Safety Report (CSR)
Organizing tests, monitoring laboratory work, and interpreting test results
Analyzing substance identity and agreeing on Substance Identity Profile (SIP)
Compiling the registration dossier
Assessing and agreeing on the content of safety data sheets (SDS) to be consistent with registration details
Identifying and agreeing to cooperate with importers
Monitoring supply patterns (import volumes and SDS check with each importer)
Communicating with importers and downstream users on certificates, volumes, uses, regulatory updates etc.,
Checking risk management measures that are being communicated in the supply chain
Considering exposure scenarios for downstream users in the supply chain
Cooperating with the authorities
Monitoring communication, messages, and alerts from the authorities

The REACH process continues even after the completion of the registration. This applies to all parties involved in REACH and not just the OR.

The exposure scenarios, Chemical Safety Assessment (CSA), and Chemical Safety Report (CSR) are ongoing ‘live’ documents that need updating with new test data or new exposure details if necessary. The safety data sheet is also a live document that would need an update and revision when required by the regulations.

Annual data on importing volumes and downstream users must also be updated in the system. In addition, from time to time, there are critical notifications and alerts from the European Chemicals Agency (ECHA) or from the consortiums on the registration system that require confirmations or further actions without delays from the registrants.

Therefore, the registration page should be taken care of to stay compliant. As an Only Representative, Chementors is here to assist you.

The process to appoint Chementors as your Only Representative:

Chementors checks clients' substance information and requests tonnage band for REACH registration costs, timeline, and process. Determining the OR yearly fee cost.

Chementors provides OR service quotation and REACH registration quotation for the client.

Once the quotation(s) is/are accepted, possible OR legal entity change will be handled by Chementors.

Sign the Only Representative Service Agreement with the substance manufacturer (s).

Chementors will handle all REACH registrations according to the agreed quotations with separate REACH Service Agreements.

FAQs

What are the main responsibilities of a REACH Only Representative?

Generally, an OR will take care of some main tasks as follow:

Representing the non-EU manufacturer of the substance for the REACH registration
Accepting the OR responsibility under REACH regulation for the substances according to OR Service Agreement
Maintenance of the REACH-IT account and checking communications from ECHA

Can a REACH Only Representative represent multiple companies?

Yes, it can. It is legally allowed under the REACH Regulation that an OR can represent more than one non-EU supplier.

How often do REACH Only Representatives need to communicate with regulatory authorities?

There is no definite frequency when an OR should communicate with ECHA. In short, communication is often needed:

During the registration process when there are technical questions, administrative inquiries, or IT issues to be clarified or fixed.
When ECHA registration result is published and requires the registrant to further exchange with ECHA in order to provide relevant proofs or documents, or to fulfill missing information.
During the post-registration follow-up process if any notifications from ECHA require immediate clarification and actions.

Can we change our EU REACH OR?

Yes, you can. Changing legal entities is allowed by the EU REACH regulation. Therefore, non-EU enterprises can change their OR following a process well guided by ECHA.

We plan to establish an EU-legal entity in the EU in the future. If we use OR service now to manage our substance registration, could we later switch the management role to our EU-legal entity? Do we have to do the registration again?

REACH regulation allows changing the legal entity, for instance from OR to another appointed EU company, to manage the registration on REACH-IT, in the same process as the above case, while keeping the registration intact. In other words, there is no re-registration when switching the legal entity.

How much does it cost to have Chementors as our OR?

The cost of Only Representative Service depends on the substance, tonnage band, and the number of importers. OR fee is charged yearly basis for every calendar year. The introductory prices are much less than 1000 € / year, up to 2000 € / year, depending on the above matters. Please get in touch with us for an exact quotation of OR fees for your substances.

What are the key points when choosing an excellent Only Representative?

Choose an OR, who