The import of chemicals into the European Union is regulated by the Registration, Evaluation, and Authorization of Chemicals (REACH) Regulation (EU Regulation No. 1907/2006).
According to the EU REACH regulation, registration must be made when manufacturing, importing, placing on the market, and using substances on their own, in mixtures, or in articles in quantities of one tonne or more per year.
According to EU-REACH regulation, the registration must be done by EU manufacturers, EU importers, and 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.
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.
“Non-EU entities cannot do REACH registration. Instead, they should appoint an EU-based Only Representative.”
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.
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.
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.
Chementors’ Only Representative responsibilities are the following:
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.
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.
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.
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.
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Chementors is fully qualified and respected OR in Finland and Europe.