REACH requires all companies manufacturing or placing a substance on the EU market in quantities greater than one tonne per year (1t/year) to register that substance with the European Chemicals Agency (ECHA). For legal reasons, only companies with a legal entity in Europe are allowed to submit a registration under REACH. However, non-EU companies may submit a REACH registration by appointing an EU-based Only Representative (OR) to register on their behalf, in which case their importers will be regarded as downstream users and do not need to carry out registrations.
Benefits of Appointing a REACH Only Representative (OR)
- Relieve importers of their obligations to register and obtain continued market access in the EU (many EU importers will try to avoid registrations by purchasing REACH-registered chemicals).
- Avoid dependence on a single importer and keep market access should one EU importer cease trading.
- Gain advantages over other non-EU suppliers who do not appoint an OR to register their substances.
Note: Importers will be exempt from REACH registration if their non-EU suppliers have registered. However, importers need to confirm with their suppliers' OR that they are included in the inventory of importers and that their tonnage and uses are covered by the OR. This can be done by asking for a REACH Certificate of Compliance and Tonnage Coverage Certificate from the OR of their suppliers before they put chemicals on the EU market.
Who Can Be Appointed as a REACH OR?
An OR must be an EU-based legal entity that has sufficient background in the practical handling of substances and the information related to them required by the REACH regulation Article 8(2). To be more specific, an OR shall:
- have the ability/expertise to understand and implement the responsibilities of an importer that ORs take on under the provisions of REACH (including pre-registration, registration, and authorization);
- be capable of keeping an up-to-date list of EU importers within the same supply chain of the non-EU manufacturer it represents;
- have a record-keeping system with data on imported quantities and all uses covered; and
- be capable of keeping the latest information on the supply of safety data sheets.
What does a REACH OR do?
In accordance with Article 8 of REACH, the OR takes on the obligations of importers under REACH, in which case importers will be regarded as downstream users (thus do not need to register).
Those obligations include:
- Maintaining pre-registration data (including company identity and annual tonnage) submitted to ECHA through REACH-IT;
- Represent your company in the SIEF/Consortium after pre-registration and keep you informed of the latest progress of the SIEF/Consortium;
- Supply Safety Data Sheets (SDSs) or transmit SDSs along the supply chain and keep information on the supply of the latest update of the SDS;
- Communicate with EU importers and regulatory authorities and issue necessary documents to ensure REACH compliance;
- Keep an up-to-date list on the inventory of importers and the tonnage covered for each of these importers and keep the above information for at least ten years and provide it to enforcement authorities upon request;
- Registration, notification, and authorization of substances (additional contract needed).
How to Change a REACH OR?
Perhaps your existing REACH OR has not communicated SIEF/consortium information to you, has not recorded customers sold to and quantities imported, has not completed adequate supply chain communications, does not have the capability to complete a REACH registration, or charges you too much for their OR service. If so, and if you are unsatisfied with your existing OR or you wish to transfer from your existing OR, it is possible to appoint the CIRS Group as your new OR.
Non-EU companies have the right to change OR if they are unsatisfied. If the non-EU manufacturer nominates a new OR, the newly appointed OR can benefit from the pre-registration done by the previous OR if ECHA is informed about the change. Normally the agreement shall be reached with the previous OR, new OR and the non-EU company that the previous OR agrees to terminate the OR relationship and transfer all its liabilities and obligations under REACH to the new OR. The power of attorney between the new OR and non-EU company shall be reached for OR appointment, and the OR transfer shall be done in REACH-IT.
About the CIRS Group
The Chemical Inspection and Regulation Service (CIRS) Group is a leading product safety and chemical management consulting firm providing valued product regulatory compliance services, tailored solutions, and original information to help clients gain a competitive advantage by reducing business risks associated with regulatory affairs and removing barriers to entry. We have provided cost-effective regulatory support to over 3,000 companies while doing business in both the EU and China. The CIRS Group is the largest REACH OR in the world.
Since 2007, we have:
- pre-registered over 10,000 substances;
- registered over 1,000 substances;
- served as the lead registrant for over 100 substances;
- prepared over 5,000 REACH SDSs and classification, labelling and packaging (CLP) labels to date;
- acted as the OR for over 3,000 non-EU companies;
- served clients in more than 25 countries;
The CIRS Group is a recommended service provider by China Inspection and Quarantine Bureau, the US Mission to the EU, and IDA. We are also a member of Helsinki REACH Centre.
CIRS Ireland (CIRS OR):