EU & UK REACH Only Representative (OR) Consultancy Services

• The OR ensures execution of the Only Representative obligations as outlined in Article 8 of REACH (see below).

Article 8: Only representative of a non-Community manufacturer

1. A natural or legal person established outside the Community who manufactures a substance on its own, in preparations or in articles, formulates a preparation or produces an article that is imported into the Community may by mutual agreement appoint a natural or legal person established in the Community to fulfil, as his only representative, the obligations on importers under this Title.

2. The representative shall also comply with all other obligations of importers under this Regulation. To this end, he shall have a sufficient background in the practical handling of substances and the information related to them and, without prejudice to Article 36, shall keep available and up-to-date information on quantities imported and customers sold to, as well as information on the supply of the latest update of the safety data sheet referred to in Article 31.

3. If a representative is appointed in accordance with paragraphs 1 and 2, the non-Community manufacturer shall inform the importer(s) within the same supply chain of the appointment. These importers shall be regarded as downstream users for the purposes of this Regulation.

• Manage the substances as communicated by the client (Non-EU Manufacturer/Formulator). The set of substances listed on the H2 Compliance IT platform, element1, will act as the plan of record for substances under management by H2 Compliance. The client will have access to this system.
• Populate element1, with all information pertinent to the service delivery including substances, customers, tonnages, dossiers, costs and supporting documents including Registration dossiers
• More specifically to:
  • Track substance tonnages and quantities provided to importers
  • Ensure that Registrations are submitted in a timely manner
  • Track and communicate requirements for the update of dossiers as mandated by ECHA or Consortia as appropriate
  • Ensure a high level of communication with the customer single point of contact, particularly for time-sensitive matters, to ensure efficiency in service delivery
  • Support the preparation of costs with client
  • Operate and track communications within ECHA platform and communicate to customer as appropriate
  • Engage with Lead Registrants, Consortia, Laboratories, and other parties, with the support of the client, for exploratory purposes
• Ensure prompt support to the client, importers, and non-EU Suppliers in the event of a Competent Authority inspection
• Promptly and professionally respond to communications from Importers and agree suitable template responses with supplier. For all other cases, ensure communication to supplier for their advice on suitable response.
• Provide certificates to Downstream Users (Importers) to confirm the annual compliance status.

We estimate that a REACH Registration will take approximately 12 weeks from when the analytical testing of the substance is started. If the analytical data is available (provided by the client), the time is reduced to 6 weeks.

The trigger for a REACH registration is when an EU importer imports greater than or equal to 1Mt of a substance (not product) in a calendar year. The obligation is for the importer to submit a registration, but the non-EU manufacturer/formulator (supplier) may appoint an Only Representative to act as their EU Legal Entity and assume the importer role. The OR can then submit a REACH registration on behalf of all the importers within the defined supply chain.

A REACH Only Representative (OR) manages substance registration, maintains the SDS, fulfills reporting obligations to ECHA/HSE, and represents non-EU manufacturers in all regulatory matters.

Yes. Following the UK’s departure from the EU, the two regulatory frameworks operate independently. H2 Compliance provides dual-market Only Representative (OR) services, managing registrations and reporting for both ECHA (EU REACH) and the HSE (UK REACH). This streamlined approach ensures non-EU manufacturers maintain seamless market access to both regions under a single compliance partner like H2 Compliance.

The proposed universal PFAS restriction under EU REACH represents a significant shift in chemical compliance. As your Only Representative, H2 Compliance proactively monitors the ECHA and UK REACH restriction timelines, provides detailed impact assessments for your portfolio, and manages the submission of data during consultation periods to ensure your substances remain compliant with evolving thresholds.