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The ‘only representative' (OR) is a natural or legal person established in the EU (European Union) appointed by a non-EU manufacturer of substances on their own, in preparations or in articles, formulates preparations, or produces articles.
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TRC can deliver the ‘Essential' Activities of an OR
- Provide the expertise with substances, their properties and the REACH requirements to make judgements on the significance of information coming from, and required by, the supply chain, data sharing consortia and regulatory authorities.
- Maintain records on imports into the EU
- Make a formal enquiry to ECHA (European Chemicals Agency) prior to making a registration submission for a new (or non pre-registered phase-in (existing)) substance
- Make the pre-registration for an existing (phase-in) substance
- Submit a Registration dossier for a substance in accordance with the deadlines
- Act in the SIEF (Substance Information Exchange Forum) for pre-registered substances to ensure fair and reasonable data and cost sharing
- Manage all formal communication with ECHA and MS (Member State) competent authorities
- Act as a conduit for information up and down supply chain (Registration number, end uses, SDS's etc)
- Act as the applicant for uses of substances subject to authorisation
- Comment on decisions, and make appeals as appropriate
- Make any relevant PPORD (Product and Process Orientated Research and Development) notifications
TRC can deliver the ‘Non-Essential' activities of an OR
- Act as a third party representative for pre-registration and registration purposes
- Project manage substance identification for pre-registration and registration
- Prepare and project manage the preparation of a Registration technical dossier
- Legal representation within the SIEF and/or consortia
- Recommend testing strategies and supervise testing required
- Carry out certain testing associated with Registration dossier preparation
- Prepare chemical safety assessments and reports (CSA/R)
- Generate safety data sheets (SDS) and prepare classification and labelling (C&L) proposals
- Advise on strategies to minimise costs
- Prepare applications for authorisation of uses
- Take responsibility for all non-EU manufacturer REACH compliance matters
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