CS Regulatory Ltd, as an EU legal entity, can offer to act as Only Representative under contractual conditions, in order to fulfil the legislative requirements of non-EU client organisations. We are currently Only Representative for some 50+ companies. The process to change an Only or Third Party Representative is easy, and CS Regulatory Ltd handle all of the requirements.
Under REACH Article 8, a non-EU entity that either (1) manufactures a substance (on its own, in preparations, or in articles), (2) formulates a mixture, or (3) produces an article that is imported into the EU, can appoint an Only Representative (OR) and thereby relieve the actual EU importer(s) of the substance, preparation, or article of the obligation to register a particular substance.
The OR, rather than the importer(s), would carry out the registration (and fulfill all other importer obligations), and the importer(s) would be regarded as (a) downstream user(s) (DU) of the OR. While the appointment of an OR does not obviate the need for a registration, this convention provides commercial value as it allows a non-EU entity to avoid having to disclose to its EU customers potentially sensitive data (e.g., mixture compositional details), as well as have a greater, though still indirect hand in the substance's registration while maintaining anonymity of its corporate identity in Europe.
Similarly, under REACH Article 4, any EU entity regarded as a substance manufacturer, importer, or, where relevant, downstream user, may, whilst retaining full responsibility for complying with his obligations under REACH, appoint a "Third Party Representative" for all proceedings involving discussions with other manufacturers, importers, or, where relevant, downstream users. In these cases, the identity of the entity appointing the Third Party Representative shall not normally be disclosed to other manufacturers, importers, or, where relevant, downstream users. This convention again provides commercial value as it allows a business entity to avoid having direct contact with potential competitors, plus allows technical discussions to be progressed by the third party of whom should have greater experience of the due process than the individual company.
CS Regulatory Ltd, as an EU legal entity, can offer to act as OR under contractual conditions, in order to fulfil the legislative requirements of non-EU client organisations. We are currently Only Representative for some 50+ companies. The process to change an Only or Third Party Representative is easy, and CS Regulatory Ltd handle all of the requirements.
CS Regulatory Ltd has numerous Information Sheets available for use by our Clients and Colleagues.