Under the REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) regulation, it is the responsibility of companies to collect information on the properties and uses of substances produced or imported over one tonne per year unless this substance is exempted from the scope of registration. It is also necessary to assess the potential risks and hazards presented by the substance. This information is then communicated to the European Chemicals Agency (ECHA) through a registration dossier that includes data about the substance’s hazards and, where applicable, an assessment of how potential risks can be managed.

Registration Process

ComplianceXL, in collaboration with trusted partners in the EU, assists customers seeking REACH registration for their products or materials. We partner with experienced REACH registration specialists, including Only Representative (OR) services. Additionally, ComplianceXL assists manufacturers and importers in collecting information about the substances they manufacture or import. As a result, potential risks associated with the manufacture and use of their substances can be assessed. During the registration process, the information obtained, and the assessment carried out is documented in the registration dossier, which is the collection of data submitted electronically by the registrant to ECHA for the registration of a substance.

Manufacturers and importers of the same substance must submit their registrations jointly. It is based on the principle of “one substance, one registration”. Joint submission of data helps to minimize costs for registrants and avoid the duplication of tests. In addition, registrants submitting data jointly can benefit from a reduced registration fee.

Who needs to register?

A registration is required if you are:

  • Manufacturing or importing substances on their own or in mixtures in the EU.
  • Producer or importer of articles that contains a substance in quantities over 1 tonne per year and the substance is intended to be released under normal or reasonably foreseeable conditions of use of the article.
  • An EU-based “only representative” appointed by an outside-EU manufacturer, formulator, or article producer to fulfil importer registration obligations.

Substances to be registered.

  • Registration is required for individual substances, substances in mixtures, and certain substances in articles.
  • Articles containing a substance or mixture that is intentionally released from the product during normal and foreseeable conditions.
  • When the amount of the substance imported for this purpose exceeds one metric ton per year.

Exemption Clause:

  • Substances that present minimum risk to human health and substances for which registration is deemed inappropriate or unnecessary are exempted from registration.
  • REACH does not cover substances already regulated by other legislations, such as substances in medicinal products or radioactive substances.
  • Additional exemptions from registration apply to already registered substances and are either exported and re-imported into the EU or recovered through a recovery process in the EU.