Registration

Under REACH, companies are responsible for collecting information on the properties and uses of the substances they manufacture or import above 1 ton per year. They also have to assess the hazards and potential risks presented by the substance.

This information needs to be communicated to ECHA in the form of a registration dossier containing the hazard information and, where relevant, an assessment of the risks that the use of the substance may pose and how these risks should be controlled.

Registration applies to substances on their own, substances in mixtures, and certain cases of substances in articles. Chemical substances that are already regulated by other legislations such as medicines, or radioactive substances are partially or completely exempted from REACH requirements.

Registration is based on the “one substance, one registration” principle. This means that manufacturers and importers of the same substance have to submit their registration jointly. The analytical and spectral information provided should be consistent and sufficient to confirm the substance’s identity.

As the deadline for registration for existing substances passed in 2018, only for new substances does a registration-dossier have to be compiled from the start. Currently, newly starting manufacturers (or importers) of existing substances only need to join the existing registration for their substances. They do this by demonstrating “sameness of substance” using analytical studies suitable for substance identification and quantification (e.g. UV-VIS, LC-MS, GC, etc). In order to ensure fair competition, new registrants of an existing substance buy a Letter of Access to gain access to the existing registration. This way, they retroactively pay their fair share of the original registration cost of the substance.

Under certain conditions, ECHA offers recyclers an exemption from the obligation to register substances from recycling processes. This exemption is laid down in Article 2(7) of REACH.

The main conditions for this exemption are:

• conformity of the identity of the recovered substance with a (already) registered substance can be demonstrated;
• availability of relevant information about the registered substance (e.g., for the preparation of an SDS and exposure scenarios);

Although this exemption was explicitly implemented by ECHA to accelerate the transition to a more circular economy, these recycling privileges are still relatively unknown within the chemical industry.  Additionally, not having your recovered substance registered under REACH may lead to additional requirements under the Waste Frameworks Directive End-of-Waste evaluation.

Substances occurring in nature are exempt from registration, evaluation and other downstream user obligations. However, this exemption only applies if they are not chemically modified or classified as dangerous, according to the Directive on Dangerous Substances 67/548/EEC.

Depending on your needs we can take the full registration project off your hands or parts thereof, for:

• Preparation of (IUCLID) substance dossiers
• Performing Chemical Safety Assessments (CSAs)
• Drafting of Chemical Safety Reports (CSRs)
• Generation of Exposure Scenarios (ESs)
• Literature research and documentation
• Preparation of test plans and use of waivers
• Downstream user (DU) support