Registration and notification are two separate requirements under the EU Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation. Some aspects of these requirements are easy to confuse, so it's important to understand them.
REACH registration is required for:
- Substances or substances in mixtures, which are
- Manufactured in or imported into the EU in quantities of one metric ton per year or more.
The registration requirement applies to:
- Any substance, not just those listed on specific declarable substance lists (e.g. the Candidate List of substances of very high concern (SVHCs).
- Substances themselves, either alone or in mixtures; it does not apply to substances in articles.
However, some substances that are already regulated by other legislation do not require registration. For instance, substances notified under the Dangerous Substances Directive (NONS), some medicines, and some radioactive substances may be exempt from REACH registration requirements.
The European Chemicals Agency (ECHA) has an overview, guidance, and a description of information requirements associated with registration. As part of the registration process, the applicant must compile a technical dossier and may also need to provide a chemical safety report and chemical safety assessment.
Registration is a "one substance, one registration" process. 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 identity."
REACH SVHC Notification
REACH SVHC notification is a requirement associated with substances on the REACH Candidate List of SVHCs. Notification is required for SVHCs in articles when:
- An SVHC is present at or above the 0.1 percent w/w threshold at the article level, and
- That substance is present in the articles at quantities totaling more than one metric ton per EU producer or importer per year.
However, notification is not required if:
- The substance has already been registered under REACH for the use in question, whether the registration was requested by the same entity or an entirely different entity, or
- The producer or importer of an article can exclude the exposure of humans and the environment to the substance during normal or reasonably foreseeable conditions of use of the article, including its disposal. In these cases, the producers and importers will give appropriate instructions to the recipient of the article.
Articles, Substances, and Mixtures: When SVHCs are present over threshold, it's important to consider whether the SVHC in question is present in an article, or present as a substance alone or as part of a mixture. There are different REACH requirements in each case; registration requirements do not apply to substances which are chemically bound as part of article, while notification requirements apply only to SVHCs in articles. This distinction can be more complicated in cases of container-type articles that may hold substances or mixtures.
This article is current as of 2021-07-09.