EU Manufacturers and Importers of Chemicals

The intentions of REACH (and CLP) are clear - to make EU/EEA manufacturers and importers of chemicals responsible for the safety of their chemicals, from synthesis or import to disposal. But what does this mean in practice?

REACH is simple in its key principles but complex in the detail. So let’s start with the basics! You can then find out more of the details using the links to other areas of our website.

Registration

The fundamental part of REACH is registration; a substance cannot be made in or imported to the EU/EEA unless it is registered, exempted from registration or manufactured or imported by the legal entity in question in quantities of less than 1 tonne per year. Registration requires the submission of a dossier of information to ECHA together with a registration fee. The dossier will vary with the tonnage produced but it will always contain a minimum amount of scientific data about the chemical. The dossier may be expensive to produce and may require new tests; to minimise these REACH requires data be shared between registrants. Joint registration (i.e. by independent manufacturers and importers working together) is mandated, but there are specific reasons why companies may opt out and submit certain information separately.

You will need to submit an Inquiry dossier and register before starting to manufacture or import a substance at 1 tpy or more. Let’s be clear, whether you manage REACH in-house, or appoint a service provider to help - or even work on your behalf - REACH can be very costly. Your planning must take into account your ability to cover the costs of REACH compliance.

Safety Data Sheets

There are other requirements in REACH which affect manufacturers and importers. The most important relates to Safety Data Sheets (SDS) which must (nearly always) be supplied at or before the first delivery of a substance or mixture; even if they do not supply onwards, importers must have compliant SDS for the hazardous chemicals introduced to the EU/EEA. One theme of REACH is better communication in the supply chain and the SDS provisions are part of this. REACH has updated the old SDS provisions so you need to be sure you are up to date with the current Annex II requirements.

REACH also contains provisions to restrict or otherwise regulate the supply of the most dangerous chemicals. These controls may be in the form of a requirement for authorisation, or a restriction relating to certain uses.

Please note that since 1 January 2021, the UK government has set up a separate regulatory UK REACH regime. Please visit our Brexit page for more information including responsibilities of manufacturers and importers, taking into account transitional arrangements to mitigate the impact of the UK exit from the European Union.

You can call our Helpdesk number on +44 (0) 20 7901 1444. Or e-mail us on enquiries@reachready.co.uk.