SETAC Globe - Environmental Quality Through Science
15 June 2017
Volume 18 Issue 6

Return to the Globe

Last Registration Deadline of Existing Chemicals is Getting Closer – Are You Affected?

Tiiu Bräutigam, European Chemicals Agency

Low-volume chemicals manufactured and imported in the European Union (EU) or European Economic Area (EEA) must be registered with the European Chemicals Agency (ECHA) by 31 May 2018 in order to remain on the market legally. This closes the 10-year transition period foreseen in the REACH Regulation for existing chemicals.

The REACH 2018 deadline is extremely important for European businesses. If your company manufactures or imports chemicals and does not register them on time, you are not allowed to manufacture, import or supply the chemical in the EU or EEA after the deadline.

Some chemicals are hazardous for human health and the environment. You need to know the hazards and potential for exposure to be able to take responsible action. Information gathered during registration enables you to manage chemical risks in your business and to play your part in protecting human health and the environment.

In addition, even if your company does not have registration obligations and is not directly affected by the deadline, indirectly it almost certainly is. If a producer or importer fails to register a chemical that is crucial for your product or professional business, it could have serious consequences for your company.

Do you need to register?

Whether or not you need to register depends on three factors. First, your role in the supply chain. The registration obligation falls on manufacturers and importers, so if you are a downstream user, and for example, buy the chemical from a EU importer, you do not have to register but the importer does. Downstream users, however, need to inform their manufacturers of their uses to make sure that these are taken into account in the registration and that correct safe use advice can be given.

The second thing to check is whether your substance is exempted from registration. For example, substances that by evidence are known to cause minimum risk to human health and the environment do not have to be registered. These are listed in Annex IV of REACH – also other exemptions exist.

The third aspect is your production or import volume. Registration obligations under REACH kick in when the annual volume is one metric ton or more. If you manufacture or import less, you do not need to register. If you have manufactured or imported your substance during three consecutive years, your annual volume is calculated as the average of these years.  

It is also good to keep in mind that REACH concerns chemical substances. This means that each substance needs its own registration. If you import mixtures of substances from outside the EU or EEA, such as detergents and paints or products releasing substances, you need to register the different substances that are in the mixture or product.

What do you need to do?

As a registrant, you need to compile information on the properties, uses, hazards and risks of your substance in an electronic registration dossier. The information required depends on the volume of your substance. The lower the volume, the less information is required. However, if your substance shows any indications of hazards, the information requirements will increase – regardless of the low production volume.

You need to work together with other companies registering the same substance as you. You will share scientific data and its costs, prepare and submit a joint registration to ECHA. A registration fee needs to be paid after submission.

Following the “one substance, one registration” principle of REACH lowers your own registration costs and avoids unnecessary testing on animals.

Where can you get help?

If you are affected by the deadline and have not yet started to prepare, start now. ECHA, national REACH helpdesks and sector associations are here to help. Visit REACH 2018 web pages, available in 23 languages, where you can find a complete support package. Follow ECHA’s website for the latest news.

REACH 2018 – What is it about?

The REACH 2018 registration deadline is for:

  • Companies manufacturing or importing non-CMR* substances between 1-100 metric tons per year
  • Companies that have pre-registered their substances but have not yet registered them

If you manufacture or import a CMR chemical or your production or import volume is more than 100 metric tons per year, you need to register immediately before you can enter the market. This is also the case if you have not pre-registered your substance.

Author’s contact information:

Return to the Globe

Contact SETAC Globe
Contact the SETAC Europe office
Contact the SETAC Europe office