There are many companies that, due to lack of awareness or understanding, still haven’t submitted a REACH registration dossier to ECHA or received a REACH registration number. These companies will face great difficulties when trying to sell their substances in the European Union since most of their clients will ask them for a ‘REACH Certificate’ that they don’t have.
If this sounds familiar to you, continue reading to find out how can you fix this.
What is the REACH Registration?
The REACH registration is one of the main requirements established in Regulation (EC) no. 1907/2006 (REACH Regulation), a European regulation that originated from the need to correctly protect human health and the environment against the risks that may occur from the manufacturing, marketing and use of chemical substances.
The aim of the REACH registration is to compile information about the hazards of a substance, identify its uses and establish the risk management measures necessary for the substance to be used safely.
Do I need to register a substance under REACH?
All European companies that manufacture and/or import a substance in quantities higher than or equal to 1 tonne per year are required to submit a REACH registration for that substance.
It is important to remember that REACH registration only concern substances. Mixtures and articles, as such, are not subject to the REACH registration, but the substances they are made from may be.
Some substances may be exempt from the REACH registration as well, for example because of the substance’s nature, the way it is obtained or the way it is used. Before submitting a REACH registration, it is a good idea to check the existing exemptions and correctly assess if one or several are applicable to your situation.
Some European companies that purchase substances directly from a European provider are not obliged to register these substances under REACH, but they must make sure that their providers comply with their obligations with regard to the REACH registration.
Non-European companies are not obliged to register under REACH the substances that they market in Europe, but they may appoint a European company to act as their only representative and register the substances for them, thus making it easier for the former to introduce their products to the European market. If you would like to learn more about the Only Representative’s role, click here.
Another company has already registered the substance, do I also need to register it?
If your company is manufacturing and/or importing a substance in quantities higher than or equal to 1 tonne per year, and even if another company has already registered this substance, you must also submit your own REACH registration.
As a general rule, for each substance there is one register entry made up of all of the companies that are obliged to register said substance. We call this a Joint Submission and it means that the majority of the costs of keeping a REACH registration entry is divided between all of the companies involved, which considerably reduces the costs that would be incurred from doing so individually. These joint submissions are usually managed by SIEFs or Consortia that sell Letters of Access to the information that has been submitted in the registration dossier.
How much does a REACH registration cost?
This is the million-dollar question… ‘what about the REACH registration, how much does that cost?’ Unfortunately, there is no set price for this process. We have come across register entries in which a company hasn’t needed to pay more than €3,000, and others involving over €500,000.
The total cost may vary greatly depending on factors such as the substance, the tonnage range that needs to be registered, the tests that need to be done, the number of companies involved in the same registration process and the official registration fees that vary depending on the size of the company (SME status). Accordingly, the economic costs of registering under REACH must be evaluated always on a case-by-case basis.
If you would like us to look into your particular case and help you to estimate the costs, and timelines of this process please contact us.
I have to register a substance, but I haven’t done so yet. What do I have to do?
- Phase 1. Economic study Before starting preparations for submitting a new registration, we recommend that you evaluate the costs that your company will need to pay for this REACH registration: for example, the laboratory testing, documentation development, letter of access fees for joint submissions, risk assessment and administrative fees, among others. You should know about these costs before starting your submission because, as we have mentioned, these costs vary depending on the substance, range of tonnage, etc.
- Phase 2. Informing ECHA Once you have checked the costs, after making the decision to continue manufacturing and/or importing the substance and before you submit your REACH registration application, you must inform ECHA of your intention to register the substance. This can be done by submitting an inquiry to ECHA.
- Phase 3. The substance has been registered by other companies In a best-case scenario, the substance may have already been correctly registered by other companies. If this is the case, your company must join the joint submission, upon prior acceptance of a joining agreement and upon paying for the Letter of Access fees, and prepare its own individual dossier to send to the ECHA.
- Phase 4. The substance has not yet been registered If the substance has not yet been registered, the company will have to find all existing information about the substance and assess whether this information complies with the requirements described in the REACH Regulation. It is most likely that the company will need to generate information through computational research (e.g. QSAR). Once all of the required information has been obtained, it must be evaluated with the aim of establishing the substance’s hazard classification and a list of recommended uses and safety conditions. All of this information will form part of the registration dossier that will be sent to ECHA.
- Phase 5. Obtaining the REACH Registration number Once the Registration dossier has been submitted to ECHA, payment must be made for certain administrative tasks (official ECHA registration fees), which will vary depending on the size of the company and the range of annual registration tonnage. When ECHA has checked the information contained in the dossier and confirmed that it is all correct, a letter will be sent to the company confirming that the substance has been registered, together with the corresponding REACH registration number.