After last week’s post on CLP and REACH, I thought it might be helpful to go over the requirements of REACH in the EU.
REACH compliance in the EU depends on two main facts:
- whether your company is domiciled in the EU
- what role, or roles, your company takes under REACH
These two facts define whether you have REACH registration liabilities for any substances, and whether other REACH duties apply. Of course, anyone placing a hazardous substance on the EU and UK market must comply with Annex II of REACH, and ensure that a Safety Data Sheet is provided, where one is required.
Whether your company is domiciled in the EU is very important, because companies can only place chemicals on the EU market if they are based there. This applies to both REACH and CLP.
The reason for this is (theoretically) in order for the EU to protect health, safety and the environment by making sure that all substances are compliant with these over-arching EU regulations. Of course, to enforce REACH and CLP requires a company to be domiciled in the EU, or to have an EU representative or at least an EU address. In other words, the EU need someone inside the EU whom they can prosecute, if necessary.
Only a cynic would suggest that this is actually a major barrier to international trade, which conveniently works in favour of EU domiciled and EU owned businesses. But somehow, it ends up having that effect! How very interesting!
ECHA have a useful image showing all of the roles which they think can occur under EU chemical regulation (not just REACH):
The REACH roles for companies in the supply chain domiciled in the EU/EEA (European Economic Area) are:
- User (or Downstream User)
And the REACH roles for companies in the supply chain outside the EU are:
- Manufacturer outside the EEA
REACH role for companies in the EU which are not necessarily in the supply chain, who act on behalf of a Manufacturer outside the EEA
- Only Representative
Companies can have more than one role under REACH, for different substances. For example, a manufacturer may also be an importer., or an importer may also be an Only Representative for another company. The role is defined by what happens to each individual substance.
Definitions of roles
- Under REACH, a Manufacturer is someone who makes a substance by reaction.
- Formulators or makers of mixtures are not classed as manufacturers, unless a reaction takes place to make a new substance when they make a mixture.
- If you are a formulator who occasionally also makes a new substance in a mixture, you would fall under manufacturer for the new substance for REACH liability
- An importer brings in substances from outside the EU/ EEA, either as substances (chemical elements or compounds), or in mixtures
- Anyone bringing in materials from outside the EU/EEA automatically becomes an Importer, unless their supplier has an Only Representative in the EU/EEA
- A distributor sells products on behalf of other companies
- This can either be as an agent, or through purchasing the products and reselling them
- The products remain identified as being made by the original manufacturer
- These companies buy and use substances (by themselves, or in mixtures) which have already been registered for REACH (if required). They do not alter the substances chemically by reaction, although they can make them into mixtures
- This company acts on behalf of an external Manufacturer, registers for REACH on their behalf (if required), and tracks tonnages imported into the EU under that registration, in case it needs to be increased (if not at the maximum level)
REACH duties on inside the EU
If you are domiciled in the EU, everyone has these duties, on substances in any quantity (unless exempt from CLP for some reason):
- classify, label and package for CLP (under the CLP regulations) and produce a Safety Data Sheet containing CLP and other information (REACH Annex II). This duty applies to all potentially hazardous substances and mixtures, in any quantity, unless they are exempt from CLP.
- comply with the rules on Substances of Very High Concern, Authorised substances and Restricted substances. This duty applies to all substances which are on the Candidate List (that is they are an SVHC or Authorised substance); that are on the Authorisation List; or that are on the Restricted List.
Manufacturers and Importers have liability for these REACH duties for substances they make or import:
substance made or imported at < 1 tonne per annum
- if the substance is classified as hazardous (manufacturer), or is in an imported mixture which is classified as hazardous and gives rise to the hazard classification of the mixture, it must be notified to the Classification and Labelling Inventory (under CLP). This is not required for substances which are already registered for REACH in your supply chain, because these are copied across to the C&L Inventory as an automatic entry.
substances made or imported at 1 tonne per annum and above
- Register for REACH, unless exempt, in the following tonnage bands (which define the data which is required for your registration application)
1 – 10 tonnes per annum
10 – 100 tonnes per annum
100 – 1000 tonnes per annum
1000 + tonnes per annum
1 – 1000 tonnes per annum, transported isolated intermediate
1000 + tonnes per annum, transported isolated intermediate
Distributors do not have any specific REACH duties, unless they also hold another REACH role.
Downstream Users must:
- Check whether a substance has been registered for REACH in their supply chain
- If it has, they should make sure that their uses have been included in the REACH registration. If they have not been included, there are a variety of options, including:
- asking the Lead Registrant to include that use in the registration;
- registering the use or uses separately;
- changing to a different chemical;
- or simply stopping using the substance for that use.
- Downstream Users must also comply with the terms of any Authorisation or Restriction placed on the substance
- They should also pass their user’s uses back up the supply chain to the REACH registrant, (if requested to do so, e.g. where those uses are not included in the registration)
Note that if a company brings in a substance which holds a registration via an Only Representative, they become a Downstream User rather than an Importer. However, there may be limits on what they can bring in, to ensure that a tonnage band is not breached inadvertently. Companies in this position must contact the Only Representative to ensure that their tonnage is covered by the registration.
Useful links at ECHA:
REACH duties on companies outside the EU
If you aren’t domiciled in the EU, for REACH purposes, and you manufacture the products, that is make substances by reaction, you can appoint an Only Representative (O.R.) to act on your behalf, purchase REACH registrations etc. (Formulators, that is companies who make mixtures of chemicals where no reaction takes place, can’t appoint an O.R.).
If you don’t do this, all the people you sell to become Importers for REACH purposes, and take on responsibility for REACH registration if they’re bringing in more than 1 tonne per annum. However, if you do appoint an O.R., you will have to pay for REACH registration for all of the substances you wish to sell in the EU. This applies to substances in their own right, and also substances in mixtures.
For more information on what to do if you’re domiciled outside the EU, the ECHA website has a great deal of information, and this page is probably the best place to start: https://echa.europa.eu/support/getting-started/enquiry-on-reach-and-clp .
The REACH registration process and costs
If you are liable for REACH registration, the process varies depending on whether your substance has already been registered, or whether it has not.
If the substance has been registered, you will need to:
- make contact with the Lead Registrant, or their representative, to get a price for the data, and if necessary confirm what SIP tests will be needed (see below)
- have the relevant Substance Identity Profile (SIP) tests carried out, to confirm that your substance is sufficiently similar to the registered material to use that data (you don’t give this to the Lead Registrant, you submit it separately to ECHA)
- Set up an identity on the ECHA website for your company
- Buy the data you need for the tonnage band from the Lead Registrant, who will provide you with a token to use when you register
- Either use IUCLID6 or the online version at ECHA to make the actual registration application, which includes:
- information on your company
- the SIP information on the substance
- the token from the Lead Registrant which allows your application to access the data
- pay the fees at ECHA
You will see that there are 3 sets of costs: the cost of SIP tests; the cost of registration data from the Lead Registrant; and the cost to register at ECHA. SIP profile tests can vary, but current budget figures in the UK suggest that this is around £2,000. The cost to register at ECHA varies according to the size of company, and tonnage band of registration, see the Fee Regulation at https://echa.europa.eu/regulations/reach/legislation/#implementing .
The great cost variable is the cost of data, which will depend on the costs to acquire the data, and the number of people who have already registered and need that data. more registrants should mean lower cost. There is no “one size fits all” quote for this, the only way to find out is to contact the Lead Registrant and get a quote from them. There are rules on sharing costs fairly, given in the Regulation on the Joint Submission of Data and Data-sharing (on the same page as the Fee Regulation).
If you are domiciled outside the EU/EEA, you will also need to pay an Only Representative to manage the process on your behalf, which is not just a one-off cost, as they must check that your tonnage band has not been exceeded every year, and therefore communicate with you and with all of the people who import under your registration.
If the substance has not been registered for REACH, you (or your Only Representative) will become the Lead Registrant, and will have to bear all of the registration costs alone, unless you find other companies who are also interested in registering to share those costs with you.
As you can see, REACH is a very complicated topic, and it is very important to read up on the guidance at the ECHA website if it is something which potentially affects your company. (I may have got something incorrect in this overview, as it’s not my main area of interest).
In the event that we do get Brexit, the current plan is that the UK will end up with a parallel REACH system, and I will let you know how that will work, and how it may work alongside EU-REACH, if it is going to be implemented.
GHS Classification Courses from TT Environmental Ltd
10th December 2019
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