REACH roles and duties

REACH roles

Almost every business in the UK will have a new responsibility under REACH. There are three main types of REACH dutyholder, which are explained below - you may also wish to look at the navigat or tool provided by the European Chemicals Agency (ECHA) to see how you fit in.

Manufacturers/importers

Businesses that manufacture or import (from outside the EU) one tonne or more of any given substance each year are responsible for 'registering' that substance with the European Chemicals Agency. Registration involves submitting a dossier of information about the substance and its uses, etc. Because substances in articles also count (if these substances are intended to be released during use), it's possible that some manufacturers/importers of such articles will be registrants.

The registrant directs downstream users in the appropriate risk management measures for any particular use of the substance and responds to other actors on other aspects of REACH. Registrants of phase-in substances should have pre-registered them between 1 June and 30 November 2008 to benefit from the phased registration deadlines. Late pre-registration is now only available to first time importers/manufacturers.

You may find the following information useful:

• What REACH means for Manufacturers
• What REACH means for EU importers 

Downstream users

Downstream users include any business using chemicals, which probably includes most businesses in some way. Companies that use chemicals have a duty to use them in a safe way, and according to the information on risk management measures that should be passed down the supply chain. There is also an opportunity to pass information about use back to registrants so that this can be taken account of when assessing the risks of the chemical used.

Downstream users may need to supply risk assessment and risk management measures to the European Chemicals Agency if they don't want their supplier to know about how they use the chemicals. Some users may also be importers and have a duty to register.

You may find the following information useful:

• What REACH means for users of chemicals

Other actors in the supply chain (i.e. distributors, suppliers)

Businesses that sell chemicals have specific duties to pass information down to their customers, and also to pass information back to their own suppliers when customers ask them to do so. For more information look at the overview for actors in REACH on the ECHA page.

When to comply with REACH?

When and how you have to comply with REACH depends on your status within the supply chain and also if you have pre-registered your substance.

What if I have pre-registered?

If you have pre-registered then you qualify for the phased-in registration deadlines, these deadlines depend on the classification and tonnage of the substance supplied. These deadlines are set out in the timeline below as phases one, two and three.

What happens if I haven't pre-registered my substance?

This means that you cannot take advantage of the 'phase-in' periods under REACH and must register your substance straight away.

You may be able to take advantage of late pre-registration, if you are manufacturing or importing a phase-in substance for the first time after 1 December 2008.

How do I register?

Registration is the process of collecting and collating specified sets of information on the properties of substances. How much information is needed depends on the tonnage of the substance to be registered. These requirements can be found within the REACH text. The information is then used to perform an assessment of the hazards and risks that a substance may pose and how these risks can be controlled. This information and the associated assessment are then submitted to the European Chemicals Agency (ECHA) in Helsinki.

Timeline - when do I register?

What do I need to do to prepare for REACH?

Preparing for REACH

REACH will impact most businesses in the UK in some way. It is important to understand what your role is in REACH, and what you can do now to be sure you are ready. If you import/manufacture substances at 1 tonne or more per year, you will have additional registration duties to consider.

Compile an inventory

If your company is new to REACH, it is important that you build an inventory of every chemical that comes into, is part of, or goes out of the business - what feedstocks, intermediates (isolated or otherwise), and products are used or created.

You need to know all the substances you use; for mixtures you need to find out what the ingredients are. Keep a record of each one, and include essential information for example the name of the chemical and the percentage in any preparations. You can use this information to determine the tonnage per year.  If you obtain your substances from another EU based company, you could contact them to check that they have fulfilled any registration duties appropriate to them.

Additionally you need to know whether you produce or import articles. If you do, establish if any substance (which is intended to be released under normal or reasonably foreseeable conditions of use) is present in these articles in quantities totalling over one tonne. An example of an article that intentionally releases substances is a fragranced bin liner (which intentionally releases the substances that create the fragrance)

Once this inventory has been established, you can begin to understand what substances you rely on, and consider the impact on your business should REACH influence the supply (or for registrants, the production or import) of a substance. Consider contingencies, for example alternative supply, routes, chemicals or processes, or supporting suppliers in their REACH obligations, etc.

We have leaflets on articles and how to prepare an inventory on our bitesized advice page:

• REACH Bitesize Advice

Prioritise

Every business making use of chemicals that aren't exempt from REACH needs to understand how valuable these substances are to them, and plan to make effective business decisions based on this knowledge. Consider the importance of each substance to your business. Ask yourself the following sorts of question:

• what do you use it for?
• are the uses to which you put chemicals going to be supported by their registrants?
• how much of it do you use?
• are there any alternative substances or processes that could replace this?
• will your supplier/s maintain supply of important substances if REACH impacts the commercial viability of doing so?
• what will be the impact for you if the price increases or the supply drops, and what can you do about it?
• do you want to share information back to registrants about what you use chemicals for, or is this information so sensitive that you would prefer to compile risk assessments yourself, and submit these directly to the European Chemicals Agency? What will this involve?
• identify any chemicals that may be 'substances of very high concern'.
• determine your role in relation to each substance on the inventory.

Build relationships

Establish a relationship with your suppliers and any downstream users. You need to know how REACH is going to impact on your supply chain before you can decide what to do about it. Identify an appropriate person as the main REACH contact in your organisation and make them the focus for communications with suppliers and customers.

REACH pre-registration

As the 1 December 2008 deadline for general pre-registration has already passed, the only pre-registration function now available is for late pre-registration.

Late pre-registration

For a substance to be eligible for late pre-registration the substance must be what is known as a 'phase-in' substance. This means that:

• the substance is listed on EINECS, i.e. those on the EU market before 1981
• the substance was manufactured in the Community, or in countries acceding to the EU on the 1 January 1995 or on 1 May 2004, but not placed on the market by the manufacturer, at least once in the 15 years before entry into force of this Regulation, provided the manufacturer has documentary evidence of this. (Basically, these are substances that have been made in the EU but not placed on the market there. They will generally be site limited or export only substances. Evidence of this should be available if challenged)
• the substance is a so called 'no longer polymer'

In addition, it must be the first time that the substance has been imported or manufactured in quantities of one tonne per year or more by the legal entity in question. The pre-registration needs to be done within 6 months of the first import/manufacture and no later than 12 months prior to the appropriate registration deadline. This that any further pre-registrations need to be submitted by 31 May 2017 and can only cover supply at less that 100 tonnes per year.

What do I need to do?

Pre-registration will mean informing the European Chemicals Agency (ECHA) of:

• The name of the substance as specified in section 2 of REACH Annex VI, this includes CAS, EINECS or other identification codes
• name and address of the contact person or representative
• envisaged deadline for the registration and the tonnage band
• identifier information of any structurally similar chemical which you may wish to rely on to provide useful evidence on hazards as part of your registration package

You can do this by going to the IT portal accessible via the ECHA website. This will take you through the pre-registration process.

• ECHA website

What happens next?

Once pre-registered the European Chemicals Agency put the late pre-registrant in contact with other pre-registrants of the substance. These will already be members of a 'Substance Information Exchange Forum' (SIEF) where they can negotiate sharing their available data and the costs of generating any new data required for registration. Further details on this can be found in the ECHA guidance on data sharing.

REACH registration

What is registration?

Registration is the process in which manufacturers, importers and Only Representatives (ORs) collate information on the substances they manufacture or import and use that information to assess the potential hazards. This information is added to a registration dossier that is sent to the European Chemicals Agency (ECHA). With this information on the properties of the substance, and by working with others in the supply chain, the manufacturer, importer or OR can assess any risks to human health and/or the environment and develop appropriate risk management measures for the various uses of the substance.

How to register

Registration involves a number of steps; looking for existing data, sharing data where it exists, creation of the electronic registration dossier and sending that dossier to ECHA. These processes are explained below.

Data-sharing

One of the key objectives in REACH is to obtain and share information about the properties of substances being manufactured, supplied and used in the EU. This ensures that registrations use existing data rather than commissioning new studies. REACH prohibits the duplication of animal testing. Datasharing is achieved using one of two mechanisms, SIEFs or the Article 26 Inquiry. The SIEF is the data sharing forum used for phase-in substances that have been pre-registered. For non-phase-in (new) substances, the main data sharing process is the Article 26 Inquiry. This process allows prospective registrants to be put in touch with any existing registrants so that data sharing can be organised. In some cases, data can be made freely available for registration purposes.

Creating and submitting your registration dossier

Dossiers are created using the IUCLID software system. This is available free of charge from ECHA. For each substance the data is divided into separate sections, e.g., company information, substance identity information, toxicological information, etc. IUCLID is then used to create the file that will be sent to ECHA using their REACH-IT system. There are two main components to a registration dossier, the technical dossier required in all cases and a chemical safety report (CSR) which is only required for substances registered at 10 tonnes or more per annum. The amount of information you need to add to your dossier will depend on your registration tonnage band and, as requirements are cumulative, more data will be required at higher tonnages. All registrants need a certain minimum amount of data, but those who are part of a joint submission can exclude certain sections as this information will be provided in the main dossier of the Lead Registrant. The CSR is added as an attached stand-alone document.

All registration activity with ECHA is done through their REACH-IT system and will be done through your REACH-IT account.

What happens next?

ECHA will contact you within a set time from the date of submission and either issue a registration number or provide information on why they do not consider the dossier complete. The time for a response is usually 3 weeks, but if the registration is submitted within two months of a registration deadline, then this response limit is extended to three months. The submission works on a default acceptance principle, and if you do not receive anything to the contrary within the times given above, then you can assume the dossier has been accepted. If your dossier is not considered complete you will be given a deadline to submit the missing information. If again the information is found lacking the registration will be rejected and you risk losing your registration fee. Once you have a registration in place, it is your responsibility to ensure it is kept up to date.

If you are part of a joint registration, the Lead Registrant will issue a security token to grant you access to the data in the lead dossier. It is important that you maintain good communications between Lead and Member Registrants, including for the issuing and acceptance of these tokens.

ECHA have issued a Technical Completeness Check tool (TCC tool) available for download and use within IUCLID. You are strongly advised to download this and use it to check your dossier prior to submission.

Resources

• REACH Bitesize advice
• ECHA website
• European Commission website
• REACH Glossary
• How to comply with REACH chemical regulations from 1 January 2021 - GOV.UK - UK REACH, the UK’s independent chemicals regulatory framework, starts on 1 January 2021. Anyone importing, manufacturing or distributing chemicals in GB and/or Northern Ireland needs to understand how the  UK REACH and EU REACH rules might affect their business after 1 January 2021.