REACHREACH
What you need to know if you wish to sell chemicals in Europe
REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is the new system for controlling chemicals across the European Union which became law on 1 June 2007.
The primary objective of the new legislation is to improve the protection of human health and the environment from the use of chemicals. It places the responsibility for understanding and developing procedures for handling the substance safely, firmly on the manufacturer or importer.
All manufacturers or importers of any substance (a single chemical or a mixture, or an article that is likely to release chemicals during its lifetime), that is used in quantities of greater than 1 tonne/year must register with the European Chemicals Agency (ECHA) in Helsinki, Finland. Registration will involve submitting a dossier on the properties of the chemical. This information is used to assess the hazards of the substance and to develop a protocol for its control.
PRE-REGISTRATION:
Pre-registration applies to chemical substances that are already used in the EU (these are called Phased-In Substances that appear on the EINECS list). To avoid having to register the estimated 30,000 chemicals already in use in the EU at one time, manufacturers and importers will be able to pre-register their chemicals from 1 June to 30 November 2008. Pre-registration is a relatively easy process and is free. Once a substance has been pre-registered, it does not have to be registered until at least December 2010. By 1 January the ECHA will publish a list of pre-registered substances and will start to form the SIEFs (Substance Information Exchange Forum) of manufacturers/importers with an interest in the same chemical.
It is essential that manufacturers and importers pre-register all of their chemicals and substances of interest by 30th Nov 2008.
AUTHORISATION FOR CHEMICALS OF “HIGH CONCERN”:
On 1st June 2009 the ECHA will publish a list of priority substances for which there are particular concerns over their hazards. Manufacturers/importers will need to apply for authorisation before they can supply these substances. The ECHA could restrict their use.
REGISTRATION:
Phased-in substances that have been pre-registered are subject to the following transitional arrangements:
Phase 1 Registration must be completed by 1st Dec 2010. These are substances whose annual usage is:
- > 1000 te/yr
- > 100 te/yr but which are classed as being hazardous to aquatic organisms
- > 1 te/yr and which are classed as Cat. 1 or 2 carcinogens, mutagens or reproductive toxins
Phase 2 Registration must be completed by 1st June 2013 for substances which are used at a rate of
- >100 te/yr
Phase 3 Registration must be completed by 1st June 2018 for substances which are used at a rate of
- >1 te/yr
Phased-in substances that have not been pre-registered by 30th November 2008 will need to be registered by 1st Dec 2008. The first step in registration is the submission of an Inquiry Dossier (see later).
REGISTRATION PROCESS:
Registration requires manufactures or importers of chemical substances to provide the ECHA with data on the chemical of interest. The data required depends on the hazards and amount of the chemical sold. The information on the chemical can be obtained from a number of reputable sources. The registration documents need to identify further information or testing required and to suggest how this should be done. The information will be submitted in two registration documents:
- Technical Dossier: The Technical Dossier will contain information on the identity of the manufacture/importer, identity of the substance, the manufacture, uses and likely exposure of the chemical, classification and labeling of the chemical and guidance on its safe use. It will include a description of available information, further information required and proposals for further testing
- Chemical Safety Report documents the applicant’s chemical safety assessment (CSA) of the chemical. It will assess the human health hazards, physicochemical hazards, environmental hazards and bioaccumulative hazards of the substance.
The registration documents will be submitted electronically using IUCLID software.
The cost of registration is not yet known but will be published by 1st June 2008.
CHEMICALS THAT DO NOT HAVE TO BE REGISTERED:
A small number of substances will not need to be registered:
- Radioactive substances, those in transit through the EU, waste, non-isolated intermediates and sixty eight naturally occurring low hazard substances.
- Medicines, food and food additives, plant protection additives and biocides which are governed by other regulations.
- Polymers are not required to be registered, although the monomers and chemicals used in their manufacture will need to be registered.
- Recycled or recovered materials need not be registered provided they were registered initially and have not been changed chemically by the recycling process.
- Naturally occurring minerals, provided they have not been chemically altered (eg mineral ores and concentrates, crude oil, coal, natural gas, etc).
NEW CHEMICALS AND CHEMICALS USED FOR RESEARCH AND DEVELOPMENT:
The Notification of New Substances Regulations (NONS) will continue to apply until 1st June 2008. Substances notified under NONS will be considered as having been already registered under REACH. Thereafter, new non phased-in substances (substances that are not already being used in the EU) will need to be registered under REACH before they can be supplied in the EU. Before they are registered their manufactures/importers need to submit an Inquiry Dossier to enable the ECHA to determine whether they have already been registered, to encourage data sharing and prevent duplicate testing.
The European Chemicals Agency is keen to encourage the development of new chemicals and encourage research to improve chemical processes. So substances which are being used in product or process research and development (PPORD) are exempt from registration for at least 5 years, provided they are notified with the Agency.
JOINT REGISTRATION AND SHARING OF INFORMATION:
The ECHA wish to avoid the need for duplicate testing and will encourage the formation of consortia or SEIFs, (Substance Information Exchange Forum) in which organisations registering the same substance work together to prepare the Technical Dossier and Chemical Safety Reports. This is a legal requirement if testing the substance involves tests on animal vertebrates. The SEIFs will organize themselves as they see fit. The final registration data will be submitted by the Lead Registrant. Commercially sensitive information (eg sales and usage information) need not be shared with colleagues in the SIEF, can be submitted by individual companies and will not be made public.
The SEIFs wiil be expected to share substance data with new manufacturers and importers for an agreed price.
RESPONSIBILITIES:
A Manufacturer or Importer is a natural or legal person established in the EU who introduces the chemical into the EU. It is the responsibility of the manufacture/importer to register their chemicals. They must also supply their customers with Safety Data Sheets (SDS) on the chemical and advise the customer if the chemical required authorisation and details of any restrictions.
The Downstream User is the natural or legal person based in the EU who uses the chemical. The Downsteam user is not required to register the chemical but is responsible for using the chemical as recommended by their supplier and is also required to advise the supplier on his use of the chemical, to enable the supplier to supply the correct information for registration.
A chemical can only be registered under REACH by a person or organisation based in the EU. If you are importing a chemical, it must be registered by an EU based subsidiary of your company, or your EU based importer. If you do not wish to rely on one importer (who could decide to resource the chemical from another supplier) you can appoint an EU based REACH only representative to register the chemical on your behalf.
The only representative would pre-register the chemical, liaise with your downstream users, participate in the SEIF, and prepare the documentation for registration. Once the chemical has been pre-registered (and eventually registered), you will be able to supply the chemical using your importer(s) of choice anywhere in the EU, provided you comply with the requirements of the ECHA
If you have any further questions about REACH, or would like Chemical Associates to act as your REACH Only Representative, please use the Enquiry Form on our contact page