REACH is a regulation of the European Union, adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the EU chemicals industry. It also promotes alternative methods for the hazard assessment of substances in order to reduce the number of tests on animals.
In principle, REACH applies to all chemical substances; not only those used in industrial processes but also in our day-to-day lives, for example in cleaning products, paints as well as in articles such as clothes, furniture and electrical appliances. Therefore, the regulation has an impact on most companies across the EU.
REACH places the burden of proof on companies. To comply with the regulation, companies must identify and manage the risks linked to the substances they manufacture and market in the EU. They have to demonstrate to ECHA how the substance can be safely used, and they must communicate the risk management measures to the users.
If the risks cannot be managed, authorities can restrict the use of substances in different ways. In the long run, the most hazardous substances should be substituted with less dangerous ones.
REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. It entered into force on 1 June 2007.
How does REACH work?
REACH establishes procedures for collecting and assessing information on the properties and hazards of substances.
Companies need to register their substances and to do this they need to work together with other companies who are registering the same substance.
ECHA receives and evaluates individual registrations for their compliance, and the EU Member States evaluate selected substances to clarify initial concerns for human health or for the environment. Authorities and ECHA’s scientific committees assess whether the risks of substances can be managed.
Authorities can ban hazardous substances if their risks are unmanageable. They can also decide to restrict a use or make it subject to a prior authorisation.
REACH’s effect on companies
REACH impacts on a wide range of companies across many sectors, even those who may not think of themselves as being involved with chemicals.
In general, under REACH you may have one of these roles:
Manufacturer: If you make chemicals, either to use yourself or to supply to other people (even if it is for export), then you will probably have some important responsibilities under REACH.
Importer: If you buy anything from outside the EU/EEA, you are likely to have some responsibilities under REACH. It may be individual chemicals, mixtures for onwards sale or finished products, like clothes, furniture or plastic goods.
Downstream users: Most companies use chemicals, sometimes even without realising it, therefore you need to check your obligations if you handle any chemicals in your industrial or professional activity. You might have some responsibilities under REACH.
Companies established outside the EU: If you are a company established outside the EU, you are not bound by the obligations of REACH, even if you export their products into the customs territory of the European Union. The responsibility for fulfilling the requirements of REACH, such as pre-registration or registration lies with the importers established in the European Union, or with the only representative of a non-EU manufacturer established in the European Union.
Substance identification is a process by which the identity of the substance is established.
Accurate identification of a substance is a pre-requisite to most REACH, CLP and biocides processes. In particular, it enables joint REACH registrations to be prepared efficiently and correctly, and ensures that test data is appropriate for the substance registered under REACH. This leads to a robust hazard and risk assessment of the registered substance.
The correct identification of a substance will also enable the:
- sharing of information to prevent unnecessary animal testing and costs;
- use of test data across companies and read-across within a group of substances;
- assessment of whether a substance is included in the Authorisation List, the list of restrictions or has a harmonised classification and labelling.
Typically, the identity of a substance can be described by a:
- chemical name, for example, benzene;
- number, for example, EC number 200-753-7, and
- chemical composition, for example, >99 % benzene and <1 % toluene. The composition is determined by chemical analysis.
Regulatory processes where substance identification plays a key role are:
Companies planning to register a non-phase-in substance or a phase-in substance they have not pre-registered, have a duty to inquire from ECHA whether a registration has already been submitted for that substance.
Accurate identification of a substance is important in the inquiry process to ensure that companies planning to register or that have already registered the same substance are correctly put into contact with one another. This ensures that data is shared appropriately.
Companies are responsible for collecting information on the properties and uses of the substances they manufacture or import above one tonne a year. They also have to assess the hazards and potential risks presented by the substance.
This information is communicated to ECHA through a registration dossier containing the hazard information and, where relevant, an assessment of the risks that the use of the substance may pose and how these risks should be controlled.
Registration applies to substances on their own, substances in mixtures and certain cases of substances in articles. Chemical substances that are already regulated by other legislations such as medicines, or radioactive substances are partially or completely exempted from REACH requirements.
Registration is based on the “one substance, one registration” principle. This means that manufacturers and importers of the same substance have to submit their registration jointly. The analytical and spectral information provided should be consistent and sufficient to confirm the substance identity.
For substance registration a fee is usually charged.
Substances to be registered
There is a special transitional regime for substances which were already manufactured or placed on the market before REACH entered into force. Such substances are called phase-in substances.
Companies benefit from the transitional regime if they pre-registered their substances by 1 December 2008 (or in certain circumstances, made a later pre-registration before the relevant registration deadline).
Substances that fulfil at least one of the following criteria may be considered as phase-in substances in accordance with REACH:
- Substances listed in the European Inventory of Existing Commercial Chemical Substances (EINECS)
- Substances that have been manufactured in the EU (including the countries that joined on 1 January 2007) but have not been placed on the EU market after 1 June 1992
- Substances that qualify as “no-longer polymer”
For these substances, the REACH Regulation sets the following registration deadlines:
30 November 2010
Deadline for registering substances manufactured or imported at 1 000 tonnes or more a year; substances that are carcinogenic, mutagenic or toxic to reproduction above 1 tonne a year; and substances dangerous to aquatic organisms or the environment above 100 tonnes a year.
31 May 2013
Deadline for registering substances manufactured or imported at 100-1 000 tonnes a year.
31 May 2018
Deadline for registering substances manufactured or imported at 1-100 tonnes a year.
All substances that do not fulfil any of the criteria for phase-in substances are considered as non-phase-in substances. Normally, non-phase-in substances have not been manufactured, placed on the market or used in the EU before 1 June 2008, (unless they were notified under the Dangerous Substances Directive (67/548/EEC)).
Potential manufacturers and importers of non-phase-in substances have to submit an inquiry to ECHA and subsequently register the substance before they can manufacture or import the substance.
All substances notified under the Dangerous Substances Directive (also called NONS) are considered to be registered under REACH and ECHA has assigned registration numbers to all the notifications. The owners of the notifications can claim the registration numbers from ECHA.
Who needs to register?
|You need to register if you are an: EU manufacturer or importer of substances on their own or in a mixtureEU producer or importer of articles meeting the criteria explained in the Guidance on requirements for substances in articles”Only representative” established in the EU and appointed by a manufacturer, formulator or article producer established outside the EU to fulfil the registration obligations of importers|