B7.2.6 REACH Regulation (1907/2006)
The REACH Regulation “Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)” entered into force in June 2007. It replaced a number of European Directives and Regulations with a single system.
The aim of REACH is to improve the protection of human health and the environment through the better, and earlier, identification of the intrinsic properties of chemical substances.
As a Regulation, the requirements within REACH apply directly, without the need to be transposed into national legislation.
REACH applies to substances manufactured or imported into the EU in quantities of 1 tonne per year or more. Some substances are specifically excluded:
- Radioactive substances.
- Substances under customs supervision.
- The transport of substances.
- Non-isolated intermediates.
- Waste.
- Some naturally occurring low-hazard substances.
Some substances, covered by more specific legislation, have tailored provisions, including:
- Human and veterinary medicines.
- Food and foodstuff additives.
- Plant protection products and biocides.
Other substances have tailored provisions within the REACH legislation, as long they are used in specified conditions:
- Isolated intermediates.
- Substances used for research and development.
Registration
Substances that are covered by the REACH Regulation must be registered. Due to the large number of substances involved, this is being phased in over 11 years. However, to benefit from the transitional phase in manufacturers or importers should have pre-registered their substances between 1st June and 1st December 2008.
Manufacturers and importers must collect and collate specified sets of information on the properties of those substances they manufacture or supply at or above 1 tonne per year. This information is used to perform an assessment of the hazards and risks that a substance may pose and how those risks can be controlled. This information and its assessment is submitted to the European Chemicals Agency in Helsinki.
Registration Timeline
| Date | Action |
| 1 June 2007 | REACH came in to force |
| 1 June 2008 | Pre-registration for existing (‘phase-in’) substances starts Registration for new (‘non phase-in’) substances starts |
| 30 November 2008 | Pre-registration for ‘phase-in’ substances ends |
| 1 December 2008 | Registration for existing substances (that have not been pre-registered) starts |
| 1 January 2009 | List of pre-registered substances published and SIEFs are formed |
| 1 December 2010 PHASE 1 |
By this date the following pre-registered ‘phase-in’ substances should have been registered when supplied at:
> 1000 tonnes per annum (tpa) or; > 100 tpa and classified under CHIP as very toxic to aquatic organisms or; > 1 tpa and classified under CHIP as Cat 1 or 2 carcinogens, mutagens or reproductive toxicants |
| 1 June 2013 PHASE 2 |
Deadline for registration of substances supplied at ≥ 100 tpa |
| 1 June 2018 PHASE 3 |
Deadline for registration of substances supplied at ≥ 1 tpa |
Joint Registration
The principle is that for any one substance, there should be a single set of information that is shared by all companies who manufacture or supply that substance.
Business specific (e.g. company name) and business sensitive (e.g. how it is used) information is submitted separately by each company. The Companies will work together to get an agreement on information sharing through a Substance Information Exchange Forum (SIEF). The details of how this information is shared, is the responsibility of the businesses involved in the SIEF. A role for national authorities in this aspect of REACH is not foreseen. Companies who submit joint registrations via a SIEF benefit from a reduced registration fee.