Manufacturers and importers of substances have a general obligation to submit a registration to the Agency for each substance manufactured or imported in quantities of 1 tonne or more per year per company (legal entity).
This obligation applies to substances as such and in preparations. A special registration regime applies for substances in articles (e.g. manufactured goods such as cars, textiles, electronic chips). However, certain substances are exempted from registration under REACH (see chemicals covered).
Failure to register means that the substance cannot be manufactured or imported.
The phase-in substances (substances which have long been on the EU market) and the non-phase-in substances have different timelines for registration under REACH.
Substances which have not previously been placed on the EU market (non phase-in substances), and phase-in substances which have not been pre-registered, must be registered before they can be manufactured, placed on the market or used.
For phase-in substances which are manufactured or imported in a quantity of 1 tonne or more per year and which have been pre-registered, the registration provisions will apply in a stepwise way to facilitate the transition to REACH. Substances manufactured or imported at or above 1000 tonnes/year as well as Carcinogenic Mutagenic or Reprotoxic substances category 1 and 2 (CMR cat 1 and 2) manufactured or imported at or above 1 tonne/year, or substances classified as dangerous for the aquatic environment with R50/53 and manufactured or imported at or above 100 tonnes/year will have to be registered before 1 December 2010, while substances manufactured or imported in lower volumes will have to be registered before 1 June 2013 (if 100 – 1000 tonnes/year) or 1 June 2018 (if 1 – 100 tonnes/year).
Similar obligations were in place before REACH for certain substances, e.g. substances notified under the former chemicals legislation for new substances. These substances are considered as already registered under REACH. However, such registrations will need to be updated as appropriate if new circumstances arise, e.g. if production or import is increased to a higher tonnage band or if new information becomes available.
Manufacturers and importers of substances will need to gather information on the environmental and health properties of their substances, assess the risks arising from the uses of their substances and ensure that these risks are properly managed. To demonstrate that this has been done, manufacturers and importers need to submit:
and, in addition,
The technical dossier contains information on the properties and classification of a substance as well as on uses and guidance on safe use. The information required to determine the properties of the substances varies according to the tonnage in which the substance is manufactured or imported. The higher the tonnage the more information on the intrinsic properties of the chemical is required. The information requirements are set out in the Annexes VI to XI of the Regulation. REACH foresees data sharing between registrants to gather the required information.
For substances manufactured or imported in quantities starting at 10 tonnes, the chemical safety report(CSR) documents the hazards and classification of the substance and the assessment as to whether the substance is persistent, bioaccumulative and toxic (PBT) or very persistent and very bio-accumulative (vPvB).
If the substance is classified as dangerous or is PBT or vPvB, then an exposure assessment and risk characterisation shall be performed to demonstrate that the risks are adequately controlled. This exposure assessment is done using exposure scenarios for each use of the substance.
Exposure scenarios are sets of conditions that describe how substances are manufactured or used during their life-cycle and how the manufacturer or importer controls, or recommends downstream users to control, exposures of humans and the environment.
The registration dossier has to be submitted electronically, using IUCLID 5 format.
Registrants must pay a fee for submitting a dossier.
Registrants must update their registration as appropriate, e.g. if the production or import increases to a higher tonnage band or on the basis of new information that require to modify the dossier.
In cases where a substance is manufactured or imported by more than one company, they are required to jointly submit information on the hazardous properties of the substance and its classification. If registrants agree they can also submit a joint chemical safety report.
The Agency is responsible for managing all registration dossiers.
The Agency will perform a simple electronic completeness check at the dossier submission stage (the quality of the information submitted may be checked afterwards in the evaluation process).
If the Agency does not indicate otherwise within 3 weeks of the registration, the registrant may begin (for non-phase-in substances) or continue (for phase-in substances) to manufacture or import the substance.
However, a positive completeness check does not imply any form of approval of the registration dossier or use of the substance from the Agency.
See also: