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1. Pre-registration
Phase-in substances can be pre-registered at the Agency starting 12 months and ending 18 months after entry into force of REACH.
The pre-registration gives an authorization for registration grace periods, from 3.5 to 11 years according to the total volume contained in the article produced or imported and to the classification of the substance.
With pre-registering, the manufacturer or importer can also participate in SIEF, the Substance Information Exchange Forum, in order to share information.
Without pre-registration, producers/importers will have to register the substances for their specific use before they can place their articles on the EU market.
2. Registration
Under REACH, each producer and importer of chemicals in volumes of 1 tonne or more per year per producer or importer will have to register with the European Chemicals Agency, submitting information on chemical properties and uses as well as safety measures for handling the chemicals.
For the purpose of registration, the registrant can use existing scientific data or share data with another registrant if the chemical concern is identical.
The producers or importers are also required to pass the safety information to downstream users via a Safety Data Sheet (SDS).
The registration is obligatory for substances in articles with following conditions:
- the total amount of the substance present in the articles exceeds 1 t/a per producer or importer
- the substance is intended to be released during normal and reasonable foreseeable conditions of use
- the substance has not yet been registered for this use
Notification is required for substances of very high concern (SVHC) present in articles and for which the following conditions are met:
- the substances are present in those articles in a concentration above 0.1% (weight/weight) in a homogeneous material and
- the total amount of those articles exceeds 1t/a per producer and importer
It is however not obligatory to notify if the producer or importer can exclude exposure to humans or the environment during normal or reasonably foreseeable conditions of use or if the substance has already been registered for that specific use.
Progressive Registration phases
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CMR = Carcinogen, Mutagen and Toxic to reproduction
The registration dossier includes:
- a Technical Dossier (start at 1t/a): company information and substances identity; manufacture and uses, guidance on safe use, exposure information, classification and labeling; robust study summaries and proposal for testing are required.
- for substances in quantities of 10 tonnes or more: a CSR, Chemical Safety Report (risks assessment) is required which includes hazard and PBT assessment, exposure assessment, risk characteristics and exposure scenarios.
3. Evaluation
There will be a Dossier evaluation and a Substance evaluation. Public authorities will review the registration dossiers and may request additional information when deemed necessary. At this stage, the authorities will scrutinize all proposals for animal testing and may suggest alternative methods whenever possible. One of the main objectives of REACH is to minimize animal testing and make sharing experimental data compulsory.
4. Authorization
Use-specific authorizations are required for four chemical categories namely:
(i) carcinogen, mutagen and toxic to reproduction (CMR)
(ii) persistent bioaccumulative toxic (PBT)
(iii) very persistent and very bioaccumulative (vPvB)
(iv) substances of equivalent concern with scientific evidenceof probable serious effects.
Authorization will be granted only if there are no suitable alternative substances or technologies available and the social and economic benefits outweigh the risks.
5. Restriction
The regulation laid out conditions to restrict manufacturers from placing certain dangerous substances on it own, in preparation or in articles on the market. Manufacturers are prohibited from placing the substance, preparation or article on the market if the requirements cannot be met and the manufacturers are not able to prove with evidences that the socio-economic benefits outweigh the risk to human health or the environment.
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