REACH requires industry to mitigate the risks from chemicals by providing information on their properties and risks and registering that data with European Chemical Agency (ECHA). What this means, in effect, is that the responsibility for ensuring that chemicals are used safely is shifted from the regulatory authorities to the manufacturers and importers of the chemicals.
The goal of REACH is to provide a greater level of protection for humans and the environment by ensuring that proper information on handling, storage and chemical make-up together with risk management measures, if appropriate, are readily available.
In order to benefit from the phased registration deadlines and to allow continued manufacture or import in quantities >1t/yr, each EU manufacturer or importer was required to pre-register each substance with ECHA by Dec 1st 2008.
Only companies importing or manufacturing low hazardous substances at volumes below the 2018 registration threshold of 100 ton/year for the first time may benefit from the provisions of late pre-registration. If you do not meet the requirements for a first time manufacture or import you must complete and submit an appropriate registration dossier prior to manufacturing or placing the product on the EU market.
All registrants of the same substance are obligated to participate in Substance Information Exchange Fora (SIEFs). The purpose of a SIEF is to exchange information to avoid unnecessary testing, agree on classification and labelling, and appoint a Lead Registrant. Once a registration is completed, downstream users will be informed about potential hazard and risk management measures via the Safety Data Sheet.
The registration obligation for non-EU manufactured substances has to be fulfilled by the EU importer established within the European Union. However, non-EU manufacturers and formulators can choose to appoint an EU-based legal entity to represent them as an Only Representative (OR). The OR then assumes the same REACH obligations as an EU manufacturer.
After Registration, ECHA will perform a dossier evaluation to assess the testing proposals made by registrants or to check the compliance of the registration dossiers. ECHA will also coordinate substance evaluation to be conduted by the Member States with the Community Rolling Action Plan, CoRAP. As part of this exercise the evaluating Member State may conclude that no further action is required or request more data, but can also propose the substance for a harmonized classification or to be included as a Substance of Very High Concern or any other restriction following the scrutiny process.
The route to authorisation starts with the identification of a Substance of Very High Concern (SVHC). Where the substance is identified as an SVHC, it is included in the Candidate List for eventual inclusion in the Authorisation List. Not all SVHC substances on the Candidate list will be proposed for authorisation, but this list is the main tool for ECHA to select substances to be proposed for authorisation.
Criteria for a substance to be added:
- CMRs cat 1 or 2 (carcinogens, mutagens and reprotoxic).
- PBTs (Persistent, Bio accumulative and Toxic substances).
- vPvBs (very Persistent and very Bio accumulative substances).
- Substances of equivalent concern
Once a substance is included in the authorisation list, it cannot be placed on the market or used after the “sunset date” unless an authorisation has been granted. The authorisationprocess will include an assessment of whether the risks are adequately controlled, whether a suitable alternative exists and whether the socio-economic benefit of continued use of a substance may outweigh the risks associated with its use.
Substances registered as intermediates are not subject to authorisation.
In the REACH scope will you find substances on their own, substances in mixtures (a solution composed of two or more substances) and to some extent, substances in articles. All chemicals are included in the scope unless exempted.
Below are some examples of exemptions:
Exempted from REACH:
- Non-isolated intermediates
- Radioactive substances
- Substances customs supervision
Exempted from REACH registration:
- Substances manufactured/imported below 1 ton/year (per manufacturer/importer).
- Substances occurring in nature, if not chemically modified, eg. natural gas, crude oil.
- Polymers (but monomers and certain additives are subject to REACH requirements).
- Substances with well known properties and low hazard listed in Annex IV (water, nitrogen)
- Substances already registered that are re-imported and supply chain could be demonstrated
- Substances for Product and Process-Oriented Research and Development (notification required)
- Substances used in products covered by specific end use legislation, such as medicinal products, foodstuffs.