REACH is the Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals. It entered into force on 1st June 2007. It streamlines and improves the former legislative framework on chemicals of the European Union (EU).
The main aims of REACH are to ensure a high level of protection of human health and the environment from the risks that can be posed by chemicals, the promotion of alternative test methods, the free circulation of substances on the internal market and enhancing competitiveness and innovation.
REACH makes industry responsible for assessing and managing the risks posed by chemicals and providing appropriate safety information to their users. In parallel, the European Union can take additional measures on highly dangerous substances, where there is a need for complementing action at EU level.
Registration is the main requirement of REACH and it means that for any substance manufactured or imported in quantities equal or above 1 t/y a defined set of information has to be provided to ECHA by the manufacturer or importer in the form of a registration dossier. If the quantity manufactured or imported reaches or exceeds 10 t/y also a chemical safety assessment is required to assess the hazards resulting from the intrinsic properties of the substance. If the substance fulfills certain hazard criteria the chemical safety assessment includes also an assessment of the exposure to demonstrate that the risk stemming from the exposure can be controlled with a set of operational conditions and risk management measures designed for the supported uses. The chemical safety assessment is documented in a Chemical Safety Report (CSR) by the registrant.
Downstream users should communicate their uses to the registrants and, in return, for hazardous substances will typically receive information on the safe use of the substance via the safety data sheet which may include exposure scenario information (see chapter 2.3 of this Guidance in a Nutshell).
Evaluation is undertaken by the authorities on a certain number of substances and dossiers. Even if downstream users are not directly affected by these processes, a dossier evaluation may result in a change of the registrant’s assessment and consequently in the uses supported or in the recommendations received from the supplier.
Furthermore a substance may be eventually identified as Substance of Very High Concern (SVHC) and placed on the Candidate List, triggering obligations for downstream users, in particular communication obligations.Over 150 chemicals are considered to be Substances of very high concern (SVHC)
When a SVHC included in the Candidate List is subsequently placed in Annex XIV of REACH, it will be subject to authorisation. A downstream user may use such a substance only if he complies with the conditions specified in the authorisation granted to an actor up his supply chain or if he applies for an authorisation himself (an application can also be submitted by different actors together). To be noted that the REACH Regulation provides for exemptions from the authorisation requirements for uses of substances placed in Annex XIV under certain conditions (more information is provided in chapter 8 of the parent Guidance for downstream users).
Finally, restrictions may limit or ban the manufacture, placing on the market or use of a substance in order to protect human health and environment from unacceptable risks. This substance can be used by a downstream user only if the use is not one of the restricted uses. Chapter 8 of the parent Guidance for downstream users provides the details which are relevant for downstream users.