REACH REGULATION
REACH is the Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals.
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.
When REACH is fully in force, it will require all companies manufacturing or importing chemical substances into the European Union in quantities of one tonne or more per year to register these substances with a new European Chemicals Agency (ECHA) in Helsinki, Finland. Since REACH applies to some substances that are contained in objects (articles in REACH terminology), any company importing goods into Europe could be affected.
The European Chemicals Agency has set three major deadlines for registration of chemicals. In general these are determined by tonnage manufactured or imported, with
- 1000 tonnes/a being required to be registered: by 1 December 2010,
- 100 tonnes/a by 1 June 2013
- and 1 tonne/aby 1 June 2018.
In addition, chemicals of higher concern or toxicity also have to meet the 2010 deadline.
The CLP regulation sets the rules for classification and labelling of chemicals. It aims to determine whether a substance or mixture displays properties that lead to a classification as hazardous. CLP itself does not set information requirements (except for determining physical properties). The information requirements laid down in REACH will however, ensure availability of much data.
Once such properties are identified and the substance or mixture is classified accordingly, manufacturers, importers, downstream users and distributors of substances or mixtures, as well as producers and importers of certain specific articles (explosive articles which are subject to classification according to Part 2 of Annex I to CLP) should communicate the identified hazards of these substances or mixtures to other actors in the supply chain, including to consumers.
The hazard of a substance or mixture is the potential for that substance or mixture to cause harm. It depends on the intrinsic properties of the substance or mixture. In this connection hazard evaluation is the process by which information about the intrinsic properties of a substance or mixture is assessed to determine their potential to cause harm. In cases where the nature and severity of an identified hazard meets the classification criteria, hazard classification is the assignment of a standardised description of this hazard of a substance or a mixture causing harm to human health or the environment.
Hazard labelling allows for the communication of hazard classification to the user of a substance or mixture, to alert the user to the presence of a hazard and the need to avoid exposures and the resulting risks. CLP sets general packaging standards, in order to ensure the safe supply of hazardous substances and mixtures. The aim of the Regulation is to enable a judgment on a substance or mixture (preparation) with respect to its hazardous properties and to provide a hazardous chemical with pertinent hazard labelling and information on safety measures.