REACH, the Registration, Evaluation and Authorisation of Chemicals, was adopted by the European Union (EU) on 19 December 2006 and entered into force on 1 June 2007. The Regulation replaces more than 40 existing pieces of legislation and presents some of the most important changes to the EU’s management of chemicals in 30 years.
In a nutshell, REACH represents a new chemicals strategy, which the EU is planning to implement alongside a globally congruent system, the Globally Harmonized System (GHS), for the classification and labelling of chemicals. A new body called the European Chemicals Agency (ECHA), located in Helsinki, is being erected to manage all technical, administrative, and scientific aspects of the system in order to ensure REACH operates in an efficient manner and is credible to all stakeholders.
The Regulation is set to have the furthest reaching impact on the chemical sector and how it is managed by the EU since the Dangerous Substance Directive (67/548/EEC), first introduced in 1967. REACH will impact all sectors of the chemical industry, including silicones, siloxanes and silanes producers within the EU, as well as those exporting products into the EU. As REACH has come into force already, it is crucial for those affected by the legislation to understand what it means for them; currently, major companies are having to change the way they manage chemicals not only in a regulatory sense, but also in terms of the way health, safety and environment issues are handled.
The Registration element of REACH requires manufacturers and importers of substances, (including new and existing chemicals, on their own, in imported preparations, and in certain cases in imported articles) to obtain and submit information to the ECHA. A single set of data is required per registered substance; registration requirements starting at one tonne per manufacturer per year. Hazard and risk information is to be passed down the supply chain in order to ensure downstream users are better aware of how to manage substances. Downstream users are also made responsible for providing Registrants exposure information to be part of the registration dossiers. Uses which are not part of the registration dossier will no longer be allowed. The underlying idea is “no data, no market”.
The Evaluation aspect of REACH focuses on preventing unnecessary animal testing. This is accomplished by having the ECHA evaluate testing proposals made by manufacturers aiming to register substances. Data sharing is required for substances needing studies on animals. Data gaps may also be fulfilled by computer modelling techniques based on the known properties of similar substances. The evaluation also allows authorities to further investigate substances they consider to potentially carry risk by asking the industry for more information. This information can later on be used to prepare proposals under Restrictions or Authorisation.
The Authorisation process demands those using substances with properties of high concern (persistent, bio-accumulative and/or toxic) to demonstrate that risks associated with these substances are being controlled. In case this is adequately demonstrated an authorisation for that substance and its use will be granted. Substitutes or alternative substances will be looked into, yet ultimately authorisation may be granted if socio-economic benefits outweigh the risks posed by the use of the substance.
Finally, the Restrictions procedure enables conditions and even bans to be placed on the manufacture, use and trade of certain hazardous substances. All substances, including those registered, authorised and restricted, are classified and labelled, and registered in a central inventory. Access of information rules stipulate information to be publicly available, while keeping in force certain rules on the protection of confidential business information (CBI).
1 Jun - 30 Nov 2008: pre-registration of all phase-in substances by manufacturers
30 Nov 2010: substances classified as dangerous for the environment at >100t and carcinogens, mutagens and reproductive toxicants at >1t