Regulatory
REACH, the European Union Regulation for the Registration, Evaluation, Authorization and Restriction of CHemicals came into force on 1st June 2007.
REACH fundamentally alters the way in which all Chemicals are regulated and, given the global nature of the regulatory process, may well prove to be a blueprint for other countries. Already China is looking at the possibility of introducing similar laws.
REACH is radical, but it is also very simple. The fundamental principle underlying REACH is that if a company manufactures chemicals in the EU, or if anyone wants to import chemicals into the EU, then they must:
- Know what those chemicals are used for
- Know what the effects on man and the environment will be
- Provide an assessment of risk to the authorities to demonstrate that any risks are known, understood and manageable.
Manufacturers and Importers must take responsibility for their actions.
Behind that simple idea is a piece of legislation that is 849 pages long, with another 700+ pages covering standard methods for determining physico-chemical, toxicological and environmental properties. This replaces over 40 existing pieces of legislation. Delphic HSE can assist in all aspects of REACH and have produced a guidance document that explains the evolution of the Regulation, the actions that are required and the timeline for each activity.
The first thing that must be done is Pre-Registration. The window of opportunity is open on 1st June 2008 and closes on 1st December 2008.
Pre-Registration Information
The information required at pre-registration, for all substances manufactured or imported into the EU in quantities greater than 1 tonne per year is as follows:
- Name of chemical substance
- EINECS number
- CAS number (or any other identity code)
- Name and address of registrant
- Name of contact person
- Envisaged deadline date for registration
- Tonnage band.
This information will be submitted to the ECHA (European Chemicals Association) by means of a software download that is available free of charge from the ECHA website. The information will be entered into a database, known as IUCLID 5, which will form the basis of the entire registration process.
The importance of the pre-registration process and the 6-month window from 1st June to 1st December 2008 cannot be over emphasized.
If manufacturers and importers wish to make use of the extended deadlines for the completed registration process they must pre-register their substances; if they do not, and the window is missed, then the chemicals that they produce or import will be classed as “new” and will be subject to the full registration process before they can be legally sold. In short, they will have to be withdrawn from sale until a registration is completed.
After pre-registration, there is a period of information exchange (see Guidance Document) and companies will form consortia to work together to develop the data needed for Registration.
