REACh. Introduction
REACh to the point
REACH is a new EU regulation concerning the Registration, Evaluation, and Authorisation of CHemicals which has become valid on 1st June 2007. REACH replaces a number of European Directives and Regulations with a single coherent system for "existing" (phase-in) and "new" (non-phase-in) chemicals.
The estimated number of existing substances that have to be registered is 30.000. The whole registration process for existing substances will be completed by 2018. Non-phase-in substances need to be registered before they can be manufactured in or introduced into the EU.
REACH establishes the "no data - no market" principle, meaning that manufacturers and importers must identify and manage risks linked to their chemicals before they can be placed on the market. Main aims of REACH are to minimize risks to human health and the environment related to exposure to chemicals. In addition, reduction of animal testing by promoting alternative methods for the assessment of hazards of substances is another objective.
Explanations
phase-in
Phase-in chemicals (around 100000 chemicals) are subject to the registration system in different phases over time and are defined as those meeting at least one of the following criteria:
- listed in European Inventory of Existing Commercial Chemical Substances (EINECS)
- having been manufactured in one of the current EU Member States at least once within the period of 15 years before the entry into force of REACH, but not placed on the market
- "No-Longer Polymers" placed on the market in one of the current EU Member States before REACH has entered into force
non-phase-in
Non-phase-in chemicals do not meet the criteria of phase-in chemicals. They have not been manufactured previously and need to be registered before they can be manufactured, imported or placed on the market in the EU. Non-phase-in chemicals do not benefit from the transitional regime for the registration.
Registration deadlines for pre-registered phase-in-substances:
- 1 December 2010 [> 1000 t/a; very toxic to aquatic organisms (R50-53) > 100 t/a; carcinogenic, mutagenic or toxic to reproduction (CMR) (cat 1 or 2) > 1 t/a]
- 1 June 2013 (> 100 t/a)
- 1 June 2018 (> 1 t/a)
aims of REACH
The main objectives of REACH are:
- guarantee of protection of human health and the environment
- maintenance and enhancement of the competitiveness of the EU chemicals industry
- increment of transparency
- promotion of non-animal testing
- compliance with EU international obligations under the WTO