REACH (the Registration, Evaluation, Authorisation and Restriction of Chemicals) and GHS (Globally Harmonization System) are two separate but cohesive regulative bodies. Their scopes differ, but the objective for both is to create better protection from the hazards associated with chemicals. This article will focus on REACH, who should be concerned with REACH, and how REACH will be affected by GHS.
More About REACH
The REACH Regulation (1907/2006) gives greater responsibility to industry to manage the risks from chemicals and to provide safety information on substances. Manufacturers and importers will be required to gather information on the properties of their substances and to register the information with the EU in a central database. The aim is to improve the protection of human health and the environment, through better and earlier identification of the properties of chemical substances. The Regulation will become effective June 1, 2007 with the understanding that obligations will be applied in stages. It is predicted that all obligations will be enforced within 11 years from the effective date.
REACH includes substances, preparations and articles within a life cycle. This is applied to the manufacturing, importing, placing on the market, and general use of products. Each qualifying product that is to be placed on the European market must be registered electronically by the European Chemicals Agency. All phase-in substances will be given a pre-registration period from January 1, 2007 through January 12, 2008. Beyond that, substances will be required for registration in a tiered manner from the effective date (June 1, 2007). During the first three to five years, special substances (carcinogens, mutagens, reproductive toxins, dangers to the environment - very toxic with long term effects), and those substances manufactured/imported at greater than 1000 tons per year, must be registered. After the sixth year those substances manufactured/imported at 100 to 1000 tons per year must be registered, and after 11 years those substances manufactured/imported at 1 to 100 tons per year must be registered.
Each substance manufactured/imported at greater than 1 ton annually must submit a technical dossier for registration. A Chemical Safety Report (CSR) must be submitted for those materials at greater than 10 tons per year, if the substance is classified as dangerous, or is a PBT/vPvB (persistent bioaccumulative and toxic/very persistent, very bioaccumulative) substance. A notification must be sent to the Agency for substances of very high concern contained at greater than 0.1% in an article beginning December 1, 2008. Registration data requirements increase with the tonnages and are set forth in Annexes 7- 10.
There are a few new conditions surrounding Safety Data Sheets (SDS) under the REACH regulation. A SDS must be provided for PBT and vPvB substances and mixtures containing these substances at greater than 0.1%. Exposure Scenarios must be annexed including Risk Management Measures (RMM) and attached to the SDS. The REACH regulation requires that once the new GHS Standard is adopted, a SDS must be compiled and the material must be classified according to that standard. SDSs need not be revised simply for the switch of sections two and three but only when new information becomes available impacting other parts of the SDS. In the interim, a dual system will be used where both the existing European classification and labeling legislation as well as the new GHS system will be accepted.
REACH & GHS, Compared
While REACH and GHS have different scopes there are many essential links between the two regulations. REACH aims to produce information on hazards, risks, and Risk Management Measures (RMM) while GHS aims to harmonize the classification and labeling of materials. GHS is that system recommended by the United Nations (UN) which will be applied across multiple countries, including the European Union. REACH refers to classification criteria of the present European legislation established by the EU, with the intention of replacing this with the new GHS regulation. REACH also introduces provisions on safety data sheets based on GHS with a few additional REACH specialties. GHS is intended to be applied to the classification and labeling inventory and registration of substances under REACH beginning December 1, 2010 when the new GHS regulation will be available. Substances will be phased in the first three and a half years and mixtures will be given an additional four and a half years for reclassification.
Many changes are coming down the pike. If you don’t know already, find out how your company will be affected by these changes so you can make plans today! Remember, preparation is the best prescription for prevention.