One of the most significant changes to European EHS legislation has recently occurred with REACH, the Registration, Evaluation and Authorisation of Chemicals regulation that came into force June 1, 2007. Being a regulation instead of a directive means it is directly applicable as law throughout the 27 countries that comprise the European Union (EU). It will have a significant impact on American EHS professionals (see sidebar) as it will affect businesses manufacturing in or importing into the EU as well as those depending on EU companies as suppliers.
Among the stated objectives of REACH are to protect human health and the environment, increase transparency, promote non-animal testing and facilitate conformity with EU international obligations under the World Trade Organization.
REACH requirements are being phased in gradually during the next 11 years, with pre-registration of substances starting next June. Like all new regulations it introduces a new array of acronyms that we will introduce in this article.
Anyone who manufactures or imports more than one tonne of a substance in or into the EU is required to register basic information about the substance for entry into a central database. Registration under REACH is only required for substances, not preparations or articles, but substances in preparations and articles are potentially subject to registration if they exceed the threshold of one tonne per year.
The information system maintained by the European Chemicals Agency (ECHA) in Helsinki to store information is the REACH-IT system. The central database in REACH-IT containing the information is called IUCLID5. This database forms an information exchange platform intended to reduce the need for animal testing. Substance Information Exchange Fora (SIEFs) will use IUCLID5 to provide a method for industry to share information on substances and submit data to the ECHA.
The information to be registered includes the intrinsic properties and hazards of each substance, its intended uses and information on how it may come into contact with people and/or the environment. This will take the form of a technical dossier for substances in quantities of one tonne or more, or a Chemical Safety Report (CSR), for substances in quantities of ten tonnes or more. The CSR is the end product of a Chemical Safety Assessment (CSA) prepared to give an assessment of risks for human health and the environment.
One important part of the CSR is the Exposure Scenario (ES) describing intended uses of the substance and the resultant exposures expected. The ESs give appropriate Risk Management Measures (RMMs) to adequately control the risks associated with the substance and will be disseminated as annexes to Safety Data Sheets (SDSs).
The CSA will include a human health hazard assessment that will determine a Derived No Effect Level (DNEL) for workers and the general population. The DNEL is termed “an exposure level below which an adverse effect will not occur.” An environmental hazard assessment is required to determine a Predicted No Effect Concentration (PNEC) below which adverse environmental effects are not expected to occur. The CSA will go on to include a risk characterization comparing the expected human or environmental exposure with the appropriate DNEL or PNEC. If the estimated exposure exceeds either, an iterative process involving more stringent RMMs occurs until the risks are adequately controlled.
Evaluation takes two forms: dossier evaluations or substance evaluations. Dossier evaluations check the completeness and compliance of registration dossiers. Substance evaluations check whether further information is needed on a substance.
Authorization is required for Substances of Very High Concern (SVHCs) on a case-by-case basis. SVHCs are substances that are carcinogenic, mutagenic or toxic to reproduction (CMR), persistent, bio-accumulative and toxic (PBT), very persistent, very bio-accumulative (vPvB) or endocrine disrupting. To attain authorization, companies will have to demonstrate that risks are adequately controlled, socio-economic benefits outweigh risks and no suitable alternative substitutes or technologies exist.
Substances that have not had the risks associated with their use adequately addressed by another part of the REACH system can be restricted in their use.
Manufacturers and importers of substances are not the only links in the supply chain with requirements under REACH. Downstream Users (DU) are customers that use substances in processes either as industrial users or in preparing formulations. They are required to apply the risk management measures identified in the SDS exposure scenario. They need to make their uses known to manufacturers/importers or they will have to carry out their own CSA. Some DUs may want to do so for confidentiality reasons as their use may constitute a trade secret.
REACH will evolve over the next decade as more requirements come into force. There are ongoing REACH Implementation Projects (RIPs) that provide guidance on specific areas. The main area of interest to U.S. EHS practitioners is RIP 3, which provides guidance documents for industry. The guidance for RIP 3 topics should be complete by the end of the year, and ongoing information is available from the European Chemicals Agency (http://reach.jrc.it/guidance_en.htm).