REACH
REACH: Registration, Evaluation, Authorization and Restriction of Chemicals
In July 2007, the European Union’s REACH Regulation reformed chemicals legislation in Europe. This EC Regulation [REGULATION (EC) No. 1907/2006] governs the registration, evaluation, authorization, and restriction of chemicals. REACH affects all players in the supply chain – from manufacturers, processors, and dealers to end users of chemical substances. It applies to virtually all chemical substances (as such or in preparations), irrespective of whether they have hazardous properties or not. Articles are only affected by REACH if they release substances or contain substances causing particular concern.
See how the registration, authorization and restriction of chemicals works.
Registration of substances at LANXESS
Since the REACH Regulation came into effect, LANXESS has submitted approximately 1,000 substance dossiers to the European Chemicals Agency (ECHA) in Helsinki in due time in three phases (2010, 2013, and 2018). All information about LANXESS substances required for registration was identified, and production and all applications were systematically evaluated.
Preparing the registration dossiers was an enormous undertaking, but it has also allowed us to achieve a great deal – we now know much more about the safe production and use of our products than we did ten years ago.
REACH remains important
The registration of all LANXESS phase-in substances only represents one part of REACH, as REACH encompasses registration, evaluation, authorization, and restriction of chemicals. The topic remains important. Some dossiers need to be revised, and in the future new substances will always need to be registered prior to production or import. This applies to quantities of one or more metric tons per year and per legal entity of the Group.Registration within defined deadlines
REACH stipulates that substances produced in the EU or imported into the EU in volumes of one or more metric tons per year must be registered. (Substances already on the market – referred to as phase-in substances – were subject to transition periods. Producers and importers affected by this had to initially pre-register their substances by December 1, 2008. Actual registration of these substances then needed to take place in phases within fixed periods by 2018 and is now completed.)
Companies file information on substances electronically with the European Chemicals Agency (ECHA) in Helsinki in the form of technical dossiers and chemical safety reports. They submit the necessary data for evaluation and must be able to demonstrate that the substances are safe to handle and do not compromise the health of processors or consumers or the environment. The relevant substance is given a registration number by the ECHA to indicate that the submitted dossier has been accepted. The authorities decide whether additional information is required during dossier or substance evaluation.
The registration of all phase-in substances only represents one part of REACH, as REACH encompasses registration, evaluation, authorization, and restriction of chemicals. In the future new substances will always need to be registered prior to production or import. This applies to quantities of one or more metric tons per year and per company (legal entity).
Some substances are also subjected to extensive approval procedures. Laws similar to REACH with comprehensive registration requirements for the production and import of all chemicals are now also in place in South Korea, Taiwan, and Turkey. Further countries are planning corresponding legislative changes. Experiences from Europe are very useful in the implementation of these regulations.
Transparency and more safety at all levels
REACH aims to ensure safe handling of substances across all areas of application, which requires continuous exchange of suitable information between all those involved in a supply chain. REACH has intensified the exchange of information on substance applications, conditions of use, and risk management measures between manufacturers/importers, processors, and users, which has increased transparency and thus ensures greater safety throughout the entire product chain:
- Manufacturers and importers assess the risks of all designated applications of their substances and describe how to use them safely with the help of exposure scenarios.
- Dealers need to share information to ensure the information chain is not broken.
- Users thus receive more information about using specified substances safely and can thus assess their own conditions of use.
REACH is everyone’s concern
Few chemical substances do not need to be registered. The obligation to register does not apply to some natural substances, active ingredients for pharmaceuticals, biocides, and crop protection for which there are already applicable rules, and polymers.
Registration of polymers
The REACH obligation to register does not apply to polymers. Instead, the monomer components of polymers need to be registered, which is the responsibility of the monomer manufacturer. When polymers are imported into the EU, the polymer importer needs to register their monomer components, provided these make up two or more percentage points of the polymer weight and the total imported volume of the monomer exceeds one metric ton per year.