Case StudiesREACH Regulation Compliance Assessment (0072) REACH Regulation and Biocidal Product Directive Compliance Assessment (0073) REACH Regulation Compliance GAP Analysis and Action Plan for a Non- European Union Manufacturer (0074) REACH Regulations Support (0075)
REACH is a European Union (EU) regulation (Regulation (EC) No 1907/2006) concerning the registration, evaluation, authorisation and restriction of chemicals which came into force on the 1st June 2007. REACH is based on the premise that industry should be responsible for demonstrating that all chemicals put on the market do not have an adverse affect on human health or the wider environment. REACH covers virtually all chemicals manufactured, imported into or exported from the EU.
Manufacturers, importers, suppliers and distributors are required to register impacted chemicals if they place more that one metric tonne of the substance on the market. For certain substances of very high concern (SVHC) there is a requirement to notify the European Chemicals Agency (ECHA) when products are to be placed on the market containing greater than 0.1% w/w even, where the aggregated amount does not breach the one tonne threshold for registration.
Downstream users of impacted substances also have obligations under REACH including the requirement to ensure that they provide suitable information to suppliers to ensure an adequate risk assessment has been performed by the upstream manufacturer or supplier. Users who prefer to keep the details of their applications confidential must perform their own risk assessment and supply this to the ECHA in the form of a Chemical Safety Report (CSR).
What is the benefit?
The REACH regulation provides a single system for chemicals regulation within the European Union, replacing a number of other EU directives and regulations. The REACH regulation will ultimately simplify and improve management of chemical hazards in the EU.
The aims of the REACH regulation are:
- To provide a high level of protection of human health and the environment from the use of chemicals;
- To make the people who place chemicals on the market responsible for understanding and managing the risks associated with their use;
- To allow the free movement of substances on the EU market;
- To enhance innovation in and the competitiveness of the EU chemicals industry; and
- To promote the use of alternative methods for the assessment of the hazardous properties of substances.
CRA has worked with our industrial clients in Europe and North America to assist them in the early stages of REACH compliance: assessing obligations; compiling site chemicals inventories; reviewing purchasing management; developing action plans; and liaising with suppliers, downstream users, regulatory authorities and industry groups to provide advice on pre-registration requirements.
CRA can provide support to companies wishing to benefit from late pre-registration, i.e. those who started manufacturing or importing after 1st December 2008. CRA also have highly qualified technical staff that can provide the specialist input required by Substance Information Exchange Forums (SIEFS) which have been set up to facilitate registration of chemicals (toxicology assessment, environmental exposure and use assessment, process change and reformulation, and chemicals safety assessment). CRA is a subscriber to REACH Ready, established by the Chemical Industries Association, and is working towards REACH and CLP compliance for our clients.
For additional information on how CRA could help you, please contact Gwenda McIntyre on firstname.lastname@example.org or 0115 965 6700.