European Union's REACH Regulation
The EU’s REACH regulation has a clear message: meet the requirements or you will not be able to produce in, export to, or market within the EU. Is your company able to meet this challenge?
The EU’s REACH regulation has a clear message: meet the requirements or you will not be able to produce in, export to, or market within the EU. Is your company able to meet this challenge?
The new European Union chemicals regulation came into force in June 2007. The regulation is known as REACH, which stands for Registration, Evaluation, Authorization and Restriction of Chemicals. The implications of REACH for chemical and down-stream industries and for associated individual companies are significant in terms of cost, managing ongoing customer and supplier relationships, and because of its far-reaching regulatory requirements.
The capability of a company to comply with the regulations and manage the implications of REACH will instill confidence in its customers, strengthen long-term partnerships and have a tremendous impact on business. REACH is not simply a regulatory requirement but also an important business opportunity, whether in optimizing a company’s product range, maximizing further innovation, or for increasing sales through better downstream understanding.
Preparation for pre-registration and developing a REACH master plan are essential if you intend to import into the European Union post REACH. Each non-EU company must identify a legal entity in the EU, referred to in the legislation as an Only Representative. The substances that you inventoried in your portfolio assessment must now be identified under the new REACH criteria. Companies importing formulations into the EU, such as paints, must pre-register each component and identify them according to the new, complicated Substance Identity guidelines (RIP 3.10). This new identification process can differ greatly from the recipe of CASNumbers that we are familiar with in NAFTA. Your customers will be coming to you, as their non-EU supplier, for this information, which means that you will have to build an understanding of this RIP and a plan to address confidential business information. Company-owned and publicly available data should be identified and a data gap analysis performed. Classification and labeling should be reviewed. After pre-registration, your plan should consider formation of consortia, your company’s role in the mandatory SIEF (Substance Information Exchange Forum), preparation of registration dossiers aligning with phase-in deadlines, completion of the Chemical Safety Reports and Exposure Scenarios, and sustainability/phase-out strategies for hazardous substances impacted with Authorization or Restriction. The list of compliance tasks is extensive.
Joyce Borkhoff, Head of Regulatory Services Canada, is a member of the Expert Services Business Unit of Ciba Corporation. In her role, Joyce manages REACH activities for Ciba Expert Services’ North American clients. Since October of 2001, Ciba Expert Services has been providing knowledge-based consulting services to the manufacturing community. These services, marketed and delivered independent of the company’s chemical business, essentially grant third-party clients full access to the core competencies of Ciba Corporation. Their clients represent a wide array of technologies and industries including specialty chemicals, pharmaceuticals, automotive, textiles, manufacturing and plastics companies. Ciba Expert Services’ global network of experts help customers in highly regulated industries achieve compliance, efficiencies and sustainable success. Their service portfolio includes: Regulatory Services; Analytical Testing Services; Safety Services; Environmental Services; Educational Services; and Color Services. For more information on Ciba Expert Services, visit www.ciba.com/expertservices.
The EU’s REACH regulation has a clear message: meet the requirements or you will not be able to produce in, export to, or market within the EU. Is your company able to meet this challenge?
The new European Union chemicals regulation came into force in June 2007. The regulation is known as REACH, which stands for Registration, Evaluation, Authorization and Restriction of Chemicals. The implications of REACH for chemical and down-stream industries and for associated individual companies are significant in terms of cost, managing ongoing customer and supplier relationships, and because of its far-reaching regulatory requirements.
The capability of a company to comply with the regulations and manage the implications of REACH will instill confidence in its customers, strengthen long-term partnerships and have a tremendous impact on business. REACH is not simply a regulatory requirement but also an important business opportunity, whether in optimizing a company’s product range, maximizing further innovation, or for increasing sales through better downstream understanding.
REACH Purpose
The purpose of the REACH regulation is to ensure a high level of protection of human health and the environment as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation. The regulation will achieve this goal by requiring businesses to register the substances in their products and fully identify, and make public, any potential risks from the use of these chemicals. For certain substances, classified as potentially dangerous under REACH definitions, the company must define exactly how to safely use the chemical throughout the lifecycle. Maintaining compliance for hazardous substances subject to authorization will involve formal requests to the agency, development of substitution plans and high fees.Implementation Preparation
European Union chemical manufacturers, importers of substances, preparations and articles and downstream users will all be affected by the implementation of REACH. The time to prepare is now. Pre-registration for substances manufactured or imported into Europe begins June 1, 2008 and ends November 30, 2008. It is important that companies take advantage of the regulatory benefits offered with pre-registration, similar to the advantages gained in the transitional period of the Canadian New Substance Notification Regulations back in the 90s. Preparation for implementation can be addressed by the following four steps:- assessment of product portfolio;
- company in-house implementation;
- preparation for pre-registration; and
- development of a REACH master plan.
REACH Strategies
Developing a REACH strategy within your company is essential to your success. You must have in-house awareness and communication. You should establish a timeline (what, when, whom), estimate resources for both direct and indirect costs, strategize business opportunities, stay on top of confidentiality issues, and collect general information on the uses of your products.Preparation for pre-registration and developing a REACH master plan are essential if you intend to import into the European Union post REACH. Each non-EU company must identify a legal entity in the EU, referred to in the legislation as an Only Representative. The substances that you inventoried in your portfolio assessment must now be identified under the new REACH criteria. Companies importing formulations into the EU, such as paints, must pre-register each component and identify them according to the new, complicated Substance Identity guidelines (RIP 3.10). This new identification process can differ greatly from the recipe of CASNumbers that we are familiar with in NAFTA. Your customers will be coming to you, as their non-EU supplier, for this information, which means that you will have to build an understanding of this RIP and a plan to address confidential business information. Company-owned and publicly available data should be identified and a data gap analysis performed. Classification and labeling should be reviewed. After pre-registration, your plan should consider formation of consortia, your company’s role in the mandatory SIEF (Substance Information Exchange Forum), preparation of registration dossiers aligning with phase-in deadlines, completion of the Chemical Safety Reports and Exposure Scenarios, and sustainability/phase-out strategies for hazardous substances impacted with Authorization or Restriction. The list of compliance tasks is extensive.
REACH Impact
The REACH regulation has a clear message, meet the requirements or there will be no production, importation and market within the EU. REACH impacts any manufacturer, importer, downstream user or distributor placing a substance, a preparation or an article on the market. REACH is not simple; careful planning is essential.Joyce Borkhoff, Head of Regulatory Services Canada, is a member of the Expert Services Business Unit of Ciba Corporation. In her role, Joyce manages REACH activities for Ciba Expert Services’ North American clients. Since October of 2001, Ciba Expert Services has been providing knowledge-based consulting services to the manufacturing community. These services, marketed and delivered independent of the company’s chemical business, essentially grant third-party clients full access to the core competencies of Ciba Corporation. Their clients represent a wide array of technologies and industries including specialty chemicals, pharmaceuticals, automotive, textiles, manufacturing and plastics companies. Ciba Expert Services’ global network of experts help customers in highly regulated industries achieve compliance, efficiencies and sustainable success. Their service portfolio includes: Regulatory Services; Analytical Testing Services; Safety Services; Environmental Services; Educational Services; and Color Services. For more information on Ciba Expert Services, visit www.ciba.com/expertservices.
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