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Understanding Your Organization's Liability Under RoHS and REACH


If your Organization manufactures, imports, or distributes goods in the EU market, you have to carefully consider its obligations under the EU product compliance and producer regulations.

Adhering to the policies protects people from risks associated with thousands of consumer products they buy and use every day.

    Liability

    Market Compliance authorities perform checks on products that are already placed on the EU market. Customs authorities also check the products and can seize the cargo upon arrival and ask for documentation supporting compliance of the product. They can even forward the product for further investigation to other government authorities.

    If found non-compliant or defective, the business involved in the supply chain will be facing the associated risks and challenges. There is also a requirement to take relevant corrective action for products already supplied to customers.

    Noncompliance can result in corporate criminal sanctions, product recalls, product buybacks, personal liabilities for management, and reputational damage. Companies in the EU can be levied heavy fines if they do not have the correct required documentation. Companies outside the EU selling products in the EU may get blacklisted from selling to the EU. They may not be protected by the Government in their home country.

    So, it is important that manufacturers, importers, distributors, and the supply chain companies have a deep understanding of REACH and RoHS Compliance.

    The Regulatory Requirements for Product Safety - An Overview

    REACH

    This Regulation pertains to the Registration, Evaluation, Authorisation, and Restriction of Chemicals placed on the EU Market. Manufactures, Importers, and others involved in the supply chain are expected to ensure safe and environmentally use of chemicals. Also, some substances and mixtures that are deemed hazardous are imposed specific restrictions. Restricted substances include (but are not limited to) lead, cadmium, and AZO dyes. New restricted substances are included in the list every year.

    These additional requirements are aimed at fostering innovation and the development of environmentally friendly and safer chemicals.

    RoHS

    RoHS stands for Restriction of Hazardous Substances. RoHS imposes restrictions on the use of hazardous substances in electronic components and solders. Large household appliances, small household appliances, IT and telecommunications equipment, consumer equipment, lighting equipment, electronic and electrical tools, toys, leisure and sports equipment, medical devices and monitoring and control instruments are the RoHs concerned equipment.

    The differences between REACH and RoHS are here.

    Labelling Requirements

    CE Mark

    The manufacturer is required to display a declaration on the product that it complies with the requirements of the relevant European health, safety, and environmental protection legislation. It allows the free movement of products within the EU Market. Having a CE Mark is obligatory if the product is covered by a so-called 'CE directive'.

    Distributors of products must check the presence of CE marking and the required documentation of the product they distribute. Similarly, importers of such products must check that manufacturers outside the EU have undertaken the compliance steps and ensure that documentation is available.

    CE

    WEEE Mark

    WEEE stands for waste electrical and electronic equipment. WEEE Mark is used to indicate that a separate collection of waste electrical and electronic equipment. Manufacturers and importers are required to put the WEEE mark on their products and in writing to let the users know about the WEEE management and indicate that electrical and electronic equipment must not take place together with the normal domestic waste and it must be treated as WEEE.

    WEEE

    Planning to Prevent Regulatory Issues

    Product Conceptualization

    The regulatory environment is a key element that must be considered during the product conceptualization stage. The regulatory requirements vary depending on the type of product and the target market.

    Design

    When making decisions about product design, careful planning must be done keeping in mind the specific regulatory design requirements, packaging and labelling requirements, and consideration of the restrictions on substances and components.

    Manufacture

    Keeping track of regulatory environment changes during manufacturing is highly crucial to preventing issues. Also, the manufacturer conformance to the testing and approval procedures, regulatory compliance with the documentation requirements for CE compliance must be well planned.

    Supply

    Compliance considerations at this stage include regulatory compliance with registration requirements with national authorities and monitoring of regulatory requirements and changes and responding if safety or liability issues arise.

    Disposal

    Compliance obligations that include collection, treatment, recycling, or disposal must be considered.

ComplianceOnline has a rich repository of the latest regulatory training programs for every stage of the product lifecycle. Browse through our website to find one relevant to your product. Whether you are looking to understand a specific regulatory requirement or want to reduce the cost of compliance, our webinars, seminars, and free resources cover them all.