One of the most far-reaching pieces of EU legislation for almost all products is REACh – “Registration, Evaluation, Authorisation and Restriction of Chemicals in Articles”.
Many everyday products and devices lack important information about the chemical substances they contain. The final version of the REACh Regulation (1907/2006/EC) was adopted by the European Parliament on 18 December 2006 and entered into force on 1 June 2007. This is automatically regarded as a national law in Germany without conversion, as it is an EU Regulation. REACh “Registration, Evaluation, Authorisation and Restriction of Chemicals” governs the registration, evaluation, authorisation and restriction of chemical substances. Not only the chemical industry (manufacturers and importers), but also the import trade and dealers in products and articles are affected by this Regulation.
REACh generally distinguishes between substances, mixtures (preparations) and articles. A substance is therefore a chemical element (e.g. metals and minerals). Blends or preparations are defined as mixtures, mixes or solutions consisting of two or more substances (e.g. lubricating oils). For manufacturers of products and equipment, however, the definition of products according to REACh is important. Accordingly, an article is an ‘object which, during its manufacture, is given a specific shape, surface or design which determines its function to a greater extent than its chemical composition’. Products such as electrical and electronic equipment therefore are, by definition, products as contemplated by REACh.
In principle, every company can be affected by REACh, whether as a manufacturer, importer of equipment from the EU area or as a manufacturer/importer of products. Product distributors are not exempt from the REACh obligations either.
Generally, REACh requires manufacturers and importers to assume responsibility for the safety of the chemicals contained in their equipment and for the procurement of the data necessary for assessment. This calls for convincing evidence that their substances are safe to handle for all uses and do not cause excessive harm to the health of users or consumers or to the environment.
REACh – obligations of producers, suppliers and users of products Articles have a special position under REACH. This is because producers, suppliers and users of articles may, in certain conditions, have information and notification obligations as well as the obligation to register substances. The products themselves do not need to be registered. However, registration is mandatory if a classified substance is to be released and the volume of such substance in products exceeds 1 tonne per annum. This volume comprises the total volume of the substance in all products of the importer or producer. The total volume comprises both the released volume as well as the residual volume (still) contained in the product.
Companies that manufacture or supply products are additionally subject to reporting and information obligations to their purchasers – these may be further processors, dealers, users or consumers of the relevant products. In certain cases, obligations also arise in relation to the European Chemicals Agency (ECHA). Those producers, processors and importers who use substances of very high concern (SVHC) in products or who supply such products to a purchaser or consumer are subject to these obligations to provide information. Such substances have, for example, carcinogenic, mutagenic or reprotoxic properties. In the case of articles containing SVHC substances in quantities above 0.1%, the supplier is required to provide the recipient of the article with sufficient information available to it for safe use of the article, but must at least indicate the name of the substance concerned. The supplier is required to provide the same information to the consumer, but only at the latter’s request. The information must be passed on to the customer in appropriate form. As a rule, the information is transmitted on paper (e.g. in the official language of the respective country of destination). Moreover, it is possible to pass on additional information a party’s own homepage or by e-mail.
Together with accredited partners, TMK offers a consulting service especially developed for dealers and importers for the implementation of REACh. In individual training sessions, TMK and its partners convey the basics and knowledge of the contents and tasks of REACh and provide you with approaches to solutions on how to comply with the obligations of the REACh Regulation.
In individual consultancy sessions, we support you in applying the knowledge you have gained to the specific requirements of your company and in marketing REACh-compliant products. This does not require a complex substance database: We build on your existing processes and product knowledge.