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Compliance in Complex Supply Chains: A Unique Solution for Multi-Stage Supply Chains Under REACH, Turkey-REACH (KKDIK), UK REACH and Korean REACH (K-REACH) journal article open-access

Dieter Drohmann, Thomas Schaefer, Christopher Cohrs

International Chemical Regulatory and Law Review, Volume 4 (2021), Issue 3, Page 94 - 100

According to the European REACH regulation and its counterparts KKDIK in Turkey, UK REACH in Great Britain and K-REACH in Korea, importers are subject to the obligation to register all imported chemical substances, unless substances are exempted from this obligation. To enable importers to be exempted from these registration obligations, the respective regulations provide that non-domestic manufacturers and formulators can appoint a so-called Only Representative (OR), who registers the respective substances on behalf of the manufacturer/formulator and thus makes the respective importers so-called Downstream Users (DU). For this purpose, the OR must keep records of the respective importers as well as their annual imported substance quantities, which leads to problems in complex and multi-stage non-domestic supply chains, since indirect customers and suppliers as well as compositions of formulations are not known in many cases. Compliance with the OR's record keeping obligation would therefore only be possible by disclosing Confidential Business Information (CBI) in the supply chains, which may even be contrary to competition law rules if the OR is a related legal entity of the manufacturer/formulator. Therefore, in these cases, neither the manufacturers/formulators (represented by ORs) nor the importers can fulfil their obligations without disclosing such CBI and also risking loss of business. In the following article, a solution to this problem is presented using the example of EU REACH, which is also used in Turkey and Great Britain and works very well there. In Korea, the system is used in a slightly modified form.

Risk of Regrettable Substitution under EU REACH: Level Playing Field in the EU Regulatory Context journal article

Dieter Drohmann, Francisco Hernández

International Chemical Regulatory and Law Review, Volume 3 (2020), Issue 1, Page 25 - 35

The substitution process is an important tool defined in the REACH Regulation to remove the risks derived from the use of hazardous chemicals. However, when the alternative substance is suitable in technical and economic terms, but it is just as harmful or potentially worse as the replaced one, the process results in regrettable substitution. The absence of information regarding the hazard properties of the substitute substance, inconsistencies on implementation of the European chemicals Regulations, and the lack of interest of some part of the industry to manage stringent classifications, are the main reasons why this situation is generated. Change in the paradigm ‘No data, no market’ to ‘No data, no problem’, and replacement with the ‘Least regulated alternative’ instead of the ‘Least hazardous alternative’ are the results of the regrettable substitution scenarios. In order to avoid this practice, EU Authorities and the chemical industry should work together to achieve solutions, like clarifying the objective of substitution, improving the regulatory processes, or involving industry and stakeholders into rigorous evaluations of potential alternatives to substances of concern. This will guarantee a level playing field for companies on the European market of chemicals in front of regrettable substitution.