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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.




Differentiation of Biocides and Cleaning Agents – Where is the Boundary? journal article open-access

Dieter Drohmann, Lara Dickens

International Chemical Regulatory and Law Review, Volume 3 (2020), Issue 2, Page 61 - 68

The EU Biocidal Products Regulation (BPR) regulates the placing on the market and use of biocidal products. Biocidal products require an authorisation before they can be placed on the market. The active substances contained in the biocidal product must be approved beforehand. Questions repeatedly arise about the distinction between biocides and cleaning agents/detergents and about certain labelling obligations. In particular the question of how products are claimed and marketed, and which factors may lead to a cleaning product having to be authorised as a biocide under the BPR. Due to a lack of clarity in the regulations and the non-availability of guidelines, especially in borderline areas, this article attempts to differentiate between cleaning agents and a biocide application with a concrete example from the pulp and paper industry and to illustrate which circumstances are relevant.





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