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. To this end, REACH introduces, among other instruments, the authorisation regime for substances of very high concern (SVHC) that are listed on Annex XIV of the regulation. After expiration of the transitional period for each Annex XIV-SVHC, articles, such as most products of daily use, produced in the European Economic Area (EEA) may not contain such substances unless an authorisation was granted for the specific use or this use falls within the scope of an exemption from the authorisation requirement. The authorisation scheme does, however, only apply to SVHC used in the EEA. As a consequence, REACH does not regulate SVHC entering the European market as part of imported articles which burden human health and the environment. Moreover, from an economic perspective, domestic articles are subject to stricter requirements than those which are produced abroad, putting actors from within the EEA at competitive disadvantage and thus impeding the intention of REACH to enhance competitiveness and innovation. One option to close this regulatory gap could be to extend the authorisation requirement to SVHC present in imported articles. A legal appraisal on behalf of the German Environment Agency (UBA) assesses whether such option would be in accordance with the specifications of WTO world trade law. It concludes that, measured by the standards of the WTO dispute settlement practice, such an extended authorisation scheme would neither violate the principles of national treatment and most-favoured nation treatment. Also, such regulation would not constitute an unnecessary obstacle to trade, since the extended authorisation requirement would pursue a legitimate objective covered by the regulatory autonomy of the EU and, furthermore, the regulation would not be more trade-restrictive than necessary. The contribution at hand summarises the main findings while taking into account first reactions to the legal appraisal.
Regulatory hazard and risk assessments of chemical substances have to include all reliable and relevant data to be credible and complete. However, screening the literature for appropriate studies and extracting data is burdensome. Therefore, reducing impediments by making data easily and readily accessible to risk assessors could result in more comprehensive hazard and risk assessments. In this paper, we study WikiPharma, a database that aggregates ecotoxicity data for pharmaceuticals, extracted from peerreviewed studies. The use of the WikiPharma database is explored to develop strategies on how similar tools can bridge between science and policy by providing risk assessors with easily accessible summary data. Specifically, adapting the concept of WikiPharma to industrial chemicals regulated under the REACH regulation is discussed. Experiences with WikiPharma show that there is interest in using peerreviewed studies in regulatory decision-making. However, tools like WikiPharma require constant updates. Hence, as for "WikiREACH", effective incentives are needed to motivate researchers to feed in relevant data for regulatory assessments. Besides, support by automated processes can aid in the labourintensive activity of gathering data. To ensure that such a tool is continuously maintained and compatible with the regulatory system, and thereby useful for hazard and risk assessments of chemicals, it would benefit from being developed in collaboration with the major stakeholders in the field, i.e. regulatory agencies, academia, industry, scientific journals, and providers of research network platforms.
Environmental signicanceThis paper addresses how scientic research is (not) used in decision-making, focusing on peer-reviewed toxicity and ecotoxicity studies for regulatory assessments of chemicals. One possible reason for the overall low regulatory use of peer-reviewed studies is that the process of searching for studies is resource demanding. As a consequence, regulatory decisions are not based on all available information. This paper suggests the development of a tool that can facilitate the use of peer-reviewed studies in the REACH context ("WikiREACH"), based on experiences from the use and development of the WikiPharma database for ecotoxicity studies for pharmaceuticals. Creating equivalent tools for other groups of chemicals is possible and an important way forward.
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