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.
Dieser Bericht dokumentiert die Ergebnisse des Forschungsprojekts „Marktchancen für ‚nachhaltigere Chemie‘ durch die REACH-Verordnung [Sustainable Sporting Goods - SuSport]“. Ziel des im Jahr 2018 abgeschlossenen Projektes ist es, eine „nachhaltigere Chemie“ in der textilen Lieferkette zu unterstützen und dabei den Blick von der „reaktiven“ Compliance Position auf eine „proaktive“ Beyond Compliance Perspektive zu erweitern. Strategisch stützt sich dieser Ansatz auf folgende Überlegung: Wer morgen noch „Compliant“ sein will, muss heute bereits „Beyond Compliance“ agieren. Mit einer solchen Strategie ist nicht nur die Rechtskonformität gewährleistet, es lassen sich viel-mehr auch neue Marktchancen erschließen.4 Die Notwendigkeit für diesen Perspektivenwechsel ergibt sich bereits aus der normativen Ausgangssituation Ein solcher Perspektivenwechsel und die damit verbundenen Veränderungen bedeuten für die Akteure der Textilbranche eine große Herausforderung Denn letztlich führt dies zu der Frage, wie man ein Chemikalienmanagement in der globalen Lieferkette organisiert Aus diesem Kontext ergeben sich die Empfehlungen für die Akteure der textilen Lieferkette Methodisch bestand die Herausforderung darin, die vorherrschenden Denk- und Argumentationsmuster der beteiligten Akteure der textilen Kette für die Ziele dieses Vorhabens zu öffnen Es bleibt abzuwarten, ob der entstandene Prozess ein Momentum erzeugt, der zu den gewünschten Veränderungen in der textilen Lieferkette führt erste Schritte in diese Richtung sind aber bereits erkennbar.
Companies producing or importing articles (or parts thereof) as well as retailers are facing new challenges coming from societal demands and expectations directed at transparency of (problematic) substances in articles (SiA), and the overall “sustainability” of supply chain operations. Legislation on chemicals in the EU (e.g., REACH) and beyond stipulating legal SiA requirements reflect these developments. In addition, with a view to eliminating problematic substances in material circles, the recently amended Waste Framework Directive requires, from January 2021 on, companies placing articles on the European Economic Area (EEA) market to report to authorities the presence of substances of very high concern (SVHC) above a certain threshold in such articles. ´ Chemical compliance management is not part of the core business for many companies. Many actors perceive related challenges as an overwhelming task. IT-based solutions offer opportunities to establish a systematic approach to transparency and traceability of SiA within complex global supply chains. In order to “be prepared” for future legislation, the long-term vision of a Full Material Declaration (FMD) is a promising approach. This way, firms can meet their present requirements from law as well as from sectoral or company specifications, and can prepare for future requirements. This article compares supply chain communication requirements and needs on the one hand and actual practice on the other in order to subsequently identify the respective delta. The article also introduces FMD as a strategy to overcome the delta and shows development perspectives for existing approaches. Finally, after drawing conclusions, the article formulates recommendations for EU policies.
20 years ago a concept of “Green Chemistry” was formulated by Paul Anastas and John Warner, aiming at an ambitious agenda to “green” chemical products and processes. Today the concept, laid down in a set of 12 principles, has found support in various arenas. This diffusion was supported by enhancements of the legislative framework; not only in the European Union. Nevertheless industry actors – whilst generally supporting the idea – still see “cost and perception remain barriers to green chemistry uptake”. Thus, the questions arise how additional incentives as well as measures to address the barriers and impediments can be provided. An analysis addressing these questions has to take into account the institutional context for the relevant actors involved in the issue. And it has to reflect the problem perception of the different stakeholders. The supply chain into which the chemicals are distributed are of pivotal importance since they create the demand pull for chemicals designed in accordance with the “Green Chemistry Principles”. Consequently, the scope of this study includes all stages in a chemical’s life-cycle, including the process of designing and producing the final products to which chemical substances contribute. For each stage the most relevant legislative acts, together establishing the regulatory framework of the “chemicals policy” in the EU are analysed. In a nutshell the main elements of the study can be summarized as follows: Green Chemistry (GC) is the utilisation of a set of principles that reduces or eliminates the use or generation of hazardous substances in the design, manufacture and application of chemical products. Besides, reaction efficiency, including energy efficiency, and the use of renewable resources are other motives of Green Chemistry. Putting the GC concept in a broader market context, however, it can only prevail if in the perception of the relevant actors it is linked to tangible business cases. Therefore, the study analyses the product context in which chemistry is to be applied, as well as the substance’s entire life-cycle – in other words, the six stages in product innovation processes): 1. Substance design, 2. Production process, 3. Interaction in the supply chain, 4. Product design, 5. Use phase and 6. After use phase of the product (towards a “circular economy”). The report presents an overview to what extent the existing framework, i.e. legislation and the wider institutional context along the six stages, is setting incentives for actors to adequately address problematic substances and their potential impacts, including the learning processes intended to invoke creativity of various actors to solve challenges posed by these substances. In this respect, measured against the GC and Learning Process assessment criteria, the study identified shortcomings (“delta”) at each stage of product innovation. Some criteria are covered by the regulatory framework and to a relevant extent implemented by the actors. With respect to those criteria, there is thus no priority need for further action. Other criteria are only to a certain degree covered by the regulatory framework, due to various and often interlinked reasons. For those criteria, entry points for options to strengthen or further nuance coverage of the respective principle already exist. Most relevant are the deltas with regard to those instruments that influence the design phase; both for the chemical substance as such and for the end-product containing the substance. Due to the multi-tier supply chains, provisions fostering information, communication and cooperation of the various actors are crucial to underpin the learning processes towards the GCP. The policy options aim to tackle these shortcomings in the context of the respective stage in order to support those actors who are willing to change their attitude and their business decisions towards GC. The findings are in general coherence with the strategies to foster GC identified by the Green Chemistry & Commerce Council.
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