Suchergebnisse

The objective of the present article is to examine whether current regulations at the European level are capable of adequately controlling the risks associated with engineered nanomaterials of anthropogenic origin (ENM) in food products. In this context it is crucial to examine closely the Novel Food Regulation (EC) 258/977 and its attempted revision, which recently failed. The article also includes a consideration of the legislative procedure and a discussion of the legislative bodies' different positions. In contrast, the regulatory controls of food contact materials such as food packaging or food additives would go beyond the scope of this article. Prior to the legal analysis some remarks are made about the state of the art regarding risk assessment and the application of ENM in the food sector.

According to Art. 3(3) of the Treaty on the European Union, the Community is working towards the sustainable development of Europe – this constitutes the overriding long-term goal of the European Union. The guiding principle of sustainable development aspires towards the reduced exploitation of natural resources aimed at their long-term preservation and a reduced pollutant burden for protected natural resources. The target for 2020 is that "chemicals are used and produced in ways that lead to the minimization of significant adverse effects on human health and the environment" ('Johannesburg goals'). In addition, the guiding principle pursues the safeguarding of the basis for survival and economic production in order to maintain an adequate quality of life. These aims can only be achieved by far-reaching changes to the economic and social structures and also to patterns of consumption and production – consequently innovations are required. This requires specific regulatory strategies – particularly for product or process innovations – in order to create adequate incentives so that actors from trade and industry get innovations for sustainability off the ground. In connection with this the question arises as to how nanomaterials are to be regulated so that the innovation processes linked to these substances are aligned with the guiding principle of sustainable development. Nanomaterials are substances in terms of the REACH Regulation and therefore fall within its scope. However, REACH does not contain any provisions directed specifically at nanomaterials. The regulatory omissions arising from this – no definition for nanomaterials; tonnage quantity thresholds may be inappropriate for nanoscale substances; transitional periods for existing substances (phase-in substances, Art. 23) also apply to certain nanomaterials; test procedures are not designed to nanomaterial specifications, etc. – are discussed in depth in the literature. This article takes a different perspective. It examines to what degree REACH promotes innovations for sustainability through nanomaterials. The question of how the regulation affects the manufacturers' approach to nanomaterials was the subject of a survey sent to companies which manufacture and/or use nanomaterials. The survey questioned 37 companies based in Germany. Besides the issues of registering for REACH and carrying out safety assessments, the main focus of interest was on the relationships between substance risks and innovation and between REACH and innovation. The findings obtained from the survey were augmented by telephone interviews on this subject and by the results of a workshop held in Darmstadt, Germany, in December 2011 with representatives from companies and industry associations and experts on the regulation of nanomaterials. Finally, this contribution refers to the results of a study carried out for the European Commission on the innovative effects of REACH on emerging technologies. This document summarises the most important results from the empirical data and, where the data permits, draws some preliminary conclusions for a possible adaptation of the legal framework for nanomaterials.

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.

Vorgaben des Völkerrechts, des europäischen Primärrechts und des Stoffrechts der Europäischen Union (REACH und CLP) fordern ein hohes Schutzniveau für die menschliche Gesundheit und die Umwelt. Nanomaterialien stellen besondere Herausforderungen an diesen Schutzauftrag, weil deren Risikomanagement durch eine strukturelle Ungewissheit gehemmt ist. Die Arbeit untersucht zunächst die Frage, ob das Stoffrecht hinreichende Anreize setzt, so dass Hersteller und Importeure von Nanomaterialien das normativ angestrebte hohe Schutzniveau sicherstellen. [...] (Quelle: Verlag) Zitierte Vorschriften u.a.: Verordnung (EG) Nr. 1272/2008; Richtlinie 2010/75/EU; Verordnung (EG) Nr. 1907/2006; Richtlinie 98/24/EG; Richtlinie 85/374/EWG; Richtlinie 2001/95/EG;

Abstract
Background
The EU chemicals regulation "Registration, Evaluation, Authorisation and Restriction of Chemicals" (REACH) aims to reduce the usage of substances of very high concern (SVHCs) by firms. Therefore, a consumer right-to-know about SVHCs in articles is intended to create market-based incentives. However, awareness of the right-to-know among EU citizens is low. Moreover, the response window of 45 days afforded to suppliers impedes immediate, informed decisions by consumers. Consequently, despite being in effect for more than 10 years, only few consumer send requests. Civil society actors have developed smartphone applications reducing information search costs, allowing users to send right-to-know requests upon scanning an article's barcode. Answers are stored in a database and made available to the public immediately. This paper assesses to which extent smartphone tools contribute to an increased use of the right-to-know by undertaking a case study of the application "ToxFox" by the German non-profit organisation Bund für Umwelt und Naturschutz Deutschland (BUND).

Results
An analysis of the data from the BUND database for the period 2016 to 2018 reveals that about 20 thousand users have sent almost 49 thousand requests. This has led to more than 9 thousand database entries, including 189 articles which contain SVHCs above the legal threshold. The data also indicate that receiving information on requested articles encourages further use of the application. Many suppliers accept the application and pro-actively provide information on articles without SVHCs above the threshold. However, most consumers use the application only for a short time, and suppliers are struggling to reply to right-to-know requests.

Conclusion
Evaluating the results, the study identifies options to enhance the application's design in terms of user motivation and legal certainty, and to enhance the framework governing "barcode" assignments to articles with a view to better contributing to transparency. As for policy implications, a lack of consumer requests can in part be traced back to design flaws of the right-to-know and a lack of implementation and enforcement of REACH. In addition, suppliers have to increase their supply chain communication efforts to make sure they are in a position to properly answer consumer requests. We recommend several policy options addressing these and additional aspects, thus contributing to the legislative review of Art. 33 REACH.

Background The EU chemicals regulation "Registration, Evaluation, Authorisation and Restriction of Chemicals" (REACH) aims to reduce the usage of substances of very high concern (SVHCs) by firms. Therefore, a consumer right-to-know about SVHCs in articles is intended to create market-based incentives. However, awareness of the right-to-know among EU citizens is low. Moreover, the response window of 45 days afforded to suppliers impedes immediate, informed decisions by consumers. Consequently, despite being in effect for more than 10 years, only few consumer send requests. Civil society actors have developed smartphone applications reducing information search costs, allowing users to send right-to-know requests upon scanning an article's barcode. Answers are stored in a database and made available to the public immediately. This paper assesses to which extent smartphone tools contribute to an increased use of the right-to-know by undertaking a case study of the application "ToxFox" by the German non-profit organisation Bund für Umwelt und Naturschutz Deutschland (BUND). Results An analysis of the data from the BUND database for the period 2016 to 2018 reveals that about 20 thousand users have sent almost 49 thousand requests. This has led to more than 9 thousand database entries, including 189 articles which contain SVHCs above the legal threshold. The data also indicate that receiving information on requested articles encourages further use of the application. Many suppliers accept the application and pro-actively provide information on articles without SVHCs above the threshold. However, most consumers use the application only for a short time, and suppliers are struggling to reply to right-to-know requests. Conclusion Evaluating the results, the study identifies options to enhance the application's design in terms of user motivation and legal certainty, and to enhance the framework governing "barcode" assignments to articles with a view to better contributing to transparency. As for policy implications, a lack of consumer requests can in part be traced back to design flaws of the right-to-know and a lack of implementation and enforcement of REACH. In addition, suppliers have to increase their supply chain communication efforts to make sure they are in a position to properly answer consumer requests. We recommend several policy options addressing these and additional aspects, thus contributing to the legislative review of Art. 33 REACH. ; Open-Access-Publikationsfonds 2020