Scientific Opinion Paper

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https://openumwelt.de/handle/123456789/20

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A blind spot in the assessment of POP/PBT/vPvB properties
(2018) Priegnitz, Jan; Deutschland. Umweltbundesamt
This paper relates to the assessment of transformation products (i.e. metabolites, degradation or reaction products), which are formed from plant protection products. It addresses a detail in Regulation (EC) No. 1107/2009 which is not in line with other substance regulations for ⁠REACH⁠, medicinal products, and biocides.Our concern: Also transformation products can be hazardous substances. Meanwhile, they are not yet covered within the ⁠POP⁠/⁠PBT⁠/vPvB assessment and the approval criteria for active substances.Our proposal: At least transformation products occurring in a relevant amount should be included in the assessment and the approval criteria in the same way as active substances.
Improving environmental protection in EU pharmaceutical legislation
(Umweltbundesamt, 2022) Gildemeister, Daniela; Buck, Annika; Hein, Arne; Rönnefahrt, Ines; Ebert, Ina; Debiak, Malgorzata
In preparation of the revision of Directive 2001/83/ EC and Regulation (EC) No 726/2004, the German Environment Agency (UBA) proposes legal changes to reduce pharmaceutical residues in the environment. The proposals are based on UBA's experiences as competent authority for the environmental risk assessment (ERA) of pharmaceuticals. Our overall aim is to ensure a comprehensive risk management system without compromising availability of medicines for patients. In this context we consider the recent EU strategy on pharmaceuticals and initiatives in connection with EU`s Green Deal particularly the Zero Pollution Ambition and the one substance one assessment approach. Quelle: www.umweltbundesamt.de
Monographs of Environmental Data for Active Substances in Veterinary Pharmaceuticals
(Umweltbundesamt, 2023) Rönnefahrt, Ines; Schmitz, Susanne; Ebert, Ina; Deutschland. Umweltbundesamt
This scientific opinion paper outlines existing problems related to data gaps, non-harmonized assessments, insufficient post-market control, and data transparency of pharmaceuticals, and identifies possible solutions through the introduction of a monograph system for active pharmaceutical substances. From UBA's point of view, monographs are the crucial bridge between risk assessment, risk communication and risk management and this across different regulatory areas. The current revision of the general pharmaceutical legislation of the EU offers the opportunity to establish a monograph system for active substances for both veterinary medicinal products and medicinal products for human use. Quelle: www.umweltbundesamt.de
Moving forward: the European Commission's proposal for a Recast Urban Wastewater Treatment Directive
(Umweltbundesamt, 2023) Bannick, Claus Gerhard; Flügel, Ines; Braun, Ulrike; Eisenträger, Adolf; Obermaier, Nathan; Osiek, Dirk; Rechenberg, Jörg; Deutschland. Umweltbundesamt
This scientific opinion paper discusses the key topics of the European Commission's Proposal for a Recast Urban Wastewater Treatment Directive. It shows how the proposed changes could affect wastewater treatment in Germany and highlights further refinement needs. In general, the proposal of the revised UWWTD is endorsed. The clear shift from basic wastewater collection and treatment to efficient wastewater management will have a positive influence on various environmental targets. It will also reduce the impact of wastewater treatment on the receiving water bodies as well as the impact of climate change on both, our cities, and the environment. Quelle: www.umweltbundesamt.de
The Revision of the REACH Authorisation and Restriction System
(German Environment Agency, 2022)
The European Commission recently announced a targeted revision of the ⁠REACH⁠ Regulation, in view of strengthening the level of protection from hazardous chemicals and simplifying the legal text.The German Environment Agency makes in this Scientific Opinion Paper specific recommendations, including on compliance checks for registration dossiers, additional information requirements, a simplified procedure for the identification of substances of very high concern, the extension of the generic risk approach to further hazard classes and derogations from restrictions for essential uses.The recommendations support current proposals at the European level. They are directed at stakeholders from academia, civil society, industry, governments and European institutions.
Shaping a proper use of biocides
(German Environment Agency, 2024)
Further action is required beyond active substance approval and product authorization of biocidal products to protect the environment. This action could be European legislation on the use-phase of certain biocides to shape their “proper use”. Whilst such piece of legislation is missing on EU level, countries have been implementing national measures. Within this document, we compiled examples from 13 different countries. The objective of this was (i) to provide examples for other Member States that would like to develop their national legislation further, and (ii) to provide exemplary legislation to the EU Commission to support drafting a harmonised European framework.
The Zero Pollution Action Plan as a chance for a cross-regulatory approach to pollution prevention and reduction
(Umweltbundesamt, 2021) Conrad, André; Hildebrandt, Sophia; Klauk, Anja; Langner, Marcel; Schubert, Tim; Schulte, Christoph; Schwan, Johannes; Suhr, Michael; Tietjen, Lars; Vierke, Lena; Deutschland. Umweltbundesamt
To further prevent and reduce the pollution of air, water, and soil and to safeguard human health and well-being, the European regulatory framework needs to be improved to include a cross-regulatory approach. This scientific opinion paper presents such an approach for the systemic protection of air, water, soil and human health- the Zero Pollution Ambition Cycle developed by the German Environment Agency (UBA)- The implementation of the measures announced by the European Commission within the EU Action Plan 'Towards Zero Pollution for Air, Water and Soil' published in May 2021 is an excellent opportunity for the different stakeholders for further developing and applying this integrated approach. Source: www.umweltbundesamt.de
Towards sustainable plant protection
(Umweltbundesamt, 2022) Bär, Susanne; Foit, Kaarina Pirko; Heß, Michael; Knillmann, Saskia; Kotschik, Pia; Kuppe, Konstantin; Matezki, Steffen; Müller, Alexandra; Otto, Sally; Petzold, Nora; Pieper, Silvia; Wogram, Jörn; Deutschland. Umweltbundesamt
With the new draft regulation on the "Sustainable Use of Plant Protection Products" (SUR), the European Commission is concretising the pesticide reduction target of 50% by 2030 stipulated in the Farm-to-Fork Strategy. The legally binding implementation of integrated pest management sets a new course for sustainable agriculture. However, for the success of practical implementation to contribute to species conservation and to create resilient ecosystems in the agricultural landscape, further preconditions are necessary. This scientific opinion paper provides four major recommendations for action that are needed from an environmental perspective to achieve the envisaged objectives. Quelle: www.umweltbundesamt.de
The upcoming European Soil Health Law – chances and challenges for an effective soil protection
(German Environment Agency, 2023)
The European Soil Strategy for 2030 by the European Commission has set the foundations for an overarching approach to the protection of soils in Europe. In this scientific opinion paper, the German Environment Agency (⁠UBA⁠) lays down its key recommendations for the upcoming Soil Health Law. Feedback on legislative options is provided and experience gained in Germany in the past years on soil protection and restoration is shared. Knowing the outstanding importance of soils for human and ecosystem health, UBA strongly agrees that a new binding European legislative framework on soils with high ambition is urgently needed.

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Auflistung Scientific Opinion Paper nach Themengebiet "Chemicals"

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