瑞士生物杀灭剂产品的授权方案

D. Kappes, Brunhilde Kolp Buchs
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摘要

瑞士生物杀灭剂条例在技术上等同于欧盟的生物杀灭剂条例(BPR)。因此,欧盟和瑞士关于统一授权程序和活性物质清单的要求是相同的。因此,在2015年,双方更新了欧盟相互承认协议中现有的“生物杀灭剂产品”章节,该章节直到2013年都是基于生物杀灭剂产品指令。由于相互承认杀菌剂产品的授权,避免了技术性贸易壁垒,同时保持了高水平的保护。此外,瑞士还参加了欧盟一级的几个业务流程再造专家组。这种知识和经验的国际交流为不断改进评估技术和促进其协调发展提供了机会。瑞士必须遵守收购协议。因此,它在务实解决方案(如针对利基产品)方面的回旋余地是有限的。民众受益于高水平的保护。一方面,行业受益于相同的要求和相互认可授权的可能性。另一方面,只在相对较小的瑞士市场上经营的中小型企业则承受着档案准备和费用的成本。总的来说,由于高水平的保护,积极的影响可能占主导地位。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The Authorisation Scheme for Biocidal Products in Switzerland
The Swiss Ordinance on Biocidal Products is technically equivalent to the Biocidal Products Regulation (BPR) of the EU. As a result, the requirements concerning the harmonised authorisation procedures and the lists of active substances in the EU and Switzerland are identical. Therefore, in 2015 both parties renewed the existing chapter on ‘Biocidal Products’ in the EUCHMutual Recognition Agreement, which until 2013 had been based on the Biocidal Products Directive. Due to mutual recognition of authorisations of biocidal products, technical barriers to trade are avoided while maintaining the high level of protection. Furthermore, Switzerland participates in several BPR expert groups on EU level. This international exchange of knowledge and experience offers the opportunity to continuously improve the assessment techniques and to contribute to its harmonised development. Switzerland has to comply with the acquis. Consequently its room for manoeuvre concerning pragmatic solutions, eg for niche products, is therefore limited. The population benefits from the high level of protection. On the one hand, industry benefits from the same requirements and the possibility of mutual recognition of authorisations. On the other hand, small and medium enterprises operating only on the relatively small Swiss market suffer under the costs for the dossier preparation and the fees. Overall, the positive effects are likely to predominate due to the high level of protection.
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