Borchert Flora, Figuière Romain, Cousins Ian T, Rudén Christina, Ågerstrand Marlene
Department of Environmental Science, Stockholm University, Stockholm, Sweden.
Front Toxicol. 2024 Nov 1;6:1488336. doi: 10.3389/ftox.2024.1488336. eCollection 2024.
The essential use concept aims to better protect consumers, vulnerable groups, and the environment from the most harmful chemicals by phasing out uses considered non-essential for society. Given the lack of empirical research evaluating this novel approach for chemical management in real-world settings, the aims of the present analysis were to 1) investigate if the information provided in applications for authorisation under REACH allowed for the identification of non-essential uses of substances of very high concern (SVHCs), and 2) identify data gaps, challenges and potential needs for revising the assessment criteria to effectively implement the essential use concept in the REACH authorisation. In total, 100 uses covering 11 SVHCs were analysed. 4-(1,1,3,3-tetramethylbutyl) phenol (OPnEO) and chromium trioxide were among the most frequently used substances, covering 42% and 35% of the analysed uses. Using the current essential use criteria, 55% of all analysed uses were categorised as essential, while 10% were categorised as non-essential. Potentially, authorisations would not have been granted for the identified non-essential uses under REACH if the concept had been implemented at the time. However, for 35% of the uses it was not possible to assess their essentiality and these uses were therefore categorised as "complex." These challenges were due to the multiple purposes of the technical function, lack of detailed information on the spectrum of end-uses, and difficulties in interpreting the essential use criteria. Consequently, for a successful implementation of the essential use concept, we recommend the European Commission to develop guidance for applicants and refine the essential use criteria to ensure a transparent and resource-efficient authorisation procedure under REACH.
基本用途概念旨在通过逐步淘汰被认为对社会非必要的用途，更好地保护消费者、弱势群体和环境免受最有害化学物质的影响。鉴于缺乏在现实环境中评估这种新型化学品管理方法的实证研究，本分析的目的是：1）调查根据《化学品注册、评估、授权和限制法规》（REACH）授权申请中提供的信息是否有助于识别高度关注物质（SVHCs）的非必要用途；2）识别数据缺口、挑战以及修订评估标准的潜在需求，以便在REACH授权中有效实施基本用途概念。总共分析了涵盖11种SVHCs的100种用途。4-（1,1,3,3-四甲基丁基）苯酚（OPnEO）和三氧化铬是使用最频繁的物质，分别涵盖了42%和35%的分析用途。根据当前的基本用途标准，所有分析用途中有55%被归类为必要用途，而10%被归类为非必要用途。如果当时实施该概念，根据REACH法规，对于已识别的非必要用途可能不会授予授权。然而，对于35%的用途，无法评估其必要性，因此这些用途被归类为“复杂用途”。这些挑战是由于技术功能的多种目的、缺乏关于最终用途范围的详细信息以及解释基本用途标准的困难所致。因此，为了成功实施基本用途概念，我们建议欧盟委员会为申请人制定指南，并完善基本用途标准，以确保在REACH法规下有一个透明且资源高效的授权程序。
