Faculty of Life Sciences, University of Manchester, Manchester M13 9PT, UK.
DABMEB Consultancy Ltd, Sharnbrook, Bedfordshire MK44 1PR, UK.
Regul Toxicol Pharmacol. 2014 Apr;68(3):488-92. doi: 10.1016/j.yrtph.2014.02.004. Epub 2014 Feb 15.
Characterisation of the relative sensitizing potency of protein and chemical allergens remains challenging, particularly for materials causing allergic sensitization of the respiratory tract. There nevertheless remains an appetite, for priority setting and risk management, to develop paradigms that distinguish between individual respiratory allergens according to perceptions of the hazards and risks posed to human health. One manifestation thereof is recent listing of certain respiratory allergens as Substances of Very High Concern (SVHC) under the provisions of REACH (Registration, Evaluation, Authorisation and restriction of Chemicals). Although priority setting is a laudable ambition, it is important the process is predicated on evidence-based criteria that are transparent, understood and owned. The danger is that in the absence of rigorous criteria unwanted precedents can be created, and confidence in the process is compromised. A default categorisation of sensitisers as SVHC requiring assessment under the authorisation process is not desirable. We therefore consider here the value and limitations of selective assignment of certain respiratory allergens as being SVHC. The difficulties of sustaining such designations in a sound and equitable way is discussed in the context of the challenges that exist with respect to assessment of potency, and information available regarding the effectiveness of exposure-based risk management.
对蛋白质和化学过敏原的相对致敏性进行特征描述仍然具有挑战性，特别是对于引起呼吸道过敏的物质。然而，出于优先排序和风险管理的目的，仍然存在一种需求，即根据对人类健康构成的危害和风险的看法，开发区分个体呼吸道过敏原的范式。其中一种表现形式是，根据 REACH（化学品注册、评估、授权和限制）的规定，将某些呼吸道过敏原最近列为高度关注物质 (SVHC)。尽管优先排序是一个值得称赞的目标，但重要的是，该过程基于透明、理解和拥有的基于证据的标准。危险的是，如果没有严格的标准，可能会产生不必要的先例，并且对该过程的信心会受到损害。将敏化剂默认归类为 SVHC，并要求在授权过程中进行评估是不可取的。因此，我们在这里考虑将某些呼吸道过敏原选择性指定为 SVHC 的价值和局限性。在评估效力方面存在挑战的背景下，以及关于基于暴露的风险管理的有效性的信息，讨论了以合理和公平的方式维持此类指定的困难。
