December 14, 2021

Insight 7: Substantiating biocidal product efficacy

Samantha Walker, 利记网址公司的生物杀菌剂高级顾问研究了如何识别和纠正可能阻碍欧盟生物杀菌剂产品授权和续期的功效数据差距, Norway, Switzerland and Great Britain.

When biocidal products sold in the EU, Norway, Switzerland and GB enter first authorisation or renewal, 它们通常面临不同的效力标准,与它们之前根据过渡性规则注册或根据98/8号生物杀菌产品指令授权时的效力标准不同. 这可能会导致数据缺口,如果不解决这些问题,可能会减缓甚至阻止《利记网址》的授权.

The importance of data gap analysis

有时有必要进行新的功效研究以满足当前的需求 EU Biocidal Products Regulation (BPR) and its GB equivalent. 数据差距分析是任何研究的关键步骤,以提出最佳/最聪明的功效测试策略,以支持产品的声明.

Timing is also a critical factor. For instance, some study types, such as field tests for insecticides and repellents, are influenced by seasonal variations. And, at present, 由于COVID-19导致需求增加,消毒剂产品的实验室检测工作出现积压,因此被推迟.

疗效数据差距分析通过确保正确的研究以正确的方式进行,及时生成相关数据,从而降低风险并加强成本控制. 一旦产品的核心数据集建立起来,这应该是准备获得授权的公司的首要任务. (Read about how to build a core dataset for a biocidal product here).

Start with performance claims

Claims made in product specifications, on labels and packaging are the starting point for efficacy data requirements. To enable the assessment and evaluation process of the competent authority body, all claims should be properly supported by data, or a robust and scientifically reasoned case.

Efficacy Guidance on the BPR published by the European Chemicals Agency (ECHA) in 2018 states:

药效数据是生物杀菌剂产品监管管理和决策过程中的一个基本组成部分. 需要有功效数据来确定使用生物杀菌剂产品所产生的益处,并且必须与使用这些产品对人类和环境造成的风险相平衡. 生物杀菌剂产品只有在被证明有效的情况下才会被批准.

At the minimum, companies must prove that any proposed outcomes can be achieved in the intended applications. The nature of the product’s claimed effect on target organisms is significant here, ranging from ‘control’ or ‘repel’ to ‘prevent’ or ‘kill’.

根据所提出的主张,可能还有其他更复杂的因素作为证据. These might include speed of effectiveness or residual protection. 也可能有必要证明与产品所应用的表面类型有关的功效水平.g. porous and non-porous surfaces.

Interrogate historic studies

利记在线网址经常发现,公司以往的疗效研究已不再符合当前的监管指南. 在过去十年中,欧盟和国标中与生物杀菌产品的安全和可持续使用有关的标准已变得更加严格,导致生物杀菌产品的施用量或活性物质浓度下降. Other changes may have been introduced as well, 例如,针对蚊子等昆虫群体的广泛的一般性索赔要求可能要求在测试中包括更多的物种,而且将需要考虑在热带地区使用的索赔要求.

如果不符合要求的早期研究被用作授权档案中风险评估的基础,可能会出现严重的问题. It’s vital that the data stands up to scrutiny during assessment.

一个重要的考虑因素是确定达到预期功效所需产品的数量或浓度. This is a key area where requirements are likely to have changed since earlier authorisations. So, 虽然历史上利记网址杀虫剂粉末的说明可能会说“在有爬行昆虫的地方随意摇晃”,但现在有必要具体说明需要多少杀虫剂粉末, where it should be applied and which insects the product is effective against. 这反过来又导致了应用模式和用户以受控的方式分配精确数量的能力.

A fine balance is required here. According to the ECHA’s Guidance on the BPR, 虽然要求将使用限制在“必要的最低限度”,但同样重要的是,杀菌剂要达到预期的效果。.

Develop an efficacy testing strategy

Once efficacy data gaps have been established, a testing strategy can be devised to address them in the most efficient and cost-effective way. The core product property – preservation, disinfection, pest control etc. -需要以一种证实产品声明的方式被证实,并满足业务流程再造要求的深度和广度. Study types specified for BPR product authorisation can include laboratory studies, simulation tests and field tests, carried out in accordance with existing standards or protocols. However, 对于某些用途,如产品用于保存液冷系统或控制材料上的黏液生长, the guidance and testing methods are vague or even still non-existent. 因此,在试运行研究之前,使用具有特定经验的专家进行产品授权,对于非指导性测试方法可能是非常有价值的. In theory, 此类测试方法应在开始测试前与评估授权申请的主管部门讨论,但在实践中,这并不总是可能的,因为测试可能需要在选定一个主管部门之前就开始.

According to EU timescales, 当生物杀菌产品委员会对某一特定产品类型的活性物质的批准给出了积极的意见时, there is a two-year window before the substance is approved, 已上市且含有该物质/产品类型组合的产品必须提交授权申请的日期. For product authorisation renewal, renewal application must be submitted 550 days before the authorisation expiry date. However, there is nothing to prevent a company initiating data gap analysis beforehand. In fact, 利记在线网址强烈建议在上述情况下,季节性因素或实验室能力可能会影响时间. What’s more, efficacy has a bearing on wider aspects of biocidal product authorisation, such as human health and environmental factors. The uses, target organisms, application rate, 用于进行风险评估的可治疗领域将从疗效测试的结果中得出. As such, it is prudent to begin focused efficacy testing at the earliest opportunity.

This is part of a series on authorisation for biocidal products in the EU and GB. We’ve previously looked at How to get a head-start on biocidal product authorisation. Next month, we’ll focus on environmental considerations and human health risk assessments.

A robust efficacy testing strategy is the cornerstone of biocidal product authorisation. 利记网址的监管专家和科学家拥有丰富的经验和见解,可以帮助企业做出知情和有效的决策,帮助流程从开始到结束顺利运行. Contact us at to find out more.

Stay tuned for tomorrow's insight!

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