An unprecedented challenge
The COVID-19 pandemic has increased the demand for hand disinfectants, driven by recommendations from bodies such as the WHO. Handwashing is a vital measure for reducing the risk of contracting the virus. The谁特别建议所有人“经常和彻底地清洁（他们）手用基于酒精的手臂或用肥皂和水洗涤。”
Sales of hand disinfectant have risen dramatically across the world. For example, in the UK,disinfectant sales have risen 255%2020年2月同比。
Chemical companies are struggling to keep up with the unprecedented demand because of shortages of active substances. Finding new sources of actives may not be straightforward because of regulatory controls. New products are often slow to enter the market due to regulatory frameworks and time-consuming authorization procedures. Regulators across Europe appreciate these challenges and are responding by relaxing regulations and providing guidance.
The production of hand disinfectant is one of the many critical activities that chemical companies are undertaking to address the challenge of Covid-19. This blog summarizes some of the EU’s key regulatory considerations and changes that manufacturers of hand disinfectants should be aware of.
在欧盟的手中的正确调节之后
In the EU/EEA, hand cleaners/disinfectants could fall under either Cosmetics Product Regulation (EU 1223/2009) or Biocidal Product Regulation (BPR; EU 528/2012). Which regulation applies depends on the presence of an active ingredient and the primary purpose of the product, although this can be open to interpretation. In general:
- 化妆品产品调节涵盖主要旨在清洁或清洁皮肤的产品（通常在没有水漂洗的情况下）
- BPR涵盖含有活性物质的产品，其具有控制有害生物的主要目的，即它们具有生物侵入目的。这包括诸如“消毒”，“杀死病毒”或“杀菌细菌”的预期用途。
Product claims are one way in which product intention is captured. If a product claim targets general human hygiene by exerting a biocidal action, such as through skin disinfection, or claims an antimicrobial function, then that is primarily a public health claim based on biocidal activity. It is therefore regulated under BPR.
在目前的危机中，许多生产化妆品的公司现在正在寻求制造手工消毒剂。在这种情况下，公司应遵循BPR根据规定的规则。因此，ECHA建议公司联系该产品的主管当局将用于特定指导。
欧盟委员会制作了guidanceto support interpretation of the regulations related to hand disinfectants.
Defining hand disinfectants and sanitizers for regulatory purposes
手工消毒剂或消毒剂旨在清洁手，意图除去或杀死病毒或细菌。手消毒产品包括手洗或手工卷。用水用水，手动手工不使用。产品可以采用液体，凝胶，湿巾，泡沫等的形式
通常，推荐用于粘附Covid-19的手消毒剂含有醇作为活性成分。使用的常用醇是乙醇，丙烷-2-醇（异丙醇）或丙烷-1-醇（正丙醇）。手中的酒精含量在60％和95％之间变化。批准的醇以外的醇以外的活性成分，例如过氧化氢，小二甲基氯化铵或碘，也可用于手部消毒剂。手消毒剂还可含有润肤剂，例如甘油。
You can find details on hand disinfectant products and ECHA definitions of efficacy这里。
谁推荐的Handrub配方
The WHO have long understood that in some global settings, commercially available hand disinfectant may be difficult or expensive to source. The WHO therefore recommends two alcohol-basedhandrub formulations用于本地准备。随着Covid-19由于Covid-19的需求激增，更多的制造商和当地药店正在转向世卫组织的制剂。因此，正在释放更多的监管指导，以支持制造这些配方的公司。
欧洲an regulation on biocides
In the EU/EEA/Switzerland and UK, BPR EU 528/2012 regulates hand disinfectants intended for controlling harmful organisms like bacteria, yeasts and viruses. Under BPR, the active substance in a product needs approval before the biocidal product can be authorized. Both approval and authorization are required before a hand disinfectant can be marketed in a specific EEA country; the only exception is if a biocidal product has been notified under a member states transitional notification scheme prior to approval of the active substance. During the current coronavirus crisis, supplies of both approved active substances and final products are limited.
ECHA has provided advice to EU/EEA member states (MSs) to help them consider ways of increasing hand disinfectant availability. These are entirely voluntary, and member states can choose to employ any number of them or none. The options include:
- The ability to grant a permit in accordance with Article 55 (1) BPR to disinfectant products not currently authorised in their territory but authorized in other MSs.
- 允许授权消毒产品的制造商可以通过申请BPR第55（1）条申请许可，改变技术规范，来源或制造地点/流程。
- 能够放松审查中的活性物质的过渡要求，但尚未批准。
- Allowing a ‘do then tell’ approach to variation in disinfectant products, enabling companies to make changes and then inform the relevant MS after the event. Companies should, preferably, seek advice before implementing any changes.
- 允许（根据第55（1）条）药房和其他公司符合世卫组织推荐的规范制造消毒剂。
ECHA recommends that companies planning to upscale, alter or begin hand disinfectant production should contact the relevantmember statefor guidance. MSs enforce BPR in each country based on local factors.
Variations in technical specification and source of active substances
All active substances (both approved and yet to be approved), and their suppliers, appear on theArticle 95 list。在BPR下，只有来自上市供应商的列出的物质可用于授权的杀生物产品。
There are 11 active substances approved under BPR for use in hand disinfectants (product type 1), with 14 active substances under evaluation. In terms of alcohols, however, only propan-1-ol and propan-2-ol are approved in the EU. Ethanol is currently under evaluation as an active substance for BPR disinfectant product types 1, 2 and 4. Each MS should make theirown national decisionsregarding authorization of ethanol-based products and derogation from established transitional procedures during the current Covid-19 pandemic.
You can find out more about the active substances approved and under evaluation这里。
第55条减斯
The most effective way to increase biocidal products on the market is for competent authorities within member states to use Article 55 (1) of the BPR to permit derogation from the technical equivalence requirement in Article 19 (1) (c).
第55条减斯使成员国能够允许产品上的产品，这些产品不满足典型产品授权的要求。为了减轻对公共卫生，动物健康或环境的可能危险，贬损涵盖了180天的初始期间。延长延长至550天，但必须由委员会授予。
Compositional requirements for propan-1-ol and propan-2-ol
公司95年文章列表必须确保their active substances are suitably efficacious and minimize risk to human health and the environment. To help such companies, ECHA has发表compositional requirements for propan-1-ol and propan-2-ol. This is particularly relevant to companies looking to develop WHO formulations or who have substances approved under REACH but not BPR.
Applying for technical equivalence for active substances under BPR
Manufacturers of authorized biocidal products who want to use new sources of propan-1-ol or propan-2-ol should submit a request for a technical equivalence assessment of the new source to ECHA. Given the current situation, ECHA is applying reduced information requirements and a modified assessment procedure. This allows immediate work on the assessment to start and a draft decision can be issued even in the absence of fee payment. Detailed information on this process can be found这里。
Conclusions
The coronavirus pandemic has placed a huge strain on the chemical industry and its supply chain as companies respond to the increased demand for hand disinfectants. EU regulators have also responded and relaxed regulations to facilitate supply. By working together positively towards a shared interest, chemical companies and regulators can help protect human health.
Useful sources of information
关于解决Covid-19的建议继续发展。下面的列表捕获了与化学制造商相关的一些信息来源。
| 欧洲 | ECHA page providing a general overview on regulatory issues related to disinfectants with links to further information. There are multiple links from this page to key resources.https://echa.europa.eu/covidd-19 |
| 欧洲 | 欧洲an Centre for Disease Prevention and Control on disinfection of environments in healthcare and non-healthcare settings potentially contaminated with SARS-CoV-2.https://www.ecdc.europa.eu/en/publications-data/disinfection-environments-.covidd-19 |
| 谁 | 谁technical advice and guidance for countries.https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance |
