Biocidal hand sanitisers and handwashes placed on the market in the EU are regulated under the 生物杀菌产品法规528/2012 (BPR). This regulation concerns the making available and use of biocidal products on the market.
The continuing COVID-19 pandemic has seen a global surge in demand for such products, requiring industry to respond by supplying new hand sanitiser products under significant time-pressures. 无论是来自欧盟还是其他国家, the appropriate rules and regulations must still be followed to ensure the safety of the product.
已获欧盟批准的活性物质, specific derogations have been granted by some Member States allowing 公司 to place hand sanitisers on the national market without a BPR authorisation. For biocidal products containing an active substance not yet approved, the process to place the product on the market is specific to each Member State according to the transitional rules. This means that t在这里 are differing requirements between countries making it more challenging to place biocidal products on the EU market.
利记网址's 咨询顾问 are available to 帮助 navigate the regulatory landscape for biocidal hand sanitiser and handwash products, 包括:
- Applying for transitional national registrations/notifications a交叉 欧洲
- Compiling BPR dossiers for product authorization and active substance approval
- Reviewing of existing labels or drafting of compliant labels
- Strategic advice to assist with identification of the best route to market
利记网址 provides 公司 with high-quality regulatory and scientific consulting services. 利记在线网址的目标是了解客户的目标和目的, learn the scientific and technical aspects of projects and anticipate compliance challenges to plan a strategic path forward. 利记网址's team of experts is deadline-focused, responsive and committed to professionalism. We have the utmost respect for the confidentiality of our work, 较强的项目管理能力, take great measure to cultivate long-term partnerships with clients.
It will depend on the active substance(s) in the biocidal product. If not all the actives are approved yet and at least one is still in the review programme under Product Type 1 (human hygiene), the hand sanitiser may be placed on the market under transitional measures. 在一些国家, the national regulations in place allow an almost ‘immediate’ placing on the market w在这里as others have recently published temporary derogations to place such products on the market. Fast track measures also apply in some countries to disinfectants under Product Type 2 (disinfectants and algaecides not intended for direct application to humans or animals) and Product Type 4 (food and feed). 利记网址’s regulatory specialists will be able to advise the most appropriate route for your 公司 to take.
The 欧洲an Chemicals Agency (ECHA) maintains a list of the approved active substances for biocidal products on its website 在这里.
Depending on whether the biocidal product contains ethanol or propan-2-ol, 不同的国家适用不同的规定. It is important to comply with the requirements and eventual derogations in place in the appropriate 欧洲an country before placing your product on the market. 利记网址's specialists routinely assist 公司 in complying with the relevant regulations.
Products coming from outside the EU may not be compliant with the different 欧洲an regulations in place. 例如, the active substance may not be sourced from an approved supplier and the labelling may not be compliant with CLP. 利记网址's specialists will be able to advise on complying with the relevant regulations.
‘CE’ marking means that the product sold has been assessed to meet high safety, 健康, 以及环保要求. It does not mean the product is compliant with the BPR nor that it has been approved as safe.
A biocidal product is made available on the market when supplied for distribution or use on the EU market in the course of a commercial activity, 无论是有偿还是免费. 在这两种情况下, the hand sanitiser must comply with the regulations in place before it is placed on the market.