Helping biocides companies and authorities
It is essential that healthcare professionals and Europe’s citizens have access to disinfectants during the global coronavirus pandemic.
To increase the manufacture and supply of disinfectants on the European market, ECHA is supporting EU/EEA and UK authorities to apply derogations from the normal authorisation requirement for biocidal products.
If your company would like to quickly place products on the EU/EEA and UK market using already approved active substances (e.g. propan-1-ol, propan-2-ol), we advise you to apply for permission from the relevant national authority using the public health danger provision of Article 55 (1) of the Biocidal Products Regulation (BPR). Several Member States have granted such permissions to pharmacies or companies that are producing disinfectants. While some national competent authorities, like Belgium, make product specific derogations under Article 55 (1), others grant general derogations to products that are in line with nationally agreed requirements (e.g. France and Germany). You are advised to check what is the approach followed in the country of your interest and consider whether your product is already covered by existing national measures. A full list of contacts for national competent authorities is available under Related.
To help companies and competent authorities ensure that products permitted under Article 55(1) derogations can be used effectively and safely, we recommend certain compositional requirements for propan-1-ol, propan-2-ol, active chlorine released from sodium hypochlorite, hydrogen peroxide and peracetic acid (see under Related).
If you are interested in supplying disinfectant products with active substances that are still under assessment (e.g. ethanol), you should contact your national authority.
It should be noted that, in principle, Article 95 of the BPR applies to all biocidal products placed on the EU/EEA market. This means that a biocidal product cannot be made available on the market unless the substance supplier or product supplier is included in the Article 95 list for the relevant product types. However, the national authorities are responsible for enforcing this obligation, and some of them have stated that disinfectant products do not have to fulfil this obligation for the time being. Still, Article 95 applications for disinfectants will be prioritised by ECHA. Final decisions will, however, be issued only after the fees have been paid.
To further help companies to fulfil their regulatory obligations, we have also published a set of Q&As.
The European Commission has also prepared a document on the measures that national authorities can use (or have already used) to permit sales of disinfectants to reduce the spread of the novel corona virus and a document providing guidelines on the identification of the applicable legislation for leave-on hand cleaners and hand disinfectants (gel, solution, etc.).
To ease the work of authorities and for companies looking for information, we have published lists of active substances approved or being reviewed for their use in disinfectant products as well as a list of products that are authorised under the BPR. You can access these from the links below:
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- List of disinfectant active substances approved (product-types 1 and 2) [XLSX]
- List of disinfectant active substances under review (product-types 1 and 2) [XLSX]
- List of disinfectant products authorised under the BPR with virucidal claims [XLSX]
The first list covers active substances that are already approved for disinfectant products, the second list covers active substances being assessed under the review programme.
The third lists disinfectant products authorised under the BPR that contain already approved active substances. This is not a comprehensive representation of all the disinfectant products available on the EU/EEA market as many of the products are currently under various national regimes, while awaiting approval of the active substance (e.g. ethanol) at EU level.
In addition to our assistance in getting disinfectants quickly onto the EU/EEA market, we are also helping EU companies to export substances/mixtures that fight against the viral spread to non-EU countries – as part of our activities under the Prior Informed Consent (PIC) Regulation. The PIC regulation allows quick exports if they related to a public health or environmental emergency (Art. 8(5)).
So far, companies have submitted requests to export didecyldimethylammonium chloride (DDAC), which is used as a disinfectant in many biocidal applications. We are supporting the national authorities and the Commission in validating the emergency export requests and are committed to assess these cases in less than 24 hours from receipt of the export notification.
To ensure efficacy of any disinfectant it is important to read and respect the use instructions. All disinfectants with virucidal activity, if used properly and after an effective cleaning, will be efficacious against enveloped coronaviruses. Hand disinfectants may have three different levels of virucidal activity - virucidal activity, limited virucidal activity, activity against enveloped viruses - and all of them are applicable against coronaviruses. Currently, many do not specify that they are active against viruses, but, for example, alcohol-based (ethanol/propan-2-ol/propan-1-ol, ~70%) products are in general efficacious against coronaviruses. You can read more on the ECDC's website.
- Letter from HCWH Europe [PDF] [EN]
- ECHA's response [PDF] [EN]
- EU Member States report illegal and ineffective disinfectants, 5 June 2020
- Letter from the European Chemical Industry Council (Cefic) [PDF] [EN]
- ECHA's response [PDF] [EN]
- Letter from Bundesverband der Deutschen Industrie e.V. to ECHA [PDF] [EN]
- ECHA's response [PDF] [EN]
- Speeding up the supply of disinfectants, News 24 March 2020
- ECHA to support EU-wide action against COVID-19, News 20 March 2020
- Completeness check of chemical safety reports postponed until October 2020, News 8 April 2020
- Information about meetings and visits to ECHA
- Contacts of the member states competent authorities and designated national authorities
- List of active substances and suppliers - Art. 95
- ECHA's Helpdesk
- ECHA's news
- ECHA's events
Other EU agencies/institutions
- Austria: Biocides Helpdesk
- Czech Republic: Information on import, transport and use of alcohol for the production of disinfectants [PDF]
- Denmark: Environmental Protection Agency
- Estonia: Health Board
- Finland: Finnish Safety and Chemicals Agency
- Germany: REACH, CLP, Biocides Helpdesk
- Iceland: Environment Agency
- Ireland: Health and Safety Executive
- Italy: Ministry of Health
- Latvia: Latvian Center for Environment, Geology and Meteorology
- Lithuania: National Centre for Public Health
- Norway: Environment Agency
- Sweden: Swedish Chemicals Agency
- United Kingdom: Health and Safety Executive