ECHA is supporting EU/EEA and UK authorities to apply derogations from the normal authorisation requirement for biocidal products.

 

Biocides

Getting disinfectants quickly onto the EU market 

 

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 already 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 competent authorities is available on the ECHA website

 

To help companies and competent authorities ensure that products containing propan-1-ol and/or propan-2-ol permitted under Article 55(1) derogations can be used effectively and safely, we recommend certain compositional requirements for these two substances (see below).

 

If your company already has a product authorisation under the BPR but wants to use additional sources of active substances, you can apply to ECHA for a technical equivalence decision for the new source. If your new source is for propan-1-ol or propan-2-ol, we have an accelerated procedure in place where the information required is less strict than for normal procedures. Moreover, to speed up the process, we will start working on the evaluation and issue our draft decision before you pay the fees. More information on the procedure to follow is available in the document on the procedures and requirements for accelerated technical equivalence for propan-1-ol and propan-2-ol.

 

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. You can find their contact details on our website. 

 

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, we have decided to also speed the evaluation procedure of Article 95 applications for disinfectants and start the evaluations before the fees are paid. 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.). 

 

Lists of active substances and products

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. In addition, we have collected a lists of products authorised in some Member States. You can access these from the links on the ECHA website or by requesting them from BAMA: tizianadorigo@bama.co.uk. 

They include: 

 

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.

To give a better indication of the market situation for disinfectant products, we have also collected information from two Member States (Spain and the Netherlands) and from Switzerland, which each have a national authorisation system in place for disinfectant products (fourth list). 

 

Use of disinfectants: read instructions carefully

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.

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