To alleviate the difficulties companies and Member State authorities may be facing during the global coronavirus pandemic, ECHA is supporting EU/EEA countries and companies to ensure that disinfectants can quickly enter the market.
Together with the Commission, the Agency is also exploring the possibility of allowing more flexibility for companies in meeting certain deadlines associated to ECHA’s decisions.
14 May 2020: Contributions to consultations related to REACH restrictions - flexibility in time frames to be assessed case-by-case. More
4 May 2020: Information about the extensions to companies' deadlines now available. More
15 April 2020: Have a look at our recommendations for compositional requirements for three additional active substances to be used in disinfectants. More
6 April 2020: We are supporting EU countries to export disinfectants to non-EU countries as part of our activities under the Prior Informed Consent (PIC) Regulation. More under Helping biocides companies and authorities.
31 March 2020: Contact information for competent authorities now available. More
30 March 2020: Do you already have a disinfectant product authorised under the BPR and want to use additional sources? We are now speeding up technical equivalence assessments for propan-1-ol and propan-2-ol. More
27 March 2020: Q&As for companies seeking to place disinfectants on the EU/EEA market. More
It is essential that healthcare professionals and Europe’s citizens have access to disinfectants during this time. 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.
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 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 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 below:
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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).
Supporting EU companies to export disinfectants
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.
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.
During these exceptional circumstances, we understand that companies may be lacking human or financial resources or facing technical difficulties in meeting certain deadlines associated with ECHA’s decisions.
ECHA is committed to helping industry meet its regulatory obligations during the COVID-19 pandemic. Therefore, the Agency has decided on a number of deadline extensions which will apply until end of May 2020. The companies concerned have been informed directly about these extensions since the end of March.
Technical completeness check of registration dossiers
Companies who initially failed to provide a complete registration and had a final deadline to submit information to ECHA between March and May 2020, will have an additional two months to finalise their submissions.
Revised completeness check for registration dossiers
The extension of the technical completeness check to include the chemical safety report has been postponed from April to October 2020. More information and background can be found here.
Deadline for further information on confidentiality claims
Companies will have two additional months to provide information if they submitted a confidentiality claims to ECHA according to the REACH Regulation and have been requested to provide additional information with a final deadline between March and May 2020.
Comments on draft decisions in substance or dossier evaluation
Companies who receive draft decisions from ECHA, asking for additional information on their registration or the chemical registered, will have an additional 30 days to provide their comments. These are the draft decisions issued as a result of a testing proposal examination under the REACH Regulation (Article 40), compliance check (Article 41), follow-up to dossier evaluation (Article 42(1)) and substance evaluation (Article 46). The extension only applies to commenting under Article 50(1) and will be in place until the end of May.
All other deadlines, for example, the deadline set in the adopted ECHA decision to provide the requested information, are not subject to the above arrangements. If there are delays, companies should follow the instructions outlined in Q&A 1061. More information about the deadlines of adopted ECHA decisions is available in Q&A 1658.
PIC notifications to national authorities
Companies notifying their national authorities about 2019 imports and exports of chemicals falling under the PIC Regulation have an additional two months to submit them until the end of May 2020. The companies have received information about this through the ePIC tool.
Invoices to companies
Companies receiving invoices from ECHA with a deadline between mid-March and the end of April 2020 have an extended deadline until 30 May 2020 to pay their invoices. The companies have been informed directly with the invoices sent.
Authorisation decisions - monitoring programme
Companies that have received a Commission decision on their application for authorisation stating a condition that a monitoring programme needs to be established with first measurements to be performed by spring 2020, are advised to contact the national enforcement authorities without delay and ask them how to address the situation. See Q&A 1657.
Contributions to consultations on restriction proposals and SEAC draft opinions
Companies and other parties that want to submit comments in ongoing consultations on REACH restriction dossiers, or on draft SEAC opinions, should do so within the time frames specified. This is so that the deadlines for ECHA Committees to prepare their opinions are respected and to comply with the legal deadlines for submitting the opinions to the European Commission.
However, if potential respondents express that the current COVID-19 situation is adversely affecting their ability to make comments, ECHA will assess their justifications on a case-by-case basis. The Agency will then decide whether or not to take comments submitted by that party into account after the close of the consultation, for a specified period.
Any such justifications should come before the specified deadline of the consultation period. If a post-consultation period is agreed, it will not be further extended.
- 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