ECHA

As the COVID-19 pandemic caused a surge in demand for disinfectants in the EU, Member States, supported by the European Commission and ECHA, took decisive action to speed up the supply by relying on a special provision of the Biocidal Products Regulation (BPR). This ‘public health danger’ provision allows individual Member States to grant exceptional emergency permits for products that do not have an authorisation under the BPR.

The Commission was alerted in early March by Member States and industry associations about shortages in disinfectant supply, mainly due to a lack of active substances such as isopropanol or ethanol. The recognised suppliers of disinfectants were also operating already at their maximum production capacity. “The situation was difficult particularly for the healthcare sector as a lot of people were being hospitalised. There was clearly a shortage there,” says Klaus Berend, Head of Unit for Pesticides and Biocides at the Commission’s Directorate-General for Health and Food Safety.

The Commission organised a virtual meeting with national authorities to discuss the options for increasing the supply. The starting point was Article 55(1) of the BPR, the ‘public health danger’ provision, which allows Member States to grant emergency permits for 180 days for non-authorised biocidal products when there is a threat to public health.

A crucial point raised by almost all Member States was that companies on the list of approved suppliers under the BPR (Article 95 list), which are normally the only ones that can place active substances or biocidal products on the market, could not manufacture enough disinfectants alone to meet demand.

Klaus Berend. Image: European Commission.

“We agreed that, in the spirit of the emergency provision, Member States could allow companies and other operators not included on the Article 95 list to supply disinfectants for 180 days. At the same time, we asked Member States to urge companies that were getting such permits to apply to ECHA to become a recognised supplier in the future.”

“We agreed that, in the spirit of the emergency provision, Member States could allow companies and other operators not included on the Article 95 list to supply disinfectants for 180 days. Several Member States then allowed, for example, pharmacies to start mixing disinfectants and cosmetics producers to convert their production. At the same time, we asked Member States to urge companies that were getting such permits to apply to ECHA to become a recognised supplier in the future,” Mr Berend says.

Keeping an eye on the situation

The Commission has kept in close contact with the three main industry associations, International Association for Soaps, Detergents and Maintenance Products (A.I.S.E), the European Chemical Industry Council (Cefic) and the European Association of Chemical Distributors (Fecc) throughout spring and summer to monitor the situation. “In April, things already started to look better. The emergency permits in Member States were increasing – in some countries faster and in others slower – and more and more companies signalled that they were able to meet demand,” Mr Berend explains.

New sources of active substances were found and big producers of isopropanol and ethanol were making donations to the healthcare sector. ”The German authorities, for example, approved bioethanol as a new source. It is normally used as a fuel, but as people were driving less, there was an excess. The German authorities considered that bioethanol could be used safely and effectively as a source of ethanol. This opened a source of huge supply in Germany,” Mr Berend tells. Donations from companies normally operating outside the chemical industry have also played an important part. “For example, drinks and spirits producers donated ethanol, which came, for example, from the production of alcohol-free beer. There was a lot of goodwill from industry,” Mr Berend states.

Lessons learnt

This was the first time the ‘public health danger’ provision of the BPR has been used in such a wide manner in the EU. The generous interpretation of the legal text was appreciated by all.

“The BPR provision allowed different tactics to be used in the Member States. Some countries gave general derogations, for example, to all pharmacies to produce disinfectants in formulations recommended by the World Health Organization (WHO), while others granted permits to individual products and companies. The most important feedback we received is that we have managed to make the legal text work in practice to respond effectively and quickly to the critical situation,” Mr Berend says.

According to Mr Berend, one element to keep in mind for the future is how to get quantitative information on supply and demand. “This kind of information has been very difficult to obtain but it is important in order to take the right actions at the right time. Another question is about creating and maintaining stockpiles – is this something we could do collectively as a Union to be better prepared?” he asks.

180 days are over – what then?

The time-limited permits given in early March expired in September. Will we then face a new shortage in supply as some of the products covered by the emergency permits will disappear from the market? According to Mr Berend, if the situation has not yet stabilised, Member States have two options: apply for an extension to the existing emergency permit or grant a new permit.

“Extensions can be granted for a maximum period of 550 days. In this scenario, Member States requesting the extension should clearly identify the companies and products in question. For those that have granted general derogations this might be difficult unless they have kept records of all new actors and products. Another option is to grant a new 180-day emergency permit – the BPR does not exclude that. However, before doing so, the Member State should check that the demand cannot be met with authorised disinfectants and recognised suppliers – we know that in some Member States such companies have in the meantime ramped up their production considerably.”

The decision about the extension is made by the Commission. The Member States vote on the draft decisions. The European Parliament scrutinises the Commission’s draft decisions, but cannot block decision-making.

Whether new permits or extensions are needed, remains to be seen. According to media reports, European industry seems to have adapted to the situation and has little appetite for further legal exemptions. The increase of suppliers compliant with the Article 95 obligations for the main active substances used in disinfectants and especially for ethanol supports this view.

“When Member States loosened the restrictions over summer, the demand for disinfectants went up as many public spaces, such as shops and restaurants, needed to be equipped with disinfectants. Maybe we have reached a plateau of demand which will remain high but stable. In any case, the Commission and ECHA are here to help Member States and companies. We should also not forget that we do not need to use disinfectants at home. The best thing is to just wash your hands with soap and water if possible,” Mr Berend concludes.

Spotlight: Derogations for disinfectants in Germany

The German authorities were among the first to grant derogations to the biocidal product authorisations to meet the high demand in early March. They started by giving derogations only to pharmacies and pharmaceutical companies and to products following specific formulations.

“These first measures were, however, not sufficient to meet the demand and the shortage of the necessary active substances, such as isopropanol and ethanol. We broadened the target group to include other actors like the chemical industry and public organisations like universities. Companies that produce or import the required active substances, such as breweries and distilleries, could also be used as suppliers of raw materials,” says Suzanne Wiandt, Head of Unit at the German REACH, CLP and BPR Helpdesk.

Granting derogations to companies not familiar with the biocides legislation led to a huge increase in enquiries. “We have published over 50 FAQs on this and a guide to classification and labelling when we found out that some of the disinfectants on the market were being labelled in a ‘very creative’ way – in particular, health-endangering properties had been played down. The number of enquiries in March and April was around 530 a month whereas in January and February we had around 70 a month,” Ms Wiandt mentions.

Currently, the situation in Germany looks stable and companies can meet the demand. “However, it is uncertain how the situation will develop. A further extension of the derogations is under examination. Whether any adjustment of the measures taken or extensions are needed, is yet to be decided.”

Member States check products to protect citizens   The risk for non-compliant products increases when companies not familiar with the legal framework enter the market quickly. Although many act in good faith, some appear to be taking advantage of the situation. Enforcement authorities in at least 20 of the 27 Member States have found increased numbers of illegal and ineffective disinfectants on their national markets.   Many Member States reported about disinfectants that do not have the required authorisation or permit, or lack hazard labelling. Some also found products that claimed to be disinfectants but had a formulation that is not effective against viruses – for example, due to too low concentrations of active substances that stop the spread of viruses.   To ensure safety of products, the national enforcement authorities continue to perform market inspections, including controls of online sales to ensure that illegal disinfectants are removed from the market. Enforcement actions may result in measures such as fines and the withdrawal of the products from the market.   Member States are responsible for enforcing the BPR. However, ECHA coordinates a network of representatives from Member States’ enforcement authorities aimed at harmonising enforcement on the EU level.

Further information:

Speeding up the supply of disinfectants, News release 24 March 2020

EU Member States report illegal and ineffective disinfectants, News release 5 June 2020

COVID-19 updates

Understanding BPR

Overview on biocides – Commission webpage

Statement: Bottleneck in the crisis – derogations for disinfectants in Germany [PDF] [EN]

Interviews by Hanna-Kaisa Torkkeli

Published on: 29 September 2020

Top image: © Pexels/Anna Shvets

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