Fresh EU applications from global biocides firms fail to materialise despite shortages
LONDON (ICIS)–There has been no uptick in the number of global players seeking new approvals to sell biocidal products into the EU despite the current shortages in the region due to the coronavirus pandemic, according to regulator the European Chemicals Agency (ECHA).
There has been no increase in the number of applications from outside the EU to be added to the Article 95 list of the Biocidal Products Directive allowing players to make products containing active ingredients such as ethanol and isopropanol (IPA) in the EU market.
“Until now, we have not received an increased amount of Article 95 applications from outside of Europe,” said an ECHA spokesperson.
Chemicals producers in Europe have scrambled to increase output of IPA and ethanol; IPA prices have rocketed since the onset of the coronavirus outbreak in the region.
Some major chemicals producers, including Arkema, Shell, and BASF have shunted a portion of their product into disinfectant production.
Since the mass spread of the virus through Europe, leading to population lockdowns and industrial shutdowns, ECHA said it has moved to speed the rollout of new sources of hand sanitizer.
Companies with an already-approved active substance such as IPA or ethanol can currently apply to national governments to market disinfectants.
National policymakers are empowered to derogate standard authorisation requirements to get product to pharmacies and hospitals as quickly as possible, ECHA said in March.
The efficacy of those measures has been evident in the rollout of sanitizer production facilities in the UK, Germany, and France by European chemicals major INEOS, which said it had developed in 10 days production capacities for the product.
The moves to streamline market access applies to producers who already have approvals to distribute biocides within the EU, with INEOS producing disinfectants from its existing IPA and ethanol production sources.
For producers who have not distributed pharmaceutical-grade biocidal products in Europe before, the path can remain difficult, with interpretation of the Article 95 list requirement resting at present on national authorities, according to ECHA.
“In principle, the obligation still applies, but some national authorities, which are responsible for enforcing this obligation, have stated that disinfectant products do not have to fulfil this obligation for the time being,” the spokesperson said.
The application of this leeway has varied so far. The UK, which remains bound by EU legislation until the withdrawal transition period comes to an end, has stated that manufacturers of ethanol or IPA-based hand sanitizers can sell in the country as long as they meet World Health Organization (WHO) formulation rules.
Finland has made an exception for makers of ethanol-based hand sanitizers, but only for EU-based producers.
ECHA is working to speed the process of Article 95 approval, but registration fees need to be paid, which come to €2,000 for ECHA and whatever fee charged by the data owner of the dossier.
The complexity of registration could be discouraging some global producers from trying to market product in Europe despite the shortages, particularly as the runaway need for hand sanitizer may not be a long-running theme.
“We are not [looking to register], it is quite complicated. We don’t want to try that. Most customers do not require this. Demand in China is good,” said a China-based producer, who noted an increase in enquiries from Europe-based players for product.
Front page picture source: Ashley Crowden/Shutterstock
Focus article by Tom Brown
Additional reporting by Anne-Sophie Briant-Vaghela