An unprecedented challenge
The COVID-19 pandemic has increased the demand for hand disinfectants, driven by recommendations from bodies such as the WHO. Handwashing is a vital measure for reducing the risk of contracting the virus. The WHO specifically recommends that all individuals “regularly and thoroughly clean (their) hands with an alcohol-based handrub or wash them with soap and water.”
Sales of hand disinfectant have risen dramatically across the world. For example, in the UK, disinfectant sales have risen 255% year-to-year in February 2020.
Chemical companies are struggling to keep up with the unprecedented demand because of shortages of active substances. Finding new sources of actives may not be straightforward because of regulatory controls. New products are often slow to enter the market due to regulatory frameworks and time-consuming authorization procedures. Regulators across Europe appreciate these challenges and are responding by relaxing regulations and providing guidance.
The production of hand disinfectant is one of the many critical activities that chemical companies are undertaking to address the challenge of Covid-19. This blog summarizes some of the EU’s key regulatory considerations and changes that manufacturers of hand disinfectants should be aware of.
Following the correct regulation for hand disinfectants in the EU
In the EU/EEA, hand cleaners/disinfectants could fall under either Cosmetics Product Regulation (EU 1223/2009) or Biocidal Product Regulation (BPR; EU 528/2012). Which regulation applies depends on the presence of an active ingredient and the primary purpose of the product, although this can be open to interpretation. In general:
- Cosmetics Product Regulation covers products primarily intended to clean or cleanse the skin (usually in the absence of water rinsing)
- BPR covers products containing an active substance which have the primary purpose of controlling harmful organisms, i.e. they have a biocidal purpose. This includes intended uses such as “disinfecting”, “killing viruses” or “killing bacteria”.
Product claims are one way in which product intention is captured. If a product claim targets general human hygiene by exerting a biocidal action, such as through skin disinfection, or claims an antimicrobial function, then that is primarily a public health claim based on biocidal activity. It is therefore regulated under BPR.
In the current crisis, many companies producing cosmetics are now looking to manufacture hand disinfectants. In such circumstances, companies should follow the rules established under BPR. ECHA therefore advises companies to contact the competent authority of the country in which the product will be used for specific guidance.
The EU Commission has produced guidance to support interpretation of the regulations related to hand disinfectants.
Defining hand disinfectants and sanitizers for regulatory purposes
Hand disinfectants or sanitizers are designed to clean hands with the intention of removing or killing viruses or bacteria. Hand disinfectant products include handwash or handrub. Handwash products are used with water, while handrubs are not. The products can take the form of liquids, gels, wipes, foams etc.
In general, the hand disinfectants recommended to tackle COVID-19 contain alcohol as the active ingredient. The usual alcohols used are ethanol, propan-2-ol (isopropanol) or propan-1-ol (n-propanol). Alcohol content in hand disinfectants varies between 60% and 95%. Approved active ingredients other than alcohols, such as hydrogen peroxide, didecyldimethylammonium chloride or iodine, can also be used in hand disinfectants. Hand disinfectants may also contain an emollient such as glycerol.
You can find details on hand disinfectant products and ECHA definitions of efficacy here.
WHO-recommended handrub formulation
The WHO have long understood that in some global settings, commercially available hand disinfectant may be difficult or expensive to source. The WHO therefore recommends two alcohol-based handrub formulations for local preparation. With the surge in demand due to COVID-19, many more manufacturers and local pharmacies are turning to WHO formulations. As a result, more regulatory guidance is being released to support companies manufacturing these formulations.
European regulation on biocides
In the EU/EEA/Switzerland and UK, BPR EU 528/2012 regulates hand disinfectants intended for controlling harmful organisms like bacteria, yeasts and viruses. Under BPR, the active substance in a product needs approval before the biocidal product can be authorized. Both approval and authorization are required before a hand disinfectant can be marketed in a specific EEA country; the only exception is if a biocidal product has been notified under a member states transitional notification scheme prior to approval of the active substance. During the current coronavirus crisis, supplies of both approved active substances and final products are limited.
ECHA has provided advice to EU/EEA member states (MSs) to help them consider ways of increasing hand disinfectant availability. These are entirely voluntary, and member states can choose to employ any number of them or none. The options include:
- The ability to grant a permit in accordance with Article 55 (1) BPR to disinfectant products not currently authorised in their territory but authorized in other MSs.
- Permitting manufacturers of authorized disinfectant products to vary the technical specification, source or manufacturing site/process from that which is authorized by applying for a permit through Article 55 (1) of the BPR.
- The ability to relax transitional requirements for active substances in review but not yet approved.
- Allowing a ‘do then tell’ approach to variation in disinfectant products, enabling companies to make changes and then inform the relevant MS after the event. Companies should, preferably, seek advice before implementing any changes.
- Permitting (under Article 55(1) BPR) pharmacies and other companies to manufacture disinfectants in line with the specifications recommended by the WHO.
ECHA recommends that companies planning to upscale, alter or begin hand disinfectant production should contact the relevant member state for guidance. MSs enforce BPR in each country based on local factors.
Variations in technical specification and source of active substances
All active substances (both approved and yet to be approved), and their suppliers, appear on the Article 95 list. Under BPR, only listed substances from listed suppliers can be used in authorized biocidal products.
There are 11 active substances approved under BPR for use in hand disinfectants (product type 1), with 14 active substances under evaluation. In terms of alcohols, however, only propan-1-ol and propan-2-ol are approved in the EU. Ethanol is currently under evaluation as an active substance for BPR disinfectant product types 1, 2 and 4. Each MS should make their own national decisions regarding authorization of ethanol-based products and derogation from established transitional procedures during the current Covid-19 pandemic.
You can find out more about the active substances approved and under evaluation here.
Article 55 derogation
The most effective way to increase biocidal products on the market is for competent authorities within member states to use Article 55 (1) of the BPR to permit derogation from the technical equivalence requirement in Article 19 (1) (c).
Article 55 derogation enables a member state to allow products on the market which do not fulfil the requirements of a typical product authorization. To mitigate possible danger to public health, animal health or the environment, derogation covers an initial period of 180 days. A further extension up to 550 days is possible but must be granted by the Commission.
Compositional requirements for propan-1-ol and propan-2-ol
Companies not on the Article 95 list must ensure their active substances are suitably efficacious and minimize risk to human health and the environment. To help such companies, ECHA has published compositional requirements for propan-1-ol and propan-2-ol. This is particularly relevant to companies looking to develop WHO formulations or who have substances approved under REACH but not BPR.
Applying for technical equivalence for active substances under BPR
Manufacturers of authorized biocidal products who want to use new sources of propan-1-ol or propan-2-ol should submit a request for a technical equivalence assessment of the new source to ECHA. Given the current situation, ECHA is applying reduced information requirements and a modified assessment procedure. This allows immediate work on the assessment to start and a draft decision can be issued even in the absence of fee payment. Detailed information on this process can be found here.
The coronavirus pandemic has placed a huge strain on the chemical industry and its supply chain as companies respond to the increased demand for hand disinfectants. EU regulators have also responded and relaxed regulations to facilitate supply. By working together positively towards a shared interest, chemical companies and regulators can help protect human health.
Useful sources of information
Advice on tackling COVID-19 continues to evolve. The list below captures some sources of information relevant to chemical manufacturers.
|Europe||ECHA page providing a general overview on regulatory issues related to disinfectants with links to further information. There are multiple links from this page to key resources. https://echa.europa.eu/covid-19|
|Europe||European Centre for Disease Prevention and Control on disinfection of environments in healthcare and non-healthcare settings potentially contaminated with SARS-CoV-2. https://www.ecdc.europa.eu/en/publications-data/disinfection-environments-covid-19|
|WHO||WHO technical advice and guidance for countries. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance|