The COVID-19 outbreak has been the stage of a new gold rush: masks, gloves, hand-sanitizers, those products that hadn’t raised crowds’ attention until they became a must-have within both our social practices and legislation. Recommended by the World Health Organization, EU institutions, and governments, the hand-sanitizer product market has been subject to huge pressures. Studying how sufficient market supply was finally granted and at what cost gives us perspectives on how EU’s chemical legislation may adapt in times of crisis.

But first, what is a hand-sanitizer, how is it regulated? The answer is not completely straight forward. As a product in contact with the skin, claiming an anti-virus/anti-bacterial effect, hand-sanitizers are heavily regulated under EU law. Two legal frameworks are potentially applicable to such products: the Cosmetic Products Regulation, or the Biocidal Products Regulation. Defining which legal framework applies to them is subject to a couple of considerations. First, whether the product follows a primary cosmetic purpose (such as cleaning), or a primary biocidal purpose (control harmful organisms). The latter products can, secondly, be identified through their claims. A biocidal product will make claims such as “disinfecting”, “killing viruses”. Additional considerations relate to the composition and active substance, purpose, and mode of action of the product. For the purpose of the following analysis we will hereby exclusively focus on hand-sanitizers considered as biocidal products.

Biocidal products were covered by a first specific legal scheme under Directive 98/8/EC, aiming to establish harmonized pre-market authorization procedures. Following the first authorization in a Member State, producers could then seek mutual recognition in the other Member States. In 2012 the Directive was replaced by the Biocidal Products Regulation (hereafter ‘the BPR’). Harmonization was deepened through the introduction, alongside national authorization procedures, of an EU-wide authorization as well as an EU list of active substance suppliers, mandatory data sharing, and a centralized management by the European Chemicals Agency (hereafter ‘ECHA’).

The BPR authorization system

Placing a hand sanitizing product on the market requires producers to go through a series of legal obligations. Both active substances and biocidal products are subject to authorization. Active substances are approved for certain product types, which refers to the possible use(s) of the biocidal product. Hand sanitizers, belonging to product type 1, shall then be submitted for authorization, either national or European. Each prospective authorization holder shall submit its own request. The product shall contain an active substance approved at the EU level. Products containing active substances that haven’t been yet approved at the EU level are subject to the national procedures that preceded the BPR.

In addition to those requirements, from September 2015, a biocidal product consisting of, containing or generating a defined active substance cannot be placed on the market without prior inclusion in Article 95 BPR list of the substance or product supplier. Such provision aims at ensuring that producers who have incurred the substantial costs induced by the different safety assessments required do not suffer unfair competition.

Those processes aim at preventing negative impacts on both the environment and human health while guaranteeing equal treatment of producers and products’ efficiency. Yet, both types of obligations have recently been subject to alterations in relation to the COVID-19 outbreak, through the procedure of Article 55 of the BPR.

The flexibility clause of Article 55

From the early days of the COVID-19 outbreak, ECHA recommended hand-sanitizer producers to apply for national temporary authorisations under Article 55 (1) of the BPR.

Under Article 55 (1) of the BPR, “a competent authority may permit, for a period not exceeding 180 days, the making available on the market or use of a biocidal product which does not fulfil the conditions for authorisation laid down in this Regulation, for limited and controlled use under the supervision of the competent authority, if such a measure is necessary because of a danger to public health, animal health or the environment which cannot be contained by other means.”

This mechanism allows for great flexibility in times of substantial shortages for products recognised as essential. Allowing substantial time and cost-saving (safety assessment studies and applications are particularly costly), it was recognized by ECHA as “the most effective way to address the needs to have more biocidal products on the market”. The procedural adaptations in such situations are decided upon by each Member State.

National authorities shall inform the Commission as well as the other Member States. If the first temporary authorisation of a product can be authorized independently by the State for 180 days, its prorogation will require a decision from the European Commission.

Under Article 55, pre-market requirements imposed under the BPR suffer important adaptations. First, regarding active substances, ECHA issued recommendations on the compositional requirements of approved active substances propan-1-ol, propan-2-ol, active chlorine released from sodium hypochlorite, hydrogen peroxide, and peracetic acid for the purpose of Article 55 derogations. However, other active substances such as ethanol are still under review and are thus not yet approved under the BPR. As a consequence, States are left to apply their pre-existing national legislation on biocidal products, which leads to substantial diversity in the applicable norms. Where this focus on specific active substances takes great importance is in consideration of the substantive shortage of such substances, which led to the entrance in the market of new producers such as breweries and liquor producers.

Consequently, flexibility was also granted in terms of which active substances’ sources may be relied on. Indeed, under Article 95, biocidal products manufacturers may only use active substances sourced from approved suppliers. States such as Sweden and Denmark, despite ECHA’s advice against it, have excluded such requirements for the measures taken under article 55 BPR. In addition to such national specificities, ECHA has also announced fast-tracking the technical equivalence procedure assessing new substance sources for already authorised products. Consequently, procedures may differ to a great extent from one state to another.

Finally, regarding products per se, very different approaches have also been adopted. In Belgium for instance, authorisations are granted on an individual basis while in France, a general Arrêté established which product formulations may be deemed conform to the legal requirements. The different national regimes may equally diverge regarding what substances are recommended and what product compositions and procedures shall be followed.

Perspectives on the current application of Article 55

These adaptations of the BPR rules bring with them a series of concerns. Indeed, while the use of such mechanism is nothing but new (precedent uses targeted for instance spores, rodents, mosquitoes), the current flow of notifications, covering the vast majority of Member States is unprecedented and as is the need for such products on the market. If the intended effect – avoiding shortages- was effectively addressed, we would highlight two series of concerns.

The use of Article 55 has prompted the entry into the market of new producers such as alcohol brewers supplying ethanol. Such producers are less familiar with the BPR legal framework and requirements granting both the safety and efficiency of hand-sanitizing products which may lead to shortcomings on those two grounds. Alongside those concerns, Member States have also reported an increase in the number of unauthorised products on the market. When dealing with products used for sanitary purposes and in contact with the skin, these elements are not to be taken lightly. On the other side, compliance with the full BPR authorisation is a very heavy, costly, and lengthy process that could have led to worsened shortages. States needed to strike a balance between the emergency of the need for such products and the BPR processes, guided by the principle of precaution. Whether or not safety is ensured by national processes is subject to caution.

While the Member States developed their own temporary authorisation system, this step back on harmonization leads to increased complexity. This enters in contradiction with the innovations brought by the BPR, notably the capacity to directly request a Union-wide authorisation.

While ECHA was said to be working on a centralized application system for disinfectant producers back in March, as was requested by the chemical industry, such a plan was retracted in April. As a consequence, producers have been bound to adapt to each State’s procedural specificities and could solely rely on ECHA’s non-binding recommendations.

A final element of complexity that must be highlighted lies in the duration of the authorization period. Indeed, they will expire within 180 days unless being prolonged by the Commission. Consequently, new shortages may occur in autumn, while uncertainties remain as to how long such products will be needed to face the pandemic. Producers will then be confronted with the full complexity of the BPR rules.

In conclusion, the use of Article 55 appears as a -temporary but significant- success as regards market supply, yet it can also be perceived as a missed occasion for ECHA to further harmonisation in the field.

Sources

• Cefic, COVID-19 Helpdesk
• Chemical Watch, “Disinfectants freed from the law as Europe battles Covid-19”, 24 March 2020.
• Chemical Watch, “ECHA cancels plans for central derogation submission system, 8 April 2020.
• Chemical watch, “ECHA cancels plans for central derogation submission system, 8 April 2020.
• Europe eyes further legal exemptions as disinfectant demand changes, 06 May 2020, https://members.chemicalwatch.com/article?id=113753
• Cross-Industry Alliance on COVID-19, “Practical Guide Fast-Tracking Disinfectants during the COVID-19 Pandemic”European Chemicals Agency, COVID-19 updates page
• European Commission, Guidance on the applicable legislation for leave-on hand cleaners and hand disinfectants (gel, solution, etc.)
• Politico, “Dodgy disinfectants on the rise due to coronavirus”, 24 April 2020.
• Politico, “One bourbon, one scotch, one beer to kill coronavirus”, 11 May 2020.

 

 

 

Marie Escorneboueu is currently a trainee within the Chemicals and Life Science team of the Washington-based law firm Steptoe & Johnson LLP, after experiences within the European Court of Justice and the European Commission. Before that she graduated from the Master 2 Droit Economique de l’Union at the University Paris 1 Panthéon Sorbonne and from the College of Europe.