Economic operators are facing a number of practical and legal questions as EU and national authorities work to facilitate the supply of biocidal products.
The COVID-19 crisis has increased demand for disinfectants, hand cleaners, and other biocidal products, resulting in general shortages across most EU Member States. Many companies are currently working to increase the supply of such products and are considering shifting production.
EU companies and non-EU economic operators (through their EU importers) and regulatory authorities are striving to make fast-track procedures fully available via derogation to the lengthy pre-market authorisation procedures established under the EU Biocidal Products Regulation (BPR) and other relevant regulations. In this respect, many questions have arisen surrounding: (i) which legislation applies; (ii) what is the competent regulatory body; and (iii) how to deal in practice with the legal and technical requirements in a timely and cost-effective manner.
The applicable EU Regulatory Framework
With respect to products such as alcohol-based solutions, gels, hand cleaners, and hand disinfectants, there is a lack of clarity as to which EU regulatory framework the products fall under. Indeed, these products can be subject either to the Cosmetic Products Regulation or the BPR, given that “normally only one legislation should be applicable to a product”.[i]
Therefore, sector-specific existing practices are important to address the applicable legal and technical requirements, in particular if the purpose of a product is not clear or not declared and the products are marketed without any claim. However, the claims themselves are not the only decisive factor to understand whether the product falls under the BPR or another piece of legislation.
The issue is of particular interest for those companies producing cosmetics. Many such companies aim to manufacture disinfectants so that these products can be more broadly available to the general public, professionals, and healthcare facilities.
The competent regulatory body
Under the BPR, the supply of disinfectants is regulated both at the EU and national level. Fast-tracking procedures in the public health emergency situation to make products available on to the market can follow: (i) Article 55 (1) of the BPR or (ii) the applicable national legislation.
By way of derogation from the standard BPR authorisation requirements, Article 55 (1) of the BPR allows Member States competent authorities (MSCAs) to grant — for a period not exceeding 180 days — the making available on the market or use of a biocidal product, “for a limited and controlled use”.[ii] The decision to apply Article 55(1) falls entirely under the remit of the Member States and derogations are notified to other authorities and the Commission. Furthermore, only upon a justified request of the relevant MSCA, the European Commission can extend the derogation period by no more than 550 days.[iii]
Applying for the fast-track regime means that the derogations can be granted only within a given national territory, and can have different lengths — as they can also end earlier than the 180 days. Moreover, different procedures apply depending on the substances contained in the biocidal product at issue and whether they are approved active substances, and/or whether they are included in the Review Programme, according to the European Chemical Agency (ECHA), or are “new” substances.[iv]
By way of example, under the COVID-19 emergency, if all substances contained in a disinfectant have been assessed and approved under the BPR, the MSCA can grant to the applicant an emergency permit under Article 55(1), without following the standard BPR authorisation procedure (as set out in Article 17 and 19 of the BPR).
When the disinfectant contains substances which are under examination in the Review Programme set out in Regulation (EU) No 1062/2014, the product to be placed on the market in the Member States shall comply with the applicable national rules and potential derogation therefrom.
To increase the supply of disinfectants, industry has requested the competent authorities to adopt a more flexible “Do and Tell” principle, by which industry can simply inform authorities of minor changes related to already authorised biocidal products without having to wait for prior agreement.[v] In respect to the requirements of the Article 95 list of the BPR, although, in principle, the supplier of the active substance used in a biocidal product, or the supplier of the biocidal product has to be included in the Article 95 list, some Member States have clarified that, in light of the current COVID-19 pandemic, disinfectant products do not have to comply with this legal requirement.
Therefore, the procedure to be followed and the relevant legal and technical requirements are to be assessed on a case by-case basis.
The Italian national guidance
On 6 April 2020, the Italian Ministry of Health issued a communication providing guidance for the authorisation procedures for the marketing and production of disinfectant products in Italy (PT1 /PT2).
As a general principle, all products to be placed on the market that claim a disinfectant, bactericidal, and virucidal action or any action able to fight microorganisms must have been previously authorized by the Italian Ministry of Health.
In particular, if all the active substances in a biocidal product have already been approved at the EU level, the Italian Ministry of Health may authorise the making available and use of the product in the Italian territory under Article 55 (1) of the BPR, as described above.
According to the Italian Ministry of Health, this procedure can also be followed in case of products authorised in other Member States and/or for products containing active substances with different technical specifications, different places, and/or different production processes.[vi]
In this regard, the Ministry of Health also provides practical information concerning the application to be submitted. Applications shall be sent via registered email (pec) to the address email@example.com or to the helpdesk at firstname.lastname@example.org, with the subject: “COVID-19 Emergency – Request for authorization in derogation pursuant to art. 55 BPR”. The following documents shall also be provided:
- Documents relating to active substance supplier
- Product efficacy study according to EN 14476; however, such documentation is not required if:
- The product is similar to the formulations recommended by the European Centre for Disease Prevention and Control and/or the World Health Organization
- Efficacy of the product can be deduced by the composition (providing justification)
- The products have already been authorised in another Member States and the virucidal efficacy has already been assessed (providing a copy of the authorisation in the relevant Member State)
- Technical data sheet
- Full composition
- Product label proposal reporting the following: “Exemption authorization pursuant to art. 55.1 BPR”
As regards products containing an active ingredient not yet approved and included in the Review Programme, in accordance with the BPR, they can be placed on the Italian market pursuant to Presidential Decree n. 392/98, known as Medical Surgical Devices “Presidi Medico-Chirurgici” Decree (PMC Decree).
Pursuant to the PMC Decree, companies that intend to manufacture disinfectants in Italy need to submit an application, providing the information and data required in Annexes 1 and 2 of the Decree of the Ministry of Health of 15 February 2006 and Art. 3 of the Presidential Decree no. 392 of 6 October 1998[vii], to obtain an authorisation from the Ministry of Health. In particular, the application shall include:
- A chemical analysis certificate
- A description of the complete qualitative and quantitative composition of the formulation
- An explanation of the analytical method (test method) for qualitative and quantitative control of the active substance(s)
- A stability test
- A technical data sheet
- An efficiency test, according to EN 14885[viii]
- Confirmation of meeting classification and labelling requirements according to Regulation No. 1272/2008 (CLP Regulation)
Any further change in the conditions on the basis of which the production authorisation was issued requires a specific application be sent to the Italian Ministry of Health (pursuant to Article 4 of Presidential Decree no. 392 of 6 October 1998). Following the inspection of the worksite, the Ministry of Health issues the authorisation decree.
The full list of active substances under review and approved active substances is available at the following link: https://echa.europa.eu/it/information-on-chemicals/biocidal-active-substances.
Lastly, on 25 April 2020, the Italian Institute of Health issued interim recommendations on disinfectant products during the COVID-19 health emergency, including medical surgical devices and biocidal products. The document intends to clarify issues such as the types of disinfectants, for either skin or surfaces, which are available in the Italian market; the efficacy and safe use of these products; and labelling issues.[ix]
Latham & Watkins will continue to monitor regulatory developments in this area.
[i] Commission Guidelines on the applicable legislation for leave-on hand cleaners and hand disinfectants are intended only to facilitate the application of Regulation (EU) 1223/2009 on cosmetics products, and Regulation (EU) 528/2012.
[ii] Article 55(1) of Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (BPR).
[iv] ECHA published a guidance (1 April 2020 – version 2.0) to target biocidal products that are meant to be used in the following product types (PTs): human hygiene (PT 1); surface disinfection (PT 2); and disinfection of surfaces in contact with food and feed (PT 4).
[v] The following examples were provided by the European Soap and Detergents Industry Association (AISE): An authorisation holder that will use the same active substance manufactured on another site, change of supply source of other ingredients (co-formulants) in products, or change of the packaging size (due to supply constraints for certain containers), etc.
[vi] Italian Ministry of Health Guidance issued on 6 April 2020, page 2.
[vii] Decree of the Ministry of Health of 15 February 2006, “Specificazione dei contenuti della domanda di autorizzazione alla produzione di presidi medico chirurgici. (GU Serie Generale n.45 del 23-02-2006)”
[viii] For viruses, the evaluation of effectiveness must be made according to the specific technical standards UNI EN 14476 (for the skin) and UNI EN14476 and UNI EN 16777 (for surfaces), as also explained in the National Health Institute Report on COVID-19 n. 19/2020.
[ix] National Health Institute Report on COVID-19 • n. 19/2020.