The European Union and USA are taking emergency measure to facilitate the placing on the market for biocidal products

European emergency measures

To face the consequences of the COVID-19 pandemic, ECHA and the European Commission are taking necessary measures in addressing disinfectant shortages, a critical issue in most Member States, by acting on the availability of active substances used in biocidal products - in particular isopropanol, 1-propanol and ethanol-.

ECHA’s activity, aimed particularly to target biocidal products that are meant to be used in hand products (PT1) and surface disinfection (PT2), directly concerns the authorization procedures and methods for requesting it.

What do I need to do to quickly place on the market my products?

If a company wishes to place on the EU/EEA/Swiss/UK market a hand sanitizer product, the authorization procedure according to Regulation 528/2012 (BPR) is different if the substance is new, under evaluation or already authorized.

• In case a biocidal product contains new active substances or already authorized ones (e.g. isopropanol, 1- propanol), normally the procedure stipulates that the biocidal product must be authorized prior to being made available on the market, in accordance with Article 17 and 19 of the BPR. However, in exceptional situations, a Member States may permit products on its market that do not comply with the BPR, under Article 55(1) of the BPR.

Note that the decision to apply Article 55(1) falls entirely under the remit of the Member States and, as a consequence, we recommend contacting with the relevant national helpdesks.

• In case a biocidal product contains substances under evaluation (e.g. ethanol, which is beign evaluated for approval for biocidal product PT1, PT2 and PT4), it not possible to get a Union-wide authorization for products containing it and, as a consequence, it is the national rules of each country that apply for regular authorization of the products.

Since for these substances the national procedures are in force, we recommend contacting the national Helpdesks to find out what procedures must be followed for placing on the market in the individual countries.

What happens in Italy

Last April 6^th 2020, the Italian Health Ministry released a note providing the methods for requesting the authorization for biocidal product PT1 and PT2.

Regarding biocidal products containing active substances yet to be approved, please refer to the ISS guidance in which it is reported that these products must be authorized as “Presidio Medico-Chirurgico” and must be formulated in a workplace authorized by the Ministry.

As for biocidal products containing already approved active substances, the ISS guidance provides adaptation to the European procedure with the adoption of Article 55(1), granting the placing on the market upon authorization request through an application inclusive of:

• Quali-Quantitative full composition
• Safety Data Sheet
• Supplier of the active substance
• Label proposal, in which it is necessary to report “Autorizzazione in deroga ex art. 55.1 BPR”
• EN14476 evaluation, which may not be necessary if:
  • the product composition is similar to recommended ECDC and/or WHO formulations
  • the product is already authorized in other Member States for which the virucidal activity has been verified
  • the product effectiveness is easily deductible from the formulation (in this case, a justification is needed)

This application must be sent via PEC to dgfdm@postacert.sanita.it or to the biocidal Helpdesk at biocidi@sanita.it with the indication in the subject “Emergenza Covid-19 – Richiesta di autorizzazione in deroga ex art. 55 BPR”.

What happens in France?

France is also having difficulties in meeting the demand for authorized hydroalcoholic gels placed on the market and, therefore, the "Ministère de la Transition écologique et solidire" (MTES) has adopted exemptions in accordance with Article 55 (1) of the BPR for certain hydroalcoholic products used as biocides through a series of decrees:

• Decree of March 13^th , which guarantees the exemption for products based on 2 WHO formulations (one based on ethanol, one based on isopropanol) or one formulation approved by Anses
• Decree of March 20^th , which addresses the worsening of the pandemic with various measures, including the addition of a fourth authorized formulation
• Decree of March 27^th , which eases the supply of ethanol and isopropanol
• Decree of April 3^rd , which allows the supply of ethanol and isopropanol beyond the list of suppliers listed on the ECHA website (known as “Article 95”)

In any case, it is always possible to put on the market formulations other than those specified in the decrees, provided that the requirements in force (such as the SIMMBAD declaration, SYNAPSE, etc.) are respected, provided that the substance has not yet been approved at European level (e.g. ethanol).

To facilitate compliance with regulatory requirements, MTES has published a list of FAQs available at the following this link.

For further information, we recommend consulting with the Direction générale des Entreprises (DGE) via the links gelcoronavirus.dge@finances.gouv.fr or the StopCOVID19.fr platform.

Regarding companies established outside of the EU, we remind you that the responsibility for fulfilling the requirements of the communitarian regulation BPR, such as the authorization of biocidal product, lies in principle with the importers established in the European Union.

What happens in the USA?

Because of the public health emergency posed by COVID-19, customers and health care professionals in the USA are experiencing difficulties accessing hand sanitizers products. In this regard, FDA declared that does not intend to take action against compounders or firms that prepare alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs for the duration of the public health emergency, provided the circumstances reported here below are followed:

• Temporary FDA Policy for compounders
• Temporary FDA Policy for firms

For more informations, please use the following links:

• Homepage ECHA, COVID-19 section
• ECHA’s Q&A regarding the sanitizer availability on the European market
• ECHA’s National Helpdesk contact page
• Federchimica’s communications regarding COVID-19 emergency
• Italian Health Ministry’s guidance on authorization for selling and production of biocidal products

Newsletter 131