The shortage of hands and surfaces disinfectants on the European market due to the COVID-19 pandemic has led companies to increase the supply of such products and/or consider shifting their chemical production.

Hand and surface disinfectants defined as biocidal products in Product Type (PT) 1 and 2 fall under the EU biocidal products Regulation (BPR). Companies placing a biocidal product on the EU market must source their active substance or biocidal product from suppliers listed on Article 95 of the Biocidal Products Regulation (BPR, Regulation (EU) 528/2012), limiting the market access exclusively to companies on this list.

The partial suppression of BPR during the pandemic

However, the BPR provides alternative provisions to standard requirements (Article 55 of BPR) allowing Member States to fast-track biocidal products when there is a public health emergency.

Article 55 allows Member States, at their discretion, to allow non-authorised biocidal products on the market, for a period not exceeding 180 days, during a public/animal health or environmental emergency. An extension may be granted for a period not exceeding 550 days by the EU Commission.

Several European Countries have adopted rules in order to fast-track the availability of disinfectants, under two main routes: Article 55 (BPR derogation) and national legislations:

• Article 55 only applies to active substances that have already been approved in the EU for a specific product type (e.g. propan-2-ol in PT1) or to ‘new active substances’ (e.g. Active chlorine released from hypochlorous acid in PT1) currently under evaluation.

• National legislative decisions were used by selected Member States to temporary authorise products with selected active substances (i.e. propan-2-ol, propan-1-ol and ethanol) and formulations for use in PT 1 and PT2.

When will derogations expire?

The temporary derogations have fixed terms and do not offer a grace period when they end. Therefore, products must be removed from the market with immediate effect after the expiry date.

The expiry date will depend on the type of derogation granted, and on when and for how long individual Member States decide to issue derogations:

• Under Article 55, derogations will expire at the end of the 180 days period granted or following an extension up to 550 if granted by the Commission.

• Under National Rules, derogations will expire at the end of the duration.

Rules subject to change already this autumn

So for example in Germany, the BAuA has emitted a decision decree (710 30/01.00003) for specific derogatory formulations of hand disinfectants containing propan-2-ol, propan-1-ol and ethanol as specified in the decree which is going to expire on 6 Oct 2020; while for surface disinfectants containing ethanol, sodium hypochlorite and chloramine-T the decision decree is going to expire on 30 Sept 2020.

Four different derogatory formulations are authorised in France until 31 Dec 2020.

How to prepare for the expiry of derogations?

• Monitor the evolution of the COVID-19 pandemic, to identify possible extensions due to further supply demands for disinfectants.

• Check individual Member State national rules. Products with active substances under evaluation, may continue to be placed on the market in accordance with national regulations.

• Article 55(1) of the BPR does not provide a grace period when derogations expires. Therefore, the following will apply:

  • Companies wanting to continue to market products containing approved active substances must remove their products from the market immediately after the expiry date of the derogation and submit a product authorisation dossier in accordance with BPR.

  • Companies placing products on the market containing active substance in the review programme will need to comply with Member states national rules in accordance with BPR transitional provisions (Article 89).

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