Fast-tracking biocidal products: BPR and Article 55

The spread of the SARS-CoV-2 virus has strongly increased demand for disinfectants globally. The use of disinfectants is essential to prevent the spread of novel coronavirus. Countries around the globe have put in place emergency legislations and derogations to respond to the crisis.

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 market in the EU must source their active substance or biocidal product from suppliers listed on Article 95 of the BPR. Therefore, the current demand has created shortages of disinfectants in several Member states due to the requirements of Article 95 limiting the access to the market only to companies only included on this list.

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. A Member state must notify the derogation they have applied in their territory to the European Commission and other Member States on a temporary basis; the derogation cannot be valid for more than 180 days.

Yordas supports clients manufacturing, formulating and distributing disinfectants by facilitating their access to the market during this crisis. Contact us to find out more.