Authorisation of Biocides in the EU
The first milestone in the European history of biocides regulation was set with the Biocidal Products Directive 98/8/EC (BPD) adopted in February 1998 and aiming at harmonising the EU market for biocidal products and their active substances, while ensuring a high level of protection of the environment, human and animal health. According to the Directive, biocides are divided into 23 diverse product types, including disinfectants, preservatives, pest control, anti-fouling and embalming products.
In September 2013, the BPD was replaced by the Biocidal Products Regulation No 528/2012 (BPR) concerning the making available on the market and use of biocidal products. Among major revisions brought forward in the BPR was the introduction of the possibility to authorise certain biocidal products and product families at Union level by means of the so-called union authorisation or mutual recognition. The latter is applicable for companies wishing to extend their national product authorisation to other markets within the EU. The BPR also lays down the provisions for the renewal of already approved active substances and regulates the use of articles treated with or intentionally incorporating biocidal products.
With the authorisation process of biocidal products being regulated at EU Member State level, excluding union authorisation, the lack of harmonisation of mutual recognition procedures within individual Member States still poses a challenge to the biocides companies authorising their products in the EU. SCC experts can guide you through the regulatory challenges of the biocidal authorisation process.
Established in 2000, our Biocides team of experts have successfully submitted dossiers for more than 20 existing biocidal active substances, covering nearly all product types. We have established excellent working relationships with many competent authorities in the EU and have become an acknowledged partner of authorities and industry.