Biocide regulation: changes in recent years

In 2012, the European Union issued a new regulation (No. 528) concerning the placing on the market and use of biocidal products and treated articles, which are used to control harmful organisms, such as bacteria or insects, that can attack humans, animals or materials.

The new regulation replaces the previous Directive 98/8/EC and aims to improve both the functioning of the European market and the use of these products, ensuring greater protection of human, animal and environmental health.

In a nutshell, the Regulation and its subsequent amendments govern:

• the authorisation for the placing on the market of biocidal products;
• the mutual recognition of authorisations by EU countries;
• the creation of an EU-approved list of biocidal active substances (so-called 'positive list');
• nanomaterials (through the creation of guidelines);
• the placing on the market of treated articles.

This regulation not only simplifies the authorisation of biocidal products and the approval of active substances for these products, but also promotes the reduction of animal testing by obliging manufacturers to share data and encouraging the use of alternative testing methods.

Not all active substances have yet been evaluated: there are products on the market that, although they have a biocidal use, are currently placed on the market without authorisation. These are referred to as products of free sale (prodotti di libera vendita - PLV).

Thus, biocidal products within the European Union require authorisation before they can be placed on the market. While the approval of active ingredients is left to the EU, the authorisation of the final product takes place at Member State level. This means that if a product is sold in Italy, authorisation is sought from the competent authority of the Italian state, i.e. the Ministry of Health.

If approved, the authorisation will only be valid for that specific country. If you also want to sell the product in other EU countries, you must then apply for mutual recognition.

Biocidal products include 22 Product-Types (PT) defined according to use and divided into 4 main groups:

• Main Group 1: Disinfectants (PT 1, 2, 3, 4 and 5)
• Main Group 2: Preservatives (PT 6, 7, 8, 9, 10, 11, 12 and 13)
• Main Group 3: Pest control (PT 14, 15, 16, 17, 18, 19 and 20)
• Main Group 4: Other biocidal products (PT 21 and 22).

For further information on biocide regulation, visit the ECHA (European Chemical Agency) website:

• ECHA – Understanding Biocidal Products Regulation (BPR) 
• ECHA – List of active substances and suppliers 

 

 

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