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17 Jun 2019

Understanding The Biocidal Product Regulation

Understanding The Biocidal Product Regulation

In EU, the Biocidal Products Regulation (BPR) refers to Regulation (EU) 528/2012) concerning the placing on the market and use of biocidal products. It repeals the Biocidal Products Directive (Directive 98/8/EC) and comes into force on 1 Sept 2013. The regulation not only impacts manufacturers and importers of biocidal products, but also affects article producers who use biocidal products to treat their products. In this article, we will summarize how to comply with EU BPR regulation from different perspectives.


Main Requirements of EU BPR Regulation

The key requirement of BPR regulation is that all biocidal products require an authorisation by European Chemicals Agency (ECHA) before they can be placed on the EU market, and the active substances contained in that biocidal product must be previously approved.


The Biocidal Products Regulation (BPR) also sets rules for the use of articles treated with, or intentionally incorporating, one or more biocidal products. Articles can only be treated with biocidal products containing active substances approved in the EU. This also applies to articles manufactured outside of EU. Some treated articles require additional labelling.


Definition of Biocidal Products and Scope

The definition of biocidal active substance, biocidal products and treated article is listed as follows:

Active substance: a substance or a micro-organism that has an action on or against harmful organisms.
Biocidal produdcts: any substance or mixture, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.
Treated article: Articles that have been treated with, or intentionally incorporating, one or more biocidal products.
Biocidal products covered by the BPR regulation are classified into 22 biocidal product-types, grouped in 4 main groups.


Group

Product Types

Group 1 Disinfectant
PT 1 Human hygiene
PT 2 Disinfectants and algaecides not intended for direct application to humans or animals
PT 3 Veterinary hygiene
PT 4 Food and feed area
PT 5 Drinking water

Group 2 Preservatives
PT 6 Preservatives for products during storage
PT 7 Film preservatives
PT 8 Wood preservatives
PT 9 Fibre, leather, rubber and polymerised materials preservatives
PT 10 Construction material preservatives
PT 11 Preservatives for liquid-cooling and processing systems
PT 12 Slimicides
PT 13 Working or cutting fluid preservatives

Group 3 Pest control
PT 14 Rodenticides
PT 15 Avicides
PT 16 Molluscicides, vermicides and products to control other invertebrates
PT 17 Piscicides
PT 18 Insecticides, acaricides and products to control other arthropods
PT 19 Repellents and attractants
PT 20 Control of other vertebrates

Group 4 Other Products
PT 21 Antifouling products
PT 22 Embalming and taxidermist fluids

Note: It is very important to know your product type first to determine whether BPR regulation applies to your product or not. Take preservatives for example, BPR regulation does not apply to preservatives used in cosmetics and food because such uses are not covered by above product types. A treated article that has a primary biocidal function shall be considered a biocidal product. 

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