Biocidal Products Regulation

The Biocidal Products Regulation (BPR, (EU) 528/2012) regulates the placing on the market and the use of biocidal products in the EU.

Whether you want to approve a new active substance or register your biocidal product, LAUS can support you with information requirements according to Annex II (active substances) and Annex III (biocidal products) of the BPR or any other international guideline.

We have comprehensive experience with biocides that are difficult to test, e.g. biocides with in situ generated active substances, and offer our expertise to develop an appropriate test strategy with you.

LAUS offers the following tests according to the principles of Good Laboratory Practice (GLP):

Analytical Chemistry

• Chemical Equivalence Studies
• 5-Batch Analysis (Active Ingredient and Impurities)
• Residue Studies

Stability Studies

• Accelerated Storage Stability
• Low Temperature Stability
• Long Term Stability (Shelf Life)

Physico-chemical Properties (CIPAC, EU, UN, OECD and FEA)

in vitro / in vivo* Toxicology

Aquatic and Terrestrial Ecotoxicology

Environmental Fate

Mutagenicity / Genotoxicity

Endocrine Properties

Please don’t hesitate to contact us for a testing proposal or to discuss an individual approach for the authorization/registration of your AS or Biocidal Product.

Approval of Active Substances

A new active substance for biocidal products needs to be approved on Union level in a first step before any biocidal product containing the active substance can be authorized. You can find a list of approved active substances on the ECHA website.

Authorization of Biocidal Products

In order to place a biocidal product on the market, the product needs to be authorized after approval of the active substance. The authorization can be on national or Union level, depending on the market served.

Existing Active Substances

The Biocidal Products Regulation (BPR) from 2012 repealed the Biocidal Products Directive (Directive 98/8/EC) from 1998. Transitional measures apply for biocidal products containing existing substances which were on the market on 14 May 2000 as an active substance of a biocidal product. According to Article 89 of the BPR those can temporarily continue to be made available on the market to facilitate the transition.

The table below lists the deadlines for Union authorization applications (depending on active substance and product type), which are necessary to keep existing products on the market. This review program shall be completed until 2024.

Biocide Definition

The BPR (EU) No 528/2012 considers any substance or mixture a biocidal product which

• comes in the form in which it is supplied to the user or
• is in situ generated from substances or mixtures
• consists of, contains or generates one or more active substances
• has 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
• or is a treated article that has a primary biocidal function

Product Types

In Annex V to the BPR, 22 biocidal product-types (PT 1-22) are specified and grouped in four main areas.

Main group 1: Disinfectants

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

Main 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

Main 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

Main group 4: Other biocidal products

PT 21   Antifouling products

PT 22   Embalming and taxidermist fluids

E.g. surface disinfectant, hand sanitizer, algicide for treatment of swimming pools, disinfection of drinking water are biocides you can find in these groups.

*subcontracted