23 April, 2017

Biocides 101 - How to navigate the regulatory process

By David Arrowsmith

Here you can find all you ought to know about biocides. Discover what they are, how they’re regulated, and the secrets to getting your product registered successfully.

What is a biocidal product?

In the words of the European Chemicals Agency (ECHA), a “biocidal product” means:

“...any substance or mixture, in the form in which it is supplied to the user,
or generated from that form, 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.”


What types of biocidal products are there?

As you can imagine, there are many. The EU classifies 22 different types, including:

Water drops on grassDisinfectants - That’s human and veterinary hygiene, drinking water, products to be incorporated into materials which may enter into contact with food

Preservatives - Examples are food products during storage, in film, in wood, in fiber, in rubber and polymerized materials, in leather, and in construction material preservatives

Pest control - Such as repellants and attractants, rodenticides, insecticides, avicides, molluscicides

Other - This covers antifouling products, embalming and taxidermist fluids


How are biocides regulated?

In Europe:

The EU Biocidal Products Regulation (BPR) was applied in EU member states in September 2013. The BPR revises and replaces the previous regulatory framework for the marketing and use of biocidal products.

The BPR considers the authorization of biocidal products that fulfill both these conditions:

  • The substance is an active substance for use in a biocidal product
  • The substance is included in one of the following:
  • List of approved substances according to Regulation (EU) No 528/2012
  • Annex to Regulation (EU) No 528/2012
  • Regulation (EU) No 1062/2014

The ECHA also regulates the use of biocidal products under both:

In the United States:

All biocides (referred to as antimicrobial pesticides) in America are regulated by FIFRA. FIFRA requires the EPA to evaluate active substances. Amongst other things, the EPA must also register formulated pesticides for sale and distribution.

Please note, FIFRA requires all pesticides distributed or sold in the United States to be registered and licensed.

You can find out more about FIFRA ‘s powers and the EPA’s role hereUS registration can take one of four forms. You can explore them all in more detail by clicking the links below:


In Asia:

Some Asian countries regulate, for example The Philippines. Others don’t - for example China.

Remember : before any biocide developer anywhere in the world seeks regulatory approval, its substance must be tested first.

Revealed: your five steps to navigating the regulatory process
It’s no secret that the regulatory process for gaining approval of a biocide product can be expensive and time-consuming. Here is a five step model that you may find useful. It’s the quickest and most efficient way to navigate the regulatory process. To find out more about these steps to success, click any of the links below:

  1. Evaluate your product types and uses
  2. Assess national and global legislations
  3. Create an IUCLID dossier
  4. Submit your application using R4BP3
  5. Gain approval of your active substance

For more information on biocides, their regulations, and how to register your biocidal product successfully download the whitepaper today.
Understanding biocidal development and regulation

About the Author

David’s main focus and area of expertise is biocides regulations, including regulatory advice and strategy. The latter often involves preparing documents such as data gap analysis, or setting up and identifying the format of product families. You may also be interested in reading his other blogs;

Category // Biocides, Chemical, Crop protection, David Arrowsmith