What is it?
Biocides are chemicals aimed at the protection of humans, animals, materials etc. against harmful organisms. The products are biocidal products which contain one or more active substances.
The Biocidal Products Regulation (BPR) is the legislation under which the active substances and products are regulated. Some Active Substances (ASs) are still in the Review Programme. For these National Transitional Arrangements apply.
Where does it apply?
The legislation applies in the European Union (EU). Because the rules were redefined in 2012 it allows for the transition of the products and active substances from the old regime to the new one.
As the United Kingdom (UK) has withdrawn from the EU it will operate its own biocides legislation, which at the start will be almost of copy of EU rules, but has some changes. The withdrawal is commonly referred to as Brexit. Active substances and products approved at the EU level before Brexit will continue to be legal in the UK until they come up for renewal.
The UK also has arrangements in place for substances in the Review Programme.
How can it affect you?
Once the active substance has been reviewed under the new 2012 rules the product in which it is present will be given a date by which a product authorisation needs in principle to have been approved.
Before that time or when the active substances are still in the so-called Review Programme national rules apply and these rules may differ in each EU member state as the active substances and the products come under the Transitional Arrangements. This can make the whole process rather complicated. But you need to be meeting the national requirements to legally market your product in each country.
Solutions for you
We support applicants with their approval for active substances and also users of those substances in their biocidal products when they need to apply for product authorisation. The active substances contained in that biocidal product must be previously approved, although there are certain exceptions to this principle. For example, biocidal products containing active substances in the Review Programme can be made available on the market and used pending the final decision on the approval of the active substance (and up to 3 years after), yet during this period they are subject to national laws in each Member State.
We will ensure the suppliers of the actives appear on the Art. 95 list, which is a pre-requisite for use in finished products.
Not sure where to start?
You may wish contact us to determine your obligations. We will be happy to assist you with your needs.
All biocidal products require an authorisation before they can be placed on the market, and the active substances contained in that biocidal product must be previously approved. There are, however, certain exceptions to this principle. For example, biocidal products containing active substances in the Review Programme can be made available on the market and used (subject to national laws) pending the final decision on the approval of the active substance (and up to 3 years after). Products containing new active substances that are still under assessment may also be allowed on the market where a provisional authorisation is granted.