Article 95 of Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products states that the supplier of an active substance must be on the list of active substances and suppliers (i.e. lists under Article 95).
To be included in the list of suppliers, two conditions must be met:
- The supplier must provide the required evidence of the active substance the supplier is marketing, and
- The supplier must be established within the EU.
If the supplier is not on the list, it cannot market the substance as active. This means that a biocidal product containing such a substance cannot be notified or authorised in the EU. In other words, you can not market such a product in the EU.
What can you do in such a case?
There are a few options, but each requires significant time to arrange.
The first, seemingly simpler option is to agree with the manufacturer to change the suppliers of the active substance. This means you change the supplier and choose one on the list of active substances.
Alternatively, the manufacturer of the active substance can find a way to enter the list.
My experience shows that usually, the realisation of the first or second option takes approximately 6-12 months.
If you would like to start selling immediately, you must look for another biocidal product, the manufacturer of which already has the documentation in place.
How is the supply of the active substance proven to the authorities?
Supply is confirmed by the following two declarations:
- Confirmation of supply as substance supplier
- Self-declaration by reference to a substance supplier
The template declarations are available here.
When importing from outside the EU, another obstacle emerges that applies to all other substances in the biocidal product. I am talking about the requirements of Regulation (EC) No 1907/2006 REACH.
The latter requires that each imported substance in a mixture imported in quantities of over one (1) tonne in one year is REACH registered (there are exceptions).
Therefore, if you are importing from outside the EU, first check the estimated amount of imported product in one year. Then check if you exceed one (1) tonne for each substance. For these substances, it is then necessary to check that their supplier has evidence of REACH registrations.
Only after confirming the supply of active substances and REACH registrations, you can initiate the notification or authorisation process in the selected EU Member State. Because of the above, the import itself should only take place after obtaining the relevant documents.
If you need help with this, you can contact me at urska.poje@bens-consulting.eu.
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