Producing and/or making available biocidal active substances and biocidal products on the EU market?
If so, you need to be aware of the Biocidal Products Regulation -BPR ((EU) No. 528/2012), which came into force on the 1st of September 2013 and has repealed and replaced the Biocidal Products Directive, BPD (Directive 98/8/EC).
Who is affected?
Manufacturers, Importers, Formulators, Treated article suppliers. *Non-EU companies can appoint an EU representative to comply with the BPR
Not sure if you have biocides in your product portfolio? Here we have a definition for you to check:
“Biocides are chemicals (substances/mixtures) used to suppress organisms that are harmful to human or animal health, or that cause damage to natural or manufactured materials. These harmful materials includes pests and germs (i.e. moulds and bacteria). Example of biocidal products are insect repellents, disinfectants and industrial chemicals like anti-fouling paints for ships and material preservatives”. ( Source: ECHA)”
Found that your company is producing/placing biocides on the EU market?
Be aware of the following challenges you have ahead:
- From the 1st of September 2015, biocidal products can only contain active substances from suppliers placed on the ECHA’s Art.95 list
- Biocidal Product Authorisation: All biocidal products require an authorisation before they are placed on the market and all active substances used in the product must be approved.
- Active substances: For a new active substance, a dossier must be submitted for evaluation and the substance must be approved before it can be used in the products.
- Treated articles : Treated articles are subjects, mixtures or articles that are treated with biocides in order to preserve or protect the treated article itself. Suppliers of treated articles need to ensure that their articles are only treated with active substances which are included in the review programme or have been approved for use on the EU market for this purpose.