We’ve arrived at the final branch on our Biocidal Product Decision Tree – If you have reached this stage, your biocidal product contains approved active substances covering your specified uses (Product Type). This means that your product must be registered under the EU Biocidal Products Regulation (referred to as the ‘BPR’), Regulation (EU) No 528/2012. There is a formal process of application and review for product dossiers along with stipulated data requirements.
At stage 6 of our Biocides decision tree we look at what is required if all of the biocides contained in (or generated by) your product aren’t approved under the EU BPR?
The Biocidal Products Regulation (BPR) covers the registration for sale and use of biocidal products. These are products used to protect people, animals and materials against harmful pests such as insects or bacteria via the action of an active substance in the product.
The EU BPR is an EU regulation, and as such it covers all EU member states. Not all biocidal products will fall under the remit of the BPR, or don’t yet. These may need to be registered or ‘notified’ under national registration routes – sometimes referred to as transitional rules.
As we reach the half-way point on the biocidal product decision tree (4/8). Our attention turns to borderline products.
Borderline products are those which lie close to the boundary between multiple regulations. Examples include biocidal products, biocidal carriers, treated articles, cosmetic products, medical devices, medicinal products, herbal medicines or food supplements.
These are complex healthcare products which require further investigation to determine which regulatory framework applies to their registration and are determined on a case-by-case basis by national competent authorities. They are called borderline products until their status has been decided.
Are all the biocides contained in (or generated by) your product part of the EU BPR review programme? Branch 5 on the decision tree looks at what you need to do if the answer is no and a new biocide (active substance) dossier must be submitted to ECHA for approval.
Instalment 3 of 8 sees us work our way down the decision tree to look at treated articles and their consequent regulatory obligations.