Defining Treated Articles and your regulatory obligations
Instalment 3 of 8 sees us work our way down the decision tree to look at treated articles and their consequent regulatory obligations.
A treated article refers to a product where the main function of the product is something other than to act as a biocide, and the presence of the biocide is secondary to this main function. A treated article is defined in the EU/UK as “any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products”.
In this scenario the rules for Treated Articles (BPR Art. 58) as laid down in the BPR need to be followed. Article 58 states that only treated product that are compliant with the BPR may be placed on the market, and that the treated article must be clearly labelled, detailing the biocidal product(s) that have been used.
The compliance rules which must be followed for treated articles in the EU/UK ultimately depend on the primary function of the product, where “a treated article that has a primary biocidal function shall be considered a biocidal product”.
To determine if a product can be considered as a treated article only, the simple question of “does the primary function of the product change if the biocide is removed?” will direct the regulatory path which needs to be followed. In the case of a treated article, the regulatory compliance requirements are significantly reduced compared to those of a full BPR registration, focussing on sufficient product labelling.
These requirements include providing relevant instructions for use - including any precautions to be taken, a statement that the treated article incorporates biocidal product(s), the biocidal property given to the treated article the name of all active substances contained in the biocidal product(s) as well as clearly visible, legible and appropriately durable labelling in the local language of sale.
To learn more about treated articles and the BPR, look out for our “Introduction to the Biocidal Products Regulation” eBook, coming soon.