Spotlight on Treated Articles

Spotlight on Treated Articles

During the 2024 Dublin Biocides Symposium in March, Hazel O’Keefe, Partner at law firm Keller & Heckman in Brussels, spoke about the current status of treated articles according to the Biocidal Products Regulation (EU) No. 528/2012 (the BPR), Article 58.

A treated article is defined as any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products for instance everyday items such as chopping boards for food, grab bars in transport, etc. Treated articles with a primary biocidal function, such as disinfectant wipes are classified as biocidal products. Hazel referred to the useful decision tree in the EU guidance in order to help to distinguish between a treated article and a biocidal product. https://circabc.europa.eu/sd/a/15baa078-162c-4186-aaa2-6293a80e1561/CA-Nov14-Doc.6.1%20-%20Treated%20articles%20guidance%20note.doc

The presentation continued with the requirements applicable to treated articles. As stated in Chapter XIII (Article 58) of the BPR a treated article may not be placed on the EU market unless all active substances in biocidal products are included in the list to be drawn up in accordance to Article 9(2) for the relevant product-type and use or in Annex I and any conditions or restrictions specified therein are met. Furthermore, the active substance in a treated article must be in the Article 95 List for the relevant Product Type (PT) or in the List of Notifications for the relevant PT.

Labelling requirements for treated articles are only applicable if a claim is made on biocidal properties of the treated article containing a biocidal product or if it is required in the approval of the active substance. These requirements include statements that the treated article incorporates biocidal products, as well as the name of all active substances and any relevant instructions for use and other specific requirements.

In addition to that, more specific requirements are listed for treated articles intended for use as food contact materials (‘FCMs’). Examples of these FCMs are surface biocides used in plastic FCMs (i.e. treated articles) that have additional requirements as they must be listed on the Plastics Regulation (EU) No. 10/2011 or in the Provisional List of Additives, unless the biocide is separated from the food by a functional barrier to migration. These FCMs may be placed on the EU market subject to Member State legislation.

Hazel stressed the importance of following strict standards for active substances, labels, and materials that touch food, which are essential for businesses in the EU dealing with treated articles.

If you need support with treated articles or any other aspects of the registration of your biocidal products, please contact Kerona’s Biocide Team at info@kerona.ie