Introduction

Many sellers entering the EU market are already aware of the requirements under the EU Biocidal Products Regulation (BPR).

However, one of the most common challenges is the extremely high compliance cost associated with traditional biocidal product authorisation. In many cases, full BPR registration can require extensive data packages, long approval timelines, and significant financial investment.

The good news is that not all products require the most expensive compliance route.

For many products, Treated Articles and Simplified Authorisation provide more practical and lower-cost pathways to legally access the EU market.

Treated Articles: A Practical Route for Many Consumer Products

Under the EU BPR, a treated article refers to any substance, mixture, or article that has been treated with or intentionally incorporates a biocidal product. Unlike biocidal products themselves, treated articles do not require product authorisation.

This makes them an attractive compliance option for many products that contain antimicrobial or protective functions. Typical examples include antibacterial textiles or clothing, anti-mould coatings, antibacterial household products, etc.

A treated article can be placed on the EU market without BPR product authorisation as long as the active substances used in the treatment meet one of the following conditions:

• The active substance has been approved under BPR.

• The active substance is included in the EU Review Programme.

• The active substance is classified as a low-risk active substance.

Although treated articles are exempt from product authorisation, companies must still ensure BPR-compliant labelling before selling products in the EU. Non-compliant claims or labels are a common reason for product listing removal or regulatory enforcement.

Simplified Authorisation: A Lower-Cost BPR Registration Pathway

Another highly relevant option is Simplified Authorisation, a special product authorisation route under the EU BPR.

Compared with traditional BPR authorisation routes, simplified authorisation offers lower data requirements, lower regulatory costs and faster approval timelines.

According to Article 25 of the BPR, a product may qualify for simplified authorisation only if all of the following conditions are met:

• All active substances are approved low-risk active substances

• The product contains no substances of concern

• The product does not contain nanomaterials

• The product demonstrates sufficient efficacy

• The product does not require personal protective equipment (PPE) during normal use

Low-risk active substances are listed in Annex I of the BPR and include commonly used ingredients such as Peppermint oil, Lactic acid, Ascorbic acid, etc. These ingredients are widely used in natural antimicrobial, deodorizing, and household hygiene products.

For many cross-border e-commerce companies, the cost of traditional BPR registration is often the biggest barrier to entering the EU market. By identifying whether a product qualifies for simplified authorisation, companies can:

• Reduce regulatory costs significantly

• Avoid unnecessary data generation

• Shorten compliance timelines

• Maintain stable EU market access

If you are selling antibacterial, deodorizing, preservative, or insect-repellent products in the EU, it may be worth evaluating whether your products qualify for Treated Articles or Simplified Authorisation under the EU BPR.

For more information or assistance, please feel free to contact us at customer@reach24h.com.