Recently, the Ministry of Health (Ministero della Salute) of Italy officially published the National Plan of Official Controls on Biocides for the year 2026 (Piano Nazionale dei Controlli Ufficiali sui Biocidi, hereinafter referred to as PNCB). Formulated in strict accordance with the EU Biocidal Products Regulation (BPR, Reg. (EU) No. 528/2012), the plan establishes the official regulatory framework for biocidal products and treated articles on the Italian market for the year 2026. Its core change lies in explicitly intensifying inspection efforts and achieving deep coordination with the enforcement of the EU REACH and CLP regulations.
With the continuous deepening of EU chemical management requirements, the independent enforcement of a single regulation has gradually transitioned to joint multi-regulation inspections. The PNCB plan introduced by Italy not only aims to protect the health of end users but also actively responds to the “Biocidal En-Force” (BEF) projects initiated by the ECHA Enforcement Forum, shifting from a single registration verification to a comprehensive compliance review covering product classification, labelling, packaging, and supply chain information transmission.
Main Content of the Control Plan
According to the official document, the 2026 control activities will span the entire supply chain (including manufacturers, importers, distributors, and retailers), focusing on the following key areas:
Full participation in ECHA Enforcement Projects (BEF): Italy will focus on implementing the three major projects BEF 1, 2, and 3. In particular, the BEF 3 project will conduct strict reviews of authorized biocidal products, with a focus on the compliance of special types of packaging (such as fold-out/booklet labels).
Strengthened document consistency review: Inspectors will verify the consistency between the product’s Safety Data Sheet (SDS), the Summary of Biocidal Product Characteristics (SPC), and the actual product label. Specifically, the Hazard Statements (H-phrases), Precautionary Statements (P-phrases), and hazard pictograms on the label must strictly match the authorized SPC and SDS.
Broader focus on sampled product categories: In addition to the widely distributed conventional disinfectants (Product Types PT 1-4) on the market, insecticides and repellents (PT 18 and 19), driven by the increase in insects and mosquitoes due to climate change, as well as pest control products with surging usage such as rodenticides (PT 14-20), have been listed as key inspection targets for this year.
Analytical controls (laboratory testing): Although sample testing is listed as an optional item, it is strongly recommended to conduct chemical analysis where deemed necessary to verify whether the concentration and purity of active substances align with the product authorization information.
The publication of this control plan means that companies exporting biocidal products to the Italian market or selling them locally will face a more multi-dimensional and stringent enforcement environment. Inspections are no longer limited to confirming whether a product has BPR authorization, but delve into the cross-compliance requirements of the Classification, Labelling and Packaging Regulation (CLP, Reg. (EC) No. 1272/2008). If there is any information misalignment in label updates, SDS preparation, or supply chain information transmission (e.g., first aid measures on the label not matching the SPC), companies may face the risk of product withdrawal or hefty fines.
In light of the 2026 inspection priorities, relevant companies are advised to conduct self-inspections as soon as possible, review the compliance of all types of packaging, and verify whether the source of active substances remains compliant.
