Disinfectant & Biocide

ECHA Biocidal Substitution & Derogation Consultation

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Recently, the European Chemicals Agency (ECHA) issued an announcement officially launching two public consultations regarding two biocidal active substances as "potential candidates for substitution" and related conditions for derogation. Relevant enterprises and stakeholders are required to submit their comments before the deadlines in August 2026.

Under the framework of the EU Biocidal Products Regulation (BPR), when an active substance poses a higher risk to human health or the environment, regulatory authorities will assess it as a "candidate for substitution". This means that during the product authorization stage, the regulatory authorities will conduct a comparative assessment. If safer alternatives exist on the market, biocidal products containing the substance may face the risk of authorization refusal or restriction. The consultation on derogation conditions aims to determine whether there are specific essential uses that need to be retained.

Key Compliance Warning: If zineb and alphachloralose are confirmed as substitution candidates without sufficient derogation data, manufacturers may face shortened authorization periods, restricted uses, or even mandatory market withdrawal.

According to the ECHA announcement, these public consultations involve the following two active substances and their corresponding product-types (PT):

Two Active Substances Under Consultation

1. Zineb

Substance Information: EC No. 235-180-1, CAS No. 12122-67-7

Product-type: PT 21 (Antifouling products, typically used in marine antifouling coatings)

Consultation Deadline: August 3, 2026

2. Alphachloralose

Substance Information: EC No. 240-016-7, CAS No. 15879-93-3

Product-type: PT 14 (Rodenticides)

Consultation Deadline: August 13, 2026

The outcome of these two public consultations will directly impact the EU market access for the related biocidal products. If zineb and alphachloralose are ultimately confirmed as candidates for substitution, and there is insufficient data to support derogation conditions, relevant manufacturers and formulators may face risks such as shortened product authorization periods, restricted uses, or even mandatory market withdrawal. This requires the downstream supply chain to seek safer alternatives.

REACH24H Reminder

Enterprises producing, importing, or placing products containing the above two substances on the EU market should immediately evaluate the potential impact of substitution or restriction on their product lines. It is strongly recommended that stakeholders actively participate in the public consultations and submit data and comments to ECHA regarding the safety, non-substitutability (technical or economic), or critical uses of the substances, in order to strive for the necessary derogation conditions.

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REACH24H Agrochemical Compliance Team

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REACH24H Agrochemical Compliance Team

REACH24H

The agrochemical team of REACH24H delivers one-stop global regulatory compliance services for pesticide, biopesticide, biocide, biostimulant and fertilizer enterprises. Covering markets including China, the US, Europe, Asia-Pacific and Latin America, we have served over 600 enterprises worldwide, with China's Top 100 pesticide enterprises exceeding 90% coverage.