Introduction
Recently, the European Commission submitted a draft delegated regulation to the World Trade Organization (WTO) regarding the amendment of the Biocidal Products Regulation (BPR, Regulation (EU) No 528/2012). The draft aims to amend the approval conditions for the active substance Carbon Dioxide in Annex I.
The core change lies in the removal of the rigid restriction on specific application devices, shifting to using more scientific exposure concentration limits as the basis for control.
Current Restrictions and Challenges in Annex I
According to Article 28(1) of the EU Biocidal Products Regulation (BPR), active substances listed in Annex I are eligible for the simplified authorisation procedure for related products due to their lower risk. Currently, Carbon Dioxide is listed in Annex I as a Category 6 active substance, but its existing entry contains a strict restriction: “Only for use in ready-for-use gas canisters functioning together with a trapping device”.
This restriction appears too narrow in practical application, hindering the use of Carbon Dioxide in other equally safe but technically different biocidal applications. Based on an amendment application received in November 2023, the competent authority of the Netherlands conducted an evaluation, followed by an opinion issued by the European Chemicals Agency (ECHA) on 10 September 2025. The Agency concluded that the original specific device restriction should be removed and replaced by new control measures based on safe exposure limits. This shift aims to encourage broader product innovation and market access while ensuring safety.
Key Revisions
According to the draft text, the entry regarding Carbon Dioxide will undergo the following key revisions:
Removal of Specific Device Restriction
Delete the original description “Only for use in ready-for-use gas canisters functioning together with a trapping device”. This means the form of future Carbon Dioxide biocidal products will no longer be limited to specific gas canister devices.
Introduction of Exposure Limits
The new regulation stipulates that the authorisation of biocidal products containing carbon dioxide as an active substance must be subject to the following safety exposure conditions:
1. Professional Users
Short-term exposure limit (STEL, 15 minutes): Carbon dioxide concentration must remain below 1.5% (v/v);
Time-weighted average (TWA, 8 hours): Carbon dioxide concentration must remain below 0.5% (v/v).
2. General Public or By-standers:
Carbon dioxide exposure concentration must remain below 0.1% (v/v).
Risk Mitigation Measures
The draft explicitly states that, where appropriate, the necessary measures shall be taken by the user as described in the summary of product characteristics (SPC) to ensure exposure levels remain within the aforementioned limits.
Compliance Recommendations
Given that this regulation is expected to enter into force in 2026, it is recommended that relevant companies take the following measures:
Re-evaluate Product Portfolio: For Carbon Dioxide products that were previously unable to apply for Annex I simplified authorisation due to “non-gas canister devices,” companies should re-evaluate their potential for market entry.
Conduct Exposure Assessment: R&D departments should conduct simulation testing for existing or planned products to ensure that, under the operations specified in the instructions for use, the carbon dioxide concentration in the environment is strictly controlled within the new limits (0.1% - 1.5%).
Update Summary of Product Characteristics (SPC): For products currently under application or planned for application, necessary risk mitigation measures (such as ventilation requirements, usage duration limits, etc.) must be explicitly listed in the SPC to meet compliance obligations.
This revision marks a shift towards more scientific and flexible management of low-risk active substances by the EU. The draft is currently in the WTO notification and comment period (deadline is 1 May 2026). Companies exporting to the EU are advised to closely monitor the final published version of the regulation and plan product compliance strategies in advance to fully utilize policy benefits.
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