Key Updates on Biocidal Regulations in Europe, Korea, ASEAN, and the USA

This December, significant updates from regulatory bodies in Europe, Korea, ASEAN, and the USA are directly impacting companies in the biocidal products, chemicals, and related industries. Below is a comprehensive summary of these critical developments.

Developments in Europe

Upcoming ECHA Events

The ECHA Biocides Stakeholders’ Workshop will return in April 2025 in a hybrid format. This event offers a great opportunity for stakeholders to connect with industry representatives and authorities.

Regulatory Changes and Documents

New CA Documents: Updates to delegated regulations amending the rules for biocidal product renewals (CA-Sept24-Doc3.2). Applications for minor changes must now be submitted 345 days and major changes 570 days before the authorization renewal.

Updated Confidentiality Claims Guidance: ECHA has revised its guidance on confidentiality claims under the Biocidal Products Regulation (BPR).

CA Meeting Agenda: Key topics include environmental risk assessments, amendments to mutual recognition procedures, and updates to guidance on in-situ generated active substances.

APCP TAB Updates

Storage testing for liquid formulations (considering worst-case packaging sizes).

Categorization of pre-soaked wipes (classified as “impregnated wipes”).

Source requirements for active substances in biocidal products.

Data waiving justifications for self-reactive/explosive properties.

Developments in Korea

SME Support Project

The Korean Chemicals and Management Association (KCMA) has completed the first selection process for SME support projects under the K-BPR. Financial support is provided to SMEs meeting the eligibility criteria.

KCMA Seminar

The 2024 KCMA seminar highlighted active substance approvals under the K-BPR. Notably, only six wood preservative applications remain under review, with others rejected.

Developments in ASEAN

Philippines

The list of banned pesticides is being updated.

Public consultations are underway regarding proposed bans, particularly for urban pesticide applications.

Singapore

The 2024 Active Disinfectant Ingredients List has been updated, including substances effective against infectious pathogens like COVID-19 and Mpox.

Thailand

A public hearing is being conducted on proposed exemptions for hazardous substance imports for specific purposes, including exhibitions and foreign film productions.

Developments in the USA

New Draft Guidance

The U.S. Environmental Protection Agency (EPA) has issued draft guidance for registering pre-saturated disinfectant wipes.

ASTM E3363 is recommended as the efficacy testing method.

The guidance emphasizes testing disinfectant wipes in their final packaging and form.

Public Comment Period

The draft guidance is open for public comment for 60 days, with comments accepted via www.regulations.gov.

These regulatory changes significantly impact companies in the biocidal products, chemicals, and related sectors. The Doruksistem team is ready to support new submissions, renewals, and updates. Staying informed and compliant with these changes is crucial for staying ahead in the industry.

Key Updates on Biocidal Regulations in Europe, Korea, ASEAN, and the USA