Biocides Regulatory Insights

Dear readers,

We are excited to share the latest edition of our Biocide Regulatory Insights Newsletter with you this month. As usual, we have compiled the most important news from around the world for you. What's new this time is that articles are summarized for an overview, and if any topic piques your interest, simply click the provided link for more details on our webpage.

We welcome you to explore further and look forward to your visit.

Best regards,

The knoell Biocide-Team

EXPERT TIPS

?? Exciting News in Biocides Efficacy Testing!

A new Technical Agreement on Efficacy (TAB) has been released, offering detailed guidance for biocidal products in Main Group 2 (preservatives) and product types 6-13 (excluding PT 8).

Learn about the tiered testing approach, including simulated use conditions and efficacy requirements.

For the full article and insights, visit our webpage.

Stay informed on the latest in biocides efficacy testing!

EUROPE

Stay informed with the latest updates from ECHA (European Chemicals Agency):

• New Technical Agreement for Biocides (TAB) on APCP: Recently published TAB includes editorial amendments for waiving explosive properties and changes in the number of reference sources.
• Integration of New CLP Hazard Classes in IUCLID: Starting April 29th, IUCLID software will include updated hazard classifications, covering endocrine disruptors and substances like PBT, vPvB, and PMT.
• Expansion of ECHA CHEM Database: ECHA plans to expand its chemicals database in autumn 2024 to accommodate revamped hazard classifications. Guidance materials will be accessible later this year.
• Updates on ECHA Working Procedures: Several working procedures were updated by ECHA at the end of March, including those for active substance approval and Union authorization applications.

For more insights and further details, please visit our webpage.

News from ISO

ISO 7581:2023 Evaluation of bactericidal activity of a non-porous antimicrobial surface used in a dry environment?

We shortly discussed the topic in the March newsletter. If you wish to have a deeper understanding of this Standard, click here.?

ASIA

South Korea: New Guidance on K-BPR 'Simplified Authorisation'

Exciting news from South Korea!

The National Institute of Environmental Research (NIER) has released new guidance on the special authorisation of biocidal products containing 'low risk' active substances through the official submissions portal for biocides (CHEMP).

Key points from the guidance:

• The low-risk active substance list in Korea is akin to the EU BPR Annex I list, including substances like lactic acid, sodium acetate, and lavender oil.
• The publication of this guidance may encourage more companies to apply for special authorisations, as none have been granted to-date.
• Requirements for special authorisations include efficacy testing, analysis reports, stability data, and data on physical-chemical properties.

For assistance in bringing your biocidal product containing low-risk active substances to the Korean market, reach out to our team of experts.

Read more.

Thailand: Recent FDA Draft Announcements

Stay informed about Thailand's regulatory updates:

1. Responsible Advertising Draft: The FDA has released a draft to regulate advertising of hazardous substances responsibly. It prohibits statements involving royalty without permission and contests promoting hazardous products. Visit our webpage for details.
2. Combatting Counterfeit Substances: Thailand's Ministry of Public Health introduced a draft to combat counterfeit hazardous substances. Products with less than or exceeding 20% of active substances will be classified as counterfeit. This initiative prioritizes public health safety.

For concise information and further details, visit our webpage.

USA

EPA's Child Resistant Packaging Requirements for Pesticide Flexible Packaging

Key update from the Environmental Protection Agency (EPA):

• Child Resistant Packaging (CRP) Mandate: EPA has required Child Resistant Packaging (CRP) measures for pesticide products in flexible packaging (e.g., pouches) of 20 fluid ounces or less, when labelled or interpreted for residential use. This requirement applies based on visual packaging similarity to children's food products, irrespective of acute toxicity.
• Compliance Details: Pesticide applicants and registrants must comply with CRP measures for designated packaging sizes. New product applications or packaging amendments under FIFRA (PRIA 5) will be evaluated accordingly.
• Recommended Labelling Mitigation: EPA includes labelling recommendations for all flexible packaging, irrespective of size or use site.

Registrants with non-compliant products should contact the EPA Product Manager by August 6, 2024, for guidance.

For comprehensive regulatory guidance and support, contact knoell USA LLC.

For further details and assistance, visit our webpage.

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Reach out to us for personalized regulatory advice tailored to your specific needs. Whether you have questions about compliance, product registrations, or any regulatory matter, we're here to help. Contact us or visit our website's contact page for more information.