News & InsightsNewsletterLegislation Hub

Foresight

Foresight
AboutContactLog in
Book a Demo
Foresight logo
All News & Insights

MHRA Confirms Mycobacteria Claims in PT 1 Biocide Products Fall Under Medicines Regulations

BPR GB
BPR
24
October 2024
•
2 min read
Dr Steven Brennan
MHRA confirms biocide products in PT 1 making mycobacteria claims now fall under medicines regulations.
Disinfecting hairscalp
Quick prompts

AI Generated

Get to the point quicker with prompts - a smarter way to get the information you need from our articles.

Summarise this article

AI Assistant

This feature and much more is available on our platform. If you would like early access, please leave your email and we'll get in touch.

We'll be in touch when the Assistant is ready.
Oops! Something went wrong while submitting the form.
Mountains

On 21 October 2024, the UK Medicines and Healthcare products Regulatory Agency (MHRA) confirmed that biocidal products in PT 1, which are applied directly to human skin, must comply with medicines regulations if they make claims against mycobacteria. This change impacts the authorisation process for products like hand sanitisers and disinfectants in Great Britain and Northern Ireland.

Mycobacteria Claims and Regulatory Scope

The clarification from MHRA stems from Article 2 of the Biocidal Product Regulation (BPR), which governs the scope of biocides regulations in the UK. Traditionally, products making claims to be effective against specifically named pathogens, such as mycobacteria, fall under the purview of medicines regulations. PT 1 products, used for disinfecting human skin or scalp, are now subject to these rules if such claims are made.

Implications for Product Authorisation

Manufacturers seeking product authorisation under the BPR for PT 1 products in the GB and NI markets must now adhere to medicines regulations when making mycobacteria-related claims. As a result, applications for these products will no longer be accepted under the BPR framework. This change, however, does not affect biocides in other product types (PTs 2, 3, 4, and 5), where mycobacteria claims remain valid under BPR.

Guidance and Next Steps

The Health and Safety Executive (HSE), responsible for biocides regulation in GB and NI, is aware that current efficacy guidelines reference mycobacteria claims for PT 1 products. The agency plans to update these guidelines in accordance with the MHRA’s clarification. Manufacturers unsure whether their products are affected by this change are advised to contact MHRA through their advice form.

While this adjustment streamlines the classification of mycobacteria-related claims in biocidal products, manufacturers will need to ensure compliance with medicines regulations to continue selling in the GB and NI markets.

Read the source story

Read this article now for free!

You have read 3 articles.
Create a free account
or
Log in
to finish reading this article now.

Subscribe to our weekly digest

Sign up to receive our newsletter every Tuesday and get access to all of our content.

By creating an account, you agree to the Terms of Service and Privacy Policy.
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.
This is some text inside of a div block.

Trusted by professionals at

Dupont
ECHA - European Chemicals Agency
Energizer
Chemours
This is some text inside of a div block.

Get Foresight Today

Stay compliant, reduce risk, and protect your business with our AI-powered chemical policy monitoring—tailored just for you.

Global monitoring of 1,200+ sources
Expert-reviewed, trusted regulatory alerts
Instant risk identification for 350k+ substances

Ready to supercharge your policy monitoring workflow?

We’ll be in touch soon with more details and support to help you get started.
Oops! Something went wrong while submitting the form.
Share with a friend
Copy link

Related Articles

Pet mouseBPC-55: EU Committee Approves Biocide Renewals, Union Authorisations and Technical Updates

May 23, 2025

Personal care productsECHA's Assessment Highlights Potential Risks of Quaternary Ammonium Compounds

January 30, 2025

Man with paperworkUK HSE Issues Notice on EU Biocides Regulation: Key Active Substances Face Non-Approval in Northern Ireland

January 30, 2025

Foresight regulatory experts
Streamline your chemical compliance
Easy-to-use product compliance management for small and mid-sized manufacturers — mitigate risk and protect market access.
Get started
Subscribe to Foresight's newsletter
Stay ahead with the latest news & insights
Join 1,000s of compliance professionals getting the latest insights right to their inbox for free, every Tuesday.
100% free. No spam. Unsubscribe any time.
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.
Stay ahead with the latest news & insights
Subscribe to our free weekly newsletter covering news, events, and expert insights.

Related articles

Pet mouse

BPC-55: EU Committee Approves Biocide Renewals, Union Authorisations and Technical Updates

ECHA’s BPC delivers key decisions on rodenticides, disinfectants, and procedural reforms at its May 2025 meeting. Understand the agenda outcomes.

23

May 2025

BPR
Personal care products

ECHA's Assessment Highlights Potential Risks of Quaternary Ammonium Compounds

ECHA's new assessment on quaternary ammonium compounds may have future impacts on disinfectants, pest control, and personal care products.

30

Jan 2025

CLP
REACH
BPR
Man with paperwork

UK HSE Issues Notice on EU Biocides Regulation: Key Active Substances Face Non-Approval in Northern Ireland

Discover the latest UK HSE notice on EU biocides regulation changes affecting Northern Ireland.

30

Jan 2025

BPR
Foresight
Providing critical insights, analysis, and guidance to help businesses anticipate changes, make informed decisions, and stay ahead.
News & Insights
Newsletter
Legislation Hub
Coverage
Contact
About
© 2025 Foresight. All rights reserved.
SitemapTerms of servicePrivacy policyCookie policy