Updated EU CLP Regulations
In late 2024 the European Union published an important amendment to the CLP regulation (1272/2008 ) that controls labelling and classification of hazardous chemicals.
Amendment (2024/2865) updated a selection of different areas related to product labelling which affects products manufactured by Topdental Products Ltd and our Bossklein brand of disinfectants and cleaners.
You can read the full regulation on the European Union website – https://eur-lex.europa.eu/procedure/EN/2022_432
Why does this apply to our products?
Not only are our disinfection and cleaning products registered medical devices but many are biocide registered and available throughout the European Union (find out more)
They are designed for use in dental, medical and other clinical environments where cleanliness and infection control is paramount.
Our products are subject to the highest standards of compliance by appointed notified bodies and must conform to these rules in order to remain available on the market.
Do you sell online?
One of the major changes outlined in this recently published EU article is in regard to advertising and “distance sales”.
A distance sale is classified as a consumer contract for goods completed using a distance communication method.
This includes phone and e-commerce sales completed online via websites, and without the consumer or seller being physically present at the same time.
According to the updated regulation (Article 48a); the online presentation of a product that is classified as hazardous needs to clearly and visually include the same elements that are contained on the label, this includes the CLP hazard statements and pictograms.
What does this mean for me?
Partners, resellers and distributors that advertise medical device and biocide registered products manufactured by Topdental (including Bossklein infection control products) are obliged to make available the same hazard and warning information as appears on the product label.
In simple terms...
All partners inside the European Union are now required to display the same hazard information that appears on product labels on that product’s page on their own website.
How can we help you?
To aid our partners in this process we have now added a new specific tab to each product page on both Bossklein.com and Topdental.co.uk.
You can find this under the Hazard, CLP & Disposal tab.
Where this new tab clearly displays all the hazard information required for each product which includes the correct hazard statement information, pictograms and general good usage guidance about incompatible materials and advice regarding disposal..
How do I use the information?
This information has been designed to be easily usable for all partners. We want to encourage customers to access this hazard information and create similar areas of information on their own websites.
Just hop on to either Bossklein.com or Topdental.co.uk and locate the product you are looking for. Scroll down to find the Hazard, CLP & Disposal tab and here you will find all the information you need. Highlight the info you require, right click and select copy before pasting into your own website editor.
Other Changes
Major changes to label formatting were introduced concerning font size, spacing and the use of specific colours (Article 31 Annex 1). These changes are designed to make the legibility of CLP hazards and statements more recognisable and easier to comprehend.
Changes to the CLP hazards on labels include but are not limited to:
- Text is required to printed in black and appear upon a white background
- The minimum vertical height of text has been updated across all sizes of container.
- A label must use a single and easily readable font. The use of serif fonts is prohibited
- The space between two lines of text is required to be at least 120% of the actual font size
Digital labelling
Digital labels are now permitted (Article 34a) alongside physical labels. The use of a data carrier such as a scannable QR code can be printed on the label.
The user can locate additional information including extra hazard details, microbiological data and more online.
Keep an eye out for more on this from Bossklein very soon!
Future First
Topdental / Bossklein products follow our “Future First” policy.
If there is opportunity for reformulation using more modern and kinder / less hazardous materials that perform the same if not better than their more hazardous equivalent, we will strive to include in our formulations. You can read more about this policy here https://bossklein.com/eco-facts/
Although Topdental / Bossklein make all effort to use less hazardous chemical components and raw materials in the formulation of our infection control products it is not possible and unrealistic to create high performance disinfectants that are completely hazard free.
As our products are registered medical devices for use in high-risk clinical environments by professional healthcare staff, we will never compromise anti-microbial performance.
When is the deadline?
Changes must be implemented within 24 months after the publication of the regulation – so the deadline for full compliance is November 2026
We are happy to communicate that products manufactured by Topdental including the Bossklein infection control range are already in full compliance with these new guidelines.
We encourage partners to familiarise themselves with the guidelines and ensure they are also in compliance. We are here to help if you have any questions.