As the owners of the active substance dossiers for active chlorine released from hypochlorous, we can help guide you through EU and GB BPR regulatory process, including your application for the GB Article 95 list by 31st December 2022 in order to keep your products legally on the market.
As the market leader in the science, production and application of hypochlorous (HOCl) our products and solutions provide complete infection control and a reduction in cross-contamination effectively, in a range of environments. We are fully compliant with the rigorous European Biocide Regulations (EU 528/2012) and own the approved active substance dossiers and can help and support other companies achieve BPR EU 528, Article 95, compliance.
As of 29th June 2021, Aqualution Systems Ltd has also filed its UK BPR Active Substance Dossiers and is a legal manufacturer and supplier of hypochlorous acid in the UK. All brands who have a Letter Of Access with us are also legal to sell their products in the UK.
As of 31st December 2022 we will also be on the new GB Article 95 list meaning that our products, those we manufacture and those who have a GB LoA from us are on the UK market legally. Manufacturers who do not reapply for inclusion on the GB Article 95 list and brands who source their active substance and / or products from companies who have not re-applied by the 31st December will be operating illegally.
SUPPORTING OTHERS TO GET BIOCIDAL PRODUCT COMPLIANCE
Aqualution Systems Ltd owns the active substance dossiers for active chlorine released from hypochlorous and active chlorine generated from sodium chloride by electrolysis which are approved by the ECHA BPC for PT1, 2, 3, 4 and 5.
At Aqualution, we take the need to comply with local regulatory requirements seriously and ensure compliance before putting our products on the market.
Companies currently not compliant and wishing to acquire a letter of access so that they may legitimately place their products on the market in the UK and EU are welcome to contact us as review programme participants and we would be happy to support you in becoming compliant.
For anyone producing or looking to produce active chlorine by electrolysis by salt, water, and electricity, either for in-situ production or bottled products we can help guide you through the approval process.
What is Article 95 and Biocidal Regulations?
Article 95 is the scheme under the Biocidal Products Regulation (BPR) for establishing a list of approved sources of biocidal products.
A biocidal product can be sold on the EU market only if the manufacturer or supplier of the relevant substance in the biocidal product, or the manufacturer or supplier of the biocidal product for the applicable product type, is included on the Article 95 list of the Biocidal Products Regulation.
As of 1st January 2023, due to the UK leaving the EU, there is a new GB only Article 95 list. The deadline for applying for inclusion on the GB Article 95 list is 31st December 2022. Aqualution has filed to be on this list and is supporting other UK manufacturers with Letters of Access to our dossier to ensure their legality going into the New Year.
The European Chemicals Agency (ECHA) is responsible for the publication of this list in Europe and the HSE is responsible in the UK.
If you want to sell a biocidal product, what should you do?
If you formulate biocidal products or put them on the market, you do not have to apply for inclusion in Article 95 yourself, but you must ensure that the active substances contained in the products have been supplied by a supplier included in this list.
You can either:
- Apply for a Letter of Access (LOA).
Companies currently not compliant and wishing to acquire a Letter of Access so that they may legitimately place their products on the market in the UK and EU are welcome to contact us as review programme participants and we would be happy to support you in becoming compliant.
- Have your product manufactured by a company on the Article 95 list.
If you do not wish to gain a Letter of Access, we can supply you with compliant active substance for re-bottling or own-label use.
Aqualution Systems Ltd owns the active substance dossiers for active chlorine released from hypochlorous and active chlorine generated from sodium chloride by electrolysis which have now both been approved by the ECHA BPC for PT1, 2, 3, 4 and 5.
We are committed to raising the standards of the supply and use of biocidal products. We are able to support you through the process of either securing a Letter of Access or, as the only company able to manufacture stable and reliable hypochlorous, we can manufacture and supply your product for you.
We would be happy to discuss either route and recommend what might be best for your situation.
What to do next?
Contact us to help guide you through the regulations and approvals.
You are also welcome to contact ECHA and they will formally provide you with our contact details as the review programme participants for these active substances.
Please contact Samantha.email@example.com.