REQUIREMENTS
Do you produce active chlorine?
If you produce active chlorine using salt, water, and electricity, or if you use it in your products, we can guide you through the regulatory approval process.
Active chlorine generated from sodium chloride by electrolysis.
Relevant product types: PT 1, 2, 3, 4, 5, and 11
Active chlorine released from hypochlorous acid.
Relevant product types: PT 1, 2, 3, 4, and 5
Water
Salt
Electricity
Article 95 compliance
Since September 2015, biocidal products may only be placed on the EU market if the active substance or product supplier is listed under Article 95 for the relevant product type.
How you comply depends on how you use or market active chlorine.
Customer Requirements
Whether you are producing, distributing or using disinfectant liquids, EU regulations apply.
We help you understand what applies to you – and what doesn’t.
End users of disinfectant liquids
If you use disinfectant liquids directly, compliance depends on where the liquid originates.
✔ If the liquid comes from an Article 95-listed generator, you are compliant
✔ If the precursor manufacturer (sodium chloride) is Article 95-listed, you are also compliant
This typically applies to end users who do not place products on the market.
Liquid manufacturers & distributors
Companies that place disinfectant liquids on the market must comply with EU regulations.
Compliance can be achieved by:
Obtaining a Letter of Access
Submitting a new application
This also applies when supplying OEM customers.
OEM customers (private label & integrated solutions)
OEM customers placing disinfectant solutions on the market under their own brand or as part of a system have specific regulatory obligations.
Compliance depends on:
how the liquid is sourced
how it is marketed
and who holds the authorization
We supports OEM customers with access to core dossiers, LoA’s and regulatory guidance.
Active substance approval
The active substance must be approved at EU level before a biocidal product can be authorized.
ECA Consortium supports both in-situ generated active chlorine and bottled solutions.
Product authorization
In addition to the active substance approval, the biocidal product itself must be authorized for the relevant product types and use cases.
Core dossier – what it is & why it matters
The core dossier is the foundation of product authorization. Without access to it, authorization is not possible.
- Precursor information
- Disinfection liquid composition
- Approved use cases
- Efficacy documentation
- Risk assessment
Access to a core dossier is required when applying for authorization – either via a Letter of Access or your own application.
Ready to start your application process?
Tell us about your product and we’ll outline the fastest, most cost-effective compliance route.