Choosing glycolic acid for biocidal formulations in Europe involves more than evaluating product performance and price. Manufacturers, formulators and distributors must also ensure that their supply chain meets the requirements of the EU Biocidal Products Regulation (BPR).
For companies sourcing glycolic acid for disinfectant applications, Article 95 supplier status is an essential consideration. PureTech Scientific supports the regulatory review of Glyclean® D Glycolic Acid for specified biocidal applications in Europe.
Article 95 of Regulation (EU) No 528/2012 establishes requirements for suppliers of active substances used in biocidal products.
Since 1 September 2015, biocidal products covered by these requirements can only be made available on the EU market when either the active substance supplier or the biocidal product supplier is included on the European Chemicals Agency (ECHA) Article 95 list for the relevant Product Type. The requirement supports fair competition between suppliers participating in the regulatory framework and helps establish a consistent basis for sourcing biocidal active substances.
For buyers, Article 95 status is an important part of supplier qualification. A glycolic acid product may meet technical specifications, but its use in a biocidal formulation must also be supported by the appropriate regulatory arrangements.
Purchasing Consideration |
Why It Matters |
|---|---|
Regulatory compliance |
Confirms whether the active substance or product supplier meets the relevant Article 95 listing requirement. |
Supply-chain continuity |
Helps reduce the risk of disruption associated with sourcing from suppliers that do not meet the applicable listing requirement. |
Supplier qualification |
Gives procurement and regulatory teams a defined requirement to verify before selecting a source. |
Market access |
Supports continued supply of eligible biocidal products when other applicable BPR and national requirements are also met. |
An Article 95 listing is not the same as active-substance approval or finished biocidal product authorisation. Each requirement must be considered separately.
PureTech Scientific's Glyclean® D Glycolic Acid (CAS 79-14-1; EC 201-180-5) is supported under the EU BPR regulatory review programme for three biocidal Product Types.
Product Type |
Application Area |
|---|---|
PT 2 |
Disinfectants and algaecides not intended for direct application to humans or animals |
PT 3 |
Veterinary hygiene disinfectants |
PT 4 |
Food and feed area disinfectants |
PureTech Scientific supports glycolic acid as a biocidal active substance in the BPR review process, with PureTech Scientific International BV acting as its EU representative for Article 95 purposes.
This provides a documented regulatory basis for sourcing Glyclean® D for the supported Product Types, subject to applicable product and market requirements.
Not every glycolic acid supplier necessarily provides the same regulatory support for biocidal applications. PureTech Scientific's participation in the BPR review programme and its Article 95 arrangements distinguish Glyclean® D from sources without an applicable Article 95-listed supplier.
For customers comparing glycolic acid sources, this creates three practical considerations:
Regulatory participation: PureTech Scientific supports glycolic acid through the EU BPR active-substance review process.
Defined application coverage: Its regulatory support addresses biocidal Product Types 2, 3 and 4.
Supplier qualification: Customers can assess Glyclean® D against the relevant Article 95 requirements as part of their purchasing and compliance procedures.
The distinction is regulatory rather than a claim that Glyclean® D has superior chemical performance to competing glycolic acid products. Buyers should verify the relevant Article 95 supplier and Product Type coverage when comparing available sources.
For manufacturers and distributors supplying biocidal products in Europe, selecting an appropriately supported active substance source is an important step in regulatory compliance and purchasing decisions. ChemPoint supports customers evaluating PureTech Scientific Glyclean® D Glycolic Acid for biocidal Product Types 2, 3 and 4.
Talk to our experts to discuss Glyclean® D, confirm current Article 95 supplier status and product availability, or review sourcing requirements for your European biocidal application.
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