The EU Biocidal Products Regulation (EU BPR) concerns the use of biocidal products, that are used to protect humans, animals, materials, or articles against harmful organisms like pests or bacteria, by the action of the active substances contained in the biocidal product.
This regulation aims to ensure a high level of protection for humans and the environment.
As of 1 September 2015, a biocidal product consisting of, containing, or generating an active substance, could not be made available on the EU market unless the product supplier is included in the EU Article 95 list for the product type to which the product belongs.
The Article 95 list is a register of suppliers that have submitted technical dossiers for the active substances in their biocidal product for evaluation by the allocated competent authority of an EU member state for the specific active substance.
These technical dossiers must have included data covering all aspects of toxicity to humans and the environment so that maximum allowed concentrations of the active substance can be determined for the relevant product type.
The current deadline for the end of this EU review program is March 2024.
Following Brexit, the EU BPR has been implemented in the UK as the GB BPR, and the EU Article 95 list has become the GB Article 95 list.
ProEconomy’s copper and silver are listed in both the EU and GB Article 95 lists under the EU BPR and the GB BPR, and are, therefore, allowed to be used in the EU as well as in the UK for the relevant product types (PTs).
The PTs in which ProEconomy’s copper is used are: PT2 (Disinfectants and algaecides not intended for direct application to humans or animals), PT5 (Drinking water), and PT11 (Preservatives for liquid-cooling and processing systems).
The PTs in which ProEconomy’s silver is used are: PT2 (Disinfectants and algaecides not intended for direct application to humans or animals), PT4 (food and feed area), PT5 (Drinking water), and PT11 (Preservatives for liquid-cooling and processing systems).
The technical dossiers that were submitted by ProEconomy for copper and for silver to the EU competent authorities, ANSES in France for copper and KemI in Sweden for silver, are now, however, also required to be examined by HSE as the competent authority of the UK.
The deadline for the end of this GB review is not known yet but is likely to be also March 2024.
Copper was originally not supported under the EU BPR and was, consequently, not allowed to be used in the EU as a biocide.
ProEconomy, therefore, submitted an essential use derogation application to the European Commission through HSE, following which an exemption from the EU BPR for copper was granted.
ProEconomy’s copper was subsequently allowed to be used as a biocide in the EU and is, therefore, listed in the EU Article 95 list for use in PT2, PT5, and PT11.
A copper task force, consisting of suppliers that support copper as a biocide, was formed soon after this essential use derogation was granted.
ProEconomy are founder member of this task force and are submitting technical dossiers for evaluation by HSE.
Technical dossiers for use in PT4 (food and feed area) will also be submitted to HSE in due course.
ProEconomy’s silver has always been supported for use in PT2, PT4, PT5, and PT11 under the EU BPR and has as such, since onset, been listed in the EU Article 95 list.
ProEconomy are founder member of the silver task force.
ProEconomy are currently the only copper and silver ionisation company that are member of this task force and that has let HSE know, before the given deadline of the 29th June 2021, that they are supporting silver for PT2, PT4, PT5, and PT11 in the UK.
To our knowledge, other copper and silver ionisation companies have not advised HSE that they will be supporting silver in the UK.
These companies are, therefore, currently dependent on the registrations for silver listed in the GB Article 95 list, and are allowed to only use the silver that is listed for the product types they want to apply it in.
Once the silver review by HSE is completed, these companies must gain access to the technical dossiers that will have been evaluated by HSE, or else they will not be allowed to use their silver as a biocide in the UK.
As, to our knowledge, no other copper and silver ionisation company have notified HSE they want to support silver as a biocide in the UK, it is likely that only ProEconomy’s technical dossiers for silver will have been evaluated by HSE.
Frequently asked questions:
What is the BPR?
The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) concerns the placing on the market and use of biocidal products, which are used to protect humans, animals, materials or articles against harmful organisms like pests or bacteria, by the action of the active substances contained in the biocidal product.
The aim of the Regulations is to provide a high level of protection for people, animals and the environment and to ensure that products are sufficiently effective against the target species.
What is Article 95?
As of the 01st September 2015, a biocidal product that comprises, contains or generates a relevant active substance may not be made available on the market if the substance supplier or product supplier is not registered on the Article 95 list for the Products Type (PT) the biocidal product is intended to be used in.
A substance is considered relevant only when a complete dossier for the substance has been submitted and accepted in accordance with Article 95 of the EU Biocides Regulation.
What product types do ProEconomy support?
|Product||Supported product type|
|Copper||2, 5 and 11|
|Silver||2, 4, 5 and 11|
What do these product type mean?
|Product type||Product type use||Product type description|
|PT 11||Preservatives for liquid-cooling and processing systems||Used for the preservation of water or other liquids used in cooling and processing systems by the control of harmful organisms such as microbes, algae and mussels.
Products used for the disinfection of drinking water or of water for swimming pools are not included in this product-type.
|PT 5||Drinking water||Used for the disinfection of drinking water for both humans and animals.|
|PT 4||Food and feed area||Used for the disinfection of equipment, containers, consumption utensils, surfaces or pipework associated with the production, transport, storage or consumption of food or feed (including drinking water) for humans and animals.
Used to impregnate materials which may enter into contact with food.
|PT 2||Disinfectants and algaecides not intended for direct application to humans or animals||Used for the disinfection of surfaces, materials, equipment and furniture which are not used for direct contact with food or feeding stuffs. Usage areas include, inter alia, swimming pools, aquariums, bathing and other waters; air conditioning systems; and walls and floors in private, public, and industrial areas and in other areas for professional activities.
Used for disinfection of air, water not used for human or animal consumption, chemical toilets, waste water, hospital waste and soil.
Used as algaecides for treatment of swimming pools, aquariums and other waters and for remedial treatment of construction materials.
Used to be incorporated in textiles, tissues, masks, paints and other articles or materials with the purpose of producing treated articles with disinfecting properties.
What is a Letter of Access (LOA)?
A Letter of Access (LOA) is required for a company that is not within the review program to sell or distribute biocidal copper and silver within the EU and within the UK.
Article 3(1)(t) of the BPR defines an LoA as:
“an original document, signed by the data owner or its representative, which states that the data may be used for the benefit of a third party by Competent Authorities, the Agency, or the Commission for the purposes of this Regulation.”
Why are silver and copper being evaluated?
Silver and copper are used to protect humans, animals, and materials against harmful organisms. Complete dossiers for silver and copper have, therefore, been submitted in accordance with Article 95.
Since Brexit, is the UK still involved?
Following Brexit, the EU BPR 528/2012 has been implemented in the UK as the GB BPR, and the EU Article 95 list has become the GB Article 95 list.
What happens if I plan to use silver or copper as a biocide?
The silver or copper supplier must be registered on the EU or GB Article 95 list for the Products Type (PT) the biocide is intended to be used in.
What happens if I already use silver or copper as a biocide?
The silver or copper supplier must be registered on the Article 95 list for the Products Type (PT) the biocide is used in.
What happens if I don’t comply with the BPR?
Your biocidal product may not be used in the EU or in Great Britain.