The data package looks complete, the studies were run by a competent lab, the reports are in the PAR and IUCLID. And still the competent authority comes back with questions, because the efficacy evidence does not support the claim, or the claim does not fit the product type.
Contact our BPR team to discuss the efficacy strategy for your product, review existing data, or plan a test programm that supports the authorisation you are seeking.
Under Regulation (EU) No 528/2012, a biocidal product can only be authorised if it is shown to be sufficiently effective for its intended use. Article 19(1)(b) makes this explicit. Efficacy is not a label claim to add later. It is a regulated property of the product, evaluated against specific organisms, conditions and uses.
The consequence is that efficacy data define what is allowed to be claimed, against which organisms, under which conditions, and at which concentrations. An incomplete efficacy data package limits the Summary of Product Characteristics (SPC), narrows commercial positioning, and often triggers evaluation rounds that delay market entry.
BPR groups biocidal products into 22 product types across four main groups: disinfectants (PT1 to PT5), preservatives (PT6 to PT13), pest control (PT14 to PT20), and other biocidal products (PT21 and PT22). Detailed efficacy requirements are set out in Annex II and Annex III of the BPR and elaborated in ECHA’s Guidance Volume II, Parts B and C.
For disinfectants in PT1 to PT5, the framework follows a tiered approach with phase 2 quantitative tests under defined laboratory conditions (with step 1 suspension tests and step 2 carrier or surface tests), and where relevant phase 3 field studies. Examples of EN standards that often apply are: EN 1276 and EN13697for bactericidal activity in the non-medical areas, EN 1650 and EN 13697 for yeasticidal activity in food-areas, EN 14476 and EN 16777 for virucidal activity in medical and non-medical areas. The exact testnorm, soiling target organisms will depend on the product type and the claim.
For preservatives in PT6 to PT13, the structure is different. In-can, film, wood and material preservatives each have their own data requirements.
For pest control in PT14 to PT20, efficacy is demonstrated through laboratory dose-response studies, simulated-use studies and field trials, with requirements that differ sharply between rodenticides, insecticides, acaricides and .
For PT21 antifouling products simulated field test tests using rafts are often required in the relevant water types, for instance in coastal waters with a high fouling intensity
The principle is consistent across product types: the efficacy package must reflect intended function, target organisms and realistic conditions of use.
This is where most challenges originate. The same biocidal product can need fundamentally different efficacy data depending on three decisions made before testing begins.
The first is the choice of product type. A surface disinfectant marketed for hospital use (PT2) requires a different test panel than a sold for food contact surfaces (PT4) or a veterinary environment (PT3). Expanding the PT scope changes required organisms, contact times, soiling conditions and acceptance criteria.
The second is the claim. Bactericidal, fungicidal, yeasticidal, virucidal, mycobactericidal, sporicidal: each opens a separate test pathway. A virucidal claim alone has three levels: activity against enveloped viruses only, limited spectrum virucidal activity, and full virucidal activity.
The third is the use conditions. Dirty versus clean conditions, contact times of 30 seconds versus 5 minutes, spray versus wipe, hard water versus distilled. These are not just laboratory details. They are the regulatory conditions under which authorisation is granted and changing them later requires new data.
By prioritizing efficacy testing early as a strategic investment rather than a routine procurement task, companies ensure their testing align better with their intended claims. This proactive approach secures a smooth, more predictable dossier process, and gives more control over the market claims, and saves valuable time and resources.
We can offer support with the strategy / study design, study moitoring and dossier work. Efficacy decisions are made with the dossier in mind from the start.
Strategic test design: we translate the intended claim and use pattern into a test strategy hat matches BPR requirements and authority expectations, including PT-specific standards.
Test execution:, with documentation ready for submission.
Data interpretation: we assess whether existing data, including existing or read-across, can support with the dossier building, and where new testing is genuinely needed.
Dossier integration: we align the SPC, claim wording and efficacy section so the product claim is aligned with data.
Which EN standard applies to my product?
That depends on product type, claim and field of use. EThe right standard matches the conditions of intended use.
Can I reuse efficacy data from an older dossier?
Sometimes. If formulation, claim and conditions of use are sufficiently similar, existing data can support a new authorisation.
Does efficacy testing need to be GLP?
GLP is not mandatory for efficacy studies under BPR. ECHA guidance accepts ISO 17025 or ISO 9001, and competent authorities expect a documented quality framework around the data.
What if I want to extend my claim later?
A new or broader claim almost always requires additional efficacy data.
Contact our BPR team to discuss the efficacy strategy for your product, review existing data, or plan a test programm that supports the authorisation you are seeking.
