0- ECHA- Evaluation of efficacy - Liste der mikrobiologischen Untersuchungen

 

Untersuchungen

x = für erforderlich für Basisanspruch; o = optional; (x) Basisanforderung für spezielle Anforderungen

Anforderungen für die PT-Gruppen:

Nr.:

Beschreibung

PT 2 PT 3 PT 4 PT 5 PT 11 PT 12

Mikroorganismen

Bakterien

1 Staphylococcus aureus ATCC 6538

x

x

x

x

2 Pseudomonas aeruginosa ATCC 15442 (not for teat disinfection)

x

x

x

x

3 Enterococcus hirae ATCC 10541 (not for teat disinfection)

x

x

x

x

4 Escherichia coli ATCC 10536 (teat disinfection)

o

x

x

5 Escherichia coli K12 NCTC 10538

x

o

6 Proteus vulgaris ATCC 13315 (not for teat disinfection)

x

Legionella pneumophila ATCC 33152

(PT2: pools, hot tubs; PT4:

7

(x)

x

drinking water systems, PT5: in collective drinking water systems)

Hefen

8 Candida albicans ATCC 10231

x

x

x

x

Pilzsporen

9 Aspergillus brasiliensis** ATCC 16404

x

x

x

x

Vieren

10 Polio virus type 1, LSc-2ab (Picornavirus)

x

11 Adenovirus, type 5, strain Adenoid 75, ATCC VR-5.

x

x

12 Murine norovirus, strain S99 Berlin

x

x

13 Bovine Enterovirus Type 1, ECBO - Virus ATCC VR-248

x

Bakteriophagen

11 Bacteriophage P001 DMS 4262 (milk industry)

x

12 Bacteriophage P008 DMS 10567 (milk industry)

x

Mykobakterien

13 Mycobacterium terrae ATCC 15755

x

14 Mycobacterium avium ATCC 15769

x

x

Bakterielle Sporen

15 Spores of Bacillus subtilis ATCC 6633 (bee hives)

x

o (x)

x

https://echa.europa.eu/documents/10162/23036412/bpr_guidance_assess

ment_evaluation_part_vol_ii_part_bc_en.pdf/950efefa-f2bf-0b4a-a3fd-41c86daae468

4.2.2 Evaluation of efficacy 

Efficacy of an active substance has to be demonstrated both in part A of the CAR (related to the intrinsic efficacy of the active substance) and in part B (where the active substance is incorporated in a formulated product). Evaluation of each part is described below. 

4.2.2.1 Active substance efficacy (part A): 

As the testing of an active substance is normally carried out using the technical active substance, or a simple dilution of the active substance in water or an appropriate matrix (so that the testing is carried out in the absence of other substances which may affect the efficacy), an extensive data package and evaluation is not required at this stage. However, efficacy studies should be submitted on the active substance, and these data should be capable of demonstrating the innate activity of the active substance against representatives of the proposed target organisms at the concentration relevant for the risk assessment. For that purpose, innate activity of an active substance could be defined as the capacity of an active substance to provide a sufficient effect on one or several relevant target organisms, for the use considered. The following minimum requirements should be fulfilled to demonstrate innate activity:

 For main group 1 (disinfectants: PT1, 2, 3, 4 and 5), innate activity is at least a “cidal” activity demonstrated in a suspension test and has to be demonstrated against one or more representative target organism(s) for the activity claimed (e.g. bactericide, yeasticide), preferably according to the CEN norms (phase 1 tests and phase 2 step 1 tests). Test organism(s) should be that or those specified in the respective norm. Phase 1 tests are sufficient for the active substance if a phase 2 step 1 test is available for the representative product. When only specific biostatic activity (e.g. bacteriostatic, fungistatic) is claimed, an appropriate method should be used. 

 For main group 2 (preservatives: PT6, 7, 8, 9, 10, 11, 12 and 13), innate activity is generally a static activity demonstrated in challenge tests on several and relevant target organisms, in the relevant matrix. However, if curative effects are claimed, cidal activity is requested. To demonstrate efficacy against one target organism only could also be acceptable in the case of a strictly defined use relevant for the PT ( e.g. the control of Legionella in cooling water in PT11). For PT8, CEN norms are available to support efficacy testing and give indications on representative target organisms to be tested. Growth in the untreated control is essential to show the validity of the test. If the claim is only for a curative effect, it is sufficient to show that the decline in the microbial population in the treated samples is statistically significantly more than in the untreated control samples. 

 For main group 3 (pest control: PT14, 15, 16, 17, 18, 19 and 20), innate activity can be demonstrated for one target organism only (for instance, control of mice or control of bedbugs). 

 For main group 4 (other biocidal products: PT21 and PT22), innate activity is generally supported on a group of organisms (algae, animals, bacteria) and examples of appropriate target organisms are available in the Efficacy guidance for PT21 and PT22. When minimum requirements are not met this should be justified.

When minimum requirements are not met this should be justified. Generally, efficacy data are generated from laboratory tests, performed by the applicant. Nevertheless efficacy data from literature could also be acceptable if the application rate, target organisms, area of use and the identity of the active substance is described and are relevant. If cited literature is used to support a preserving effect it must also show that untreated test specimens supported growth. When curative effects are claimed the cited literature must demonstrate the efficacy of the active substance according to the requirements per PT. The use of cited literature should be agreed between the applicant and the evaluation CA (eCA) on a case by case basis. The level of efficacy demonstrated at this stage of the process need not be high, as an active substance in a simple solution may not be as effective as when it is used in a fully formulated product. For that reason an active substance should still be considered suitable for approval if the levels of efficacy demonstrated fulfil the minimum requirements above. In the case where the levels of efficacy of the active substance alone are lower than expected, efficacy tests performed with the representative product has to show a sufficient/basic efficacy, according to the requirements above. If both are insufficient, approval for the Union list should not be proposed. If no efficacy tests with the active substance itself are available, but only tests with a formulation, a justification has to be given by the applicant regarding the possible influence of co-formulants on the efficacy. If the co-formulants used potentially have biocidal activity it is essential to demonstrate that the efficacy is due to the active substance and not to the co-formulants, e.g. a control should be performed with all co-formulants but without the active substance.

4.2.2.2 Product efficacy (part B): Although approval for the Union list is primarily concerned with the active substance, efficacy data is also required for a representative product. Ideally efficacy data on an existing biocidal product should be submitted. If this is not possible data on a dummy product could be acceptable in order to demonstrate that the active substance is capable of producing an effect on the target organism and in a relevant matrix according to the proposed use, when included in a formulated product. However, a detailed evaluation of the effectiveness of the product (including an evaluation of the proposed label claims) is not in all cases required at the active substance approval stage. This may for example be the case where no marketed product is available. Nevertheless, the level of efficacy (e.g. the kind of activity “biocidal” or “biostatic”) have to be consistent with the uses claimed and fulfil the minimum requirements mentioned in the active substance part (part A).

4.2.3 Overall evaluation for active substance approval It is concluded that efficacy data are required on the active substance, to demonstrate on the one hand the innate activity of the substance (either the technical grade active substance or a dilution in water or a solvent) and on the other hand the efficacy of the representative product against one or more of the proposed target organisms. Efficacy should be demonstrated in accordance with the use(s) considered in the risk assessment. If for some justified reasons, the results of the biocidal product do not completely fulfil the requirements described above, this could still be acceptable as long as the results of the active substance are sufficient to demonstrate efficacy. The other way around, if the results of the active substance do not fulfil the requirements described above acceptable data of the biocidal product may be sufficient as long as it can be excluded that the co-formulants contribute to the efficacy of the product. Where the levels of efficacy demonstrated are low enough to raise concerns by the evaluating Member State, the applicant should be asked to justify why the result should still be considered acceptable. Two specific reasons are discussed below: the use of ‘dummy products’ and the case of active substances not used alone but always in combination with other active substances.

4.2.4 Link to risk assessment There is an essential link between efficacy testing and the risk assessment for human health and the environment at the active substance approval stage:  Efficacy has to be proven for active substance concentrations used in the risk assessment  Efficacy has to be sufficient for the use assessed in the risk assessment. The information on efficacy is relevant in assessing the dose recommended for the use(s) applied for. The dose (or the "likely concentration(s) at which the active substance will be used" as stated in Annex II 6.4 of the BPR) is the starting point in the exposure assessment for human health and the environment.