Michele Cavalleri Eurofins Biolab

Transcription

1 Efficacy Studies on Biocidal Product Families Michele Cavalleri Eurofins Biolab

2 Case study Biocidal product Family on Sodium Hypochlorite Active ingredient expiry date: 1 January 2019 HURRY UP!!! 2

3 Biocidal Product Families Oxford English Dictionary: Family (noun) A group of people consisting of one set of parents and their children, whether living together or not. In wider sense: any group of people connected by blood, marriage, adoption, etc Biol. (orig. Bot.). A group of related plants, animals, or other organisms Min. A group of minerals that have some features or properties in common typically a similar chemical composition 3

4 Biocidal Product Families - Same active ingredient - Similar composition - Similar use - Similar risk - Similar efficacy 4

5 Similar composition They must have a similar composition within specified variations, so within certain boundaries: Actives substances contained in a BPF contributing to the efficacy of the products have to be present in each product of the BPF (i.e. content 0). Differences in composition do not affect significantly the overall conclusions from the risk assessment and efficacy evaluation Concentrate and ready to use products can be included in a BPF. Where the risk assessment only allows for certain dilutions, concentrates and dilutions could be kept within the same meta SPC; otherwise, they should be allocated in different meta SPCs An active substance present in any product in a concentration in which it can be proven to not add to the efficacy of the product, should not be regarded as an active and therefore does not have to be present in all products. 5

6 Similar Use 6

7 Similar Use What constitutes similar use? All purpose cleaners Washing up liquid Spray cleaners Bathroom cleaners Kitchen cleaners Floor cleaners Concentrates 7

8 Similar Risk Acceptable risk resulting from the assessment of the maximum risk, in connection with the assessment of the minimum efficacy Different RMMs, but the same within a meta-spc Different classification and labelling, but the same H&P statements within a meta-spc 8

9 Similar Efficacy 9

10 Biocidal Product Families Family structure CA-Nov14-Doc.5.8 Three-levels of information Level 1 Overall information Biocidal Product Family Level 2 Grouped by classification, RMMs etc Meta SPC 1 Meta SPC 2 Meta SPC 3 Level 3 Detailed information on individual products Product 1 Product 3 Product 5 Product 2 Product 4 Product 6 10

11 Biocidal Product Families Family structure CA-Nov14-Doc.5.8 Rev 3 Three-levels of information Level 1 Overall information Authorisation holder Manufacturer (a.i.) Manufacturer (b.p) Formulation type(s) Overall composition range Classification range Level 2 Grouped by classification, RMMs etc Formulation type Composition range Same classification Same H,P&EUH statements Same RMM Same stability range Level 3 Detailed information on individual products Product name Composition Classification RMM Detailed use instructions 11

12 Biocidal Product Family It is an opportunity to account for future innovation. Example: Product family containg Sodium Hypochlorite from 1% to 6% Foam Gel Clear solution 12

13 Biocidal Product Family Meta SPC NaClO Liquid Clear Solutions Foaming Gels Product 1 Product 3 Product 5 Product 2 Product 4 Product 6 13

14 Biocidal Product Family Claims Clear solutions: - Product 1: disinfection of baby s dummies (bactericidal claim) - Product 2: swimming pool disinfection (including algaecidal claim) Foaming products: - Product 3: pump spray inactivates Bacteria and Yeast on surfaces - Product 4: CIP against Bacteria and Biofilm Gels: - Product 5: Toilet disinfection inactivates Bacteria and Viruses on surfaces - Product 6:Surface disinfection inactivates Bacteria, Fungi and Viruses 14

15 Test List on Fresh products Test/product Product 1 Product 2 Product 3 Product 4 Product 5 Product 6 Chemical Physical x x x x x x Bactericidal suspesion EN1276 x x x x x x Fungicidal suspension EN1650 x* x Virucidal Supension EN14476 x x x Bactericidal Surface EN13697 x x x Fungicidal Surface EN13697 x* x Virucidal Surface FprEN16777 x x Swimming pool OECD 170 and OECD 201 modified Biofilm (under static conditions) ASTME x x *Candida albicans only as test organism 15

16 Stability tests Sodium hypochlorite is not a stable molecule. ECHA guidance on information requirements, demands: - To monitor the increase of any impurity with a toxicological relevance - To monitor the product efficacy During the long term stability testing. 16

17 Testing strategy Containing the costs is vital, so once identified the products to be tested it is crucial to decide which tests to perform. Since the guidance on BPF does not provide details on this topic, we suggest 3 different approaches: - Conservative: this approach, requires to repeat all the phase 2 step 2 tests at each sampling point. Safe but extremely expensive. - Reasonable: this approach requires that the most representative organisms (for each category) are tested. The choice is supported by the efficacy data obtained on the fresh samples. This approach is not the cheapest option, but it allows to significantly cut the costs. - Minimal: only the most resistant organism, determined, by the efficacy data on the fresh sample, is tested. It is the cheapest option but not all authorities may agree on it. 17

18 Product 1: Shelf life stability study Test: shelf life 25 C Product 1: clear solution disinfection of baby s dummies (bactericidal efficacy) Time point T3 T6 T9 T12 Chemical Physical x x x x Conservative approach all bacteria T0 all bacteria T0 all bacteria T0 all bacteria T0 Reasonable approach 1 gram + and 1 gram - 1 gram + and 1 gram - 1 gram + and 1 gram - 1 gram + and 1 gram - Minimal approach The most resistant T0 The most resistant T0 The most resistant T0 The most resistant T0 18

19 Product 2: Shelf life stability study Test: shelf life 25 C Product 2: clear solution Swimming pool disinfection Time point T3 T6 T9 T12 Chemical Physical x x x x Conservative approach The full OECD 170 (only phase 2 step 2 test) The full OECD 170 (only phase 2 step 2 test) The full OECD 170 (only phase 2 step 2 test) The full OECD 170 (only phase 2 step 2 test) Reasonable approach (based upon T0 data) 1 bacteria 1 virus No Algae because are less resistant 1 bacteria 1 virus No Algae because are less resistant 1 bacteria 1 virus No Algae because are less resistant 1 bacteria 1 virus No Algae because are less resistant Minimal approach (based upon T0 data) All bacteria since they have the shortest contact time All bacteria since they have the shortest contact time All bacteria since they have the shortest contact time All bacteria since they have the shortest contact time 19

20 Product 3: Shelf life stability study Test: shelf life 25 C Product 3: Foaming product Pump spray inactivates Bacteria and Yeasts from surfaces Time point T3 T6 T9 T12 Chemical Physical x x x x Conservative approach Reasonable approach (based upon T0 data) Minimal approach (based upon T0 data) All the phase 2 step 2 tests 1 gram+ and 1 gram- and yeast (ph/st 2,2) If test conditions are the same, test the most resistant T0 All the phase 2 step 2 tests 1 gram + and 1 gram - and yeast (ph/st 2,2) If test conditions are the same, test the most resistant T0 All the phase 2 step 2 tests All the phase 2 step 2 tests 1 gram+ and 1 gram- and yeast 1 gram+ and 1 gram- and (ph/st 2,2) yeast (ph/st 2,2) If test conditions are the same, test the most resistant T0 If test conditions are the same, test the most resistant T0 20

21 Product 4: Shelf life stability study Test: shelf life 25 C Product 4: Foaming product CIP against Bacteria and Biofilm Time point T3 T6 T9 T12 Chemical Physical x x x x Conservative approach The full EN1276 and ASTM E The full EN1276 and ASTM E The full EN1276 and ASTM E The full EN1276 and ASTM E Reasonable approach (based upon T0 data) ASTM E worst case scenario ASTM E worst case scenario ASTM E worst case scenario ASTM E worst case scenario Minimal approach (based upon T0 data) Not applicable Not applicable Not applicable Not applicable 21

22 Product 5: Shelf life stability study Test: shelf life 25 C Product 5: Gels Toilet disinfection removes Bacteria and Viruses from surfaces Time point T3 T6 T9 T12 Chemical Physical x x x x Conservative approach Reasonable approach (based upon T0 data) Minimal approach (based upon T0 data) All the phase 2 step 2 tests 1 gram + 1 gram Aspergillus FprEN16777 If test conditions are the same,the most resistant T0 All the phase 2 step 2 tests 1 gram + 1 gram Aspergillus FprEN16777 If test conditions are the same,the most resistant T0 All the phase 2 step 2 tests 1 gram + 1 gram Aspergillus FprEN16777 If test conditions are the same, the most resistant T0 All the phase 2 step 2 tests 1 gram + 1 gram Aspergillus FprEN16777 If test conditions are the same,the most resistant T0 22

23 Product 6: Shelf life stability study Test: shelf life 25 C Product 6: Gels Surface disinfection removes Viruses Time point T3 T6 T9 T12 Chemical Physical x x x x Conservative approach All the phase 2 step 2 tests All the phase 2 step 2 tests All the phase 2 step 2 tests All the phase 2 step 2 tests Reasonable approach (based upon T0 data) the most resistant T0 the most resistant T0 the most resistant T0 the most resistant T0 Minimal approach (based upon T0 data) Not applicable Not applicable Not applicable Not applicable 23

24 Biocidal Product Families Open points: Subjectivity Expert judgment Certainty on what will be agreed between CAs 24

25 THANKS FOR YOUR ATTENTION! Michele Cavalleri Biocidal Products Division & GLP Facility Manager Eurofins Biolab Phone: Mail: Web: