Update on the Biocidal Products Regulation (BPR) Formulators, importers and distributors of disinfection products

Transcription

1 Update on the Biocidal Products Regulation (BPR) Formulators, importers and distributors of disinfection products Michael Fink, DHI, Denmark 5 th of May 2015 SEPAWA Nordic Radisson Blu Hotel, Malmö

2 DHI Environment and Toxicology (EAT) International consulting and research organisation within water, environment and health Supporting industry in keeping chemical products compliant with regulation Human and environmental risk assessments Chemicals and consumer products Biocides and pesticides Marine waste and ballast water Food, feed, cosmetics IT and chemical management Pharmaceuticals and medical devices Water safety and contaminants #2

3 DHI Environment and Toxicology- Biocides Biocidal-team of 15 persons Scoping of projects and cost analysis Data gap analysis Testings and studies Exposure and risk assessments IUCLID Authorisations Art. 95 listings Authority contact, MS, ECHA #3

4 Michael Fink Biologist, from 2008 at DHI-EAT Danish/German Risk assessment of biocidal actives and products Strategic advice to industry Researchprojects: Disinfection (Efficacy, safety, resistance) Course leader: Authorisation of biocidal products #4

5 Agenda 1. The BPR and disinfectants 2. Status of the active substances of disinfectants 3. Important deadline: 1. September Article Opportunity: Biocidal product family 5. Procedures and costs within the BPR 6. Recommendations #5

6 01. The BPR and disinfectants #6

7 1. The BPR and disinfectants Main purpose of BPR Biocidal products are safe for humans, animals and the environment Biocidal products are sufficiently effective Harmonisation of rules concerning Making available of biocidal products on the market Use of biocidal products Evaluation of biocidal products #7

8 1. The BPR and disinfectants Large amount of biocidal products on the market Germany: > products registered France: > products registered Denmark: > products (300 registered) Huge variation of products (22 Product types) Disinfection products (PT1-5) the largest #8

9 1. The BPR and disinfectants Approval process of biocidal products: Active substance(s) sets the pace a. Evaluation and approval of active substance (AS) b. Authorisation of biocidal product containing the AS #9

10 02. Status of the active substances of disinfectants #10

11 2. Status of the active substances of disinfectants BPC= Biocidal Products Committee Detailed work programme with 2-year visibility #11

12 2. Status of the active substances of disinfectants Active substance Iodine Propan-2-ol And more to come soon Status: approved PT1, PT3, PT4, PT22 Application deadline 1. September 2015 PT 1, PT2, PT4 Application deadline 1. July 2016 PT1, PT2, PT3, PT4, PT6 #12

13 2. Status of the active substances of disinfectants Selected active substances Status: soon to be approved Glutaraldehyde PT 2, PT3, PT4; BPC opinion published Hydrogen peroxide PT1-6; BPC opinion published C(M)IT/MIT PT6, PT11; BPC opinion published PAA PT1-6; BPC opinion published PHMB PT1-4, PT6; on the table BPC June 2015 DDAC PT 8; on the table BPC June 2015 BKC PT 8; on the table BPC June 2015 Bardap 26 PT 8; on the table BPC September 2015 Ethanol PT1, PT2, PT4; on the table BPC December 2015 NaClO PT1-5; on the table BPC February 2016 CaClO, Chlorine PT2, PT5; on the table BPC February 2016 #13

14 #14

15 2. Status of the active substances of disinfectants Status of actives BPC work programme Contact active substance supplier #15

16 03. Important deadline: 1. September Article 95 #16

17 3. Important deadline: 1. September Article 95 From 1. September 2015, a biocidal product consisting of, containing, or generating a relevant substance, cannot be made available on the EU market - if the substance supplier or product supplier is not included in the list for the product type to which the product belongs. #17

18 3. Important deadline: 1. September Article 95 Biocidal products which do not comply with art. 95 will be illegal on the market after 1. September no period of grace. Alternative active substance suppliers, that have not contributed to the reviewprogramme, must be listed in order to continue to market biocidal active substance. The obligation of art. 95 lies within the supply chain #18

19 3. Important deadline: 1. September Article 95 Variations Formulators and importers of biocidal products can be in a situation where they have to get listed, since their active substance suppliers are not! Producers of certain precursors to in situ generated active substances must also be listed in order to market the precursors for biocidal use. Listing has to be applied to ECHA Active substance supplier Product supplier #19

20 3. Important deadline: 1. September Article 95 How to get listed: LoA to complete dossier ECHA fee EUR Own complete dossier, mix of own data and LoA to data from complete dossier ECHA fee EUR Own complete dossier, own data ECHA fee EUR #20

21 04. Opportunity: Biocidal product family #21

22 4. Opportunity: Biocidal product family New biocidal product family concept A biocidal product family refers to a group of products having similar uses, the same active substances, similar composition within specified variations and similar levels of risk and efficacy #22

23 4. Opportunity: Biocidal product family New biocidal product family concept All products within the biocidal product family are covered by one authorisation for the family as a whole rather than each individual product requiring authorisation. Each product within the biocidal product family will have a suffix to the authorisation number New products can be added to the family if they fall within the existing ranges of the biocidal product family authorisation Opportunity for disinfection products #23

24 05. Procedures and costs within the BPR #24

25 5. Procedures and costs within the BPR National authorisations and mutual recognition First approvals of own formulations Biocidal product Biocidal product family #25

26 5. Procedures and costs within the BPR National authorisation of identical product Refers to already approved biocidal product Biocidal product #26

27 5. Procedures and costs within the BPR Own biocidal products/bpf Identical biocidal products Full IPR No IPR 1 year days LoA on active(s) Full data package Fee to MS CA: 1. MS EUR MR EUR Fee to ECHA for MR: 700 EUR pr. MS No LoA on active(s) No data package Fee to MS CA: EUR No fee to ECHA Abbreviations: BPF = Biocidal product family; IPR = Intellectual property rights; LoA= Letter of Access; MS= Member State; CA= Competent authority; MR= Mutual recognition #27

28 06. Recommendations #28

29 6. Recommendations 1. priority: Art. 95 list of approved substance suppliers Check supply chain before September 2015 deadline For all biocidal products No period of grace #29

30 6. Recommendations Leave biocidal market Plan your exit Stay #1 Authorisation of identical products Buy into approved formulations and keep customers Less costs Private label #30

31 6. Recommendations Stay #2 Authorisation of own products Reduce costs- strategic and cost efficient regulatory projects Get the most out of the LoA Choose the right MS Invest in few but solid product dossiers Exploit biocidal product family concept Invest only in data or studies when really needed Sell access to approved formulations #31

32 Thank you for your attention Michael Fink, DHI, Denmark