Union Authorisation. Gosia Oledzka. A.I.S.E. Bratislava May Scientific and Technical Affairs Manager

Transcription

1 Union Authorisation Gosia Oledzka Scientific and Technical Affairs Manager A.I.S.E. Bratislava May 2014

2 A.I.S.E., the international Association for Soaps, Detergents and Maintenance Products, the official representative body of this industry in Europe. Its membership includes: 34 national associations in 39 countries 9 direct member companies A.I.S.E. covers about 900 companies ranging from small and medium-sized enterprises to large multinationals active both in the consumer goods market and the industrial & institutional (I&I) domains 2

3 Relevance of BPR to A.I.S.E. members* PT products on the market PT3 430 products on the market PT4 561 products on the market Relevance of Biocides in everyday life (e.g.): Secure consumers safety: prevent food contamination Limit disease spreading: disinfection in hospitals (e.g. linen) Secure animal welfare: disinfection of stables Home disinfection: when and where needed * Based on Joint A.I.S.E. EBPF Union Authorisation Survey (2011) with input of about 90 companies (8000 products across PT s) 3

4 Content: I. Overview (and timing of application) of Union Authorisation as set out in Regulation 528/2012 II. Practical applications for Union Authorisation III. Advantages/Disadvantages of Union Authorisation IV. Industry view on Union Authorisation

5 I. Overview (and timing of application) of Union Authorisation as set out in Regulation 528/2012 BPR Art.3(n) Union authorisation means an administrative act by which the Commission authorises the making available on the market and the use of a biocidal product or a biocidal product family in the territory of the Union or in a part thereof;

6 UA may be granted for Biocidal Products which: Have similar conditions of use across Union Do not contain Active Substances falling under the Art 5. (exclusion criteria) Products Types excluded from UA: Products to control rodents, birds, fish and other vertebrates (PT14, 15, 17, 20) Antifouling products ( PT21)

7 UA Timelines (Art. 42) Biocidal product types for which Union authorisation may be granted: from 1 September 2013 PT: 1,3,4,5,18,19 from 1 January 2017 PT: 2,6,13 from 1 January 2020 all remaining PTs

8 The European Chemical Agency set up under Regulation (EC) No 1907/2006 Management of the technical, scientific and administrative aspects of BPR Specific tasks with regard to evaluation of active substances Tasks related to Union Authorisation of certain categories of Biocidal Products

9 II. Practical applications for Union Authorisation

10 Pre-submission meeting Biocidal Product or Biocidal Product Family First dossiers for disinfectants under European scheme

11 Who: Pre-submission meeting Applicant ECHA Evaluating Competent Authority The Commission (in case of scope the discussions) When: At least 6 months before the dossier submission In principle, possible to hold a meeting before AS is approved Where: Face to Face meeting not obligatory Teleconference or a Web conference

12 Matters to be discussed during Pre-submission meeting? Draft Summary of Product Characteristic (SPC) Borderline discussion Other potential issues or questions = BPF, classification, safety/risk, efficacy Why Pre-submission meeting? Streamline process, avoid delays Clarity on potential issues in advance (e.g. be ready for additional data generation and submission)

13 III. Advantages/disadvantages of Union Authorisation

14 Advantages Market harmonisation One procedure = Access to the EU Market Policy disagreements solved in advance (no MR disputes)

15 Disadvantages Cost ( = 10years) = Annual fees! Complexity of the procedure Not all PT s are eligible for UA Uncertainty of a new process SME s specific difficulties (e.g. language?)

16 IV. Industry view on Union Authorisation Industry supports Union Authorisation which is in the spirit of the EU market harmonisation.

17 UA will create some opportunities: Union Authorisation ECHA involvement (more consistency with REACH & CLP) More predictable authorisations system Added value: clear timelines, harmonised approaches (e.g.spc) Some companies are considering applying this concept 16

18 IND Concerns with regards to BPR: New concepts (e.g. treated articles, substances of concern, substitution & comparative assessment, etc.) Resources implications Lack of technical & regulatory expertise in SME s) Higher administrative burden Data sharing ( LoA negotiations) Limited number of active substances suppliers 17

19 Still unclear: Possible boundaries between Biocidal Product and Treated Article (Public Health Claim vs. Biocidal Product) In-situ generation Biocidal Product Family Concept how to apply in practice Meta SPC concept (work ongoing)? 18

20 Potential long term consequences : Possibly fewer active substances & Biocidal Products on the market Could be a possible threat to public health (e.g. epidemics, resistance) Less competition on the market will lead to more expensive products High cost and complexity will slow down R&D Fewer niche products 19