Application for First Authorisation before and after 1 September 2013

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2 Application for First Authorisation before and after 1 September 2013 Lena Gruhn, Federal Institute for Occupational Safety and Health (BAuA), Germany 1

3 Contents 1. Introduction 2. The new national authorisation (NA) 3. Transitional rules 4. Practical experience 5. Conclusion 2

4 Introduction BPD 98/8/EG BPR (EU) No 528/2012 3

5 Introduction Authorisation procedures National Authorisation Union Authorisation Mutual recognition Simplified authorisation Registration 4

6 The new national authorisation (NA) NA existed under the BPD What is new about it? Procedural rules Substantive rules Product Family NA SPC Fees others 5

7 The new NA Procedural rules Fees Validation Evaluation Applicant s comments 30 days 30 days 30 days 365 days Application Acceptance Date of Validation Authorisation 6

8 The new NA Some new procedural steps (fees, acceptance, validation ) Strict time lines (BPD: without undue delay ) Deadlines for additional information (validation 90days / evaluation 180 days) stop the clock vs. restart the clock 7

9 The new NA Substantive rules Exclusion / substitution criteria Comparative assessment Some new elements with regard to the conditions for authorisation 8

10 The new NA Exclusion criteria (Active substances) CMR cat. 1A/B Endocrine disrupting properties PBT or vpvb unless : risk of exposure negligible shall not be approved AS essential for prevention or control of serious danger to health or environment disproportionate negative impact on society

11 The new NA Even with very restrictive RMMs there is still a concern AS that fulfil the exclusion criteria Toxicity significantly higher than majority of other approved AS (same PT and use) Respiratory sensitiser Candidates for substitution Identified at AS approval Significant proportion Non active isomers or impurities AS fulfilling 2 of the PBT criteria

12 The new NA Comparative assessment part of the evaluation Alternatives other authorised BPS or non-chemical Sufficient chemical diversity minimise occurrence of resistance Significantly lower overall risk, sufficiently effective No significant economic and practical disadvantages Guidance: Comparative Assessment of biocidal products CA-March14-Doc.5.4-Final 11

13 The new NA New elements of the authorisation conditions: MRLs are established where appropriate (active substance) Risks of nanomaterial need to be assessed separately No authorisation for the general public under certain conditions (Art. 19 (4) BPR, e.g. CMR Cat. 1 A/B) Amendment of BPR if it contains a substance that meets the criteria for being PBT or vpvb if not disproportionate negative impacts for society 12

14 The new NA BPD: Frame Formulation 1. Establishment of a frame Product Family BPR: Product Families (BPF) 1. Authorisation of the family 2. Authorisation with reference to the frame 2. Notification of a new BP in the BPF 13

15 The new NA SPC BPD: all information in PAR and SPC (Art. 22) authorisation certificate Trade name Authorisation holder Date of authorisation and expiry BPR: Authorisation Authorisation number contains terms and Composition as far as essential for conditions proper use and summary of BP Manufacturer AS/BP characteristics (SPC) Type of formulation Hazard and Precautionary statements PT and use Target organism Instructions for use User categories First aid instructions / emergency measures Instructions for disposal Conditions of storage Other information 14

16 The new NA Fees Revision of national fee regulations for BPR New fee regulation in Germany entered into force 30 April

17 The new NA others IT R4BP as information system, adapted to be used by all parties involved, submission of all applications IUCLID format (DE) No more marketing permits multiple names instead Duration of the authorisation no longer linked to AS approval 16

18 Transitional rules New NA brings some crucial changes to product authorisation When do the new rules apply? 17

19 Transitional rules Authorisation granted before 1 September 2013 application authorisation 1 Sept 2013 Authorisation under BPD Article 92: can be made available until authorisation expires Renewal under BPR rules

20 Transitional rules Authorisation applied for after 1 September Sept 2013 application authorisation Authorisation under BPR All new rules of the BPR apply

21 Transitional rules Application submitted before 1 Sept 2013 but procedure not finished by 1 Sept 2013 evaluation application 1 Sept 2013 authorisation Submission of application under BPD Start of evaluation of BPD BPD repealed by 1 Sept 2013

22 Transitional rules Which procedural rules apply? (time lines) SPC, R4BP, IUCLID? What are the conditions for authorisation? (comparative assessment) How long will the authorisation be granted for? Which Fee Regulation applies? What happens for applications for the establishment of FFs? 21

23 Transitional rules Article 91 Article subpara. BPD applications will be evaluated according to BPD Article 96 BPD is repealed without prejudice to Article 91 Article subpara. if AS fulfils exclusion criteria/is a candidate for substitution authorisation according to Article 19/23 BPR What does that mean? 22

24 Transitional rules Our initial understanding: If there is no AS fulfilling the exclusion/substitution criteria all BPD rules apply If there are exclusion/substitution AS all BPR rules apply Reasoning: Wording of the transitional rules Application was submitted under BPD to fit the requirements of the BPD Possible inconsistencies (time lines, data, SPC, R4BP ) German legislator ( 28 (10) ChemG) 23

25 Transitional rules Discussions at the CA Meeting Guidance: Implementation of Article 91 CA-Sept13-Doc.5.1.g-Final.Rev1 evaluation in Article 91 only refers to criteria and principles to be taken into account: Conditions for authorisation: Exclusion +substitution AS Article 19/23 BPR Only substitution AS Article 5 BPD and Article 23 BPR No exclusion or substitution AS Article 5 BPD Procedural rules: All procedural rules of the BPR apply Time lines, conflict resolution in MR Reasoning: Article 91 leaves room for interpretation, BPD and BPR running at the same time will be too complicated - pragmatism 24

26 Transitional rules Guidance on FF and BPF: Handling the transfer from frame formulations to biocidal product families CA-Sept13-Doc.6.2.c If applied FF not established by 1 Sept 13 BPF will be authorised Authorisation granted with reference to a FF remain valid Article 92 existing FF may be converted into BPFs by administrative change (exact copy of the FF) 25

27 Practical experience Picture: M. Mansinh Does it really work? A very difficult situation both for applicants and CAs CAs try to apply the new rules but it does not always work e.g. time lines (there was no validation) Problems with mutual recognition if there is no SPC, Problems with R4BP 26

28 Conclusion New NA has some crucial differences to the BPD Transition esp. difficult for BPD applications that are still under the assessment at the time of the applicability of the BPR Transitional rules of the BPR are not clear 27

29 Conclusions Guidance MS try to apply the new rules but it does not always work harmonised approach important - MR Time will solve the issue eventually as there is only a certain number of applications affected 28

30 29 Thank you for your attention!

31 30 Questions

32 Contact Lena Gruhn Bundesanstalt für Arbeitsschutz und Arbeitsmedizin Friedrich-Henkel-Weg Dortmund Germany