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Product Authorisation

Product Authorisation. Procedures and Requirements. Workshop on REACH and EU Biocidal Product Legislation in practice (Experiences from EU Industry) INT MARKT 48493 Belgrade, Serbia Raf Bruyndonckx 1 June 2012. Outline. General principles Procedures Application Data requirements Fees

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Product Authorisation

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  1. Product Authorisation Procedures and Requirements Workshop on REACH and EU Biocidal Product Legislation in practice (Experiences from EU Industry) INT MARKT 48493 Belgrade, Serbia Raf Bruyndonckx 1 June 2012

  2. Outline • General principles • Procedures • Application • Data requirements • Fees • Role of industry associations

  3. Cefic • Cefic – European Chemical Industry Council • Membership • 28 national chemical federations • > 600 companies • > 20 affiliated sector associations • Horizontal - vertical • EU Policy Centre: REACH, International trade, energy and climate change, HSE, logistics, R&I … • 104 Sector Groups

  4. EBPF • European Biocidal Products Forum • Sector group of Cefic • Regulatory developments of EU biocides legislation • AS producers & BP formulators • 70 members: companies, associations, federations • Recognised stakeholder & observer • Implementation BPD: AS evaluation – BP authorisation • New Regulation

  5. BPR - New era starting Sep 2013 • Updated EU biocides law applicable 1 Sep 2013 • Regulation – directly applicable to all EU • Same principles, improved procedures – mutual recognition, changes to products • New concepts – EU authorisation, product family • Extended scope – treated articles • European Chemicals Agency

  6. Abbreviations • BPD Biocidal Product Directive 98/8/EC • BPR Biocidal Product Regulation • AS active substance • BP biocidal product • PT product type • PA product authorisation • MR mutual recognition • LoA letter of access • MS member state(s)

  7. Product AuthorisationGeneral Principles

  8. General principles • Authorisation is required before placing on the market • Authorisation is granted for max. 10 years • Authorisation can be granted if all conditions are fulfilled: • AS is approved for relevant PT + AS source is on positive list • The product is effective • No unacceptable effects on target organism (resistance) • No unacceptable effects on HH, ENV or animal health • Chemical identity is known (impurities/residues) • Phys-chem properties acceptable for transport and use

  9. General principles • A BP cannot be authorised for use by general public if: • It is classified acute tox. (dermal, oral, inhalation); • It is classified CMR 1 or 2; • It has PBT properties; • It has endocrine disrupting properties or • It has developmental neurotoxic or immunotoxic effects

  10. General principles • Dossier elements: • AS data: LoA or complete dossier • BP data: complete dossier (or LoA) • Assessment of hazard, risk (through relevant exposure) and efficacy • Draft Summary of the biocidal Product Characteristics (SPC)

  11. SPC – the ID card of a BP • Trade name • Authorisation holder – authorisation number • Date of authorisation & expiry date • Manufacturer of BP and AS • Qualitative and quantitative composition • Type of formulation – categories of users • Instructions for use and safe disposal

  12. Product AuthorisationProcedures

  13. Different procedures • (National) authorisation – provisional authorisation • Mutual recognition (in parallel or in sequence) • BPR: • Union authorisation • Coordination by ECHA, evaluation by MS, decision by COM • Simplified authorisation procedure • Parallel trade authorisation • “Same product” authorisation

  14. Timelines • 2 years to submit dossier • 2 years to grant, amend or withdraw authorisations • 3 months for completeness check • 12 months for first authorisation • 2 months to apply for mutual recognition • 4 months to recognise first authorisation • 3 months to resolve diverging opinions

  15. Timelines 8/09/06 1/01/09 31/12/10 1/01/07 † No application/notification (30/06/09) † Failed completeness check (30/09/09) 12 months1st evaluation and authorisation (01/04/09 to 31/03/10) 2 monthsapplication for mutual recognition (01/04 to 31/05/10) 4 monthsrecognition of 1st authorisation (01/06 to 30/09/10) 3 months (01/10 to 31/12/10) 3 monthscompleteness check (01/01 to 31/03/09)

  16. Union authorisation - scope • Valid across all MS at once • Similar conditions of use across the Union - guidance • Excluded: Art 5 – PTs 14, 15, 17, 20 and 21 • Sep 2013: new AS - PTs 1, 3, 4, 5, 18 and 19 • Jan 2017: PTs 2, 6 and 13 • Jan 2020: all categories • Assessment report by 31 Dec 2017

  17. Simplified authorisation procedure • Conditions: AS in Annex I (BPR), no SoC, no nano, no PPE, sufficiently efficient • No requirement for a LoA to AS dossier • Submission to the Agency • Evaluation by a MS within 90 days • Once authorised, notification to other MS is sufficient – no MR

  18. “Same product” authorisations • Identical products • Existing practice (NL, FI, CH, SE, DK, PT, BE, IT ...) • Mutual recognition within a MS between companies • Faster procedures • Principle in BPR, follow-up regulation

  19. Product AuthorisationApplication

  20. R4BP • Register for Biocidal Products • Electronic database – “EU catalogue of products” • Application form – Applicant & product • Decision and assessment report • BPR: • Electronic submissions – no more paper • Central communication and process management tool • Covers both AS and BP

  21. R4BP

  22. Product AuthorisationData requirements

  23. General outline • Data on the active substance(s) – LoA to Annex I dossier • Substances of concern • Data on the biocidal product • Use description – exposure assessment • Analytical methods • Properties/Effect/hazard assessment (PC, TOX, ENV) • Risk assessment • Efficacy

  24. Dossier

  25. Data waiving • A data requirement is not relevant to the product and/or the intended use • A study cannot be performed because the test is not feasible • The outcome of a study can be accurately predicted based on a scientific argumentation • The outcome of the study is in no way relevant to the risk assessment, classification and labelling or intended use

  26. Principle approach • Collate info on components - AS and SoC • Start with detailed use description • Derive possible exposure (exclude specific routes) • Properties/Effect/hazard assessment • Risk assessment – Risk reduction measures • Efficacy

  27. Availability of data • Active substance dossier (LoA required) • Co-formulants: REACH – MSDS • Public literature

  28. Product AuthorisationFees

  29. Fees • Broad variation across MS • First authorisation: 10.000 – 50.000 Euro • Changes: 500 – 25.000 Euro • Renewal: 500 – 50% of original fee • Annual fee: fixed or related to sales

  30. Role of industry associations

  31. Role of industry associations • General representation of industry • Endeavour to be recognised stakeholder • Consensus driven position taking • Competition law considerations • No specific role regarding data sharing

  32. Useful sources of information • Note for guidance to applicants for PA and MR - link • EU Evaluation Manual - link • TNsG on data requirements – link • TNsG on product evaluation – link • Joint Research Centre – biocides section - link

  33. Raf Bruyndonckx +32 2 676 7366 rbr@cefic.be

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