1 / 34

Product Authorisation

Join us at the workshop to learn about product authorization under REACH and EU Biocidal Legislation. Gain insights from EU industry experiences and understand key procedures, data requirements, fees, and the role of industry associations. Discover the general principles, application processes, and the changing regulatory landscape. Get acquainted with the European Chemicals Agency abbreviations and timelines involved in the authorization procedures.

erna
Download Presentation

Product Authorisation

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related