product authorisation
DESCRIPTION
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 - PowerPoint PPT PresentationTRANSCRIPT
Product Authorisation
Workshop on REACH and EU Biocidal Product Legislation in practice(Experiences from EU Industry)INT MARKT 48493Belgrade, Serbia
Raf Bruyndonckx1 June 2012
Procedures and Requirements
Outline
• General principles
• Procedures
• Application
• Data requirements
• Fees
• Role of industry associations
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Cefic
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• 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
EBPF
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• 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
EBPF – European Biocidal Products Forum
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
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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)
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Product Authorisation
General Principles
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General principles
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• 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
General principles
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• 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
General principles
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• 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)
SPC – the ID card of a BP
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• 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
Product Authorisation
Procedures
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Different procedures
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• (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
Timelines
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• 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
31/12/101/01/07 1/01/098/09/06
3 monthscompleteness
check(01/01 to 31/03/09)
2 monthsapplication for
mutual recognition
(01/04 to 31/05/10)
12 months1st evaluation and authorisation
(01/04/09 to 31/03/10)
4 monthsrecognition of
1st authorisation(01/06 to 30/09/10)
3 months(01/10 to 31/12/10)
††
No application/notification (30/06/09)
Failed completeness check (30/09/09)
Timelines
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Union authorisation - scope
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• 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
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• 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
Simplified authorisation procedure
“Same product” authorisations
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• 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
Product Authorisation
Application
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R4BP
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• 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
R4BP
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Product Authorisation
Data requirements
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General outline
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• 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
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Doc. IV-A or LoA*: Test and Study Reports
a.s.(s)
Doc. IV-B or LoA*: Test and Study Reports
b.p.**
Doc II-B or LoA* - Effects
Assess.** - Exposure Assess.
- Efficacy Assess.
for Biocidal Prod.2)
Doc II-A or LoA*
Effects and exposure Ass.
Active Subst.(s)2)
Doc. II-C Risk Characterisation for Biocidal Product
Doc. II Risk and Efficacy Assess.
Doc. I Overall
Summary and Assessment1)
Document III-A or LoA*
Study Summaries Active Substance(s)2)
Document III-B or LoA*: Study Summaries Biocidal Product2)
1) To append: List of end points 2) To append: Reference lists List of abbreviations Check for completeness
Summary Dossier
Complete Dossier
Data waiving
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• 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
Principle approach
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• 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
Availability of data
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• Active substance dossier (LoA required)
• Co-formulants: REACH – MSDS
• Public literature
Product Authorisation
Fees
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Fees
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• 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
Role of industry associations
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Role of industry associations
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• General representation of industry
• Endeavour to be recognised stakeholder
• Consensus driven position taking
• Competition law considerations
• No specific role regarding data sharing
Useful sources of information
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• 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
Raf Bruyndonckx+32 2 676 7366