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
• Role of industry associations
2
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
3
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
4
EBPF – European Biocidal Products Forum
Advocacy Team
General Assembly
Communication
Issues Team
Data Sharing WG
General Issues
Product
Authorisation WG
Management
Committee
Sustainable Use WG
Dietary RA ISG
Disinfectants WG
Sector-Specific
Issues
Insecticides WG
RDDG
Rodenticides WG
Best Practice WG
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
BPR
AS
BP
PT
PA
MR
LoA
MS
Biocidal Product Directive 98/8/EC
Biocidal Product Regulation
active substance
biocidal product
product type
product authorisation
mutual recognition
letter of access
member state(s)
7
Product Authorisation
General 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)
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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 Authorisation
Procedures
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
1/01/07
1/01/09
31/12/10
†No application/notification (30/06/09)
†Failed completeness check (30/09/09)
3 months
completeness
check
(01/01 to 31/03/09)
1st
12 months
evaluation and authorisation
(01/04/09 to 31/03/10)
2 months
4 months
3
application for recognition of
months
st
mutual
1 authorisation (01/10 to
recognition (01/06 to 30/09/10) 31/12/10)
(01/04 to
16
31/05/10)
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
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“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
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Product Authorisation
Application
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
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Product Authorisation
Data requirements
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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
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CompleteDossier
Dossier
Summary
D
o
s
s
i
e
r
Doc. I
Overall
Summary 1)
and Assessment
Doc. II Risk and Efficacy Assess.
Doc. II-C Risk Characterisation
for Biocidal Product
Doc II-A or LoA*
Effects and
exposure Ass.
Active Subst.(s)
2)
Doc II-B or LoA*
- Effects
Assess.**
- Exposure Assess.
- Efficacy Assess.
Document III-A or LoA*
Study Summaries 2)
Active Substance(s)
1)
To append:
lists
for Biocidal
Document
2)III-B or LoA*:
Prod.Summaries
Study
2)
Biocidal Product
List of end points
2)
To append: Reference
List of abbreviations
Check for completeness
Doc. IV-A or LoA*:
Test and Study Reports
a.s.(s)
Doc. IV-B or LoA*: Test
and Study Reports
b.p.**
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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
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Product Authorisation
Fees
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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
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Role of industry
associations
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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
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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
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Raf Bruyndonckx
+32 2 676 7366
rbr@cefic.be