Maristella Rubbiani
Istituto Superiore di Sanità
Roma
Italy
28/07/2017
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Introduction
 Some info related to application
 Some info related to dossier
 Some info related to what’s going on
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Who can apply for authorisation?
 Application for authorisation shall be made by, or on
behalf of, the natural person or legal entity responsible
for the first placing the product on the market.
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Applicant
 The applicant may be either native or foreign but shall
have a permanent office within the European Union,
Norway or Switzerland.
 If the applicant is not the manufacturer of the product
or its active substance, he has to present a letter of
access providing him the right to represent his
principal in matters concerning the product or the
active substance.
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Applicant
may
be
The future authorisation holder or
 a company or person who handles practical issues of the
application on behalf of future authorisation holder(s).
 Authorisation holder is person/entity to whom the decision on
authorisation is issued to.
 Responsibility for the placing on the product on the market,
classification and labelling etc. always lies on the authorisation
holder.
 Please note that different MS may have different interpretations
on the applicant, i.e. they may require that application shall
always be made by the future authorisation holder.
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When to apply for authorisation?
 Products already on the market: The deadline for the
submission of product application can be found in the different
MSs CA publication implementing the inclusion directives of
active substances.
 Authorisation has to be applied for by the date of Annex I
inclusion of the active substance used in the product.
 Consolidated list of approved active substances by product type
can be found at:
http://ec.europa.eu/environment/biocides/index.htm
 The inclusion directives can be found at:
http://ec.europa.eu/environment/biocides/annexi_and_ia.htm
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Specific issues
 If a product contains more than one active substance
the deadline for the product application is the one set
out in the latest of the inclusion directives relating to
its active substances
 If a product belongs to several product types,
authorisation for each product type shall be applied
for separately at the deadline determined by the
inclusion of the active substance.
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Important !
 If no application for the authorisation of a biocidal
product is submitted by the given deadline the product
shall be phased out of the market in 6 months from
this deadline for the application.
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Phasing out
 The 6month deadline for the phasing out of products
not supported refers to the first placing on the market.
 For subsequent storage, marketing, use and disposal of
existing stocks different periods of grace applies
depending on MS
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Specific cases
 Products that are not on the market: If you intend to start to place on
the market a new biocidal product with active substance(s) which is
already included in Annex I for the relevant product type there are no
binding deadlines for submitting the application for authorisation.
Placing the product on the market is not allowed before authorisation.
 Products containing new active substances: If you intend to start to
place on the market a biocidal product with a new active substance which
is not yet included in Annex I procedures are according to the Art 11 of the
BPD. Only after Annex I inclusion the product can be authorised.
Application may be submitted at any time. Placing the product on the
market is not allowed before authorisation.
 Uses of active substances in product types not notified : and
therefore not included in the review programme of existing active
substances are treated the same way as products containing new active
substances.
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Before preparing application
 In addition to the status of the active substances in
Annex I there are a few other things to consider before
preparing an application for a biocidal product:
 Make sure that you consider the right product type with
respect to the use purpose and pattern of your biocidal
product.
 Further information about scope of the BPD is compiled
by the European Commission in the Manual of
Decisions (MoD),
http://ec.europa.eu/environment/biocides/manual.htm
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??????????
 If you have any doubts as to whether your products or
active substances are biocides or to which product type
they belong to take contact to the CA.
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Technical equivalence
 Check that the active substance of your product is
technically equivalent to the one covered by the Annex
I inclusion directive.
 This means that the active substance has to be so
similar in purity, impurities and possible isomers that
the active substance evaluation for the Annex I
inclusion is still applicable.
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Technical equivalence
 In case of similarity, an access to the data package used
for the inclusion of the active substance or equivalent
data is needed.
 If the active substance is not considered equivalent
corresponding data on the active substance as
submitted for the Annex I active substance is needed.
 The CA makes the final decision on the equivalence
based on the data submitted by the applicant.
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available at:
 http://ihcp.jrc.ec.europa.eu/our_activities/health-
env/risk_assessment_of_Biocides/
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Evaluation
 Consider carefully the use purpose and pattern of your
product.
 Does the risk and efficacy assessment conducted with
the representative product in the active substance
evaluation for the Annex I inclusion directive apply to
the use of your product and there are no further
elements to be taken into account in the product
phase?
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Evaluation of efficacy
 Applicants should always consider if the efficacy data
meet the requirements.
 If not, further data and risk assessment are necessary.
 The applicant is responsible for providing further data
and the outstanding risk assessment for the product
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General requirements for
documentation
 The application consists of application forms and the
dossier.
 The applicant is responsible for providing the required
information and for including the study reports and other
documents needed.
 The evaluation of the data by the applicant will form the
basis of the evaluation by the CA.
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Format
 The MS and the European Commission have agreed
that the information included in dossiers on biocidal
products should be submitted in a standard format .
 The format is the same in whichever MS the dossier is
submitted.
 This will make it easier for the applicants to know
exactly what must be done and what a dossier must
contain.
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Application forms
 Application form consists of two parts.
 The whole form isavailable at the European Register for
Biocidal Products (R4BP).
 The first part of the application form for authorisation of a
biocidal product is made via the R4BP.
 The register is maintained by the European Commission.
 The application form is available in all of the EU official
languages.
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The R4BP
 In the R4BP the applicant fills in the details on the
applicant and the product.
 The applicant has to indicate in which MS he applies
for the first product authorisation and in which
EU/EEA countries mutual recognition.
 Furthermore, the applicant is requested to indicate in
which MS the product is already on the market.
R4BP: https://webgate.ec.europa.eu/env/r4bp/
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Timing
 The product may only stay on the market of a
particular MS without interruption if this MS is
indicated in the application form generated via the
register and submitted to all of these MS by the
deadline of the application.
 The second part of the application form is a word
document which contains further details about the
product and the type of application.
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Dossier
 Product dossier consists of data and documents
 In addition, proposal for Safety Data Sheet (SDS) and
proposal for labelling in the official languages shall be
presented by the applicant
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How is the Dossier structured?
TNsG on Preparation of Dossiers
Complete Dossier
Summary
Dossier
CAs' Report
Doc. I
Overall
Summary
and
Assessment1)
Doc. I
Evaluation/
Assessment
Report1
Doc. II Risk
Assessment
Doc. II-C Risk Ass.
Use of a.s. in b.p.(s)
Doc II-B
Effects and
Exposure
Ass. b.p.(s)
Doc II-A
Effects
Assessment
a.s.
Document III-B
Study
Summaries
b.p.(s)2)
Doc III-A
Study Summaries
a.s.2)
1) To append:
List of end points
List of abbreviations
Check for completeness
Doc. IV-A: Test
Reports a.s.
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2) To append:
Reference lists
Doc. IV-B: Test
Reports
b.p.(s)
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Doc. II Risk
Assessment
Doc. II-C Risk Ass.
Use of A.S. in B.P.(s)
Doc II-A
Effects
Assessment
a.s.
Document III-A
Study Summaries
a.s.2)
Doc II-B
Effects and
Exposure
Ass. b.p.(s)
Document III-B
Study Summaries
b.p.(s) 2)
1) To include: I.1 Subject Matter
I.2 Overall Summary and Conclusions
I.3 Proposal for Decision Annex I Inclusion;
List of end points; List of abbreviations
2) To append:
Reference lists
Initial check for completeness of dossiers
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Data requirements
Data requirements for the biocidal active substances and products are listed in Annexes II-IV of the BPD
Table 2. Data requirements
for active substances and
biocidal products. BPD
Annex number
Chemical active substances (a.s.) and products (b.p.)
Core data for a.s.
II A
Annex 2
Core data for b.p.
II B
Annex 1
Additional data for a.s.
III A Annex 2
Additional data for b.p.
III B Annex 1
Biological active substances (a.s.) and products (b.p.)
Data for a.s.
IV A Annex 4
Data for b.p.
IV B Annex 3
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Submission of the application
 Application should be sent to CA
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The structure of the dossier documentation required for the
application for authorisation of a biocidal product,
provided that the active substance is listed in
Annex I. Doc. IVA or LoA*: Test and Study Reports a.s.(s)


















Doc. IVB or LoA*: Test and Study Reports b.p.**
Doc IIB 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
* LoA = Letter of access
** In the case of applications for registration of low-risk products, the effects assessment is confined to data on
the active substance(s) only. In general, the data to be provided in Doc. IV-B and III-B are limited.
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Technical requirements:
 one paper copy of the whole application (application
forms, Doc I – IV, Safety Data Sheet (SDS), draft labels,
use instructions, Summary of Products Characteristics
(SPC)).
 Docs I-II must be MS Word-documents or MS Wordcompatible.
 Doc III i.e. study summaries must be either in IUCLID
5 or Word-documents
 one electronic copy of the whole application on CDrom
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Language
 SDS, draft label and use instructions must be available
in national languages
 SPC, in national languages
 Other documents are accepted also in English.
 If the application is for an authorisation, which is to
be used later for the purpose of mutual recognition, it
is recommended that the dossier is submitted in
English.
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General principles on the
submission of experimental
studies
 The applicant shall submit to the CA all data on
physicalchemical properties, toxicological,
environmental fate and ecotoxicological effects,
efficacy and other properties of the chemical that is
necessary for the assessment of the conditions for
authorisation.
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TNsG
 The Technical Notes for Guidance (TNsG) on Data
Requirements describes the data needed which was
originally set by Annexes II and III of the BPD.
 MS specific data may be required in some cases (e.g.
country specific exposure data, data related to specific
resistance phenomena).
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Reports
 The original study reports shall be attached to the
application.
 However, the original study reports (Doc IV) and the
study summaries (Doc III) are not required if the
applicant has a written proof of his right to refer to
them in his application (letter of access, LoA) and
these documents have already been submitted either
for the evaluation of the active substance for Annex I
or in another application for product authorisation.
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Appendices
 The appendices of the application shall be numbered
using the codes in the TNsG on Data Requirements 7.
 If several studies are related to one item, they should
be distinguished by lower case letters following the
appendix number (e.g. 6.1.1a, 6.1.1b).
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Methods
 Studies must be conducted and reported either
according to the methods mentioned in the Council
Regulation 440/2008 on test methods or according to
the OECD (Organisation for Economic Cooperation
and Development) guidelines for testing of chemicals.
 The main rule is that studies must also comply with
the principles of Good Laboratory Practice (GLP) and
the study report shall contain a certificate of this.
 Further guidance on GLP is given in the TNsG on Data
Requirements, Chapter 6 6.
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Animal welfare
 The processing of the application will continue after
the supplementary data has been presented.
 The BPD encourages limiting the duplication of
testing on vertebrate animals, whenever possible.
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Attention!
 According to this principle, before starting a new test,
literature searches should be conducted and the other
owners of the required documentation should be
consulted in order to find out, whether the available
information is sufficient for the reliable evaluation of
the possible hazards of the chemical
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Sharing data
 In order to receive the contact details of other data
owners the applicants are invited to contact the CA.
 If information is available, but it is inadequate, the
scope of the additional studies required will be
considered on a case-by-case basis.
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Information and data requirements
Core data and additional data


Core data
• always required
• read across feasible
•
BPD Annex IIA for active substance
•
BPD Annex IIB for biocidal product
•
BPD Annex IV A for fungi, micro-organisms and viruses
•
BPD Annex IV B for biocidal product with fungi, microorganisms and viruses
Additional data
•
Required under certain circumstances: product type,
exposure/intended uses, characteristics of substance/product
•
BPD Annex IIIA for active substance
•
BPD Annex IIIB for biocidal product
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Information and data requirements
Core data IIA and IIB
•
•
•
•
•
•
•
Applicant
Identity
Physical and chemical properties
Analytical methods for detection and identification
Effectiveness against target organisms and intended uses
Exposure (ESD + monitoring)
Toxicological and metabolic studies: acute, irritation,
sensitisation, (sub)chronic, CMR
• Ecotoxicolgical studies: fate and behaviour, acute toxicity
fish/invertebrate/algae, inhibition of microbiological activity,
bio-concentration
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Information and data requirements
Additional data IIIA and IIIB – example
Additional data
Annex IIIA for substance, IIIB for product, e.g.
o if indications of neurotoxicty from other studies ⇒ neurotoxicity
endpoints
o if necessary ⇒ mechanistic studies (es: placental passage)
o if available ⇒ medical data
o private area and health area disinfectants ⇒ chronic aquatic toxicity
o Veterinary hygiene products with possible release to manure storage
facility ⇒ anaerobic biodegradation, acute toxicity to plants.
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waiving
 If it is not technically possible or scientifically
justifiable to submit the required information or carry
out the required studies, or if the studies are not
conducted according to the guidelines referred above,
then the reasoning must be given in the application.
 If such justifications are not given, or if the application
is otherwise insufficient, the CA will ask the applicant
to submit the missing information and studies.
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Information and data requirements
Waiving
• For each endpoint necessary according to BPD Annexes
IIA/IIB/IIIA/IIIB at least one acceptable study or a justification
for non-submission of data (= waiving) has to be submitted
• Waiving arguments
• Technically not possible to perform (es: 2nd gen.
anticoagulants)
• Sufficiently valid other existing data available
• Read across to another similar substance or product
• Other scientifically acceptable method, calculation
method, alternative study, literature study
• Study scientifically not necessary, e.g. Biodegradability of
inorganic chemicals, eye irritation for skin corrosive
substance …
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Information and data requirements
Waiving
• Study not necessary due to limited exposure and toxicity profile:
 Level of exposure: MOE > 1000 to rep. dose studies that
cannot be waived
 Frequency of exposure: < 12 x per year
 Duration of exposure: < 3 months per year
AND
 Low toxicological concern, e.g.
if subchronic studies in rodents and non-rodents are
without
indication of substance-related effects at
the limit dose level –
waive chronic toxicity studies
if no developmental effects in first species and no
developmental or
reproductive effects in 2-generation study –
no developmental study
in second species
• for further details see: TNsG on data requirements (chapter 1,
1.3.)
• actual practice: increasing flexibility, largely depending on “expert
judgment”
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Which methods are available for toxicological hazard
assessment and how much it costs ?
sub-acute oral (OECD 407)
sub-acute inhalative (OECD 412)
sub-chronic oral (OECD 408)
Sub-chronic inhalative (OECD 409)
Fertility 2 generation (OECD 416)
Teratogenicity (OECD 414)
Toxicokinetics (OECD 417)
Chronic toxicity (OECD 452)
Chronic toxicity/carcinogenicity (OECD 453)
Fish acute toxicity (OECD 203)
Fish early life stage (OECD 210)
€
40 500
71 400
110 000
132 000
250 000
68 000
75 600
395 000
767 000
6 000
39 000
More than 1 Million Euro are necessary for testing a single new
biocidal substance.
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Animal Welfare Considerations:
More than 3000 Animals
are necessary for the
evaluation of one biocidal
substance
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Which studies are used for risk assessment? The
key study concept
For each endpoint necessary according to BPD Annexes
IIA/IIB/IIIA/IIIB at least one acceptable study or a justification for
non-submission of data has to be submitted
 If more than one study is submitted for an endpoint one key study
should be defined: study regarded as sufficient and adequate for
risk assessment
 Key studies should be
 the study with the most sensitive species and endpoint = lowest
NOAEL or EC
 GLP and test guideline-conform
 each study’s value to the risk assessment has to be judged
individually
 detailed study summaries have to be provided just for key studies
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Which studies are used for risk assessment?
The key study concept
•
Several studies can be considered as key studies for the same
endpoint, e.g. when
 data are available on several species or different routes of
exposure or if different results are observed in valid tests
 several studies compensate the deficiencies of each other?
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Which studies are used for risk assessment?
The key study concept
• Flexibility is necessary
 All data for key studies should be of an acceptable quality,
but flexibility is necessary for studies with deficiencies, if
they are crucial or support special risk assessment
aspects;
 this would apply to all carcinogenicity, mutagenicity
and reproductive toxicity studies with “positive” results
 this could apply to literature data, studies on
mechanisms of action, other non-guideline or non-GLP
studies
• For further details to the key study concept see TNsG on
Dossier Preparation and Study Evaluation, Part I: Chapter 4.2
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What defines the validity of data?
Reliability
TNsG risk assessment, part I, 3(2), p86
o exact description of the test substances, including the impurities
o OECD or Annex V method or complete method description
o in case not accepted OECD or Annex V method:
o proper test set up: like control groups, exclusion of unspecific
effects, concentration range, replicate number ...
o eventually supported by other literature data, QSAR
o if approximate value for the specific endpoint is sufficient for risk
assessment
o Good Laboratory Practice
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What defines the validity of data?
Relevance
TNsG risk assessment, part I, 3(2), p86
o proper species
o knowledge of toxicokinetics and metabolism (does not exclude
extrapolation to human)
o route of exposure relevant for population and exposure scenario
o substance tested = substance supplied
o dose-response established (where possible)
o for in vitro data, QSAR: could established correlation to in vivo
endpoint
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What defines the validity of data?
Klimisch scoring system
•
Each study submitted has to be classified according to
Klimisch scoring system:
1 = reliable without restrictions: generated according to
generally valid and/or internationally accepted testing guidelines
2 = reliable with restrictions: test parameters documented do
not totally comply with the specific testing guideline, but are
sufficient for risk assessment
3 = not reliable
4 = not assignable: not sufficient experimental details, e.g.
abstracts or secondary literature (books, reviews, etc.)
 1 and 2 can be considered for risk assessment
 3 or 4 can be considered limited or no value for risk assessment
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Can data from literature be used?
 The applicant has to submit a survey of the available
literature on the effects of the biocide
 The respective literature data are considered as additional,
complementing for risk assessment
 Only in justified cases some core endpoints could be
covered without an appropriate standard, GLP study, but
with literature data only  BPD Article 8 (8) and (9)
 Also legal property and copy rights have to be respected
 The same holds true for other public available information
like study summaries and evaluations from EPA, WHO, …
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Can data from literature be used?
Pro´s
 Avoid animal testing
 Safe costs (for applicant)
 Independent data, generated by science
 In line with “weight of evidence evaluation” (REACH
approach)
Con´s
 Identity of active substance often unclear
 No GLP
 Scarce description of methods
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What is the difference between
Data Protection and Confidentiality?
 Data
Protection (Art 12 of 98/8/EC)
• ensures that data can be used for
 Confidentiality (Art 19 98/8/EC)
• protects commercially sensitive
registration/authorisation only by
o companies who own the data, or
o those holding a letter of access
results of R&D of companies
o technical details of the
manufacturing process
o details of full product
• allows industry to recover costs for Annex I/IA
formulation (composition)
inclusion and authorisation of the biocidal product
o names and addresses of test
• public available data not protected
laboratories, sites and personnel
• does not prejudice the use of data by EC,
o individual medical details
Scientific Committees (Art 27), MS
(animal welfare)
• for a defined period of time
• for indefinite period of time
• release of information does not affect the status
of data protection! (e.g. regulations on the freedom
of access to information on the environment)
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• should only be made known to
CA and EC, not on web
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What is the difference between
Data Protection and Confidentiality?
 Data Protection List in CA-report for Annex I inclusion
Doc. 1.4
Data Confidentiality List in CA-report for Annex I inclusion
Doc. 2.a
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What is the difference between
Data Protection and Confidentiality?
Data Protection
•
New active substances, Art 12 (1b)
15 years from the date of first inclusion in Annex I or IA
•
Existing active substances, Art 12 (1c)
10 years from 14.05.2000
except where information is already protected under
existing national rules relating to biocidal products –
national data protection period remains valid up to
max. 14. May 2010
10 years from the date of first inclusion in Annex I/ IA
Product : 10 year from the first authorization
Confidentiality: indefinite time period
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'letter of access' means
 an original document, signed by the data owner or
its representative, which states that the data may be
used by the competent authorities, the European
Chemicals Agency, or the Commission for the purpose
of evaluating an active substance or granting an
authorisation;
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How is the Risk Assessment structured?
Use of IUCLID
• Templates provided in TNsG Dossier Preparation were
developed as basis for IUCLID 5.1 version
•since old IUCLID 4 version is not adequate for biocides
evaluation it should have been used in parallel to word doc III
for priority list 1 and 2, but only few Member States sticked to
this requirement ( 2nd ReviewR, Annex IV).
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How is the Risk Assessment structured?
Use of IUCLID
• IUCLID 5 will be free of charge
• IUCLID 5 will replace doc III level
• is a data-base file and therefore a significant improvement
compared to word files!
• still under discussion, if mandatory already for priority list 3
or only for priority list 4
• new OECD html study summaries will be directly loadable
• will be standard also for chemicals evaluation under REACH
• for details see: http://ecb.jrc.it/reach-it_informatics/
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What questions are addressed to test evaluation?
 Substance tested identical to the substance produced for the
market?
• Same quantity and quality of impurities?
 Study carried out according to OECD standard method?
• If not, are the deviations critical?
• Are the validity criteria of the method met? – e.g. mortality
rates, body weight loss
 Study carried out under Good Laboratory Practice (GLP)
conditions?
• If not is the study nevertheless reliable? Was other quality
assurance system in place?
 Is it possible to derive a NOAEL? (see ECETOC TR N. 85)
 Is there a difference between test and control groups?
Statistically, biologically significant?
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What questions are addressed to test evaluation?
• Is the difference an effect of treatment?
Dose –response? Due to outlier? Precision of endpoint?
Within historical control range? Biological plausibility?
• Is the treatment related effect adverse?
Alteration of general function of test organism or
organ/tissue affected? Is it secondary to other adverse
effects? Is it an adaptive response? Transient? Severity?
Isolated effect or expected change with other parameters –
in parallel or in time line? Consequence of specific animal
model?
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What questions are addressed to test
evaluation?
 Was the tested dose range appropriate?
 Are the study- results in line with the finding of other studies?
 Interspecies differences?
 Which results are relevant for C&L?
 Are scientific arguments for waiving or read across of data
acceptable?
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Some key elements for biocidal product evaluation:
 Is active substance within submitted product identical to active
substance evaluated within CA-report?
• if not – no authorisation/registration
 Letters of access available for all key studies from the active
substances defined in the CA reports?
• if not – no authorisation/registration
 Hazard evaluation for product has to be carried out based on
acute toxicity data for the product and on the integrated long
term toxicity data of the active substances and substances of
concern
 Is efficacy assessment complete?
• for a.s. evaluation just a minimal efficacy evaluation was
required
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Some key elements for biocidal product
evaluation:
 Is exposure assessment of the representative product relevant
and sufficient for intended use of submitted product?
• if not – exposure assessment needs to be amended
 Can some of the restrictions defined in document I of CA-report
of the active substance be cancelled due to new data/information
and evaluation?
 Are other restrictions necessary due to new data/information or
evaluation?
 CA-report and possibly Annex I criteria of active substance need
to be updated with new data/information and evaluation
 CA-report for product with specific restrictions has to be compiled
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What data and dossier structure are required for
national authorisation or registration of biocidal
products?
Summary Dossier Biocidal Product
•
98/8/EC, Art 8(2) the data – or the appropriate letters of access - covering annex IIA and
IIIA and IIB and IIIB have to be submitted
•
98/8/EC Annex IIA (10) and IIB (10): summary and evaluation of the data submitted
•
Structure? – no obligation to use Frauenhofer Formats (in contrast to Annex 1 inclusionComm. Reg. 2032/2003 Annex 4)
CA-Report Biocidal Product
•
98/8/EC Art 8(10) the MS has to generate a file containing at least:
•
A copy of application
•
A record of the administrative decision taken by the member state concerning the
application and the dossier submitted
•
A summary of the application and dossier submitted
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What data and dossier structure are required for
national authorisation or registration of biocidal
products?
Deviations from standard product evaluation:
• for low risk products/ Art. 2(1b), containing
• only active substance(s) listed in Annex IA
o full data requirements for AS and BP (similar to Annex I incl.)
o but not classified as CMR, sensitising, bioaccumulating, not readily
biodegradable/ Art 10 (1)
o concentration limits, other specific conditions may be attached to
Annex IA listing
• and no substance(s) of concern/ Art. 2(1e)
o any substance other than the active substance
o which has inherent capacity to cause adverse effects
o is present/produced in effect sufficient concentration in BP
⇒ product registration
• reduced data requirements/ Art 8(3)
no (eco)tox; but identity, uses, efficacy, analytics,
classification, safety data sheets
• faster decision: 60 days
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What data and dossier structure are required for
national authorisation or registration of biocidal
products?
Deviations from standard product evaluation:
•
for frame formulations/ Art. 2(1j)
• specifications for a group of biocidal products with same use
• must contain the same active substances of the same specifications,
and
• their composition must present only variations from a previously
authorised product which do not affect the level of risk associated
with them and their efficacy
• are established by MS/ Art 3(4)
either on request of an applicant or on the CA owns initiative
⇒ no difference for mother substance/product
⇒ reduced data requirements for frame formulation- product/ Art 8(5)
⇒ 60 days for frame formulation product authorisation/ Art 3(4)
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What data and dossier structure are required for
national authorisation or registration of biocidal
products?
Deviations from standard product evaluation:
•
Mutual recognition/ Article 4
• active substance is on Annex I/IA
• Annex I inclusion criteria are met by product
• product already authorised/registered in other MS possibly with
additional restrictions
• summary of dossier and copy of first authorisation submitted
⇒ authorisation/registration within 120/60 days after submission for mutual
recognition
⇒ deviating restrictions only in case of deviating abundance of target species or
tolerance or resistance compared to MS with first authorisation/registration
⇒ commission procedure in case of disagreement of MS with first authorisation
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Fees
 Ranging from 10.000 to 354.000 EUR for active
substance evaluation and from 1.000 to 70.000 for
product authorisation.
 Up to 1 million to be paid for a substance supported in
13 product-types.
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Some useful guidance documents
European Chemicals Bureau; http://ecb.jrc.it/biocides/
Technical Guidance Documents (TGD) on risk assessment
Technical Notes for Guidance
for human exposure assessment for biocides
for Annex I inclusion
for data requirements
for product evaluation
OECD, http://www.oecd.org
Test Guidelines
Series on Testing and Assessment /Adopted Guidance and Review
Documents
International Conference on Harmonisation (ICH)
ICH Guidelines, Safety topics, http://www.ich.org/cache/compo/276-2541.html
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Some useful guidance documents
DG Health and Consumer Protection, Plant Health
Guidance Documents
http://europa.eu.int/comm/food/plant/protection/resources/publi
cations_en.htm
European Food and Safety Agency (EFSA)
EPCO – manuals
http://www.efsa.europa.eu/it/science/praper/praper_guidance.html
European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC);
http://www.ecetoc.org/
Technical Reports, Monographs, Special Reports
Word Health Organisation–International Programm on Chemical Safety;
http://www.who.int/ipcs/methods/en/
Methods for Chemical Assessment
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Thank you for your attention!
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