Health and Safety
Executive
Feedback on the work of the Post
Approval Issues (PAI) group
Darren Flynn
Chemicals Regulation Directorate
CRD - who we are and what we
do ......
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A Directorate of the Health and Safety Executive (HSE)
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Regulatory project managers, specialist regulatory
scientists = Operational Delivery Team
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Policy team
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… and others (me?)
2 locations: York and Bootle
250 staff (approx)
– 180 people based in York
– 70 people based in Bootle
Compliance team
Context
The primary aim of CRD is:
“ to ensure the safe use of biocides,
industrial chemicals, pesticides and
detergents to protect the health of people
and the environment”
Chemicals Regulation – ‘under one
roof’
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REACH (Registration, Evaluation, Authorisation and
Restriction of Chemicals) Regulation.
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The Biocidal Products Regulation (BPR) and also
ongoing responsibilities under the UK Control of Pesticides
Regulations (COPR).
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Plant Protection Products Regulation and COPR.
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Detergents Regulations.
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EU Classification, Labelling and Packaging
Regulation.
Feedback on the work of the PAI
Remit of PAI
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PAI; COM Working group established to discuss and
develop procedural regulatory issues relating to PPPs,
developing regulatory GD where necessary.
… not to be confused with
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ZSC; to organise work in zone (planning and management
of workload) and to develop harmonised risk assessment
standards within zone.
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IZSC; to organise work across zones (planning and
management) and to develop harmonised standards
between/across zones. Representatives are for the zone
rather than the MS.
Feedback on the work of the PAI
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Updates on guidance and procedures
– Application of guidance
– Data protection
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Article 43, and data to be evaluated at product renewal
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Update on draft Registration Report review
Application of guidance
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Article 36 Examination for authorisation
1. The Member State examining the application shall make
an independent, objective and transparent assessment in
the light of current scientific and technical knowledge using
guidance documents available at the time of application. It
shall give all Member States in the same zone the
opportunity to submit comments to be considered in the
assessment.
Application of guidance
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Common interpretation:
– Any application for an authorisation submitted under Art 33 has to
be assessed in accordance with Art 36 – in the light of current
scientific and technical knowledge using the latest guidance
documents available at the time of application
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Significant problems being experienced with this approach,
which is not actually what Article 36 requires:
– wasting resource on unnecessary assessments
– inequitable treatment of applicants
– different conditions and restrictions for identical products
Application of guidance
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Example of problems (1):
Application for new use – triticale, with product already
approved for wheat and barley at same GAP
– new risk assessment to latest guidance provided
– new assessment failed against the new bird and mammal guidance
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Possible outcomes:
– triticale refused, but use on wheat and barley continue
– ignore the new risk assessment, authorisation granted in line with
previous assessment for wheat and barley
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CRD risk management decision - issued authorisation, as no
additional risk from the new use over and above that already
authorised
Application of guidance
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Example of problems (2):
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Application for new generic product – uses identical to those
authorised (UP assessment) for the reference product + 60
– new risk assessment to latest guidance provided
– new assessment failed against new bird & mammal guidance
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Possible outcomes
– New generic product refused, even though identical to those already
on the market (but no action taken against authorised products)
– Ignore the new risk assessment, authorisation granted in line with
products already authorised and on the market
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CRD risk management decision - issued authorisation, as no
additional risk over and above that already authorised for all
other products
Application of guidance
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Example of problems (3):
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Application for new generic product – uses identical to those
authorised (UP assessment) for the reference product
– new risk assessment to latest guidance provided
– new aquatic risk assessment requires a larger buffer zone
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Possible outcomes
– New generic product has larger buffer zone, rendering the product
unmarketable
– Ignore the new risk assessment, authorisation granted in line with
previous assessment for existing product
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CRD risk management decision - issued authorisation with same
buffer zone as reference product – all products should pick up
the larger buffer zone at the same time
Application of guidance
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Last 2 examples of approach now followed for true generic
applicants, in line with GD on applications relying an Article
34:
– Latest guidance being used for assessment of
equivalence of the active substance and comparability
of the formulation.
– Applicant relying on unprotected data for the rest of the
assessment – often unable to provide an updated risk
assessment in line with latest guidance in other areas
as they do not have the data
– Where equivalent and comparable – no further
assessment required - issue authorisation in line with
the reference product
Application of guidance
Ideal solution
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Use the latest guidance for the risk assessment associated
with the approval or renewal of the active substance.
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Then, for the lifetime of the approval of the active
substance, apply the same guidance to all products.
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New guidance should then be applied at the next review of
the active and the products.
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Heard the arguments relating to ‘freezing’ science for 7 –
15 years etc, but that is what happens for the active
substance!
Application of guidance
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Already agreed that certain types of application do not
involve any technical assessment – purely administrative
applications
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Still applications for new authorisations, being submitted
under Article 33, but latest guidance not being applied
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Change in packaging size and material;
Change of the name of the authorised products;
Change of authorisation holder or marketing company.
Authorisations of the same product by using different trade
names / marketing companies (back-to-backs)
Application of guidance
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Alternative ‘purposive’ interpretation – an assessment
using the latest guidance documents is only necessary
where a new risk assessment is required to support the
authorisation.
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If no risk assessment is being undertaken in certain areas,
there is nothing to apply the latest guidance to!
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Approach now adopted for :
– Article 34 generic applications
– New uses within the risk envelope already authorised.
Data protection
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Guidance Document on Data Protection,
SANCO/12576/2012 – rev.1.1, 1 February 2013
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Originally a Working Document but subsequently noted as
a Guidance Document
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Reviewed at PAI in light of specific issues raised by MS:
– confirmatory data
– clarification of general requirements for attracting data
protection
– Other minor clarifications
Data protection
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Confirmatory data
– only protected where approval is amended as a result
of the data
– originally protection for 5 years from the date of the
amended approval
– now confirmed that the data would be protected for 5 or
10 years from the date of the original approval
Data protection
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The Regulation specifies that in order to attract protection, the following
requirements apply to tests and studies:
a) The studies must be necessary to support the authorisation;
b) Studies must be performed to Good Laboratory Practices/Good Experimental
Practices (GLP/GEP) standards;
c) The applicant must claim protection for the studies;
d) The studies must not have been protected previously (or be subsequently
unprotected) in the MS where the authorisation is sought.
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b) should be determined by the RMS/ZRMS (for the approval and zonal
assessments respectively), and reflected in the lists of studies produced in
accordance with Article 60 of the Regulation.
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a), c) and d) must be specified by the applicant in their approval and
authorisation submissions. The applicant must also identify vertebrate studies.
Data required for Article 43 product renewals
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Art 43 2 requires only:
– Copy of authorisation
– new information required as a result of amendments in
data requirements or criteria
– information that the product meets the requirements of
the renewal regulation (i.e. any new specific provisions
of renewal of approval limiting use)
– a report on monitoring
Data required for Article 43 product renewals
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In summary, Art 43 2 allows us to consider only the
following:
– Any new data submitted to meet the new data
requirements
• Only these data (if relevant) should then be taken
forward in a risk assessment to modern guidance
• No new data requirements in a particular specialist
area = no need for a new risk assessment (echoing
principles of Art 34)
– any restrictions with respect to the uses specified in the
renewed approval (e.g max doses, field of use - Step 1)
Data required for Article 43 product renewals
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Any new assessment relevant to an issue identified as an
area for ‘MS to pay particular attention to’ in the approval
regulation - must be addressed to modern standards
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Any monitoring data provided (usually national
requirements so national rather than zonal assessment?)
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Comparative assessment if required
Data gaps in EFSA conclusions ……
… and when to evaluate
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Data gaps identified can be split into three subsets:
– Confirmatory data specified in Part B of the approval
– Data relating to areas of concern listed as issues that
member States should pay particular attention to in
Part B of the approval document – Art 43 Renewal
– Annex II data gaps not listed as confirmatory data
Data gaps in EFSA conclusions ……
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Text from typical approval – Part B
Data gaps in EFSA conclusions ……
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Confirmatory data specified in Part B of the approval need to be evaluated
– the confirmatory data requirements and a date for
submission (from the notifier to COM) is specified in
Part B of the approval
– details on procedures for assessment are outlined in
the SANCO GD on confirmatory data
– product assessments should continue without prejudice
to the outcome of the assessment of confirmatory data
Data gaps in EFSA conclusions ……
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Data relating to areas of concern listed as issues that member
States should pay particular attention to in Part B of the
approval document
– for example the EFSA conclusions may state that risk
assessments must be undertaken in certain areas.
– since these will be undertaken for the product/use anyway,
these should perhaps not be considered as EFSA data
gaps - rather product requirements to be assessed for the
product.
Data gaps in EFSA conclusions ……
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Annex II data not gaps not listed as confirmatory data
In principle agreed that Annex II data addressing EFSA data
gaps should be left to renewal of the active. However:
– where the Annex II EFSA data gap has been addressed by
the applicant,
– and the data relates to ‘an area MS must pay particular
attention to in the UP assessment’
……. then the Annex II data should be evaluated as part of the
product assessment, and evaluation recorded in the Registration
Report for the product.
Registration Report review
A diagram of the structure of the revised dRR:
Part C
Confidential
information
Part A
Risk
Management
(core)
(MS)
Part B 0
Part B 1,2,4
Product
background,
regulatory
context and GAP
information
(core)
Identity, physical
and chemical
properties,
further
information
(core)
Part B 3
Part B 5
Part B 6
Efficacy data and
information
(core)
Analytical
methods
(core)
Mammalian
toxicology
(core)
Part B 7
Part B 8
Part B 9
Part B 10
Metabolism and
residues
(core)
Environmental
fate
(core)
Ecotoxicology
(core)
Relevance of
metabolites in
GW
(core)
Registration Report review
As with the original dRR, the revised dRR is split into 3 main sections:
•Part A –risk management (national)
•Part B –data evaluation and risk assessment (core and national
addenda)
•Part C – confidential information (core)
Part B is split further into ‘subject’ sections, and may be further
divided into core assessments (to be assessed by the zonal RMS)
and national addenda (covering MS specific national requirements).
Registration Report review
Key changes:
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Inclusion of section on comparative assessment in Part A
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New Section B.0 – background, regulatory context and GAP
information about all intended uses
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Re-numbered to align with new data requirements and Guidance
documents
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An overview on the data gaps should be included in the
summary of each section
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Summary/conclusion at the beginning of each section including
table with cGAP/summary of cGAPs
Registration Report review
Timeline:
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Circulated for comment by 1 February 2015
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Discussion on final version at March PAIG
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Revised template to be noted at March SCoPAFF
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Overarching Guidance Document on use of the dRR and
worked examples also being prepared.
Conclusions
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Further consideration needed on the application of latest
guidance
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Art 34 GD establishes the principle that we should only
apply latest guidance to new risk assessments
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Slight change to the data protection rules for confirmatory
information
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Process and procedure for Art 43 renewals being finalised
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New format for dRRs to be available soon.
Thank you for your attention
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Further information
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E-mail: pesticides&detergents@defra.gsi.gov.uk
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Website: www.hse.gov.uk/crd