Consultation on Fees to Support EU Biocides Regulation 528 ... - HSE

<strong>Consultation</strong> on Fees to Support EU Biocides
Regulation 528/2012
Introduction
1. The Health and Safety Executive (HSE) is writing to you because
we believe you currently place biocidal products on the market and so
will be affected by provisions regarding fees under the new EU
Regulation 528/2012 on placing on the market and use of biocidal products.
2. This document outlines HSE’s proposals for new fees regulations to allow
it to recover its costs for the services it will provide in operating the
biocides authorisation regime under the new EU Regulation 528/2012
on placing on the market and use of biocidal products.
3. We are consulting those affected by these proposals in order to
introduce fees regulations to give HSE the power to continue to charge
fees by 1 September 2013, the date of application of the new EU
Regulation.
4. We are therefore seeking your views on a proposed fee structure under
the EU Regulation.
Background – new EU biocides Regulation
5. Placing on the market and use of biocidal products is currently
regulated at EU level through Directive 98/8/EC (the ‘Biocidal Products
Directive’ or BPD). The Directive aims to harmonise the EU market in
biocides and provide a high level of protection for human and animal
health and the environment by introducing an EU-wide authorisation
regime for biocidal products.
6. The BPD is implemented in Great Britain through the Biocidal Products
Regulations 2001 (BPR 2001) and in Northern Ireland through the
Biocidal Products Regulations (Northern Ireland) 2001 (BPRNI). Since
these SIs entered into force, each has been amended four times.
7. The BPD will be repealed on 1 September 2013 and replaced by a new
directly applicable EU Regulation on placing on the market and use of
biocidal products. The new Regulation retains the basic structure of
the BPD – a two step procedure for approving active substances at EU
level and authorising biocidal products in Member States. However it
aims to improve and update the system by introducing changes in a
number of areas. Information on the new Regulation is available here:
http://www.hse.gov.uk/aboutus/europe/euronews/dossiers/biocide.htm
8. Because the BPD will effectively be replaced by the new EU
Regulation, we intend to revoke the GB legislation that implements the
BPD on the same date.
1

9. As a result, new domestic regulations will be required to support certain
parts of the EU Regulation. A consultation has already taken place on
regulations to introduce enforcement measures and penalties for the
EU Regulation, consolidating these with related provisions on
classification and labelling of chemicals and export and import of
hazardous chemicals:
http://www.hse.gov.uk/consult/condocs/cd249.htm. New legislation is
also required to enable HSE to continue charging fees to recover its
costs under the new EU Regulation. The new fees regulations are the
subject of this consultation.
Proposals for fees and charges under the new EU Regulation 528/2012
10. It has been the policy of successive governments to recover the costs
of services it provides from those who benefit from them. Accordingly,
HSE already seeks to recover the full costs of its activities in acting as
national competent authority for biocides in the UK through charging
businesses for work done under the BPR 2001 and will continue to do
so under the new EU Regulation. Article 80(2) of the EU Biocides
Regulation also requires Member States to “directly charge applicants
fees for services that they provide with respect to the procedures under
this Regulation, including the services undertaken by Member States’
competent authorities when acting as evaluating competent authority”.
Cost recovery arrangements - fees
11. To achieve this HSE proposes to put in place a fee structure by which
applicants will be charged for the services that HSE carries out under
the EU Regulation. The fee structure will set out each of the services
that HSE will provide to applicants under the Regulation together with a
corresponding daily rate for the staff time used in delivering the service.
12. Article 80(2) of the EU Regulation requires that Member States should
introduce charging provisions that cover all the services that are carried
out by Competent Authorities with respect to procedures in the
Regulation. The main services that HSE will deliver under the
Regulation will be evaluating applications to grant, renew and amend
active substance approvals and biocidal product authorisations, where
the UK is acting as evaluating Member State. Other chargeable
services that HSE is required to provide under the Regulation include
granting a parallel trade permit (Article 53) or evaluating an
experimental notification (Article 56(2)). A full list of services that HSE
will charge for is given in Annex 1. A draft of the Statutory
instrument (The Biocidal Products (Fees and Charges) Regulations
2013) including the proposed fee structure and fee levels is attached
at Annex 2.
13. HSE’s fees in delivering these services will correspond to the full cost
of staff time in undertaking the relevant technical assessments and
associated administrative work calculated in accordance with Annex
6.2 of HM Treasury’s document, Managing Public Money
(http://www.hm-treasury.gov.uk/psr_mpm_index.htm). This also

ensures compliance with the requirement in Article 80(3) of the
Regulation, stating that “fees shall be set at such a level as to ensure
that the revenue derived from the fees is, in principle, sufficient to cover
the cost of the services delivered and shall not exceed what is
necessary to cover those costs.”
14. To make the system as transparent as possible, HSE proposes to set
daily charging rates for each type of service that it will provide under
the Regulation. The proposed daily charging rates will fall into two
categories: £447 per day for work on active substances and £393 per
day for other work, including on biocidal products (see Annex 1).
Where only part a day is used in providing a service, the corresponding
fraction of the daily rate will be charged pro rata.
15. The proposed daily rates are based on average daily costs for the
combination of staff grades who work on each type of application
calculated in line with Annex 6.2 of Managing Public Money. The
figures for actives and products differ because work on active
substances involves a greater proportion of specialist scientific input at
a higher grade than comparable work on biocidal products. The rates
are based on average costs of processing similar types of application
under the current system (Biocidal Products Regulations 2001).
16. Costs for evaluating each application will vary depending on the
amount of work required to complete the evaluation. However the
estimated time required for the evaluation of common types of
application that HSE receives are also given in the table in Annex 1.
17. HSE will be monitoring the operation of the fee structure closely
particularly during the early months of its operation. We will keep the
system under review and may in due course bring forward proposals
with a view to further increasing the transparency and efficiency of the
system and bringing down costs where possible.
Cost recovery arrangements – General Industry Charge
18. In addition to fees for specific services provided to applicants, HSE
currently charges a General Industry Charge (GIC) to biocides
businesses. The GIC recovers certain costs that HSE incurs in
carrying out the activities required under those regulations, but which
are not easily attributable to particular applicants. These include the
costs of technical support to the development of the EU biocides
authorisation regime, commenting on other Member States’ Competent
Authority Reports and provision of advice to dutyholders in cases
where this is not related to a specific application.
19. HSE intends to carry out a review of the basis for recovering the costs
currently attributed to the GIC, with a view to making any required
legislative changes on 1 April 2014 to coincide with the common
commencement date for the Health and Safety (Fees) Regulations.
However the current GIC, based on an annual flat fee, will be
maintained until the review of the GIC is completed.
20. A separate consultation will be carried out in due course in relation to
any proposed legislative changes arising from the review of the GIC.

Impact on business
21. HSE currently recovers its full costs through fees and charges under
the existing biocides regime set out in the Biocidal Products Directive
98/8/EC and the Biocidal Products Regulations 2001. The new
regulations will ensure that full cost recovery continues to take place as
required under the new EU Regulation 528/2012, under a new fee
structure corresponding to the services provided under the new
Regulation.
22. Under the new Regulation HSE will provide a broadly similar set of
services to those provided under the Biocidal Products Directive
98/8/EC (BPD), focusing on evaluating applications to grant, renew and
amend active substance approvals and biocidal product authorisations.
There will be some differences: for example, the new Regulation gives
the European Chemicals Agency a role in managing applications for
active substance approvals whereas this was not the case under the
BPD. However the impact of these changes has already been taken
into account in a full impact assessment of the EU Regulation itself
so is not considered again here (see
http://www.hse.gov.uk/research/rrhtm/rr826.htm for details).
23. Because the proposed fees regulations simply implement
the continuing requirement for full cost recovery in the EU Regulation,
we anticipate that they will not have any financial impacts on
businesses beyond those already taken into account in the Impact
Assessment of the EU Regulation.
<strong>Consultation</strong> questions
24. The purpose of this consultation is to seek your views and feedback on
HSE’s proposals to put in place fees under the new EU Biocides
Regulation. In particular we would like your views on the following:
Question 1: do you have any comments on the proposed fee structure under
the new EU Biocides Regulation 528/2012, set out in Annex 1?
Question 2: do you have any additional comments on the issues raised in this
consultation?
Responses should be sent to Chemicals<strong>Consultation</strong>@hse.gsi.gov.uk by
22 nd March 2013.

Annex 1 – Proposed biocides fees structure under EU Regulation 528/2012
Table A1 sets out the list of Articles under Regulation 528/2012 on placing on the market and use of biocidal products for which HSE will
provide a service to applicants as competent authority, and for which we therefore propose to make a charge. It also sets out the proposed
daily rates for each service. Actual costs will be calculated using out work-recording system as set out above.
The charges derive from the overarching provision in Article 80(2) of Regulation 528/2012 – “Member States shall directly charge applicants
fees for services that they provide with respect to the procedures under this Regulation, including the services undertaken by Member
States’ competent authorities when acting as evaluating competent authority.”
Table A1 – services for which HSE will charge under Regulation 528/2012 and daily rates
Article
in
528/2012
Article Text
7(3) Within 30 days of the Agency accepting an
application, the evaluating competent
authority shall validate the application if the
data required in accordance with points (a)
and (b) and, where relevant point (c) of
Article 6(1), and any justifications for the
adaptation of data requirements, have been
submitted […]
Service provided/ estimated cost
range
Validation of an application for
approval of an active substance in
accordance with Article 7.
£5,000 Active substance
Completeness Check
Daily rate/
estimated
timescale
range
£447
11.2 days
Comments
This covers the work involved in
an initial check of the
completeness of a data package
submitted. It does not involve
assessment of the quality or
adequacy of the data.
5

Article
in
528/2012
Article Text
8(1) The evaluating competent authority shall,
within 365 days of the validation of an
application, evaluate it in accordance with
Articles 4 and 5, including, where relevant,
any proposal to adapt data requirements
submitted in accordance with Article 6(3),
and send an assessment report and the
conclusions of its evaluating to the Agency.
Service provided/ estimated cost
range
Evaluation of an application to
approve an active substance under
Article 8.
£185,000 (min) Active substance
(AS) Full Data Package plus Active
substance EU Discussion
£315,000 (max) Active substance
Full Data Package plus 7 Extra data
Packages and Active substance EU
Discussion
Daily rate/
estimated
timescale
range
£447
414 days
705 days
Comments
Covers work in carrying out the
substantive evaluation of an
application for active substance
approval.
6

Article
in
528/2012
Article Text
14 14(1) – On the basis of an assessment of the
available information and the need to review
the conclusions of the initial evaluation of the
application for approval or, as appropriate,
the previous renewal, the evaluating
competent authority shall, within 90 days of
the Agency accepting an application in
accordance with Article 13(3), decide
whether, in the light of current scientific
knowledge, a full evaluation of the application
for renewal is necessary […]
Service provided/ estimated cost
range
Evaluation of an application to
renew an active substance approval
under Article 14.
£12,000 (min) Active substance
renewal Initial Fee
If a full evaluation is required then
fees as 8(1)
Daily rate/
estimated
timescale
range
£447
27 days
Comments
Covers work on renewing an
existing approval of an active
substance. The quantity and
timeframe will depend on
whether the evaluating
competent authority (HSE)
decides that a full evaluation of
the substance is necessary. Full
evaluations are carried out under
Article 8.
14(2) Where the evaluating competent
authority decides that a full evaluation of the
application is necessary, the evaluation shall
be carried out in accordance with paragraphs
1, 2 and 3 of Article 8.
Where the evaluating competent authority
decides that a full evaluation of the
application is not necessary, it shall, within
180 days of the Agency accepting the
application in accordance with Article 13(3),
prepare and submit to the Agency a
recommendation on the renewal of the
approval of the active substance. It shall
provide the applicant with a copy of its
recommendation.
7

Article
in
528/2012
Article Text
26(3) Within 90 days of accepting an application
[for authorisation via the simplified procedure]
the evaluating competent authority shall
authorise the biocidal product if satisfied that
the product meets the conditions laid down in
Article 25.
Service provided/ estimated cost
range
Evaluation of an application to
authorise a biocidal product under
the simplified procedure.
£1,420 (min) Sift plus Co-ordination
and 1 Specialist Case
Daily rate/
estimated
timescale
range
£393
3.6 days
Comments
Covers HSE’s work in checking
that the biocidal product meets a
number of conditions set out in
Article 25 of the Regulation for
eligibility for the simplified
procedure.
£3,920 (max) as above but with 6
Specialist Cases
10 days
29 29(1) – Applicants wishing to apply for a
national authorisation in accordance with
Article 17 shall submit an application to the
receiving competent authority […].
29(2) – Within 30 days of acceptance, the
receiving competent authority shall validate
the application if it complies with the following
requirements […]
30(1) The receiving competent authority shall,
within 365 days of the validation of an
application in accordance with Article 29,
decide whether to grant an authorisation in
accordance with Article 19. It shall take into
account the results of the comparative
assessment carried out in accordance with
Article 23, if applicable.
Validation of an application for a
national approval of a biocidal
product.
£220 Sift
Evaluation of an application to
authorise a biocidal product.
£150 (min) admin only i.e. Marketing
Authorisations
£10,900 (max) Technical Sift, Coordination,
6 Specialist Data and an
EU Surcharge
£393
0.6 days
£393
0.4 days
28 days
Covers HSE’s work in checking
the completeness (validating) an
application for a national
approval of a biocidal product. It
does not involve assessment of
the quality or adequacy of the
data.
Covers work in carrying out the
substantive evaluation of an
application to authorise a biocidal
product.
8

Article
in
528/2012
Article Text
31(2) The receiving competent authority shall
renew the national authorisation, provided
that the conditions set out in Article 19 are
still satisfied. It shall take into account the
results of the comparative assessment
carried out in accordance with Article 23, if
applicable.
Service provided/ estimated cost
range
Evaluation of an application to
renew a national authorisation of a
biocidal product.
£1,420 (min) Sift, Co-ordination and
1 Specialist Case
£10,120 (max) Sift, Technical Sift,
Co-or 1, and 6 Specialist Data (but
this would be exceptional)
Daily rate/
estimated
timescale
range
£393
3.6 days
26 days
Comments
Covers HSE’s work in evaluating
a renewal application for a
biocidal product. This may or
may not require a full review of
the initial evaluation – this will be
decided by the competent
authority (HSE) on the basis of
the information submitted.
33(2), (3) 33(2) - Within 30 days of acceptance [of an
application for mutual recognition] referred to
in paragraph 1, the Member States
concerned shall validate the application and
inform the applicant accordingly, indicating
the date of acceptance.
Within 90 days of validating the application
[…] the Member States concerned shall
agree on the summary of biocidal product
characteristics referred to in Article 22(2) and
shall record their agreement in the Register
for Biocidal Products.
Validating, processing and
determining an application to
mutually recognise a biocidal
product in sequence, and
subsequent authorisation.
£1,420 (min) Sift, Co-ordination and
1 Specialist Case
£3,920 (max) as above but with 6
Specialist Cases
£393
3.6 days
10 days
Covers HSE’s work in processing
an application for mutual
recognition in sequence –
covering validation,
evaluation/agreement with other
Member States, and
authorisation.
33(3) – Within 30 days of reaching
agreement, each of the Member States
concerned shall authorise the biocidal
product in conformity with the agreed
summary of biocidal product characteristics.
9

Article
in
528/2012
Article Text
34 33(5) – Within 90 days of receipt of the
documents referred to in paragraph 4 […] the
Member States concerned shall agree on the
summary of biocidal product characteristics,
and hall record their agreement in the
Register for Biocidal Products […]
33(6) – Within 30 days of reaching
agreement, the reference Member State and
each of the Member States concerned shall
authorise the biocidal product in conformity
with the agreed summary of biocidal product
characteristics.
39 39(1) - […] official or scientific bodies
involved in pest control activities or the
protection of public health may apply, under
the mutual recognition procedure provided for
in Article 33 […]
The application shall be accompanied by the
fees payable under Article 80.
39(2) – Where the competent authority of the
Member State concerned considers that the
biocidal product fulfils the conditions referred
to in Article 19 and the conditions under this
Article are met, the competent authority shall
authorise making available on the market of
the biocidal product […]
Service provided/ estimated cost
range
Processing and determining an
application for mutual recognition in
parallel as concerned Member
States.
£1,420 (min) Sift, Co-ordination and
1 Specialist Case
£3,920 (max) as above but with 6
Specialist Cases
Processing and determining an
application for mutual recognition by
an official or scientific body.
£1,420 (min) Sift, Co-ordination and
1 Specialist Case
£3,920 (max) as above but with 6
Specialist Cases
Daily rate/
estimated
timescale
range
£393
3.6 days
10 days
£393
3.6 days
10 days
Comments
Covers HSE’s work in mutually
recognising a biocidal product in
parallel when it acts as
concerned Member State (i.e. not
the Member State to whom the
main application is made).
10

Article
in
528/2012
Article Text
43(3) Within 30 days of the Agency accepting an
application, the evaluating competent
authority shall validate the application if the
relevant information referred to in Article 20
has been submitted.
Service provided/ estimated cost
range
Validating an application for Union
Authorisation of a biocidal product.
£220 Sift
Daily rate/
estimated
timescale
range
£393
0.6 days
Comments
Covers HSE’s work in validating
an application for Union
Authorisation – initial
validation/completeness check
(no substantive assessment).
44(1) The evaluating competent authority shall,
within 365 days of the validation of an
application, evaluate it in accordance with
Article 19 […] and send an assessment
report and the conclusions of its evaluation to
the Agency.
Evaluating an application for Union
Authorisation of a biocidal product.
£150 (min) admin only i.e. Marketing
Authorisations
£10,900 (max) Technical Sift, Coordination,
6 Specialist Data and an
EU Surcharge
£393
0.4 days
28 days
11

Article
in
528/2012
Article Text
46 46(1) - On the basis of an assessment of the
available information and the need to review
the conclusions of the initial evaluation of the
application for Union authorisation or, as
appropriate the previous renewal, the
evaluating competent authority shall within 30
days […] decide whether, in the light of
current scientific knowledge, a full evaluation
of the application for renewal is necessary.
Service provided/ estimated cost
range
Evaluation of an application to
renew a Union Authorisation.
£1,420 (min) Sift, Co-ordination and
1 Specialist Case
£10,120 (max) Sift, Technical Sift,
Co-ordination, and 6 Specialist Data
Daily rate/
estimated
timescale
range
£393
3.6 days
26 days
Comments
Covers HSE’s work in processing
and evaluating the renewal
application. May be a full or
shortened renewal depending
whether there is substantial new
evidence to take into account – a
decision on this will be taken by
the Competent Authority.
46(2) - Where the evaluating competent
authority decides that a full evaluation of the
application is necessary, the evaluation shall
be carried out in accordance with paragraphs
1 and 2 of Article 44.
Where the evaluating competent authority
decides that a full evaluation of the
application is not necessary, it shall, within
180 days of the Agency accepting the
application, prepare and submit to the
Agency a recommendation on the renewal of
the authorisation. It shall provide the
applicant with a copy of its recommendation.
12

Article
in
528/2012
Article Text
50(2) An authorisation holder seeking to change
any other information submitted in relation to
the initial application for authorisation of the
product shall apply to the competent
authorities of the relevant Member States
having authorised the product […]. Those
competent authorities shall decide, […]
whether the conditions of Article 19, or where
relevant, Article 25 are still met and whether
the terms and conditions of the authorisation
need to be amended.
Service provided/ estimated cost
range
Determination of an application to
amend an existing biocidal product
authorisation.
£370 (min) Sift and admin only
(admin amendment)
£10,120 (max) Sift, Technical Sift,
Co-ordination, and 6 Specialist Data
evaluations (major amendment)
Daily rate/
estimated
timescale
range
£393
0.9 days
26 days
Comments
Covers HSE’s work on any
application for amendment of an
existing authorisation. Scale of
work will differ depending on
whether the change is classified
as an administrative change,
minor change, or major change.
The application shall be accompanied by the
fees payable under Article 80(1) and (2).
53 53(1) A competent authority of a Member
State […] shall at the request of the
applicant, grant a parallel trade permit for a
biocidal product that is authorised in another
Member State […] if it determines in
accordance with paragraph 3 that the biocidal
product is identical to a biocidal product
already authorised in the Member State of
introduction. […]
Determination of an application for a
parallel trade permit.
£420 (min) Sift and Verification
£1120 (max) As above plus coordination
fee
£393
1.1 days
2.8 days
53(2) Where the competent authority of the
Member State of introduction determines that
a biocidal product is identical to the reference
product, it shall grant a parallel trade permit
within 60 days of receipt of the fees payable
under Article 80(2).
13

Article
in
528/2012
Article Text
55(1) By way of derogation from Articles 17 and 19,
a competent authority may permit, for a
period not exceeding 180 days, the making
available on the market or use of a biocidal
product which does not fulfil the conditions
for authorisation laid down in this Regulation,
for a limited and controlled use under the
supervision of the competent authority, if
such a measure is necessary because of a
danger to public health, animal health or the
environment which cannot be contained by
other means.
56(2) Any person intending to carry out an
experiment or test that may involve, or result
in, release of the biocidal product into the
environment shall first notify the competent
authority of the Member State where the
experiment or test will occur. […]
In the absence of an opinion from the
competent authority within 45 days of the
notification referred to in the first
subparagraph, the notified experiment or test
may take place.
Service provided/ estimated cost
range
Evaluation of an application for an
emergency use permit.
£1,420 (min) Sift, Co-ordination and
1 Specialist Case
£10,120 (max) Sift, Technical Sift,
Co-or 1, and 6 Specialist Data
evaluations
Evaluation of an experiment or test
notification.
£1,420 (min) Sift, Co-ordination and
1 Specialist Case
£10,120 (max) Sift, Technical Sift,
Co-ordination, and 6 Specialist data
evaluations.
Daily rate/
estimated
timescale
range
£393
3.6 days
26 days
£393
3.6 days
26 days
Comments
Charge made to any applicant for
an emergency use permit, to
cover HSE’s costs in evaluating
their application.
Charge made to cover HSE’s
costs in checking the
experiment/test notification in
order to determine whether any
restrictions or conditions need to
be imposed.
14

Annex 2 – draft statutory instrument, The Biocidal Products (Fees and
Charges) Regulations 2013
Please note that this draft is incomplete and will be subject to amendment.
STATUTORY INSTRUMENTS
2013 No.
HEALTH AND SAFETY
The Biocidal Products (Fees and Charges) Regulations 2013
Made - - - - ***
Laid before Parliament ***
Coming into force - - ***
The Secretary of State is designated for the purposes of section 2(2) of the European Communities Act
1972(1) (“the 1972 Act”) in relation to measures relating to biocides.
The Secretary of State makes these regulations—
(a) in exercise of the powers conferred on him by section 2(2) of the 1972 Act (“the 1972 Act”) and
sections 43(2), (4), (5) and (6) and 83(3)(a) of the Health and Safety at Work etc. Act 1974(2) (“the 1974
Act”), and
(b) for the purposes of giving effect without modifications to proposals submitted to him by the Health and
Safety Executive under section 11(3) of the 1974 Act.
Citation, commencement and extent
1.—(1) These Regulations may be cited as The Biocidal Products (Fees and Charges) Regulations 2013
and come into force on 1 st September 2013.
(2) These Regulations extend to Great Britain.
(3) These Regulations apply outside Great Britain as sections 1 to 59 and 80 to 82 of the 1974 Act apply
by virtue of the [Health and Safety at Work etc. Act 1974 (Application Outside Great Britain) Order 2013].
Interpretation
2.—(1) “The 1998 Regulations” means the Health and Safety (Enforcing Authority) Regulations 1998(3)
(2) “Regulation 528/2012” means Regulation (EU) No 528/2012 of the European Parliament and of the
Council of 22 May 2012 concerning the making available on the market and use of biocidal products.
(3) “Northern Ireland Regulations” means the [relevant Northern Ireland Regulations].
(1) 1972 c.68. The power of the Ministers to make regulations in or regards Scotland is preserved by section 57(1) of the Scotland Act
1998 (c.46).
(2) 1974 c.37
(3) SI 1998/494 as amended by S.I. 1999/2024 and S.I. 1999/3232.
15

(4) “Liability period” means the period beginning with the 1 st April and ending with the 31 st March the
following year.
(5) “competent authority” means the designated competent authority appointed under Regulation [5] of the
[Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013].
Functions of the Member State
3.The functions of the Member State referred to in Article 80(2) of Regulation 528/2012 are to be
performed by the competent authority.
Fees
4.—(1) The competent authority shall charge fees for work it carries out within the scope of Regulation
528/2012 which relates to the activities listed in column 1 of the Table in the Schedule.
(2) Any fee payable under paragraph (1) shall be calculated in accordance with paragraphs (3) to (9).
(3) Where a fee is payable under paragraph (1), the competent authority shall prepare and send to the
applicant, the person providing the information or the person making the request, as the case may be, an
estimate of the cost of the work necessary for the evaluation of the application.
(4) The estimate of costs referred to in paragraph (3) must be paid to the competent authority within 30
days of its issue by the competent authority.
(5) Upon completion of the work necessary for the evaluation of the application, the competent authority
must prepare a detailed statement of the work carried out and of the cost incurred by the competent authority
or any person acting on their behalf in carrying out that work.
(6) If the cost referred to in paragraph (5) is greater than the amount estimated in accordance with
paragraph (3), the competent authority must notify the amount of difference to the applicant, the person
providing the information or the person making the request as the case may be, who must pay the amount of
the difference, which will be the final fee payable, immediately.
(7) If the cost referred to in paragraph (5) is less than the amount estimated in accordance with paragraph
(3), the fee shall be adjusted accordingly and the amount of difference shall be paid forthwith by the
competent authority to the applicant.
(8) Subject to paragraph (9), in estimating or stating the cost of carrying out any work, the competent
authority shall determine that cost by reference to the daily rate specified in column 2 of the Table in the
Schedule that corresponds to the activity listed in column 1.
(9) The daily rate shall be adjusted pro rata for a period worked of less than 7.4 hours on any one day
by—
(a) dividing the daily rate by 14.8 to create a half hourly rate; and
(b) multiplying that figure by the number of half hours worked, rounded up or down to the nearest
half hour.
Annual charge
5.—(1) In respect of a given liability period a charge shall be payable by anyone placing one or more
biocidal products on the market, on invoice, to the competent authority.
(2) The charge referred to in paragraph (1) shall be in respect of any costs incurred by the competent
authority, or on its behalf, associated with making biocidal products available on the market but shall not
include any costs in respect of which a fee is payable under regulation 4.
(3) If a person (“P”) pays the annual fee under Article 80(1)(a) in respect of all biocidal products that P
places on the market, P shall not be liable to pay the charge referred to in paragraph (1).
(4) No payment shall be required from a person liable to pay the charge referred to in paragraph (1) where
that person has made payment in respect of the same liability under the Northern Ireland Regulations.
(5) The competent authority may exclude anyone from the requirement to pay a charge where that
authority decides that it would not be fair to collect that charge.
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(6) Where a person becomes liable to pay a charge in accordance with paragraph (1) at any time during the
liability period, that person will be liable to pay a charge for the whole of that liability period.
Calculation of charge and number of persons liable to pay the charge
6.—(1) Upon expiry of the liability period, the competent authority shall calculate the number of persons
liable to pay the charge under regulation 5 in accordance with paragraph (2).
(2) The competent authority must calculate the charge by dividing the costs incurred in accordance with
regulation 5(2) during the liability period by the number of persons by whom the charge is payable under
these Regulations and the Northern Ireland Regulations.
Notification of liability to pay
7.—(1) Subject to paragraph (2), a person who is liable to pay a charge under regulation 5 must notify in
writing to the competent authority, or to a person designated by them—
(a) the name of the person liable to pay the charge and the address to which communications should
be sent; and
(b) the name of the person to whom requests for payment of the charge are made;
and must indicate clearly that the notification is for the purposes of this paragraph.
(2) A person is not required to make a notification under paragraph (1) if that person has made an
application for the authorisation of a biocidal product under Regulation 528/2012 and that authorisation has
been granted.
(3) The notification in paragraph (1) must be made—
(a) before the biocidal product is placed on the market; or
(b) if the product in question has already been placed on the market before 1 st September 2013, within
three months of that date.
(4) The competent authority must keep the information supplied pursuant to paragraph (1) on a register and
if there is a change to the details required to be notified under paragraph (1), the person liable to pay the
charge shall inform the Ministers, or the body designated by them under paragraph (1), forthwith in writing
of the relevant changes.
Review
8.—(1) The Secretary of State must from time to time—
(a) carry out a review of regulations 1 to 7;
(b) set out the conclusions of the review in a report, and
(c) publish the report.
(2) In carrying out the review the Secretary of State must, so far as is reasonable, have regard to the
measures taken to implement rules on fees and charging in relation to Regulation 528/2012 in other member
States.
(3) The report must in particular—
(a) set out the objectives intended to be achieved by the regulatory system established by Regulation
528/2012,
(b) assess the extent to which those objectives are achieved, and
(c) assess whether those objectives remain appropriate and, if so, the extent to which they could be
achieved with a system that imposes less regulation.
(4) The first report under this regulation must be published before the end of the period of five years
beginning with the day on which regulations 1 to 10 come into force.
(5) Reports under this regulation are afterwards to be published at intervals not exceeding five years.
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SCHEDULE
ACTIVITIES IN RESPECT OF WHICH A FEE IS PAYABLE AND DAILY
RATE
Table
Regulation 4
1.
Purpose of application and Article number
(a) Validation of an application for approval of
an active substance in accordance with Article
7.
(b) Evaluation of an application to approve an
active substance under Article 8.
(c) Evaluation of an application to renew an
active substance approval under Article 14.
(d) Evaluation of an application to authorise a
biocidal product under the simplified
procedure.
(e) Validation of an application for a national
approval of a biocidal product.
(f) Evaluation of an application to authorise a
biocidal product.
(g) Evaluation of an application to renew a
national authorisation of a biocidal product.
(h) Validating, processing and determining an
application to mutually recognise a biocidal
product in sequence, and subsequent
authorisation.
(i) Processing and determining an application
for mutual recognition in parallel as concerned
Member States
(j) Processing and determining an application
for mutual recognition by an official or
scientific body.
(k) Validating an application for Union
Authorisation of a biocidal product.
(l) Evaluating an application for Union
Authorisation of a biocidal product
(m) Evaluation of an application to renew a
Union Authorisation.
(n) Determination of an application to amend
an existing biocidal product authorisation.
(o) Determination of an application for a
parallel trade permit.
(p) Evaluation of an application for an
emergency use permit.
(q) Evaluation of an experiment or test
notification.
2.
Fee per day worked
£447
£447
£447
£393
£393
£393
£393
£393
£393
£393
£393
£393
£393
£393
£393
£393
£393
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