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

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

ong>Consultationong> 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 The BPD will be repealed on 1 September 2013 and replaced by a new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.

ong>Consultationong> 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 Chemicalsong>Consultationong>@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.

16


(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.

17


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

18

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