Consultation on Fees to Support EU Biocides Regulation 528 ... - HSE
Consultation on Fees to Support EU Biocides Regulation 528 ... - HSE
Consultation on Fees to Support EU Biocides Regulation 528 ... - HSE
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<str<strong>on</strong>g>C<strong>on</strong>sultati<strong>on</strong></str<strong>on</strong>g> <strong>on</strong> <strong>Fees</strong> <strong>to</strong> <strong>Support</strong> <strong>EU</strong> <strong>Biocides</strong><br />
Regulati<strong>on</strong> <strong>528</strong>/2012<br />
Introducti<strong>on</strong><br />
1. The Health and Safety Executive (<strong>HSE</strong>) is writing <strong>to</strong> you because<br />
we believe you currently place biocidal products <strong>on</strong> the market and so<br />
will be affected by provisi<strong>on</strong>s regarding fees under the new <strong>EU</strong><br />
Regulati<strong>on</strong> <strong>528</strong>/2012 <strong>on</strong> placing <strong>on</strong> the market and use of biocidal products.<br />
2. This document outlines <strong>HSE</strong>’s proposals for new fees regulati<strong>on</strong>s <strong>to</strong> allow<br />
it <strong>to</strong> recover its costs for the services it will provide in operating the<br />
biocides authorisati<strong>on</strong> regime under the new <strong>EU</strong> Regulati<strong>on</strong> <strong>528</strong>/2012<br />
<strong>on</strong> placing <strong>on</strong> the market and use of biocidal products.<br />
3. We are c<strong>on</strong>sulting those affected by these proposals in order <strong>to</strong><br />
introduce fees regulati<strong>on</strong>s <strong>to</strong> give <strong>HSE</strong> the power <strong>to</strong> c<strong>on</strong>tinue <strong>to</strong> charge<br />
fees by 1 September 2013, the date of applicati<strong>on</strong> of the new <strong>EU</strong><br />
Regulati<strong>on</strong>.<br />
4. We are therefore seeking your views <strong>on</strong> a proposed fee structure under<br />
the <strong>EU</strong> Regulati<strong>on</strong>.<br />
Background – new <strong>EU</strong> biocides Regulati<strong>on</strong><br />
5. Placing <strong>on</strong> the market and use of biocidal products is currently<br />
regulated at <strong>EU</strong> level through Directive 98/8/EC (the ‘Biocidal Products<br />
Directive’ or BPD). The Directive aims <strong>to</strong> harm<strong>on</strong>ise the <strong>EU</strong> market in<br />
biocides and provide a high level of protecti<strong>on</strong> for human and animal<br />
health and the envir<strong>on</strong>ment by introducing an <strong>EU</strong>-wide authorisati<strong>on</strong><br />
regime for biocidal products.<br />
6. The BPD is implemented in Great Britain through the Biocidal Products<br />
Regulati<strong>on</strong>s 2001 (BPR 2001) and in Northern Ireland through the<br />
Biocidal Products Regulati<strong>on</strong>s (Northern Ireland) 2001 (BPRNI). Since<br />
these SIs entered in<strong>to</strong> force, each has been amended four times.<br />
7. The BPD will be repealed <strong>on</strong> 1 September 2013 and replaced by a new<br />
directly applicable <strong>EU</strong> Regulati<strong>on</strong> <strong>on</strong> placing <strong>on</strong> the market and use of<br />
biocidal products. The new Regulati<strong>on</strong> retains the basic structure of<br />
the BPD – a two step procedure for approving active substances at <strong>EU</strong><br />
level and authorising biocidal products in Member States. However it<br />
aims <strong>to</strong> improve and update the system by introducing changes in a<br />
number of areas. Informati<strong>on</strong> <strong>on</strong> the new Regulati<strong>on</strong> is available here:<br />
http://www.hse.gov.uk/aboutus/europe/eur<strong>on</strong>ews/dossiers/biocide.htm<br />
8. Because the BPD will effectively be replaced by the new <strong>EU</strong><br />
Regulati<strong>on</strong>, we intend <strong>to</strong> revoke the GB legislati<strong>on</strong> that implements the<br />
BPD <strong>on</strong> the same date.<br />
1
9. As a result, new domestic regulati<strong>on</strong>s will be required <strong>to</strong> support certain<br />
parts of the <strong>EU</strong> Regulati<strong>on</strong>. A c<strong>on</strong>sultati<strong>on</strong> has already taken place <strong>on</strong><br />
regulati<strong>on</strong>s <strong>to</strong> introduce enforcement measures and penalties for the<br />
<strong>EU</strong> Regulati<strong>on</strong>, c<strong>on</strong>solidating these with related provisi<strong>on</strong>s <strong>on</strong><br />
classificati<strong>on</strong> and labelling of chemicals and export and import of<br />
hazardous chemicals:<br />
http://www.hse.gov.uk/c<strong>on</strong>sult/c<strong>on</strong>docs/cd249.htm. New legislati<strong>on</strong> is<br />
also required <strong>to</strong> enable <strong>HSE</strong> <strong>to</strong> c<strong>on</strong>tinue charging fees <strong>to</strong> recover its<br />
costs under the new <strong>EU</strong> Regulati<strong>on</strong>. The new fees regulati<strong>on</strong>s are the<br />
subject of this c<strong>on</strong>sultati<strong>on</strong>.<br />
Proposals for fees and charges under the new <strong>EU</strong> Regulati<strong>on</strong> <strong>528</strong>/2012<br />
10. It has been the policy of successive governments <strong>to</strong> recover the costs<br />
of services it provides from those who benefit from them. Accordingly,<br />
<strong>HSE</strong> already seeks <strong>to</strong> recover the full costs of its activities in acting as<br />
nati<strong>on</strong>al competent authority for biocides in the UK through charging<br />
businesses for work d<strong>on</strong>e under the BPR 2001 and will c<strong>on</strong>tinue <strong>to</strong> do<br />
so under the new <strong>EU</strong> Regulati<strong>on</strong>. Article 80(2) of the <strong>EU</strong> <strong>Biocides</strong><br />
Regulati<strong>on</strong> also requires Member States <strong>to</strong> “directly charge applicants<br />
fees for services that they provide with respect <strong>to</strong> the procedures under<br />
this Regulati<strong>on</strong>, including the services undertaken by Member States’<br />
competent authorities when acting as evaluating competent authority”.<br />
Cost recovery arrangements - fees<br />
11. To achieve this <strong>HSE</strong> proposes <strong>to</strong> put in place a fee structure by which<br />
applicants will be charged for the services that <strong>HSE</strong> carries out under<br />
the <strong>EU</strong> Regulati<strong>on</strong>. The fee structure will set out each of the services<br />
that <strong>HSE</strong> will provide <strong>to</strong> applicants under the Regulati<strong>on</strong> <strong>to</strong>gether with a<br />
corresp<strong>on</strong>ding daily rate for the staff time used in delivering the service.<br />
12. Article 80(2) of the <strong>EU</strong> Regulati<strong>on</strong> requires that Member States should<br />
introduce charging provisi<strong>on</strong>s that cover all the services that are carried<br />
out by Competent Authorities with respect <strong>to</strong> procedures in the<br />
Regulati<strong>on</strong>. The main services that <strong>HSE</strong> will deliver under the<br />
Regulati<strong>on</strong> will be evaluating applicati<strong>on</strong>s <strong>to</strong> grant, renew and amend<br />
active substance approvals and biocidal product authorisati<strong>on</strong>s, where<br />
the UK is acting as evaluating Member State. Other chargeable<br />
services that <strong>HSE</strong> is required <strong>to</strong> provide under the Regulati<strong>on</strong> include<br />
granting a parallel trade permit (Article 53) or evaluating an<br />
experimental notificati<strong>on</strong> (Article 56(2)). A full list of services that <strong>HSE</strong><br />
will charge for is given in Annex 1. A draft of the Statu<strong>to</strong>ry<br />
instrument (The Biocidal Products (<strong>Fees</strong> and Charges) Regulati<strong>on</strong>s<br />
2013) including the proposed fee structure and fee levels is attached<br />
at Annex 2.<br />
13. <strong>HSE</strong>’s fees in delivering these services will corresp<strong>on</strong>d <strong>to</strong> the full cost<br />
of staff time in undertaking the relevant technical assessments and<br />
associated administrative work calculated in accordance with Annex<br />
6.2 of HM Treasury’s document, Managing Public M<strong>on</strong>ey<br />
(http://www.hm-treasury.gov.uk/psr_mpm_index.htm). This also
ensures compliance with the requirement in Article 80(3) of the<br />
Regulati<strong>on</strong>, stating that “fees shall be set at such a level as <strong>to</strong> ensure<br />
that the revenue derived from the fees is, in principle, sufficient <strong>to</strong> cover<br />
the cost of the services delivered and shall not exceed what is<br />
necessary <strong>to</strong> cover those costs.”<br />
14. To make the system as transparent as possible, <strong>HSE</strong> proposes <strong>to</strong> set<br />
daily charging rates for each type of service that it will provide under<br />
the Regulati<strong>on</strong>. The proposed daily charging rates will fall in<strong>to</strong> two<br />
categories: £447 per day for work <strong>on</strong> active substances and £393 per<br />
day for other work, including <strong>on</strong> biocidal products (see Annex 1).<br />
Where <strong>on</strong>ly part a day is used in providing a service, the corresp<strong>on</strong>ding<br />
fracti<strong>on</strong> of the daily rate will be charged pro rata.<br />
15. The proposed daily rates are based <strong>on</strong> average daily costs for the<br />
combinati<strong>on</strong> of staff grades who work <strong>on</strong> each type of applicati<strong>on</strong><br />
calculated in line with Annex 6.2 of Managing Public M<strong>on</strong>ey. The<br />
figures for actives and products differ because work <strong>on</strong> active<br />
substances involves a greater proporti<strong>on</strong> of specialist scientific input at<br />
a higher grade than comparable work <strong>on</strong> biocidal products. The rates<br />
are based <strong>on</strong> average costs of processing similar types of applicati<strong>on</strong><br />
under the current system (Biocidal Products Regulati<strong>on</strong>s 2001).<br />
16. Costs for evaluating each applicati<strong>on</strong> will vary depending <strong>on</strong> the<br />
amount of work required <strong>to</strong> complete the evaluati<strong>on</strong>. However the<br />
estimated time required for the evaluati<strong>on</strong> of comm<strong>on</strong> types of<br />
applicati<strong>on</strong> that <strong>HSE</strong> receives are also given in the table in Annex 1.<br />
17. <strong>HSE</strong> will be m<strong>on</strong>i<strong>to</strong>ring the operati<strong>on</strong> of the fee structure closely<br />
particularly during the early m<strong>on</strong>ths of its operati<strong>on</strong>. We will keep the<br />
system under review and may in due course bring forward proposals<br />
with a view <strong>to</strong> further increasing the transparency and efficiency of the<br />
system and bringing down costs where possible.<br />
Cost recovery arrangements – General Industry Charge<br />
18. In additi<strong>on</strong> <strong>to</strong> fees for specific services provided <strong>to</strong> applicants, <strong>HSE</strong><br />
currently charges a General Industry Charge (GIC) <strong>to</strong> biocides<br />
businesses. The GIC recovers certain costs that <strong>HSE</strong> incurs in<br />
carrying out the activities required under those regulati<strong>on</strong>s, but which<br />
are not easily attributable <strong>to</strong> particular applicants. These include the<br />
costs of technical support <strong>to</strong> the development of the <strong>EU</strong> biocides<br />
authorisati<strong>on</strong> regime, commenting <strong>on</strong> other Member States’ Competent<br />
Authority Reports and provisi<strong>on</strong> of advice <strong>to</strong> dutyholders in cases<br />
where this is not related <strong>to</strong> a specific applicati<strong>on</strong>.<br />
19. <strong>HSE</strong> intends <strong>to</strong> carry out a review of the basis for recovering the costs<br />
currently attributed <strong>to</strong> the GIC, with a view <strong>to</strong> making any required<br />
legislative changes <strong>on</strong> 1 April 2014 <strong>to</strong> coincide with the comm<strong>on</strong><br />
commencement date for the Health and Safety (<strong>Fees</strong>) Regulati<strong>on</strong>s.<br />
However the current GIC, based <strong>on</strong> an annual flat fee, will be<br />
maintained until the review of the GIC is completed.<br />
20. A separate c<strong>on</strong>sultati<strong>on</strong> will be carried out in due course in relati<strong>on</strong> <strong>to</strong><br />
any proposed legislative changes arising from the review of the GIC.
Impact <strong>on</strong> business<br />
21. <strong>HSE</strong> currently recovers its full costs through fees and charges under<br />
the existing biocides regime set out in the Biocidal Products Directive<br />
98/8/EC and the Biocidal Products Regulati<strong>on</strong>s 2001. The new<br />
regulati<strong>on</strong>s will ensure that full cost recovery c<strong>on</strong>tinues <strong>to</strong> take place as<br />
required under the new <strong>EU</strong> Regulati<strong>on</strong> <strong>528</strong>/2012, under a new fee<br />
structure corresp<strong>on</strong>ding <strong>to</strong> the services provided under the new<br />
Regulati<strong>on</strong>.<br />
22. Under the new Regulati<strong>on</strong> <strong>HSE</strong> will provide a broadly similar set of<br />
services <strong>to</strong> those provided under the Biocidal Products Directive<br />
98/8/EC (BPD), focusing <strong>on</strong> evaluating applicati<strong>on</strong>s <strong>to</strong> grant, renew and<br />
amend active substance approvals and biocidal product authorisati<strong>on</strong>s.<br />
There will be some differences: for example, the new Regulati<strong>on</strong> gives<br />
the European Chemicals Agency a role in managing applicati<strong>on</strong>s for<br />
active substance approvals whereas this was not the case under the<br />
BPD. However the impact of these changes has already been taken<br />
in<strong>to</strong> account in a full impact assessment of the <strong>EU</strong> Regulati<strong>on</strong> itself<br />
so is not c<strong>on</strong>sidered again here (see<br />
http://www.hse.gov.uk/research/rrhtm/rr826.htm for details).<br />
23. Because the proposed fees regulati<strong>on</strong>s simply implement<br />
the c<strong>on</strong>tinuing requirement for full cost recovery in the <strong>EU</strong> Regulati<strong>on</strong>,<br />
we anticipate that they will not have any financial impacts <strong>on</strong><br />
businesses bey<strong>on</strong>d those already taken in<strong>to</strong> account in the Impact<br />
Assessment of the <strong>EU</strong> Regulati<strong>on</strong>.<br />
<str<strong>on</strong>g>C<strong>on</strong>sultati<strong>on</strong></str<strong>on</strong>g> questi<strong>on</strong>s<br />
24. The purpose of this c<strong>on</strong>sultati<strong>on</strong> is <strong>to</strong> seek your views and feedback <strong>on</strong><br />
<strong>HSE</strong>’s proposals <strong>to</strong> put in place fees under the new <strong>EU</strong> <strong>Biocides</strong><br />
Regulati<strong>on</strong>. In particular we would like your views <strong>on</strong> the following:<br />
Questi<strong>on</strong> 1: do you have any comments <strong>on</strong> the proposed fee structure under<br />
the new <strong>EU</strong> <strong>Biocides</strong> Regulati<strong>on</strong> <strong>528</strong>/2012, set out in Annex 1?<br />
Questi<strong>on</strong> 2: do you have any additi<strong>on</strong>al comments <strong>on</strong> the issues raised in this<br />
c<strong>on</strong>sultati<strong>on</strong>?<br />
Resp<strong>on</strong>ses should be sent <strong>to</strong> Chemicals<str<strong>on</strong>g>C<strong>on</strong>sultati<strong>on</strong></str<strong>on</strong>g>@hse.gsi.gov.uk by<br />
22 nd March 2013.
Annex 1 – Proposed biocides fees structure under <strong>EU</strong> Regulati<strong>on</strong> <strong>528</strong>/2012<br />
Table A1 sets out the list of Articles under Regulati<strong>on</strong> <strong>528</strong>/2012 <strong>on</strong> placing <strong>on</strong> the market and use of biocidal products for which <strong>HSE</strong> will<br />
provide a service <strong>to</strong> applicants as competent authority, and for which we therefore propose <strong>to</strong> make a charge. It also sets out the proposed<br />
daily rates for each service. Actual costs will be calculated using out work-recording system as set out above.<br />
The charges derive from the overarching provisi<strong>on</strong> in Article 80(2) of Regulati<strong>on</strong> <strong>528</strong>/2012 – “Member States shall directly charge applicants<br />
fees for services that they provide with respect <strong>to</strong> the procedures under this Regulati<strong>on</strong>, including the services undertaken by Member<br />
States’ competent authorities when acting as evaluating competent authority.”<br />
Table A1 – services for which <strong>HSE</strong> will charge under Regulati<strong>on</strong> <strong>528</strong>/2012 and daily rates<br />
Article<br />
in<br />
<strong>528</strong>/2012<br />
Article Text<br />
7(3) Within 30 days of the Agency accepting an<br />
applicati<strong>on</strong>, the evaluating competent<br />
authority shall validate the applicati<strong>on</strong> if the<br />
data required in accordance with points (a)<br />
and (b) and, where relevant point (c) of<br />
Article 6(1), and any justificati<strong>on</strong>s for the<br />
adaptati<strong>on</strong> of data requirements, have been<br />
submitted […]<br />
Service provided/ estimated cost<br />
range<br />
Validati<strong>on</strong> of an applicati<strong>on</strong> for<br />
approval of an active substance in<br />
accordance with Article 7.<br />
£5,000 Active substance<br />
Completeness Check<br />
Daily rate/<br />
estimated<br />
timescale<br />
range<br />
£447<br />
11.2 days<br />
Comments<br />
This covers the work involved in<br />
an initial check of the<br />
completeness of a data package<br />
submitted. It does not involve<br />
assessment of the quality or<br />
adequacy of the data.<br />
5
Article<br />
in<br />
<strong>528</strong>/2012<br />
Article Text<br />
8(1) The evaluating competent authority shall,<br />
within 365 days of the validati<strong>on</strong> of an<br />
applicati<strong>on</strong>, evaluate it in accordance with<br />
Articles 4 and 5, including, where relevant,<br />
any proposal <strong>to</strong> adapt data requirements<br />
submitted in accordance with Article 6(3),<br />
and send an assessment report and the<br />
c<strong>on</strong>clusi<strong>on</strong>s of its evaluating <strong>to</strong> the Agency.<br />
Service provided/ estimated cost<br />
range<br />
Evaluati<strong>on</strong> of an applicati<strong>on</strong> <strong>to</strong><br />
approve an active substance under<br />
Article 8.<br />
£185,000 (min) Active substance<br />
(AS) Full Data Package plus Active<br />
substance <strong>EU</strong> Discussi<strong>on</strong><br />
£315,000 (max) Active substance<br />
Full Data Package plus 7 Extra data<br />
Packages and Active substance <strong>EU</strong><br />
Discussi<strong>on</strong><br />
Daily rate/<br />
estimated<br />
timescale<br />
range<br />
£447<br />
414 days<br />
705 days<br />
Comments<br />
Covers work in carrying out the<br />
substantive evaluati<strong>on</strong> of an<br />
applicati<strong>on</strong> for active substance<br />
approval.<br />
6
Article<br />
in<br />
<strong>528</strong>/2012<br />
Article Text<br />
14 14(1) – On the basis of an assessment of the<br />
available informati<strong>on</strong> and the need <strong>to</strong> review<br />
the c<strong>on</strong>clusi<strong>on</strong>s of the initial evaluati<strong>on</strong> of the<br />
applicati<strong>on</strong> for approval or, as appropriate,<br />
the previous renewal, the evaluating<br />
competent authority shall, within 90 days of<br />
the Agency accepting an applicati<strong>on</strong> in<br />
accordance with Article 13(3), decide<br />
whether, in the light of current scientific<br />
knowledge, a full evaluati<strong>on</strong> of the applicati<strong>on</strong><br />
for renewal is necessary […]<br />
Service provided/ estimated cost<br />
range<br />
Evaluati<strong>on</strong> of an applicati<strong>on</strong> <strong>to</strong><br />
renew an active substance approval<br />
under Article 14.<br />
£12,000 (min) Active substance<br />
renewal Initial Fee<br />
If a full evaluati<strong>on</strong> is required then<br />
fees as 8(1)<br />
Daily rate/<br />
estimated<br />
timescale<br />
range<br />
£447<br />
27 days<br />
Comments<br />
Covers work <strong>on</strong> renewing an<br />
existing approval of an active<br />
substance. The quantity and<br />
timeframe will depend <strong>on</strong><br />
whether the evaluating<br />
competent authority (<strong>HSE</strong>)<br />
decides that a full evaluati<strong>on</strong> of<br />
the substance is necessary. Full<br />
evaluati<strong>on</strong>s are carried out under<br />
Article 8.<br />
14(2) Where the evaluating competent<br />
authority decides that a full evaluati<strong>on</strong> of the<br />
applicati<strong>on</strong> is necessary, the evaluati<strong>on</strong> shall<br />
be carried out in accordance with paragraphs<br />
1, 2 and 3 of Article 8.<br />
Where the evaluating competent authority<br />
decides that a full evaluati<strong>on</strong> of the<br />
applicati<strong>on</strong> is not necessary, it shall, within<br />
180 days of the Agency accepting the<br />
applicati<strong>on</strong> in accordance with Article 13(3),<br />
prepare and submit <strong>to</strong> the Agency a<br />
recommendati<strong>on</strong> <strong>on</strong> the renewal of the<br />
approval of the active substance. It shall<br />
provide the applicant with a copy of its<br />
recommendati<strong>on</strong>.<br />
7
Article<br />
in<br />
<strong>528</strong>/2012<br />
Article Text<br />
26(3) Within 90 days of accepting an applicati<strong>on</strong><br />
[for authorisati<strong>on</strong> via the simplified procedure]<br />
the evaluating competent authority shall<br />
authorise the biocidal product if satisfied that<br />
the product meets the c<strong>on</strong>diti<strong>on</strong>s laid down in<br />
Article 25.<br />
Service provided/ estimated cost<br />
range<br />
Evaluati<strong>on</strong> of an applicati<strong>on</strong> <strong>to</strong><br />
authorise a biocidal product under<br />
the simplified procedure.<br />
£1,420 (min) Sift plus Co-ordinati<strong>on</strong><br />
and 1 Specialist Case<br />
Daily rate/<br />
estimated<br />
timescale<br />
range<br />
£393<br />
3.6 days<br />
Comments<br />
Covers <strong>HSE</strong>’s work in checking<br />
that the biocidal product meets a<br />
number of c<strong>on</strong>diti<strong>on</strong>s set out in<br />
Article 25 of the Regulati<strong>on</strong> for<br />
eligibility for the simplified<br />
procedure.<br />
£3,920 (max) as above but with 6<br />
Specialist Cases<br />
10 days<br />
29 29(1) – Applicants wishing <strong>to</strong> apply for a<br />
nati<strong>on</strong>al authorisati<strong>on</strong> in accordance with<br />
Article 17 shall submit an applicati<strong>on</strong> <strong>to</strong> the<br />
receiving competent authority […].<br />
29(2) – Within 30 days of acceptance, the<br />
receiving competent authority shall validate<br />
the applicati<strong>on</strong> if it complies with the following<br />
requirements […]<br />
30(1) The receiving competent authority shall,<br />
within 365 days of the validati<strong>on</strong> of an<br />
applicati<strong>on</strong> in accordance with Article 29,<br />
decide whether <strong>to</strong> grant an authorisati<strong>on</strong> in<br />
accordance with Article 19. It shall take in<strong>to</strong><br />
account the results of the comparative<br />
assessment carried out in accordance with<br />
Article 23, if applicable.<br />
Validati<strong>on</strong> of an applicati<strong>on</strong> for a<br />
nati<strong>on</strong>al approval of a biocidal<br />
product.<br />
£220 Sift<br />
Evaluati<strong>on</strong> of an applicati<strong>on</strong> <strong>to</strong><br />
authorise a biocidal product.<br />
£150 (min) admin <strong>on</strong>ly i.e. Marketing<br />
Authorisati<strong>on</strong>s<br />
£10,900 (max) Technical Sift, Coordinati<strong>on</strong>,<br />
6 Specialist Data and an<br />
<strong>EU</strong> Surcharge<br />
£393<br />
0.6 days<br />
£393<br />
0.4 days<br />
28 days<br />
Covers <strong>HSE</strong>’s work in checking<br />
the completeness (validating) an<br />
applicati<strong>on</strong> for a nati<strong>on</strong>al<br />
approval of a biocidal product. It<br />
does not involve assessment of<br />
the quality or adequacy of the<br />
data.<br />
Covers work in carrying out the<br />
substantive evaluati<strong>on</strong> of an<br />
applicati<strong>on</strong> <strong>to</strong> authorise a biocidal<br />
product.<br />
8
Article<br />
in<br />
<strong>528</strong>/2012<br />
Article Text<br />
31(2) The receiving competent authority shall<br />
renew the nati<strong>on</strong>al authorisati<strong>on</strong>, provided<br />
that the c<strong>on</strong>diti<strong>on</strong>s set out in Article 19 are<br />
still satisfied. It shall take in<strong>to</strong> account the<br />
results of the comparative assessment<br />
carried out in accordance with Article 23, if<br />
applicable.<br />
Service provided/ estimated cost<br />
range<br />
Evaluati<strong>on</strong> of an applicati<strong>on</strong> <strong>to</strong><br />
renew a nati<strong>on</strong>al authorisati<strong>on</strong> of a<br />
biocidal product.<br />
£1,420 (min) Sift, Co-ordinati<strong>on</strong> and<br />
1 Specialist Case<br />
£10,120 (max) Sift, Technical Sift,<br />
Co-or 1, and 6 Specialist Data (but<br />
this would be excepti<strong>on</strong>al)<br />
Daily rate/<br />
estimated<br />
timescale<br />
range<br />
£393<br />
3.6 days<br />
26 days<br />
Comments<br />
Covers <strong>HSE</strong>’s work in evaluating<br />
a renewal applicati<strong>on</strong> for a<br />
biocidal product. This may or<br />
may not require a full review of<br />
the initial evaluati<strong>on</strong> – this will be<br />
decided by the competent<br />
authority (<strong>HSE</strong>) <strong>on</strong> the basis of<br />
the informati<strong>on</strong> submitted.<br />
33(2), (3) 33(2) - Within 30 days of acceptance [of an<br />
applicati<strong>on</strong> for mutual recogniti<strong>on</strong>] referred <strong>to</strong><br />
in paragraph 1, the Member States<br />
c<strong>on</strong>cerned shall validate the applicati<strong>on</strong> and<br />
inform the applicant accordingly, indicating<br />
the date of acceptance.<br />
Within 90 days of validating the applicati<strong>on</strong><br />
[…] the Member States c<strong>on</strong>cerned shall<br />
agree <strong>on</strong> the summary of biocidal product<br />
characteristics referred <strong>to</strong> in Article 22(2) and<br />
shall record their agreement in the Register<br />
for Biocidal Products.<br />
Validating, processing and<br />
determining an applicati<strong>on</strong> <strong>to</strong><br />
mutually recognise a biocidal<br />
product in sequence, and<br />
subsequent authorisati<strong>on</strong>.<br />
£1,420 (min) Sift, Co-ordinati<strong>on</strong> and<br />
1 Specialist Case<br />
£3,920 (max) as above but with 6<br />
Specialist Cases<br />
£393<br />
3.6 days<br />
10 days<br />
Covers <strong>HSE</strong>’s work in processing<br />
an applicati<strong>on</strong> for mutual<br />
recogniti<strong>on</strong> in sequence –<br />
covering validati<strong>on</strong>,<br />
evaluati<strong>on</strong>/agreement with other<br />
Member States, and<br />
authorisati<strong>on</strong>.<br />
33(3) – Within 30 days of reaching<br />
agreement, each of the Member States<br />
c<strong>on</strong>cerned shall authorise the biocidal<br />
product in c<strong>on</strong>formity with the agreed<br />
summary of biocidal product characteristics.<br />
9
Article<br />
in<br />
<strong>528</strong>/2012<br />
Article Text<br />
34 33(5) – Within 90 days of receipt of the<br />
documents referred <strong>to</strong> in paragraph 4 […] the<br />
Member States c<strong>on</strong>cerned shall agree <strong>on</strong> the<br />
summary of biocidal product characteristics,<br />
and hall record their agreement in the<br />
Register for Biocidal Products […]<br />
33(6) – Within 30 days of reaching<br />
agreement, the reference Member State and<br />
each of the Member States c<strong>on</strong>cerned shall<br />
authorise the biocidal product in c<strong>on</strong>formity<br />
with the agreed summary of biocidal product<br />
characteristics.<br />
39 39(1) - […] official or scientific bodies<br />
involved in pest c<strong>on</strong>trol activities or the<br />
protecti<strong>on</strong> of public health may apply, under<br />
the mutual recogniti<strong>on</strong> procedure provided for<br />
in Article 33 […]<br />
The applicati<strong>on</strong> shall be accompanied by the<br />
fees payable under Article 80.<br />
39(2) – Where the competent authority of the<br />
Member State c<strong>on</strong>cerned c<strong>on</strong>siders that the<br />
biocidal product fulfils the c<strong>on</strong>diti<strong>on</strong>s referred<br />
<strong>to</strong> in Article 19 and the c<strong>on</strong>diti<strong>on</strong>s under this<br />
Article are met, the competent authority shall<br />
authorise making available <strong>on</strong> the market of<br />
the biocidal product […]<br />
Service provided/ estimated cost<br />
range<br />
Processing and determining an<br />
applicati<strong>on</strong> for mutual recogniti<strong>on</strong> in<br />
parallel as c<strong>on</strong>cerned Member<br />
States.<br />
£1,420 (min) Sift, Co-ordinati<strong>on</strong> and<br />
1 Specialist Case<br />
£3,920 (max) as above but with 6<br />
Specialist Cases<br />
Processing and determining an<br />
applicati<strong>on</strong> for mutual recogniti<strong>on</strong> by<br />
an official or scientific body.<br />
£1,420 (min) Sift, Co-ordinati<strong>on</strong> and<br />
1 Specialist Case<br />
£3,920 (max) as above but with 6<br />
Specialist Cases<br />
Daily rate/<br />
estimated<br />
timescale<br />
range<br />
£393<br />
3.6 days<br />
10 days<br />
£393<br />
3.6 days<br />
10 days<br />
Comments<br />
Covers <strong>HSE</strong>’s work in mutually<br />
recognising a biocidal product in<br />
parallel when it acts as<br />
c<strong>on</strong>cerned Member State (i.e. not<br />
the Member State <strong>to</strong> whom the<br />
main applicati<strong>on</strong> is made).<br />
10
Article<br />
in<br />
<strong>528</strong>/2012<br />
Article Text<br />
43(3) Within 30 days of the Agency accepting an<br />
applicati<strong>on</strong>, the evaluating competent<br />
authority shall validate the applicati<strong>on</strong> if the<br />
relevant informati<strong>on</strong> referred <strong>to</strong> in Article 20<br />
has been submitted.<br />
Service provided/ estimated cost<br />
range<br />
Validating an applicati<strong>on</strong> for Uni<strong>on</strong><br />
Authorisati<strong>on</strong> of a biocidal product.<br />
£220 Sift<br />
Daily rate/<br />
estimated<br />
timescale<br />
range<br />
£393<br />
0.6 days<br />
Comments<br />
Covers <strong>HSE</strong>’s work in validating<br />
an applicati<strong>on</strong> for Uni<strong>on</strong><br />
Authorisati<strong>on</strong> – initial<br />
validati<strong>on</strong>/completeness check<br />
(no substantive assessment).<br />
44(1) The evaluating competent authority shall,<br />
within 365 days of the validati<strong>on</strong> of an<br />
applicati<strong>on</strong>, evaluate it in accordance with<br />
Article 19 […] and send an assessment<br />
report and the c<strong>on</strong>clusi<strong>on</strong>s of its evaluati<strong>on</strong> <strong>to</strong><br />
the Agency.<br />
Evaluating an applicati<strong>on</strong> for Uni<strong>on</strong><br />
Authorisati<strong>on</strong> of a biocidal product.<br />
£150 (min) admin <strong>on</strong>ly i.e. Marketing<br />
Authorisati<strong>on</strong>s<br />
£10,900 (max) Technical Sift, Coordinati<strong>on</strong>,<br />
6 Specialist Data and an<br />
<strong>EU</strong> Surcharge<br />
£393<br />
0.4 days<br />
28 days<br />
11
Article<br />
in<br />
<strong>528</strong>/2012<br />
Article Text<br />
46 46(1) - On the basis of an assessment of the<br />
available informati<strong>on</strong> and the need <strong>to</strong> review<br />
the c<strong>on</strong>clusi<strong>on</strong>s of the initial evaluati<strong>on</strong> of the<br />
applicati<strong>on</strong> for Uni<strong>on</strong> authorisati<strong>on</strong> or, as<br />
appropriate the previous renewal, the<br />
evaluating competent authority shall within 30<br />
days […] decide whether, in the light of<br />
current scientific knowledge, a full evaluati<strong>on</strong><br />
of the applicati<strong>on</strong> for renewal is necessary.<br />
Service provided/ estimated cost<br />
range<br />
Evaluati<strong>on</strong> of an applicati<strong>on</strong> <strong>to</strong><br />
renew a Uni<strong>on</strong> Authorisati<strong>on</strong>.<br />
£1,420 (min) Sift, Co-ordinati<strong>on</strong> and<br />
1 Specialist Case<br />
£10,120 (max) Sift, Technical Sift,<br />
Co-ordinati<strong>on</strong>, and 6 Specialist Data<br />
Daily rate/<br />
estimated<br />
timescale<br />
range<br />
£393<br />
3.6 days<br />
26 days<br />
Comments<br />
Covers <strong>HSE</strong>’s work in processing<br />
and evaluating the renewal<br />
applicati<strong>on</strong>. May be a full or<br />
shortened renewal depending<br />
whether there is substantial new<br />
evidence <strong>to</strong> take in<strong>to</strong> account – a<br />
decisi<strong>on</strong> <strong>on</strong> this will be taken by<br />
the Competent Authority.<br />
46(2) - Where the evaluating competent<br />
authority decides that a full evaluati<strong>on</strong> of the<br />
applicati<strong>on</strong> is necessary, the evaluati<strong>on</strong> shall<br />
be carried out in accordance with paragraphs<br />
1 and 2 of Article 44.<br />
Where the evaluating competent authority<br />
decides that a full evaluati<strong>on</strong> of the<br />
applicati<strong>on</strong> is not necessary, it shall, within<br />
180 days of the Agency accepting the<br />
applicati<strong>on</strong>, prepare and submit <strong>to</strong> the<br />
Agency a recommendati<strong>on</strong> <strong>on</strong> the renewal of<br />
the authorisati<strong>on</strong>. It shall provide the<br />
applicant with a copy of its recommendati<strong>on</strong>.<br />
12
Article<br />
in<br />
<strong>528</strong>/2012<br />
Article Text<br />
50(2) An authorisati<strong>on</strong> holder seeking <strong>to</strong> change<br />
any other informati<strong>on</strong> submitted in relati<strong>on</strong> <strong>to</strong><br />
the initial applicati<strong>on</strong> for authorisati<strong>on</strong> of the<br />
product shall apply <strong>to</strong> the competent<br />
authorities of the relevant Member States<br />
having authorised the product […]. Those<br />
competent authorities shall decide, […]<br />
whether the c<strong>on</strong>diti<strong>on</strong>s of Article 19, or where<br />
relevant, Article 25 are still met and whether<br />
the terms and c<strong>on</strong>diti<strong>on</strong>s of the authorisati<strong>on</strong><br />
need <strong>to</strong> be amended.<br />
Service provided/ estimated cost<br />
range<br />
Determinati<strong>on</strong> of an applicati<strong>on</strong> <strong>to</strong><br />
amend an existing biocidal product<br />
authorisati<strong>on</strong>.<br />
£370 (min) Sift and admin <strong>on</strong>ly<br />
(admin amendment)<br />
£10,120 (max) Sift, Technical Sift,<br />
Co-ordinati<strong>on</strong>, and 6 Specialist Data<br />
evaluati<strong>on</strong>s (major amendment)<br />
Daily rate/<br />
estimated<br />
timescale<br />
range<br />
£393<br />
0.9 days<br />
26 days<br />
Comments<br />
Covers <strong>HSE</strong>’s work <strong>on</strong> any<br />
applicati<strong>on</strong> for amendment of an<br />
existing authorisati<strong>on</strong>. Scale of<br />
work will differ depending <strong>on</strong><br />
whether the change is classified<br />
as an administrative change,<br />
minor change, or major change.<br />
The applicati<strong>on</strong> shall be accompanied by the<br />
fees payable under Article 80(1) and (2).<br />
53 53(1) A competent authority of a Member<br />
State […] shall at the request of the<br />
applicant, grant a parallel trade permit for a<br />
biocidal product that is authorised in another<br />
Member State […] if it determines in<br />
accordance with paragraph 3 that the biocidal<br />
product is identical <strong>to</strong> a biocidal product<br />
already authorised in the Member State of<br />
introducti<strong>on</strong>. […]<br />
Determinati<strong>on</strong> of an applicati<strong>on</strong> for a<br />
parallel trade permit.<br />
£420 (min) Sift and Verificati<strong>on</strong><br />
£1120 (max) As above plus coordinati<strong>on</strong><br />
fee<br />
£393<br />
1.1 days<br />
2.8 days<br />
53(2) Where the competent authority of the<br />
Member State of introducti<strong>on</strong> determines that<br />
a biocidal product is identical <strong>to</strong> the reference<br />
product, it shall grant a parallel trade permit<br />
within 60 days of receipt of the fees payable<br />
under Article 80(2).<br />
13
Article<br />
in<br />
<strong>528</strong>/2012<br />
Article Text<br />
55(1) By way of derogati<strong>on</strong> from Articles 17 and 19,<br />
a competent authority may permit, for a<br />
period not exceeding 180 days, the making<br />
available <strong>on</strong> the market or use of a biocidal<br />
product which does not fulfil the c<strong>on</strong>diti<strong>on</strong>s<br />
for authorisati<strong>on</strong> laid down in this Regulati<strong>on</strong>,<br />
for a limited and c<strong>on</strong>trolled use under the<br />
supervisi<strong>on</strong> of the competent authority, if<br />
such a measure is necessary because of a<br />
danger <strong>to</strong> public health, animal health or the<br />
envir<strong>on</strong>ment which cannot be c<strong>on</strong>tained by<br />
other means.<br />
56(2) Any pers<strong>on</strong> intending <strong>to</strong> carry out an<br />
experiment or test that may involve, or result<br />
in, release of the biocidal product in<strong>to</strong> the<br />
envir<strong>on</strong>ment shall first notify the competent<br />
authority of the Member State where the<br />
experiment or test will occur. […]<br />
In the absence of an opini<strong>on</strong> from the<br />
competent authority within 45 days of the<br />
notificati<strong>on</strong> referred <strong>to</strong> in the first<br />
subparagraph, the notified experiment or test<br />
may take place.<br />
Service provided/ estimated cost<br />
range<br />
Evaluati<strong>on</strong> of an applicati<strong>on</strong> for an<br />
emergency use permit.<br />
£1,420 (min) Sift, Co-ordinati<strong>on</strong> and<br />
1 Specialist Case<br />
£10,120 (max) Sift, Technical Sift,<br />
Co-or 1, and 6 Specialist Data<br />
evaluati<strong>on</strong>s<br />
Evaluati<strong>on</strong> of an experiment or test<br />
notificati<strong>on</strong>.<br />
£1,420 (min) Sift, Co-ordinati<strong>on</strong> and<br />
1 Specialist Case<br />
£10,120 (max) Sift, Technical Sift,<br />
Co-ordinati<strong>on</strong>, and 6 Specialist data<br />
evaluati<strong>on</strong>s.<br />
Daily rate/<br />
estimated<br />
timescale<br />
range<br />
£393<br />
3.6 days<br />
26 days<br />
£393<br />
3.6 days<br />
26 days<br />
Comments<br />
Charge made <strong>to</strong> any applicant for<br />
an emergency use permit, <strong>to</strong><br />
cover <strong>HSE</strong>’s costs in evaluating<br />
their applicati<strong>on</strong>.<br />
Charge made <strong>to</strong> cover <strong>HSE</strong>’s<br />
costs in checking the<br />
experiment/test notificati<strong>on</strong> in<br />
order <strong>to</strong> determine whether any<br />
restricti<strong>on</strong>s or c<strong>on</strong>diti<strong>on</strong>s need <strong>to</strong><br />
be imposed.<br />
14
Annex 2 – draft statu<strong>to</strong>ry instrument, The Biocidal Products (<strong>Fees</strong> and<br />
Charges) Regulati<strong>on</strong>s 2013<br />
Please note that this draft is incomplete and will be subject <strong>to</strong> amendment.<br />
STATUTORY INSTRUMENTS<br />
2013 No.<br />
HEALTH AND SAFETY<br />
The Biocidal Products (<strong>Fees</strong> and Charges) Regulati<strong>on</strong>s 2013<br />
Made - - - - ***<br />
Laid before Parliament ***<br />
Coming in<strong>to</strong> force - - ***<br />
The Secretary of State is designated for the purposes of secti<strong>on</strong> 2(2) of the European Communities Act<br />
1972(1) (“the 1972 Act”) in relati<strong>on</strong> <strong>to</strong> measures relating <strong>to</strong> biocides.<br />
The Secretary of State makes these regulati<strong>on</strong>s—<br />
(a) in exercise of the powers c<strong>on</strong>ferred <strong>on</strong> him by secti<strong>on</strong> 2(2) of the 1972 Act (“the 1972 Act”) and<br />
secti<strong>on</strong>s 43(2), (4), (5) and (6) and 83(3)(a) of the Health and Safety at Work etc. Act 1974(2) (“the 1974<br />
Act”), and<br />
(b) for the purposes of giving effect without modificati<strong>on</strong>s <strong>to</strong> proposals submitted <strong>to</strong> him by the Health and<br />
Safety Executive under secti<strong>on</strong> 11(3) of the 1974 Act.<br />
Citati<strong>on</strong>, commencement and extent<br />
1.—(1) These Regulati<strong>on</strong>s may be cited as The Biocidal Products (<strong>Fees</strong> and Charges) Regulati<strong>on</strong>s 2013<br />
and come in<strong>to</strong> force <strong>on</strong> 1 st September 2013.<br />
(2) These Regulati<strong>on</strong>s extend <strong>to</strong> Great Britain.<br />
(3) These Regulati<strong>on</strong>s apply outside Great Britain as secti<strong>on</strong>s 1 <strong>to</strong> 59 and 80 <strong>to</strong> 82 of the 1974 Act apply<br />
by virtue of the [Health and Safety at Work etc. Act 1974 (Applicati<strong>on</strong> Outside Great Britain) Order 2013].<br />
Interpretati<strong>on</strong><br />
2.—(1) “The 1998 Regulati<strong>on</strong>s” means the Health and Safety (Enforcing Authority) Regulati<strong>on</strong>s 1998(3)<br />
(2) “Regulati<strong>on</strong> <strong>528</strong>/2012” means Regulati<strong>on</strong> (<strong>EU</strong>) No <strong>528</strong>/2012 of the European Parliament and of the<br />
Council of 22 May 2012 c<strong>on</strong>cerning the making available <strong>on</strong> the market and use of biocidal products.<br />
(3) “Northern Ireland Regulati<strong>on</strong>s” means the [relevant Northern Ireland Regulati<strong>on</strong>s].<br />
(1) 1972 c.68. The power of the Ministers <strong>to</strong> make regulati<strong>on</strong>s in or regards Scotland is preserved by secti<strong>on</strong> 57(1) of the Scotland Act<br />
1998 (c.46).<br />
(2) 1974 c.37<br />
(3) SI 1998/494 as amended by S.I. 1999/2024 and S.I. 1999/3232.<br />
15
(4) “Liability period” means the period beginning with the 1 st April and ending with the 31 st March the<br />
following year.<br />
(5) “competent authority” means the designated competent authority appointed under Regulati<strong>on</strong> [5] of the<br />
[Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulati<strong>on</strong>s 2013].<br />
Functi<strong>on</strong>s of the Member State<br />
3.The functi<strong>on</strong>s of the Member State referred <strong>to</strong> in Article 80(2) of Regulati<strong>on</strong> <strong>528</strong>/2012 are <strong>to</strong> be<br />
performed by the competent authority.<br />
<strong>Fees</strong><br />
4.—(1) The competent authority shall charge fees for work it carries out within the scope of Regulati<strong>on</strong><br />
<strong>528</strong>/2012 which relates <strong>to</strong> the activities listed in column 1 of the Table in the Schedule.<br />
(2) Any fee payable under paragraph (1) shall be calculated in accordance with paragraphs (3) <strong>to</strong> (9).<br />
(3) Where a fee is payable under paragraph (1), the competent authority shall prepare and send <strong>to</strong> the<br />
applicant, the pers<strong>on</strong> providing the informati<strong>on</strong> or the pers<strong>on</strong> making the request, as the case may be, an<br />
estimate of the cost of the work necessary for the evaluati<strong>on</strong> of the applicati<strong>on</strong>.<br />
(4) The estimate of costs referred <strong>to</strong> in paragraph (3) must be paid <strong>to</strong> the competent authority within 30<br />
days of its issue by the competent authority.<br />
(5) Up<strong>on</strong> completi<strong>on</strong> of the work necessary for the evaluati<strong>on</strong> of the applicati<strong>on</strong>, the competent authority<br />
must prepare a detailed statement of the work carried out and of the cost incurred by the competent authority<br />
or any pers<strong>on</strong> acting <strong>on</strong> their behalf in carrying out that work.<br />
(6) If the cost referred <strong>to</strong> in paragraph (5) is greater than the amount estimated in accordance with<br />
paragraph (3), the competent authority must notify the amount of difference <strong>to</strong> the applicant, the pers<strong>on</strong><br />
providing the informati<strong>on</strong> or the pers<strong>on</strong> making the request as the case may be, who must pay the amount of<br />
the difference, which will be the final fee payable, immediately.<br />
(7) If the cost referred <strong>to</strong> in paragraph (5) is less than the amount estimated in accordance with paragraph<br />
(3), the fee shall be adjusted accordingly and the amount of difference shall be paid forthwith by the<br />
competent authority <strong>to</strong> the applicant.<br />
(8) Subject <strong>to</strong> paragraph (9), in estimating or stating the cost of carrying out any work, the competent<br />
authority shall determine that cost by reference <strong>to</strong> the daily rate specified in column 2 of the Table in the<br />
Schedule that corresp<strong>on</strong>ds <strong>to</strong> the activity listed in column 1.<br />
(9) The daily rate shall be adjusted pro rata for a period worked of less than 7.4 hours <strong>on</strong> any <strong>on</strong>e day<br />
by—<br />
(a) dividing the daily rate by 14.8 <strong>to</strong> create a half hourly rate; and<br />
(b) multiplying that figure by the number of half hours worked, rounded up or down <strong>to</strong> the nearest<br />
half hour.<br />
Annual charge<br />
5.—(1) In respect of a given liability period a charge shall be payable by any<strong>on</strong>e placing <strong>on</strong>e or more<br />
biocidal products <strong>on</strong> the market, <strong>on</strong> invoice, <strong>to</strong> the competent authority.<br />
(2) The charge referred <strong>to</strong> in paragraph (1) shall be in respect of any costs incurred by the competent<br />
authority, or <strong>on</strong> its behalf, associated with making biocidal products available <strong>on</strong> the market but shall not<br />
include any costs in respect of which a fee is payable under regulati<strong>on</strong> 4.<br />
(3) If a pers<strong>on</strong> (“P”) pays the annual fee under Article 80(1)(a) in respect of all biocidal products that P<br />
places <strong>on</strong> the market, P shall not be liable <strong>to</strong> pay the charge referred <strong>to</strong> in paragraph (1).<br />
(4) No payment shall be required from a pers<strong>on</strong> liable <strong>to</strong> pay the charge referred <strong>to</strong> in paragraph (1) where<br />
that pers<strong>on</strong> has made payment in respect of the same liability under the Northern Ireland Regulati<strong>on</strong>s.<br />
(5) The competent authority may exclude any<strong>on</strong>e from the requirement <strong>to</strong> pay a charge where that<br />
authority decides that it would not be fair <strong>to</strong> collect that charge.<br />
16
(6) Where a pers<strong>on</strong> becomes liable <strong>to</strong> pay a charge in accordance with paragraph (1) at any time during the<br />
liability period, that pers<strong>on</strong> will be liable <strong>to</strong> pay a charge for the whole of that liability period.<br />
Calculati<strong>on</strong> of charge and number of pers<strong>on</strong>s liable <strong>to</strong> pay the charge<br />
6.—(1) Up<strong>on</strong> expiry of the liability period, the competent authority shall calculate the number of pers<strong>on</strong>s<br />
liable <strong>to</strong> pay the charge under regulati<strong>on</strong> 5 in accordance with paragraph (2).<br />
(2) The competent authority must calculate the charge by dividing the costs incurred in accordance with<br />
regulati<strong>on</strong> 5(2) during the liability period by the number of pers<strong>on</strong>s by whom the charge is payable under<br />
these Regulati<strong>on</strong>s and the Northern Ireland Regulati<strong>on</strong>s.<br />
Notificati<strong>on</strong> of liability <strong>to</strong> pay<br />
7.—(1) Subject <strong>to</strong> paragraph (2), a pers<strong>on</strong> who is liable <strong>to</strong> pay a charge under regulati<strong>on</strong> 5 must notify in<br />
writing <strong>to</strong> the competent authority, or <strong>to</strong> a pers<strong>on</strong> designated by them—<br />
(a) the name of the pers<strong>on</strong> liable <strong>to</strong> pay the charge and the address <strong>to</strong> which communicati<strong>on</strong>s should<br />
be sent; and<br />
(b) the name of the pers<strong>on</strong> <strong>to</strong> whom requests for payment of the charge are made;<br />
and must indicate clearly that the notificati<strong>on</strong> is for the purposes of this paragraph.<br />
(2) A pers<strong>on</strong> is not required <strong>to</strong> make a notificati<strong>on</strong> under paragraph (1) if that pers<strong>on</strong> has made an<br />
applicati<strong>on</strong> for the authorisati<strong>on</strong> of a biocidal product under Regulati<strong>on</strong> <strong>528</strong>/2012 and that authorisati<strong>on</strong> has<br />
been granted.<br />
(3) The notificati<strong>on</strong> in paragraph (1) must be made—<br />
(a) before the biocidal product is placed <strong>on</strong> the market; or<br />
(b) if the product in questi<strong>on</strong> has already been placed <strong>on</strong> the market before 1 st September 2013, within<br />
three m<strong>on</strong>ths of that date.<br />
(4) The competent authority must keep the informati<strong>on</strong> supplied pursuant <strong>to</strong> paragraph (1) <strong>on</strong> a register and<br />
if there is a change <strong>to</strong> the details required <strong>to</strong> be notified under paragraph (1), the pers<strong>on</strong> liable <strong>to</strong> pay the<br />
charge shall inform the Ministers, or the body designated by them under paragraph (1), forthwith in writing<br />
of the relevant changes.<br />
Review<br />
8.—(1) The Secretary of State must from time <strong>to</strong> time—<br />
(a) carry out a review of regulati<strong>on</strong>s 1 <strong>to</strong> 7;<br />
(b) set out the c<strong>on</strong>clusi<strong>on</strong>s of the review in a report, and<br />
(c) publish the report.<br />
(2) In carrying out the review the Secretary of State must, so far as is reas<strong>on</strong>able, have regard <strong>to</strong> the<br />
measures taken <strong>to</strong> implement rules <strong>on</strong> fees and charging in relati<strong>on</strong> <strong>to</strong> Regulati<strong>on</strong> <strong>528</strong>/2012 in other member<br />
States.<br />
(3) The report must in particular—<br />
(a) set out the objectives intended <strong>to</strong> be achieved by the regula<strong>to</strong>ry system established by Regulati<strong>on</strong><br />
<strong>528</strong>/2012,<br />
(b) assess the extent <strong>to</strong> which those objectives are achieved, and<br />
(c) assess whether those objectives remain appropriate and, if so, the extent <strong>to</strong> which they could be<br />
achieved with a system that imposes less regulati<strong>on</strong>.<br />
(4) The first report under this regulati<strong>on</strong> must be published before the end of the period of five years<br />
beginning with the day <strong>on</strong> which regulati<strong>on</strong>s 1 <strong>to</strong> 10 come in<strong>to</strong> force.<br />
(5) Reports under this regulati<strong>on</strong> are afterwards <strong>to</strong> be published at intervals not exceeding five years.<br />
17
SCHEDULE<br />
ACTIVITIES IN RESPECT OF WHICH A FEE IS PAYABLE AND DAILY<br />
RATE<br />
Table<br />
Regulati<strong>on</strong> 4<br />
1.<br />
Purpose of applicati<strong>on</strong> and Article number<br />
(a) Validati<strong>on</strong> of an applicati<strong>on</strong> for approval of<br />
an active substance in accordance with Article<br />
7.<br />
(b) Evaluati<strong>on</strong> of an applicati<strong>on</strong> <strong>to</strong> approve an<br />
active substance under Article 8.<br />
(c) Evaluati<strong>on</strong> of an applicati<strong>on</strong> <strong>to</strong> renew an<br />
active substance approval under Article 14.<br />
(d) Evaluati<strong>on</strong> of an applicati<strong>on</strong> <strong>to</strong> authorise a<br />
biocidal product under the simplified<br />
procedure.<br />
(e) Validati<strong>on</strong> of an applicati<strong>on</strong> for a nati<strong>on</strong>al<br />
approval of a biocidal product.<br />
(f) Evaluati<strong>on</strong> of an applicati<strong>on</strong> <strong>to</strong> authorise a<br />
biocidal product.<br />
(g) Evaluati<strong>on</strong> of an applicati<strong>on</strong> <strong>to</strong> renew a<br />
nati<strong>on</strong>al authorisati<strong>on</strong> of a biocidal product.<br />
(h) Validating, processing and determining an<br />
applicati<strong>on</strong> <strong>to</strong> mutually recognise a biocidal<br />
product in sequence, and subsequent<br />
authorisati<strong>on</strong>.<br />
(i) Processing and determining an applicati<strong>on</strong><br />
for mutual recogniti<strong>on</strong> in parallel as c<strong>on</strong>cerned<br />
Member States<br />
(j) Processing and determining an applicati<strong>on</strong><br />
for mutual recogniti<strong>on</strong> by an official or<br />
scientific body.<br />
(k) Validating an applicati<strong>on</strong> for Uni<strong>on</strong><br />
Authorisati<strong>on</strong> of a biocidal product.<br />
(l) Evaluating an applicati<strong>on</strong> for Uni<strong>on</strong><br />
Authorisati<strong>on</strong> of a biocidal product<br />
(m) Evaluati<strong>on</strong> of an applicati<strong>on</strong> <strong>to</strong> renew a<br />
Uni<strong>on</strong> Authorisati<strong>on</strong>.<br />
(n) Determinati<strong>on</strong> of an applicati<strong>on</strong> <strong>to</strong> amend<br />
an existing biocidal product authorisati<strong>on</strong>.<br />
(o) Determinati<strong>on</strong> of an applicati<strong>on</strong> for a<br />
parallel trade permit.<br />
(p) Evaluati<strong>on</strong> of an applicati<strong>on</strong> for an<br />
emergency use permit.<br />
(q) Evaluati<strong>on</strong> of an experiment or test<br />
notificati<strong>on</strong>.<br />
2.<br />
Fee per day worked<br />
£447<br />
£447<br />
£447<br />
£393<br />
£393<br />
£393<br />
£393<br />
£393<br />
£393<br />
£393<br />
£393<br />
£393<br />
£393<br />
£393<br />
£393<br />
£393<br />
£393<br />
18