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The Biocidal Products (Fees and Charges) Regulations (Northern Ireland) 2013

Status:

This is the original version (as it was originally made).

Statutory Rules of Northern Ireland

2013 No. 207

Health And Safety

The Biocidal Products (Fees and Charges) Regulations (Northern Ireland) 2013

Made

2nd August 2013

Coming into operation

1st September 2013

The Department of Enterprise, Trade and Investment (“the Department”)(1), is designated(2)for the purposes of section 2(2) of the European Communities Act 1972 (“the 1972 Act”)(3) in relation to the notification and control of substances and to measures relating to biocides.

The Department, being the Department concerned(4), makes the following Regulations in exercise of the powers conferred by section 2(2) of the 1972 Act(5) and Articles 40(2) and (4), and 55(2) of the Health and Safety at Work (Northern Ireland) Order 1978(6) (“the 1978 Order”).

The Regulations give effect without modifications to proposals submitted to the Department by the Health and Safety Executive for Northern Ireland under Article 13(1A) of the 1978 Order(7).

Citation and commencement

1.  These Regulations may be cited as the Biocidal Products (Fees and Charges) Regulations (Northern Ireland) 2013 and shall come into operation on 1st September 2013.

Application within the territorial sea

2.  Within the territorial sea these Regulations shall apply only to and in relation to the premises and activities to which any of paragraphs 2 to 9 of Schedule 2 applies.

Interpretation

3.—(1) In these Regulations—

“the Biocides Regulation” 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(8);

“the competent authorities in Great Britain” means any of the competent authorities appointed by regulation 5 of the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013(9);

“the Executive” means the Health and Safety Executive for Northern Ireland;

“the Great Britain Regulations” means the Biocidal Products (Fees and Charges) Regulations 2013(10);

“liability period” means—

(a)

the period beginning on 1st September 2013 and ending on 31st March 2014; or

(b)

from 1st April 2014, the period beginning on 1st April and ending on 31st March the following year; and

“territorial sea” means the territorial sea of the United Kingdom adjacent to Northern Ireland and “within the territorial sea” includes on, over and under it.

(2) Expressions used in both these Regulations and the Biocides Regulation have the same meaning in these Regulations as they have in the Biocides Regulation.

(3) The Interpretation Act (Northern Ireland) 1954(11) shall apply to these Regulations as it applies to an Act of the Northern Ireland Assembly.

Functions of the Member State

4.  The functions of the Member State referred to in Article 80(2) of the Biocides Regulation are to be performed by the Executive.

Fees

5.—(1) The Executive shall charge fees for—

(a)work it carries out within the scope of the Biocides Regulation which relates to the activities listed in column 1 of the Table in Schedule 1; and

(b)work it carries out in order to evaluate an application under regulation 12 of the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations (Northern Ireland) 2013(12).

(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 Executive 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.

(4) The person to whom the estimate of costs specified in paragraph (3) is sent by the Executive must pay to the Executive the amount of that estimate within 30 days of its issue.

(5) Upon completion of the work, the Executive shall prepare a detailed statement of the work carried out and of the cost incurred by the Executive or any person acting on its 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 Executive shall 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 shall pay the amount of the difference, which will be the final fee payable, without delay.

(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 without delay by the Executive to the applicant, the person providing the information or the person making the request, as the case may be.

(8) Subject to paragraph (9), in estimating or stating the cost of carrying out any work, the Executive shall determine that cost by reference to the daily rate specified in column 2 of the Table in Schedule 1 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.

(10) Any unpaid fees may be recovered by the Executive as a civil debt.

Annual charge

6.—(1) In respect of a given liability period a charge shall be payable to the Executive on invoice by anyone placing one or more biocidal products on the market.

(2) The charge referred to in paragraph (1) shall be in respect of any costs incurred by, or on behalf of—

(a)the Executive, in Northern Ireland; and

(b)the competent authorities in Great Britain,

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 5.

(3) If a person (“P”) pays the annual fee under Article 80(1)(a) of the Biocides Regulation 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 a payment in respect of the same liability to any of the competent authorities under the Great Britain Regulations.

(5) The Executive may exclude anyone from the requirement to pay a charge where it decides that it would not be fair to collect that charge.

(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.

(7) Any unpaid charge may be recovered by the Executive as a civil debt.

Calculation of charge and number of persons liable to pay the charge

7.—(1) Upon expiry of the liability period, the Executive shall calculate the number of persons liable to pay the charge under regulation 6 in accordance with paragraph (2).

(2) The Executive shall calculate the charge by dividing the costs incurred during the liability period in accordance with regulation 6(2) by the number of persons by whom the charge is payable under these Regulations and the Great Britain Regulations.

Notification of liability to pay

8.—(1) Subject to paragraph (2), a person who is liable to pay a charge under regulation 6 shall notify in writing to the Executive, or a person designated by the Executive—

(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 should be 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—

(a)that person has made an application for the authorisation of a biocidal product under the Biocides Regulation and that authorisation has been granted;

(b)that person has been granted a parallel trade permit under Article 53 of the Biocides Regulation;

(c)that person made a notification under paragraph 15 of Schedule 11A to the Biocidal Products Regulations (Northern Ireland) 2001(13) or paragraph 15 of Schedule 12A to the Biocidal Products Regulations 2001(14) prior to 1st September 2013; or

(d)that person was granted an authorisation in respect of a biocidal product under the Biocidal Products Regulations (Northern Ireland) 2001 or under the Biocidal Products Regulations 2001 prior to 1st September 2013.

(3) The notification in paragraph (1) shall 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 1st September 2013, by 1st December 2013.

(4) The Executive shall 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 Executive, or the body designated by it under paragraph (1), in writing of the relevant changes, without delay.

Revocations and savings provisions

9.—(1) Regulations 39 and 39A of, and Schedules 11 and 11A to, the Biocidal Products Regulations (Northern Ireland) 2001 are revoked subject to paragraphs (2) and (3).

(2) Regulation 39 of, and paragraphs 2, 3 and 7 to 12 of Schedule 11 to, the Biocidal Products Regulations (Northern Ireland) 2001 continue to apply for the purposes of calculating the fee payable in respect of the evaluation of applications for biocidal product authorisations submitted before 1st September 2013 for the purposes of Directive 98/8/EC(15) under Regulation 14(1) of the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations (Northern Ireland) 2013.

(3) Regulation 39A of, and Schedule 11A to, the Biocidal Products Regulations (Northern Ireland) 2001(16), continue to apply for the purposes of calculating the annual charge payable for the period beginning on 1st April 2013 and ending on 31st August 2013 as if, in Schedule 11A—

(a)the liability period in paragraph 1 means the period beginning on 1st April 2013 and ending on 31st August 2013;

(b)the costs referred to in paragraph 2 mean the costs incurred during the period beginning on 1st April 2013 and ending on 31st August 2013;

(c)in paragraph 7, the words “upon the expiry of the liability period” were replaced with the words “after 31st March 2014”.

Sealed with the Official Seal of the Department of Enterprise, Trade and Investment on 2nd August 2013.

Legal seal

D Sterling

A senior officer of the Department of Enterprise, Trade and Investment

Regulation 5

SCHEDULE 1ACTIVITIES IN RESPECT OF WHICH A FEE IS PAYABLE AND DAILY RATE

Table

1.

Activity

2.

Fee per day worked

(a) Validation of an application for approval of an active substance.£447
(b) Evaluation of an application to approve an active substance.£447
(c) Evaluation of an application to renew an active substance approval.£447
(d) Work relating to a request for inclusion of an active substance in Annex I on behalf of an economic operator.£447
(e) Meetings with applicants and prospective applicants.£447
(f) Evaluation of an application to authorise a biocidal product under the simplified procedure.£393
(g) Validation of an application for a national authorisation of a biocidal product.£393
(h) Evaluation of an application for a national authorisation of a biocidal product.£393
(i) Evaluation of an application to renew a national authorisation of a biocidal product.£393
(j) Validating, processing and determining an application to mutually recognise a biocidal product in sequence, and subsequent authorisation.£393
(k) Processing and determining an application for mutual recognition in parallel as a concerned Member State.£393
(l) Processing and determining an application for mutual recognition by an official or scientific body.£393
(m) Validating an application for Union Authorisation of a biocidal product.

£393

(n) Evaluation of an application for Union Authorisation of a biocidal product£393
(o) Evaluation of an application to renew a Union Authorisation.£393
(p) Determination of an application to amend an existing biocidal product authorisation.£393
(q) Determination of an application for a parallel trade permit.£393
(r) Evaluation of an application for an emergency use permit.£393
(s) Evaluation of an application under Regulation 12 of the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations (Northern Ireland) 2013.£393

Regulation 2

SCHEDULE 2PREMISES AND ACTIVITIES WITHIN THE TERRITORIAL SEA

1.—(1) In this Schedule—

“activity” includes a diving project and standing a vessel by;

“designated area” means any area designated by Order under section 1(7) of the Continental Shelf Act 1964(17)and “within a designated area” includes over and under it;

“diving project” has the meaning assigned to it by regulation 2(1) of the Diving at Work Regulations (Northern Ireland) 2005(18)save that it includes an activity in which a person takes part as a diver wearing an atmospheric pressure suit and without breathing in air or other gas at a pressure greater than atmospheric pressure;

“gas importation and storage zone” has the meaning assigned to it by section 1(5) of the Energy Act 2008(19);

“offshore installation” shall be construed in accordance with paragraph 2(2) and (3);

“supplementary unit” means a fixed or floating structure, other than a vessel, for providing energy, information or substances to an offshore installation;

“vessel” includes a hovercraft and any floating structure which is capable of being navigated.

(2) For the purposes of this Schedule, any structures and devices on top of a well shall be treated as forming part of the well.

(3) Any reference in this Schedule to premises and activities includes a reference to any person, article or substance on those premises or engaged in, or, as the case may be, used or for use in connection with any such activity, but does not include a reference to an aircraft which is airborne.

Offshore installations

2.—(1) This paragraph shall apply to a designated area or a gas importation and storage zone to and in relation to—

(a)any offshore installation and any activity on it;

(b)any activity in connection with, or any activity immediately preparatory to an activity in connection with, an offshore installation, whether carried on from the installation itself, in or from a vessel or in any manner, other than an activity falling within sub-paragraph (4);

(c)a diving project involving—

(i)the survey and preparation of the sea bed for an offshore installation;

(ii)the survey and restoration of the sea bed consequent on the removal of an offshore installation.

(2) Subject to sub-paragraph (3), in this paragraph, “offshore installation” means a structure which is, or is to be, or has been, used while standing or stationed in water, or on the foreshore or other land intermittently covered with water—

(a)for the exploitation, or exploration with a view to exploitation, of mineral resources by means of a well;

(b)for undertaking activities falling within paragraph 6(2);

(c)for the conveyance of things by means of a pipe;

(d)for undertaking activities that involve mechanically entering the pressure containment boundary of a well; or

(e)primarily for the provision of accommodation for persons who work on or from a structure falling within any of the provisions of heads (a) to (d),

together with any supplementary unit which is ordinarily connected to it, and all the connections.

(3) Any reference in sub-paragraph (2) to a structure or supplementary unit does not include—

(a)a structure which is connected with dry land by a permanent structure providing access at all times and for all purposes;

(b)a well;

(c)a mobile structure which has been taken out of use and is not yet being moved with a view to its being used for any of the purposes specified in sub-paragraph (2);

(d)any part of a pipeline; and

(e)a structure falling within paragraph 8(c).

(4) Subject to sub-paragraph (5), the following activities fall within this paragraph—

(a)transporting, towing or navigating an installation;

(b)any of the following activities carried on in or from a vessel—

(i)giving assistance in the event of an emergency;

(ii)training in relation to the giving of assistance in the event of an emergency;

(iii)testing equipment for use in giving assistance in the event of an emergency.

(iv)putting or maintaining a vessel on stand-by ready for an activity referred to in any of sub-heads (i) to (iii).

(5) Sub-paragraph (4)(b) does not apply in respect of a vessel in or from which an activity is carried on in connection with, or any activity that is immediately preparatory to an activity in connection with, an offshore installation other than an activity falling within sub-paragraph 4(b).

Wells

3.—(1) Subject to sub-paragraph (2), this paragraph applies to and in relation to—

(a)a well and any activity in connection with it; and

(b)an activity which is immediately preparatory to any activity in head (a).

(2) Sub-paragraph (1) includes keeping a vessel on station for the purpose of working on a well but otherwise does not include navigation or an activity connected with navigation.

Pipelines

4.—(1) This paragraph applies to and in relation to—

(a)any pipeline;

(b)any pipeline works;

(c)the following activities in connection with pipeline works—

(i)the loading, unloading, fuelling or provisioning of a vessel;

(ii)the loading, unloading, fuelling, repair and maintenance of an aircraft on a vessel,

being in either case a vessel which is engaged in pipeline works; or

(iii)the moving, supporting, laying or retrieving of anchors attached to a pipe-laying vessel including the supervision of those activities and giving of instruction in connection with them.

(2) In this paragraph—

“pipeline” means a pipe or system of pipes for the conveyance of any thing, together with—

(a)

any apparatus for inducing or facilitating the flow of any thing through, or through part of, the pipe or system;

(b)

any apparatus for treating or cooling any thing which is to flow through, or through part of, the pipe or system;

(c)

valves, valve chambers and similar works which are annexed to, or incorporated in the course of, the pipe or system;

(d)

apparatus for supplying energy for the operation of any such apparatus or works as are mentioned in heads (a) to (c);

(e)

apparatus for the transmission of information for the operation of the pipe or system;

(f)

apparatus for the cathodic protection of the pipe or system; and

(g)

a structure used or to be used solely for the support of a part of the pipe or system;

but not including a pipeline of which no initial or terminal point is situated in the United Kingdom, within the territorial sea adjacent to the United Kingdom, or within a designated area;

“pipeline works” means—

(a)

assembling or placing a pipeline or length of pipeline including the provision of internal or external protection for it;

(b)

inspecting, testing, maintaining, adjusting, repairing, altering or renewing a pipeline or length of pipeline;

(c)

changing the position of or dismantling or removing a pipeline or length of pipeline;

(d)

opening the bed of the sea for the purposes of the works mentioned in heads (a) to (c), and tunnelling or boring for those purposes;

(e)

any activities incidental to the activities described in heads (a) to (d);

(f)

a diving project in connection with any of the works mentioned in heads (a) to (e) or for the purpose of determining whether a place is suitable as part of the site of a proposed pipeline and the carrying out of surveying operations for settling the route of a proposed pipeline.

Mines

5.—(1) This paragraph applies to and in relation to a mine within the territorial sea or extending beyond it, and any activity in connection with it, while it is being worked.

(2) In this paragraph “mine” has the same meaning as in the Mines Act (Northern Ireland) 1969(20) (“the 1969 Act”).

(3) For the purposes of this paragraph a mine is treated as being worked when it is so treated for the purposes of the 1969 Act.

Gas Importation and Storage

6.—(1) Subject to sub-paragraph (3), this paragraph applies within a gas importation and storage zone to and in relation to any activities connected with or immediately preparatory to the activities set out in sub-paragraph (2).

(2) The activities are—

(a)the unloading of gas to an installation or pipeline;

(b)the storage of gas, whether temporary or permanent, in or under the shore or bed of any water;

(c)the conversion of any natural feature for the purpose of storing gas, whether temporarily or permanently;

(d)the recovery of gas stored;

(e)exploration with a view to, or in connection with, the carrying on of activities within heads (a) to (d).

(3) Sub-paragraph (1) does not apply to an activity falling within sub-paragraph (2) if the provisions of this Schedule apply to or in relation to that activity by virtue of paragraph 2(1).

(4) In this paragraph—

“gas” means any substance which is gaseous at a temperature of 15°C and a pressure of 101.325 kPa (1013.25 mb); and

“installation” includes any floating structure or device maintained on a station by whatever means.

(5) For the purposes of sub-paragraphs (2) and (4), references to gas include any substance which consists wholly or mainly of gas.

Production of Energy from Water or Wind

7.—(1) This paragraph applies within a renewable energy zone to and in relation to any energy structure or activities connected with or preparatory to—

(a)the exploitation of those areas for the production of energy from water or wind,

(b)the exploration of such areas with a view to, or in connection with, the production of energy from water or wind, or

(c)the operation of a cable for transmitting electricity from an energy structure.

(2) In this paragraph—

“energy structure” means a fixed or floating structure or machine, other than a vessel, which is, or is to be, or has been, used for producing energy from water or wind; and

“renewable energy zone” has the meaning given by section 84(4) of the Energy Act 2004(21) and “within a renewable energy zone” includes over and under it.

Underground Coal Gasification

8.    This paragraph applies within a designated area to and in relation to—

(a)underground coal gasification and any activity in connection with it;

(b)any activity which is immediately preparatory to any activity in sub-paragraph (a); and

(c)any fixed or floating structure which is, or is to be, or has been, used in connection with the carrying on of activities within sub-paragraphs (a) and (b).

Other activities

9.—(1) Subject to sub-paragraph (2), this paragraph applies to and in relation to—

(a)the construction, reconstruction, alteration, repair, maintenance, cleaning, use, operation, demolition and dismantling of any building, or other structure, not being in any case a vessel, or any preparation for any such activity;

(b)the transfer of people or goods between a vessel or aircraft and a structure (including a building) mentioned in head (a);

(c)the loading, unloading, fuelling or provisioning of a vessel;

(d)a diving project;

(e)the laying, installation, inspection, maintenance, operation, recovery or repair of a cable;

(f)the construction, reconstruction, finishing, refitting, repair, maintenance, cleaning or breaking up of a vessel except when carried out by the master or any officer or member of the crew of that vessel;

(g)the maintaining on a station of a vessel which would be an offshore installation were it not a structure to which paragraph 2(3)(c) applies;

(h)the transfer of people or goods between a vessel or aircraft and a structure mentioned in head (g).

(2) This paragraph does not apply—

(a)to a case where paragraph 2, 3, 4, 5, 6, 7 or 8 applies; or

(b)to vessels which are registered outside the United Kingdom and are on passage through the territorial sea.

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations provide the charging regime in relation to 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 (“the Biocides Regulation”; OJ No L167, 27.06.12, p.1).

The Biocides Regulation replaces Directive 98/8/EC (OJ No. L123, 24.4.98, p.1) of the European Parliament and the Council of 16th February 1998, which laid down harmonised rules for the placing on the market of biocidal products. The Biocides Regulation lays down revised harmonised rules for the approval of active substances and the making available on the market of biocidal products.

Regulation 4 makes provision for the functions of the Member State referred to in Article 80(2) to be performed by the Executive.

Regulation 5 and Schedule 1 enables the Executive to charge fees, at a daily rate, for work carried out within the scope of the Biocides Regulation and within Regulation 12 of the Biocidal Products (Appointment of Authorities and Enforcement) Regulations (Northern Ireland) 2013, relating to applications for the authorisation and mutual recognition of biocidal products, the approval of active substances and permits and notification under specific conditions.

Regulations 6 and 7 provide for an annual charge to be paid to the Executive by persons placing biocidal products on the market in respect of costs incurred by or on behalf of the Executive and the competent authorities in Great Britain, associated with any work carried out within the scope of the Biocides Regulation that cannot be attributed to an individual application.

Regulation 8 requires anyone liable to pay the annual charge to notify the Executive, or a person designated by the Executive, of information specified in that regulation, subject to exceptions set out in that regulation.

Regulation 9 revokes regulations 39 and 39A of, and Schedules 11 and 11A to, the Biocidal Products Regulations (Northern Ireland) 2001 (and associated amending provisions in the Biocidal Products (Amendment) Regulations 2003), subject to savings provisions which: (i) enable fees to be charged in respect of the evaluation of biocidal product authorisation applications submitted before 1st September 2013, and (ii) allow the annual charge to be recovered in respect of the period from 1st April 2013 to 31st August 2013.

In Great Britain the corresponding legislation is the Biocidal Products (Fees and Charges) Regulations 2013 (S.I. 2013/1507). The Great Britain Health and Safety Executive has prepared a full impact assessment of the effect that the Regulations will have on costs to business and the voluntary sector. A copy of that assessment is available from the Health and Safety Executive for Northern Ireland, 83 Ladas Drive, Belfast, BT6 9FR. A copy of the impact assessment has been placed in the library of the Northern Ireland Assembly and is annexed to the Explanatory Memorandum which is available alongside these Regulations at www.legislation.gov.uk.

(1)

Formerly the Department of Economic Development; see S.I. 1999/283 (N.I. 1), Article 3(5); that Department was formerly the Department of Manpower Services; see S.I. 1982/846 (N.I.11), Article 3

(2)

S.I. 1981/1536 for the designation in relation to the notification and control of substances and S.I. 1999/2788 in relation to measures relating to biocides

(4)

See Article 2(2) of S.I. 1978/1039 (N.I. 9)

(5)

1972 c.68; the enabling powers conferred by section 2(2) were extended by virtue of section 1 of the European Economic Area Act 1993 (c.51). Section 2(2) was further amended by section 27(1), and paragraphs 2 and 3 of Schedule 2 by section 27(2), of the Legislative and Regulatory Reform Act 2006 (C .51)

(7)

Article 13(1A) was substituted by S.I. 1998/2795 (N.I. 18), Article 4

(8)

OJ L167 27.06.2012, p.1.

(14)

SI 2001/880 as amended by SI 2003/429 and SI 2007/293

(15)

OJ No. L123, 24.4.98, p.1.

(16)

As inserted by regulation 4(c) and (d) of, and Schedule 2, to the Biocidal Products (Amendment) Regulations 2003, SI 2003/429

(17)

1964 c. 29; section 1 was amended by the Oil and Gas (Enterprise) Act 1982 (1982 c. 23), section 37 and Schedule 3, paragraph 1

(19)

2008 c.32; section 1(5) is prospectively amended by the Marine and Coastal Access Act 2009 (c.23), Schedule 4 Part 1, paragraph 5(1) and (2). Section 1(5) of the Energy Act 2008 would continue to define the term “gas importation and storage zone” after the amendment

(21)

2004 c.20; section 84(4) is prospectively amended by the Marine and Coastal Access Act 2009 (c. 23), Schedule 4, Part 1, paragraph 4. Section 84(4) of the Energy Act 2004 would continue to define the term “renewable energy zone” after the amendment.

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