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Biocidal Products Regulations (Northern Ireland) 2001

Type Ni-Statutory-Rule

Publication 2001-12-05

State In force

Jurisdiction Northern Ireland

Department Government Printer for Northern Ireland

Source legislation.gov.uk

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articles Not indexed

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(1) A person to whom an authorisation or a registration has been granted in accordance with these Regulations shall immediately notify the Executive of any information of which he is aware or may reasonably be expected to be aware concerning—

(a) the biocidal product; or

(b) an active substance contained in the biocidal product,

to which the authorisation or the registration relates, which may affect that authorisation or registration.

(2) The information referred to in paragraph (1) shall include—

(a) new knowledge or information on the effects of that biocidal product, or the active substance which the biocidal product contains, on humans, animals or the environment;

(b) changes in the source or composition of the active substance which the biocidal product contains;

(d) development of resistance to the biocidal product in the harmful organisms which it is intended to control;

(e) changes of an administrative nature; or

(f) changes in the nature of the packaging.

(3) A notification made pursuant to paragraph (1) shall include—

(a) a statement that the notification is made in compliance with this regulation; and

(b) the number of the authorisation or registration relating to the biocidal product with which the notification is concerned.

(4) The Executive shall immediately notify member States and the Commission of any information it receives by virtue of paragraph (1) relating to—

(a) potentially harmful effects for humans, animals or the environment of—

(i) a biocidal product,

(ii) an active substance, an impurity or a co-formulant which a biocidal product contains, or

(iii) a residue of a biocidal product; and

(b) changes in the composition of a biocidal product, including changes in the active substance which a biocidal product contains.

Emergency prohibition or restriction

22

(1) The Executive may prohibit or restrict the sale or use of a biocidal product which has been authorised or registered under these Regulations, where it has valid reasons to consider that the biocidal product constitutes an unacceptable risk to human or animal health or to the environment.

(2) Where the Executive prohibits or restricts the sale or use of a biocidal product pursuant to paragraph (1), it shall immediately inform the Commission and member States of that prohibition or restriction and of the reasons for it.

(3) A person shall not sell a biocidal product—

(a) whose sale has been prohibited pursuant to paragraph (1); or

(b) in a manner which contravenes any restriction on the sale of that biocidal product imposed pursuant to paragraph (1).

(4) A person shall not use a biocidal product—

(a) whose use has been prohibited pursuant to paragraph (1); or

(b) in a manner which contravenes any restriction on the use of that biocidal product imposed pursuant to paragraph (1).

(5) The Executive shall revoke a prohibition or restriction issued under this regulation where a decision made in accordance with the procedures set out in Article 28(3) does not uphold the prohibition or restriction.

Part IV — Use of Information

Data protection for active substances

23

(1) Subject to the following paragraphs, the Executive shall not make use of relevant information relating to an active substance for the benefit of a person making an application under these Regulations other than—

(a) the person who submitted; or

(b) the person on whose behalf was submitted,

that relevant information.

(2) The Executive may make use of relevant information relating to an active substance for the benefit of a person making an application under these Regulations who has a letter of access to that relevant information.

(3) In the case of relevant information relating to a new active substance which was submitted other than for a purpose referred to in paragraph (4), paragraph (1) shall not apply after the expiry of the period of 15 years from the date on which that new active substance was first included in either Annex I or Annex IA.

(4) In the case of relevant information relating to a new active substance which was submitted for the first time for the purpose of an application under regulation 7 to renew the inclusion of that new active substance in Annex I or Annex IA or to vary the requirements subject to which the new active substance was included in Annex I or Annex IA, paragraph (1) shall not apply after either—

(a) the expiry of the period of 5 years from the date of the decision relating to the application under regulation 7; or

(b) the expiry of the period of 15 years from the date on which that new active substance was first included in either Annex I or Annex IA,

whichever is the later.

(5) In the case of relevant information relating to an existing active substance which was also submitted in support of an application for an approval (except an approval in the form of an experimental permit) under the 1987 Regulations, paragraph (1) shall not apply after either—

(a) the expiry of the period of 10 years from the date on which the approval was first given on the basis of that relevant information; or

(b) 14th May 2010,

whichever is the sooner.

(6) Subject to paragraph (10), in the case of relevant information relating to an existing active substance which was also submitted in response to a requirement imposed under section 16(11) of the 1985 Act to supply information relating to the review, revocation or suspension of, or the amendment of the conditions of, an approval given under the 1987 Regulations (except an approval in the form of an experimental permit), paragraph (1) shall not apply after either—

(a) the expiry of the period of 5 years from the date of the decision to continue, revoke or suspend, or amend the conditions of, the approval in question; or

(b) 14th May 2010,

whichever is the sooner.

(7) Subject to paragraph (11), in the case of relevant information relating to an existing active substance which was also submitted in support of an application for approval in the form of an experimental permit under the 1987 Regulations, paragraph (1) shall not apply after 14th May 2010.

(8) In the case of relevant information relating to an existing active substance which was not submitted in the specified circumstances but which was submitted for the first time in support of an application for the first inclusion in Annex I or Annex IA of that existing active substance or of an additional product-type for that existing active substance, paragraph (1) shall not apply after the expiry of the period of 10 years from the date on which that existing active substance, or additional product-type for that existing substance, as the case may be, was first included in either Annex I or Annex IA.

(9) In the case of relevant information relating to an existing active substance which was not submitted in the specified circumstances but which was submitted for the first time for the purpose of an application under regulation 7 to renew the inclusion of that existing active substance in Annex I or Annex IA, or to vary the requirements subject to which the existing active substance was included in Annex I or Annex IA, paragraph (1) shall not apply after either—

(a) the expiry of the period of 5 years from the date of the decision relating to the application under regulation 7; or

(b) the expiry of the period of 10 years from the date on which that existing active substance was first included in either Annex I or Annex IA,

whichever is the later.

(10) Paragraph (6) shall not apply where the relevant information submitted in response to a requirement imposed under section 16(11) of the 1985 Act is also submitted in support of an application referred to in paragraph (5).

(11) Paragraph (7) shall not apply where the relevant information submitted in support of an application referred to in that paragraph is also submitted in support of an application referred to in paragraph (5).

(12) In this regulation—

(a) “the 1985 Act” means the Food and Environment Protection Act 1985[^f00019];

(b) “the 1987 Regulations” means the Control of Pesticides Regulations (Northern Ireland) 1987[^f00020];

(i) submitted under the 1987 Regulations, as described in paragraphs (5) or (7), or

(ii) submitted in response to a requirement imposed under section 16(11) of the 1985 Act, as described in paragraph (6); and

(d) “relevant information” means information submitted to the Executive under these Regulations.

Data protection for biocidal products

24

(1) Subject to the following paragraphs, the Executive shall not make use of relevant information relating to a biocidal product for the benefit of a person making an application under these Regulations other than—

(a) the person who submitted; or

(b) the person on whose behalf was submitted,

that relevant information.

(2) The Executive may make use of relevant information relating to a biocidal product for the benefit of a person making an application under these Regulations who has a letter of access to that relevant information.

(3) In the case of relevant information relating to a biocidal product containing a new active substance which was submitted other than for a purpose referred to in paragraph (4), paragraph (1) shall not apply after the expiry of the period of 10 years from the date on which that biocidal product was first authorised or registered, as the case may be, under these Regulations.

(4) In the case of relevant information relating to a biocidal product containing a new active substance which was submitted for the first time in connection with a modification under regulation 20 of a condition of use subject to which was granted the authorisation or registration, as the case may be, relating to that biocidal product, or for the first time in connection with an application under regulation 7 to renew the inclusion of that new active substance in Annex I or Annex IA, paragraph (1) shall not apply after either—

(a) the expiry of the period of 5 years from the date on which the Executive first received that relevant information, or

(b) the expiry of the period of 10 years from the date on which that biocidal product was first authorised or registered, as the case may be, under the Regulations,

whichever is the later.

(5) In the case of relevant information relating to a biocidal product containing an existing active substance which was also submitted in support of an application for an approval (except an approval in the form of an experimental permit) under the 1987 Regulations, paragraph (1) shall not apply after either—

(a) the expiry of the period of 10 years from the date on which the approval was first given on the basis of that relevant information; or

(b) 14th May 2010,

whichever is the sooner.

(6) Subject to paragraph (10), in the case of relevant information relating to a biocidal product containing an existing active substance which was also submitted in support of an application for approval in the form of an experimental permit under the 1987 Regulations, paragraph (1) shall not apply after 14th May 2010.

(7) In the case of relevant information relating to a biocidal product containing an existing active substance which was not submitted under the 1987 Regulations as described in paragraphs (5) or (6) but which was submitted for the first time in support of an application for the first inclusion in Annex I or Annex IA of that existing active substance or of an additional product-type for that existing active substance, paragraph (1) shall not apply after the expiry of the period of 10 years from the date on which that existing active substance, or additional product-type for that existing substance, as the case may be, was first included in either Annex I or Annex IA.

(8) In the case of relevant information relating to a biocidal product containing an existing active substance which—

(a) was not submitted under the 1987 Regulations as described in paragraphs (5) or (6); nor

(b) submitted for the first time in support of an application for the first inclusion in Annex I or Annex IA of that existing active substance or of an additional product-type for that existing active substance,

but which was submitted in support of an application for the grant of an authorisation or a registration under these Regulations, paragraph (1) shall not apply after 14th May 2010.

(9) In the case of relevant information relating to a biocidal product containing an existing active substance which was not submitted under the 1987 Regulations as described in paragraphs (5) or (6), but which was submitted for the first time in connection with a modification under regulation 20 of a condition of use subject to which was granted the authorisation or registration, as the case may be, relating to that biocidal product, or for the first time in connection with an application under regulation 7 to renew the inclusion of that existing active substance in Annex I or Annex IA, paragraph (1) shall not apply after either—

(a) the expiry of the period of 5 years from the date on which the Executive first received that relevant information; or

(b) after the expiry of the period of 10 years from the date on which that existing active substance was first included in either Annex I or Annex IA,

whichever is the later.

(10) Paragraph (6) shall not apply where the relevant information submitted in support of an application referred to in that paragraph was also submitted in support of an application referred to in paragraph (5).

(11) In this regulation, “the 1987 Regulations” and “relevant information” have the same meaning as they have in regulation 23.

Co-operation in the use of information

25

(1) Subject to paragraph (2), the Executive may give its consent to a new applicant referring to the information contained in the dossiers included in the application submitted to the Executive in respect of an approved biocidal product.

(2) The Executive shall not give its consent under paragraph (1) unless—

(a) the new applicant can provide evidence to the satisfaction of the Executive that—

(i) the biocidal product to which his application relates is sufficiently similar to, and

(ii) the active substance contained in that biocidal product is the same as that contained in,

the approved biocidal product, including in relation to the degree of purity and the nature of the impurities; and

(b) the information referred to in paragraph (1) is information—

(i) in respect of which the new applicant has a letter of access, or

(ii) which the Executive already holds and, by virtue of regulation 23 or 24, is entitled to use for the benefit of that new applicant.

(3) Notwithstanding the obligations contained in these Regulations to submit dossiers in support of an application for the authorisation of a biocidal product under regulation 9, 11, 13 or 17, or the registration of a biocidal product under regulation 10, 12 or 14, before carrying out an experiment on vertebrate animals, a new applicant shall ask the Executive—

(a) whether an authorisation or registration has been granted under these Regulations in respect of a biocidal product similar to that which the new applicant intends to use in such an experiment (whether or not that authorisation or registration has been revoked); and

(b) for the name and address of the authorisation holder in respect of that biocidal product.

(4) When a new applicant makes an enquiry pursuant to paragraph (2), he shall provide evidence that—

(a) he intends to apply on his own behalf for an authorisation of a biocidal product under regulation 9, 11, 13 or 17 or a registration of a biocidal product under regulation 10, 12 or 14; and

(b) the other information, which he has to provide with such an application in accordance with these Regulations, is available.

(5) If the Executive is satisfied that the new applicant intends to apply for an authorisation or a registration referred to in paragraph (4)(a), it shall provide him with the name and address of the authorisation holder and shall inform the authorisation holder of the name and address of the new applicant.

(6) The authorisation holder and the new applicant shall take all reasonable steps to reach agreement on the sharing of information in order to avoid, if possible, the duplication of testing on vertebrate animals.

(7) The Executive shall encourage the authorisation holder to co-operate in the provision of information, with a view to limiting the duplication of testing on vertebrate animals.

(8) In this regulation—

(a) “approved biocidal product” means a biocidal product which has been authorised under regulation 9, 11 or 13 or registered under regulation 10, 12 or 14;

(b) “authorisation holder” means the person to whom—

(i) an authorisation of a biocidal product has been granted under regulation 9, 11, 13 or 17, or

(ii) a registration of a biocidal product has been granted under regulation 10, 12 or 14,

as the case may be;

(d) “new applicant” means a person who intends to apply for an authorisation or registration of a biocidal product under these Regulations.

Confidentiality

26

(1) Information provided to the Executive under these Regulations shall not be treated as relevant information for the purposes of Article 30 of the 1978 Order.

(2) Subject to the following paragraphs, where a person indicates to the Executive in writing that information provided by him to it under these Regulations should be kept confidential because the disclosure of that information might harm his industrial and commercial position—

(a) he shall provide to the Executive full written justification for that indication; and

(b) the Executive shall decide which information shall be kept confidential on the basis of that justification.

(3) Information which a person has indicated should be kept confidential and in relation to which the Executive has not made a decision under paragraph (2)(b) shall not be disclosed except—

(a) to a Government Department, the Great Britain Executive, the Commission or to a competent authority;

(b) where the information is provided in support of an application made under these Regulations, to the extent necessary to enable the Executive to deal with the application in question.

(4) Where the Executive has made a decision under paragraph (2)(b) that certain information shall not be kept confidential, that information shall not be disclosed until there has elapsed a period of 14 days following the day on which the Executive informed the person providing the information of its decision except—

(a) to a Government Department, the Great Britain Executive, the Commission or to a competent authority;

(b) where the information is provided in support of an application made under these Regulations, to the extent necessary to enable the Executive to deal with the application in question.

(5) A person who receives information by virtue of paragraph (3)(b), (4)(b) or (11)(b) shall not use that information except for the purposes of the Executive.

(6) After a biocidal product has been authorised or registered under these Regulations, the Executive shall not keep the information specified in Schedule 6 relating to that biocidal product confidential.

(7) If—

(a) the applicant for the authorisation or registration of a biocidal product; or

(b) the manufacturer or the importer of that biocidal product or an active substance contained in that biocidal product,

discloses any information relating to that biocidal product or that active substance which the Executive has decided under paragraph (2)(b) shall be kept confidential, that applicant shall inform the Executive accordingly, and such information shall no longer be treated as being confidential for the purposes of these Regulations.

(8) Subject to paragraph (9), where, pursuant to paragraph (2), a person has indicated that he has provided confidential information, he shall forthwith inform the Executive in writing of any change in circumstances which may affect the justification given by him under paragraph (2)(a).

(9) Paragraph (8) shall not apply if the Executive has informed the person in question that the information he has provided shall not be kept confidential.

(10) Where—

(a) the Executive has decided to keep information confidential pursuant to paragraph (2)(b); and

(b) a person has informed it of a change in circumstances pursuant to paragraph (8),

after consulting that person as appropriate, the Executive shall review whether the information in question should continue to be kept confidential and shall inform that person of the result of that review.

(11) If, following a review referred to in paragraph (10), the Executive decides that the information in question shall not be kept confidential, that information shall not be disclosed until there has elapsed a period of 14 days following the day on which the Executive informed the person providing the information of its decision except—

(a) to a Government Department, the Great Britain Executive, the Commission or to a competent authority;

(b) where—

(i) the information is provided in support of an application made under these Regulations, and

(ii) the Executive has not finally disposed of that application,

to the extent necessary to enable the Executive to deal with the application.

(12) This regulation is without prejudice to the provisions of the Environmental Information Regulations (Northern Ireland) 1993[^f00021].

Treatment of confidential information

27

(1) The Executive shall inform the competent authorities and the Commission of the information it has decided shall be kept confidential in accordance with regulation 26.

(2) When the Executive receives information from a competent authority which that competent authority has decided shall be kept confidential, it shall treat that information as confidential and shall not disclose it except to the Commission or to another competent authority.

Exchange of information

28

(1) The Executive shall inform the Commission and the competent authorities within one month from the end of each quarter of the information, including the information specified in Schedule 7, relating to every biocidal product in respect of which, in that quarter, an authorisation or, as the case may be, a registration has been granted, refused, modified, renewed or revoked under these Regulations.

(2) Where the Executive receives a summary of a dossier submitted in support of an application in a member State for inclusion, or for changes to the inclusion, of an active substance in Annex I, IA or IB and is of the opinion that the dossier is incomplete, it shall—

(a) immediately communicate that opinion to the competent authority which is responsible for the evaluation of that dossier; and

(b) without undue delay inform the Commission and the member States of that opinion.

(3) The Executive shall draw up annually a list of the biocidal products authorised or registered under these Regulations and shall send a copy of that list to the Commission and the member States.

(4) In this regulation, “quarter” means the periods in each year—

(a) commencing on 1st January and ending on 31st March;

(b) commencing on 1st April and ending on 30th June;

(d) commencing on 1st October and ending on 31st December,

and “end of each quarter” shall be construed accordingly.

Notification of information to the Poison Information Service

29

(1) This regulation shall not apply to a biocidal product on the market in Northern Ireland on 14th May 2000 until 6th May 2003.

(2) The person responsible for first placing a biocidal product on the market in Northern Ireland shall submit to the Poison Information Service written notification of the information specified in Schedule 8 relating to that biocidal product.

(3) Subject to paragraph (4), the notification referred to in paragraph (2) shall be submitted to the Poison Information Service—

(a) within three months after the date on which these Regulations come into operation; or

(b) within one month after the date on which the biocidal product in question was first placed on the market in Northern Ireland,

whichever is the later.

(4) In the case of a biocidal product which is on the market in Northern Ireland on 14th May 2000, the notification referred to in paragraph (2) shall be submitted to the Poison Information Service by 13th May 2003.

(5) A person who has submitted a notification under paragraph (2) shall also submit to the Poison Information Service written notification of any change to the information notified by him in accordance with that paragraph.

(6) Notifications to be submitted in accordance with this regulation shall be sent to the Poison Information Service at the Royal Victoria Hospital, Grosvenor Road, Belfast BT12 6BA.

(7) In the event of an emergency referred to in paragraph (4)(c) of Schedule 8, the individual to be contacted shall provide such further information relating to the biocidal product in question as the Poison Information Service may require.

(8) The Poison Information Service shall not disclose any information notified to it in pursuance of this regulation except to, and at the request of—

(a) a registered medical practitioner; or

(b) a person working under the direction of a registered medical practitioner,

in connection with the medical treatment of a person who may have been affected by the biocidal product in question.

Part V — Packaging, Labelling and Advertisements

Packaging

30

(1) A person shall not place on the market an authorised biocidal product which may be mistaken for food, drink or feedingstuff unless—

(a) it is packaged to minimise the likelihood of such a mistake being made; and

(b) where that authorised biocidal product is available to the public, it contains a substance or preparation to discourage its consumption.

(2) In this regulation, “authorised biocidal product” means a biocidal product which has been authorised or registered in accordance with these Regulations or the Great Britain Regulations.

Labelling

31

(1) A person shall not place on the market a biocidal product whose label—

(a) is misleading or gives an exaggerated impression of the authorised biocidal product; or

(b) contains, in relation to the authorised biocidal product, the descriptions “low-risk biocidal product”, “non-toxic” or “harmless”, or similar descriptions.

(2) Subject to paragraph (3), a person shall not place on the market an authorised biocidal product unless—

(a) that authorised biocidal product is labelled clearly and indelibly with the information specified in Schedule 9; and

(b) that information is in English, whether or not it is also in any other language.

(3) Subject to paragraph (4), the information referred to in sub-paragraphs 3, 5 to 12 and 14 of Schedule 9 may be given on the packaging of the authorised biocidal product or in an accompanying leaflet integral to the packaging of that authorised biocidal product.

(4) Where any information referred to in paragraph (3) is given in an accompanying leaflet, the authorised biocidal product shall be labelled clearly and indelibly with the words “Read attached instructions before use.”.

(5) In this regulation, “authorised biocidal product” has the same meaning as it has in regulation 30.

Samples, models and drafts

32

When required to do so by the Executive, a person who has submitted an application under regulations 9 to 15 or 17 or a person who places, or has placed, a biocidal product on the market shall provide it with—

(a) a sample or model of the packaging of, or a sample or draft of the labelling of, the biocidal product in question;

(b) a sample or draft of any accompanying leaflet integral to the packaging of the biocidal product in question.

33

(1) A person who places a biocidal product on the market shall ensure that—

(a) any advertisement of that biocidal product—

(i) subject to paragraph (2), contains the sentences “Use biocides safely. Always read the label and product information before use.”,

(ii) does not refer to the biocidal product in a manner likely to mislead in respect of the risks of that biocidal product to humans, animals or the environment,

(iii) does not contain, in relation to the biocidal product, the descriptions “low-risk biocidal product”, “non-toxic” nor “harmless”, nor similar descriptions; and

(b) the sentences referred to in sub-paragraph (a)(i) shall be clearly distinguishable from the rest of the advertisement.

(2) The word “biocides” in the first sentence required by paragraph (1)(a)(i) may be replaced by the product-type of the biocidal product being advertised.

Part VI — Miscellaneous and General

General provisions on applications for authorisations and registrations

34

(1) An application for—

(a) an authorisation of a biocidal product under regulation 9, 11, 13, 15 or 17; and

(b) a registration of a biocidal product under regulation 10, 12 or 14,

shall be made to the Executive by, or on behalf of, the person responsible for first placing the biocidal product in question on the market in Northern Ireland.

(2) An application referred to in paragraph (1), and information submitted in support of such an application, shall be in English.

(3) An applicant shall have a permanent office within the Community.

(4) When requested to do so by the Executive, an applicant shall submit to it samples of—

(a) the biocidal product in question; and

(b) its ingredients.

(5) The Executive shall communicate its decision in respect of an application referred to in paragraph (1) to the applicant.

(6) Every authorisation and every registration granted under these Regulations shall be in writing.

(7) In this regulation, “applicant” means an applicant for—

(a) an authorisation of a biocidal product under regulation 9, 11, 13, 15 or 17; or

(b) a registration of a biocidal product under regulation 10, 12 or 14.

Files on applications

35

(1) The Executive shall ensure that a file is compiled in respect of each application made under regulations 9 to 15 and 17.

(2) A file referred to in paragraph (1) shall include—

(a) a copy of the application to which it relates;

(b) a record of the decision relating to the application taken by the Executive;

(c) a record of the decision concerning the dossiers submitted in support of that application taken by the Executive; and

(d) a summary of those dossiers.

(3) The Executive shall, on request, make available to the competent authorities and the Commission—

(a) a copy of a file compiled in accordance with paragraph (1); and

(b) all information necessary for the full comprehension of the application to which the file relates.

(4) When requested to do so by a competent authority or the Commission, the Executive shall require an applicant under regulations 9 to 15 and 17, to forward copies of the dossiers submitted in support of his application to that competent authority or to the Commission, as the case may be and the applicant shall comply with that requirement.

Appeals

36

(1) Subject to paragraph (3), a person may appeal to the Department of Enterprise, Trade and Investment if that person is aggrieved by a decision of the Executive—

(a) not to grant his application for—

(i) the authorisation, or the renewal of an authorisation, of a biocidal product under regulation 9 or 13,

(ii) the authorisation of a biocidal product under regulation 17, or

(iii) the registration, or the renewal of a registration, of a biocidal product under regulation 10 or 14;

(b) to impose a condition or restriction when granting his application for—

(i) an authorisation of a biocidal product under regulation 9, 13 or 17, or

(ii) a registration of a biocidal product under regulation 10 or 14;

(c) made pursuant to regulation 16(6), to prohibit him from conducting an experiment or test or to impose conditions regarding the conduct by him of an experiment or test;

(d) made pursuant to regulation 20(1), to modify a condition of use subject to which an authorisation or registration has been granted to him under regulations 9 to 15 or 17;

(e) not to modify a condition of use, subject to which an authorisation or registration has been granted to him under regulations 9 to 15 or 17, when requested by him to do so under regulation 20(2);

(f) made pursuant to regulation 19, other than paragraph (12) of that regulation, to revoke an authorisation or a registration granted to him under regulations 9 to 15 or 17;

(g) not to revoke an authorisation or registration granted to him under regulation 9 to 15 or 17, when requested by him to do so under regulation 19(12);

(h) not to issue a frame-formulation, when requested by him to do so under regulation 18(1)(a);

(i) made pursuant to regulation 25, not to give its consent to him referring to information;

(j) made pursuant to regulation 26(2)(b), not to keep confidential information submitted by him to the Executive.

(2) A person may appeal to the Department of Enterprise, Trade and Investment if that person is aggrieved by a decision of the Executive—

(a) not to grant him a period of time longer than 3 months in which to make an application under regulation 9, 10, 11 or 12 pursuant to paragraphs 5 or 8 of Schedule 12;

(b) not to grant him a certificate of exemption;

(d) to revoke a certificate of exemption granted to him;

(e) relating to the period of time for which a certificate of exemption is granted to him,

and in this paragraph, “certificate of exemption” means a certificate of exemption referred to in Schedule 12.

(3) Paragraph (1) shall not apply where the decision of the Executive in question is made to give effect to a Commission decision.

(4) Chapter I of the Schedule to the Deregulation (Model Appeal Provisions) Order (Northern Ireland) 1997[^f00022] shall apply where an aggrieved person appeals to the Department of Enterprise, Trade and Investment.

(5) Where an appeal is brought under paragraphs (1)(d), (1)(f) or (2)(d), the decision in question shall be suspended pending the final determination of the appeal.

(6) Where an appeal is brought under paragraph (1)(j), pending final determination of the appeal, the Executive shall not disclose the information except—

(a) to a Government Department, the Great Britain Executive, the Commission or to a competent authority; and

(b) to the extent necessary to enable the Executive to deal with the application in question made under these Regulations.

(7) A person who receives information by virtue of paragraph (6)(b) shall not use that information except for the purposes of the Executive.

Tests

37

Every test carried out in support of an application under regulations 9 to 15 and 17 shall be conducted in accordance with such guidance as may be issued by the Executive.

Enforcement, offences and civil liability

38

Schedule 10 shall have effect.

Fees

39

(1) Schedule 11 shall have effect.

(2) The period of time within which the Executive must—

(a) comply with the provisions of regulation 6(2) when dealing with an application under regulation 5, 7(1) or 7(2);

(b) make a decision relating to an application submitted under regulations 9 to 14 or 17; or

shall not begin until there have been paid all fees payable under these Regulations in respect of the application or evaluation in question, other than those fees payable in accordance with paragraph 10 of Schedule 11.

(3) The Executive shall not be bound to consider a request made under regulation 20(2) until there have been paid the fee or fees payable under paragraph (6) of Schedule 11, other than those payable in accordance with paragraph 10 of that Schedule.

Transitional provisions

40

Schedule 12 shall have effect.

Application within territorial waters

41

Within territorial waters these Regulations shall apply only to and in relation to the premises and activities mentioned in paragraphs 2 to 6 of Schedule 13.

Amendments

42

(1) At the end of regulation 3(2) of the Control of Pesticides Regulations (Northern Ireland) 1987 there shall be added the following sub-paragraph—

(j) any biocidal product— (i) authorised or registered under the 2001 Regulations, (ii) placed on the market for use in an experiment or test in accordance with regulation 16 of the 2001 Regulations, or (iii) the placing on the market and use of which are subject to any of the prohibitions specified in regulation 8 of the 2001 Regulations, and in this sub-paragraph, “the 2001 Regulations” means the Biocidal Products Regulations (Northern Ireland) 2001, and “biocidal product” shall have the meaning assigned to it in regulation 2(1) of the 2001 Regulations.

(2) For sub-paragraph (d) of regulation 3(2) of the Notification of New Substances Regulations (Northern Ireland) 1994[^f00023] there shall be substituted the following sub-paragraph—

(d) a new substance which is placed on the market exclusively for use as an active substance in one or more of the following, namely— (i) a biocidal product to which the Biocidal Products Regulations (Northern Ireland) 2001 apply, (ii) a biocidal product to which the Biocidal Products Regulations (Northern Ireland) 2001 would have applied but for regulation 3(2) of those Regulations, (iii) a plant protection product to which the Plant Protection Products Regulations (Northern Ireland) 1995[^f00024] apply, or (iv) a pesticide to which the Control of Pesticides Regulations (Northern Ireland) 1987 apply.

[^f00025].

(3) In regulation 5(6) of the 1995 Regulations, after the words “the Food and Environment Protection Act 1985”, there shall be inserted the words “or a biocidal product which has been authorised or registered under the Biocidal Products Regulations (Northern Ireland) 2001.”.

SCHEDULE 1 — Biocidal product-types and their descriptions

1

Human hygiene biocidal products

2

Private area and public health area disinfectants and other biocidal products

3

Veterinary hygiene biocidal products

4

Food and feed area disinfectants

5

Drinking water disinfectants

6

In-can preservatives

7

Film preservatives

8

Wood preservatives

9

Fibre, leather, rubber and polymerised materials preservatives

10

Masonry preservatives

11

Preservatives for liquid-cooling and processing systems

12

Slimicides

13

Metalworking-fluid preservatives

14

Rodenticides

15

Avicides

16

Molluscicides

17

Piscicides

18

Insecticides, acaricides and products to control other arthropods

19

Repellents and attractants

20

Preservatives for food or feedstocks

21

Antifouling products

22

Embalming and taxidermist fluids

23

Control of other vertebrates

SCHEDULE 2 — Regulations relating to Biocidal products

The Regulations referred to in regulation 3(1)(a) are—

(a) the Materials and Articles in Contact with Food Regulations (Northern Ireland) 1987[^f00026];

(b) the Flavourings in Food Regulations (Northern Ireland) 1992[^f00027];

(d) the Active Implantable Medical Devices Regulations 1992[^f00029];

(e) the Egg Products Regulations (Northern Ireland) 1993[^f00030];

(f) the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994[^f00031];

(g) the Medical Devices Regulations 1994[^f00032];

(h) the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994[^f00033];

(i) the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994[^f00034];

(j) the Dairy Products (Hygiene) Regulations (Northern Ireland) 1995[^f00035];

(k) the Plant Protection Products Regulations (Northern Ireland) 1995[^f00036];

(l) the Feeding Stuffs Regulations (Northern Ireland) 1995[^f00037];

(m) the Miscellaneous Food Additives Regulations (Northern Ireland) 1996[^f00038];

(n) the Cosmetic Products (Safety) Regulations 1996[^f00039];

(o) the Registration of Homoeopathic Veterinary Medicinal Products Regulations 1997[^f00040];

(p) the Food Safety (Fishery Products and Live Shellfish) (Hygiene) Regulations (Northern Ireland) 1998[^f00041];

(q) the Medicated Feedingstuffs Regulations 1998[^f00042];

(r) the Feedingstuffs (Zootechnical Products) Regulations 1999[^f00043].

SCHEDULE 3 — Determinations of the Executive

1

Subject to paragraph 2, the Executive has determined that the biocidal product satisfies the following requirements, namely—

(a) the biocidal product is sufficiently effective;

(b) the biocidal product has no unacceptable effects on the target organisms, such as unacceptable resistance, cross-resistance, or unnecessary suffering and pain for vertebrates;

(c) the biocidal product and its residues, have no unacceptable effects on human or animal health, surface water or groundwater, whether directly or indirectly; and

(d) the biocidal product and its residues, have no unacceptable effects on the environment, having particular regard to—

(i) its fate and distribution in the environment, including in particular contamination of surface water (including estuarian and sea water), ground water and drinking water, and

(ii) its impact on non-target organisms.

2

In making the determinations referred to in paragraph 1, the Executive shall have regard to—

(a) current scientific and technical knowledge;

(b) the evaluation, according to the common principles for the evaluation of dossiers laid down in Annex VI, of the dossiers submitted with the application in question;

(d) the ways in which any material treated with the biocidal product may be used; and

(e) the consequences of use and disposal of the biocidal product.

3

The Executive has determined, according to the relevant requirements in Annexes IIA, IIB, IIIA, IIIB, IVA and IVB—

(a) the nature and quantity of—

(i) the active substance; and

(ii) where appropriate, any toxicologically or ecotoxicologically significant impurities and co-formulants,

contained in the biocidal product; and

(b) the nature and quantity of the residues of toxicological or environmental significance which would result from the uses of the biocidal product if such biocidal product were authorised or registered.

4

The Executive has determined—

(a) the physical and chemical properties of the biocidal product; and

(b) that such properties are acceptable for the purposes of the intended use, storage and transport of the biocidal product.

SCHEDULE 4 — Information to be contained in a dossier submitted in support of an application for the registration of a biocidal product

1

The name and address of the applicant.

2

The name and address of the manufacturer of the biocidal product.

3

The name and address of the manufacturer of the active substance in the biocidal product, and the location of manufacture.

4

The trade name of the biocidal product.

5

The name of each substance in the biocidal product, including the name of its active substance, and the amount of each substance, as a percentage of the whole.

6

The physical and chemical properties of the biocidal product relating to use, storage and transport.

7

The product-type and field of use of the biocidal product.

8

The intended category of users.

9

The intended method of use.

10

Efficacy data.

11

Analytical methods.

12

The classification, packaging and labelling of the biocidal product, including a draft label.

13

Where the biocidal product is a substance or preparation dangerous for supply within the meaning of regulation 2(1) of the 1995 Regulations [^f00044], a safety data sheet for that biocidal product prepared in accordance with regulation 6 of those Regulations.

SCHEDULE 5 — Matters in respect of which additional conditions may be imposed on the mutual recognition of an authorisation or a registration of a biocidal product

1

Directions for use of the biocidal product in question, including its dose rate expressed in metric units.

2

Particulars of any likely direct or indirect adverse side effects and any directions for first-aid.

3

Directions for safe disposal of the biocidal product in question and its packaging, including any prohibition on the re-use of packaging.

4

The period of time needed for the biocidal effect.

5

The interval to be observed between—

(a) applications of the biocidal product;

(b) application and the next use of the article, material or substance treated by the biocidal product; or

including particulars of decontamination means and measures and duration of necessary ventilation of treated areas.

6

Particulars for adequate cleaning of equipment.

7

Particulars concerning precautionary measures during use, storage and transport, such as personal protective equipment to be used, measures for protection against fire, covering of furniture, removal of food and feedingstuff and directions to prevent animal exposure to the biocidal product in question.

8

Information on any specific dangers to the environment, including protection of non-target organisms and avoidance of contamination of water.

SCHEDULE 6 — Non-confidential information

1

The name and address of the applicant for the authorisation or registration of the biocidal product.

2

The name of the biocidal product.

3

The name and address of the manufacturer of the biocidal product.

4

The name and address of the manufacturer of the active substance in the biocidal product.

5

The name and content of the active substance in the biocidal product.

6

The name of any other substance in the biocidal product which—

(a) is listed in Part I of the approved supply list; or

(b) is classified as being in one or more of the categories of danger specified in column 1 of Schedule 1 to the 1995 Regulations,

except a substance of which no account would be taken in the classification of that biocidal product by virtue of paragraph 18(1) of Part I of Schedule 3 to those Regulations.

7

Physical and chemical data concerning the biocidal product and the active substance contained in that biocidal product.

8

Any ways of rendering harmless the biocidal product and the active substance contained in that biocidal product.

9

A summary of the results of the tests, referred to in the dossiers submitted in support of an application under these Regulations, to establish—

(a) the efficacy;

(b) the effects on humans, animals and the environment; and

of the biocidal product and the active substance contained in that biocidal product.

10

Recommended methods and precautions to reduce dangers from handling, storage, transport, use, fire or other hazards.

11

Safety data sheets.

12

Methods of analysis necessary to enable the Executive to make the determination referred to in paragraph 3 of Schedule 3.

13

Methods of disposal of the biocidal product and its packaging.

14

Procedures to be followed and measures to be taken in the case of spillage or leakage of the biocidal product and the active substance contained in that biocidal product.

15

First aid and medical advice to be given in the case of injury to persons.

SCHEDULE 7 — Information relating to Biocidal products to be given to the Commission and to the competent authorities

1

The name of the applicant for, or the person to whom, the authorisation or registration was granted.

2

The trade name of the biocidal product.

3

The name and amount of each active substance which the biocidal product contains.

4

The name and amount of each substance which the biocidal product contains which is a substance dangerous for supply within the meaning of regulation 2(1) of the 1995 Regulations and its classification.

5

The product-type for the biocidal product and the use for which it is authorised or registered, as the case may be.

6

The type of formulation of the biocidal product, namely whether it is in the form of a powder, granules, a solid, a liquid concentrate or some other form.

7

Any proposed limits on residues which have been determined by the Executive in accordance with paragraph 3(b) of Schedule 3.

8

Any conditions subject to which the authorisation or registration was granted.

9

The reasons for the modification or cancellation of an authorisation or registration.

10

Whether the biocidal product is a low-risk biocidal product or within a frame-formulation.

SCHEDULE 8 — Information to be notified to the Poison Information Service

1

The name of the biocidal product.

2

If the biocidal product is authorised or registered under these Regulations—

(a) the use for which it is so authorised or registered; and

(b) the name, address and telephone number and any e-mail address and any fax number of the person to whom the authorisation or registration was granted.

3

The date on which the biocidal product was first placed on the market in Northern Ireland.

4

The name, address and telephone number and any e-mail address and any fax number of—

(a) the manufacturer of the biocidal product;

(b) any importer of the biocidal product; and

5

A description of the packaging of the biocidal product, including its size and type.

6

The pH, physical state and colour of the biocidal product.

7

The identity of the ingredients of the biocidal product, and their concentration in metric units.

8

The effects on human health of contact with the biocidal product.

9

Particulars of the likely direct or indirect adverse side effects of the biocidal product and any directions for first aid.

10

Any other information relating to the health and safety of humans which is given on the label of the biocidal product.

SCHEDULE 9 — Information to be included on labels

1

The identity of the active substance in the biocidal product and its concentration in metric units.

2

The authorisation or registration number allocated to the biocidal product by the Executive.

3

The type of formulation of the biocidal product, namely whether it is in the form of a powder, granules, a solid, a liquid concentrate or some other form.

4

The use for which the biocidal product is authorised or registered.

5

Directions for use of the biocidal product, including its dose rate in metric units.

6

Particulars of likely direct or indirect adverse side effects and any directions for first aid.

7

Directions for safe disposal of the biocidal product and its packaging, including any prohibition on the re-use of packaging.

8

The number or other reference assigned by the manufacturer of the biocidal product to the batch of biocidal products with which that biocidal product was made and the expiry date relevant to normal conditions of storage.

9

The period of time needed for the biocidal effect.

10

The interval to be observed between—

(a) applications of the biocidal product;

(b) application and the next use of the article, material or substance treated by the biocidal product; or

including particulars of decontamination means and measures and duration of necessary ventilation of treated areas.

11

Instructions for adequate cleaning of equipment for use with the biocidal product.

12

Instructions concerning precautionary measures during use, storage and transport, such as personal protective equipment to be used, measures for protection against fire, covering of furniture, removal of food and feedingstuff and directions to prevent animal exposure to the biocidal product.

13

Any restriction on the category of persons who may use the biocidal product.

14

Information on any specific dangers to the environment, including protection of non-target organisms and avoidance of contamination of water.

SCHEDULE 10 — Enforcement, offences and civil liability

Interpretation

1

In this Schedule—

“the 1999 Regulations” means the Health and Safety (Enforcing Authority) Regulations (Northern Ireland) 1999[^f00045];

“domestic premises” means premises occupied as a private dwelling (including any garden, yard, garage, outhouse or other appurtenance of such premises which is not used in common by the occupants of more than one such dwelling);

“inspector” means an inspector appointed under Article 21 of the 1978 Order; and

“work” shall be construed in accordance with Article 2(4) of the 1978 Order.

Application of the Health and Safety at Work (Northern Ireland) Order 1978

2

(1) Articles—

(a) 18 to 28 (approval of codes of practice and enforcement);

(b) 31 to 39 (provisions as to offences); and

of the 1978 Order shall, subject to the following provisions of this Schedule, and to the extent that they would not otherwise do so, apply to these Regulations as if they were health and safety regulations for the purposes of that Order.

(2) The Articles of the 1978 Order which are applied to these Regulations by sub-paragraph (1) shall so apply as if any reference to—

(a) danger, or danger to health and safety, were a reference to danger to the health or safety of humans or animals or to danger to the environment; and

(b) harm were a reference to harm to humans, animals or the environment.

(3) Articles 24 and 27 of the 1978 Order, as applied to these Regulations by sub-paragraph (1), shall apply as if the reference in those Articles to serious personal injury were a reference to—

(a) serious personal injury to humans;

(b) a breach of the Regulations and serious injury to animals; or

Offences

3

A failure to discharge a duty—

(a) placed on the Executive by these Regulations; or

(b) placed on any person by regulation 5, 7(3), 9(4) to (6), 9(8), 10(4) to (6), 10(9), 11(5), 12(5), 17(4), 25(6), 26(2), 34(1) to (4) and 37,

shall not be an offence under Article 31(1)(c) of the 1978 0rder.

Limitation on entry to domestic premises in certain circumstances

4

(1) An inspector may not enter domestic premises in the exercise of his powers under the 1978 Order, as applied to these Regulations by virtue of paragraph 2, in respect of any activity which is not, or is not related to, an activity involving work, unless a justice of the peace has issued a warrant authorising him to enter and exercise his powers in those domestic premises.

(2) A justice of the peace may not issue such a warrant, unless on an application made by the inspector, he is satisfied—

(a) that the inspector has reasonable grounds for believing that there is present in the domestic premises anything to which those powers relate; and

(b) that—

(i) it is not practicable to communicate with any person entitled to grant entry to the domestic premises,

(ii) a person entitled to grant entry to the domestic premises has unreasonably refused an inspector entry,

(iii) entry to the domestic premises is unlikely to be granted unless a warrant is produced, or

(iv) the purpose of entry may be frustrated or seriously prejudiced unless an inspector arriving at the domestic premises can secure immediate entry to them.

Allocation of enforcement responsibility

5

(1) Notwithstanding the 1999 Regulations, and subject to sub-paragraphs (2) to (7), the enforcing authority for these Regulations shall be the Executive.

(2) Where an active substance is placed on the market—

(a) in or from any shop, mobile vehicle, market stall or other retail outlet; or

(b) otherwise to members of the public, including by way of free sample, prize or mail order,

the enforcing authority for regulation 4 shall be the district council for the district in which the active substance is placed on the market.

(3) Where a biocidal product is placed on the market—

(a) in or from any shop, mobile vehicle, market stall or other retail outlet; or

(b) otherwise to members of the public, including by way of free sample, prize or mail order,

the enforcing authority for regulations 8(1), 30 and 31 shall be the district council for the district in which the biocidal product is placed on the market.

(4) Where a biocidal product is sold—

(a) in or from any shop, mobile vehicle, market stall or other retail outlet; or

(b) otherwise to members of the public, including by way of free sample, prize or mail order,

the enforcing authority for regulation 22(3) shall be the district council for the district in which the biocidal product is sold.

(5) Where a biocidal product is placed on the market, the enforcing authority for regulation 33 shall be the district council for the district in which the biocidal product is placed on the market.

(6) The 1999 Regulations shall apply to the enforcement of regulations 8(2), 8(5) and 22(4).

(7) The enforcing authority for regulations 8(2), 8(5) and 22(4)—

(a) in respect of any use not related to an activity involving work; or

(b) in respect of any use by a domestic servant in a private household,

shall be the district council for the district in which the use occurs.

SCHEDULE 11 — Fees

1

On the making of an application to the Executive under regulation 5 for the inclusion of an active substance in Annex I, IA or IB, there shall be payable by the applicant to the Executive—

(a) for ensuring that the dossiers submitted as part of that application satisfy the requirements of regulation 5 in accordance with regulation 6(1); and

(b) for determining the application in accordance with regulation 6(2),

a fee or fees to be determined in accordance with paragraphs 7 and 9 to 12.

2

There shall be payable by the applicant to the Executive in connection with the determination of an application to the Executive specified in paragraph 3, a fee or fees to be determined in accordance with paragraphs 7 and 9 to 12.

3

The applications to the Executive referred to in paragraph 2 are—

(a) an application under regulation 7(1) for a variation of the requirements subject to which an active substance is included in Annex I, IA or IB;

(b) an application under regulation 7(2) for the renewal of the inclusion of an active substance in Annex I, IA or IB;

(c) an application under regulation 9 for the authorisation of, or the renewal of an authorisation of, a biocidal product;

(d) an application under regulation 10 for the registration of, or the renewal of the registration of, a biocidal product;

(e) an application under regulation 11(5) for the authorisation of a biocidal product;

(f) an application under regulation 12(5) for the registration of a biocidal product;

(g) an application under regulation 13 for the provisional authorisation of, or the renewal of the provisional authorisation of, a biocidal product;

(h) an application under regulation 14 for the provisional registration of, or the renewal of a provisional authorisation of, a biocidal product;

(i) an application for an authorisation under regulation 17.

4

There shall be payable by the applicant to the Executive in connection with the evaluation of dossiers following a decision referred to in regulation 6(6) or regulation 7(5), a fee or fees to be determined in accordance with paragraphs 7 and 9 to 12.

5

There shall be payable by a person who provides information under regulation 16(5) or 20(5)(b) a fee or fees to be determined in accordance with paragraphs 7 and 9 to 12.

6

There shall be payable by a person who requests a modification under regulation 20(2) a fee or fees to be determined in accordance with paragraphs 7 and 9 to 12.

7

On receipt of—

(a) an application referred to in paragraph 1;

(b) an application specified in paragraph 3;

(d) information referred to in paragraph 5; or

(e) a request referred to in paragraph 6,

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 necessary for the determination of the application, the evaluation of dossiers, or the consideration of the information or the request.

8

The amount estimated in accordance with paragraph 7 shall be paid forthwith by the person to whom the estimate is sent.

9

On the determination of the application, completion of the evaluation of dossiers or consideration of the information or request, the Executive shall prepare a detailed statement of the work carried out in relation to that determination, evaluation or consideration, as the case may be, and of the cost reasonably incurred by the Executive or any person acting on its behalf in carrying out that work.

10

If the cost referred to in paragraph 9 is greater than the amount estimated in accordance with paragraph 7, the amount of the difference shall be—

(a) notified by the Executive to the applicant or the person providing the information or making the request, as the case may be;

(b) the amount of the final fee payable; and

11

If the cost referred to in paragraph 9 is less than the amount estimated in accordance with paragraph 7, the fee shall be adjusted accordingly and the amount of the difference shall be paid forthwith by the Executive to the applicant or the person providing the information or making the request, as the case may be.

12

In estimating or stating the cost of carrying out any work, the Executive may take into account the cost to it, or to any person acting on its behalf, of employing an officer for any period to perform the work concerned and shall determine that cost by reference to the average cost of employing an officer of the grade appropriate for that work for that period.

SCHEDULE 12 — Transitional Provisions

1

In this Schedule—

“COPR 1987” means the Control of Pesticides Regulations (Northern Ireland) 1987[^f00046];

“COPR approval” means an approval granted under COPR 1987;

“COPR biocidal product” means a biocidal product to which COPR 1987 applies; and

“unlisted active substance” means an existing substance which is not included in Annex I, IA or IB.

2

Subject to paragraphs 3 and 4, where a decision is made under Article 16(2) that—

(a) an unlisted active substance shall be included in Annex I, IA or IB; or

(b) an unlisted active substance shall not be included in either Annex I, IA or IB,

these Regulations shall apply to every biocidal product which contains the unlisted active substance to which the decision in question relates when that decision takes effect.

3

These Regulations shall not apply to a biocidal product—

(a) when a decision referred to in paragraph 2(a) relating to an unlisted active substance in that biocidal product takes effect, if that biocidal product is not within a product-type in which the unlisted active substance may be used in accordance with any requirement to which the inclusion of the unlisted active substance in Annex I, IA or IB, as the case may be, is subject;

(b) when a decision referred to in paragraph 2(b) relating to an unlisted active substance in that biocidal product takes effect, if the biocidal product is not within a product-type in which, in accordance with that decision, the unlisted active substance may not be used.

4

Where there is more than one unlisted active substance in a biocidal product, these Regulations shall not apply to that biocidal product until a decision referred to in paragraph 2 is made in relation to the last of those unlisted active substances to be considered for inclusion in Annex I, IA or IB, provided that such a decision has been made to include all the other active substances in that biocidal product in either Annex I, IA or IB.

5

Where—

(a) there is made a decision referred to in paragraph 2(a); and

(b) by virtue of that paragraph, these Regulations apply to a biocidal product containing the unlisted active substance in question,

the person responsible for first placing the biocidal product on the market in Northern Ireland may make an application under regulation 9 or regulation 10, as the case may be, in respect of that biocidal product not later than 3 months after that decision takes effect, or such longer period as the Executive may determine.

6

Where—

(a) there is made a decision referred to in paragraph 2(a); and

(b) by virtue of that paragraph, these Regulations apply to a biocidal product containing the unlisted active substance in question,

the Executive may grant a certificate of exemption in accordance with paragraph 15 where a person informs the Executive in writing that he intends to make an application to the Executive under regulation 11 or regulation 12 after a competent authority in another member State has authorised or registered that biocidal product for placing on the market and use under the Directive.

7

During—

(a) the period of time in which an application may be made in accordance with paragraph 5; and

(b) the period of time between such application being made and the Executive deciding whether or not to authorise or register the biocidal product in question,

the Executive may grant a certificate of exemption in accordance with paragraph 15.

8

Where—

(a) there is made a decision referred to in paragraph 2(a);

(b) by virtue of that paragraph these Regulations apply to a biocidal product containing the unlisted active substance in question; and

(c) the competent authority of a member State has authorised or registered that biocidal product for placing on the market and use,

the person responsible for first placing the biocidal product on the market in Northern Ireland may make an application under regulation 11 or 12, as the case may be, in respect of that biocidal product not later than 3 months after that authorisation or registration was granted, or such longer period as the Executive may determine.

9

During—

(a) the period of time in which an application may be made in accordance with paragraph 8; and

(b) the period of time between such application being made and the Executive deciding whether or not to authorise or register the biocidal product in question,

the Executive may grant a certificate of exemption in accordance with paragraph 15.

10

Where—

(a) no application is made in accordance with paragraph 5 or 8; and

(b) such an application is made but the Executive refuse to authorise or register the biocidal product in question,

the Executive may grant a certificate of exemption in accordance with paragraph 15.

11

Where—

(a) an application is made in accordance with paragraph 8;

(b) the Executive refuses to authorise or register the biocidal product, as the case may be; and

the Executive may grant a certificate of exemption in accordance with paragraph 15.

12

Where—

(a) there is made a decision referred to in paragraph 2(b); and

(b) by virtue of that paragraph these Regulations apply to a biocidal product containing the unlisted active substance in question,

the Executive may grant a certificate of exemption in accordance with paragraph 15.

13

Where—

(a) there is made a decision referred to in paragraph 2; and

(b) by virtue of that paragraph these Regulations apply to a COPR biocidal product containing the unlisted active substance in question,

COPR 1987 shall cease to apply to that COPR biocidal product when that decision takes effect.

14

The Executive shall—

(a) notify in writing the holder of a COPR approval in respect of a COPR biocidal product to which paragraph 10 applies that COPR 1987 no longer applies to that biocidal product; and

(b) at the same time, revoke that COPR approval.

15

A certificate of exemption granted pursuant to paragraph 6, 7, 9, 10, 11 or 12 shall be in writing and may exempt any person or class of persons or any biocidal product or class of biocidal products from all or any of the requirements or prohibitions imposed by these Regulations, other than regulation 29, relating to—

(a) placing on the market;

(b) use;

(d) packaging and labelling; or

(e) storage (including storage for disposal).

16

An exemption certificate granted in accordance with paragraph 15—

(a) may be granted subject to conditions;

(b) may be revoked by the Executive by a further certificate in writing at any time; and

SCHEDULE 13 — Application within territorial waters

Interpretation

1

(1) In this Schedule—

“designated area” means any area designated by order under section 1(7) of the Continental Shelf Act 1964[^f00047] and “within a designated area” includes over and under it;

“offshore installation” shall be construed in accordance with paragraph 2(4) and (5);

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