Made | 5th December 2001 | ||
Coming into operation | 16th January 2002 |
1. | Citation and commencement. |
2. | Interpretation. |
3. | Application. |
4. | Placing on the market of active substances. |
5. | Applications concerning new active substances. |
6. | Assessment of applications concerning new active substances. |
7. | Applications for variation or renewal of the inclusion of active substances in Annex I, IA or IB. |
8. | Prohibitions. |
9. | Authorisation of a biocidal product. |
10. | Registration of a low-risk biocidal product. |
11. | Mutual recognition of authorisations. |
12. | Mutual recognition of registrations. |
13. | Provisional authorisation. |
14. | Provisional registration. |
15. | Emergency authorisation. |
16. | Research and development. |
17. | Experimental authorisation. |
18. | Frame-formulations. |
19. | Revocation of authorisations and registrations. |
20. | Modification and review of authorisations and registrations. |
21. | Notification of new information. |
22. | Emergency prohibition or restriction. |
23. | Data protection for active substances. |
24. | Data protection for biocidal products. |
25. | Co-operation in the use of information. |
26. | Confidentiality. |
27. | Treatment of confidential information. |
28. | Exchange of information. |
29. | Notification of information to the Poison Information Service. |
30. | Packaging. |
31. | Labelling. |
32. | Samples, models and drafts. |
33. | Advertisements. |
34. | General provisions on applications for authorisations and registrations. |
35. | Files on applications. |
36. | Appeals. |
37. | Tests. |
38. | Enforcement, offences and civil liability. |
39. | Fees. |
40. | Transitional provisions. |
41. | Application within territorial waters. |
42. | Amendments. |
Schedule 1. | Biocidal product types and their descriptions. |
Schedule 2. | Regulations relating to biocidal products. |
Schedule 3. | Determinations of the Executive. |
Schedule 4. | Information to be contained in a dossier submitted in support of an application for the registration of a biocidal product. |
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. |
Schedule 6. | Non-confidential information. |
Schedule 7. | Information relating to biocidal products to be given to the Commission and to the competent authorities. |
Schedule 8. | Information to be notified to the Poison Information Service. |
Schedule 9. | Information to be included on labels. |
Schedule 10. | Enforcement, offences and civil liability. |
Schedule 11. | Fees. |
Schedule 12. | Transitional provisions. |
Schedule 13. | Application within territorial waters. |
(b) signed by the owner of that information;
other than a supply for storage followed by consignment from the customs territory of the European Community or followed by disposal, and "on the market" shall be construed accordingly;
(2) In these Regulations, any requirement to submit or provide information, including information comprising, or included in, a dossier, in support of an application for the authorisation or the registration of a biocidal product under these Regulations, may be satisfied in whole or in part by -
(3) In these Regulations, a reference to "frame-formulation" is a reference to specifications for a group of biocidal products which -
and whose composition, when compared, subject to paragraph (4), with the composition of a biocidal product which has been authorised or registered in accordance with these Regulations, is the same as the composition of that biocidal product.
(4) In carrying out the comparison referred to in paragraph (3), there shall be disregarded a variation which does not reduce the efficacy of, nor affect the level of risk associated with, the biocidal products in question.
(5) In paragraph (4), "variation" means one or more of the following, that is to say -
(6) In these Regulations, any reference to the name of an active substance is a reference to -
the International Organisation for Standardisation common name of that active substance; or
(d) if the name -
and there is no International Organisation for Standardisation common name for that active substance, the chemical designation of that active substance according to International Union of Pure and Applied Chemistry rules.
(7) In paragraph (6),
(8) In these Regulations, a reference to a biocidal product which contains an active substance shall include a reference to a biocidal product which is an active substance.
(9) In these Regulations a reference to a numbered Article or Annex is a reference to the Article in or Annex to the Directive so numbered.
(10) The Interpretation Act (Northern Ireland) 1954[13] shall apply to these Regulations as it applies to an Act of the Northern Ireland Assembly.
Application
3.
- (1) These Regulations shall not apply to a biocidal product where and to the extent that the biocidal product is placed on the market or used for a purpose over which control is exercised under -
(2) Subject to Schedule 12, these Regulations, except regulation 29, shall not apply to a biocidal product which contains an existing active substance.
(3) These Regulations shall not apply to a biocidal product which is a relevant plant protection product where and to the extent that that biocidal product is placed on the market or used for a purpose over which, but for the provisions of Schedule 3 to the PPP Regulations, control under the PPP Regulations would otherwise be exercisable.
(4) These Regulations shall not apply to a biocidal product which, by virtue of regulation 19(1) of the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994[16], continues to have a product licence under section 7 of the Medicines Act 1968 so long as that licence remains in force.
(5) These Regulations shall not apply to the placing on the market of a biocidal product prepared extemporaneously in the circumstances described in regulation 5(1)(c) of the Medicines (Restrictions on the Administration of Veterinary Medicinal Products) Regulations 1994[17].
(6) Regulations 30 to 32 shall not apply to the carriage of biocidal products by rail, road, inland waterway, sea or air.
(7) In this regulation -
(2) Paragraph (1) shall not apply to a new active substance intended for use in a biocidal product where that new active substance is placed on the market for use in an experiment or test for the purposes of -
(3) A person shall not place on the market an active substance intended exclusively for use in a biocidal product for the purpose of any experiment or test in Northern Ireland which may involve or result in the release into the environment of that active substance unless that active substance has been authorised in accordance with regulation 17.
Applications concerning new active substances
5.
A person who applies to the Executive for the inclusion of a new active substance in Annex I, IA or IB shall submit to the Executive -
(b) a dossier satisfying the requirements of regulation 9(4) to (6) for at least one biocidal product containing the new active substance; and
(c) a declaration that the new active substance is intended for inclusion in a biocidal product.
Assessment of applications concerning new active substances
6.
- (1) Where the Executive receives an application under regulation 5, it shall ensure that the dossiers submitted as part of that application satisfy the requirements of that regulation and, where those dossiers do so, the Executive shall -
(2) Subject to paragraph (5) and subject to regulation 39(2), within the period of 12 months of the Executive accepting the dossiers in accordance with paragraph (1)(a), the Executive shall -
(3) Where necessary for the purpose of carrying out an evaluation required by paragraph (2)(a), the Executive shall -
(4) Where the Executive requests additional information under paragraph (3), the period of time between the date when the Executive requests the information and the date when the applicant responds to its satisfaction shall not be taken into account in calculating the period of 12 months referred to in paragraph (2).
(5) After the Executive has accepted the dossiers in accordance with paragraph (1)(a), it may make a request to the Commission for the evaluation of the dossiers to be carried out by a competent authority, and, in such a case -
(6) Where there is a Commission decision that the Executive shall evaluate the dossiers submitted to a competent authority in support of an application for the inclusion of a new active substance in Annex I, IA or IB, subject to regulation 39(2), within the period of 12 months of receiving the dossiers, the Executive shall -
(7) Paragraphs (3) and (4) shall apply where the Executive evaluates dossiers under paragraph (6)(a) as if the dossiers had been submitted under regulation 5.
Applications for variation or renewal of the inclusion of active substances in Annex I, IA or IB
7.
- (1) A person may apply to the Executive for a variation of the requirements subject to which an active substance was included in Annex I, IA or IB.
(2) Before the expiry of the initial period, or any renewed period, as the case may be, of the inclusion of an active substance in Annex I, IA or IB, a person may apply to the Executive, for the renewal of the inclusion of that active substance in Annex I, IA or IB for a period not exceeding 10 years.
(3) A person who applies to the Executive under paragraph (1) or (2) shall submit dossiers in accordance with regulation 5.
(4) Regulation 6(1) to (5) shall apply to an application made under paragraph (1) or (2) as it applies to an application made under regulation 5, save that -
(5) Where there is a Commission decision that the Executive shall evaluate the dossiers submitted to a competent authority in support of an application for -
subject to regulation 39(2), within the period of 12 months of receiving the dossiers, the Executive shall comply with the requirements specified in paragraph (6).
(6) The requirements referred to in paragraph (5) are that the Executive shall -
as the case may be; and
(c) send a copy of its evaluation and recommendation to the Commission, the member State and the applicant.
(7) Regulation 6(3) and (4) shall apply where the Executive evaluates dossiers under paragraph (6)(a) as if the dossiers had been submitted under regulation 5.
(2) Subject to paragraphs (3) and (4), a person shall not use a biocidal product which has been placed on the market unless that biocidal product -
(3) Paragraphs (1) and (2)(a) shall not apply to a biocidal product which is placed on the market for use in an experiment or test for the purposes of -
pursuant to regulation 16.
(4) Paragraphs (1) and (2) shall not apply to a biocidal product which does not contain any active substance other than an active substance included only in Annex IB.
(5) A person shall not use a biocidal product containing an active substance which is included in Annex IB unless that biocidal product is used in a manner which involves the rational application of a combination of physical, biological, chemical or other measures as appropriate to limit the use of biocidal products to the minimum necessary for the effective control of target organisms.
(6) In this regulation, "properly used" means used both -
Authorisation of a biocidal product
9.
- (1) Subject to the following paragraphs, the Executive may authorise a biocidal product for placing on the market and use for a period of time which ends on a date not later than the earliest date on which the entry in Annex I of any active substance in that biocidal product expires.
(2) The Executive shall not authorise a biocidal product under paragraph (1) unless -
(b) the Executive has made the determinations referred to in Schedule 3.
(3) The Executive shall not authorise a biocidal product under paragraph (1) for use by the public, or for placing on the market for use by the public, where that biocidal product is classified as -
(4) An applicant for the authorisation of a biocidal product under paragraph (1) shall submit his application to the Executive and with that application shall include -
(b) a dossier for each active substance in that biocidal product satisfying, in the light of current scientific and technical knowledge, the requirements of -
(5) A dossier submitted in accordance with paragraph (4) shall include -
(6) The information in dossiers submitted to the Executive in accordance with paragraph (4) shall be sufficient to enable the Executive to make the determination referred to in Schedule 3.
(7) The Executive -
(8) If the evaluation of a dossier shows that additional information, which may include data and results from further testing, is necessary for the purpose of evaluating the risks of the biocidal product in question, the Executive shall request in writing the applicant to provide such additional information as it may specify.
(9) Where the Executive requests additional information under paragraph (8), the period of time within which the Executive shall decide whether or not to authorise the biocidal product in question shall not commence until the dossier is complete.
(10) In an authorisation granted under paragraph (1), the Executive shall specify -
(b) any other conditions or restrictions subject to which the authorisation is granted.
(11) The Executive may renew an authorisation granted under this regulation for a period of time which ends on a date not later than the earliest date on which the entry in Annex I of any active substance in the biocidal product the subject of the authorisation expires.
(12) Paragraphs (2) to (10) shall apply in the case of an application for the renewal of an authorisation under paragraph (11) as they apply in the case of an application for an authorisation under paragraph (1).
(13) Where an application for the renewal of an authorisation of a biocidal product granted under this regulation has been made, the Executive may, where necessary, renew that authorisation for such further period as is required to enable the Executive -
Registration of a low-risk biocidal product
10.
- (1) Subject to the following paragraphs, the Executive may register a low-risk biocidal product for placing on the market and use for a period of time which ends on a date not later than the earliest date on which the entry in Annex IA of any active substance in that low-risk biocidal product expires.
(2) The Executive shall not register a low-risk biocidal product under paragraph (1) unless -
(3) The Executive shall not register a low-risk biocidal product under paragraph (1) for use by the public, or for placing on the market for use by the public, where that low-risk biocidal product is classified as toxic or very toxic.
(4) Subject to paragraph (7), an applicant for the registration of a low-risk biocidal product under paragraph (1) shall submit his application to the Executive and with that application shall include -
(5) A dossier submitted in accordance with paragraph (4) shall include -
(6) The information in dossiers submitted to the Executive in accordance with paragraph (4) shall be sufficient to enable the Executive to make the determinations referred to in Schedule 3.
(7) Where the applicant justifies the omission to the satisfaction of the Executive, the applicant may omit from a dossier submitted in accordance with paragraph (4)(a) information which -
(b) it is not scientifically necessary or technically possible to supply.
(8) The Executive -
(9) If the evaluation of a dossier shows that additional information, which may include data and results from further testing, is necessary for the purpose of evaluating the risks of the low-risk biocidal product in question, the Executive shall request in writing the applicant to provide such additional information as it may specify.
(10) Where the Executive requests additional information under paragraph (9), the period of time referred to in paragraph (8)(b) shall not commence until the dossier is complete.
(11) In a registration granted under paragraph (1), the Executive shall specify -
(b) any other conditions or restrictions subject to which the registration is granted.
(12) The Executive may renew a registration granted under this regulation for a period of time which ends on a date not later than the earliest date on which the entry in Annex IA of any active substance in the low-risk biocidal product the subject of the registration expires.
(13) Paragraphs (2) to (11) shall apply in the case of an application for the renewal of a registration under paragraph (12) as they apply in the case of an application for a registration under paragraph (1).
(14) Where an application for the renewal of a registration of a low-risk biocidal product granted under this regulation has been made, the Executive may, where necessary, renew that registration for such further period as is required to enable the Executive -
Mutual recognition of authorisations
11.
- (1) Where a biocidal product has been authorised for placing on the market and use under the Directive in a member State, a person may apply to the Executive for authorisation of that biocidal product for placing on the market and use under this regulation.
(2) Subject to the following paragraphs and to regulations 18(3) and 39(2), within 120 days of the Executive receiving an application in accordance with this regulation, it shall authorise the biocidal product in question subject to the conditions and restrictions imposed on authorisation of that biocidal product in the member State where authorisation was first granted.
(3) Subject to paragraphs (8) and (9), the Executive shall not authorise a biocidal product under this regulation unless the following conditions are satisfied, namely -
(4) Subject to paragraphs (8) and (9), the Executive shall not authorise a biocidal product under this regulation if it considers that -
the biocidal product cannot be determined according to the relevant requirements in Annexes IIA, IIB, IIIA, IIIB, IVA and IVB.
(5) An applicant for authorisation of a biocidal product under this regulation shall submit with his application -
(6) Where the Executive is satisfied that -
it may propose conditions and restrictions relating to the matters referred to in Schedule 5 concerning the placing on the market and the use of the biocidal product in addition to those conditions and restrictions imposed in the member State in which the biocidal product was first authorised.
(7) The additional conditions and restrictions proposed pursuant to paragraph (6) shall be such as to ensure -
(8) Where, under this regulation, the Executive proposes to refuse to authorise a biocidal product or to impose conditions or restrictions in addition to those imposed in the member State in which the biocidal product was first authorised, it shall -
(9) Where a Commission decision -
(c) confirms that an authorisation, which the Executive proposes should be refused, should be granted, the Executive shall authorise the biocidal product in question subject to any conditions and restrictions imposed in the member State in which the biocidal product was first authorised;
(d) confirms that none of the additional conditions and restrictions proposed by the Executive should be imposed, the Executive shall authorise the biocidal product in question subject to any conditions and restrictions imposed in the member State in which the biocidal product was first authorised but without imposing the additional conditions and restrictions which it proposed.
Mutual recognition of registrations
12.
- (1) Where a biocidal product has been registered for placing on the market and use under the Directive in a member State, a person may apply to the Executive for registration of that biocidal product for placing on the market and use under this regulation.
(2) Subject to the following paragraphs and to regulation 39(2), within 60 days of the Executive receiving an application in accordance with this regulation, it shall register the biocidal product in question subject to the conditions and restrictions imposed on registration of that biocidal product in the member State where registration was first granted.
(3) Subject to paragraphs (10) to (13), the Executive shall not register a biocidal product under this regulation unless -
(4) Subject to paragraphs (12) and (13), the Executive shall not register a biocidal product under this regulation if it considers that -
the biocidal product cannot be determined according to the relevant requirements in Annexes IIA, IIB, IIIB, IVA and IVB.
(5) Subject to paragraphs (6) and (7), an applicant for registration of a biocidal product under this regulation shall submit with his application -
(6) Where the applicant justifies the omission to the satisfaction of the Executive, the applicant may omit from a dossier submitted in accordance with paragraph (5)(a) information which -
(b) it is not scientifically necessary or technically possible to supply.
(7) The data referred to in paragraph 10 of Schedule 4 may be provided in summary form.
(8) Where the Executive is satisfied that -
it may propose conditions and restrictions relating to the matters referred to in Schedule 5 concerning the placing on the market and the use of the biocidal product in addition to those conditions and restrictions imposed in the member State in which the first registration was granted.
(9) The additional conditions and restrictions proposed pursuant to paragraph (8) shall be such as to ensure -
(10) If the Executive is satisfied that the biocidal product, in respect of which an application has been made under paragraph (1), is not a low-risk biocidal product, it -
(11) If, within 90 days of the Executive communicating its concerns in accordance with paragraph 10(b), the Executive and the competent authority which verified the dossier submitted in support of the application for first registration cannot reach an agreement as to whether a biocidal product is a low-risk biocidal product, the Executive shall notify the Commission of the lack of agreement.
(12) Notwithstanding paragraphs (10) and (11), where, under this regulation the Executive proposes to refuse to register a biocidal product, or to impose conditions or restrictions in addition to those imposed in the member State in which the low-risk biocidal product was first registered, it shall -
(13) Where a Commission decision -
(c) confirms that a registration, which the Executive proposes should be refused or has provisionally refused, should be granted, the Executive shall register the biocidal product in question subject to any conditions and restrictions imposed in the member State in which the biocidal product was first registered;
(d) confirms that none of the additional conditions and restrictions proposed by the Executive should be imposed, the Executive shall register the biocidal product in question subject to any conditions and restrictions imposed in the member State in which the biocidal product was first registered but without imposing the additional conditions and restrictions which it proposed.
Provisional authorisation
13.
- (1) Subject to the following paragraphs, the Executive may authorise, for a period not exceeding three years, a biocidal product for placing on the market and use which contains a new active substance which is not included in Annex I or Annex IA but in respect of which an application has been made to the Executive under regulation 5.
(2) The Executive shall not authorise a biocidal product under paragraph (1) unless -
(3) The Executive shall not authorise a biocidal product under paragraph (1) where -
(4) The Executive shall not authorise a biocidal product under paragraph (1) where the evaluation required by paragraph (2)(a) shows that -
(5) The Executive shall not authorise a biocidal product under paragraph (1) for use by the public, or for placing on the market for use by the public, where that biocidal product is classified as -
(6) Paragraphs (4) to (9) of regulation 9 shall apply in the case of an application for an authorisation under paragraph (1) as they apply in the case of an application for an authorisation under paragraph (1) of that regulation.
(7) In an authorisation granted under paragraph (1), the Executive shall specify -
(b) any other conditions or restrictions subject to which the authorisation is granted.
(8) If, on the expiry of the period for which an authorisation has been granted under paragraph (1), a decision has not been taken concerning the inclusion in Annex I of the new active substance in the biocidal product referred to in that authorisation, the Executive may authorise that biocidal product for placing on the market and use for a further period of one year.
(9) Paragraphs (2) to (7) shall apply in the case of an application for an authorisation under paragraph (8) as they apply in the case of an application for an authorisation under paragraph (1).
(10) The Executive shall inform the Commission and the member States of every authorisation granted in accordance with paragraph (8).
Provisional registration
14.
- (1) Subject to the following paragraphs of this regulation, the Executive may register, for a period not exceeding three years, a biocidal product for placing on the market and use which -
(2) The Executive shall not register a biocidal product under paragraph (1) unless -
(3) The Executive shall not register a biocidal product under paragraph (1) where -
(4) The Executive shall not register a biocidal product under paragraph (1) where the new active substance contained in that biocidal product which is not included in Annex IA -
(5) The Executive shall not register a biocidal product under paragraph (1) where the evaluation required by paragraph (2)(a) shows that -
(6) The Executive shall not register a biocidal product under paragraph (1) for use by the public, or for placing on the market for use by the public, where that biocidal product is classified as toxic or very toxic.
(7) Paragraphs (4)-(10) of regulation 10 shall apply in the case of an application for a registration granted under paragraph (1) as it applies in the case of an application for a registration granted under paragraph (1) of that regulation, and, in the application of this paragraph, a reference to a low-risk biocidal product in paragraphs (4)-(10) of regulation 10 shall be deemed to be a reference to a biocidal product.
(8) In a registration granted under paragraph (1), the Executive shall specify -
(b) any other conditions or restrictions subject to which the registration is granted.
(9) If, on the expiry of the period for which a registration has been granted under paragraph (1), a decision has not been taken concerning the inclusion in Annex IA of the new active substance in the biocidal product referred to in that registration, the Executive may register that biocidal product for placing on the market and use for a further period of one year.
(10) Paragraphs (2) to (8) shall apply to an application for a registration under paragraph (9) as they apply to an application for registration under paragraph (1).
(11) The Executive shall inform the Commission and the member States of every registration granted under paragraph (9).
Emergency authorisation
15.
- (1) Where a person submits an application to the Executive for the authorisation of an unauthorised biocidal product under this regulation, the Executive may authorise, for a period not exceeding 120 days, the placing on the market of an unauthorised biocidal product for a limited and controlled use if such authorisation appears necessary because of an unforeseen danger which cannot be contained by any other means.
(2) The Executive shall immediately inform the Commission and the member States of an authorisation granted in accordance with paragraph (1) and the justification for it.
(3) An authorisation granted under paragraph (1) shall specify such conditions and restrictions relating to the placing on the market and the use of the biocidal product in question as the Executive considers appropriate.
(4) If there is a Commission decision that -
the Executive may extend that period or renew that authorisation.
(5) Where the Executive extends the period of, or renews, an authorisation under paragraph (4), it shall at the same time specify any conditions referred to in the Commission decision subject to which the period may be extended or the authorisation may be renewed, as the case may be.
(6) In this regulation, "unauthorised biocidal product" means a biocidal product which -
Research and development
16.
- (1) This regulation shall not apply to the placing on the market of a relevant product for use in an experiment or test in Northern Ireland which may involve or result in the release into the environment of that relevant product.
(2) A person shall not place on the market a relevant product for use in an experiment or test for the purposes of scientific research and development, or process-orientated research and development, unless that person compiles a dossier containing all available information on the possible effects of the relevant product on human or animal health and on the environment.
(3) A person shall not place on the market a relevant product for use in an experiment or test for the purposes of scientific research and development unless that person draws up and maintains a written record of the following information relating to that relevant product, namely -
(4) A person, who places on the market a relevant product for use in an experiment or test for the purposes of scientific research and development, which is to be conducted in Northern Ireland, shall provide to the Executive on request the written record and dossier relating to that relevant product which he is required to compile and maintain in accordance with paragraphs (2) and (3).
(5) A person, who intends to place on the market a relevant product for use in an experiment or test for the purpose of process-orientated research and development in Northern Ireland, shall provide to the Executive before the relevant product is placed on the market -
(6) If an experiment or test referred to in paragraph (2) or (3) is liable to have harmful effects on human or animal health or an unacceptable adverse influence on the environment, the Executive may -
(7) A person shall not conduct an experiment or test which the Executive has prohibited under paragraph (6)(a).
(8) Where the Executive has imposed conditions regarding the conduct of an experiment or test under paragraph (6)(b), the person conducting the experiment or test shall comply with the conditions, or shall ensure that the conditions are complied with.
(9) In this regulation -
(b) "relevant product" means -
Experimental authorisation
17.
- (1) Subject to the following paragraphs of this regulation, the Executive may authorise a biocidal product, or an active substance intended exclusively for use in a biocidal product, for placing on the market for the purpose of any experiment or test in Northern Ireland which may involve or result in the release into the environment of that biocidal product or active substance, as the case may be.
(2) An authorisation granted under this regulation -
(b) may contain such further conditions, including any conditions necessary to prevent harmful effects on human or animal health or unacceptable adverse influence on the environment, as the Executive considers necessary.
(3) An authorisation granted under this regulation may relate to more than one experiment or test and, if it does so, shall -
(4) An applicant for an authorisation under this regulation shall submit his application to the Executive together with a dossier setting out, in relation to each experiment or test -
(5) Subject to regulation 39(2), the Executive shall assess the information provided by the applicant before deciding whether or not to grant an authorisation under this regulation.
Frame-formulations
18.
- (1) At the same time the Executive grants an authorisation in respect of a biocidal product under regulation 9 or 13, or grants a registration in respect of a biocidal product under regulation 10 or 14 -
issue a frame-formulation which includes that biocidal product and it shall communicate that frame-formulation to that applicant.
(2) Where an application is made under regulation 9, 10, 13 or 14 in respect of a biocidal product within an issued frame-formulation, the Executive shall take that issued frame-formulation into account in evaluating the dossiers submitted with the application in question.
(3) Where a person makes an application for an authorisation under regulation 9 or 13 and that person has a letter of access in respect of the information relating to the biocidal products within an issued frame-formulation, the Executive shall decide whether or not to grant the authorisation within 60 days of its receiving the application.
(4) In this regulation, "issued frame-formulation" means a frame-formulation issued by the Executive in accordance with paragraph (1).
Revocation of authorisations and registrations
19.
- (1) The Executive shall revoke an authorisation granted under regulation 9 or 11 where -
(b) a requirement laid down in Annex I or Annex IA in respect of an active substance in the biocidal product to which the authorisation relates is no longer satisfied.
(2) The Executive shall revoke an authorisation -
(3) The Executive shall revoke an authorisation of a biocidal product for use by the public, or for placing on the market for use by the public, where that biocidal product is classified as -
(4) The Executive shall revoke a registration granted under regulation 10 or 12 where -
(5) The Executive shall revoke a registration granted under regulation 10 if -
(6) The Executive shall revoke a registration granted under regulation 10, 12 or 14 where -
(7) The Executive shall revoke a registration of a biocidal product for use by the public or for placing on the market for use by the public, where that low-risk biocidal product is classified as toxic or very toxic.
(8) The Executive shall revoke an authorisation granted under regulation 13 where there is a Commission decision that an active substance in the biocidal product to which the authorisation relates shall not be included in Annex I, and no decision is made to include that active substance in Annex IA.
(9) The Executive shall revoke a registration granted under regulation 14 where there is a Commission decision that an active substance in the biocidal product to which the registration relates shall not be included in Annex IA.
(10) The Executive shall revoke an authorisation granted under regulation 15 where a Commission decision does not uphold it.
(11) The Executive may revoke an authorisation granted under regulation 17 if the experiment or test in question is liable to have harmful effects on human or animal health or an unacceptable adverse effect on the environment.
(12) The Executive may revoke an authorisation or registration granted under these Regulations at the written request of the holder, who shall state the reasons for that request.
(13) Before revoking an authorisation or a registration, except following a request made in accordance with paragraph (12), the Executive shall -
(b) consider any representations which are duly made and not withdrawn.
(14) Before refusing to revoke an authorisation or a registration following a request made in accordance with paragraph (12), the Executive shall -
(b) consider any representations which are duly made and not withdrawn.
(15) When the Executive revokes -
it may grant a period of grace for the disposal, storage, placing on the market or use of existing stocks of the biocidal product to which the authorisation or the registration relates, or the active substance to which the authorisation relates, as the case may be.
(16) The period of grace referred to in paragraph (15) shall be of a length commensurate with the reason for the revocation, but shall be without prejudice to any period provided for in connection with the removal from Annex I or Annex IA of an active substance in the biocidal product in question or the active substance in question, as the case may be.
(17) In this regulation, "holder" means a person to whom an authorisation or a registration has been granted in accordance with these Regulations.
Modification and review of authorisations and registrations
20.
- (1) The Executive shall modify the conditions of use, subject to which an authorisation or a registration is granted under these Regulations, where it considers that, on the basis of developments in scientific and technical knowledge, such modification is necessary to protect human or animal health or the environment.
(2) Subject to regulation 39(3), the Executive may modify the conditions of use, subject to which an authorisation or a registration is granted under these Regulations, at the written request of the holder, who shall state the reasons for that request.
(3) The Executive may review an authorisation of a biocidal product granted under regulation 9, 11 or 13 or a registration of a biocidal product granted under regulation 10, 12 or 14 at any time if there are indications that -
(4) Where a Commission decision confirms the refusal of a member State to register a biocidal product in respect of which the Executive has granted a registration under regulation 10, if considered appropriate by the Standing Committee, the Executive shall review that registration, taking the refusal of the member State into consideration.
(5) Where the Executive reviews an authorisation or a registration under paragraph (3), or a registration under paragraph (4), the Executive -
(6) Where the Executive requires further information in accordance with paragraph (5), the Executive shall extend the authorisation or registration for the period necessary to enable the holder to provide such information.
(7) In this regulation -
Notification of new information
21.
- (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 -
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 -
(3) A notification made pursuant to paragraph (1) shall include -
(4) The Executive shall immediately notify member States and the Commission of any information it receives by virtue of paragraph (1) relating to -
(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 -
(4) A person shall not use a biocidal product -
(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.
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 -
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 -
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 -
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 -
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 -
(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 -
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 -
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 -
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 -
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 -
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 -
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 -
(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 -
(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 -
as the case may be;
(c) "dossier" includes a summary of a dossier;
(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 -
(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 -
(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 -
(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 -
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 -
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 -
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[21].
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 -
(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 -
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 -
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 -
in connection with the medical treatment of a person who may have been affected by the biocidal product in question.
(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 -
(2) Subject to paragraph (3), a person shall not place on the market an authorised biocidal product unless -
(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 -
Advertisements
33.
- (1) A person who places a biocidal product on the market shall ensure that -
(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.
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 -
(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 -
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 -
(3) The Executive shall, on request, make available to the competent authorities and the Commission -
(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 -
(b) to impose a condition or restriction when granting his application for -
(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);
(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 -
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[22] 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 -
(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 -
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 -
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[23] there shall be substituted the following sub-paragraph -
(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.".
Sealed with the Official Seal of the Department of Enterprise, Trade and Investment on
5th December 2001.
L.S.
Michael J. Bohill
A senior officer of the Department of Enterprise, Trade and Investment
Column 1 | Column 2 |
Product-type | Description |
MAIN GROUP 1 |
Disinfectants and general biocidal products These product-types exclude cleaning products that are not intended to have a biocidal effect, including washing liquids, powders and similar products. |
1
Human hygiene biocidal products |
Products used for human hygiene purposes. |
2
Private area and public health area disinfectants and other biocidal products |
Products (which are not used for direct food or feedingstuff contact) used for the disinfection of air, surfaces, materials, equipment and furniture in private, public and industrial areas, including hospitals, as well as products used as algaecides. Usage areas include swimming pools, aquariums, bathing and other waters; air-conditioning systems; walls and floors in health and other institutions; chemical toilets, waste water, hospital waste, soil or other substrates (in playgrounds). |
3
Veterinary hygiene biocidal products |
Products used for veterinary hygiene purposes including products used in areas in which animals are housed, kept or transported. |
4
Food and feed area disinfectants |
Products used for the disinfection of equipment, containers, consumption utensils, surfaces or pipework associated with the production, transport, storage or consumption of food, feed or drink (including drinking water) for humans and animals. |
5
Drinking water disinfectants |
Products used for the disinfection of drinking water (for both humans and animals). |
MAIN GROUP 2 | Preservatives |
6
In-can preservatives |
Products used for the preservation of manufactured products, other than food or feedingstuff, in containers by the control of microbial deterioration to ensure their shelf life. |
7
Film preservatives |
Products used for the preservation of films or coatings by the control of microbial deterioration in order to protect the initial properties of the surface of materials or objects such as paints, plastics, sealants, wall adhesives, binders, papers, art works. |
8
Wood preservatives |
Products (both preventive and curative) used for the preservation of wood, from and including the saw-mill stage, or wood products by the control of wood-destroying or wood-disfiguring organisms. |
9
Fibre, leather, rubber and polymerised materials preservatives |
Products used for the preservation of fibrous or polymerised materials, such as leather, rubber or paper or textile products and rubber by the control of microbiological deterioration. |
10
Masonry preservatives |
Products used for preservation and remedial treatment of masonry or other construction materials other than wood by the control of microbiological and algal attack. |
11
Preservatives for liquid-cooling and processing systems |
Products used for the preservation of water (other than drinking water) or other liquids used in cooling and processing systems by the control of harmful organisms such as microbes, algae and mussels. |
12
Slimicides |
Products used for the prevention or control of slime growth on materials, equipment and structures, used in industrial processes, such as on wood and paper pulp or porous sand strata in oil extraction. |
13
Metalworking-fluid preservatives |
Products used for the preservation of metalworking fluids by the control of microbial deterioration. |
MAIN GROUP 3 | Pest control |
14
Rodenticides |
Products used for the control of mice, rats or other rodents. |
15
Avicides |
Products used for the control of birds. |
16
Molluscicides |
Products used for the control of molluscs. |
17
Piscicides |
Products used for the control of fish except products for the treatment of fish diseases. |
18
Insecticides, acaricides and products to control other arthropods |
Products used for the control of arthropods (including insects, arachnids and crustaceans). |
19
Repellents and attractants |
Products used to control harmful organisms (invertebrates such as fleas, vertebrates such as birds), by repelling or attracting, including those that are used for human or veterinary hygiene either directly or indirectly. |
MAIN GROUP 4 | Other Biocidal products |
20
Preservatives for food or feedstocks |
Products used for the preservation of food or feedstocks by the control of harmful organisms. |
21
Antifouling products |
Products used to control the growth and settlement of fouling organisms (microbes and higher forms of plant or animal species) on vessels, aquaculture equipment or other structures used in water. |
22
Embalming and taxidermist fluids |
Products used for the disinfection and preservation of human or animal corpses, or parts thereof. |
23
Control of other vertebrates |
Products used for the control of vermin. |
2.
In making the determinations referred to in paragraph 1, the Executive shall have regard to -
3.
The Executive has determined, according to the relevant requirements in Annexes IIA, IIB, IIIA, IIIB, IVA and IVB -
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 -
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.
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 -
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.
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 -
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.
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.
Application of the Health and Safety at Work (Northern Ireland) Order 1978
2.
- (1) Articles -
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 -
(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 -
Offences
3.
A failure to discharge a duty -
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 -
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 -
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 -
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 -
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) -
shall be the district council for the district in which the use occurs.
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 -
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 -
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 -
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.
2.
Subject to paragraphs 3 and 4, where a decision is made under Article 16(2) that -
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 -
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 -
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 -
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 -
the Executive may grant a certificate of exemption in accordance with paragraph 15.
8.
Where -
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 -
the Executive may grant a certificate of exemption in accordance with paragraph 15.
10.
Where -
the Executive may grant a certificate of exemption in accordance with paragraph 15.
11.
Where -
the Executive may grant a certificate of exemption in accordance with paragraph 15.
12.
Where -
the Executive may grant a certificate of exemption in accordance with paragraph 15.
13.
Where -
COPR 1987 shall cease to apply to that COPR biocidal product when that decision takes effect.
14.
The Executive shall -
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 -
16.
An exemption certificate granted in accordance with paragraph 15 -
(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) For the purposes of this Schedule, a person shall be deemed to be engaged in diving operations throughout any period from the time when he commences to prepare for diving until the time when -
and diving operations include the activity of any person in connection with the health and safety of a person who is, or is deemed to be engaged in diving operations.
(4) Any reference in this Schedule to premises and activities (howsoever described) shall include 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) Any offshore installation and any activity on it.
(2) Any activity, including diving operations, in connection with an offshore installation, or any activity which is immediately preparatory thereto, whether carried on from the installation itself, on or from a vessel or in any other manner, other than -
(3) Diving operations involving the survey and preparation of the sea bed for an offshore installation.
(4) Subject to sub-paragraph (5), in this Schedule "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 -
and which is not an excepted structure.
(5) For the purposes of sub-paragraph (4), the excepted structures are -
Wells
3.
- (1) Subject to sub-paragraph (2) -
(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) Any pipeline.
(2) Any pipeline works.
(3) The following activities in connection with pipeline works -
being in either case a vessel which is engaged in pipeline works.
(4) In this paragraph -
but not including a pipeline of which no initial or terminal point is situated in the United Kingdom or within territorial waters, United Kingdom territorial waters adjacent to Great Britain or a designated area;
Mines
5.
- (1) The working of a mine, and work for the purpose of or in connection with the working of any part of a mine.
(2) In this paragraph "mine" and "working of a mine" have the same meaning as in the Mines Act (Northern Ireland) 1969[48].
Other activities
6.
- (1) Subject to sub-paragraph (2) -
(2) Sub-paragraph (1) shall not apply to vessels which are registered outside the United Kingdom and are on passage through territorial waters.
Schedule 1 to these Regulations is based on Annex V of the BP Directive.
The principal provisions are as follows.
3.
These Regulations do not apply to certain biocidal products nor to the carriage of biocidal products by rail, road, inland waterway, sea or air (regulation 3 and Schedule 2).
4.
A person shall not place on the market a new active substance for use in a biocidal product unless an application to the Health and Safety Executive for Northern Ireland ("the Executive") or (under the Great Britain Regulations) to the Ministers, or to a competent authority of a member State of the Communities other than the United Kingdom has been made for inclusion of that new active substance in Annex I, IA or IB of the BP Directive. An application to the Executive must be accompanied by dossiers containing information which the Executive must evaluate, following which it must recommend to the European Commission whether or not an active substance should be included in Annex I, IA or IB of the BP Directive (regulations 4, 5 and 6). (The terms "active substance", "biocidal product", "competent authority", "the Executive", "the Great Britain Regulations", "the Ministers", "new active substance" and "place on the market" are defined in regulation 2(1).
5.
A person shall not place on the market or use a biocidal product unless that biocidal product has been authorised in accordance with the provisions of these Regulations or the Great Britain Regulations. Where a biocidal product is a low-risk biocidal product, then a registration is required. Where a biocidal product contains an active substance which is included in Annex IB of the BP Directive then that biocidal product may only be used in a particular manner (regulation 8). (The term "low-risk biocidal product" is defined in regulation 2(1)).
6.
To obtain an authorisation or a registration under these Regulations, a person must submit an application to the Executive together with the information specified in the Regulations. The Executive may grant a mutual authorisation or registration where another member State has granted an authorisation or a registration in respect of the same biocidal product and the Executive may also grant provisional authorisations and registrations. An authorisation and a registration may be granted subject to conditions (regulations 9 to 14).
7.
The Executive may grant an emergency authorisation where such authorisation appears necessary because of an unforeseen danger (regulation 15).
8.
Provision is made for a biocidal product to be placed on the market for use in tests and experiments, including those involving the release into the environment of a biocidal product (regulations 16 and 17).
9.
The Executive may revoke an authorisation or a registration in certain circumstances. It may also modify the conditions of use subject to which an authorisation or a registration is granted and review an authorisation or a registration (regulations 19 and 20).
10.
Provision is made requiring a person to whom an authorisation or a registration has been granted to notify the Executive of information of which he is aware relating to the biocidal product in question (regulation 21).
11.
The Executive may prohibit or restrict the sale or use of a biocidal product if it considers that the biocidal product constitutes an unacceptable risk to human or animal health or to the environment (regulation 22).
12.
The Executive shall not make use of information submitted to it under the Regulations except in certain circumstances. A person providing information to the Executive may claim confidentiality in respect of that information if he considers that disclosure might harm his industrial or commercial position (regulations 23, 24 and 26).
13.
Provision is made for co-operation between applicants for, and the holders of, authorisations or registrations regarding information relating to biocidal products. Provision is also made for the exchange of information between the Executive and the European Commission and the competent authorities in other member States (regulations 25 and 28).
14.
The person responsible for first placing a biocidal product on the market is responsible for providing information to the Poisons Information Service. The information may only be disclosed for the purposes of medical treatment of a person affected by the biocidal product (regulation 29).
15.
The Regulations impose obligations concerning the packaging, labelling and advertisement of a biocidal product (regulations 30, 31 and 33).
16.
An application for an authorisation or a registration of a biocidal product is to be made by, or on behalf of, the person who first places the biocidal product on the market. An applicant must have a permanent office within the Community and the application must be in English (regulation 34).
17.
The Executive must ensure that a file is kept in respect of every application for an authorisation or a registration made under the Regulations (regulation 35).
18.
There is a right of appeal for any person aggrieved by certain decisions of the Executive made under the Regulations (regulation 36).
19.
Provision is made for the enforcement of the Regulations, for the payment of fees and for transitional measures (regulations 38, 39 and 41 and Schedules 10, 11 and 13).
20.
Regulation 42(2) amends the Notification of New Substances Regulations (Northern Ireland) 1994 (S.R. 1994 No. 6) by amending the disapplication in respect of plant protection products to include pesticides and adding a disapplication in respect of biocidal products, thereby implementing the 2000 Directive.
21.
In Great Britain the corresponding Regulations are The Biocidal Products Regulations 2001 (S.I. 2001/880) and the Notification of New Substances (Amendment) Regulations 2001 (S.I. 2001/1055). The Great Britain Health and Safety Executive has prepared a regulatory impact assessment in respect of those Regulations and a copy of that assessment, together with a Northern Ireland supplement prepared by the Health and Safety Executive for Northern Ireland, is held at the offices of that Executive at 83 Ladas Drive, Belfast BT6 9FR from where copies may be obtained.
[2] S.I. 1981/1536 and S.I. 1999/2788back
[4] See Article 2(2) of S.I. 1978/1039 (N.I. 9)back
[5] S.I. 1978/1039 (N.I. 9)back
[6] Article 13(1A) was substituted by S.I. 1998/2795 (N.I. 18), Article 4back
[7] Article 46(3) was amended by S.I. 1998/2795 (N.I. 18), Article 6(1) and Schedule 1, paragraphs 8 and 18back
[8] S.R. 1995 No. 60, amended by S.R. 1996 No. 376, S.R. 1997 No. 398, S.R. 1998 No. 459, S.R. 1999 No. 150, S.R. 1999 No. 303 and S.R. 2001 No.168back
[9] O.J. No. L123, 24.4.98, p.1back
[12] A copy of the European Inventory of Existing Chemical Substances may be obtained from the European Communities Information Office, 8 Storey's Gate, London SW1P 3ATback
[14] O.J. No. L214, 24.8.93, p. 1back
[15] 1968 c. 67; section 58B was added by the Medicines Act 1968 (Amendment) (No. 2) Regulations 1992 (S.I. 1992/3271)back
[16] S.I. 1994/3142, to which there are amendments not relevant to these Regulationsback
[17] S.I. 1994/2987, to which there are amendments not relevant to these Regulationsback
[18] S.R. 1995 No. 371, as amended by S.R. 1996 No. 456, S.R. 1997 No. 471, S.R. 1997 No. 507, S.R. 1999 No. 57 and S.R. 1999 No. 282back
[19] 1985 c. 48, as amended by 1989 c. 27 and 1998 c. 26back
[20] S.R. 1987 No. 414, as amended by S.R. 1991 No. 203 and S.R. 1997 No. 469back
[21] S.R. 1993 No. 45, as amended by S.R. 1998 No. 238back
[23] S.R. 1994 No. 6, to which there are amendments not relevant to these Regulationsback
[24] S.R. 1995 No. 371, as amended by S.R. 1996 No. 456, S.R. 1997 No. 471, S.R. 1997 No. 507, S.R. 1999 No. 57 and S.R. 1999 No. 282back
[25] S.R. 1987 No. 414, as amended by S.R. 1991 No. 203 and S.R. 1997 No. 469back
[26] S.R. 1987 No. 432, as amended by S.R. 1994 No. 174back
[27] S.R. 1992 No. 416, as amended by S.R. 1994 No.270back
[28] S.R. 1992 No. 417, as amended by S.R. 1996 Nos. 48, 49 and 50back
[29] S.I. 1992/3146, amended by S.I. 1995/1671back
[31] S.I. 1994/105, to which there are amendments not relevant to these Regulationsback
[33] S.I. 1994/3142, to which there are amendments not relevant to these Regulationsback
[34] S.I. 1994/3144, to which there are amendments not relevant to these Regulationsback
[35] S.R. 1995 No. 201, as amended by S.R. 1995 No. 260, S.R. 1996 No.287 and S.R.1998 No.359back
[36] S.R.1995 No. 371, as amended by S.R. 1996 No. 456, S.R.1997 No. 471, S.R. 1997 No. 507, S.R. 1999 No. 57 and S.R. 1999 No.282back
[37] S.R. 1995 No. 451, as amended by S.R. 1996 No. 259back
[38] S.R. 1996 No. 50, as amended by S.R. 1997 No. 340 and S.R. 1999 No. 244back
[40] S.I. 1997/322, to which there are amendments not relevant to these Regulationsback
[41] S.R. 1998 No. 207, as amended by S.R. 1999 Nos. 83 and 285back
[44] S.R. 1995 No. 60, as amended by S.R. 1996 No. 376, S.R. 1997 No. 398, S.R. 1998 No. 459, S.R. 1999 No. 150, S.R. 1999 No. 303 and S.R. 2001 No. 168back
[45] S.R. 1999 No. 90, as amended by S.R. 2000 No. 375back
[46] S.R. 1987 No. 414, as amended by S.R. 1991 No. 203 and S.R. 1997 No. 469back
[47] 1964 c. 29; section 1 was amended by the Oil and Gas (Enterprise) Act 1982 (1982 c. 23), Schedule 3, paragraph 1back