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Biocidal Products Regulations (Northern Ireland) 2001

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Regulation 2(1)

SCHEDULE 1Biocidal product-types and their descriptions

Column 1Column 2
Product-typeDescription
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 2Preservatives

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 3Pest 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 4Other 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.

Regulation 3(1)

SCHEDULE 2Regulations 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(1);

(b)the Flavourings in Food Regulations (Northern Ireland) 1992(2);

(c)the Food Additive Labelling Regulations (Northern Ireland) 1992(3);

(d)the Active Implantable Medical Devices Regulations 1992(4);

(e)the Egg Products Regulations (Northern Ireland) 1993(5);

(f)the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994(6);

(g)the Medical Devices Regulations 1994(7);

(h)the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994(8);

(i)the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994(9);

(j)the Dairy Products (Hygiene) Regulations (Northern Ireland) 1995(10);

(k)the Plant Protection Products Regulations (Northern Ireland) 1995(11);

(l)the Feeding Stuffs Regulations (Northern Ireland) 1995(12);

(m)the Miscellaneous Food Additives Regulations (Northern Ireland) 1996(13);

(n)the Cosmetic Products (Safety) Regulations 1996(14);

(o)the Registration of Homoeopathic Veterinary Medicinal Products Regulations 1997(15);

(p)the Food Safety (Fishery Products and Live Shellfish) (Hygiene) Regulations (Northern Ireland) 1998(16);

(q)the Medicated Feedingstuffs Regulations 1998(17);

(r)the Feedingstuffs (Zootechnical Products) Regulations 1999(18).

Regulations 9(2), (6) and (10), 10(2), (6) and (11), 11(4) and (7), 12(4) and (9), 13(2) and (7), 14(2) and (8), 19(2) and (6) and 20(3) and Schedules 6 and 7

SCHEDULE 3Determinations 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;

(c)all normal conditions under which the biocidal product may be used;

(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.

Regulations 10(4) and 12(5) and (7)

SCHEDULE 4Information 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 (19), a safety data sheet for that biocidal product prepared in accordance with regulation 6 of those Regulations.

Regulations 11(6) and 12(8)

SCHEDULE 5Matters 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

(c)application and the next access by humans or animals to the area where the biocidal product has been used,

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.

Regulation 26(6)

SCHEDULE 6Non-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

(c)where applicable, any ability to promote resistance,

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.

Regulation 28(1)

SCHEDULE 7Information 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.

Regulation 29(2) and (7)

SCHEDULE 8Information 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

(c)the individual to be contacted in an emergency in the event of an individual being affected by the biocidal product.

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.

Regulation 31(2) and (3)

SCHEDULE 9Information 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

(c)application and the next access by humans or animals to the area where the biocidal product has been used,

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.

Regulation 38

SCHEDULE 10Enforcement, offences and civil liability

Interpretation

1.  In this Schedule—

“the 1999 Regulations” means the Health and Safety (Enforcing Authority) Regulations (Northern Ireland) 1999(20);

“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

(c)43(2) (civil liability),

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

(c)a breach of the Regulations and serious harm to the environment.

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.

Regulation 39(1), (2) and (3)

SCHEDULE 11Fees

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;

(c)dossiers referred to in paragraph 4;

(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

(c)paid by the applicant or that person forthwith.

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.

Regulations 3(2), 36(2) and 40

SCHEDULE 12Transitional Provisions

1.  In this Schedule—

“COPR 1987” means the Control of Pesticides Regulations (Northern Ireland) 1987(21);

“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

(c)such refusal is upheld by a Commission decision,

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;

(c)advertisements;

(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

(c)shall be granted for a period not exceeding three years.

Regulation 41

SCHEDULE 13Application 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(22) and “within a designated area” includes over and under it;

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

“stand-by vessel” means a vessel which is ready to give assistance in the event of an emergency on or near an offshore installation;

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

(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—

(a)he is no longer subjected to raised pressure;

(b)he has normal inert gas partial pressure in his tissues; and

(c)if he entered the water, he has left it,

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—

(a)transporting, towing or navigating the installation; and

(b)any activity on or from a vessel being used as a stand-by vessel.

(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—

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

(b)for the storage of gas in or under the shore or bed of any water or the recovery of gas so stored;

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

(d)mainly for the provision of accommodation for persons who work on or from a structure falling within any of the provisions of this sub-paragraph,

and which is not an excepted structure.

(5) For the purposes of sub-paragraph (4), the excepted structures are—

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

(b)a well;

(c)a structure which has ceased to be used for any of the purposes specified in sub-paragraph (4) and has since been used for a purpose not so specified;

(d)a mobile structure which has been taken out of use and is not for the time being intended to be used for any of the purposes specified in sub-paragraph (4); and

(e)any part of a pipeline.

Wells

3.  (1)  Subject to sub-paragraph (2)—

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

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

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

Pipelines

4.  (1)  Any pipeline.

(2) Any pipeline works.

(3) The following activities in connection with pipeline works—

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

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

being in either case a vessel which is engaged in pipeline works.

(4) In this paragraph—

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

    (a)

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

    (b)

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

    (c)

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

    (d)

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

    (e)

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

    (f)

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

    (g)

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

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

  • “pipeline works” means—

    (a)

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

    (b)

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

    (c)

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

    (d)

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

    (e)

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

    (f)

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

Mines

5.  (1)  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(23).

Other activities

6.  (1)  Subject to sub-paragraph (2)—

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

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

(c)diving operations;

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

(e)the maintaining on a station of a vessel which would be an offshore installation were it not a structure to which paragraph 2(5)(d) relates.

(2) Sub-paragraph (1) shall not apply to vessels which are registered outside the United Kingdom and are on passage through territorial waters.

(1)

S.R. 1987 No. 432, as amended by S.R. 1994 No. 174

(2)

S.R. 1992 No. 416, as amended by S.R. 1994 No.270

(3)

S.R. 1992 No. 417, as amended by S.R. 1996 Nos. 48, 49 and 50

(4)

S.I. 1992/3146, amended by S.I. 1995/1671

(5)

S.R. 1993 No. 329

(6)

S.I. 1994/105, to which there are amendments not relevant to these Regulations

(7)

S.I. 1994/3017

(8)

S.I. 1994/3142, to which there are amendments not relevant to these Regulations

(9)

S.I. 1994/3144, to which there are amendments not relevant to these Regulations

(10)

S.R. 1995 No. 201, as amended by S.R. 1995 No. 260, S.R. 1996 No.287 and S.R.1998 No.359

(11)

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.282

(12)

S.R. 1995 No. 451, as amended by S.R. 1996 No. 259

(13)

S.R. 1996 No. 50, as amended by S.R. 1997 No. 340 and S.R. 1999 No. 244

(14)

S.I. 1996/2925

(15)

S.I. 1997/322, to which there are amendments not relevant to these Regulations

(16)

S.R. 1998 No. 207, as amended by S.R. 1999 Nos. 83 and 285

(17)

S.I. 1998/1046

(18)

S.I. 1999/1871

(19)

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. 168

(20)

S.R. 1999 No. 90, as amended by S.R. 2000 No. 375

(21)

S.R. 1987 No. 414, as amended by S.R. 1991 No. 203 and S.R. 1997 No. 469

(22)

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

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