LegalizeThe Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 2015
| Containment Measures | Containment Levels | Containment Levels | Containment Levels | Containment Levels | |
|---|---|---|---|---|---|
| Containment Measures | 1 | 2 | 3 | 4 | |
| (1)“isolation” means, in relation to a laboratory, separation of the laboratory from other areas in the same building, or being in a separate building. | (1)“isolation” means, in relation to a laboratory, separation of the laboratory from other areas in the same building, or being in a separate building. | (1)“isolation” means, in relation to a laboratory, separation of the laboratory from other areas in the same building, or being in a separate building. | (1)“isolation” means, in relation to a laboratory, separation of the laboratory from other areas in the same building, or being in a separate building. | (1)“isolation” means, in relation to a laboratory, separation of the laboratory from other areas in the same building, or being in a separate building. | (1)“isolation” means, in relation to a laboratory, separation of the laboratory from other areas in the same building, or being in a separate building. |
| (2)Entry must be through an airlock which is a chamber isolated from the laboratory. The clean side of the airlock must be separated from the restricted side by changing or showering facilities and preferably by interlocking doors. | (2)Entry must be through an airlock which is a chamber isolated from the laboratory. The clean side of the airlock must be separated from the restricted side by changing or showering facilities and preferably by interlocking doors. | (2)Entry must be through an airlock which is a chamber isolated from the laboratory. The clean side of the airlock must be separated from the restricted side by changing or showering facilities and preferably by interlocking doors. | (2)Entry must be through an airlock which is a chamber isolated from the laboratory. The clean side of the airlock must be separated from the restricted side by changing or showering facilities and preferably by interlocking doors. | (2)Entry must be through an airlock which is a chamber isolated from the laboratory. The clean side of the airlock must be separated from the restricted side by changing or showering facilities and preferably by interlocking doors. | (2)Entry must be through an airlock which is a chamber isolated from the laboratory. The clean side of the airlock must be separated from the restricted side by changing or showering facilities and preferably by interlocking doors. |
| (3)Where viruses are not retained by the HEPA filters, extra requirements will be necessary for extract air. | (3)Where viruses are not retained by the HEPA filters, extra requirements will be necessary for extract air. | (3)Where viruses are not retained by the HEPA filters, extra requirements will be necessary for extract air. | (3)Where viruses are not retained by the HEPA filters, extra requirements will be necessary for extract air. | (3)Where viruses are not retained by the HEPA filters, extra requirements will be necessary for extract air. | (3)Where viruses are not retained by the HEPA filters, extra requirements will be necessary for extract air. |
| (4)Where the autoclave is outside the laboratory in which the contained use is being undertaken, but within the laboratory suite, there must be validated procedures for the safe transfer of material into that autoclave, which provide a level of protection equivalent to that which would be achieved by having an autoclave in that laboratory. | (4)Where the autoclave is outside the laboratory in which the contained use is being undertaken, but within the laboratory suite, there must be validated procedures for the safe transfer of material into that autoclave, which provide a level of protection equivalent to that which would be achieved by having an autoclave in that laboratory. | (4)Where the autoclave is outside the laboratory in which the contained use is being undertaken, but within the laboratory suite, there must be validated procedures for the safe transfer of material into that autoclave, which provide a level of protection equivalent to that which would be achieved by having an autoclave in that laboratory. | (4)Where the autoclave is outside the laboratory in which the contained use is being undertaken, but within the laboratory suite, there must be validated procedures for the safe transfer of material into that autoclave, which provide a level of protection equivalent to that which would be achieved by having an autoclave in that laboratory. | (4)Where the autoclave is outside the laboratory in which the contained use is being undertaken, but within the laboratory suite, there must be validated procedures for the safe transfer of material into that autoclave, which provide a level of protection equivalent to that which would be achieved by having an autoclave in that laboratory. | (4)Where the autoclave is outside the laboratory in which the contained use is being undertaken, but within the laboratory suite, there must be validated procedures for the safe transfer of material into that autoclave, which provide a level of protection equivalent to that which would be achieved by having an autoclave in that laboratory. |
| Facilities | Facilities | Facilities | Facilities | Facilities | Facilities |
| 1 | Laboratory suite: isolation[^f01000] | not required | not required | required | required |
| 2 | Laboratory: sealable for fumigation | not required | not required | required | required |
| Equipment | Equipment | Equipment | Equipment | Equipment | Equipment |
| 3 | Surfaces impervious to water, resistant to acids, alkalis, solvents, disinfectants and decontam-ination agents and easy to clean | required for any bench | required for any bench | required for any bench and floor | required for any bench, floor, ceiling and walls |
| 4 | Entry to laboratory via airlock[^f01001] | not required | not required | required where and to extent the risk assessment shows it is required | required |
| 5 | Negative pressure relative to the pressure of the immediate surroundings | not required | not required | required except for activities where transmission does not occur by the airborne route | required |
| 6 | Extract and input air from the laboratory must be HEPA filtered | not required | not required | HEPA filters required for extract air except for activities where transmission does not occur by the airborne route | HEPA filters required for input and extract air[^f01002] |
| 7 | Micro-biological safety cabinet /enclosure | not required | required where and to extent the risk assessment shows it is required | required, and all procedures with infective materials required to be contained within a cabinet/ enclosure | required,and all procedures with infective materials required to be contained within a cabinet/enclosure |
| 8 | Autoclave | required on site | required in the building | required in the laboratory suite[^f01003] | double ended autoclave required in laboratory |
| System of work | System of work | System of work | System of work | System of work | System of work |
| 9 | Access restricted to authorised personnel only | not required | required | required | required (via airlock key procedure) |
| 10 | Biohazard sign on door | not required | required | required | required |
| 11 | Specific measures to control aerosol dissem-ination | not required | required so as to minimise | required so as to prevent | required so as to prevent |
| 12 | Shower | not required | not required | required where and to extent the risk assessment shows it is required | required |
| 13 | Protective clothing | suitable protective clothing required | suitable protective clothing required | suitable protective clothing required; footwear required where and to extent the risk assessment shows it is required | complete change of clothing and footwear required before entry and exit |
| 14 | Gloves | not required | required where and to extent the risk assessment shows they are required | required | required |
| 15 | Efficient control of disease vectors (e.g. rodents and insects) which could disseminate GMMs | required where and to extent the risk assessment shows it is required | required | required | required |
| Waste | Waste | Waste | Waste | Waste | Waste |
| 16 | Inactivation of GMMs in effluent from hand-washing sinks and showers and similar effluents | not required | not required | required where and to extent the risk assessment shows it is required | required |
| 17 | Inactivation of GMMs in contaminated material and waste | required by validated means where and to extent the risk assessment shows it is required | required by validated means | required by validated means, with waste inactivated within the laboratory suite | required by validated means, with waste inactivated within the laboratory |
| Other measures | Other measures | Other measures | Other measures | Other measures | Other measures |
| 18 | Laboratory to contain its own equipment | not required | not required | required, so far as is reasonably practicable | required |
| 19 | An observation window or alternative is to be present so that occupants can be seen | required where and to extent the risk assessment shows it is required | required where and to extent the risk assessment shows it is required | required where and to extent the risk assessment shows it is required | required |
| 20 | Safe storage of GMMs | required where and to extent the risk assessment shows it is required | required | required | secure storage required |
| 21 | Written records of staff training | not required | required where and to extent the risk assessment shows it is required | required | required |
| Containment Measures | Containment Levels | Containment Levels | Containment Levels | Containment Levels | |
| --- | --- | --- | --- | --- | --- |
| Containment Measures | 1 | 2 | 3 | 4 | |
| (1)A permanent structure refers to a fixed structure with walls, a roof and a floor. Where the permanent structure is a greenhouse, that structure shall also have a continuous waterproof covering and self-closing lockable outer doors, and be located on a site designed to prevent the entry of surface run-off water. | (1)A permanent structure refers to a fixed structure with walls, a roof and a floor. Where the permanent structure is a greenhouse, that structure shall also have a continuous waterproof covering and self-closing lockable outer doors, and be located on a site designed to prevent the entry of surface run-off water. | (1)A permanent structure refers to a fixed structure with walls, a roof and a floor. Where the permanent structure is a greenhouse, that structure shall also have a continuous waterproof covering and self-closing lockable outer doors, and be located on a site designed to prevent the entry of surface run-off water. | (1)A permanent structure refers to a fixed structure with walls, a roof and a floor. Where the permanent structure is a greenhouse, that structure shall also have a continuous waterproof covering and self-closing lockable outer doors, and be located on a site designed to prevent the entry of surface run-off water. | (1)A permanent structure refers to a fixed structure with walls, a roof and a floor. Where the permanent structure is a greenhouse, that structure shall also have a continuous waterproof covering and self-closing lockable outer doors, and be located on a site designed to prevent the entry of surface run-off water. | (1)A permanent structure refers to a fixed structure with walls, a roof and a floor. Where the permanent structure is a greenhouse, that structure shall also have a continuous waterproof covering and self-closing lockable outer doors, and be located on a site designed to prevent the entry of surface run-off water. |
| Facilities | Facilities | Facilities | Facilities | Facilities | Facilities |
| 1 | Permanent structure[^f01004] | required where and to extent the risk assessment shows it is required | required | required | required |
| Equipment | Equipment | Equipment | Equipment | Equipment | Equipment |
| 2 | Entry via a separate room with two interlocking doors | not required | required where and to extent the risk assessment shows it is required | required where and to extent the risk assessment shows it is required | required (via airlock key procedure) |
| 3 | Control of contaminated run-off water | required where and to extent the risk assessment shows it is required | required so as to minimise run-off | required so as to prevent run-off | required so as to prevent run-off |
| System of work | System of work | System of work | System of work | System of work | System of work |
| 4 | Effective control of disease vectors such as insects, rodents and arthropods which could disseminate GMMs | required | required | required | required |
| 5 | Effective control of pollen, seeds and other plant material which could disseminate GMMs | required where and to extent the risk assessment shows it is required | required so as to minimise dissem-ination | required so as to prevent dissem-ination | required so as to prevent dissem-ination |
| 6 | Procedures for transfer of living material between the plant growth facilities, protective structure and laboratory shall control dissemination of GMMs | required so as to minimise dissem-ination | required so as to minimise dissem-ination | required so as to prevent dissem-ination | required so as to prevent dissem-ination |
| Containment Measures | Containment Levels | Containment Levels | Containment Levels | Containment Levels | |
| --- | --- | --- | --- | --- | --- |
| Containment Measures | 1 | 2 | 3 | 4 | |
| (1)“animal unit” means a building, or separate area within a building, containing an animal facility and other areas including changing rooms, showers, autoclaves and food storage areas. | (1)“animal unit” means a building, or separate area within a building, containing an animal facility and other areas including changing rooms, showers, autoclaves and food storage areas. | (1)“animal unit” means a building, or separate area within a building, containing an animal facility and other areas including changing rooms, showers, autoclaves and food storage areas. | (1)“animal unit” means a building, or separate area within a building, containing an animal facility and other areas including changing rooms, showers, autoclaves and food storage areas. | (1)“animal unit” means a building, or separate area within a building, containing an animal facility and other areas including changing rooms, showers, autoclaves and food storage areas. | (1)“animal unit” means a building, or separate area within a building, containing an animal facility and other areas including changing rooms, showers, autoclaves and food storage areas. |
| (2)“animal facility” means a facility normally used to house stock, breeding or experimental animals or one which is used for the performance of minor surgical procedures on animals. | (2)“animal facility” means a facility normally used to house stock, breeding or experimental animals or one which is used for the performance of minor surgical procedures on animals. | (2)“animal facility” means a facility normally used to house stock, breeding or experimental animals or one which is used for the performance of minor surgical procedures on animals. | (2)“animal facility” means a facility normally used to house stock, breeding or experimental animals or one which is used for the performance of minor surgical procedures on animals. | (2)“animal facility” means a facility normally used to house stock, breeding or experimental animals or one which is used for the performance of minor surgical procedures on animals. | (2)“animal facility” means a facility normally used to house stock, breeding or experimental animals or one which is used for the performance of minor surgical procedures on animals. |
| (3)“isolators” means transparent boxes where small animals are contained within or outside a cage; for large animals, isolated rooms may be more appropriate. | (3)“isolators” means transparent boxes where small animals are contained within or outside a cage; for large animals, isolated rooms may be more appropriate. | (3)“isolators” means transparent boxes where small animals are contained within or outside a cage; for large animals, isolated rooms may be more appropriate. | (3)“isolators” means transparent boxes where small animals are contained within or outside a cage; for large animals, isolated rooms may be more appropriate. | (3)“isolators” means transparent boxes where small animals are contained within or outside a cage; for large animals, isolated rooms may be more appropriate. | (3)“isolators” means transparent boxes where small animals are contained within or outside a cage; for large animals, isolated rooms may be more appropriate. |
| Facilities | Facilities | Facilities | Facilities | Facilities | Facilities |
| 1 | Isolation of animal unit[^f01005] | required where and to extent the risk assessment shows it is required | required | required | required |
| 2 | Animal facilities[^f01006] separated by lockable doors | required where and to extent the risk assessment shows it is required | required | required | required |
| 3 | Animal facilities (cages, etc.) designed to facilitate decontamin-ation (waterproof and easily washable material) | required where and to extent the risk assessment shows it is required | required where and to extent the risk assessment shows it is required | required | required |
| 4 | Floor, walls and ceiling easily washable | required where and to extent the risk assessment shows it is required | required for floor | required for floor and walls | required for floor, walls and ceiling |
| 5 | Appropriate filters on isolators or isolated rooms[^f01007] | not required | required where and to extent the risk assessment shows it is required | required | required |
| 6 | Appropriate barriers at the room exit, and at drains or ventilation duct work | required | required | required | required |
| 7 | Animals kept in appropriate containment facilities, such as cages, pens or tanks but not isolators | required where and to extent the risk assessment shows it is required | required where and to extent the risk assessment shows it is required | required where and to extent the risk assessment shows it is required | required where and to extent the risk assessment shows it is required |
| 8 | Animals kept in isolators | not required | required where and to extent the risk assessment shows it is required | required | required |
| Containment Measures | Containment Levels | Containment Levels | Containment Levels | Containment Levels | |
| --- | --- | --- | --- | --- | --- |
| Containment Measures | 1 | 2 | 3 | 4 | |
| General | General | General | General | General | General |
| 1 | Viable micro-organisms shall be contained in a system which separates the process from the workplace and wider environment (closed system) | required where and to extent the risk assessment shows it is required | required | required | required |
| 2 | Closed systems located within a controlled area | not required | required where and to extent the risk assessment shows it is required | required | required |
| 3 | Control of exhaust gases from the closed system | not required | required so as to minimise release | required so as to prevent release | required so as to prevent release |
| 4 | Control of aerosols during sample collection, addition of material to a closed system or transfer of material to another closed system | required where and to extent the risk assessment shows it is required | required so as to minimise release | required so as to prevent release | required so as to prevent release |
| 5 | Inactivation of bulk culture fluids before removal from the closed system | required where and to extent the risk assessment shows it is required | required by validated means | required by validated means | required by validated means |
| 6 | Seals shall be designed so as to minimise or prevent release | not required | required so as to minimise release | required so as to prevent release | required so as to prevent release |
| 7 | The controlled area designed to contain spillage of the entire contents of the closed system | required where and to extent the risk assessment shows it is required | required where and to extent the risk assessment shows it is required | required | required |
| 8 | The controlled area sealable to permit fumigation | not required | required where and to extent the risk assessment shows it is required | required where and to extent the risk assessment shows it is required | required |
| 9 | Biohazard signs posted | not required | required | required | required |
| Equipment | Equipment | Equipment | Equipment | Equipment | Equipment |
| 10 | Entry via airlock | not required | not required | required where and to extent the risk assessment shows it is required | required |
| 11 | Surfaces resistant to water, acids, alkalis, solvents, disinfectants and decontamination agents and easy to clean | required for any bench | required for any bench | required for any bench and floor | required for any bench, floor, ceilings and walls |
| 12 | Specific measures to ventilate adequately the controlled areas in order to minimise air contamination | required where and to extent the risk assessment shows they are required | required where and to extent the risk assessment shows they are required | required where and to extent the risk assessment shows they are required | required |
| 13 | The controlled area maintained at an air pressure negative to the immediate surroundings | not required | not required | required where and to extent the risk assessment shows it is required | required |
| 14 | Extract and input air from the controlled area must be HEPA filtered | not required | not required | required for extract air; required where and to extent the risk assessment shows they are required for input air | required for input and extract air |
| System of work | System of work | System of work | System of work | System of work | System of work |
| 15 | Access restricted to authorised personnel only | not required | required | required | required |
| 16 | Personnel must shower before leaving the controlled area | not required | not required | required where and to extent the risk assessment shows it is required | required |
| 17 | Personnel shall wear protective clothing | work clothing required | work clothing required | required | complete change required before exit and entry |
| 18 | Written procedures and records of staff training | not required | required where and to extent the risk assessment shows they are required | required | required |
| Waste | Waste | Waste | Waste | Waste | Waste |
| 19 | Inactivation of GMMs in effluent from hand-washing sinks and showers or similar effluents | not required | not required | required where and to extent the risk assessment shows it is required | required |
| 20 | Inactivation of GMMs in contaminated material and waste including those in process effluent before final discharge | required by validated means where and to extent the risk assessment shows it to be required | required by validated means | required by validated means | required by validated means |
Signed
Sealed with the Official Seal of the Department of Enterprise, Trade and Investment on 18th September 2015.
J Kerr — A senior officer of the Department of Enterprise, Trade and Investment
Explanatory note
(This note is not part of the Order)
EXPLANATORY NOTE
1 These Regulations consolidate, revoke and replace the Genetically Modified Organisms (Contained Use) Regulations (Northern Ireland) 2001 (S.R. 2001 No.295) and its amending instruments (S.R. 2006 No.524, S.R. 2010 No.343). The Regulations implement Directive EC No 2009/41 (O.J. L 125 21.5.2009 p. 75) which lays down measures for the contained use of genetically modified micro-organisms with a view to protecting human health and the environment. Section 2(2) of the European Communities Act 1972 is used to implement the aspects of the Directive which relate to protection of the environment. The Regulations also apply to the contained use of genetically modified organisms that are not micro-organisms, known as larger GMOs, but only in relation to risks to human health. Larger GMOs are not covered by the Directive.
2 Contained use includes any activity or other action (for example storage) involving a genetically modified organism within a controlled environment where there are physical barriers and/or other controls in place to ensure that any genetically modified organism is not released into the environment. Certain techniques are or are not regarded as genetic modification and the Regulations do not apply to genetically modified organisms in a number of circumstances, for example, where there is a consent for use under other legislation. Some of the regulations are disapplied to genetically modified organisms when they are being transported (regulation 3 and Schedule 2).
3 The Regulations impose duties on people who are undertaking or proposing to undertake contained use (users) and persons responsible for contained use. These are people who either have the authority to determine whether contained use can take place, or people with control over the planning or conduct of the contained use. The competent authority is the Department of the Environment and the Health and Safety Executive for Northern Ireland acting jointly.
4 The meaning of some terms within the Health and Safety at Work (Northern Ireland) Order 1978 is modified so that the Regulations apply to educational institutions as if they were workplaces and students as if they were employees of the educational institution. They also apply to any person who is not an employee undertaking contained use (except a student) as if they were self-employed within the meaning of that Order (regulation 4).
5 Before contained use involving micro-organisms can commence, a person responsible for the contained use must ensure that an assessment of the risks to human health and the environment has been carried out. The person carrying out the risk assessment must classify the contained use (from class 1 to class 4) depending on the seriousness of the risks posed, with 4 being the highest risk (regulation 5, Schedule 1 and Schedule 3). Contained use involving larger GMOs cannot commence until the person responsible has ensured that an assessment is carried out in relation to risks to human health (regulation 6 and Schedule 4) although there is no requirement to assign a class of use. There are specific requirements relating to the review, recording and keeping of risk assessments (regulation 7). A person responsible for contained use must obtain advice on the risk assessment either from an individual or a genetic modification safety committee with relevant expertise (regulation 8).
6 Before premises are used for the first time, for contained use, a person responsible for the first contained use must notify the competent authority and provide information specified by regulation 9 and Schedule 5. One notification can include more than one premises.
7 Before class 2 contained use can commence, a person responsible for the contained use must notify the competent authority of the contained use and provide information specified in Schedule 6 (regulation 10). A period of time must then elapse before contained use can begin. Class 3 or 4 contained use cannot commence unless the competent authority has given consent for the contained use. A person responsible must submit a notification for the contained use and provide the information specified in Schedule 6. Consent must be notified within a specified period that is dependent on whether the notifier already has consent for class 3 or class 4 contained use (regulation 11).
8 Before contained use can commence involving a larger GMO (and the contained use will result in a more hazardous organism than its parent organism) a person responsible for that contained use must notify the competent authority of that contained use and provide the information specified in Schedule 6 (regulation 12).
9 In certain circumstances the competent authority may accept single notifications for a connected programme of work or contained use at more than one premises (regulation 13). There are various duties to notify the competent authority of changes of circumstances and changes that affect risks (regulations 14 and 15).
10 If the competent authority asks for further information about a notification, the contained use must not commence or continue, except to store or destroy the genetically modified organisms, until the competent authority has agreed in writing that it may (regulation 16). A notifier may withdraw their application as long as the contained use has not commenced (regulation 17).
11 Users are required to ensure that occupational and environmental safety principles are observed (Schedule 7) and that risks are kept to the lowest level reasonably practicable (regulation 18).
12 A user carrying out contained use involving genetically modified micro-organisms is required to apply the containment measures which are appropriate to that contained use in accordance with the risk assessment. The containment measures are classified into different containment levels which largely correspond with the class assigned to the contained use, with level 4 being the highest level of containment. The measures are set out in Schedule 8 (regulation 19). A user carrying out contained use involving a larger GMO must apply the containment measures applicable in accordance with the risk assessment for that contained use (regulation 20).
13 Where a risk assessment shows it is warranted, an emergency plan must be prepared before contained use can commence. In the case of genetically modified micro-organisms the plan must address risks to human health and the protection of the environment, in the case of larger GMOs the plan need only address human health, (regulation 21). If an accident occurs the person responsible for the contained use must notify the competent authority immediately and provide specified information (regulation 22).
14 The competent authority is placed under a duty to examine a notification submitted to it under regulations 9(2), 10(2), 11(2) and 12(2) (regulation 23) and the Executive may ask the notifier for additional information on behalf of the competent authority (regulation 24). The competent authority has power to impose time limits or conditions on contained use, to suspend or terminate contained use or require that the contained use is not commenced. The competent authority may also vary or revoke any consent previously granted under regulation 11 (regulation 25). The competent authority may grant an exemption from the requirements of the Regulations but only if it is satisfied that the health and safety of persons and the environment are not prejudiced by the granting of an exemption (regulation 26).
15 The competent authority is to maintain a register of all notifications and copies of the register are to be made available by the Executive for public inspection by appropriate means (regulation 28). Certain information may not be published if it would be a breach of confidentiality (regulation 29).
16 Provision is made for the enforcement of the Regulations under the Health and Safety at Work (Northern Ireland) Order 1978 (regulation 30).
17 There is a right of appeal for any person who is aggrieved by certain decisions or actions of the competent authority or the Executive (regulation 31).
18 Anything that must be submitted to the competent authority under the regulations must be submitted to the Executive at the address it publishes on its website for the purpose (regulation 32).
19 There are various transitional, saving and consequential provisions and a number of instruments are revoked (see paragraph 1 above) (regulations 33 to 35).
20 In Great Britain the corresponding Regulations are the Genetically Modified Organisms (Contained Use) Regulations 2014 (S.I. 2014/1663). The Great Britain Health and Safety Executive has prepared a regulatory impact assessment in relation to those Regulations. A copy of that assessment together with a Northern Ireland supplement prepared by the Health and Safety Executive for Northern Ireland can be accessed at http://www.hseni.gov.uk/ or may be obtained, on request, from the Executive, at 83 Ladas Drive, Belfast, BT6 9FR. A copy of the transposition note in relation to implementation of the Directive can also be obtained from the Health and Safety Executive for Northern Ireland at the above address. Copies of both documents are annexed to the Explanatory Memorandum which is available alongside these Regulations at www.legislation.gov.uk.
Footnotes
[^f00001]: Formerly the Department of Economic Development; see S.I. 1999/283 (N.I. 1), Article 3(5); that Department was formerly the Department of Manpower Services; see S.I. 1982/846 (N.I.11), Article 3
[^f00002]: 1972 c.68
[^f00003]: S.I. 1991/755
[^f00004]: SeeArticle 2(2) of S.I. 1978/1039 (N.I. 9)
[^f00005]: Article 17 shall be read with S.I. 1992/1728 (N.I.17), Articles 3(2) and 4(2)
[^f00006]: S.I. 1978/1039 (N.I. 9); the general purposes of Part II referred to in Article 17(1) were extended by S.I. 1992/1728 (N.I. 17), Articles 3(1) and 4(1). Article 55(2) was amended by S.I. 1998/2795 (N.I. 18), Article 6(1) and Schedule 1, paragraph 19
[^f00007]: Article 13(1A) was substituted by S.I. 1998/2795 (N.I. 18), Article 4
[^f00008]: Article 46(3) was amended by S.I. 1998/2795 (N.I. 18), Article 6(1) and Schedule 1, paragraphs 8 and 18 and the Health Protection Agency Act 2004 (c.17), section 11 and Schedule 3 paragraph 10
[^f00009]: S.R. 2001 No.295. The 2001 Regulations and all amending instruments are revoked by these Regulations (see regulation 36).
[^f00010]: 1990 c.37. Sections 1(1) and (6) were substituted by section 1(2) and (5) of the Human Fertilisation and Embryology Act 2008 (c.22) and section 4A was inserted by section 4(2) of that Act.
[^f00011]: OJ No L 287 5.11.2003, p. 1.
[^f00012]: 1971 c.80
[^f00013]: 1954 c.33 (N.I.)
[^f00014]: 1990 c 43. The functions of the Secretary of State under section 111(1) are exercisable in relation to Scotland by the Scottish Ministers, by virtue of section 53 of the Scotland Act 1998 (c.46). The functions of the Secretary of State under section 111(1) are exercisable in relation to Wales by the Welsh Ministers. Those functions were originally conferred on the National Assembly for Wales under S.I. 1999/672, which was an Order in Council made under section 22 of the Government of Wales Act 1998 (c .38). Functions which had been conferred on the Assembly under an Order in Council under section 22 were transferred to the Welsh Ministers by virtue of paragraph 30 of Schedule 11 to the Government of Wales Act 2006 (c .32).
[^f00015]: S.I. 1991/1714 (N.I. 19)
[^f00016]: OJ No L 106, 17.04.2001, p1. Under Article 4.4 member States must designate a competent authority responsible for complying with the requirements of the Directive.
[^f00017]: OJ No L 136, 30.4.2004, p. 1 as amended by Regulation (EC) No 1901/2006 (OJ No L378 27.12.2006 p. 1), Regulation (EC) No 1394/2007 (OJ No L 324 , 10.12.2007 , p. 121), Regulation (EC) No 219/2009 (OJ No L87 31.3.2009, p. 109), Regulation (EC) No 470/2009 (OJ No L 152, 16.6.2009, p. 11), Regulation (EU) No 1235/2010 (OJ No L348, 31.12.2010, p 1) (which was corrected by Corrigendum, OJ No L 201, 27.7.2012, p 138) and Regulation (EU) No 1027/2012 (OJ No L 316, 14.11.2012, p38).
[^f00018]: OJ No L268 18.10.2003, p 1 as amended by Regulation (EC) No 1981/2006 (OJ No L368, 23.12.2006 p 99) and Regulation (EC) No 298/2008 (OJ No L 97 9.4.2008, p 64).
[^f00019]: S.I. 2004/3391
[^f00020]: S.I.1978/1039 (N.I.9); Articles 18 to 20 and 31 were amended by, and Article 34A was inserted by, S.I. 1998/2795 (N.I..18), Article 6(1) and Schedule 1
[^f00021]: S.R. 1994 No.1
[^f00022]: S.R. 1999 No.90
[^f00023]: S.R. 1997 No.269
[^f00024]: S.R. 2012 No.255
[^f00025]: S.I. 2008/2852
[^f00026]: S.R. 2006 No.524
[^f00027]: S.R. 2010 No.343
[^f00028]: OJ No L262, 17.10.2000, p21
Editorial notes
[^key-10a308b6f94bc5f5d3c3bdb6cdcdc495]: Reg. 1 in operation at 23.10.2015, see reg. 1
[^key-d86ff335d0de38a70f66375ed0367536]: Reg. 2 in operation at 23.10.2015, see reg. 1
[^key-8d174f366a3cd2f52233a5291940e0d8]: Reg. 3 in operation at 23.10.2015, see reg. 1
[^key-032975770646e06f0eba7c645aca662c]: Reg. 4 in operation at 23.10.2015, see reg. 1
[^key-e51b0915d5f41ee049d11bb43610e7f8]: Reg. 5 in operation at 23.10.2015, see reg. 1
[^key-cea5a75770c1523199740a917eff3e82]: Reg. 6 in operation at 23.10.2015, see reg. 1
[^key-ee6501500c79ea461d35d88cdb0f00d1]: Reg. 7 in operation at 23.10.2015, see reg. 1
[^key-40f1e75f04cc53216a256ebccd34904b]: Reg. 8 in operation at 23.10.2015, see reg. 1
[^key-70c9fe2b6aa2ed1c92f2a470e7689e9e]: Reg. 9 in operation at 23.10.2015, see reg. 1
[^key-62d6fe54c66ac66dedccd73fd6458232]: Reg. 10 in operation at 23.10.2015, see reg. 1
[^key-46f8d93ed028ce3bb27a9732bb391346]: Reg. 11 in operation at 23.10.2015, see reg. 1
[^key-1f559dfd1c373438219b6feffa13bdb9]: Reg. 12 in operation at 23.10.2015, see reg. 1
[^key-7f8b075de2e08b3e9189b4609f3e46cd]: Reg. 13 in operation at 23.10.2015, see reg. 1
[^key-e2373f7e541bc8b3acc5f7d5a3ebb43f]: Reg. 14 in operation at 23.10.2015, see reg. 1
[^key-532f907338e02f40db4d9a4ccaa10ca4]: Reg. 15 in operation at 23.10.2015, see reg. 1
[^key-9f31c4106c44fcba820ff8714b9906e6]: Reg. 16 in operation at 23.10.2015, see reg. 1
[^key-3aca5aacd7c17fcb18ed94eef071ca33]: Reg. 17 in operation at 23.10.2015, see reg. 1
[^key-9ec8030097434c15e7d8db0178c043ff]: Reg. 18 in operation at 23.10.2015, see reg. 1
[^key-87dc139f4120fcf7c516e259c3042ef7]: Reg. 19 in operation at 23.10.2015, see reg. 1
[^key-6bb201b6b79cf832b35fadf702f82b1b]: Reg. 20 in operation at 23.10.2015, see reg. 1
[^key-a902c78895b0f8815d0027c24d08dfd3]: Reg. 21 in operation at 23.10.2015, see reg. 1
[^key-59e44757adc4ed1415a49eecd63bdbdc]: Reg. 22 in operation at 23.10.2015, see reg. 1
[^key-a998597190f2601804ad86309dd76243]: Reg. 23 in operation at 23.10.2015, see reg. 1
[^key-277ed180cf355dce9f9b0bba7253b2d4]: Reg. 24 in operation at 23.10.2015, see reg. 1
[^key-7818ed6b9d4d55a18b4d7f31c3d07e54]: Reg. 25 in operation at 23.10.2015, see reg. 1
[^key-df0bef024d9519ac3d3c28b2d916d0a7]: Reg. 26 in operation at 23.10.2015, see reg. 1
[^key-02deb78f95dbb9c81c19a21f4f16069d]: Reg. 27 in operation at 23.10.2015, see reg. 1
[^key-c89e0da30655146d3990a4c7bce20fef]: Reg. 28 in operation at 23.10.2015, see reg. 1
[^key-4b9aacc8b6fef6d5edbfd14ef2fb6290]: Reg. 29 in operation at 23.10.2015, see reg. 1
[^key-cc968e70f8cac26c68c4bf062a78ec8c]: Reg. 30 in operation at 23.10.2015, see reg. 1
[^key-3af23182a822d1e30867e40d11217c8c]: Reg. 31 in operation at 23.10.2015, see reg. 1
[^key-a5e734d6f02cc7081f17b77e7bfe12d2]: Reg. 32 in operation at 23.10.2015, see reg. 1
[^key-c54e6825f0a211cafc2b801dd84bc0df]: Reg. 33 in operation at 23.10.2015, see reg. 1
[^key-5efb8bc3c5104fb0d5ab45c8e7db983a]: Reg. 34 in operation at 23.10.2015, see reg. 1
[^key-2ee85566001bba3c1f11500d848c025b]: Reg. 35 in operation at 23.10.2015, see reg. 1
[^key-80d12474043ed3dda42ea1b5706e1f9d]: Reg. 36 in operation at 23.10.2015, see reg. 1
[^key-9b58e16a00d943caca2c18a1824795a5]: Sch. 2 para. 1 in operation at 23.10.2015, see reg. 1
[^key-7bc25fa3a71deedd4621990ab4d437ab]: Sch. 2 para. 2 in operation at 23.10.2015, see reg. 1
[^key-76f7f46c3ed14c435e972cc28c3b85c0]: Sch. 2 para. 3 in operation at 23.10.2015, see reg. 1
[^key-60ddbb43efdddd97b1ad2554c90cb489]: Sch. 2 para. 4 in operation at 23.10.2015, see reg. 1
[^key-26f003c9170dbb40cc85d2a444be9808]: Sch. 3 para. 1 in operation at 23.10.2015, see reg. 1
[^key-45001aa5e181b312e5c4cfabd554f2b2]: Sch. 3 para. 2 in operation at 23.10.2015, see reg. 1
[^key-bd5d063a384c96fee3c5cdfc64f2cf0c]: Sch. 3 para. 3 in operation at 23.10.2015, see reg. 1
[^key-7cf7815f761c4536451a07d93a3e8855]: Sch. 3 para. 4 in operation at 23.10.2015, see reg. 1
[^key-77ee17ebaf18ec34ac1d9b39eafa739e]: Sch. 3 para. 5 in operation at 23.10.2015, see reg. 1
[^key-871a21598ac03fff8bc63a4ed799b92a]: Sch. 4 para. 1 in operation at 23.10.2015, see reg. 1
[^key-26ae17edd7c5833006102fde25796620]: Sch. 4 para. 2 in operation at 23.10.2015, see reg. 1
[^key-b7cf444d2d3eefb947fde976cc6343f4]: Sch. 4 para. 3 in operation at 23.10.2015, see reg. 1
[^key-9edca79787762bcf927a6c65b7c5072e]: Sch. 8 para. 1 in operation at 23.10.2015, see reg. 1
[^key-cc5a768bb788c8dc0dd36d39ccb7bb5d]: Sch. 8 para. 2 in operation at 23.10.2015, see reg. 1
[^key-43d7aaf9c6e336b926ce02063386b107]: Sch. 8 para. 3 in operation at 23.10.2015, see reg. 1
[^key-42a4c2ef57aabf6d127378ec5760a1f1]: Sch. 1 in operation at 23.10.2015, see reg. 1
[^key-d53be0c0efa4f33be9e4bc9a1d6fcf1d]: Sch. 5 in operation at 23.10.2015, see reg. 1
[^key-67563cb1a736fcbe5645a3bac34abdff]: Sch. 6 in operation at 23.10.2015, see reg. 1
[^key-c508504dcae4bcdf81f5a870e85764bb]: Sch. 7 in operation at 23.10.2015, see reg. 1
[^key-90bdbd10835c4379fee9807380c9aeab]: Sch. 8 Pt. 2 in operation at 23.10.2015, see reg. 1
[^key-fb9314f2eef84adc73205637979c92dd]: Reg. 3(2)(b)(iii) omitted (31.12.2020) by virtue of The Health and Safety (Amendments and Revocation) (EU Exit) Regulations (Northern Ireland) 2020 (S.R. 2020/330), regs. 1(2), 10(2)(c)
[^key-474cff48e798aa9c02fa77a9970e3370]: Reg. 3(2)(b)(iv) and word inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 8 para. 14; 2020 c. 1, Sch. 5 para. 1(1)
[^key-8e97b4422f50131b36577ceb48248544]: Word in reg. 3(2)(b)(i) inserted (31.12.2020) by The Health and Safety (Amendments and Revocation) (EU Exit) Regulations (Northern Ireland) 2020 (S.R. 2020/330), regs. 1(2), 10(2)(a)
[^key-9ecb0e9842295d952b2e6867dfae8960]: Words in reg. 3(2)(b)(ii) omitted (31.12.2020) by virtue of The Health and Safety (Amendments and Revocation) (EU Exit) Regulations (Northern Ireland) 2020 (S.R. 2020/330), regs. 1(2), 10(2)(b)
[^key-f23352a898f9ca8ade038fe331bb53a8]: Word in reg. 27(a) inserted (31.12.2020) by The Health and Safety (Amendments and Revocation) (EU Exit) Regulations (Northern Ireland) 2020 (S.R. 2020/330), regs. 1(2), 10(3)(a)
[^key-9d6c17bebfcace9cc02072d05a79d3a7]: Reg. 27(b) omitted (31.12.2020) by virtue of The Health and Safety (Amendments and Revocation) (EU Exit) Regulations (Northern Ireland) 2020 (S.R. 2020/330), regs. 1(2), 10(3)(b)(i)
[^key-1380f9ac80dffd269369640a07a057fc]: Word in reg. 27(c) omitted (31.12.2020) by virtue of The Health and Safety (Amendments and Revocation) (EU Exit) Regulations (Northern Ireland) 2020 (S.R. 2020/330), regs. 1(2), 10(3)(b)(ii)
[^key-12003376f5acb41f9da81bffaa35263d]: Reg. 27(d) omitted (31.12.2020) by virtue of The Health and Safety (Amendments and Revocation) (EU Exit) Regulations (Northern Ireland) 2020 (S.R. 2020/330), regs. 1(2), 10(3)(b)(iii)
[^key-46027962f368f08143d3cf4235a2f90b]: Reg. 3(2)(b)(v) and word inserted (23.2.2026) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment) (EU Exit) Regulations (Northern Ireland) 2026 (S.R. 2026/9), regs. 1, 3(2)
[^key-760d40a782ec51829c9febb130e8d50c]: Sch. 3 para. 3(dd) inserted (23.2.2026) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment) (EU Exit) Regulations (Northern Ireland) 2026 (S.R. 2026/9), regs. 1, 3(3)
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