The Genetically Modified Organisms(Contained Use) Regulations 2000

Explanatory Note

(This note is not part of the Regulations)

1.  These Regulations have effect with a view to protecting persons and the environment from risks arising from activities involving the contained use of genetically modified micro-organisms and protecting persons from risks arising from activities involving the contained use of genetically modified organisms which are not micro-organisms.

2.  Save as regards the matters referred to in regulations 7, 12, 17(1)(b), 17(3), 19, 20(2), 24, 25, 27 and 29, Schedule 4, Part III of Schedule 6, Schedule 9 and Schedule 11, these Regulations implement as respects Great Britain Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms (O.J. No. L117, 8.5.90, p. 1), as amended by Commission Directive 94/51/EC of 7 November 1994 (O.J. L297, 18.11.94, p. 29) and Council Directive 98/81/EC of 26 October 1998 (O.J. No. L330, 5.12.98, p. 13).

3.  The Regulations revoke and replace the Genetically Modified Organisms (Contained Use) Regulations 1992, as amended. The principal provisions are as follows.

4.  Any activity involving genetic modification of micro-organisms is prohibited unless the person intending to undertake the activity in question has ensured that an assessment of the risks created by that activity to human health and the environment has been carried out. Any activity involving genetic modification of organisms other than micro-organisms is prohibited unless the person intending to undertake the activity in question has ensured that an assessment of the risks created by that activity to human health has been carried out. A person who carries out such an assessment is required to establish a safety committee to advise him. (Regulations 6, 7 and 16.) (The terms “activity involving genetic modification”, “micro-organism” and “organism” are defined in regulation 2(1).)

5.  No person shall use premises for the first time for the purpose of undertaking an activity involving genetic modification unless he has notified the competent authority (also defined in regulation 2(1)) of his intention to do so and provided to the competent authority certain information. (Regulation 9 and Schedule 5.)

6.  The Regulations prohibit the undertaking of certain types of activity involving the genetic modification of micro-organisms and the genetic modification of organisms other than micro-organisms unless the competent authority has been given prior notification together with certain information and, in specified circumstances, the competent authority has given its consent. (Regulations 10, 11 and 12 and Schedule 6.)

7.  The competent authority is placed under a duty to examine a notification submitted to it under regulations 9, 10, 11 and 12 and the Health and Safety Executive may ask the notifier for additional information. (Regulation 14.)

8.  The competent authority has power to vary or revoke any consent under regulation 11, and a notifier is required to inform the competent authority of changes in the information supplied with the notification submitted by him or other changes in circumstances relating to the undertaking of the activity involving genetic modification. (Regulation 15.)

9.  The Regulations impose on a person who undertakes an activity involving genetic modification a requirement to ensure that safety principles are observed. (Regulation 17.)

10.  A person who undertakes an activity involving genetic modification of micro-organisms is required to apply the containment measures which are appropriate to that activity as set out in the relevant table in Schedule 8. (Regulation 18.)

11.  A person who undertakes an activity involving genetic modification of organisms other than micro-organisms is required to apply the containment measures selected in accordance with the assessment made under regulation 7. (Regulation 19.)

12.  In certain circumstances, before a person undertakes an activity involving genetic modification of micro-organisms, he must prepare an emergency plan to secure the health of persons and the protection of the environment. In certain circumstances, before a person undertakes an activity involving genetic modification of genetically modified organisms other than micro-organisms, he must prepare an emergency plan to secure the health of persons. (Regulation 20.)

13.  A person who undertakes an activity involving genetic modification of organisms must report to the competent authority every accident and provide that authority with information about the accident. (Regulation 21.) (The term “accident” is defined in regulation 2(1).)

14.  The Regulations contain provisions relating to the confidentiality of information provided to the competent authority. (Regulations 22 and 23.)

15.  The competent authority is to maintain a register of the notifications made under regulations 9 to 12 and copies of the register are to be kept at certain offices of the Health and Safety Executive. The register is to be open to public inspection at any reasonable time and is to contain certain information. (Regulation 24.)

16.  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 such an exemption. (Regulation 25.)

17.  Provision is made for the enforcement of the Regulations, for the payment of fees and for transitional measures. (Regulations 26, 27 and 28 and Schedules 9 and 10.)

18.  There is a right of appeal for any person who is aggrieved by certain decisions of the competent authority, a request for information or an instruction given to him by the Health and Safety Executive. (Regulation 29 and Schedule 11.)

19.  A copy of the regulatory impact assessment prepared in respect of these Regulations can be obtained from the Health and Safety Executive, Economic Adviser’s Unit, Rose Court, 2, Southwark Bridge, London SE1 9HS. A copy has been placed in the Library of each House of Parliament.