# Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (Recast) (Text with EEA relevance), Division CONTAINMENT AND OTHER PROTECTIVE MEASURES: General principles

Extent: E+W+S+N.I.

Table I A
Containment and other protective measures for laboratory activities
Isolation the laboratory is separated from other areas in the same building or is in a separate building.
Airlock 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.
Activities where transmission does not occur via airborne route.
HEPA High efficiency particulate air.
Where viruses which are not retained by HEPA filters are used, extra requirements will be necessary for extract air.
With validated procedures, allowing the safe transfer of material into an autoclave outside the lab, and providing an equivalent level of protection.
Specifications
Containment levels
1
2
3
4
1
Laboratory suite: isolation
Not required
Not required
Required
Required
2
Laboratory: sealable for fumigation
Not required
Not required
Required
Required
Equipment
3
Surfaces resistant to water, acids, alkalis, solvents, disinfectants and decontamination agents, and easy to clean
Required (bench)
Required (bench)
Required (bench, floor)
Required (bench, floor, ceiling, walls)
4
Entry to lab via airlock
Not required
Not required
Optional
Required
5
Negative pressure relative to the pressure of the immediate environment
Not required
Not required
Required except for
Required
6
Extract and input air from the laboratory should be HEPA-filtered
Not required
Not required
Required (HEPA — extract air except for)
Required (HEPA— input and extract air)
7
Microbiological safety post
Not required
Optional
Required
Required
8
Autoclave
On site
In the building
En suite
In lab = double-ended
System of work
9
Restricted access
Not required
Required
Required
Required
10
Biohazard sign on the door
Not required
Required
Required
Required
11
Specific measures to control aerosol dissemination
Not required
Required minimise
Required prevent
Required prevent
13
Shower
Not required
Not required
Optional
Required
14
Protective clothing
Suitable protective clothing
Suitable protective clothing
Suitable protective clothing and (optional) footwear
Complete change of clothing and footwear before entry and exit
15
Gloves
Not required
Optional
Required
Required
18
Efficient vector control (e.g. for rodents and insects)
Optional
Required
Required
Required
Waste
19
Inactivation of GMMs in effluent from hand-washing sinks or drains and showers and similar effluents
Not required
Not required
Optional
Required
20
Inactivation of GMMs in contaminated material and waste
Optional
Required
Required
Required
Other measures
21
Laboratory to contain its own equipment
Not required
Not required
Optional
Required
23
An observation window or alternative is to be present so that occupants can be seen
Optional
Optional
Optional
Required
Table I B
Containment and other protective measures for glasshouses and growth-rooms
The terms ‘glasshouse’ and ‘growth-room’ refer to a structure with walls, a roof and a floor designed and used principally for growing plants in a controlled and protected environment.
All provisions of Table I A shall apply with the following additions/modifications:
The glasshouse shall consist of a permanent structure with a continuous waterproof covering, located on a site graded to prevent entry of surface-water run-off, and with self-closing lockable doors.
Where transmission can occur through the ground.
Specifications
Containment levels
1
2
3
4
Building
1
Glasshouse: permanent structure
Not required
Required
Required
Required
Equipment
3
Entry via a separate room with two interlocking doors
Not required
Optional
Optional
Required
4
Control of contaminated run-off water
Optional
Minimise run-off
Prevent run-off
Prevent run-off
System of work
6
Measures to control undesired species such as insects, rodents, arthropods
Required
Required
Required
Required
7
Procedures for transfer of living material between the glasshouse/growth-room, protective structure and laboratory shall control dissemination of GMMs
Minimise dissemination
Minimise dissemination
Prevent dissemination
Prevent dissemination
Table I C
Containment and other protective measures for activities in animal units
All provisions of Table I A shall apply with the following additions/modifications:
Animal unit a building or separate area within a building containing facilities and other areas such as changing rooms, showers, autoclaves, food storage areas, etc.
Animal facility a facility normally used to house stock, breeding or experimental animals or one which is used for the performance of minor surgical procedures.
Isolators transparent boxes where small animals are contained within or outside a cage; for large animals, isolated rooms may be more appropriate.
Specifications
Containment levels
1
2
3
4
Facilities
1
Isolation of animal unit
Optional
Required
Required
Required
2
Animal facilities separated by lockable doors
Optional
Required
Required
Required
3
Animal facilities designed to facilitate decontamination (waterproof and easily washable material (cages, etc.))
Optional
Optional
Required
Required
4
Floor and/or walls easily washable
Optional
Required (floor)
Required (floor and walls)
Required (floor and walls)
5
Animals kept in appropriate containment facilities such as cages, pens or tanks
Optional
Optional
Optional
Optional
6
Filters on isolators or isolated room
Not required
Optional
Required
Required
Table II
Containment and other protective measures for other activities
Specifications
Containment levels
1
2
3
4
General
1
Viable micro-organisms should be contained in a system which separates the process from the environment (closed system)
Optional
Required
Required
Required
2
Control of exhaust gases from the closed system
Not required
Required, minimise dissemination
Required, prevent dissemination
Required, prevent dissemination
3
Control of aerosols during sample collection, addition of material to a closed system or transfer of material to another closed system
Optional
Required, minimise dissemination
Required, prevent dissemination
Required, prevent dissemination
4
Inactivation of bulk culture fluids before removal from the closed system
Optional
Required, by validated means
Required, by validated means
Required, by validated means
5
Seals should be designed so as to minimise or prevent release
No specific requirement
Minimise dissemination
Prevent dissemination
Prevent dissemination
6
The controlled area should be designed to contain spillage of the entire contents of the closed system
Optional
Optional
Required
Required
7
The controlled area should be sealable to permit fumigation
Not required
Optional
Optional
Required
Equipment
8
Entry via airlock
Not required
Not required
Optional
Required
9
Surfaces resistant to water, acids, alkalis, solvents, disinfectants and decontamination agents, and easy to clean
Required (bench if any)
Required (bench if any)
Required (bench if any, floor)
Required (bench, floor, ceiling, walls)
10
Specific measures to adequately ventilate the controlled area in order to minimise air contamination
Optional
Optional
Optional
Required
11
The controlled area should be maintained at an air pressure negative to the immediate surroundings
Not required
Not required
Optional
Required
12
Extract and input air from the controlled area should be HEPA filtered
Not required
Not required
Required (extract air, optional for input air)
Required (input and extract air)
System of work
13
Closed systems should be located within a controlled area
Not required
Optional
Required
Required
14
Access should be restricted to nominated personnel only
Not required
Required
Required
Required
15
Biohazard signs should be posted
Not required
Required
Required
Required
17
Personnel should shower before leaving the controlled area
Not required
Not required
Optional
Required
18
Personnel should wear protective clothing
Required (work clothing)
Required (work clothing)
Required
Complete change before exit and entry
Waste
22
Inactivation of GMMs in effluent from hand-washing sinks and showers or similar effluents
Not required
Not required
Optional
Required
23
Inactivation of GMMs in contaminated material and waste, including those in process effluent before final discharge
Optional
Required, by validated means
Required, by validated means
Required, by validated means

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Source: https://www.legislation.gov.uk/eudr/2009/41/annex/IV/division/CONTAINMENT (the official version)
Page: https://openlegislation.uk/eu-directive-2009-41/annex-IV/division-CONTAINMENT
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.