Division (4) Annex VI to Directive 2000/54/EC is replaced by the following:

United Kingdom

‘ANNEX VI

CONTAINMENT FOR INDUSTRIAL PROCESSES

(Article 4(1) and Article 16(2)(a))

Preliminary note

In the table, “Recommended” means that the measures should in principle be applied, unless the results of the assessment referred to in Article 3(2) indicate otherwise.

Group 1 biological agents

For work with group 1 biological agents including live attenuated vaccines, the principles of good occupational safety and hygiene should be observed.

Groups 2, 3 and 4 biological agents

It may be appropriate to select and combine containment requirements from different categories below on the basis of a risk assessment related to any particular process or part of a process.

HEPA: High efficiency particulate air

Closed system: A system that physically separates the process from the environment (e.g. incubator vats, tanks, etc.).

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.

A. Containment measures B. Containment levels
2 3 4
General
1. Viable organisms should be handled in a system which physically separates the process from the environment Yes Yes Yes
2. Exhaust gases from the closed system should be treated so as to: Minimise release Prevent release Prevent release
3. Sample collection, addition of materials to a closed system and transfer of viable organisms to another closed system, should be performed so as to: Minimise release Prevent release Prevent release
4. Bulk culture fluids should not be removed from the closed system unless the viable organisms have been: Inactivated by validated chemical or physical means Inactivated by validated chemical or physical means Inactivated by validated chemical or physical means
5. Seals should be designed so as to: Minimise release Prevent release Prevent release
6. The controlled area should be designed to contain spillage of the entire contents of the closed system No Recommended Yes
7. The controlled area should be sealable to permit fumigation No Recommended Yes
Facilities
8. Decontamination and washing facilities should be provided for personnel Yes Yes Yes
Equipment
9. Input air and extract air to the controlled area should be HEPA^f1 filtered No Recommended Yes
10. The controlled area should be maintained at an air pressure negative to atmosphere No Recommended Yes
11. The controlled area should be adequately ventilated to minimise air contamination Recommended Recommended Yes
System of work
12. Closed systems^f2 should be located within a controlled area Recommended Recommended Yes, and purpose-built
13. Biohazard signs should be posted Recommended Yes Yes
14. Access should be restricted to nominated personnel only Recommended Yes Yes, via an airlock^f3
15. Personnel should shower before leaving the controlled area No Recommended Yes
16. Personnel should wear protective clothing Yes, work clothing Yes Yes, complete change
Waste
17. Effluent from sinks and showers should be collected and inactivated before release No Recommended Yes
18. Effluent treatment before final discharge Inactivated by validated chemical or physical means Inactivated by validated chemical or physical means Inactivated by validated chemical or physical means

’

HEPA: High efficiency particulate air
Closed system: A system that physically separates the process from the environment (e.g. incubator vats, tanks, etc.).
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.
A. Containment measures	B. Containment levels
2	3	4
General
1. Viable organisms should be handled in a system which physically separates the process from the environment	Yes	Yes	Yes
2. Exhaust gases from the closed system should be treated so as to:	Minimise release	Prevent release	Prevent release
3. Sample collection, addition of materials to a closed system and transfer of viable organisms to another closed system, should be performed so as to:	Minimise release	Prevent release	Prevent release
4. Bulk culture fluids should not be removed from the closed system unless the viable organisms have been:	Inactivated by validated chemical or physical means	Inactivated by validated chemical or physical means	Inactivated by validated chemical or physical means
5. Seals should be designed so as to:	Minimise release	Prevent release	Prevent release
6. The controlled area should be designed to contain spillage of the entire contents of the closed system	No	Recommended	Yes
7. The controlled area should be sealable to permit fumigation	No	Recommended	Yes
Facilities
8. Decontamination and washing facilities should be provided for personnel	Yes	Yes	Yes
Equipment
9. Input air and extract air to the controlled area should be HEPA^f1 filtered	No	Recommended	Yes
10. The controlled area should be maintained at an air pressure negative to atmosphere	No	Recommended	Yes
11. The controlled area should be adequately ventilated to minimise air contamination	Recommended	Recommended	Yes
System of work
12. Closed systems^f2 should be located within a controlled area	Recommended	Recommended	Yes, and purpose-built
13. Biohazard signs should be posted	Recommended	Yes	Yes
14. Access should be restricted to nominated personnel only	Recommended	Yes	Yes, via an airlock^f3
15. Personnel should shower before leaving the controlled area	No	Recommended	Yes
16. Personnel should wear protective clothing	Yes, work clothing	Yes	Yes, complete change
Waste
17. Effluent from sinks and showers should be collected and inactivated before release	No	Recommended	Yes
18. Effluent treatment before final discharge	Inactivated by validated chemical or physical means	Inactivated by validated chemical or physical means	Inactivated by validated chemical or physical means

Annotations

Footnotes

f1: HEPA: High efficiency particulate air
f2: Closed system: A system that physically separates the process from the environment (e.g. incubator vats, tanks, etc.).
f3: 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.