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)
Article 1
Article 2
Article 3
Article 4
Article 5
Article 6
Article 7
Article 8
Article 9
Article 10
Article 11
Article 12
Article 13
Article 14
Article 15
Article 16
Article 17
Article 18
Article 19
Article 20
Article 21
Article 22
Article 23
ANNEX I
PART A
PART B
ANNEX II
PART A
PART B
Criteria establishing the safety of GMMs for human health and the environment
1.
Introduction
2.
General criteria
2.1. Strain verification/authentication
2.2. Documented and established evidence of safety
2.3. Genetic stability
3.
Specific criteria
3.1. Non-pathogenic
3.1.1. Non-toxigenic
3.1.2. Non-allergenic
3.2. No harmful adventitious agents
3.3. Transfer of genetic material
3.4. Safety for the environment in the event of a significant and unintended release
PART C
ANNEX III
Principles to be followed for the assessment referred to in Article 4(2)
A.
Elements of assessment
B.
Procedure
ANNEX IV
CONTAINMENT AND OTHER PROTECTIVE MEASURES
General principles
Specifications |
Containment levels |
||||
1 |
2 |
3 |
4 |
||
1 |
Laboratory suite: isolation(1) |
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(2) |
Not required |
Not required |
Optional |
Required |
5 |
Negative pressure relative to the pressure of the immediate environment |
Not required |
Not required |
Required except for(3) |
Required |
6 |
Extract and input air from the laboratory should be HEPA(4)-filtered |
Not required |
Not required |
Required (HEPA — extract air except for(3)) |
Required (HEPA— input and extract air(5)) |
7 |
Microbiological safety post |
Not required |
Optional |
Required |
Required |
8 |
Autoclave |
On site |
In the building |
En suite(6) |
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 |
Specifications |
Containment levels |
||||
1 |
2 |
3 |
4 |
||
Building |
|||||
1 |
Glasshouse: permanent structure(7) |
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(8) 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 |
Specifications |
Containment levels |
||||
1 |
2 |
3 |
4 |
||
Facilities |
|||||
1 |
Isolation of animal unit(9) |
Optional |
Required |
Required |
Required |
2 |
Animal facilities(10) 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(11) |
Not required |
Optional |
Required |
Required |
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 |
ANNEX V
Information required for the notification referred to in Articles 6, 8 and 9
PART A
PART B
PART C
ANNEX VI
PART A
Repealed Directive with list of its successive amendments
(referred to in Article 21)
Council Directive 90/219/EEC |
|
Commission Directive 94/51/EC |
|
Council Directive 98/81/EC |
|
Council Decision 2001/204/EC |
|
Regulation (EC) No 1882/2003 of the European Parliament and of the Council |
Annex III, point 19, only |
PART B
Time limits for transposition into national law
(referred to in Article 21)
Directive |
Time limit for transposition |
90/219/EEC |
23 October 1991 |
94/51/EC |
30 April 1995 |
98/81/EC |
5 June 2000 |
ANNEX VII
Directive 90/219/EEC |
This Directive |
Article 1 |
Article 1 |
Article 2 |
Article 2 |
Article 3, introductory wording |
Article 3(1), introductory wording |
Article 3, first indent |
Article 3(1), point (a) |
Article 3, second indent |
Article 3(1), point (b) |
Article 4, first paragraph |
Article 3(2) |
Article 4, second paragraph |
Article 3(3) |
Article 5 |
Article 4 |
Article 6 |
Article 5 |
Article 7 |
Article 6 |
Article 8 |
Article 7 |
Article 9 |
Article 8 |
Article 10 |
Article 9 |
Article 11(1), (2) and (3) |
Article 10(1), (2) and (3) |
Article 11(4), introductory wording |
Article 10(4), introductory wording |
Article 11(4), first indent |
Article 10(4), point (a) |
Article 11(4), second indent |
Article 10(4), point (b) |
Article 12, first paragraph |
Article 11(1) |
Article 12, second paragraph |
Article 11(2) |
Article 13 |
Article 12 |
Article 14, first paragraph |
Article 13(1) |
Article 14, second paragraph |
Article 13(2) |
Article 15(1), introductory wording |
Article 14(1), introductory wording |
Article 15(1), first indent |
Article 14(1), point (a) |
Article 15(1), second indent |
Article 14(1), point (b) |
Article 15(1), third indent |
Article 14(1), point (c) |
Article 15(1), fourth indent |
Article 14(1), point (d) |
Article 15(2), introductory wording |
Article 14(2), introductory wording |
Article 15(2), first indent |
Article 14(2), point (a) |
Article 15(2), second indent |
Article 14(2), point (b) |
Article 16 |
Article 15 |
Article 17 |
Article 16 |
Article 18 |
Article 17 |
Article 19(1) |
Article 18(1), first subparagraph |
Article 19(2) |
Article 18(1), second subparagraph |
Article 19(3), introductory wording |
Article 18(2), introductory wording |
Article 19(3), first indent |
Article 18(2), point (a) |
Article 19(3), second indent |
Article 18(2), point (b) |
Article 19(3), third indent |
Article 18(2), point (c) |
Article 19(4) |
Article 18(3) |
Article 19(5) |
Article 18(4) |
Article 20 |
Article 19 |
Article 20a |
— |
Article 21(1) |
Article 20(1) |
Article 21(2), first subparagraph |
Article 20(2) and (3), first subparagraph |
Article 21(2), second subparagraph |
Article 20(3), second subparagraph |
Article 21(3) |
— |
Article 22 |
— |
— |
Article 21 |
— |
Article 22 |
Article 23 |
Article 23 |
Annexes I-V |
Annexes I-V |
— |
Annex VI |
— |
Annex VII |