• disease to humans, including allergenic or toxic effects,

• disease to animals or plants,

• deleterious effects due to the impossibility of treating a disease or providing an effective prophylaxis,

• deleterious effects due to establishment or dissemination in the environment,

• deleterious effects due to the natural transfer of inserted genetic material to other organisms.

1. (a)

   the identification of any potentially harmful effects, in particular those associated with:

   1. (i)

      the recipient micro-organism;

   2. (ii)

      the genetic material inserted (originating from the donor organism);

   3. (iii)

      the vector;

   4. (iv)

      the donor micro-organism (as long as the donor micro-organism is used during the operation);

   5. (v)

      the resulting GMM;

2. (b)

   the characteristics of the activity;

3. (c)

   the severity of the potentially harmful effects;

4. (d)

   the likelihood of the potentially harmful effects being realised.

The first stage in the assessment process should be to identify the harmful properties of the recipient and, where appropriate, the donor micro-organism, and any harmful properties associated with the vector or inserted material, including any alteration in the recipient’s existing properties.

1. (i)

   the recipient or parental micro-organism is unlikely to cause disease to humans, animals or plants10;

2. (ii)

   the nature of the vector and the insert is such that they do not endow the GMM with a phenotype likely to cause disease to humans, animals or plants10, or likely to have deleterious effects on the environment;

3. (iii)

   the GMM is unlikely to cause disease to humans, animals or plants10 and is unlikely to have deleterious effects on the environment.

These schemes concern natural micro-organisms and as such are usually based on the ability of micro-organisms to cause disease to humans, animals or plants and on the severity and transmissibility of the disease likely to be caused. Directive 2000/54/EC classifies micro-organisms, as biological agents, into four classes of risk on the basis of potential effects on a healthy human adult. These classes of risk can be used as guidance for the purposes of categorisation of the contained use activities in the four classes of risk referred to in Article 4(3). The user may also take into consideration classification schemes referring to plant and animal pathogens (which are usually established on a national basis). The abovementioned classification schemes give only a provisional indication of the risk class of the activity and the corresponding set of containment and control measures.

The hazard identification process carried out in accordance with points 3 to 5 should lead to the identification of the level of risk associated with the GMM.

1. (i)

   the characteristics of the environment likely to be exposed (e.g. whether in the environment likely to be exposed to the GMMs there are known biota which can be adversely affected by the micro-organisms used in the contained use activity);

2. (ii)

   the characteristics of the activity (e.g. its scale and/or nature);

3. (iii)

   any non-standard operations (e.g. the inoculation of animals with GMMs; use of equipment likely to generate aerosols).

Consideration of items (i) to (iii) for the particular activity may increase, reduce or leave unaltered the level of risk associated with the GMM as identified under point 6.

The analysis carried out as described above will finally lead to the assignment of the activity to one of the classes described in Article 4(3).

The final classification of the contained use should be confirmed by reviewing the completed assessment referred to in Article 4(2).

Containment is also achieved through the use of good work practices, training, containment equipment and special installation design. For all activities involving GMMs the principles of good microbiological practice and the following principles of good occupational safety and hygiene shall apply:

1. (i)

   to keep workplace and environmental exposure to any GMM to the lowest practicable level;

2. (ii)

   to exercise engineering control measures at source and to supplement these with appropriate personal protective clothing and equipment when necessary;

3. (iii)

   to test adequately and maintain control measures and equipment;

4. (iv)

   to test, when necessary, for the presence of viable process organisms outside the primary physical containment;

5. (v)

   to provide appropriate training of personnel;

6. (vi)

   to establish biological safety committees or subcommittees, if required;

7. (vii)

   to formulate and implement local codes of practice for the safety of personnel, as required;

8. (viii)

   where appropriate, to display biohazard signs;

9. (ix)

   to provide washing and decontamination facilities for personnel;

10. (x)

    to keep adequate records;

11. (xi)

    to prohibit eating, drinking, smoking, applying cosmetics or the storing of food for human consumption in the work area;

12. (xii)

    to prohibit mouth pipetting;

13. (xiii)

    to provide written standard operating procedures where appropriate to ensure safety;

14. (xiv)

    to have effective disinfectants and specified disinfection procedures available in case of spillage of GMMs;

15. (xv)

    to provide safe storage for contaminated laboratory equipment and materials, when appropriate.

• Table I A presents minimum requirements for laboratory activities.

• Table I B presents additions to and modifications of Table I A for glasshouse/growth-room activities involving GMMs.

• Table I C presents additions to and modifications of Table I A for activities with animals involving GMMs.

• Table II presents minimum requirements for activities other than laboratory activities.

In some particular cases, it might be necessary to apply a combination of measures, from Table I A and Table II, of the same level.

In some cases users may, with the agreement of the competent authority, not apply a specification under a particular containment level or combine specifications from two different levels.

In these tables ‘optional’ means that the user may apply these measures on a case-by-case basis, subject to the assessment referred to in Article 4(2).

In implementing this Annex, Member States may in addition incorporate in the following tables the general principles set out in points 1 and 2, with a view to clarifying the requirements.