Directive 2009/41/EC of the European Parliament and of the CouncilShow full title

Article 4

1. Member States shall ensure that all appropriate measures are taken to avoid adverse effects on human health and the environment which might arise from the contained use of GMMs.

2. To that end, the user shall carry out an assessment of the contained uses as regards the risks to human health and the environment that those contained uses may pose, using as a minimum the elements of assessment and the procedure set out in Annex III, Sections A and B.

3. The assessment referred to in paragraph 2 shall result in the final classification of the contained uses in four classes applying the procedure set out in Annex III, which will result in the assignment of containment levels in accordance with Article 5:

Class 1

:

activities of no or negligible risk, that is to say activities for which level 1 containment is appropriate to protect human health and the environment.

Class 2

:

activities of low risk, that is to say activities for which level 2 containment is appropriate to protect human health and the environment.

Class 3

:

activities of moderate risk, that is to say activities for which level 3 containment is appropriate to protect human health and the environment.

Class 4

:

activities of high risk, that is to say activities for which level 4 containment is appropriate to protect human health and the environment.

4. Where there is doubt as to which class is appropriate for the proposed contained use, the more stringent protective measures shall be applied unless, by agreement with the competent authority, there is sufficient evidence to justify the application of less stringent measures.

5. The assessment referred to in paragraph 2 shall especially take into account the question of disposal of waste and effluents. Where appropriate, the safety measures needed in order to protect human health and the environment shall be implemented.

6. A record of the assessment referred to in paragraph 2 shall be kept by the user and made available in an appropriate form to the competent authority as part of the notification pursuant to Articles 6, 8 and 9 or on request.