Division 4.2.3.3 Studies concerning the safety of the additive for users/workers

The whole of subsection 3.3 of Annex II applies except:

• enzymes and micro-organisms, as proteinaceous substances, are assumed to be respiratory sensitisers unless convincing evidence to the contrary is provided. Therefore, no direct testing is required.

• the formulation of the product (e.g. micro-encapsulation) may obviate the need for some or all tests. In such cases, appropriate justification shall be provided.