Division 8.3 Section III: studies concerning the safety of the additives

The most recent formal assessments of the safety of the food additive shall be included and shall be supplemented with any subsequently produced data.

For those additives which are authorised as food additives or approved as components for foodstuffs in F1Great Britain without any restriction, studies concerning the safety for the consumer and the workers are generally not necessary.

Subsections 3.1, 3.2 and 3.3 of Annex II shall be provided considering the present knowledge on the safety of these substances when used in food. Accordingly, such substances also used in food can be classified as:

• ADI not specified (without an explicit indication of the upper limit of intake, assigned to substances of very low toxicity),

• ADI or UL established, or

• no ADI allocated (applicable to substances for which the available information is not sufficient to establish their safety).