Commission Regulation (EC) No 429/2008Show full title

8. ADDITIVES ALREADY AUTHORISED FOR USE IN FOOD

8.1. Section I: summary of the dossier

The whole of Section I of Annex II applies.

8.2. Section II: identity, characterisation and conditions of use of the additive; methods of analysis

The Section II of Annex II applies as following:

• for additives subject to a specific holder of the authorisation, the whole of Section II applies,

• for other additives the paragraphs 2.1.2, 2.1.3, 2.1.4, 2.1.4.2, 2.2, 2.3.1, 2.3.2., 2.4.1, 2.4.2, 2.4.4, 2.5, 2.6 apply.

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 the European Union 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).

8.3.1. Studies concerning the safety of use of the additive for the target animals

If the use level as for the feed additive is similar to that used in food, the safety for target species can be assessed based on the in vivo toxicological data available, a consideration of chemical structure and the metabolic capacity of the target species. If the use level in feed is considerably higher than the corresponding use in food, a tolerance study in the target animal may be required, depending on the nature of the substance.

8.3.2. Studies concerning the safety of use of the additive for consumers

If the use as a feed additive results in a higher consumer exposure, or to a different pattern of metabolites than that resulting from use in food, then further toxicological and residue data will be required.

8.3.2.1. Food additives for which an ADI is not specified

Assessment of the safety for consumers is not required, except when the use of the additive in feed leads to a different pattern of metabolites than when used in food.

8.3.2.2. Food additives with an established ADI or UL

Consumer safety must be assessed taking into consideration the additional exposure from feed use, or specific exposure related to metabolites arising from the target species. This can be done by extrapolating residue data from literature.

Where residue studies are necessary, the requirement is limited to a comparison of the tissue or product levels in an untreated group to the group supplemented with the highest dose that is claimed.

8.3.2.3. Food additives for which no ADI is allocated

The reasons why an ADI was not allocated shall be clearly specified. If concerns arise from this, and the use of the additive in feed would contribute to a significant increase in consumer exposure, a full toxicological evaluation is required.

Additional exposure from feed use can be extrapolated from residue data from the literature.

Where residue studies are necessary, the requirement is limited to a comparison of the levels in tissues or products in an untreated group with the group supplemented with the highest dose that is claimed.

8.3.3. Studies concerning the safety of use of the additive for users/workers

The whole of the subsection 3.3 of Annex II applies.

Precautionary measures set for handling these substances used in food shall be taken into account when considering user safety for the feed additive.

8.3.4. Studies concerning the safety of use of the additive for the environment

Subsection 3.4 of Annex II is required.

8.4. Section IV: studies concerning the efficacy of the additive

Where the function requested for feed is the same as that used in food, no further demonstration of efficacy might be necessary. Otherwise the requirements for efficacy are as those shown in Section IV of Annex II.

8.5. Section V: post-market monitoring plan

This section of Annex II shall apply under provision of Article 7(3)(g) of Regulation (EC) No 1831/2003.