CHAPTER IV

OPINION OF THE AUTHORITY

Information to be included in the opinion of the Authority
Article 13
1
The opinion of the Authority shall include the following information:
a
the identity and characterisation of the food additive, food enzyme or flavouring;
b
the assessment of the biological and toxicological data;
c
a dietary exposure assessment for the ... population taking into account other possible sources of dietary exposure;
d
an overall risk assessment establishing if possible and relevant a health-based guidance value, and highlighting uncertainties and limitations where relevant;
e
when the dietary exposure exceeds the health-based guidance value identified in the overall risk assessment, the dietary exposure assessment of the substance shall be detailed, providing where possible the contribution to the total exposure of each food category or foodstuff for which the use is authorised or has been requested;
f
conclusions.
2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Word in Art. 13(1)(c) omitted (31.12.2020) by virtue of The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 148; 2020 c. 1, Sch. 5 para. 1(1)
Art. 13(2) omitted (31.12.2020) by virtue of The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 149; 2020 c. 1, Sch. 5 para. 1(1)