CHAPTER III

ARRANGEMENTS FOR CHECKING THE VALIDITY OF AN APPLICATION

Procedures
Article 12
1
On receipt of an application the Authority shall without delay verify whether the food additive, food enzyme or flavouring falls within the scope of the appropriate sectoral food law and whether the application contains all the elements required under Chapter II.
2
Where the application contains all the elements required under Chapter II, the Authority is to verify the suitability of the data for risk assessment in accordance with the scientific opinions on data requirements for the evaluation of substance applications and to prepare, if appropriate, an opinion.
3
... If the data is considered suitable for risk assessment, the evaluation period referred to in Article 5(1) of Regulation (EC) No 1331/2008 shall begin from the date when the application is received by the Authority.
However, in accordance with point (a) of the second subparagraph of Article 17(4) of Regulation (EC) No 1332/2008, in the case of the determination of applications for initial authorisation of food enzymes, Article 5(1) of Regulation (EC) No 1331/2008 shall not apply.
4
In case of an application to determine the authorisation status of food additives, food enzymes or flavourings, the Authority may request additional information from the applicant on matters regarding the validity of the application and inform the applicant of the period within which that information shall be provided. In the case of applications submitted in compliance with Article 17(2) of Regulation (EC) No 1332/2008, the Authority shall determine that period together with the applicant.
5
When the application does not fall within the appropriate sectoral food law or when it does not contain all the elements required under Chapter II or when the Authority considers that the data for risk assessment are not suitable, the application shall be considered as not valid. In such a case the Authority shall inform the applicant, ... indicating the reasons why the application is considered not valid.
6
By way of derogation from paragraph 5, an application may be considered as valid even if it does not contain all the elements required under Chapter II, provided that the applicant has submitted verifiable justification for each missing element.
Word in Art. 12(1) substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 147(a); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 12(2) substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 147(b); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 12(3) 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, 147(c)(i)(aa); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 12(3) substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 147(c)(i)(bb); 2020 c. 1, Sch. 5 para. 1(1)
Word in Art. 12(4) substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 147(d)(ii); 2020 c. 1, Sch. 5 para. 1(1)
Word in Art. 12(5) substituted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 147(e)(i); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 12(5) 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, 147(e)(ii); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 12(3) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 10(6)(a) (with reg. 23)
Words in Art. 12(4) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 10(6)(b) (with reg. 23)