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- Point in Time (31/12/2020)
- Original (As adopted by EU)
Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (Text with EEA relevance)
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There are currently no known outstanding effects for the Regulation (EC) No 1331/2008 of the European Parliament and of the Council, CHAPTER III.
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1.F1... The implementing measures for this Regulation [F2may be prescribed by the appropriate authority after seeking advice from the Authority], and shall concern in particular:
(a)the content, drafting and presentation of the application referred to in Article 4(1);
(b)the arrangements for checking the validity of applications;
(c)the type of information that must be included in the opinion of the Authority referred to in Article 5.
F32.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F1Words in Art. 9(1) 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, 47(a)(i); 2020 c. 1, Sch. 5 para. 1(1)
F2Words in Art. 9(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, 47(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)
In exceptional circumstances, the periods referred to in Article 5(1) and Article 7 may be extended by the [F4Authority] on its own initiative F5..., if the nature of the matter in question so justifies, without prejudice to Article 6(1) and Article 8(1). In such cases the [F4Authority] shall, where appropriate, inform the applicant F6... of the extension and the reasons for it.
Textual Amendments
F4Word in Art. 10 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, 48(a); 2020 c. 1, Sch. 5 para. 1(1)
F5Words in Art. 10 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, 48(b); 2020 c. 1, Sch. 5 para. 1(1)
F6Words in Art. 10 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, 48(c); 2020 c. 1, Sch. 5 para. 1(1)
The Authority [F7must] make its opinions public without delay. It shall also make public any request for its opinion as well as any extension of period pursuant to Article 6(1).
Textual Amendments
F7Word in Art. 11 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, 49; 2020 c. 1, Sch. 5 para. 1(1)
1.Among the information provided by applicants, confidential treatment may be given to information the disclosure of which might significantly harm their competitive position.
Information relating to the following shall not, in any circumstances, be regarded as confidential:
(a)the name and address of the applicant;
(b)the name and a clear description of the substance;
(c)the justification for the use of the substance in or on specific foodstuffs or food categories;
(d)information that is relevant to the assessment of the safety of the substance;
(e)where applicable, the analysis method(s).
2.For the purposes of implementing paragraph 1, applicants shall indicate which of the information provided they wish to be treated as confidential. Verifiable justification must be given in such cases.
3.The [F8Authority] shall decide after consulting with the applicants which information can remain confidential and shall notify applicants F9... accordingly.
4.After being made aware of the [F10Authority's] position, applicants shall have three weeks in which to withdraw their application so as to preserve the confidentiality of the information provided. Confidentiality shall be preserved until this period expires.
F115.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.If an applicant withdraws, or has withdrawn, its application, the [F12appropriate authority and the Authority] shall not disclose confidential information, including information the confidentiality of which is the subject of disagreement between the [F13Authority] and the applicant.
7.The implementation of paragraphs 1 to 6 shall not affect the circulation of information between the [F14appropriate authority and the Authority].
Textual Amendments
F8Word 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, 50(a)(i); 2020 c. 1, Sch. 5 para. 1(1)
F9Words 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, 50(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)
F10Word 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, 50(b); 2020 c. 1, Sch. 5 para. 1(1)
F11Art. 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, 50(c); 2020 c. 1, Sch. 5 para. 1(1)
F12Words in Art. 12(6) 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, 50(d)(i); 2020 c. 1, Sch. 5 para. 1(1)
F13Word in Art. 12(6) 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, 50(d)(ii); 2020 c. 1, Sch. 5 para. 1(1)
F14Words in Art. 12(7) 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, 50(e); 2020 c. 1, Sch. 5 para. 1(1)
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Textual Amendments
F15Art. 13 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, 51; 2020 c. 1, Sch. 5 para. 1(1)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F16Art. 14 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, 51; 2020 c. 1, Sch. 5 para. 1(1)
1.Any power to make regulations under this Regulation—
(a)so far as exercisable by a Minister of the Crown, is exercisable by statutory instrument;
(b)so far as exercisable by the Welsh Ministers, is exercisable by statutory instrument.
2.Any power to make regulations under this Regulation includes power—
(a)to make different provision in relation to different cases or classes of case (including different provision for different areas or different classes of business);
(b)to provide for such exceptions, limitations and conditions, and to make such supplementary, incidental, consequential or transitional provisions, as the appropriate authority considers necessary or expedient.
3. Any statutory instrument or Scottish statutory instrument containing regulations under this Regulation is subject to annulment in pursuance of a resolution—
(a)in the case of England, of either House of Parliament;
(b)in the case of Wales, of Senedd Cymru;
(c)in the case of Scotland, of the Scottish Parliament.
4.In this Regulation, any power—
(a)of the Secretary of State to make regulations is limited to regulations which apply in relation to England only;
(b)of the Welsh Ministers to make regulations is limited to regulations which apply in relation to Wales only;
(c)of the Scottish Ministers to make regulations is limited to regulations which apply in relation to Scotland only.]
Textual Amendments
F17Art. 14A inserted (31.12.2020) by The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 52 (as amended by S.I. 2020/1504, regs. 1(2), 18(11)); 2020 c. 1, Sch. 5 para. 1(1)
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Textual Amendments
F18Art. 15 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, 53; 2020 c. 1, Sch. 5 para. 1(1)
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