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Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes and amending Council Directive 83/417/EEC, Council Regulation (EC) No 1493/1999, Directive 2000/13/EC, Council Directive 2001/112/EC and Regulation (EC) No 258/97 (Text with EEA relevance)
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1.The [F2domestic] list of food enzymes shall be drawn up on the basis of applications made pursuant to paragraph 2.
2.Interested parties may submit applications for the inclusion of a food enzyme in the [F3domestic] list.
[F4The deadline for submitting such applications is to be prescribed by the appropriate authority.]
3.The [F5Authority] shall establish a Register of all food enzymes to be considered for inclusion in the [F6domestic] list in respect of which an application complying with the validity criteria to be laid down in accordance with Article 9(1) of Regulation (EC) No 1331/2008 [establishing a common authorisation procedure for food additives, food enzymes and food flavourings] has been submitted in accordance with paragraph 2 of this Article (hereinafter referred to as the Register). The Register shall be made available to the public.
The [F7appropriate authority] shall submit the applications to the Authority for its opinion.
4.The [F8domestic] list shall be adopted by the [F9appropriate authority] in accordance with the procedure laid down in Regulation (EC) No 1331/2008 [establishing a common authorisation procedure for food additives, food enzymes and food flavourings], once the Authority has issued an opinion on each food enzyme included in the Register.
However, by way of derogation from that procedure:
(a)Article 5(1) of Regulation (EC) No 1331/2008 [establishing a common authorisation procedure for food additives, food enzymes and food flavourings] shall not apply to the Authority's adoption of its opinion;
(b)the [F10appropriate authority] shall adopt the [F11domestic] list for the first time after the Authority has delivered its opinion on all the food enzymes listed in the Register.
5.If necessary, any appropriate transitional measures for the purposes of this Article which are designed to amend non-essential elements of this Regulation, inter alia, by supplementing it, [F12are to be prescribed by the appropriate authority].
Textual Amendments
F1Word in Art. 17 heading 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, 74; 2020 c. 1, Sch. 5 para. 1(1)
F2Word in Art. 17(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, 75(a); 2020 c. 1, Sch. 5 para. 1(1)
F3Word in Art. 17(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, 75(b)(i); 2020 c. 1, Sch. 5 para. 1(1)
F4Words in Art. 17(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, 75(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)
F5Word in Art. 17(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, 75(c)(i)(aa); 2020 c. 1, Sch. 5 para. 1(1)
F6Word in Art. 17(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, 75(c)(i)(bb); 2020 c. 1, Sch. 5 para. 1(1)
F7Words in Art. 17(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, 75(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)
F8Word in Art. 17(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, 75(d)(i)(aa); 2020 c. 1, Sch. 5 para. 1(1)
F9Words in Art. 17(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, 75(d)(i)(bb); 2020 c. 1, Sch. 5 para. 1(1)
F10Words in Art. 17(4)(b) 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, 75(d)(ii)(aa); 2020 c. 1, Sch. 5 para. 1(1)
F11Word in Art. 17(4)(b) 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, 75(d)(ii)(bb); 2020 c. 1, Sch. 5 para. 1(1)
F12Words in Art. 17(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, 75(e); 2020 c. 1, Sch. 5 para. 1(1)
1.Notwithstanding Articles 7 and 17 of this Regulation, the [F13domestic] list shall, when drawn up, include the following food enzymes:
(a)E 1103 Invertase and E 1105 Lysozyme, stating the conditions governing their use as specified in Annex I and Part C of Annex III to Directive 95/2/EC;
(b)Urease, beta-glucanase and lysozyme for use in wine in accordance with Regulation (EC) No 1493/1999 and the implementing rules for that Regulation.
2.Food enzymes, food enzyme preparations and food containing food enzymes placed on the market or labelled before 20 January 2010 which do not comply with the provisions of Articles 10 to 12 may be marketed until their date of minimum durability or use-by-date.
Textual Amendments
F13Word in Art. 18 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, 76; 2020 c. 1, Sch. 5 para. 1(1)
In Directive 83/417/EEC, in Annex I, Section III(d), the indents shall be replaced by the following:
‘rennet meeting the requirements of Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes(1);
other milk-coagulating enzymes meeting the requirements of Regulation (EC) No 1332/2008.’
In Regulation (EC) No 1493/1999, the following paragraph shall be added to Article 43:
‘3.Enzymes and enzymatic preparations used in the authorised oenological practices and processes listed in Annex IV shall meet the requirements of Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes(2).’
Directive 2000/13/EC is hereby amended as follows:
Article 6(4) shall be amended as follows:
point (a) shall be replaced by the following:
“Ingredient” shall mean any substance, including additives and enzymes, used in the manufacture or preparation of a foodstuff and still present in the finished product, even if in altered form.’;
in point (c)(ii), the introductory word ‘additives’ shall be replaced by ‘additives and enzymes’;
in point (c)(iii), the words ‘additives or flavouring’ shall be replaced by ‘additives or enzymes or flavourings’;
the following indent shall be added to Article 6(6):
‘enzymes other than as referred to in paragraph 4(c)(ii) shall be designated by the name of one of the categories of ingredients listed in Annex II, followed by their specific name,’.
In Directive 2001/112/EC, in Annex I, Section II(2), the fourth, fifth and sixth indents shall be replaced by the following:
‘Pectolytic enzymes meeting the requirements of Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes(3);
Proteolytic enzymes meeting the requirements of Regulation (EC) No 1332/2008;
Amylolytic enzymes meeting the requirements of Regulation (EC) No 1332/2008.’
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F14Implicitly repealed by virtue of Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (Text with EEA relevance), Art. 34 (with Art. 35)
This Regulation shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.
Article 4 shall apply from the date of application of the [F15domestic] list. Until that date, national provisions in force concerning the placing on the market and use of food enzymes and food produced with food enzymes shall continue to apply F16....
Articles 10 to 13 shall apply from 20 January 2010.
Textual Amendments
F15Word in Art. 24 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, 77(i); 2020 c. 1, Sch. 5 para. 1(1)
F16Words in Art. 24 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, 77(ii); 2020 c. 1, Sch. 5 para. 1(1)
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