CHAPTER VTRANSITIONAL AND FINAL PROVISIONS

Article 17F1Initial authorisation of food enzymes

F21.

This Article applies for the purpose of the authorisation (“initial authorisation”) of food enzymes which are to be included in the domestic list of food enzymes published and maintained under Regulation (EC) No 1331/2008 when it is first established by the Authority. The initial authorisation of food enzymes must be made in accordance with this Article.

2.

Interested parties may submit applications for the F3initial authorisation of a food enzyme F4....

F5The deadline for submitting such applications is to be prescribed by the appropriate authority.

3.

The F6Authority shall establish a Register of all food enzymes to be considered for F7initial authorisation 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 (F8referred to in this Regulation as the ‘Register’). The Register shall be made available to the public.

The F9appropriate authority shall submit the applications to the Authority for its opinion.

4.

F10In 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], F11the appropriate authority must determine the authorisation status of all of the applications for initial authorisation entered in the Register 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;

F12(b)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F13(4A.

This Article, and the Register, shall cease to have effect at the start of the day after the day on which the appropriate authority has determined the authorisation status of all initial authorisation applications 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, F14are to be prescribed by the appropriate authority.

Article 18Transitional measures

1.

Notwithstanding Articles 7 and 17 of this Regulation, F15... the following food enzymes F16are, immediately after the end of the day on which the appropriate authority determines the authorisation status of all the applications for initial authorisation in the Register in accordance with Article 17, to be deemed to be authorised for the purposes of this Regulation:

(a)

E 1103 Invertase and E 1105 Lysozyme, F17in accordance with any conditions of use set out in authorisations under Regulation (EC) No 1333/2008;

(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.

Article 19Amendments to Directive 83/417/EEC

In Directive 83/417/EEC, in Annex I, Section III(d), the indents shall be replaced by the following:

  1. ‘—
    rennet meeting the requirements of Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes18;
  2. —

    other milk-coagulating enzymes meeting the requirements of Regulation (EC) No 1332/2008.’

Article 20Amendment to Regulation (EC) No 1493/1999

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 enzymes19.’

Article 21Amendments to Directive 2000/13/EC

Directive 2000/13/EC is hereby amended as follows:

  1. 1.

    Article 6(4) shall be amended as follows:

    1. (a)

      point (a) shall be replaced by the following:

      1. ‘(a)

        “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.’;

    2. (b)

      in point (c)(ii), the introductory word ‘additives’ shall be replaced by ‘additives and enzymes’;

    3. (c)

      in point (c)(iii), the words ‘additives or flavouring’ shall be replaced by ‘additives or enzymes or flavourings’;

  2. 2.

    the following indent shall be added to Article 6(6):

    1. ‘—

      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,’.

Article 22Amendments to Directive 2001/112/EC

In Directive 2001/112/EC, in Annex I, Section II(2), the fourth, fifth and sixth indents shall be replaced by the following:

  1. ‘—
    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 enzymes20;
  2. —

    Proteolytic enzymes meeting the requirements of Regulation (EC) No 1332/2008;

  3. —

    Amylolytic enzymes meeting the requirements of Regulation (EC) No 1332/2008.’

F18Article 23Amendment to Regulation (EC) No 258/97

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Article 24Entry into force

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 F19start of the day after the day on which the appropriate authority has determined the authorisation status of all initial authorisation applications in the Register in accordance with Article 17. 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 F20....

Articles 10 to 13 shall apply from 20 January 2010.