1.Additives, processing aids and other substances and ingredients used for processing food or feed and any processing practice applied, such as smoking, shall respect the principles of good manufacturing practice.
2.Operators producing processed feed or food shall establish and update appropriate procedures based on a systematic identification of critical processing steps.
3.The application of the procedures referred to in paragraph 2 shall guarantee at all times that the produced processed products comply with the organic production rules.
4.Operators shall comply with and implement the procedures referred to in paragraph 2. In particular, operators shall:
(a)take precautionary measures to avoid the risk of contamination by unauthorised substances or products;
(b)implement suitable cleaning measures, monitor their effectiveness and record these operations;
(c)guarantee that non-organic products are not placed on the market with an indication referring to the organic production method.
5.Further to the provisions laid down in paragraphs 2 and 4, when non-organic products are also prepared or stored in the preparation unit concerned, the operator shall:
(a)carry out the operations continuously until the complete run has been dealt with, separated by place or time from similar operations performed on non-organic products;
(b)store organic products, before and after the operations, separate by place or time from non-organic products;
(c)inform the control authority or control body thereof and keep available an updated register of all operations and quantities processed;
(d)take the necessary measures to ensure identification of lots and to avoid mixtures or exchanges with non-organic products;
(e)carry out operations on organic products only after suitable cleaning of the production equipment.
1.For the purpose of Article 19(2)(b) of Regulation (EC) No 834/2007, only the following substances can be used in the processing of organic food, with the exception of wine:
(a)substances listed in Annex VIII to this Regulation;
(b)preparations of micro-organisms and enzymes normally used in food processing;[F1 however, enzymes to be used as food additives have to be listed in Annex VIII, Section A;]
(c)substances, and products as defined in Articles 1(2)(b)(i) and 1(2)(c) of Council Directive 88/388/EEC(1) labelled as natural flavouring substances or natural flavouring preparations, according to Articles 9(1)(d) and (2) of that Directive;
(d)colours for stamping meat and eggshells in accordance with, respectively, Article 2(8) and Article 2(9) of European Parliament and Council Directive 94/36/EC(2);
(e)drinking water and salt (with sodium chloride or potassium chloride as basic components) generally used in food processing;
(f)minerals (trace elements included), vitamins, aminoacids, and micronutrients, only authorised as far their use is legally required in the foodstuffs in which they are incorporated.
2.For the purpose of the calculation referred to in Article 23(4)(a)(ii) of Regulation (EC) No 834/2007,
(a)food additives listed in Annex VIII and marked with an asterisk in the column of the additive code number, shall be calculated as ingredients of agricultural origin;
(b)preparations and substances referred to in paragraph (1)(b),(c),(d),(e) and (f) of this Article and substances not marked with an asterisk in the column of the additive code number shall not be calculated as ingredients of agricultural origin[F2;]
[F1(c) yeast and yeast products shall be calculated as ingredients of agricultural origin as of 31 December 2013 .]
3.The use of the following substances listed in Annex VIII shall be re-examined before 31 December 2010:
(a)Sodium nitrite and potassium nitrate in Section A with a view to withdrawing these additives;
(b)Sulphur dioxide and potassium metabisulphite in Section A;
(c)Hydrochloric acid in Section B for the processing of Gouda, Edam and Maasdammer cheeses, Boerenkaas, Friese, and Leidse Nagelkaas.
The re-examination referred to in point (a) shall take account of the efforts made by Member States to find safe alternatives to nitrites/nitrates and in establishing educational programmes in alternative processing methods and hygiene for organic meat processors/manufacturers.
[F14. For the traditional decorative colouring of the shell of boiled eggs produced with the intention to place them on the market at a given period of the year, the competent authority may authorise for the period referred to above, the use of natural colours and natural coating substances. The authorisation may comprise synthetic forms of iron oxides and iron hydroxides until 31 December 2013 . Authorisations shall be notified to the Commission and the Member States.]
Textual Amendments
F1 Inserted by Commission Regulation (EC) No 1254/2008 of 15 December 2008 amending Regulation (EC) No 889/2008 laying down detailed rules for implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control.
F2 Substituted by Commission Regulation (EC) No 1254/2008 of 15 December 2008 amending Regulation (EC) No 889/2008 laying down detailed rules for implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control.
For the purpose of the application of Article 20(1) of Regulation (EC) No 834/2007, the following substances may be used in the production, confection and formulation of yeast:
substances listed in Annex VIII, Section C to this Regulation;
products and substances referred to in Article 27(1)(b) and (e) of this Regulation.]
Textual Amendments
F1 Inserted by Commission Regulation (EC) No 1254/2008 of 15 December 2008 amending Regulation (EC) No 889/2008 laying down detailed rules for implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control.
For the purpose of Article 19(2)(c) of Regulation (EC) No 834/2007, non-organic agricultural ingredients listed in Annex IX to this Regulation can be used in the processing of organic food.
1.Where an ingredient of agricultural origin is not included in Annex IX to this Regulation, that ingredient may only be used under the following conditions:
(a)the operator has notified to the competent authority of the Member State all the requisite evidence showing that the ingredient concerned is not produced in sufficient quantity in the Community in accordance with the organic production rules or cannot be imported from third countries;
(b)the competent authority of the Member State has provisionally authorised, the use for a maximum period of 12 months after having verified that the operator has undertaken the necessary contacts with suppliers in the Community to ensure himself of the unavailability of the ingredients concerned with the required quality requirements;
(c)no decision has been taken, in accordance with the provisions of paragraphs 3 or 4 that a granted authorisation with regard to the ingredient concerned shall be withdrawn.
The Member State may prolong the authorisation provided for in point (b) a maximum of three times for 12 months each.
2.Where an authorisation as referred to in paragraph 1 has been granted, the Member State shall immediately notify to the other Member States and to the Commission, the following information:
(a)the date of the authorisation and in case of a prolonged authorisation, the date of the first authorisation;
(b)the name, address, telephone, and where relevant, fax and e-mail of the holder of the authorisation; the name and address of the contact point of the authority which granted the authorisation;
(c)the name and, where necessary, the precise description and quality requirements of the ingredient of agricultural origin concerned;
(d)the type of products for the preparation of which the requested ingredient is necessary;
(e)the quantities that are required and the justification for those quantities;
(f)the reasons for, and expected period of, the shortage;
(g)the date on which the Member State sends this notification to the other Member States and the Commission. The Commission and/or Member States may make this information available to the public.
3.Where a Member State submits comments to the Commission and to the Member State which granted the authorisation, which show that supplies are available during the period of the shortage, the Member State shall consider withdrawal of the authorisation or reducing the envisaged period of validity, and shall inform the Commission and the other Member States of the measures it has taken or will take, within 15 working days from the date of receipt of the information.
4.At the request of a Member State or at the Commission's initiative, the matter shall be submitted for examination to the Committee set up in accordance with Article 37 of Regulation (EC) No 834/2007. It may be decided, in accordance with the procedure laid down in paragraph 2 of that Article, that a previously granted authorisation shall be withdrawn or its period of validity amended, or where appropriate, that the ingredient concerned shall be included in Annex IX to this Regulation.
5.In case of an extension as referred to in the second subparagraph of paragraph 1, the procedures of paragraphs 2 and 3 shall apply.