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1. The Commission may authorise certain products and substances for use in organic production, and shall include any such authorised products and substances in restrictive lists, for the following purposes:

(a) as active substances to be used in plant protection products;

(b) as fertilisers, soil conditioners and nutrients;

(c) as non-organic feed material of plant, algal, animal or yeast origin or as feed material of microbial or mineral origin;

(d) as feed additives and processing aids;

(e) as products for the cleaning and disinfection of ponds, cages, tanks, raceways, buildings or installations used for animal production;

(f) as products for the cleaning and disinfection of buildings and installations used for plant production, including for storage on an agricultural holding;

(g) as products for cleaning and disinfection in processing and storage facilities.

2. In addition to products and substances authorised in accordance with paragraph 1, the Commission may authorise certain products and substances for use in the production of processed organic food and of yeast used as food or feed, and shall include any such authorised products and substances in restrictive lists, for the following purposes:

(a) as food additives and processing aids;

(b) as non-organic agricultural ingredients to be used for the production of processed organic food;

(c) as processing aids for the production of yeast and yeast products.

3. The authorisation of the products and substances referred to in paragraph 1 for use in organic production shall be subject to the principles laid down in Chapter II and to the following criteria, which shall be evaluated as a whole:

(a) they are essential for sustained production and for the use for which they are intended;

(b) all of the products and substances concerned are of plant, algal, animal, microbial or mineral origin, except in cases where products or substances from such sources are not available in sufficient quantities or qualities or where alternatives are not available;

(c) in the case of products referred to in point (a) of paragraph 1:

(i) their use is essential for the control of a pest for which other biological, physical or breeding alternatives, cultivation practices or other effective management practices are not available;

(ii) if such products are not of plant, algal, animal, microbial or mineral origin and are not identical to their natural form, their conditions for use preclude any direct contact with the edible parts of the crop;

(d) in the case of products referred to in point (b) of paragraph 1, their use is essential for building or maintaining the fertility of the soil or to fulfil specific nutritional requirements of crops, or for specific soil-conditioning purposes;

(e) in the case of products referred to in points (c) and (d) of paragraph 1:

(i) their use is necessary to maintain animal health, animal welfare and vitality and contributes to an appropriate diet fulfilling the physiological and behavioural needs of the species concerned or their use is necessary to produce or preserve feed because the production or preservation of feed is not possible without having recourse to such substances;

(ii) feed of mineral origin, trace elements, vitamins or provitamins are of natural origin, except in cases where products or substances from such sources are not available in sufficient quantities or qualities or where alternatives are not available;

(iii) the use of non-organic feed material of plant or animal origin is necessary because feed material of plant or animal origin produced in accordance with organic production rules is not available in sufficient quantity;

(iv) the use of non-organic spices, herbs and molasses is necessary because such products are not available in organic form; they have to be produced or prepared without chemical solvents and their use is limited to 1 % of the feed ration for a given species, calculated annually as a percentage of the dry matter of feed from agricultural origin.

4. The authorisation of the products and substances referred to in paragraph 2 for use in the production of processed organic food or for the production of yeast used as food or feed shall be subject to the principles laid down in Chapter II and to the following criteria, which shall be evaluated as a whole:

(a) alternative products or substances authorised in accordance with this Article or techniques compliant with this Regulation are not available;

(b) it would be impossible to produce or preserve the food or to fulfil given dietary requirements provided for on the basis of Union legislation without having recourse to those products and substances;

(c) they are to be found in nature and may only have undergone mechanical, physical, biological, enzymatic or microbial processes, except in cases where products or substances from such sources are not available in sufficient quantities or qualities;

(d) the organic ingredient is not available in sufficient quantity.

5. The authorisation of the use of chemically synthesised products and substances, in accordance with paragraphs 1 and 2 of this Article, shall be strictly limited to cases where the use of external inputs referred to in point (g) of Article 5 would contribute to unacceptable impacts on the environment.

6. The Commission is empowered to adopt delegated acts in accordance with Article 54 amending paragraphs 3 and 4 of this Article by adding further criteria for the authorisation of products and substances referred to in paragraphs 1 and 2 of this Article for use in organic production in general, and in the production of processed organic food in particular, as well as further criteria for the withdrawal of such authorisations, or by amending those added criteria.

7. Where a Member State considers that a product or substance should be added to or withdrawn from the lists of authorised products and substances referred to in paragraphs 1 and 2, or that the specifications of use referred to in the production rules should be amended, it shall ensure that a dossier giving the reasons for the inclusion, withdrawal or other amendments is officially sent to the Commission and to the other Member States and is made publicly available, subject to Union and national legislation on data protection. The Commission shall publish any requests referred to in this paragraph.

8. The Commission shall regularly review the lists referred to in this Article. The list of non-organic ingredients referred to in point (b) of paragraph 2 shall be reviewed at least once a year.

9. The Commission shall adopt implementing acts concerning the authorisation or withdrawal of authorisation of products and substances in accordance with paragraphs 1 and 2 that may be used in organic production in general and in the production of processed organic food in particular, and establishing the procedures to be followed for such authorisations and the lists of such products and substances and, where appropriate, their description, compositional requirements and conditions for use. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).