1. (a)

   applying processing method 1 (pressure sterilisation), when Category 2 material is used as starting material;

2. (b)

   F1using processed animal protein, including processed animal protein produced in accordance with point B.1(b)(ii) of Section 1 of Chapter II of Annex X, which has been produced from Category 3 material in accordance with Section 1 of Chapter II of Annex X, or materials which have been subject to another treatment, where such materials may be used for organic fertilisers and soil improvers in accordance with this Regulation; or

3. (c)

   by applying any of the processing methods 1 to 7, as set out in Chapter III of Annex IV, when Category 3 material is used as starting material which is not used for the production of processed animal protein.

Organic fertilisers and soil improvers which consist of or which have been produced from meat-and-bone meal derived from Category 2 material or from processed animal protein, shall be mixed, in a registered establishment or plant, with a sufficient minimum proportion of a component which is authorised by the competent authority of the Member State where the product is to be applied to land, in order to exclude the subsequent use of the mixture for feeding purposes.

1. (a)

   the component shall consist of lime, manure, urine, compost or digestion residues from the transformation of animal by-products into biogas or other substances, such as mineral fertilisers, which are not used in animal feed and which exclude the subsequent use of the mixture for feeding purposes according to good agricultural practice;

2. (b)

   the component shall be determined based on an assessment of the climatic and soil conditions for the use of the mixture as a fertiliser, on indications that the component renders the mixture unpalatable to animals or it is otherwise effective in preventing misuse of the mixture for feeding purposes and in accordance with the requirements laid down in Union legislation or, where applicable, national legislation, for the protection of the environment regarding the protection of soil and groundwater.

The competent authority shall make the list of the authorised components available to the Commission and to other Member States upon request.

1. (a)

   to organic fertilisers and soil improvers which are in ready-to-sell packages of not more than 50 kg in weight for use by the final consumer; or

2. (b)

   to organic fertilisers and soil improvers in big bags of not more than 1 000 kg in weight, on the packages of which it is indicated that the organic fertilisers are not destined to land to which farmed animals have access, provided that the competent authority of the Member State where the organic fertiliser or soil improver is to be applied to land, has authorised the use of such big bags on the basis of an assessment of the likelihood of a potential diversion of the materials to farms keeping animals or to land to which farmed animals have access.

• Chapter I of Annex X, in the case of processed animal protein or derived products from Category 2 or Category 3 material,

• Section 3 of Chapter III of Annex V in the case of compost and digestion residues from the transformation of animal by-products or derived products into biogas.