10.1  Requirements for the inclusion of substances in Section 10

10.1.1 The following criteria will be used for amending Section 10:

(a) they are consistent with principles of organic production (see Section 2.1);

(b) use of the substance is necessary/essential for its intended use;

(c) use of the substance does not result in, or contribute to harmful effects on the environment;

(d) they have the lowest negative impact on human or animal health and quality of life; and

(e) approved alternatives are not available in sufficient quantity and /or quality.

(f) with regard to minerals and trace elements used in animal nutrition, additional sources for these products may be included in Table 5 provided that they are of natural origin or failing that, synthetic in the same form as natural products.

The above criteria are intended to be evaluated as a whole in order to protect the integrity of organic production. In addition, the following criteria should be applied in the evaluation process:

(a) if they are used for fertilization, soil conditioning purposes:

- they are essential for obtaining or maintaining the fertility of the soil or to fulfil specific nutrition requirements of crops, or specific soil-conditioning and rotation purposes, which cannot be satisfied by the practices, included in Section 4., or other products included in Section 10, Table 1;
 and

- the ingredients will be plant, animal, microbial, or mineral origin and may undergo the following processes: physical (e.g., mechanical, thermal), enzymatic, microbial;
and
  - their use does not have harmful impact on soil organisms and/or physical characteristics of the soil;

(b) If they are used for the purpose of plant disease, pest control or weed control:

- they should be essential for the control of a harmful organism or a particular disease for which other biological, physical, or plant breeding alternatives and/or effective management practices are not available,
and
- substances should be plant, animal, microbial, or mineral origin and may undergo the following processes: physical (e.g. mechanical, thermal), enzymatic, microbial (e.g. composting, digestion);

However
- if they are used, in exceptional circumstances, in traps and dispensers such as pheromones, which are chemically synthesized, they will be considered for addition to the lists if the products are not available in sufficient quantities in their natural form, provided that the conditions for their use do not directly or indirectly result in the presence of residues of the product in the edible product;

(c) if they are used as additives or processing aids in the preparation or preservation of the food:

- these substances are found in nature and may have undergone mechanical/physical processes (e.g. extraction, precipitation), biological/enzymatic processes and microbial processes (e.g. fermentation),
or
- if these substances mentioned above are not available from such methods and technologies in sufficient quantities, then those substances that have been chemically synthesized may be considered for inclusion in exceptional circumstances;

- They are essential to prepare such products because there are no other available technologies;

- the consumer will not be deceived concerning the nature, substance and quality of the food.

10.1.2 Proposal for inclusion of products to Section 10

The following should be submitted with any proposal to include substances in section 10:

(a) a detailed description of the product and the conditions of its envisaged use;

(b) any information to demonstrate that the requirements under Section 10.1.1 are satisfied.