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The Open Nature of the Lists

5.1 At least the following criteria should be used for the purposes of amending the permitted substance lists referred to in Section 4. In using this criteria to evaluate new substances for use in organic production, countries should take into account all applicable statutory and regulatory provisions. Any new substances must meet the following general criteria:

a) they are consistent with principles of organic production (see Foreword, paragraph 7);

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.

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 Annex 1, or other products included in Table 2 of Annex 2; and

- the ingredients will be of 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 the physical characteristics of the soil;

b) if they are used for the purpose of plant disease or pest and 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 products used, in exceptional circumstances, in traps and dispensers such as pheromones, which are chemically synthesized they will be considered for addition to 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 parts;

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 product because there are no other available technologies;

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

In the evaluation process of substances for inclusion on lists all stakeholders should have the opportunity to be involved.

5.2 Countries should develop a list of substances which satisfy the requirements of these guidelines. Substances included in the list developed by a country but not included in Annex 2 of these guidelines may be a part of the equivalence judgement and decision referred to in section 7.4 of these guidelines. In developing national lists, countries may reduce the list of substances indicated in the lists included in Annex 2. Countries may include in their own lists substances other than those listed in Annex 2 only if:

- the criteria in 5.1 are used as a basis for these additions;
- they are notified in accordance with 5.3 and 5.4 below.
5.3 When a country proposes inclusion of a substance in Annex 2 it should submit the following information:
a) a detailed description of the product and the conditions of its envisaged use;
b) any information to demonstrate that the requirements under Section 5.1 are satisfied.

The Open Nature of the Lists

5.4 Because of the primary purpose of providing a list of substances, the lists in Annex 2 are open and subject to the inclusion of additional substances or the removal of existing ones on an ongoing basis. The procedure for requesting amendments to the lists is se out under Section 8 of these Guidelines.

[13] These criteria are recommended to governments on a trial basis in order to achieve experience with organic production principles and rules at national level. They will be reviewed within a period of 4 years. Until such review has taken place, Member Countries may implement these criteria or the criteria which they have developed on the basis of the experience they have made at national level.

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