REQUIREMENTS FOR INCLUSION OF SUBSTANCES IN ANNEX 2 AND CRI...

SECTION 5. REQUIREMENTS FOR INCLUSION OF SUBSTANCES IN ANNEX 2 AND CRITERIA

FOR THE DEVELOPMENT OF LISTS OF SUBSTANCES BY COUNTRIES

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 these criteria to evaluate new substances for use in organic production,

countries should take into account all applicable statutory and regulatory provisions and make them available

to other countries upon request.

Any proposals for the inclusion in Annex 2 of new substances must meet the following general criteria:

i) they are consistent with principles of organic production as outlined in these Guidelines;

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

iii) manufacture, use and disposal of the substance does not result in, or contribute to, harmful effects on the

environment;

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

v) 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 (e.g., composting, fermentation);

only when the above processes have been exhausted, chemical processes may be considered and

only for the extraction of carriers and binders;

¹³

and

– their use does not have a harmful impact on the balance of the soil ecosystem or the physical

characteristics of the soil, or water and air quality; and

– their use may be restricted to specific conditions, specific regions or specific commodities;

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

– their use should take into account the potential harmful impact on the environment, the ecology (in

particular non-target organisms) and the health of consumers, livestock and bees; and

– substances should be of 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

13

The use of chemical processes in the context of these Criteria is an interim measure and should be reviewed.

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 used only if it has been shown that, without having recourse to them, it is

impossible to:

– produce or preserve the food, in the case of additives, or

– produce the food, in the case of processing aids

in the absence of other available technology that satisfies these Guidelines;

– 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;

– their use maintains the authenticity of the product;

– the consumer will not be deceived concerning the nature, substance and quality of the food;

– the additives and processing aids do not detract from the overall quality of the product.

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

involved.

5.2 Countries should develop or adopt a list of substances that meet the criteria outlined in Section 5.1.