2.
The authorisation of the products and substances referred to in paragraph 1 is subject to the objectives and principles laid down in Title II and the following general and specific criteria which shall be evaluated as a whole: their use is necessary for sustained production and essential for its intended use; all products and substances shall be of plant, animal, microbial or mineral origin except where products or substances from such sources are not available in sufficient quantities or qualities or if alternatives are not available; in the case of products referred to in paragraph 1(a), the following shall apply: their use is essential for the control of a harmful organism or a particular disease for which other biological, physical or breeding alternatives or cultivation practices or other effective management practices are not available; if products are not of plant, animal, microbial or mineral origin and are not identical to their natural form, they may be authorised only if their conditions for use preclude any direct contact with the edible parts of the crop; in the case of products referred to in paragraph 1(b), their use is essential for obtaining or maintaining the fertility of the soil or to fulfil specific nutrition requirements of crops, or specific soil-conditioning purposes; in the case of products referred to in paragraph 1(c) and (d), the following shall apply: they are necessary to maintain animal health, animal welfare and vitality and contribute to an appropriate diet fulfilling the physiological and behavioural needs of the species concerned or it would be impossible to produce or preserve such feed without having recourse to such substances; feed of mineral origin, trace elements, vitamins or provitamins shall be of natural origin. In case these substances are unavailable, chemically well-defined analogic substances may be authorised for use in organic production.
← art_16__para_1__text_2 · All articles · art_16__para_2__text_1 →
Source: EUR-Lex (Cellar) · retrieved 2026-11-05 · Text as adopted (Official Journal); later amendments are not incorporated in this text.