Article 16Products and substances used in farming and criteria for their authorisation
1.The Commission shall, in accordance with the procedure referred to in Article 37(2), authorise for use in organic production and include in a restricted list the products and substances, which may be used in organic farming for the following purposes:
(a)as plant protection products;
(b)as fertilisers and soil conditioners;
(c)as non-organic feed materials from plant origin, feed material from animal and mineral origin and certain substances used in animal nutrition;
(d)as feed additives and processing aids;
(e)as products for cleaning and disinfection of ponds, cages, buildings and installations for animal production;
(f)as products for cleaning and disinfection of buildings and installations used for plant production, including storage on an agricultural holding.
Products and substances contained in the restricted list may only be used in so far as the corresponding use is authorised in general agriculture in the Member States concerned in accordance with the relevant Community provisions or national provisions in conformity with Community law.
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:
(a)their use is necessary for sustained production and essential for its intended use;
(b)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;
(c)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;
(d)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;
(e)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.
3.(a)The Commission may, in accordance with the procedure referred to in Article 37(2), lay down conditions and limits as regards the agricultural products to which the products and substances referred to in paragraph 1 can be applied to, the application method, the dosage, the time limits for use and the contact with agricultural products and, if necessary, decide on the withdrawal of these products and substances.
(b)Where a Member State considers that a product or substance should be added to, or withdrawn from the list referred to in paragraph 1, or that the specifications of use mentioned in subparagraph (a) should be amended, the Member State shall ensure that a dossier giving the reasons for the inclusion, withdrawal or amendments is sent officially to the Commission and to the Member States.
Requests for amendment or withdrawal, as well as decisions thereon, shall be published.
(c)Products and substances used before adoption of this Regulation for purposes corresponding to those laid down in paragraph 1 of this Article, may continue to be used after said adoption. The Commission may in any case withdraw such products or substances in accordance with Article 37(2).
4.Member States may regulate, within their territory, the use of products and substances in organic farming for purposes different than those mentioned in paragraph 1 provided their use is subject to objectives and principles laid down in Title II and the general and specific criteria set out in paragraph 2, and in so far as it respects Community law. The Member State concerned shall inform other Member States and the Commission of such national rules.
5.The use of products and substances not covered under paragraph 1 and 4, and subject to the objectives and principles laid down in Title II and the general criteria in this Article, shall be allowed in organic farming.