1. The authorisation of products and substances for use in organic production and their inclusion in a restricted list of the products and substances referred to in Article 19(2)(b) and (c) shall be subject to the objectives and principles laid down in Title II and the following criteria, which shall be evaluated as a whole:
(i)
alternatives authorised in accordance with this chapter are not available;
(ii)
without having recourse to them, it would be impossible to produce or preserve the food or to fulfil given dietary requirements provided for on the basis of the Community legislation.
In addition, the products and substances referred to in Article 19(2)(b) are to be found in nature and may have undergone only mechanical, physical, biological, enzymatic or microbial processes, except where such products and substances from such sources are not available in sufficient quantities or qualities on the market.
2. The Commission shall, in accordance with the procedure referred to in Article 37(2), decide on the authorisation of the products and substances and their inclusion in the restricted list referred to in paragraph 1 of this Article and lay down specific conditions and limits for their use, and, if necessary, on the withdrawal of products.
Where a Member State considers that a product or substance should be added to, or withdrawn from the list referred to in paragraph 1, or that the specifications of use mentioned in this paragraph should be amended, the Member State shall ensure that a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.
Products and substances used before adoption of this Regulation and falling under Article 19(2)(b) and (c) may continue to be used after the said adoption. The Commission may, in any case, withdraw such products or substances in accordance with Article 37(2).