Traduction de «Prodotto non liberalizzato a livello comunitario » (Italien → Anglais) :

An active substance, safener or synergist shall only be approved if, on the basis of the assessment of Community or internationally agreed test guidelines or other available data and information, including a review of the scientific literature, reviewed by the Authority, it is not considered to have endocrine disrupting properties that may cause adverse effect in humans, unless the exposure of humans to that active substance, safener or synergist in a plant protection product, under realistic proposed conditions of use, is negligible, that is, the product is used in closed systems or in other conditions excluding contact with humans and ...[+++]where residues of the active substance, safener or synergist concerned on food and feed do not exceed the default value set in accordance with point (b) of Article 18(1) of Regulation (EC) No 396/2005.

According to Directive 89/106/EEC a product is presumed to be fit for use if it conforms to a harmonised standard, a European technical approval or a non-harmonised technical specification recognised at Community level.

nevertheless, where an agricultural or other product or a foodstuff possesses particular characteristics which are due to its geographical origin, it is possible for the producers of the product or foodstuff to apply, through the competent authorities of the Member State concerned, for registration at Community level of a protected designation of origin (PDO) or a protected geographical indication (PGI) in accordance with the provisions of Council Regulation No 510/2006 of 20 March 2006 on the protection of geographical indications an ...[+++]d designations of origin for agricultural products and foodstuffs (49); the granting of registration means that the Community has recognised the existence of very close links between the specific qualities of the product concerned and its geographical origin; in such cases, the common interest does not oppose the granting of aid for advertising which includes a reference to the origin of the product concerned, provided that the references to origin correspond exactly to those references which have been registered by the Community; similar considerations apply to other designations of origin which are protected under Community legislation, for example wines produced in specified regions in accordance with Articles 54–58 of Council Regulation (EC) No 1493/1999 of 17 May on the common organisation of the market in wine (50);

Member States shall evaluate the possibility of the plant protection product reaching surface water under the proposed conditions of use; if this possibility exists they shall estimate, using a suitable calculation model validated at Community level, the short-term and long-term predicted concentration of the active substance and of metabolites, degradation and reaction products that could be expected in the surface water in the area of envisaged use after use of the plant protection product according to the proposed conditions of us ...[+++]e.

Member States shall evaluate the possibility of the plant protection product reaching the groundwater under the proposed conditions of use; if this possibility exists, they shall estimate, using a suitable calculation model validated at Community level, the concentration of the active substance and of relevant metabolites, degradation and reaction products that could be expected in the groundwater in the area of envisaged use after use of the plant protection product according to the proposed conditions of use.

- refrain from requiring the repetition of tests and analyses already carried out in connection with the authorization of the product in that Member State, and to the extent that agricultural, plant health and environmental (including climatic) conditions relevant to the use of the product are comparable in the regions concerned, and