Traduction de «Essai de produits phytopharmaceutiques » (Français → Anglais) :

3. Data protection under paragraph 1 shall only be granted where the first applicant has claimed data protection for test and study reports concerning the active substance, safener or synergist, adjuvant and the plant protection product at the time of submitting the dossier and has provided to the Member State concerned for each test or study report the information referred to in point (f) of Article 8(1) and in point (d) of Article 33(3) as well as confirmation that a period of data protection has never been granted for the test or study report or that any period granted has not expired.

This Regulation, and the legislation establishing data requirements for active substances, plant protection products, safeners and synergists, should ensure that testing on vertebrate animals is minimised and that double testing is avoided, and promote the use of non-animal test methods and intelligent testing strategies.

for each point of the data requirements for the plant protection product referred to in paragraph 3 , the summaries and results of tests and studies, the name of their owner and of the person or institute that carried out the tests and studies, relevant to the assessment of the criteria referred to in Article 4 for one or more plant protection products which are representative of the uses referred to in point (a), taking into account the fact that any data gaps in the dossier, as provided for in paragraph 2, resulting from the proposed limited range of representative uses of the active substance, shall lead to non-approval of the active ...[+++]substance ;

This Regulation, and the legislation establishing data requirements for active substances, plant protection products, safeners and synergists, should ensure that testing on vertebrate animals is minimised and that double-testing is avoided, and promote the use of non-animal test methods and intelligent testing strategies.

the ▐data requirements for active substances and for plant protection products, as referred to in Article 9 (1)(b) and (c), including measures to minimise animal testing, in particular the use of non-animal testing methods and intelligent testing strategies, taking into account scientific and technical knowledge;

for each point of the data requirements for the plant protection product referred to in paragraph 3 , the summaries and results of tests and studies, the name of their owner and of the person or institute that carried out the tests and studies, relevant to the assessment of the criteria referred to in Article 4 for one or more plant protection products which are representative of the uses referred to in point (a), taking into account the fact that any data gaps in the dossier, as provided for in paragraph 2, resulting from the proposed limited range of representative uses of the active substance, shall lead to non-approval of the active ...[+++]substance ;