The Plant Protection Products Regulations 1995

Duplication of experiments

16.—(1) Notwithstanding regulation 5(4), and without prejudice to regulation 11, where an active substance has been included in Annex I—

(a) any person who intends to apply for approval under regulation 5 or 7 of a plant protection product containing that substance, and who intends to use that plant protection product in an experiment involving vertebrate animals, shall enquire of the Ministers—

(i) whether approval has already been granted for that plant protection product and, if so,

(ii) as to the name and address of any holder of a previous or existing approval,and shall supply evidence that he intends to apply for approval on his own behalf and that the other information specified in regulation 5(4) is available;

(b) the Ministers, if satisfied that that person intends to make such an application, shall provide him with the name and address of the holder or holders of previous or existing approvals and at the same time inform the holders of those approvals of the name and address of that person.

(2) The holder or holders of previous approvals and the person intending to make the application shall take all reasonable steps to reach agreement on the sharing of information so as to avoid the duplication of testing on vertebrate animals.

(3) Where a person requests any information with a view to inclusion of an old active substance in Annex I, the Ministers shall encourage holders of such information to co-operate in the provision of the requested information, with a view to limiting the duplication of testing on vertebrate animals.

(4) Where a person who intends to apply for approval of a plant protection product and holders of previous approvals of the same product cannot reach an agreement on the sharing of information, the Ministers may direct that person and holders of previous approvals located within Great Britain to share the information with a view to avoiding duplicative testing on vertebrate animals and determine both the procedure for utilising information and the reasonable balance of the interests of the parties concerned.

(5) Any person who—

(a) fails to make enquiries as required in paragraph (1)(a) above; or

(b) fails to comply with a direction made by the Ministers under paragraph (4) above,shall be guilty of an offence.

(6) Any person who causes or permits any person to—

(a) fail to make enquiries as required in paragraph (1)(a) above; or

(b) fail to comply with a direction made by the Ministers under paragraph (4) above,shall be guilty of an offence.