CHAPTER IIIPLANT PROTECTION PRODUCTS
SECTION 1Authorisation
Article 47Placing on the market of low-risk plant protection products
1.
Where all the active substances contained in a plant protection product are low-risk active substances as referred to in Article 22, that product shall be authorised as a low-risk plant protection product provided no specific risk mitigation measures are needed following a risk assessment. This plant protection product shall also meet the following requirements:
(a)
the low-risk active substances, safeners and synergists contained in it have been approved under Chapter II F1in relation to the constituent territory of application;
(b)
it does not contain a substance of concern;
(c)
it is sufficiently effective;
(d)
it does not cause unnecessary pain and suffering to vertebrates to be controlled;
(e)
it complies with points (b), (c) and (f) to (i) of Article 29(1).
These products are referred to as ‘low-risk plant protection products’.
2.
An applicant for authorisation of a low-risk plant protection product shall demonstrate that the requirements set out in paragraph 1 are met and shall submit with the application a complete and a summary dossier for each point of the data requirements of the active substance and the plant protection product.
3.
F2A competent authority shall decide within 120 days whether to approve an application for authorisation of a low-risk plant protection product.
Where the F3competent authority needs additional information, it shall set a time limit for the applicant to supply it. In that case, the period specified shall be extended by the additional time limit granted by the F3competent authority.
The additional period shall be of a maximum of 6 months and shall cease at the moment when the additional information is received by the F3competent authority. Where at the end of that period the applicant has not submitted the missing elements, the F3competent authority shall inform the applicant that the application is inadmissible.
4.
Unless otherwise specified, all provisions relating to authorisations under this Regulation shall apply.