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Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC article 47 CELEX: 02009R1107-20221121 Placing 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; (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. |
Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC article 47 CELEX: 02009R1107-20221121 3. The Member State shall decide within 120 days whether to approve an application for authorisation of a low-risk plant protection product.
Where the Member State 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 Member State.
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 Member State. Where at the end of that period the applicant has not submitted the missing elements, the Member State shall inform the applicant that the application is inadmissible. 4. Unless otherwise specified, all provisions relating to authorisations under this Regulation shall apply. |