7. Provisions in the Regulation
The provisions on authorisations through mutual recognition can be found in Articles 40 to 42 in the Regulation.
A plant protection product can only be mutually recognised if it has been granted an authorisation in the reference Member State according to article 29 in the Regulation. The procedure of mutual recognition means that the authorisation holder of a plant protection product may apply for an authorisation for the same plant protection product, for the same use and under comparable agricultural practices in another Member State, according to Article 40.1. It is our understanding that this should be interpreted the following way:
- “The same plant protection product” means identical in terms of: Manufacturing process and composition of the formulation; Sources of the technical active substance, safeners and synergists, as well as co-formulants. Please note that an equivalent product is not considered to qualify as being the same plant protection product.
- “The same use” means that it is not possible to extend the use to additional crops other than those authorised by the reference Member State. It is however possible to limit the use to certain crops.
- “Comparable agricultural practices” means that an authorisation through mutual recognition can only be granted based on the prerequisites and conditions adopted by the reference Member State. This means that the application technique and time of application cannot be changed. The number of applications and dose rates can be reduced if efficacy data, the risk through dermal exposure (please see in the section "Health hazard") and the test concentrations for each technical property still supports the change.
Regulations
Regulation 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market
Article 40
Mutual recognition
1. The holder of an authorisation granted in accordance with
Article 29 may apply for an authorisation for the same plant
protection product, the same use and under the comparable
agricultural practices in another Member State under the
mutual recognition procedure, provided for in this subsection,
in the following cases:
(a) the authorisation was granted by a Member State (reference
Member State) which belongs to the same zone;
(b) the authorisation was granted by a Member State (reference
Member State) which belongs to a different zone provided
that the authorisation for which the application was made is
not used for the purpose of mutual recognition in another
Member State within the same zone;
(c) the authorisation was granted by a Member State for use in
greenhouses, or as post-harvest treatment, or for treatment
of empty rooms or containers used for storing plant or
plant products, or for seed treatment, regardless of the
zone to which the reference Member State belongs.
2. Where a plant protection product is not authorised in a
Member State because no application for an authorisation has
been submitted in that Member State, official or scientific bodies
involved in agricultural activities or professional agricultural
organisations may apply, with the consent of the authorisation
holder, for an authorisation for the same plant protection
product, the same use and under the same agricultural
practices in that Member State under the mutual recognition
procedure referred to in paragraph 1. In that case the applicant
must demonstrate that the use of such a plant protection
product is of general interest for the Member State of introduction.
Where the authorisation holder refuses its consent, the
competent authority of the Member State concerned may
accept the application, on grounds of public interest.
Article 41
Authorisation
1. The Member State to which an application under
Article 40 is submitted shall, having examined the application
and the accompanying documents referred to in Article 42(1),
as appropriate with regard to the circumstances in its territory,
authorise the plant protection product concerned under the
same conditions as the Member State examining the application,
except where Article 36(3) applies.
2. By way of derogation from paragraph 1, the Member State
may authorise the plant protection product where:
(a) an authorisation under point (b) of Article 40(1) was
applied for;
(b) it contains a candidate of substitution;
(c) Article 30 has been applied; or
(d) it contains a substance approved in accordance with
Article 4(7).
Article 42
Procedure
1. The application shall be accompanied by the following:
(a) a copy of the authorisation granted by the reference
Member State as well as a translation of the authorisation
into an official language of the Member State receiving the
application;
(b) a formal statement that the plant protection product is
identical to that authorised by the reference Member State;
(c) a complete or summary dossier as required in Article 33(3)
when requested by the Member State;
(d) an assessment report of the reference Member State
containing information on the evaluation and decision on
the plant protection product.
2. The Member State to which an application under
Article 40 is submitted shall decide on the application within
120 days.
3. Where requested by the Member State, the applicant shall
submit the application in the national or official languages of
that Member State or one of those languages.