ANNEX I
INFORMATION ON THE PLANT PROTECTION PRODUCT IDENTIFICATION AND CONDITIONS OF USE
1. INFORMATION ON PLANT PROTECTION PRODUCT IDENTIFICATION
(a) | Trade name or proposed trade name. |
(b) | Authorisation number of the plant protection product. |
(c) | Name, address and telephone number of the authorisation holder and, if different, the name and address of the company placing the product on the market. |
(d) | Formulation type (for example: wettable powder, emulsifiable concentrate). |
(e) | Name and the concentration of active substance(s) that the plant protection product contains. The name of each active substance as common name expressed as provided for in Commission Implementing Regulation (EU) No 540/2011 (1) with clear indication of the chemical form, or if not included therein its ISO common name. If the latter is not available, the active substance shall be designated by its chemical designation according to IUPAC rules. In case the active substance is a micro-organism, the name of the approved strain as provided for in Implementing Regulation (EU) No 540/2011 and any other designation which may be relevant to identify the micro-organism (for example, isolate level, if relevant for viruses). The concentration of each active substance expressed as follows: for chemical active substances in formulations which are solids, aerosols, volatile liquids (maximum boiling point 50 °C) or viscous liquids (lower limit 1 Pa s at 20 °C), as % w/w and g/kg, for chemical active substances in other liquids/gel formulations, as % w/w and g/l, for chemical active substances in formulations which are gases, as % v/v (at atmospheric pressure) and % w/w, for active substances that are micro-organisms: the number of active units per volume or weight of plant protection product, for example, colony forming units or international units per volume or weight, or any other manner that is most relevant to the plant protection action and the weight of active substance per volume or weight of plant protection products, if applicable. |
(f) | Name and the concentration of the safener(s) and synergist(s) that the plant protection product contains. |
(g) | Net quantity of plant protection product given in: g or kg for solid formulations ml or l for liquid formulations (at room temperature) g, kg, ml or l for gases (as measured at atmospheric pressure and room temperature). |
(h) | Formulation batch number and date of manufacture. This information may be included only on the packaging of the plant protection product. The digital label of the plant protection product shall include the following: ‘Refer to the formulation batch number and date of manufacture indicated on the physical label or on the packaging of the plant protection product.’. |
(i) | Information on first aid. This information may be also included on the packaging of the plant protection product. |
2. CONDITIONS OF USE OF THE PLANT PROTECTION PRODUCT
(j) | The categories of users allowed to use the plant protection product, where use is limited to certain categories. |
(k) | The type of action of the plant protection product (for example: insecticide, growth regulator, herbicide, fungicide) and where relevant the pest(s) to be controlled. If available and relevant, the mode of action of the active substance(s) in accordance with Resistance Committees Codes (2). This statement may use descriptive terms such as ‘kills’, ‘controls’, ‘repels’, ‘eradicates’. |
(l) | Crop(s), where relevant, growth stage(s) of plants in accordance with the BBCH monograph (3), or situations/land use(s) (4) for which the plant protection product has been authorised. |
(m) | Conditions of use for which the plant protection product has been authorised. Where relevant, any other specification of the method of application required in the authorisation should be stated. The label of plant protection products authorised for professional users shall include the following: ‘To be used in accordance with the general principles of integrated pest management’. |
(n) | Dose rate including the maximum rate per application, where applicable, also the minimum rate per application, the maximum number of applications, information on season at time of application and the interval between each application. Where relevant, the label of a plant protection product limited to professional users shall include the following: ‘When using equipment that increases the precision and accuracy of the application compared to conventional application equipment, reductions of the applied plant protection product per hectare are allowed if the authorised application rate on the target surfaces is maintained.’ |
(o) | Where relevant, safety interval, re-entry intervals, withholding intervals necessary to minimise the presence of residues in or on crops, plants and plant products, or in treated areas or spaces, with a view to protecting humans, animals and the environment, shall be specified, such as: pre-harvest interval re-entry interval (in days) for livestock, to areas to be grazed re-entry interval (in hours or days) for humans to crops, buildings or spaces treated withholding interval (in days) for animal feeding stuffs and for post-harvest uses waiting period (in days) between application and handling treated products. |
(p) | Restrictions/specific farming practices set by the competent authorities when authorising the plant protection product with consideration for specific local conditions. |
(q) | Particulars of possible phytotoxicity, varietal susceptibility, and any other direct or indirect adverse side effects on plants or products of plant origin together with the intervals to be observed between application and sowing or planting of: the crop in question, or succeeding and adjacent crops. |
(r) | Appropriate conditions of storage (for example: humidity, storage temperature, exposure to light of the package) and safe disposal of the plant protection product and of the packaging according to the specific provisions set by Member States if these differ from the standard phrases of Annex II. |
(s) | Where considered necessary, the expiry date of the plant protection product. This information may be included only on the packaging of the plant protection product. The digital label of the plant protection product shall include the following: ‘Refer to the expiry date indicated on the physical label or on the packaging of the plant protection product.’. |
(1) Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1, ELI: http://data.europa.eu/eli/reg_impl/2011/540/oj).
(2) Resistance Action Committee for herbicides (HRAC), insecticides (IRAC) and fungicides (FRAC).
(3) Meier, Uwe, ed. Growth stages of mono- and dicotyledonous plants. BBCH Monograph. Quedlinburg 2018. Open Agrar Repositorium. doi: 10.5073/20180906-074619 ISBN: 978-3-95547-071-5.
(4) Refers to not agricultural areas: forests, public spaces, railways, etc.