Application and amendment of packaging of plant protection products
In accordance with Article 31 of Regulation (EU) No 1107/2009, the Federal Office of Consumer Protection and Food Safety (BVL) determines the permissible packaging with the authorisation of a plant protection product. The data requirements for plant protection products according to Regulation (EU) No 284/2013 apply to the application.
Application for packaging
All intended packaging must be stated in the application for authorisation. The information includes size, material and type of packaging and should be supported by specifications (see below for more information). The applicant can apply for any number of packages with different packaging sizes, materials and types.
After a final assessment, the packaging is specified by the BVL in the authorisation certificate. The information in the notice includes the size, material and type of packaging. If it is a plant protection product for non-professional use, this packaging is mentioned separately, as additional requirements apply for this (see below).
Change of packaging
If different packaging (in terms of packaging size, material and/or type) is to be used for an authorised plant protection product, this must be applied for again at the BVL. After examination of the application, a corresponding notice of amendment will be issued.
The application for changing the packaging is made informally. In principle, all the above-mentioned information that is required when applying for packaging should also be provided when applying for a packaging change. In cases where the packaging is to be authorised for non-professional users, this information must be provided explicitly. The documents can either be submitted by e-mail (200@bvl.bund.de) or via the applicant portal.
Packaging size
The packaging sizes are decided by the BVL as requested in the application form. The packaging size to be indicated is the quantity of plant protection product contained in the packaging and not the nominal size of the packaging chosen.
It is possible to use the following size classes when applying for packaging:
- packaging containing less than 1 L or kg
- packaging containing 1 L/ kg to 20 L/ kg
- packaging containing more than 20 L/ kg up to 1000 L / kg
- packaging containing more than 1000 L or kg.
Likewise, defined sizes such as 1 L or 5 kg can be applied for.
It should be noted that solid formulation types such as WG (water dispersible granules) or WP (wettable powders) should be declared in kg containers and liquid formulations such as SC (suspension concentrates) or EC (emusifiable concentrates) in L containers.
Packaging material
The packaging material shall be specified precisely, e.g. "HDPE" or "fluorinated HDPE"; "plastic" alone is not sufficient. The packaging materials are stored in the application form as a code list. If there is a new packing material, a precise description must be provided in the application form under "Remarks".
When changing a packaging, transferability of the study data of the new packaging materials should be ensured. Otherwise, appropriate studies need to be submitted. New packaging (material and/or type of packaging) should be allocated a specification.
| German | English |
|---|---|
| HDPE | HDPE |
| HDPE, fluoriert | HDPE, fluorinated |
| PE | PE |
| PP | PP |
| PET | PET |
| PA | PA |
| Kunststoff, wasserlöslich (wasserlöslicher Folienbeutel) | plastic, water-soluble (water soluble bag) |
| Metall | metal |
| Beschichtetes Metall | metal, coated |
| Stahl | steel |
| Metall mit Kunststoffbeutel | metal with plastic bag |
| Aluminium innenliegend PVA | aluminium inside PVA |
| Aluminium | aluminium |
| Pappe, Karton | cardboard |
| Papier | paper |
| Karton, beschichtet | cardboard, coated |
| Pappe mit Innenfolie | cardboard, inside plastic bag |
| Papier/PE | paper/PE |
| Glas | glass |
| LDPE | LDPE |
| LDPE/Verbundmaterial | LDPE/composite material |
| LDPE/Karton | LDPE/cardboard |
| Verbundmaterial | composite material |
| COEX | COEX |
| HDPE/PA | HDPE/PA |
| HDPE/EVOH | HDPE/EVOH |
| PE/PA | PE/PA |
| PE/EVOH | PE/EVOH |
| PET/PE | PET/PE |
| PET/PE/EVOH | PET/PE/EVOH |
| Sonstige | other |
Only packaging material that has been tested by means of storage stability studies or whose suitability has been proven by transferable data from other tested materials can be authorised. The packaging information should be consistent with the application form, the draft Registration Report (dRR) and the tested material in the storage stability studies.
Extrapolation of study data from other packaging materials is possible.
The storage stability studies of the plant protection product must be based on the least stable packaging material used. For example, for a plant protection product, study data can be submitted in HDPE material and extrapolated to packaging materials such as HDPE/PA or HDPE/F. The reverse is not possible. If studies are available in HDPE/PA, packaging materials made of HDPE are not eligible for approval.
The packaging materials HDPE/EVOH, HDPE/F, HDPE/PA are comparable with each other, so that no additional studies need to be carried out.
Type of packaging
The type of packaging, e.g. canister or can, must be stated. The packaging types are stored in the application form by means of a code list. If it is a new type, a precise description must be given in the application form under "Remarks".
| German | English |
|---|---|
| Flasche | bottle |
| Flasche mit Pipette | bottle with pipette |
| Flasche mit Pumpsprüher | bottle with pump sprayer |
| Flasche mit separater Dosiereinheit | bottle with separate dosing unit |
| Dosierflasche | dosage bottle |
| Kartusche mit Dosierflasche | cartridge with dosing bottle |
| Dose | can |
| Eimer | bucket |
| Kanister | jerry can |
| Kanister mit Pumpsprüher | canister with pump sprayer |
| Kanister mit elektrischer Sprüheinheit | canister with electric spray unit |
| Dosierkanister | dosage jerry can |
| Beutel | bag |
| Beutel in Dose | bag in can |
| Beutel in Druckdose | bag in pressure can |
| Kartusche | cartridge |
| Kartusche (mit Beutel) | cartridge (with bag) |
| Sack | sack |
| Sack in Karton | sack in cardboard box |
| Schachtel | box |
| Faltschachtel | folding box |
| Karton | cardboard box |
| Faltschachtel mit Innenbeutel | folding box with inner bag |
| Tank | tank |
| Trommel, Fass, Tonne | barrel |
| IBC Intermediate Bulk Container | IBC-Container |
| Druckbehälter | pressure tank |
| Aerosoldose | aerosol can |
| Verbundbeutel in Aerosoldose | composite bag in aerosol can |
| Blister | blister |
| Tube | tube |
| Kapsel | capsule |
| Patrone | bullet |
| Ampulle | ampoule |
| Pflaster | plaster |
| Stäbchen | sticks |
| Röhrchen | tube |
| (Einweg-)Spritze | disposable syringe |
| Sonstige | other |
Requirements for packaging for non-professional use
Detailed information on the requirements for packaging for non-professional use is summarised in a separate document.
For all plant protection products that are not formulated ready for use, a dosing accuracy of ± 10 % must be ensured. The dosing system for the preparation of a ready-to-use product (e.g. spray liquid) must be designed in such a way that the user cannot be endangered if the product is used properly and as intended.
A maximum packaging size must not be exceeded. The basis for the calculation of the maximum packaging sizes are:
- the treatment of an area of 500 m² and
- the lowest application rate intended for an area of application.
If only one packaging size is intended for the treatment of an area of 400 - 500 m², at least one further packaging size must be offered for the treatment of a smaller area. In addition, the packaging size can be assessed individually if, for example, a calculation is not possible or does not make sense (e.g. spray can, plant protection sticks).