Labelling of plant protection products

Plant protection products may only be placed on the market in Germany if they are correctly labelled. Labelling is checked by the plant protection services of the federal states. Correct and up-to-date labelling enables safe handling, facilitates advice and is a prerequisite for correct and intended use. The following content provides an overview of the structure of correct labelling.

In Germany, legal regulations from different regulatory areas apply. In principle, plant protection products may only be placed on the market or transferred within Germany if the provisions of Sections 13 and 14 of the Chemicals Act have been applied. The information required by Section 31 of the Plant Protection Act and Annex I of the Implementing Regulation on the Labeling of Plant Protection Products Regulation (EU) No. 547/2011 must be printed on the containers and outer packaging ready for delivery.

The labelling must be in German and clearly visible. The text must be easy to read and indelible.

The labelling of plant protection products at a glance

Relevant legal regulations

The following legislation is relevant for the labelling of plant protection products:

International, EU:

National:

Definitions of terms relating to labelling

Labelling:
The labelling refers to the written part on the label and, if applicable, the supplementary information sheet.

Product:
The product is the plant protection product.

Packaging or container:
The packaging or container (e.g. glass bottle, plastic bottle, canister, spray can or plastic bag) contains the plant protection product and is in direct contact with it. When unopened, the packaging or container safely separates the crop protection product from its environment.

Outer packaging:
The outer packaging is, for example, an outer cardboard box containing the packaging or container with the product.

Label:
The label is a sign on the packaging or container. It contains all the information for labelling the product. If there is not enough space on the label, certain parts of the labelling can be included in an accompanying leaflet.

Instructions for use:
In Germany, the term instructions for use is often used synonymously with the term labelling. In this case, the term instructions for use includes all written information required for the labelling of plant protection products. These are either printed in full on the label or certain information can also be included on a leaflet accompanying the packaging. Occasionally, the term instructions for use is also used synonymously.

Container:
A container is a packaging unit consisting of packaged goods (in this case the product pesticide) and packaging or container.

Leaflet:
Regulation (EU) No. 547/2011 states: If the label space available on the packaging is not sufficient for labelling, certain information may appear on a leaflet accompanying the packaging. Such a leaflet is then considered part of the labelling. If an information sheet is enclosed, the following sentence must appear on the label: "Read the enclosed instructions before use". In Germany, this leaflet is often also referred to as the instructions for use.

Placing on the market:
Placing on the market means importing, offering for sale and any form of transfer to third parties.

Intra-Community transfer:
Plant protection products for which a valid authorisation for parallel trade exists are not imported into Germany, but rather brought into Germany.

Information that MUST appear on the label

The labelling provisions of §§ 13 and 14 of the Chemicals Act are to be applied. These stipulate the classification, packaging and labelling obligations of those who place substances and mixtures on the market. The classification, labelling and packaging of substances and mixtures are based on the provisions of Regulation (EC) No. 1272/2008 (CLP Regulation). The following must be indicated:

  • GHS pictograms and signal words, as well as hazard statements (H-phrases) and precautionary statements (P-phrases)
  • Information on first aid

The ECHA provides a guideline on labelling and packaging in accordance with Regulation (EC) No. 1272/2008 (CLP Regulation). This includes information on the size and arrangement of the hazard symbols. The BAuA is the responsible authority for the REACH and CLP Regulation in Germany.

According to Article 1 in conjunction with Annex I of Regulation (EU) No. 547/2011, the following information MUST be included on the label of plant protection products:

  • Trade name of the plant protection product.
  • Name and address of the authorisation holder or the holder of the parallel trade permit (PT) and, if different, the name and address of the person responsible for the final packaging and/or labelling of the plant protection product.
  • Authorisation number or the parallel trade number of the plant protection product.
  • Name and concentration of each active substance (for further details, see Annex I, paragraphs (1) c) and d) of Regulation (EU) No. 547/2011)
  • Active substances must also be named if the active substance has been added in the function of an adjuvant.
  • The area of application of the plant protection product (e.g. insecticide, growth regulator, herbicide, fungicide, etc.) and the mode of action (according to FRAC/IRAC/HRAC).
  • The net quantity of the plant protection product (for more information, see Annex I, paragraph (1) e) of Regulation (EU) No. 547/2011)
  • The batch number of the formulation and the date of manufacture (usually printed directly on the packaging/container)
  • Type of formulation (e.g. water-dispersible granules or suspension concentrate).
  • Waiting periods to be observed between the last application and sowing or planting of the crop to be protected or subsequent crops.
  • Re-entry periods.
  • The period to be observed between the last application and the harvest, and between the consumption of the plant products.
  • Restrictions on the distribution and use of the plant protection product.
  • Information on any phytotoxicity, sensitivity of certain crops and/or varieties and other undesirable direct or indirect side effects on plants or plant products.
  • Instructions for appropriate storage and safe disposal of the plant protection product and its packaging.
  • Where necessary, the expiry date under normal storage conditions. If the plant protection product has a shelf life of less than two years, the storage life, including the corresponding temperature values, must be stated.
  • Prohibition on reusing the packaging, except by the authorisation holder, provided that the packaging has been designed so that it can be reused.

If the space available on the label is not sufficient to display all the information required for labelling, instructions for use may be included as part of the labelling. In this case, the sentence: "Read attached instructions before use" must appear on the label.

According to § 31 (2) of the Plant Protection Act, the information required by Regulation (EU) No. 547/2011 in Annex I, points 1 (h), (i), (l), (m) and (u) MUST be clearly separated from the other information and labelling under the following heading:

„Fields of application and conditions of use as determined by the authorising authority“

  • Information on any special risks for human or animal health or for the environment in the form of appropriate standard phrases taken by the competent authority from Annex II to Regulation (EU) No. 547/2011.
  • Safety precautions to protect human or animal health or the environment in the form of appropriate standard phrases taken by the competent authority from Annex III to Regulation (EU) No. 547/2011.
  • The uses for which the plant protection product has been authorised, and the specific agricultural, plant health and environmental conditions under which the product may or may not be used.
  • Instructions for use and conditions of use, including the application rate, including where appropriate the maximum application rate per hectare per application and the maximum number of applications per year. The application rate shall be specified for each use according to the conditions of the authorisation and shall be expressed in metric units.
  • The categories of users who may use the plant protection product, where use is restricted to certain categories.
  • Any conditions of use and labelling requirements imposed by the authorisation decision.

OPTIONAL information to be included on the labeln

The following information may be included on the label as OPTIONAL:

  • the BVL authorisation mark for plant protection products.
  • Information on the protection of bees or other non-target species if the authorisation explicitly permits use under these conditions.

The authorisation holder is free to print other objectively verifiable information on the packaging or label without evaluation, such as:

  • A reference to the PAMIRA disposal system, which has been developed and is offered by industry and agricultural wholesalers.
  • Barcodes, such as GTIN, which can be used to identify any article, product or product variant worldwide.
  • QR codes that link to further information.

Information that must NOT appear on the label

The following information must NOT appear on the label:

  • No information such as "non-toxic" or "not harmful to health" may be printed (Regulation (EU) No. 547/2011 Annex I Paragraph (3)).
  • The term "authorised as a low-risk plant protection product in accordance with Regulation (EC) No 1107/2009" may not appear on the packaging or label of the plant protection product (Regulation (EC) No. 1107/2009 Article 66 (2)).

Information sheet as part of the label if space is limited

If the space available on the label is not sufficient to display all the information required for labelling, a leaflet may be attached as part of the labelling (Regulation (EU) No. 547/2011, Annex I, paragraph (2)). In this case, the sentence: "Read attached leaflet before use." must appear on the label..

The following information from the above may appear in an enclosed leaflet:

  • Instructions for use and conditions of use, including the application rate, where appropriate including the maximum application rate per hectare per application and the maximum number of applications per year. The application rate shall be specified for each application according to the conditions of authorisation and shall be expressed in metric units.
  • Waiting periods between last application and sowing or planting of the crop to be protected or subsequent crops, re-entry periods and period between last application and harvest, and use and consumption.
  • Information on phytotoxicity, sensitivity of certain varieties and other undesirable direct or indirect side-effects on plants or plant products.
  • Instructions for appropriate storage and safe disposal of the plant protection product and its packaging.
  • the expiry date under normal storage conditions, where necessary
  • any conditions of use and labelling requirements specified in the authorisation.

The authorisation number (or distribution number or parallel trade number)

Only ONE number may be printed on the plant protection product so that a plant protection product can be clearly assigned to an authorisation or approval. This also applies to distribution extensions or plant protection products that are traded in parallel.

Recommendations for harmonised instructions for use

The BVL has published recommendations for harmonised instructions for use for plant protection products. The harmonisation proposal is intended to serve as a template for voluntary implementation within the industry. It was developed by the BVL's "Plant Protection and Sustainability" expert advisory committee and the IVA project group "Harmonisation of Instructions for Use". The harmonisation proposal can be downloaded here in German in pdf format.

Labelling of extension of marketing authorisation

According to § 30 of the Plant Protection Act, a plant protection product authorised in Germany may also be placed on the market by parties other than the authorisation holder under a different name on the basis of an agreement with the authorisation holder. This is referred to as an extension of marketing authorisation.

The labelling of plant protection products based on extended marketing authorisations is exactly the same as for the basic authorisation. The BVL assigns a marketing authorisation number for the plant protection product that is placed on the market on the basis of an extended marketing authorisation. The two digits after the hyphen are different from the authorisation number of the corresponding plant protection product, e.g. 001234-60 for a marketing authorisation extension instead of -00 for the basic authorisation, and must be indicated in full on the labelling.

Labelling of authorisations for minor use

Article 51 (5) and (6) of Regulation (EC) No. 1107/2009 regulates the labelling of authorisations for minor uses. If a Member State grants an extension of the scope of an authorisation for a minor use, it shall, where appropriate, inform the authorisation holder and request him to adapt the labelling accordingly. If the authorisation holder refuses to do so, the Member States shall ensure that users are informed in full and in detail of the conditions of use by means of an official publication or an official website. The official publication or, where appropriate, the label shall contain the following information and instructions:

  • If the authorisation holder amends the labelling, he shall indicate the extension of the scope to minor uses separately on the label.
  • The person using the plant protection product shall be liable for any lack of efficacy or phytotoxicity of the product for which the authorisation extension for a minor use has been granted.

Labelling of plant protection products for experimental purposes

The labelling of plant protection products for experimental purposes for research and development purposes in accordance with Article 54 (1) of Regulation (EC) No. 1107/2009 must contain the following information:

  • All conditions specified in the authorisation to prevent adverse effects on human or animal health and unacceptable effects on the environment. If the space available on the label is not sufficient to display all the required information, a leaflet may be attached as part of the labelling (Regulation (EU) No. 547/2011, Annex I, paragraph (2)). In this case, the sentence: "Read attached instructions before use." must appear on the label.
  • The quantities to be used and the limited area to be treated.
  • The following wording must appear on the label: "Product intended for experimental purposes, not fully characterised, handle with extreme care".

According to Regulation (EU) No. 547/2011 Annex I (5), the following additional information is sufficient for labelling:

  • the name and address of the authorisation holder and, where available, the authorisation number of the plant protection product.
  • The name of each active substance, clearly indicating the chemical form (see Regulation (EU) No. 547/2011 Annex I No. 1 c for further details).
  • Concentration of each active substance (see Regulation (EU) No. 547/2011 Annex I No. 1 d for further details).
  • The type of effect of the plant protection product (e.g. insecticide, growth regulator, herbicide, fungicide, etc.) and the mode of action (according to FRAC/IRAC/HRAC).
  • The type of preparation (e.g. granules, emulsion concentrate, etc.).

If applicable, the requirements of Regulation (EC) No. 1907/2006 ( REACH Regulation) must be met. Accordingly, a safety data sheet must be attached to the plant protection product if the conditions of Article 31 of the REACH Regulation are met. Since some of the products are still in development, information must only be provided if the relevant information is available at the time of authorisation. In individual cases, the greatest possible protection of humans, animals and the environment must be ensured, unless otherwise specified in the decision.

to the top

FAQ about the labelling of plant protection products

Does the BVL authorisation mark for plant protection products have to be on the label?

No. The BVL authorisation mark for plant protection products indicates that the plant protection product has been authorised. The BVL authorisation mark can be printed on the label or packaging of a plant protection product, but it is not mandatory.

You can find more information about the BVL authorisation mark here, along with the option to download the BVL authorisation mark in various formats.

Can labels be attached to the plant protection product in an adhesive pocket?

No. The authorisation holder must label the plant protection products in accordance with the Plant Protection Act §31 and Annex I of the Implementing Regulation on the Labelling of Plant Protection Products (EU) No. 547/2011. Accordingly, provisional solutions such as an adhesive pocket are not in accordance with the law. No special provision is made for the remaining stocks that are being sold off, even if the authorisation holder no longer has enough labels to sell off their product after the authorisation has expired.

Can two different authorisation numbers appear on one label?

No. In Germany, plant protection products may only be placed on the market if they are correctly labelled. Correct and up-to-date labelling should help users to avoid mistakes and make it easier for the federal states to carry out their control activities. For this reason, the labelling of plant protection products must not be misleading, in accordance with § 31, paragraph 5 of the Plant Protection Act.

In Germany, the authorisation number plays an important role in labelling, as it enables the product to be clearly assigned to a specific authorisation. The authorised areas of application and the conditions and regulations for use are directly linked to the authorisation, as are the expiry date of the authorisation and the resulting sell-off and use-up periods. If two authorisation numbers are given on the label, it is not possible to clearly assign the product, which is therefore not permissible.

Do all authorised uses have to be mentioned on the label?

Yes, the label must state all the uses for which the plant protection product has been authorised, together with the associated conditions and regulations for use. This is a non-binding interpretation of the law by the BVL. This issue is a control matter for which the plant protection services of the federal states are responsible in Germany.

According to Section 31 (2) of the Plant Protection Act, the information required under Annex I, points 1 (h), (i), (l), (m) and (u) of Regulation (EU) No. 547/2011 must be included on the packaging of plant protection products under the heading "Areas of application and instructions for use". This means that the authorisation holder is not free to choose not to include authorised areas of application and instructions for use on the packaging. If a licence holder wishes to remove an authorised area of application or an authorised application provision from the packaging, a corresponding application for a change to the authorisation must be submitted.

An exception is made if a product is authorised for commercial horticulture (professional users) and for home and small gardens (non-professional users). In this case, it makes sense to split the authorisation of a plant protection product, once for commercial cultivation and once for home and small gardens. In this case, the packaging for professional use will only show the areas of application and instructions for professional users, while the packaging for home and garden use will only show the areas of application and instructions for non-professional users.

The above-mentioned regulations serve to ensure transparency and safe application. In particular, non-professional users are not aware of any reliable sources of information (such as the BVL online database) other than the instructions for use / label to find out about the current authorisation. If additional (permissible) uses for a product are identified during research on the internet, there is not always sufficient information available there about application rates or application times. The instructions for use/labelling are indispensable as a comprehensive source of information to prevent misuse.

How binding is the classification and labelling of hazardous substances stated in the authorisation notice?

The responsibility for the classification and labelling of the plant protection product in accordance with Regulation (EC) No. 1272/2008 lies with the person placing it on the market. The information on the assessment result provided by the authorities in the authorisation notice (Article 31 (2), 2nd subparagraph) is therefore to be understood as a reference and is not binding (Hohgardt, K, Uteß, M. J. Verbr. Lebensm. 1 (2006), S. 62). This may lead to discrepancies between the information on the packaging and the information published by the BVL. In such cases, the authorisation holder may request the BVL to review the classification and labelling, including a justification.

In contrast, the application provisions issued with the authorisation notice in accordance with the Plant Protection Act, which are derived directly from the classification and labelling of hazardous substances (Lichtenberg, B. et al., J. Verbr. Lebensm. 10 (2015) S. 373–384), must also be listed by the authorisation holder if there are deviations between the BVL and the authorisation holder in the classification and labelling of the product under hazardous substances law.

Find out more