Update 21/12/2022

We have recently started to use a new IT tool to draw up authorization certificates for plant protection products.

The layout of the certificate is partly adapted, some sections are added and in some cases the information is reworded. An overview of the possible changes is given below to help authorisation holders to better understand the content of the authorisations. The most frequently asked questions are also answered.

In general

• The former dossier number will be replaced by an automatically generated dossier number that will be different for each new application for a product. The dossier number of the original application for authorisation will be converted to the authorisation number after authorisation. Subsequent applications for the same plant protection product will receive an independent dossier number.
• From 1 January 2025, in the entire distribution chain, the label of the product must correspond to the certificate delivered in 2022 in the new format. Any other adjustments to the authorisation certificate, e.g. as a result of European legislation or an application by the authorisation holder, must still be made within the standard period of 18 months from the end of the year in which the adjustments were made to the authorisation.

Company data admission holder

• If the authorisation holder is known in the Crossroads Bank for Enterprises (CBE), the details are taken from the CBE. Both the address details and the legal form are shown on the certificate under the authorisation holder's name. Any adjustments should be made through the CBE. Nowadays, the legal form of the company is listed in full under the company name in the language of the certificate. The abbreviations will be included on a later version of the certificates.
• For certain authorisation holders, the address details in the CBE contain 'extra address info'. Currently, this 'extra address info' is not yet mentioned on the certificate. In future, it may also be listed on the certificate.

Labelling

• The signal word 'Avertissement' was replaced by 'Attention' on the French-language certificates. 'Attention' is mentioned in the CLP Regulation (Regulation (EC) No 1272/2008), but it was not correctly reproduced in our earlier database. In Dutch, this remains 'Warning' and in English 'Warning'.
• The wording of sentences P260 and P261 has been adjusted as necessary. All ways in which inhalation of the product may occur are now taken into account. For example, for liquid formulations, exposure may occur via vapour when opening the container and during mixing/loading, while during application via spraying, exposure may occur via spray mist.
• If a co-formulant is required to be declared on the label in accordance with Article 18(3b) of the CLP Regulation (product identification of a mixture), 'Co-formulants to be declared:' is present on the certificate. It is no longer displayed if there are no co-formulants to be listed. Note that active substances must always be listed on the label of plant protection products, regardless of their contribution to the classification of the mixture, and are therefore not listed separately in this section of CLP labelling.
• There are two versions of the phrase P302 + P352: 'IF IN CONTACT WITH SKIN: wash with plenty of water/...' (the European regulation allows certain P phrases to be adapted). The applicable version is determined by the hazard classification of the product.
• If labelling H314/H315/H317 is applicable, sentence P302 + P352 should specify '[...] wash with plenty of water for at least 15 minutes'. If the phrase H310/H311/H312 applies, the version reads: '[...] wash with plenty of soap and water for at least 15 minutes'.
• A number of warning and SP phrases were standardised, so these phrases may differ from earlier authorisations. However, this was done taking into account that the meaning does not change or changes as little as possible. Examples include the sentence SPe8 and sentences with restrictions on following and replacement crops.
• A standard SPa1 sentence was added for products containing an active substance for which a resistance code (HRAC/IRAC/FRAC) is available. Pre-existing entries relating to resistance were also replaced by this standard SPa1 sentence.
• The phrases P330 ('Rinse the mouth') and P331 ('DO NOT induce vomiting') used to be often listed separately but, in fact, should always be combined with P301 ('AFTER INGESTION:') because as stand-alone phrases, they have no meaning. In addition, P331 is no longer mentioned without P330, leading to the combination P301+P330+P331.
• The sentence SPo 'After treatment, do not re-enter the plots/surfaces until the spray liquid has dried' is standard for all spray applications except for pre-emergence use and drip irrigation.
• The legally correct version of the phrase P280 concerning personal protective equipment in Dutch is '[beschermingsmiddelen] dragen' but the alternative version 'Draag [beschermingsmiddelen]' is equivalent.

GAP

• The crop application stages (BBCH codes) and enemies/pests were harmonised. A simpler version of the BBCH codes may appear on the label. As stages '0' do not always exist in practice, these were replaced by stages 'X1' (e.g. BBCH 51-59 instead of BBCH 50-59).
• In order to unambiguously indicate within which stages of cultivation a product may be applied, the mentions 'before'/'up'/'after'/'from'/'<'/'>' were removed and the symbols '≥' and '≤' are now uniformly used. This unambiguously indicates that the application may also take place at the stated stage. Bv:
  • 'Until BBCH 15' becomes on the certificate: '≤ BBCH 15'.
  • ‘From BBCH 15' becomes on the certificate: '≥ BBCH 15'.
  • 'Before flowering (< BBCH 60)' becomes on the certificate: ≤ BBCH 59.
  • 'After flowering (> BBCH 70)' becomes on the certificate: '≥ BBCH 71'.
• If 'all' is listed under crop type, this means that no restriction is imposed on the way the crop is grown. Consequently, the plant protection product in question may be used in the specified crop regardless of the method of cultivation.
• The number of authorised applications is always stated.
• If the product may only be applied curatively, i.e. in the presence of the pest or symptoms, this is not (or no longer) mentioned. When a product must be applied preventively or when other conditions regarding the application stage of the enemy apply, this is mentioned.
• The uses 'Common borage consumption of flowers (open air)' and 'Common borage consumption of flowers) (under protection)' are replaced by cultivation 'edible flowers (consumption flowers)'.
• Given the definition of the crop 'cultivation of seed potatoes' at the end of the certificate, oversized seed potatoes may be sold for consumption and therefore the same waiting period as for consumption potatoes must be respected.
• The sentence 'To avoid crop damage, it is recommended to do a test on some plants before treating the entire field.' was added to some crops. This sentence has been added for some years for all aromatic and medicinal herbs, babyleaf, cress, watercress, sea aster, garden orache and leaf beet/chards, because selectivity studies are not always available for all these crops. Moreover, no efficacy or selectivity studies are required by Regulation 1107/2009 for the extensions for small crops.
• Ornamental plants, trees and shrubs are no longer labelled 'not suitable for consumption'. This statement was included in the description of the crops at the end of the certificate.
• For apple trees and pear trees, 'ha hedge' is now used instead of 'ha fruit tree hedge' for more uniformity. Obsolete references to 'ha standard orchard' were deleted.
• The crop 'tree nursery' was replaced by 'ornamental trees and shrubs', but as the definition of the crop indicates, products authorised in this crop may also be used for the propagation of fruit trees and shrubs insofar as they are not yet in their final position and the fruit is not harvested.
• The dose expression kg/100 l or l/100 l is no longer used (neither for stone fruit nor for standard orchards).
• Side effect/secondary effect or information regarding efficacy is considered vulgarisation and no longer appears on the certificate. However, the authorisation holder may include such information on the label. Regarding information on potential resistance, it is the responsibility of the authorisation holder to explain resistance management on the label in cases where resistance management (in the broadest sense, e.g. susceptibility to powdery mildew) is required. It is therefore strongly recommended to include resistance management advice on the product label in addition to the mode of action number, in line with the recommendations of the Resistance Management Committees (RACs). The wording of this resistance management advice should be consistent with any comments made during the efficacy assessment.

Extensions by third parties

• For crops listed in the annex "Extension of authorisation for minor uses", the responsibility for use lies with the user. For all other crops, the responsibility for use lies with the authorisation holder. Moreover, if, for the same crop, certain enemies are not supported by the authorisation holder, the crop will be listed twice. Thus, the crop with the unsupported enemies will be found in the Applications section under the user's responsibility, but also in the Applications category with the pests supported by the authorisation holder.

Label/Package leaflet

• The authorisation certificate is a model that allows the preparation of a label that must be equivalent in terms of content but may differ in terms of wording, sequence, layout, sentence structure, etc.
• Only the legally defined CLP sentences must be reproduced verbatim, except of course when "(to be completed by manufacturer)" is mentioned next to a P-phrase (e.g. P370 + P378). For logical and clear communication of the safety recommendations, the order of the P phrases may differ from that on the certificate. Finally, it is not mandatory to include the code of H, P and EUH phrases on the label.
• Common crop names are allowed, as long as they are understandable to the user and do not contradict the authorisation. Latin names were added for clarification but do not have to be reproduced on the label.
• An authorisation certificate contains a description of the crops. These should not be reproduced on the label.
• If the risk mitigation measures are 'No buffer zone to surface water', no indication should be placed on the label.
• The dossier number should not appear on the label.
• From 1 January 2025, the application technique must be stated on the label as it appears on the authorisations.

Packaging

• All authorised packagings will be listed on the authorisation.
• For packagings above 3 litres, we refer to a jerry can instead of a bottle.