We have recently started to use a new IT tool to establish the authorisations for plant protection products.
Firstly, all the data on our current database has been transferred to the new tool. The authorisation holders have received or will receive a draft version of each authorisation certificate for review, except in the case of a derived authorisation or a parallel trade permit. Subsequently, a new document will be delivered.
The presentation of the certificate has been partly adapted; certain sections have been added and, in some cases, the information has been reformulated. An overview of the possible modifications can be found below and helps the authorisation holders to compare the current certificate with the new one. Responses are also provided to the most frequently asked questions.
Secondly, planned for Spring 2022, the authorisation holder will be able to submit all requests via this tool and a new search function will be available. More information will follow later.
- There is no longer an N number, but a file number is created automatically and will be different for each new application for the product.
- When the definitive certificate is signed, the starting date of the authorisation will be adjusted accordingly.
- There is a deadline for the evaluation of the draft version of each authorisation certificate. The authorisation holders can still let us know if they need more time. The authorisations are handled in the order that is the most efficient for us.
- On 1/01/2025 the labels of your product in the entire distribution chain will have to comply with this migrated certificate. Any other modification of the authorisation certificate, e.g. in application of European law or following an application of the authorisation holder, will still need to be applied within the standard time frame of 18 months after the end of the year in which the modification of the certificate was made.
Contact details of authorisation holder
- If the authorisation holder is known in the Crossroads Bank for Enterprises (CBE), the data will be extracted from the CBE. The address and the legal form will feature on the certificate under the name of the authorisation holder. All amendments must be carried out via the CBE. Currently, the full legal form of the company is stated in the language of the certificate and is found in full in the line after the name of the company. Abbreviations will be included in a later version of the certificates.
- For certain authorisation holders, the address details of the CBE contain "additional information". Currently, this "additional information" is not yet stated on the certificate. In future, this information will also be stated on the certificate.
- The mention "Avertissement" has been replaced by "Attention" in French. "Attention" is mentioned in the CLP regulation, but this was not correctly reproduced in our previous database. In Dutch, this remains "Waarschuwing", in English "Warning".
- The phrase P261 has been amended. It now takes into account all different routes of inhalation of the product. When opening the bottle and when mixing/loading, exposure can happen by means of the vapour. During application, exposure can happen via the spraying mist.
- If an additive must be mentioned on the label, the mention "Co-formulants to be mentioned:" is present on the certificate. It is no longer displayed if no additives are to be mentioned.
- Two versions of the phrase P302 + P352: IN CASE OF CONTACT WITH SKIN: wash with plenty of water/..." are possible since the European regulation allows the adaptation of certain P phrases. The version is determined by the hazard classification of the product.
If labelling H314/H315/H317 applies, the phrase P302 + P352 should specify "[...] wash with plenty of water for at least 15 minutes". If the phrase H310/H311/H312 applies, the correct version is: "[...] wash with plenty of water and soap for at least 15 minutes.".
- A number of warning and SP phrases have been standardised, which means that these statements may deviate slightly from previous versions of the authorisation certificate. However, care has been taken to ensure that the meaning did not change, or changed as little as possible. Examples include the phrase SPe8 and restrictions with regard to succeeding/replacement crops.
- A standard SPa1 phrase has been added to the products containing an active substance for which a resistance code (HRAC/IRAC/FRAC) is available. Other pre-existing statements regarding resistance have also been replaced by this standard SPa1 phrase.
- The P331 used to stand alone, but in fact it is always in combination with P301 (because as a stand-alone sentence it has no meaning) and moreover, the P331 is never (anymore) given without the P330 (it used to be). This automatically leads to the combination P301+P330+P331+310.
- The SPo was missing for some products and has been added because it is standard for all liquid products or put in solution before spraying, except for pre-emergence uses and drip irrigation.
- The application stages of crops (BBCH codes) and the enemies have been harmonised. A simplified version of the BBCH codes may be indicated on the label.
As the stages "0" do not appear to exist in practice (0 leaves), they have been replaced by the stages "1" (for examples, BBCH 51-59 instead of BBCH 50-59).
- In order to clearly indicate at which the stages of the crops a product can be used, the terms "before"/"until"/"from"/"<"/">" are no longer used and are uniformly replaced by the symbols "≥" and "≤". This way, it is clearly indicated that the application can also take place at the indicated stage. For example:
- "Until BBCH 15" becomes: "≤ BBCH 15" on the new certificate.
- "From BBCH 15" becomes: "≥ BBCH 15" on the new certificate.
- "Before flowering (< BBCH 60)" becomes: "≤ BBCH 59" on the new certificate.
- "After flowering (< BBCH 70)" becomes: "≥ BBCH 71" on the new certificate.
- When the crop type is stated as "any", this means that there is no restriction on the way the crop is grown. The concerned PPP can therefore be used on the crop mentioned regardless of the growing method.
- For certain products/uses, there is no application number. It is not good practice to leave the number of applications undetermined. The number of applications will be taken over from comparable products or from the application for renewal.
- If the product can only be applied in a curative manner, i.e. in the presence of a harmful organism or symptoms, this is not (or no longer) mentioned on the certificate. If a product must be applied in a preventative manner or if other conditions apply regarding the application stage of the enemy, this will be mentioned.
- The uses 'borrage (consumption of flowers) (open air)' and 'bernagy (consumption of flowers) (under protection)' have disappeared and been replaced by the crop ‘edible flowers (consumption of flowers)’.
- The use in potatoes (for seed potatoes) will, from now on, receive a pre-harvest interval because, taking into account the definition of the crop at the end of the certificate, larger calibres of seed potatoes can be sold for consumption and as a result the same pre-harvest interval as for consumption potatoes needs to be respected.
- The sentence "To prevent damage to the crop, it is advisable to test a few plants before treating the entire field." was added. This sentence had already been added several years ago for all aromatic and medicinal herbs, babyleaves, cress, watercress, sea aster, garden orache and leaf beet/chards because for these crops not always selectivity trials were available. Furthermore, no efficacy nor selectivity trials are prescribed by Regulation 1107/2009 for minor crops.
- The ornamental plants and shrubs no longer have the mention "not for consumption". This mention is now included in the description of the crops which is included at the end of the certificate.
- For apple and pear trees, now ha leaf wall is used instead of ha fruit tree hedge for greater harmonisation. The obsolete references to "ha de verger standard" have been removed.
- The crop "tree nursery" has been replaced by "ornamental trees and shrubs", but as the definition clarifies, products authorised in this crop may be used on young fruit plants as long as these are not yet planted on their final location and as long as the fruits are 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 effects or efficacy information are part of the vulgarisation and no longer belong on the act. However, this information can be mentionned on the label. Regarding information on possible resistance, it is the responsibility of the holder to explain the resistance management on the label for cases where resistance management is required (in the broad sense of the term, for example the lower sensitivity of powdery mildew). In addition to mode of action number labelling, it is strongly recommended to include guidance on the management of resistance on the product label that is in agreement with recommendations of the Resistance Action Committees (RACs). Wording of this guidance on the management of resistance should fit to remarks that might have been issued in the context of the efficacy evaluation.
Extensions by third parties
- For the crops mentioned in the appendix "Extension of the authorisation for minor uses", the responsibility for use lies with the user. For all other crops, the responsibility for use falls to the authorisation holder. In addition, if, for the same crop, certain enemies are not supported by the holder, the crop will be duplicated. Thus, the crop with unsupported enemies will be found in the section of uses under the responsibility of the user but also under the category "Uses" with the enemies supported by the holder.
- The authorisation certificate is a model that should allow for the drafting of the label, that needs to have an equivalent content but that can differ for the lay-out, wording, order, construction of sentences, etc.
- Only the legally defined CLP phrases should be taken literally.
- It is permitted to use the common names of the crops, provided that they are understandable by the user and do not contradict the authorisation. The Latin names have been added as a clarification.
- An authorisation certificate contains a description of the crops. It is not necessary to copy these on the label.
- The file number should not be mentioned on the label.
- If the risk mitigation measures are "No buffer zone with regard to surface water", no mention on the label is required.
- From 1/01/2025, the spraying method will have to be indicated on the label.
- All authorised packaging mentioned in the file has been attached.
- For packaging larger than 3 litres, we normally use jerrycans instead of bottles, which is more in line with reality.