Emergency authorizations
of crop protection products in the European Union 
Crop protection products are usually approved via the standard regulatory process. However, there can be exceptions – called ‘emergency authorizations’ – in exceptional situations.
Row of Corn

Before a crop protection product is approved for use in the European Union (EU), thorough evaluations are carried out to ensure that the product can be used in a way which is safe for people and the environment. EU law sets out stringent conditions for this rigorous procedure, which can take approximately 3 years.

 

Sometimes, farmers can face exceptional situations where a crop protection product which is not (or not yet) authorized is the only viable option available to successfully handle an imminent threat to their crops.    

 

In cases such as these, EU law recognizes that swift intervention is needed to protect the farmer’s harvest against otherwise unavoidable losses. This is why the bloc’s plant protection regulation includes a provision allowing EU countries to grant approvals known as ‘emergency authorizations’.

Emergency Authorizations are temporary approvals which are only permitted in exceptional situations and according to specific conditions. They allow an otherwise unapproved use of a product to be used on a specific crop, in a limited and controlled way, for a maximum period of 120 days in one year.

 

Emergency authorizations can only be granted when strictly necessary: EU countries must always complete a comprehensive justification for their decision to allow this temporary measure. In addition, the initial request for an emergency authorization usually comes from farmers’ groups and national agricultural associations within the EU country concerned. These groups have a detailed understanding of the local agronomic conditions and the solutions available to them – so they are best placed to make the request when necessary. 

 

The following situations all constitute reasons that may lead to an EU country granting an emergency authorization:  

  • The product is only authorized for use on certain crops, so a separate authorization is required to use that product on a different crop;  
  • The product contains a newly approved active substance at EU level, but the specific EU country has not yet approved products containing that active substance;  
  • The problem is caused by a new, invasive species that is not native to that particular geographic area, so no products are currently approved for use against it; 
  • The only effective solution is to use a product containing a non-approved active substance (which may be a “new” substance which is not yet approved, or a substance that was previously approved but has been withdrawn, or a substance that had been denied approval altogether, or a substance that has never been approved in the EU).
 

Tomato growers in Portugal noticed a significant increase of a type of mite in the two years prior to 2018. When left untreated, these mites – known as eriophids – cause considerable harm to both the tomato plants and their fruit, resulting in yield losses and damaged plants. These farmers had no suitable product to control this pest; they had the option of using powder sulfur, but this could only be applied during the early growing stages and was not effective once the plants were more established.  

 

This situation necessitated an emergency authorization for the product Oberon®, which is highly effective against these mites. Oberon had already been registered for use in other EU countries, such as Spain, as its active ingredient (spiromesifen) had been approved at EU level. The reason it was not approved in Portugal at that time was that the standard product authorization process – which, in this case, entailed “mutual recognition” of the Spanish product authorization – had not yet been completed. By granting an emergency authorization valid between May and August 2018, the Portuguese authorities allowed their farmers access to a vital tool to save their harvest and their crops. 

All Belgian pear orchards are infested with insects called pear suckers. These pests damage pear trees, causing necrosis (wilting) in leaves and flower buds and preventing the plants from photosynthesizing effectively. Pear suckers also cause damage to the pears themselves; effects range from skin damage, known as “russeting”, to the appearance of a type of mold which blackens the fruit. The poor quality of the fruit and decline of infected trees represent a major threat for Belgian orchards: in 2016, an estimated 20-30% of the country’s pear harvest was damaged by pear suckers, which translated into an economic loss of €30-45 million. 

 

Pear suckers thrive under the climactic conditions in Belgium and manage to produce four or five generations in one year, meaning that a year-round control strategy is needed to keep them at bay. However, the means available to growers are not always able to handle the problem. 

 

For example, the second generation of pear suckers develops significantly in the springtime, infesting entire trees. To combat this, growers can use products containing abamectin – but they are not allowed to spray the product higher than two meters, and most pear orchards have trees of three meters or taller. While there are other products available, they are less effective at controlling pear suckers and can also harm beneficial insects, meaning that these are not viable options. 

 

In summer, the only option farmers had for keeping pear sucker populations low was potassium bicarbonate spray. This substance is more suited to low-pressure pest situations and is not suitable in cases where pear suckers have already taken hold significantly. 

 

In contrast, there is a product called Movento® (containing the active ingredient spirotetramat) which is effective against pear suckers and has a favorable safety profile towards beneficial insects. However, Belgian growers were only allowed to apply it one time in the growing season; a second application was necessary to respond to the year-round control needs. 

 

Authorities in Austria had already approved this second application of Movento for trees affected by pear sucker. This authorization would also eventually apply in Belgium via a process known as “mutual recognition”, though it was unlikely to be completed in time for the 2018 growing season – meaning that farmers would be left economically vulnerable to further damage from pear suckers. So, to save the 2018 growing season, Belgium granted an emergency authorization permitting a second application of Movento between May and June 2018.  

Olive fruit fly is the most significant pest affecting olive groves in Spain. The larvae feed on olives, damaging the flesh and causing the fruit to drop prematurely from the tree. As a result, this reduces yields of both olive oil and table olives, while also impacting the quality of the oil obtained by making the oil more acidic and reducing its shelf life. 

 

The solutions to handle olive fruit fly traditionally available to farmers were insecticide sprays. However, these sprays were sometimes not enough to control the pest and were also unsuitable for use in organic farming. 

 

By 2018, a new method to control olive fruit fly had been developed: fly traps, which would be placed in the field and would control the pest using the EU-approved active ingredient deltamethrin. This would provide an effective way to control the olive fruit fly, while being very low risk for humans and the environment as the product would not come directly into contact with the olives themselves.  

 

Given the severity of olive fruit fly attacks in recent years, it was vital for farmers to have access to this trap. The product was not yet approved for use, though, as the request for authorization was still under consideration by the French authorities (who were in charge of assessing the application on behalf of countries in the southern zone of Europe). As such, Spain granted an emergency authorization for these fly traps valid from April to August 2018, ensuring that their farmers could access an environmentally friendly solution to avoid dramatic crop losses while awaiting a standard product authorization. 

Please visit the European Commission’s Emergency Authorizations database to see the emergency approvals granted by EU countries. For more information on the EU’s standard approval procedure, see the European Commission’s 'Approval of active substances' page.  

 

For more detail, please consult the text of the EU’s plant protection regulation. The wording of Article 53 of this regulation, which pertains to emergency authorizations, can be found below. 

  1. By way of derogation from Article 28, in special circumstances a Member State may authorize, for a period not exceeding 120 days, the placing on the market of plant protection products, for limited and controlled use, where such a measure appears necessary because of a danger which cannot be contained by any other reasonable means. The Member State concerned shall immediately inform the other Member States and the Commission of the measure taken, providing detailed information about the situation and any measures taken to ensure consumer safety. 
  2. The Commission may ask the Authority for an opinion, or for scientific or technical assistance. The Authority shall provide its opinion or the results of its work to the Commission within 1 month of the date of the request. 
  3. If necessary, a decision shall be taken, in accordance with the regulatory procedure referred to in Article 79(3), as to when and under what conditions the Member State: (a) may or may not extend the duration of the measure or repeat it; or (b) shall withdraw or amend its measure. 
  4. Paragraphs 1 to 3 shall not apply to plant protection products containing or composed of genetically modified organisms unless such release has been accepted in accordance with Directive 2001/18/EC.