Guidance on plant protection product authorisation XXVI: What is an emergency authorisation (Art 53)?

Emergency authorisations are not something the applicant can use strategically, but these kinds of authorisations are helpful for the farmer in urgent need of a plant protection product to control a specific pest.

 Article 53 of Regulation (EC) 1107/2009 provides for the Member States to authorise, in special circumstances, the placing on the market of a plant protection product for a maximum period of 120 days and for limited and controlled use, where such a measure is needed to control a serious danger that cannot be controlled by any other reasonable means.

The Commission and all other Member States must be informed when an emergency authorisation is granted, and the Commission may ask the European Food Safety Authority for an opinion or scientific/technical assistance.

These emergencies demand quick and effective responses that cannot await the outcome of the normal authorisation process. Therefore, we have Article 53.

The agronomic and environmental field situation in respect of plant protection continues to present emergency situations that pose a danger to plant production and ecosystems that cannot be contained by any available reasonable means. These emergencies demand quick and effective responses that cannot await the outcome of the normal authorisation process. Therefore, we have Article 53.

Use of this Article should be exceptional and restricted to cases of obvious dangers to plant production or ecosystems that cannot be contained by any other reasonable means. Member States should demonstrate, based on the application received, that the use authorised is justified in this sense and share detailed information about the situation and any measures taken to ensure consumer safety with the other Member States and the Commission, which may consult the European Food Safety Authority (EFSA).

 Article 53 can be used in 2 different ways.

The first one is the use of a plant protection product containing approved active substance or substances. In many cases, it is possible to solve an emergency situation by permitting the use of a plant protection product containing an approved active substance already authorised for other uses. The same applies to pending active substances. Such authorisation is temporary in nature, in most cases only locally needed, and could be within the limits of the already existing Good Agricultural Practice for other uses.

The other way to use Article 53 is the use of a plant protection product containing non-approved active substance or substances. In some cases, it may only be possible to address an emergency with the temporary authorisation of a plant protection product containing a non-approved active substance. Full and clear reasoning following the attached notification format should be provided.

The applicant cannot see the application for an emergency use as a shortcut to full approval of an unauthorised active substance.

Member States should bear in mind the following points for authorisations in this category:

• Providing a complete and detailed report.
• Safeguarding the protection of human health and the environment.
• No other reasonable means of control is available.
• The Member State should explain how use is limited and what conditions have been set.
• The use shall be monitored and exact data on the dose and frequency employed and the area treated should be delivered.
• Repeat authorisations should be avoided by all means.

The applicant cannot see the application for an emergency use as a shortcut to full approval of an unauthorised active substance. The applicant will only be granted a maximum of 120 days and the use is very limited to one Member State or a specific area within a Member State. The applicant will not be able to upgrade this to full approval. The applicant must still fulfil all the requirements set out in Regulation 1107/2009.

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This article is part of a series of articles about the authorisation of plant protection products in the EU. +25 articles are planned for this series, another series on Active substance approval is already published and one more series will follow about dossier preparation of both active substances and plant protection products. Look out for more articles and share them with your network!

The articles are aimed at people who are new to Regulatory Affairs for agrochemicals or professionals from other departments who do not work with Regulatory Affairs on a daily basis. They are written in an easy-to-access language and will give you an overview of almost any area of the subject.

About me

I am an independent Regulatory Affairs consultant of agrochemicals, pesticides, biopesticides and biostimulants and I hold a master’s degree in Pharmaceutical Chemistry.

I worked at Cheminova A/S (later FMC) for 10 years as a regulatory affairs specialist, but also as a patent specialist and a QA specialist.

In January 2016 I founded my consultancy company, Manna Regulatory. Today I work for different multinational companies helping them achieve authorisations of plant protection products, biopesticides and biostimulants in the EU. My main focus is the North Zone (the Nordics and the Baltics) where I work with the authorisation of new PPPs, mutual recognitions, Art 43 renewals, change of authorisation holder, parallel authorisations, label preparations, liaison with local authorities etc. I do also provide project management of EU projects. Further, I work with my local agents in Eastern and Southern Africa to achieve authorisations of plant protection products in countries like Kenya and South Africa.

Lastly, I am the co-founder of Frontloader Group, an independent collaboration that addresses the need for external frontloading of crop protection projects to identify and solve development obstacles.