17 June 2020
Current “emergency use” authorisations
Last month, Eden announced that its commercial partner, Eastman, had received its second consecutive “emergency use” authorisation for the use of our bionematicide, Cedroz, in Italy for the upcoming 2020 season. The renewed “emergency use” approval came after Eastman had worked with farmers across Italy to successfully apply the product during the 2019 season to a number of popular summer fruits and vegetables. In 2019, Eden’s commercial partner in France, Sumi Agro, received the same type of “emergency use” authorisation, this time for our biofungicide, Mevalone, which was to be used for the treatment of storage diseases on apples. This blog showcases how these emergency use authorisations work in practice and our perspective on the unique regulatory process.
Fighting post-harvest losses in France
Key statistics:
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15.5% of Europe’s apples come from France
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$573 million worth of apples are exported from the region each year
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France is also the fifth largest exporter of apples globally by value
It is fascinating to look at the Mevalone “emergency use” authorisation in France, which demonstrates the urgent need for innovative products to sustainably extend the shelf life of French apples.
The apple industry in France is large with over 1.5million tonnes of the fruit produced annually. Roughly 43% of this amount is sold in the French market and 38% is exported with the remainder used for processing. The largest apple producing region is Tarn-et-Garonne which is home to 5,300 ha of orchards and an annual production of around 427,000 tonnes. After harvest, most pome fruit is stored for a number of months and farmers in Tarn-et-Garonne and other apple growing regions are affected by a range of post-harvest storage diseases, typically caused by fungal pathogens. Post-harvest rots cause significant economic losses worldwide and typically range from 5-20% fruit loss, but more susceptible cultivars can experience fruit losses of over 50%. In fact, one UK harvest previously recorded that 88% of its apples had rotted as a result of post-harvest disease.
Sumi Agro has been selling Mevalone in France for the treatment of botrytis on table and wine grapes since January 2017. In 2019, once identifying that Mevalone is also effective at fighting post-harvest rots, Sumi Agro secured a 120-day “emergency use” authorisation for the pre-harvest treatment of apples to control post-harvest diseases. Due to growing concern regarding conventional pesticide residues in apples, there is a need for an alternative product that is residue free; this is something that is of growing importance to food producers and is even more of a priority in some food industries such as baby food. Mevalone offers a sustainable and residue free solution to control fungal pathogens and prevent crop losses. Unlike many conventional options, Mevalone has a low pre-harvest interval, which allows it to be applied almost to the point of harvest and then control the diseases during storage.
Explaining the authorisation
“The official position of the EU Commission is that derogations for “emergency use” are meant solely to be in the interest of agriculture, environment and governments. Applications solely based on industry interests should be refused.' - Dr Mike Carroll, Director of Regulatory Affairs at Eden Research
“Emergency use” authorisations are a unique regulatory process in the EU allowing Member States to authorise the use of a plant protection product, which has not been authorised at EU level, for a period not exceeding 120 days. Under this authorisation there is a limited and controlled use of the product as exemplified in France.
They are granted when the product is needed and necessary in a local market because there is an absence of suitable commercially available alternatives. For example, in Italy, Cedroz has been approved for “emergency use” as there are a limited number of alternative products available to tackle nematodes in the Italian market and consequently growers need new tools to help control this damaging pest on a range of important high value crops. This point was also demonstrated when we explored the situation in France.
When a Member State issues an emergency authorisation, it must inform other Member States and the Commission of the authorisation and give detailed information about the situation and any measures taken to ensure consumer safety. The Commission has the authority to decide if a Member State can extend or repeat the emergency authorisation or not or whether the authorisation must be amended or withdrawn but it rarely intervenes in the process.
Eden’s perspective
Receiving full authorisations in the EU for new agrochemicals is a complex process. When novel technologies are presented to the Commission, it is often impossible to reach a consensus as some Member States are very cautious about approving new agrochemicals. Normally, regulatory consensus is only reached in the EU once science is mature and there is resounding evidence that a technology is completely safe. Until that point, the regulation of novel technologies is ultimately driven by political and economic factors. “Emergency use” authorisations therefore give Member States the opportunity to approve the limited use of an agrochemical which they view as being safe and vital to supporting growers in their jurisdiction to adequately protect crops.
Eden’s CEO, Sean Smith, commented: “From Eden’s perspective, receiving “emergency use” authorisations for our products is constructive as it allows regulators to see our products in use on a much wider scale, giving them confidence in the quality and efficacy of our products. Correspondingly, the authorisations allow us to collect expansive feedback from growers about how they are using our products and the unique challenges they face. This helps us to innovate our current portfolio of products and develop new ideas to help growers integrate sustainable practices into their pest management strategy.”
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