The article has been updated with new information on Nicotine regulations by the European Commission. (click here to read)
As a leading supplier of vanilla beans, De Monchy Natural Products stands at the forefront of these developments, and ensures that our commitment to quality and sustainability standards remains unwavering.
Import restrictions on US Vanilla Extract pertaining to the usage of Ethylene Oxide
Ethylene Oxide (EtO) is a chemical used to sterilize spices, dried herbs, certain grains, and other food products to ensure they are free from harmful bacteria and pests. However, its usage in food processing has declined due to concerns about its potential carcinogenicity.
As such, the European Union has enacted some of the strictest regulations regarding the application of EtO in food products, including vanilla. EtO maximum residue level (MRL) for Vanilla Extracts in the European Union is set at 0.1 mg/kg, which is significantly lower than the 7 mg/kg (7 ppm) MRL set by the Food and Drug Administration of the United States of America.
As part of the Commission Implementing Regulation (EU) 2023/174 of 26 January 2023, Vanilla Extracts join a list of products for which special import conditions are currently in effect. With this new regulation, US vanilla extract shipments into the member states are required to include an official certificate proving, based on sampling and analysis, that the EtO level is in line with the MRL set by the EU.
The US government currently lacks a standardized process for issuing this certificate, and third-party certificates are not accepted by the EU at the time of writing.
Consequently, US vanilla extract exports to the EU are effectively banned until the authorities in either the US or the EU change their stance. These temporary but indefinite restrictions impact the industry on both sides of the pond.
The use of Ethylene Oxide for food treatment has been banned in the EU since 1991, resulting in a much stricter MRL compared to the US. This import ban might serve as a catalyst, urging the US to update its regulations on this chemical.
To be compliant with food safety regulations, vanilla and spices supplied by De Monchy Natural Products are treated by heat pasteurization or steam sterilization only (on request).
Updated Nicotine MRL Regulations affecting Vanilla Beans
Nicotine, a natural alkaloid found in tobacco plants, has historically been used in agriculture, primarily as an insecticide, fumigant and repellant to control pests in crops and stored agricultural products. However, its use in agriculture has significantly decreased due to its high toxicity to humans, animals, and non-target insects, as well as the development of safer and more effective alternatives. Moreover, concerns about nicotine’s association with health issues, especially those related to tobacco use, have led to stricter regulations and reduced its agricultural application.
Since its announcement, the EU’s plan for new regulations on nicotine MRL for vanilla has raised concerns within the industry, in Madagascar as well as other vanilla producing countries. The latest amendment, Commission Regulation (EU) 2023/1536, decreases the tolerance level for nicotine in vanilla from 0.3 mg/kg to 0.05 mg/kg (see update below). This significant change is expected to impact over 30% of the vanilla production.
Initially scheduled for implementation on September 14, the EU’s new regulation on Nicotine MRL in vanilla is now set to take effect from January 2024. This extension was granted following discussions between the European Commissioner for Health and Consumer Protection and a Malagasy delegation composed of the Minister of Foreign Affairs; the Minister of Industrialization, Trade and Consumption; and the Minister responsible for Agriculture and Livestock.
This regulatory extension will allow Madagascar to pursue its vanilla exports to the EU market, a market representing approximately 40% of all exports from the island nation. It is also important to note that after the measure extension, Madagascar’s authorities submitted an import tolerance request, outlining conditions for accepting vanilla with nicotine levels exceeding the current EU limit.
While the regulations come into play as a way to control food safety along the supply chain, to date there has been no peer-reviewed research published on whether nicotine is naturally occurring or is due to external factors (tobacco leaves, smoking, pesticide, etc). Until such a study exists, some industry actors are calling for further delays in the implementation until an informed decision can be made.
The discussions at the European Commission regarding Nicotine MRL are on-going and as such the planned regulations and their implementation may be subject to further changes. De Monchy will continue to monitor this evolving situation closely and will update this article accordingly.
Conclusions
De Monchy Natural Products remains dedicated to providing the highest quality vanilla products while complying to the evolving regulatory requirements. We welcome regulations aimed at improving food safety for the public, which should be done in consultation with all stakeholders along the supply chain.
Edit - February 2024
On the 5th of February 2024, with Commission Regulation (EU) 2024/451, the European Commission officially revised the Nicotine MRL back to 0.3mg/kg for conventional vanilla beans, amid pressure from the stakeholders in the vanilla industry.
This regulation took effect on the 22nd of February and is valid until 2030.
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