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SAFEGUARDS | Food NO. 053/16

On February 19 2016, the European Commission published Regulation (EU) 2016/239 [1] to amend maximum levels for tropane alkaloids (TA) in certain cereal based foods for infants and young children.

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Regulation (EU) No 881/2006 [2], is amended by Regulation (EU) 2016/239, and the European Union has announced four Commission Regulations amending Annexes II, III and V to Directive 2005/396/EC of the European Parliament, and of the Council, with regard to maximum residue levels for pesticides in or on food and feed of plant and animal origin.

The changes and amendments in the aforementioned Commission Regulations (EU) are related to maximum levels (MLs) for tropane alkaloids in certain cereal based foods for infants and young children imported into the EU. Details of the changes are shown in Table 1.

Table 1

Foodstuffs(*) Maximum Level (µg/kg)
8.2 Tropane alkaloids(*) Atropine Scopolamine
8.2.1 Processed cereal-based foods and baby foods for infants and young children, containing millet, sorghum, buckwheat or their derived products 1.0 μg/kg 1.0 μg/kg

(*)The tropane alkaloids referred to are atropine and scopolamine. Atropine is the racemic mixture of (-)-hyoscyamine and (+)-hyoscyamine of which only the (-)-hyoscyamine enantiomer exhibits anticholinergic activity. As for analytical reasons it is not always possible to distinguish between the enantiomers of hyoscyamine, the maximum levels are established for atropine and scopolamine.’

Amendments of the Commission Regulations

  • The changes to MLs for Tropane Alkaloids in Certain cereal based foods for infants and young children, in Commission Regulation (EU) No 2016/239 of February 19, 2016 shall apply from March 10, 2016

Tropane alkaloids are plant derived organic compounds that contain a tropane ring in their chemical structure and they are among the oldest medicines known to man. For example, cocaine has insecticidal properties at naturally occurring concentrations, due to potentiation of insect octopaminergic neurotransmission (Nathanson, 1993). Crude drugs and alkaloids prepared from these poisonous plants are used as antispasmodics, sedatives, anesthetics, mydriatics, etc. in therapies.

Tropane alkaloids have secondary metabolites which naturally occur in the plants of several families, including Brassicaceae, Solanaceae and Erythroxylaceae. To date, more than 200 TAs have been identified. The most studied tropane alkaloids are (-)-hyoscyamine and (-)-scopolamine. Atropine is the racemic mixture of (-)-hyoscyamine and (+)-hyoscyamine, of which only the (-)-hyoscyamine enantiomer exhibits anticholinergic activity.

Scopolamine, acting as an antagonist at both peripheral and central muscarinic receptors, is thought to be the primary compound responsible for the toxic effects of these plants. Tropane alkaloids are found in all parts of the plants, with the highest concentrations found in their roots and seeds.

Atropine is an artifact of purification, produced by racemization of l-hyoscyamine. The proportion of each alkaloid present varies between species, time of year, location, and part of plant. As little as one-half teaspoon of Datura seed, equivalent to 0.1 mg of atropine per seed, has caused death from cardiopulmonary arrest. The usual route of ingestion is as a tea, although ingesting seeds or other plant parts and smoking dried leaves also are common.

The presence of tropane alkaloids in the genus Datura is well known. Datura stramonium is widely distributed in temperate and tropical regions. For this reason seeds of Datura stramonium have been found as impurities in linseed, soybean, sorghum, millet, sunflower and buckwheat and products thereof. The Datura stramonium seeds cannot be easily removed from sorghum, millet and buckwheat by sorting and cleaning and therefore sorghum, millet and buckwheat, their derived products and cereal based foods containing these, are found to be contaminated with tropane alkaloids.

Toxicity from plants containing tropane alkaloids manifests as classic anticholinergic poisoning. Symptoms usually occur 30-60 minutes after ingestion and may continue for 24-48 hours because tropane alkaloids delay gastric emptying and absorption.

Consignments in transit

These Regulations shall enter into force 20 days after their publication. Consignments of food and feed that left their country of origin prior to these Regulations coming into force may still be imported without being accompanied by either a health certificate, or the results of sampling and analysis.

What do the changes mean?

To ensure compliance with the new MLs, Member States shall take and analyze samples for these contaminants in foodstuffs and product combinations, including foods for infants and small children and products originating from organic farming. For more information, or to discuss your testing, analysis and certification requirements contact a food safety expert, such as SGS.

SGS is committed to keeping you informed of regulation news and developments. Leveraging our global network of laboratories and food experts, SGS provides a comprehensive range of food safety and quality solutions including analytical tests, audits, certifications, inspections, and technical support. We continually invest in our testing, capability, and state-of-the art technology to help you reduce risk, and to improve food safety and quality. For more information, please visit our website:

For enquiries, please contact:

Supaporn Surawattanaboon
Research & Development Chemist

t: +66 26830541 ext 2128

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