20.2.2016   

EN

Official Journal of the European Union

L 45/3

(1)

Commission Regulation (EC) No 1881/2006 (2) sets maximum levels for certain contaminants in foodstuffs.

(2)

The Scientific Panel on Contaminants in the Food Chain (CONTAM) of the European Food Safety Authority (EFSA) adopted an opinion on tropane alkaloids in food and feed (3).

(3)

Tropane alkaloids are secondary metabolites which naturally occur in plants of several families including Brassicaceae, Solanaceae and Erythroxylaceae. More than 200 TAs have been identified so far. 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.

(4)

The presence of tropane alkaloids in genus Datura is well known. Datura stramonium is widely distributed in temperate and tropical regions and 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 and their derived products and cereal based foods containing these are found to be contaminated with tropane alkaloids.

(5)

The CONTAM Panel established a group Acute Reference Dose (‘ARfD’) of 0,016 μg/kg body weight (‘b.w.’) expressed as the sum of (-)-hyoscyamine and (-)-scopolamine, assuming equivalent potency. The CONTAM Panel concluded that, based on the limited information available, the dietary exposure of toddlers could exceed significantly the group ARfD.

(6)

It is therefore appropriate to establish a maximum level for (-)-hyoscyamine and (-)-scopolamine in cereal-based foods for infants and young children containing millet, sorghum, buckwheat or their derived products. However, as for analytical reason it is not always possible to distinguish between the enantiomers of hyoscyamine, it is appropriate to establish the maximum level for atropine and scopolamine. As the synthesis of tropane alkaloids in plants leads to (-)-hyoscyamine and (-)-scopolamine and not to (+)-hyoscyamine, analytical results on atropine in food of plant origin reflects the occurrence of (-)-hyoscyamine.

(7)

It is appropriate to establish the sampling rules to be applied for the control of compliance with the maximum levels.

(8)

Regulation (EC) No 1881/2006 should therefore be amended accordingly.

(9)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,