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Regulation (EC) 915/2023

Annex I
Maximum levels for certain contaminants in food(1)

2.4 Pyrrolizidine alkaloids


ReferenceNumberingFoodstuffsMaximum Level (ug/kg)Remarks
The maximum level refers to the lower bound sum of the following 21 pyrrolizidine alkaloids: - intermedine/lycopsamine, intermedine-N-oxide/lycopsa­ mine-N-oxide, senecionine/senecivernine, senecionine- N-oxide/senecivernine-N-oxide, seneciphylline, seneci­ phylline-N-oxide, retrorsine, retrorsine-N-oxide, echimi­ dine, echimidine-N-oxide, lasiocarpine, lasiocarpine-N- oxide, senkirkine, europine, europine-N-oxide, heliotrine and heliotrine-N-oxide and the following additional 14 pyrrolizidine alkaloids known to co-elute with one or more of the above identi­ fied 21 pyrrolizidine alkaloids, making use of certain cur­ rently used analytical methods: - indicine, echinatine, rinderine (possible co-elution with lycopsamine/intermedine), indicine-N-oxide, echinatine- N-oxide, rinderine-N-oxide (possible co-elution with lycopsamine-N-oxide/intermedine-N-oxide), integerri­ mine (possible co-elution with senecivernine/senecio­ nine), integerrimine-N-oxide (possible co-elution with senecivernine-N-oxide/senecionine-N-oxide), heliosupine (possible co-elution with echimidine), heliosupine-N- oxide (possible co-elution with echimidine-N-oxide), spartioidine (possible co-elution with seneciphylline), spartioidine-N-oxide (possible co-elution with seneci­ phylline-N-oxide), usaramine (possible co-elution with retrorsine), usaramine N-oxide (possible co-elution with retrorsine N-oxide). Pyrrolizidine alkaloids, which can be individually and separately identified with the used method of analysis, shall be quantified and included in the sum.
For the pyrrolizidine alkaloids, maximum levels refer to lower bound concentrations, which are calculated on the assumption that all the values below the limit of quantification are zero.
B2.4.1 Borage leaves (fresh, frozen) placed on the market for the final consumer 750 Without prejudice to more restrictive national rules in certain Member States on the placing of the market of pyrrolizidine alkaloid containing plants.
B2.4.10 Food supplements containing botanical preparation (13) including extracts except products listed in 2.4.11 400 The maximum level applies to the food supplements as placed on the market. Without prejudice to more restrictive national rules in certain Member States on the placing of the market of pyrrolizidine alkaloid containing plants.
B2.4.11 Pollen based food supplements Pollen and pollen products 500 The maximum level applies to the food supplements as placed on the market.
B2.4.2 Dried herbs except products listed in 2.4.3 400 Without prejudice to more restrictive national rules in certain Member States on the placing of the market of pyrrolizidine alkaloid containing plants.
B2.4.3 Borage, lovage, marjoram and oregano (dried product) and mixtures exclusively composed of these dried herbs 1000 Without prejudice to more restrictive national rules in certain Member States on the placing of the market of pyrrolizidine alkaloid containing plants.
B2.4.4 Tea (Camellia sinensis) and flavoured tea (12) (Camellia sinensis) (dried product) except tea and flavoured tea referred to in 2.4.5 150 For teas with dried fruits and dried herbs, Article 3 applies. ‘Tea (Camellia sinensis) (dried product)’ refers to: - tea (Camellia sinensis) (dried product) from dried leaves, stalks and flowers (in sachets or in bulk) used for the preparation of tea (liquid product); and - instant teas. In the case of powdered tea extracts, a concentration factor of 4 has to be applied.
B2.4.5 Tea (Camellia sinensis), flavoured tea (12) (Camellia sinensis) and herbal infusions (dried product) and ingredients used for herbal infusions (dried products) for infants and young children 75 For teas with dried fruits and dried herbs, Article 3 applies.
B2.4.6 Tea (Camellia sinensis), flavoured tea (12) (Camellia sinensis) and herbal infusions (liquid product) for infants and young children 1.0 For teas with dried fruits and dried herbs, Article 3 applies.
B2.4.7 Herbal infusions (dried product) and ingredients used for herbal infusions (dried products) except products listed in 2.4.5 and 2.4.8 200 ‘Herbal infusions (dried product)’ refers to: - herbal infusions (dried product) from flowers, leaves, stalks, roots, and any other parts of the plant (in sachets or in bulk) used for the preparation of herbal infusion (liquid product); and - instant herbal infusions. In the case of powdered extracts, a concentration factor of 4 has to be applied. Without prejudice to more restrictive national rules in certain Member States on the placing of the market of pyrrolizidine alkaloid containing plants.
B2.4.8 Herbal infusions (dried product) and ingredients used for herbal infusions (dried products) of rooibos, anise (Pimpinella anisum), lemon balm, chamomile, thyme, peppermint, lemon verbena and mixtures exclusively composed of these dried herbs except herbal infusions referred to in 2.4.5 400 ‘Herbal infusions (dried product)’ refers to: - herbal infusions (dried product) from flowers, leaves, stalks, roots, and any other parts of the plant (in sachets or in bulk) used for the preparation of herbal infusion (liquid product); and - to instant herbal infusions. In the case of powdered extracts, a concentration factor of 4 has to be applied.
B2.4.9 Cumin 400-