Pyrrolizidine alkaloids in botanical food supplements
How the 400 µg/kg level in Regulation 2023/915 applies

A food supplement containing a botanical preparation, including an extract, may contain at most 400 µg/kg of pyrrolizidine alkaloids (PAs). That is point 2.4.10 of Annex I to Commission Regulation (EU) 2023/915. The level is the lower-bound sum of 21 PAs plus 14 PAs known to co-elute with them, N-oxides included. It applies to the food supplement as placed on the market, not to the extract used in the formulation. Pollen-based food supplements have a separate level of 500 µg/kg (point 2.4.11). Both levels have applied since 1 July 2022, and the sell-through period for older stock ended on 31 December 2023.

1. What point 2.4.10 covers: “botanical preparation” under footnote 13

Point 2.4.10 reads: “Food supplements containing botanical preparation including extracts except products listed in 2.4.11”. Footnote 13 to Annex I defines botanical preparations. They are obtained from botanicals (whole plants, plant parts, fragmented or cut plants) by processes such as pressing, squeezing, extraction, fractionation, distillation, concentration, drying and fermentation. They include comminuted or powdered plants, plant parts, algae, fungi, lichen, tinctures, extracts, essential oils, expressed juices and processed exudates. Excluded are vegetable oils and fats intended for direct human consumption or for use as a food ingredient (butter and coconut oil excepted).

Three consequences follow that are easy to miss:

• The scope is wider than “herbs”. A capsule with a mushroom extract, a tablet with an alga or drops with an essential oil are also supplements containing a botanical preparation within footnote 13.
• There is no minimum share. Point 2.4.10 sets no threshold for the botanical content. A multivitamin with a small amount of extract still “contains a botanical preparation”, so the 400 µg/kg level covers the whole product.
• A vegetable oil carrier alone does not bring a product into 2.4.10. Sunflower oil used to dissolve vitamin D is excluded from the footnote 13 definition. Such a product falls under 2.4.10 only if it contains another botanical preparation.

A supplement that contains no botanical preparation at all (for example calcium carbonate with vitamin D) has no specific PA level in point 2.4. That does not mean no rules apply. Article 2 of Regulation (EEC) No 315/93 still applies: food containing a contaminant in an amount unacceptable from the public-health viewpoint must not be placed on the market, and contaminant levels must be kept as low as can reasonably be achieved. Article 14 of Regulation (EC) No 178/2002 also applies.

2. Map of point 2.4: supplement, herbal infusion, herb, pollen

The same raw material can face different levels depending on the product it is sold as. The starting point is therefore the legal category. Under Article 2(a) of Directive 2002/46/EC, a food supplement is a concentrated source of nutrients or other substances with a nutritional or physiological effect, marketed in dose form (capsules, tablets, sachets of powder, ampoules, drop dispensing bottles).

The most frequent dispute concerns products on the border between infusion and supplement. A herb blend in infusion sachets, described as a herbal tea, falls under 2.4.7 or 2.4.8 with 200 or 400 µg/kg in the dried product. The same blend in capsules, notified as a supplement, falls under 2.4.10. The food business operator classifies the product, and the competent authority can challenge that classification. The name on the label decides nothing by itself. What counts is whether the product meets the definition in Directive 2002/46/EC.

3. What is actually measured: the lower-bound sum of 21 + 14 PAs

The remarks to point 2.4 define the sum. The maximum level refers to the lower-bound sum of 21 pyrrolizidine alkaloids: intermedine/lycopsamine, senecionine/senecivernine, seneciphylline, retrorsine, echimidine, lasiocarpine, senkirkine, europine, heliotrine and their N-oxides (senkirkine is listed without an N-oxide). To these are added 14 further PAs known to co-elute with the 21 using certain current methods, among them indicine, echinatine, rinderine, integerrimine, heliosupine, spartioidine and usaramine and their N-oxides. PAs that the method can identify individually and separately must be quantified and included in the sum.

The sum uses a lower-bound approach: results below the limit of quantification (LOQ) count as zero. Regulation 2023/2783 (Annex II, Table 1) requires an LOQ for each individual PA of ≤ 10 µg/kg in dried products and ≤ 0.15 µg/l in liquid products. Recovery correction, where applied, is done for each alkaloid before summation. The average recovery of a confirmatory method should lie between 70 and 120%.

The definition also has a limit. PAs outside the list of 35 compounds do not count towards the level, even where the plant contains them. A result compliant with 2.4.10 is therefore not a safety assessment of a raw material from a plant that itself produces PAs (see section 6).

4. “As placed on the market”: a level for the finished product, not the extract

Point 2.4.10 carries the remark: “The maximum level applies to the food supplements as placed on the market”. The result is therefore expressed in µg per kg of the supplement in the form sold: tablets with excipients, capsules or a liquid. It is not recalculated to the extract alone or to the daily portion. Article 3 of the Regulation, which requires drying, dilution and processing factors and ingredient proportions to be taken into account, applies only where no specific Union level exists for that food. A botanical supplement has one.

In practice, the share of the extract in the product mass sets the acceptable PA level in the raw material. Worked example (hypothetical formulation, not a specific product):

The dilution arithmetic has three legal limits:

• A raw material with its own Annex I entry must meet that level before use. Under Article 2(1), food listed in Annex I must not be used as a raw material or ingredient where it exceeds its maximum level. This covers, for example, pollen and pollen products (500 µg/kg, point 2.4.11) and dried herbs (400 or 1,000 µg/kg, points 2.4.2–2.4.3). Article 2(2) prohibits mixing compliant food with food exceeding the levels.
• The ALARA principle. Article 2(2) of Regulation 315/93 requires contaminant levels to be kept as low as can reasonably be achieved by following good practices. Deliberately buying a heavily contaminated extract in the hope of “diluting” it with excipients is hard to square with that principle. Recital 6 of Regulation 2020/2040 ties the PA levels precisely to good agricultural and harvest practices.
• No detoxification. Article 4 of Regulation 2023/915 prohibits deliberate chemical detoxification of food containing Annex I contaminants.

For liquid supplements (tinctures, drops) the level also refers to the product as sold, in µg/kg, without recalculating for dilution before consumption. The concentration factor of 4 in points 2.4.4, 2.4.7 and 2.4.8 concerns powdered tea and herbal-infusion extracts. It does not apply to point 2.4.10.

5. Sample and official decision: Part L of Regulation 2023/2782 and the x − U rule

For sampling methods, the plant-toxin Regulation 2023/2783 refers to Part II of Annex I to Regulation 2023/2782. For food supplements, pollen and pollen products, Part L applies. Key parameters:

At retail, Part L applies where possible. Otherwise an alternative sampling method may be used if the aggregate sample is sufficiently representative and the method is fully described and documented. The aggregate sample must be at least 0.05 kg.

The result is reported as x ± U, where U is the expanded measurement uncertainty with a coverage factor of 2. A laboratory meeting the precision criteria may report a default uncertainty of 50%. A lot is rejected only when the recovery-corrected result minus U exceeds 400 µg/kg, i.e. when non-compliance is established “beyond reasonable doubt” (point L.3).

• Result 700 ± 350 µg/kg (U = 50%): 700 − 350 = 350, the lot is not rejected.
• Result 900 ± 450 µg/kg (U = 50%): 900 − 450 = 450 > 400, non-compliant.
• Result 600 ± 180 µg/kg (U = 30%): 600 − 180 = 420 > 400, non-compliant.

Two practical notes. First, x − U is the authority’s decision rule for an official sample. It does not replace the production target, which remains 400 µg/kg together with ALARA. Second, with a 35-analyte sum, the laboratory’s own uncertainty decides where the rejection threshold lies. If the official sample shows non-compliance beyond reasonable doubt and the defence sample shows non-compliance but not beyond reasonable doubt because its laboratory has a larger uncertainty, the defence result cannot supersede the official finding (point 4.3.1 of Annex II to Regulation 2023/2783). Methods validated before 1 April 2024 may stay in use until 1 July 2028 even if they do not meet every specific requirement of point 4.2.

The same “result minus uncertainty” logic appears for pesticide residues, covered in our analysis of Regulation 2026/765. There, however, the sampling plan and default uncertainty come from a different act.

6. What the level does not decide

• The safety of PA-producing plants. PAs are produced, among others, by plants of the borage family (Boraginaceae), the daisy family (Asteraceae, tribe Senecioneae) and the legume family (genus Crotalaria). In its 2017 statement EFSA noted that consumption of food supplements based on PA-producing plants could result in exposure less than 100 times lower than doses known to cause severe acute or short-term toxicity. The 400 µg/kg level concerns contamination, not whether such a plant is acceptable as an ingredient. That question turns on Article 14 of Regulation 178/2002 and, where the plant was not consumed to a significant degree before 15 May 1997, on the novel-food rules.
• National rules on plants. Point 2.4.10 states that the level applies without prejudice to more restrictive national rules on placing PA-containing plants on the market. Meeting the level does not lift a national ban or restriction on a given plant.
• The GIS notification. Notifying the first placing of a supplement on the Polish market does not confirm compliance with contaminant levels. Under Article 17(1) of Regulation 178/2002 that responsibility lies with the food business operator. See our guide to the GIS notification.
• Health claims and Regulation 1925/2006 restrictions. Meeting the PA level gives no right to health claims (Regulation 1924/2006). Nor does it change the conditions for substances in Annex III to Regulation 1925/2006, such as EGCG from green-tea extract.
• Border controls. Certain botanical supplements from third countries are also subject to increased entry checks (see Regulation 2026/1206). That is a separate regime, but a PA result is often part of the file for the same consignment.

7. Checklist: raw-material specification and batch release

1. Product category. Establish whether the product is a supplement in dose form (point 2.4.10 or 2.4.11), a herbal infusion (points 2.4.5–2.4.8) or another product in point 2.4.
2. Botanical preparation under footnote 13. Check every ingredient, including fungi, algae, lichens and essential oils. A vegetable oil carrier does not bring the product into 2.4.10.
3. Analytical scope. In the laboratory contract, require the lower-bound sum of 21 + 14 PAs, LOQ ≤ 10 µg/kg per analyte (dried product), results for each alkaloid and the stated uncertainty U.
4. Extract specification from the inclusion rate. Calculate the maximum PA level in the raw material from the extract’s share of the finished product mass, then deduct a margin for uncertainty. For pollen and other raw materials with their own Annex I entry, check that level too.
5. Finished-product testing. Base batch release on the result for the product as sold, not on the extract supplier’s certificate alone.
6. PA-producing plants. If the raw material comes from such a plant, assess its admissibility (Article 14 of Regulation 178/2002, novel-food status, national rules) regardless of the sum result.
7. A new supplier or raw-material batch means a new assessment. PAs in botanical raw materials often come from weeds harvested with the crop. That is why recital 6 of Regulation 2020/2040 points to good agricultural and harvest practices, and variation between harvests is typical.

Glossary

Pyrrolizidine alkaloids (PAs)

Plant toxins. According to EFSA, 1,2-unsaturated PAs may act as genotoxic carcinogens. In food they also occur as N-oxides.

Lower bound

A way of calculating a sum in which results below the limit of quantification are set to zero.

Botanical preparation (footnote 13)

Plants or plant parts processed into a powder, extract, tincture, essential oil, juice or exudate, including algae, fungi and lichens, excluding vegetable oils for direct consumption.

Expanded measurement uncertainty (U)

An interval around the result with a coverage factor of 2, corresponding to about 95% confidence. A default of 50% may be used.

EFSA reference point

237 µg/kg body weight per day, set in 2017 to assess the carcinogenic risk of PAs by the margin-of-exposure approach.

Conclusion

A supplement with a botanical preparation is subject to a single EU level: 400 µg/kg for the lower-bound sum of 21 + 14 pyrrolizidine alkaloids, calculated for the product as placed on the market. Pollen-based supplements have a level of 500 µg/kg. The scope of point 2.4.10 is broad: it covers fungi, algae, lichens and essential oils and has no minimum share. The extract’s share of the tablet or capsule mass sets the acceptable PA level in the raw material. That arithmetic is limited by Article 2 of Regulation 2023/915 for raw materials with their own level, by ALARA and by the ban on detoxification. A lot is rejected when the recovery-corrected result minus measurement uncertainty exceeds the level. Meeting the level does not settle whether a PA-producing plant is acceptable, and it does not override stricter national rules.

Primary sources

1. Commission Regulation (EU) 2023/915, consolidated version of 19.08.2026: Articles 2, 3, 4, 10(2); Annex I points 2.4.1–2.4.11 with footnote 13.
2. Commission Regulation (EU) 2020/2040 of 11.12.2020: PA levels inserted into Regulation 1881/2006, applicable from 1.07.2022, recitals 2–8.
3. Commission Implementing Regulation (EU) 2023/2783 of 14.12.2023: sampling and analysis of plant toxins; Article 5; Annex II points 4.2–4.3, Table 1.
4. Commission Implementing Regulation (EU) 2023/2782 of 14.12.2023: Annex I Part II, Part L (food supplements, pollen), points L.1–L.3.
5. Council Regulation (EEC) No 315/93: Article 2(1)–(2) (unacceptable levels, ALARA).
6. Directive 2002/46/EC: Article 2(a) (definition of food supplement).
7. Regulation (EC) No 178/2002: Article 14, Article 17(1).
8. EFSA CONTAM, EFSA Journal 2017;15(7):4908: PA risks in honey, tea, herbal infusions and food supplements; reference point 237 µg/kg bw per day; 17 PAs for monitoring.
9. EFSA, EFSA Journal 2016;14(8):4572: dietary exposure to PAs in the European population.
10. EFSA CONTAM, EFSA Journal 2011;9(11):2406: scientific opinion on PAs in food and feed.