PAHs in food supplements
The 10 µg/kg benzo(a)pyrene and 50 µg/kg PAH4 limits (point 5.1.16 of Regulation 2023/915), vegetable oils and batch testing

A food supplement containing botanicals and their preparations, or propolis, royal jelly or spirulina, may contain at most 10.0 µg/kg benzo(a)pyrene and at most 50.0 µg/kg of the sum of four PAHs (benzo(a)pyrene, benz(a)anthracene, benzo(b)fluoranthene and chrysene). That is point 5.1.16 of Annex I to Commission Regulation (EU) 2023/915. Both limits apply at the same time. They refer to the product as placed on the market (Art. 2(3)), and the sum is calculated as a lower bound: any value below the limit of quantification counts as zero. Food supplements containing vegetable oils are carved out of point 5.1.16. For the oil as an ingredient of a supplement, point 5.1.11 applies (2.0 µg/kg benzo(a)pyrene and 10.0 µg/kg sum). A supplement with no botanicals, propolis, royal jelly, spirulina or oils has no PAH entry of its own, so its ingredients are assessed against their own limits (Art. 2(1) and Art. 3). Sampling and methods of analysis come from Regulation (EC) No 333/2007, not from Implementing Regulations (EU) 2023/2782 and 2023/2783, which cover mycotoxins and plant toxins.

1. What point 5.1.16 says and why there are two limits

Section 5.1 of Annex I to Regulation 2023/915 (“Polycyclic aromatic hydrocarbons (PAHs)”) has two columns of maximum levels in µg/kg: benzo(a)pyrene and “sum of PAHs: benzo(a)pyrene, benz(a)anthracene, benzo(b)fluoranthene and chrysene”. The two columns go back to the 2008 EFSA opinion. The Commission took from it that benzo(a)pyrene alone is not a suitable marker for the occurrence of carcinogenic PAHs in food, and that a system of four substances (PAH4) is the most suitable. Regulation No 835/2011 therefore introduced the sum of four substances while keeping a separate limit for benzo(a)pyrene (recitals 4 and 7). In practice a batch can exceed the benzo(a)pyrene limit while the sum stays under 50 µg/kg, and it can exceed the sum while benzo(a)pyrene stays under 10 µg/kg.

The limits for supplements were added by Regulation (EU) 2015/1933, applicable from 1 April 2016. Recitals 5 and 6 say that high PAH levels in supplements containing or derived from botanical ingredients were linked to bad drying practices, and that in supplements from propolis, royal jelly and spirulina high levels in some cases were also linked to bad practices. Such levels can be avoided by good practice. The entry was added as point 6.1.13 of the Annex to Regulation 1881/2006, and Regulation 2023/915 took it over without changing the numbers. Point 5.1.16 has not been amended since the Regulation was adopted. Of the eleven amending acts (M1–M11 in the consolidated version of 19.08.2026), only Regulation 2024/1756 changed section 5.1, and only at points 5.1.13 and 5.1.15 (infant formulae and food for special medical purposes for infants). Article 10 provides no transitional period for PAHs.

2. Which point applies to which supplement

Point 5.1.16 names two groups: “food supplements containing botanicals and their preparations (13)” and “food supplements containing propolis, royal jelly, spirulina or their preparations”. Footnote 13 defines botanical preparations broadly: preparations obtained from botanicals by various processes (e.g. pressing, squeezing, extraction, fractionation, distillation, concentration, drying up and fermentation). They include comminuted or powdered plants, plant parts, algae, fungi, lichen, tinctures, extracts, essential oils, expressed juices and processed exudates. Algae therefore fall into the first group even apart from spirulina. The footnote carves vegetable oils and fats intended for direct human consumption or use as an ingredient in food out of botanical preparations (its parenthesis names butter and coconut oil).

The Annex sets no minimum share of the botanical ingredient. The entry covers supplements “containing” these ingredients. If the recipe includes a botanical extract, even as a minor part of the mass, the product falls under point 5.1.16 and the whole finished supplement is assessed against 10.0 / 50.0 µg/kg. The exception of point 5.1.10 for cardamom and smoked Capsicum spp. concerns dried spices and has not been repeated in point 5.1.16.

For a vegetable oil in a supplement, the carve-out from point 5.1.16 and the cross-reference to point 5.1.11 decide. Point 5.1.11 names “oils and fats placed on the market for the final consumer or use as an ingredient in food”, and its remark adds that the limit “applies to vegetable oils used as an ingredient in food supplements”. So the limit is checked on the oil (for instance on the raw material before softgels are filled), not on the whole capsule with its shell. What the Annex does for a recipe combining an oil and a botanical extract is not expressly settled (section 7).

3. How the sum is calculated and how to read a result

A result is expressed in the same units and with the same number of significant figures as the maximum level (Regulation 333/2007, point D.1.1), that is in µg/kg. Table 7 requires recovery of 50–120 %. Where the method has an extraction step, the result is corrected for recovery and the recovery value is reported (point D.1.2). The result is reported as x ± U, where U is the expanded measurement uncertainty with a coverage factor of 2 (point D.1.3). A batch is rejected where the result exceeds the maximum level “beyond reasonable doubt”, taking into account the expanded uncertainty and the correction for recovery (point D.2.2). In practice laboratories and authorities subtract U from the result and compare it with the limit. These rules apply to the enforcement sample. For defence or reference analysis national rules apply (point D.2.3).

Table 7 of Regulation 333/2007 sets the performance criteria for the four PAHs: a limit of detection (LOD) of at most 0.30 µg/kg and a limit of quantification (LOQ) of at most 0.90 µg/kg for each of the four substances, recovery of 50–120 %, repeatability and reproducibility HORRAT below 2, and specificity with verification of positive detection. Against a limit of 10.0 µg/kg, a well-chosen method has a wide sensitivity margin. A report in which the LOQ of a single substance is above 0.90 µg/kg does not meet these criteria.

4. “As placed on the market”: what it means for a capsule, a powder and an extract

Article 2(3) of Regulation 2023/915 provides that the maximum levels in Annex I apply to food as placed on the market and to the edible part of the food, unless the Annex provides otherwise. Point 5.1.16 has no different remark, so the finished supplement is assessed. Article 3 (adjustments for drying, dilution, processing and the proportion of ingredients) applies only where Annex I sets no specific limit for dried, diluted, processed or compound food. For supplements under point 5.1.16 the limit is specific, so it is not converted to the raw material, to a fresh-plant equivalent or to the daily portion. We described the same mechanism for metals in supplements.

The capsule case. A capsule shell is an edible part of the product as placed on the market, so it belongs to the sample, as with metals. The packaging (blister, bottle) does not. Regulation 333/2007 requires all the sample material received by the laboratory to be used for preparing the laboratory sample, and the whole part to which the maximum level applies to be used for homogenisation (point C.2.1). It follows that a result for the fill mixture alone does not replace testing of the finished product. The text of point 5.1.16 says nothing separately about capsule shells.

By comparison, for infant formulae (points 5.1.13 and 5.1.15) the original text referred the limit to the ready-to-use product after reconstitution, and Regulation 2024/1756 changed this to the product as placed on the market, split into powder and liquid. For supplements there is no dilution or reconstitution rule: what reaches the market is assessed, at the concentration at which it reaches the market.

5. Sample and analysis: Regulation 333/2007, not 2023/2782 or 2023/2783

Commission Regulation (EC) No 333/2007 lays down the methods of sampling and analysis for the control of the levels of trace elements and processing contaminants in foodstuffs. Its Article 1(1) names PAHs listed in section 5 of Annex I to Regulation 2023/915 expressly. Implementing Regulations (EU) 2023/2782 (mycotoxins) and 2023/2783 (plant toxins) contain no reference to PAHs. It is easy to mix them up, because for pyrrolizidine alkaloids in supplements the sample is set by Part L of Regulation 2023/2782. That scheme does not apply to PAHs.

Where the point B.2 method cannot be applied because of unacceptable commercial consequences (e.g. packaging form, damage to the lot), an alternative method may be used provided the sample is sufficiently representative and the sampling is fully documented in the record. Samples for enforcement, defence and referee purposes are taken from the homogenised aggregate sample unless this conflicts with national rules on the rights of the food business operator (point B.1.6).

Article 35 of Regulation 2017/625 gives an operator whose goods are subject to sampling and analysis in an official control the right to a second expert opinion at its own expense. Where relevant, appropriate and technically feasible and if the operator requests it, the authority must take a quantity sufficient for the second opinion, or inform the operator that this is not possible. For lots of up to 250 packages Table 4b requires the entire content of the package, so the quantity left for a second opinion may be limited. Article 35(2) then provides for informing the operator.

6. Raw material and finished product: the supplier contract and the recipe arithmetic

The legal line runs through the finished supplement, but the cause of a problem usually lies in the raw material. In recital 5 of Regulation 2015/1933 the Commission links high PAH levels to bad drying of botanical raw materials. Control therefore starts at supplier qualification: the drying method (drying directly with combustion gases or smoke versus indirect drying), storage conditions and, for propolis, extracts and spirulina, the production parameters. A certificate of analysis (COA) for a raw material should cover the four substances determined separately, the sum calculated as a lower bound, the LOQ of each substance (up to 0.90 µg/kg), recovery and uncertainty.

The share in the recipe can be applied to the raw-material limit, but only as an internal specification. The concentration in the product is the sum of the products of each ingredient’s share and its concentration, separately for each of the four substances. Hypothetical example: an extract makes up 40 % of the mass of the product as sold (shell included) and the other ingredients contribute no PAHs. The sum limit of 50.0 µg/kg in the product then allows at most 125 µg/kg of the sum in the extract (50.0 divided by 0.40), and the benzo(a)pyrene limit of 10.0 µg/kg at most 25 µg/kg in the extract. This is an arithmetical boundary condition for a supplier agreement. Legally, the product is tested, not the extract.

• Blending lots. Food complying with the maximum levels must not be mixed with food that exceeds them (Art. 2(2)). Diluting a non-compliant raw material with a compliant one to get a result under the limit is therefore not permitted. Food listed in Annex I that exceeds a limit must not be used as an ingredient either (Art. 2(1)).
• Detoxification. Article 4 prohibits the deliberate chemical detoxification of food containing contaminants listed in Annex I.
• Smoked raw materials. The exemption for cardamom and smoked paprika comes from point 5.1.10 for dried spices. Point 5.1.16 has no such exception, and recital 7 of Regulation 2015/1933 justifies the exemption by the low consumption of those spices, not of supplements.
• A COA for benzo(a)pyrene only. Older specifications often stop at one substance. The current system needs four determinations and two limits.

7. What the Annex does not settle

• A recipe with an oil and an extract. The carve-out from point 5.1.16 concerns supplements “containing vegetable oils”. The text gives no threshold for the share of oil and does not say how to assess the botanical ingredient in a softgel in which the extract is dissolved in oil. Read literally, point 5.1.16 then does not apply, and the limit of 2.0 / 10.0 µg/kg concerns the oil. The Annex gives no separate limit for the extract in such a capsule.
• Oils other than vegetable. The heading of point 5.1.11 covers “oils and fats” without limiting them to vegetable ones, while the remark on supplements names vegetable oils. Fish and algal oils in supplements are not discussed separately in the text.
• Powders for drinks. Point 5.1.2 covers “powders of food of plant origin for the preparation of beverages”, has the same limits of 10.0 / 50.0 µg/kg and refers to powders that are finely ground and stirred into drinks. For a botanical supplement in powder form both points may overlap. There is no numerical difference, but it is worth recording in the file which point was applied.
• Uncertainty of the sum. Part D of Regulation 333/2007 has no separate rule for determining the uncertainty of the sum of four substances. How U for the sum is calculated depends on the laboratory and should be described in the report.
• Testing frequency. Neither Regulation 2023/915 nor Regulation 333/2007 says how many batches an operator must test. This is part of the risk assessment in the HACCP system.
• Compliance and safety. A limit does not settle safety in every case. Compliance with specific provisions does not bar authorities from restricting the placing on the market where there are reasons to suspect that, despite such conformity, the food is unsafe (Art. 14(8) of Regulation 178/2002). Recital 2 of Regulation 2023/915 says that limits are set at a strict level reasonably achievable by good practice and, where a health risk is possible, as low as reasonably achievable (ALARA).

8. Consequences of an exceedance: official controls and the operator’s duties

Food listed in Annex I whose contaminant level exceeds the maximum level must not be placed on the market or used as a raw material or ingredient (Art. 2(1) of Regulation 2023/915). The operator is responsible for ensuring that its food satisfies the requirements of food law and for verifying that they are met (Art. 17(1) of Regulation 178/2002). Notifying the Chief Sanitary Inspector (GIS) of the first placing of a supplement on the market does not verify the contaminant content. We describe the procedure in the article on GIS notification.

Where an authority establishes non-compliance, Article 138 of Regulation 2017/625 requires it to take any action necessary to determine the origin and extent of the non-compliance and appropriate measures to ensure that the operator remedies it and prevents recurrence. The list of measures is open and includes restricting or prohibiting the placing on the market, ordering recall, withdrawal, removal and destruction of goods, ordering an increase in the frequency of own controls and subjecting the operator’s activities to increased official controls. The authority takes account of the nature of the non-compliance and the operator’s past record. Penalties are laid down by Member States and must be effective, proportionate and dissuasive (Art. 139(1)). We do not discuss national penal provisions in this article.

Where an operator considers or has reason to believe that food it has produced, imported or distributed does not comply with the food safety requirements and has left its immediate control, it must immediately initiate withdrawal procedures and inform the competent authorities (Art. 19(1) of Regulation 178/2002). Where the product may have reached the consumer, consumers are informed of the reason and, if necessary, the product is recalled. The limits in Annex I were set to protect public health (recital 2 of Regulation 2023/915). In our view an operator who learns of an exceedance in a batch already on the market should treat Article 19 as triggered. This requires working traceability: the supplier of the raw material and the recipients of the product (Art. 18).

9. Typical operator pitfalls

• Citing Regulation 2023/2782 or 2023/2783 as the sampling scheme for PAHs instead of Regulation 333/2007.
• Treating the COA of an extract as proof that the finished capsule complies. The law assesses the product as placed on the market.
• Limiting the test to benzo(a)pyrene. The sum limit needs four determinations.
• Reporting the sum as an upper bound or with LOQ values, which inflates the result and makes it hard to compare with an authority’s report.
• Applying 10.0 / 50.0 µg/kg to an oil capsule or, the other way round, assessing the oil against the supplement limit instead of 2.0 / 10.0 µg/kg.
• Collecting the sample in a plastic container or without protection from light, which distorts the result (point B.1.7).
• Diluting a non-compliant raw-material lot with a clean one (Art. 2(2)).

10. Checklist: PAHs in a food supplement

1. Classification: establish whether the recipe contains botanical preparations within footnote 13, propolis, royal jelly, spirulina or a vegetable oil. Record which point of Annex I you apply (5.1.16, 5.1.11, 5.1.12 or assessment of ingredients under Arts 2 and 3) and why.
2. Supplier specification: require a COA with the four PAHs separately, the sum as a lower bound, the LOQ of each substance up to 0.90 µg/kg, recovery, uncertainty and the method. Ask about the drying method and about smoking.
3. Recipe arithmetic: calculate the highest permissible concentration in each ingredient so that the concentration in the product does not exceed 10.0 µg/kg benzo(a)pyrene and 50.0 µg/kg sum. Set an internal limit with a margin for uncertainty.
4. Finished-product test: test the finished supplement as placed on the market, shell included. For an oil used as an ingredient, test the oil against point 5.1.11. Order a report with x ± U and recovery.
5. Sampling: use a glass container, protect from light, avoid contact with plastic. Record the lot number and place of sampling. Model the sampling plan on Table 4b of Regulation 333/2007.
6. Batch release: hold the batch where benzo(a)pyrene exceeds 10.0 µg/kg or the sum exceeds 50.0 µg/kg, taking U and recovery into account. Do not dilute non-compliant lots.
7. Non-compliance: do not place a product above the limit on the market. If the batch has already left your control, start the Article 19 procedure of Regulation 178/2002 and notify the authority.
8. Documentation: keep COAs, test reports, the reasoning for the Annex point, recipe calculations and traceability records for an official control and a second expert opinion.

Frequently asked questions

What PAH limits apply to a food supplement with a botanical extract?

At most 10.0 µg/kg benzo(a)pyrene and at most 50.0 µg/kg of the sum of four PAHs (benzo(a)pyrene, benz(a)anthracene, benzo(b)fluoranthene and chrysene), under point 5.1.16 of Annex I to Regulation (EU) 2023/915. The limits refer to the product as placed on the market, and the sum is calculated as a lower bound.

Does point 5.1.16 cover a supplement in capsules containing a vegetable oil?

No. Point 5.1.16 does not apply to food supplements containing vegetable oils. For an oil used as an ingredient of a supplement, point 5.1.11 applies: 2.0 µg/kg benzo(a)pyrene and 10.0 µg/kg sum of PAHs.

Do Regulations 2023/2782 and 2023/2783 apply to PAH testing in a supplement?

No. Implementing Regulations 2023/2782 and 2023/2783 concern mycotoxins and plant toxins. Sampling and analysis for PAHs are governed by Regulation (EC) No 333/2007. For supplements it provides an aggregate sample of at least 100 g and the number of packages from Table 4b.

Is it enough to determine benzo(a)pyrene alone?

No. Two limits apply in parallel: benzo(a)pyrene and the sum of four PAHs. A batch can meet one and exceed the other.

Does GIS notification confirm that a supplement complies with the PAH limits?

No. Notification of the first placing on the market does not verify the contaminant content. The operator is responsible for compliance (Art. 17(1) of Regulation 178/2002), and official controls verify it.

Glossary

PAHs

Polycyclic aromatic hydrocarbons, processing contaminants formed, among other ways, by incomplete combustion and by drying directly with combustion gases or smoke.

Sum of PAHs (PAH4)

The sum of benzo(a)pyrene, benz(a)anthracene, benzo(b)fluoranthene and chrysene under section 5.1 of Annex I to Regulation 2023/915.

Lower bound concentration

A way of calculating the sum in which values of the four substances below the limit of quantification are taken as zero.

Limit of quantification (LOQ)

The lowest content of the analyte that can be measured with reasonable statistical certainty. At most 0.90 µg/kg for each of the four substances (Table 7 of Reg. 333/2007).

Botanical preparation (footnote 13)

A preparation obtained from plants, algae, fungi or lichen by processes such as extraction, concentration or drying. It includes extracts, tinctures, powdered plants and essential oils.

Aggregate sample

The combined total of the incremental samples taken from a lot. For supplements at least 100 g or 100 ml.

Conclusion

For a supplement with botanicals, propolis, royal jelly or spirulina, two limits from point 5.1.16 decide: 10.0 µg/kg benzo(a)pyrene and 50.0 µg/kg sum of four PAHs, calculated on the finished product as a lower bound. A vegetable oil switches that point off and moves the assessment to the oil as an ingredient (2.0 / 10.0 µg/kg). The sample is taken and tested under Regulation 333/2007 (Table 4b, containers without plastics, LOQ up to 0.90 µg/kg, x ± U with correction for recovery), not under Regulations 2023/2782 and 2023/2783. The most common mistakes are a raw-material COA instead of a product test, determining benzo(a)pyrene only, and blending lots. Related topics: lead, cadmium and mercury in supplements, pyrrolizidine alkaloids in herbal supplements and sampling for pesticide residues in supplements.

Primary sources

1. Commission Regulation (EU) 2023/915 of 25.04.2023 on maximum levels for certain contaminants in food (OJ L 119, 5.5.2023, p. 103): Arts 2–4, 10, Annex I points 5.1, 5.1.11, 5.1.12, 5.1.16 and footnote 13; consolidated text of 19.08.2026.
2. Commission Regulation (EC) No 333/2007 laying down the methods of sampling and analysis for the control of the levels of trace elements and processing contaminants in foodstuffs: Art. 1, Annex Parts B–D; consolidated text of 30.04.2024.
3. Commission Regulation (EU) 2015/1933 of 27.10.2015 amending Regulation (EC) No 1881/2006 as regards maximum levels for polycyclic aromatic hydrocarbons in cocoa fibre, banana chips, food supplements, dried herbs and dried spices (OJ L 282, 28.10.2015, p. 11).
4. Commission Regulation (EU) No 835/2011 of 19.08.2011 amending Regulation (EC) No 1881/2006 as regards maximum levels for polycyclic aromatic hydrocarbons in foodstuffs (OJ L 215, 20.8.2011, p. 4).
5. EFSA, Polycyclic Aromatic Hydrocarbons in Food: Scientific Opinion of the Panel on Contaminants in the Food Chain, EFSA Journal 2008;6(8):724.
6. Regulation (EU) 2017/625 on official controls: Arts 34, 35, 137, 138 and 139.
7. Regulation (EC) No 178/2002 (consolidated version): Arts 14, 17, 18 and 19.
8. Implementing Regulation (EU) 2023/2782 (mycotoxins) and 2023/2783 (plant toxins): scope as shown by the titles of the acts, no reference to PAHs.