Ochratoxin A – Draft revision of maximum levels and establishment of maximum levels for other foods
Ochratoxins are mycotoxins produced by various Aspergillus and Penicillium species, including A. ochraceus, A. carbonarius and P. verrucosum, for example. Ochratoxin A (OTA) is the most important ochratoxin in terms of quantity and toxicity. The maximum levels for ochratoxin A laid down in Regulation (EC) 1881/2006 are currently being revised following an updated toxicological assessment conducted by EFSA.
Occurrence
Ochratoxin A was isolated from corn for the first time in 1969. Today, such spices as paprika, chilli, black pepper, nutmeg, coriander, ginger and curcuma are known to be susceptible to ochratoxin producing fungi in addition to cereals, beer, cocoa and coffee. However, relevant OTA concentrations have also been found in vegetables, fruits, sultanas and liquorice. OTA levels in animal food products may be attributable to contaminated feed. Miscolonisation with Aspergillus or Penicillium species during ripening and storage can lead to OTA contamination in certain types of cheese.
Risk assessment
In July 2020, EFSA published an updated assessment of the risk associated with ochratoxin A (OTA) contamination in food. The results of more recent toxicological studies had been made available to EFSA, along with new findings relating to the occurrence of ochratoxin A derivatives (masked mycotoxins) that are not detected by the established methods of analysis for ochratoxin A. Based on these, EFSA regards ochratoxin A as being more likely to have genotoxic properties and now applies a margin of exposure (MOE) approach in the risk assessment for reasons relating to precautionary consumer protection. Although this safety margin between the toxicological point of departure (POD) and the daily intake level should amount to at least 10,000 for genotoxic compounds, the margin for OTA is considerably smaller for many consumer groups.
Legal provisions
The European Commission therefore presented proposals for a reduction of the maximum OTA levels in certain foods and for new maximum levels in other foods (DG SANTE: SUGGESTED POSSIBLE NEW AND REVISED MAXIMUM LEVELS FOR OCHRATOXIN A (OTA). The introduction of a maximum level of 10 µg/kg for dried herbs, tea and herbal and fruit teas is probably the most important change foreseen for products based on dried herbs. Liquorice root, for which a limit of 20 µg/kg shall continue to apply, remains exempt from this.
New proposals include extending the scope of application of the limit value previously applied to just pepper, ginger, nutmeg and curcuma to include all spices (with capsicum continuing to be an exception) and maximum levels for spice mixtures, various seeds and cocoa powder. The stakeholder consultation on the risk assessment conducted by the Commission ended on 1 December 2020, so that an implementation can be expected shortly in the form of an amendment to Regulation (EC) 1881/2006.
Table in accordance with: Commission draft (10/2020) for Suggested and possible new and revised maximum levels for Ochratoxin A
| Foodstuffs | Maximum level for furtherconsideration (µg/kg) |
|---|---|
|
"2.2.3 Dried vine fruit (currants, raisins and sultanas)"
to be replaced by:
Dried vine fruit (currants, raisins and sultanas) and dried figs Other dried fruit |
8.0 (10*) 2.0 |
|
"2.2.4. Roasted coffee beans and ground roasted coffee, excluding soluble coffee" to be replaced by
Roasted coffee beans and ground roasted coffee, excluding soluble coffee |
3.0 (5*) |
|
Current entry "2.2.5. Soluble coffee (instant coffee)" to be replaced by
Soluble coffee (instant coffee) |
5.0 (10*) |
|
Current entry "2.2.11 Spices, including dried spices" to be replaced by
All spices including dried spices except Capsicum spp. Capsicum spp. (dried fruits thereof, whole or ground, including chillies, chilli powder, cayenne or paprika) Mixtures of spices |
15 20 15 |
|
2.2.12 Liquorice (Glycyrrhiza glabra, Glycyrrhiza inflate and other species) 2.2.12.1 Liquorice root, ingredient for herbal infusion 2.2.12.2 Liquorice extract ( 42 ), for use in food in particular beverages and confectionary New entries under 2.2.12 Liquorice 2.2.12.3 Liquorice root placed on the market for the final consumer 2.2.12.4. Liquorice candies |
20* 80* 10 10 |
|
New entry Dried herbs, tea and herbal infusions |
10.0 |
|
New entry Sunflower seeds, pumpkin seeds, melon seeds hempseeds, soybeans and processed products thereof |
5.0 |
|
New entry Pistachios |
5.0 |
|
New entry Cocoa powder sold to the final consumer or as an ingredient in sweetened cocoa powder sold to the final consumer (drinking chocolate) |
5.0 |
*: Current values in accordance with Regulation (EU) 1881/2006, last amended by Commission Regulation (EU) 2020/1322 of 23 September 2020
Analysis and quality assurance
EFSA's updated safety assessment and the European Commission's proposals document the growing importance of mycotoxins in the testing and evaluation of botanicals, herbal medicinal products, food or feed. PhytoLab has highly sensitive validated and accredited methods at its disposal for the determination of ochratoxin A by means of HPLC fluorescence detection (FLD) and LC-MS/MS in the most diverse plant matrices. In this context, the services offered by PhytoLab also include the performance and legally compliant documentation of the matrix-specific verification procedures being required to an increasing extent for the marketing authorisation / registration of herbal medicinal products and homeopathic products, as well as novel food procedures. Our experienced specialists would be happy to advise you.
PhytoLab GmbH & Co. KG
- Dutendorfer Straße 5-7
91487 Vestenbergsgreuth
Germany
References
Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs
EFSA CONTAM Panel (EFSA Panel on Contaminants in the Food Chain): Scientific Opinion on the risk assessment of ochratoxin A in food. EFSA Journal 18(5):6113, 150 (2020), https://doi.org/10.2903/ j.efsa.2020.6113
European Commission: Draft SUGGESTED POSSIBLE NEW AND REVISED MAXIMUM LEVELS FOR OCHRATOXIN A (OTA) AS DISCUSSED IN THE WORKING GROUP "AGRICULTURAL CONTAMINANTS" IN VIEW OF THIS TARGETED STAKEHOLDER CONSULTATION (October 2020) (2020).
Sievers H: Toxische Wirkungen und Kontaminanten wichtiger Gewürze [Toxic effects and contaminants of important spices]. Pharmakon 9. Jg, 4/2021, 313-320 DOI:10.1691/pn.20210034
van den Brand, A.D., Bulder, A.S: An overview of mycotoxins relevant for the food and feed supply chain: using a novel literature screening method. National Institute for Public Health and the Environment, RIVM letter report 2019–0223 (2019), DOI 10.21945/RIVM-2019–0223.