II 
(Non-legislative acts) 
REGUL ATIONS 
COMMI SSION REGUL ATION (EU) 2020/2040 
of 11 December 2020 
amending Regulation (EC) No 1881/2006 as regards maximum levels of pyrrolizidine alkaloids in 
certain foods tuffs 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Havi ng regar d to the Treaty on the Functioning of the European Union, 
Havi ng regard to Council Regulation (EEC) No 315/93 of 8 Febr uary 1993 laying down Community procedures for 
contaminants in food (1), and in particular Article 2(3) thereof, 
Whereas: 
(1) Commission Regulation (EC) No 1881/2006 (2) sets maximum levels for certain contaminants in foodstuffs. 
(2) On 8 Novem ber 2011, the Scientifi c Panel on Contaminants in the Food Chain (CONT AM Panel) of the European 
Food Safet y Author ity (‘the Author ity’) published a scientific opinion on the risks to public health relat ed to the 
presence of pyrrolizidine alkaloids in food and feed(3). The CONT AM Panel concluded that 1,2-unsaturated 
pyrrolizidine alkaloids may act as genot oxic carcinogens in humans. The CONT AM Panel concluded that there is a 
possible health concer n for those todd lers and children who are high consumers of hone y. In addition to hone y, 
there are other possible sources of dietar y exposure to pyrrolizidine alkaloids, whic h the CONTAM Panel was not 
able to quantify due to the lack of data. It came to the conclusion that, although no occur rence data were available, 
exposure to pyrrolizidine alkaloids from pollen, tea, herbal infusions and herbal dietar y supplements could 
poten tially present a risk of both acute and chronic effects in the consumer . 
(3) In Apr il 2013, the Auth ority published a call for proposals to investigat e the concentrations of pyrrolizidine 
alkaloids in animal-der ived food products including milk and milk products, eggs and meat and meat products, and 
for plant-der ived food products including (herbal) teas and food supplements, across different regions in Europe. The 
outcome of the investigations was published on 3 August 2015 (4). 
(1)OJ L 37, 13.2.1993, p. 1. 
(2)Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs (OJ 
L 364, 20.12.2006, p. 5). 
(3)EFSA CONT AM Panel, 2011. Scientific Opinion on Pyrrolizidine alkaloids in food and feed. EFSA Journal 2011; 9(11):2406. [134 pp.], 
doi:10.2903/j.efsa. 2011.2406. 
(4)Mulder PPJ, López Sánchez P, These A, Preiss- Weiger t A and Castel lari M, 2015. Occur rence of Pyrrolizidine Alkaloids in food. EFSA 
suppor ting publication 2015:EN-859, 116 pp. http://www .efsa.europa.eu/en/suppor ting/pub/en-859 EN Offi cial Jour nal of the European Union 14.12.2020                                                                                                                                         L 420/1   (4) On 26 August 2016, the Auth ority published a scientifi c repor t on the dietar y exposure assessment to pyrrolizidine 
alkaloids in the European population (5), taking into account new occur rence data. The repor t concluded that tea and 
herbal infusions are the main contr ibut ors to human exposure to pyrrolizidine alkaloids and that pollen-based 
supplements also contr ibut e significantly to that exposure. It found that the exposure to pyrrolizidine alkaloids 
relat ed to the consump tion of hone y was lower. It also concluded that herbal food supplements can contr ibute 
signif icantly to the exposure but there was a lack of suffi cient occur rence data. 
(5) On 27 July 2017, the Author ity published the statement on the risks for human health relat ed to the presence of 
pyrrolizidine alkaloids in hone y, tea, herbal infusions and food supplements (6). The CONT AM Panel established a 
new reference point of 237 μg/kg body weight per day to assess the carcinogenic risks of pyrrolizidine alkaloids and 
concluded that there is a possible concer n for human health related to the exposure to pyrrolizidine alkaloids, in 
particular for frequent and high consumers of tea and herbal infusions in the general population but, in particular , 
for the younger groups of the population. 
(6) The presence of pyrrolizidine alkaloids in these foods can be minimised or prevented by the application of good 
agricultural and harvest practices. The setting of maximum levels ensures that good agricultural and harvest 
practices are applied in all production regions to ensure a high level of human health prote ction. It is theref ore 
appropr iate to set maximum levels in foodstuffs whic h contain signif icant levels of pyrrolizidine alkaloids and 
which theref ore contr ibute signif icantly to the human exposure or which are of relevance for the exposure of 
vulnerable groups of the population. 
(7) In certain production regions, good agricultural and harvest practices have only been recently introduced or have 
still to be implement ed, theref ore it is appropr iate to provi de for a reasonable period to allow all production regions 
to introduce such practices. Two growing seasons are necessar y for a full implementation of the good agricultural 
and harvest practices to ensure sufficient supply for food business operat ors to produce foodstuffs that comply with 
the new requirements set out in this Regulation. 
(8) Taking into account that the foodstuffs covered by this Regulation have a long shelf life of up to three years, it is 
appropr iate to provide for a signif icantly long transitional period so that foodstuffs which have been lawfully placed 
on the mark et before the date of application of this Regulation can remain suffic iently long on the market. A 
transitional period of 18 months is appropr iate to enable the selling to the final consumer of the products produced 
before the date of application. 
(9) Regulation (EC) No 1881/2006 should theref ore be amended according ly. 
(10) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
The Annex to Regulation (EC) No 1881/2006 is amended in accordance with the Annex to this Regulation. 
Article 2 
Foodstuffs listed in the Annex that were lawfully placed on the mark et before 1 July 2022 may remain on the mark et until 
31 December 2023. 
(5)EFSA (European Food Safety Authority), 2016. Dietar y exposure assessment to pyrrolizidine alkaloids in the European population. 
EFSA Journal 2016;14(8):4572, 50 pp. doi:10.2903/j.efsa.2016.4572. 
(6)EFSA CON TAM Panel, 2017. Statement on the risks for human health related to the presence of pyrrolizidine alkaloids in hone y, tea, 
herbal infusions and food supplements. EFSA Journal 2017;15(7):4908, 34 pp. https://doi.org/10.2903/j.efsa.2017.4908 EN Offi cial Jour nal of the European Union L 420/2                                                                                                                                         14.12.2020   Article 3 
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union. 
It shall apply from 1 July 2022. 
This Regulation shall be binding in its entirety and directly applicable in all Member States. 
Done at Brussels, 11 December 2020.  
For the Commission 
The President 
Ursula VON DER LEYEN     EN Offi cial Jour nal of the European Union 14.12.2020                                                                                                                                         L 420/3   ANNEX 
In Section 8 of the Annex to Regulation (EC) No 1881/2006, the followi ng entr ies are added:                                                              
"Foodstuffs (1) Maximum level (*) 
(μg/kg) 
8.4. Pyrrolizidine alkaloids  
8.4.1. Herbal infusions (dried product) (**) (***) with the excep tion of the herbal infusions referred 
to in 8.4.2. and 8.4.4. 200 
8.4.2. Herbal infusions of rooibos, anise (Pimpinella anisum), lemon balm, chamomile, thyme, pep­
permint, lemon verbena (dried product) and mixtures excl usively compo sed of these dried 
herbs (**) (***) with the excep tion of the herbal infusions refer red to in 8.4.4. 400 
8.4.3. Tea (Camellia sinensis) and flavoured tea (****)(Camellia sinensis) (dried product) (***) with the 
excep tion of the tea and flavour ed tea referred to in 8.4.4. 150 
8.4.4. Tea (Camellia sinensis), flavoured tea (****)(Camellia sinensis) and herbal infusions for infants 
and young children (dried product) 75 
8.4.5. Tea (Camellia sinensis), flavour ed tea (****)(Camellia sinensis) and herbal infusions for infants 
and young children (liquid) 1,0 
8.4.6. Food supplements containing herbal ingredients including extracts (**) with the excep tion of 
the food supplements refer red to in 8.4.7. 400 
8.4.7. Pollen based food supplements (39) 
Pollen and pollen products 500 
8.4.8. Borage leav es (fresh, frozen) placed on the mark et for the final consumer (**) 750 
8.4.9. Dried herbs with the excep tion of the dried herbs refer red to in 8.4.10. (**) 400 
8.4.10. Borage, lovage, mar joram and oregan o (dried) and mixtures excl usively composed of these 
dried herbs (**) 1 000 
8.4.11. Cumin seeds (seed spice) 400 
(*) The maximum level refers to the lowerbound sum of the following 21 pyrrolizidine alkaloids: 
— inter medine/ly copsamine, intermedine-N-oxid e/lycopsamine-N-o xide, 
— senecionine/seneciver nine, senecionine-N-o xide/seneciver nine-N-o xide, 
— seneciph ylline, seneciph ylline-N-o xide, 
— retrorsine, retrorsine-N-o xide, 
— echim idine, echi midine-N-o xide, 
— lasiocar pine, lasiocar pine-N-o xide, 
— senkirkine, 
— europine, europine-N-o xide, 
— heliotr ine and heliotr ine-N-o xide 
and the following additional 14 pyrrolizidine alkaloids known to co-elute with one or more of the above identif ied 21 pyrrolizi­
dine alkaloids, making use of certain currently used analytical methods: 
— indicine, echinatine, rinder ine (possible co-elution with lycopsamine/inter medine) 
— indicine-N-o xide, echinatine-N-o xide, rinder ine-N-o xide (possible co-elution with lycopsamine-N-o xide/inter medine-N-o xide) 
— integ errimine (possible co-elution with seneciver nine/senecionine) 
— integ errimine-N-o xide (possible co-elution with seneciver nine-N-o xide/senecionine-N-o xide) 
— heliosupine (possible co-elution with echimidine) 
— heliosupine-N-o xide (possible co-elution with echimidine-N-o xide) 
— spar tioidine (possible co-elution with seneciph ylline) 
— spar tioidine-N-o xide (possible co-elution with seneciph ylline-N-o xide) 
— usaramine (possible co-elution with retrorsine) 
— usaramine N-oxide (possible co-elution with retrorsine N-oxide) 
Pyrrolizidine alkaloids, whic h can be individually and separately identif ied with the used method of analysis, shall be quantified and 
included in the sum. 
(**) Without prejudice to more restr ictive national rules in certain Member States on the placing of the market of pyrrolizidine alkaloid 
containing plants. 
(***) The terms "herbal infusions (dried product)" and "tea (Camellia sinensis) (dried product)" refer to: 
— herbal infusions (dried product) from flowers, leaves and herbs, roots, and any other parts of the plant (in sachets or in 
bulk)/tea (Camellia sinensis) (dried product) from dried leaves, stalks and flowers (in sachets or in bulk) used for the preparation 
of herbal infusion (liquid product)/t ea (liquid product) 
— instant herbal teas/t eas. In the case of powder ed tea extracts, a concentration factor of 4 has to be applied. EN Offi cial Jour nal of the European Union L 420/4                                                                                                                                         14.12.2020   (****) Flav oured tea is tea with flavourings and certain food ingredients with flavour ing proper ties, as defined in Regulation (EC) 
No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients 
with flavour ing proper ties for use in and on foods (OJ L 354, 31.12.2008, p. 34). 
For teas with fruits and other herbs, Article 2 of Regulation (EC) No 1881/2006 applies."   EN Offi cial Jour nal of the European Union 14.12.2020                                                                                                                                         L 420/5