EN   EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/12170/2019 Rev. 1 (POOL/E2/2019/12170/12170R1-
EN.docx)  D067816/03 
[…](2020) XXX  draft 
 
COMMISSION REGULATION (EU) …/… 
of XXX  
amending Regulation (EC) No 1881/ 2006 as regards maximum levels  of pyrrolizidine 
alkaloids in certain foodstuffs 
(Text with EEA relevance) 
 EN 1  EN COMMISSION REGULATION (EU) …/… 
of XXX  
amending Regulation (EC) No 1881/ 2006 as regards maximum levels  of pyrrolizidine 
alkaloids in certain foodstuffs 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the  Functioning of the European Union, 
Having regard to Council Regulat ion (EEC) No 315/93 of 8 Februa ry 1993 laying down 
Community procedures for  contaminants in food1, 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 November 2011, the Scientific Panel on Contaminants in the  Food Chain 
(CONTAM Panel) of the European Food Safety Authority (‘the Auth ority’) published 
a scientific opinion on the risk s to public health related to t he presence of pyrrolizidine 
alkaloids in food and feed3. The CONTAM Panel concluded that 1,2-unsaturated 
pyrrolizidine alkaloids may act  as genotoxic carcinogens in hum ans. The CONTAM 
Panel concluded that there is a possible health concern for tho se toddlers and children 
who are high consumers of honey. In addition to honey, there ar e other possible 
sources of dietary exposure to pyr rolizidine alkaloids, which t he CONTAM Panel was 
not able to quantify due to the l ack of data. It came to the co nclusion that, although no 
occurrence data were available, exposure to pyrrolizidine alkal oids from pollen, tea, 
herbal infusions and herbal diet ary supplements could potential ly present a risk of both 
acute and chronic effect s in the consumer.  
(3) In April 2013, the Authority published a call for proposals to investigate the 
concentrations of pyrrolizidine alkaloids in animal-derived foo d products including 
milk and milk products, eggs and meat and meat products, and fo r plant-derived food 
products including (herbal) teas and food supplements, across d ifferent regions in 
Europe. The outcome of the inve stigations was  published on 3 Au gust 20154. 
 
1 OJ L 37, 13.2.1993, p. 1.  
2 Commission Regulation (EC) No 1881/2006 of 19 December 2006 se tting maximum levels for certain 
contaminants in foodstuffs (OJ L 364, 20.12.2006, p. 5).  
3 EFSA CONTAM Panel, 2011. Scientific Opinion on Pyrrolizidine a lkaloids in food and feed. EFSA 
Journal 2011; 9(11):2406. [134 pp.], doi:10.2903/j.efsa. 2011.2 406.  
4 Mulder PPJ, López Sánchez P, These A, Preiss-Weigert A and Cas tellari M, 2015. Occurrence of 
Pyrrolizidine Alkaloids in food. EFSA supporting publication 20 15:EN-859, 116 pp. 
http://www.efsa.europa.eu/en/supporting/pub/en-859 . EN 2  EN (4) On 26 August 2016, the Authority p ublished a scientific report on the dietary exposure 
assessment to pyrrolizidine alk aloids in the European populatio n5, taking into account 
new occurrence data. The report concluded that tea and herbal i nfusions are the main 
contributors to human exposure to  pyrrolizidine alkaloids and t hat pollen-based 
supplements also contribute signi ficantly to that exposure. It found that the exposure 
to pyrrolizidine alkaloids related to the consumption of honey was lower. It also 
concluded that herbal food suppl ements can contribute significa ntly to the exposure 
but there was a lack of su fficient occurrence data.  
(5) On 27 July 2017, the Authority published the statement on the r isks for human health 
related to the presence of pyrrolizidine alkaloids in honey, te a, herbal infusions and 
food supplements6. The CONTAM Panel established a new reference point of 237 
µg/kg body weight per day to asse ss the carcinogenic risks of p yrrolizidine alkaloids 
and concluded that there is a possible concern 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 alk aloids in these foods can be m inimized or prevented 
by the application of good agri cultural 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 protection. It i s therefore appropriate to 
set maximum levels in foodstuffs  which contain significant leve ls of pyrrolizidine 
alkaloids and which therefore contribute significantly to the h uman exposure or which 
are of relevance for the exposur e of vulnerable groups of the p opulation.   
(7) In certain production regions, good agricultural and harvest pr actices have only been 
recently introduced or have still to be implemented therefore i t is appropriate to 
provide for a reasonable period to allow all production regions  to introduce such 
practices. Two growing seasons a re necessary for a full impleme ntation of the good 
agricultural and harv est practices to ensu re sufficient supply for food business 
operators to produce foodstuffs th at comply with the new requir ements set out in this 
Regulation.  
(8) Taking into account that the f oodstuffs covered by this Regulat ion have a long shelf 
life of up to three years, it is appropriate to provide for a s ignificantly long transitional 
period so that foodstuffs which have been lawfully placed on th e market before the 
date of application of this Regulation can remain sufficiently long on the market. A 
transitional period of 18 months  is appropriate to enable the s elling to the final 
consumer of the products produce d before the date of applicatio n.  
(9) Regulation (EC) No 1881/2006 should therefore be amended accord ingly. 
(10) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plan ts, Animals, Food and Feed, 
 
5 EFSA (European Food Safety Authority), 2016. Dietary 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 CONTAM Panel, 2017. Statement on the risks for human heal th related to the presence of 
pyrrolizidine alkaloids in honey, tea, herbal infusions and foo d supplements. EFSA Journal 
2017;15(7):4908, 34 pp. https://doi.org/10.2903/j.efsa.2017.4908 . EN 3  EN HAS ADOPTED THIS REGULATION: 
Article 1 
The Annex to Regulation (EC) No 1881/2006 is amended in accorda nce with the Annex to 
this Regulation. 
Article 2 
Foodstuffs listed in the Annex th at were lawfully placed on the  market before 1 July 2022 
may remain on the market until 31 December  2023 . 
Article 3 
This Regulation shall enter into force on the twentieth day fol lowing that of its publication in 
the Official Journal of  the European Union. 
It shall apply from 1 July 2022. 
This Regulation shall be binding i n its entirety and directly a pplicable in all Member States. 
Done at Brussels, 
 For the Commission 
 The President  Ursula VON DER LEYEN