EN   EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/12170/2019 Rev. 1 ANNEX 
(POOL/E2/2019/12170/12170R1-EN 
ANNEX.docx)  D067816/03 […](2020) XXX  draft 
ANNEX 
 
ANNEX 
to the 
COMMISSION REGULATION (EU) …/… 
amending Regulation (EC) 1881/2006 as regards maximum levels of  pyrrolizidine 
alkaloids in certain foodstuffs 
 EN 1  EN ANNEX 
In Section 8 of the Annex to R egulation (EC) No 1881/2006, the following entries are added:  
‘ 
Foodstuffs (1) Maximum level (*) 
(µg/kg) 
8.4 Pyrrolizidine alkaloids   
8.4.1. Herbal infusions (dried product) (**) (***) with the 
exception 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, t hyme, peppermint, lemon 
verbena (dried product) and mixtures exclusively composed of these dried herbs (**) (***) with the exception of the herbal infus ions referred to in 8.4.4. 400  
8.4.3. Tea ( Camellia sinensis) and flavoured tea (****)( Camellia 
sinensis) (dried product) (***) with t he exception of the tea 
and flavoured 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) , flavoured 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 
referred to in 8.4.7. 400 
8.4.7. Pollen based food supplements (39) 
Pollen and pollen products 500 
8.4.8. Borage leaves (fresh, frozen) placed on the market for t he 
final consumer (**) 750 
8.4.9. Dried herbs with the exception of the dried herbs referr ed 
to in 8.4.10. (**) 400 
8.4.10. Borage, lovage, marjoram  and oregano (dried) and 
mixtures exclusivel y composed of these  dried herbs (**) 1000 
8.4.11. Cumin seeds (seed spice) 400 
(*) The maximum level refers to the lowerbound sum of the follo wing 21 pyrrolizidine 
alkaloids: 
● intermedine/lycopsamine, intermedine-N-oxide/lycopsamine-N-ox ide, 
● senecionine/senecivernine, sen ecionine-N-oxide/senecivernine- N-oxide, 
● seneciphylline, seneciphylline-N-oxide, ● retrorsine, retrorsine-N-oxide, ● echimidine, echimidine-N-oxide, ● lasiocarpine, lasiocarpine-N-oxide, ● senkirkine,  ● europine, europine-N-oxide,  ● heliotrine and he liotrine-N-oxide  EN 2  EN and the following additional 14 pyrrolizidine alkaloids known t o co-elute with one or 
more of the above identified 21 pyrrolizidine alkaloids, making  u s e  o f  c e r t a i n  
currently used analytical methods  
● indicine, echinatine, rinderi ne (possible co-elution with 
lycopsamine/intermedine) 
● indicine-N-oxide, echinatine- N-oxide, rinderine-N-oxide (poss ible co-elution 
with lycopsamine-N-oxide /intermedine-N-oxide) 
● integerrimine (possible co-e lution with senecivernine and sen ecionine) 
● integerrimine-N-oxide (possible co-elution with senecivernine -N-oxide and 
senecionine-N-oxide) 
● heliosupine (possible co -elution with echimidine) 
● heliosupine-N-oxide (possible co-elution with echimidine-N-ox ide) 
● spartioidine (possible co -elution with sen eciphylline) 
● spartioidine-N-oxide (possi ble co-elution with seneciphylline -N-oxide) 
● usaramine (possible co -elution with retrorsine) 
● usaramine N-oxide (possible c o-elution with retrorsine N-oxid e) 
Pyrrolizidine alkaloids, which can be individually and separate ly identified with the 
used method of analysis, shall be quantified and included in th e sum.  
(**) Without prejudice to more restrictive national rules in ce rtain Member States on the 
placing of the market of pyrroli zidine alkaloi d containing plan ts.  
(***) The terms ‘herbal infusi ons (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, stal ks and flowers (in sachets or i n bulk) used for 
the preparation of herbal infus ion (liquid produc t)/tea (liquid  product)  
– instant herbal teas/teas. In the  case of powdered tea extracts,  a concentration 
factor of 4 has to be applied. 
(****) Flavoured tea is tea with flavourings and certain food i ngredients with flavouring 
properties, as defined in Regul ation (EC) No 1334/2008 of the E uropean Parliament 
and of the Council of 16 December 2008 on flavourings and certa in food ingredients 
with flavouring properties for use in and on foods (OJ L 354, 3 1.12.2008, p. 34). 
For teas with fruits and other herbs, Article 2 of Regulation ( EC) No 1881/2006 
applies.’