WORLD TRADE  
ORGANIZATION  G/SPS/GEN/925 
18 May 2009 
 (09-2406) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
GUIDELINES AS REGARDS MEASURES TO BE TAKEN CONCERNING  
THE PRESENCE OF NICOTINE IN WILD MUSHROOMS 
 
Communication from the European Communities
 
 
 
 The following communication, received on 15 May 2009, is being circulated at the request of 
the Delegation of the European Communities . 
 
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I. BACKGROUND 
1. The EC Commission has been informed by food business operators that dried wild 
mushrooms (mainly Boletus edulis  hereafter called ceps, but also truffles and cantarelles) may contain 
levels of nicotine higher than 0.01 mg/kg1 (default level as set by Article 18.1.b to Regulation (EC) 
No 396/2005.  According to the information recei ved, almost all wild mushrooms are affected, 
irrespective of their origin, although most of them or iginate from China.  The da ta received show that 
99 per cent of the 2008 production does not comply with the default limit of 0.01 mg/kg as set in Regulation (EC) No 396/2005.  Residue levels f ound can be up to 9.9 mg/kg on the dried product. 
2. Food business operators have been investigati ng the reason(s) of this unexpected presence of 
nicotine in dried mushrooms, but so far no clear causal link could be established.  The nicotine 
residues found could be of various origins but also  result from the combination of various factors, 
including pesticide use, cross-c ontamination and natural presence. 
3. A monitoring and testing programme will be la unched by food business operators at the start 
of the forthcoming 2009 harvest season.  EC member States should also monitor the levels of nicotine 
in mushrooms as from the next harvest season, with a view to collect monitoring data and to have a 
clear understanding of the natural levels and una voidable background presence that can be expected 
from various EC regions. 
4. However, pending the submission of those data, urgent measures are needed to allow the 
placing on the market of dried mushrooms from the 2008 season, provided that they are safe. 
5. Therefore, with a view to setting a tempor ary MRL under Reg. (EC) No 396/2005, the EC 
Commission asked the European Food Safety Authority (EFSA) on 27 April 2009 to deliver an 
opinion in relation to the risks for human health du e to the presence of nicotine in wild mushrooms at 
concentrations up to 0.5 mg/kg. 
                                                     
 
1 Recalculated on the fresh mushroom, to which the defa ult level applies.  Acco rding to the available  
information the concentration f actor as a consequence of drying is a factor of about nine. G/SPS/GEN/925 
Page 2  
 
  6. In reply to this request, on 7 May 2009 the EFSA issued a statement concluding that a level of 
0.5 mg/kg is not safe, because it would lead to an exceedance of the acute reference dose (ARfD).
2  
The EFSA proposed alternative MRLs to be set on a temporary basis both for fresh (0.036 mg/kg) and 
for dried (1.17 mg/kg) wild mushrooms. 
7. The EFSA also highlighted that the evaluation performed was affected by a number of 
uncertainties and limitations on the data available (c onsumption of wild mushrooms in Europe, and in 
particular on dried ones, contamination levels, act ual unit-to-unit variability in fresh mushrooms). 
8. As regards dried ceps, the EC Commission notes that one of the uncertainties highlighted by 
EFSA refers to the poor data as regards children's c onsumption of ceps.  It would be therefore more 
appropriate to restrict the evaluation of a safe level of nicotine in ceps to the consumption data 
available for the adult population.  Moreover, th e EC Commission considers that, on a temporary 
basis and pending the submission of mo re detailed and reliable data, the 95th percentile of the data 
consumption should be used to estimate th e acute exposure to nicotine in dried ceps.3  A s  a  
consequence, for dried ceps, an acceptable level of 2.3 mg/kg could be derived. 
II. GUIDELINES 
9. The Standing Committee on the Food Chain and Animal health (SCoFC AH) had an exchange 
of views on the available information and on the resu lts of the risk assessment carried out by EFSA on 
the presence of nicotine in wild mushrooms.  
10. Based on the statement from EFSA, the SCoFCAH has considered that the current default 
MRL for nicotine in mushrooms is not a health standard  and that it is appropriate to take the following 
proportionate risk management measures on a tempor ary basis, ensuring a high level of consumer 
protection in the European Union: 
(a) Fresh wild mushrooms with a level of nico tine higher than 0.04 mg/kg and dried wild 
mushrooms other than ceps with a level of nicotine higher than 1.2 mg/kg should not be placed on the market and should be withdrawn from the market and safely disposed of. 
(b) Dried ceps with a level of nicotine higher  than 2.3 mg/kg should not be placed on the 
market and should be withdrawn from the market and safely disposed of. 
(c) EC member States should put in place a monitoring programme for the 2009 season 
with a view to have a clear understandi ng of the natural levels and unavoidable 
background presence of nicotine in different  wild mushroom species that can be 
expected from various origins.  EC me mber States should, without any delay, 
communicate to the EC Commission and to EFSA the results of the monitoring 
programmes with a view to setting an MRL for nicotine in fresh and dried mushrooms under the provisions of Reg. (EC) No 396/2005. 
                                                     
 
2 Statement of EFSA on the risks for public health due to the presence of nicotine in wild mushrooms, 
issued on 7 May 2009.  Available at:  
http://www.efsa.europa.eu/cs/BlobS erver/Statement/Statement_nicotine_mushrooms_ej286_en.pdf?ssb
inary=true  
3 Expressed as grams/kg body weight/day and calculated for the consuming days only (table 4-2 of the 
EFSA statement).  G/SPS/GEN/925 
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  11. The management measures referred to in points A and B are to be applied on a temporary 
basis, awaiting the setting of an MRL for nicotine in fresh and dried mushrooms foreseen by the end 
of 2009, taking into account the results of the m onitoring programme, referred to in paragraph 10(c) 
above. 
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