EN    EN EN 
SANCO/5396/2009 rev. 2  
EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels,  
C(2009)   SANCO 5396/2009 rev. 2 
Draft 
COMMISSION RECOMMENDATION 
of 
on the prevention and reduction of ethyl ca rbamate contamination in stone fruit spirits 
and stone fruit marc spirits and on the monito ring of ethyl carbamate levels in these 
beverages  
(Text with EEA relevance) 
(Memorandum from Ms A. Vassiliou)  
EN 2   EN Draft 
COMMISSION RECOMMENDATION 
of  
on the prevention and reduction of ethyl ca rbamate contamination in stone fruit spirits 
and stone fruit marc spirits and on the monito ring of ethyl carbamate levels in these 
beverages  
 (Text with EEA relevance) 
THE COMMISSION OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty es tablishing the European Comm unity, and in particular the 
second indent of Article 211 thereof, 
Whereas, (1) The Scientific Panel on Contaminants in the Food Chain of the European Food Safety 
Authority (EFSA) adopted on 20 Septem ber 2007 a scientific opinion on ethyl 
carbamate and hydrocyanic ac id in food and beverages
1. In this opinion the Panel 
derived margins of exposure (MOE) for ethyl carbamate for different scenarios of food 
and beverage consumption. Based on thes e MOE the Panel concluded that ethyl 
carbamate in alcoholic beverages indicates a health concern, particularly with respect 
to stone fruit brandies, and recommended taking mitigation measures to reduce the levels of ethyl carbamate in  these beverages. As hydrocya nic acid is an important 
precursor of ethyl carbamate formation in stone fruit spirits and stone fruit marc 
spirits, the Panel concluded that such m easures should include focus on hydrocyanic 
acid and other precursors of ethyl carbamate, to preven t the formation of ethyl 
carbamate during the shel f-life of these products. 
(2) Maximum contents of hydrocyanic acid in st one fruit spirits and stone fruit marc 
spirits have been laid down in Regulat ion (EC) No 110/2008 of the European 
Parliament and of the Council of 15 Ja nuary 2008 on the definition, description, 
presentation, labelling and the protection of geographical indications of spirit drinks 
and repealing Council Regulation (EEC) No 1576/89
2. This Regulation stipulates that 
the maximum hydrocyanic acid content in st one fruit spirits a nd stone fruit marc 
spirits shall be 7 grams per hectolitre of 100  % vol. alcohol (70 mg/l). 
                                                 
1 Opinion of the Scientific Panel on Contaminants in the Food chain on a request from the European 
Commission on ethyl carbamate and hydrocyanic acid in food and beverages, The EFSA Journal (2007) Journal 
number, 551, 1-44.  http://www.efsa.europa.eu/cs/BlobServe r/Scientific_Opinion/Contam_ej551_ethyl_carbamate_en_rev.1,0.pdf?ss
binary=true
 
2 OJ L 39, 13.2.2008, p. 16–54.   
EN 3   EN (3) A 'Code of Practice for the prevention and re duction of ethyl carbamate levels in stone 
fruit spirits and stone fruit marc spirits’ is considered a suitable tool to address the EFSA recommendations. This Code r ecommends Good Manufacturing Practices 
(GMP) for which there is evidence that lo wer ethyl carbamate levels can be achieved 
when they are applied. An ethyl carbamate ta rget level of 1 mg/l in the ready-to-drink 
spirit is realistic and achieva ble when applying good practices. 
(4) The levels of ethyl carbamate in stone fru it spirits and stone fruit marc spirits should 
be monitored during a time period of three ye ars and the results be used to assess the 
effects of this Code of Pr actice after three years of im plementation. Furthermore, the 
possibility of setting a maximum level should be assessed. 
 HEREBY RECOMMENDS TH AT MEMBER STATES: 
1. take the necessary measures to ensure that the ‘Code of Practice on the prevention 
and reduction of ethyl carbamate contamina tion in stone fruit spirits and stone fruit 
marc spirits’ as described in the Annex to this Recommendation, is implemented by 
all operators involved in th e production, packaging, trans port, holding and storage of 
stone fruit spirits and stone fruit marc spirits. 
2. ensure that all the appropriate measures  are taken to achieve levels of ethyl 
carbamate in stone fruit spirits and stone fru it marc spirits as low as possible with the 
aim to achieve the level of 1 mg/l as a target. 
3. monitor levels of ethyl carbamate in stone  fruit spirits and stone fruit marc spirits 
during the years 2010, 2011 and 2012 in order to  assess the effects of the Code of 
Practice set out in the Anne x to this Recommendation.  
4. report the monitoring data of the previous year to EFSA by 1 June  each year with the 
information and in the format set out by EFSA. 
5. follow the sampling procedures for the pur pose of the monitoring programme as laid 
down in part B of the Annex to Comm ission Regulation (EC) No 333/2007 of 28 
March 2007 on the methods of sampling and an alysis for the official control of the 
levels of lead, cadmium, mercury, inor ganic tin, 3-MCPD a nd benzo(a)pyrene in 
foodstuffs
3 
6. carry out the analysis of ethyl carbamate in accordance with the criteria laid down in 
points 1 and 2 of Annex III to Regulati on (EC) No 882/2004 of the European 
Parliament and of the Council of 29 April 2004 on official contro ls to ensure the 
verification of compliance with  feed and food law, animal health and animal welfare 
rules4. 
 
                                                 
3 OJ L 88, 29.3.2007, p. 29. 
4 OJ L 165, 3.4.2004, p.1;corrected version in OJ L 191, 28.5.2004, p.1. Regulation as amended by Council 
Regulation (EC) No 1791/2006 (OJ L 363, 20.12.2006, p.1).  
EN 4   EN  
Done at Brussels,  
 For the Commission 
 Androulla Vassiliou  Member of the Commission  
EN 5   EN ANNEX  
Code of Practice for the reduction and prev ention of ethyl carbam ate contamination in 
stone fruit spirits and stone fruit marc spirits 
 
INTRODUCTION  
1. Ethyl carbamate is a compound that occurs naturally in fermented foods and alcoholic 
beverages such as bread, yoghurt, soy sauce, wine, beer, and particularly in stone fruit spirits 
and stone fruit marc spirits, mainly those made from cherries, plums, mi rabelles and apricots. 
2. Ethyl carbamate can be formed from various substances inherent in  food and beverages, 
including hydrogen cyanide (or hydrocyanic acid) , urea, citrulline, and other N-carbamyl 
compounds. Cyanate is probably the ultimate precur sor in most cases, re acting with ethanol to 
form ethyl carbamate. 
3. In stone fruit distillates (stone fruit spirits and stone fruit marc spirits) ethyl carbamate can 
be formed from cyanogenic glycosides that are natural constituents of the stones. When 
mashing the fruit, the stones may be broken a nd cyanogenic glycosides from the stones may 
come into contact with enzymes in the fruit mash. Cyanogenic glycosides are then degraded 
to hydrocyanic acid/cyanides. Hydrocyanic acid may also be released from intact stones 
during a longer storage of the fermented mas h. During the distillati on process hydrocyanic 
acid may be enriched in all fractions. Under infl uence of light cyanide is oxidised to cyanate 
reacting with ethanol to form ethyl carbamate. Once the reacti on has been triggered, it cannot 
be stopped.  
4. A major reduction in the concentration of et hyl carbamate could be achieved using two 
different approaches: first, by  reducing the concentration of the main precursor substances; 
second, by reducing the tendency of these substan ces to react to form  cyanate. The main 
influencing factors are the concentration of precursors (e.g. hydrocyanic acid and cyanides) 
and storage conditions, such as light exposure and temperature. 
5. Although no strong correlation between the le vel of hydrocyanic acid and ethyl carbamate 
has been established so far, it is evident that  under certain conditions high concentrations of 
hydrocyanic acid lead to higher levels of et hyl carbamate. A potential increase in ethyl 
carbamate formation has been associated with levels at or above 1 mg/l hydrocyanic acid in 
the final distillate5,6. 
6. Part I gives details of the production process.  Part II contains specific recommendations 
based on Good Manufacturing Practices (GMP). 
I. DESCRIPTION OF THE PRODUCTION PROCESS 
                                                 
5 Christoph, N., Bauer-Christoph C., Maßnahmen zur Reduzierung des Ethylcarbamatgehaltes bei der 
Herstellung von Steinobstbränden (I), Kleinbrennerei 1998; 11: 9-13. 
6 Christoph, N., Bauer-Christoph C., Maßnahmen zur Reduzierung des Ethylcarbamatgehaltes bei der 
Herstellung von Steinobstbränden (II), Kleinbrennerei 1999; 1: 5-13.  
EN 6   EN 7. The production process for fruit spirits an d fruit marc spirits involves mashing and 
fermentation of the whole fruit, followed by di stillation. The process typically follows the 
steps listed below: 
• crushing the whole ripe fruit; 
• fermenting the mash in stainless steel tanks  or other suitable fermentation vessels; 
• transferring the fermented mash into th e distillation device, often a copper pot; 
• heating the fermented mash by a suitable he ating method in order to slowly boil off 
the alcohol; 
• cooling the alcohol vapour in an appropria te (e. g. stainless st eel) column where it 
condenses and is collected; 
• separation of three different fractions of  alcohol: ‘heads’, ‘hearts’ and ‘tails’; 
8. During distillation, the heads boil off first. Th ey can usually be recognised by their solvent 
or lacquer aromas. This fraction is genera lly unsuitable for consumption and should be 
discarded.  
9. During the middle distillation ru n (the ‘hearts’), the principal alcohol in all spirits, ethyl 
alcohol (ethanol), is distilled. This part of the distilling run, where the content of volatiles 
other than ethanol is lowest and the purest fruit aromas are found, is always collected.  
10. The ‘tails’ of the distillation include acetic acid and fusel oils, which are often identified 
by unpleasant vinegary and vegetal aromas. They  are also discarded, but they may be re-
distilled because some ethanol is i nvariably included with the tails. 
II. RECOMMENDED PRACTICES BASED ON GOOD MANUFAC TURING PRACTICES 
(GMP) 
Raw materials and prep aration of fruit mash  
11. The raw materials and preparatio n of the fruit mash should be suitable to avoid the release 
of hydrocyanic acid. 
12. The stone fruits should be of high qua lity, not mechanically damaged and not 
microbiologically spoiled. 
13. The fruit should preferably be de-stoned. 14. If the fruits are not de-stoned, they should be  mashed gently to avoid crushing the stones. 
Fermentation 
15. Selected yeast strains for alcohol producti on should be added to the mashed fruits, 
according to the instructions for users. 
16. Mashed fermented fruits should be handled with high standards of hygiene, and exposure 
to light should be minimised. The fermented fru it mash should be stored as short as possible 
before distillation since hydrocyanic acid may al so be released from intact stones during 
longer storage of the mash. 
Distillation equipment   
EN 7   EN 17. Distillation equipment and the distillation pr ocess should be suitable, to ensure that 
hydrocyanic acid is not transf erred into the distillate. 
18. The distillation equipment should include au tomatic rinsing devices and copper catalytic 
converters. The automatic rins ing devices will keep the stil ls cleaned while the copper 
catalytic converters will bi nd hydrocyanic acid before it pa sses into the distillate.  
19. Automatic rinsing devices are not necessary in the case of discontinuous distillation. The 
distillation equipment should be cleaned by systematic and thorough cleaning procedures. 
20. In certain cases, when no copper catalytic conv erters or other dedicat ed cyanide separators 
are used, copper agents should be  added to the fermented fruit mash before distillation. The 
purpose of the copper agents is to bind hydrocyanic acid. Copper agents are sold at 
specialised shops and should be  used very carefu lly according to the manufacturer’s 
instructions. 
Distillation process 
21. Stones settled in the fermented mash should not be pumped into the distillation device. 
22. Distillation should be carried out in such a way that alcohol  is boiled off slowly (e.g. by 
using steam instead of a direct flame as the heating source).  
23. The first fractions of the distillate, cal led ‘heads’, should be separated carefully. 
24. The middle fraction, called ‘hearts’, should th en be collected and should be stored in the 
dark. When the alcohol content reaches 50  % vol. in the receiver, collection should be 
switched to the ‘tails’, so that any ethyl carbamate that may have  been formed is separated in 
the tail fraction. 
25. The separated tails, possibly containing ethyl  carbamate, should be collected and if they 
are used for re-distilling, they should be re-distilled separately.  
Checks on the distillate, re- distillation and storage 
Hydrocyanic acid: 
26. The distillates should be re gularly checked for their leve ls of hydrocyanic acid. The 
determination should be carried ou t by appropriate tests, either by kits for rapid testing of the 
hydrocyanic acid levels, or, alterna tively, by a specialist laboratory.  
27. If the concentration of hydrocyanic acid in the distillate exceeds a level of 1 mg/l, re-
distillation with catalytic conve rters or copper agents (cf. poi nts 18 and 20) is recommended, 
where appropriate.  
28. Distillates with hydrocyanic aci d levels close to 1 mg/l should ideally also be re-distilled 
or, where this is not possible, be stored in  lightproof bottles or c overing boxes with storage 
times as short as possible in order to avoi d ethylcarbamate formation during storage. 
Ethylcarbamate  
EN 8   EN 29. Testing of ethyl carbamate is recommended for distillates in which the compound may 
already have been formed (e.g. distillates with unknown history of production, higher levels 
of cyanide, storage at light). The level of ethyl carbamate ca n only be tested by a specialist 
laboratory.  
30. If the distillate shows an ethyl carbamate concentration exceeding the target level of 1 
mg/l, the distillate should be re-distilled, where appropriate.