EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10126/2019 
(POOL/E2/2019/10126/10126 -EN.docx)  
D063903/03  
[…](2019) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EC) 1881/2006 as regards maximum levels of perchlorate in 
certain foods  
(Text with EEA relevance)    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EC) 1881/2006 as regards maximum levels of perchlorate in 
certain foods  
(Text with EEA  relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Council Regulation (EEC) No  315/93 of 8  February 1993 laying down 
Community procedures for contaminants in food1, and in particular Article  2(3) thereof,  
Whereas:  
(1) Commission Regulation (EC) No  1881/20062 sets maximum levels for certain 
contaminants in foodstuffs.  
(2) On 30 September 2014, t he Scientific Panel on Contaminants in the Food Chain ( ‘the 
CONTAM Panel ’) of the European Food Safety Authority ( ‘the Authority ’) adopted  a 
scientific opinion on the risks to public health related to the presence of perchlorate in 
food3. The CONTAM Panel established a tolerable daily intake of 0.3 micrograms per 
kilogram of body weight per day, base d on the inhibition of thyroid iodine uptake in 
healthy adults. The CONTAM Panel concluded that the current estimated chronic 
dietary exposure to perchlorate is of potential concern, in particular for the high 
consumers in the younger age groups of the pop ulation with mild to moderate iodine 
deficiency. Furthermore, it is possible that current estimated short -term exposure to 
perchlorate is of concern for breast -fed infants and small children with low iodine 
intake.  
(3) The CONTAM Panel recommended that Member  States collect additional data on the 
occurrence of perchlorate in food in Europe, especially in relation to vegetables, infant 
formula, milk and dairy products, in order to further reduce the uncertainty in the risk 
assessment.  
(4) Commission Recommendation (EU) 2015/6824 was adopted on foot of the scientific 
report with the objective of monitor ing the presence of perchlorate in food , in 
particular in food sampled after 1 September 2013, when mitigation measures were 
put in place .  
                                                 
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 CONTAM Panel (EFSA Panel on Contaminants in the Food Chain), 2014. Scientific Opinion on 
the risks to public health related to the presence of perchlorate in food, in particular fruits and 
vegetables. EFSA Journal 2014;12(10):3869, 106 pp. doi:10.2903 /j.efsa.2014.3869 
http://www.efsa.europa.eu/en/efsajournal/pub/3869   
4 Commission Recommendation (EU) 2015/682 of 29 April 2015 on the monitoring of the presence of 
perchlorate in food ( OJ L  111, 30.4.2015, p. 32) .  
EN 2  EN (5) The Authority  carried out a human exposure assessment to perchlorate taking into 
account the occurrence data available in its database from samples taken after 1 
September 2013 and published a scientific report on the “Dietary exposure assessment 
to perchlorate in the European popu lation”5 in 2017.  
(6) The CONTAM Panel considered the outcome of the report on perchlorate in food at its 
87th plenary meeting in November 20176 and noted a substantial alignment of the 
exposure levels estimated in this report with those estimated in the opini on of the 
CONTAM Panel in 2014. Given the previously established tolerable daily intake of 
0.3 µg/kg bw per day, the CONTAM Panel confirmed the conclusion that the current 
chronic and short -term exposure to perchlorate may pose a possible concern for human  
health.  
(7) It is therefore appropriate to set maximum levels of perchlorate both in foodstuffs 
which contain significant levels of perchlorate and which contribute significantly to 
human exposure and in foodstuffs which are of relevance as regards the possib le 
exposure of vulnerable groups of the population such as infant s and young children.   
(8) Regulation (EC) No 1881/2006 should therefore be amended accordingly.  
(9) Food business operators should be allowed time to adapt to the new requirements set 
out in this Regulation. The date of application of the maximum levels of perchlorate 
for those foodstuffs should therefore be deferred.   
(10) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
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 to this Regulation that were lawfully placed on the market 
before 1 July 2020 may continue to be marketed until their date of minimum durability or use -
by-date.   
Article 3  
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union.  
It shall apply from  1 July 2020 .  
                                                 
5 EFSA (European Food Safety Authority), Arcella D, Binaglia M and Vernazza F,  2017. Scientific 
Report  on the Dietary exposure assessment to perchlorate in the European population.  EFSA Journal 
2017;15(10):5043, 24 pp. https://doi.org/10.2903/j.efsa.2017.5043   
6 http://www.efsa.europa.eu/sites/default/files/event/171121 -m.pdf   
EN 3  EN This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President