EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10296/2017 Rev. 0  
[…](2016) XXX  draft  
  
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II and III to Regulation (EC) No 396/2005 of the European 
Parliament and of the Council as regards maximum residue levels for mercury 
compounds in or on certain products  
(Text with EEA relevance)   EN 2   EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II and III to Regulation (EC) No 396/2005  of the European 
Parliament and of the Council as regards maximum residue levels for mercury 
compounds in or on certain products  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having  regard to Regulation (EC) No  396/2005 of the European Parliament and of the 
Council of 23  February 2005 on maximum residue levels of pesticides in or on food and feed 
of plant and animal origin and amending Council Directive 91/414/EEC1, and  in particular  
Article 14(1)(a), Article 16(1)(a)  and Article 49(2) thereof,  
Whereas:  
(1) For mercury compounds , maximum residue levels (MRLs) were set in Annex II and 
Part B of Annex III to Regulation (EC) No  396/2005.   
(2) Council Directive 79/117/EEC prohibits the placing on  the market and use of plant 
protection products containing mercury compounds.  All authorisations were revoked  
and consequently all  MRLs were  set at the relevant limit of determination (LOD).  
(3) Recent monitoring data show that residues occur in several produ cts at levels higher 
than the LOD . Taking into account the 95th percentile of all the sample results , the 
following occurrences were reported: tree nuts at 0,02 mg/kg; fresh herbs at 
0,03 mg/kg; cultivated fungi at 0,05 mg/kg; wild fungi at 0,50  mg/kg, except for ceps 
at 0,90 mg/kg; oilseeds at 0,02 mg/kg; cocoa beans at 0,02 mg/kg; spices at 
0,02 mg/kg, except ginger, nutmeg, mace and turmeric at  0,05 mg/kg; meat at 
0,01 mg/kg , except for  duck meat at 0,04 mg/kg  and meat of wild game animals at 
0,015 mg/kg; animal fat at 0,01 mg/kg; edible offal at 0,02 mg/kg  except  for offal of 
wild game animals at 0,025  mg/kg  and offal of wild boar at 0,10 mg/kg;  milk at 0,01 
mg/kg; and  honey at 0,01 mg/kg . 
(4) As m ercury containing pesticides have been phased out since more than thirty years in 
the Union, the presence of mercury in food can be considered solely due to 
environmental contamination. It is therefore appropriate to take into account 
environmental backgro und levels  to enable Member States to take enforcement action 
under Regulation (EC) No  396/2005  on the basis of real istic MRLs . 
                                                 
1 OJ L 70, 16.3.2005, p. 1.  EN 3   EN (5) The Scientific Panel on contaminants in the Food Chain (CONTAM Panel) of the 
European Food Safety Authority , hereinafter 'the Authority', adopted an opinion on 
mercury and methylmercury in food2.  
(6) As mercury compounds occur at low levels in the products  listed  in recital 3  and 
taking into account the available consumption data within the Union, the overall 
contri bution to the dietary exposure is considered low  and there is no health risk for 
consumers . The MRL s for those  products  should be set as temporary in Annex III  to 
Regulation (EC) No  396/2005. Those MRLs will be reviewed; the review will take 
into account t he information available within 10 years from the publication of this 
Regulation.  
(7) The Commission consulted the European Union reference laboratories for residues of 
pesticides as regards the need to adapt certain LODs. Those laboratories concluded 
that fo r certain products  technical development requires the setting of specific limits of 
determination.  
(8) Based on the opinion  of the Authority and taking into account the factors relevant to 
the matter under consideration, the appropriate modifications to the MRLs fulfil the 
requirements of Article  14(2) of Regulation (EC) No  396/2005.  
(9) Through the World Trade Organisation, the t rading partners of the Union were 
consulted on the new MRLs and their comments have been taken into account.  
(10) Regulation (EC) No  396/2005 should therefore be amended accordingly.  
(11) In order to allow for the normal marketing, processing and consumption of prod ucts, 
this Regulation should provide for a transitional arrangement for products which have 
been produced before the modification of the MRLs and for which information shows 
that a high level of consumer protection is maintained.  
(12) A reasonable period shoul d be allowed to elapse before the modified MRLs become 
applicable in order to permit Member States, third countries and food business 
operators to prepare themselves to meet the new requirements which will result from 
the modification of the MRLs.  
(13) The meas ures 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  
Annexes II and III to Regulation (EC) No 396/2005 are amended in accordance with the  
Annex to this Regulation.  
Article 2  
Regulation (EC) No 396/2005 as it stood before being amended by this Regulation shall 
continue to apply to products which were produced before [ Office of Publications please 
insert date 6 months after entry into force o f this Regulation ]. 
                                                 
2  EFSA Panel on Contaminants in the Food Chain (CONTAM); Scientific Opinion on the risk for public  
health related to the presence of mercury and methylmercury in food. EFSA Journal 2012;10(12):2985. 
[241 pp.]  doi:10.2903/j.efsa.2012.2985.  EN 4   EN 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 [Office of Publication: please insert date 6 months after entry into force] . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER