EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANCO/10946/2014 […](2015) XXX  
  
COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending Regulation (EC) No 1881/2006 as re gards maximum levels of lead in certain 
foodstuffs 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending Regulation (EC) No 1881/2006 as regar ds maximum levels of lead in certain 
foodstuffs 
(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 food
1, and in particular Article 2(3) thereof, 
Whereas: (1) Commission Regulation (EC) No 1881/2006
2 sets maximum levels for certain 
contaminants in foodstuffs. 
(2) The Scientific Panel on contaminants in the Food Chain (CONTAM Panel) of the 
European Food Safety Authority (EFSA) adopted an opinion on lead in food on 
18 March 20103. The CONTAM Panel identified developmental neurotoxicity in 
young children and cardiovascular effects and nephrotoxicity in adults as potential 
critical adverse effects of lead on which to base the risk assessment. It further 
indicated that protection of children a nd women of child-bearing age against the 
potential risk of neurodevelopmental effect s is sufficient to pr otect all populations 
from the other adverse effects of lead. It is  therefore appropriate to reduce the dietary 
exposure to lead in food by lowering exis ting maximum levels and setting additional 
maximum levels for lead in relevant commodities. 
(3) Maximum levels already exist for infant fo rmulae and follow-on formulae. In order to 
further guarantee a continued lowering of  dietary exposure of infants and young 
children, existing maximum levels should be lowered and new maximum levels 
established for processed cereal-based foods and baby foods for infants and young 
children, food for special medical purposes for infants and young children and drinks, 
which are highly consumed by this vulnerable group of consumers. 
(4) New occurrence data show that some of  the existing exemptions from default 
maximum levels are no longer necessary as the default maximum levels can be 
complied with by following good practices or that lower maximum levels would be achievable. Specific maximum levels are th erefore no longer necessary for brassica 
other than leafy brassica, fresh legumes, mo st of the berries and small fruits while 
existing maximum levels should be lowered for cephalopods, most fruiting vegetables, 
most fruit juices, wine and aromatised wine. 
                                                
 
1 OJ L 37, 13.2.1993, p. 1. 
2 Commission Regulation (EC) No 1 881/2006 of 19 Decembe r 2006 setting maximum levels for certain 
contaminants in foodstuffs (OJ L 364, 20.12.2006, p. 5). 
3 EFSA Panel on Contaminants in the Food Chain (CONTAM); Scientific Opinion on Lead in Food. 
EFSA Journal 2010; 8(4):1570.  
EN 3   EN (5) For salsify, compliance with current maximum levels is difficult. Since consumption 
of this commodity is low and effects on human exposur e are negligible, it is 
appropriate to raise the maximu m levels of lead for salsify. 
(6) Erratic findings of high levels of lead in  honey have triggered enforcement actions by 
Member States at differing le vels of lead. Differences in  rules adopted by the Member 
States may hinder the functioning of the common market therefore, a harmonised 
maximum level for lead in honey should be set. 
(7) As consumption of tea and herb al infusions can be an impor tant contributor to dietary 
exposure, a maximum level for these commod ities should be established. However, in 
absence of data on dry tea l eaves and dry herbal infusions  allowing the establishment 
of such a maximum level, occurrence data s hould be collected in view of the possible 
establishment of a specific maximum level in the future.  
(8) Legislation related to processed cereal-ba sed foods, baby foods for infants and young 
children and dietary foods for special medical purposes has been replaced 
necessitating changes to certain endnotes. 
(9) Member States and food business operators s hould be allowed time to adapt to the new 
maximum levels established by this Regul ation. The date of application of the 
maximum levels of lead s hould therefore be deferred. 
(10) The measures provided for in this Regulati on 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 
The maximum levels of lead set out in th e Annex to Regulation (EC) No 1881/2006, as 
amended by this Regulation, shall apply from 1 January 2016. Foodstuffs not complying with 
these maximum levels which are lawfully place d on the market prior to 1 January 2016 may 
continue to be marketed after that date 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 . 
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  
EN 4   EN  
ANNEX  
The Annex to Regulation (EC) No 1881/2006 is amended as follows: 
(1) Subsection 3.1 (Lead) is re placed by the following: 
'3.1 Lead  
3.1.1 Raw milk(6), heat-treated milk and milk for the manufacture 
of milk-based products  0,020 
3.1.2 Infant formulae and follow-on formulae   
 marketed as powder(8)(29) 0,050 
 marketed as liquid(8)(29) 0,010 
3.1.3 Processed cereal-based foods and baby foods for infants 
and young children(3)(29) other than 3.1.5 0,050 
3.1.4 Foods for special medical purposes(9) intended specifically 
for infants and young children  
  marketed as powder(29) 0,050 
  marketed as liquid(29) 0,010 
3.1.5 Drinks for infants and young children labelled and sold as 
such, other than those mentioned in 3.1.2 and 3.1.4  
 marketed as liquids or to be reconstituted following 
instructions of the manufacturer including fruit juices 
(4) 0,030 
 to be prepared by steeping, brewing, infusion or 
decoction(29) 1,50 
3.1.6 Meat (excluding offal) of bovine animals, sheep, pig and 
poultry(6) 0,10 
3.1.7 Offal of bovine animals, sheep, pig and poultry(6) 0,50  
3.1.8 Muscle meat of fish(24)(25) 0,30  
3.1.9 Cephalopods(52) 0,30 
3.1.10 Crustaceans(26)(44) 0,50 
3.1.11 Bivalve molluscs(26) 1,50 
3.1.12 Cereals and pulses 0,20 
3.1.13 Vegetables excluding leafy brassica, salsify, leaf 
vegetables & fresh herbs, fungi, seaweed and fruiting 
vegetables(27)(53) 0,10 
3.1.14 Leafy brassica, salsify, leaf vegetables excluding fresh 
herbs and the following fungi Agaricus bisporus  (common 
mushroom), Pleurotus ostreatus  (Oyster mushroom), 
Lentinula edodes (Shiitake mushroom)(27) 0,30 
3.1.15 Fruiting vegetables  
 sweet corn (27) 0,10 
 other than sweet corn (27) 0,05  
EN 5   EN 3.1.16 Fruit, excluding cranberries, currants, elderberries and 
strawberry tree(27) 0,10 
3.1.17 Cranberries, currants, elderberries and strawberry tree(27) 0,20 
3.1.18 Fats and oils, including milk fat 0,10 
3.1.19 Fruit juices, concentrated  fruit juices as reconstituted and 
fruit nectars   
 exclusively from berries and other small fruits(14) 0,05 
 from fruits other than berries and other small fruits(14) 0,03 
3.1.20 Wine (including sparkling wine, excluding liqueur wine), 
cider, perry and fruit wine(11)  
 products produced from the 2001 fruit harvest to 2015 
fruit harvest 0,20 
 products produced from the 2016 fruit harvest onwards 0,15 
3.1.21 Aromatised wine, aromatised wine-based drinks and 
aromatised wine-product cocktails(13)  
 products produced from the 2001 fruit harvest to 2015 
fruit harvest 0,20 
 products produced from the 2016 fruit harvest onwards 0,15 
3.1.22 Food supplements(39) 3,0 
3.1.23 Honey 0,10' 
 
(2) Endnote (3) is replaced by the following endnote: 
'(3) Foodstuffs listed in this category as defined in Regulati on (EU) No 609/2013 
of the European Parliament and of  the Council of 12 June 2013 on food 
intended for infants and young children, f ood for special medical purposes, and 
total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/ 8/EC, 1999/21/EC, 2006/125/EC and 
2006/141/EC, Directive 2009/39/EC of the European Parliament and of the 
Council and Commission Regulations (EC)  No 41/2009 and (EC) No 953/2009 
(OJ L181, 29.6.2013, p. 35).' 
(3) Endnotes 
(8) and (9) are deleted. References to endnot es (8) and (9) ar e replaced by 
references to endnote (3). 
(4)  Endnote (11) is replaced by the following endnote: 
 “(11) Wine and sparkling wines as defined in Regulation (EU) No 1308/2013 of the 
European Parliament and of the C ouncil of 17 December 2013 establishing a 
common organisation of the markets in ag ricultural products and repealing Council 
Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 
1234/2007 (OJ L 347, 20.12.2013, p. 671)  
(5)  Endnote (13) is replaced by the following endnote: 
 “(13) Foodstuffs listed in this category as de fined in Regulation (EU) No 251/2014 of 
the European Parliament and of the C ouncil of 26 February 2014 on the definition, 
description, presentation, la belling and the protection of geographical indications of 
aromatised wine products and repealing Council Regulation (EEC) No 1601/91(OJ L 
84, 20.3.2014, p. 14).    
EN 6   EN The maximum level for OTA applicable to  these beverages is function of the 
proportion of wine and/or grape must present in the finished product.  
(6) Endnote (16) is replaced by the following endnote: 
'(16) Infants and young children as defined in Regulation (EU) No 609/2013 of the 
European Parliament and of the Counc il of 12 June 2013 on food intended for 
infants and young children, food for special  medical purposes, and total diet 
replacement for weight control and repealing Council Di rective 92/52/EEC, 
Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, 
Directive 2009/39/EC of the European Parliament and of the Council and 
Commission Regulations (EC) No 41 /2009 and (EC) No 953/2009 (OJ L181, 
29.6.2013, p. 35)' 
(7) Endnote (28) is deleted 
(8) Endnote (44) is replaced by the following endnote: 
'(44): Muscle meat from appendages and abdomen. This definition excludes the 
cephalothorax of crustaceans. In case of crabs and crab-like crustaceans 
(Brachyura  and Anomura ): muscle meat from appendages.' 
(9) The following endnotes are added:  
'(52): the maximum level applies to the an imal as sold without viscera.  
(53): for potatoes the maximum level applies to peeled potatoes.'