EN    EN EN 
SANCO/1524/2007 rev. 5  
EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 
C(2007) draft 
SANCO/1524/2007 rev. 5  
Draft 
COMMISSION REGULATION 
of 
amending Regulation (EC) No 1881/2006 setting maximum levels for certain 
contaminants in foodstuffs as regards heavy metals  
(Text with EEA relevance) 
(Memorandum from Ms A. VASSILIOU)  
EN 2   EN Draft 
COMMISSION REGULATION 
of 
amending Regulation (EC) No 1881/2006 setting maximum levels for certain 
contaminants in foodstuffs as regards heavy metals  
 (Text with EEA relevance) 
 
THE COMMISSION OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty esta blishing the European Community, 
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 1881/2006
2 sets maximum levels for certain 
contaminants in foodstuffs, including maxi mum levels for the metals lead, cadmium 
and mercury. 
(2) High levels of lead, cadmium and merc ury have been found in certain food 
supplements as defined in Article 2 of  Directive 2002/46/EC of the European 
Parliament and of the Council of 10 June 20023 on the approximation of the laws of 
the Member States relating to food supplem ents and were notified through the Rapid 
Alert System for Food and Feed (RASFF).  It has been shown that these food 
supplements can contribute significantly to human exposure to lead, cadmium and 
mercury. In order to protect public health, it  is therefore appropriate to set maximum 
levels for lead, cadmium and mercury in  food supplements. These maximum levels 
must be safe and as low as reasonab ly achievable based upon good manufacturing 
practices. 
(3) Member States and food business operators should be allowed time to adapt to this 
Regulation. Its application s hould therefore be deferred. 
(4) Seaweed accumulates cadmium naturally. Food supplements consisting exclusively or 
mainly of dried seaweed or of products de rived from seaweed (e.g. seaweed extracts, 
                                                 
1  OJ L 37, 13.2.1993, p. 1 Regulation as amended  by Regulation (EC) No 1882/2003 of the European 
Parliament and of the Council (OJ L 284, 31.10.2003, p. 1) 
2  OJ L 364, 20.12.2006, p. 5. Regulation as last amended by Regulation (EC) No 1126/2007 (OJ L 255, 
29.9.2007). 
3  OJ L 183 of 12.7.2002, p. 51  
EN 3   EN composite products with seaweed as major ingredient, etc.) can therefore contain 
higher levels of cadmium than other food supplements. To take this into account, a 
higher maximum level for cadmium is needed for food supplements consisting exclusively or mainly of seaweed.  
(5) Regulation No 1881/2006 should ther efore be amended accordingly. 
(6) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on the Food Chain and Animal Health, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Section 3 of the Annex to Regulation (EC) No  1881/2006 is amended as set out in the Annex 
to this Regulation. 
Article 2 
This Regulation shall enter into force on the 20th day following its publication in the Official 
Journal of the European Union. 
It shall apply from 1 April 2009. 
It shall not apply to products lawfully placed  on the market before 1 April 2009. The burden 
of proving when the products were  placed on the market shall be borne by the food business 
operator. 
This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, 
 For the Commission 
 Androulla VASSILIOU  Member of the Commission  
EN 4   EN ANNEX   
The Annex to Regulation (EC) No 1881/2006 is amended as follows: 
(1) In Subsection 3.1 ( Lead ), a new point 3.1.18 is added:  
   
'3.1.18 Food supplements(*) 3,0 mg/kg  
 
 
(*)The maximum level applies to the food supplements as sold.' 
 
(2) In Subsection 3.2 ( Cadmium ), new points 3.2.19 and 3.2.20 are added: 
   
'3.2.19 Food supplements(*) excl. food supplements listed 
in point 3.2.20 1,0 mg/kg  
3.2.20 Food supplements consisting exclusively or mainly 
of dried seaweed or of products derived from seaweed(
**) 3,0 mg/kg 
 
(*)The maximum level applies to the food supplements as sold. 
(**)e.g. seaweed extracts, composite products  with seaweed as major ingredient, etc.' 
 
(3) In Subsection 3.3 (Mercury),  a new point 3.3.3 is added: 
   
'3.3.3 Food supplements(*)  0,10 mg/kg  
(*)The maximum level applies to the food supplements as sold.'