COMMISSION REGULATION (EC) No 629/2008
of 2 July 2008
amending Regulation (EC) No 1881/2006 setting maximum levels for certain contaminants in
foodstuffs
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European
Community,
Having regard to Council Regulation (EEC) No 315/93 of
8 February 1993 laying down Community procedures forcontaminants 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,including maximum levels for the metals lead, cadmiumand mercury.
(2) It is essential, in order to protect public health, to keepcontaminants at levels which do not cause healthconcerns. Maximum levels for lead, cadmium andmercury must be safe and as low as reasonablyachievable based upon good manufacturing and agricul-tural/fishery practices.
(3) On the basis of new information, good agricultural andfisheries practices do not allow keeping levels of lead,cadmium and mercury in certain aquatic species andfungi as low as required in the Annex of Regulation(EC) No 1881/2006. It is therefore necessary to revisethe maximum levels fixed for those contaminants whilemaintaining a high level of consumer health protection.
(4) High levels of lead, cadmium and mercury have beenfound in certain food supplements as defined inArticle 2 of Directive 2002/46/EC of the EuropeanParliament and of the Council of 10 June 2002 on theapproximation of the laws of the Member States relating
to food supplements (
3) 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 andmercury. In order to protect public health, it is thereforeappropriate to set maximum levels for lead, cadmiumand mercury in food supplements. These maximumlevels must be safe and as low as reasonably achievablebased upon good manufacturing practices.
(5) Seaweed accumulates cadmium naturally. Foodsupplements consisting exclusively or mainly of driedseaweed or of products derived from seaweed cantherefore contain higher levels of cadmium than otherfood supplements. To take this into account, a highermaximum level for cadmium is needed for foodsupplements consisting exclusively or mainly of seaweed.
(6) Member States and food business operators should beallowed time to adapt to the new maximum levels forfood supplements. The application of the maximumlevels for food supplements should therefore be deferred.
(7) An amendment of Footnote 1 of the Annex of Regu-lation (EC) No 1881/2006 is necessary to clarify that themaximum level for fruit does not apply to tree nuts.
(8) New monitoring recommendations have been introducedby Commission Recommendation 2007/196/EC of28 March 2007 on the monitoring of the presence offuran in foodstuffs (
4) and Commission Recommendation
2007/331/EC of 3 May 2007 on the monitoring ofacrylamide levels in food (
5). The provisions on moni-
toring and reporting in Regulation (EC) No 1881/2006therefore need to be completed with references to thosenew Recommendations. The monitoring exercise on
polycyclic aromatic hydrocarbons set out in Commission
Recommendation 2005/108/EC (
6) has been finalised.
Therefore, the reference to that monitoring Recommen-dation can be deleted.EN L 173/6 Official Journal of the European Union 3.7.2008
(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 amended by Regulation
(EC) No 1126/2007 (OJ L 255, 29.9.2007, p. 14).(3) OJ L 183, 12.7.2002, p. 51. Directive as amended by Commission
Directive 2006/37/EC (OJ L 94, 1.4.2006, p. 32).
(4) OJ L 88, 29.3.2007, p. 56.
(5) OJ L 123, 12.5.2007, p. 33.
(6) OJ L 34, 8.2.2005, p. 43.(9) Regulation (EC) No 1881/2006 should therefore be
amended accordingly.
(10) The measures provided for in this Regulation are inaccordance with the opinion of the StandingCommittee on the Food Chain and Animal Health,
HAS ADOPTED THIS REGULATION:
Article 1
Regulation (EC) No 1881/2006 is amended as follows:
1. In Article 9, paragraph 3 is replaced by the following:
‘3. Member States should report to the Commission
findings on aflatoxins, dioxins, dioxin-like PCBs, non-
dioxin-like PCBs as specified in Commission Decision
2006/504/EC (44) and Commission Recommendation
2006/794/EC (45). Member States should report to EFSAfindings on acrylamide and furan as specified in Commission
Recommendation 2007/196/EC (46) and Commission
Recommendation 2007/331/EC (47).
___________
(44) OJ L 199, 21.7.2006, p. 21.
(45) OJ L 322, 22.11.2006, p. 24.
(46) OJ L 88, 29.3.2007, p. 56.
(47) OJ L 123, 12.5.2007, p. 33. ’
2. The Annex is amended in accordance to 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 .
The maximum levels laid down in points 3.1.18, 3.2.19, 3.2.20
and 3.3.3 of the Annex shall apply from 1 July 2009. Theyshall not apply to products lawfully placed on the market before
1 July 2009. The burden of proving when the products were
placed on the market shall be borne by the food businessoperator.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 2 July 2008.
For the Commission
Androulla VASSILIOU
Member of the CommissionEN 3.7.2008 Official Journal of the European Union L 173/7ANNEX
The Annex to Regulation (EC) No 1881/2006 is amended as follows:
(1) In Subsection 3.1 ( Lead ), point 3.1.11 is replaced by the following and a new point 3.1.18 is added:
‘3.1.11 Brassica vegetables, leaf vegetables and the following fungi (27):Agaricus bisporus
(common mushroom), Pleurotus ostreatus (Oyster mushroom) , Lentinula edodes
(Shiitake mushroom)0,30
3.1.18 Food supplements (*) 3,0
(*) The maximum level applies to the food supplements as sold. ’
(2) Subsection 3.2. ( Cadmium ) is replaced by the following:
‘3.2 Cadmium
3.2.1 Meat (excluding offal) of bovine animals, sheep, pig and poultry (6) 0,050
3.2.2 Horsemeat, excluding offal (6) 0,20
3.2.3 Liver of bovine animals, sheep, pig, poultry and horse (6) 0,50
3.2.4 Kidney of bovine animals, sheep, pig, poultry and horse (6) 1,0
3.2.5 Muscle meat of fish (24)(25), excluding species listed in points 3.2.6, 3.2.7 and
3.2.80,050
3.2.6 Muscle meat of the following fish (24)(25):
bonito ( Sarda sarda )
common two-banded seabream ( Diplodus vulgaris )
eel ( Anguilla anguilla )
grey mullet ( Mugil labrosus labrosus )
horse mackerel or scad ( Trachurus species )
louvar or luvar ( Luvarus imperialis )
mackerel (Scomber species)
sardine ( Sardina pilchardus )
sardinops ( Sardinops species )
tuna ( Thunnus species, Euthynnus species, Katsuwonus pelamis )
wedge sole ( Dicologoglossa cuneata )0,10
3.2.7 Muscle meat of the following fish (24)(25):
bullet tuna (Auxis species)0,20
3.2.8 Muscle meat of the following fish (24)(25):
anchovy ( Engraulis species )
swordfish ( Xiphias gladius )0,30
3.2.9 Crustaceans, excluding brown meat of crab and excluding head and thorax meat of
lobster and similar large crustaceans ( Nephropidae and Palinuridae )(26)0,50
3.2.10 Bivalve molluscs (26) 1,0
3.2.11 Cephalopods (without viscera) (26) 1,0
3.2.12 Cereals excluding bran, germ, wheat and rice 0,103.2.13 Bran, germ, wheat and rice 0,203.2.14 Soybeans 0,20
3.2.15 Vegetables and fruit, excluding leaf vegetables, fresh herbs, fungi, stem vegetables,
root vegetables and potatoes (
27)0,050EN L 173/8 Official Journal of the European Union 3.7.20083.2.16 Stem vegetables, root vegetables and potatoes, excluding celeriac (27). For potatoes
the maximum level applies to peeled potatoes.0,10
3.2.17 Leaf vegetables, fresh herbs, celeriac and the following fungi (27):Agaricus bisporus
(common mushroom), Pleurotus ostreatus (Oyster mushroom), Lentinula edodes
(Shiitake mushroom)0,20
3.2.18 Fungi, excluding those listed in point 3.2.17 (27) 1,0
3.2.19 Food supplements (*) excl. food supplements listed in point 3.2.20 1,03.2.20 Food supplements (*) consisting exclusively or mainly of dried seaweed or of
products derived from seaweed3,0
(*) The maximum level applies to the food supplements as sold. ’
(3) In Subsection 3.3 ( Mercury ), point 3.3.2 is replaced by the following and a new point 3.3.3 is added:
‘3.3.2 Muscle meat of the following fish (24)(25):
anglerfish ( Lophius species )
Atlantic catfish ( Anarhichas lupus )
bonito ( Sarda sarda )
eel ( Anguilla species )
emperor, orange roughy, rosy soldierfish ( Hoplostethus species )
grenadier ( Coryphaenoides rupestris )
halibut ( Hippoglossus hippoglossus )
kingklip (Genypterus capensis)
marlin ( Makaira species )
megrim ( Lepidorhombus species )
mullet ( Mullus species )
pink cusk eel (Genypterus blacodes)
pike ( Esox lucius )
plain bonito ( Orcynopsis unicolor )
poor cod ( Tricopterus minutes )
Portuguese dogfish ( Centroscymnus coelolepis )
rays ( Raja species )
redfish ( Sebastes marinus, S. mentella, S. viviparus )
sail fish ( Istiophorus platypterus )
scabbard fish ( Lepidopus caudatus, Aphanopus carbo )
seabream, pandora ( Pagellus species )
shark (all species)
snake mackerel or butterfish ( Lepidocybium flavobrunneum, Ruvettus pretiosus, Gempylus
serpens )
sturgeon ( Acipenser species )
swordfish ( Xiphias gladius )
tuna ( Thunnus species, Euthynnus species, Katsuwonus pelamis )1,0
3.3.3 Food supplements (*) 0,10
(*) The maximum level applies to the food supplements as sold. ’
(4) In footnote (1) the following sentence is added:
‘Tree nuts are not covered by the maximum level for fruit. ’
(5) Footnote (8) is replaced by the following:
‘(8) Foodstuffs listed in this category as defined in Commission Directive 2006/141/EC (OJ L 401, 30.12.2006, p. 1). ’EN 3.7.2008 Official Journal of the European Union L 173/9