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| 20.1.2005 | EN | Official Journal of the European Union | L 16/43 |

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COMMISSION REGULATION (EC) No 78/2005

of 19 January 2005

amending Regulation (EC) No 466/2001 as regards heavy metals

(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 for contaminants in food [(1)](#ntr1-L_2005016EN.01004301-E0001), and in particular Article 2(3) thereof,

After consulting the Scientific Committee on Food and the European Food Safety Authority,

Whereas:

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| (1) | Commission Regulation (EC) No 466/2001 [(2)](#ntr2-L_2005016EN.01004301-E0002) sets maximum levels for certain contaminants in foodstuffs. These measures, as specifically amended by Commission Regulation (EC) No 221/2002 [(3)](#ntr3-L_2005016EN.01004301-E0003), include maximum levels for the heavy metals lead, cadmium and mercury. |

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| (2) | It is essential, in order to protect public health, to keep contaminants at levels which do not cause health concerns. Maximum levels for lead, cadmium and mercury must be safe and as low as reasonably achievable (ALARA) based upon good manufacturing and agricultural/ fishery practices. On the basis of new information on the achievability of maximum levels in certain aquatic species it is necessary to revise the relevant provisions of Annex I to Regulation (EC) No 466/2001 for these contaminants in certain foods. The revised provisions maintain a high level of consumer health protection. |

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| (3) | Regulation (EC) No 466/2001 should be amended accordingly. |

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| (4) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |

HAS ADOPTED THIS REGULATION:

Article 1

Annex I to Regulation (EC) No 466/2001 is amended as set out in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the 20th 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, 19 January 2005.

For the Commission

Markos KYPRIANOU

Member of the Commission

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[(1)](#ntc1-L_2005016EN.01004301-E0001)  
[OJ L 37, 13.2.1993, p. 1](http://publications.europa.eu/resource/oj/JOL_1993_037_R_TOC). 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](http://publications.europa.eu/resource/oj/JOL_2003_284_R_TOC)).

[(2)](#ntc2-L_2005016EN.01004301-E0002)  
[OJ L 77, 16.3.2001, p. 1](http://publications.europa.eu/resource/oj/JOL_2001_077_R_TOC). Regulation as amended by Regulation (EC) No 684/2004 ([OJ L 106, 15.4.2004, p. 6](http://publications.europa.eu/resource/oj/JOL_2004_106_R_TOC)).

[(3)](#ntc3-L_2005016EN.01004301-E0003)  
[OJ L 37, 7.2.2002, p. 4](http://publications.europa.eu/resource/oj/JOL_2002_037_R_TOC).

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ANNEX

Section 3 of Annex I to Regulation (EC) No 466/2001 is modified as follows:

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| 1. | As regards Lead (Pb), points 3.1.4, 3.1.4.1 and 3.1.5 are replaced by the following points: | | | | | | --- | --- | --- | --- | | Product | Maximum level (mg/kg wet weight) | Performance criteria for sampling | Performance criteria for methods of analysis | | | | | | --- | --- | | ‘3.1.4. | Muscle meat of fish[(1)](#ntr1-L_2005016EN.01004401-E0001) [(2)](#ntr2-L_2005016EN.01004401-E0002), excluding species listed in 3.1.4.1. | | 0,20 | Directive 2001/22/EC | Directive 2001/22/EC | | | | | | | | | | | | | | | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 3.1.4.1. | Muscle meat of the following fish[(1)](#ntr1-L_2005016EN.01004401-E0001) [(2)](#ntr2-L_2005016EN.01004401-E0002): | | | | --- | --- | | | common two-banded seabream (Diplodus vulgaris) | | | | | --- | --- | | | eel (Anguilla anguilla) | | | | | --- | --- | | | grey mullet (Mugil labrosus labrosus) | | | | | --- | --- | | | grunt (Pomadasys benneti) | | | | | --- | --- | | | horse mackerel or scad (Trachurus species) | | | | | --- | --- | | | sardine (Sardina pilchardus) | | | | | --- | --- | | | sardinops (Sardinops species) | | | | | --- | --- | | | spotted seabass (Dicentrarchus punctatus) | | | | | --- | --- | | | wedge sole (Dicologoglossa cuneata) | | | 0,40 | Directive 2001/22/EC | Directive 2001/22/EC | | | | | | --- | --- | | 3.1.5. | Crustaceans, excluding brown meat of crab and excluding head and thorax meat of lobster and similar large crustaceans (Nephropidae and Palinuridae) | | 0,50 | Directive 2001/22/EC | Directive 2001/22/EC’ | |

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| 2. | As regards Cadmium (Cd), points 3.2.5 and 3.2.5.1 are replaced by the following and a new point 3.2.5.2 is inserted: | | | | | | --- | --- | --- | --- | | Product | Maximum level (mg/kg wet weight) | Performance criteria for sampling | Performance criteria for methods of analysis | | | | | | --- | --- | | ‘3.2.5. | Muscle meat of fish[(3)](#ntr3-L_2005016EN.01004401-E0003) [(4)](#ntr4-L_2005016EN.01004401-E0004), excluding species listed in 3.2.5.1 and 3.2.5.2. | | 0,05 | Directive 2001/22/EC | Directive 2001/22/EC | | | | | | | | | | | | | | | | | | | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 3.2.5.1. | Muscle meat of the following fish[(3)](#ntr3-L_2005016EN.01004401-E0003) [(4)](#ntr4-L_2005016EN.01004401-E0004): | | | | --- | --- | | | anchovy (Engraulis species) | | | | | --- | --- | | | 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) | | | | | --- | --- | | | sardine (Sardina pilchardus) | | | | | --- | --- | | | sardinops (Sardinops species) | | | | | --- | --- | | | tuna (Thunnus species, Euthynnus species, Katsuwonus pelamis) | | | | | --- | --- | | | wedge sole (Dicologoglossa cuneata) | | | 0,10 | Directive 2001/22/EC | Directive 2001/22/EC | | | | | | --- | --- | | 3.2.5.2. | Muscle meat of swordfish (Xiphias gladius) | | 0,30 | Directive 2001/22/EC | Directive 2001/22/EC’ | |

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| 3. | As regards Mercury (Hg), points 3.3.1 and 3.3.1.1 are replaced by the following points: | | | | | | --- | --- | --- | --- | | Product | Maximum level (mg/kg wet weight) | Performance criteria for sampling | Performance criteria for methods of analysis | | | | | | --- | --- | | ‘3.3.1. | Fishery products and muscle meat of fish[(5)](#ntr5-L_2005016EN.01004401-E0005) [(7)](#ntr7-L_2005016EN.01004401-E0007), excluding species listed in 3.3.1.1. | | 0,50 | Directive 2001/22/EC | Directive 2001/22/EC | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 3.3.1.1. | Muscle meat of the following fish[(3)](#ntr3-L_2005016EN.01004401-E0003) [(4)](#ntr4-L_2005016EN.01004401-E0004): | | | | --- | --- | | | 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) | | | | | --- | --- | | | marlin (Makaira species) | | | | | --- | --- | | | megrim (Lepidorhombus species) | | | | | --- | --- | | | mullet (Mullus species) | | | | | --- | --- | | | pike (Esox lucius) | | | | | --- | --- | | | plain bonito (Orcynopsis unicolor) | | | | | --- | --- | | | poor cod (Tricopterus minutes) | | | | | --- | --- | | | portuguese dogfish (Centroscymnes 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 | Directive 2001/22/EC | Directive 2001/22/EC’ | |

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[(1)](#ntc1-L_2005016EN.01004401-E0001)  Where fish are intended to be eaten whole, the maximum level shall apply to the whole fish.

[(2)](#ntc2-L_2005016EN.01004401-E0002)  Fish as defined in the category (a) of the list of Article 1 of Council Regulation (EC) No 104/2000 ([OJ L 17, 21.1.2000, p. 22](http://publications.europa.eu/resource/oj/JOL_2000_017_R_TOC)).

[(3)](#ntc3-L_2005016EN.01004401-E0003)  Where fish are intended to be eaten whole, the maximum level shall apply to the whole fish.

[(4)](#ntc4-L_2005016EN.01004401-E0004)  Fish as defined in the category (a) of the list of Article 1 of Council Regulation (EC) No 104/2000 ([OJ L 17, 21.1.2000, p. 22](http://publications.europa.eu/resource/oj/JOL_2000_017_R_TOC)).

[(5)](#ntc5-L_2005016EN.01004401-E0005)  Where fish are intended to be eaten whole, the maximum level shall apply to the whole fish.

[(6)](#ntc6-L_2005016EN.01004401-E0006)  Fish as defined in the category (a) of the list of Article 1 of Council Regulation (EC) No 104/2000 ([OJ L 17, 21.1.2000, p. 22](http://publications.europa.eu/resource/oj/JOL_2000_017_R_TOC)).

[(7)](#ntc7-L_2005016EN.01004401-E0007)  Fish and fishery products as defined in the category (a), (c) and (f) of the list of Article 1 of Council Regulation (EC) No 104/2000 ([OJ L 17, 21.1.2000, p. 22](http://publications.europa.eu/resource/oj/JOL_2000_017_R_TOC)).

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