Commission Directive 2008/76/EC

of 25 July 2008

amending Annex I to Directive 2002/32/EC of the European Parliament and of the Council on undesirable substances in animal feed

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed [1], and in particular Article 8(1) thereof,

Whereas:

(1) Directive 2002/32/EC provides that the use of products intended for animal feed which contain levels of undesirable substances exceeding the maximum levels laid down in Annex I to that Directive is prohibited.

(2) Recent developments in technical knowledge on formulating fish feed with the increasing use of marine crustaceans such as marine krill as feed material in fish feed make a review of the maximum level for fluorine in fish feed appropriate. It results from the opinion of the European Food Safety Authority (EFSA) of 22 September 2004 [2] that an increase of the maximum allowable level of fluorine in fish feed would not result in unacceptable risks for animal and public health. As regards Lolium temulentum and Lolium remotum, EFSA recommends to delete the separate entries for those two plant species in its opinion of 25 January 2007 [3] and to apply the general maximum content for weed seeds and unground and uncrushed fruits containing alkaloids, glucosides and other toxic substances, as set out in row 14 of Annex I to Directive 2002/32/EC.

(3) As regards DDT, the name DDD should be included in the row concerning that substance in Annex I to Directive 2002/32/EC, since that name is more commonly used for the metabolite dichlorodiphenyl-dichloroethane than TDE [4].

(4) As regards apricots (Prunus armeniaca L.) and bitter almond (Prunus dulcis var. amara or Prunus amygdalus Batsch var: amara), it may be concluded from the EFSA opinion of 23 November 2006 [5] that the requirement for absence of quantifiable amounts of apricots and bitter almond is not necessary for the protection of animal and public health and that it is sufficient to apply the general maximum levels for hydrocyanic acid, as set out in row 8 of Annex I to Directive 2002/32/EC. It is therefore appropriate to delete the specific requirements for apricot and bitter almond.

(5) Camelina (Camelina sativa) is included in the Annex to Directive 2002/32/EC and the seeds and fruits of these plant species as well as their processed derivatives may only be present in feedingstuffs in trace amounts not quantitatively determinable.

(6) There is a renewed interest in Camelina sativa as oilseed crop because of an increasing demand for alternative low-input oilseed crops with the potential for use of the by-products of the oilseed production in animal feed. From the EFSA opinion of 27 November 2007 [6] it can be concluded that the requirement for absence of quantifiable amounts of Camelina sativa and their derivatives is not necessary for the protection of animal and public health provided that the amount of total glucosinolates in the diet does not endanger animal and public health. The protection of animal and public health against the toxic effects of glucosinolates is ensured by the provision for volatile mustard oil in complete feed, for which the maximum level is expressed as allyl isothiocyanates, as the toxicity of the glucosinolates is according to the EFSA opinion generally attributed to the (iso)thiocyanates. It is therefore appropriate to delete the requirement for absence of quantifiable amounts of Camelina sativa from Annex I to Directive 2002/32/EC.

(7) Directive 2002/32/EC should therefore be amended accordingly.

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

HAS ADOPTED THIS DIRECTIVE:

Article 1

Annex I to Directive 2002/32/EC is amended in accordance with the Annex to this Directive.

Article 2

Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 April 2009 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

Article 3

This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 25 July 2008.

For the Commission

Androulla Vassiliou

Member of the Commission

[1] OJ L 140, 30.5.2002, p. 10. Directive as last amended by Commission Directive 2006/77/EC (OJ L 271, 30.9.2006, p. 53).

[2] Opinion of the Scientific Panel on contaminants in the Food Chain of the European Food Safety Authority (EFSA) on a request from the Commission related to fluorine as undesirable substances in animal feed, adopted on 22 September 2004, http://www.efsa.europa.eu/EFSA/Scientific_Opinion/opinion_contam08_ej100_fluorine_en1,0.pdf

[3] Opinion of the Scientific Panel on contaminants in the Food Chain of the European Food Safety Authority (EFSA) on a request from the European Commission related to pyrrolizidine alkaloids as undesirable substances in animal feed, adopted on 25 January 2007, http://www.efsa.europa.eu/EFSA/Scientific_Opinion/contam_ej447_op_pyrrolizidine%20alkaloids%20in%20feed_en.pdf

[4] Opinion of the Scientific Panel on contaminants in the Food Chain of the European Food Safety Authority (EFSA) on a request from the Commission related to DDT as undesirable substances in animal feed, adopted on 22 November 2006, http://www.efsa.europa.eu/EFSA/Scientific_Opinion/CONTAM_ej433_DDT_en,2.pdf

[5] Opinion of the Scientific Panel on contaminants in the Food Chain of the European Food Safety Authority (EFSA) on a request from the Commission related to cyanogenic compounds as undesirable substances in animal feed, adopted on 23 November 2006, http://www.efsa.europa.eu/EFSA/Scientific_Opinion/CONTAM_ej434_op_cyanogenic_compounds_in_feed_en,1.pdf

[6] Opinion of the Scientific Panel on contaminants in the Food Chain of the European Food Safety Authority (EFSA) on a request from the Commission related to glucosinolates as undesirable substances in animal feed, adopted on 27 November 2007, http://www.efsa.europa.eu/EFSA/Scientific_Opinion/contam_op_ej590_glucosinolates_en.pdf

--------------------------------------------------

ANNEX

Annex I to Directive 2002/32/EC is amended as follows:

1. Row 3, Fluorine, is replaced by the following:

Undesirable substances | Products intended for animal feed | Maximum content in mg/kg (ppm) relative to a feedingstuff with a moisture content of 12 % |

(1) | (2) | (3) |

"3.Fluorine [1] | Feed materials with the exception of | 150 |

—feedingstuffs of animal origin with the exception of marine crustaceans such as marine krill | 500 |

—marine crustaceans such as marine krill | 3000 |

—phosphates | 2000 |

—calcium carbonate | 350 |

—magnesium oxide | 600 |

—calcareous marine algae | 1000 |

Vermiculite (E 561) | 3000 [2] |

Complementary feedingstuffs | |

—containing ≤ 4 % phosphorus | 500 |

—containing > 4 % phosphorus | 125 per 1 % phosphorus |

Complete feedingstuffs with the exception of | 150 |

—complete feedingstuffs for cattle sheep and goats | |

—in lactation | 30 |

—other | 50 |

—complete feedingstuffs for pigs | 100 |

—complete feedingstuffs for poultry | 350 |

—complete feedingstuffs for chicks | 250 |

—complete feedingstuffs for fish | 350 |

2. Row 14, Weed seeds and unground and uncrushed fruits containing alkaloids, glucosides or other toxic substances, is replaced by the following:

Undesirable substances | Products intended for animal feed | Maximum content in mg/kg (ppm) relative to a feedingstuff with a moisture content of 12 % |

(1) | (2) | (3) |

"14.Weed seeds and unground and uncrushed fruits containing alkaloids, glucosides or other toxic substances separately or in combination including | All feedingstuffs | 3000 |

Datura stramonium L. | | 1000" |

3. Row 21, DDT, is replaced by the following:

Undesirable substances | Products intended for animal feed | Maximum content in mg/kg (ppm) relative to a feedingstuff with a moisture content of 12 % |

(1) | (2) | (3) |

"DDT (sum of DDT-, DDD- (or TDE-) and DDE-isomers, expressed as DDT) | All feedingstuffs with the exception of | 0,05 |

—fats and oils | 0,5" |

4. Row 28, Apricots — Prunus armeniaca L., row 29, Bitter almond — Prunus dulcis (Mill.) D.A. Webb var. amara (DC.) Focke (=Prunus amygdalus Batsch var. amara (DC.) Focke), and row 31, Camelina — Camelina sativa (L.) Crantz, are deleted.

[*] Maximum levels refer to an analytical determination of fluorine, whereby extraction is performed with hydrochloric acid 1 N for 20 minutes at ambient temperature. Equivalent extraction procedures can be applied for which it can be demonstrated that the used extraction procedure has an equal extraction efficiency.

[**] The levels shall be reviewed by 31 December 2008 with the aim of reducing the maximum levels."

--------------------------------------------------