Commission Directive 2005/7/ECShow full title

ANNEX

The Annexes to Directive 2002/70/EC are amended as follows:

(1)

Annex I is replaced by the following:

‘1. Purpose and scope

The samples intended for the official control of the levels of dioxins (PCDD/PCDF) content, as well for the determination of the content of dioxin like PCBs(1) in feedingstuffs, shall be taken in accordance with the provisions of Directive 76/371/EEC. The quantitative requirements in relation to the control of substances or products uniformly distributed throughout the feedingstuffs as provided for in point 5.A of the Annex to Directive 76/371/EEC have to be applied. Aggregate samples thus obtained shall be considered as representative for the lots or sublots from which they are taken. Compliance with maximum levels laid down in Directive 2002/32/EC of the European Parliament and of the Council(2) shall be established on the basis of the levels determined in the laboratory samples.

2. Compliance of the lot or sublot with the specification

The lot is accepted if the analytical result of a single analysis does not exceed the respective maximum level as laid down in Directive 2002/32/EC taking into account the measurement uncertainty.

The lot is non-compliant with the maximum level as laid down in Directive 2002/32/EC, if the analytical result confirmed by duplicate analysis and calculated as mean of at least two separate determinations exceeds the maximum level beyond reasonable doubt taking into account the measurement uncertainty.

Measurement uncertainty may be taken into account according to one of the following approaches:

• by calculating the expanded uncertainty, using a coverage factor of 2 which gives a level of confidence of approximately 95 %,

• by establishing the decision limit (CCα) in accordance with Commission Decision 2002/657/EC(3) (point 3.1.2.5 of the Annex — the case of substances with established permitted level).

The present interpretation rules apply for the analytical result obtained on the sample for official control. It does not affect the right of Member States to apply national rules to analyses for defence or referee purposes referred to in Article 18 of Directive 95/53(4).’

(2)

In Annex II, the following paragraph is added at the end of point 2 Background:

‘For the purposes of this Directive only, the accepted specific limit of quantification of an individual congener is the concentration of an analyte in the extract of a sample which produces an instrumental response at two different ions to be monitored with an S/N (signal/noise) ratio of 3:1 for the less sensitive signal and fulfilment of the basic requirements such as e.g. retention time, isotope ratio according to the determination procedure as described in EPA method 1613 revision B.’

(1)

Table of dioxin-like PCBs

Abbreviations used: “T” = tetra; “Pe” = penta; “Hx” = hexa; “Hp” = hepta; “O” = octa; “CDD” = chlorodibenzo-p-dioxin; “CDF” = chlorodibenzofuran; “CB” = chlorobiphenyl.
Congener	TEF value
Dibenzo-p-dioxins (“PCDDs”)
2,3,7,8-TCDD	1
1,2,3,7,8-PeCDD	1
1,2,3,4,7,8-HxCDD	0,1
1,2,3,6,7,8-HxCDD	0,1
1,2,3,7,8,9-HxCDD	0,1
1,2,3,4,6,7,8-HpCDD	0,01
OCDD	0,0001
Dibenzofurans (“PCDFs”)
2,3,7,8-TCDF	0,1
1,2,3,7,8-PeCDF	0,05
2,3,4,7,8-PeCDF	0,5
1,2,3,4,7,8-HxCDF	0,1
1,2,3,6,7,8-HxCDF	0,1
1,2,3,7,8,9-HxCDF	0,1
2,3,4,6,7,8-HxCDF	0,1
1,2,3,4,6,7,8-HpCDF	0,01
1,2,3,4,7,8,9-HpCDF	0,01
OCDF	0,0001
“Dioxin-like” PCBs: Non-ortho PCBs + Mono-ortho PCBs)
Non-ortho PCBs
PCB 77	0,0001
PCB 81	0,0001
PCB 126	0,1
PCB 169	0,01
Mono-ortho PCBs
PCB 105	0,0001
PCB 114	0,0005
PCB 118	0,0001
PCB 123	0,0001
PCB 156	0,0005
PCB 157	0,0005
PCB 167	0,00001
PCB 189	0,0001

(2)

OJ L 140, 30.5.2002, p. 10.

(3)

OJ L 221, 17.8.2002, p. 8.

(4)

OJ L 265, 8.11.1995, p. 17.