# L_2005027EN.01004101.xml

| 29.1.2005 | EN | Official Journal of the European Union | L 27/41 |
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29.1.2005

EN

Official Journal of the European Union

L 27/41

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COMMISSION DIRECTIVE 2005/7/EC

of 27 January 2005

amending Directive 2002/70/EC establishing requirements for the determination of levels of dioxins and dioxin-like PCBs in feedingstuffs

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 70/373/EEC of 20 July 1970 on the introduction of Community methods of sampling and analysis for the official control of feeding-stuffs (1), and in particular Article 2 thereof,

Whereas:

| (1) | Commission Directive 2002/70/EC of 26 July 2002 establishing requirements for the determination of levels of dioxins and dioxin-like PCBs in feedingstuffs (2), lays down specific provisions concerning the methods of analysis to be applied for the official control provided for in Directive 70/373/EEC. |
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(1)

Commission Directive 2002/70/EC of 26 July 2002 establishing requirements for the determination of levels of dioxins and dioxin-like PCBs in feedingstuffs (2), lays down specific provisions concerning the methods of analysis to be applied for the official control provided for in Directive 70/373/EEC.

| (2) | The sampling procedure laid down in Commission Directive 76/371/EEC of 1 March 1976 establishing Community methods of sampling for the official control of feedingstuffs (3) has to be applied for the official control of the levels of dioxins and the determination of dioxin-like PCBs in certain feedingstuffs. It is appropriate to specify that the quantitative requirements in relation to the control of substances or products uniformly distributed throughout the feedingstuffs should be applied. |
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(2)

The sampling procedure laid down in Commission Directive 76/371/EEC of 1 March 1976 establishing Community methods of sampling for the official control of feedingstuffs (3) has to be applied for the official control of the levels of dioxins and the determination of dioxin-like PCBs in certain feedingstuffs. It is appropriate to specify that the quantitative requirements in relation to the control of substances or products uniformly distributed throughout the feedingstuffs should be applied.

| (3) | It is of major importance that analytical results are reported and interpreted in a uniform way in order to ensure a harmonised implementation approach in all Member States. |
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(3)

It is of major importance that analytical results are reported and interpreted in a uniform way in order to ensure a harmonised implementation approach in all Member States.

| (4) | Directive 2002/70/EC should therefore be amended accordingly. |
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(4)

Directive 2002/70/EC should therefore be amended accordingly.

| (5) | The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
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(5)

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

The Annexes to Directive 2002/70/EC are amended in accordance with the Annex to this Directive.

Article 2

1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive 12 months after the entry into force 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.

2.   Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive.

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, 27 January 2005.

For the Commission

Markos KYPRIANOU

Member of the Commission

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(1)  
  OJ L 170, 3.8.1970, p. 2. Directive as last amended by Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36).

1

(2)  
  OJ L 209, 6.8.2002, p. 15.

2

(3)  
  OJ L 102, 15.4.1976, p. 1.

3

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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 %, |
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(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). |
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—

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).’

Table of dioxin-like PCBs

| 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 |
| 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

Abbreviations used: “T” = tetra; “Pe” = penta; “Hx” = hexa; “Hp” = hepta; “O” = octa; “CDD” = chlorodibenzo-p-dioxin; “CDF” = chlorodibenzofuran; “CB” = chlorobiphenyl.

(*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."

| (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.’ |
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(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.’

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(*1)

Table of dioxin-like PCBs

| 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 |
| 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

Abbreviations used: “T” = tetra; “Pe” = penta; “Hx” = hexa; “Hp” = hepta; “O” = octa; “CDD” = chlorodibenzo-p-dioxin; “CDF” = chlorodibenzofuran; “CB” = chlorobiphenyl.

(*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.’

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