# L_2005061EN.01003101.xml

| 8.3.2005 | EN | Official Journal of the European Union | L 61/31 |
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8.3.2005

EN

Official Journal of the European Union

L 61/31

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COMMISSION RECOMMENDATION

of 1 March 2005

concerning a coordinated Community monitoring programme for 2005 to ensure compliance with maximum levels of pesticide residues in and on cereals and certain other products of plant origin and national monitoring programmes for 2006

(Text with EEA relevance)

(2005/178/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community, and in particular Article 211 thereof,

Having regard to Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals (1), and in particular Article 7(2)(b) thereof,

Having regard to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables (2), and in particular Article 4(2)(b) thereof,

Whereas:

| (1) | Directives 86/362/EEC and 90/642/EEC provide that the Commission should progressively work towards a system which would permit the estimation of dietary exposure to pesticides. To make realistic estimations possible, data on the monitoring of pesticide residues should be available in a number of food products which constitute major components of the European diet. It is generally recognised that major components of the European diet are constituted by some 20 to 30 food products. In view of the resources available at national level for pesticide residue monitoring, Member States are only able to analyse samples of eight products each year within a coordinated monitoring programme. Pesticide uses show changes within the timescale of three-year cycles. Each pesticide should thus generally be monitored in 20 to 30 food products over a series of three-year cycles. |
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(1)

Directives 86/362/EEC and 90/642/EEC provide that the Commission should progressively work towards a system which would permit the estimation of dietary exposure to pesticides. To make realistic estimations possible, data on the monitoring of pesticide residues should be available in a number of food products which constitute major components of the European diet. It is generally recognised that major components of the European diet are constituted by some 20 to 30 food products. In view of the resources available at national level for pesticide residue monitoring, Member States are only able to analyse samples of eight products each year within a coordinated monitoring programme. Pesticide uses show changes within the timescale of three-year cycles. Each pesticide should thus generally be monitored in 20 to 30 food products over a series of three-year cycles.

| (2) | Residues of the pesticides covered by this Recommendation should be monitored in 2005, as this will allow using these data for the estimation of actual dietary exposure to them. |
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(2)

Residues of the pesticides covered by this Recommendation should be monitored in 2005, as this will allow using these data for the estimation of actual dietary exposure to them.

| (3) | A systematic statistical approach to numbers of samples to be taken in each coordinated monitoring exercise is necessary. Such an approach has been set out by the Commission of the Codex Alimentarius (3). On the basis of a binomial probability distribution, it can be calculated that examination of 613 samples allows with a certainty of more than 99 %, the detection of a sample containing pesticide residues above the limit of determination (LOD), provided that less than 1 % of products of plant origin contain residues above that limit. Collection of these samples should be apportioned between Member States on the basis of population and consumer numbers, with a minimum of 12 samples per product and per year. |
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(3)

A systematic statistical approach to numbers of samples to be taken in each coordinated monitoring exercise is necessary. Such an approach has been set out by the Commission of the Codex Alimentarius (3). On the basis of a binomial probability distribution, it can be calculated that examination of 613 samples allows with a certainty of more than 99 %, the detection of a sample containing pesticide residues above the limit of determination (LOD), provided that less than 1 % of products of plant origin contain residues above that limit. Collection of these samples should be apportioned between Member States on the basis of population and consumer numbers, with a minimum of 12 samples per product and per year.

| (4) | Guidelines concerning quality control procedures for pesticide residue analysis are published on the Commission website (4). It is agreed that these guidelines should be applied as far as possible by the analytical laboratories of the Member States and should be reviewed continuously in the light of experience gained in the monitoring programmes. |
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(4)

Guidelines concerning quality control procedures for pesticide residue analysis are published on the Commission website (4). It is agreed that these guidelines should be applied as far as possible by the analytical laboratories of the Member States and should be reviewed continuously in the light of experience gained in the monitoring programmes.

| (5) | Directives 86/362/EEC and 90/642/EEC require Member States to specify the criteria applied in drawing up their national inspection programmes. Such information should include the criteria applied in determining the numbers of samples to be taken and analyses to be carried out and the reporting levels applied, the criteria by which the reporting levels have been fixed and details of accreditation under Council Directive 93/99/EEC of 29 October 1993 on the subject of additional measures concerning the official control of foodstuffs (5) of the laboratories carrying out analyses. The number and type of infringements and the action taken should also be indicated. |
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(5)

Directives 86/362/EEC and 90/642/EEC require Member States to specify the criteria applied in drawing up their national inspection programmes. Such information should include the criteria applied in determining the numbers of samples to be taken and analyses to be carried out and the reporting levels applied, the criteria by which the reporting levels have been fixed and details of accreditation under Council Directive 93/99/EEC of 29 October 1993 on the subject of additional measures concerning the official control of foodstuffs (5) of the laboratories carrying out analyses. The number and type of infringements and the action taken should also be indicated.

| (6) | Maximum residue levels for baby food have been established in accordance with Article 6 of Commission Directive 91/321/EEC of 14 May 1991 on infant formulae and follow-on formulae (6) and Article 6 of Commission Directive 96/5/EC, Euratom of 16 February 1996 on processed cereal-based foods and baby foods for infants and young children (7). |
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(6)

Maximum residue levels for baby food have been established in accordance with Article 6 of Commission Directive 91/321/EEC of 14 May 1991 on infant formulae and follow-on formulae (6) and Article 6 of Commission Directive 96/5/EC, Euratom of 16 February 1996 on processed cereal-based foods and baby foods for infants and young children (7).

| (7) | Information on the results of monitoring programmes is particularly appropriate for treatment, storage and transmission by electronic/informatic methods. Formats have been developed for supply of data by e-mail from the Member States to the Commission. Member States should therefore be able to send their reports to the Commission in the standard format. The further development of such a standard format is most effectively undertaken by the development of guidelines by the Commission. |
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(7)

Information on the results of monitoring programmes is particularly appropriate for treatment, storage and transmission by electronic/informatic methods. Formats have been developed for supply of data by e-mail from the Member States to the Commission. Member States should therefore be able to send their reports to the Commission in the standard format. The further development of such a standard format is most effectively undertaken by the development of guidelines by the Commission.

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

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

HEREBY RECOMMENDS:

| 1. | Member States are invited, during the year 2005, to take and analyse samples for the product/pesticide residue combinations set out in Annex I, on the basis of the number of samples of each product allocated to them in Annex II, reflecting as appropriate, national, Community and third country share of the Member State’s market.
  Preferably for pesticides posing an acute risk, e.g. OP-esters, endosulfan and N-methylcarbamates, reasonable number of samples of the products: pears, potatoes, carrots, oranges or mandarines, and cucumbers should also be subjected to individual analysis of the individual units in the second laboratory sample in case such pesticides are detected and particularly if it is the produce of a single producer. The number of units should be in line with Commission Directive 2002/63/EC (8).
  Two samples should be taken. If the first laboratory sample contains a detectable residue of a targeted pesticide, the units of the second sample should be analysed individually.
  At least 10 samples of baby food based mainly on vegetables, fruits or cereals should be taken by each Member States.
  Samples should be taken from produce originating from organic farming. The number of samples should be in proportion to the market share of organic produce in each Member State, with a minimum of one sample. |
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1.

Preferably for pesticides posing an acute risk, e.g. OP-esters, endosulfan and N-methylcarbamates, reasonable number of samples of the products: pears, potatoes, carrots, oranges or mandarines, and cucumbers should also be subjected to individual analysis of the individual units in the second laboratory sample in case such pesticides are detected and particularly if it is the produce of a single producer. The number of units should be in line with Commission Directive 2002/63/EC (8).

Two samples should be taken. If the first laboratory sample contains a detectable residue of a targeted pesticide, the units of the second sample should be analysed individually.

At least 10 samples of baby food based mainly on vegetables, fruits or cereals should be taken by each Member States.

Samples should be taken from produce originating from organic farming. The number of samples should be in proportion to the market share of organic produce in each Member State, with a minimum of one sample.

| 2. | Member States are invited to report the results of the analysis of samples tested for the product/pesticide residue combinations set out in Annex I by 31 August 2006 at the latest, indicating:






  (a) | the analytical methods used and reporting levels achieved, in accordance with the quality control procedures set out in the Quality Control Procedures for Pesticide Residue Analysis; |
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2.

(a)

the analytical methods used and reporting levels achieved, in accordance with the quality control procedures set out in the Quality Control Procedures for Pesticide Residue Analysis;

| (b) | the number and type of infringements and the action taken. |
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(b)

the number and type of infringements and the action taken.

The report should be produced in a format, including the electronic format, conforming to the guidance to the Member States with regard to implementation of Commission recommendations concerning coordinated Community monitoring programmes provided by the Standing Committee on the Food Chain and Animal Health.

The result on samples taken from produce originating from organic farming should be reported in a separate datasheet.

| 3. | Member States are invited to send to the Commission and to the other Member States, by 31 August 2005 at the latest, the information required under Article 7(3) of Directive 86/362/EEC and Article 4(3) of Directive 90/642/EEC concerning the 2004 monitoring exercise to ensure, at least by check sampling, compliance with maximum pesticide residue levels including:






  (a) | the results of their national programmes concerning pesticide residues; |
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3.

(a)

the results of their national programmes concerning pesticide residues;

| (b) | information on their laboratories quality control procedures and, in particular, information concerning aspects of the guidelines concerning quality control procedures for pesticide residue analysis which they have not been able to apply or have had difficulty in applying; |
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(b)

information on their laboratories quality control procedures and, in particular, information concerning aspects of the guidelines concerning quality control procedures for pesticide residue analysis which they have not been able to apply or have had difficulty in applying;

| (c) | information on accreditation in accordance with the provisions of Article 3 of Directive 93/99/EEC (including type of accreditation, accreditation body and copy of accreditation certificate) of the laboratories carrying out the analyses; |
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(c)

information on accreditation in accordance with the provisions of Article 3 of Directive 93/99/EEC (including type of accreditation, accreditation body and copy of accreditation certificate) of the laboratories carrying out the analyses;

| (d) | information about the proficiency tests and ring tests in which the laboratory has participated. |
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(d)

information about the proficiency tests and ring tests in which the laboratory has participated.

| 4. | Member States are invited to send to the Commission, by 30 September 2005 at the latest, their intended national programme for monitoring maximum pesticide residue levels fixed by Directives 90/642/EEC and 86/362/EEC for the year 2006, including information on:






  (a) | the criteria applied in determining the number of samples to be taken and analyses to be carried out; |
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4.

(a)

the criteria applied in determining the number of samples to be taken and analyses to be carried out;

| (b) | the reporting levels applied and the criteria by which the reporting levels have been fixed; and |
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(b)

the reporting levels applied and the criteria by which the reporting levels have been fixed; and

| (c) | details of accreditation, under Directive 93/99/EEC of the laboratories carrying out analyses. |
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(c)

details of accreditation, under Directive 93/99/EEC of the laboratories carrying out analyses.

Done at Brussels, 1 March 2005.

For the Commission

Markos KYPRIANOU

Member of the Commission

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(1)  
  OJ L 221, 7.8.1986, p. 37. Directive as last amended by Commission Directive 2004/61/EC (OJ L 127, 29.4.2004, p. 81).

1

(2)  
  OJ L 350, 14.12.1990, p. 71. Directive as last amended by Commission Directive 2004/115/EC (OJ L 374, 22.12.2004, p. 64).

2

(3)  Codex Alimentarius, ‘Pesticide Residues in Foodstuffs’, Rome, 1994, ISBN 92-5-203271-1, volume 2, p. 372.

3

(4)  Document number SANCO/10476/2003, http://europa.eu.int/comm/food/plant/protection/resources/qualcontrol_en.pdf

4

(5)  
  OJ L 290, 24.11.1993, p. 14. Directive as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

5

(6)  
  OJ L 175, 4.7.1991, p. 35. Directive as last amended by Directive 2003/14/EC (OJ L 41, 14.2.2003, p. 37).

6

(7)  
  OJ L 49, 28.2.1996, p. 17. Directive as last amended by Directive 2003/13/EC (OJ L 41, 14.2.2003, p. 33).

7

(8)  
  OJ L 187, 16.7.2002, p. 30.

8

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ANNEX I

Pesticide/product combinations to be monitored

| Pesticide residue to be analysed for |
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| | 2005 | 2006 (*1) | 2007 (*1) |
| Acephate | (a) | (b) | (c) |
| Aldicarb | (a) | (b) | (c) |
| Azinphos-methyl | (a) | (b) | (c) |
| Azoxystrobin | (a) | (b) | (c) |
| Benomyl group | (a) | (b) | (c) |
| Bifenthrin | (a) | (b) | (c) |
| Bromopropylate | (a) | (b) | (c) |
| Bupirimate | (a) | (b) | (c) |
| Captan | (a) | (b) | (c) |
| Carbaryl | (a) | (b) | (c) |
| Chlormequat (*2) | (a) | (b) | (c) |
| Chlorothalonil | (a) | (b) | (c) |
| Chlorpropham | (a) | (b) | (c) |
| Chlorpyriphos | (a) | (b) | (c) |
| Chlorpyriphos-methyl | (a) | (b) | (c) |
| Cypermethrin | (a) | (b) | (c) |
| Cyprodinil | (a) | (b) | (c) |
| Deltamethrin | (a) | (b) | (c) |
| Diazinon | (a) | (b) | (c) |
| Dichlofluanid | (a) | (b) | (c) |
| Dicofol | (a) | (b) | (c) |
| Dimethoate | (a) | (b) | (c) |
| Diphenylamine (*3) | (a) | (b) | (c) |
| Endosulfan | (a) | (b) | (c) |
| Fenhexamid | (a) | (b) | (c) |
| Fludioxonil | (a) | (b) | (c) |
| Folpet | (a) | (b) | (c) |
| Imazalil | (a) | (b) | (c) |
| Imidacloprid | (a) | (b) | (c) |
| Iprodione | (a) | (b) | (c) |
| Kresoxim-methyl | (a) | (b) | (c) |
| Lambda-cyhalothrin | (a) | (b) | (c) |
| Malathion | (a) | (b) | (c) |
| Maneb group | (a) | (b) | (c) |
| Metalaxyl | (a) | (b) | (c) |
| Methamidophos | (a) | (b) | (c) |
| Methidathion | (a) | (b) | (c) |
| Methiocarb | (a) | (b) | (c) |
| Methomyl | (a) | (b) | (c) |
| Myclobutanil | (a) | (b) | (c) |
| Oxydemeton-methyl | (a) | (b) | (c) |
| Parathion | (a) | (b) | (c) |
| Phosalone | (a) | (b) | (c) |
| Pirimicarb | (a) | (b) | (c) |
| Pirimiphos-methyl | (a) | (b) | (c) |
| Procymidone | (a) | (b) | (c) |
| Propargite | (a) | (b) | (c) |
| Pyretrins | (a) | (b) | (c) |
| Pyrimethanil | (a) | (b) | (c) |
| Spiroxamine | (a) | (b) | (c) |
| Thiabendazole | (a) | (b) | (c) |
| Tolcloflos-methyl | (a) | (b) | (c) |
| Tolylfluanid | (a) | (b) | (c) |
| Triadimefon | (a) | (b) | (c) |
| Vinclozolin | (a) | (b) | (c) |
| (a) | Pears, beans (fresh or frozen), potatoes, carrots, oranges or mandarines, spinach (fresh or frozen), rice and cucumber. |
| (b) | Cauliflower, peppers, wheat, aubergines, grapes, peas (fresh/frozen, without pod), bananas and orange juice. |
| (c) | Apples, tomatoes, lettuce, strawberries, leek, head cabbage, rye or oats, peaches including nectarines and similar hybrids. |

Pesticide residue to be analysed for

2005

2006 (*1)

2007 (*1)

Acephate

(a)

(b)

(c)

Aldicarb

(a)

(b)

(c)

Azinphos-methyl

(a)

(b)

(c)

Azoxystrobin

(a)

(b)

(c)

Benomyl group

(a)

(b)

(c)

Bifenthrin

(a)

(b)

(c)

Bromopropylate

(a)

(b)

(c)

Bupirimate

(a)

(b)

(c)

Captan

(a)

(b)

(c)

Carbaryl

(a)

(b)

(c)

Chlormequat (*2)

(a)

(b)

(c)

Chlorothalonil

(a)

(b)

(c)

Chlorpropham

(a)

(b)

(c)

Chlorpyriphos

(a)

(b)

(c)

Chlorpyriphos-methyl

(a)

(b)

(c)

Cypermethrin

(a)

(b)

(c)

Cyprodinil

(a)

(b)

(c)

Deltamethrin

(a)

(b)

(c)

Diazinon

(a)

(b)

(c)

Dichlofluanid

(a)

(b)

(c)

Dicofol

(a)

(b)

(c)

Dimethoate

(a)

(b)

(c)

Diphenylamine (*3)

(a)

(b)

(c)

Endosulfan

(a)

(b)

(c)

Fenhexamid

(a)

(b)

(c)

Fludioxonil

(a)

(b)

(c)

Folpet

(a)

(b)

(c)

Imazalil

(a)

(b)

(c)

Imidacloprid

(a)

(b)

(c)

Iprodione

(a)

(b)

(c)

Kresoxim-methyl

(a)

(b)

(c)

Lambda-cyhalothrin

(a)

(b)

(c)

Malathion

(a)

(b)

(c)

Maneb group

(a)

(b)

(c)

Metalaxyl

(a)

(b)

(c)

Methamidophos

(a)

(b)

(c)

Methidathion

(a)

(b)

(c)

Methiocarb

(a)

(b)

(c)

Methomyl

(a)

(b)

(c)

Myclobutanil

(a)

(b)

(c)

Oxydemeton-methyl

(a)

(b)

(c)

Parathion

(a)

(b)

(c)

Phosalone

(a)

(b)

(c)

Pirimicarb

(a)

(b)

(c)

Pirimiphos-methyl

(a)

(b)

(c)

Procymidone

(a)

(b)

(c)

Propargite

(a)

(b)

(c)

Pyretrins

(a)

(b)

(c)

Pyrimethanil

(a)

(b)

(c)

Spiroxamine

(a)

(b)

(c)

Thiabendazole

(a)

(b)

(c)

Tolcloflos-methyl

(a)

(b)

(c)

Tolylfluanid

(a)

(b)

(c)

Triadimefon

(a)

(b)

(c)

Vinclozolin

(a)

(b)

(c)

(a)

Pears, beans (fresh or frozen), potatoes, carrots, oranges or mandarines, spinach (fresh or frozen), rice and cucumber.

(b)

Cauliflower, peppers, wheat, aubergines, grapes, peas (fresh/frozen, without pod), bananas and orange juice.

(c)

Apples, tomatoes, lettuce, strawberries, leek, head cabbage, rye or oats, peaches including nectarines and similar hybrids.

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(*1)  Indicative for 2006 and 2007, subject to programmes which will be recommended for these years.

(*2)  Chlormequat should be analysed in pears and cereals only.

(*3)  Diphenylamine should be analysed in apples and pears only.

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ANNEX II

Number of samples of each product to be taken by each Member State

| Code country | Samples |
| --- | --- |
| AT | 12 |
| BE | 12 |
| CY | 12 |
| CZ | 12 |
| DE | 93 |
| DK | 12 |
| ES | 45 |
| EE | 12 |
| EL | 12 |
| FR | 66 |
| FI | 12 |
| HU | 12 |
| IT | 65 |
| IE | 12 |
| LU | 12 |
| LT | 12 |
| LV | 12 |
| MT | 12 |
| NL | 17 |
| PT | 12 |
| PL | 45 |
| SE | 12 |
| SI | 12 |
| SK | 12 |
| UK | 66 |
| Total number of samples: 613 |

Code country

Samples

AT

12

BE

12

CY

12

CZ

12

DE

93

DK

12

ES

45

EE

12

EL

12

FR

66

FI

12

HU

12

IT

65

IE

12

LU

12

LT

12

LV

12

MT

12

NL

17

PT

12

PL

45

SE

12

SI

12

SK

12

UK

66

Total number of samples: 613

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