# L_2005139EN.01002001.xml

| 2.6.2005 | EN | Official Journal of the European Union | L 139/20 |
| --- | --- | --- | --- |

2.6.2005

EN

Official Journal of the European Union

L 139/20

---

RECOMMENDATION OF THE EFTA SURVEILLANCE AUTHORITY

No 55/04/COL

of 30 March 2004

concerning a coordinated monitoring programme for 2004 to ensure compliance with maximum levels of pesticide residues in and on cereals and certain other products of plant origin

THE EFTA SURVEILLANCE AUTHORITY,

Having regard to the Agreement on the European Economic Area (EEA), and in particular Article 109 and Protocol 1 thereof,

Having regard to the Agreement between the EFTA States on the establishment of a Surveillance Authority and a Court of Justice, and in particular Article 5(2)(b) and Protocol 1 thereof,

Having regard to the Act referred to at point 38 of Chapter XII of Annex II to the EEA Agreement (Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals (1)), as last amended and adapted to the EEA Agreement by Protocol 1 thereto, and in particular Article 7(2)(b) thereof,

Having regard to the Act referred to at point 54 in Chapter XII of Annex II to the EEA Agreement (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)), as last amended and adapted to the EEA Agreement by Protocol 1 thereto, and in particular Article 4(2)(b) thereof,

After consulting the EFTA Foodstuffs Committee assisting the EFTA Surveillance Authority,

Whereas:

| (1) | The EFTA Surveillance Authority should progressively work towards a system which would permit the estimation of dietary exposure to actual 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, the EFTA 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 the three-year period. Each pesticide should thus generally be monitored in 20 to 30 food products over a series of three-year cycles. |
| --- | --- |

(1)

The EFTA Surveillance Authority should progressively work towards a system which would permit the estimation of dietary exposure to actual 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, the EFTA 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 the three-year period. Each pesticide should thus generally be monitored in 20 to 30 food products over a series of three-year cycles.

| (2) | Residues of all the pesticides covered by this Recommendation should be monitored in 2004, as this will allow using these data for the estimation of actual dietary exposure to them.
  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). Based on a binomial probability distribution it can be calculated that examination of about 650 samples gives a confidence of more than 99 % for detecting one sample containing pesticide residues above the limit of determination (LOD) where less than 1 % of products of plant origin contain residues above the LOD. These samples should be taken across the European Economic Area. For the EFTA States it is recommended, on the basis of population and consumer numbers, to take a minimum of 12 samples per product and per year. |
| --- | --- |

(2)

Residues of all the pesticides covered by this Recommendation should be monitored in 2004, as this will allow using these data for the estimation of actual dietary exposure to them.

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). Based on a binomial probability distribution it can be calculated that examination of about 650 samples gives a confidence of more than 99 % for detecting one sample containing pesticide residues above the limit of determination (LOD) where less than 1 % of products of plant origin contain residues above the LOD. These samples should be taken across the European Economic Area. For the EFTA States it is recommended, on the basis of population and consumer numbers, to take a minimum of 12 samples per product and per year.

| (3) | A new guideline concerning Quality Control Procedures for Pesticide Residue Analysis has been published by the European Commission (4). These guidelines should be implemented as far as possible by the analytical laboratories of the EFTA States and should be reviewed continuously in the light of experience gained in the monitoring programmes. |
| --- | --- |

(3)

A new guideline concerning Quality Control Procedures for Pesticide Residue Analysis has been published by the European Commission (4). These guidelines should be implemented as far as possible by the analytical laboratories of the EFTA States and should be reviewed continuously in the light of experience gained in the monitoring programmes.

| (4) | Article 4(2)(a) of Directive 90/642/EEC and Article 7(2)(a) of Directive 86/362/EEC require the EFTA States to specify the criteria applied in drawing up their national inspection programmes. Such information should include: (i) the criteria applied in determining the numbers of samples to be taken and analyses to be carried out and the reporting levels applied and the criteria by which the reporting levels have been fixed; (ii) details of accreditation under the Act referred to at point 54n of Chapter XII of Annex II to the EEA Agreement (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; (iii) the number and type of infringements and the action taken. |
| --- | --- |

(4)

Article 4(2)(a) of Directive 90/642/EEC and Article 7(2)(a) of Directive 86/362/EEC require the EFTA States to specify the criteria applied in drawing up their national inspection programmes. Such information should include: (i) the criteria applied in determining the numbers of samples to be taken and analyses to be carried out and the reporting levels applied and the criteria by which the reporting levels have been fixed; (ii) details of accreditation under the Act referred to at point 54n of Chapter XII of Annex II to the EEA Agreement (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; (iii) the number and type of infringements and the action taken.

| (5) | 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 EC Member States to the Commission. The EFTA States could use the same format and should therefore be able to send their reports to the EFTA Surveillance Authority in the standard format. The further development of such a standard format is most effectively undertaken by the development of guidelines, |
| --- | --- |

(5)

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 EC Member States to the Commission. The EFTA States could use the same format and should therefore be able to send their reports to the EFTA Surveillance Authority in the standard format. The further development of such a standard format is most effectively undertaken by the development of guidelines,

HEREBY RECOMMENDS THE EFTA STATES TO:

| 1. | Sample and analyse for the product/pesticide residue combinations set out in the Annex to this Recommendation, taking a minimum of 12 samples of each product and reflecting as appropriate, national, EEA and third country share of the EFTA State’s market.
  Preferably for pesticides posing an acute risk, e.g. OP-esters, endosulfan and N-methylcarbamates, selected samples of the products: apples, tomatoes, lettuce, leek and head cabbage 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 the Act referred to at point 54zz of Chapter XII of Annex II to the EEA Agreement (Commission Directive 2002/63/EC of 11 July 2002 establishing Community methods of sampling for the official control of pesticide residues in and on products of plant and animal origin and repealing Directive 79/700/EEC (6)).
  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. |
| --- | --- |

1.

Preferably for pesticides posing an acute risk, e.g. OP-esters, endosulfan and N-methylcarbamates, selected samples of the products: apples, tomatoes, lettuce, leek and head cabbage 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 the Act referred to at point 54zz of Chapter XII of Annex II to the EEA Agreement (Commission Directive 2002/63/EC of 11 July 2002 establishing Community methods of sampling for the official control of pesticide residues in and on products of plant and animal origin and repealing Directive 79/700/EEC (6)).

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.

| 2. | Report the results of the analysis of samples tested for the product/pesticide residue combinations set out in the Annex to this Recommendation, by 31 August 2005 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; |
| --- | --- | --- |

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. |
| --- | --- |

(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 (7) to the EEA States with regard to implementation of recommendations concerning coordinated monitoring programmes.

| 3. | Send to the EFTA Surveillance Authority and to the EFTA States, by 31 August 2004 at the latest, all the information as required by Article 7(3) of Directive 86/362/EEC and Article 4(3) of Directive 90/642/EEC concerning the 2003 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; |
| --- | --- | --- |

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; |
| --- | --- |

(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; |
| --- | --- |

(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. |
| --- | --- |

(d)

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

| 4. | Send to the EFTA Surveillance Authority, by 30 September 2004 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 2005, including information on:






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

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; |
| --- | --- |

(b)

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

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

(c)

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

This Recommendation is addressed to Iceland, Liechtenstein and Norway.

Done at Brussels, 30 March 2004.

For the EFTA Surveillance Authority

Bernd HAMMERMANN

College Member

Niels FENGER

Director

---

(1)  
  OJ L 221, 7.8.1986, p. 37.

1

(2)  
  OJ L 350, 14.12.1990, p. 71.

2

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

3

(4)  Doc. No 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.

5

(6)  
  OJ L 187, 16.7.2002, p. 30.

6

(7)  Presented to and taken note of in the Standing Committee on the Food Chain and Animal Health (SCFCAH) every year.

7

---

ANNEX

Pesticide/product combinations to be monitored

| Pesticide residue to be analysed for | Year |
| --- | --- |
| | 2004 | 2005 (*1) | 2006 (*1) |
| Acephate | (c) | (a) | (b) |
| Aldicarb | (c) | (a) | (b) |
| Azinphos-methyl | (c) | (a) | (b) |
| Azoxystrobin | (c) | (a) | (b) |
| Benomyl group | (c) | (a) | (b) |
| Bromopropylate | (c) | (a) | (b) |
| Captan | (c) | (a) | (b) |
| Chlorothalonil | (c) | (a) | (b) |
| Chlorpyriphos | (c) | (a) | (b) |
| Chlorpyriphos-methyl | (c) | (a) | (b) |
| Cypermethrin | (c) | (a) | (b) |
| Cyprodinil | (c) | (a) | (b) |
| Deltamethrin | (c) | (a) | (b) |
| Diazinon | (c) | (a) | (b) |
| Dichlofluanid | (c) | (a) | (b) |
| Dicofol | (c) | (a) | (b) |
| Dimethoate | (c) | (a) | (b) |
| Diphenylamine (*2) | (c) | (a) | (b) |
| Endosulfan | (c) | (a) | (b) |
| Fenhexamid | (c) | (a) | (b) |
| Folpet | (c) | (a) | (b) |
| Imazalil | (c) | (a) | (b) |
| Iprodione | (c) | (a) | (b) |
| Kresoxim-methyl | (c) | (a) | (b) |
| Lambda-cyhalothrin | (c) | (a) | (b) |
| Malathion | (c) | (a) | (b) |
| Maneb group | (c) | (a) | (b) |
| Mecarbam | (c) | (a) | (b) |
| Methamidophos | (c) | (a) | (b) |
| Metalaxyl | (c) | (a) | (b) |
| Methidathion | (c) | (a) | (b) |
| Methiocarb | (c) | (a) | (b) |
| Methomyl | (c) | (a) | (b) |
| Myclobutanil | (c) | (a) | (b) |
| Omethoate | (c) | (a) | (b) |
| Oxydemeton-methyl | (c) | (a) | (b) |
| Parathion | (c) | (a) | (b) |
| Permethrin | (c) | (a) | (b) |
| Phorate | (c) | (a) | (b) |
| Pirimiphos-methyl | (c) | (a) | (b) |
| Procymidone | (c) | (a) | (b) |
| Propyzamide | (c) | (a) | (b) |
| Spiroxamine | (c) | (a) | (b) |
| Thiabendazole | (c) | (a) | (b) |
| Tolylfluanid | (c) | (a) | (b) |
| Triazophos | (c) | (a) | (b) |
| Vinclozolin | (c) | (a) | (b) |
| (a) | Pears, bananas, beans (fresh or frozen), potatoes, carrots, oranges/mandarines, peaches/nectarins, spinach (fresh or frozen). |

Pesticide residue to be analysed for

Year

2004

2005 (*1)

2006 (*1)

Acephate

(c)

(a)

(b)

Aldicarb

(c)

(a)

(b)

Azinphos-methyl

(c)

(a)

(b)

Azoxystrobin

(c)

(a)

(b)

Benomyl group

(c)

(a)

(b)

Bromopropylate

(c)

(a)

(b)

Captan

(c)

(a)

(b)

Chlorothalonil

(c)

(a)

(b)

Chlorpyriphos

(c)

(a)

(b)

Chlorpyriphos-methyl

(c)

(a)

(b)

Cypermethrin

(c)

(a)

(b)

Cyprodinil

(c)

(a)

(b)

Deltamethrin

(c)

(a)

(b)

Diazinon

(c)

(a)

(b)

Dichlofluanid

(c)

(a)

(b)

Dicofol

(c)

(a)

(b)

Dimethoate

(c)

(a)

(b)

Diphenylamine (*2)

(c)

(a)

(b)

Endosulfan

(c)

(a)

(b)

Fenhexamid

(c)

(a)

(b)

Folpet

(c)

(a)

(b)

Imazalil

(c)

(a)

(b)

Iprodione

(c)

(a)

(b)

Kresoxim-methyl

(c)

(a)

(b)

Lambda-cyhalothrin

(c)

(a)

(b)

Malathion

(c)

(a)

(b)

Maneb group

(c)

(a)

(b)

Mecarbam

(c)

(a)

(b)

Methamidophos

(c)

(a)

(b)

Metalaxyl

(c)

(a)

(b)

Methidathion

(c)

(a)

(b)

Methiocarb

(c)

(a)

(b)

Methomyl

(c)

(a)

(b)

Myclobutanil

(c)

(a)

(b)

Omethoate

(c)

(a)

(b)

Oxydemeton-methyl

(c)

(a)

(b)

Parathion

(c)

(a)

(b)

Permethrin

(c)

(a)

(b)

Phorate

(c)

(a)

(b)

Pirimiphos-methyl

(c)

(a)

(b)

Procymidone

(c)

(a)

(b)

Propyzamide

(c)

(a)

(b)

Spiroxamine

(c)

(a)

(b)

Thiabendazole

(c)

(a)

(b)

Tolylfluanid

(c)

(a)

(b)

Triazophos

(c)

(a)

(b)

Vinclozolin

(c)

(a)

(b)

(a)

Pears, bananas, beans (fresh or frozen), potatoes, carrots, oranges/mandarines, peaches/nectarins, spinach (fresh or frozen).

| (b) | Cauliflower, peppers, wheat, aubergines, rice, grapes, cucumber, peas (fresh/frozen, without pod). |
| --- | --- |

(b)

Cauliflower, peppers, wheat, aubergines, rice, grapes, cucumber, peas (fresh/frozen, without pod).

| (c) | Apples, tomatoes, lettuce, strawberries, leek, orange juice, head cabbage, rye/oats. |
| --- | --- |

(c)

Apples, tomatoes, lettuce, strawberries, leek, orange juice, head cabbage, rye/oats.

---

(*1)  Indicative for 2005 and 2006, subject to programmes which will be recommended for these years.

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

---