Recommendation of the EFTA Surveillance Authority

No 97/03/COL

of 19 June 2003

concerning a coordinated monitoring programme for 2003 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 in 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 consultation of the EFTA Foodstuffs Committee assisting the EFTA Surveillance Authority,

Whereas:

(1) Article 7(2)(b) of Directive 86/362/EEC and Article 4(2)(b) of Directive 90/642/EEC require the EFTA Surveillance Authority, by 31 December each year, to submit to the EFTA Foodstuffs Committee assisting the EFTA Surveillance Authority, a recommendation setting out a coordinated monitoring programme to ensure compliance for maximum levels of pesticide residues set out in Annex II to the said directives. Article 1(1) of Commission Regulation (EC) No 645/2000(3) provides that such recommendations may cover periods of between one and five years.

(2) The EFTA Surveillance Authority should progressively work towards a system which would permit the estimation of actual dietary exposure to pesticides, as provided for in the second paragraph of Article 7(3) of Directive 86/362/EEC and the second paragraph of Article 4(3) of Directive 90/642/EEC. 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.

(3) Residues of the pesticides acephate, the benomyl group, chlorpyriphos, iprodione, methamidophos, diazinon, metalaxyl, methidathion, thiabendazole, triazophos chlorpyriphos-methyl, deltamethrin, endosulfan, imazalil, kresoxim-methyl, lambda-cyhalothrin, the maneb group, mecarbam, permethrin, pirimiphos-methyl, vinclozolin, azinphos-methyl, captan, chlorothalonil, dichlofluanid, dicofol, dimethoate, folpet, malathion, omethoate, oxydemeton-methyl, phorate, procymidone, propyzamide, azoxystrobine, aldicarb, bromopropylate, cypermethrin, methiocarb, methomyl, parathion and tolylfluanid should be monitored in 2003, as this will allow, using these data, for the estimation of actual dietary exposure to them, since these compounds have already been monitored since 2001.

(4) 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(4). Based on a binomial probability distribution it can be calculated that examination of 459 samples gives a 99 % confidence of detecting one sample containing pesticide residues above the limit of determination (LOD) where 1 % of products of plant origin contain residues above the LOD. At least 459 samples should therefore 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.

(5) Draft guidelines concerning Quality Control Procedures for Pesticide Residue Analysis have been published by the Commission(5). These draft 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.

(6) 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 when sending to the EFTA Surveillance Authority information on their implementation during the following year. 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 and the criteria by which the reporting levels have been fixed. 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(6) of the laboratories carrying out analyses should be indicated.

(7) Information on the results of monitoring programmes is particularly appropriate for treatment, storage and transmission by electronic/informatics methods. Formats have been developed for supply of data in diskette form 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. In addition, to specifically monitor for the combination nitrofen/wheat, with the same sampling frequency.

For pesticides possibly posing an acute risk, such as OP-esters, endosulfan and N-methylcarbamates, 10 samples of the products grapes, pepper and cucumber should be subjected to individual analysis of the individual units in the laboratory sample in case such pesticides are detected. Two samples of an appropriate number of units should be taken, where possible the produce of a single producer; if in the first laboratory sample, a detectable level of the pesticide is found, the units of the second sample should be analysed individually.

2. Report the results for the part of the specific exercise allocated for 2003 in the Annex to this Recommendation by 31 August 2004, indicating 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.

The report should be produced in a format, including the electronic format, as set out in Annex II and III to the Recommendation of the EFTA Surveillance Authority concerning a coordinated monitoring programme for the year 1999(7).

3. Send to the EFTA Surveillance Authority and to the EFTA States, by 31 August 2003, 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 2002 monitoring exercise to ensure, at least by check sampling, compliance with maximum pesticide residue levels including:

(a) the results of their national programmes concerning pesticides listed in Annex II to Directive 86/362/EEC and Annex II to Directive 90/642/EEC, in relation to harmonised levels and, where these have not yet been fixed at EEA level, in relation to the national levels in force;

(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;

(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 2003, their intended national programme for monitoring maximum pesticide residue levels fixed by Directives 90/642/EEC and 86/362/EEC for the year 2004.

This Recommendation is addressed to Iceland, Liechtenstein and Norway.

Done at Brussels, 19 June 2003.

For the EFTA Surveillance Authority

Niels Fenger

Director

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

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

(3) OJ L 78, 29.3.2000, p. 7.

(4) Codex Alimentarius, Pesticide residues in foodstuffs, Rome 1994, ISBN 92-5-203271-1; Vol. 2, page 372.

(5) Doc. No SANCO/3103/2000 (http://europa.eu.int/comm/food/ fs/ph_ps/pest/index_en.htm).

(6) OJ L 290, 24.11.1993, p. 14.

(7) OJ L 74, 23.3.2000, Annex II (Quality Control Procedures) p. 25 and Annex III (Working Document/Reporting format) p. 38.

ANNEX

Pesticide/product combinations to be monitored in the specific exercise set out in point 1 of the Recommendation

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