Recommendation of the EFTA Surveillance Authority

of 5 March 2002

concerning a coordinated monitoring programme for 2002 to ensure compliance with maximum levels of pesticide residues in and on cereals and certain other products of plant origin

(2002/C 216/06)

THE EFTA SURVEILLANCE AUTHORITY,

HAVING REGARD to the Agreement on the European Economic Area, 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, in particular Article 5(2)(b) and Protocol 1 thereof,

HAVING REGARD to the Act added in 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, in particular Article 7(2)(b) thereof,

HAVING REGARD to the Act added in 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, in particular Article 4(2)(b) thereof,

AFTER CONSULTING 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 the Annexes 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 pesticide dietary exposure, 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 facilitate examination of the feasibility of such estimations, data concerning the monitoring of residues of pesticides in a number of food products, which constitute major components of European diets, should be available. 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 a five years rolling programme timescale. Each pesticide should thus generally be monitored in 20-30 food products over a series of three-year cycles.

(3) The EFTA States should adopt continuous monitoring methods, since these facilitate the recognition of changes in the occurrence of pesticides.

(4) Residues of the pesticides acephate, the benomyl group, chlorpyriphos, iprodione and methamidophos should be monitored in 2002, as this will allow examination of the feasibility of using these pesticides for estimation of actual dietary exposure to them, since these compounds (identified as Group A in the Annex) have already been monitored between 1996 and 2001.

(5) Residues of the pesticides diazinon, metalaxyl, methidathion, thiabendazole and triazophos should be monitored between 2002 and 2005, as this will allow examination of the feasibility of using these pesticides for estimation of actual dietary exposure to them, since these compounds (identified as Group B in the Annex) have already been monitored between 1997 and 2001.

(6) Residues of the pesticides chlorpyriphos-methyl, deltamethrin, endosulfan, imazalil, lambda-cyhalothrin, the maneb group, mecarbam, permethrin, pirimiphos-methyl and vinclozolin should be monitored between 2002 and 2005, as this will allow examination of the feasibility of using these pesticides for estimation of actual dietary exposure to them, since these compounds (identified as Group C in the Annex) have already been monitored between 1998 and 2001.

(7) Residues of the pesticides azinphos-methyl, captan, chlorothalonil, dichlofluanid, dicofol, dimethoate, folpet, malathion, omethoate, oxydemeton-methyl, phorate, procymidone, propyzamide and azoxystrobine should be monitored between 2002 and 2005, as this will allow examination of the feasibility of using these pesticides for estimation of actual dietary exposure to them, since these compounds (identified as Group D in the Annex) have already been monitored in 2001.

(8) Residues of the pesticides aldicarb, bromopropylate, cypermethrin, methiocarb, methomyl, parathion and tolylfluanid should be monitored between 2002 and 2005, as this will allow examination of the feasibility of using these pesticides for estimation of actual dietary exposure to them, since these compounds (identified as Group E in the Annex) will be monitored in 2002.

(9) A systematic statistical approach to numbers of samples to be taken in each coordinated monitoring exercise is necessary. The Commission of the Codex Alimentarius has set out such an approach(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 detection (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.

(10) Draft guidelines concerning quality control procedures for pesticide residue analysis have been discussed by the experts of the EC Member States at Oeiras, Portugal, on 15 and 16 September 1997 and discussed and taken note of in the Subgroup Pesticide Residues of the Working Group on Plant Health on 20 and 21 November 1997. It is agreed that these draft guidelines should be implemented as far as possible by the analytical laboratories of the EC Member States and should be reviewed in the light of this experience. The guidelines were again discussed and revised by the experts of the EC Member States at Athens, Greece on 15 to 17 November 1999. The revised guidelines have been submitted to the Standing Committee on Plant Health and have been published by the Commission(5).

(11) Article 7(2)(a) of Directive 86/362/EEC and Article 4(2)(a) of Directive 90/642/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 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.

(12) 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 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; for at least one pesticide possibly posing an acute risk, one of the products will be subjected to individual analysis of the individual units in the laboratory sample: 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; in 2002 this should include at least one of the following combinations: aldicarb/potatoes, aldicarb/bananas, oxydemeton-methyl/spinach, chlorpropham/potatoes and phosmet/pears.

2. By 31 August 2003, report the results for the part of the specific exercise allocated for 2002 in the Annex, 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 Annexes II and III to the Recommendation of the EFTA Surveillance Authority for the year 1999(7).

3. By 31 August 2002, send to the EFTA Surveillance Authority and to the EFTA States 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 2001 monitoring exercise to ensure, at least by check sampling, compliance with maximum pesticide residue levels including:

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

(2) 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;

(3) 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;

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

4. By 30 September 2002, send to the EFTA Surveillance Authority their intended national programme for monitoring maximum pesticide residue levels fixed by Directives 90/642/EEC and 86/362/EEC for the year 2003.

This Recommendation is addressed to Iceland, Liechtenstein and Norway.

Done at Brussels on 5 March 2002.

For the EFTA Surveillance Authority.

Bernd Hammermann

College Member

Peter Dyrberg

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, p. 372.

(5) Document 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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