Recommendation of the EFTA Surveillance Authority

No 174/01/COL

of 8 June 2001

concerning a coordinated monitoring programme for 2001 to ensure compliance with maximum levels of pesticide residues in and on cereals and certain products of plant origin, including fruit and vegetables

THE EFTA SURVEILLANCE AUTHORITY,

Having regard to the EEA Agreement, and in particular Article 109 and Protocol 1 thereof,

Having regard to the Surveillance and Court Agreement, and in particular Article 5(2)(b) and Protocol No 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, and 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 90/64 2/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 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 to submit to the EFTA Foodstuffs Committee assisting the EFTA Surveillance Authority by 31 December each year a recommendation setting out a coordinated monitoring programme to ensure compliance with maximum levels of pesticide residues set out in Annex II to the said Directives.

(2) Experience gained in establishing, carrying out and reporting on the three previous annual coordinated monitoring programmes indicates that multi-annual programmes appear to be most effective and practical. It appears appropriate to indicate in this recommendation the framework of future programmes. Article 1(1) of Commission Regulation (EC) No 645/2000(3) provides for Commission Recommendations covering periods between one and five years.

(3) 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 (see Annex II). In view of the resources available at national level for pesticide residue monitoring, the EFTA States are only able to analyse samples of 10 products each year within a coordinated monitoring programme. Pesticide uses show changes within a five-year rolling programme time-scale. Each pesticide should generally be monitored in 20 to 30 food products over a series of three-year cycles.

(4) The residues recommended to be monitored in 2001 will allow examination of the feasibility of using the data concerning the pesticides acephate, the benomyl group, chlorpyriphos, iprodione and methamidophos as these compounds (identified as Group A in Annex I) have already been monitored between 1996 and 2000 for estimation of actual dietary exposure. Continued monitoring facilitates recognising changes in pesticide occurrence.

(5) The residues recommended to be monitored between 2001 and 2004 will allow examination of the feasibility of using the data concerning the pesticides diazinon, metalaxyl, methidathion, thiabendazole and triazophos for estimation of actual dietary exposure as these compounds (identified as Group B in Annex I) have already been monitored between 1997 and 2000.

(6) The residues recommended to be monitored between 2001 and 2004 will allow examination of the feasibility of using the data concerning the pesticides chlorpyriphos-methyl, deltamethrin, endosulfan, imazalil, lambda-cyhalothrin, the maneb group, mecarbam, permethrin, pirimiphos-methyl and vinclozolin for estimation of actual dietary exposure, as these compounds (identified as Group C in Annex I) have already been monitored in 1998, 1999 and 2000.

(7) The residues recommended to be monitored between 2000 and 2004 will allow examination of the feasibility of using the data concerning the pesticides azinphos-methyl, captan, chlorothalonil, dichlofluanid, dicofol, dimethoate, folpet, malathion, omethoate, procymidone, propyzamide and azoxystrobine for estimation of actual dietary exposure as these compounds, except azoxystrobine (identified as Group D in Annex I) have already been monitored in 1998, 1999 and 2000.

(8) The monitoring of disulfoton, phorate, thiometon and oxydemeton-methyl is not feasible within routine monitoring multi-residue analytical methods. It is appropriate to collect data on occurrence of these residues when expected, in those EFTA States where the pesticide residues are most likely to be detected.

(9) 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 a total sample number of 459 gives a 99 % confidence of detecting 1 sample containing pesticide residues above the 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 and 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, published in Annex II of the monitoring recommendation for 1999, have been discussed by the experts of the EU 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 EU Member States and should be reviewed in the light of this experience. The guidelines were discussed and revised by the experts of the EU Member States at Athens, Greece on 15 to 17 November 1999. The revised guidelines will be submitted to the Standing Committee on Plant Health and are to be published by the Commission(5).

(11) Articles 7(2)(a) of Directive 86/362 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 programmes for the following calendar 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 of the laboratories carrying out analyses should be indicated (provisions on accreditation under the Act referred to in point 54n of Chapter XII of Annex II to the EEA Agreement; Directive 93/99/EC of 29 October 1993 on the subject of additional measures concerning the official control of foodstuffs(6)).

(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 EU 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 Annex I, 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 items in the composite sample: two samples of an appropriate number of items will be taken, where possible the produce of a single producer; if in the first, composite sample a detectable level of the pesticide is found, the items of the second sample will be analysed individually; in 2001 this will include the combination phorate/potatoes and/or metidathion/apples.

2. Sample products for the analysis of disulfoton, phorate, thiometon and oxydemeton-methyl in those countries where authorisations exist for the use of these pesticides on those products, on the basis of the number of samples of each product mentioned under point 1.

3. By 31 August 2002, report the results for the part of the specific exercise allocated for 2001 in Annex I, 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 and in a format, including the electronic format, as set out in Annex II and III to the Recommendation of the EFTA Surveillance Authority for the year 1999(7).

4. By 31 August 2001, send to the EFTA Surveillance Authority and to the EEA/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 2000 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/EC (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 the laboratory has participated in.

5. By 30 September 2001, 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 2002.

6. This Recommendation is addressed to Iceland, Liechtenstein and Norway.

Done at Brussels, 8 June 2001.

For the EFTA Surveillance Authority

Hannes Hafstein

College Member

(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) Published in OJ L 128, 21.5.1999, p. 30. A revised version will be available in document number 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 I

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

>TABLE>

(a) Apples, tomatoes, lettuce, strawberries, grapes.

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

(c) Cauliflower, peppers, wheat, melon, rice, cucmber, head cabbage, peas (fresh/frozen, without pod).

(d) Apples, oats, tomatoes, lettuce, grape, strawberries, leek, onions, orange juice, apple juice, rye, aubergines.

ANNEX II

Coordinated monitoring programme of the years 1996 to 2004 with the intake estimation time windows and scope

>TABLE>

z Apple, strawberry, grape, tomato, lettuce.

y Mandarin, pear, banana, bean, potato.

x Orange, peach, carrot, spinach.

w Cauliflower, pepper, wheat, melon.

v Rice, cucumber, head cabbage, pea.

u Onion, leek, orange juice, apple juice, rye.