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
Date: 2001-06-08
Institutions: EFTA Surveillance Authority
Subjects: cereals, crop production, fruit, pesticide residue, plant health control, vegetable

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Official Journal of the European Communities

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EUROPEAN ECONOMIC AREA

EFTA SURVEILLANCE AUTHORITY

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)

(2)

(3)

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.

Experience gained in establishing, carrying out and reporting on the three previous annual coordi-
nated 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.

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

(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.

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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)

(5)

(6)

(7)

(8)

(9)

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 moni-
tored between 1996 and 2000 for estimation of actual dietary exposure. Continued monitoring
facilitates recognising changes in pesticide occurrence.

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, thiabenda-
zole 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.

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, endo-
sulfan, 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.

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.

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.

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 (1). 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 (2).

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

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(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 (1)).

(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 metida-
thion/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 (2).

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
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;

laboratories quality control procedures and,

in particular,

(1) OJ L 290, 24.11.1993, p. 14.
(2) OJ L 74, 23.3.2000, Annex II

format) p. 38.

(Quality Control Procedures) p. 25 and Annex III

(Working Document/Reporting

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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

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Pesticide/product combinations to be monitored in the specific excercise set out

in point 1 of

the

ANNEX I

Pesticide residue
to be analysed for

Group A

Acephate

Benomyl group

Chlorpyriphos

Iprodione

Methamidophos

Group B

Diazinon

Métalaxyl

Methidathion

Thiabendazole

Triazophos

Group C

Chlorpyriphos-methyl

Deltamethrin

Endosulfan

Imazalil

Lambda-cyhalothrin

Maneb group

Mecarbam

Permethrin

Pirimiphos-methyl

Vinclozolin

Group D

Azinphos-methyl

Captan

Chlorothalonil

Dichlofluanid

Dicofol

Recommendation

Years (**)

2001

2002

2003

2004

(a)

(a)

(a)

(a)

(a)

(a)

(a)

(a)

(a)

(a)

(a)

(a)

(a)

(a)

(a)

(a)

(a)

(a)

(a)

(a)

(a)

(a)

(a)

(a)

(a)

(b)

(b)

(b)

(b)

(b)

(b)

(b)

(b)

(b)

(b)

(b)

(b)

(b)

(b)

(b)

(b)

(b)

(b)

(b)

(b)

(b)

(b)

(b)

(b)

(b)

(c)

(c)

(c)

(c)

(c)

(c)

(c)

(c)

(c)

(c)

(c)

(c)

(c)

(c)

(c)

(c)

(c)

(c)

(c)

(c)

(c)

(c)

(c)

(c)

(c)

(d)

(d)

(d)

(d)

(d)

(d)

(d)

(d)

(d)

(d)

(d)

(d)

(d)

(d)

(d)

(d)

(d)

(d)

(d)

(d)

(d)

(d)

(d)

(d)

(d)

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Pesticide residue
to be analysed for

Dimethoate

Disulfoton

Folpet

Malathion

Omethoate

Oxydemeton-methyl

Phorate

Procymidone

Propyzamide

Thiometon

Azoxystrobin

Group E

Aldicarb

Bromopropylate

Cypermethrin

Methiocarb

Methomyl

Monocrotophos

Parathion

Tolylfluanid

2001

(a)

(a)

(a)

(a)

(a)

(a)

(a)

Years (**)

2002

2003

2004

(b)

(b)

(b)

(b)

(b)

(b)

(b)

(b)

(b)

(b)

(b)

(b)

(b)

(b)

(b)

(b)

(b)

(b)

(b)

(c)

(c)

(c)

(c)

(c)

(c)

(c)

(c)

(c)

(c)

(c)

(c)

(c)

(c)

(c)

(c)

(c)

(c)

(c)

(d)

(d)

(d)

(d)

(d)

(d)

(d)

(d)

(d)

(d)

(d)

(d)

(d)

(d)

(d)

(d)

(d)

(d)

(d)

lettuce, strawberries, grapes.

(a) Apples, tomatoes,
(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,
leek, onions, orange juice, apple juice, rye, aubergines.
(**) Indicative for 2002, 2003 and 2004, subject to progammes which will be recommended for these years.

lettuce, grape, strawberries,

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

ANNEX II

Year

Product groups monitored

Pesticides
groups (Annex IA) moni-
tored

Intake estimation period

Intake pesticides scope

1996

1997

1998

1999

2000

2001

2002

2003

2004

2005

z

y

x

w

v

z

y + x

w + v

z + u

A

A,B

A,B,C

A,B,C

A,B,C

A,B,C,D

A,B,C,D,E

A,B,C,D,E

A,B,C,D,E

1996-2000

1997-2001

1999-2002

2001-2003

A

A,B

A,B,C

A,B,C,D

2002-2004

A,B,C,D,E

lettuce.

z Apple, strawberry, grape, tomato,
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.