Ref.

Ares(2018)512877 - 29/01/2018

EUROPEAN COMMISSION
DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

Health and food audits and analysis

DG(SANTE) 2017-6190

FINAL REPORT OF AN AUDIT

CARRIED OUT IN
MOROCCO
FROM 11 TO 22 SEPTEMBER 2017
IN ORDER TO
EVALUATE THE CONTROL OF RESIDUES AND CONTAMINANTS IN LIVE
ANIMALS AND ANIMAL PRODUCTS INCLUDING CONTROLS ON VETERINARY
MEDICINAL PRODUCTS
 Executive Summary

This report describes the outcome of an audit in Morocco, carried out from 11 to 21
September 2017 as part of the published DG Health and Food Safety audit programme.
The objective of the audit was to evaluate the effectiveness of official controls on residues
and contaminants in live animals and animal products eligible for export to the European
Union (EU). The audit assessed the implementation of the residue monitoring plan and also
covered the authorisation, distribution and use of veterinary medicinal products, given that
these areas have an impact on the monitoring of residues.
The report concludes that the current control system for residues in food of animal origin in
Morocco largely underpins guarantees that exported products do not contain residues in
excess of EU limits. Nevertheless, the audit has identified deficiencies in the planning and
implementation of the residue monitoring plan, most notably the use of some analytical
methods which are not validated, a scope of testing which does not reflect the use of certain
substances in the poultry and aquaculture sectors and sample handling practices which
weaken the legal and analytical validity of the samples and results generated.
Notwithstanding these deficiencies, the implementation of a prescription system for
veterinary medicinal products and the effective operation of official controls on the
distribution and use of veterinary medicines mitigates the risk of residue violations in
products eligible for export to the EU.
The report contains recommendations to the Moroccan competent authorities aimed at
rectifying the shortcomings identified and enhancing the implementing and control
measures in place.

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 TABLE OF CONTENTS

1. INTRODUCTION .......................................................................................................1
2. OBJECTIVES OF THE AUDIT..................................................................................1
3. LEGAL BASIS FOR THE AUDIT .............................................................................2
4. BACKGROUND .........................................................................................................2
4.1. Country status in relation to EU-approval of residue monitoring plans ............2
4.2. Rapid Alert System for Food and Feed (RASFF) notifications.........................2
4.3. Production, Trade Information and Specific Import Requirements...................2
5. FINDINGS AND CONCLUSIONS ............................................................................2
5.1. Residue monitoring ............................................................................................2
5.2. Veterinary medicinal products .........................................................................11
6. OVERALL CONCLUSION ......................................................................................15
7. CLOSING MEETING ...............................................................................................15
8. RECOMMENDATIONS...........................................................................................15
Annex 1 – Legal References

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 ABBREVIATIONS & DEFINITIONS USED IN THIS REPORT

EU European Union
ISO International Organisation for Standardisation
Laboratoire Régional d'Analyses et de Recherche d'Agadir (Regional
LRAR
Laboratory for Analysis and Research, Agadir)
Laboratoire Officiel d'Analyses et de Recherches Chimiques (Official
LOARC
Laboratory for Analysis and Chemical Research, Casablanca)
ML Maximum Level
MRL Maximum Residue Limit
MRPL Minimum Required Performance Limit
Office National de Sécurité Sanitaire des produits Alimentaires (National
ONSSA
Office of Food Safety)
RASFF Rapid Alert System for Food and Feed
Laboratoire Service du Contrôle et des Expertises (Control Service and
SCE Rabat
Expertise Laboratory, Rabat)

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1. INTRODUCTION

The audit took place in Morocco from 11 to 21 September 2017 and was undertaken
as part of the published work programme of the Directorate-General for Health and
Food Safety.
An opening meeting was held on 11 September with representatives of the central
competent authority, the National Office for Health Security of Food Products
(Office National de Sécurité Sanitaire des Produits Alimentaires, ONSSA) and the
Official Laboratory for Analysis and Chemical Research (Laboratoire Officiel
d'Analyses et de Recherches Chimiques, LOARC). At this meeting, the objectives
and the itinerary of the audit were confirmed and the control systems were described
by the competent authority. Representatives from ONSSA accompanied the audit
team during the audit.

2. OBJECTIVES OF THE AUDIT

The objective of the audit was to evaluate the performance of competent authorities
and other officially authorised entities in implementing official controls on residues
and contaminants in live animals and animal products. The scope of the audit
concerned only animals and products eligible for export to the European Union
(EU) – poultry and aquaculture finfish. This was the first Commission audit in
Morocco dealing with this topic.
It assessed whether the controls were consistent with the guarantees provided by the
residue monitoring plan approved by the EU and whether the controls provide
adequate assurance that products and animals eligible for export to the EU do not
contain residues of veterinary medicinal products, pesticides and contaminants
exceeding EU maximum limits.
The principal audit criteria against which fulfilment of the above objective was
assessed comprise:
 Council Directive 96/23/EC;
 Directive 2001/82/EC of the European Parliament and of the Council; and
The following table lists the sites visited and meetings held in order to achieve the
audit objective.

MEETINGS/VISITS n COMMENTS
Central 2 Opening and closing meetings with ONSSA and the LOARC
COMPETENT
AUTHORITIES Meetings with ONSSA in the Rabat, Casablanca and Tangier
Regional 3
regions
LABORATORY 2 Two laboratories
2 aquaculture finfish farms and 2 poultry farms (1 broiler, 1 turkey
FARMS 4
farm)
Two slaughterhouses for poultry (broiler and turkey) and one
ESTABLISHMENTS 3
slaughterhouses for aquaculture finfish
1 wholesaler and 1 veterinary practice distributing veterinary
OTHER SITES 2
medicinal products for food-producing animals

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3. LEGAL BASIS FOR THE AUDIT

The audit was carried out under the general provisions of EU legislation, and in
particular:
 Article 29 of Directive 96/23/EC;
 Article 46 of Regulation (EC) No 882/2004.
A full list of the legal instruments referred to in this audit report is provided in
Annex 1 and refers, where applicable, to the last amended version.

4. BACKGROUND

4.1. Country status in relation to EU-approval of residue monitoring plans

Morocco is listed in the Annex to Commission Decision 2011/163/EU with a

residue monitoring plan approved in accordance with Directive 96/23/EC for
aquaculture finfish and poultry.

4.2. Rapid Alert System for Food and Feed (RASFF) notifications

Since 2011 there have been no RASFF notifications for residues of veterinary
medicinal products in any of the commodities for which the country has an
approved residue monitoring plan.

4.3. Production, Trade Information and Specific Import Requirements

In 2016, Morocco produced around 540 tonnes of aquaculture finfish and 560,000
tonnes of poultry meat products (470,000 tonnes of broiler meat and 90,000 tonnes
of turkey meat) of which 110,000 tonnes (largely turkey) are processed in ONSSA
approved slaughterhouses. The large majority of broilers are sold live at local
markets for domestic consumption. Since 2011 no aquaculture finfish have been
exported to the EU. No export of poultry meat to the EU is possible as Morocco is
not yet included in the list of third countries and territories from which poultry
products may be imported (Commission Decision 2007/777/EC and the Annex to
Commission Regulation (EC) No 798/2008).

5. FINDINGS AND CONCLUSIONS

5.1. Residue monitoring

5.1.1. Competent authorities

1. ONSSA within the Ministry of Agriculture and Fisheries is the central competent
authority responsible for food safety. The Sanitary Safety Division of Animal
Products, By-products and Feed within the Food Products Control Directorate of
ONSSA is responsible for the planning, implementation and supervision of the
residue monitoring plan for poultry, while the Fisheries and Aquaculture Division
within the same Directorate is responsible for the plan in aquaculture finfish. There
are 10 Regional Directorates of ONSSA which are responsible for implementing the
plan. The Veterinary Services at the provincial or prefectural level carry out
sampling for the aquaculture finfish residue monitoring plan. Collection of poultry

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 samples is carried our either by the provincial Veterinary Services or are
subcontracted to private companies.
2. The Laboratory Division within the Veterinary Products and Laboratories
Directorate is responsible for the services from laboratories conducting analyses
under the residue monitoring plan.

5.1.2. Planning of residue monitoring

Legal requirements
Article 29 of Directive 96/23/EC.
The following list of legislation and elements thereof is provided for informative
purposes, encompassing the various aspects of Union legislation applicable to this
section of the report as regards the obligations of EU Member States.
Articles 3 to 7 of, and Annex I and IV to, Directive 96/23/EC; Commission
Decision 97/747/EC; Article 11(2) of Council Directive 96/22/EC; Article 11 of
Regulation (EC) No 178/2002 of the European Parliament and of the Council;
Commission Regulation (EU) No 37/2010; Regulation (EC) No 396/2005 of the
European Parliament and of the Council; Commission Regulation (EC) No
1881/2006; Commission Regulation (EC) No 124/2009; Council Regulation (EEC)
No 315/93; Article 4 of Commission Decision 2002/657/EC; Commission Decision
2011/163/EU.
Findings
3. National legislation 1 provides the basis for the planning and implementation of the
residue monitoring plan.
4. Both the 2016 and 2017 plans covered all of the essential substance groups required 2.
The number of samples for aquaculture finfish species and poultry species (turkey
and broiler) are based on national production in the calendar year, similar to what is
required in the EU 3, with a minimum number of samples planned for broiler (200)
and turkey (300).
5. When planning the annual residue monitoring plan, the ONSSA involves, similar to
EU requirements 4, the relevant laboratory capacity and capabilities, taking into
account commodity production volumes in different regions and authorised
pharmacologically active substances. The collection of sales data of veterinary
medicinal products started in 2017. ONSSA staff met by the audit team stated, that
they will use these data when developing future residue monitoring plans.

1 Law No 28-07 on food safety as amended by Law No 1-10-08 and Chapter VI of Decree No 2-10-473.
2 Article 5 and Annexes II and IV to Directive 96/23/EC.
3 Article 6 and Annexes I to IV to Directive 96/23/EC.
4 Article 14 of Directive 96/23/EC.

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6. All aquaculture finfish samples as well as 80% of all poultry samples had been
planned for collection at farm level. After discussions with the audit team, the
ONSSA staff met, stated that they plan in future to take all poultry samples at
slaughterhouse level, except for 10% of samples to be taken on farm which are
analysed for Group A substances, which is similar to what is required in the EU 5.
In case of poultry, sampling activities are planned to take place largely on those
farms and in slaughterhouses which deliver to establishments intending to export
poultry products to the EU.
7. With regard to the range of substances covered by the 2017 residue monitoring plan
the audit team found that this is largely similar to what is required in the EU 6
except that:
a) in the aquaculture finfish plan, within Group A3, trenbolone is the sole anabolic
compound tested for. This is unlikely to be used in fish. Methyltestosterone
which, although not nationally authorised for use for sex inversion in fish (see
finding 46), would be more likely to be illegally used is not included in the plan.
Analysis for Group A3 substances has also not yet been implemented (see also
finding 12).
b) in the poultry plan the antibiotics florfenicol, colistin and trimethoprim (B1),
which are authorised for use in poultry in several veterinary medicinal products,
as well as the coccidiostats maduramycin and diclazuril (B2b), which are used
in Morocco for treatment of poultry, were not included. The audit team also
clarified that the residue monitoring plan for poultry sent to the Commission
services, wrongly indicated only single compounds for each of the substance
Groups A1, A3, A5 and A6 (nitroimidazoles), while actually the sub-contracted
testing laboratory covered an adequate number of substances per substance
group, similar to what is required in the EU 7.
8. Levels of action/decision limits in the residue monitoring plan are clearly indicated
and are suitable to detect concentrations at and below the respective EU Minimum
Required Performance Levels/Maximum Residue Limits/Levels (MRPLs and
MRLs, respectively) or Maximum Levels (MLs) applicable in the EU 8. National
MRLs and MLs have not yet been established. For heavy metals, national
legislation 9 establishes ‘alert thresholds’ for poultry and aquaculture finfish. The
threshold for lead in aquaculture finfish (0.5 mg/kg) is higher than the one
applicable in the EU (0.3 mg/kg) 10 (see also finding 37). The audit team was
informed by ONSSA staff met, that a legal act implementing MRLs similar to those
required in the EU 11 is in the legislative approval process.

5 Article 6 and Annex IV to Directive 96/23/EC.

6 Article 7 of Directive 96/23/EC.
7 Article 7 of Directive 96/23/EC.
8 Regulation (EU) No 37/2010, Regulation (EC) No 1881/2006, Regulation (EC) No 396/2005.
9 Joint Order of the Minister of Agriculture and Fisheries and the Minister of Health No 1643-16.
10 Annex to Regulation (EU) No 1881/2006.
11 Regulation (EU) No 37/2010.

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 9. The residue monitoring plan is to be implemented from 1 January to 31 December
each year. The number of samples assigned for collection from regions and
subsequently from supplying farms and processing establishment should be
proportionate to their previous year’s production volumes.

Conclusion on planning of residue monitoring

10. The planning of the residue monitoring complies with the requirements of and
largely adheres to the guarantees provided for by the EU approved plan.
Notwithstanding the discrepancies in the content of the poultry plan submitted to the
Commission services for evaluation compared to what is actually being tested for,
the fact that the current scope of testing for poultry and aquaculture finfish does not
take account of some of the pharmacologically active substances which can be used
in those sectors, weakens the effectiveness of the plan.

5.1.3. Implementation on of the residue monitoring plan

Legal requirements
Article 29 of Directive 96/23/EC.
The following list of legislation and elements thereof is provided for informative
purposes, encompassing the various aspects of Union legislation applicable to this
section of the report as regards the obligations of EU Member States.
Articles 4, 5, and 12 of, and Annex IV to, Directive 96/23/EC; Decision 97/747/EC;
Decision 98/179/EC; Commission Directive 2002/63/EC; Commission Regulation
(EU) No 589/2014; Commission Regulation (EC) No 333/2007; Commission
Regulation (EC) No 401/2006; Article 69 of Directive 2001/82/EC; Annex I, Part A
III, point 8(b) to Regulation (EC) No 852/2004 of the European Parliament and of
the Council; Annex II, Section III, point 3(c) to Regulation (EC) No 853/2004 of the
European Parliament and of the Council; Article 5 and Annex I, Section I, chapter
IIA, point 1 of Regulation (EC) No 854/2004 of the European Parliament and of the
Council.
Findings
11. Instructions are in place 12,13 to ensure the uniform sampling and implementation of
the residue monitoring plan. The instructions related to poultry have been modified
during the time of the audit with regard to the distribution of sampling on farm
versus slaughterhouse similar to those required in the EU (see also finding 6).
12. With regard to the number of collected samples, the 2016 residue monitoring plan
was largely implemented as foreseen with implementation rates of 94% for
aquaculture finfish and 90% for poultry. However, samples collected for substance
Group A3 in aquaculture finfish have not been tested for, due to the lack of an
analytical method (See also finding 7a).

12 National residue monitoring plan for poultry (implementation) and Instruction (management method No 05) on
sample collection on farms for veterinary testing laboratories.
13 Instruction (management method No 24) on the implementation and management of the residue monitoring plan
for aquaculture.

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13. Similar to what is required in the EU 14, ONSSA has appointed either official staff
to conduct sampling activities under the residue monitoring plan or Regional
Directorates can subcontract sampling to a private company selected by ONSSA
through a public procurement procedure. Samples are collected based on a plan
received from ONSSA central services (see also finding 1).
14. Similar to the situation in the EU 15, sample collection is unannounced. In the three
regions visited, the audit team met with local competent authorities and farmers
who confirmed that this requirement had been adhered to.
15. In 2016 and 2017 up to the time of the audit sampling for poultry was carried out
from January to December, but in one region visited, only to September. Samples
from poultry for testing substance Groups A1, A3, A4, A6 (nitroimidazoles) and
B2e were sent three times a year to a testing laboratory in an EU Member State.
Aquaculture finfish samples are collected only twice a year (the production period
for aquaculture finfish is the whole year). Thus sampling (and testing) was not
spread over the whole production period, which is in contrast to what is required in
the EU 16.
16. In addition, in contrast to what is required in the EU 17, many examples of multiple
sampling from one producer were seen by the audit team:
 at an aquaculture finfish farm, where more than six different samples had been
collected from the same production cage, although several cages were containing
suitable fish for sampling. This cage was then again sampled during other visits
at this farm.
 at a poultry slaughterhouse where up to 10 samples were collected from the same
farm and delivery truck.
17. Similar to what is required in the EU 18, sampling at aquaculture finfish farms was
done at all stages of production including fish ready to go to market.
18. The sampling reports reviewed at regional level, processing plants, farms and the
laboratory visited by the audit team allowed the traceability of the samples and
included information similar to that required in the EU 19.
19. Sampling materials are generally adequate. However, in contrast to the situation in
the EU 20, no seals were used to prevent the substitution of samples in particular in
regions, where samples are collected, stored and transported to laboratories by
private subcontractors. Similar to what is required in the EU 21, tissue samples are
stored and transported frozen to ensure the stability of analytes.

14 Article 1 and point 1.1 of the Annex to Decision 98/179/EC.

15 Article 12 of Directive 96/23/EC.
16 Article 1and point 2.1 of the Annex to Decision 98/179/EC.
17 Article 1 and point 2.3.3.1 of the Annex to Decision 98/179/EC
18 Chapter 3 of the Annex IV to Directive 96/23/EC.
19 Article 1 and point 2.7 of the Annex to Decision 98/179/EC.
20 Article 1 and point 2.6 of the Annex to Decision 98/179/EC.
21 Article 1 and point 2.9 of the Annex to Decision 98/179/EC.

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 Conclusion on implementation of residue monitoring
20. The residue monitoring plan is largely implemented as designed, thus supporting the
guarantees provided by Article 29 of Directive 96/23/EC. However, the fact that
sample containers are not sealed to hinder the possibility of sample substitution,
thus not ensuring the legal and analytical validity of the samples in question, that
multiple sampling from one producer occurs frequently and sampling is not spread
throughout the whole production period, weakens the effectiveness of the plan.

5.1.4. Follow-up of non-compliant results

Legal Requirements
Article 29 of Directive 96/23/EC.
The following list of legislation and elements thereof is provided for informative
purposes, encompassing the various aspects of Union legislation applicable to this
section of the report as regards the obligations of EU Member States.
Articles 13, 16, 17, 18, 19, 23, 24, 27 and 28 of Directive 96/23/EC.
Findings
21. ONSSA is responsible for the follow-up of non-compliant results. There is a legal
basis for follow-up of non-compliances, one objective of which is to identify the
reason for the non-compliance. National legislation also allows the competent
authorities to take measures to avoid future non-compliances and include the recall,
seizure and destruction of product, the short- or longer-term withdrawal of the
establishment from the list of export-approved establishments and the imposition of
fines, which is similar to EU requirements 22.
22. For the aquaculture sector documented follow-up procedures describe the measures
to be taken in the event of non-compliances being detected. These include, inter
alia, to identify and eliminate the source, to identify farms of origins, to take
follow-up samples, trace and recall products, check veterinary medicine records,
verify and analyse feed sources. These are similar to what is required in the EU 23.
23. For poultry documented follow-up procedures were not yet in place at the start of
the audit. However, ONSSA took immediate action and issued instructions with
measures similar to what is required in the EU 24. Due to the absence of any non-
compliant results since 2014 (see finding 24), there was no opportunity during the
audit to see how the system had worked or would work in practice.
24. No samples analysed for both aquaculture finfish and poultry products were non-
compliant in the 2014, 2015 and 2016 residue monitoring plan (see also finding 56).

22 Articles 16, 17 and 18 of Directive 96/23/EC.

23 Articles 16, 17 and 18 of Directive 96/23/EC.
24 Articles 16, 17 and 18 of Directive 96/23/EC

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 Conclusion on follow-up of non-compliant results
25. Notwithstanding the absence of non-compliant results for the last three years,
national rules for follow-up investigations, traceability of products and the exclusion
of non-compliant products from export to the EU, allied with newly developed
instructions on how to conduct follow-up investigations, should guarantee the
effectiveness of follow-up in the event that a non-compliance would occur in future.

5.1.5. Laboratories

Legal Requirements
Article 29 of Directive 96/23/EC.
The following list of legislation and elements thereof is provided for informative
purposes, encompassing the various aspects of Union legislation applicable to this
section of the report as regards the obligations of EU Member States.
Article 15 of Directive 96/23/EC; point 1.2 of the Annex to Decision 98/179/EC;
Articles 3, 4, 5 and 6 of Decision 2002/657/EC; Annexes to Regulation (EU) No
589/2014, Regulation (EC) No 333/2007 and Regulation (EC) No 401/2006.
Findings
26. The current laboratory network comprises four national public laboratories and one
in an EU Member State. The network covers all testing for poultry and aquaculture
finfish under the residue monitoring plan.
27. ONSSA has a contract with LOARC to ensure testing for those substance groups
and analytes/matrix combinations for which there are no methods in other ONSSA
laboratories. This contract of maximum 3-years duration was signed in December
2016 to cover retroactively testing in 2016 and two subsequent years. There are no
specific requirements in the contract regarding method validation, the number of
samples, conditions for testing of follow-up samples or suspect samples.
28. LOARC subcontracts testing in poultry for substance Groups A1, A3, A4, A6
(nitroimidazoles only) and B2e to an accredited laboratory in an EU Member State.
This testing is not based on a detailed contract; analyses are carried out based on an
offer inquiry. During the audit the audit team confirmed that the scope of testing
carried out by LOARC was much wider than communicated to and indicated by
ONSSA in the residue monitoring plan submitted to the European Commission.
ONSSA staff met by the audit team stated that they will request that LOARC to
report the results of all substances tested for. They also stated that the complete list
of substances tested for will be included in the 2018 residue monitoring plan.
29. ONSSA´s contract with the LOARC, requires a sample turnaround time of 21
working days from sample receipt to reporting of results. However, no monitoring
of this deadline was required at the laboratory and a 2017 ONSSA audit at the
LOARC found that staff was not aware about the required 21 working day deadline.
Sample turnaround times in laboratories varied generally from 21 to 30 days, but
delays of up to three months were seen by the audit team in both laboratories visited

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 as well as in the subcontracted laboratory in the EU for which no turnaround time
had been contractually agreed with LOARC. Long turnaround times can adversely
affect the detectability of unstable analytes, such as penicillins and
aminoglycosides. ONSSA staff informed the audit team that they intend to monitor
and to ensure that analyses are carried out within the agreed turnaround time.
30. Similar to what would be expected in the EU 25, national laboratories are ISO 17025
accredited, either by the Moroccan accreditation Service SEMAC (which is an
associate member of the International Laboratory Accreditation Cooperation) or by
the French accreditation body COFRAC. The ONSSA laboratory testing for
aflatoxins (B3d) in feed for aquaculture finfish (testing for Group B3d was not
included in the scope of accreditation), had its accreditation suspended due to a
move to another premises (see also finding 35). With regard to the residue
monitoring plan, currently valid scopes of accreditation of national laboratories
include in:
o the Control, Service and Expertise Laboratory (SCE) in Rabat: for
microbiological screening for B1 in fish and muscle, confirmatory methods for
chloramphenicol in different matrices, nitrofuran metabolites in aquaculture
finfish and beta-agonists in liver.
o the Regional Laboratory for Analysis and Research (LRAR) in Agadir, heavy
metals (B3c) in fish
o the LOARC in Casablanca, organochlorines (B3a) in muscle and fish.
31. The audit team visited two laboratories: SCE Rabat and LOARC Casablanca. Both
have adequate equipment to carry out the required analyses as well as staff trained
to operate it.
32. Similar to what is required in the EU 26, adequate instructions and procedures are in
place to ensure that samples of inadequate quality are not accepted for testing.
Samples are anonymous to the staff when analysed. Whilst samples were adequately
stored at both laboratories visited, records of temperature monitoring in
fridge/freezers at the SCE Rabat laboratory were not kept up to date. This
shortcoming was rectified during the time of the audit.
33. The audit team examined a number of analytical methods. At the SCE Rabat
laboratory: (1) nitrofuran metabolites (A6) in poultry and (2) a multi-residue
method for antibiotics (B1) in fish muscle (both by Liquid Chromatography-
(Tandem) Mass Spectrometry (LC-MS/MS). In LOARC Casablanca: (1) methods
for polychlorinated biphenyles (B3a) by Gas Chromatography-Electron Capture
Detection and Gas Chromatography-(Tandem) Mass Spectrometry and (2) heavy
metals (B3c) by Atomic Absorption Spectroscopy in poultry and fish.

25 Point 1.2. of the Annex to Decision 98/179/EC.

26 Article 1 and point 2.9. of the Annex to Decision 98/179/EC.

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34. The fitness for purpose for some methods was adequately demonstrated. However,
in contrast to what is required in the EU 27, the confirmatory methods for substance
Groups B1 and B3a (at SCE) both for fish and poultry were not validated. The
method for screening antibiotics in fish (at SCE) was in the course of validation and
the ONSSA informed the audit team that the method for heavy metals (at LRAR)
was validated in crustaceans but not in poultry and fish muscle. In addition, there is
no method for testing substance Group A3 in fish and methods in use for substance
Groups B2c (at the LOARC) and B3d (at the ONSSA laboratory) are also not
validated.
35. As regards the sensitivity of the methods, it is considered adequate, as detection
limits of the methods in use are equal to the respective MRPL 28 and lower than the
respective MRLs 29 or MLs 30 applicable according to EU legislation.
36. In contrast to what would be expected in an accredited laboratory 31, an expired
internal standard for the nitrofuran metabolite AMOZ was in use at the SCE Rabat
laboratory and no expiry date was established for the enrofloxacin (B1) standard.
The laboratory has no routines to keep records of use/disposal of standards and for
establishing expiry dates for standards purchased without such information from a
producer/distributor.
37. Quality control routines in place include the use of internal standards, blank and
recovery tests in every assay series and repetition of the whole analytical procedure
in case of residues detection. Similar to what is required in the EU and according to
ISO requirements 32, control charts or other methods to monitor trends in the
method performance are maintained. Spiking concentration levels are equal or
lower than applicable MRPL 33 and MRLs 34 with the exception of heavy metals, for
which controls in place do not check the method performance at the concentration
level of interest in the EU (see also finding 8).
38. Similar to what is required in the EU 35, the network of residue laboratories have
participated in proficiency tests organised by European Union Reference
Laboratories and commercial providers with largely satisfactory results. Whilst the
SCE Rabat laboratory has participated in numerous proficiency tests for various
compounds in different matrices, the participation of the LOARC laboratory has
been limited to the tests for heavy metals

27 Article 3(b), (c) and (d) of Decision 2002/657/EC, Guidelines for the validation of screening methods for residues
of veterinary medicines of 20/1/2010, Article 28 of Regulation (EC) No 396/2005, Guidance document on
analytical quality control and method validation procedures for pesticides residues analysis in food and feed,
Article 1 and Annex to Regulation (EC) No 333/2007.
28 Annex II to Decision 2002/657/EC.
29 Annex to Regulation (EU) No 37/2010.
30 Regulation (EC) No 1881/2006, Regulation (EC) No 396/2005.
31 Point 5.6.3 of ISO 17025.
32 Article 5 of Decision 2002/657/EC and ISO 17025 standard.
33 Annex II to Decision 2002/657/EC.
34 Annex to Regulation (EU) No 37/2010.
35 Point 1.2 of the Annex to Decision 98/179/EC.

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 Conclusion on laboratories
39. The performance of residue laboratories largely supports the guarantees provided by
the residue monitoring plan approved by the EU. However, the confidence in the
reliability of the results is weakened by the fact that some non-validated methods
are used.

5.2. Veterinary medicinal products

5.2.1. Competent authorities

40. ONSSA’s Directorate for laboratories and inputs within the Ministry of Agriculture
together with the Ministry of Health are responsible for the registration and for the
issuing of marketing authorisations for veterinary medicinal products 36. Both are
also jointly responsible for the authorisation of, and controls on, veterinary
medicinal product producers, importers and wholesalers. Veterinary practitioners
are authorised by the Moroccan veterinary college based on a delegation from the
Ministry of Agriculture, and Pharmacies selling medicines for human and veterinary
medicinal products are authorised by the Moroccan pharmacist college based on a
delegation from the Ministry of Health.
41. Official controls on veterinary practitioners and farms are done by the regional
office of ONSSA. Official controls at pharmacies selling human and veterinary
medicinal products are conducted by the Ministry of Health.

5.2.2. Authorisation and distribution

Legal requirements
Article 29 of Directive 96/23/EC.
The following list of legislation and elements thereof is provided for informative
purposes, encompassing the various aspects of Union legislation applicable to this
section of the report as regards the obligations of EU Member States.
Articles 4, 7, 10 and 29 of Directive 96/23/EC; Articles 4, 5, 7 and 11(2) of, and
Annexes II and III to Directive 96/22/EC; Articles 5-15, 21-30, 58-62, 65-71 and 83
of Directive 2001/82/EC; Articles 30-40 of Regulation (EC) No 726/2004 of the
European Parliament and of the Council; Regulation (EC) No 470/2009 of the
European Parliament and of the Council; Annex to Regulation (EU) No 37/2010;
Annex I, Part A III, point 8(b) to Regulation (EC) No 852/2004; Annex II, Section
III, point 3(c) to Regulation (EC) No 853/2004; Articles 2, 8 and 9 of Council
Directive 90/167/EEC; Regulation (EC) No 1831/2003 of the European Parliament
and of the Council.

36 Article 13 of Law 21-80 of 26 December 1980.

11
 Findings
42. There are 7 manufacturers of veterinary medicinal products in Morocco plus 10
companies which use these manufacturers as contractors for their licensed
medicines. Similar to what is required in the EU 37, national legislation describes the
legal provisions for marketing authorisation (registration), distribution and use of
veterinary medicinal products. The registration procedures are also legally defined 38.
The list of authorised veterinary medicinal products is publicly available.
43. All imports require an import certificate from the Ministry of Agriculture and the
Ministry of Health, following a legal procedure. Similar to what is required in the
EU 39, national rules require that the distribution of imported veterinary medicinal
products takes place through licensed importers. At present, 27 companies have a
licence to import and distribute nationally-registered veterinary medicinal products.
44. Only veterinary medicinal products authorised and registered in Morocco and
complying with national legislation can be circulated and used 40, which is similar
to what is required in the EU 41. Among all products in the register of veterinary
medicinal products are 13 products authorised for all species including poultry.
These contain active pharmaceutical ingredients like for example certain antibiotics,
glucocorticoids and chloramphenicol not authorised for use in poultry in the EU.
ONSSA staff met, provided evidence that the prospective species indications will be
revised this year to comply with what is required in the EU.
45. Similar to what is required in the EU 42, national legislation prohibits the use of
substances in Groups A1, A2, A4 and A6 in all food-producing animals as well as
beta-agonists for growth promotion 43 and there are no dyes (B3d) registered for
use. Certain hormones are only allowed and registered to be used for zootechnical
purposes in cows, mares and sows which is similar to the situation in the EU 44. No
veterinary medicinal products are registered for sex-inversion in aquaculture finfish.
46. Similar to what is required in the EU 45, national rules foresee that veterinary
medicinal products and medicated feedingstuffs for food producing animals can
only be sold based on a veterinary prescription 46.
47. Labelling requirements for veterinary medicinal products 47 are similar to what is
required in the EU 48.
48. Different to the situation in the EU 49, off-label use of veterinary medicinal products
is not allowed 50.

37 Directive 2001/82/EC.
38 Joint circular No 1-94.
39 Articles 65 of Directive 2001/82/EC.
40 Articles 4 and 6 of Law 21-80 of 26 December 1980.
41 Articles 5 of Directive 2001/82/EC.
42 Directive 96/22/EC and Table 2 of the Annex to Regulation (EU) No 37/2010.
43 Decree No 4260-12 of 31 December 2012.
44 Article 5 of Council Directive 96/22/EC.
45 Article 67(aa) of Directive 2001/82/EC and Article 8 of Directive 90/167/EEC.
46 Article 7 of Law 21/80 and Article 54 of the code of veterinary practice.
47 Article 18 and chapter IV of Decree No 2-82-541.
48 Article 58 of Directive 2001/82/EC and Article 6 of Council Directive 90/167/EEC.
49 Article 11 of Directive 2001/82/EC.
50 Article 1 of Decree No 4260-12 (Morocco) of 31 December 2012.

12
 49. National legislation allows the import and production of premixes for the
production of medicated feedingstuffs. Similar to the situation in the EU 51, there
are national legal requirements governing the import of medicated premixes for the
manufacturing and use of medicated feedingstuffs. Medicated feedingstuffs can
only be produced from authorised premixes.
50. Labelling requirements for premixes 52 for the production of medicated
feedingstuffs are similar to those in the EU 53.
51. All farmers producing food of animal origin for human consumption, are required to
have an on-farm register 54 which contains information similar to those required in
the EU 55 and to keep prescriptions at the farm 56.

Conclusion on the authorisation, distribution and use of veterinary medicinal

products
52. The legal framework governing the marketing authorisation and use of veterinary
medicinal products and the range of substances used is broadly similar to that
foreseen in EU legislation and support the guarantees required by Article 29 of
Directive 96/23/EC.

5.2.3. Official controls on the use of veterinary medicinal products

Legal requirements
Article 29 of Directive 96/23/EC.
The following list of legislation and elements thereof is provided for informative
purposes, encompassing the various aspects of Union legislation applicable to this
section of the report as regards the obligations of EU Member States.
Article 10 of Directive 96/23/EC, Article 80 of Directive 2001/82/EC; Article 4(2)
of Regulation (EC) No 854/2004; Directive 90/167/EEC.
Findings
53. The frequency of inspections at processing establishments, importers, wholesalers
of veterinary medicinal products on veterinary practitioners and farms is defined at
national level. Checklists are used to guide what is inspected and results are
reported to the central level of ONSSA.

51 Directive 90/167/EEC.
52 Article 1 of Decree No 4260-12 of 31 December 2012.
53 Article 58 of Directive 2001/82/EC and Article 6 of Council Directive 90/167/EEC.
54 Article 79 of Decree 2-10-473 from 6 September 2011.
55 Article 10 of Directive 96/23/EC.
56 Law 44-99 from 13 June 2002 and Decree 2126-05 from 15 December 2005.

13
54. Both at the wholesaler and the veterinarian practice visited, the nationally-required
authorisation certificates were available. The competent authority had visited these
establishments in line with the established frequency and records were available
including information on whether shortcomings identified during previous
inspections had been rectified. Inspections were conducted using a comprehensive
checklist, verifying, inter alia, storage conditions, traceability, prescription
requirements, the presence of unauthorised or expired medicines and labelling
requirements.
55. Official controls of aquaculture finfish and poultry farms took place in line with the
planned control frequency using checklists developed at national level. The controls
did not verify if the correct application of the withdrawal period had been observed.
ONSSA immediately rectified this shortcoming for controls on aquaculture finfish
farms by issuing new checklists including checks that the correct withdrawal period,
measured in degree days is observed. ONSSA also revised the checklists for
controls on poultry farms to include all of the above plus verification that feed
containing anticoccidials and labels for veterinary medicinal products, medicated
feedingstuffs or feed, complied with legal requirements.
56. At the fish and poultry farms visited by the audit team, treatment records were
available. These were in line with national requirements which are largely similar to
those in the EU and no evidence of misuse or inappropriate use of veterinary
medicinal products was seen.
57. In a feedmill producing medicated feedingstuffs all production batches were based
on a prescription and official controls took place with the required frequency. The
audit team noted that labels for medicated feedingstuffs were not fully in line with
national requirements and neither the feedmill staff nor the ONSSA inspectors
responsible, were familiar with these. This was immediately rectified by ONSSA
which issued a revised instruction describing the labelling requirements required to
be verified during official controls.

Conclusion on official controls on the use of veterinary medicinal products

58. The official control system in place to ensure that legal requirements on the
distribution and use of veterinary medicinal products is largely effective
underpinning the guarantees provided for by the residues monitoring plan.

14
6. OVERALL CONCLUSION

The current control system for residues in food of animal origin in Morocco largely
underpins guarantees that exported products do not contain residues in excess of EU
limits. Nevertheless, the audit has identified deficiencies in the planning and
implementation of the residue monitoring plan, most notably the use of some analytical
methods which are not validated, a scope of testing which does not reflect the use of
certain substances in the poultry and aquaculture sectors and sample handling practices
which weaken the legal and analytical validity of the samples and results generated.
Notwithstanding these deficiencies, the implementation of a prescription system for
veterinary medicinal products and the effective operation of official controls on the
distribution and use of veterinary medicines mitigates the risk of residue violations in
products eligible for export to the EU.

7. CLOSING MEETING

A closing meeting was held on 21 September 2017 with representatives of ONSSA.

At this meeting, the audit team presented the main findings and preliminary
conclusions of the audit. The authorities had no comments and stated that they
would take all actions necessary in order to address the areas for improvement
identified during the course of the audit.

8. RECOMMENDATIONS

The competent authorities are invited to provide details of the actions taken and
planned, including deadlines for their completion ('action plan'), aimed at addressing
the recommendations set out below, within 25 working days of receipt of this audit
report.

No Recommendation

1 To ensure that the residue monitoring plan for poultry and aquaculture finfish,
includes all relevant substances in line with the range of veterinary medicinal
products authorised and/or likely to be used in these production sectors and
accurately reflects all of the substances tested for, so that the guarantees
provided under Article 29 of Directive 96/23/EC remain effective.
Recommendation based on conclusion 10.
Associated finding 7.

15
2 To ensure that sample containers are sealed, that sampling is spread over the
whole production period and that no multiple sampling from individual
producers occurs, so that the guarantees provided under Article 29 of Directive
96/23/EC are effective.
Recommendation based on conclusion 20.
Associated findings 15, 16 and 19.

3 To ensure that all the analytical methods used for the residue monitoring plan
are validated, so that the guarantees provided under Article 29 of Directive
96/23/EC remain effective.
Recommendation based on conclusion 39.
Associated finding 34.

The competent authority's response to the recommendations can be found at:

http://ec.europa.eu/food/audits-analysis/rep_details_en.cfm?rep_inspection_ref=2017-6190

16
ANNEX 1 – LEGAL REFERENCES

Legal Reference Official Journal Title

Food Law

Reg. 178/2002 OJ L 31, 1.2.2002, p. Regulation (EC) No 178/2002 of the

1-24 European Parliament and of the Council of
28 January 2002 laying down the general
principles and requirements of food law,
establishing the European Food Safety
Authority and laying down procedures in
matters of food safety

Reg. 852/2004 OJ L 139, 30.4.2004, Regulation (EC) No 852/2004 of the

p. 1, Corrected and European Parliament and of the Council of
re-published in OJ L 29 April 2004 on the hygiene of foodstuffs
226, 25.6.2004, p. 3
Reg. 853/2004 OJ L 139, 30.4.2004, Regulation (EC) No 853/2004 of the
p. 55, Corrected and European Parliament and of the Council of
re-published in OJ L 29 April 2004 laying down specific hygiene
226, 25.6.2004, p. 22 rules for food of animal origin

Reg. 854/2004 OJ L 139, 30.4.2004, Regulation (EC) No 854/2004 of the

p. 206, Corrected and European Parliament and of the Council of
re-published in OJ L 29 April 2004 laying down specific rules for
226, 25.6.2004, p. 83 the organisation of official controls on
products of animal origin intended for human
consumption

Reg. 798/2008 OJ L 226, 23.8.2008, Commission Regulation (EC) No 798/2008

p. 1-94 of 8 August 2008 laying down a list of third
countries, territories, zones or compartments
from which poultry and poultry products may
be imported into and transit through the
Community and the veterinary certification
requirements

Dec. 2007/777/EC OJ L 312, 2007/777/EC: Commission Decision of 29

30.11.2007, p. 49-67 November 2007 laying down the animal and
public health conditions and model
certificates for imports of certain meat
products and treated stomachs, bladders and
intestines for human consumption from third
countries and repealing Decision
2005/432/EC

Monitoring of residues and contaminants in food of animal origin

Dir. 96/23/EC OJ L 125, 23.5.1996, Council Directive 96/23/EC of 29 April 1996
p. 10-32 on measures to monitor certain substances
and residues thereof in live animals and
animal products and repealing Directives
85/358/EEC and 86/469/EEC and Decisions
89/187/EEC and 91/664/EEC

Dec. 97/747/EC OJ L 303, 6.11.1997, 97/747/EC: Commission Decision of 27

p. 12-15 October 1997 fixing the levels and
frequencies of sampling provided for by
Council Directive 96/23/EC for the
monitoring of certain substances and residues
thereof in certain animal products

Dec. 98/179/EC OJ L 65, 5.3.1998, p. 98/179/EC: Commission Decision of 23

31-34 February 1998 laying down detailed rules on
official sampling for the monitoring of
certain substances and residues thereof in live
animals and animal products

Reg. 37/2010 OJ L 15, 20.1.2010, Commission Regulation (EU) No 37/2010 of

p. 1-72 22 December 2009 on pharmacologically
active substances and their classification
regarding maximum residue limits in
foodstuffs of animal origin

Dec. 2002/657/EC OJ L 221, 17.8.2002, 2002/657/EC: Commission Decision of 12

p. 8-36 August 2002 implementing Council Directive
96/23/EC concerning the performance of
analytical methods and the interpretation of
results

Reg. 396/2005 OJ L 70, 16.3.2005, Regulation (EC) No 396/2005 of the

p. 1-16 European Parliament and of the Council of
23 February 2005 on maximum residue
levels of pesticides in or on food and feed of
plant and animal origin and amending
Council Directive 91/414/EEC

Dir. 2002/63/EC OJ L 187, 16.7.2002, Commission Directive 2002/63/EC of 11

p. 30-43 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

Reg. 1881/2006 OJ L 364, Commission Regulation (EC) No 1881/2006

20.12.2006, p. 5-24 of 19 December 2006 setting maximum
levels for certain contaminants in foodstuffs
Reg. 333/2007 OJ L 88, 29.3.2007, Commission Regulation (EC) No 333/2007
p. 29-38 of 28 March 2007 laying down the methods
of sampling and analysis for the official
control of the levels of lead, cadmium,
mercury, inorganic tin, 3-MCPD and
benzo(a)pyrene in foodstuffs

Reg. 315/93 OJ L 37, 13.2.1993, Council Regulation (EEC) No 315/93 of 8

p. 1-3 February 1993 laying down Community
procedures for contaminants in food

Reg. 124/2009 OJ L 40, 11.2.2009, Commission Regulation (EC) No 124/2009

p. 7-11 of 10 February 2009 setting maximum levels
for the presence of coccidiostats or
histomonostats in food resulting from the
unavoidable carry-over of these substances in
non-target feed

Reg. 401/2006 OJ L 70, 9.3.2006, p. Commission Regulation (EC) No 401/2006

12-34 of 23 February 2006 laying down the
methods of sampling and analysis for the
official control of the levels of mycotoxins in
foodstuffs

Reg. 589/2014 OJ L 164, 3.6.2014, Commission Regulation (EU) No 589/2014

p. 18-40 of 2 June 2014 laying down methods of
sampling and analysis for the control of
levels of dioxins, dioxin-like PCBs and non-
dioxin-like PCBs in certain foodstuffs and
repealing Regulation (EU) No 252/2012

Dec. 2011/163/EU OJ L 70, 17.3.2011, 2011/163/EU: Commission Decision of

p. 40-46 16 March 2011 on the approval of plans
submitted by third countries in accordance
with Article 29 of Council Directive
96/23/EC

Veterinary medicinal products

Dir. 2001/82/EC OJ L 311, Directive 2001/82/EC of the European

28.11.2001, p. 1-66 Parliament and of the Council of 6 November
2001 on the Community code relating to
veterinary medicinal products
Reg. 726/2004 OJ L 136, 30.4.2004, Regulation (EC) No 726/2004 of the
p. 1-33 European Parliament and of the Council of
31 March 2004 laying down Community
procedures for the authorisation and
supervision of medicinal products for human
and veterinary use and establishing a
European Medicines Agency

Dir. 96/22/EC OJ L 125, 23.5.1996, Council Directive 96/22/EC of 29 April 1996

p. 3-9 concerning the prohibition on the use in
stockfarming of certain substances having a
hormonal or thyrostatic action and of beta-
agonists, and repealing Directives
81/602/EEC, 88/146/EEC and 88/299/EEC

Dir. 2006/130/EC OJ L 349, Commission Directive 2006/130/EC of 11

12.12.2006, p. 15-16 December 2006 implementing Directive
2001/82/EC of the European Parliament and
of the Council as regards the establishment of
criteria for exempting certain veterinary
medicinal products for food-producing
animals from the requirement of a veterinary
prescription

Dir. 90/167/EEC OJ L 92, 7.4.1990, p. Council Directive 90/167/EEC of 26 March

42-48 1990 laying down the conditions governing
the preparation, placing on the market and
use of medicated feedingstuffs in the
Community

Reg. 1831/2003 OJ L 268, Regulation (EC) No 1831/2003 of the

18.10.2003, p. 29-43 European Parliament and of the Council of
22 September 2003 on additives for use in
animal nutrition

Reg. 470/2009 OJ L 152, 16.6.2009, Regulation (EC) No 470/2009 of the

p. 11-22 European Parliament and of the Council of 6
May 2009 laying down Community
procedures for the establishment of residue
limits of pharmacologically active substances
in foodstuffs of animal origin, repealing
Council Regulation (EEC) No 2377/90 and
amending Directive 2001/82/EC of the
European Parliament and of the Council and
Regulation (EC) No 726/2004 of the
European Parliament and of the Council