دليل آلية اعتماد الجهة الرقابية - sfda · 2020. 10. 20. · 5 ˚ ˙ˆ ˚...
TRANSCRIPT
آلية اعتمادالجهة الرقابية الرســـمية والمنشـــآت
في الدولة الراغبة في تصدير منتجات
إلـــى الحيوانـــي الأصـــل الأغذيـــة ذات
المملكة العربية السعودية
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�����ت ا�����1: ���ذج ����� ا� �� وا� ���
Kingdom of Saudi Arabia
Saudi Food and Drug Authority
Executive Department of Imported Food Control
QUESTIONNAIREFOR
A DESK STUDY ON FOOD SAFETY OF COUNTRIES FROM WHICH
EXPORTING OF MEAT AND POULTRY MEAT AND THEIR PRODUCTS INTO
THE KINGDOM OF SAUDI ARABIA ARE PERMITTED
NOTE TO THE COMPETENT AUTHORITY
This questionnaire should be completed
And returned to the Saudi Food and Drug Authority within sixty days starting from the date it
is officially received and submitted officially to SFDA through the Ministry of Foreign Affairs.
From:
The competent authority in the exporting country ………
To:Director of Executive Department of Imported Food Control
Saudi Food and Drug Authority
Kingdom of Saudi Arabia
And the information requested should be sent electronically (word)
to email [email protected]
6
COUNTRY FOOD SAFETY EVALUATION
Questionnaire
COUNTRY FOOD SAFETY EVALUATION
Explanatory note:
The evaluation shall provide to the KSA a comprehensive description under which kind of
legal conditions food in the exporting country is produced. The results of the evaluation
of the questionnaire will have influence on:
1. The listing of a country for the import of a specific product category.
2. The frequency of onsite assessments of establishments and competent authorities through
Saudi Food and Drug A.
3. The guarantees to be provided by the exporting country by issuing specific certificates
for a specific product.
4. The physical inspection frequency of the products from a specific country at the border.
5. The frequency of laboratory checks on the imported product.
6. The conditions for bans and lifting of bans for products in certain situations.
7
The general chapters (column 2 of the questionnaire table) of the questionnaire may,
depending on the type of product, intended for import, include:
A. Organization of Legal Bodies, general empowerments for the Food Safety Controls
B. Organization General
C. Organization in Detail
D. Qualification of staff
E. Training
F. Food safety Rules
G. Food Hygiene Rules
H. Animal health
I. Veterinary Medical and Biotechnical products
J. Animal Identification and control of animal movements
K. Animal by Products
L. Plant Health
M. Plant protection Products and Agrochemicals
N. Primary Production
O. Feeding Stuff
The competent Authority is asked to indicate for each different topic (column 3) of the
chapters (column 2) whether rules/regulations are available (yes/no/partially) (column 4)
and where the answer can be verified (column 5).
Additional explanations could be provided on a separate sheet.
8
Each question under the chapters A – O is further explained in a Footnote reference!
Which bodies (ministries, Authorities, other legal bodies,…) are legally empowered to implement the legal
framework for Food safety; By which legal text this empowerment is fixed?
Is there a legislation available describing the duties of inspection bodies
Are there rules for the issuing of official certificates or written instructions made available to certifying officials
(controls over printing, storage, distribution of blank certificate, procedures for the completion and signatures of
certificates, who is responsible for signature? procedures for the withdrawal or amendment of signed certificates)
1.
2.
3.
Column 2 Column 3 Column 4 Column 5 Column 6
Organization of Legal Bodies, general empowerments
Rules/regulations/working procedures are available for:
Empowerment of legal bodies1
Duties of inspection bodies and persons2
Certification of animals/plants and products3
Available and implemented(Yes/No/started but incomplete)
Please indicate how the implemented requirement can be verified ( e.g. the source of publication or other verification means)
Comments
A1 – A 12
1
2
3
9
Is there a legislation defining the official controls in the Food Chain
what kind of inspection tasks are outsourced and conducted by third parties (Non Governmental Organizations);
How is the surveillance of the outsourced tasks.
In case that private veterinarians or organizations are carrying out official duties ( e.g. meat inspection in
Slaughterhouses) how their independence is ensured ; any rules on this?
Are there rules or working procedures for handling Food Crisis and emergencies? Were are theses rules or
procedures oublished?
4.
5.
6.
7.
Column 2 Column 3 Column 4 Column 5 Column 6
official controls on Food (control and surveillance of Food Chain)4
official inspection tasks which are outsourced5
ensuring the independence of private veterinarians/auxiliaries carrying out official duties6
Food Crisis Handling and emergency procedures7
4
5
6
7
10
Data recording of official controls; how is it done? Any rules, working procedures available?
Is there a system for the notification of food hazards to other authorities or inspection bodies in place?
In case that fees are charged for official controls, how are theses fees structured, are rules or regulations on charging
fees in place?
Are there any official legal controls on the primary production. if Yes how are the controls called and where are the
legal conditions for those controls fixed.
Is notification of food borne diseases mandatory? legal basis?
8.
9.
10.
11.
12.
Column 2 Column 3 Column 4 Column 5 Column 6
Data recording and Information system for official controls8
Rapid Alert System9
Fee structure for official controls( fees for control’s)10
Official controls on primary production11
8
9
10
11
Notification of Food poisoning and other food borne diseases12
12
Organization and management of
risk assessment, risk communication
and risk management ( including
competences of the different
bodies, if there are)17
11
Please provide an overview of the general structure of the organization of AH, PH and FS and their relation.
Please provide the organizational chart of each service involved in animal health, plant health and food safety. The
procedures for co-ordination and co-operation between the above services should be given. The management lines from
central to regional to local services should be clearly indicated
Number of official laboratories, type of quality assurance system?, distribution in the country, number and type of
reference laboratories, Laboratory network and embedment of the laboratories in the Food Administration;
How many local inspection units exist, how distributed in the country, average number of personnel in each unit
Who is competent for the risk management, risk assessment and risk communication? Are there different bodies,
interrelationship of the bodies;
13.
14.
15.
16.
17.
Column 2 Column 3 Column 4 Column 5 Column 6
Structure and organization of
Animal health (AH), Plant health
(PH)and Food safety (FS)and their
relation to each other13
Describe the organization of Food and Feed Control:
Please attach the referring documents to the questionnaire
Organization General
Structure and organizational chart
of each service (Central
Competent Authorities) (animal
health, plant health, food safety);14
Organization of laboratory
services15
Presentation of number and
location of local inspection units,
Border Posts and laboratories16
1
B
2
3
4
5
12
Budget available for the different
tasks, e.g.
operation of inspections
animal health control programs
residue monitoring 20
Naming of web sources of the information possible
Approximate number is sufficient
Indicate the proportion of the budget provided by government, and that provided by other sources (the status of any
other sources should be clearly indicated).,
For example: how are side jobs regulated, with or without approval of superiors,
18.
19.
20.
21.
Column 2 Column 3 Column 4 Column 5 Column 6
Name, responsibilities and contact details of the Directors of:
Animal Health Services Public Health Services (food safety)Controls on veterinary medicines and medicated feedstuffsLaboratory Services18
Describe the organization of Food and Feed Control:
Please attach the referring documents to the questionnaire
Organization in Detail
Approximate number of permanent staff (academic, administrative, technical) available for inspection services:
Animal healthFood safetyLaboratory services19
1
C
2
3
4
•
•
•
•••
••
•
Rules for professional activities of
the permanent officials regarding
activities outside of the service 21
13
Training plan for the continuous
development of private
veterinarians/inspectors
carrying out official duties24
Are qualification requirements regulated; Describe the minimum qualifications (and years of experience, where
appropriate)
Give details of routine or special training programmes available for newly recruited and established academic and
technical staff.
Give details of the arrangements for continued professional development of private veterinarians/inspectors, who carry
out official duties
22.
23.
24.
Column 2 Column 3 Column 4 Column 5 Column 6
qualifications of staff for entering official services
academic staff administrative stafftechnical staff22
Rules/regulations/working procedures are available for:
Available and implemented(Yes/No/started but incomplete)
Available and implemented(Yes/No/started but incomplete)
Please indicate how the implemented requirement can be verified ( e.g. the source of publication or other verification means)
Qual ification of Staff
The following requirements are realizedTraining
Training plan for continued
professional development of
official staff theoretical
knowledge23
1
D
E
1
2
14
Are Food safety rules/regulations or working procedures available for the topics F1 – F22. Are these rules implemented
and supervised?
Do the food safety rules follow CODEX Guidelines/Standards of other Legislation/Standards (e.g. EU or US
legislation/standards)
25.
26.
Novel Foods and GMO
Column 2 Column 3 Column 4 Column 5 Column 6
Labeling of Food stuff
Rules/regulations/working procedures are available for:
Available and implemented(Yes/No/started but incomplete)
Please indicate how the implemented requirement can be verified ( e.g. the source of publication or other verification means)
Food Safety Rules ;25 26
Materials & Articles (M&A) in
contact with Food
1
F
3
Prohibition of certain additives
in food4
Traceability of Food stuff5
Quality of drinking water
including quality of water to
be used in food (chemical and
microbiological requirements)
2
6
GMO traceability and labeling 7
Maximum Levels of
Contaminants
Pesticides on fruit & vegetables
Erucic acid in oils and fats
Pesticide residues in Food of
animal origin
Radioactive contamination
Pesticide residues in Foodstuff
of plant origin
Veterinary medicinal products
residues in Foodstuff of animal
origin
8
15
“Product safety” refers to the physical health and safety of citizens with regards to non-food products, such as
toys,household appliances, cars and cosmetics.
27.
Column 2 Column 3 Column 4 Column 5 Column 6
Food additives and extraction solvents
11
10
9
12
15
16
17
18
19
Good Manufacturing practice for materials in contact
Radiation of foodstuff
Monitor substances & residues in animals & animal products
Sampling & analysis methods for Heavy metals in Food
Migration testing of plastic material constituents
Sampling methods for different microbial and chemical analyses
Identification system for packaging material
Infant formulae and follow-on formulae
Processed cereal-based foods and baby foods for infants and young children
Composition and labeling of foodstuffs suitable for people intolerant to gluten
General Product safety27
visual inspection for the purpose of detecting parasites in fishery products
Detection of residues of substances having hormonal or thyrostatic action
13
14
20
21
22
16
Do the Food Hygiene Rules comply with CODEX Guidelines/Standards or with another framework e.g. EU Aquis
Is there a regulation available containing rules for the hygiene of all those food products which in particular not fall under
specific vertical regulations.
Vertical regulation existent, implemented and supervised? I no vertical regulation exist, where is the subject regulated?
Vertical regulation existent, implemented and supervised?
Is the registration and/or licensing of establishments mandatory. Do establishments have to fulfill conditions for getting
a license. Legal provisions?
Vertical regulation existent, implemented and supervised?
Vertical regulation existent, implemented and supervised?
Vertical regulation existent, implemented and supervised?
Vertical regulation existent, implemented and supervised?
29.
28.
30.
31.
32.
33.
34.
35.
36.
Column 2 Column 3 Column 4 Column 5 Column 6
General hygiene of Food products29
Meat and Meat Products (slaughter, hygiene, ante and post mortem inspection, storage and transport, …)30
Legal provisions are available for :
Available and implemented(Yes/No/started but incomplete)
Please indicate how the implemented requirement can be verified ( e.g. the source of publication or other verification means)
Food Hygiene Rules 28
Meat for Poultry and rabbits
(slaughter, hygiene, ante and
post mortem inspection,
storage and transport, …)31
1
G
3
Registration and licensing of
Establishments32 4
2
Milk hygiene33
Fish hygiene 34
5
6
Aquaculture products35 7
Egg and Egg products 36 8
17
Which diseases are notifiable? List available?
Regulation on notifiable diseases available?
How is Foot and Mouth Disease controlled? Vaccination? stamping out? Freedom of FMD? national regulations?
Number of laboratories and type of tests accredited for.
Is an eradication program implemented? What is the actual stand of play?
Legal provisions for the control of avian influence available and implemented?
Legal provisions for the control of avian influence available and implemented?
Which fish and aquaculture diseases are under official control?
Are programs in place for the monitoring of zoonotic diseases in food animals
Is the test used for TSE Monitoring in line with OIE requirements
38.
37.
39
40.
41.
42.
43.
44.
45.
46.
Column 2 Column 3 Column 4 Column 5 Column 6
List of notifiable diseases37
Rules for notification of animal diseases38
Legal p rovisions are available for:
Available and implemented(Yes/No/started but incomplete)
Please indicate how the implemented requirement can be verified ( e.g. the source of publication or other verification means)
Animal Health
The control of Foot and Mouth Disease39
TSE prevention, monitoring, control and eradication
Laboratories approved and or accredited for Animal Health diagnosis40
Eradication of brucellosis,tuberculosis and leucosis in cattle41
Control of Avian Influenza42
Control of Newcastle diseases43
Control of fish diseases44
Test (s) used for TSE monitoring46
Monitoring and control of zoonoses and zoonotic agents e.g.SalmonellaAnthraxRift Valley Fever 45
1
H
5
6
2
3
4
7
8
9
10
11
18
Are veterinary medical products regulated, are the provision supervised?
Is possession , distribution, dispensing regulated and supervised?
Who is doing controls, control frequencies? Legal provisions available?
Corresponds with question F8: maximum levels; do legal MRLs exist, does a monitoring program exist, what are the
results in the past 3 years;
List available implemented and supervised?
Legal provisions on production, distribution and use available and implemented?
48.
47.
49
50.
51.
52.
Column 2 Column 3 Column 4 Column 5 Column 6
Use of Veterinary Medicinal products part 1 (marketing authorization, manufacture and imports, labeling,)47
Use of Veterinary Medicinal products part 2 (possession, distribution and dispensing of veterinary medicinal products, pharmacovigilance, supervision and sanctions)48
Rules are available for: Available and implemented(Yes/No/started but incomplete)
Please indicate how the implemented requirement can be verified ( e.g. the source of publication or other verification means)
Veterinary medical and biotechnical products
Control of Veterinary pharmacies and treatment on farms (e.g. Systematic records of veterinary treatments )49
MRL's of Veterinary Medicinal products in foodstuffs of animal origin50
Drugs prohibited for use in Food Production Animals51
Vaccine and sera products52
1
I
3
2
5
6
4
Legal provisions are available for:
Available and implemented(Yes/No/started but incomplete)
Please indicate how the implemented requirement can be verified ( e.g. the source of publication or other verification means)
ProductsK
19
Legal provisions for the identification and movement control of bovine animals are available, implemented and
supervised. Explain the cornerstones of the system (e.g. eartags, cattle passports, databases, individual registers at
holdings….)
Legal provisions for the identification and movement control of ovine/caprine animals are available, implemented and
supervised.
Is the beef labeling system compulsoty or voluntary. Are there legal provisions regulating the labeling of the origin,
raising and slaughtering of cattle? How is it supervised? Can beef be traced at all stages of the food chain. Does same
rules apply for imported beef?
Responsibilities for the control of the animal identification system, control frequency? Measures in case of irregularities?
Are legal Provisions available, implemented and supervised? Do the provisions contain rules for Production, Collection,
Transport , Storage , Use and Disposal of ABPs?
53.
54.
55.
56.
57.
Column 2 Column 3 Column 4 Column 5 Column 6
Bovine identification system;53
Ovine/caprine identification system54
The following systems are legally installed and operational
Available and implemented(Yes/No/started but incomplete)
Please indicate how the implemented requirement can be verified ( e.g. the source of publication or other verification means)
Animal ID and Movement control
Beef labeling system55
Control and sanctions for the animal identification system56
1
J
3
4
2
1
Animal by-products (ABPs) and derived products not intended for human consumption (restrictions, disposal, processing, transport, identification, traceability)57
20
Please provide an overview of the general structure of the organization competent for plant health control; The
management lines from central to regional to local services should be clearly indicated
What are the legal protective measures against quarantine pests and quality pests.
Regulation of Plant Protection Products available implemented and supervised? Is the regulation taking into account
supranational standards (e.g. CODEX, ..) Exist a list of approved active substances?
Implemented and supervised?
59.
58.
60.
61.
Legal provisions are available for:
Available and implemented(Yes/No/started but incomplete)
Please indicate how the implemented requirement can be verified ( e.g. the source of publication or other verification means)
Plant Protection products and Agrochemicals
M
Column 2 Column 3 Column 4 Column 5 Column 6
Official controls to ensure plant health 58
Protective measures against pests of plants 59
Legal provisions are available for:
Available and implemented(Yes/No/started but incomplete)
Please indicate how the implemented requirement can be verified ( e.g. the source of publication or other verification means)
Plant health
1
L
2
1
Use of Plant Protection Products part 1 (approval of active substances, criteria, authorization of PPP and adjuvants)60
1
Use of Plant Protection Products part 2 (packaging, labeling and advertising of plant protection products and adjuvant, monitoring and controls)61
21
Legal provisions are available for:
Available and implemented(Yes/No/started but incomplete)
Please indicate how the implemented requirement can be verified ( e.g. the source of publication or other verification means)
Feeding stuff0
Guide of good hygiene practice in primary production available? Is primary production controlled? Records?
Please provide an overview of the general structure of the organization of Feed Control; The management lines from
central to regional to local services should be clearly indicated
Ban on feeding animal protein to Ruminants? how are the rules supervised? If so exemptions?
Is there a re register of Feed Additives? If so , supported by CODEX or other supranational Standards?
Regulation on undesirable substances in Feed including maximum levels to limit as far as possible the presence of
undesirable substances and products ; how is it implemented and supervised;
What are the regulations on GMO in Feed, its traceability and labeling requirements?
62.
63.
64.
66.
67.
65.
Column 2 Column 3 Column 4 Column 5 Column 6
Available and implemented(Yes/No/started but incomplete)
Please indicate how the implemented requirement can be verified ( e.g. the source of publication or other verification means)
Primary Production
Systematic production records( e.g. medical treatment at farms, use of PPP in primary production, records for post-harvest treatments,…)62
1
N
1
2
3
4
5
Control of Feed (organization of official inspections in the field of animal nutrition)63
Additives in feedstuff65
Feeding of proteins derived from animals in order to prevent the dissemination of transmissible spongiform encephalopathy’s (TSEs) to animals.64
Undesirable substances in animal nutrition 66
GMO in Feed, traceability and labeling67
22
The competent Authority states that the specifications and informations as provided above
are true and correspond with the real situation. It is understood that false or non-retrievable
statements may affect:
The data as provided can be verified by the SFDA on site.
Signature
• The listing of a country for the import of a specific product category
• The frequency of onsite assessments of establishments and competent authorities
through SFDA.
• The guarantees to be provided by the exporting country through certificates for
a specific product.
• The physical inspection frequency of the products from a specific country at the borders
of the Kingdom of Saudi Arabia.
• The conditions for banning and lifting of bans for products in certain situations.
23
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:Est. Nameا�® ا�����½ة:
Requested date:
Reply Due date:
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���Competent authority Authenticationد�� ا���� ا������ا�® و���± ���ول ا���½ة Name and sig of Est. Official
Non conformity 1حالة عدم المطابقة 1
Location of non-conformity
Non-conformity category
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Description of non-conformity ����° �م ا� ���� µو�
Identified causes ����¬��ت ا����
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According to reasons mentioned below: ��ب ا�����:�Ë� وذ�
Corrective action: ا��ºاء ا������:
Names & Sig. of the SFDA officers أ��ء و��ا�± ���ول ا��²�
التوقيع المسمى الوظيفيالاســــــم NameJob TitleSignature
SFDA Use لاستخدام الهيئة العامة لغذاء والدواء
[email protected] يتم إرسال النموذج رسمياً ونسخة بصيغة وورد على البريد الإلكتروني
AcceptedRejected
24
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�ة.����ت ا��²� ا����� ����اء وا��واء و�°�� ا§·��ا¨�ت ا���� وا���ا�Ì ا���� ا��°��
Addition
No. Name
PP (processing plant)
MM(Minced Meat) FR (frozen)
SH (Slaughterhouse) CP (cutting plant)
MP(Meat Preparations)
CS (cold store)
OF(Offal)
City/town Region Activity Type Date listed note StatusApproval Number
1.
2.
3.
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.........................................................................................................................................................................................................................................
Removal
No. Name
PP (processing plant)
MM(Minced Meat) FR (frozen)
SH (Slaughterhouse) CP (cutting plant)
MP(Meat Preparations)
CS (cold store)
OF(Offal)
City/town Region Activity Type Date listed note StatusApproval Number
1.
2.
3.
25
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اسم الشخص المسؤول اسم الجهة الرقابية ختم الجهة الرقابيةالتوقيعالتاريــــخ
Current Status
No. Name
PP (processing plant)
MM(Minced Meat) FR (frozen)
SH (Slaughterhouse) CP (cutting plant)
MP(Meat Preparations)
CS (cold store)
OF(Offal)
City/town Region Activity Type Date listed note StatusApproval Number
1.
2.
3.
New Status
No. Name
PP (processing plant)
MM(Minced Meat) FR (frozen)
SH (Slaughterhouse) CP (cutting plant)
MP(Meat Preparations)
CS (cold store)
OF(Offal)
City/town Region Activity Type Date listed note StatusApproval Number
1.
2.
3.
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