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REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
Plant Health – Plant
Protection Products
(PPP`s)
Bilateral Screening
Brussels 20 – 24 October 2014
Ministry of Agriculture and Environmental Protection Plant Protection Directorate
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REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
CONTENT
I. PLACING ON THE MARKET
•Institutional framework
•Legal framework
•Approval of active substances
•Authorisation of PPP`s
•Trade and use of PPP`s – Official control Import Market share Distribution Use
•Gaps, challenges, future plans
•Trainings
II. PESTICIDES RESIDUES • Establishing of MRL`s Institutional framework Legal framework
• Official control Institutional framework Legal framework Annual control plan Import control Laboratories
• Gaps, challenges, future plans
• Trainings 2
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
I. PLACING ON THE MARKET
3
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
4
INSTITUTIONAL FRAMEWORK
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
Official control POLICY AND REGULATION
DIRECTORATE FOR NATIONAL REFERENCE LABORATORIES (DNRL)
Administrative procedures/control
MINISTRY OF AGRICULTURE AND ENVIRONMENTAL
PROTECTION (MAEP)
PLANT PROTECTION DIRECTORATE (PPD)
Department for PPP`s and PNP`s
Evaluation (EVAL), GEP, Machinery, Services (SERV)
LABORATORIES (LABS) External institutions
i m p l e m e n t a t i o n
MINISTRY OF FINANCE
CUSTOM SERVICE
Border Phytosanitary Inspection (BPHI)
Phytosanitary inspection – Internal
(IPHI)
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REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
Official control POLICY AND REGULATION
DNRL 1
Administrative procedures/control
MAEP
3 + 2
PPD
Department for PPP`s and PNP`s
5
EVAL – future; GEP – Provisional; Machinery - 2;
SERV – 34 LABS – 5 External institutions
i m p l e m e n t a t i o n
MINISTRY OF FINANCE
CUSTOM SERVICE
BPHI 36
IPHI 59
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REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
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LEGAL FRAMEWORK
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
EU SRB ALIGNMENT
Dir. 91/414/EEC
The Law on Plant Protection Products (OG RS No 41/09)
Partially aligned
Reg. 1107/2009/EC No
Dir. 128/2009/EC Partially aligned
Reg. 1185/2009/EC No
- The Decision on fees and charges in area of plant protection products (OG RS No 113/13, 30/14)
-
APROVAL OF ACTIVE SUBSTANCES
Reg. 1107/2009/EC Article 6
Conditions and restrictions
The Rulebook on content and keeping of the List of approved active substances, the List of the prohibited active substances and the List of the PPP`s based on decision issued on authorisation of PPP`s (OG RS No 92/11, 92/13, 61/14)
Aligned
Reg. 540/2011/EU The List of approved active substances (OG RS No 72/14)
Aligned 8
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
EU SRB ALIGNMENT
AUTHORISATION OF PPP`s
Reg. 544/2011/EU
The Rulebook on content and manner of treatment and keeping of documentation for assessment of active substances and basic substances (OG RS No 69/12)
Aligned
Reg. 545/2011/EU
The Rulebook on content and manner of treatment and keeping of documentation for assessment of plant protection products (OG RS No 69/12)
Aligned
Reg. 546/2011/EU
The Rulebook on uniform principles for evaluation and authorization of PPP`s (OG of RS No 94/13)
Aligned
Reg. 547/2011/EU
The Rulebook on labeling requirements, standard phrases and safety precautions for special risks to human or animal health or the environment and handling with empty packaging of PPP`s (OG RS No 21/12, 89/14)
Aligned
- The Rulebook on pesticide testing methods (OJ FRY No 63/99, 65/99; OG RS No 93/05)
-
- The list of minor uses (OJ FRY No 6/03) - 9
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
EU SRB ALIGNMENT
DEROGATIONS
Reg. 1107/2009/E
C (Art. 54)
The rulebook on form and content of application for research and development with non-authorised plant protection products (OG RS No 44/13)
Partially aligned
DISTRIBUTION, IMPORT
Reg. 547/2011/EU
The Rulebook on labeling requirements, standard phrases and safety precautions for special risks to human or animal health or the environment and handling with empty packaging of PPP`s (OG RS No 21/12, 89/14)
YES
The rulebook on form and content of application for entry into the Register of Distributors and Importers of plant protection products (OG RS No 5/10)
-
Dir. 2009/128/EC (Art. 5, 6, 13)
The Rulebook on conditions in terms of facilities, equipment and qualification of personnel to be met by the distributor or importer for entry into the Register Distributors and Importers of plant protection products (OG RS No 21/12)
Partially aligned
10
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
EU SRB ALIGNMENT
DISTRIBUTION, IMPORT, USE
- The Rulebook on putting on the market, importation and sampling of pesticides (O J FRY No 58/01 and OG RS No 104/05)
-
-
Ordinance on determination of border inspection posts through which it will be exported, imported and transited consignments of plant protection products and plant nutrition products (OG RS No 111/04)
-
Reg. 547/ 2011/EU
The Rulebook on labeling requirements, standard phrases and safety precautions for special risks to human or animal health or the environment and handling with empty packaging of PPP`s (OG RS No 21/12, 89/14)
Aligned
Dir. 2009/ 128/EC (Art. 8)
The Rulebook on providing services in the field of plant protection (O. FRY No 42/99)
Partially aligned
- The Rulebook on conditions for performing disinfection, insect and rodent control in the field of plant protection (OJ FRY No 12/99)
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REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
OTHER LAWS AND BY-LAWS RELATED TO PPP`S (1)
The Law on Chemicals (OG RS No 36/09, 88/10, 92/11)
The List of classified substances (O.G. RS No 82/10)
The Rulebook on classification, packaging, labeling and advertizing of chemicals and certain product (OG RS No 59/10, 25/11, 5/12)
The Rulebook on classification, packaging, labeling and advertizing of chemicals and certain product in accordance with the Globally Harmonized System of Classification and Labeling of the UN (OG RS No 64/10, 26/11, 5/12) (valid for mixtures from 1.7.2015/1.7.2017)
The Rulebook on classification, packaging, labeling and advertizing of chemicals and certain product in accordance with the Globally Harmonized System of Classification and Labeling of the UN (OG RS 105/13)
The List of substance of concern (OG RS 94/13)
The Rulebook on methods of testing the hazardous properties of chemicals (OG RS No 117/13)
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REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
OTHER LAWS AND BY-LAWS RELATED TO PPP`S (2)
The Rulebook on criteria for identification of substance as PBT or vPvB (OG RS No 23/10)
The Rulebook on restriction and prohibition of production, put on the market and use of chemicals (OG RS No 90/13)
The Rulebook on content of safety data sheet (OG RS No 100/11)
The Rulebook on import and export of certain dangerous chemicals (OG RS No 89/10, 15/13)
The Rulebook on Register of chemicals (OG RS No 100/11, 16/12, 47/12, 15/13, 115/13)
The Patent Law (OG RS 99/11)
The Law on Trademarks (OG RS No 104/09, 10/13)
The Law on Protection of Trade Secret (OG RS No 72/11)
The Law on Packaging and Packaging Waste (OG RS No 36/09)
The Law on Management of Waste (OG RS No 36/09, 88/10) 13
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APPROVAL OF ACTIVE SUBSTANCES
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
PART А1.1: Active substances deemed to have been approved under EU regulations
No
Common Name,
Identification Numbers
IUPAC Name
Purity Entry into
force
Expiration of
inclusion Specific provisions
25 Glyphosate CAS No 1071-83-6 CIPAC No 284
N-(phos-phono-methyl)-glycin
950 g/kg
1 July 2002
31 Decem-ber 2015
Only uses as herbicide may be authorised . In the process of authorisation CA must takes into account conclusions of the review process of the active substance of the relevant bodies of the European Union. In this overall assessment CA must pays particular attention to the protection of the groundwater in vulnerable areas, in particular with respect to non-crop uses.
PART А1.2: Active substances approved under EU regulations
No
Common Name,
Identification Numbers
IUPAC Name
Purity Entry into force
Expiration of inclusion
Specific provisions
38 Helicoverpa armigera nucleopoly-hedrovirus DSMZ number: BV-0003
Not applicable
Min. conc: 1,44 × 1013OB/l (occlu-sion bodies/l)
1 June 2013
31 May 2023
In the process of authorisation CA must takes into account conclusions of the review process of the active substance of the relevant bodies of the European Union. In this overall assessment CA must pays particular attention to the protection of the groundwater in vulnerable areas, in particular with respect to non-crop uses.
PART A2: Basic substances
No
Common Name,
Identification Numbers
IUPAC Name Purity Entry into
force Specific provisions
3 Sucrose CAS No 57-50-1
α-D-glucopyranosyl-(1→2)-β-D-fructofuranoside or β-D-fructofuranosyl-(2→1)-α-D-glucopyranoside
Food grade
1 Janu-ary 2015
Only uses as basic substance being an elicitor of the crop's natural defence mechanisms are approved. In the process of authorisation CA must takes into account conclusions of the review process of the basic substance of the relevant bodies of the European Union.
PART А3: Pending substances
No Common Name,
Identification Numbers IUPAC Name
Specific provisions
35 Topramezone CAS No 210631-68-8 CIPAC No 800
[3-(4,5-dihydro-1,2-oxazol-3-yl)-4-mesyl-o-tolyl](5-hydroxy-1-methylpyrazol-4-yl)methanone
Herbicide
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REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
WITHDRAWN AUTHORISATIONS OF PPP`s
• Non-approved A.S.
• 27 A.S.
• 70 PPP`s
WITHDRAWN AUTHORISATIONS OF PPP`s
• Neonicotinoid insecticides – treatment of specified seed , soil treatment
• Fipronil – seed treatment, soil treatment
• Other PPP`s – intended use not in compliance with specific provisions (Part A restrictions of the List of approved AS)
AMENDED AUTHORISATIONS OF PPP`s
• Neonicotinoid insecticides – foliar treatment
• Other PPP`s – intended use not in compliance with specific provisions (Part A restrictions of the List of approved AS)
16
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
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AUTHORISATION OF PPP`s
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
OLD SYSTEM
The Law on PPP`s; Art. 86, para. 3
The Law on Plant Protection
Articles: 47, 48 (para . 2), 50 (para. 1, 3, 4),
52 (para . 1), 54 (para. 1, 2), 55 (para. 1, 2), 56
Duration of authorisation: Not exceeding 10 years
Grace period: 18 months (6 + 6 + 6)
NEW SYSTEM
The Law on PPP`s; Articles 11-24
IN FORCE: Recognition Administrative amendment Derogations: Emergency situation,
Research and development
FROM OCTOBER 2015 (UP): Full and provisional authorisation, Existing product alignment
Duration of authorisation: Not exceeding 10 years (incl. 3 years from the date of expiry of the approval of
the A.S.)
Grace period: 18 months (6 + 6 + 6)
PPP`s based on generic A.S.
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REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
OLD SYSTEM
Reports
Dossier
APPLICANT
Toxicological evaluation 4 institutions
Report
2 Efficacy tests in RS
Phys/Chem test in RS
6 institutions
APPLICANT
Advisory Body
Opinion
Final Decision Authorisation
5 institutions
List of PPPs Annual publication
MAEP - PPD
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REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
Content of the List of authorised PPP`s
No Trade name
Active substance Short business name Decision
Dura-tion Generic
name Con-tent
of produ-
cer
of agent/ representative
on authorisation on amendment of
authorisation
Number Date Number Date
1. PPP`S BASED ON CHEMICAL SUBSTANCES
1.1. HERBICIDES
1.2. PLANT GROWTH REGULATORS
1.3. FUNGICIDES 1.3.1. Fungicides for seed treatment
1.4. INSECTICIDES 1.4.1. Insecticides for seed treatment
1.5. ACARICIDES
1.6. NEMATOCIDES
1.7. LIMACIDES
1.8. RODENTICIDES
1.9. REPELLENTS
1.10. SOIL DESINFECTANT
2. BIOPESTICIDES 2.1 PLANT GROWTH REGULATORS - BIOCHEMICAL
2.2. BIO-FUNGICIDES 2.2.1. Bio-fungicides – Microbiological 2.2.2. Bio-fungicides – Biochemical
2.3. BIO-INSECTICIDES 2.3.1. Bio-insecticides – Microbiological 2.3.2. Bio-insecticides – Biochemical
2.4. BIO-ACARICIDES – MICROBIOLOGICAL
2.5. REPELLENTS – BIOCHEMICAL
3. PROTECTANTS
4. ADJUVANTS 20
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
387
325
196 42
1 15 Herbicides
Fungicides
Insecticides
Others
Protectants
Adjuvants
Domestic producers
27%
223
727 Domestic producers
Foreign producers
21
Source: PPD
Generic foreign producers
R&D Companies
50%
23%
AUTHORISED PPP`s
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
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GAPS, CHALENGES
AND FUTURE PLANS
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
• NO GLP INSTITUTIONS IN RS • NO ACCESS TO THE DARS AND OTHER DOCUMENTS OF A.S.
APPROVED AT EU LEVEL • EXISTING PPP`S ALIGNMENT Initial plan have started within the IPA 2008 (TW partner UK –
CRD) Final plan with precise deadlines was made on 31.12.2013 Administrative extension of authorisations Deadline for submission of data for Compliance of technical
specification/ Letter of Access and Access to Annex II data 6 group of A.S. (aligned with the renewal programme) Recognition process
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REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
• LACK OF IT SOURCES • PLAN
Amendments of the Law on PPP`s
External Evaluators – Contracting in procedure
Trainings - New Twinning project approved (existing PPP`s / new system)
New law according to Reg. 1107/2009
GEP Institutions – Final Control and Certification
24
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
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REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
DRAFT SCHEME OF THE NEW SYSTEM OF AUTHORISATION
APPLICANT
Meetings of Evaluators &
Co-ordinators
Distribution to Evaluators
External Institutions
Contracts
CO-ORDINATORS
- completness check -
Final authorization
Advisory
Body
Final
authorization APPLICANT
In MAEP – PPD
MAEP – PPD
“regular”
procedure
certain “more
complex”
applications
MAEP – PPD
26
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
Twinning Project SR2005/IB/AG/02 (2007 – June 2010)
Twinning Project SR2008/IB/AG/01 (October 2010 – June 2013)
TAIEX TAIEX AGR 46300 (2011) – Regional Workshop on Registration of PPP`s Map 2014 TAIEX AGR 5035 Evaluation of PPP`s – Efficacy TAIEX AGR 5036 Evaluation of PPP`s - ECOTOX TAIEX AGR 5037 Evaluation of PPP`s - PHYS/CHEM TAIEX AGR 5038 Evaluation of PPP`s – TOX TAIEX AGR 57681 Evaluation of PPP`s – OPEX TAIEX AGR 56040 SOP TAIEX AGR 5042 Evaluation of PPP`s – STUDY VISIT PHYS/CHEM
BTSF TRAINING COURSES ON “PLANT PROTECTION PRODUCTS” Evaluation and Registration of Plant Protection Products
EFSA Study Tour 2010, 2011, 2013
TRAININGS
FUTURE TAIEX AGR 56039 Evaluation of PPP`s – FATE & BEHAV
IPA 2013 unallocated funds – TW Authorisation of PPP`s Information system/Project ITCM 12SER01/10/81 27
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
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TRADE AND USE OF PPP`s
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
IMPORT OFFICIAL CONTROL
• Total number of BIP`s - 24 • Number of BIP`s for PPP`s import - 14 • Every consignment is under control
2.500
PPP`s
A.S.
160
840
Annually scope of work – Number of consignment
3 4
2012
2013
Non-compliance consignments
Documentary check
Identification of consignment
Inspection of consignment
Sampling
Phys/Chem tests
Import allowed or banned - Based
on results 29
Source: PPD
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
2.500 2.500
0 1000 2000 3000 4000 5000 6000 7000
Export of OTHERS
Export of INSECTICIDES
Export of FUNGICIDES
Export of HERBICIDES
Production of HERBICIDES
Import of OTHERS
Import of INSECTICIDES
Import of FUNGICIDES
Import of HERBICIDES
Total import of A.S.
Total Import of PPP`s
2013
2012
30 Source: PPD, Chamber of commerce
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
2.500
MARKET OF PPP`s (about 91.5 million €)
Market share of PPP`s by class in 2013 (VALUE)
INSECTICIDES 25% FUNGICIDES 25%
HERBICIDES 49%
Market share of PPP`s by producers in 2013 (VALUE)
Generic ino producers 24%
Domestic producers 29%
R&D 47%
31 Source: Chamber of commerce
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
DISTRIBUTION OF PPP`s - OFFICIAL CONTROL
Register of distributors and importers of PPP`s
• Facilities 743
• Entities 601
Control of quality of PPP`s on the market
Documentary check
Identification of PPP`s
Inspection of PPP`s
Sampling/Opcionally
Phys/Chem tests/Opcionally
Infringement procedures - Based of results of checks and/or results
2.500 2.500
555
126 62
Reatail
Wholesale
Both
Monitoring of formulations Not implemented Reasons •Import control •Budgetary cuttings Control on request – 20 cases (2011-2012)
32
Source: PPD
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
USE OF PPP`s – OFFICIAL CONTROL
Register of service providers of PPP`s
- Advisory services (2)
- Operational services/Treatment (68)
Control of use of PPP`s
- Documentary check/Record of treatments
- Identification of end user
- Inspection of end user
- Sampling/Optionally
- Phys/Chem tests/Optionally
- Residue analysis/Optionally
-Infringement procedures - Based on results
of checks and/or results
CONTROL OF USE ON REQUEST
2012
Apple leaves - (beekeepers)
Cherry leaves and fruits
- (beekeepers)
Tomato clothianidin
Carrot -
30%
70% YES NO
Records keeping
33
Source: PPD
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
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GAPS, CHALENGES
AND FUTURE PLANS
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
• FORMULATION MONITORING PLAN Reference laboratory – Amendments of the Law on PPP`s Official Laboratories – Amendments of the Law on PPP`s Budget resources – planed in 2015, 2016, 2017
• FEES AND CHARGES OF OFFICIAL CONTROL Independency between sampling, analyzing and results on import
• HOME GARDEN PRODUCTS – Amateur use Amendments of the Law on PPP`s
• LACK OF PPP`s IN ORGANIC PRODUCTION
• NO STATISTICS ON PESTICIDES (EXCEPT IMPORT) New Twinning project planned – IPA 2016 Resources – Collecting of data – plan: Agricultural services Resources – Statistics and Reporting – plan: Statistic office
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REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
• TWINNING PROJECT SR2012/IB/AG/01 (IMPLEMENTATION OF SUD DIRECTIVE)
Amendments of the Law on PPP`s
Trainings of end users, distributors and service providers
Improve requirements for retail distribution of PPP`s
Inspection of application equipment – supply of measuring instruments is in progress
Aerial spraying
IPM
National Action Plan • LACK OF IT SOURCES Information system / Approved Project ITCM 12SER01/10/81
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REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
Twinning Project SR2005/IB/AG/02 (2007 – June 2010)
Twinning Project SR2008/IB/AG/01 (October 2010 – June 2013)
Twinning Project SR2012/IB/AG/01 (in implementation from October 2013) (SUD Directive)
TAIEX TAIEX AGR (2011) – IPM TAIEX AGR 48162 (2012) – Application equipment TAIEX AGR 46369 (2012) – Neonicotinoide insecticides TAIEX AGR 51446 (2013) – Fake products
BTSF TRAINING COURSES ON “PLANT PROTECTION PRODUCTS” Control on use and marketing of plant protection products
Information system / Approved Project ITCM 12SER01/10/81 37
TRAININGS
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
II. PESTICIDES RESIDUES
38
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
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ESTABLISHING OF MRLs
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
INSTITUTIONAL FRAMEWORK
POLICY AND REGULATION
WITH THE CONSENT
MINISTRY OF
AGRICULTURE AND
ENVIRONMENTAL
PROTECTION
(MAEP)
MINISTRY OF HEALTH (MH)
DRAFTING
PUBLICATION OF MRL
Administrative procedures/control
PLANT PROTECTION DIRECTORATE (PPD)
Department for PPP`s
and PNP`s
EU PUBLISHED HARMONISED
MRL
40
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
LEGAL FRAMEWORK
41
Alignment with REG. 396/2005 National Legislation
Partially Art. 3 para. 2 point a, c, d; Art. 4 para. 1; Art. 34, 38
The Law on PPPs (OG RS No 41/09)
Partially Art. 2 para. 1 and 2 , Art. 3 para. 2 point e, f, h, I, j; Art. 4 para. 1; Art. 5. para. 1; Art. 18. para. 1; Art. 20 para. 1;
Annex I – Reg.2012/2013 – Aligned, NOT with Reg. 752/2014
Annex II – Reg. 149/2008 – Aligned
Annex III – Reg. 149/2008 – Aligned
Annex IV – Reg. 149/2008 – Aligned
Annex V – Reg. 889/2012 – Aligned
Annex VI – NO
Annex VII – NO Annex Reg. 1881/2006/EC – Aligned
The Rulebook on MRL`s of PPP`s in food and feed and on food and feed for which MRL`s of plant and animal origin are establishing (OG RS No 29/14, 37/14, 39/14, 72/14) Annex I
Annex II Annex III
Annex V Annex IV
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OFFICIAL CONTROL
-INSTITUTIONAL FRAMEWORK-
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
Official control POLICY AND REGULATION
Administrative procedures/control
MINISTRY OF AGRICULTURE AND ENVIRONMENTAL
PROTECTION (MAEP)
PLANT PROTECTION DIRECTORATE (PPD)
LABORATORIES (LABS) External institutions
i m p l e m e n t a t i o n
Veterinary Inspection – Border and Internal –
Phytosanitary inspection – Border and Internal –
43
VETERINARY DIRECTORATE (VD)
MINISTRY OF HEALTH (MH)
Secretariat for Health, Social Policy and
Demography (SHSPD)
Sector for Agricultural Inspection (SAI)
Department for Sanitary Inspection (DSI)
SECTOR FOR INSPECTION AFFAIRS (SIS)
Sector for Sanitary Surveillance and Public
Health (SSSPH)
Departments for Sanitary Inspection (DSI)
Directorate for National Reference Laboratories
(DNRL)
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
Official control POLICY AND REGULATION
Administrative procedures/control
PPD 5
LABS 20 External institutions
i m p l e m e n t a t i o n
VI 31 + 309
PHI 36 + 18 + 59
44
VD 5
DSI 185 + 30
DSI 57
SAI 30 + 25
MAEP
3 + 2
MH 1 + 1
SIA
SHSPD SSSPH
INSTITUTIONAL FRAMEWORK (1) - Resources
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
LEGAL FRAMEWORK
45
EU SRB Alignment
Reg. 396/2005, Art. 26; Art. 27; Art. 30 para. 1
The Law on Plant Protection Products (OG RS No 41/09)
Partially
Reg. 178/2002/EC, 882/2004/EC
The Law on Food Safety (OG RS No 41/09) Partially
Dir. 2002/63/EC The Rulebook on methods of sampling and analyses of residues of PPP`s in food (OG RS No 110/12)
Aligned
Reg. 788/2012/EU The Rulebook on monitoring program of residues in food for 2013 (OG RS No 12/13)
Partially
Reg. 788/2012/EU The Rulebook on monitoring program of residues in food for 2014 (OG RS No 12/14)
Partially
-
The Decision on the fees for laboratory analysis of food and feed of plant origin taken during official controls (OG RS No 57/09, 31/10, 113/13)
-
Reg. 669/2009/EC - -
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
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ANNUAL CONTROL PLAN
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
2013 – planned
•53 A.S. in food of plant origin •20 A.S. in food of animal origin
2014 – planned
• Additionally – 40 samples of
tomatoes • 63 A.S. in food of plant origin • Additionally – etefon • 22 A.S. in food of animal origin
No of samples
Total Domestic Import
789 66% 34%
Plant origin 661 64% 36%
Animal origin 48 46% 54%
Composite 95 83% 17%
No of samples
Total Domestic Import
1.159 63% 37%
Plant origin 911 66% 34%
Organic production
9%
Animal origin 108 50% 50%
Composite 140 49% 51%
Organic production
7%
47 Source: PPD
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
2013 – FOOD OF PLANT ORIGIN FINDINGS
2014 – FOOD OF PLANT ORIGIN FINDINGS
Food A.S. Level
mg/kg
RS MRL
mg/kg
EU MRL
mg/kg
Rasp-berries
Acet-amiprid
0,025 0,01 2,0
Peaches Chlorpy-rifos
0,35 0,2 0,2
Nectarines Captan 0,035 0,02 4,0
Apples Acet-amiprid
0,16 0,1 0,8
Table grapes
Procy-midon
0,2 0,02 0,01
Sweet peppers
Procy-midon
0,06 0,02 0,05
Eggplant Pyridate 0,121 0,05 0,05
Food A.S. Level
mg/kg RS =EU MRL
mg/kg
Table grapes
Dimethoate 0,372 0,02
Methomyl 0,194 0,02
Peaches Chlorpyrifos 0,605 0,2
Beans
Fenitrothion 2,52 0,01
Chlorpyrifos 0,46 0,05
Carbaryl 0,258 0,01
Spinach fresh
Dithio-carbamates
0,71 0,05
Ethofenprox 15,41 3
Dithio-carbamates
0,86 0,05
Spinach frozen
Dithio-carbamates
0,35 0,05
48 Source: PPD
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
REGULATORY PROGRAMME FOR CONTROL OF RESIDUES IN FOOD OF ANIMAL ORIGIN
FOOD OF ANIMAL ORIGIN
2012 AND 2013 – 66 SAMPLES NO non-compliant samples
B3a. ORGANOCHLORINE COMPOUNDS
aldrin and dieldrin
DDT
endrin
heptachlor and heptachlor epoxide
HCB
HCH
lindane
B3b. ORGANOPHOSPHORUS COMPOUNDS
malathion
cumaphos
diazinon
49
Source: UV
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
50
IMPORT CONTROL
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
FOOD OF NON-ANIMAL ORIGIN
1.353
0
10,000
20,000
30,000
40,000
50,000
60,000
70,000
80,000
90,000
Total No of consignement No of consignement analised onorganochlorine pesticides
58,187 58,187
82,771
12.596 (15%)
1st January 2011 - 1st October 2012 1st October 2012 - 1st October 2014
CARB
OP
triazine
….
82.771
12.596
51 Source: PPD
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
FINDINGS
1.1.2011-1.10.2012 – FOOD OF PLANT ORIGIN
1.10.2012-1.10.2014 – FOOD OF PLANT PRIGIN
Food A.S.
Apples Dipheylamine
Cucumber Dimethoate
Lettuce Chlorpyrifos
Vine leaves stuffed with rice
Boscalid Mеtalaxyl Penconazole Pyrimеthanil Triadimеnol Trifloxystrobin
Sesame Lindane, gamma-HCH
Spinach – dried Аzoxystrobin
Marinated vine leaf
Chlorpyrifos Boscalid Trifloxystrobin Кrеsoxime-mеthyl
Marinated vine leaf
Chlorpyrifos Lambda-cyhalothrin Mеtalaxyl Myclobutanil Pyrimеthanil Tebuconazole Penconazole Кrеsoxime-mеthyl Fludioxonil Boscalid
Food A.S.
Wheat flour (durum)
Permеthrin
52 Source: PPD
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
FOOD OF ANIMAL ORIGIN
82.771
0
1,000
2,000
3,000
4,000
5,000
6,000
7,000
Total No of consignement No of consignement analised onpesticides
2012
2013
53
OCH: aldrin and dieldrin; DDT; endrin; heptachlor and heptachlor epoxide; HCB; HCH; lindane; OPH: malathion; cumaphos; diazinon NO NON-COMPLIANT CONSIGNMENT
Source: UV
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
54
CONTROL OF OTHER FOOD
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
55
TYPE OF FOOD •Dietetic products •Additives •Enzyme preparations
0 500 1000 1500 2000 2500 3000 3500 4000 4500
Total number of samples
Number of samples for residues
Non-complient samples
Total number of samples
Number of samples for residues
Non-complient samples
Total number of samples
Number of samples for residues
Non-complient samples
Die
teti
c p
rod
uct
sA
dd
itiv
es
Enyz
me
pre
par
atio
ns
2012 2011 2010
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
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LABORATORIES SRPS ISO/IEC 17 025:2006
Source: Accreditation Body of Serbia
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
FOOD OF PLANT ORIGIN COMPOSITE / BABY FOOD FOOD OF ANIMAL ORIGIN
SP Laboratory, Bečej Public health institute of Belgrade
Institute of meat hygiene and technology, Belgrade
LC-MS, GC-MS, GC-ECD, GC-ECD-HSS and LC-MS/MS
LCDAD and FLD, LCVWD and DAD, GC-ECD-HSS, GC-MS, GC-MS/MS, LC-MS/MS
GC-MS and GC-ECD
Multi-residue methods (402 analytes), one single methods (dithiocarbamates)
QuEChERS multi residue method (203 analytes for quantitative analyses and 927 for screening method)
QuEChERS multi residue method (8 organochlorine pesticides)
LOQ for all analytes were set to 0.01 mg/kg
LOQ for all analytes were set to 0.005 mg/kg
LOQ for all analytes were set to 0.01 mg/kg
LIMS inernal LIMS
EU-RL PTs FAPAS PT FAPAS PT
ANNUAL CONTROL PLAN
57
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
Laboratory Method Number of
analytes LOQ
Center for food analysis, Belgrade
GC-MS, GC-ECD, QuEChERS multi residue method
88 0,010 mg/kg
Knjaz Milos, Arandjelovac
GC-MS, GC-ECD, QuEChERS multi residue method
101 0,01-1 mg/kg
Anahem, Belgrade GC-MS, GC-ECD QuEChERS multi residue method
62 0,0025 - 0,02 mg/kg
Oenology station, Vrsac
GC-MS, GC-ECD 71 5-250 μg/kg 0,01 – 0,5 mg/l
FINSLab, Novi Sad GC-MS multi residue screening method
49 0,005 -0,05 mg/kg
Public Institut of Vojvodina, Novi Sad
GC-MS QuEChERS multi residue method
58 0,01 mg/kg 58
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
Laboratory Method Number of
analytes LOQ
ORGANOCHLORINE, ORGANOPHOSPHOROUS, TRIAZINE, CARBAMATE
Public health institute of Kragujevac
GC-MS 51 Och: 0,01-2,5 mg/kg Oph, T: 0,01-2,0 mg/kg Carb: 0,3-2,0 mg/kg
A BIO TECH LAB , Sremska Kamenica
GC-MS 60 0,001 - 50 mg/kg
ORGANOCHLORINE, ORGANOPHOSPHOROUS, TRIAZINE
Public health institute of Sabac
GC-μECD, GC-NPD
60 0,0004-0,4 mg/kg
Public health institute of Leskovac
GC-ECD 30 Och, T: 0,0007-0,04 mg/kg Oph 0,05-0,50)mg/kg
59
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
Laboratory Method Number of
analytes LOQ
ORGANOCHLORINE, ORGANOPHOSPHOROUS
Public health institute of Nis GC-MS, GC-ECD 22 0,01-2,0 mg/kg
Public health institute of Cacak GC-ECD, GC-TSD 17 0,002-1 mg/kg
Public health institute of Uzice GC-ECD, GC-NPD 57 Och: 0,003-0,1 mg/kg Oph: 0,02-1 mg/kg
ORGANOCHLORINE
Eko-Lab, Padinska Skela GC-ECD 8 0,001-1 mg/kg; 0,0001-0,5 mg/kg
Alfa Lab, Aleksandrovac GC-MS 18 0,001 mg/kg
Public health institute “dr Milan Jovanovic-Batut”, Belgrade
GC-MS 16 0,02-2,0 mg/kg
Public health institute of Zajecar
GC-ECD 19 0,005-0,10 mg/kg
Public health institute of Vranje
GC-ECD 16 0,001-0,4 mg/kg
Public health institute “Pomoravlje”, Cuprija
GC-ECD 17 0,01-1,00 mg/kg
Jugoinspekt, Belgrade GC-ECD 9 0,001mg/l
60
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
• NO REFERENCE RESIDUE LABORATORY Amendments of the Law on PPP`s and the Law on food safety Independency between sampling, analyzing and results
• NATIONAL MULTI/ANNUAL CONTROL PLANS Preparation phase Budget resources – planed in 2015, 2016, 2017
• LACK OF IT SOURCES Development of integrated IT system / Approved Project ITCM
12SER01/10/81
• Harmonisation with Reg. 752/2014 Forth Quarter 2015
• New Twinning project – Post-registration control including residues – planned – IPA 2016
GAPS, CHALENGES AND FUTURE PLANS
61
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
TRAININGS
Twinning Project SR2005/IB/AG/02 (2007 – June 2010)
Twinning Project SR2008/IB/AG/01 (October 2010 – June 2013)
BTSF TRAINING COURSES “OFFICIAL IMPORT CONTROLS ON FEED AND FOOD NON-ANIMAL ORIGIN ” “ TRACES – TRADE CONTROL AND EXPERT SYSTEM USE AT IMPORT OF PRODUCT OF PLANT ORIGIN”
TAIEX PREPARING AND IMPLEMENTATION OF NATIONAL MULTI-ANNUAL CONTROL PLANS Development of integrated IT system / Approved Project ITCM 12SER01/10/81
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REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
63
“If you want to go fast, go alone. If you want to go far, go together.”
African proverb
REPUBLIC OF SERBIA Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
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THANK YOU FOR YOUR ATTENTION