Food Safety, Veterinary and Phytosanitary Policy

REPUBLIC OF SERBIA
Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
Bilateral Screening
Genetically Modified Organisms(GMOs),
Release Into The Environment,
Genetically Modified Food and Feed
Ministry of Agriculture and Environmental Protection
Plant Protection Directorate
Brussels
20 – 24 October 2014
REPUBLIC OF SERBIA
Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
LEGAL FRAMEWORK
- Law on Genetically Modified Organisms (OG RS No 41/09)
- Food Safety Law (OG RS No 41/09)
Bylaws (rulebooks):
 Rulebook on deliberate release of GMO and products derived from GMO into the
environment (OG FRY No 62/02),
 Rulebook on the content and data of the register of GMO and products derived from the
GMO (OG FRY No 66/02),
 Rulebook on the content and application form for use in closed systems GMOs, manner of
protection of confidential information in the application, as well as the content of the
application for renewal of approval for use in closed systems (OG RS No 69/12).
REPUBLIC OF SERBIA
Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
NATIONAL LEGISLATION
EU Legislation
Dir. 2001/18/EC
Dir. 2009/41/EC
Reg. (EC) No 1829/2003
Reg. (EC) No 1830/2003
Dir. 2001/18/EC
Dir. 2009/41/EC
SR Legislation
Law on Genetically Modified
Organisms (OG RS No 41/09)
Food Safety Law
(OG RS No 41/09)
Level of
harmonisation
Partly (Part B of Dir.
2001/18/EC)
partly
partly
partly
Rulebook on deliberate release
of GMO and products derived
from GMO into the environment
(OJ FRY No 62/02)
partly,
Part B of Dir. 2001/18/EC
Rulebook on the content and
application form for use in closed
systems
genetically
modified
organisms, manner of protection of
confidential
information
in
the
application, as well as the content of
the application for renewal of
approval for use in closed systems
(OG RS No 69/12 )
partly
REPUBLIC OF SERBIA
Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
LEGAL FRAMEWORK
√
the experimental work with GMOs
Law on Genetically Modified Organisms (scope)
 covers GMOs, as well as LMOs to be used:

in closed systems,

for the deliberate release of GMOs into the environment,
REPUBLIC OF SERBIA
Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
LEGAL FRAMEWORK
Law on Genetically Modified Organisms (exemptions):

product containing GMOs which is not a LMOs and is not used as
food, feed, medicine or auxiliary medicine

GMMs and product containing GMOs which is not a LMOs, if they are
intended for medical use and if their use is governed entirely by other
regulations
REPUBLIC OF SERBIA
Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
LEGAL FRAMEWORK
Law on Genetically Modified Organisms (Ban on trade):
„ No genetically modified organisms or product containing genetically
modified organisms can be traded or grown for commercial use at the
territory of the Republic of Serbia.“
REPUBLIC OF SERBIA
Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
LEGAL FRAMEWORK
Law on Genetically Modified Organisms (Art. 3):
„Agriculture products of plant origin are not considered genetically
modified organism if contain up to 0.9% threshold of genetically
modified organism and impurities of genetically modified organisms.
Seed and reproductive material are not considered genetically
modified organisms if contain up to 0.1% threshold of genetically
modified
organisms
organisms.“
and
impurities
of
genetically
modified
REPUBLIC OF SERBIA
Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
LEGAL FRAMEWORK
Food Safety Law (scope):
 GMOs for food/feed use,
 food/feed containing or consisting of GMOs,
 food/feed produced from or containing ingredients produced
from GMOs.

first placing on the market of GM food and GM feed
REPUBLIC OF SERBIA
Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
COMPATIBILITY (1)
(national level)
Law on GMO
„none living modified organisms or
Law on Food Safety
„...prescribes the manner of the first
products of genetically modified
placing on the market of genetically
organisms cannot be put on the
modified food (GM food) and
market, or grown in commercial
genetically modified feed (GMO feed),
purposes on the territory of the
the manner of issuing permits for the
Republic of Serbia (art.2 of Law on
first placing on the market of of GMO
GMO)“
food and GMO feed, the records of
issued permits, traceability and
labeling of GMO food and GMO feed...“
REPUBLIC OF SERBIA
Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
COMPATIBILITY (2)
National Legal Framework
EU Legal Framework
► ban on commercial cultivation and
► „..pursues the global
placing on the
ensuring a high level of protection of
market of GMOs and
products of GMO
objective of
human life and health and welfare,
environment and consumer interests,
►article 3, Law on GMO
whilst
ensuring
that
the
internal
market works effectively.“
► National legislation regulates GM
► EU has specific legislativ framework
food and feed through the Law on
for GM food and feed Regulations
Food Safety
1829/2003 and 1830/2003
REPUBLIC OF SERBIA
Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
INSTITUTIONAL FRAMEWORK
PLANT PROTECTION DIRECTORATE
Group for Plant Variety
Protection and Biosafety
VETERINARY DIRECTORATE
Expert Council
for Biosafety
Border phytosanitary
inspection Division
Phytosanitary inspection
Division
Other Divisions
Veterinary Inspection
Divisions
Other Divisions
Authorised
Laboratory
REPUBLIC OF SERBIA
Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
INSTITUTIONAL FRAMEWORK
Ministry of Agriculture and Environmental Protection is NCA:
 drafting legislation
 the authorisation process
 supervision and inspection control
REPUBLIC OF SERBIA
Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
INSTITUTIONAL FRAMEWORK
Group for Plant Variety Protection and Biosafety (4 officers)
 drafting legislation
 cooperation with international organisations - UPOV, CPVO, Cartagena Protocol
on Biosafety
 keeping of required registers – PVP & Biosafety
 coordinating the work of the Expert Council for Plant Breeders' Rights and the
Expert Council for Biosafety (ECB)
 check of completeness of submitted applications with Law on GMO & Rulebooks
 preparation of documentation for the final decision in accordance with the
opinion of the ECB
REPUBLIC OF SERBIA
Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
PROCEDURE (1) - Law on GMO
GMO MUST be approved for: - use in closed systems,
- the deliberate release of GMOs into the envir.
(experimental releases)
Application by the user: -
information in accordance with Law and Rulebooks,
plan and methods of supervision of GMOs,
plan of measures in case of an incident,
risk assessment,
propose classification for use in closed system:
class 1 to 4,
- propose of location where GMO will be released
into the environment.
Check of completeness – 30 days
Public discussion – 30 days
REPUBLIC OF SERBIA
Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
PROCEDURE (2) – Law on GMO
Risk assessment – Expert Council for Biosafety(ECB)
Final decision – by the Minister, based on the opinion of Expert Council,
and relevant public comments
Register of GMOs and products of GMOs – approved for deliberate release
into the environment
Duration of authorisation procedure – 90 days + additional time
(additional information, if are asked)
Informing the Public - opinion of ECB & final decision
There were no submitted applications beyond 2009
REPUBLIC OF SERBIA
Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
PROCEDURE (3) – Food Safety Law
The first placing on the market of GM food & feed - HAVE to be
approved
Records keeping of issued approval
Requirements for traceability & obligatory labelling
REPUBLIC OF SERBIA
Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
CONTROL (1)
Inspection supervision is conducted by the Plant Protection
Directorate and Vaterinary Directorate, through the:
 Border phytosanitary inspection Division,
 Phytosanitary inspection Division, and
 Veterinary Inspection Division;
REPUBLIC OF SERBIA
Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
CONTROL (2)
Division of Phytosanitary Inspection control:
- closed system
Law on GMO
- deliberate release into the environment
Food Safety Law
all stages of food production, processing and
transport
Veterinary Inspection controls the feed at all stages of production,
processing and placing on the market
Border Inspections – controls the presence of GMOs in certain import
consignments of plants and plant products (and take samples)
REPUBLIC OF SERBIA
Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
Shipments sampled for the presence of GMOs (B. Phyto. I)
2011.
imports
allowed
Types of shipments
No. of
ship.
batch
(t)
mercantile soy
34
mercantile oilseed rape
2012.
import
prohibited
batch
(t)
7539
228
5
328
mercantile maize
69
rice
No. of
ship.
batch
(t)
56009
180
16236
5
243
0
0
9
511
974
166
4500
84
1335
504
13981
548
14055
627
13138
soybean meal
70
12044
537
75154
391
64467
1
25
oilseed rape meal
11
340
35
1379
31
1224
feed yeast
33
811
29
710
14
342
pet food
38
269
38
313
34
306
seed maize
383
2788
482
5480
585
6958
4
0,01
sugarbeet seed
102
210
161
325
124
293
35
∑
1284
29
42
2266
39
2
batch
(t)
import
prohibited
batch
(t)
392
No. of
ship.
imports
allowed
No. of
ship.
8
batch
(t)
import
prohibited
No. of
ship.
oilseed rape seed
No. of
ship.
imports
allowed
2013.
0,05
42
2121
44
REPUBLIC OF SERBIA
Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
Imported products sampled for the presence of GMOs
2011.
2012.
2013.
presence
of GMOs
Types of products
No. of
imported
products
No. of
samples
No. of
imported
products
No. of
samples
No. of
imported
products
No. of
samples
cereals, milling and bakery
products, pasta and frozen
dough
4801
43
4691
18
4526
5
no
glairy
products
and
mixtures of glairy products
393
115
257
74
251
52
no
fine
bakery
products,
breakfast cereals and snack
products
7702
55
6469
15
8045
12
no
other food products
2436
4
2184
3
other
products
654
5
740
1
3622
6
1002
14
609
2
1504
10
agricultural
feed
∑
236
113
no
no
85
REPUBLIC OF SERBIA
Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
Inspection control of mercantile production of soybeans for the
presence of GMOs
year
No. of examined
plots
No.
of samples
positive
2009.
1625
57
2010.
1100
160
2011.
negative
size of the
area
(ha)
destruction of
GMO crops
121
destruction of
GMO crops
152
9
234,9
destruction of
GMO crops
47
11
50,9
destruction of
GMO crops
25
3
25,4
destruction of
GMO crops
45
4
31
destruction of
GMO crops
161
2012.
1010
58
2013.
1351
28
2014.
1600
49
undertaken
measures
REPUBLIC OF SERBIA
Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
BORDER VETERINARY INSPECTION
Feed
2013
2014
No. of samples
No. of samples
Lab.
report
Fish feed
2
1
negative
Dog feed
1
1
negative
additives for animal feed
9
3
negative
Types of products
REPUBLIC OF SERBIA
Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
AUTHORISED LABORATORIES
 Authorised by the Ministry – 4 laboratories
 GMOs and GMO products – detection, identification & quantification
 Analytical methods for detection, identification and quantification of
GMOs - polymerase chain reaction (real-time PCR)
 Accredited SRPS ISO/IEC 17025 standard by Accreditation Body of
Serbia.
 NO national reference laboratory for GM food and GM feed
REPUBLIC OF SERBIA
Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
INTERNATIONAL OBLIGATIONS
Law on Ratification of Cartagena Protocol on Biosafety to the Convention on
Biological Diversity (OJ SUSM – International Treaties No16/05)
Law on Ratification of Convention on Access to Information, Public
Participation in Decision-Making and Access to Justice in Environmental
Matters (OG RS - International Treaties No 38/09)
* the amendment on GMOs has not been ratified
REPUBLIC OF SERBIA
Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
FUTURE PLANS
In accordance with NPAA (National Programme for
Adoption of the Acquis) it is planned to adopt the new
law on GMO in line with relevant EU legislation
REPUBLIC OF SERBIA
Negotiating Group 12 - Food Safety, Veterinary and Phytosanitary Policy
THANK YOU FOR YOUR ATTENTION

Download Report