US embassy cable - 03ZAGREB2224

UNCLAS  ZAGREB 002224 
 
SIPDIS 
 
 
STATE FOR EB/DMALAC AND OES/HLEE 
 
STATE PASS USAID/JLEWIS 
 
STATE PASS FDA/RLAKE 
 
STATE PASS EPA/JANDERSEN 
 
USDA FOR FAS/OA/BSIMMONS 
 
USDA FOR APHIS/DRS/JTURNER 
 
E.O. 12958: N/A 
TAGS: EAGR, ECON, ETRD, SENV, TBIO, TSPL, HR, Trade 
SUBJECT: STATUS OF CROATIAN BIOTECH REGULATIONS 
 
REF: STATE 263456 
 
1.  The following information responds to questions 
reftel, approximately in the order questions were asked. 
 
Entry Into Force 
---------------- 
 
2.  Over the past five months in Croatia, several pieces 
of legislation regulating the importation, cultivation 
and marketing of biotech crops and foods have been 
passed.  Many provisions of these laws are still not in 
force and thus it is difficult to state definitively how 
they will function in practice. 
 
3.  The Law on Consumer Protection was the first biotech- 
related law to be passed.  It was published in the 
government gazette, number 96/03 on June 10, 2003, after 
being approved May 29.  The Food Act was approved by 
Parliament on July 14 and published in government gazette 
number 117 on July 23.  The third law that passed 
Parliament (03/09/03) is the Law on Protection of Nature 
(not yet published in the government gazette).  Since we 
still do not have this law's actual text, this cable was 
compiled on the basis of the final draft that went to 
parliamentary procedure.  According to newspapers and 
governmental sources, the amendments made to the final 
text deal only with the restriction of GMO planting in 
national parks, nature parks, and other protected zones, 
as well as in areas intended for ecological agriculture 
and tourism. 
 
4.  Normally laws enter into force eight days after being 
published in the government gazette.  The Consumer 
Protection law was applied 90 days (enforced 8 days) 
after being publishing (it is unclear to us the 
difference being "being in force" and "application," but 
these two periods are laid out in the law).  Provisions 
on product labeling from the Consumer Protection Law will 
be regulated by sub-laws.  Until they are enacted, the 
old provisions from the Law on Norms will be applied as 
long as they do not contradict the Law on Consumer 
Protection. 
 
5.  Articles 29, 74 (section 4), and 75 of the Food Law 
will be applied at the latest three years after the law 
came into force.  Article 29 deals with introduction of 
HACCP in food handling and processing facilities. 
Articles 74 (section 4) and 75 deal with authorized 
testing laboratories and reference laboratories for 
official food control. 
 
Regulatory Process 
------------------ 
 
6.  The Law on Protection of Nature is the overarching 
law for biotechnology issues and, together with the Food 
Law and future sub-laws, regulates the importation, 
transshipment, production, usage, and sale of products of 
agricultural biotechnology (all food, feed and seed).  To 
import agricultural biotechnology products into Croatia, 
the importer must, according to the Law on Protection of 
Nature, have a permit for limited usage or intentional 
introduction into the environment before placing the 
product on the market.  "Limited usage" is only relevant 
for trials and will not be considered in detail in this 
cable. 
 
-- Procedure for obtaining a permit for intentional 
release into the environment 
 
7.  To introduce a GMO into the environment, a permit 
from the Ministry of Environment is needed, as well as 
the consent of the Ministry of Agriculture.  Before 
applying for a permit, a risk assessment study by an 
authorized company is mandatory (though existing risk 
assessment studies from other sources may be used, with 
the source's written consent). 
 
8.  The Minister of the Environment, with the consent of 
the Minister of Agriculture, will specify in special 
regulation the content, scope, and methodology of these 
 
risk assessments, as well as the companies authorized to 
perform the assessment studies.  Before introducing the 
GMO into the environment, a contingency plan (in case of 
uncontrolled spreading of the GMO) is also required.  The 
government will outline the approximate contents and 
application plan of these measures.  The permit 
application must contain: technical documentation with 
prescribed parts, a risk assessment, contingency plan, 
and other relevant data.  The Minister of the Environment 
will describe, in a special regulation with consent of 
the Minister of Agriculture, how to apply for a permit, 
and contents of the permit application.  The Ministry of 
Environment, with consent of Ministry of Agriculture, 
will issue the permit within 90 days of receiving the 
application.  Permits may be issued in an abbreviated 
procedure if there is enough information and experience 
about releasing the particular GMO into the environment. 
In that case, the permit can be issued within 30 days. 
 
-- Procedure for obtaining a permit for placing product 
onto the market 
 
9.  Any GMO placed on the market for the first time 
requires a special permit.  The permit is issued for a 
maximum of 5 years, but is renewable.  Permits for 
products used in agriculture, forestry and fishery are 
issued by an agency of the Ministry of Agriculture, with 
the consent of the Ministry of Environment.  Permits for 
foodstuffs are issued by an agency of the Ministry of 
Health, with the consent of the Ministry of Agriculture. 
Before applying for a permit, a risk assessment study is 
mandatory.  The Minister of the Environment with the 
consent of the Minister of Agriculture and the Minister 
of Health will prescribe the contents and scope of the 
risk assessment study, to be laid out in a special 
regulation.  Each application must contain technical 
documentation, a risk assessment study, conditions of 
placing the product on the market, a monitoring plan, a 
time-span proposal for the permit, a labeling proposal, a 
packaging proposal, and a summary of technical 
documentation.  Another permit must be obtained for each 
additional application of approved GMOs.  The Minister of 
the Environment, with the consent of the Minister of 
Agriculture and Minister of Health, will describe the 
required contents of the application and technical 
documentation, and the conditions of monitoring, labeling 
and packaging, in a special regulation.  If placing the 
product on the market causes intentional or unintentional 
introduction of GMOs into the environment, a copy of the 
application will go to the Board for Introduction of GMOs 
into the Environment.  If food or feed will be placed on 
the market a copy of the application will go to the Board 
for Novel Food and Feed.  These boards must report back 
within 60 days of receiving the application. 
 
10.  Additionally, the Food Law requires that all novel 
foods introduced into the market be approved by the 
Minister of Health in agreement with the Minister of 
Agriculture, based on the previously obtained scientific 
expert statement of the Croatian Food Agency.  The 
conditions and the procedure for issuing the approval 
shall be provided by the Minister of Health in 
cooperation with the Minister of Agriculture. 
 
Enforcement 
----------- 
 
11.  The following Ministries and Agencies monitor and/or 
enforce the mentioned laws: 
 
-- Ministry of Environmental Protection and Spatial 
Planning (Ministry of Environment) 
 
Contact:  Roko Andricevic 
 
Assistant Minister for Environmental Protection 
Grada Vukovara 78 
10 000 Zagreb 
tel. 00385 1 6106 556 
fax 00385 1 6116 388 
zastita-okolisa(at)mzopu.hr 
 
-- Ministry of Health 
 
Contact:  Croatian Institute for Public Health 
 
Krunoslav Capak 
Rockefeller 7 
10 000 Zagreb 
tel. 00385 1 468 3007 
 
-- Ministry of Agriculture and Forestry (Ministry of 
Agriculture) 
 
Contact:  Miroslav Bozic 
 
Assistant Minister for Agricultural Policy and Rural 
Development 
Vukovarska 78 
10 000 Zagreb 
tel. 00385 1 6106 111 
fax. 00385 1 6109 206 
 
-- Croatian Food Agency 
 
Not yet established. 
 
-- State Inspectorate 
 
-- Law on Protection of Nature 
 
12.  Oversight will be done by environmental protection 
inspectors, sanitary inspectors, veterinary inspectors, 
agricultural inspectors, plant protection inspectors, 
state inspectorate inspectors, etc.  The testing 
laboratory will be established by the Ministry of Health 
with support from the Ministry of Agriculture and the 
Ministry of Environmental Protection. 
 
Company penalties for violating the biotech provisions of 
the Law on Protection of Nature will range from Kn 
100,000 to Kn 1,000,000 depending on the violation, with 
responsible employee penalties from Kn 15,000 to Kn 
70,000. 
 
-- Food Law 
 
13.  Oversight is done by sanitary inspectors, border 
sanitary inspectors, veterinary inspectors, border 
veterinary inspectors and other state officials who are 
authorized by a competent Minister. 
 
Company penalties for violating the "novel food" 
provisions of the Food Law concerning placing novel food 
on the market or labeling (see below) will be from Kn 
100,000 to Kn 500,000, with each responsible individual 
fined from Kn 5,000 to Kn 10,000. 
 
-- Consumer Protection Law 
 
14.  Oversight (see below on labeling) is done by the 
State Inspectorate and other designated inspectors. 
 
Manufacturer or trader penalties for releasing 
incorrectly labeled (or unlabeled) product on the market 
will range from Kn 50,000 to Kn 100,000 and each 
responsible employee will be penalized from Kn 3,000 to 
Kn 5,000. 
 
The current exchange rate is approximately $1 = Kn 6.5. 
 
Shipments of Biotech Products 
----------------------------- 
 
15.  Shipments of agricultural biotech products should be 
tested in the newly opened biotechnology-testing 
laboratory.  This laboratory is not yet testing samples 
because there are still no specific regulations 
specifying what tests should be done.  Thus, for the 
moment, agricultural biotechnology products can enter 
Croatia undetected.  But there are indications that 
testing will start soon. 
 
Traceability System 
 
------------------- 
 
16.  Traceability as mentioned in the Food Law deals not 
only with biotech products.  It is a system for all 
levels of production, processing and distribution of 
foodstuffs, raw materials of vegetable and animal 
origins, food-producing animals or animals used in food 
production, which includes the tracing of any other sort 
of material intended for incorporation (or which shall be 
incorporated) into food.  Food business operators must 
establish a record keeping system of their suppliers and 
customers.  Food placed on the market must be identified 
by specific documentation or other information. 
 
17.  The Law on Protection of Nature requires that all 
agricultural biotechnology products have documentation 
indicating the product as a GMO or containing GMOs, and a 
correct code that is given to a particular GMO.  All 
companies that place GMOs or products containing GMOs on 
the market must keep a database and have a procedure 
enabling the identification of companies from which the 
product was obtained or to which it was sold, for five 
years after it was placed on the market (excluding end 
consumers). 
 
Documentation 
------------- 
 
18.  For agricultural products that may contain the 
products of agricultural biotechnology, special 
documentation is needed.  Documentation is the same as 
for 100 percent agricultural biotechnology products. 
Unfortunately, there are no specifications yet because 
regulations that should outline documentation are still 
unpublished. 
 
In-country Field Tests 
---------------------- 
 
19.  In-country field tests are not required prior to 
regulatory approval of a biotech crop by current 
legislation (see previous text). 
 
Biotech Approvals 
----------------- 
 
20.  A complete list of the information required by the 
government for biotech crop application consideration 
(under the Law on Protection of Nature, see the procedure 
for obtaining a permit for intentional release into the 
environment) is: technical documentation with specific 
parts (data about the applicant; data on GMO; data on 
conditions of environmental release; data on interaction 
of GMO and environment; monitoring program; data on 
methods of supervision over release of GMO; data on 
handling GMO waste; summary of technical documentation), 
risk assessment of GMO introduction in environment, 
contingency plan (in case of uncontrolled spread of GMO 
in environment), and other relevant data. 
 
Labeling 
-------- 
 
21.  Food and feed containing agricultural biotechnology 
products must be labeled according to the Food Law, the 
Law on Protection of Nature and the Consumer Protection 
Law.  The threshold is still undetermined, but under the 
Law on Protection of Nature, in cases where coincidental 
and technologically unavoidable traces of permitted GMO 
are found, the government can determine the threshold 
below which the products need not be labeled. 
 
22.  According to the Food Law, food and feed labels 
should have additional special information to keep 
consumers informed about any ways in which the novel food 
or its ingredients no longer corresponds to the existing 
food or food ingredient.  In that case, the declaration 
must contain information about the changed 
characteristics or features, including the method used to 
produce that indication or characteristic.  The food and 
food ingredients containing (or consisting of) GMOs must 
have a visible indication that it contains or consists of 
 
GMOs.  The indication must clearly state "genetically 
modified organisms" or contain the sentence "this product 
contains genetically modified organisms." Food and food 
ingredients originating from GMOs but not containing them 
must have a visible indication that they originate from 
GMOs. 
 
23.  The requirements regarding the declaration of novel 
food under the Food Law will be provided for by a 
regulation developed by the Minister of Health in 
accordance with the Minister of Agriculture and Forestry 
within one year from enactment of the Law. 
 
24.  According to the Law on Protection of Nature, any 
agricultural biotechnology product placed on the market 
must have a visible mark on its package and accompanying 
documentation stating that the product is a GMO or 
contains GMOs.  This label should clearly say 
"genetically modified organism" or contain the sentence 
"this product contains genetically modified organisms." 
 
25.  The Consumer Protection Law establishes minimum 
product labeling requirements, which manufacturers should 
use to identify transformed products, including 
transformed ingredients and supplements, as well as the 
type of transformation, in accordance with special 
regulations.  It is unclear if this is a reference to the 
Food Law (generally considered to be the main legislation 
on labeling), or subsequent implementing regulations for 
the Consumer Protection Law.  The designated Minister 
(depending on the product) will establish the detailed 
content of the label, in concert with other Ministries 
and laws (such as the Food Law) and regulations. 
 
Extent of Labeling 
------------------ 
 
26.  It could be said that all levels of food products 
(i.e. processed and unprocessed) must carry a label. 
 
Other Labeling 
-------------- 
 
27.  Post is unaware of any laws or regulations governing 
the use of labels such as "biotech-free," "non-biotech," 
"GMO-free," or "non-GMO." 
 
MOON 
 
 
NNNN