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Cablegate: Status of Croatian Biotech Regulations

This record is a partial extract of the original cable. The full text of the original cable is not available.

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
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

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