Required Report - public distribution

**Date:** 2/27/2004

**GAIN Report Number:** RO4003

RO4003

**Romania**

**Food and Agricultural Import Regulations and Standards**

**Annual Report**

**2004**

**Approved by:**

![](media/image1.wmf)Brian Goggin

U.S. Embassy Bucharest

**Prepared by:**

Cristina Cionga

**Report Highlights:**

Most of the norms and regulations relevant to food and agricultural
imports to Romania were harmonized with the EU ones. Currently, the
process of transposing the *acquis* into domestic legislation is being
accelerated, as the authorities are determined to move faster towards
country's European accession, scheduled, optimistically, for 2007.

Includes PSD Changes: No

Includes Trade Matrix: No

Unscheduled Report

Sofia \[BU1\]

\[RO\]

Table of Contents

[I. FOOD LAWS 4](#food-laws)

[The Ministry of Agriculture, Forests, Waters and Environment
4](#the-ministry-of-agriculture-forests-waters-and-environment)

[The Veterinary and Food Safety Agency (VFSA)
5](#the-veterinary-and-food-safety-agency-vfsa)

[The Ministry of Health 5](#the-ministry-of-health)

[The National Authority for Consumer Protection (NACP)
6](#the-national-authority-for-consumer-protection-nacp)

[II. LABELING REQUIREMENTS 6](#ii.-labeling-requirements)

[Specific requirements for selected product labeling
7](#specific-requirements-for-selected-product-labeling)

[III. PACKING AND CONTAINER REQUIREMENTS
8](#iii.-packing-and-container-requirements)

[1. Details on the merchandise origin and destination
8](#details-on-the-merchandise-origin-and-destination)

[2. Means of transport 9](#means-of-transport)

[3. Specific Requirements for Poultry Meat
9](#specific-requirements-for-poultry-meat)

[IV. FOOD ADDITIVES REGULATIONS 10](#iv.-food-additives-regulations)

[V. PESTICIDE AND OTHER CONTAMINANTS
10](#v.-pesticide-and-other-contaminants)

[VI. OTHER REGULATIONS AND REQUIREMENTS
10](#vi.-other-regulations-and-requirements)

[Proper export documentation 10](#proper-export-documentation)

[VII. OTHER SPECIFIC STANDARDS 12](#vii.-other-specific-standards)

[Organic Food 12](#organic-food)

[Products derived from Biotechnology
13](#products-derived-from-biotechnology)

[Legal Framework for Biotech in Romania
13](#legal-framework-for-biotech-in-romania)

[Contact Information 14](#contact-information)

[Monitoring and Enforcement 14](#monitoring-and-enforcement)

[Traceability 14](#traceability)

[Notification Dossier 15](#notification-dossier)

[Phytosanitary regulations 15](#phytosanitary-regulations)

[Veterinary regulations 16](#veterinary-regulations)

[Marine Products 16](#marine-products)

[VIII. COPYRIGHT/ TRADEMARK LAWS 18](#viii.-copyright-trademark-laws)

[Patents 18](#patents)

[Copyrights 18](#copyrights)

[IX. IMPORT PROCEDURES 18](#ix.-import-procedures)

[APPENDIX. GOVERNMENTAL REGULATORY AGENCY CONTACTS
20](#appendix.-governmental-regulatory-agency-contacts)

# 

**DISCLAIMER:** This report has been prepared by the Office of
Agricultural Affairs of the USDA/Foreign Agricultural Service in
Bucharest, Romania for U.S. exporters of domestic food and agricultural
products. While every possible care has been taken in the preparation of
this report, information provided may not be completely accurate either
because policies have changed since its preparation, or because clear
and consistent information about these policies were not available. It
is highly recommended that U.S. exporters verify the full set of import
requirements with their foreign customers, who are normally best
equipped to research such matters with local authorities, before any
goods are shipped. FINAL IMPORT APPROVAL OF ANY PRODUCT IS SUBJECT TO
THE IMPORTING COUNTRY'S RULES AND REGULATIONS AS INTERPRETED BY BORDER
OFFICIALS AT THE TIME OF PRODUCT ENTRY.

Please contact this office, if you have any comments, corrections or
suggestions about the material contained in this report. Our telephone,
fax, and e-mail address are provided at the end of this report.

#  

# FOOD LAWS

Several Government agencies and ministries in Romania have
responsibilities related to agri-food supply safety and quality and
regulate food importation. Most of the relevant norms and regulations
were harmonized with the EU ones. Currently, the process of transposing
EU laws into domestic legislation is being accelerated, as the
authorities are determined to move faster towards country's European
accession, scheduled, optimistically, for 2007.

Licenses, permits, health and quality certificates are required in order
to produce, process or import agri-food products. Even though the
legislation is in place, its enforcement is not always effective.

The most relevant provisions are set out within the following general
framework:

-   Government Emergency Ordinance No. 97/2001 regarding food
    production, distribution and commercialization.

-   Law 214 of April 19, 2002, effective from May 2002, enforces and
    amends GOR Ordinance 49/2000 on obtaining, testing, utilization, and
    commercialization of genetically modified organisms (GMOs), as well
    as products derived from GMOs.

-   Law 67/1997 on wine and wine-making practices, modified as per GOR
    Ordinance 34/2000.

-   Ministerial Order 86/1998 providing the list of geographical
    indications and traditional names admitted for wine labeling in
    Romania.

-   Ministerial Order 17/2000 providing norms for distilled spirit
    commercialization, referring to origin, production, bottling,
    labeling, and quality.

-   Ministerial Order 38/2001 with provisions for distilled spirits
    commercialization.

-   Government Decision 760/2001 providing technical norms for natural
    mineral water exploitation and commercialization.

These pieces of legislation are jointly proposed and/or endorsed by the
GOR agencies with competency in protecting consumers and lay down
conditions and requirements regarding food quality all along the
marketing chain.

## The Ministry of Agriculture, Forests, Waters and Environment 

As of today, the Ministry of Agriculture, Forests, Waters and
Environment (MAFWE) is the specialized body of the central public
administration being under governmental jurisdiction. It applies the
Government's strategy in the field of agriculture, food processing,
rural development, as well as forests, waters and environment field.

However, pursuant to an already announced Government reshuffle, the
Ministry of Environment will be set up independently in the first half
of 2004.

MAFWE has attributes related to:

a.  agricultural and food policy design and implementation, in
    cooperation with product-specific inter-professional organizations;

b.  initiating and promoting legislation which regulates food
    production, distribution, importation;

c.  authorizing the activity of food processing companies; supervising
    law observance by firms which produce, process and sell agri-food
    products;

d.  elaborating standards for agri-food products in conformity with
    Codex Alimentarius, compliant with FAO and WTO documents.

Within the MAFWE, the *General Directorate for Policy Design and
Implementation* regulates both crop production (including approvals for
new seed varieties and biotech products and phytosanitary activity) and
livestock production.

Likewise, the *General Directorate for Environmental Protection* has
competency in environmental risk assessment (including for GMOs),
monitoring activities that might harm human health and the environment.

Under the Ministry of Agriculture, Waters, Forests and Environment the
following agencies and institutes participate in the regulation of the
agri-food market:

-   The Testing and Control Lab for Seeding Material Quality.

-   The State Institute for Vegetable Breed Testing and Registration.

-   The National Office for Wines.

-   The National Agency for Livestock Breed Amelioration and
    Reproduction.

Further information on the main activities of the Ministry of
Agriculture, Waters, Forests and Environment can be found at:
http://www.maap.ro

## 

## The Veterinary and Food Safety Agency (VFSA)

In January 2004, a new executive body was established (via the GOR
Ordinance 90/2003 and the GOR Emergency Ordinance 42/2004), by
reorganizing the sanitary-veterinary and food processing departments,
previously components of the MAFWE**.**

Currently, the Agency performs activities related to animal health and
foodstuffs of animal origin hygiene and safety. Its activity will be
significantly broadened to all aspects generally encompassed by food
safety regulating and monitoring.

The Agency organizes and coordinates all sanitary-veterinary activities,
elaborates national norms and regulations, including on the use of
animal medical drugs. It also has attributes in animal reproduction and
breed improvement. It is responsible for negotiating health certificates
with international veterinary authorities for animals and products of
animal origin for Romanian imports, in order to ensure conformity with
the national veterinary requirements. It issues health certificates for
live animals/livestock products exported from Romania. The Agency is
responsible for monitoring and controlling the animal health condition
nation-wide.

According to its constitutive act (GOR Ordinance 90/2003), the Agency
assesses risks possibly associated with food and feed consumption. To
make sure that consumers have access to product information, VFSA will
post information on the Agency's Web site, consistent with applicable
disclosure laws.

Other ministries and Governmental bodies involved in the regulation of
the agri-food market are:

## 

## The Ministry of Health

The Ministry of Health is responsible for overseeing the production and
registration of drugs, food additives, and medical equipments. It is
also responsible for the public health as it relates to food and
contaminants.

Thus, prior to begin operations, food processing Romanian firms and
multinational companies established in Romania must obtain the approval
of the Ministry of Health, which has competency in authorizing and
controlling the activity of the companies involved in food production,
processing and distribution.

The Public Health General Directorate and the State Sanitary Inspection
within the Ministry of Health are responsible for food safety and public
health. Law no. 438/2002 refers to food additives used in products for
human consumption. A list of forbidden additives is further provided in
this report.

The official web site of the Romanian Ministry of Health is: www.ms.ro

## The National Authority for Consumer Protection (NACP)

The National Authority for Consumer Protection is a Government agency
established with the aim of protecting the consumers' rights and
interests. Its activity is performed within the framework given by the
GOR Decision 166/2001 and the GOR Decision 349/2001.

NACP is actively involved in proposing, endorsing and promoting
legislation related to consumer protection, including for ensuring food
safety, and is responsible for harmonizing it with the relevant EU norms
and regulations. Specifically, NACP has competency in regulating food
product processing, packaging, labeling, preservation, storage,
transportation, importation and distribution.

It conducts lab analyses and tests in its own or other accredited
facilities for assessing food quality and possible risks and widely
distributes the agency's conclusions via public awareness campaigns.

It enforces law observance through surveillance and monitoring at all
links of the marketing chain. Law violations may become infringements
according to the penal law and NACP has the right to charge fines and/or
request the other authorities to temporary or indefinitely suspend the
activity of the operators that do not observe the legal provisions.

More information about the National Authority for Consumer Protection
can be found at the following web site: [www.apc-romania.ro]{.underline}

# II. LABELING REQUIREMENTS

The following authorities are responsible for regulating and enforcing
labeling requirements in Romania:

-   The Ministry of Agriculture Forests, Waters and Environment

-   The Ministry of Public Health

-   The National Authority for Consumer Protection

-   The Veterinary and Food Safety Agency

The methodology and requirements for food labeling for are set out in
the GOR Decision 106/February 2002 - further detailed in its
accompanying Methodological Norm 7/2002 .

Beginning with February 2002 all packaged/canned food products for
retail distribution are required to have Romanian language labels.

Bilingual labels (English/Romanian) are required on all products
exported to Romania.

The labels must contain the following compulsory specifications:

-   the name of the product;

-   the ingredient\* list (for processed products only). These
    ingredients must correspond to the ones specified in the technical
    description of the product. The ingredients must be presented in
    descending order as a percentage of the total weight of the product.
    The vitamins and minerals must be also mentioned in the list;

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-   the net content (weight/capacity);

-   the expiration date (best before);

-   the required storage conditions (temperature, humidity, etc.), when
    applicable;

-   usage instructions, in case the absence might result in improper
    usage;

-   place of origin or provenance if its absence would mislead
    consumers;

-   information meant to help the lot identification, which has to
    correspond with the number written in the export documents.

-   the name and address of the producer/packager/ distributor/ importer

-   date of manufacturing.

\*Ingredients must be specified if they belong to the following
categories: colorants, preservatives, antioxidants, emulsifiers, gels,
stabilizers, aroma (flavorings), acidity correctors, modified potato
starch, sweeteners antifoam, melting salt.

In addition to these specifications, the labeling of alcoholic beverages
requires the alcohol concentration to be displayed, in percent terms at
20 degrees Celsius, if it is greater than 1.2%. These requirements do
not apply to the products classified under the HTS code 22.04 and 22.05
of the Romanian import schedule.

It is forbidden to use label specifications that refer to potential
effects on human health, such as: energizer, fortifier, tonic or
refresher.

## Specific requirements for selected product labeling 

1.  Dairy products:

    -   labeling must specify the fat content, in percent terms;

    -   for the pasteurized milk the following specification is
        required: "Store at temperatures of 2-4 degree C";

    -   the processing technology (pasteurized/UHT sterilized);

    -   the dry matter content for powdered milk;

    -   nutritional data for dietetic and dairy food products (energetic
        value, proteins, glucose, fats, fatty acids, fiber and sodium)
        as well as the added flavorings.

2.  Meat and products derived from meat**.** The label must specify:

-   the animal specie the meat comes from;

-   the processing technology/treatment used (salted, smoked, boiled,
    refrigerated, frozen, sterilized);

-   for meat products, the type of casing (natural or collagenic
    membrane, edible or non-edible).

####### Eggs and egg products 

> When shelving the product a label should be attached mentioning:

-   fresh big eggs ( weight \> 50 grams/egg) or

-   fresh small eggs (weight between 40-50 grams/egg).

-   the expiration date should be stamped on each piece of egg.

3.  Vegetables and fruits: the date of freezing, if applicable.

4.  Natural juices: the minimum fruit content (in percent terms); if
    obtained from concentrate, this will be specified on the label, as
    well as whether the juice is with or without fruit pulp.

5.  Genetically modified products: According to Law 214/2002 ("the
    Biotech Law"), the producer is responsible for labeling biotech
    products placed on the market. This complies with EU legislation and
    regulations 1/39/98, 49/2000, and 50/2000. When applying for a
    biotech product deregulated status, the applicant is required to
    provide a description of the envisaged conditions for placing the
    product on the market, including use, handling, and a proposal for
    labeling and packaging which should comply with the requirements
    laid down by Law 214/2002. The label shall clearly state if the
    genetically modified organism is present. The label bearing the
    inscription "This product contains genetically modified organisms"
    is compulsory. There is currently no law or regulation governing the
    use of labels such as biotech-free, non-biotech, GMO-free, or
    non-GMO, Law 214/2002 states that within a period of 10 years
    procedures for such labeling will be established. The GOR Decision
    106/February 2002 - further detailed in its accompanying
    Methodological Norm 7/2002 - provides more on the labeling
    methodology of foods obtained from biotechnology or containing
    genetically modified additives derived from GMOs. Interestingly,
    this norm is narrowed to foodstuffs delivered as such to the final
    consumer and to processed food entirely or partially obtained
    from: (i) genetically modified soybean and/or (ii) genetically
    modified corn. "Product derived from GM Soybean" or "product derived
    from GM corn" must be clearly written on the label. These additional
    labeling requirements can be ignored if the content of biotech
    soybean or corn is less than 1 percent in total ingredients.

# III. PACKING AND CONTAINER REQUIREMENTS

Packing and container requirements in Romania do not differ from general
international standards. The packaged products must specify on their
labels the following information:

## 1. Details on the merchandise origin and destination

‑ the country of origin;

‑ the country from where the product is dispatched;

‑ the consignor;

‑ the consignee;

‑ the country of destination.

The required information may be written directly on the packages or on
"stick-on" labels. Romanian authorities will accept the information
written only on separate documents that accompany the products in two
situations:

a.  The prepackaged products will change their form before they reach
    the final consumer and they will not be sold for HRI consumption.

b.  The products are destined to HRI consumption, but only after
    processing.

In the case of prepackaged frozen products, the labels will mention that
"re-freezing after defrosting is prohibited".

The Romanian authorities will not accept any inconsistency between the
number of establishment (producer) or the shelf life written in the
export documents and the ones written on the labels.

All U.S. exporters are advised to ask the importer about special
requirements regarding labeling of goods they intend to export.

Romanian authorities do not accept the transfer of the labels from one
establishment to another even if such establishments belong to the same
producer and are officially inspected by the FSIS authorities. The
Romanian authorities do not accept the transfer of the labels from one
establishment to another in USA even though they belong to the same
producer and U.S. authorities may have officially approved both
establishments. The Romanian authorities do not accept the transfer of
the labels from one establishment to another in USA even though they
belong to the same producer and U.S. authorities may have officially
approved both establishments.

All the information written on the certificates and the labels must be
comprehensible and clear, with no traces of change.

# DOCUMENTATION REQUIREMENTSDOCUMENTATION REQUIREMENTS

All animal product shipments must be accompanied by the export
certificate, health certificate and quality certificate/conformity
declaration.

## 2. Means of transport

-for air transportation: the flight number;

-for transportation on water: the name of vessel and the no. of the
container.

Also, the seal number should be posted on the container.

The packaging practices must comply with the EU regulations, with which
the Romanian relevant legislation was harmonized. This refers to the
packaging materials, the presence of stamps and/or of the requested
specifications.

Container shipments specified as dangerous require special permission.

## 3. Specific Requirements for Poultry Meat

In September 2002, the Romanian Ministry of Agriculture and the Ministry
of Health jointly issued a regulation on the requirements for packaging
poultry meat, which was effective from November 23, 2002.

This regulation impacts bulk- packed products. According to it, bulk
packed products are still be accepted by Customs, and can be sold in
wholesale, retail and to restaurants and institutions. Bulk packed
products for retail and wholesale must however be repacked in packages
of unspecified size. Since the US were in 2003 the top poultry meat
exporter to Romania, it is important to note that:

a.  Bulk packed products (i.e. the U.S. industry's 4x10) can be imported
    and sold to institutions, restaurants, and processors, wholesalers
    and retailers.

b.  Poultry cuts removed from bulk packages at wholesale and retail
    outlets must be repackaged.

c.  U.S. shippers are encouraged to either ship in ready-for-retail,
    properly labeled packaging, or in layer pack. Since repackaging of
    bulk packed products is extremely difficult without completely
    defrosting the product, layer packing may be a good alternative.

d.  This law impacts imports and domestic production equally.

Other aspects of the regulation relate to grading, classification, and
microbiological testing of imported and domestically produced poultry. A
translation of the regulation is available from AgBucharest by request.

# IV. FOOD ADDITIVES REGULATIONS 

The Public Health General Directorate and the State Sanitary Inspection
within the Ministry of Health, together with The Department of Food
Industry, Standards, Marks and Licenses within the Ministry of
Agriculture are the authorities responsible for the regulating food
additives and coloring additives for foodstuffs. The Order 438 of June
18, 2002 and the Order 295 of July 12, 2002, jointly issued by the two
ministries, define additives permitted for use in foodstuffs. The
National Authority for Consumer Protection - as a supervisory body - is
also in charge of this issue.

In general, the relevant legislation parallels the UE regulatory
framework in this field.

Part of their national wide public awareness effort regarding food
product safety, the National Authority for Consumer Protection and the
Ministry of Health have recently launched an informative brochure
containing a list of forbidden additives. The forbidden additives listed
in this brochure are: E 116a, E 161 c-f, E 201, E 225, E 233, E 236, E
303, E 305, E 313, E 317, E 342, E 411, E 462, E 467, E 472 g, E 550, E
557, E 560, E 636, E 637, E 900 B as well as alpha and beta-ionone,
fermented rice.

# V. PESTICIDE AND OTHER CONTAMINANTS 

Generally, Romania adopts the international standards (Codex
Alimentarius) for tolerance for pesticides, herbicides and fungicides
used against crop diseases and pests. The authority responsible for the
registration of agricultural chemicals is the General Directorate for
Environmental Protection within the Ministry of Agriculture.

US exporters can obtain a list of approved pesticides from:

**The Ministry of Agriculture, Forests, Waters and Environment**

**General Directorate for Environmental Protection**

**12, Libertatii Blvd., sector 5**

**Bucharest, Romania**

**Phone: 40 21 4110298**

**Fax: 40 214110298**

The major laws and regulations that provide regulatory framework for
domestic and imported pesticides are:

GOR Emergency Ordinance 97/2001

Law 91 of March 18, 2003

Norm 157 of February 03, 2003

# 

# VI. OTHER REGULATIONS AND REQUIREMENTS

Romanian regulations require US companies exporting products of animal
origin to Romania to be inspected by the US federal inspection service,
respectively the Food Safety Inspection Service (FSIS).

The Romanian counterpart is the Veterinary and Food Safety Agency, which
verifies whether import documentation complies with country's
legislation. It also negotiates with the FSIS the type of certificate
required for each product in accordance with the Romanian legislation.

## Proper export documentation

Required documents for livestock products to be imported in Romania:

-   Sanitary-veterinary approval.

-   Health Certificate for meat intended for import to Romania
    (bilingual).

-   Freezing Certificate issued by the producer, when applicable.

-   Declaration of Conformity/Quality Certificate issued by the
    producer.

-   Technical Description (especially for processed products).

-   Certificate of origin (required by the Romanian Customs for
    calculating the applicable duty)

As an example, the bilingual (English and Romanian) health certificate
(FSIS Form 9260-1) for poultry meat (the largest agricultural product
shipped by the US to Romania) is summarized below.

Fresh poultry meat means any parts of domestic fowl, turkeys, guinea
fowl, geese and ducks, which are fit for human consumption and which
have not undergone any treatment other than cold treatment to ensure its
preservation, and is vacuum wrapped meat or meat wrapped in a controlled
atmosphere.

The following type of information should be provided by the USDA health
certificate for poultry meat:

-   name and address in full of company-importer;

-   name and address in full of company-exporter;

-   country of origin: the United States of America;

-   region of origin;

-   name of the products;

-   number and type of packages;

-   date of freezing;

-   identification marks;

-   export number of the establishment registered for exports (company,
    slaughterhouse, cutting plant, warehouse or refrigerated warehouse);

-   countries of transit;

-   means of transportation;

-   certificate of fitness of the goods for the consumption;

-   date and place of issuing of the document;

-   name and self signed signature of the officially authorized state
    official issuing the document;

-   original stamp of the state veterinary service.

The certificate of fitness of the goods for the consumption is a
veterinary-sanitary statement by which the authorized person issuing the
document officially declares the wholesomeness, safety and purpose of
use of the product. By this, the official veterinarian certifies that:

1\. That the United States or region is free from avian influenza and
Newcastle disease, as defined in the International Animal Health Code of
OIE.

2\. That the meat described above is obtained from poultry which:

\(a\) have been held in the territory of the United States, the
specified region, since hatching or have been imported as day-old
chicks;

\(b\) came from holdings:

\- which have not been placed under animal health restrictions in
connection with a poultry disease;

\- around which, within a radius of 10 km, there have been no outbreaks
of avian influenza or Newcastle disease for at least 30 days;

\(c\) have not been slaughtered in the context of any animal health
scheme for the control or eradication of poultry diseases;

\(d\) have/have not been vaccinated against Newcastle disease using a
live vaccine during the 30 days preceding slaughter;

\(e\) during transport to the slaughterhouse did not come into contact
with poultry suffering from avian influenza or Newcastle disease.

3\. That the poultry meat described:

\(a\) comes from the slaughterhouses which, at the time of the
slaughter, are not under restrictions due to a suspect or actual
outbreak of avian influenza or Newcastle disease and around which,
within a radius of 10 km, there have been no outbreaks of avian
influenza or Newcastle disease for at least 30 days;

\(b\) has not been in contact, at any time of slaughter, cutting,
storage or transport with meat which does not fulfill the requirements
of Directive 91/494/EEC.

4\. That the meat described fulfils the requirements of condition
equivalent to Council Directive 71/118/EEC, and has been found fit for
human consumption following ante and post-mortem inspection carried out
in a manner equivalent to this Directive.

5\. That the meat described above has/has not been subjected to an
immersion chilling process.

6\. That the meat described above has been marked in a manner equivalent
to Article 2 of Decision 96/712/EEC.

Product samples shipped via express mail or parcel post are subject to
the same import regulations.

# VII. OTHER SPECIFIC STANDARDS 

## Organic Food 

The Romanian market for organic food is at the very beginning. Even
though the growth is estimated to double within the next couple years,
the actual area of 44,000 HA (1% of the total arable area) is very low
in comparison with other European countries. Except for ecological eggs
and honey, the Romanian organic products are generally produced for
exportation, due to both the reduced purchasing power of the population
and the general low importance given to environmental and food issues.
Production is limited mostly to grains, vegetables and forest fruits.

The Governmental Decision 34 of April 2000 sets out standards for
production, classification, processing, packaging, importation,
distribution, certification of the organic products and establishes the
labeling procedure for such products. In 2003, the Romanian National
Stamping Company revealed its intention to produce the secured
"ecological" label, in an attempt to eliminate counterfeits.

In order to put into practice the existing regulations, the National
Authority for Ecological Products was established within the Ministry of
Agriculture. Imported products should be labeled as organic if they were
produced by organic methods confirmed by the certificate of compliance.
The label must contain: the name and the address of the
producer/processor, the name of the product and the producing method,
the name and the mark of the inspecting and certifying institution, the
storage conditions, the minimum term of validity. The labels will also
contain a special stamp for organic products registered at the State
Office for Inventions and Patents (OSIM). It is forbidden to store
ecological products and ordinary products in the same place. The
competent authority, which issues the ecological label, is the Ministry
of Agriculture, Waters, Forests and Environment.

Organic products for trade should be stored separately from non-organic
products. Storage and transportation of organic products is done in
closed packaging and containers with the information on the name and
address of manufacturer, name of certifying institutions, its ID number
and certificate number.

## Products derived from Biotechnology

Unique among the candidates to EU membership, Romania has pioneered the
planting of biotech crops, especially soybeans. Currently, herbicide
resistant soy is approved for commercialization, while several biotech
corn and sugar beet products are approved for testing. In 2003, local
farmers planted 70,000 hectares of a herbicide resistant variety
soybeans, including 30,000 hectares of. These figures climbed in 2003 to
110,000 hectares and 60,000 hectares, respectively. However, the current
GOR official position reflected in recently passed regulations favor the
EU-line on biotech.

### Legal Framework for Biotech in Romania

The GOR efforts to bring its regulatory capacity into line with EU rules
and international agreements resulted in the passage of new legislation
over the past two years. For genetically modified organisms (GMOs), Law
214 of April 19, 2002, effective from May 2002, enforces and amends GOR
Ordinance 49/2000 on obtaining, testing, utilization, and
commercialization of GMOs, as well as products derived from GMOs. The
Law provides the main framework for bio-engineered products in Romania.
Two other pieces of legislation relevant to biotech-related issues are:
(1) GOR Decision 106/February 2002 on labeling food derived from GMOs or
containing genetically modified additives or derived from GMOs and (2)
Minister of Agriculture, Forests, Waters and Environment Order 462/2003,
effective from July 2003, with provisions aimed at tracing biotech
products.

According to Law 214/2002, the competent authorities in implementing and
enforcing all activities related to the use of GMOs, respectively all
activities concerning the deliberate release of GMOs are: (1) the
Ministry for Waters and Environmental Protection, responsible for the
issuance of authorizations/permits and carrying out the post-control of
all related activities; (2) the Ministry of Agriculture and Food; (3)
The Ministry of Health and Family; (4) the National Authority for
Consumer Protection. As a result of the 2003 GOR reshuffle, the Ministry
of Environment was absorbed by the Ministry of Agriculture and Food,
which was renamed the Ministry of Agriculture, Forests, Waters and
Environment per GOR Decision 739/2003.

The National Biosafety Commission (NBC), an independent scientific body,
advises the executive authorities during the decision making process on
biotech policy. The NBC consists of twelve scientists with a relevant
background and who are members of the Romanian Academy or
representatives of research institutes in life sciences, agriculture or
medicine.

Law 214/2002 stipulates that, the user shall submit to the National
Authority, prior to the utilization of any GMO, notification containing
at least the information specified by Law 214. After receiving the
notification, the NA will inform and consult with the public regarding
the received notification and consult the Biosafety Commission, which
will then evaluate the environmental and agricultural impact of such
use. The NA will then also request specific assessments from the
Ministry of Health and the National Authority for Consumer Protection
(which is responsible for food and feed safety) on the impacts of such
use on human health.

As the NA, the Ministry of Agriculture, Forests, Waters and Environment
responds to the notifier within a period of 90 days after receipt of the
notification whether the received notification is in compliance with the
current legislation. The notifier may be required to submit additional
information. If the proposed activity does not comply with the
legislation in effect, the notification is rejected. The 90-day period
referred does not include any periods of time during which the NA: (a)
is awaiting further information requested from the notifier, (b) is
awaiting the approval of the Biosafety Commission; (c) is conducting
public hearings. If the National Authority considers that sufficient
evidence has been gathered by releasing in the environment certain
genetically modified organisms, it can decide to apply simplified
approval procedures. The notifier may proceed with the proposed activity
only after obtaining the NA authorization, and it must observe the
conditions specified in the authorization. In-country field tests are
required prior to granting the commercial status to biotech crops.

### Contact Information

Notifications must be submitted to the General Directorate for
Environmental Protection, headed by Dr. Ioan Jelev, tel. 40 1 410 0243,
fax 40 1 335 5662. Dr. Jelev directly supervises the Department for
Pollution Control and Bio-diversity Preservation, headed by Mrs. Adriana
Baz, who is responsible for assessing the environmental impact of
biotech products for which a notification is submitted. Likewise,
agricultural aspects (i.e. is a particular bio-engineered crop a
potential plant pest?) are dealt with by the General Directorate for
Agricultural Policy Regulation and Implementation, headed by Mr. Vasile
Bacila, tel. 40 1 315 9985, fax 40 1 313 2187. Dr. Klaus Fabritius from
the Institute for Public Health of the Ministry of Health and Family,
tel. 40 1 204 9209 and Mrs. Anica Popa, head of the Food Products Office
of the National Authority for Consumer Protection, tel. 40 1 315 6692,
are responsible for food and feed safety risk assessments in connection
with GMOs.

### Monitoring and Enforcement

According Law 214/2002, the NA officially issues the approval for
releasing a specified genetically modified organism in the environment,
while relevant departments respectively responsible for assessing
different types of risk conduct post-approval surveillance to check
compliance with authorization requirements.

Violations of Law 214/2002 provisions may become infringements according
to the penal law and they are punished with a fine from ROL 10 million
to 100 million (i.e. approximately \$300 to \$3000 at the current
exchange rate) and/or temporary or final suspension of the activity, on
a case by case basis. Specialized personnel authorized by the Ministry
Agriculture, Waters, Forests and Environment, Ministry of Public Health
and Family and the National Authority for Consumer Protection enforce
the sanctions provided under Article (50) of the law. Law 214/2002 also
states that if damage results from activities regulated through this law
that is detrimental to human or animal health, to biological diversity
or to the environment, the user is responsible for the damage. The
nature and scope of the damage are to be established by a commission of
experts appointed by the National Authority.

### Traceability

Tracking biotech products in Romania has become stricter and more
rigorous lately, from the regulatory perspective. Traceability is
required as a consequence of the labeling requirements provided by Law
214/2002 and GOR Decision 106/2002, brought in line EU directives.

On July 29 the Minister of Agriculture, Waters, Forests and Environment
issued its Order 462 which requires all farmers using seeds for biotech
crops to report the area planted to such seeds and the yields obtained.
More specifically, all individuals/companies that cultivate biotech
crops must submit two declarations to the Directorate for Agriculture
and Rural Development of the Ministry of Agriculture, Waters, Forests
and Environment, the first one within 10 days after sowing completed,
while the second one within 10 days after harvest. The first declaration
must describe the name of the crop, area cultivated with it, and the
origin of the seed (whether acquired via procurement or own production).
The second declaration must include the name of the plant, the
production obtained and its destination (seed for sowing or
consumption).

The new regulation on traceability requires companies involved in this
business, when using or handling biotech products, to submit and keep
information at each stage of placing them on the market. Companies are
responsible for ensuring that a tracking system is in place.

### Notification Dossier

The notification must include:

-   a technical dossier providing specified information for carrying out
    the environmental risk assessment, especially: (i) general
    information on the notifier, including information on personnel and
    training; (ii) information regarding the genetically modified
    organism/organisms; (iii) information regarding the conditions of
    the release and the characteristics of the potential recipient
    environment; (iv) information regarding the impact of the
    genetically modified organism/organisms on the environment; (v) a
    monitoring plan, to identify the effects of the genetically modified
    organism/organisms on human health and environment; (vi) information
    on control and corrective methods, waste treatment and emergency
    response plans; (vii) a summary of the dossier.

-   the environmental risk assessment study together with any
    bibliographic references and indications of the methods used;

-   information regarding the results of the release of the same
    genetically modified organisms or of the same combinations of
    genetically modified organisms on the territory of Romania or
    elsewhere.

The notifier may refer to the data or the results from the notifications
previously submitted by other notifiers, provided that the information,
data and results are not confidential or the notifier has their consent.
Simplified procedures may apply for GMOs already notified and/or
approved in EU members and in OECD countries. In this situation, the
notifier will present: (i) either a copy of the notification summary
submitted by the national competent authorities in the member states to
EU and OECD; (ii) or a copy of the EU and OECD documents which approve
the release of the genetically modified organism on the territory of the
member states.

## Phytosanitary regulations

The import of live plants, fresh fruits, vegetables, grains, seeds and
seeding materials, GM breeds as well as importation of samples for
testing and experimentation or for market testing needs the approval of
The Ministry of Agriculture, Waters, Forests and Environment. The MAWFE
issues import approvals for seeds and seeding material valid for a
maximum 6 month-period.

The phytosanitary legal framework is provided by the GOR Ordinance
136/2000, GOR Decision 1030/2001 and its accompanying Methodological
Norm published on 10/18/2001. This Norm provides a full list of
organisms considered pernicious on the Romanian territory and which are
forbidden for importation. Also, agricultural products contaminated with
the specified organisms are forbidden for importation.

Another annex to the Norm lists countries from which specified
plants/agricultural products are banned for importation to Romania.

Very important is the Annex 5 to the Methodological Norm, specifying all
plants and crop products which should be accompanied by a pytosanitary
passport on the Romanian territory (Part A) or would require a
phytosanitary certificate when imported to Romania.

This phytosanitary certificate, issued by APHIS, must accompany the
products imported from the US, certifying that the product is free of
quarantine organisms. The identification documents and quality documents
(purity certificate and analysis bulletin) and the original labeling
stamped on packages must also accompany the imported products.

## Veterinary regulations

Imports of animals and products of animal origin are supervised by the
Romanian Veterinary and Food Safety Agency, which closely cooperates
with FAS Bucharest, FSIS and APHIS in Washington DC.

Live animals, meat, meat products, tripe and offals as well as bovine
semen imported in Romania must be accompanied by a health certificate
issued by a government-approved veterinary body. Importers must apply
for an import license at the Veterinary and Food Safety Agency (VFSA).

The VFSA and FSIS are currently revisiting the health beef certificate
for export to Romania, after an already reached agreement for
eliminating the hormone-free requirement. This was needed after the BSE
outbreak in Washington.

US exporters are advised to check with the Romanian importers about
various standards that must be fulfilled regarding products which are to
be sold on the Romanian market. The US exporters must also check with
FSIS, the Romanian local authorities, FAS Bucharest or local importers
in order to comply with the Romanian quality standards for storage
conditions of meat and meat products and shelf life of the product
(which depends on storage and temperature conditions provided by the
Romanian legislation).

Before exporting semen or embryos to Romania, the US exporter should
contact APHIS/VS at the following address:

National Center for Import and Export

Animals Program

Veterinary Service

Animal and Plant Health Inspection Service (APHIS)

US Department of Agriculture

4700 River Road Unit 39

Riverdale, MD 20737-1231

Phone: (301) 734-7511

Fax: (301) 734-6402

## Marine Products

Seafood products to be exported to Romania require a special bilingual
(English/Romanian) certificate, issued by the Seafood Inspection Program
of the US Department of Commerce.

Contact information:

Seafood Inspection Program

1315 East-West Highway

Silver Spring, MD 20910

Tel. 301 713 2355

Fax 301 713 1081

The certificate is summarized below.

DETAILS IDENTIFYING THE FISHERY PRODUCTS

## 

Species (scientific name)

State or type of processing*:* (refrigerated, frozen, dried, smoked,
semi-cans, cans, etc)

Type of packaging

Number of packages

Net weight

Manufacturing date

Date of freezing

Temperature required during storage and transport

Identifying marks of packages

ORIGIN OF FISH AND FISHERY PRODUCTS

Address(es) and number(s) of preparation (s) or processing
establishment(s) authorized for export by the competent authority

DESTINATION OF FISH OR FISHERY PRODUCTS

The fishery products are to be dispatched from*:* Place of dispatch

To: country and place of destination

By the following means of transport

Name and address of consignor

Name and address of consignee

HEALTH ATTESTATION

The official inspector should certify that:

the fish, crustaceans, gasteropodes, etc, are originated from
hydrographic basins and fishing areas which are nor under veterinary
restrictions and are unconditional fit for human consumption;

the fishery products described above have been handled, prepared or
processed, identified, stored and transported under conditions at least
equivalent to those laid down in Council Directive 91/493/EEC of 22 July
1991 laying down the health conditions for the production and placing on
the market of fishery products;

in addition, in the case of frozen or processed bivalve molluscs, the
latter have been gathered in production areas subject to conditions at
least equivalent to those laid down in Council Directive 91/492/EEC of
15 July 1991 laying down the health conditions for the production and
placing on the market of live bivalve molluscs.

# 

# VIII. COPYRIGHT/ TRADEMARK LAWS

Intellectual property laws are in place in Romania. Each company is
responsible for protecting its intellectual property rights. Although
enforcement has been improving lately, the authorities still struggle to
be more effective. Romania is signatory to a number of international
Intellectual Property Rights conventions, including the Bern and Paris
Conventions.

## Patents

The Romanian Law protects the invention acts through patents. The
applications, including a description of the invention, must be
submitted in the Romanian language to the Sate Office for Inventions and
Patents (OSIM). When written in another language, a translation into
Romanian of the already submitted documentation must be provided within
2 months.

Law 64 of October 1991 regulates the invention patents.

The State Office for Inventions and Patents can be found at:
http://www.osim.ro

## Copyrights

Romania enacted in March 1996 a new copyright law, which complies with
international standards. It provides copyright protection during the
author's life and another 70 years after his death, and protects
authors, but also producers, artists and performers for both commercial
and personal rights. The Romanian Office for Copyrights handles the
issues related to copyrights.

US companies might find that enforcement of copyrights is still
inadequate in Romania. The major problems are in the area of sound and
video recordings as well as software. Law 202 of November 2000,
regulates the involvement of customs bodies in copyright problem
solving. The Romanian Office for Copyrights, the Sate Office for
Inventions and Patents and the General Customs Department collaborate to
solve the copyright infringements.

Detailed information concerning the General Customs Department can be
found at: [http://www.customs.ro](http://www.customs.ro/)

# IX. IMPORT PROCEDURES 

The possibility of establishing a business relationship as to
imports/exports of animals, products and by-products of animal origin
and fodder is regulated by the Ministerial Order 70 of August 11, 1998,
issued by the Ministry of Agriculture, Waters, Forests and Environment.

This order approves the Sanitary-Veterinary Norm regarding the
conditions and the procedure for sanitary veterinary notification of the
import, export, and transit of animals, products and by-products of
animal origin, fodder and other products, which might affect the public
health and animals.

Veterinary and Food Safety Agency is responsible for enforcing all
sanitary-veterinary legislation.

Importation and exportation of livestock and products require a
sanitary-veterinary permit issued by the field office of the Veterinary
and Food Safety Agency. In this case the following documents are
necessary.

‑ a transit sanitary-vet certificate and an official document issued by
the Veterinary and Food Safety Agency (pre-notification : the
confirmation given by the Veterinary and Food Safety Agency that to the
the import can be made in specified sanitary-veterinary conditions);

‑ international sanitary certificate : issued by an official vet (FSIS)
which confirms that the products of animal origin destined for the human
consumption comply with the international norms enforced referring to
veterinary hygiene of the products.

‑ international animal sanitation certificate issued by an official vet
(FSIS) from the exporter country which confirms the health state of the
animals and the vaccinations they have been administered.

In order to export/ import products, or by-products of animal origin any
potential importer/ exporter must submit to the central or field office
of the Veterinary and Food Safety Agency the following documents:

-   a pro-forma invoice for the products to be exported into Romania;

-   a copy of the certificate of registration, fiscal code, and the
    certificate of incorporation of the importing firm;

-   a copy of the rental contract drawn up with the storage or
    processing company of the imported products;

-   a copy of the sanitary -veterinary license to operate of the
    processing/importing company;

-   ‑a technical description of the processed products issued by
    producers which must specify the composition , physical and chemical
    parameters as well as the microbiological parameters of the
    products.

# APPENDIX. GOVERNMENTAL REGULATORY AGENCY CONTACTS

The Ministry of Agriculture, Forests, Waters and Environment

24, Bd. Carol I, sector 3,

Bucharest, Romania

Phone: 40 21 3072345

Fax: 40 21 3078635

Web site: http://www.maap.ro

The Romanian Veterinary and Food Safety Agency

1B Negustori St.

Bucharest, Romania

Phone: 40 21 3157875

Fax: 40 21 3124967

The General Directorate for Environmental Protection

12 Libertatii Blvd.

Bucharest, Romania

Phone: 40 214100215

Fax: 40 214100243

Web site: http://www.mapm.ro

The Ministry of Health

1-3, Cristian Popisteanu Str., sector 1

Bucharest, Romania

Phone: 40 213072500 or 40 213072600

Fax: 40 213136660

Web site: http://www.ms.ro

The National Authority for Consumer Protection

Address: 5 George Clemenceau St., Bucharest.

Phone: 40-21-312 12 75

Fax: 40 21 314 3462

Web site: www.anpc.ro

www.apc-romania.ro

For further information on this report, please contact the following
office in Bucharest:

Foreign Agricultural Service Bucharest

American Embassy, Romania

7-9 Tudor Arghezi St.

Phone: 40 21 2100398

Fax: 40 21 2105998

E-mail: AgBucharest@usda.gov

Web site: http://www.amembassy.ro