Required Report - public distribution

**Date:** 7/20/2006

**GAIN Report Number:** IS6015

IS6012

**Israel**

**Biotechnology**

**Annual**

**2006**

**Approved by:**

![](media/image1.wmf)Kurt Seifarth

U.S. Embassy, Cairo

**Prepared by:**

Gilad Shachar

**Report Highlights:**

Currently, there is no commercial production of biotechnology crops in
Israel. This situation is not expected to change in the next few years.
The Israeli "New Foods" Committee published new regulations for new
foods registration in February 2006. It is expected that the
registration of foods containing GMO ingredients will begin by the end
of 2006. The February 2006 procedures cover food registrations but do
not set labeling requirements for modified food products.

Includes PSD Changes: No

Includes Trade Matrix: No

Annual Report

Tel Aviv \[IS1\]

\[IS\]

**Table of Contents**

+------------------------------------------------------------+---------+
| Section I                                                  | Page 3  |
+------------------------------------------------------------+---------+
| Executive Summary                                          | Page 3  |
+------------------------------------------------------------+---------+
| Section II                                                 | Page 4  |
+------------------------------------------------------------+---------+
| Biotechnology Trade and Production                         | Page 4  |
+------------------------------------------------------------+---------+
| Section III                                                | Page 4  |
+------------------------------------------------------------+---------+
| Biotechnology Policy                                       | Page 4  |
+------------------------------------------------------------+---------+
| Israel's Regulatory Framework                              | Page 4  |
|                                                            |         |
| Figure 1. Treatment of the registration of a new food.     | Page 5  |
+------------------------------------------------------------+---------+
| Testing for Biotechnology Crops                            | Page 6  |
+------------------------------------------------------------+---------+
| Labeling                                                   | Page 6  |
+------------------------------------------------------------+---------+
| Biosafety Protocol                                         | Page 6  |
+------------------------------------------------------------+---------+
| Section IV                                                 | Page 6  |
+------------------------------------------------------------+---------+
| Marketing Issues                                           | Page 6  |
+------------------------------------------------------------+---------+
| Section V                                                  | Page 7  |
+------------------------------------------------------------+---------+
| Annex 1: Official Work Procedure of New Food Products      | Page 7  |
+------------------------------------------------------------+---------+
|                                                            |         |
+------------------------------------------------------------+---------+
|                                                            |         |
+------------------------------------------------------------+---------+

**Section I. Executive Summary**

Currently, there is no local commercial production of biotechnology
crops in Israel. This situation is not expected to change in the next
few years. Field experiments of genetically engineered plants began
eleven years ago and are continuing. Experiments have been conducted on
tomatoes, potatoes, eucalyptus, flowers, soybean, cotton, corn,
strawberries bananas, tobacco, lemon, zucchini, wheat, alfalfa,
grapevine, ginseng, pine and microorganisms, mostly for biological
control.

Since the legislative process is expected to take approximately three
years, the New Foods Committee has published the procedures for food
registrations for the time being. New regulations on new food products
were published in February 2006 (see annex 1). Currently, the new
regulations do not include GMO foods. However, it is estimated that
registration of GMO food products will begin by the end of 2006. The new
procedures will not require the labeling of modified food products.

**Section II. Biotechnology Trade and Production**

Currently, there is no local production of biotechnology crops in
Israel. This situation is not expected to change in the next few years.
The local food industry, however uses biotech raw materials for food
production, mainly corn and soybean. In addition, there are imports of
non-GMO corn and soybeans from Brazil. These products are used for
cosmetics, dietary supplements, meal supplements and for the food
industry. GMO corn and soybeans are used both for feed and processed
foods. Currently, there are no labeling requirements for imported food
products that contain biotech components.

Due to the fact that the local industry uses biotech raw materials, it
is likely that a fraction of the Israeli food products exported to the
U.S. contain biotech ingredients. Exports of Israeli food products to
the EU, which contain more than 0.9 percent of biotech components, must
be labeled.

Currently it is unknown what is the total quantity of GMO imports to
Israel, however, FAS/Tel Aviv estimates that in CY 2005, approximately
60-70 percent (400-470 tmt) of the soybean imports to Israel were GMO,
and approximately 40-60 percent (440-660 tmt) of corn imports to Israel
were GMO.

# Food Aid 

Israel is not a food aid recipient and is unlikely to be a recipient in
the future.

# Section III. Biotechnology Policy

# Israel's Regulatory Framework

Two committees are responsible for the biotechnology regulatory
framework in Israel: The Governmental New Foods Committee of the
Ministry of Health and The National Committee for Transgenic Plants
(NCPT) of the Ministry of Agriculture. The labeling of food products and
the registration of food ingredients, which contain biotech components,
are under the responsibility of the Food Committee. The testing of
biotechnology crops and the regulations concerning genetically modified
organism plants are under the responsibility of the NCPT.

The Food Committee has suggested new regulations governing GMO products
in two areas:

1)  the registration process of new food products and GMO foods; and

2)  the labeling process of GMO foods

Since the legislative process is expected to take approximately three
years, the New Food Committee has published the procedures for food
registration for the time being. The New regulations on new foods were
issued in February 2006 (see annex 1). Currently the new regulations do
not refer GMO food. However, it is expected that registration of GMO
food products will begin by the end of CY 2006. Since the legislative
process is expected to take approximately three years, in the immediate
future, the new procedures will not cover the labeling of modified food
products.

The purpose of the new regulations is to establish a clear, orderly and
systematic registration process for new food and updating the New Foods
Register. Its purpose is also to provide information as to designation
of authority and operational responsibility.

Imported food products will be divided into two groups -- food products
existing in the food market and new food products. The procedures for
the two groups will be as follows:

> 1\. Existing food products -- The new food committee will issue a list
> of GMO agricultural varieties, which have been already imported to
> Israel (soybean, corn, canola, chicory and more), and it is assumed
> that those varieties will be exempt from the registration procedure.
> However, the Israeli food committee did not finish the drafting
> procedures for food registration of existing food products. It is
> estimated that the committee will finish the drafting by the end of
> 2006.
>
> 2\. For new food products which have not been yet registered, the
> importer must submit the following registration applications:
> Application to register a new food (Annex A), Legislative status of
> the new food (Annex B), and Additional requirements of new foods
> according to the type of new food (Annex C) (see pages 13-23).

The importer must submit annex B (page 15) accompanied by a risk
assessment certificate. The Israeli Health Ministry have authorized the
following institutions to carry out food risk assessments:

-   The European Communities/EFSA

-   U.S.F.D.A./USDA (FSIS)

-   Health Canada

-   ANZFA -- Australia and New Zealand Food Authority/\
    FSANZ Food Standards Australia New Zealand

-   Japan -- Department of Food Safety, Ministry of Health

-   WHO/FAO CODEX ALIMENTARIUS Expert Committees

If the new food should be approved by at least two institutions on the
List of Authorized Bodies, the application for a new food will be
considered under paragraph 8.3.2 (a) (see page 10). If it does not, it
will be considered under paragraph 8.3.2 (b) (see page 11).

> **Figure 1. Treatment of the registration of a new food.**
>
> **[EXAMINATION OF LEGAL STATUS -- DOES IT HAVE 2
> APPROVALS?]{.underline}**

**\| \|**

**YES \| \| NO**

**\|\-\-\-\-\-\-\-\-- New Food Committee
**\-\-\-\-\-\-\-\-\-\-\-\-\--**\| \| \^ V**

**\| \^ CONSULTATION V V \^ V**

**RECOMMANDATION \|\<\< \< \< \< \< \< \< \< \|**

**\| \|**

**\|\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ \|**

**\|**

**\|**

**\|**

\|

  -----------------------------------------------------------------------
  **[DIRECTOR'S DECISION]{.underline}**

  -----------------------------------------------------------------------

\| \|

**AFFIRMATIVE \_\_\_**\_\_\_ **NEGATIVE \_\_\_**

**\| \| \|**

**\| \| \|**

\| \| \|

**UPDATE NEW \-\-\-\-\-\-\-\-\-\-\-- \-\-\-\-\-\-\-\-- NOTIFY
\-\-\-\-\-\-\-\-\-\--**

**FOOD REGISTRY APPLICANT**

**Testing for Biotechnology Crops**

Field experiments of genetically engineered plants began in Israel
eleven years ago. To date, experiments have been conducted on tomatoes
(increasing lycopene level), potatoes, zucchini, eucalyptus, flowers,
wheat, alfalfa, soybean, cotton, corn, tobacco, strawberries, bananas,
lemon, grapevine, ginseng, pine and microorganisms, mostly for
biological control. Experiments carried out in Israel are in the areas
of yield improvement, resistance to diseases, and various stress agents
(drought, salinity, etc), edible vaccines, color variation in flowers,
long shelf life and pests. Experiments are conducted at Israeli
universities, research institutes, field experiments and greenhouses.
The Monsanto Company has financed a number of experiments.

In CY 2005 planted area for experimental crops totaled 0.4 hectares, 85
percent decrease compared to the previous year (2.6 ha in CY 2004). In
CY 2005, no new experiments were conducted for biotechnology crops in
Israel. However, 3 experiments, which began in

CY 2004, continued in CY 2005 (eucalyptus and banana). It is estimated
that 2 new field experiments will begin by the end of 2006. It is
prohibited to conduct field experiments for biotechnology crops near
seed fields, organic or commercial fields. In order to conduct an
experiment an application must be submitted to the Plant Protection and
Inspection Services of Israel (PPIS), (see annex 1 -- Gain report
IS5008). Genetically modified organisms are the responsibility of the
Ministry of Agriculture and the Ministry of Health. The PPIS is the
competent authority in Israel concerning genetically modified crops. New
regulations on genetically modified plants were issued in June 2005 (see
annex 2- Gain report IS5008).

# Labeling 

Currently, labeling requirements do not apply to modified food products
and crops in Israel; however, periodically EU and South-Korea importers
from Israel require certification that Israeli food and non-food
products are non-GMO. In these cases the director of the PPIS or the
chairperson of the NCTP provides the necessary certification.

Recently a new governmental food committee approved a plan to prepare
regulations covering the labeling of GMO products. The regulation must
first be approved by the Attorney General of the Health Ministry and
must then be approved by the Economic Committee of the Israeli
Parliament and finally signed by the Ministers of Industry and Trade and
Minister of Health of Israel. All in all it is unlikely that the
approval will be in the near future. It is expected that regulations
will require that food containing more than one percent of GMO
components will be labeled.

# Biosafety Protocol

Israel did not sign the Cartagena Protocol on Biosafety and is unlikely
to do so at present.

**Section IV. Marketing Issues**

Currently the Israeli consumer is unaware of the biotechnology food
issue or the GMO content in food products. Even if GMO labeling
requirements come into effect, the GMO issue will likely not change the
Israeli consumers' approach to buying.

# Section V. Reference Materials

Annex 1:

Ministry of Health Food Inspection Services Public Health Services

**OFFICIAL WORK PROCEDURES**

DATE: 22 December, 2005 Effective from: 19 February, 2006

1.  **General\
    **The following is designed to set out the procedures for
    registering a new food.

2.  **Purpose\
    **To organize the clear, orderly and systematic registration of a
    new food and the updating of the New Foods Register. This procedure
    creates proper rules and regulations for registering a new food. Its
    purpose is to provide information as to designation of authority and
    operational responsibility. **\
    **

3.  **Principles\
    -** The Director, based on recommendations of the New Food
    Committee, decides whether to register a new food (Para 6.5
    below)**\
    -** No document will be issued under the authority of the Food
    Inspection and Nutrition Services for a new food or for a food
    containing a new food ingredient, whether a permit, a license,
    preliminary authorization to import or their equivalents, in
    contradiction to these procedures.

4.  **Users**

    -   The staff of the Food Inspection and Nutrition Services

    -   The New Food Committee members (Para 6.5 below)

    -   The Unit for Risk Assessment in Food and Nutrition (Para 6.6
        below)

    -   All applicants to register new foods

    -   Anyone wishing to manufacture, to sell or to import a new food

5.  **Scope**\
    This procedure applies to the staffs of the Food Inspection and
    Nutrition Service and of the New Food Committee

6.  **Definitions\
    6.1 New Food**\
    Any food or ingredient (other than exceptions noted in paragraph
    6.2) that has not been in significant use in Israel and belongs to
    one of the following groups:\
    \
    **6.1.1 Change in primary structure (A)\
    **A food or food ingredient containing a new molecular structure or
    which has undergone an intentional change in its primary structure
    at the molecular level, including genetically modified organisms
    (GMO)**\
    **

    2.  **New source (B)**

> A food or ingredient that has been isolated or contains plants,
> animals, micro-organisms, funghi and algae (except enzymes), that does
> not have a lengthy history of safe human consumption\
> \
> **6.1.3 New Process (C)\
> **A food or ingredient whose nutritional value, metabolism or
> undesirable material content level have changed significantly in a new
> manufacturing process (except cleaning and disinfections). **\
> **\
> **6.2 New food -- exceptions\
> **New food does not include nutritional additives or their
> ingredients, food additives, flavor and aroma enhancers, food cleaning
> and disinfecting processes and processing aids.\
> \
> **6.3 Registration of a new food\
> **The procedure under which the Director registers a new food in the
> New Foods Registry.

4.  **New Foods Registry**

> A list, compiled by the Director of the Ministry of Health, of new
> foods that are allowed to be sold in Israel, and the conditions for
> their use. The list is updated periodically and is available for
> public inspection in the offices of the Food Inspection and Nutrition
> Services.
>
> **6.5 New Food Committee**
>
> A committee appointed by the Director and comprised of staff members
> of the Food
>
> Inspection and Nutrition Services. The necessary quorum for passing a
> resolution, is the
>
> presence of two-thirds of the committee membership.

6.  **Unit** **for the Assessment of Risk in Food and Nutrition**

> A unit in the Food Inspection and Nutrition Services that carries out
> risk assessments.

7.  **List of Authorized Bodies**

> The list of bodies or institutions throughout the world that are
> authorized by the Director to carry out food risk assessments is
> updated periodically:

-   The European Communities/EFSA

-   U.S.F.D.A./USDA (FSIS)

-   Health Canada

-   ANZFA -- Australia and New Zealand Food Authority/\
    FSANZ Food Standards Australia New Zealand

-   Japan -- Department of Food Safety, Ministry of Health

-   WHO/FAO CODEX ALIMENTARIUS Expert Committees

> **6.8** **The Director\
> **Director of the National Food Inspection and Nutrition Services or a
> person so authorized.

1.  **Statutory basis\
    **7.1 Public Health Ordinance (Food) (New Version), 5743 -- 1983

7.2 Commodities and Services Control Order (Food Quality),\
5718 -- 1958.\
\
\
**8. The Method\
\
8.1 Initiative to register a new food\
**

**8.1.1** Any person, company or organization may apply to register a
new food.

**8.1.2** The staff of the Food Inspection and Nutrition Services is
authorized to update the Registry of New Foods according to the progress
of legislation in developed countries or as a result of new information
abut a specific new food. (In relation to paragraph 8.4).

> **8.2 Details to be submitted in an application for registration of a
> new food\
> \
> **Applications for registration of new foods shall be sent by mail to
> The Director of the Food Inspection and Nutrition Services, 12
> Ha'Arba'a St, 61203 Tel Aviv. P. O. Box 20301.
>
> Applications shall contain the following:
>
> **8.2.1 Application to register a new food\
> a.** An application form: "Request to Register a New Food", Annex A.
>
> **b.** Form "Legislative Status of a New Food" -- Annex B.\
> **c.** Additional requirements regarding new foods, according to the
> type of food -- Annex C.
>
> **8.3 Method of handling an application to register a new food**
>
> **8.3.1** Within three weeks of receipt of the application, the
> secretary of the New Food Committee will inform the applicant of its
> receipt, and request the completion of any missing details as
> necessary.\
> **8.3.2** Treatment of an application to register a new food.

**Figure 1. Treatment of the registration of a new food.**

> **[EXAMINATION OF LEGAL STATUS -- DOES IT HAVE 2
> APPROVALS?]{.underline}**

**\| \|**

**YES \| \| NO**

**\|\-\-\-\-\-\-\-\-- New Food Committee
**\-\-\-\-\-\-\-\-\-\-\-\-\--**\| \| \^ V**

**\| \^ CONSULTATION V V \^ V**

**RECOMMENDATION \|\<\< \< \< \< \< \< \< \< \|**

**\| \|**

**\|\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ \|**

**\|**

**\|**

**\|**

\|

  -----------------------------------------------------------------------
  **[DIRECTOR'S DECISION]{.underline}**

  -----------------------------------------------------------------------

\| \|

**AFFIRMATIVE \_\_\_**\_\_\_ **NEGATIVE \_\_\_**

**\| \| \|**

**\| \| \|**

\| \| \|

**UPDATE NEW \-\-\-\-\-\-\-\-\-\-\-- \-\-\-\-\-\-\-\-- NOTIFY
\-\-\-\-\-\-\-\-\-\--**

**FOOD REGISTRY APPLICANT**

The secretary of the New Food Committee shall check the legal status of
the new food.

If the new food is approved by at least two institutions on the List of
Authorized Bodies in paragraph 6.7 above, the application for a new food
will be considered under paragraph 8.3.2 (a). If it does not, it will be
considered under paragraph 8.3.2 (b).

> **8.3.2 (a)** If the new food in the application conforms to the
> specifications in the list of authorized institutions:
>
> **a.1** The application will be sent for consideration by the New Food
> Committee.
>
> **a.2** The Committee will recommend to The Director to either approve
> or reject the application. In addition, the Committee may request
> additional information from the applicant, if required. Where doubt
> exists or in irregular cases, the Committee may send the application
> to the Unit of Risk Assessment in Food and Nutrition for its
> consideration.
>
> **a.3** The application to register new food will be treated according
> to The Director's decision to register or to reject the new food.
>
> **a.3.1** If The Director decides to register the new food in Israel,
> he will notify the applicant in writing of the registration, and of
> the conditions, including the uses of the new food, required warnings
> and labeling requirements if they exist.
>
> **a.3.2** If The Director decides to reject the application, he will
> explain his reasons in writing to the applicant.
>
> **a.4** The New Food Registry will be updated accordingly.
>
> **a.5** The duration of the application treatment -- up to six months
> from the day of its full submission, according to the legislative
> status of the new food.
>
> **8.3.2 (b)** If the new food in the application does not fit the
> criterion of approval by two institutions on the List of Authorized
> Bodies, then
>
> **b.1** The New Food Committee will pass the application to the Unit
> for Risk Assessment in Food and Nutrition for its consideration.
>
> **b.2** The Unit for Risk Assessment in Food and Nutrition will
> recommend either to accept or to reject the new food. Its
> recommendation shall be passed to the New Food Committee that will
> proceed according to paragraphs a.2 -- a.4.
>
> **b.3** The duration of the treatment of the application -- up to one
> year from the submission of the complete application, according to the
> legislative status of the new food.
>
> **8.3.3** The secretary of the New Food Committee will publish the
> decision with respect to the registration of the new food according to
> paragraph 8.6.

4.  **Updating of the New Food Registry in instances when no new
    registration applications exist (para 8.1.2)\
    **In those cases when a decision is made to update the Registry
    following receipt of new information on a specific new food, the
    handling of the updating of the Registry shall be as set out in
    paragraphs 8.3.2 and 8.3.3.

> **8.5 Criteria governing the addition of new foods to the New**
>
> **Food Registry\
> **A new food may be added to the New Food Registry under the following
> conditions:\
> - The new food must meet the safety requirements set out for food
> products.\
> - The new food and its manufacture must meet all requirements of the
> law.\
> - The new food must conform to specifications and standards of hygiene
> governing food.
>
> \- The new food must not mislead the consumer.
>
> **8.6 Publication of the New Food Registry updates**

1.  In the even of an updating of the Registry, notice should be sent to
    the Regional Ministry of Health Offices, the staff of the Food
    Inspection and Nutrition Services, the director of the Laboratory
    Division, the Manufacturers' Association and the Federation of
    Chambers of Commerce. A notice should be posted on the Food
    Inspection and Nutrition Services' website (URL --
    [www.health.gov.il](http://www.health.gov.il/) ).

2.  The updated Registry shall be found at the offices of the Food
    Inspection and Nutrition Services.

**8.7 Cancellation of the registration of a new food**

> **8.7.1** The Director may cancel the registration of a new food in
> the Registry of New Foods:\
> **\
> a.** In the event that information has been received indicating that
> the new food may endanger public health.\
> \
> **b.** If the conditions and requirements appearing in the notice of
> registration are not met, including labeling requirements.**\
> \
> 8.7.2** In the event that The Director decides to cancel the
> registration of a new food, he/she has the authority to halt its
> production, importation and sale, and to execute a recall, if
> necessary.

**ANNEX A**

> **[APPLICATION TO REGISTER A NEW FOOD]{.underline}**
>
> **The New Food Committee**
>
> **The Food Inspection and Nutrition Services**
>
> **Ministry of Health**
>
> **A. [Applicant's Details]{.underline}**
>
> **Name and position of applicant
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**
>
> **Name of company/organization
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**
>
> **I.D. No.\_\_\_\_\_\_\_\_\_\_\_\_\_\_ VAT No. / Company No.
> \_\_\_\_\_\_\_\_\_\_\_\_**
>
> **Address
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**
>
> **Fax: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**
>
> **Phone: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**
>
> **e-mail:
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**
>
> **Attach copies of applicant's identity card, VAT registration
> certificate or Registrar of Companies certificate.**
>
> **B. [Certification of authenticity of documentation and
> signatures]{.underline}**
>
> **I,
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ ,
> representing**
>
> **Given name and surname**
>
> **\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_,
> undertake and**
>
> **Name of Organization**
>
> **ensure with my signature that:**
>
> **1. I am aware that presentation of false information and/or**
>
> **concealment of relevant information are criminal acts.**
>
> **2. All of the following information is submitted as an integral part
> of our application to the Food Inspection and Nutrition Services of
> the Ministry of Health for the registration of a new food or
> ingredient.\
> **
>
> **3. The information submitted is, to the best of my knowledge,
> complete and correct.**
>
> **Date: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Signature:
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**
>
> **\* When there is more than one new ingredient in a given product,
> this document, and all other Annexes attached, should be completed for
> each new ingredient separately.**
>
> **[C. Application Details]{.underline}**
>
> **[Type of food/new ingredient]{.underline}**
>
> **\_\_\_ Plant \_\_\_ Animal \_\_\_\_ Micro organism**
>
> **[\_\_]{.underline} Funghi or algae \_\_\_ chemical compound or
> preparation**
>
> **[Groups]{.underline}**
>
> **A. \_\_\_ Molecular transformation, including genetic (GMO)**
>
> **B. \_\_\_ New source C. \_\_\_ New process**
>
> **Name of new food
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**
>
> **Description of new food, including information on the nature of the
> product, its development, its manufacture, preparation, packaging and
> storage.**
>
> **Description of the main change (if there is one)**
>
> **Description of the proposed use of the new food**
>
> **Product formulation
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

**[ANNEX B]{.underline}**

**[LEGISLATIVE STATUS OF THE NEW FOOD]{.underline}**

**A. Name of new food/ingredient
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

**Synonyms
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

**B. 1. Has undergone a risk assessment by an Authorized Body: yes/no**

**Name of body \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Year \_\_\_\_\_\_**

**Source in literature:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

**ADI/TDI etc. if any:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

**\_\_\_\_ Documentation attached.**

**B. 2. Approved in the EU yes/no \_\_\_\_**

**Title of Directive
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

**Page \_\_\_\_**

**\_\_\_\_ Documentation attached.**

**B. 3. Approved in the U.S.A. yes/no \_\_\_\_**

**Source in literature
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

**\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

**\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

**\_\_\_\_ Documentation attached.**

**B. 4. Other approval**

**\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

**\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

**\_\_\_\_ Documentation attached.**

**B. 5. Other approval**

**\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

**\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**

**\_\_\_\_ Documentation attached.**

# ANNEX C

**[ADDITIONAL REQUIREMENTS OF NEW FOODS ACCORDING TO THE TYPE OF NEW
FOOD]{.underline}**

**A. [CHANGE IN PRIMARY STRUCTURE -- (]{.underline}SEE PARAGRAPH 6.1.1
OF OFFICIAL WORK PROCEDURE)**

**A1. [GENETICALLY MODIFIED ORGANISM (GMO)]{.underline}**

**Definition; A Genetically Modified Organism -- A plant, animal, micro
organism, fungus or alga related to food or destined for human
consumption, that has undergone genetic transformation by methods of
genetic engineering.**

**1. Requirements in addition to two approvals provided by organizations
on the List of Authorized Bodies. These should be attached to the
application for registration in Israel of a genetically modified
organism.**

**a. Description of the genetic transformation and its nature, in
addition to full data on consumption and the possible effects on
humans.**

**b. Professional literature on the results of experiments on the
genetically engineered organism and its uses outside of Israel.**

**c. Details of the method proposed for detecting the genetically
engineered organism in food, including a sample of the engineered
material.**

**d. Additional data, as required by The Director, including tests in a
recognized laboratory.**

**2. Additional requirements of items to be attached to the application
form for a new food that has not received two approvals from the List of
Authorized Bodies, or any approval at all.**

a.  **Description of the genetic transformation and its nature, in
    addition to full data on the possible effects on humans.\
    **

b.  **A complete toxicology file.\
    **

c.  **1. In the case of an organism that was developed outside of
    Israel, a report on experiments with the GMO and its uses abroad.\
    2. In the case of an organism that was developed in Israel, a report
    on the experiments run on the GMO and on its uses in Israel. A
    license from the Director General of the Ministry of Agriculture
    according to section 7-a of the Seed Regulations (Engineered Plants
    and Organisms, 5762 -- 2002).\
    **

d.  **Details of the method proposed for detecting the genetically
    engineered organism in food, including a sample of the engineered
    material.\
    **

e.  **Presentation of a permit, if one exists, from an authorized body
    (a government body in the country, that is legally authorized to
    issue such a permit) in countries in which the genetically
    engineered organism was approved for use and was found fit for human
    consumption. Any limitations on consumption should be noted.\
    **

f.  **Additional data, as required by The Director, including tests in a
    recognized laboratory.**

**A2. [NEW COMPOUNDS OR CHEMICAL PREPARATIONS]{.underline}**

**a. General information on the compounds and their technical
specifications**

**a.1. Chemical name (according to the rules of nomenclature, if
possible)**

**a.2. Trade name\
a.3. CAS number, if it has one.**

**a.4. Compound characteristics, such as: structure, molecular weight,
physical state, color etc.**

**a.5. Spectroscopic data**

**a.6. Degree of purity**

**a.7. Solubility**

**a.8 The nature of the compound, e.g. protein, fatty acid, sugar,
etc.**

**a.9. Any other relevant data**

**b. Analytical method for identifying the compound in food**

**c. History of its use as a food or as a food ingredient in food in the
world (if such a history exists)**

**c.1. Food products on the world market that contain the new compound**

**c.2. History of its medical use (if one exists)**

**c.3. Limitations on use and consumption (if they exist)**

**c.4. If no history was found on the use of the compound as a food or
as a food ingredient, the applicant should note all information sources
searched.**

**d. Known pharmacological effects (if any)**

**d.1. Active mechanism and symptoms of overexposure to the new
compound.**

**d.2. The active ingredient or ingredients in the compound and their
activity.**

**d.3. Interaction with medications.**

**d.4. Interaction with other materials in the environment, such as food
ingredients.**

**[B. A NEW SOURCE]{.underline} (SEE SECTION 6.1.2 OF OFFICIAL WORK
PROCEDURE)**

**[B1. PLANTS]{.underline}**

**a. Methods to ensure the plant's identity and prevent contamination**

**a.1. Scientific name and synonyms (including genus and species,**

**family, division (phylum) and order)**

**a.2 Commercial name and synonyms**

**a.3 Other species also known by these names and that can create
confusion.**

**a.4. Identification methods that can prevent confusion in the
production of the product.**

**a.5 Plant parts intended for use as food or as ingredients.**

**b. Certificate of Free Sale (if there is one).**

**c. History of its use as a food or as an ingredient (if there is
one).**

**c.1. Food products in the world market that contain the new
ingredient.**

**c.2. History of medical use (if it exists).**

**c.3. Limitations on use and consumptions (if they exist).**

**c.4. If nothing was found on the history of its use as food or an
ingredient, all sources of information checked should be noted in
detail.**

**d. Known pharmacological effects**

**d.1 Activity mechanism and symptoms of overexposure to each
ingredient.**

**d.2. Active ingredient or ingredients found in the product. For
example, it is possible to cite "Active principle and other chemical
components" as appears in decisions of the Council of Europe (COE) to
approve natural materials for foods.**

**d.3. Interactions with medication or other materials.**

**e. If the application refers to a concentrate or an essence, the
following should also be referred to:**

**e.1. Description of the extraction process, including:**

**e.1.1 Solvents and other materials employed.**

**e.1.2 Environnemental conditions: temperature, pressure, etc.**

**e.2. Chemical analysis of the final essence, including\
e.2.1 All materials and reagents employed in the extraction process**

**e.2.2 All active components of the raw material for the essence.**

**[B2. ANIMALS]{.underline}**

**a. Methods to ensure identification of animals**

**a.1. Scientific name and synonyms (including species, genus, family,
order, division)**

**a.2. Commercial name and synonyms**

**a.3 Other livestock species known by these same names (that might
cause confusion)**

**a.4. Methods for differentiating among the various species, to prevent
confusion**

**a.5. Description of the animal and designation of the parts intended
for consumption**

**b. Certificate of Free Sale (if one exists)**

**c. History of its use as food or as a food ingredient**

**c.1. Food products in the world market that contain the new ingredient
or are based on the animal.**

**c.2. Limitations on use and consumption (if they exist).**

**c.3. History of medical use (if it exists).**

**c.4. If nothing was found on the history of its use as food or an
ingredient, all sources of information used should be set out in
detail.**

**d. Known pharmacological effects**

**d.1 Activity mechanism and symptoms of overexposure to each new
ingredient**

**d.2. Active ingredient or ingredients found in the product**

**d.3. Interactions with medication or other materials**

**B3 [MICRO ORGANISMS OR FUNGHI OR ALGAE]{.underline}**

**(Note: The intention is to include any living organism that does not
fall into the**

**definition of a plant or an animal but is related to food and is
intended for**

**consumption.)**

**a. Methods to ensure the identification of the micro organism, fungus
or alga**

**a.1 Scientific name (including species, genus, family, order and
division)**

**a.2 Commercial name and synonyms**

**a.3 Please list "relatives" that serve as food, if any**

**a.4 Other species known by these same names (that might cause
confusion)**

**a.5 Methods for differentiating among species to prevent possible
confusion in the course of the production process**

**b. General information on the micro organism, fungus or alga**

**b.1 Requirements, such as environmental conditions, propagation,
mortality.**

**b.2 Characteristics, such as morphology, gram staining, motility, pH
resistance.**

**b.3 Methods for identification of the micro organism, fungus or alga
in food.**

**c. History of its use as a food or food ingredient in the world (if it
exists).**

**c.1 Food products on world markets that contain the micro organism,
fungus or alga**

**c.2 History of its medical use (if any)**

**c.3 Limitations of use or consumption (if any)**

**c.4 If nothing was found on the history of its use as food or an
ingredient, all sources of information used should be noted in detail.**

**d. Information on toxicity of the micro organism, fungus or alga**

**d.1 Toxicological or pathogenic effects of the micro organism, fungus
or alga to mammals, including humans**

**d.2 Detailed list of all toxins (if any), including: type of toxin,
toxicity level, when and where it is created and any other relevant
information.**

**e. The status of the micro organism, fungus or alga**

**e.1 Please describe in detail the physical state of the micro
organism, fungus or alga in the food, i.e. whether it is live, dead, or
not found in the final product.**

**e.2 In the event that the micro organism, fungus or alga is live in
the food, please note its concentration in the final product.**

**e.3 In the event that the micro organism, fungus or alga are alive in
the food, please describe the potential for their survival or
colonization in the intestines of mammals, including humans.**

**e.4 To the extent that there is beneficial activity for humans, please
describe the active ingredient and its activity.**

**e.5 In the event that there is activity of technological importance,
please describe the activity and the active ingredient.**

**e.6 Declaration as to the degree of cleanliness suitable for food.**

**e.7 The degree of purity of the culture and the steps required to
maintain the purity of the culture source from contamination, including
its genetic purity.**

**C. [NEW PROCESS]{.underline} (SEE SECTION 6.1.3 OF THE PROCEDURE)**

**[LIST OF PARTICIPANTS IN PREPARATION OF THE PROCEDURE]{.underline}**

**- Engineer Eli Gordon, Food Inspection and Nutrition Services**

**- Dr. Rina Versano, Food Inspection and Nutrition Services**

**- Dr. John Young, Food Inspection and Nutrition Services**

**- Dr. Yinon Yoni, Food Inspection and Nutrition Services**

**- Dr. Ziva Stahl, Food Inspection and Nutrition Services**

**- Engineer Anat Averbuch, Food Inspection and Nutrition Services**

**- Engineer Riva Gur Arie Sharon, Food Inspection and Nutrition
Services**