THIS REPORT CONTAINS ASSESSMENTS OF COMMODITY AND TRADE ISSUES MADE BY USDA STAFF AND NOT NECESSARILY STATEMENTS OF OFFICIAL U.S. GOVERNMENT POLICY Required Report - public distribution Date: 7/26/2010 GAIN Report Number: IS1009 Israel Food and Agricultural Import Regulations and Standards - Narrative FAIRS Country Report Approved By: Jonathan P Gressel Minister Counselor for Agricultural Affairs, U.S. Embassy Cairo Prepared By: Gilad Shachar Agricultural Marketing Specialist, U.S. Embassy Tel Aviv Report Highlights: In the current report the following sections have been updated: 1) Packaging Law; 2) Color additives approved for use in human food; 3) Updated treatments requirements for plant and its products; 4) New infant formula regulations; 5) New import guidelines regarding BSE; 6) New cold treatment requirements for apples and pears to mitigate the risks of apple maggot and plum curulio; 7) Botanical names; 8) Labeling a food product called ?Natural? or an equivalent title; 9) Proposed amendment for olive oil; 10) New regulations regarding the importation of specific fish species; 11) The following Plants have been approved by the Israeli Ministry of Health for use in food and/or food additives. Section I. Food Laws: General Food Import Considerations Israeli importers face two main considerations when selecting a particular product - quality and price. In the price range, American products are not always attractive, due to the high production costs in the U.S., and high transportation costs to Israel, relative to suppliers from near-by Europe and the Mediterranean basin. Transport costs from the United States are about the same as transportation costs from the Far East. From Europe, the costs are significantly lower, not to mention even closer countries such as Turkey, which competes with the United States for imports of dried fruit and nuts into Israel. The problem of transportation costs is less crucial when dealing with expensive products and materials, or with products with very high value-to-volume ratios such as spices, essences, flavorings, concentrates etc. The problem is also partially resolved when dealing with products that are eligible for tariff preferences as imports from the United States. This partially compensates for the high transport costs. US goods enjoy a 10-22 percent tariff advantage over European and third-world country suppliers on a broad range of processed and semi-processed foodstuffs. Another subject to be considered is the issue of ?kashrut?. Kosher certification is not a legal requirement for importing food into Israel. However, non-kosher products have a much smaller market, as most supermarkets and hotels refuse to carry them. Manufacturers who produce kosher products must be able to satisfy Israeli rabbinical supervisors that all ingredients and processes are kosher. According to the Law for Prevention of Fraud in Kashrut, only the Chief Rabbinate of Israel is authorized to determine and approve a product as kosher for consumption in Israel, or may authorize another supervisory body to act in its name. Here too United States products have an advantage as the kashrut certification issued by many American rabbis is recognized by Israel?s Chief Rabbinate. It is, however, quite simple for Israeli importers to send an Israeli rabbi to any supply source, thereby reducing the American advantage. In recent years, opportunity for non- kosher foods has been increasing as immigrants from the Former Soviet Union (FSU) now account for a significant share of purchasing power (15 percent). Prohibited Imports Israel, which is a signatory to the WTO Agreement, maintains relatively few restrictions on agricultural imports. However, U.S. meat exports face an especially difficult environment due to the enactment at the end of 1994 of a ban on all non- kosher meat and poultry imports except offals. The United States - Israel FTA of 1985 allows both countries the use of non-tariff restrictions or prohibitions on products from agricultural sub sectors, which are subject to agricultural policy considerations. The recent WTO accords do not. Instead WTO rules call for tariffication of administrative and technical barriers. Israel has removed most administrative barriers to United States imports but has retained high levies on sensitive products and imposes various constraints and barriers, for example, those pertaining to kosher certification, for meat and poultry. The only other product prohibitions are targeted against internationally controlled substances and/or are designed to protect public morals, human, animal or plant health, or national security. Section II. Labeling Requirements: Labeling and Marking Requirements Israel has strict marking and labeling requirements, which frequently differ from those of other countries. It is recommended that United States exporters consult with their Israeli importer prior to shipping. All imports into Israel must have a label indicating the country of origin, the name and address of the producer, the name and address of the Israeli importer, the contents, and the weight and volume in metric units. In all instances, Hebrew must be used; English may be added provided the printed letters are no larger than those in Hebrew. Nutritional labeling is compulsory on all packaged foods. Specific information on weights and measures standards is available from the Commissioner of Standards, Ministry of Industry and Trade, 30 Agron Street, Jerusalem 94190. As of September 1, 1998 weights and measures have become voluntary and no longer serve as a barrier to entry of foods packaged in avoirdupois units. However, where packaging is non- standard, the package must indicate the unit price of the product. Marking should be done by printing, engraving, stamping, or any other means, on the package on the goods themselves. If marking is not possible, a label should be well sewn or stuck to the goods or package. Marking details should be clear, legible, easy to trace, and in a different color from the background in order to be clearly distinguishable. Printing dyes and other marking materials should not affect merchandise quality. The marking should not be blurred. On a multi-layered package, the external layer should be marked. If the external layer is transparent, the marking should be done underneath that layer, provided it is still clear and legible. On a package containing sub packages, the labeling should specify: the number of sub packages, the net content of a sub package, and the overall net weight of the package. For products that tend to lose weight under regular marketing/commercial conditions, the maximum quantity of expected depletion should be mentioned. Specific labeling regulations apply to some consumer goods, as well as fertilizers, insecticides, chemicals, pharmaceuticals, some food products, seeds, and alcoholic beverages. In addition, special packaging requirements apply to fruit, plants and meat. Outside and inside containers of dangerous articles, such as poisons, insecticides, drugs, reptiles, insects, bacteria should be clearly marked. For information on food labeling and packaging contact: Israel Ministry of Health, Food Control Administration, 12-14 Ha?Arba?a St., Tel Aviv 64739; Telephone: 972-3-6270100; Fax: 972-3-5619549. Labeling of pre-packaged food: Description of content: This 7th amendment to the Mandatory Standard SI 1145 deals with the normative references, with the marking of food ingredients and with the food description when labeling pre-packaged food. A copy of the proposed draft amendments is available at the FAS post in Tel Aviv: Email: agtelaviv@usda.gov Application of the Labeling Standard The Standard sets requirements for labeling prepackaged food intended for retail sale, excluding unprocessed fruits and vegetables. It also sets the labeling requirements for prepackaged foods listed below, not intended for retail sale: food for industrial processing and for repackaging; -food in wholesale packaging; -prepackaged food containing packaged sub units. Where there is a contradiction between the requirements of Standard 1118 for prepackaged foods and the labeling requirements of the Special Standard which applies to a particular food or the labeling requirements in a Group Standard which applies to a particular group of foods, the requirements of the special Standard or of the group Standard shall take precedence. All labels shall be accurate and not misleading and shall be capable of proof. The label of the product shall not give indication of medicinal properties attributed to the food nor shall it state that the product?s use is likely to heal or prevent illness. However, see the section on nutritional labeling in Section F for special references to certain types of food. Mandatory labeling information must be in Hebrew: such writing may be repeated in a foreign language provided that it includes all the required information and that it is identical in content to the Hebrew. The size of the Hebrew letters and numbers on the label must be at least as large as indicated in Table 1 below. The size of the letters in the other language must not be larger than the size of the Hebrew letters. The size of the letters of the trade name shall not be larger than three times the size of the letters of the name of the food. Food, which can be marketed in a number of forms, which are of significance to the consumer, shall be appropriately labeled: whole, sliced, crushed, segments, cubes, etc. The size of the letters of this labeling shall be at least half the size of that of the letters in the name of the product. The Name of the Food The label shall include the name of the food. If there are several words in the name of the food, all these words shall be written in the same size and with the same emphasis. If there is a special Standard for the product, the name of the food shall be that name which appears in the special Standard. In addition to the name of the food, it is permissible to also add a trade name. The size of Hebrew lettering required on labels, see Annex 6. The Name of the Manufacturer, Importer, Marketer, and Packer The label shall include a clear indication of the name of the manufacturer and his address. Alternatively, instead of indicating his name, the manufacturer may indicate in addition to his address, his registered trademark for the product, which he produces, on condition that the trademark includes letters and does not mislead concerning the nature of the product. The labeling of an imported product, which is marketed in its original package, shall also include the name of the importer and his address. It is permitted to indicate on the food the name and address of some other person instead of the name and address of the manufacturer of the food if that other person has taken all the necessary measures to ensure compliance with all the regulations relating to manufacture of the food, including constant control of the production, packaging, weighing, labeling, marketing, transport, and storage of the product. If the name of a person other than the manufacturer is indicated, the name of the manufacturer shall be noted in code. Producer Country Imported food shall be labeled with the name of the producer country. It is permitted not to indicate the producer country of imported products, which are used in the manufacture of food in Israel. For purposes of this paragraph, if only the packaging is changed, it will not be considered as manufacture. Content Labeling shall include the net content of the food in the package, by weight or by volume. The content of liquid food shall be indicated in units of volume: - Milliliters (ml) for a product containing less than 1000 ml; - liters for a product containing 1000 ml or more. The content of solid, semi-solid, or viscous food shall be designated by weight: - grams (gr.) for a product containing less than 1000 grams; - kilograms (kg) for a product containing 1000 grams or more. The net content of a product packed in aerosol containers shall be marked in units of weight when the product is in a semi- solid or powdered state or marked in units of volume when the product is liquid. It is prohibited to add alongside the units of volume or weight any adjective, which is likely to be misleading. The content of food packed in liquid shall be indicated in units of weight and will state the content after draining as well as the net weight. When indicating the content after draining, the words ?weight after draining...? shall be included. On the composite package the number of units inside shall be marked as well as the net content of each packaged unit and the total net content. For a product, which is liable to lose weight in regular commercial or marketing conditions due to storage or display for sale, the expected lesser content shall be indicated. New Requirements Regarding Labeling of Package Content The Ministry of Industry, Trade and Labor (MOITAL) published new requirements regarding labeling when the package weight of food and non?food product is reduced. Specifically, these requirements apply to products that were already sold in a defined, already known size, and the manufacturers or the sellers intended to reduce the weight or the content of the product in the package in order to remain competitive in the market. The new requirements were published after it was found that manufacturers and/or sellers were reducing the weight/content of the packages, but not changing the labeling of the package to reflect the new size. According to the new requirements, the labeling on the package must be changed, mentioning clearly the new quantity. In addition, a special notification should be added: ?The package contains ??% less than the regular package?. The size of the letters of the notification on the package should be the same as the product?s name letters. It is the manufacturers? or importers? obligation to inform the retailers and the buyers about the change in the size of the packages. If the notification on the package is unclear, it is the supplier?s obligation to supply the retailers with appropriate signs to be put on shelves. The manufacturer or the importer must also inform the customers about the change by advertising in the national media. Ingredients and Food Additives The contents shall be indicated for all ingredients, including water in descending order according to their relative weight in the food except for the following foods: For dry food, which is to be reconstituted by the addition of water, it is permissible to indicate the ingredients in descending order of their relative content in the reconstituted product if the words ?ingredients after reconstitution? are included. If one of the ingredients is food to which an Israeli Standard applies, the name of the food shall be indicated in the list of ingredients as required in the applicable Standard and its ingredients shall not be listed. However, if coloring and preservatives have been added to the above food their presence shall be indicated in the list of ingredients of the labeled food. A food product to which no Israel Standard applies shall be labeled with the percent of an ingredient that significantly affects the price of the product, if so required by the authorities. Date The date of manufacture or alternatively identification of the production lot as well as the last date for marketing shall be marked as indicated below: Products whose shelf life is up to 60 days from the date of manufacture: The date of manufacture shall be marked openly or in code (day and month or else day, month, and year). The last date for marketing shall be marked openly (day and month or else day, month and year). Products whose shelf life is between 60-365 days from the date of manufacture: The date of manufacture shall be marked openly or in code (day, month, and year). The last date for marketing shall be marked openly (day, month and year or month and year) if the date of manufacture is indicated in code. It is not required to indicate the last date for marketing if the date of manufacture is marked openly. Products whose shelf life is longer than a year: Either the date or the code (day, month and year) of the date of manufacture shall be indicated. It is not required to indicate the last date for marketing. The manufacturer shall determine the shelf life of the product and shall mark the dates accordingly. The length of the shelf life shall be determined in accordance with the nature of the product, the form of its packaging, and the recommended storage conditions assigning the product to one of the three groups of products according to the nature of the explicit marking of the date. The manufacturing date indicated on the product is not to be changed except in the case where a mistake has been made in the marking and the product has still not left the plant for market. Instructions for Storage, Transport, and Use Instructions for storage, transport and use shall be included in the label when: -the food has been cooled to a temperature of less than +8 degrees Centigrade or has been frozen; -there are special instructions for handling either before or after the package is opened; -when the nature of the product demands it, for example the words ?keep in a dry place?, ?keep in a cool place?, ?keep in the shade?, ?do not refreeze after thawing? etc. Choking Warning Labeling Required On 18 September 2006 new regulations regarding choking warning labeling were announced by the Food Control Service with the Ministry of Health. The new regulations came into effect on 18 March, 2007 (see GAIN Report IS7007). The regulations state that a warning must be marked in both Hebrew and Arabic on the following products intended for retail sale: nuts and seeds, with or without shells, popcorn, dried corn kernels for popcorn, spreads containing fragments of shelled nuts and sausages. When these foodstuffs are sold by weight (not pre-packaged), the warning must be prominently and visibly displayed on an adhesive label attached to the packaging or alternatively printed on the packaging itself. The warning must also be included in advertisements for the aforementioned foodstuffs. Labeling Prepackaged Food, Which Is Not Intended For Retail Sale Food used in industrial manufacture (including repackaging): the following items shall be marked on the package of food used in industrial manufacture: -the name of the food; -labeling which identifies the lot. If required by the responsible authority, the manufacturer shall present the specifications of the food. Note: Despite what is stated above, the language of the labeling of food to be used in industrial production (including repackaging) may be not in Hebrew but rather in one of the following languages: English, French, German, Spanish, Italian instead of Hebrew. Food in a Wholesale Package The following items shall be marked on wholesale packages: -the name of the food -the name and address of the manufacturer as specified -ingredients as specified -the date as specified Prepackaged food, which contains several packed units The following items shall be marked on the package: -the name of the food -labeling which identifies the lot. -number and size of retail units in the large package. Sweeteners (1) No person shall produce or market a food which contains any sweetener unless the sweetener is listed in column A of the Fifth Appendix below, the food is low calorie, and the amount of sweetener in it is not greater than the amount indicated beside each sweetener in column C. (2) No person shall produce a sweetener, a non-high-intensity sweetening substance or food, which contains such substances unless ? (a) the sweetener meets the requirements for purity and quality as indicated alongside it in column B of the Second Appendix; (b) the non-high-intensity sweetening substance meets the requirement for purity and quality as indicated alongside it in column B of the Fourth Appendix. (C) if the product is a personal (tabletop) sweetener - it does not contain any food additive other than those listed in the Fifth Appendix; Personal (Tabletop) Sweeteners No person shall produce or market any personal (tabletop) sweetener unless it meets the following conditions; (a) it is in its pure form or in a mixture with carbohydrates or food additives; (b) it is packed in a packet weighing one gram (henceforth - packet) or in a container whose net weight is not more than 200 gr.; (c) if it is in the form of a solution or powder - attached to its packaging there will be some implement for measuring the sweetener with a capacity equal to 5 gr. of sucrose. Section III. Packaging and Container Regulations: On June 21, 2010, Israel's Knesset (parliament) approved the Packaging Bill in first reading (To become law, a regular state state bill must pass three readings in the Knesset), submitted by the Ministry of Environmental Protection. The aim of the law is to minimize the generation of excess packaging waste and encourage reuse, recycling and reduction of waste transferred for land filling. The law seeks to regulate the treatment of packaging in Israel and is based on the principle of extended producer responsibility, whereby the manufacturer or importer is responsible for the collection and recycling of the packaging they produce or import for sale in Israel and for their full cost. It is estimated that the law will go into effect in 2011. Main provisions of the proposed law and its impact on the public: Type of packaging - based on the European directive, the proposed law will apply to packaging from different materials and for a wide range of products (both household and industrial). The law differentiates between single and multi-use packaging in order to encourage the use of multi-use packaging. Recycling targets - by 2014 manufacturers and importers will be required to recycle 60% of the total weight of the packaging of the products they sell or import each year. Producers will have to comply with annual recycling targets according to type of material: glass, water and cardboard - 70%, metal - 65% and plastic - 40%. (Large beverage containers included in the recycling targets incorporated in the Deposit Law will be included within the plastic recycling targets in this law). Accessible infrastructure for the sorting of waste in local authorities - the proposed law will enable local authorities to adopt advanced models of separating waste at source in order to increase recycling rates and the quality of the resulting products. Zero waste for landfilling - according to the Environmental Protection Ministry's policy on solid waste management, the landfilling of packaging waste will be prohibited by January 2020, as a complementary step to other activities taken by the ministry, and in order to reach the recycling and recovery rates of developed countries. Marking of packages - the manufacturer will mark each packaging with information on its designation for recycling, recovery or reuse, type of raw material and weight of the packaging, hazardous waste content and identity of the corporation from which the producer received the services. In addition, the producer will be responsible for registering and reporting the scope of packaging for which he is responsible. Fines and financial sanctions for non-compliance - the financial sanction for non-compliance with the recycling targets is 5,000 shekels ($1,300) for every ton for which a violation is committed. For most of the provisions of the proposed law, a financial sanction of 67,000 shekels ($17,400) was set. Violation of the provision prohibiting the landfilling of waste carries a proposed sanction in the sum of 202,000 shekels ($52,500) in light of the concrete environmental repercussions associated with this form of disposal. Section IV. Food Additives Regulations: The food additive regulations are based on "The Public Health Regulations (Food) (Food Additives) 1997. A new full list of approved food additives was published by the Food Control Service (FCS) in 2010. The basic ingredients and the additives must be marked with either their group or specific names except when the responsible authority has required that the specific name either of the basic ingredient or of the additive be used or when it has required some other identifying label concerning either the basic ingredients or the additives. The group names for the basic ingredients and the additives shall be as follows: Basic ingredients -animal fats and oils -vegetable fats and oils (if the fat is hardened, it shall be so stated) -starches (except for modified starches) -sugars -vegetable protein -animal protein -flours -alcohols -herbs -spices Additives -anti foaming agents -anti caking agents -anti oxidants -bleaching agents -food colorings -emulsifiers -flavor and odor additives -ripening agents -preservatives -stabilizers -thickeners (including modified starches) -acidifiers -gelling agents -whipping agents -clarifying agents -leavening agents -vitamins -neutralizers -flavor enhancers -enzymes -non-nutrient sweeteners -solvent residues Food Additives Importation Guidance In order to get a permit for the import food additives to Israel, the following documentation is required, in accordance with the Food Additive Regulation from 5/18/97: 1. Confirmation submitted by an approved authority that the production plant is under inspection. 2. Free Sale Certificate, submitted by an approved authority. 3. A Confirmation that the manufacturer is producing under Good Manufacturing Practice (GMP). Confirmation will be accepted only if submitted by an approved authority, or by an independent body that was approved by the Israeli Food Control Service (FCS) to submit GMP certificates. 4. Content - A certificate from the manufacturer listing the content of the capsule, including botanical names of the plants. 5. Analysis results - A document from an authorized laboratory, signed by the test executer, detailing the analysis results. In addition, microbiological test should be executed for the following products; food additives made of vegetative raw materials (leaves, dried plants and powders), plant extracts and food additives that include microorganisms. 6. Original label of the product. 7. Stability of the product - test results of the shelf life of the product, or an announcement made by the manufacturer that the claimed shelf life was determined on the basis of stability tests. Color Additives Approved for Use in Human Food In March 2010, the following food color additives were approved for use in food products in Israel: http://www.health.gov.il/Download/pages/fcsmar2010.pdf - see pages: 8-10. Banned Food Additives In August 2007, the following food color additive have been totally forbidden for use in food products in Israel: E128(Red 2G). Since March 2009, the following food additives were completely banned for use in food products in Israel: Propyl p- hydroxybenzoate E216, Sodium propyl p-hydroxybenzoate E217. Starting December 2009, the following food additives were banned for usage in food products in Israel: PARA- HYDROXY-BENZOATES (PHB): Ethyl p-hydroxybenzoate E214, Sodium ethyl p-hydroxybenzoate E215, Methyl p- hydroxybenzoate E218, Sodium methyl p-hydroxybenzoate E219. Source:http://www.efsa.europa.eu/EFSA/Scientific_Opinion/opinion_afc16_ej83_parabens_v2_en1,0.pdf Section V. Pesticides and Other Contaminants: The Plant Protection and Inspection Services (P.P.I.S.) publishes the ?Israeli Directory of Pesticides? which lists pesticides registered in Israel under the Plant Protection Law of 1956, and the Regulation concerning the sale of pesticides, 1994. The Pesticide Data Bank of the PPIS contains all the information regarding correct and safe usage of the pesticides permissible for sale in Israel. The database is being updated 2-3 times per year. PPIS Pesticide Site: http://www.hadbaraeng.moag.gov.il/hadbara/english/ The following information can be obtained through the data bank: ? Generic name of the active ingredient and its concentration ? Formulation ? Rats LD50 ? Toxicity for fish, bees and birds ? Application specifications for the control of pests in various crops, including doses, volumes and harvest intervals ? Scientific names of the pests ? Maximum residue levels in food (MRL) ? Permissible combinations of pesticides for each crop This list is based whenever appropriate on the Codex Alimentarius limits. The system used for the pesticide compounds is according to the IUPAC nomenclature. During the last 10 years, the following pesticides have been totally forbidden for use in Israel: Ethylmercuric chloride, Methoxyethlmercuric Chloride, Dinitro-ortho-cresol (DNOC), Sodium arsenite, Pentachlorophenol, 2,4.5- trichloroacetic acid (2,4,5-T), Monocrothophos, Ethyl parathion, Chlorphenapyr. ** On May 28th 2009, the Plant Protection and Inspection Service notified the WTO of a new Regulations Concerning Plant Protection (Import of Plants, Plant Products, Pests and Regulated Articles). The new regulations came into effect on June 23rd 2009. Under the new regulations, the PPIS will better manage and monitor plant protection import requirements. Report Highlights - Regulations Concerning Plant Protection New Plant Protection Regulations (Plant Import), approved by the Knesset Economics and Finance Committees, were published March 25, 2009. These regulations are due to go into effect 90 days after their publication, that is ? June 23, 2009. As of this date, the Plant Protection Regulations which have been around since 1970 (Importation of Plants), 5731- 1970, will be revoked. After a decade-long "gestation period," during which the Plant Protection Regulations (Plant Import, Plant Products, Pests and Regulated Articles) have undergone revision, the task is now complete and the new regulations are finally seeing the light of day. The import regulations, which have been around since 1970, have undergone a major change, and what was once a thin 8- page leaflet has now become a 129-page tome. The unofficial translation into English of the new regulations can be found on the web site of the Israeli Plan Protection and Inspection Services (PPIS): http://www.moag.gov.il/NR/rdonlyres/EA507B2D-E18F-44A4-B71D- A249C73121B1/0/PlantImportRegulations2009UnofficialTranslation.pdf The new Plant Protection Regulations (Plant Import) went into effect on June 23, 2009. The import of plants into Israel is anchored in the Plant Protection Law ? Plant Protection Regulations (Plant Import), which regulate the variety of plant material imported, pests and regulated articles: fresh produce (fruit, vegetables, cut flowers, etc.), propagation material, potted plants, growth media, vegetal feed for animals, edible kernels, etc. Such import poses numerous risks to plant health in Israel because of the possible introduction of pests that do not exist in Israel, and their subsequent acclimatization and establishment, resulting in extensive economic damage to domestic agriculture as well as environmental harm to natural vegetation. Owing to the dangers entailed in this type of import, every country is entitled to protect itself by prescribing import restrictions. This notwithstanding, the international trade agreements (WTO/SPS, IPPC) call for acting with transparency, with a commitment to harmonization and in conformity with international criteria with regard to all provisions and restrictions imposed on import, to prevent, insofar as possible, barriers to international trade. The import regulations in force today, enacted back in 1970, do not jibe with the spirit of current international agreements regarding transparency and the establishment of phytosanitarily warranted restrictions. Due to the foregoing reasons, it was decided at the Plant Protection and Inspection Services (PPIS) of the Ministry of Agriculture (in charge of enforcing the aforesaid regulations) to extensively modify the plant import regulations in terms of both structure and essence. Following are the highlights of the modification: A. License Exemption The new import regulations introduce a substantive change in the licensing system, manifested by the exemption of a long list of plants and plant products from the requirement for an import permit. All imported products have been categorized into three groups: 1) Third Schedule ? Goods listed in this schedule are exempt from an import permit and a phytosanitary certificate, but must be accompanied by a Certificate of Origin. Their release is conditional on a visual inspection at the port of entry and on being pest-free. 2) Fourth Schedule ? Goods listed in this schedule are exempt from an import permit, but must be accompanied by a phytosanitary certificate from the country of origin, complying with all the import requirements specified in the body of the schedule. Their release is conditional on the approval of all the accompanying documents, on a visual inspection at the port of entry and on compliance with all the import terms. 3) Licensed import ? As to goods not appearing in the aforementioned schedules, an import permit application must be submitted in respect thereof. Following a pest risk assessment (PRA), it will be decided whether to approve the application and under what restrictions. Such goods must be accompanied by an import permit, phytosanitary certificate and visual inspection at the port of entry as a condition for release from the port of entry. B. Phytosanitary Certificate Exemption Another change introduced into the new import regulations is the addition of a new schedule (Third Schedule), giving a list of products exempt from the requirement of being accompanied by a phytosanitary certificate. C. Transparency In the new Plant Import Regulations there is full transparency as regards the phytosanitary means established for preventing the entry of pests with imported plants and plant products, so as to protect Israel's flora from the dangers inherent in such import. Such means have been established according to the PRA-determined risk level. This transparency is manifested in several ways: 1) First Schedule ? List of treatments approved as quarantine treatments. 2) Second Schedule ? List of quarantine pests of the State of Israel. This list includes all pests not existing in Israel, whose whose arrival with imported plant material is liable to endanger domestic agriculture and natural vegetation; therefore, their presence in an imported consignment is likely to prevent the entry of this consignment into Israel. 3) Third and Fourth Schedules ? List of goods allowed for import into the State of Israel and enumeration of all the specific requirements (if any) for each product. 4) Seventh Schedule ? List of goods prohibited for import. D. Fees In the new regulations there has been a re-pricing of inspection costs (Eighth Schedule ? Fees). In addition, a fee will be charged for submitting a license application and for requesting a license copy. The new regulations will significantly facilitate the import process and allow for the import of a variety of products, including also some not imported in the past and from new import sources, subject, of course, to a risk assessment. Likewise, the change will promote openness, transparency and conformance with the requirements of international agreements. Nevertheless, the quarantine inspectors of the PPIS are charged with the task of ascertaining that the public's desire for variegated import from a variety of sources as well as the need to fulfill the State of Israel's commitment to international trade agreements does not lead to increased exposure to the potential dangers posed by such openness to domestic agriculture and natural vegetation Treatments as Requested by the Plant Import Regulations In August 2009, the PPIS updated it?s treatments requirements for plants and its products: http://www.ppiseng.moag.gov.il/NR/rdonlyres/90BED4A9-EB14-41BD-99DD- 10EF0C3C1B57/0/TreatmentRegulationsPPISImport2009.pdf ** ISPM 15 - On May 18th 2009, the Plant Protection and Inspection Service notified to the WTO of a new SPS measure for all Wood packaging material (G/SPS/N/ISR/8): Description of content: All wooden packing material must be marked according to standard ISPM 15 of the IPPC. In this matter, wood packing material includes pallets and supporting beams. Israel's compliance with the ISPM 15 wood packaging standard will begin on October 1st 2009. ISPM 15 is the international standards criterion for importing and exporting wood packaging. Its implementation means that Israel will join an extensive and emerging list of 65 countries requiring adherence to the ISPM 15 Standards. Wood packaging material must be subject to either a heat treatment or fumigation as per ISPM 15. * Methyl Bromide (MB) Fumigation or Heat Treatment. With the MB treatment, the wood packaging material is fumigated with methyl bromide. * Heat Treatment (HT) of wood packaging material must be heated in a schedule that achieves a minimum core temperature of 56ºC for a minimum of 30 minutes. Unofficial translation into English of the new standard: http://www.flying-cargo.com/media/Upload/169.DOC Organic Pesticides The PPIS are in charge of the approval and registration of preparations suitable for organic agriculture. Suitability is checked by an advisory committee to the General Director of the PPIS, in relation to the Israeli standard of fresh and processed organic produce from plant origin, and the EU Council Regulation (EEC) No. 2092/91. All the inputs for organic agriculture (nutrients, plant protection products, and supplements for the organic food industry) have to be checked for compliance with the standard?s requirements. To enter a substance for a review in the advisory committee for organic agriculture, the following documents must be submitted: 1. Identification of the substance and its ingredients. 2. Production method. 3. Products containing an animal ingredient must have a preliminary approval of the Veterinary Services of the Ministry of Agriculture. Registration will be carried out according to the procedure described in ?Registration and Licensing of Pesticides? The following products have been approved for use in organic farming in Israel: http://www.ppis.moag.gov.il/NR/rdonlyres/6A981AA1-A6F4-4520-8D77- 10E3728E9CE0/0/OrganicPesticidePublication.doc Plant Disease Gallery A gallery of documented plant diseases (mainly fungal) diagnosed at the Plant Disease Diagnostic Lab of the PPIS: http://www.ppis.moag.gov.il/ppis/plant_disease_gallery/ Insect Gallery The Insect Gallery is a database with images, containing ecological, biological and systematic information on insects in Israel, particularly those considered agricultural pests. The Plant Disease Gallery is planned by the Plant Protection Diagnostic Service Phytopathology Unit. http://www.ppis.moag.gov.il/ppis/insect_gallery/ Section VI. Other Regulations and Requirements: 1. Kashrut Any food marked with the word ?kosher? shall also be marked with the name and location of the person certifying the kashrut or the registered mark in Israel of the organization certifying the kashrut. It is recommended to add to the word ?kosher? the words ?meat? ?dairy? or Passover? ?donations and tithes have been set aside? ?free from suspicion of ?orla? or third year fruit?, ?not from the Sabbatical year?, etc. According to the nature of the matter and on the authority of the person certifying the Kashrut. Meat products, including poultry meat, which are not ?kosher?, non-kosher fish products and products made from non- kosher fish shall be marked with the words ?non-kosher?. It is illegal to import non-kosher meat, including poultry, to Israel. The size of the letters in the word ?kosher? shall not be smaller than the minimum size of letters of the name of the product as stipulated in Table 1 above. The size of the letters denoting the name and location of the person giving the certification shall not be smaller than the minimum size of the letters of the name of the manufacturer as stipulated in table 1.Similar products, produced by one manufacturer, some of which contain the kashrut certification as noted in paragraphs 12.1 and 12.2 of the Regulation and some of which do not carry this marking, shall have conspicuously different labels. This requirement does not apply to those products, which are marked ?Kosher for Passover?. As Israeli law stipulates that the council of the Chief Rabbinate of Israel is the sole authority responsible for determining whether a product is kosher, exporters of kosher products should ensure through their importing agents, that their kosher certification is accepted by Israel?s Chief Rabbinate. 2. New Food Registration Procedure and Biotechnology Policy In February 2006, the Israeli ?New Food Committee? published new regulations for new food registration. It is expected that the registration of foods containing GMO ingredients will begin by the end of 2006. The new procedure deals with food registration and will not concern 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 the designation of authority and operational responsibility (See Annex 2: New Food Registration Procedure). Imported food products will be divided into two groups ? food products already existing in the food market and new to the market food products. The procedures for each group will be as follows: 1. Already 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). It is assumed that those varieties will be exempt from the registration procedure. However, the Israeli food committee has not yet decided finally on that. It is estimated that the committee will finish its discussions by the end of 2006. 2. For new food products which have not yet been registered, the importer must submit the following registration documents: 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 27-35). The importer must submit annex B (page 29) 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 USDA (FSIS) FDA 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 Section VII. Other Specific Standards: 1. General It is the declared policy of the Government of Israel to adopt international standards wherever possible, and to implement mandatory standards related only to safety, health, and the environment. In practice, however, many products are still subject to mandatory standards some of which were designed to favor domestic producers over importers. As in the case of plywood, these local standards often specify in terms of design rather than performance. The Israel plywood standard effectively excludes most United States plywood from the market. The Standards Institution of Israel (SII) is the agency responsible for the development of most product standards, compliance testing, and certification of products and industry quality assurance systems. For further information, interested firms should contact: The Standards Institution of Israel, 42 Levanon Street, Tel Aviv 69977; Tel: 972-3-6465154; Fax: 972-3-6419683. Email: General Information: vered@sii.org.il. Web site: http://www.sii.org.il Israel has not officially adopted ISO-9000 standards, although there is a growing preference for ISO-9000 standards among Israeli importers. This is especially important in the case of ingredients and raw materials destined for the production of export products. In the past, most imported food products were subject to specified size (weight or volume) requirements which often excluded standard non-metric sizes used by United States companies. Late in 1998 the imposed metric weight and measure standards became voluntary, i.e. served as guidelines to manufacturers but ceased to be obligatory. It remains obligatory to denote on the package the contents in metric terms. Packages of a size which does not conform to the official standard must bear an indication of the unit cost of the product. The Government of Israel requires that food and health products be registered with the Ministry of Health before they can be sold in the country. FDA approval for food and health care products is not mandatory, but Israeli importers prefer it as it accelerates the product registration process and import license approval. Product registration normally takes from 4-6 weeks if all documentation is in order. 2. Nutritional Labeling Nutritional labeling of food is mandatory and should list the following values per 100 grams or 100 milliliters of food content: - Caloric value (kilo-calories per 100 gr. or 100 ml of net content); - Protein content (grams per 100 gr. or 100 ml of net content) - Carbohydrates (grams per 100 gr. or 100 ml of net content); - Fat content (grams per 100 gr. or 100 ml of net content). If the product label indicates the size of the portion and the number of portions, it is also permitted to indicate these nutritional values per serving portion. For minimum content of other nutrients which allows its inclusion in the nutritional labeling See Annex 7. The labeling of food using expressions which refer to its qualities in regard to: calories, fat, salt, and cholesterol content must be labeled as follows: I Calories Concerning the reduction of calories in a food product, two categories are defined: 1. Low Calories 2. Reduced Calories 1. Low Calories a. Non-alcoholic beverages, including concentrates and powders for the preparation of beverages containing not more than 20 calories per 100 ml of ready-to-drink beverage. b. Food that is not non-alcoholic beverages, including milk products in which the amount of calories is not more than 40 per 100 gr./ml of food. 2. Reduced Calories. A food product which contains not more than 2/3 the caloric content of a product covered by a standard or order or regulation. II Fat. Concerning the reduction of fat in food products, three categories are defined: 1. Food Without Fat Or Fat Free. Food in which the amount of fat is not more than 0.5%. 2. Low Fat. Food in which the total amount of fat is not more than 2 grams of fat per 100 gr. or 100 ml of food. 3. Reduced Fat. A food which contains not more than 2/3 the fat contents of a product covered by a Standard or Order or Regulation. This requirement does not apply to food rich in fat such as: butter, margarine, peanut butter, and sesame paste. III Salt (For labeling purposes, salt means sodium) Concerning the reduction of sodium in food products, three categories are defined: 1. Without Salt or Salt Free. Food in which the amount of salt is no more than 0.5 percent. 2. Low Sodium. A food product in which the amount of sodium is not more than 100 mg of sodium per 100 gr. or ml of food. 3. Reduced Sodium. Food which contains not more than 1/4 the sodium content of a product covered by a standard or order or regulation and which contains more than 100 mg of sodium per 100 gr. or ml of food. IV Cholesterol Concerning the reduction of the amount of cholesterol in food products, three categories are defined: 1. Without Cholesterol or Cholesterol Free. A food product in which the amount of cholesterol is zero. In a laboratory test, deviation of up to 2.5 mg cholesterol per 100 gr. or ml of food will be permitted. 2. Low Cholesterol. A food product in which the amount of cholesterol is not more than 30 mg per 100 gr. or ml of food. 3. Reduced Cholesterol. A food product which contains not more than two-thirds of the cholesterol content in a food covered by a standard or order or regulation. V General The nutritional labeling of food products generally relates to 100 gr. or ml of food. If the package indicates the number of portions contained in it, the nutritional content may be shown on a per portion basis. If the producer?s instructions indicate that the product is to be diluted with water, the nutritional labeling shall be for 100 gr. or ml of food consumed. For Full List of Israeli food standards see Annex 6 and 7. Section VIII. Copyright and/or Trademark Laws: Application Any proprietor of a trademark used, or proposed to be used in Israel, may apply for registration of the mark. Collective marks and certification marks are also entitled to registration. Application may be made by the owner of the mark or by the owner?s agent. The agent must work in Israel and must present written authorization by the owner. All applicants must present a local address for correspondence and contact, so that the Government of Israel generally advises foreign trademark owners to engage a local attorney to file their applications. The fee for a trademark application changes from time to time. At present it is approximately $175. The term of protection for a trademark is seven years. This may be renewed indefinitely for periods of 14 years on payment of fees. Case law in Israel gives priority of registration to the first local user of the trademark. Every application for trademark registration must specify goods falling in one class only, according to the International Classification of Goods and Services (ICGS). Under the terms of the Paris Convention, one who has made an application to register a trade or service mark in another signatory country has a right to claim priority for registration of the same mark in Israel for the same use. An application for registration of the trademark claiming such priority must be made within six months from the date of the first application in a Convention country. A draft unfair competition law has been submitted for consideration. It contains a substantial section on trade secrets which aims to clarify ambiguities governing trade secrets as well as addressing appropriate remedies for their breech. Enforcement Injunction relief, damages and forfeiture or destruction of the competing wares, are all available remedies under Israeli civil civil law. Criminal sanctions include imprisonment for up to a year and a fine of the local currency equivalent of close to $5,000. The Israel Patent and Trade Mark Office can supply information to interested parties on patents, registered designs and trademarks. Contact: Israel Patent and Trade Mark Office, P.O.Box 354, 91002, Jerusalem, Israel. Need for a Local Attorney United States companies should seek professional legal and/or accountancy advice whenever engaged in complicated contractual arrangements in Israel. Companies, who wish to establish an office, invest, or apply for Intellectual Property Rights (IPR) registration in Israel, should seek professional legal advice. Companies may also wish to seek legal assistance when encountering trade or payment problems. A list of local law firms is available from the Consular Section of the United States Embassy, Tel Aviv. Section IX. Import Procedures: See detailed procedures and requirements for food importation in Annex 5. Imported products are divided into two groups ? ?sensitive? and ?non-sensitive? products. (see Annex 3 and 4). The procedures for the two groups are as follows: Importer Registration: 1. The importer must fill out an application that he is a qualified importer, and he declares that he or someone on his behalf has a warehouse for the purpose of storage. This procedure is used for the two kinds of products. 2. An importer of regular products has to fill out the following certificate: Importer Statement. 3. Following the importer certificates filling, he will receive an official importer certificate from the Israeli Food & Nutrition Services. Product Registration: 1. Requires filing a preliminary application for authorization to import regular food products. Non-Regular Products: Importation of these kinds of products requires the following procedures: 1. See section 1- importer registration. 2. A preliminary application for authorization to import food products, and a border station release application. The following certificates are required for the purpose of releasing the food products from the border station: a. original/copied official importer certificate. b. original/copied food certificate. c. shipment invoice. d. gate pass certificate. e. copy of the bill of lading and packing list. f. copy of the import tax. Import Licenses All import licensing requirements for U.S. made consumer and industrial goods have been eliminated under the United States - Israel Free Trade Area Agreement (FTAA) of 1985 and World Trade Organization (WTO) agreements. Imported food items require the approval of the Ministry of Health?s Food Control Administration, which is also responsible for approval of labeling and packaging. All plant material (including dried fruits and nuts) requires import approval from the Plant Protection and Inspection Service. Unprocessed and unpackaged imported meat must be licensed by the Israel Veterinary Services (IVS) and originate in a plant which has been certified as approved by the IVS. Packaged meat and poultry for retail sale is subject to licensing by the Food Control Administration of the Ministry of Health. Israel law requires that all meat and poultry imports be certified kosher by the Rabbinical Council of the Chief Rabbinate or a body authorized by the Council. As an exception it is possible to import nonkosher beef offal. Israel?s veterinary authorities ban imports of bone-in beef from countries where there is a danger of transmitting Foot and Mouth Disease (FMD) or Bovine Spongiform Encephaly (BSE), also known as the Mad Cow Disease. A) Import Documentation 1. Shipping documentation United States exporters to Israel must follow United States Government requirements regarding export control documentation. The Israeli Customs Services prefer that exporters use their own commercial invoice forms containing all required information including name and address of supplier, general nature of the goods, country of origin of the goods, name and address of the customer in Israel, name of agent in Israel, terms, rate of exchange (if applicable), Israel import license number (if applicable), shipping information, and a full description of all goods in the shipment including shipping marks, quantity or measure, composition of goods (by percentage if mixed), H.S. tariff heading number, gross weight of each package, net weight of each package, total weight of shipment, price per unit as sold, and total value of shipment. The total value of the shipment includes packing, shipping, dock and agency fees, and insurance charges incurred in the exportation of the goods to Israel. The commercial invoice must be signed by the manufacturer, consignor, owner, or authorized agent. United States exporters should also double-check whether other documentation, including bill of lading and packing list, is required. Fresh produce and seeds require a phytosanitary certificate (PC) issued by USDA/APHIS. Fresh and frozen meat and poultry products must be accompanied by an FSIS inspection certificate. The veterinary or phytosanitary requirements of the Israeli authorities are indicated on the import permit which must be obtained prior to contracting for the goods. Application for an import permit must be made by a resident of Israel. 2. United States Certificates of Origin for Exporting to Israel In order to benefit from the provisions of the FTAA, a special ?United States Certificate of Origin for Exporting to Israel? (CO) must be presented to Israel Customs. The certificate does not need to be notarized or stamped by a Chamber of Commerce if the exporter is also the manufacturer. Instead, the exporter should make the following declaration in box 11 of the certificate: ?The undersigned hereby declares that he is the producer of the goods covered by this certificate and that they comply with the origin requirements specified for those goods in the United States -Israel Free Trade Area Agreement for goods exported to Israel.? The actual forms are printed by a number of commercial printing houses in the United States For further information on how to obtain them, United States exporters should contact the United States Department of Commerce Israel Desk Officer in Washington DC. 3. Approved Exporter Status It is possible for exporters to apply for a blanket CO, or ?Approved Exporter? status. An ?approved exporter? needs only to present an invoice which substitutes for the CO, and which contains an ?approved exporter? number and a declaration that the goods comply with the origin requirements. Certification and notarization are not necessary. 4. ?Approved Exporter? Authorization Procedures a) A manufacturer or exporter who wishes to become an ?Approved Exporter? should complete a declaratory form and present it to: Export Department, Israel Customs Services, 32 Agron Street, P.O. Box 320, Jerusalem. Potential candidates are United States firms with total annual exports to Israel of at least $20 million who have an unblemished record with the Israel Customs Services. b) Israel Customs will check whether the manufacturer or exporter complies with the criteria and grant approval for ?Approved Exporter? status. The approved exporter will be given an identity number to be stamped on all invoices. The approval is valid for six months after which the exporter should receive an automatic extension from Israel Customs. Exporters who do not receive an automatic extension from Israel Custom, must terminate use of the approval. 5. Compliance Procedures for Approved Exporters a) The ?Approved Exporter? should stamp the invoice with the firm?s identity number and add the following declaration: ?The undersigned hereby declares that the goods listed in this invoice were prepared in the United States of America and they comply with the origin requirements specified for those goods in the United States - Israel Free Trade Area Agreement for goods exported to Israel.? b) Invoices involving mixed goods: Separate invoices must be prepared for goods which do not comply with origin requirements and/or for which approval to operate as an ?Approved Exporter? has not been granted. B) Import Requirement for Dairy Products All milk products and their substitutes are within the non-regular products group (see annex 4). See annex 17 for import milk requirement. For the Annexes, please refer to the following link: http://www.fas.usda.gov/gainfiles/200807/146295318.pdf All Israeli import regulations can be purchased through the U.S. Dairy Export Council 2101 Wilson Blvd., Suite 400 Arlington, VA 22201 ; Tel: 703-528-3049 ; http://www.usdec.org/home.cfm?navItemNumber=82205 C) Baby Food Formula In December 2009, the Israeli Ministry of Health published new directives for the handling of food compositions for babies (FCB) and food directed for complete nutrition. These directives suspend former directive/requirements. Hereunder are the new directives: A. Imports 1. Each imported batch should be sampled for all required tests. 2. After sampling the shipment can be released for storage in the importer?s warehouse, conditioned that the importer have a proper warehouse, fitted for the storage of such kind of food and conditioned with the submitance of a bank guarantee and an obligation by the importer not to sell of the imported product, until the approval by the Import Division at the Food and Nutrition Services. 3. Public Health Laboratories are requested to forward the test results to the Manager of the Import Division with the MOH (Eng. Ruth Shimberg) 4. The required tests and the places where they can be executed are detailed below: A. Laboratory: Test Laboratories Comments K, Ca, Na, Fe, Zn, Cu, Mg Public Health, Haifa Up to 5 tests, weekly. K, Ca, Na Public Health, Beer Sheva Fe Public Health, Abu Kabir Protein, Fat, Saturated Fat, Public Health, Haifa Up to 10 tests, weekly Necessary Fat Acids Total Microbiology, Public Health, Beer Sheva, Up to 50 tests, Enterobacter Sakazaki Public Health, weekly, Up to 40 tests Haifa, Public Health, weekly, Up to 15 tests Abu Kabir weekly Vitamins: C, B1, B2, Folic Acid Public Health, Abu Kabir Up to 15 tests daily Aflatoxins, B1, B2, G1, Public Health, Abu Kabir G2+M1, in milk+Ochrotoxin (in pulses and cereals) Pesticides: chlorine organic, Control & Standards phosphor organic, carbamates Institutes of pesticides, MOH, Jerusalem Heavy metals: Mercury Control & Standards Institutes of medications Lead, Arsenic, Control & Standards Cadmium, Copper Institutes of medications Selenium Control & Standards Institutes of medications Pesticide residues, food Control & Standards based on dairy Institutes of medications B. Eye check and accompanied documents check should be executed for each batch, including the original form of the lab tests executed for each batch. C. All lab tests results should be forwarded to Eng. Ruth Shimberg, for the purpose of submitting an approval to release the shipment for marketing. D. The tests will be executed on the importer?s account. B. Local Production A. A condition should be added to the Manufacturer license, in which he is demanded to Test, in an authorized laboratory all the batches, following the list of tests above. B. The QA system in the plant should be inspected at least 4 times a year. In the frame of the inspection the existence of the required results should be checked and each deviation should be reported to the Regional Food Engineer and a recall should be executed, when needed. C. At the inspection visit the available batches should be randomly sampled and checked according the list above. D. A formal report on the results of the tests should be forwarded to Eng. Dorin Morero. E. The said above (B ? D) should not prevent delivery of FCB samples for testing in laboratories approved by the Laboratories D