The Standards Institution of Israel (SII) is the only statutory body in Israel that develops and establishes standards. Created by an act of the Knesset (Parliament), "The Standards Law of 1953" mandates SII’s responsibility for the preparation, publication of technical specifications and standards for products and services, which are produced locally or imported. Today, the SII incorporates standardization, testing, conformity assessment, product certification, management system certification and training activities under one roof. It has laboratories in almost all technological areas, providing testing and inspection services to industry and commerce, as well as regulatory services to government. Overseeing the SII’s policy is the Ministry of Industry, Trade & Labor’s Commissioner of Standards.
The supreme body of the SII is the General Assembly, comprised of 70 members from the following sectors: manufacturing, construction, commerce, services, trades, consumers, engineering associations, universities and government. The General Assembly annually elects a Board of Directors and President. The SII’s Standardization Division coordinates the preparation of standards through the work of hundreds of standardization committees that include volunteer representatives from all sectors of the Israeli economy. The adoption of Israeli standards is voluntary, however, standards may be declared mandatory by the relevant government ministry in the interest of public health and safety or protection of the environment.
As the mandated national standards body, the SII represents Israel in two international standards organizations, the International Organization for Standards (ISO) and the International Electromechanical Commission (IEC). Israeli legislation also mandates the adoption of multiple, proven international standards whenever possible to maximize benefits to the Israeli consumer of a competitive market.
However, a disturbing trend in Israeli standards policy is its clear drift towards European standards. The SII has joined the European Committee for Standardization (CEN) and the European Committee for Electro technical Standardization (CENELEC), though as of January 2009, it has not joined any technical committees.
Under the terms of the CEN agreement, SII will become a Partner Standardization Body (PSB). As a PSB, Israel must agree to implement as a national standard the European standards developed by the CEN technical committees in which it participates. PSB agreements typically include a clause requiring signatories to withdraw conflicting standards from the market. This is particularly troublesome in the case of Israel and deviates from domestic legislation, which specifically allows for the adoption of multiple international standards, in compliance with technical regulations. The USG has expressed concern at the highest levels of the Israeli Government that CEN membership will further disadvantage U.S. exporters, particularly small and medium sized firms. The SII states that it will maintain the right to adopt parallel standards, including U.S.-based standards, citing national deviations as the reason to include non CEN-developed standards.
According to the terms of the agreement with CENELEC, the SII would be allowed to join any committee, with the requirement that it adopt standards developed by the technical body of which it is a member. SII will be able to join at the level of Working Group, which usually deals with one specific standard. As a member of the working group, SII will commit to adopt any standard(s) resulting from the working group. Eighty-five percent of CENELEC standards are IEC-based standards. SII indicated its interest in joining only those committees where no international standard exists and only in cases where there is interest by the Israeli industry. This affiliate status is not a government-to-government agreement, but an arrangement between SII and CENELEC.
Standards Related Issues
Technical standards may pose non-tariff barriers, which limit U.S. exporters' access to the Israeli market. Since 1999, Israeli law has mandated that the SII adopt multiple international technical standards whenever possible. However, this legislation has not been implemented widely, to the detriment of U.S. exporters. In addition, SII's formal process for adopting or developing technical standards is a significant market access obstacle to U.S. exporters, despite concerted U.S. Government efforts to address issues of access and transparency. Each government ministry may adopt additional mandatory regulations that can prevent the importation of U.S.-made products and services to Israel. This procedure has created difficulties for U.S. exporters who contend that transparency and due process are frequently lacking, especially for food imports.
In addition, U.S. industry sources report that requirements for technical standards are often not uniformly enforced. In some instances, domestic products appear to have an advantage over imports because enforcement of labeling requirements and standards on domestic producers has been inconsistent, while standards requirements are more strictly enforced with respect to imported goods. U.S. companies that have been doing business in Israel for many years are increasingly confronted with new, often EU-based, standards that arbitrarily discriminate against U.S. products. In addition, the SII will not recognize U.S. testing or accreditation of electrical components and products unless the product undergoes additional and often costly tests in Israel.
It is the position of the U.S. Government that American products and services exports should not be disadvantaged by the adoption of technical standards. Relevant bodies, including the SII should recognize U.S. technical standards alongside other, internationally recognized standards, wherever feasible. The Embassy and the U.S. Department of Commerce continue to actively advocate this position with the appropriate Israeli governmental authorities and urge all affected U.S. companies, or their agents, to contact the Commercial Service with any standards-related market access issues. The Embassy proactively supports the work of the AmCham’s Technical Standards and Regulations Committee, one of four such ad-hoc committees created by the Chamber’s Forum of U.S. Companies in Israel.
The SII is the sole organization that develops standards in Israel. On a yearly basis the SII prepares its work plan that includes a list of standards they plan to develop. Members of the various technical committees, as well as government ministries, provide input.
The sole authority for conformity assessment in Israel is the SII.
SII operates product and system certification programs. Use of the Standards Mark is generally voluntary but Israeli law mandates that certain classes of products must be certified before they are sold. The Standards Mark program operates in accordance with EN 45011. To qualify for the Standards Mark, a product must conform to the requirements of the applicable standard or standards, and be manufactured in a plant with an approved quality assurance system, similar to ISO 9002. The Standards Mark Board appoints technical committees of representatives from the public and private sectors in various technological areas, which meet regularly to evaluate the findings of the test reports and quality assessment reports. These committees report their findings to the Licensing Committee, which is responsible for granting or canceling a license. Once a license is issued, follow-up inspections of the product and quality assurance review is performed. These inspections are performed by laboratory personnel and certified auditors. In addition, samples of the product are taken several times a year to insure continuous compliance of the product with the relevant standard or standards. In order to ease the process for foreign manufacturers wishing to enter the Standards Mark program, agreements have been reached with independent foreign testing and certification organizations to perform testing and inspection services on behalf of SII.
The Israel Laboratory Accreditation Authority (ISRAC) is the only body in Israel, which is internationally and legally recognized to accredit testing and calibration laboratories according to ISO/IEC 17025 and to recognize laboratories in accordance with the OECD rules of Good Laboratory Practice (GLP). The Government of Israel decided in its resolution No. 3778 from August 14, 1994 to set up a National Authority for the accreditation of testing and calibration laboratories (ISRAC) and empowered the Minister of Industry, Trade & Labor to implement this resolution as a voluntary scheme for laboratories wishing to be internationally recognized for their competence in testing. The law for the national accreditation authority (ISRAC) was passed in the Knesset in May of 1997. ISRAC has accredited laboratories in the areas of food, water, cosmetics, pesticide chemistry, biology, microbiology as well as many calibration, engineering, construction laboratories NDT (non destructive testing) and EMC (telecommunications).
Publication of Technical Regulations
Technical standards are published in the official Israel Government Gazette in hard copy only and can be purchased in bookstores that sell legal textbooks or by subscription. Prior to publication, the Director General of the SII officially informs the relevant industry sectors of pending additions and amendments. U.S. entities can influence the content and adoption of technical standards through active participation at the technical committee level.
Labeling and Marking
Israel has strict marking and labeling requirements that frequently differ from those of other countries. U.S. exporters should consult with their Israeli importer prior to shipping any product that will be offered to the local market. Specific information on labeling and packaging standards is available from the Director, Department of Weights and Measures, Ministry of Industry and Trade, 30 Agron Street, Jerusalem 94190;Tel: 972-2-6220678, fax: 972-2-6220670. 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 or 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. For information on food labeling and packaging contact the Israel Ministry of Health, Food Control Services, 12-14 Haarba’a Street, Tel Aviv 61070; phone: 972-3-5634812, fax: 972-3-5684602.
Israel has no declared government policy on genetically modified organisms (GMO) although regulations are being prepared which will require positive labeling when a product or an ingredient is genetically modified. Israel’s main export market for food is Europe where consumer concern over GMO is considerable. Thus, many Israeli importers of raw materials require an exporter’s declaration that the product is free of GMO.
Marking should be done by printing, engraving, stamping, or any other means, on the package or 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 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 such sub-packages, the net content of a sub-package, and the overall net weight of the package. An aerosol container should indicate the net quantity weight unit for semi-solid or powder products, and volume unit for liquids. 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, paper products, handbags, musical recordings, fertilizers, insecticides, chemicals, pharmaceuticals, some food products, seeds, and alcoholic beverages. Outside and inside containers of dangerous articles, such as poisons, insecticides, drugs, flammable goods, ammunition, explosives, reptiles, insects, bacteria and radioactive materials should be clearly marked.
Special Licensing Procedures for Medical Equipment
Licensing of imported and locally manufactured medical devices and equipment is subject to enforcement according to a Ministry of Health directive, which went into effect on January 1, 1995. Companies interested in exporting medical equipment or devices to Israel should first request a letter of acceptance from the Ministry of Health in accordance with the export provisions contained in Section 801(e) of the U.S. Federal Food, Drug & Cosmetic (FD&C) Act. The request discussed above should be accompanied by one of the following documents: - 510(k) - Pre-Market Approval (PMA), or - Investigational Device Exemption (IDE) Because the Ministry of Health uses the FDA’s standards and ECRI nomenclature for the purpose of issuing licenses, the licensing procedures for American-made medical equipment are fairly easily facilitated.
Implantable medical devices require mandatory labeling in the patient’s file for tracking and surveillance purposes. The labels must contain the following information: - Name and address of the manufacturer - Name and address of the importer - Type of implant - Sub-type of implant - Size - Serial number - Batch number - Reused implant - Medication element needed
The registration authority can be reached at: Ministry of Health Pharmaceutical Division Medical Device Department P.O. Box 1176 Jerusalem 91010 Tel: 972-2-568-1216/17; Fax: 972-2-672-5827