3.80.  Standards, conformity assessment, and their enforcement are governed by the Standards Law of 1953 (as amended). Under this Law, the Standards Institution of Israel (SII), a statutory non-governmental organization, is the sole authority for the development of standards and for permitting manufacturers the use of the Standard Mark, indicating that a product conforms to an Israeli standard. The SII is a largely self-financing institution, but receives support from the Government for work on standards preparation. The Commissioner of Standardization, under the Ministry of Economy and Industry, is in charge of enforcement of mandatory standards and approval of testing laboratories. It also has responsibility for enforcement of technical regulations (mandatory standards). However, there are more than 20 governmental authorities that enforce technical regulations pertinent to their fields of activity. For example, the Ministry of Health enforces regulations on pharmaceuticals, medical equipment, cosmetics, and food; the Ministry of Transport is responsible for automobiles and spare parts; the Ministry of Communications is in charge of communications equipment (wire and wireless); and the Ministry of National Infrastructure deals with fuel and energy efficiency.[91]

3.81.  In October 2014, a resolution on Regulatory Impact Analysis (RIA) was adopted. It came into effect in January 2016 as a mandatory process throughout the Israeli Government.[92] The Prime Minister's office overlooks the implementation of the RIA across the Government. The purpose of this resolution was to bring about a reduction in the unnecessary regulatory burden, and to create the correct balance between vital governmental intervention and leaving room for market forces to operate. The resolution introduced a plan of action based on two central components: reducing the regulatory burden of existing regulation, and carrying out an assessment of the expected impact of regulation before formulating new regulations. The regulations' drafts and the RIA are published on each Ministry's website and on the site of the Prime Minister's Office.[93]

3.82.  The Ministry of Economy and Industry is the TBT enquiry point under the TBT Agreement. In the period 2012-17, Israel submitted 453 notifications (420 during 2006-11) to the Committee on Technical Barriers to Trade, mostly concerning the revision of mandatory standards or the adoption of international or regional standards.[94] During the period under review, two specific trade concerns were raised in the TBT Committee.[95]

3.83.  Steps have been taken to align all of Israel's technical standards to international standards. Over 2016-17, various government resolutions were adopted regarding standards, including Amendments Nos. 12 and 13 to the Standards Law of 1953. The amendments require the adoption of international and regional standards in place of Israeli standards that have no national deviations, and also set out timetables for a three-year re-evaluation of all mandatory standards, by August 2019. Food standards, for example, are undergoing a gradual revision under the existing food standards committees, with the purpose of bringing them closer to existing international standards such as those of the Codex Alimentarius

3.84.  By the end of 2017, the SII has published 3,504 standards (compared with 3,192 as of January 2012). In 2017, 653 standards (excluding food standards) were mandatory. Mandatory standards are important in electrical and mechanical engineering, and in food (Table 3.13). In 2017, 78% of Israel's mandatory standards involved the adoption of international, regional or other foreign standards. Of these, 53% are international (ISO/IEC), 35% are European (CEN/CENELEC), and 12% are "other", including standards of the United States

3.85.  The SII is a signatory to the Code of Good Practice for the Preparation, Adoption and Application of Standards, and operates in accordance with the ISO/IEC guidelines set out for this purpose. The standardization process is laid down in the Rules for the Preparation of Israeli Standards of 1991. Voluntary standards are elaborated by the SII's technical committees, after which the SII circulates each draft standard for comments prior to adoption. At present, 17 central committees, 130 technical committees, and 863 experts groups are active in the SII. The Minister of Economy and Industry may declare a particular standard to be mandatory after consultation with representatives of producers, importers and consumers (one month), and obtaining the written consent of the competent Minister, following which they are published in the Official Gazette. If there are several standards suitable for adoption, the SII may publish alternative standards, provided that each is based on a current international standard

3.86.  Most imports that are subject to technical requirements (as listed in Annex 2 of the Free Import Order, 2014 (Section 3.1.5) are inspected at the port of entry. Domestic products are subject to market inspection. Compliance testing, for both domestic and imported products, is generally carried out by one of the SII's laboratories or by a laboratory which holds an approval and/or recognition certificate from the Commissioner of Standardization to carry out the tests and issue a compliance certificate. Imports with an SII Standards Mark, certifying compliance with a certain standard, may enter Israel without being tested. As of 2017, 2,290 permits had been granted for marking products with a Standard Mark, to 863 companies, mainly domestic. The SII has also licensed 745 production processes. There is, however, no requirement that imported goods be supervised by the SII and bear a Standards Mark

3.87.  The procedures for imports without the Mark depend on the degree of product safety and the reliability of the importer. All imported goods subject to mandatory standards (Annex 2 of the Free Import Order, 2014) have been classified into four levels of examination according to the degree to which they might endanger public health and safety. The goal of creating these groups was to ease the inspection burden on imported consumer products by evaluating possible risk, and to shift the emphasis of enforcement to inspection at the post-marketing stage. For goods in Group 1, representing the highest danger level, an examination of each shipment remains mandatory (e.g. electrical home appliances, toys); goods in Group 2, with an intermediate danger level, are subject to type approval tests; while goods in Group 3 must be accompanied by a supplier's declaration of conformity (SDoC). Imported goods intended solely for industrial use (Group 4) do not undergo any special inspection. Like a number of high income countries[96], Israel applies the presumption of conformity approach. It places more responsibility on the supplier, including manufacturers, importers, and distributors, whose shipments must be accompanied by a personal declaration that the goods conform to Israeli mandatory standards. Penalties for infractions against the Standards Law are US$45,000 for each infraction by an individual, and up to US$70,000 in the case of corporate bodies. Moreover, the Commissioner is empowered to impose Group 1 status (i.e. examination of each shipment) on the goods of any unreliable supplier. This status may be maintained for one year

3.88.  Israel has few mutual recognition agreements (MRAs). The first MRA was a Good Laboratory Practice Agreement with the European Union, in force since 2000. Israel and the European Union also have an MRA on acceptance of conformity assessment (ACAA) with a sectoral annex on Good Manufacturing Practice in pharmaceuticals, in force since December 2013. Israel and Canada have an MRA on conformity assessment procedures for telecoms equipment, in force since January 2013. Israel and the United States also have an MRA on conformity assessment procedures for telecoms equipment, in force since December 2013. Israel, through the SII, has also signed MRAs on test data with 18 certification organizations which have testing facilities in 135 countries. It has also signed memoranda of understanding for mutual recognition of ISO 9000 registration with 35 organizations worldwide