3.114.  During the period under review, the legal and institutional framework for sanitary and phytosanitary (SPS) requirements in Iceland remained largely unchanged.[182] The Icelandic Food and Veterinary Authority (MAST), under the Ministry of Industries and Innovation,[183] is responsible for implementing legislation concerning food safety, animal health and welfare, control of feed, seed and fertilizers, plant health, and water for human consumption. According to the authorities, the Ministry of Industries and Innovation is the national notification authority and MAST is the enquiry point in the WTO for Iceland's SPS measures

3.115.  During the review period, a number of amendments were made to the legislation affecting SPS measures: Act No. 54/1990 on the Importation of Animals was amended in 2013 through Act No. 60/2013 on the Protection of Nature requiring that before a certain species of animal or plant that is foreign to Iceland can be imported, a licence from the Environment Agency of Iceland must be obtained, as well as a licence from the Ministry of Industries and Innovation; Act No. 54/1990 was further amended by Act No. 48/2015 authorizing MAST to grant licences for the importation of genetic material for beef cattle, if certain requirements are fulfilled. These requirements are related, for example, to the origin of the genetic material and to an investigation of the health standards of the animals born in the quarantine station. MAST was also granted powers to set standards for the farms receiving these animals. In the event that these requirements are not met, or if MAST considers there to be a risk of infectious diseases, MAST shall revoke the licence, destroy the genetic material and euthanize the animals; and Act No. 25/1993 on Animal Diseases and their Prevention was amended by Act No. 71/2015 transferring the processing of applications for imports of raw products of animal origin from the Ministry of Industries and Innovation to MAST in order to simplify import procedures for these products

3.116.  Iceland notified two regular SPS measures to the WTO between 1 January 2012 and 30 April 2017.[184] The notifications covered the inspection procedures for imports of animal products originating outside of the European Economic Area (EEA), and measures on importation of animal products. Iceland did not notify any emergency measures during the review period

3.117.  Iceland is a member of the World Organisation for Animal Health (OIE) and the Codex Alimentarius Commission, and a contracting party to the International Plant Protection Convention (IPPC). Sanitary

3.118.  Iceland, as a member of the EEA, has adopted EU legislation on SPS measures including foodstuffs, feed, and other food chain related issues, but maintains national rules on live terrestrial animals, germplasm (e.g. ova, embryo, and semen), and plant health. Measures on live aquatic animals follow EU legislation. MAST is the national European Food Safety Authority (EFSA) focal point and the contact point for the EU's Rapid Alert System for Food and Feed (RASFF)

3.119.  Most EU food safety rules are implemented in Iceland. All food business operators in the primary production of food and feed, irrespective of animal origin, must be registered with and approved by MAST.[185] Imported food must comply with the relevant requirements that are at least equivalent to those set forth in the EU food law and animal and plant health rules. EU legislation on novel foods[186] was adopted in Iceland through Regulation No. 990/2015 on novel foods

3.120.  Imports of live animals and animal products are subject to controls through an import permit system. Under Act No. 54/1990 on Importation of Animals, Act No. 25/1993 on Animal Disease Prevention, and related regulations (e.g. Regulation No. 448/2012 on the prevention of animal diseases and contaminated products), import prohibitions are maintained on live terrestrial animals, raw meat, raw eggs, and animal products not for human consumption[187] (e.g. meat and fat meal, raw skins and hides which have not been disinfected, and animal wastes). However, the Minister for Fisheries and Agriculture may grant permits for imports, based on a positive recommendation from MAST

3.121.  Imports of used agricultural machinery, riding gear, and fishing gear are subject to similar import permit requirements provided they meet the cleaning and disinfection conditions set by MAST. However, some used riding equipment[188] and used fishing equipment[189] are strictly prohibited from importation

3.122.  Permit requests for first-time imports of live animals (i.e. new species) and products of animal origin (raw or unsterilized) must undergo a risk assessment by MAST. The authorities indicated that risk assessments follow international standards such as those laid down by the OIE, and are based on the information from exporting countries, OIE and other international institutions concerning animal and public health issues.[190]

3.123.  Import permits are applied to animal products. Imports of raw meat and meat products that have not been fully heat treated must be accompanied by certificates confirming that the meat was stored for at least one month at -18˚C or colder, and are free of salmonella and contaminants. Some products that have been treated with methods that are deemed equivalent to full heat treatment, including some cheeses and meat sausages and salted, dried or smoked meat, can be imported without the freezing requirements. Meat must be derived from animals that are slaughtered and processed in the establishments approved by the EU or authorized in the EEA. Products originating from outside the EEA must be accompanied by official certificates showing: origin and health, and that the animals from which the products were derived were not given growth-promoting substances

3.124.  When an application is submitted for the first time to import raw or unsterilized products, an importer must provide the MAST with the necessary information on the product for consideration and approval before the product is dispatched from the country of export. However, if the importer submits exactly the same application as previously, MAST can issue an import permit once the products have been stored for at least one month at -18˚C or less, and that storage can take place in Iceland. Live animals, including pets, cannot be dispatched from the exporting country until all requirements have been met and the import permit has been issued

3.125.  In addition to meeting health requirements such as vaccinations and testing, pets are subject to quarantine at the isolation station for four weeks upon arrival. Fur animals have been imported in recent years, but are subject to a longer quarantine period at a special isolation station. Iceland employs the EU's Trade Control and Expert System (TRACES)[191] for its sanitary measures. All imports of animal products from outside the EEA are subject to health check at an approved Border Inspection Post (BIP).[192] Importers must notify the BIP through TRACES at least 24 hours prior to the arrival of the imports. MAST is responsible for the control at the BIP.[193]

3.126.  Feed imports may only be conducted by registered importers. Imported feed must be accompanied by documentation showing the ingredients, their chemical composition, and, if any ingredient is of animal origin, a health certificate stating the sanitary procedures used in production, packing, and handling (e.g. method of sterilization, autoclavation, etc.), and the absence of micro-organisms. Phytosanitary

3.127.  The main legislation concerning phytosanitary measures is Act No. 51/1981 on Prevention of Diseases and Pests of Plants, and Regulation No. 189/1990 on Import and Export of Plants and Plant Products and its succeeding amendments.[194] MAST is the national plant protection organization of Iceland and is responsible for plant health and seed quality

3.128.  Entry into Iceland is prohibited for harmful organisms listed in Appendix I and plants listed in Appendix III of the Regulation; entry is permitted subject to specific requirements for plants listed in Annex IV; and Appendix II lists pests that may be present in a very small proportion of plants intended for future breeding. The Appendices were amended on 27 March 2015 and entered into force on 1 June with the addition of Phytophthora ramorum to Appendix I, firs (Abies spp) to Appendix III, and azaleas (Rhododendron spp) to Annex IV (except Rhododendron simisii and plants from areas where Phytophthora ramorum does not exist)

3.129.  Iceland maintains controls of quarantine organisms on potato and the export of wood packing materials. Iceland has implemented the EU legislation on seed

3.130.  All imported plants and plant parts are subject to phytosanitary checks and phytosanitary certificates are required

3.131.  With regard to genetically modified organisms (GMOs), Iceland has implemented the EU Directive 2001/18/EC on the deliberate release of GMOs into the environment. EU Regulations (EC) Nos. 1829/2003 and 1830/2003 on the marketing, labelling and traceability of genetically modified food and feed have not been incorporated into Icelandic legislation. Regulation No. 1237/2014 on traceability and labelling of GM food and GM feed applies to food and feed when more than 0.9% of each ingredient is produced from GMOs

3.102.  As part of the EEA, Iceland applies EU legislation on technical regulations, standards, conformity assessment, certification, and accreditation, including harmonized technical regulations, and standards, and CE marking.[168] Under the EEA Agreement, Iceland is required to notify draft technical regulations, before they are adopted, to the EFTA Surveillance Authority, which publishes them on its website[169], and to DG GROW in the European Commission, which includes them in the TRIS database[170]. In March 2016, in a reasoned opinion, the EFTA Surveillance Authority stated that Iceland "still has not notified a number of the technical regulations in question, adopted in 2012, and is thus still in breach of its obligations under Directive 98/34[[171]] with respect to a number of these []. Furthermore, Iceland has not enacted a rule of non-enforceability concerning technical regulations adopted without following the due notification procedure in Directive 98/34 and the corresponding Icelandic implementing measures".[172] In July 2016, the Authority reiterated its assertion that non-enforceability rules should be implemented and the Government of Iceland again rejected this opinion in a letter dated 13 January 2017

3.103.  Several ministries are responsible for policy and legislation on technical regulations, standards, and related issues, including the Ministry of the Interior, the Ministry for the Environment and Natural Resources, the Ministry of Industries and Innovation, and the Ministry of Welfare

3.104.  Icelandic Standards (IST) is the national standards body. Under Act No. 36/2003 on Standards, all standards must be approved by IST before they become applicable in Iceland and IST is responsible for representing Iceland in international standards organizations. Four sector‑specific committees operate under IST: BSTR in the building sector, FIF in the fishing sector, FUT in the information technology sector, and RST in the electrotechnical sector.[173]

3.105.  IST is a member of the International Organization for Standardization (ISO), an associate member of the International Electrotechnical Commission (IEC), a member of the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC), and an associate member of the European Telecommunications Standards Institute (ETSI)

3.106.  The Icelandic Board for Technical Accreditation (ISAC), an independent department in the Icelandic Patent Office, is responsible for accreditation of inspection bodies, certification bodies, laboratories (testing and calibration) and notified bodies, in accordance with the relevant IST EN ISO/IEC 17000 series of standards and guides and the harmonized IST EN 45000 series of European standards. Additionally ISAC is the responsible body in Iceland for good laboratory practice (GLP). The legal basis for ISAC's status and responsibilities is set out in Act No. 24/2006 on Accreditation, etc.[174] ISAC is a full member of the European co-operation for Accreditation (EA). A list of accredited bodies in Iceland is available from ISAC.[175]

3.107.  Under Act No. 91/2006 on Measurements, Measurement Standards and Weights, the Consumer Agency has legal responsibility for metrology and calibration services. The Agency was established under Act No. 62/2005 on the Consumer Agency and Consumer Spokesman, under the Ministry of the Interior, with responsibility for market surveillance of business operators, good functioning and transparency of the markets in respect to safety and consumers' legal rights, as well as enforcement of legislation for protection of consumers' health, legal and economic rights.[176]

3.108.  The Icelandic Construction Authority, established under Act No. 160/2010 on Construction, is responsible for market surveillance for electrical equipment (except low-voltage consumer appliances), power plants and electrical installations, buildings and construction works

3.109.  Several other agencies, including the Icelandic Medicines Authority, the Environment Agency, and local health authorities, have specific responsibility for surveillance and enforcement for products for which they have competence, while the Customs Directorate is responsible for verifying conformity of imports with Icelandic legislation

3.110.  Under the TBT Agreement, Iceland's enquiry point for technical regulations is the Institute for Accreditation, Legal Metrology, Market Surveillance, Metrology and Electrical Safety and the enquiry point for standards is Icelandic Standards. The External Trade Department in the Ministry for Foreign Affairs has also been notified as an enquiry point. No specific trade concerns have been raised by other WTO Members about TBT measures taken by Iceland.[177] Iceland has made only two notifications to the WTO on TBT issues, the last in 2000.[178]

3.111.  From 1 January 2012 to 30 April 2017, Iceland made 22 notifications to the EFTA Surveillance Authority and the DG GROW TRIS database of draft technical regulations

3.112.  As of 1 December 2010, almost 22,620 European standards (i.e. nearly all standards by CEN, CENELEC, and ETSI) had been transposed in Iceland.[179] Legislation on technical issues, often including conformity assessment, is generally found in the sector-specific law adopted by relevant ministries in order to transpose EU Directives, for example, Regulation Nos. 627/2013 and 1296/2013 on the entry into force of EU Regulations on medical devices and Regulation Nos. 424/2015, 385/2015, and 384/2015 on certain construction products. At end-November 2016, eight EU regulations and 19 EU directives relating to goods technical barriers had not yet been transposed by Iceland.[180]

3.113.  As a member of the EEA, products placed on the market in accordance with harmonized technical regulations may circulate freely throughout the EEA and, when the EU negotiates mutual recognition agreements it does so on the basis that the third country will conclude a parallel MRA with the EEA. Through EFTA, Iceland has mutual recognition agreements with: New Zealand (2000) covering pharmaceuticals (good manufacturing practices, GMP), medical devices, telecommunications terminal equipment, low voltage equipment, electromagnetic compatibility (EMC), machinery, and pressure equipment; Australia (2000) covering electromagnetic compatibility (EMC), pharmaceuticals (good manufacturing practice, GMP), medical devices, telecommunications terminal equipment, automotive product, pressure equipment, machinery, and low voltage equipment; Canada (2001) covering telecommunications terminal equipment, electromagnetic compatibility (EMC), electrical safety, recreational craft, pharmaceuticals (good manufacturing practices, GMP), and medical devices; Switzerland (2002) covering machinery, personal protective equipment (PPE), safety of toys, medical devices, gas appliances and boilers, pressure equipment, telecommunications terminal equipment, equipment and protective systems intended for use in potentially explosive atmosphere (ATEX), electrical safety and electromagnetic compatibility, construction plant and equipment, measuring instruments and pre-packages, motor vehicles, agricultural and forestry tractors, good laboratory practice (GLP), good manufacturing practice (GMP) inspection and batch certification, construction products, lifts, biocidal products, cableway installations, and explosives for civil use; United States, the first (2005) covering marine equipment, and the second (2006) covering telecommunications equipment, electromagnetic compatibility, and recreational craft; and Turkey (2011) covering all sectors.[181]