3.130.  The EEA Agreement covers most aspects of sanitary and phytosanitary (SPS) measures and, as in other areas, EU legislative changes are incorporated continuously into it through decisions of the EEA Joint Committee, including simultaneous implementation in the EU and EEA EFTA members for emergency measures and some specific third country regulations (such as the list of approved countries and establishments). In addition, the EFTA Surveillance Authority routinely inspects EEA EFTA members' application of food and veterinary legislation, and participates in operating the Rapid Alert System for Food and Feed (RASFF).[218] Norwegian food and veterinary legislation is harmonized with the European Union.[219]

3.131.  Several government agencies are responsible for policy, regulation, and legislation relating to SPS measures including: the Ministry of Agriculture and Food; the Ministry of Trade, Industry and Fisheries; the Ministry of Health and Care Services; the Ministry for Foreign Affairs; and the Ministry for the Environment. Responsibility for implementation of the legislation is delegated to the Norwegian Food Safety Authority (NFSA) which is the principal agency responsible for preparation, drafting and implementing food safety and other SPS regulations

3.132.  The NFSA represents Norway in a number of committees and working groups under the Directorate General for Health and Food Safety of the European Commission, including the Standing Committee on Plants, Animals, Food and Feed (PAFF Committee) which is the principal regulatory body responsible for delivering opinions on draft implementing measures. The PAFF Committee is made up of 14 different sections, each responsible for different aspects related to SPS measures.[220] In addition, the NFSA represents Norway in five committees that are also responsible for specific SPS-related issues: Regulatory Committee under Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms (GMOs); Regulatory Committee under Directive 2009/41/EC on the contained use of GMOs; Standing Committee on Plant Variety Rights; Standing Committee on Zootechnics; and Biocidal Products Committee

3.133.  The NFSA is also responsible for Norway's participation in the Rapid Alert System for Food and Feed (RASFF) and the TRAde Control and Expert System (TRACES) online system which manages official controls and route planning for imports of animals, semen and embryos, food, feed, and plants which must be accompanied by health certificates and/or trade documents. All harmonized certificates for exporting to the EEA are available on TRACES which is used to notify the relevant authorities in the importing country of the arrival of a consignment.[221]

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

3.135.  The principal legislation relating to SPS measures in Norway is the Act Relating to Food Production and Food Safety No. 124 of 2003 and supporting regulations, many of which incorporate EU legislation into Norway. During the period 2012-17, several regulations were introduced, including: Regulation on Novel Foods No. 1215 of 25 July 2017 which implemented Regulation (EU) No. 2015/2283[222]; Regulation on Common Coordinated Programme for Pesticide Residues in Foodstuffs for 2017, 2018, and 2019 of 5 August 2017 which implemented Regulation (EU) No. 2016/662[223]; Regulation on sampling and analysis for the official control of certain pollutants in foodstuffs of 7 October 2015 implementing several EU regulations, including Regulations (EC) No. 401/2006, (EC) No. 1882/2006, (EC) No. 333/2007, (EU) No. 2017/644, and (EU) No. 2015/705; and Regulation of certain contamits in foodstuffs of 7 October 2015 implementing Regulation (EC) No. 1881/2006[224] (as amended) and setting national limits for radioactive caesium in some food products and radioactive substances in drinking water

3.136.  The Norwegian Regulations relating to alien organisms under the Act Relating to the Management of Biological, Geological and Landscape Diversity No. 100 of 2009 (the Nature Diversity Act) came into force on 1 January 2016. The purpose of the Regulations is to prevent the import, release and spread of alien organisms that have or may have adverse impacts on biological or landscape diversity. It includes a general requirement of a permit for the import of organisms, and for the release of alien organisms along with a number of exceptions. The Regulations also include a prohibition against the import, release and placing on the market of 31 alien organisms, mainly plants, but also live American Lobster (Homarus americanus). Norway has not implemented the EU Regulation 1143/2014 on invasive alien species

3.137.  Plant health protection legislation remains the Regulation relating to plants and measures against pests and diseases No. 1333 of 2000, last amended in 2016. According to the authorities, this remains as national legislation as the EU plant health legislation is not part of the EEA agreement. The purpose of the Regulation is to prevent the introduction and spread of pests, to control any plant disease outbreaks in Norway, and to safeguard the production and sale of plants intended for planting

3.138.  The Gene Technology Act No. 6 of 1993 on living GMOs (including seeds) (last amended in 2015) sets out the process for approving the use and imports of GMOs. The purpose of the Act is to ensure that the use of GMOs and the production of cloned animals take place in an ethically and socially sound manner, in accordance with the principle of sustainable development and without health and environmental harm. No authorization is required in Norway for the deliberate release of genetically modified organisms (GMOs) that have been authorized in another EEA State in accordance with the European Union's GMO Directive (2001/18/EC). However, under the Gene Technology Act, a domestic decision to prohibit GMOs can be made and the Norwegian authorities may prohibit or restrict the placing on the market of a GMO if it involves a risk to health or the environment, or if placing it on the market is otherwise in conflict with the purpose of the Gene Technology Act, provided that their decision is otherwise in accordance with the EEA Agreement.[225] In 2017, prohibitions of certain genetically modified plants[226] for use as feed and for industrial processing were laid down by Royal Decree. At the same time, Norway did not object to the EU decisions permitting the import of five genetically modified carnation lines.[227]

3.139.  The Animal Welfare Act No. 97 of 2009 and accompanying regulations set out requirements for the raising, transport and slaughtering of animals

3.140.  In general, import requirements are the same as in the European Union, and only products coming from the EU list of exporting countries, species, and establishments may be imported into Norway. Importers and/or first recipients of imports of food are required to register with the NFSA, and must take responsibility for the imported food, including compliance with regulations and internal controls (Regulation No. 1187 of 1994[228]). All imports of food from outside the EEA must be notified to the NFSA at least 24 hours before arrival. Food of animal origin must be notified to the TRACES online system, and products subjected to veterinary check at a border inspection post are those specified in Annex I of Commission Decision (EC) No. 2007/275 concerning lists of animals and products to be subject to controls at border inspection posts under Council Directives 91/496/EEC and 97/78/EC.[229]

3.141.  Regulation No. 1333 on plants and plant pests sets out the requirements for imports of plants and plant products, including packaging material. Requirements relating to import vary depending on the country of origin and the type of product. The Regulation also requires health certificates for imports of a number of products, including some fruits, vegetables, potatoes, wood, and flowers

3.142.  For 2012-17, Norway made seven notifications to the WTO for SPS measures, including the draft regulations relating to alien organisms and two addenda to this notification. During this period, no specific trade concerns were raised by other Members about measures taken by Norway. The national notification authority is the Ministry of Foreign Affairs, and the enquiry point is the Ministry of Agriculture and Food.[230]

3.113.  Like other members of the EEA, the legal basis for technical requirements, standards, conformity assessment, and accreditation is that of the European Union, and the Blue Guide by the European Commission sets out the framework for technical regulations, standards, and conformity assessment that applies to the members of the EEA.[197] Therefore, for most products, Norway follows the "New Approach" whereby common essential requirements for a product sector or to meet a particular risk are set out in legislation, and the technical specifications to achieve these essential requirements are in voluntary harmonized standards.[198] Market operators are not required to use these standards to meet the essential requirements, and alternative methods of demonstrating compliance with the regulatory requirements are the same in Norway as in the European Union and they are set out in the Blue Guide

3.114.  The New Legislative Framework is set out in EEA legislation under Decision of the EEA Joint Committee No. 126/2012[199] under which several EU regulations and decisions were adopted into the EEA Agreement, including: Regulation (EC) 765/2008 setting out the requirements for accreditation and the market surveillance of products[200]; Decision 768/2008 on a common framework for the marketing of products, which provides a template for future product harmonization legislation[201]; and Regulation (EC) 764/2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another EEA country.[202]

3.115.  At end-2017, product legislation for several areas in the EEA had been reviewed and harmonized based on the New Legislative Framework under which the essential requirements for products are set out in the legislation[203]. By end-2017, out of 20 regulations and directives on product harmonization in the European Union, Norway had transposed 17 into national legislation.[204] Areas not covered by specific legislation must comply with the General Product Safety Directive[205] or product specific legislation

3.116.  The New Legislative Framework does not apply to all products. The "old approach" of detailing technical requirements is still applied to some products, such as motor vehicles, while different approaches to EEA harmonization are followed in different sectors such as pharmaceuticals, chemicals and cosmetics. In addition, construction products are also covered by harmonization regulations although the authorities noted that the content and concepts used were different compared to other systems, in particular the mandatory nature of the harmonized standards under the Construction Product Regulation system

3.117.  As with other EU legislation with EEA relevance, harmonized regulations of the European Union are adopted by amendments to the EEA Agreement through decisions of the EEA Joint Committee, and their transposition into national legislation and application are subject to the oversight of the EFTA Surveillance Authority and the EFTA Court. The EEA Joint Committee, which is made up of the EFTA EEA members and the Commission, may decide to adapt the technical regulations before adoption, although at end-2017 there had been no adaptations to the directives and regulations on product harmonization that have been made by the Joint Committee

3.118.  Within the EEA, the principle of mutual recognition applies to all goods or aspects of goods, including those not subject to EU harmonization legislation. This ensures products lawfully put on the market in one EEA country can be marketed in another even if the product does not fully comply with the technical rules of the other EEA country. However, the principle does not preclude prohibitions or restrictions justified on grounds of legitimate public interest

3.119.  Norway and other EEA EFTA States must notify the EFTA Surveillance Authority of plans to develop a national technical regulation, and allow time for comments from other EEA members. Draft national technical regulations are notified and maintained in the TRIS (Technical Regulations Information System) database in accordance with Directive (EU) 2015/1535, which superseded Directive 98/34/EC.[206] From end-2011 to September 2017, Norway made 95 notifications to the TRIS database, although this includes some measures that are not considered technical regulations and/or state the draft has no significant impact on international trade.[207]

3.120.  Norway also applies the EEA rules on standardization as set out in Regulation (EU) No. 1025/2012 on European standardization.[208] This Regulation establishes rules for cooperation between the European standardization organizations, national standardization bodies, and the European Commission. It also sets out rules for the establishment of European standards, the roles of the bodies responsible for standardization, the role of standards as voluntary technical or quality specifications, the financing of European standardization, and stakeholder participation in European standardization

3.121.  There are three standards organizations in Norway: Standards Norway (SN) is a private and independent organization partly funded by grants from the Ministry of Trade, Industry and Fisheries. SN is a member of the European Committee on Standardization (CEN) and the International Organization for Standardization (ISO). There are about 16,500 valid Norwegian Standards, and SN publishes about 1,200 new ones each year. The Norwegian Electrotechnical Committee (NEK), a private, independent, and autonomous non-governmental organization, is a member of the European Committee for Electrotechnical Standardization (CENELEC) and the International Electrotechnical Commission (IEC). There are about 15,700 valid Norwegian electrotechnical standards mainly based on publications from the IEC and CENELEC with about 150 Norwegian electrotechnical standards. The Norwegian Communications Authority (NKom), which is an autonomous agency of the Ministry of Transport and Communications. NKom is responsible for standards for post and telecommunications, and it is a member of the European Telecommunications Standards Institute (ETSI) and the International Telecommunications Union (ITU). Nkom does not produce standards but transposes standards from ETSI

3.122.  In addition: Standard Online AS is responsible for the marketing and sale of standards and related products from SN and NEK[209]; the trade associations Nelfo (Electrical Contractors' Association) and Energy Norway (an association of companies involved in production, distribution and trading of electricity) sell Norwegian translations of electro technical standards on behalf of NEK; and SN manages and publishes NORSOK[210] standards which are owned by the Federation of Norwegian Industries, the Norwegian Oil and Gas Association, and the Norwegian Shipowners' Association. NORSOK standards are developed to ensure adequate safety, value adding and cost effectiveness for petroleum industry developments and operations. Furthermore, as far as possible, NORSOK standards are intended to replace oil company specifications and serve as references in the authorities' regulations. There are currently about 79 national NORSOK standards in active use

3.123.  As members of the CEN and CENELEC, SN and NEK monitor and delegate experts to their technical committees that draw up standards, as coordinated by the CEN-CENELEC Management Centre in Brussels. NKom participates in the work of ESTI along with the other members (which in the case of ESTI include non-governmental entities such as companies and universities) to develop telecommunications standards

3.124.  When a new standard has been developed by one of the European standards organizations, conflicting national standards should be withdrawn.[211] Furthermore, when work on a European standard is started in CEN or CENELEC, a standstill procedure applies to national work on the same subject, and the work programme of national standards must be reported at least annually by each national standardization body. In the case of harmonized standards, standstill and withdrawal are compulsory. Harmonized standards are those created following a request from the European Commission to CEN, CENELEC, or ESTI, with references and titles published in the Official Journal of the European Union. After being transposed into identical national standards by the national standard bodies, there is a presumption of conformity with the corresponding essential requirements for a product made in compliance with the standard. However, use of the standard is not required but the burden of proving conformity with the essential requirements rests with the manufacturer.[212]

3.125.  At end-June 2017, CEN and CENELEC had 20,202 standards and harmonization documents in their portfolio of European Standards, and Norway had an implementation rate of over 99%. Of the total portfolio of documents for CEN, 68% were based on ISO publications and 32% were identical to them. For CENELEC, 22% were based on IEC publications, and 72% were identical to them. Of the total for both CEN and CENELEC, 4,258 were harmonized standards (cited or intended for citation in the OJEU), of which 37% were identical to, 6% were based on, and the remainder had no relation to ISO/IEC publications.[213]

3.126.  In Norway, as in the rest of the EEA, CE marking must be applied whenever required by legislation. The marking is applied by the manufacturer as a declaration that the product meets all legal requirements for the marking and can be sold throughout the EEA. It is the manufacturer's responsibility to carry out the conformity assessment, set up the technical file, issue the EU declaration of conformity, and affix the CE marking to a product. Only then can this product be traded on the EEA market.[214]

3.127.  Norwegian Accreditation (NA) is responsible for the accreditation of conformity assessment bodies in Norway. NA is a member of the European cooperation for Accreditation (EA), the International Accreditation Forum, and the International Laboratory Accreditation Cooperation.[215]

3.128.  When the European Union negotiates mutual recognition agreements, it does so on the basis that the third country will conclude a parallel MRA with the EEA. Through the EEA, Norway 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 EMC, pharmaceuticals (GMP), medical devices, telecommunications terminal equipment, automotive products, pressure equipment, machinery, and low voltage equipment; Canada (2001), covering telecommunications terminal equipment, EMC, electrical safety, recreational craft, pharmaceuticals (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 EMC, construction plant and equipment, measuring instruments and pre-packages, motor vehicles, agricultural and forestry tractors, good laboratory practice (GLP), 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, EMC, and recreational craft; and Turkey (2011) covering all sectors.[216]

3.129.  For 2012-17, Norway made five notifications to the WTO Committee on TBT (all regular notifications), two on fertilizers, two on tobacco products, and one on laser pointers. During this period, two specific trade concerns were raised about Norway's TBT measures, one on tobacco labelling regulations, and the other an issue first raised in 2008 relating to a regulation on specific hazardous substances in consumer products.[217] SN is the enquiry point for Norway under the WTO Agreement on Technical Barriers to Trade (TBT). Norway's notifications to the TBT Committee are for national measures only