3.100.  According to the authorities, there are currently no procedures in place for the registration of food additives and flavouring matters.[194] It appears that food additives recognized by the European Union to be safe for human consumption are deemed to be approved in Ukraine. The adoption of the relevant regulation governing the approval procedure for state registration of food additives, flavourings and enzymes on the basis of EU Regulation No. 1331/2008 of 16 December 2008 is still pending.[195] According to the Law of Ukraine No. 1602-VII of 22 July 2014, the central executive body will be responsible for registration of food additives and administration of a state register

3.101.  A list of services provided by the SPS authorities was established in 2011, and the respective fees in 2013.[196] Administrative services provided by the competent authorities in the field of food safety are subject to fees that should not exceed the actual cost of the service.[197] A draft law on administrative services and fees is pending, according to the authorities

3.102.  The national certification system, administered by the State Inspection for Consumer Rights Protection was introduced in 1993.[198] In line with WTO accession commitments, the list of food products subject to mandatory certification was gradually reduced and from 2015 mandatory certification of food products, with the exception of tobacco and some alcoholic products, is no longer in place.[199] Most of the provisions of the Decree on Standardization and Certification have been cancelled and the decree is to lose its validity by 1 January 2018, in accordance with amendments under the Law No. 124-VIII of 15 January 2015 "on Technical Regulations and Conformity Assessment", in force as of 10 February 2016

3.103.  Pending its reorganization, the State Veterinary and Phytosanitary Service of the Ministry of Agrarian Policy and Food remains the competent authority for the implementation of veterinary and phytosanitary measures. Veterinary requirements are governed principally by the Law "on Veterinary Medicine" and the Food Safety Law.[200] According to the Food Safety Law, the importation of meat and meat products is conducted either on the basis of an international veterinary certificate or another relevant document issued by the competent authority of the home country. With the creation of a new institution, Ukraine will develop its own form of the international certificate. Currently, on the official website of the Veterinary Service, forms of veterinary certificates agreed with some foreign partners for export and import can be viewed in Ukrainian (http://old.vet.gov.ua/law/sert#grp_4). The requirements for products subject to veterinary surveillance and control are set out in Order No. 71 of the Ministry of Agrarian Policy and Food.[201] Activity licensing for imports of animals and animal products, and food additives, amongst others, was abolished in 2014.[202] In the context of a broader deregulation policy, the requirement to obtain a veterinary permit for imports of meat, meat products, and live animals has been eliminated.[203]

3.104.  Since April 2014, the Ministry of Agrarian Policy and Food recognizes the EU production and control systems for products of animal origin and raw materials as equivalent to Ukraine's system of food safety and quality.[204] Products from approved EU-facilities are allowed for import into Ukraine. The legal framework provides for mandatory identification and registration of farm animals.[205] Recent amendments aim to improve the monitoring of animal health and veterinary‑sanitary conditions.[206] Imports of meat and meat products treated with growth promoting hormones are permitted, according to the authorities. According to the Law "on veterinary medicine", veterinary medicines must be registered; at end-2015 no growth-promoting veterinary drugs had been registered

3.105.  Phytosanitary measures are based mainly on the framework Law "on Plant Quarantine".[207] The law was recently amended with the aim of aligning it with IPPC standards and requirements.[208] According to the amendments, two lists of subjects of phytosanitary regulation will be developed: one for imports, exports and re-exports; the other for controlling transit through Ukraine. However, the authorities have advised that some regulatory changes may not be in conformity with the relevant international standards (notably ISPM No. 32 and ISPM No. 5).[209] Phytosanitary certification is carried out in accordance with ISPM No. 12 ("phytosanitary certificates") and with shortened timelines (24 hours, instead of 5 days).[210]

3.106.  Seeds and propagating material for importation must be listed in the Register of Plant Varieties[211] maintained by the SVPS or in the Register of the OECD Seed Scheme (Ukraine is a member). Seeds listed in the OECD Seed Scheme may be imported in accordance with the procedure established by the Order of the Ministry of Agrarian Policy and Food No. 216 of 25 March 2013 for propagation purposes and subsequent export.[212]

3.107.  The use of officially registered pesticides and their application procedures are controlled by the Ministry of Ecology and Natural Resources (MENRU) using the norms established by the Ministry of Health. The MENRU publishes a catalogue, once a year, of pesticides and agricultural chemicals allowed for use in Ukraine (brand name, group, owner, country of origin, active ingredients, and duration of registration). The importation of pesticides is no longer subject to activity licensing.[213]

3.108.  The main legislation governing biotechnology is the Law "on the State System of Biosafety in Creating, Testing, Transporting and Using Genetically Modified Organisms" (Law on GMOs)[214], and Ministry of Health Order No. 971 of 9 November 2010 "on the List of Food Products Subject to Control of GMO Content". Ukraine is a party to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity. Within the framework of the Association Agreement with the EU, Ukraine has undertaken to align its GMO-legislation with the EU acquis (including EU Regulation No. 1830/2003 of 22 September 2003 concerning GMO traceability and labelling). Recent amendments introduced by the Law No. 1602-VII of 22 July 2014 provide for the implementation of EU principles for GMO regulation, notably the registration of GMO sources rather than products made from them. Ukraine has no GMO registry at the moment. In future, only crop varieties and animal breeds that are based on GMOs, GMOs for food products, and GMOs for feed use will be subject to registration.[215]

3.109.  The general labelling requirements in the Food Safety Law are further developed in the Resolution of the Cabinet of Ministers No. 468 of 13 May 2009 "on Approval of the Labelling Procedures for Foodstuffs that Contain or Were Produced with the Use of GMOs and Are to be Placed on the Market".[216] Any food product with more than 0.9% of GMOs by weight must be labelled as "Contains GMOs". A food product containing less than 0.9% of GMOs may be labelled as "No GMOs"

3.94.  Ukraine is a member of the World Organisation for Animal Health (OIE), the International Plant Protection Convention (IPPC), the European and Mediterranean Plant Protection Organization (EPPO), and the Codex Alimentarius Commission. The national Codex Alimentarius Commission that normally assists in developing food safety control methods, MRLs, and HACCP procedures, amongst others, is currently inactive.[179] The national Codex Contact Point remains operational and continues its dissemination of Codex standards in Ukraine

3.95.  Since its accession, Ukraine has submitted just over 100 SPS notifications, mainly emergency notifications, but also covering some recent reforms of the SPS regime. WTO Members have raised two specific trade concerns in the SPS Committee regarding Ukraine's SPS measures.[180]

3.96.  Recent developments include the establishment of a new State Service for Food Safety and Consumer Protection on 10 September 2014 with the aim to consolidate SPS-related responsibilities spread over several agencies.[181] However, the new agency is not yet operational (as of December 2015). Under the planned reorganization, the State Veterinary and Phytosanitary Service is to be merged with some or all of the functions of the State Sanitary and Epidemiological Service, the State Inspection for Consumer Rights Protection, the State Agricultural Inspection Service, and the State Assay Service.[182] The new agency will be accountable to the Cabinet of Ministers and function as the central executive body responsible for SPS measures, including the safety and quality of food products, sanitary legislation, veterinary measures, animal identification and registration, plant protection and quarantine, certification of seeds and planting material, and tobacco control.[183]

3.97.  The regulatory framework for food safety is based on the Law "on the Safety and Quality of Food Products" (Food Safety Law), as amended.[184] According to the Law, sanitary measures should be based on scientific evidence in line with international standards, guidelines and recommendations, and should not be more restrictive than necessary.[185] In practice, Ukraine still maintains numerous food safety and nutritional standards that were first established by the Soviet Union, for example, the standards on "Medico-biological Requirements and Sanitary Norms of Quality of Alimentary Raw Materials and Food Products" No. 5061-89 of 1 August 1989 are still in force in Ukraine.[186] Nevertheless, a number of food safety requirements were recently revised, including: Ministry of Health Order No. 368 of 13 May 2013 "on Approval of the State Sanitary Rules and Norms 'Regulations of Maximum Levels for Certain Contamits in Foodstuffs'", which provides for a list of food products and the maximum allowed levels of certain contamits (such as nitrates, mycotoxins, metals, 3-MCDP, dioxins, polycyclic aromatic hydrocarbons, melamine); and establishes some special requirements for peanuts, nuts, or other oil containing seeds, dried fruit, rice and maize. Furthermore, the new Order lists provisions contained in the "Medico-biological Requirements and Sanitary Norms of Quality of Alimentary Raw Materials and Food Products" No. 5061-89 of 1 August 1989 that will no longer apply when the new Order enters into force on 14 June 2016; Ministry of Health Order No. 695 of 6 August 2013 "on Approval of the Safety Parameters for Meat and Poultry" which establishes the permitted levels of toxins, pesticides and antibiotics in poultry meat, based on Codex Alimentarius standards and EU requirements[187]; and Ministry of Health Order No. 694 of 8 August 2013 "on Approval of Hygienic Requirements for Poultry Meat and Particular Indicators of its Quality" to harmonize the marketing standards for poultry meat with those of the EU.[188] The new sanitary requirements for poultry meat are scheduled to come into force on 6 August 2016

3.98.  A major reform of the food safety regime entered into force on 20 September 2015 with the enactment of Law No. 1602-VII of 22 July 2014 "on Amendments to Several Laws with respect to Food Safety". The law aims to align Ukrainian food safety legislation with international standards and the EU acquis ("farm-to-fork approach").[189] Under the new food safety approach, the food chain will be monitored through the gradual introduction of HACCP procedures. Mandatory traceability of food products is to be introduced and importers will be required to keep relevant documentation for six months after product expiry. Responsibility for compliance with food safety legislation will rest mainly on market operators subject to fines for non-compliance.[190] A new chapter on general food hygiene requirements was included in the Food Safety Law, with the objective to replace outdated sanitary and veterinary requirements, some of which date back to the 1980s

3.99.  The amendments require that imports of food products (except products of animal origin) and raw materials for the food industry must be accompanied by an "international certificate" or other documents issued by the competent authority of the country of origin.[191] The requirement for importers to obtain a sanitary-hygiene certificate was repealed, effective 20 September 2015, although imported food consignments may be subject to state border control. The frequency of physical inspections and laboratory testing of shipments depends on the risk posed to human health.[192] An import risk analysis may be initiated by the competent authorities, authorizing accredited laboratories to perform the assessment.[193] The results of a risk analysis must be published on the agency's website within three days. Laboratories can be accredited by the National Accreditation Agency of Ukraine and/or an international accreditation body

3.82.  Ukraine inherited from the Soviet Union a rigid system of technical requirements based on prior controls and widespread adherence to compulsory standards. The process of transforming Ukraine's TBT regime to a WTO-compatible mixture of mandatory technical regulations and standards, by definition voluntary, began during Ukraine's process of accession to the WTO. The basic laws "on standardization" and "on conformity assessment" from 2001 were supplemented with, but not superseded by, Law No. 3164-IV "on Standards, Technical Regulations and Conformity Assessment Procedures" of 1 December 2005.[165] The three laws thus had to be read together. The 2005 law clarified that only the Cabinet of Ministers had the authority to adopt technical regulations. The law was amended in 2007 to state that relevant international standards should be given priority consideration as Ukraine was developing its standards, technical regulations and conformity assessment procedures. In April 2006, the Ukrainian authorities estimated that Ukraine had some 3,100 harmonized national standards while another 8,000 standards remained to be harmonized with international standards. As this task was unlikely to be accomplished prior to Ukraine's accession to the WTO, priority areas for follow-up were products remaining subject to mandatory certification, cumbersome multiple testing requirements by different public authorities due to overlapping responsibilities, accreditation procedures for conformity assessment bodies and the possibilities for mutual recognition, the use of manufacturers' declarations, and compliance with the transparency obligations of the TBT Agreement.[166]

3.83.  On the institutional side, the Derzhspozhyvstandart (the State Committee for Technical Regulation and Consumer Policy) was the central authority responsible for all work related to the formulation and implementation of standards, technical regulations, and conformity assessment procedures until 2011, when the functions were transferred to the Ministry of Economic Development and Trade as part of the administrative reform of Ukraine. Draft texts and approved standards, technical regulations and related procedures are published in the official gazette "Ofitsiyniy Visnyk Ukrajiny" or in the journal "Standards". The Ministry of Economic Development and Trade also serves as Ukraine's WTO National Enquiry Point and Information Processing Centre

3.84.  The Law "on Standardization" was revised in 2014 to clarify the terminology used, avoid any compulsory application of standards, and to create a national standardization body fully equipped to promulgate standards while not being a state authority.[167] In November 2014, the Cabinet of Ministers designated the Ukrainian Scientific‑Research and Training Centre of Standardization, Certification and Quality Problems to serve as the new national standardization body.[168] Within this body, an information centre (ISONET) has been established to provide information about the institution's work. According to the Ukrainian authorities, 11,662 Ukrainian standards had been harmonized with international or European standards by January 2016, leading to the cancellation of 15,773 interstate (GOST) standards developed before 1992

3.85.  Simultaneously with the revision of the standardization law, a new version of the Law "on Metrology and Metrology Activity" was also adopted to separate the regulatory, supervisory and economic functions in this area in alignment with the International Organization of Legal Metrology (OIML) and the EU framework.[169]

3.86.  Law No. 124-VIII "on Technical Regulations and Conformity Assessment" of 15 January 2015 aims at establishing a legal and institutional framework for the development, adoption and application of technical regulations and conformity assessment procedures that follows the system applied by the European Union.[170] The current compulsory product certification regime is to be fully abolished by 2018 and is being replaced by conformity assessment.[171] The process of removing low-risk goods from mandatory certification requirements began more than 10 years ago, and the list has been reduced progressively over the years.[172] On 6 May 2015, The Ministry of Economic Development and Trade adopted Orders No. 451 and 452, cancelling inter alia the mandatory certification of detergents, welding equipment, bicycles and baby carriages, various items of kitchenware, light-industry products, various types of infant food or dietary nutrition mixtures, pipes and bulbs (tanks), chemical sources of electric current, and piping fittings. For small tractors, new motor vehicles (including parts and tools), petrol, diesel and marine fuel, the mandatory requirements cease as of 1 January 2016.[173]

3.87.  For goods subject to mandatory certification, Ukraine operates a State certification system (UkrSEPRO) that allows certification of either single products, groups of products or articles, serially manufactured goods, or products requiring examination or inspection of the manufacturing process, attestation of the process, or assessment or certification of a quality system. UkrSEPRO certificates of conformity can be issued for single shipments and would in such cases be valid only for one shipment or, for serially manufactured goods, certificates may be of 1‑3 years' validity.[174] Five-year certificates may be obtained for mass-produced goods, but the inspection process is complex and costly as it requires production systems certification (ISO‑9000), sample testing, and annual control and auditing

3.88.  The procedures for recognition of equivalence of conformity assessment undertaken outside of Ukraine are laid down in Articles 26 and 30 of the Law "on Standards, Technical Regulations and Conformity Assessment Procedures". Foreign certificates of conformity may be accepted on the basis of signed agreements with the corresponding authorities of other WTO Members. As of 1 September 2013, Ukraine had concluded 12 such agreements with the conformity assessment bodies of the Czech Republic, Slovak Republic, Poland, China, Republic of Korea, Germany, and the Russian Federation. Ukraine may also accept the results of international commodity testing and certification systems of which Ukraine is a member, i.e. the Worldwide System for Conformity Testing and Certification of Electrotechnical Equipment and Components (ІЕСЕЕ-CB) scheme. In November 2011, the General Assembly of the European Cooperation for Accreditation (EA) decided to admit the National Accreditation Agency of Ukraine (NAAU) as an associate member, and a document was signed at the EA General Assembly in May 2012 confirming the NAAU's recognition for the areas of accreditation of personnel certification authorities and expanding the NAAU's recognition to the accreditation of calibration laboratories, accreditation of testing laboratories, and accreditation of management systems certification authorities. The NAAU became a full member of the International Laboratory Accreditation Cooperation (ILAC) in 2014, having been an affiliate member since 2004. The NAAU has been recognized as an ILAC Mutual Recognition Arrangement (ILAC MRA) signatory in the area of inspection (in accordance with ISO/IEC 17020) since December 2014, and in October 2015 the NAAU obtained signatory status among the Accreditation of Products Certification Bodies at a meeting of the Multilateral Agreement Council of the European Cooperation for Accreditation

3.89.  Although Ukraine has been undertaking efforts for many years to adapt to internationally recognized, and in particular EU, procedures for the elaboration of standards, technical regulations and conformity assessment procedures, the work has taken on a new dimension with the conclusion of the Association Agreement, including the Deep and Comprehensive Free Trade Area. The revision of Ukraine's basic legal framework during 2014 and 2015 forms part of a progressive adaptation of Ukraine's TBT regime to the EU principles of market supervision and consumer rights protection, including an overhaul of the technical regulations framework. At a later stage, an Agreement on Conformity Assessment and Acceptance of Industrial Products (ACAA) is to be negotiated and added as an individual protocol to the existing Association Agreement

3.90.  For the ACAA to be finalized, Ukraine will need to fully harmonize its legislation with EU legislation, including the adoption of technical regulations based on all relevant EU directives, ensuring that its institutions (national standardization and conformity assessment bodies, accreditation agency, and market surveillance authorities) are acting in line with EU practice, and adopting harmonized standards evidencing product conformity with requirements set forth in technical regulations. Once in place, the ACAA will provide Ukrainian and EU manufacturers free access to a joint market for certain types of industrial products based on mutual recognition of certificates of conformity. Four priority industrial sectors have been identified for mutual free access, namely low-voltage equipment, electromagnetic compatibility, machinery, and ordinary pressure vessels

3.91.  Ukraine's commitments to bring its technical regulations legislation in line with the EU acquis communautaire are laid down in Section IV, Chapter 3, Articles 53-58 of the Association Agreement, and involve the adoption of technical regulations for 27 product categories. As of November 2015, Ukraine had adopted 24 technical regulations while the remaining three were in preparation

3.92.  Labelling provisions are to be kept to a minimum to ensure non-discrimination. The European Commission estimates that the harmonization and/or mutual recognition facilities under the ACAA should eliminate 50% of the identified trade barriers in the agro-food sector and 35% in other industrial sectors compared with the situation in 2004.[175]

3.93.  Ukraine has provided around 250 TBT notifications since it joined the WTO, of which more than 100 are notifications of draft technical regulations. Members have raised two specific trade concerns in the TBT Committee. The first concern related to a draft technical regulation on the labelling of foodstuff, which appeared to differ from the Codex Alimentarius and involved additional costs and burdens for affected operators.[176] In 2012, another Member questioned amendments to Ukraine's Law "on Advertising" introducing restrictions on the marketing of alcohol and tobacco products.[177] Ukraine, in turn, has raised 15 specific trade concerns relating to measures maintained by other WTO Members.[178]