51.  Croatia is transposing various elements of the EU technical requirements into its domestic legal system by adopting legislation on, inter alia, standardization, accreditation and conformity assessment, and metrology; and by enacting some sector-specific laws, such as on chemicals (REACH).[60] Croatia's legal framework includes, inter alia, the Accreditation Act (OG 158/03 and 75/09); the Standardization Act (OG 163/03), the Act on Technical Requirements for Products and Conformity Assessment (OG 158/03 and 79/07); the General Product Safety Act (OG 30/09); and the Metrology Act (OG 163/03, 194/03 and 111/07). It is aimed at increasing the competitiveness and quality of exports; ensuring that they do not harm the environment and that they conform to health and safety norms; and ensuring equal treatment for imported and domestic products

52.  The State Office for Standardization and Metrology (DZNM), under the Ministry of Science, was established in 1991 as the overarching body responsible for metrology, accreditation, standardization, and certification. In July 2005, the functions of standardization, accreditation, and metrology were legally and administratively separated and the DZNM was replaced by four independent institutions. Three were established as public institutions under MELE: the State Office for Metrology (DZM), responsible for legal metrology, pre-packages, precious metals, and type approval of vehicles; the Croatian Standards Institute (HZN), the national standards body and the TBT enquiry point[61]; and the Croatian Accreditation Agency (HAA), the national accreditation body, which supports the implementation of technical legislation in Croatia. The fourth institution, the Croatian Metrology Institute (HMI) is under the Ministry of Science, Education and Sport and deals with scientific and industrial metrology. These institutional changes were also made to comply with the EU conformity assessment and standardization requirements. MELE is responsible for administrative and other activities pertaining to quality infrastructure, including the coordination and development of national policy on standardization, accreditation, conformity assessment and metrology.[62] In addition, the Croatian State Inspectorate (DIRH) is, inter alia, in charge of supervising the conformity and safety of certain products

53.  MELE also has overall responsibility for ensuring compliance with Croatia's obligations under the WTO TBT Agreement.[63] Croatia has accepted the Code of Good Practice for the preparation, adoption and application of standards.[64] It has submitted 38 notifications to the TBT Committee (up to September 2009), almost all concerning regulations on metrological requirements.[65] No specific trade concerns have been raised in the Committee regarding Croatia

54.  Croatia's regulations for industrial products are based on the EU's "Old Approach" (laying down detailed specific technical requirements) and the "New and Global Approach" (setting-up of essential requirements defined to meet health, safety, and environmental objectives). The technical characteristics of the products are given in the standards (voluntary) drafted by the stakeholders following the procedures of the European standardization organizations. Technical regulations are applied to products for which safety is an issue, such as construction products, medical devices, and particular electrical equipment. These products are subject to testing, certification or prior approval procedures. Technical regulations in Croatia are developed by various Central State Administration Bodies. The heads of these government bodies adopt, according to their competence and scope of activities, technical regulations and determine conformity assessment procedures. All new technical regulations are published in the Official Gazette.[66]

55.  According to the authorities, new technical regulations or national standards are prepared only when the regulatory authorities consider international standards to be ineffective or inappropriate due to climatic, geographical, or technological factors. In preparing original national standards, and in accordance with Croatia's obligations under the Code of Good Practice for standardization, HZN notifies the new project to the European system (CEN INFOPRO).[67] Copies of draft national standards may be provided to other WTO Members upon request. The HZN allows all interested parties 60 days to comment on draft national standards. Information on new Croatian standards are published in the HZN bulletin, HZN Glasilo

56.  Croatia has continued to harmonize its national standards with international or regional, in particular European, standards. Around 98% of European standards have been adopted as Croatian standards. At end October 2009, 24,226 standards were in force in Croatia, of which 33 were national standards; 20,491 were adopted from European standards (including international standards); and 4,175 were adopted from ISO and/or IEC standards

57.  The Croatian Accreditation Agency (HAA) is responsible for, inter alia, accreditation of testing and calibration laboratories, medical laboratories, food quality and safety, accreditation of veterinary inspection bodies, certification and inspection bodies, construction products, lifts and other industrial products, as well as accreditation of certification bodies for Quality Management Systems, Environmental Management Systems and personnel. HAA has granted 157 accreditation certificates; it carries out surveillance on accredited bodies annually. HAA has signed cooperation agreements with the accreditation bodies of Bosnia and Herzegovina, Montenegro, FYR of Macedonia, the Czech Republic, and Hungary.[68] Moreover, HAA has conducted joint training activities and exchange of assessors with Slovenia, and has recently undergone peer evaluation by the European co-operation for Accreditation (EA) for the purpose of signing a mutual recognition agreement (EA MLA) in 2010

58.  Conformity with technical requirements may be certified through a supplier declaration of conformity (first party), or certificate of conformity (third party). Importers are responsible for aspects covered in the manufacturers' declaration of conformity. Product liability is established through the Civil Obligation Act (OG 35/05), as amended

59.  Pre-market mandatory certification for imported and domestic cosmetics was abolished in October 2008, although foreign test reports may be recognized certain conditions. Since 2008, quality control at the border has been abolished; imports subject to quality control included food and agricultural products, furniture, cement, textiles, and electrical and gas appliances.[69]

60.  The Croatian State Inspectorate (DIRH) is, inter alia, in charge of supervising the conformity and safety of products placed on the market or used in inter alia: machinery, electrical equipment, energy efficiency of household appliances, refrigerators, freezers; lifts, pressure equipment hot water boilers, construction products, metrology, personal protective equipment, crystal glass, textiles, and general safety of products, furniture, wood, oil fuels, motor vehicles. There are currently 94 accredited testing laboratories; 32 accredited inspection bodies; and various accredited certification bodies. Market surveillance is carried out by inspectors from the DIRH. The DIRH has recently aligned its methods of operation to EU market surveillance good practice.[70]

61.  Separate regulations (technical regulations transposing EU directives) on market surveillance contain a safeguard clause foreseeing the withdrawal of compliant products that are nonetheless found to endanger health and safety. A new regulation has been adopted on the System for Rapid Exchange of Information (RAPEX) on products representing risks for consumer health and safety. The system will take effect upon Croatia's accession to the EU. Market surveillance is financed by the State budget

62.  The Croatian Standards Institute (HZN) is a member of the International Organization of Standardization (ISO), the International Electro-technical Commission (IEC), the European Telecommunications Standards Institute (ETSI), NSO member. HZN was accepted as member of the European Committee for Standardization (CEN) and of the European Committee for Electrotechnical Standardization (CENELEC) in November 2009.[71] Croatia is also a member of the International Atomic Energy Agency (IAEA), the International Organization of Legal Metrology (OIML), the European Collaboration in Legal Metrology (WELMEC), European Collaboration in Measurement Standards (EURAMET), and the Bureau International de Poids et Mesures (BIPM). Croatia is a signatory to the Metre Convention and the CIPM Mutual Recognition Agreement and the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade

63.  To ensure consumer protection, Article 17 of the Consumer Protection Act (OG 79/07, 125/07, 79/09 and 89/09) prescribes that product information must contain all relevant information needed to help the consumer make an informed decision when buying products. These data must be presented clearly, visibly, and legibly and written in Croatian language and Latin script; other languages and characters easily comprehensible to consumers are not excluded

64.  Labelling, presentation, and advertising of food and nutritional labelling of food is regulated by the Ordinance on labelling, advertising and presentation of food (OG 41/08) and the Ordinance on nutritional labelling of food (OG 29/09), adopted pursuant to the Food Act (OG 46/07 and 155/08). The Directorate for Food Safety and Quality, under MAFRD, is responsible for drafting and interpreting such regulations as well as for the majority of regulations on food quality for specific categories

65.  Croatia will apply the so-called "C marking" until the use of CE marking becomes mandatory upon accession to the EU or the conclusion of a mutual recognition agreement with the EU. Manufacturers or their authorized representatives registered in Croatia or any natural or legal person who places a product on the market or puts one into service, must affix the conformity marking and guarantee that the product has been designed, constructed and tested in the prescribed manner, that it complies with all applicable technical requirements, and that it has a written declaration of conformity, a test report or a certificate of conformity.[72]

66.  Croatia's legal framework on SPS includes: the Food Act[73]; the Veterinary Act (OG 41/07 and 155/08); the Animal Protection Act (OG 135/06); the Sanitary Inspection Act (OG 113/08); the Act on Veterinary Medicinal Products (OG 84/08); the Wine Act (OG No. 96/03); and the Plant Health Act (OG No. 75/05). In March 2008, Croatia adopted the Strategy for Transposition, Implementation and Enforcement of the acquis for Food Safety, Veterinary and Phytosanitary Policy.[74]

67.  MAFRD has the overall responsibility for food safety in Croatia and for ensuring compliance with the WTO SPS Agreement. MAFRD has been designated as the central competent authority for food safety, feed safety, and hygiene, as well as the organization of official controls.[75] The Ministry of Health and Social Welfare has competency to ensure food safety in the area of contaminant and pesticide residue control. The Croatian Food Agency (HAH) is responsible for consumer protection and risk assessment; official controls are carried out by MAFRD, the Ministry of Health and Social Welfare, and DIRH

68.  Croatia has three enquiry points, all under MAFRD: the Veterinary Directorate (sanitary matters and animal health), the Veterinary Inspections Directorate (control and inspection of sanitary matters and animal health), and the Directorate of Agriculture and Food Industry (phytosanitary matters and plant protection). MAFRD is in the process of notifying the WTO SPS Committee of the Veterinary Inspections Directorate (OG 35/08) as its third enquiry point. In addition, the Directorate for Food Safety and Quality, also under MAFRD, functions as the SPS notification authority

69.  WTO Members have raised specific concerns in the SPS Committee regarding Croatia's restrictions on pork imports, and its import ban on live animals and meat products.[76] According to the authorities, Croatia's import restrictions on animals and products of animal origin are in line with EU legislation and OIE recommendations for prevention of occurrence and spread of contagious diseases.[77] No cases of Transmissible Spongiform Encephalopathy (TSE) have been reported in Croatia; a ban on feed from meat and bone meal is in force since 2001. Croatia is free from classical swine fever (CSF) in domestic pigs, without vaccination, but CSF may be present in the wild pig population. Since 3 March 2008, no CSF outbreak has been observed in domestic pigs in Croatia. Croatia has never submitted an emergency notification to the SPS Committee and only one notification concerning new or modified SPS measures.[78]

70.  According to the authorities, Croatia's SPS measures are based on international standards, guidelines, and recommendations, and on regulations, decisions, and directives in force in the EU. All SPS measures are based on international standards; and local provinces are not allowed to establish their own SPS measures. SPS measures are given legal effect through national legislation

71.  Official controls of food and feed have to be carried out on the basis of a risk assessment. While the Croatian Food Agency (HAH) is responsible for risk assessment, risk management is the responsibility of the Directorate for Food Safety and Quality, the Veterinary Inspection Directorate, and the Directorate for Agriculture and Phytosanitary Inspection of the MAFRD, the Sanitary Inspection Directorate of the MHSW, and the State Inspectorate. HAH establishes methods for risk assessment in all phases of production, processing, and distribution of food and feed. According to the authorities, the methods used to analyse the risks associated with importation of animals and associated with food are in accordance with the relevant models developed by the OIE. Where such models do not exist, MAFRD determines the measures to be applied in cooperation with the Croatian Veterinary Institute and Veterinary Faculty or other scientific institutions, taking into account scientific evidence in accordance with the SPS Agreement

72.  The Directorate for Food Safety and Quality is responsible for establishing and managing a Rapid Alert System for Food and Feed known as CRO RASFF at the national level, and has been designated as the RASFF single national contact point for the EU. CRO RASFF aims to ensure rapid data flow within the official control system of food and feed, as well as rapid and effective control activities and measures.[79]

73.  The Veterinary Inspections Directorate is responsible for risk management of imports, and for monitoring residues in animal and products of animal origin in imports. It draws up the Annual Monitoring Plan for residues in imported consignments in accordance with the Ordinance on principles governing the organization of veterinary checks on products across the border (OG 132/08).[80]

74.  GMOs are subject to authorization, labelling, and traceability requirements.[81] A register and coding system was established in 2007 and requirements for the traceability and placement on the market of GMOs began in 2008. No labelling is required for products containing traces of GMOs below a 0.9% threshold, provided this is adventitious and technically unavoidable. GMO seeds have not been authorized in Croatia. The Veterinary Directorate draws up the Annual National Residue Monitoring Plan (NRMP) for detecting residues in live animals and animal products.[82] The use of certain beta-agonists and substances having a hormonal or thyrostatic action is prohibited in stock farming.[83]

75.  Quality requirements for specific food categories are regulated by specific regulations (e.g. beef, preserved tuna, milk products, and fruit juices) (Table III.6); while 23 categories of products (e.g. live animals, and products of animal origin) are subject to public and animal health controls by veterinary inspectors (Table III.7). According to the authorities, Croatia has 17 permanent and 9 temporary border veterinary inspection posts. These posts control and inspect live animals, products of animal origin, feed of animal origin, straw and hay, and other items through which contagious diseases may be transmitted or which endanger human and animal health. Animals are subject to veterinary control when imported or in transit and/or welfare control when exported. The border veterinary inspector is responsible for documentary checks as well as identification and physical checks. Imports of live animals or products of animal origin must be accompanied by international veterinary certificates for animal health and public health, indicating, inter alia, origin, destination, and mode of transport

76.  Veterinary and sanitary inspection requirements are identical for domestic products and imported. Imports may enter if they are from approved third-country establishments inscribed on a list established by the EU.[84] Imports may also, exceptionally, be approved from non-EU listed establishments if Croatian requirements are met (exceptions currently exist only for heat-treated milk from Bosnia and Herzegovina, FYR of Macedonia, and Serbia). Croatia has concluded bilateral veterinary agreements with Bosnia and Herzegovina, FYR of Macedonia, and Serbia on, inter alia, imports, transit of animal products, and exchange of information. The concept of regionalization (disease or pest-free zones) has not been introduced into Croatia's SPS regime. Table III.6 Legislation on products subject to quality control, 2009 Source: Information provided by the Croatian authorities. Table III.7 Products subject to sanitary measures, 2009 Source: Information provided by the Croatian authorities

77.  Certain categories of imported plants and plant products are subject to mandatory phytosanitary inspection at the border, where phytosanitary certificates are recognized according to the International Plant Protection Convention (IPPC) standards. In 2008, a plant passport was introduced to improve the internal movement of certain categories of plants and plant products and to align this with EU legislation.[85] Upon EU accession, plant passports issued in Croatia will be valid on the EU market and vice versa. Croatia had bilateral phytosanitary agreements to facilitate trade in plants/plant products with various recently acceded EU member states; due to their accession, these agreements no longer apply. Croatia has, however, import bans on several groups of plants, plant products, and other regulated objects.[86]

78.  Accreditation of laboratories concerned with SPS measures is undertaken by the Croatian Accreditation Agency. Croatia has approximately 48 laboratories under the purview of the Croatian Institute for Public Health, 8 of which have been accredited. The Croatian Veterinary Institute operates as a reference laboratory for the control of food of animal origin and control of animal diseases. For plant health, the analysis of pesticide residues is carried out by the pesticide department of the Croatian Institute for Public Health (reference laboratory).[87] Products are tested in the internal market and costs are covered by the state budget

79.  Establishments dealing with food of animal origin (including slaughterhouses, processing facilities, and animal feed factories) must be approved or registered at the Veterinary Directorate, and are subject to veterinary inspections and controls by the Veterinary Inspections Directorate. The adoption of the Food Act and the Veterinary Act has created preconditions for further alignment of Croatian legislation with the acquis in the placing on the market of food and feed. According to the authorities, the use of antibiotics in feed is aligned with EU rules. An animal passport, issued by the Croatian Agriculture Agency is required for the internal movement of bovine animals

80.  Croatia is a member of the Codex Alimentarius Commission, the World Organization for Animal Health (OIE), the World Health Organization (WHO), and the International Plant Protection Convention (IPPC)