Tunisia
1.2 Tunisia Regulatory Departments and Quality Control
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Although Tunisia has liberalized its import regime as part of its negotiations with the WTO, a number of restrictions still exist. Thus approximately 3% of goods require an import license (agricultural products, cars, textiles) issued by the Ministry of Commerce. There are also some quotas, notably for consumer goods that compete with local industry. In order to obtain these licenses, a certain number of documents are required, such as the commercial contract (or any other equivalent document), as well as information on contractors, products, origin and provenance. Licenses are in principle valid for 12 months from the decision of the Ministry of Commerce, which may however reduce this period for certain products (but it can never be less than 2 months). The license can be used partially. It is not transferable.

There is a general rate, ranging from 10% to 230%. Tunisia sometimes applies anti-dumping duties for which the bases and the reasons for application are not clearly defined and which can sometimes be considered as minimum prices for the calculation of customs duties.  

Pharmaceutical industry

The pharmaceutical industry is protected. All imports of pharmaceutical products are controlled by the Pharmacy Center (http://www.phct.com.tn/en).

The Tunisian Ministry of Health regulates pharmaceutical product and activities.  It ensures that any pharmaceutical product having the same pharmaceutical form and the same qualitative and quantitative composition in active ingredients as well as the reference product, and for which bioequivalence with the reference medicinal product, has been demonstrated by appropriate bioequivalence studies. The scientific criteria defining the exemption of bioequivalence studies are set by the decree law of the Ministry of Health. 

(Reference: Act N°2008-32 of 13 May 2008 amending and supplementing the law N°73-55 of 03/08/1973).

The different oral pharmaceutical forms with immediate release are considered as the same pharmaceutical form. Similarly, any salts, esters, ethers, isomers, mix of isomers, complexes or derivatives of the active ingredients are considered as having the same composition in active ingredient, except if they show significantly different properties regarding the safety or the efficacy. In such case, additional information providing proof of safety and efficacy of the different salts, esters or derivatives of the authorized active ingredient must be provided by the applicant for the marketing authorization (Reference: French Public Health Code).

Telecommunications

The telecommunications market regulatory agency is the Instance Nationale des Telecommunications (INT). It guarantees an environment conducive to investment by establishing healthy and fair competition between the various market players (operators and providers of telecommunications services). It has participated, since its creation by virtue of law n ° 2001-1 of January 15, 2001, promulgating the telecommunications code, as supplemented and modified by laws n ° 2002-46 of May 7, 2002 and n ° 2008- 01 of January 8, 2008, to promote the development of the telecommunications sector.

In accordance with the regulatory framework, INT examines disputes relating to the installation, operation and operation of networks and which relate to interconnection, local loop unbundling, physical co-location, common use of infrastructure and any other telecommunications service.

Requests relating to these disputes may be brought by the Minister in charge of telecommunications, network installers and operators, Internet service providers, legally established consumer organizations or groups as well as by professional organizations in the field of telecommunications. INT can also take action ex officio to rule on infringements of legislative and regulatory provisions in the field of telecommunications. In addition, INT manages the national plans relating to numbering and addressing, sets the conditions and modalities for activating number storage, in particular the procedures for introducing and using number portability. and sets the conditions and procedures for granting domain names. INT also ensures the economic regulation of the market, on the one hand, by approving operator offers relating to interconnection, national roaming agreements and any model contract relating to any service offer; on the other hand, by fixing the method for determining the costs of networks and services, the method for sharing the costs between the various services provided by each network operator as well as the methods adopted to determine the costs taken into account in the calculation interconnection tariffs, local loop unbundling, physical co-location and common use of infrastructure. In accordance with article 3 of decree n ° 2008-3026 of September 15, 2008 setting the general operating conditions of public telecommunications networks and access networks, INT issues an opinion on the notice advertising the tariffs of details of services before they are marketed. In addition, INT conducts monthly measurement campaigns and annual surveys to assess the quality of service of telecommunications networks and to monitor compliance by telecommunications operators with their obligations and commitments relating to quality of service. as stipulated in particular in their specifications.

Energy sector

The Ministry of Industry and Energy is in charge of the energy sector. The energy regulator is the National Agency for Energy Management. The state-owned Tunisian Company of Electricity and Gas (STEG) is the sole generator, transmitter and distributor of electric energy. On a regional level, Tunisia is a member of Committee Maghrebin de Electricity (COMELEC), the power pool of the Maghreb region. There are also interconnections with the European Electricity Grid to export up to 1,000 MW (800 MW gas and 200 MW Renewable Energy (RE)).

Fuel

In Tunisia, fuel is regulated by Ministry of Industry, Energy and Mining. There is an entry into vigor of the hydrocarbons code, the holders of prospecting permits or exploration permits in course of validity and/or exploitation concessions instituted but not yet developed, have the possibility to opt, with regard to the said permits and concessions, for the application of the present hydrocarbons code and the regulating texts taken for its application. The exercise of the option foreseen above shall be subject to a notification in writing prepared on tax stamped paper and signed by the holder of the permit and/or the exploitation concession or by a representative duly mandated to that effect.  Each hydrocarbons title shall be subject to a separate notification within a maximum period of six months as from the entry in vigor of the hydrocarbons code. This notification shall be addressed by registered mail with knowledge of receipt to be requested from the administration in charge of hydrocarbons or deposited directly at the said administration for a knowledge of receipt.

Failing to exercise the above-mentioned option by the holder of a hydrocarbon title, the said title shall remain governed till its expiry by the legislative and regulating provisions and by the particular convention applicable thereto.

Agricultural production

Agricultural products from Arab countries and North Africa benefit from preferential tariffs. The Food and Agricultural Import Regulations and Standards (FAIRS) report provides an overview of the food laws and regulatory environment in Tunisia as it relates to U.S. food and agricultural exports. In 2018, Tunisia expanded the list of imported agricultural and food products subject to required technical specifications in an effort to decrease import volumes overall. Meanwhile, Tunisia also appears poised to continue harmonizing its regulatory framework with the European Union.

Tunisia’s Food and Feed Safety Law was approved in early 2019 with the aim of harmonizing Tunisian legislation with EU food directives 178/2002, 852/2004, 853/2004, 183/2005, 882/204, and 854/2004. The creation of a one-stop shop national food safety authority is currently under way. While all current regulations will likely need to be reviewed for consistency with the new food safety law, Tunisia’s other relevant laws are as follows:

  • Law #92-72 (completed by Law #99-5) concerns the quarantine and phytosanitary requirements applied to unprocessed agricultural products of plant origin,
  • Law #99-24 sets the veterinary and sanitary controls of animals and animal products,
  • Law #99-42 (amended by Law #2000-66) sets the procedures for seeds and seedlings production, propagation, import, marketing and protection of the rights relating thereto,
  • Law #94-86 addresses market distribution channels and retail services, and
  • Law #92-117 concerns consumer protections.

Through the Ministry of Trade’s Decree #2016-503, Tunisia established a National Commission to ensure its compliance with WTO regulations and facilitate trade, which also coincided with Tunisia’s third WTO Trade Policy Review. The Ministry of Industry’s Order, issued on May 20, 1998, validated Tunisian standard NT 117-01 (1995) governs the use of food additives. The purpose of this standard is to give an exhaustive listing of authorized additives (positive list), their conditions of use as well as their respective identification E-numbers. This standard is largely based on European regulations (directive 94/35/EC on sweeteners for use in foodstuffs, directive 94/36/EC on colors for use in foodstuffs, and directive 95/2/EC on food additives other than colors and sweeteners).

For goods having a shelf-life of three months or more, the mention of the month and the year is sufficient.  For non-perishable goods, a time limit for optimum use must be indicated using one of the following sentences: ‘to be consumed preferably before.../to be consumed preferably before end of.../ to be consumed preferably within a period of...’ The use of a sticker to rectify or correct required information is prohibited; [Note: in practice, stickers are used by importers/retailers to include required information, e.g., Arabic]

The Ministry of Trade’s Order, dated September 3, 2008, is partially inspired by the European Union regulations of 2006 on the use of nutrition and health claims for foods. The Order sets forth the rules for health or nutritional claims (such as “low fat” and “helps lower cholesterol”) on foodstuffs based on nutrient profiles by means of positive lists of authorized claims that can be made on food. Health claims are prohibited on food intended for babies and children. Nutritional labeling of vitamins, minerals, and other nutrients is mandatory when a producer is making health or dietary claims on the label. This provision applies to fortified products and to food items intended for a particular use (e.g. infant formula). Otherwise, nutrition information is voluntary. If the nutritional content is declared on the label, it is mandatory to display the energetic value, protein, carbohydrates (food fibers excluded), and lipids, and the quantity of any other nutritional element subject to a nutritional claim. The quantity of protein shall be calculated according to the following formula: Protein = total nitrogen (kjeldhal) x 6.25. The quantity of energy must be calculated using the following coefficients:

Carbohydrates

4 Kcal/g-17KJ

Polyalcohol

2.4 Kcal/g-10KJ/g

Protein

4 Kcal/g-17KJ

Lipid

9 Kcal/g-37KJ

Alcohol (ethanol)

7 Kcal/g-29KJ

Organic acid

3 Kcal/g/13KJ

Transportation

In accordance with Decree No. 2014-209 of January 16, 2014, the mission of the Ministry of Transport is to establish, maintain and develop a comprehensive, integrated and coordinated transport system in Tunisia that contributes to promoting sustainable economic and social development and ensures the satisfaction of needs of people in transport in the best possible conditions, in particular in terms of safety, security, cost, quality and environmental protection. The logistics infrastructures system includes land, sea and air transport and traffic, logistics, vehicle rental and meteorology. To carry out its mission, the ministry is responsible for defining general policy, plans and programs in the field of transport and monitoring their execution, notably by exercising the following powers:

  • develop and implement state policy in the areas of its competence and propose and monitor the execution of qualitative and quantitative objectives and the investment programs to be carried out within the framework of development plans;
  • to give an opinion on regional development plans and urban and retail development plans, on regional development programs and on infrastructure projects relating to the areas of its competence and to take them into account in transportation;
  • carry out sectoral research and prospective studies, implement strategies for the development and modernization of the transport system, draw up transport master plans in coordination with the parties concerned and ensure their implementation;
  • ensure the development of human resources in the field of transport by promoting training and professional learning, work in collaboration with the parties concerned to meet the growing need for specialized managers and set up evaluation and followed;
  • draw up programs and plans relating to transport safety and the quality of services and ensure their implementation;
  • oversee the development and monitoring of the implementation of the national civil aviation security program and participate in the development and monitoring of the implementation of government programs in the security of commercial seaports and maritime transport;
  • participate in the development of tax policy in the areas of its competence;
  • study and follow up on legal matters and prepare draft legislative and regulatory texts relating to the fields of its competence;
  • participate in the development and execution of programs to control energy consumption, use alternative energy and protect the environment, in collaboration with the ministries, professionals and organizations concerned;
  • develop the statistical system relating to the fields of its competence;
  • develop international cooperation programs in the fields of its competence, in coordination with the bodies concerned and consolidate relations with international and regional institutions and bodies dealing with matters falling within the competence of the ministry and participate in bilateral or multilateral international negotiations;
  • develop the information and communication function in the fields of its competence, in collaboration with the bodies concerned and consolidate relations and coordination with civil associations and national organizations having a relationship with the fields of its competence.


For information on Tunisia Regulatory departments contact details, please see the following links: 4.1 Tunisia Government Contact List and 4.3 Tunisia Regulatory Departments and Quality Control Contact List.

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