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Accreditation and Notification

Technical regulations governing quality infrastructure (standardisation, metrology, accreditation and conformity assessment) pertain to all products or what is known colloquially as “from A to Z“. They comprise the so called harmonised area. Harmonised area is based on the “Old Approach” Directives (containing detailed product specifications) or “New Approach/Global Approach” Directives (containing general or essential requirements for products and labelling of products before they are placed on the market). The “Old Approach” Directives prescribe technical requirements for products such as pharmaceutical and medical products, cosmetic products, chemicals, wood, textile, motor vehicles, glass, footwear, etc., whereas the “New Approach” Directives prescribe requirements for products such as electronic/electrical products, pressure equipment, lifts, machinery, cableways, marine equipment, toys, construction products, personal protective equipment, medical devices, etc.

Until 1985 technical legislation of the EU Member States was being harmonised through transposition of the so-called Old Approach Directives. Today there are about seven hundred of these directives. States had an interest to keep the competence in assessing conformance of such products with the requirements to be met as states issue certificates to guarantee their safety. Unlike the Old Approach Directives, New Approach directives/regulations where the state allowed, due to a lower level of risk, the private sector to assess conformance of these products with the requirements of the directives.

On the other hand, it is important to tackle the existence of non-harmonised area that imply national legislation of the Member States. The said legislation governs products that are legally produced and placed on the market in one Member State and then be freely moved within the EU common market. The mutual recognition principle is applied thereto as it derives from the European Court of Justice’s judiciary practice. These regulations can also be part of the accession negotiations.

Establishment of a modern quality infrastructure (QI) in the Republic of Serbia is crucial to the functioning of the internal market, and it is a prerequisite for marketing of safe goods and services, strengthening of consumer protection and upgrade of competitiveness and export potentials of Serbia. The Serbian QI system is based on four umbrella laws: Law on Accreditation, Law on Standardization, Law on Metrology and Law on Technical Requirements for Products and Conformity Assessment. The said laws contribute to better functioning of all important QI institutions. All four laws introduced new solutions from the new package of the EU measures for enhancing trade of products in order to gradually eliminate technical barriers to trade in accordance with the EU and WTO requirements, and to ensure, at the same time, safety of products.

For the purpose of EU membership the Republic of Serbia adopted the new legislative framework and thus, in addition to “authorisation” of conformity assessment bodies (CABs) as the "Old Approach" characteristic, the terms “designated body” and “designation” were introduced for the first time into our legal system (“New Approach”). In case of the authorisation that applies in case of the most sensitive products conformity assessment bodies are authorised by the state only to perform technical assessment of product conformity, while the state issues the appropriate certificate of conformity which confirms that the product complies with the technical requirements. This means that the state is ultimately responsible. The latter case (“New Approach”) indicates that the state designates CABs that are free to operate on the market, whereas a producer can choose one of them - in this case the chosen CAB shall issue a certificate and take responsibility. This solution enables a boost in CAB competitiveness, and a chance for producers to make their own choice thereof.

The Accreditation Body of Serbia (ATS) issues an accreditation certificate after it has assessed the competence of a CAB and its ability to meet the requirements of a standard, whereby the CAB which submitted application for designation proves its competence. Respective ministries are responsible for the designation of CABs (“New Approach”) within their area of competence. It should be emphasised that the Ministry of economy has a coordinating role as it keeps the directories of all technical regulations and their notification to the EU and WTO and keeps the industry and market inspection informed thereof.

The internal market cannot function properly without complete application of the EU legislation in this field as from the date of the EU accession. Therefore, EU expects from candidate countries to harmonise their legislation in this field by the date of their accession at the latest. European legislation in this field is completely transposed into the national legislation by transposing numerous “Old Approach” and “New Approach” directives. When it comes to “non-harmonised” products national legislation governing the marketing thereof vary from Member State to Member State and the said legislation must not contain the provisions that additionally hinder placing of foreign products on the market. The said regulations have to be in line with Articles 34-36 of the Treaty on the Functioning of the European Union (TFEU) and mutual recognition principle in order to be able to eliminate technical barriers to trade.

It is necessary for candidate countries to ensure, in addition to the transposition of the EU legislation into the national legislation in this field, unhindered enforcement and adequate application of the EU Acquis in the course of the negotiation procedure. This requires existence of administrative capacities enabling provision of information about the trade limitations and application of horizontal and procedural measures in the fields such as standardization, conformity assessment, accreditation, metrology and market surveillance.

Finalisation of negotiations in this field will ensure complete conformance of national legislation with that of the EU pertaining to products. Complete conformance of national legislation with that of the EU will ensure observance of one of fundamental freedoms of the common market – free movement of goods. This principle implies that trade in products from one part of the European Union in another part thereof must be performed without limitations. Hence the Serbian products will move through the EU market without any barriers. Serbia will become a part of the internal market on the date of its accession to EU where equal rules apply for all products from the Member States. Free movement of goods will enable high quality Serbian products to be placed on the EU market, whereas at the same time high quality EU products will be placed on the Serbian market. Certificates that are issued in Serbia will be recognised by all Member States, whereby the Serbian products will freely access the EU market and Serbian producers will not need to have the products retested when placing thereof on the EU market and this will effect the reduction of costs. Surveillance procedure will be harmonised with respective EU bodies when placing products on the market for the purpose of achieving consumer and health protection, and increased level of safety of products. Moreover, detailed information about each product will be made available to local consumers. The DG Internal Market, Industry, Entrepreneurship and SMEs (GROW), as one of the departments of the European Commission, is responsible for this field at the EU level.

*Please note that the term "designation" is used in the Republic in Serbia to denote "notification" given that Serbia is not an EU Member State.