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.

Use of Accreditation for the Purpose of Designation and/or Authorisation of CABs in the Republic of Serbia

USE OF ACCREDITATION FOR THE PURPOSE OF DESIGNATION AND/OR AUTHORISATION IN THE REPUBLIC OF SERBIA

1. Use of accreditation for the purpose designation and/or authorisation of conformity assessment bodies (CABs) or technical evaluation of products as stipulated in technical legislation (regulations transposing the New Approach Directives of the European Union or other technical regulations adopted to safeguard human safety, life and health, animal and plant safety, environmental safety, consumer safety and other users, and property safety) is laid down in the Law on Technical Requirements for Products and Conformity Assessment (“Official Gazette of the Republic of Serbia”, No. 36/09). Article 19 of the said Law prescribes that in case of issuing decisions on designation/authorisation it shall be deemed that CABs that are in the possession of accreditation certificates meet the prescribed requirements as defined in the scope of accreditation. Moreover, conformity assessment procedures and products covered by accreditation will be taken into consideration.

When a technical regulation prescribes that conformity assessment shall be performed by a designated conformity assessment body, a decision on the designation thereof shall be made by a minister in charge if the conformity assessment body, that submitted the application for designation, meets the requirements of the technical regulation, whereas the minister in charge shall also take into consideration the accreditation certificate that the conformity assessment body acquired in the course of the accreditation procedure.

The Decree on the Mode of Designation and Authorisation of Conformity Assessment Bodies (“Official Gazette of the Republic of Serbia”, No. 98/09)* prescribes that fulfilment of designation/authorisation requirements as per the technical regulation shall be determined by a committee that shall, in case of one or more technical regulations, be established by the minister in charge. The said committee shall be composed of at least the following members: one representative of the ministry in charge, one representative of the Accreditation Body of Serbia, that did not participate in the accreditation procedure, and one representative of the Institute for Standardization of Serbia.

Moreover, in the Republic of Serbia accreditation is required on the occasion of authorisation to perform measuring, testing, inspection or certification activities and in other fields to which technical legislation does not necessarily pertain (e.g. Law on Veterinary Matters, Law on Ethanol, Law on Food Safety, Law on Plant Health Products, GI Law, Law on Chemicals, Law on Organic Products, Law on Rakia and Other Alcoholic Beverages, Animal Husbandry Law, Law on Seeds, Law on Waste Management, Law on Waters, Law on the Protection Against Ionising Radiation and Nuclear Safety, Environmental Protection Law, Law on Air Protection, Regulation on the Quality of Raw Milk, Regulation on the Conditions to Be Met by Legal Entities Performing Testing of Radiation Levels of Non-ionising Sources Having Special Importance to the Environment, Regulation on the Conditions to be Met by Technical Organisations Performing Waste Testing, Regulation on the Conditions to be Met by Technical Organisations Performing Noise Measurement Activities,...).

2. Following the Stabilisation and Accession Agreement that was signed on 29.04.2008 and in order to be able to harmonise its regulations with those of the EU, the Republic of Serbia transposed the following New Approach Directives and adopted the following technical regulations:

- Lifts (Directive 2014/33/EU) - Lift Safety Regulation (“Official Gazette of the Republic of Serbia”, No. 15/2017);

- Machinery (Directive 2009/127/EC, 2006/42/EC) -  Machinery Safety Regulation (“Official Gazette of the Republic of Serbia”, No. 58/2016);

- Electromagnetic Compatibility (Directive Directive 2014/30/EU) - Electromagnetic Compability Regulation (“Official Gazette of the Republic of Serbia”, No. 25/2016);

- Electrical Equipment Designed for Use within Certain Voltage Limits (Directive 2014/35/EU) - Regulation on Electrical Equipment Designed for Use within Certain Voltage Limits (“Official Gazette of the Republic of Serbia”, No. 25/2016);

- Personal Protection Equipment (Directive 89/686/EEC) - Personal Protection Equipment Regulation (“Official Gazette of the Republic of Serbia”, No. 100/2011);

- Simple Pressure Vessels (Directive 2009/105/ЕС) - Regulation on Technical Requirements for the Design, Manufacture and Conformity Assessment of Simple Pressure Vessels (“Official Gazette of the Republic of Serbia”, No. 87/2011);

- Pressure Equipment (Directive 97/23/EC) - Regulation on Technical Requirements for the Design, Manufacture and Conformity Assessment of Pressure Equipment (“Official Gazette of the Republic of Serbia”, No. 87/2011);

- Radio and Telecommunications Terminal Equipment (Directive 1999/5/EC) - Regulation on Radio and Telecommunications Terminal Equipment (“Official Gazette of the Republic of Serbia”, No. 11/2012);

- Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres (Directive 2014/34/EU) - Regulation on Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres (“Official Gazette of the Republic of Serbia”, No. 10/17);

- Noise Emission by Equipment for Use Outdoors (Directive 2000/14/EC) - Regulation on Noise Emission by Equipment for Use Outdoors (“Official Gazette of the Republic of Serbia”, No. 1/13);

- Non-automatic Weighing Instruments (Directive 2009/23/EC) - Regulation on Metrological Conditions for Non-automatic Weighing Instruments (“Official Gazette of the Republic of Serbia”, No. 17/13);

- Measuring Instruments (Directive 2004/22/EC) - Regulation on Measuring Instruments (“Official Gazette of the Republic of Serbia”, No. 63/13, 95/16);

- Transportable Pressure Equipment (Directive 2010/35/EU) - Regulation on transportable pressure equipment ("Official Gazett of the Republic of Serbia");

- Gas appliances (Directive 2009/142/EC) - Regulation on Requirements for the Design, Manufacture and Conformity Assessment of Gas Appliances (“Official Gazette of the Republic of Serbia”, No. 41/2015).

In order to be able to harmonise its technical legislation with that of the EU the Republic of Serbia is currently performing activities related to the transposition of the remaining New Approach Directives and EU legislation for the purpose of harmonising and drafting relevant regulations.

3. Ever since the Republic of Serbia initiated the process of CAB designation/authorisation in 2010 in line with the Law on Technical Requirements for Products and Conformity Assessment, accreditation was up until now the key and practically the only element of the CAB designation/authorisation procedure when decisions on designation/authorisation were issued by the ministers in charge, although it was not the only way to determine CAB competence.

Article 9 of the Regulation on the Mode of Designation and Authorisation of Conformity Assessment Bodies (Official Gazette of the Republic of Serbia No. 98/2009) prescribes that a Directory of Designated/Authorised Conformity Assessment Bodies shall be kept.

The said Directory is available at: http://www.tehnis.privreda.gov.rs. Data on accredited and authorised CABs from other fields can be found on websites of the respective ministries.

* 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.

 

 

New EU Legal Framework

New Package of measures for enhancing trade of products, published in the Official Journal of the European Union (L218 Volume 51, 13.08.2008), include: 

- Decision No. 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on common framework for the marketing of products, and repealing Council Decision 93/465 EEC,
- Regulation (EC) No. 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93, and
- Regulation (EC) No. 764/2008 of the European Parliament and of the Council of 9 July 2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State and repealing Decision No 3052/95/EC.

Decision No. 768/2008/EC provides a legal framework and observance of principles of future harmonisation of sectoral legislation and technical requirements for specific products, obligations of manufacturers, authorised representatives, importers or distributers, and conformity assessment procedures and modules, rules and conditions for the use of CE marking, requirements for authorisation (designation/notification) of bodies to assess the conformance of products with all the requirements from specific EU directives, criteria to be met by national notification bodies, and the rules for notifying the EU Commission thereof.

Regulation (EC) No. 765/2008 establishes for the first time a common legal framework for the provision of accreditation services across Europe. The Regulation covers the operation of accreditation in support of voluntary conformity assessment as well as conformity assessment required by legislation. Under the Regulation, EU Member States are required to appoint a single national accreditation body for these activities. In order to reach a higher level of consistency as regards the performance of accreditation services in Europe, this Regulation defines general requirements for national accreditation bodies the operation of which is supervised by the competent authorities in the EU Member States. Thus, the national accreditation bodies shall:

  • be independent from the conformity assessment bodies they accredit,
  • be objective and impartial,
  • have competent staff,
  • operate on a non-profit basis,
  • refrain from providing services provided by CABs,
  • not be in competition with other national accreditation bodies.

Furthermore, this Regulation prescribes that the European co-operation for Accreditation (EA) has been established as the official European accreditation infrastructure. National accreditation bodies must become EA members and participate in the peer evaluation process carried out by the EA to confirm conformance with the legal requirements. With that end in view Article 5 of the Law on Accreditation (Official Gazette of the RS No. 73/2010) prescribes that “The Accreditation Body of Serbia is the sole accreditation body in the Republic of Serbia that is hereby delegated the performance of the accreditation activities”.

Rules and procedures applied by the competent authorities when making decisions that can limit the free trade in products lawfully marketed in another Member State are laid down in Regulation (EC) No. 764/2008.

Mutual recognition principle implies the following: products lawfully marketed in one Member State cannot be prevented from entering the market of another Member State due to differences in national regulations. The only exception that is allowed refers to general interest such as health, consumers or environment and therefore implies strict observance of the requirements of Regulation (EC) No. 764/2008.