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.