New Law on Technical Requirements for Products and Conformity Assessment was published in the Official Gazette no. 49/2021 and entered into force on 22 May 2021 (“LTR“).

On the day of entry into force of the LTR, the Law on Technical Requirements for Products and Conformity Assessment ceased to be valid (Official Gazette of RS no. 36/09) and the Rulebook on the content of form that contains the list of Serbian standards referred to in the technical regulation (Official Gazette of RS no. 110/09 and 14/12).

Application of LTR

In terms of application and relation with other laws, it should be noted that the LTR is an “umbrella” law for prescribing technical requirements, whereas technical regulations may also be drafted and enacted on basis of special (sectoral) laws, all with a view to ensuring safety of products placed on the market.

With regard to the application of LTR, the following should be noted:

• LTR applies to all products, except for those that are subject to special laws and regulations enacted on basis of such laws.
• If technical requirements for certain products are not at all prescribed by a special regulation, the LTR shall apply to product safety in the market and during use.
• If technical requirements for certain products are prescribed on basis of special laws and regulations enacted on basis of such laws, while such laws and regulations do not regulate individual issues that are regulated by LTR, such issues shall be subject to the provisions of LTR.
• The LTR provides a wide definition of product as any object, material or result of a process, obtained regardless of the degree of processing and intended for delivery to the market, whether it is new or used, which also influences its scope of application.

Technical regulations and standards

Technical requirements are established by technical regulations, directly or indirectly, and in case of the latter it is done by referring to standards. In such case, standards, whose application is usually voluntary in accordance with the Law on Standardisation, become mandatory.

Therefore, when technical regulation does not refer to a standard, the fulfillment of technical requirements from such standard improves product quality but it the producer is not obligated to apply it.

On the other hand, technical requirements are prescribed as mandatory only when it is necessary for product safety, while ensuring that the establishment of technical standards is not an obstacle to trade.

Technical regulation may stipulate the assumption that a product is in conformity with the prescribed technical requirements if it is harmonised with relevant Serbian standards that transpose the harmonised standards or, if there are no such standards in a specific area, with other relevant standards or technical specifications in the field (conformity assumption).

Technical regulation also stipulates the types of conformity documents that producer, representative or importer shall prepare or ensure of a product before its placement in the market or its use.

Conformity mark

Serbian conformity mark corresponding to CE mark that confirms that a product is in conformity with the applicable requirements of harmonised EU legislation, is lifted up to the level of legal category unlike the previous law when it was regulated by a by-law.

The LTR stipulates that a product conformed to technical requirements of a Serbian technical regulation shall be marked with Serbian conformity mark if this is provided under the technical regulation. A product that is not conformed to a technical regulation/product that is not subject to marking with a Serbian conformity mark, may not be marked with such mark.

Please be reminded that Serbian conformity mark is made of three capital A’s linked in form of an equilateral triangle.

Conformity assessment

Depending on the group of products and dangers that a product may impose, alike the previous law the LTR stipulates different entities that may conduct conformity assessment procedures, namely:

• manufacturer
• appointed/notified body for conformity assessment (laboratory, control or certifying body)
• state (public administration body) – for products that imply the highest risk.

With a view to reducing the cost for manufacturers, the state is slowly withdrawing from its role of conformity assessment authority (e.g. with many technical products). This practically means that a manufacturer individually assesses conformity of his product with the requirements from a technical regulation, prepares a conformity declaration and ensures appropriate technical documentation.

In a technical regulation that transposes the harmonised EU legislation, if certain conformity assessment activities are performed by an accredited body of a manufacturer, such body needs to be organised as a separate organisational unit and must not participate in the making, delivery, installation, use or maintenance of products whose conformity it assesses and it may render services exclusively to the manufacturer that it is a part of.

When it comes to conformity assessment bodies, a novelty introduced by the LTR is that the decisions on their appointment may not be time-limited or limited by deferral or termination.

When provided by technical regulation, a public administration body may assign certain conformity assessment activities to a certified, approved or other conformity assessment body.

General requirement

There is a general requirement for products delivered to the market and put in use to meet the requirements of all technical regulations applying to such products. In relation thereto, the LTR also regulates the responsibility of suppliers (manufacturer, representative, importer, distributor) for conformity of products supplied to the market, depending on their role in the chain of supply, as well as for accuracy and completeness of the information provided regarding the products supplied to the market.

All the while, the responsibility does not only include placement of the product on the market but also all stages in the chain of supply, therefore a product is under supervision during the chain of supply as well as in use.

Therefore, before delivery of products to the domestic market, suppliers need to establish which technical requirements must be met by such product according to the technical regulation of the Republic of Serbia currently in force so as to be legally traded. If such regulation refers to a standard, the text of standard also needs to be provided from the Serbian Institute for Standardisation. Product conformity with technical standards is controlled by several public administration bodies, including market inspection.

Compared to the previous law, the obligations of suppliers are now more general and numerous and the law allows for their more detailed specification in technical regulation, according to the needs of individual manufacturing sectors:

• The role of the manufacturer is by far the most important as he is responsible for design and manufacturing of a product, which means that his obligations are also the largest. It is envisaged that a manufacturer may, by written authorisation, transfer his obligations to a representative, except for the obligation to ensure that a product placed in the market is designed and made in accordance with the prescribed requirements, or preparation of technical documentation.
• Since importers are also the entities placing products in the market, and that the products from other countries, their responsibilities and obligations largely correspond to those of manufacturers.
• The obligations of distributors are, among other, to act conscientiously with regard to the prescribed requirements for products in order to ensure that all products they supply to the market abide by such requirements.

In accordance with the Decision 768/2008/EC, suppliers shall be obliged to keep and upon request of the relevant inspector to provide the information on all suppliers that they provided the products from, as well as all suppliers to which they supplied products. The period of keeping such data is established by a technical regulation and, if there is none specified, such period is ten years after the date of supply.

Inspection during trade age

The LTR stipulates that the owner of the product for which technical regulation establishes an obligation for inspection to ensure product conformity during trade age, may put such product in use or enable the use of the product only if the prescribed inspection has been performed so as to ensure its conformity. It is envisaged that such inspection may be done by appointed or accredited bodies for conformity assessment or public administration bodies.

According to the elaboration of the LTR proposal, such obligation was established in order to transpose certain EU directives in full, e.g. for elevators or pressure equipment.

Complex product

A novelty compared to the previous law is also the provision prescribing that, if a technical regulation applies to a complex product/facility, such regulation may stipulate an obligation for the owner to keep the prescribed documentation and to prove conformity in case of reasonable conformity doubts.

According to the elaboration of the LTR proposal, this provision is necessary to ensure the full application of provisions from certain European directives that are somewhat applied to facilities, such as e.g. the directive in the area of electromagnetic compatibility.

Validity of foreign conformity documents

A conformity document issued by a foreign conformity assessment authority is valid in the Republic of Serbia if it was issued in accordance with ratified international agreements that the Republic of Serbia is a signatory to.

In addition, the responsible minister may issue a decision on recognition of validity of a foreign conformity document, whereas the LTR establishes the conditions under which that may be done.

Application of certain provisions of the previous law

Although the LTR repeals the previous law, until the adoption of technical and other regulations based on LTR, technical and other regulations enacted on basis of the Law on Technical Requirements for Products and Conformity Assessment shall apply (Official Gazette of RS no. 36/09).

It is also envisaged that the conformity assessment bodies that were appointed, authorised and/or accredited until entry into force of the LTR shall continue to work until the adoption of technical regulations that establish the requirements for the appointed conformity assessment bodies.

This article is to be considered as exclusively informative, with no intention to provide legal advice. If you should need additional information, please contact us directly.