Based on the Rules of Procedure of the Government of the Republic of Serbia, regulators are required to attach their statement on harmonization with EU legislation to the draft regulation. The statement includes the assessment of the harmonization status of the draft regulation with relevant EU regulations, or, if there are no such regulations in the EU, the statement to that fact. This does not mean the obligation of complete harmonization with EU regulations. When economic and technical conditions are such to disable complete harmonization, it can be done at a later date. Or, being harmonized with EU legislation, it does not mean that the regulation meets the effectiveness criteria. In the first place, the solutions incorporated in the regulation can have alternatives that are also harmonized with the relevant EU legal act but in a way that those options are more favorable considering their total effects. Secondly, the level of regulatory harmonization with such sources (completely harmonized, partially harmonized, not harmonized) includes also the options needed to be considered and assessed, as well as the effects of the timeframe required for harmonization.
In situations when RIA is produced for a regulation relating to EU accession process, regulators may consider without purpose because the solutions are predetermined by the need to comply with acquis communautaire. This is not correct in the majority of cases. The reason is that EU can regulate something by regulations and by directives.
A regulation has to be adopted in total and with no amendments by member states and has to be implemented in cases where uniformity is necessary for achieving specific objectives. A directive is by far more flexible. Member states are obliged to incorporate “basic requirements” in their legislation; however, they are free to decide in what way they will achieve the objective. It gives them significant flexibility in implementation, thus influencing the resulting effects. Therefore, RIA is important to assess the best way to implement an EU directive. Even in cases like Serbia, a future candidate country, when the country has no alternatives, RIA still can be very important for the assessment of implementation effects.