Chemicals Registry

Registration of chemicals into the Registry is responsibility of the Chemical Department based in the ministry competent for environmental protection matters. 

Chemicals Registry is a part of the Integrated Chemicals Registry, which is maintained as electronic database. In addition to chemicals, the Integrated Chemicals Registry also contains data about biocidal products and plant protection products. 

However, companies submit data directly only for the Chemicals Registry pursuant to the Law on Chemicals (Official Gazette of RS, no.  36/09, 88/10, 92/11, 93/12 and 25/15) (hereinafter referred to as: the Law) and Rulebook on Chemicals Registry (Official Gazette of RS, no. 100/11, 16/12, 47/12, 115/13 and 1/15) (hereinafter referred to as: the Rulebook).

Application for registration of chemicals must be submitted by 31 March of the current year for data referring to the previous one. The Application is accompanied by the "Chemical Dossier" for each and every chemical on the prescribed template, and if such chemical must be followed by Safety Data Sheet, the SDS in Serbian language shall also be submitted. Upon the check of the submitted data completeness, if all relevant conditions have been fulfilled, the Ministry shall issue a decision.

The Law has identified substances which are not subject to the obligation for registration into the Registry:

1. Chemicals completely exempted from the Law: radioactive chemicals, chemicals in transit, chemicals in transport, chemicals which are deemed waste, chemicals under customs' supervision or in free zones, provided they are not processed there;
2. Chemicals to which certain provisions of the Law apply, but not those provisions which pertain to registration of chemicals into the Registry, and these include chemicals that are placed on the market in their final form as: biocidal products, plant protection products, medications and medical aids used in human and veterinary medicine, cosmetics, food, food additives and flavours, feed and feed additives.

In addition, the Rulebook prescribes that chemicals that are placed on the market in small quantities, i.e. quantities not exceeding 100 kilograms per year, shall also be exempted from the registration obligation.

Starting from 1 January 2016, provisions of the Law and Rulebook which had not been in place by then shall start to apply, as well as those that entered into force by virtue of the latest amendments and supplements made to the Law (Official Gazette of RS, no. 25/15) and Rulebook (Official Gazette of RS, no. 1/15), which pertain to substances of very high concern (SVHC), as well as mixtures containing those substances; the list of those substances has been included in the List of Substances of  Very High Concern (Official Gazette of RS, no. 94/13). 

The so far obligations of registration of chemicals pertained only to producers, importers and downstream users who produce or import chemicals, and now the obligations have extended also to downstream users who use substances of very high concern and/or mixtures containing such substances. In addition, and for the first time, specific attention has been paid to articles containing these substances. 

Taking into account that SVHCs impose high risk, and that the goal is to replace them by safer alternatives, it has been prescribed that more data is required for these substances compared to other chemicals. Accordingly, while for all other chemicals data is submitted on standard template (in use for five years), the "Chemical Dossier" from Appendix 4 of the Rulebook - containing six chapters (or, possibly under specific conditions "Dossier for chemical already registered in the Registry" from Appendix 5 of the Rulebook), the template submitted for these chemicals shall be "Chemical Dossier for SVHC, and/or mixture containing SVHC" from Appendix 6 of the Rulebook, which comprises eight chapters.       

All the aforementioned is aimed at the same: knowledge and awareness raising about chemicals, especially about substances of very high concern, since these are the so-called "the most dangerous of the most dangerous ones", replacement thereof by safer alternatives, definition of risk reduction measures, achievement of safer chemicals management, all with the aim to achieve overall safety, but also for the sake of adequate business planning (export to the EU in particular).