Today's text is important primarily for importers and manufacturers of the chemicals from the Republic of Srpska, but also for other persons who place chemicals on the market in the Republic of Srpska.
The Ministry of Health and Social Welfare of the Republic of Srpska has prepared a draft of the Rulebook on amendments to the Rulebook on the Inventory of Chemicals.
Below you can find an overview of the basic proposed changes.
The main differences relate to the type of entry of chemicals into the Inventory of Chemicals, as well as the conditions for grouping certain chemicals within a single submission to the Inventory of Chemicals.
In accordance with the proposed changes, all chemicals intended for industrial, professional or institutional use, regardless of whether they are classified as hazardous or not, are to be entered in the Inventory of Chemicals according to the registration procedure. Under the current rulebook, industrial chemicals that are not classified as hazardous are entered into the Inventory of Chemicals according to the notification procedure.
Additionally, a chemical that is used for both general and professional use, according to the planned changes, is to be entered into the Inventory of Chemicals according to the registration procedure. Until now, such a chemical was entered into the Inventory of Chemicals according to the notification procedure.
Bearing in mind that the registration fee is 200 BAM (ca. 100 EUR) and the notification fee is 50 KM (ca. 25 EUR), changing the type of entry into the Inventory for a large group of chemicals represents significantly increased costs for chemical manufacturers and importers.
Another novelty is the obligation to enter into the Inventory of Chemicals the active substances that are manufactured or imported exclusively for the production of biocidal products. So far, these substances have been registered according to biocides regulations.
When it comes to the conditions for grouping, there are also changes planned.
Within one notification it is possible to group chemicals that have a similar composition, the same classification and the same intended use. A similar composition, as defined by the changes, implies differences in up to two ingredients such as pigments or additives. This means that if you have a group of laundry detergents, you will not be able to group them if they differ in more than two substances, such as fragrances, which is common.
Until now, the requirement for grouping chemicals within one notification was strictly the same intended use. This means that the number of chemicals that you can group within a single notification is reduced, which certainly affects costs.
If, according to the current procedure, you entered into the Inventory of Chemicals three chemicals that were grouped within one notification, the fee for this procedure was 70 BAM (ca. 35 EUR). If, according to the planned changes, these chemicals no longer meet the grouping requirements and must be entered into the Inventory in separate procedures, through three separate notifications, the fee for these procedures is 50 BAM (ca. 25 EUR) each, or a total of 150 BAM (ca. 75 EUR) for three chemicals.
The conditions for grouping chemicals within one registration remain the same. In this case, differences in composition are tolerated for substances that do not determine the classification of the chemical, which now is not the case for the notification. Therefore, the conditions for grouping chemicals for registration under the proposed changes are milder than the grouping conditions within the notification procedure.
Changes are also foreseen for the number of chemicals that may be included in a single submission (notification or request). That number, instead of the previous 20, now stands at 10 chemicals.
Another important change concerns the volume of documentation provided in the process of entering a chemical into the Inventory of Chemicals. According to the proposed changes, in addition to the previously prescribed documentation, it is necessary to submit:
- REACH statement on compliance for the imported chemicals,
- label of a foreign manufacturer if the chemical is imported,
- proof of fulfillment of the conditions prescribed for notes related to the identification, classification and labelling of substances and mixtures,
- comparative representation of the composition of the chemicals for which accession to the group is sought.
However, the chemical card, which is currently mandatory for all chemicals classified as hazardous, is now only mandatory for chemicals for professional use imported in "transport packaging".
In accordance to the changes, new forms for notification, request and dossier on chemicals have been prepared.
Changes to this rulebook are accompanied by the Rulebook on changes to the Rulebook on the amount of fees pertaining to the chemicals.
The proposed changes relate to the amount of fees with regards to multicomponent chemicals. According to the procedure so far, multicomponent chemicals were treated as a unique chemical, and the procedure fee was 50 BAM (ca. 25 EUR) for notification, or 200 BAM (ca. 100 EUR) for registration.
According to the planned changes, each component in such chemicals will be observed individually, and the fee for certain procedures will be increased by 20% of the basic amount of the fee for each additional component. For example, for the notification of a two-component chemical, instead of 50 BAM (ca. 25 EUR) you will have to pay 60 BAM (ca. 30 EUR), while you will have to pay 240 BAM (ca. 120 EUR) for registration instead of the previous 200 BAM (ca. 100 EUR).
Both rulebooks in the form of a pre-draft are available on the web page of the Ministry of Health and Social Welfare, in the section Drafts, and you can submit comments to the Ministry.
I hope that this text has helped you to prepare in time for the upcoming changes to the procedure for entering chemicals into the Inventory of Chemicals.
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