A company manufactures 1 product, that is sold to 3 different suppliers.
Each supplier markets the product under a different trade name, tailored to the market and circumstances.
This raises a logical question, one that the manufacturer who contacted me also asked:
"Which of these names should I use in the ISK application and which in the PCN notification? Can I split them (half and half) to avoid revealing that it's the same product?"
First, let’s examine the difference between an ISK application and a PCN notification, and what this means for registering a product with different trade names:
- An ISK application is a Slovenian national submission for hazardous products that are either manufactured or imported into Slovenia, including those imported for direct use in local production. The ISK application is valid only in Slovenia, and the information is accessible to the Chemicals Office and the Slovenian Poison Control Center.
The legal basis for ISK applications is the Chemicals Data Reporting Policy.
In the ISK, you must register every trade name of a hazardous product that is placed on the Slovenian market. Therefore, if a product has multiple trade names, all trade names used in Slovenia must be registered, whether they are produced locally or imported.
- The PCN notification, on the other hand, is a European procedure through which a company submits information about a hazardous mixture to a unified European database of poison control centers. The PCN notification can be carried out for one or more countries, or for the entire European Economic Area. The information is accessible to the relevant authorities in each country and to the poison control centers in the countries where the PCN notification was made.
The legal basis for PCN notification is Article 45 of Regulation No. 1272/2008 (CLP).
The PCN notification is based on the product's composition and, like the ISK application, must include all trade names under which the product is marketed.
Based on this information, you can probably deduce what our advice to the manufacturer was...
The advice was simple but specific.
For the ISK application, the manufacturer must, in accordance with the law, separately register each trade name under which the product is marketed in Slovenia. Since there were 3 trade names, 3 separate ISK applications were required.
Due to the identical composition of the product, only 1 PCN notification should be made, including all 3 trade names and all EEA countries where the product will be marketed.
When registering hazardous products, it’s essential to follow both national (ISK applications) and European (PCN notifications) legislation. Proper use of trade names and compliance with both national and European regulations ensure appropriate market treatment of products and enable effective action in case of accidents or other hazardous situations.
If you still have doubts, feel free to email me at spela.hudobivnik@bens-consulting.eu, and I will gladly answer any questions you may have.