Have you, as a manufacturer/supplier/importer of chemicals, ever wondered why it's necessary to complete both the ISK registration and the PCN notification for the same product in Slovenia? That's exactly what I'll explain here today.
To answer the question posed in the title, let's start with the basics.
What are ISK registration and PCN notification, and what’s the difference between them?
- ISK registration is a national registration in Slovenia for reporting hazardous chemicals/mixtures that are produced or imported into Slovenia, including those imported for direct use in local production. The ISK registration applies only to Slovenia, and the data is accessible by the Chemicals Office of the Republic of Slovenia and the Slovenian Poison Center.
The legal basis for ISK registration is the Regulation on the Reporting of Chemical Data.
- PCN Notification is a European procedure where companies submit information about hazardous chemicals/mixtures to a centralized European database for Poison Centers. This notification can be done for one or multiple countries, or for the entire European Economic Area (EEA). The data is accessible to the relevant authorities and Poison Centers in the countries where the PCN notification was completed.
The legal basis for the PCN notification is Article 45 of Regulation No. 1272/2008 (CLP).
Both the ISK registration and the PCN notification are processes for reporting essential information to authorities, enabling them to act quickly and effectively. The key difference lies in who has access to this information. With ISK registration, access is limited to Slovenian authorities, whereas PCN notification provides access across the EU and the entire european economic area (EEA).
Now that we’ve clarified the definitions and differences, let’s delve deeper to answer the question at hand.
Who is responsible for ISK registration?
The company that first produces or imports the hazardous chemical/mixture into Slovenia is responsible for ISK registration. If a product has multiple trade names, all names produced in or imported into Slovenia must be registered.
What about PCN notification?
The PCN notification should be handled by the company that produces the hazardous chemical/mixture in the EU or imports it into the EU.
The manufacturer or importer is responsible for notifying all EEA countries where the chemical/mixture is placed on the market, and for all trade names associated with the product.
However, in practice, this is not always the case. In many instances, suppliers/distributors must handle the PCN notification themselves.
To understand the necessity of ISK registration and PCN notification in Slovenia, let’s connect the dots.
Firstly, companies that produce hazardous chemicals/mixtures in Slovenia or import them from non-EU countries, are required to complete both the PCN notification and ISK registration.
Secondly, companies importing hazardous chemicals/mixtures into Slovenia from other EU countries must ensure that these chemicals/mixtures are ISK registered.
Thirdly, ISK registration ensures that the Chemicals Office of the Republic of Slovenia and the Slovenian Poison Center have access to data on hazardous chemicals/mixtures in the Slovenian market. PCN notification provides access to this information across the broader European area, which is crucial for coordinated responses in emergencies. By combining both approaches, comprehensive safety is ensured on both national and European levels.
I hope it's now clear why these procedures are necessary in Slovenia.
Chemical regulations are a challenge not to be taken lightly. We can help you turn these challenges into advantages. All you need to do is contact me and let me know how we can assist you—my email is spela.hudobivnik@bens-consulting.eu.
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