Products which are notifiable to report
Content:
Chemical products and biotechnical organisms that are manufactured in or brought into Sweden must be reported to the Swedish Chemicals Agency. If the annual volume per product is at least 100 kg, you must also report the products and the amounts.
Notifiable products are in the list of customs numbers
Notifiable chemical products are those products whose customs tariff numbers are on the list of customs numbers in Annex 1 to the Chemical Products and Biotechnical Organisms Ordinance.
(In Swedish, use Ctrl+F to search the list)
If you manufacture notifiable chemical products in Sweden or import or transfer these into Sweden, you must report such activity to the Swedish Chemicals Agency. If the annual volume per product is at least 100 kg, you must also report the products and the amounts.
This information applies to you if you
- are a professional manufacturer or importer of chemical products and biotechnical organisms
- in your own name package, repackage or change the names of chemical products or biotechnical organisms for further transfer
- make mixtures of chemical products and biotechnical organisms for further transfer
- manufacture or import notifiable chemical pesticides
- engage a commercial agent to report your products on your behalf.
Compulsory declaration for nanomaterials
If you have a chemical product for which there is an obligation to notify, you will have to report whether it contains intentionally added nanomaterials. You can report this at the same time as you complete your product registration at the Products Register. If you are not sure whether your product contains intentionally added nanomaterials, contact your supplier. Intentionally added means nanomaterials that have been deliberately added in order for a specific function to be obtained for example for a material to be water repellent or to give a material absorbent properties.
Physical and chemical properties
The regulations concerning the registration of nanomaterials in chemical products require you to report the physical and chemical properties of the nanomaterial. This means that you need to provide the following information about the nanomaterial in your product:
- classification according to the CLP regulation 1272/2008
- function of the nanomaterial
- particle size
- form
- crystalline state
- surface area
- coating
- surface charge
- if the nanomaterial is present in agglomerated or aggregated state (assembly of materials) the mean size should be stated.
Exemptions from the regulations
There are exemptions from the regulations. If your company has an annual turnover of less than 5 million Swedish crowns, or if the nanomaterial is a pigment, you only need to state whether the nanomaterial is included in the product. This means that you do not need to report the nanomaterial's properties.
Creating an overview
The aim of the regulations is to create an overview of what nanomaterials are present on the Swedish market. The regulations were introduced into the Swedish Chemicals Agency Regulations (KIFS 2017:7) and came into effect on 1 January 2018.
Registration duty for highly fluorinated substances (PFAS) in chemical products
If you have a chemical product subject to notification, you must report if it contains intentionally added PFAS. This applies regardless of the concentration of the substances. But you don't need to report the concentration of PFAS in the product, nor the name of the substance. You report the PFAS content at the same time as you complete your product notification to the products register. If you already have a product registered you need to supplement the registration with information on PFAS content.
The definition of which PFAS are to be registered are substances which in their molecule contain a perfluorinated carbon chain with at least two carbon atoms and bonding to optional atoms or groups of atoms. For example, the substances PFOA and PTFE (Teflon) are subject to the notification requirement.
If you do not know if PFAS is intentionally added to your product, please contact your supplier. Intentionally added means PFAS which is deliberately added to achieve a certain function, for example repelling water and dirt or lubricating function. PFAS can be included in chemical products such as impregnating agents, ski wax, fire-fighting foams and in the raw material for plastic and paper.
You will find the new regulation in KIFS 2017:7, 3 chap. 14 § 12 a (only in Swedish).
External link.
Exemption from the regulation
There are exemptions from the regulation. If your company has an annual turnover of less than 5 million SEK you are exempted from the requirement of reporting PFAS in chemical products.
Purpose of the new regulation
Highly fluorinated substances are extremely difficult to decompose in the environment and many are mobile in soil and water. PFAS has contaminated drinking water in several places in Sweden. The purpose of the Swedish Chemicals Agency's stricter reporting requirements is to increase the knowledge about how PFAS is used. With more information about the use, it will be easier to assess what measures may be needed to protect health and the environment.