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The Swedish Chemicals and Biological Organisms Ordinance (2008:245) establishes requirements for the declaration of chemicals and biological organisms in the register of goods. This register is administered by the Swedish Chemicals Agency and is intended to help regulate chemicals used and sold in Sweden. The purpose of the registration system is to ensure the compliance of chemicals and bio-organisms and to protect public health and environmental safety. Through registration and regulation, Sweden strives to ensure the sustainable use of chemicals and to provide transparent information and accurate data to facilitate the safe management and risk assessment of chemicals and bio-organisms.
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Traders need to be aware of and comply with the registration requirements of the Swedish Chemicals and Biological Organisms Ordinance (2008:245) to ensure that the chemicals and biological organisms they sell comply with the requirements and that the products can be legally sold on the Swedish market.
TEMU reserves the right to take a series of measures against non-compliant products, including but not limited to actively responding to the requirements of the regulatory authorities, issuing risk alerts to buyers, removing the products from the shelves, and notifying buyers or other relevant parties to destroy/return the products.
Compliance Guide
(i) Scope of application of the Rules
Professionally produced or imported chemical products and biotechnology organisms into Sweden are required to be registered with the Swedish Chemicals Agency and to maintain information on them, provided that they are classified in one of the commodity classes listed in the Annex to the Chemicals and Bioorganisms Ordinance (2008:245).
(ii) Product registration and information obligations
1. Product Registration Requirements
Traders are required to ensure that the chemical products and biotechnologies they produce or import into Sweden comply with the required commodity types and to provide the Swedish Chemicals Agency with the corresponding information for registration in the product register.
A trader who packages, repackages or changes the name of a chemical product or biotechnology registered in the Product Register in his own name is required to provide the relevant change information to the CMA.
NOTE: Certain fees for registration of chemicals or bio-organisms, or both, in the Commodity Register. For more information, see: https://www.kemi.se/en/products-register/chemical-charge.
2. Exceptions
a. Exclusions: The requirement does not apply to waste chemical products and specific products involving tattoo inks, which are governed by other relevant laws.
b. Registration Exemption: If less than 100 kilograms of chemical products or biotechnology organisms are manufactured or introduced annually, registration is not required, unless otherwise specified by the CWRA.
3. Information Volunteerism
Persons who specialize in the production of chemical products or biotechnology organisms, or who import them into Sweden, are obliged to provide the relevant information to the Chemicals Agency in a timely manner.
(iii) Safety data sheets and labeling requirements
Safety data sheets and labels must be written in Swedish, as required by the relevant EU regulations. Specifically, Regulation (EC) No. 1907/2006 of the European Parliament and of the Council of 18 December 2006 on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) and Regulation (EC) No. 1272/2008 of the European Parliament and of the Council of 16 December 2008 on the Classification, Labelling and Packaging of Substances and Mixtures. These regulations emphasize that safety data sheets and labels must be written in Swedish if chemicals are sold on the Swedish market.
In addition, the Swedish Chemicals Agency may issue exceptions or decide in specific cases to waive the requirement that safety data sheets and labels for certain chemicals must be written in Swedish. These exceptions may be necessary for special reasons, e.g. danger to human health, animal health, animal welfare or the environment, or for substances or mixtures that are only suitable for professional use and may be time-limited.
Therefore, it is important to read and comply with all relevant regulations before selling to the Swedish market to ensure that the products comply with all relevant regulations and standards.
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