Product Compliance

The Globally Harmonised System of Classification and Labelling of Chemicals (GHS) managed by the United Nations includes criteria for the classification of health, physical and environmental hazards. The aim of the GHS is to harmonize classification and labelling standards around the world. More and more individual countries and regions are implementing GHS; the EU implementation is the CLP Regulation.

Borealis is following and fully compliant with the international conventions concerning chemicals, such as the Stockholm or Rotterdam conventions.

Borealis is aware of the KKDIK (Kimyasalların Kaydı, Değerlendirilmesi, Izni ve Kısıtlanması hakkinda yönetmelik) regulation on registration, evaluation, permission and restriction of chemicals. Borealis Plastik ve Kimyasal Maddeler Ticaret Limited Şirketi, acting as the regulatory importer, has pre-registered all relevant substances. Borealis intends to ensure that its pre-registered substances will be fully registered by the applicable deadlines.

All relevant substances in Borealis products that were under active sale during the Brexit transition period were downstream user import notified (DUIN) by Borealis UK Ltd. Therefore, UK customers buying from Borealis UK Ltd. are downstream users under UK REACH. Full UK REACH registrations will be carried out according to a phased registration timeline based on the tonnage threshold limits and substance hazard characteristics.

All relevant substances contained in Borealis products that are sold to customers in South Korea have been pre-registered under K-REACH by its Only Representative. Ongoing registrations will be carried out in line with the tonnage dependent registration deadlines. Borealis’ basic polymers are polymers of low concern (PLC) and the company is therefore applying for PLC exemptions for them.

For Borealis’ US business, Group Product Stewardship supports the US legal entities to ensure compliance with all relevant sections of the Toxic Substance Control Act (TSCA).

A process has been implemented to fulfil new requirements for regulated and restricted substances.

• Food is essential for human life. In addition to the quality of food itself, the materials with which food comes into contact are increasingly becoming a focus of legislation around the globe. This comprises food packaging, as well as dishes and other kitchen tools and equipment in the food industry, such as conveyor belts, funnels etc.
• Borealis’ resins, as well as Borealis’ customer’s products, are sold globally, thus, they need to be compliant with applicable food contact legislation in many regions around the world. Compliance therefore needs to be regularly assessed and confirmed in a declaration of compliance (DOC); these are provided in Borealis’ food contact statements.
• Borealis food contact statements cover relevant legislation in areas with the most developed food contact legislation. Confirmations for additional areas are available on request (please contact your Borealis sales contact).
• Please note that “general food contact statements” as published for some Borealis products, are only intended for orientation purposes and do not replace a detailed DOC, which may be made available upon request.

In many countries, the regulations and standards on finished materials and articles intended to be used in contact with drinking water are subject to an assessment by competent authorities or accredited certifiers, which typically comprises an assessment of the raw material composition. For this purpose, Borealis provides detailed information on the composition of application-specific polyolefin grades upon request.

Borealis offers a dedicated grade range of Bormed™ polyolefin products to the healthcare market. These products fulfil the stringent regulatory requirements for medical devices, pharmaceutical and diagnostic packaging, including those set out in the Eur. and U.S. Pharmacopoeia, as well as undergoing ISO 10993 testing.  For additional information, please consult Healthcare.

Transforming waste back into products creates additional regulatory challenges. In particular, recyclates derived from mechanically-recycled post-consumer waste require specialist processes and handling as their composition is not fully known. Borealis applies a testing program and risk assessment regime to enable compliance with the relevant chemicals legislation in this area.

For application-specific laws, regulations and standards, such as packaging and packaging waste directive (PPW), end-of-life vehicles (ELV) or Restriction of Hazardous Substances (RoHS), as well as a list of non-intentionally added substances, please refer to the grade-specific ‘Statement on Chemicals, Regulations and Standards’. A guidance document explaining the contents of these chemical statements can be found here.

Borealis uses a wide variety of different feedstocks for polyolefin and base chemical production. Borealis utilizes ISCC PLUS for tracking bio-based and circular raw materials. ISCC PLUS is a sustainability certification program for ensuring the traceability of bio-based and circular raw materials throughout the entire value chain. Details of ISCC PLUS-certified feedstocks and products can be found on the company’s Quality page. Please refer to the grade-specific ‘Statement on the origin of raw materials’ for the raw material origins of the additives used.