Product Compliance

Ensuring full compliance with global regulations

Product Safety and Compliance are top priorities for Borealis. These concerns are handled by the Product Stewardship department across all products, from base chemicals and fertilizers, to virgin or recycled polyolefins.

EU Regulations REACH and CLP

Borealis is in full compliance with REACH and CLP.

REACH (Regulation (EC) No 1907/2006) is the European Union regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals. The aim of REACH is the safe use of chemicals to ensure a high level of protection for human health and the environment from the risks that can be posed by chemicals.

Borealis is committed to fulfilling its legal obligations and is in full compliance with REACH. In 2019, Borealis joined Cefic’s REACH Action Plan for Review / Improvement of Registration Dossiers and follows the therein agreed roadmap to review and upgrade all of its REACH registration dossiers by 2026.

CLP (Regulation (EC) No 1272/2008) is the European Union regulation on Classification, Labelling and Packaging of substances and mixtures. Borealis issues Safety Data Sheets (SDS) in compliance with CLP and REACH (Annex II) Regulations. For non-hazardous products, which do not require a SDS according to REACH Article 31, Borealis provides Product Safety Information Sheets (PSIS) containing relevant information on product safety according to Article 32 of REACH Regulation.

Global Chemical Compliance

In recent years, several chemical legislation regimes have been developed in different parts of the world. Borealis keeps up with these emerging regulations and makes sure that its products are compliant with all legislation in the global markets it supplies.

GHS

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 harmonise classification and labelling standards around the world. More and more individual countries and regions are implementing GHS; the EU implementation is the CLP Regulation.

Global Conventions

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

Turkey REACH

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 deadline on 31 December 2023.

UK REACH

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.

South Korea REACH

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.

US TSCA

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).

Explosives Precursors Regulation (EU) 2019/1148

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

Application related product compliance

Borealis polyolefin products are used in a variety of end applications, each which have specific regulatory and safety requirements. The company supports its customers in fulfilling all of these obligations. The most highly-regulated areas are described in more detail below.

Food contact

  • 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.

Drinking water

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.

Healthcare

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.

Post-consumer recyclates (PCR)

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 programme and risk assessment regime to enable compliance with the relevant chemicals legislation in this area.

Application-specific laws, regulations and standards

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.

Feedstock and raw materials

Borealis uses a wide variety of different feedstocks for polyolefin and base chemical production. Borealis utilises ISCC PLUS for tracking bio-based and circular raw materials. ISCC PLUS is a sustainability certification programme 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.

Fertilizers regulation

In addition to compliance with relevant chemical regulations, Borealis fertilizer products must also comply with either the current provisions of the European Fertilisers Regulation (EC) No 2003/2003 (to be replaced by the new EU Fertilising Products Regulation (EU) 2019/1009 applicable since 16 July 2022) or with the national law of the country where the fertilizer is placed on the market.

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