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Product compliance

Product Safety and Compliance are top priorities in Borealis that handled by the Product Stewardship department for all our products, as diverse as base chemicals, fertilizers, and virgin or recycled polyolefins.

EU Regulations REACH and CLP

Borealis is in full compliance with 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 fully 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 we follow the therein agreed roadmap to review and upgrade all our REACH registration dossiers until 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 an 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.

For additional information, please consult the Safety Data Sheets (SDS) or Product Safety Information Sheets (PSIS) or contact us below.

Global chemical compliance

In recent years, several chemical legislation regimes have been developed in different parts of the world. Borealis follows up on these emerging regulations and makes sure that Borealis products are compliant in the global markets supplied.

GHS

The Globally Harmonised System of Classification and Labelling of Chemicals managed by the United Nations includes criteria for the classification of health, physical and environmental hazards. The aim of the GHS is to harmonize the 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 regulation and Borealis Plastik ve Kimyasal Maddeler Ticaret Limited Şirketi acting as the regulatory importer has pre-registered all relevant substances sold to Turkey. Some substances were also pre-registered through a KKDIK Only Representative. Borealis also intends to ensure that our substances will be registered by the deadline on 31 December 2023.

UK REACH

All the relevant substances for registration in Borealis products, that have been under active sales during the Brexit transition period, have been DUIN notified by Borealis UK Ltd. Borealis’ product sales can be continued as earlier on the UK market if the material is purchased from Borealis UK Ltd. Full UK REACH registrations will be carried out in 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 our customers in South Korea have been pre-registered under K-REACH by our Only Representative. Registrations will be carried out in line with the tonnage dependent registration deadlines. Our basic polymers are polymers of low concern (PLC) and we are applying for PLC exemptions for them.

US TSCA

For our US business, Borealis is in full compliance with all relevant sections of the Toxic Substance Control Act (TSCA). All relevant ingredients in Borealis products are listed on the active TSCA inventory.

Explosives Precursors Regulation (EU) 2019/1148

The system 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 of them having specific regulatory and safety requirements. We support our customers in fulfilling all these obligations. The most demanding areas are described in more detail below.

Food contact

  • Food is essential for human life and beside the quality of food itself, increasingly also the materials the food is contacting are coming into scope of legislation around the globe. This comprises food packaging, but also dishes and other kitchen tools and equipment in the food industry, like conveyor belts, funnels etc.
  • Either Borealis‘ resins or Borealis‘ customer’s products are sold globally. Thus they have to comply with the applicable food contact legislation in those regions., This compliance therefore needs to be regularly assessed and confirmed in a declaration of compliance (DOC), represented by Borealis‘ food contact statements.
  • In their current layout, Borealis food contact statements comprise a selection of areas with 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, only are intended for orientation purposes, but do not replace a detailed DOC, which in such cases is available on 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 that purpose Borealis, on request, provides detailed information on the composition of its involved polyolefin grades to such third parties.

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, like the Eur. and U.S. Pharmacopoeia as well as ISO 10993 testing.
For additional information, please consult the Healthcare.

Post-consumer recyclates (PCR)

Turning waste back into products comes with additional regulatory challenges. Especially the mechanically recycled post-consumer recyclates require special solutions for achieving these goals since their composition is not fully known. Borealis applies a testing programme and risk assessments to be able to confirm compliance with chemical legislation.

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 chemicals production. Borealis utilizes ISCC Plus for tracking bio-based and circular raw materials. ISCC Plus is a sustainability certification program for bio-based and circular raw materials. ISCC Plus certified feedstocks and products can be found on our Quality page. Furthermore, please refer to our grade-specific “Statement on the origin of raw materials” for raw material origins of the additives used.

Fertilizers regulation

Next to compliance with chemical regulations, Borealis fertiliser products must either comply with 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 from 16 July 2022) or with the national law of the country where the fertiliser is placed on the market.

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