Declarations

We are committed to delivering products that meet a high standard of innovation, performance, and environmental safety. We expect the same high standards from our suppliers. To achieve our goals, we must be able to adapt to the following environmental regulations, directives, and conventions.

• Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
• Restriction of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS)
• Per- and Polyfluoroalkyl Substances (PFAS)
• Persistent organic pollutants (POP)
• Ozone Depleting Substances (ODS)
• Minamata Convention on Mercury
• Safe Drinking Water and Toxic Enforcement Act (Proposition 65)
• Toxic Substances Control Act (TSCA)
• Waste Electrical and Electronic Equipment recycling (WEEE)
• Battery Regulation
• Packaging and Packaging Waste Regulation
• Medical Device Regulation (MDR)
• Biocompatibility
• EU Ecolabel
• Conflict Minerals

REACH

Regulation (EC) 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning registration, evaluation, authorisation and restriction of chemicals (REACH).

The REACH Regulation establishes the EU’s rules regarding chemicals. LINAK acts in accordance with the objectives of the REACH Regulation, including:

• Candidate List of substances of very high concern for Authorisation
• REACH, Annex XIV: Authorisation list
• REACH, Annex XVII: Substances restricted under REACH

At LINAK, we comply with REACH by monitoring substances of very high concern (SVHC) in our products.

We collect declarations to identify SVHCs when the concentration of one or more candidate list substances exceeds 0.1 % by weight in any component of the product. Some of our products may contain SVHCs. We aim to substitute these substances where technically possible and economically feasible. Products sold in the EU that contain SVHCs above 0.1 % are registered in the ‘Substances of Concern In articles as such or in complex objects (Products)’ (SCIP database). For further information, please contact chemicalcompliance@linak.com.

Read our statement about REACH.

RoHS

Directive 2011/65/EU restricts the use of certain hazardous substances in electrical and electronic equipment. Directive (EU) 2015/863 subsequently amended Annex II of the original directive, updating the list of restricted substances.

The RoHS Directive restricts the use of hazardous substances in electrical and electronic equipment. All LINAK products comply with the RoHS Directive and all applicable amendments.

Read our statement about RoHS.

PFAS

Per- and polyfluoralkyl substances (PFAS) are a large, complex group of synthetic chemicals that do not degrade easily in the environment.

Some LINAK products contain PFAS, primarily in the form of PTFE/Teflon. Where technically possible, we substitute PTFE. We continuously monitor applicable legislation.

Read our statement about PFAS.

POP

Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants.

The regulation on persistent organic pollutants (POP) is based on the Stockholm Convention on Persistent Organic Pollutants. The regulation includes a list of chemical substances that pose risks of adverse effects to human health and the environment. LINAK complies with the requirements of the POP regulation and does not use substances listed therein.

Read our statement about POP.

ODS

Regulation (EU) 2024/590 of the European Parliament and of the Council of 7 February 2024 on substances that deplete the ozone layer.

As of February 2024, the European Union has prohibited companies from producing or marketing the ozone-depleting substances (ODS) listed in the regulation.

LINAK products comply with the requirements of the ODS regulation and do not contain substances listed therein.

Read our statement about ODS.

Minamata Convention on Mercury

LINAK adheres to the Minamata Convention on Mercury, which was signed by Denmark on 10 October 2013. LINAK complies with the convention, which aims to protect human health and the environment from the release of mercury and mercury compounds.

Proposition 65

The California law ’Safe Drinking Water and Toxic Enforcement Act of 1986’, also known as ’Proposition 65’, prohibits any business from knowingly and intentionally exposing an individual to a chemical known by the State of California to cause cancer, birth defects, or reproductive harm without providing a ‘clear and reasonable warning’.

LINAK products contain Proposition 65 substances. Toxicological analyses have not been conducted on the products. Therefore, we recommend that our customers label their products in accordance with Proposition 65 requirements.

Read our statement about Proposition 65.

TSCA

The Toxic Substances Control Act (TSCA) is a U.S. legislation, administered by the U.S. Environmental Protection Agency (EPA). TSCA enables the EPA to regulate the use of certain chemicals that may pose environmental or health risks, including those classified as persistent, bioaccumulative, and toxic (PBT).

TSCA Section 6(h) restricts the use of 2,4,6-tris (tert-butyl) phenol (“2,4,6-TTBP”), decabromodiphenyl ether (“DecaBDE”), hexachlorobutadiene (“HCBD”), pentachlorothiophenol (“PCTP”) and phenol, isopropylated phosphate (3:1) (“PIP (3:1)”).

To the best of our knowledge, these substances are not present in LINAK products. We continue to monitor relevant regulations to ensure ongoing compliance and product safety.

Read our statement about TSCA.

WEEE

Directive 2012/19/EU of the European Parliament and of the Council of 4 July 2012 on waste electrical and electronic equipment (WEEE).

The WEEE Directive covers waste from electrical and electronic equipment. Some LINAK products feature the crossed-out wheeled bin symbol, indicating that the product must be disposed of properly and not as general household waste.

Proper disposal protects both the environment and human health. For more information about appropriate disposal, please consult your local authorities or your European retailer.

LINAK is registered with the local authorities in the countries where we operate and contributes to recycling in accordance with the WEEE Directive.

Battery Regulation

Regulation (EU) 2023/1542 of the European Parliament and of the Council of 12 July 2023 concerning batteries and waste.

The Battery Regulation and its predecessor, the Battery Directive (Directive 2006/66/EC), set out the regulations for the marketing of batteries, accumulators, and waste batteries containing hazardous substances. They also set out the guidelines for the collection, treatment, recycling, and disposal of batteries and accumulators.

LINAK complies with all obligations under the regulation, including marking batteries with a crossed-out wheeled bin symbol and the chemical symbols: Pb (lead), Cd (cadmium), and/or Hg (mercury) – depending on which chemicals a battery contains in quantities above the specified thresholds.

Read our statement about Battery Regulation.

Packaging and Packaging Waste Regulation

Regulation (EU) 2025/40 of the European Parliament and of the Council of 19 December 2024 on packaging and packaging waste establishes guidelines for the management of packaging and packaging waste in the European Union.

LINAK adheres to the Packaging and Packaging Waste Regulation. We declare that our standard packaging method consists of cardboard boxes on heat-treated pallets.

Read our statement about the Packaging and Packaging Waste Regulation.

MDR

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (MDR).

At LINAK, we aim to be a reliable partner, ensuring that our customers have access to the information necessary for their specific applications.

Our products are designed for integration into electrical medical equipment, but they are not classified as medical devices.

The Medical Device Regulation stipulates that manufacturers of medical devices must indicate whether their product contains latex. In accordance with the regulation, we confirm that our MEDLINE^® and CARELINE^® products do not contain latex.

Biocompatibility

LINAK MEDLINE and CARELINE products are intended for integration into electrical medical equipment and comply with IEC 60601-1: 2020, section 11.7. This section refers to the standards in the ISO 10993 series. All parts of the products that may come into contact with the skin of the patient or user during normal use have been assessed. The assessment is based on previous experience, as well as the nature and duration of the expected contact with human tissue during use.

The assessment concerns non-invasive LINAK products that come into contact with intact skin.

Read our statement about Biocompatibility.

EU Ecolabel

The EU Ecolabel helps consumers, retailers, and businesses make sustainable choices. The EU Ecolabel is a voluntary environmental label awarded to products that meet strict environmental criteria and have a reduced environmental impact.

LINAK manufactures components for integration, and these components are not directly covered by the EU Ecolabel. However, our customers – including an increasing number of furniture manufacturers – face requirements and standards that we aim to help them fulfil.

As a result, several of our standard DESKLINE^® products meet these requirements. For more information about which LINAK DESKLINE products can support you in obtaining the EU Ecolabel, please contact your local subsidiary or send an email to chemicalcompliance@linak.com.

Conflict Minerals

LINAK requires its employees and suppliers to eliminate the use of conflict minerals.

Conflict minerals are tantalum, tin, tungsten, and gold (3TG), which originate from conflict-affected areas, such as the Democratic Republic of Congo.

While LINAK does not procure minerals directly from smelters, LINAK sources components from suppliers that contain 3TG’s. Therefore, LINAK:

• Follows the OECD Due Diligence Guidance for Responsible Supply Chains of Minerals from Conflict-Affected and High-Risk Areas.
• Avoids using minerals and metals linked to conflicts.
• Verifies that minerals and metals are not sourced from conflict-affected or high-risk areas.
• Conducts thorough source and chain of custody reviews for conflict minerals and metals.
• Ensures transparency by providing documentation and evidence of due diligence upon request and disclosing the origins and sourcing routes of the minerals and metals in their products.
• Ensures that its operations do not support human rights abuses.

LINAK requires the same of its suppliers.

Read our statement on conflict minerals.

For further information about conflict minerals, please contact our Conflict Minerals Compliance Team via conflictminerals@linak.com.

Dodd-Frank Act
The Dodd-Frank Act applies only to US-listed companies. Suppliers, such as LINAK, are also contractually obliged to comply with its provisions.

The Dodd-Frank Act was passed in response to allegations that the extraction and trade of minerals from the Democratic Republic of the Congo (DRC) and neighbouring countries funded armed groups and contributed to regional instability.

In August 2012, the United States Securities and Exchange Commission (SEC) adopted a rule requiring US-listed companies to report on their use of conflict minerals, thereby extending the law to their suppliers.