Nordic Swan Ecolabel requirements for medical devices and products in plastic and silicone 

A Nordic Swan Ecolabelled disposable product for healthcare meets strict chemical requirements.

The product group includes products mainly made of plastic or silicone that are for storage, transfer or transport of fluid, gas or medicine; or for preventing leakage of fluids from the body. The products must be included under the Regulation (EU) 2017/745 on medical devices or EU Medicinal Products Directive (2001/83/EC).  

Products such as oxygen masks, urine catheters, gastric tubes, dialysis treatment bags, prolapse rings and syringes are included. 

Nordic Swan Ecolabel medical devices and medicinal products in plastic and silicone meet strict requirements for chemicals in materials, adhesives and surface treatments, are free from halogenated rubbers and plastics, such as PVC and meet requirements to packaging to promote recycling. 

The requirements include:

  • For products mainly made of silicone: At manufacturing of silicone raw material, emissions of dust and chlorides into air and copper and zinc into wastewater are limited. Also, data for energy consumption must be reported. 
  • Prohibition of halogenated plastics and rubbers. 
  • Environmental and health properties of chemicals used in materials, adhesives and surface treatments. Among others, PFAS and endocrine disruptors are prohibited. 
  • Materials and design of packaging to promote recycling. 
  • For products mainly made of silicone: At manufacturing of silicone raw material, emissions of dust and chlorides into air and copper and zinc into wastewater are limited. Also, data for energy consumption must be reported. 

Want to know more about environmental certification with the Nordic Swan Ecolabel?

Contact us and we will help you: Bos@svanemerket.no

Please state which product you are considering eco-labeling with the Nordic Swan Ecolabel.

Bjørn Olav Aarø Strandli

markedsansvarlig

+47 47705752bos@svanemerket.no

What does it cost?

When you apply for the Nordic Swan Ecolabel, you must pay a fee. Additionally, when you have a certification, you must pay an annual licence fee based on the turnover of the certified product or service.

Please visit our Nordic website to see the specific fees. You will find them at the bottom of the page for the relevant product group under the fees» tab. You can find all product groups here.