Disposable bags, tubes and accessories for health care
Products that can be Nordic Swan Ecolabelled are disposable products and accessories for dialysis, intravenous infusion treatment, treatment of urinary retention and incontinence, blood bags and ostomy pouches.
A Nordic Swan Ecolabelled disposable product for healthcare meets strict chemical requirements. These include adhesive used in the product and additives to the plastic, such as plasticisers, dyes and antioxidants. Quality and safety requirements are set to ensure that the products are safe to use and work as intended. The requirements include:
Prohibition of the materials PVC and latex
The siloxanes D4, D5 and D6 is not allowed in silicone, but can be in the silicone as contaminants in limited amounts
Adding phthalates to the plastic is prohibited
Chemicals classified as environmentally harmful, toxic, allergenic, endocrine disruptors and CMR (carcinogenic, mutagenic, toxic for reproduction) cannot be added to the plastic or be part of the adhesive
Product and parts must comply with EU Medical Products Directive (2001/83 / EC) and/or Medical Devices Regulation (2017/745 / EU)
Below you will find all the necessary documents and background information to apply for the Nordic Swan Ecolabel.
0.3% of turnover + VAT from 0 – 30 million EUR
0.05% of turnover + VAT > 30 million EUR
Minimum fee for Nordic region
2 000 EUR + VAT per year
Maximum fee for Nordic region
No maximum fee
Fees for sale outside the Nordic region
(Only if revenue > EUR 300,000 per year)
2 000 EUR + VAT per year
* When both the applicant and the manufacturer are micro-enterprises, the fee is reduced by 50%. A micro-enterprise is in this context defined as an enterprise with less than 10 employees and an annual turnover (of both ecolabelled and not ecolabelled products) below 2 million EUR.
** Where audits requires more than one day away from the office including travelling, Nordic Ecolabelling can invoice an additional fee of 1 000 EUR per extra day. Other extraordinary costs induced by the audit can also be invoiced the applicant.
*** As for an extension of or amendments to a licence, time consumed in connection with the review process will be invoiced according to the extent of the required task. We make a distinction between entirely administrative tasks that last less than 1 hour, and all other tasks that last between 1 and 4 hours, between 4 and 8 hours and more than 8 hours.
The recipient is liable for the VAT according to article 56 of the Council Directive 2006/112/EC. All information given on this site is subject to a disclaimer for errors and omissions