Disposable bags, tubes and accessories for health care 098
Products that can be labelled 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)
Fees valid from 1 January 2021
Application fee including one on-site inspection within the Nordic region *) 30 000 SEK excl. VAT. Renewal fee *) 15 000 SEK excl. VAT.
Annual licence fee
Annual Nordic licence fee**) 0.3% of turnover + VAT
from EUR 0–30 million
0.05% of turnover + VAT
> EUR 30 million
Minimum fee for the Nordic countries 2 000 EUR annually excl. VAT Maximum fee for the Nordic countries No maximum fee Annual licence fee outside the Nordic countries (for licence holders with a turnover of more than 300 000 EUR of Nordic Swan ecolabelled products, sold outside the Nordic countries) 2 000 EUR annually excl. VAT
If the Nordic Swan ecolabelled products are only sold outside the Nordic countries, a minimum fee is always charged.
Fee for extensions/alterations of licence
Extension/alteration of existing licence The fee is based on how long it takes to handle the matter:
- Less than 4 hours: 3 750 SEK excl. VAT
- Between 4 and 8 hours: 7 500 SEK excl. VAT
- More than 8 hours: 15 000 SEK excl. VAT
Fees for on-site inspections
Extra fee for additional on-site inspection within the Nordic countries 5 000 SEK excl. VAT per visit On-site inspection outside the Nordic region, but within Europe***) 15 000 SEK excl. VAT per visit On-site inspections outside Europe***) 25 000 SEK excl. VAT per visit
Euro rate: The exchange rate of the first day of the year is used to convert amounts in Euro to national currency:
*) Micro enterprises are charged half the fee. A micro enterprise, according to our definition, is a company with a maximum of 10 employees and with a total turnover of €2 000 000 (including both ecolabelled and non-ecolabelled products).
**) Corporations pay only one licence fee
***) There is an extra fee of 1 000 EUR per day if the inspection takes more than one day.
Background documentEnglish / 2.1
Compilation of hearing statementsNorwegian / 2.1
Information on the latest version of the criteria for disposable bags, tubes and accessories for health care
2.0 ⇛ 2.1: Adjustment of criteria
The criteria have been adjusted for exceptions for dyes classified as H317. The new version, 2.1, is valid until 31 December 2023.
1.8 ⇛ 2.0: New criteria generation
The criteria for disposable bags, tubes and accessories for health care have been revised. The new version, 2.0 is valid until 31 Decenmber 2023.
1.7 ⇛ 1.8: Prolongation of the validity of the criteria
The criteria for disposable bags, tubes and accessories for health care have been prolonged with 6 months. The new version, 1.8, is valid until 31 Decenmber 2020.
1.6 ⇛ 1.7: Prolongation of the validity of the criteria
The criteria for disposable bags, tubes and accessories for health care have been prolonged. At the same time, requirement R6 Recycling system, was removed. The new version, 1.7, is valid until June 30, 2020.
1.5 ⇛ 1.6: Prolongation of the validity of the criteria
The criteria for disposable bags, tubes and accessories for health care have been prolonged. At the same time, requirement R7 Marketing, was removed. The new version, 1.6, is valid until March 31, 2019.
1.4 ⇛ 1.5: Prolongation of the validity of the criteria
The validity of Nordic Ecolabel's criteria for disposable bags, tubes and accessories for health care has been extended. The new version, 1.5, is valid until December 31, 2017.
We are so happy you decided to send in an application for the Nordic Swan Ecolabel!
The application process starts by you downloading the application form and filling it in. You then send it to Ecolabelling Sweden.
We will register your application and send you a confirmation. You will also be assigned an advisor who will help you through the application process.
During this process, you will send in documentation that proves that your product can successfully meet each of Nordic Ecolabelling’s requirements for your specific product group.
The application consists of these parts:
- Completed application form
- Documentation Overview
- Documentation showing fulfilment of all requirements according to the criteria document
Once your product has been approved – not before, you have the right to use the Nordic Swan Ecolabel in all your marketing as long as your licence is valid.
We wish you luck with your application and, most importantly, your work towards a more sustainable world!
For more information: "Application step by step"