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  4. Disposable bags, tubes and accessories for health care 098

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)
There are 56 Ecolabelled products from 3 companies within productgroup.

  • Welcome to apply for a Nordic Swan Ecolabel licence!

    This is how you do:

    1. Read the application guide.
    2. Log in to the Nordic Ecolabelling Portal.
    3. Start your application.

     

    If this is the first time you are applying, the authorized signatory must fill in your company information and approve the application conditions. In this way, you get login to the portal and the right to assign access to other colleagues.

     

    Request login

    To the Nordic Ecolabelling Portal

    Some special cases can not be done in the Nordic Ecolabelling Portal. Contact your advisor for such cases. More information can be found on "Application step by step".

  • Valid from 1 January 2025 Amount excluding VAT

    Application fee

    Application for a new licence 3 348 EUR
    Application for a renewed licence when the requirements have been tightened 1 673 EUR

    Annual licence fee

    The licence fee for the Nordic Swan Ecolabelled products is based on their turnover in the Nordic countries The fee is 0.3% of the products' turnover in the Nordic countries up to 30.9 million EUR.
    The fee is 0.05% of the products' turnover in the Nordic countries for the amount exceeding 30.9 million EUR.
    Minimum fee in the Nordic countries 2 232 EUR per year.
    Fixed fee that is added for sales outside the Nordic countries 2 232 EUR per year if the turnover exceeds 309 000 EUR.

    Fee for extension / change of licence

    Fixed fee that is charged depending on how long the work takes.

    Up to 4 hours 418 EUR
    4–8 hours 836 EUR
    8 or more hours 1 673 EUR

    Fee for on-site inspections

    One on-site inspection in the Nordic countries is included when applying for a new or renewed licence.

    Additional on-site inspection within the Nordic countries 557 EUR per visit.
    On-site inspection outside the Nordic region, but within Europe 1 673 EUR per visit.
    On-site inspection outside Europe 2 790 EUR per visit.
    Additional fee for on-site inspections lasting longer than one day 1 115 EUR per day.

    Ecolabelling Sweden AB has no financial profit purpose and is financed through the fees above along with an annual government grant. The company is however liable for VAT according to article 56 of the European Council Directive 2006/112/EC.

    Invoicing is made in SEK with the exchange rate from the first banking day of the year.

    When both the applicant and the manufacturer are micro-enterprises, the application 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.

    Valid from 1 January 2024 Amount excluding VAT

    Application fee

    Application for a new licence 3 251 EUR
    Application for a renewed licence when the requirements have been tightened 1 625 EUR

    Annual licence fee

    The licence fee for the Nordic Swan Ecolabelled products is based on their turnover in the Nordic countries The fee is 0.3% of the products' turnover in the Nordic countries up to 30 million EUR.
    The fee is 0.05% of the products' turnover in the Nordic countries for the amount exceeding 30 million EUR.
    Minimum fee in the Nordic countries 2 167 EUR per year.
    Fixed fee that is added for sales outside the Nordic countries 2 167 EUR per year if the turnover exceeds 300 000 EUR.

    Fee for extension / change of licence

    Fixed fee that is charged depending on how long the work takes.

    Up to 4 hours 406 EUR
    4–8 hours 812 EUR
    8 or more hours 1 625 EUR

    Fee for on-site inspections

    One on-site inspection in the Nordic countries is included when applying for a new or renewed licence.

    Additional on-site inspection within the Nordic countries 541 EUR per visit.
    On-site inspection outside the Nordic region, but within Europe 1 625 EUR per visit.
    On-site inspection outside Europe 2 709 EUR per visit.
    Additional fee for on-site inspections lasting longer than one day 1 083 EUR per day.

    Ecolabelling Sweden AB has no financial profit purpose and is financed through the fees above along with an annual government grant. The company is however liable for VAT according to article 56 of the European Council Directive 2006/112/EC.

    Invoicing is made in SEK with the exchange rate from the first banking day of the year.

    When both the applicant and the manufacturer are micro-enterprises, the application 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.

    • For new applications granted after 1 July, a fee reduction will apply for the first year. The minimum or maximum fee and any breakpoint will be multiplied by the result of the following formula: “number of remaining days in the year” x 2 / 365.
      Breakpoint = Turnover where the percentage changes in the calculation of licence fee.
      Minimum fee = the lowest licence fee Nordic ecolabelling annually invoices a company or a Group per product/ commodity group/ certifying country.

      Should a former holder of a license/registration continue to make use of the Nordic Ecolabel without being granted a new license/registration, the Nordic Ecolabelling organization reserves the right to claim financial compensation. The size of such compensation shall be equivalent to the turnover-based license fee that a licensee would have been required to pay for a license, and a financial penalty, the severity of which is determined by the extent and duration of the infringement as well as the damages that Nordic Ecolabelling may have incurred as a result of such misuse. Such a financial penalty should not normally be less than EUR 4,000 (four thousand). The Nordic Ecolabelling organizations may also take legal action against the infringement of the Nordic Ecolabel or if rules in the prevailing version of the Logo Guideline for the Nordic Ecolabel are not fulfilled.

    Fee regulations for Nordic Ecolabellling

  • Information on the latest version of the criteria for disposable bags, tubes and accessories for health care

    2.6 ⇛ 2.7: Adjustment of criteria

    Nordic Ecolabelling decided on 15 October 2024 to adjust requirement O5 regarding an exemption for antioxidants classified as toxic to reproduction cat 2 (H361) in polyisoprene parts on the conditions described in the requirement.

    2.5 ⇛ 2.6: Adjustment of criteria

    Nordic Ecolabelling decided on 16 April, 2024 to adjust requirement O6 regarding an exemption for antioxidants classified as toxic to reproduction cat 2 (H361) in polyisoprene parts on the conditions described in the requirement.

    2.4 ⇛ 2.5: Prolongation of the validity of the criteria

    The criteria for disposable bags, tubes and accessories for health care have been prolonged with 24 months. The new version is called 2.5 and is valid until 31 Decenmber 2026.

    2.3 ⇛ 2.4: Prolongation of the validity of the criteria

    The criteria for disposable bags, tubes and accessories for health care have been prolonged with 12 months. The new version, 2.4, is valid until 31 Decenmber 2024.

    2.2 ⇛ 2.3: Adjustment of criteria

    Requirement O5 and O6 have been adjusted. The new version, 2.3, is valid until 31 December 2023.

    2.1 ⇛ 2.2: Adjustment of criteria

    Requirement O5 has been adjusted. The new version, 2.2, is valid until 31 December 2023.

    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.

Please contact me for more information