About Nordic Swan Ecolabelled Disposable bags, tubes and accessories for health care Version 2.2 Background to ecolabelling 15 May 2021 Content 1 Summary 3 2 Basic facts about the criteria 3 3 The Market 5 4 Environmental impact of the product group 6 5 Justification of the requirements 7 5.1 General requirements 7 5.2 Environmental and health requirements 8 5.2.1 Materials 8 5.2.2 Chemicals 13 5.3 Safety requirement 18 5.4 Quality and regulatory requirements 19 6 Changes compared to previous generation 21 098 Disposable bags, tubes and accessories for health care, version 2.2, 05 May 2021 Addresses In 1989, the Nordic Council of Ministers decided to introduce a voluntary official ecolabel, the Nordic Swan Ecolabel. These organisations/companies operate the Nordic Ecolabelling system on behalf of their own country’s government. For more information, see the websites: This document may Denmark Iceland only be copied in its Ecolabelling Denmark Ecolabelling Iceland entirety and without any Danish Standards Foundation Norræn Umhverfismerking type of change. Göteborg Plads 1, DK-2150 Nordhavn á Íslandi Fischersgade 56, DK-9670 Løgstør Suδurlandsbraut 24 It may be quoted from Tel: +45 72 300 450 IS-108 Reykjavik provided that Nordic [email protected] Tel: +354 591 20 00 Ecolabelling is stated www.ecolabel.dk [email protected] as the source. www.svanurinn.is Finland Norway Sweden Ecolabelling Finland Ecolabelling Norway Ecolabelling Sweden Urho Kekkosen katu 4-6 E Henrik Ibsens gate 20 Box 38114 FI-00100 Helsinki NO-0255 Oslo SE-100 64 Stockholm Tel: +358 9 61 22 50 00 Tel: +47 24 14 46 00 Tel: +46 8 55 55 24 00 [email protected] [email protected] [email protected] www.ecolabel.fi www.svanemerket.no www.svanen.se 2 Nordic Ecolabelling 098/2.2 05 May 2021 Background document 1 Summary The main objective of these criteria is to label products that are an alternative to products of softened PVC. PVC is still widely used in the medical industry for disposable products. There are alternatives to the use of PVC in many types of disposable products in the health care sector, so there is potential and possibility to make a difference. PVC has several environmental aspects related to production, use and disposal of PVC. The material PVC needs plasticisers to make it flexible and soft, and many of these additives have problematic properties related to the environment and health. As the plasticisers are not bound to the polymer, they can leak out and is a source to harmful chemicals for humans and in nature. The criteria set general requirements to additives to all plastic and will therefore also handle possible harmful additives in other types of plastic than PVC. The main changes in the revision from generation 1 to generation 2 are changes in the product group definition, new requirements to the materials latex and silicone and a general ban on phthalates. In the product group definition, it is now emphasized that the products that can be labelled must be alternatives to products made of softened PVC and it is extended with blood bags. Latex is not allowed to use in the products, as latex itself can cause allergic reactions. There is also a new requirement to the content of the cyclic siloxanes D4, D5 and D6 in silicone material. These substances are now on the EU's Candidate List. 2 Basic facts about the criteria Products that can be labelled The product group definition has been slightly changed from the previous generation. The product group now also comprises blood bags, as there has been a project for many years aiming to develop PVC-free blood bags1. It is also pointed out that the products must be an alternative to products made of softened PVC on the market. The materials that can replace softened PVC are mainly soft plastic, but also silicone or rubber is possible replacements. Products in hard plastic will not be a natural replacement for softened PVC, but some products need to contain products/parts in hard plastic to make the product work properly, for instance connections between the different parts of the products (tube and bag). All the products/parts necessary for the function of the ecolabelled product, can be included in the licence. Products that cannot be labelled These criteria are developed for products that are an alternative to products made of softened PVC. The environmental aspects related to disposable products made of other materials as the main material, like hard plastic or metals are not evaluated and hence cannot be ecolabelled within the scope of these criteria. 1 http://www.pvcfreebloodbag.eu/ (available 2019-01-08) Disposable bags, tubes and accessories for health care 3 Nordic Ecolabelling 098/2.2 05 May 2021 Background document Basically, only product types mentioned specifically in the product group definition can be labelled. Other relevant disposable health care products that are not mentioned above may be included in the product group if they are alternative products to products made of PVC softened with plasticisers and if they are governed by the aforementioned regulation and directive. This means that a major proportion of the products on the market must be based on PVC as a material for Nordic Ecolabelling to consider including these in the product group. This is because the environmental impact for these products are closely related to the material PVC and the different plasticisers used in PVC, see also chapter 5.2.1. Nordic Ecolabelling will decide which new products may be included in the product group based on information about the product and market situation. Medical gloves can be made of PVC, but a large proportion is also made of other materials like latex and nitrile. Nordic Ecolabelling has evaluated to set requirements for gloves specifically but have concluded to not include gloves in the product group definition. Both latex (natural) and nitrile have issues with allergy, and Nordic Ecolabelling see it as problematic to label gloves that could give an allergic reaction, either in form of the material itself (natural latex) or chemicals used in the production process, like accelerators. There is possible to make so-called accelerator-free gloves of nitrile, but at the moment these gloves make up a very little proportion of the market, around 1%. The total evaluation is therefore that Nordic Ecolabelling does not use resources to develop criteria for such a small proportion of the market. The exact product group definition in the criteria is: Disposable products that can be labelled must be single-use products included under the Regulation (EU) 2017/745 on medical devices with subsequent amendments and adaptations and/or EU Medicinal Products Directive (2001/83/EC) as applicable. It is emphasized that Nordic Ecolabelling do not put any requirements to the medicinal product, but it is important that the medicinal product is according to the regulations and relevant directives. The disposable product must be an alternative to products of softened PVC on the market. Products that can be labelled are: • intravenous (IV) infusion treatment • blood bags • peritoneal dialysis (PD) treatment • treatment of urinary retention and incontinence • ostomy pouches and accessories for treatment following ileostomy, colostomy, or ureterostomy surgery Other relevant disposable health care products, that are not mentioned above, may be included in the product group if they are an alternative to products made of softened PVC and if they are governed by the aforementioned regulation and directive. Nordic Ecolabelling will decide which new products may be included in the product group. Some disposable products for medical use that are not included in these criteria can be labelled under the criteria for sanitary products, for example plasters, compresses, mattress covers/protectors, draw sheets, surgical gowns, patient gowns/patient covers, surgical masks and caps. Disposable bags, tubes and accessories for health care 4 Nordic Ecolabelling 098/2.2 05 May 2021 Background document Disposable medical gloves cannot be labelled. Justification for Nordic Ecolabelling The motive for starting ecolabelling of disposable products for the medical industry in 2007 was a potential for improvements in the waste cycle and for health by excluding PVC and harmful phthalates which are common to use as plasticisers. Production of PVC also have negative impacts on the environment. These aspects are still relevant today. Plastic materials other than PVC can also contain additives with a possible negative impact on the environment and health. As of today, Nordic Ecolabelling considers that purchasers of hospital products have a desire and need for a simple guide to a good environmental choice. Version and validity of the criteria The generation 1 of the criteria were published the first time on December 13, 2007. Generation 1 have been changed three times where a minor limit has been introduced for environmentally hazardous substances, a change regarding mandatory text together with the Nordic Swan Ecolabel and updating of the chemical requirements according to REACH and CLP. The criteria have also been extended with catheters and ostomy bags. Generation 1 of the criteria has been prolonged 6 times. Generation 2 of the criteria was decided September 09, 2019 and are valid until December 31, 2023. Nordic Swan Ecolabel licences in the Nordic Market There is today 1 licence that is valid in all the Nordic countries. The licence is for equipment for the treatment of peritoneal dialysis and comprises bags, tubing and different accessories in different sizes. 3 The Market The medical device industry is extensive and global, with a large number of international manufacturers often represented at the national level either through subsidiaries or trading companies. In the Nordic market there is a consolidation with fewer operators on the market in the last years.