The EU Green Claims Directive and the Waste Framework Directive are currently going through the trialogue process.
Green Claims Directive
On 14 February, the ENVI and IMCO Committees of the European Parliament met to vote on their draft joint ENVI/IMCO Report on the Commission proposal for a Green Claims Directive.
The vote on the Report passed, with 85 MEPs in favour, 2 against and 14 abstentions. In addition, all 28 compromise amendments also passed.
Of particular interest, amendments 65, 66 and 67 – which included a call for establishing a proper regulatory framework for using claims relating to sustainability, circularity, and origin of the product’s components both for medicinal products and medical devices – did not pass. This means that medical devices are not specifically targeted in the legislation. They nevertheless do continue to fall within scope, if sold in a business-to-consumer model.
Going forward, the report will be voted on in the plenary session of the European Parliament, most likely between 11 and 14 March.
Waste Framework Directive
The ENVI Committee also voted on their draft report on the Commission proposal for a targeted amendment of the Waste Framework Directive on food and textiles. The vote on the Report also passed, with a remarkable 72 votes in favour, 0 against and 3 abstentions.
It is important to bring attention on the Commission proposal Article 22a which tackles the extended producer responsibility scheme for textiles. It states that Member States shall ensure that producers (defined as “any manufacturer, importer or distributor or other natural or legal person”) of textiles cover the costs of collection of used products, transportation and sorting of re-use or recycling operations.
The textile items that fall within the scope of this amendment to the Waste Framework Directive, as per the original Commission proposal, are expressed in Annex IVc. The ones that have been observed as being of interest to the Medical Devices industry are the following:
- Single use gowns of any kind used by patients or surgeons during surgical procedures (CN Code 6210 10 92);
- Hairnets of any material, whether or not lined or lined or trimmed (CN Code 6505 00 90);
- Other footwear with outer soles and uppers of rubber or plastic covering the ankle (CN Code 6402 91 90);
Certain MEPs from the ENVI Committee did table two amendments (AM 517 and AM 519) to grant derogations for the aforementioned textile items, but they were voted against in yesterday’s Committee vote. Please note that the amendments included derogations for medical apparel together with derogations for (more controversial) fashion apparel and industrial apparel – rather than being specific and targeted.
Going forward, the Report will most likely be voted in the next plenary session of the European Parliament, between 11 and 14 March. We would like to ask members to check the extent of their exposure to the products that will fall within scope of Annex IVc and Article 22a in order to decide on next steps.
This information is kindly provided by MedTech Europe.
