Trade and business associations · BE
Feedback on the EU Commission proposal for a regulation on packaging and packaging waste April 2023 General remarks EuromContact strongly supports the general objective for the revision of Directive 94/62/EC on Packaging and Packaging Waste to transform it into a regulation and tackle the environmental impact of packaging and packaging waste. The contact lens and lens care manufacturers have substantially minimized the packaging for their products. The industry is continuously seeking ways towards safe, sustainable and recyclable packaging materials, be it paper-based or recycled materials. Manufacturers are also committed to raise public awareness of the proper disposal of end-of-life products, exploiting already existing or new recycling schemes.
…public awareness of the proper disposal of end-of-life products, exploiting already existing or new recycling schemes. In order to provide a clear legal framework throughout the EU, EuromContact insists on the fact that the review must be carried out in line with the following policy objectives : - consistent requirements between sectorial legislation such as Regulation (EU)2017/745 on medical devices and the packaging and packaging waste regulation ; - a well-functioning Internal Market through fully harmonized rules on packaging waste and sorting labelling. The following proposals aims : - at increasing the consistency between the regulation on packaging and the medical devices regulation (MDR) - and at establishing harmonised EU requirements and legislation for packaging.
…the medical devices regulation (MDR) - and at establishing harmonised EU requirements and legislation for packaging. The need to ensure consistency between the regulation on packaging and the medical devices regulation (MDR) Medical Devices such as contact lenses and lens care products are governed by the Medical Devices Regulation. Specificities of medical devices should be taken in consideration when setting new requirements through the packaging and packaging waste regulation. For instance, the MDR in its Annex I provides labeling and packaging requirements specific to the medical devices sector. On the other hand, we consider that implementation of MDR should also be consistent with the ambitions set out in the Green Deal, including on higher level of ambition for packaging waste prevention.
…with the ambitions set out in the Green Deal, including on higher level of ambition for packaging waste prevention. Therefore, packaging minimization should also be fostered when implementing MDR as long as it ensures patient safety. > Recyclability (article 6) : the derogation for contact-sensitive plastic packaging is welcomed and should be extended to other material such as aluminium EuromContact welcomes the time-limited derogation for contact-sensitive plastic packaging from recyclability requirements. This will provide the necessary time to develop and validate adequate alternative materials considering the requirements of the sectorial legislation : Regulation (EU) 2017/745 on medical devices. Ref.
…considering the requirements of the sectorial legislation : Regulation (EU) 2017/745 on medical devices. Ref. Ares(2023)2890396 - 24/04/2023 2 Considering the fact that the delegated acts on recyclability are expected to be published at the earliest 3 years after the publication of the regulation, it will not be possible for other packaging of medical devices to comply by 1 January 2030 with the design for recycling criteria laid down in the delegated acts. Under the MDR, materials may have to comply with specific requirements to preserve the quality of the device. The packaging used to protect these products, especially for sterile products, are part of the medical device conformity assessment. Considering the specific process to comply with the requirements of MDR, the implementation of changes takes significantly more time than in other sectors.
…comply with the requirements of MDR, the implementation of changes takes significantly more time than in other sectors. This exemption should be extended to be material neutral for any packaging of medical devices covered by MDR, or at least to aluminum. Whereas foils in aluminum are mentioned in annex II, appropriate transition period will be necessary for these packaging between the establishment of design for recycling criteria and recycling performance grades by delegated act and their enforcement.
…establishment of design for recycling criteria and recycling performance grades by delegated act and their enforcement. > Recycled content (article 7) : the exemption for contact-sensitive plastic packaging of medical devices is a necessity EuromContact also welcomes the exemption from minimum recycled content requirements for contact- sensitive plastic packaging of medical devices, which is necessary for patient safety since to date, much like polymer based materials, qualified recycled alternatives to these materials for use in the medical device and pharma space have not been identified for commercial use. The fact that the derogation for medical devices can be revised by adopting a delegated act creates legal uncertainty whereas, as explains above, any change of material has to be anticipated several years in advance in order to be compliant with MDR.
…above, any change of material has to be anticipated several years in advance in order to be compliant with MDR. For instance, even once developed and introduced to the marketplace these alternates would require several levels of qualification ranging from basic Chemistry screening to shelf life related activities which include Toxicological analysis in accordance with ISO 10993. This testing would also include any equipment and/or sterilization process re-validation work that may be necessary. Based upon the class of each medical device it is safe to say timing for such an organizationally supported effort would easily be in the three to five year timeframe that should be added to the time for those technologies to be developed and introduced at appropriate scale to the market.
…should be added to the time for those technologies to be developed and introduced at appropriate scale to the market. Below few examples of testing timeframe: - Process Development (including accelerated shelf life and sterilization validation) – 2.25 years - Equipment verification and validation – 2.50 years - Regulatory submission and approval – 6 months to 1 year pending jurisdiction under MDD, longer time expected under MDR. EuromContact reiterates that patient safety and consistency with MDR regulation should be the priority when assessing the need for derogations. In any case, appropriate transition period should be carefully assessed before changing the regulation on the material used for medical devices packaging.
…period should be carefully assessed before changing the regulation on the material used for medical devices packaging. > Packaging minimization (article 9) : eIFU and proportionate labelling requirements would help to limit packaging size and reduce waste EuromContact welcomes the ambition set out in the regulation regarding packaging minimization. In consistency with this objective, EuromContact calls for allowing mandatory product information for consumer use, including medical devices for lay-users, to be provided through electronic means. EuromContact thinks that packaging minimization should remain a target when setting additional labelling requirements which increase the size of the packaging to be affixed.
…remain a target when setting additional labelling requirements which increase the size of the packaging to be affixed. For instance, the requirements set in the draft delegated regulation amending MDR as regards the assignment of Unique Device Identifiers for contact lenses increases the size of the information to encode in the labelling in a disproportionate way that challenges the packaging minimization objectives.
…information to encode in the labelling in a disproportionate way that challenges the packaging minimization objectives. When it comes to article 11 of the regulation on packaging and packaging waste, it is mentioned that “where EU legislation requires information on the packaged product to be provided via a data carrier, a single data carrier shall be used for providing the information required for both the packaged product and the packaging.” 3 It should be ensured that a single data carrier could provide the information required for both the medical device and its packaging without misleading patients and health care professionals. Conflict of legislation shall be avoided by all means.
14 → 12
Euromcontact a.i.s.b.l 10 rue de Tamines 1060 Brussels- BE www.euromcontact.eu Brussels, 5th January 2021 EUROMCONTACT contribution to the European Commission consultation on the rules on placing on the market of packaging and packaging waste prevention and management EUROMCONTACT is the European association representing the contact lens and lens care products manufacturers to the European Institutions and stakeholders. EUROMCONTACT is pleased to contribute to the Commission consultation on the rules on placing on the market of packaging and packaging waste prevention and management. EUROMCONTACT main comments are as follows: 1- Need of proportionate system that takes account of specificities EUROMCONTACT welcomes the ambition set out in the Green Deal including on higher level of ambition for packaging waste prevention and recycling waste targets.
…out in the Green Deal including on higher level of ambition for packaging waste prevention and recycling waste targets. The Directive on packaging and packaging waste has been amended several times, and the latest provisions shall be fully implemented as 2024. This means that the future revision of the targets should take due account of what has been achieved already. In addition, Art. 20 of the Directive 64/62 recognises the specificities of packaging for medical devices1. The contact lens and lens care manufacturers have substantially minimized the packaging for their products and this effort should be recognised. Similarly, specificities of medical devices should be taken in consideration when implementing the Directive on packaging and packaging waste.
…of medical devices should be taken in consideration when implementing the Directive on packaging and packaging waste. Medical Devices such as contact lens and lens care products are governed by the Medical Devices Directive and as from May 2021, by the Medical Devices Regulation. The MDR in its Annex I provides labeling and packaging requirements specific to the medical devices sector - these should be taken due consideration2. In particular, information regarding waste disposal should be provided in the instruction for use of the device, and not affixed on the packaging itself. 2- Need of harmonized rules for recycling logo and information relative to packaging waste EUROMCONTACT calls for fully harmonized rules when it comes to recycling logo.and information relative to packaging waste. The best solution would be to have one clearly identifiable recycling logo for the entire EU.
…to packaging waste. The best solution would be to have one clearly identifiable recycling logo for the entire EU. Indeed in recent year(s), the industry has witnessed some divergening attempts at national level on packaging - leading to possible threat to the EU internal market. 1 Art. 20 of Directive 94/62 stipulates “The Commission is empowered to adopt delegated acts in accordance with Article 21a in order to supplement this Directive where necessary to deal with any difficulties encountered in applying the provisions of this Directive, in particular, to inert packaging materials placed on the market in very small quantities (i.e. approximately 0,1 % by weight) in the Union, primary packaging for medical devices and pharmaceutical products, small packaging and luxury packaging.” 2 Reg. 2017/745 in its Annex I section 14.7 deals with environmental information. This Art.
…and luxury packaging.” 2 Reg. 2017/745 in its Annex I section 14.7 deals with environmental information. This Art. stipulates that measures on waste disposal after use shall be described in the instructions for use. The labelling and information of medical devices are part of the obligations that manufacturers shall abide to be able to place their products on the market. Ref. Ares(2021)106952 - 06/01/2021 Euromcontact a.i.s.b.l 10 rue de Tamines 1060 Brussels- BE www.euromcontact.eu Core elements of the provisions on packaging shall be defined and strengthened at European level - including scope, criteria to grant exemptions, logos including through guidance documents or harmonized European standards. These core EU principles are very much needed when transposing Directive into national legislations.
…standards. These core EU principles are very much needed when transposing Directive into national legislations. Diverging national experiences should be avoided at all costs, to avoid the fragmentation of the EU single market. Similarly, existing sectoral legislations - in the case of Medical Devices, the Medical Devices Regulation 2017/745, should be recognised and conflict of legislation avoided by all means. EUROMCONTACT is of the view that sectoral legislation governing medical devices supersedes any other legislation -as this was the intention of the legislators when shaping the MDR. The labeling requirement on the packaging of products subject to the principle of Extended Producer Responsibility should be harmonized at EU Level, to avoid further unnecessary and burdensome barriers to trade within the EU Single Market.
…be harmonized at EU Level, to avoid further unnecessary and burdensome barriers to trade within the EU Single Market. Attempts seen at national level would impose disproportionate financial and logistic burden on manufacturers to be able to place their products on members states’ markets, equivalent to a breach of the good functioning of the EU Single Market3. Finally, as one way to prevent waste and to meet the EU Green Deal ambitions, EUROMCONTACT calls for allowing mandatory product information for consumer use -including medical devices for lay-users- to be provided through electronic means. 3- Need of transition period Appropriate transition period towards new target should be carefully assessed.
…means. 3- Need of transition period Appropriate transition period towards new target should be carefully assessed. In the contact lens sector and in particular in the production of rigid gas permeable (RGP) contact lenses, made-to-order for specific patients’ needs, manufacturers are mostly local and small to medium size manufacturers. SMEs need time to adapt to new regulatory environment, especially considering that the transition from medical devices directive to medical devices regulation is absorbing all resources to upgrade the systems to be compliant by May 2021. The contact lens and lens care products manufacturers are committed to do more in terms of recycling, waste prevention and waste collection.
…lens care products manufacturers are committed to do more in terms of recycling, waste prevention and waste collection. Any objective on reusable packaging is conditional on having in place the right economically and logistically collection scheme- any objective towards more waste collection should include an appropriate transition period to accommodate the change that will impact complex and global supply chains for mass-produced devices. *** 3 As an example : French Decrêt implementing the Circular Economy Law 2020-15 of 10 February 2020 - Art 17 introducing a compulsory labelling requirement (Triman Logo) on packaging of products subject to the principle of Extended Producer Responsibility.
…requirement (Triman Logo) on packaging of products subject to the principle of Extended Producer Responsibility. Similarly, Spain’s requirement to include the Green Dot financing symbol on packaging, as evidence of participation in its Extended Producer Responsibility scheme, also undermines the EU single market, since Spain will become the only EU Member State in which this is compulsory from 2021 on.