Message 001
Communication from the Commission - TRIS/(2026) 1899
Directive (EU) 2015/1535
Notification: 2026/0369/ES
Notification of a draft text from a Member State
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Does not open the delays - N'ouvre pas de délai - Kein Fristbeginn - Не се предвижда период на прекъсване - Nezahajuje prodlení - Fristerne indledes ikke - Καμμία έναρξη προθεσμίας - No abre el plazo - Viivituste perioodi ei avata - Määräaika ei ala tästä - Ne otvara razdoblje kašnjenja - Nem nyitja meg a késéseket - Non fa decorrere la mora - Atidėjimai nepradedami - Atlikšanas laikposms nesākas - Ma jiftaħx il-perijodi ta’ dewmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Nu deschide perioadele de stagnare - Nezačína oneskorenia - Ne uvaja zamud - Inleder ingen frist - Ní osclaíonn sé na moilleanna
MSG: 20261899.EN
1. MSG 001 IND 2026 0369 ES EN 13-07-2026 ES NOTIF
2. Spain
3A. Subdirección General de Asuntos Industriales, Energéticos, de Transportes y Comunicaciones, y de Medio Ambiente
Dirección General de Coordinación del Mercado Interior y otras Políticas Comunitarias
Secretaría de Estado para la Unión Europea
Ministerio de Asuntos Exteriores, Unión Europea y Cooperación
3B. Subdirección General de Residuos
Dirección General de Calidad y Evaluación Ambiental
Secretaría de Estado de Medio Ambiente
Ministerio para la Transición Ecológica y el Reto Demográfico
4. 2026/0369/ES - S20E - Waste
5. Draft Royal Decree regulating the management of waste from wet wipes and balloons.
6. This Royal Decree applies to single-use wet wipes and single-use plastic balloons placed on the Spanish market, as well as to the waste generated by the use of those products.
7.
8. The notified measure addresses the risk arising from producers’ failure to sufficiently internalise the environmental, economic and human health impacts associated with waste from single-use wet wipes and single-use balloons containing plastic, which has resulted in high levels of litter and serious disruption to sanitation and wastewater treatment infrastructure.
The available evidence shows that both products are consistently among the most frequent items of marine litter in the European Union and generate significant transboundary impacts. This high presence indicates that current patterns of waste production, consumption and management are insufficient to prevent their release into the environment.(1)
In the case of wet wipes, the risk is not limited solely to those containing plastic. Accordingly, the draft legislation goes beyond the provisions of Directive 2019/904 and includes wet wipes made from unmodified natural polymers, where they do not comply with Standard UNE 149002:2022, Acceptance criteria for disposable products via toilet, as these products also fail to disintegrate properly and cause blockages, clogs and overflows. This in turn leads to direct discharge of waste into water bodies, generating very high economic costs for public water management bodies (2;3), borne mainly by local authorities and, ultimately, by the public.
This extension of the scope of application is based on the second paragraph of Final Provision Seven of Law 7/2022 of 8 April on waste and contaminated soil for a circular economy, which authorises extended producer responsibility to apply to other wet wipes not covered by Article 60(1) of the aforementioned law, which refers exclusively to wet wipes containing plastic.
For single-use balloons containing plastic, the risk stems from their widespread use in outdoor activities and their high propensity to become dispersed litter. The impact assessment for Directive (EU) 2019/904 also notes that there are currently no fully viable design alternatives capable of avoiding their environmental impact, which reinforces the need to introduce regulatory incentives addressing producers directly.
In this context, extended producer responsibility (EPR) is an appropriate and effective tool for achieving the public interest objectives pursued, as it allows the environmental and economic costs associated with waste prevention and management—which are not currently reflected in the price of the product—to be passed on to producers. Previous experience of implementing the EPR in Spain with other waste streams demonstrates the effectiveness of this approach.
The measure pursues the public interest objective in a coherent and systematic manner, by fully integrating itself into the framework of European and national waste legislation, applying the ‘polluter pays’ and ‘waste hierarchy’ principles, and implementing Law 7/2022 of 8 April from a circular economy perspective. The draft legislation involves all stakeholders, ensuring a proportionate and consistent approach aimed at effectively reducing the impact of these products.
(1) Impact assessment Part 2/3 - https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/1502-Reducing-marine-litter-action-on-single-use-plastics-and-fishing-gear_es
(2) https://www.eureau.org/documents/7858-position-paper-on-wet-wipes/file
(3) https://www.daquas.es/images/publicaciones/informacion-sector/2019-declaracionadhesion.pdf
(4) Impact assessment Part 2/3 - https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/1502-Reducing-marine-lit
9. The basis for this draft royal decree is found in Articles 37 and 60 of Law 7/2022 of 8 April on waste and contaminated soil for a circular economy, which provides for the development of an extended producer responsibility scheme for single-use wipes and balloons which contain plastic.
9a. The notified measure addresses the risk arising from producers’ failure to sufficiently internalise the environmental, economic and human health impacts associated with waste from single-use wet wipes and single-use balloons containing plastic, which has resulted in high levels of litter and serious disruption to sanitation and wastewater treatment infrastructure.
The available evidence shows that both products are consistently among the most frequent items of marine litter in the European Union and generate significant transboundary impacts (* 1). This high presence indicates that current patterns of waste production, consumption and management are insufficient to prevent their release into the environment.
In the case of wet wipes, the risk is not limited solely to those containing plastic. Accordingly, the draft legislation goes further and includes wet wipes made from unmodified natural polymers, where they do not comply with Standard UNE 149002:2022, Acceptance criteria for disposable products via toilet, as these products also fail to disintegrate properly and cause blockages, clogs and overflows. This in turn leads to direct discharge of waste into water bodies, generating very high economic costs for public water management bodies (*2 and 3), borne mainly by local authorities and, ultimately, by the public.
This extension of the scope of application is based on the second paragraph of Final Provision Seven of Law 7/2022 of 8 April on waste and contaminated soil for a circular economy, which allows extended producer responsibility to cover other wet wipes not included in Article 60(1) of the aforementioned law, which refers exclusively to wet wipes containing plastic.
For single-use balloons containing plastic, the risk stems from their widespread use in outdoor activities and their high propensity to become dispersed litter. The impact assessment for Directive (EU) 2019/904 (*4) also notes that there are currently no fully viable design alternatives that would prevent its environmental impact, which reinforces the need to introduce regulatory incentives addressing producers directly.
In this context, extended producer responsibility (EPR) is an appropriate and effective tool for achieving the public interest objectives pursued, as it allows the environmental and economic costs associated with waste prevention and management—which are not currently reflected in the price of the product—to be passed on to producers. Previous experience of implementing the EPR in Spain with other waste streams demonstrates the effectiveness of this approach.
The measure pursues the public interest objective in a coherent and systematic manner, by fully integrating itself into the framework of European and national waste legislation, applying the ‘polluter pays’ and ‘waste hierarchy’ principles, and implementing Law 7/2022 of 8 April from a circular economy perspective. The draft legislation involves all stakeholders, ensuring a proportionate and consistent approach aimed at effectively reducing the impact of these products.
(*1) Impact assessment Part 2/3 - https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/1502-Reducing-marine-litter-action-on-single-use-plastics-and-fishing-gear_es
(*2) https://www.eureau.org/documents/7858-position-paper-on-wet-wipes/file
(*3) 2019-declaracionadhesion.pdf
(*4) Impact assessment Part 2/3 - https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/1502-Reducing-marine-litter-action-on-single-use-plastics-and-fishing-gear_es
9b. The notified draft measure falls within the scope of the information and implementation obligations established at European level in the field of waste, and does not constitute a restriction on the internal market. It introduces obligations for producers of wet wipes and balloons (EPR), as well as labelling requirements and obligations relating to data collection and reporting. These obligations are already being widely implemented in Member States and are aligned with the objective of financing the costs arising from waste management, in particular those related to the clean-up, transport and treatment of litter.
The impact on cross-border trade and services is limited to requiring that any producer, regardless of origin (domestic, from another Member State or from a third country), placing these products on the Spanish market, complies with the established obligations, such as registration in the relevant register, participation in a EPR scheme, and therefore complies with its financial and reporting obligations. These requirements are consistent with the mandatory implementation throughout the European Union of Directive (EU) 2019/904, which ensures a harmonised framework and avoids significant distortions in the internal market.
The draft legislation incorporates two specific provisions at national level, underpinned by Spain’s primary legislation, with the aim of serving the public interest and reducing the negative environmental impacts associated with inadequate management:
(i) it includes within its scope wet wipes made from chemically unmodified natural polymers, provided that they do not comply with the UNE 149002:2022 standard, i.e. non-SUP wipes (a possibility already mentioned in paragraph 1);
(ii) it establishes an obligation for the producers of all wipes covered by the standard to finance the clean-up of litter scattered across sanitation and wastewater treatment infrastructure (an aspect that was already part of the circular economy). Furthermore, it forms part of a coordinated strategy at European Union level, ensuring regulatory consistency, legal certainty and the proper functioning of the single market (as notified through the TRIS system when Law 7/2022 was notified). This financing will be phased in gradually, reaching 100% of the costs by 2032 for SUP wipes and half the costs for non-SUP wipes.
There is currently no regulatory framework that comprehensively contemplates measures aimed at preventing and correcting the impacts of these wastes, nor are there specific legal instruments addressing these risks at source. The proposed measure constitutes the necessary development of the current regulations in order to respond effectively to these challenges.
As alternatives, consideration has been given, on the one hand, to the option of not regulating these waste streams or implementing EPR schemes. This has been ruled out as it is incompatible with the obligation to transpose Directive (EU) 2019/904. On the other hand, it has been considered to limit the scope of the measure strictly to the provisions of that Directive, thereby excluding certain wet wipes. However, this option was also rejected due to the need, in accordance with national legislation, to address the negative impact of these products which, although not expressly included in the Directive, generate significant problems in the field of sanitation and the environmental protection.
In this regard, the measure adopted is the least restrictive means of achieving the objectives sought, as it establishes a proportionate set of obligations designed to reduce the generation of litter and its impact on ecosystems – particularly marine ecosystems – as well as the costs associated with maintaining public infrastructure. If this measure is not adopted, these costs would continue to increase and be borne by taxpayers, whereas the measure encourages prevention, innovation, eco-design and the transition towards
9c. The restrictions imposed by the measure are proportionate in relation to the importance of the public interest objective pursued, which is to reduce negative impacts on the environment, the economy and health. These impacts are not hypothetical, but a proven reality that affects the beaches, seas and oceans of the European Union (1), aquatic and terrestrial ecosystems, as well as sanitation and purification infrastructures in urban and rural environments. The increasing magnitude of these impacts and their worsening trend justify the adoption of regulatory measures such as those envisaged, in line with the European Union's and the Member States' efforts to promote waste prevention and the circular economy.
In this context, due consideration has been given to the protection of the public interest in relation to the potential degree of interference with the functioning of the internal market, and it has been concluded that the former clearly takes precedence. The increase in marine plastic waste poses a significant threat to ecosystems, biodiversity and human health, as well as to key economic sectors such as tourism, fisheries and maritime transport, and is a cross-border problem. According to the impact assessment for Directive (EU) 2019/904, the implementation of the planned measures – which include extended producer responsibility, reduction targets and labelling requirements – will lead to a substantial reduction in marine litter. it is estimated that, in the case of single-use plastics, the volume of such litter could be reduced by approximately one half.
In addition, failure to achieve the public interest objectives would result in significantly greater harm than that resulting from the application of the measure. According to the aforementioned impact assessment, the implementation of the measures relating to single-use plastics by 2030 would make it possible to avoid the emission of 2.6 million tonnes of CO₂ equivalent and avoid environmental damage valued at EUR 11 billion. Although these measures entail compliance costs for businesses (around EUR 2 billion) and waste management costs (around EUR 510 million), they also result in significant savings for consumers, estimated at approximately EUR 6.5 billion, albeit accompanied by certain changes in consumption patterns.
In any event, the draft legislation sets out a phased approach to the financing of the costs of cleaning sanitation and wastewater treatment infrastructure. This will mitigate the financial impact on wet wipe producers, facilitate the gradual adaptation of the companies affected, and may be accompanied by measures to encourage consumers to adopt more appropriate consumption and waste disposal habits, which will also result in a reduction in the costs to be borne by producers.
Consequently, the measure presents an appropriate balance between the benefits pursued and the burdens imposed, as it is a proportionate and necessary instrument to address a problem of increasing environmental and social relevance.
(1) Joint Research Centre (JRC), Georg Hanke, JRC Technical Reports, “Marine Beach Litter in Europe – Top Items”, 2016
10. References to basic texts: 2020/0658/E
The basic texts were forwarded with an earlier notification:
2020/0658/E
11. No
12.
13. No
14. No
15. Yes
16.
TBT aspects:
The draft is a technical regulation or a conformity assessment
SPS aspects: No
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European Commission
Contact point Directive (EU) 2015/1535
email: grow-dir2015-1535-central@ec.europa.eu
