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Directive (EU) 2019/904 of the European Parliament and of the CouncilShow full title

Directive (EU) 2019/904 of the European Parliament and of the Council of 5 June 2019 on the reduction of the impact of certain plastic products on the environment (Text with EEA relevance)

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Directive (EU) 2019/904 of the European Parliament and of the Council

of 5 June 2019

on the reduction of the impact of certain plastic products on the environment

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 192(1) thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee(1),

Having regard to the opinion of the Committee of the Regions(2),

Acting in accordance with the ordinary legislative procedure(3),

Whereas:

(1) The high functionality and relatively low cost of plastic means that this material is increasingly ubiquitous in everyday life. While plastic plays a useful role in the economy and provides essential applications in many sectors, its growing use in short-lived applications, which are not designed for re-use or cost-effective recycling, means that related production and consumption patterns have become increasingly inefficient and linear. Therefore, in the context of the Circular Economy Action Plan laid down in the Communication of the Commission of 2 December 2015 entitled ‘Closing the loop – An EU action plan for the Circular Economy’, the Commission concluded in the European Strategy for Plastics laid down in its Communication of 16 January 2018 entitled ‘A European Strategy for Plastics in a Circular Economy’ that the steady increase in plastic waste generation and the leakage of plastic waste into the environment, in particular into the marine environment, must be tackled in order to achieve a circular life cycle for plastics. The European Strategy for Plastics is a step towards establishing a circular economy in which the design and production of plastics and plastic products fully respect re-use, repair and recycling needs and in which more sustainable materials are developed and promoted. The significant negative environmental, health and economic impact of certain plastic products calls for the setting up of a specific legal framework to effectively reduce those negative effects.

(2) This Directive promotes circular approaches that give priority to sustainable and non-toxic re-usable products and re-use systems rather than to single-use products, aiming first and foremost to reduce the quantity of waste generated. Such waste prevention is at the pinnacle of the waste hierarchy enshrined in Directive 2008/98/EC of the European Parliament and of the Council(4). This Directive will contribute to the achievement of United Nations (UN) Sustainable Development Goal 12 to ensure sustainable consumption and production patterns, which is part of the 2030 Agenda for Sustainable Development adopted by the UN General Assembly on 25 September 2015. By retaining the value of products and materials for as long as possible and generating less waste, the economy of the Union can become more competitive and more resilient, while reducing pressure on precious resources and the environment.

(3) Marine litter is transboundary in nature and is recognised as a growing global problem. Reducing marine litter is a key action for the achievement of UN Sustainable Development Goal 14 which calls to conserve and sustainably use the oceans, seas and marine resources for sustainable development. The Union must play its part in preventing and tackling marine litter and aim to be a standard setter for the world. In that context, the Union is working with partners in many international fora such as G20, G7 and the UN to promote concerted action and this Directive is part of the Union’s efforts in that regard. In order for those efforts to be effective, it is also important that exports of plastic waste from the Union do not result in increased marine litter elsewhere.

(4) In accordance with the United Nations Convention on the Law of the Sea of 10 December 1982 (UNCLOS)(5), the Convention on the Prevention of Marine Pollution by Dumping of Wastes and Other Matter of 29 December 1972 (‘London Convention’) and its 1996 Protocol (‘London Protocol’), Annex V to the International Convention for the Prevention of Pollution from Ships 1973 (MARPOL), as modified by the Protocol of 1978 relating thereto, and the Basel Convention on the control of transboundary movements of hazardous wastes and their disposal of 22 March 1989(6) and with Union waste legislation, namely Directive 2008/98/EC and Directive 2000/59/EC of the European Parliament and of the Council(7), Member States are required to ensure environmentally sound waste management to prevent and reduce marine litter from both sea and land sources. In accordance with Union water legislation, namely Directives 2000/60/EC(8) and 2008/56/EC(9) of the European Parliament and of the Council, Member States are also required to tackle marine litter where it undermines the attainment of good environmental status of their marine waters, including as a contribution to UN Sustainable Development Goal 14.

(5) In the Union, 80 to 85 % of marine litter, measured as beach litter counts, is plastic, with single-use plastic items representing 50 % and fishing-related items representing 27 % of the total. Single-use plastic products include a diverse range of commonly used fast-moving consumer products that are discarded after having been used once for the purpose for which they were provided, are rarely recycled, and are prone to becoming litter. A significant proportion of the fishing gear placed on the market is not collected for treatment. Single-use plastic products and fishing gear containing plastic are therefore a particularly serious problem in the context of marine litter, pose a severe risk to marine ecosystems, to biodiversity and to human health and damage activities such as tourism, fisheries and shipping.

(6) Proper waste management remains essential for the prevention of all litter, including marine litter. Existing Union legislation, namely Directives 2008/98/EC, 2000/59/EC, 2000/60/EC and 2008/56/EC and Council Regulation (EC) No 1224/2009(10), and policy instruments provide some regulatory responses to address marine litter. In particular, plastic waste is subject to overall Union waste management measures and targets, such as the recycling target for plastic packaging waste laid down in European Parliament and Council Directive 94/62/EC(11) and the objective in the European Strategy for Plastics to ensure that by 2030 all plastic packaging placed on the Union market is re-usable or easily recycled. However, the impact of those measures on marine litter is not sufficient and there are differences in the scope and the level of ambition amongst national measures to prevent and reduce marine litter. In addition, some of those measures, in particular marketing restrictions for single-use plastic products, could create barriers to trade and distort competition in the Union.

(7) To focus efforts where they are most needed, this Directive should cover only those single-use plastic products that are found the most on beaches in the Union as well as fishing gear containing plastic and products made from oxo-degradable plastic. The single-use plastic products covered by measures under this Directive are estimated to represent around 86 % of the single-use plastics found, in counts, on beaches in the Union. Glass and metal beverage containers should not be covered by this Directive as they are not among the single-use plastic products that are found the most on beaches in the Union.

(8) Microplastics do not fall directly within the scope of this Directive, yet they contribute to marine litter and the Union should therefore adopt a comprehensive approach to that problem. The Union should encourage all producers to strictly limit microplastics in their formulations.

(9) Terrestrial pollution and contamination of soil by larger items of plastic and resulting fragments or microplastics can be significant and such plastic can leak into the marine environment.

(10) This Directive is a lex specialis in relation to Directives 94/62/EC and 2008/98/EC. In the event of a conflict between those Directives and this Directive, this Directive should prevail within the scope of its application. That is the case for restrictions on placing on the market. In particular with regard to consumption reduction measures, product requirements, marking requirements and extended producer responsibility, this Directive supplements Directives 94/62/EC and 2008/98/EC and Directive 2014/40/EU of the European Parliament and of the Council(12).

(11) Single-use plastic products can be manufactured from a wide range of plastics. Plastics are usually defined as polymeric materials to which additives may have been added. However, that definition would cover certain natural polymers. Unmodified natural polymers, within the meaning of the definition of ‘not chemically modified substances’ in point 40 of Article 3 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council(13), should not be covered by this Directive as they occur naturally in the environment. Therefore, for the purposes of this Directive, the definition of polymer in point 5 of Article 3 of Regulation (EC) No 1907/2006 should be adapted and a separate definition should be introduced. Plastics manufactured with modified natural polymers, or plastics manufactured from bio-based, fossil or synthetic starting substances are not naturally occurring and should therefore be addressed by this Directive. The adapted definition of plastics should therefore cover polymer-based rubber items and bio-based and biodegradable plastics regardless of whether they are derived from biomass or are intended to biodegrade over time. Paints, inks and adhesives should not be addressed by this Directive and therefore these polymeric materials should not be covered by the definition.

(12) In order to clearly define the scope of this Directive, the term ‘single-use plastic product’ should be defined. The definition should exclude plastic products that are conceived, designed and placed on the market to accomplish within their life span multiple trips or rotations by being refilled or re-used for the same purpose for which they are conceived. Single-use plastic products are typically intended to be used just once or for a short period of time before being disposed of. Wet wipes for personal care and domestic use should also be within the scope of this Directive, whereas industrial wet wipes should be excluded. To further clarify whether a product is to be considered a single-use plastic product for the purposes of this Directive, the Commission should develop guidelines on single-use plastic products. In view of the criteria set out in this Directive, examples of food containers to be considered as single-use plastic products for the purposes of this Directive are fast-food containers or meal, sandwich, wrap and salad boxes with cold or hot food, or food containers of fresh or processed food that does not need further preparation, such as fruits, vegetables or desserts. Examples of food containers that are not to be considered as single-use plastic products for the purposes of this Directive are food containers with dried food or food that is sold cold requiring further preparation, containers containing food in more than single-serve portions or single-serve portion-sized food containers sold in more than one unit. Examples of beverage containers to be considered as single-use plastic products are beverage bottles or composite beverage packaging used for beer, wine, water, liquid refreshments, juices and nectars, instant beverages or milk, but not cups for beverages as these are a separate category of single-use plastic products for the purposes of this Directive. As they are not among the single-use plastic products that are found the most on beaches in the Union, glass and metal beverage containers should not be covered by this Directive. However, the Commission should, in the context of the review of this Directive, evaluate, inter alia, caps and lids made of plastic used for glass and metal beverage containers.

(13) Single-use plastic products covered by this Directive should be addressed by one or several measures, depending on various factors, such as the availability of suitable and more sustainable alternatives, the feasibility of changing consumption patterns, and the extent to which they are already covered by existing Union legislation.

(14) For certain single-use plastic products, suitable and more sustainable alternatives are not yet readily available and the consumption of most such single-use plastic products is expected to increase. To reverse that trend and to promote efforts towards more sustainable solutions, Member States should be required to take the necessary measures, for example by setting national consumption reduction targets, to achieve an ambitious and sustained reduction in the consumption of those products, without compromising food hygiene, food safety, good hygiene practices, good manufacturing practices, consumer information, or traceability requirements set out in Regulations (EC) No 178/2002(14), (EC) No 852/2004(15) and (EC) No 1935/2004(16) of the European Parliament and of the Council and other relevant legislation related to food safety, hygiene and labelling. Member States should have the highest possible ambition for those measures, which should induce a substantial reversal of increasing consumption trends and lead to a measurable quantitative reduction. Those measures should take into account the impact of products throughout their life cycle, including when they are found in the marine environment, and should respect the waste hierarchy. Where Member States decide to implement that obligation through marketing restrictions, they should ensure that such restrictions are proportionate and non-discriminatory. Member States should encourage the use of products that are suitable for multiple use and that are, after having become waste, suitable for preparing for re-use and recycling.

(15) For other single-use plastic products, suitable and more sustainable alternatives that are also affordable are readily available. In order to limit the adverse impact of such single-use plastic products on the environment, Member States should be required to prohibit their placing on the market. By doing so, the use of those readily available and more sustainable alternatives as well as of innovative solutions towards more sustainable business models, re-use alternatives and substitution of materials would be promoted. The restrictions on placing on the market introduced in this Directive should also cover products made from oxo-degradable plastic, as that type of plastic does not properly biodegrade and thus contributes to microplastic pollution in the environment, is not compostable, negatively affects the recycling of conventional plastic and fails to deliver a proven environmental benefit. Furthermore, in view of the high prevalence of expanded polystyrene litter in the marine environment and the availability of alternatives, single-use food and beverage containers and cups for beverages made of expanded polystyrene should also be restricted.

(16) Tobacco product filters containing plastic are the second most found single-use plastic items on beaches in the Union. The huge environmental impact caused by post-consumption waste of tobacco products with filters containing plastic, discarded directly into the environment, needs to be reduced. Innovation and product development are expected to provide viable alternatives to filters containing plastic and need to be accelerated. Extended producer responsibility schemes for tobacco products with filters containing plastic should also encourage innovation leading to the development of sustainable alternatives to tobacco product filters containing plastic. Member States should promote a wide range of measures to reduce litter from post-consumption waste of tobacco products with filters containing plastic.

(17) Caps and lids made of plastic which are used for beverage containers are among the single-use plastic items that are found the most on beaches in the Union. Therefore, beverage containers that are single-use plastic products should only be allowed to be placed on the market if they fulfil specific product design requirements that significantly reduce the dispersal into the environment of beverage container caps and lids made of plastic. For beverage containers that are both single-use plastic products and packaging, that requirement is in addition to the essential requirements on the composition and the re-usable and recoverable, including recyclable, nature of packaging set out in Annex II to Directive 94/62/EC. In order to facilitate conformity with the product design requirement and to ensure the smooth functioning of the internal market, it is necessary to develop a harmonised standard adopted in accordance with Regulation (EU) No 1025/2012 of the European Parliament and of the Council(17), and compliance with that standard should give rise to a presumption of conformity with those requirements. Therefore, the timely development of a harmonised standard is of the highest priority in ensuring effective implementation of this Directive. Sufficient time should be envisaged for the development of a harmonised standard and to allow the producers to adapt their production chains in relation to the implementation of the product design requirement. In order to ensure the circular use of plastics, the market uptake of recycled materials needs to be promoted. It is therefore appropriate to introduce requirements for a mandatory minimum content of recycled plastic in beverage bottles.

(18) Plastic products should be manufactured taking into account their entire life span. The design of plastic products should always take into account the production and use phase and the reusability and recyclability of the product. In the context of the review to be undertaken pursuant to Article 9(5) of Directive 94/62/EC, the Commission should take into account the relative properties of different packaging materials, including composite materials, on the basis of life cycle assessments, addressing in particular waste prevention and design for circularity.

(19) The presence of hazardous chemical substances in sanitary towels, tampons and tampon applicators should be avoided in the interest of women’s health. In the framework of the restrictions process under Regulation (EC) No 1907/2006, it is appropriate for the Commission to assess further restrictions on such substances.

(20) Certain single-use plastic products end up in the environment as a result of inappropriate disposal through the sewer system or other inappropriate release into the environment. Disposal through the sewer system can in addition cause substantial economic damage to sewer networks by clogging pumps and blocking pipes. For those products, there is frequently a significant lack of information about the material characteristics of the product or the appropriate means of waste disposal. Therefore, single-use plastic products that are frequently disposed of through the sewer system or otherwise inappropriately disposed of should be subject to marking requirements. The marking should inform consumers about appropriate waste management options for the product or which waste disposal means are to be avoided for the product in line with the waste hierarchy, and about the presence of plastics in the product as well as the resulting negative environmental impact of littering or of other inappropriate means of disposal of the product. The marking should, as appropriate, be either on the packaging of the product or directly on the product itself. The Commission should be empowered to establish harmonised specifications for the marking and when doing so should, where appropriate, test the perception of the proposed marking with representative groups of consumers to ensure that it is effective and easily understandable. Marking requirements are already required for fishing gear pursuant to Regulation (EC) No 1224/2009.

(21) With regard to single-use plastic products for which no suitable and more sustainable alternatives are readily available, Member States should, in line with the polluter-pays principle, also introduce extended producer responsibility schemes to cover the necessary costs of waste management and clean-up of litter as well as the costs of awareness raising measures to prevent and reduce such litter. Those costs should not exceed the costs that are necessary to provide those services in a cost-efficient way and should be established in a transparent way between the actors concerned.

(22) Directive 2008/98/EC lays down general minimum requirements for extended producer responsibility schemes. Those requirements should apply to the extended producer responsibility schemes established by this Directive, irrespective of whether their mode of implementation is by legislative act or by means of agreements under this Directive. The relevance of some requirements depends on the characteristics of the product. Separate collection is not required to ensure proper treatment in line with the waste hierarchy for tobacco products with filters containing plastic, wet wipes and balloons. Therefore setting up separate collection for those products should not be mandatory. This Directive should establish extended producer responsibility requirements in addition to those laid down by Directive 2008/98/EC, for example, the requirement for producers of certain single-use plastic products to cover the costs of cleaning up litter. It should also be possible to cover the costs of the setting up of specific infrastructure for collection of post-consumption waste of tobacco products, such as appropriate waste receptacles in common litter hotspots. The calculation methodology for the costs of cleaning up litter should take into account considerations of proportionality. To minimise administrative costs, Member States should be able to determine financial contributions towards the costs of cleaning up litter by setting appropriate multiannual fixed amounts.

(23) The large percentage of plastic stemming from discarded fishing gear, including abandoned and lost fishing gear, in marine litter indicates that the existing legal requirements laid down in Regulation (EC) No 1224/2009, Directive 2000/59/EC and Directive 2008/98/EC do not provide sufficient incentives to return such fishing gear to shore for collection and treatment. The indirect fee system set up under Directive (EU) 2019/883 of the European Parliament and of the Council(18) provides a system for removing the incentive for ships to discharge their waste at sea, and ensures a right of delivery. That system should, however, be supplemented by further financial incentives for fishermen to bring their waste fishing gear on shore to avoid any potential increase in the indirect waste fee to be paid. As plastic components of fishing gear have high recycling potential, Member States should, in line with the polluter-pays principle, introduce extended producer responsibility for fishing gear and components of fishing gear containing plastic to ensure separate collection of waste fishing gear and to finance environmentally sound waste management of waste fishing gear, in particular recycling.

(24) In the framework of an extended producer responsibility for fishing gear containing plastic, Member States should monitor and assess, in line with the reporting obligations laid down in this Directive, fishing gear containing plastic.

(25) While all marine litter containing plastic poses a risk to the environment and to human health and should be tackled, proportionality considerations should also be taken into account. Therefore, the fishermen themselves and artisanal makers of fishing gear containing plastic should not be considered as producers and should not be held responsible for fulfilling the obligations of the producer related to the extended producer responsibility.

(26) Economic and other incentives to support sustainable consumer choices and promote responsible consumer behaviour can be an effective tool for achieving the objectives of this Directive.

(27) Beverage bottles that are single-use plastic products are one of the marine litter items that are found the most on beaches in the Union. This is due to ineffective separate collection systems and low participation in those systems by consumers. It is necessary to promote more effective separate collection systems. Therefore, a minimum separate collection target should be established for beverage bottles that are single-use plastic products. While the obligation to separately collect waste requires that waste be kept separate by type and nature, it should be possible to collect certain types of waste together provided that this does not impede high-quality recycling in line with the waste hierarchy in accordance with Article 10(2) and point (a) of Article 10(3) of Directive 2008/98/EC. The setting of the separate collection target should be based on the amount of single-use plastic beverage bottles placed on the market in a Member State or alternatively on the amount of waste single-use plastic beverage bottles generated in a Member State. The calculation of the amount of waste generated in a Member State should take due account of all waste single-use plastic beverage bottles generated, including those which become litter instead of being disposed of through waste collection systems. Member States should be able to achieve that minimum target by setting separate collection targets for beverage bottles that are single-use plastic products in the framework of the extended producer responsibility schemes, by establishing deposit-refund schemes or by any other measure that they find appropriate. That will have a direct, positive impact on the collection rate, the quality of the collected material and the quality of the recyclates, offering opportunities for the recycling business and the market for the recyclates. It will support reaching the recycling targets for packaging waste set in Directive 94/62/EC.

(28) In order to prevent littering and other inappropriate means of waste disposal resulting in marine litter containing plastic, it is necessary for consumers of single-use plastic products and users of fishing gear containing plastic to be properly informed about the availability of re-usable alternatives and re-use systems, the most appropriate waste management options available and/or which waste disposal options are to be avoided, about best practices with regard to sound waste management and the environmental impact of bad disposal practices, as well as about the plastic content in certain single-use plastic products and fishing gear and the impact of inappropriate waste disposal on the sewer network. Member States should therefore be required to take awareness raising measures ensuring that such information is provided to those consumers and users. The information should not contain any promotional content encouraging the use of single-use plastic products. Member States should be able to choose the measures which are the most appropriate based on the nature of the product or its use. Producers of single-use plastic products and fishing gear containing plastic should cover the costs of the awareness raising measures as part of their extended producer responsibility obligations.

(29) The aim of this Directive is to protect the environment and human health. As the Court of Justice has held on numerous occasions, it would be incompatible with the binding effect which the third paragraph of Article 288 of the Treaty on the Functioning of the European Union ascribes to a Directive, to exclude, in principle, the possibility of an obligation imposed by a Directive from being relied on by persons concerned. That consideration applies particularly in respect of a Directive which has as its objective to prevent and reduce the impact of certain plastic products on the aquatic environment.

(30) It is important to monitor the levels of marine litter in the Union in order to assess the implementation of this Directive. In accordance with Directive 2008/56/EC, Member States are required to regularly monitor the properties and quantities of marine litter, including plastic marine litter. That monitoring data is also to be communicated to the Commission.

(31) Member States should lay down rules on penalties applicable to infringements of national provisions adopted pursuant to this Directive and should take all measures necessary to ensure that they are implemented. The penalties provided for should be effective, proportionate and dissuasive.

(32) Pursuant to paragraph 22 of the Interinstitutional Agreement of 13 April 2016 on Better Law-Making(19), the Commission should carry out an evaluation of this Directive. That evaluation should be based on experience gathered and data collected during the implementation of this Directive and data collected under Directives 2008/56/EC and 2008/98/EC. The evaluation should provide the basis for an assessment of possible further measures, including the setting of Union-wide reduction targets for 2030 and beyond, and an assessment whether, in view of monitoring of marine litter in the Union, the Annex listing single-use plastic products needs to be reviewed and whether the scope of this Directive can be broadened to other single-use products.

(33) In order to ensure uniform conditions for the implementation of this Directive, implementing powers should be conferred on the Commission in respect of the methodology for the calculation and verification of the annual consumption of single-use plastic products for which consumption reduction objectives have been set, the rules for the calculation and verification of the attainment of the targets on minimum recycled content for single-use plastic beverage bottles, the specifications for the marking to be affixed on certain single-use plastic products, the methodology for the calculation and verification of the collection targets of single-use plastic products for which separate collection targets have been set and the format for the reporting of data and information on the implementation of this Directive. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council(20).

(34) It is appropriate to allow Member States to choose to implement certain provisions of this Directive by means of agreements between the competent authorities and the economic sectors concerned, provided that certain requirements are met.

(35) The fight against litter is a shared effort between competent authorities, producers and consumers. Public authorities, including the Union institutions, should lead by example.

(36) Since the objectives of this Directive, namely to prevent and to reduce the impact of certain single-use plastic products, products made from oxo-degradable plastic and fishing gear containing plastic on the environment and on human health, and to promote the transition to a circular economy, including the fostering of innovative and sustainable business models, products and materials, thus also contributing to the efficient functioning of the internal market, cannot be sufficiently achieved by the Member States but can rather, by reason of the scale and effects of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives,

HAVE ADOPTED THIS DIRECTIVE:

(3)

Position of the European Parliament of 27 March 2019 (not yet published in the Official Journal) and decision of the Council of 21 May 2019.

(4)

Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3).

(7)

Directive 2000/59/EC of the European Parliament and of the Council of 27 November 2000 on port reception facilities for ship-generated waste and cargo residues (OJ L 332, 28.12.2000, p. 81).

(8)

Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1).

(9)

Directive 2008/56/EC of the European Parliament and of the Council of 17 June 2008 establishing a framework for community action in the field of marine environmental policy (Marine Strategy Framework Directive) (OJ L 164, 25.6.2008, p. 19).

(10)

Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Union control system for ensuring compliance with the rules of the common fisheries policy, amending Regulations (EC) No 847/96, (EC) No 2371/2002, (EC) No 811/2004, (EC) No 768/2005, (EC) No 2115/2005, (EC) No 2166/2005, (EC) No 388/2006, (EC) No 509/2007, (EC) No 676/2007, (EC) No 1098/2007, (EC) No 1300/2008, (EC) No 1342/2008 and repealing Regulations (EEC) No 2847/93, (EC) No 1627/94 and (EC) No 1966/2006 (OJ L 343, 22.12.2009, p. 1).

(11)

European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste (OJ L 365, 31.12.1994, p. 10).

(12)

Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC (OJ L 127, 29.4.2014, p. 1).

(13)

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).

(14)

Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).

(15)

Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004, p. 1).

(16)

Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4).

(17)

Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).

(18)

Directive (EU) 2019/883 of the European Parliament and of the Council of 17 April 2019 on port reception facilities for the delivery of waste from ships, amending Directive 2010/65/EU and repealing Directive 2000/59/EC (OJ L 151, 7.6.2019, p. 116).

(20)

Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).

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