SUPD (EU) Guidelines, Dec 20, 2020

Commission guidelines on single-use plastic products in accordance with 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

Note: This draft has not been adopted or endorsed by the European Commission. Any views expressed are the preliminary views of the Commission services and may not in any circumstances be regarded as stating an official position of the European Commission. The information transmitted is intended only for the Member State or entity to which it is addressed for discussions and may contain confidential and/or privileged material. 

Table of contents

1. INTRODUCTION ............................................................................................................................... 3

2. GENERAL TERMS AND DEFINITIONS................................................................................................ 4

2.1 Plastic definition (Article 3 point 1)..................................................................................... 4 2.1.1 Polymer definition............................................................................................................... 4 2.1.2 Can function as a main structural component of final products......................................... 5 2.1.3 Natural polymers that have not been chemically modified................................................ 6 2.2 Single Use Plastic Product (Article 3 point 2) ...................................................................... 8 2.2.1 Plastic content: ‘wholly or partly made from plastic’ ......................................................... 8 2.2.2 Single-use ............................................................................................................................ 8 2.2.3 Refillable and reusable nature of the product.................................................................... 9

3. INTERPLAY WITH DIRECTIVE 94/62/EC ......................................................................................... 10

4. SPECIFIC PRODUCT CRITERIA......................................................................................................... 10

4.1 FOOD CONTAINERS ........................................................................................................... 10 4.1.1 Product description and criteria in the Directive .............................................................. 10 4.1.2 Product overview and list of illustrative examples ........................................................... 12 4.2 PACKETS AND WRAPPERS ................................................................................................. 15 4.2.1 Product description and criteria in the Directive .............................................................. 15 4.2.2 Product overview and list of illustrative examples ........................................................... 15 4.3 CUTLERY, PLATES, STRAWS and STIRRERS ........................................................................ 18 4.3.1 Product descriptions in the Directive................................................................................ 18 4.3.2 Product overview and list of illustrative examples ........................................................... 18 4.4 BEVERAGE CONTAINERS, BEVERAGE BOTTLES AND CUPS FOR BEVERAGES (INCLUDING THEIR CAPS, COVERS AND LIDS)........................................................................................................ 20 4.4.1 Product descriptions and criteria in the Directive............................................................. 20 4.4.2 Caps, lids and covers ......................................................................................................... 21 4.4.3 Product-specific exemptions............................................................................................. 24 4.4.4 Product overview and list of illustrative examples ........................................................... 24 4.5 DIFFERENTIATION BETWEEN CERTAIN (RELATED) PRODUCT CATEGORIES...................... 27 4.5.1 Key elements to distinguish food containers from beverage containers ......................... 27 4.5.2 Key elements to distinguish food containers from cups for beverages............................ 29 This draft has not been adopted or endorsed by the European Commission. Any views expressed are the prelimina

4.5.3 Key elements to distinguish between beverage containers, beverage bottles and cups for beverages.......................................................................................................................................... 29 4.5.4 Key elements to distinguish food containers from packets and wrappers....................... 30 4.5.5 Key elements to distinguish plates from food containers................................................. 31 4.6 LIGHTWEIGHT PLASTIC CARRIER BAGS.............................................................................. 32 4.6.1 Product description and criteria in the Directive .............................................................. 32 4.6.2 Product overview and list of illustrative examples ........................................................... 33 4.7 COTTON BUD STICKS ......................................................................................................... 34 4.7.1 Product description and criteria in the Directive .............................................................. 34 4.7.2 Product-specific exemptions............................................................................................. 34 4.7.3 Product overview and list of illustrative examples ........................................................... 35 4.8 BALLOONS AND BALLOON STICKS..................................................................................... 36 4.8.1 Product description and criteria in the Directive .............................................................. 36 4.8.2 Product-specific exemptions............................................................................................. 37 4.8.3 Product overview and list of illustrative examples ........................................................... 38 4.9 SANITARY TOWELS (PADS); TAMPONS; AND TAMPON APPLICATORS.............................. 38 4.9.1 Product description and criteria in the Directive .............................................................. 38 4.9.2 Product overview and list of illustrative examples ........................................................... 39 4.10 WET WIPES ........................................................................................................................ 40 4.10.1 Product description, criteria and exemptions in the Directive ......................................... 40 4.10.2 Product overview and list of illustrative examples ........................................................... 43 4.11 TOBACCO PRODUCTS WITH FILTERS; FILTERS MARKETED FOR USE IN COMBINATION WITH TOBACCO PRODUCTS .............................................................................................................. 46 4.11.1 Product description and criteria in the Directive .............................................................. 46 4.11.2 Product overview and list of illustrative examples ........................................................... 46 ANNEX Overview of SUP products and relevant requirements laid out in the Directive................. 48

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1. INTRODUCTION This document provides guidance to the Member States on the implementation of Directive (EU) 2019/904 on the reduction of the impact of certain plastic products on the environment (hereafter referred to as the Directive)1 The Directive applies to all single-use plastic (SUP) products listed in its Annex, as well as to all products made from oxo-degradable plastics, and to fishing gear containing plastic. Article 12 thereof tasks the Commission to develop guidelines, including examples of what is to be considered a single use plastic product for the purposes of the Directive. The focus of these guidelines is on the singleuse plastic products included in the Annex, listed below in alphabetical order, and they do not specifically cover fishing gear (see section Error! Reference source not found.) and products made from oxo-degradable plastic, as the Directive bans all oxo-degradable plastic products, single-use or not.  Balloons;  Balloon sticks;  Beverage containers with a capacity of up to three litres, including their caps and lids; o Beverage containers made of expanded polystyrene, including their caps and lids; o Beverage bottles with a capacity of up to three litres, including their caps and lids;  Beverage stirrers;  Cotton bud sticks;  Cups for beverages; o Cups for beverages made of expanded polystyrene, including their covers and lids; o Cups for beverages, including their covers and lids;  Cutlery (forks, knives, spoons, chopsticks);  Food containers; o Food containers made of expanded polystyrene;  Lightweight plastic carrier bags;  Packets and wrappers;  Plates;  Sanitary towels (pads), tampons and tampon applicators;  Straws;  Tobacco products with filters and filters marketed for use in combination with tobacco products;  Wet wipes. This document provides guidance on key definitions of the Directive and examples of products to be considered as falling within or outside the scope of the Directive. These examples are non-exhaustive and serve only to provide illustration on how to interpret certain definitions and relevant requirements of the Directive in the context of specific products. The content, including examples, reflects the views of the European Commission and as such is not legally binding. The binding interpretation of EU legislation is the exclusive competence of the Court of Justice of the European Union (CJEU). The views expressed in this guidance document cannot prejudge the position that the Commission might take before the CJEU. 2. GENERAL TERMS AND DEFINITIONS 2.1 Plastic definition (Article 3 point 1) The definition of plastic is provided in Article 3 point 1: “‘plastic’ means a material consisting of a polymer as defined in point 5 of Article 3 of Regulation (EC) No 1907/20062 , to which additives or other substances may have been added, and which can function as a main structural component of final products, with the exception of natural polymers that have not been chemically modified” [Emphasis added] Article 3 point 1 refers to the definition laid out in Regulation (EC) No 1907/2006 (hereafter the “REACH Regulation”) and adds further elements to introduce an adapted and thereby separate definition (Recital 11). Several of the terms and concepts used in Article 3 point 1 and Recital 11 require further clarification due to the relatively high flexibility in interpretation. The following sections provide guidance on the key terms, notably:  “polymer”3 (section 2.1.1);  “can function as a main structural component of final products” (section 2.1.2); and  “natural polymers that have not been chemically modified” (section 2.1.3). 2.1.1 Polymer definition Article 3 point 1 of the Directive in refers to the definition of “polymer” in Article 3 point 5 of the REACH Regulation, which reads as follows: “polymer: means a substance consisting of molecules characterised by the sequence of one or more types of monomer units. Such molecules must be distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units. A polymer comprises the following: (a) a simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant; (b) less than a simple weight majority of molecules of the same molecular weight.

In the context of this definition a "monomer unit "means the reacted form of a monomer substance in a polymer”. To complement the definition of “polymer” in the REACH Regulation, additional guidance is given in the European Chemicals Agency (ECHA) Guidance for polymers and monomers4 : “A polymer, as any other substance defined in Article 3(5) [of REACH], can also contain additives necessary to preserve the stability of the polymer and impurities deriving from the manufacturing process. These stabilisers and impurities are considered to be part of the substance.” 2.1.2 Can function as a main structural component of final products In the production of many materials polymers are used to achieve specific material properties as well as higher process efficiencies. Those polymeric materials are usually synthetic chemical additives. Such polymeric materials used e.g. as retention agents or binders and processing aids in the production of materials which are by themselves not ‘plastic’ are as such not considered to meet the criterion of being able to function as a main structural component of a final product. More specifically, paper- and board-based products have been specifically assessed for their potential to serve as a sustainable alternative to single-use plastic products in the preparation of the legislative proposal for the Directive5 . Paper- and board-based single use products made up of only paper- and board-based material would, in light of the considerations above, as such not be considered as single-use plastic products in the meaning of the Directive. However, where a plastic coating or lining is applied to the surface of paper-/board material to provide resistance against water or fat, the criterion of being able to function as a main structural component is met. Such plastic coating or lining provides the necessary water or fat resistance to paper-based products for the consumption of beverages (cups) or moist and fat from food (food containers, plates). Plastic coating or lining of otherwise paper- or board-based products for the purpose of the Directive results in multi-layered products. Hence, single use paper- or board-based products with plastic coating or lining fall within the scope of the Directive. The legislative process undergone by the Directive also documents this reading: The exemption for coatings originally included in Recital 8 of the Commission proposal6 no longer appears in the corresponding Recital 11 of the final text of the Directive. Another illustration is composite beverage packaging that generally consists of several layers of paper, plastic and aluminium necessary for providing the technical properties for the beverage carton, including oxygen and water barriers. Due to this function, the respective plastic is able to function as a main structural component.

In the Impact Assessment for the Directive, paper-based products without plastic lining or coating have been identified as being an available and more sustainable alternative to single-use plastic products7 . In contrast, paper cups with a plastic layer have not been identified as an alternative option, as not being plastic free. In the absence of non-plastic alternatives for the same applications being available on a sufficient scale, single-use plastic cups were not made subject to a marketing restriction. Single-use plastic plates, on the other hand, are subject to a marketing restriction under the Directive, given that paper- or board-based plates without a plastic lining or coating are available as a single-use non plastic alternative. Some applications of polymeric material, namely paints, inks and adhesives, are explicitly excluded from the scope of the Directive as referred to in Recital 11, and consequently not considered to function as a main structural component. A final product to which they are applied is hence not for this reason a single-use plastic product under this Directive. 2.1.3 Natural polymers that have not been chemically modified In order to be exempt from the Directive, polymers have to meet the two conditions laid down in Article 3 point 1: they have to qualify as “natural polymers and meet the requirement that they “have not been chemically modified”. These terms are further clarified in Recital 11: “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…, 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” [Emphasis added] “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” [Emphasis added] - Natural polymers The term ‘natural polymer’ is defined in the ECHA Guidance for monomers and polymers8 (hereafter referred to as “the ECHA Guidance”) as follows: “Natural polymers are understood as polymers which are the result of a polymerisation process that has taken place in nature, independently of the extraction process with which they have been extracted. This means that natural polymers are not necessarily ‘substances which occur in nature’when assessed according to the criteria set out in Article 3(39) of the REACH Regulation.” [Emphasis added] Article 3 point 39 of the REACH Regulation defines “substances which occur in nature” as follows: “substances which occur in nature: means a naturally occurring substance as such, unprocessed or processed only by manual, mechanical or gravitational means, by dissolution in water, by flotation, by extraction with water, by steam distillation or by heating solely to remove water, or which is extracted from air by other means.” [Emphasis added] It is hence made clear that, the terms “natural polymer” and “naturally occurring substance” are two distinct terms and should not be confused. A key distinction relates to the extraction methods allowed. The scope of the former (natural polymer) refers to a broader group, being independent of the method used to extract the substance from nature. Furthermore, Article 3 point 39 of the REACH Regulation is not directly referred to as such in the Directive. As a consequence of this distinction and applying the definition of the ECHA guidance, for example, cellulose and lignin extracted from wood and corn starch obtained via wet milling meets the definition of “natural polymer”. Another key distinction is whether the polymerisation process has taken place in nature or is the result of an industrial process involving living organisms’. Based on the current implementation of the REACH Regulation and the ECHA Guidance, polymers produced via an industrial fermentation process are not considered ‘natural polymers’ since polymerisation has not taken place in nature. Therefore, polymers resulting from biosynthesis through artificial cultivation and fermentation processes manufactured in industrial settings, e.g. polyhydroxyalkanoates (PHA), are not considered natural polymers as not being the result of a ‘polymerisation process that has taken place in nature’. If a polymer is obtained from an industrial process and the same type of polymer happens to exist in nature, the manufactured polymer does not qualify as a “natural polymer” as such. - Not chemically modified Recital 11 of the Directive explains that the term “not chemically modified substances” should be understood in accordance with Article 3 point 40 of the REACH Regulation, which states: “not chemically modified substance: means a substance whose chemical structure remains unchanged, even if it has undergone a chemical process or treatment, or a physical mineralogical transformation, for instance to remove impurities.” [Emphasis added] Once extracted, the status of natural polymer is determined based on the production process in which it is applied. Natural polymer is considered to be ‘unmodified’ if the production process does not include steps which necessarily lead to breaking or forming of covalent bonds. For example, where the production process involves only dissolution of cellulose without the necessity to break covalent bonds in the polymers, and therefore is without a chemical modification, the polymers are considered as “not chemically modified” as it is the case for lyocell. Changes such as the orientation of the polymer chains with respect to each other are not seen as chemical modifications which would alter the status of a natural polymer. If the natural polymer is used in a production process which includes process steps which require either forming or breaking covalent bonds of the polymers, it can be concluded that the polymer 

structure changes during the manufacturing process and therefore the resulting material is chemically modified. Consequently, it is not sufficient to merely consider the difference between the ingoing and the final polymer. In the course of manufacturing materials such as viscose and cellophane (in these cases, reaction with carbon disulphide to form sodium cellulose xanthate), the natural polymer cellulose undergoes a deliberate chemical modification. Therefore, viscose and cellophane cannot be deemed to have remained ‘unmodified’, even though they may return to a cellulose structure by the end of the process. This means that viscose and cellophane (made from cellulose) are included in the Directive. Where changes in the chemical structure result from reactions that are only taking place during the extraction process of a natural polymer (e.g. wood pulping process to extract cellulose and lignin ), these are not considered to result in a chemical modification of the natural polymer in the meaning of Article 3 point 1 and Recital 11 of the Directive. This means that under this aspect paper without a plastic lining or coating is not included in the Directive as it has not been chemically modified. This is also in line with the Impact Assessment conducted for the Directive, in which paper-based products without plastic lining or coating have been identified as being an available and more sustainable alternative to single-use plastic products9 . 2.2 Single Use Plastic Product (Article 3 point 2) Article 3 point 2 of the Directive provides the following definition for “single-use plastic product”: “‘a product that is made wholly or partly from plastic and that is not conceived, designed or placed on the market to accomplish, within its life span, multiple trips or rotations by being returned to a producer for refill or re-used for the same purpose for which it was conceived;” [emphasis added] 2.2.1 Plastic content: ‘wholly or partly made from plastic’ Single-use plastic products listed in the Annex of the Directive are within its scope also if partly made from plastic. This is regardless of the amount of plastic contained as the Directive does not envisage any de minimis threshold for the plastic content in a product. This aspect of Article 3 point 2 is to be interpreted in close connection with the definition of plastic in Article 3 point 1 (see paragraph 2.1), which further supports it. 2.2.2 Single-use The cumulative use of the terms in Article 3 point 2 requires that the product should be neither conceived nor designed or placed on the market to accomplish, within its life span, multiple trips or rotations. This should rule out situations where final products could potentially be placed on the market/marketed as "multi-use”, or “re-usable", without having been conceived and designed as such, or without being placed on the market as part of a system or an arrangement to ensure their re-use. Product design characteristics can help to define whether a product should be considered as singleor multiple-use. Whether a product is conceived, designed and placed on the market for reuse, can be assessed by considering the product’s expected functional life, i.e. whether it is intended and 

designed to be used several times before final disposal, without losing product functionality, physical capacity or quality, and whether consumers typically conceive, perceive and use it as a reusable product. Relevant product design characteristics include material composition, washability and reparability, which would allow multiple trips and rotations for the same purpose as for which the product was originally conceived. For a receptacle being packaging, its ‘reusable’ nature can be determined in accordance with the Essential Requirements under the Packaging and Packaging Waste Directive10, including any declaration attesting to the conformity of the packaging with those Essential Requirements and related standards. 2.2.3 Refillable and reusable nature of the product In accordance with Article 3 point2 of the Directive, a single use product is ‘a product that is not conceived, designed or placed on the market to accomplish, within its lifespan, multiple trips and rotations by: - being returned to a producer for refill; or - reused for the same purpose for which it was conceived.’ To identify the criteria for products that are placed on the market as packaging to comply with these conditions and thus not to be considered ‘single use’, it is appropriate to consider the Packaging and Packaging Waste Directive, in particular the definition of “reusable packaging” and the relevant part of the essential requirements for ‘reusable packaging’. Under Article 3(2a) Packaging and Packaging Waste Directive, “reusable packaging shall mean packaging which has been conceived, designed and placed on the market to accomplish within its lifecycle multiple trips or rotations by being refilled or reused for the same purpose for which it was conceived”. Under Annex II Packaging and Packaging Waste Directive, which sets out the essential requirements for packaging, reusable packaging should, among others, have “physical properties and characteristics”, which “enable a number of trips or rotations in normally predictable conditions of use”. Detailed conditions for compliance with these requirements are specified in the harmonized standard EN 13429:2004 Packaging - Reuse. The product requirements listed in that standard for considering the reusable nature of packaging include11: - Intention that the package is reused (i.e. purposely designed, conceived and placed on the market); - Design of the package enables to accomplish a number of trips or rotations; - The package can be emptied/unloaded without significant damage, and without risk to the integrity of the product, and health and safety; - The package can be reconditioned, cleaned, washed, repaired, whilst maintaining its ability to perform its intended function; - Arrangements are in place to make reuse possible, i.e. a re-use system is set up and operational. One of the conditions is that a reuse system for refill/reloading is in operation. Such a system could include postal or courier packaging or drop-boxes in store. In a functioning refill system, the 

product’s functionality, physical capacity and quality are not modified by the producer and/or distributor between refills12 . However, where products listed in the Annex of the Directive are not placed on the market as packaging, further considerations have to be taken into account in order to determine if they are for single- or multiple-use. Where the same items that are generally placed on the market as nonreusable packaging are also sold empty to final consumers (such as plastic cups or food containers), it is appropriate to consider them as single-use products. It is noted that reuse systems for the service of food and drinks implemented and managed effectively by operators may provide a more consistent assurance in that the reusable items (e.g. cups, containers and cutlery) are properly sanitized to guarantee hygiene, protect public health and ensure customer and employee safety. 3. INTERPLAY WITH DIRECTIVE 94/62/EC Further clarification is needed on single use plastic products covered by the Directive that are also considered packaging as defined in Article 3 point 1 of the Packaging and packaging Waste Directive13. Those products need to comply with the requirements of both Directives. Recital 10 of the Directive clarifies that, in the event of a conflict between the two Directives, the Directive shall prevail. This is the case regarding restrictions of placing on the market. As regards consumption reduction measures, product design requirements, marking and extended producer responsibility, the Directive supplements the Packaging and Packaging Waste Directive. Single use plastic products that do not constitute packaging are subject to the requirements of the Directive only, even though they may have similar functionalities or properties to packaging. 4. SPECIFIC PRODUCT CRITERIA 4.1 FOOD CONTAINERS This Section provides further clarification of the Directive criteria for “single use food containers”. 4.1.1 Product description and criteria in the Directive

“Food containers, i.e. receptacles such as boxes, with or without a cover, used to contain food which: (a) is intended for immediate consumption, either on-the-spot or take-away, (b) is typically consumed from the receptacle, and (c) is ready to be consumed without any further preparation, such as cooking, boiling or heating, including food containers used for fast food or other meal ready for immediate consumption, except beverage containers, plates and packets and wrappers containing food.” Article 12: “In order to determine whether a food container is to be considered as a single-use plastic product for the purposes of this Directive, in addition to the criteria listed in the Annex as regards food containers, its tendency to become litter, due to its volume or size, in particular single-serve portions, shall play a decisive role.” The three criteria laid down in point (2) of Part A, point (1) of Section I of Part E, and point (1) of Part G of the Annex of the Directive apply cumulatively. Therefore, for a food container to be covered by the Directive it has to meet all three criteria. The following indicators may be used to interpret and apply the three criteria: (1) Criteria “Intended for immediate consumption, either on-the-spot or take-away” Relevant indicators:  Nature of foodstuff contained in the food container: Foodstuffs generally suitable for immediate consumption are e.g. nuts, sandwiches, yoghurts, salads and cooked meals, fruit and vegetables.  The inclusion or attachment of items such as forks, knives, spoons and sticks and/ or sauces to the single use plastic food container. However, the absence of such items should not in itself exclude the product from the scope of the Directive. (2) Criteria “Typically consumed from the food container” Relevant indicator:  The shape of the food container allows for or facilitates eating the foodstuff it contains directly from the container, i.e. by simply opening it. (3) Criteria “Ready to be consumed without any further preparation, such as cooking, boiling or heating” Relevant indicators:  The foodstuff contained in the food container can be consumed without any preparation before consumption. For example, the foodstuff does not require freezing, cooking, boiling or heating, including frying, grilling, baking, microwaving and toasting. Washing, pealing or cutting, such as fruit and vegetables should not be considered as preparation and are therefore not an indicator for exclusion from the Directive.  The foodstuff contained in the food container can be consumed without adding seasonings or sauces (unless those are provided together with the food product), cold or hot water or other 

liquids, including milk before consumption of the foodstuff such as in the case of cereals (unless portion sized servings of cereals are sold together with an additional portion sized container of milk) or powder soups. In addition to these three cumulatively applicable criteria, Article 12 of the Directive adds a criterion related to the tendency of a food container to become litter due to its size and volume. The Directive does not contain provisions that allow making this criterion sufficiently specific. While that article also contains a reference to the notion of single-serve portions as a guiding element, there is no legal definition nor a common understanding of a single-serve portion, which could provide an indication regarding the volume and size of food containers that might not be covered by the Directive. The relevant volume and the size would vary in function of the number of people consuming the food at a certain serving as well as of its nutritional value and consumption habits across the Union. The Directive determines volume and size only in the context of beverage containers, where the threshold above which the Directive does not apply to plastic beverage containers is set at three litres (Part C, point (3) of Section I of Part E and point (3) of Part G of the Annex). No such limit is defined in the Directive regarding food containers. Consequently, no specific limit value for the size or volume of a food container above which the Directive would not be applicable can be given in this Guidance in a situation where all the three cumulative criteria, as set out in the Annex, are fulfilled. 4.1.2 Product overview and list of illustrative examples Table 4-2 provides some illustrative examples of certain types of food containers that may be considered included or excluded from the scope of the Directive. 

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