Single-Use Plastics Regulations: draft guidance

Annex C – The Definition of Plastic

77. The following is reproduced from section 2.1 of the EU SUPD Guidance and provides further technical information on the definition of plastic used for the Regulations.

78. The definition of plastic is provided in point (1) of Article 3 of the SUPD, per paragraph 27 above:

79. '"plastic" means a material consisting of a polymer as defined in point (5) of Article 3 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (3), 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'.

80. According to Recital 11, point (1) of Article 3 of the Directive 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.

81. Recital 11 explicitly points to paints, inks and adhesives as polymeric materials, which are excluded from the scope of the Directive and not considered to fall under the definition of plastic in point (1) of Article 3. Consequently, a final (otherwise) non-plastic product to which they are applied is not a single-use plastic product under this Directive. Several of the terms and concepts used in point (1) of Article 3 and Recital 11 require further clarification. The following sections provide guidance on the key terms, notably:

• Polymer.
• Can function as a main structural component of final products.
• Natural polymers that have not been chemically modified.

Polymer

82. Point (1) of Article 3 of the Directive refers to the definition of polymer in point (5) of Article 3 of the REACH Regulation, which reads as follows:

83. '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 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.

Less than a simple weight majority of molecules of the same molecular weight.

84. In the context of this definition a "monomer unit" means the reacted form of a monomer substance in a polymer.'

85. To complement the definition of polymer in the REACH Regulation, additional guidance is given in the European Chemicals Agency (ECHA) Guidance for polymers and monomers (4) (hereafter referred to as 'the ECHA Guidance'):

86. 'A polymer, as any other substance defined in Article 3(1) [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.'

Can function as a main structural component of final products

87. Point (1) of Article 3 of the Directive defines plastic as 'a material (…) which can function as a main structural component of final products'. The aspect of the capability to function as a main structural component of final products concerns the definition of plastic and not the definition of a single-use plastic product. Therefore, in the context of the definition of plastic this criterion is to be understood as a generic concept. As point (1) of Article 3 does not specify or restrict in any way the type of final product, nor the amount of the polymer, in principle, a wide range of polymers can function as a main structural component of final products.

Natural polymers that have not been chemically modified

88. Polymers that meet the following two conditions laid down in point (1) of Article 3 are exempt from the Directive: (i) they qualify as natural polymers and (ii) they meet the requirement of having not been chemically modified. These terms are further clarified in Recital 11:

89. '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].

90. '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 Polymer

91. The term natural polymer is defined in the ECHA Guidance as follows:

92. '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]

93. Point (39) of Article 3 of the REACH Regulation defines substances which occur in nature as follows:

94. '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].

95. In view of the above, 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 natural polymer refers to a broader group that is independent of the method used to extract the substance from nature. Furthermore, point (39) of Article 3 of the REACH Regulation is not directly referred to in the Directive. A consequence of this distinction and applying the definition from the ECHA Guidance is, for example, that cellulose and lignin extracted from wood and corn starch obtained via wet milling meet the definition of natural polymer.

96. 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 REACH Regulation and the related 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 man-made cultivation and fermentation processes 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. In general, 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.

Not Chemically Modified

97. Recital 11 of the Directive explains that the term not chemically modified substances should be read in accordance with point (40) of Article 3 of the REACH Regulation, which states:

98. '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]

99. The terms have not been chemically modified in point (1) of Article 3 of the Directive, with regard to natural polymers, are to be interpreted as follows: the decision whether a polymer has been chemically modified in its production or not should take into account only the difference between the ingoing and the resulting polymer, disregarding any modifications which might have taken place during production processes, as those are not relevant for the properties and the behaviour of the polymer used and eventually potentially released into the environment.

100. This means that, for example, regenerated cellulose, e.g. in form of viscose, lyocell and cellulosic film, is not considered to be chemically modified, as the resulting polymers are not chemically modified compared to the ingoing polymer. Cellulose acetate is considered to be chemically modified given that, compared to the ingoing natural polymer, the chemical modifications of cellulose during the production process remain present at the end of the production process.

101. Where changes in the chemical structure of a polymer 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 point (1) of Article 3 and Recital 11 of the Directive. Therefore, paper material resulting from the wood pulping process is not considered to be made of chemically modified natural polymers. This interpretation is also in line with the Impact Assessment accompanying the European Commission's proposal for this Directive (hereafter, 'the Impact Assessment'), in which paper-based products without plastic lining or coating have been identified as available, more sustainable, alternatives to single-use plastic products.