Source: EURLEX
Language: en
Format: md

JUDGMENT OF THE GENERAL COURT (First Chamber, Extended Composition)

31 January 2024 (
[\*1](#t-ECR_62020TJ0745_EN_01-E0001)
)

(Non-contractual liability – Environment – Directive (EU) 2019/904 – Prohibition on the placing on the market of products made from oxo-degradable plastic – Sufficiently serious breach of a rule of law intended to confer rights on individuals – No distinction between products made from oxo-degradable plastic and products made from oxo-biodegradable plastic – Impact assessment – Equal treatment – Proportionality)

In Case T‑745/20,

Symphony Environmental Technologies plc, established in Borehamwood (United Kingdom),

Symphony Environmental Ltd, established in Borehamwood,

represented by P. Selley, Solicitor, J. Holmes King’s Counsel, and J. Williams, Barrister-at-law,

applicants,

v

European Parliament, represented by L. Visaggio, C. Ionescu Dima and W. Kuzmienko, acting as Agents,

Council of the European Union, represented by A. Maceroni and M. Moore, acting as Agents,

and

European Commission, represented by R. Lindenthal and L. Haasbeek, acting as Agents,

defendants,

THE GENERAL COURT (First Chamber, Extended Composition),

composed of M. Van der Woude, President, D. Spielmann, V. Valančius, I. Gâlea (Rapporteur) and T. Tóth, Judges,

Registrar: I. Kurme, Administrator,

having regard to the written part of the procedure,

further to the hearing on 20 March 2023,

having regard, following the departure from office of Judge Valančius on 26 September 2023, to Article 22 and Article 24(1) of the Rules of Procedure of the General Court,

gives the following

Judgment

| 1 | By their action based on Article 268 TFEU, the applicants, Symphony Environmental Technologies plc and Symphony Environmental Ltd, seek compensation for the damage that they claim to have suffered as a result of the adoption of Article 5 and recital 15 of 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 ([OJ 2019 L 155, p. 1](./../../../legal-content/EN/AUTO/?uri=OJ:L:2019:155:TOC)), in so far as the prohibition on the placing on the market of products made from oxo-degradable plastic laid down in Article 5 and recital 15 applies to oxo-biodegradable plastic. |

I. Background to the dispute

| 2 | The applicants are companies established in the United Kingdom, whose business involves the development, production and marketing of certain specialised plastic products together with the additives and masterbatches used for making such products. |

| 3 | A masterbatch is a compound of several chemicals in a polymer carrier which is supplied in pellet form to the manufacturers of plastic products for them to incorporate into the polymer used by them to make their plastic products. |

| 4 | One of the masterbatches produced by the applicants, which they market under the trade mark d2w (‘the d2w masterbatch’), contains an additive which they maintain promotes abiotic degradation of the plastic into which it has been incorporated and then its biodegradation once its useful life has come to an end. |

| 5 | Oxo-degradable plastic is, according to the definition set out in point 3 of Article 3 of Directive 2019/904, plastic to which one or more additives have been added which, through oxidation, lead to its fragmentation into micro-fragments or to it undergoing chemical decomposition. |

| 6 | Biodegradable plastic is, according to point 16 of Article 3 of that directive, plastic capable of undergoing physical, biological decomposition, such that it ultimately decomposes into carbon dioxide, biomass and water. |

| 7 | According to the applicants, the additive contained in the d2w masterbatch causes the plastic into which it has been incorporated to fragment as a result of oxidation into very small pieces (oxo-degradation), the molecular weight of which is reduced to the point where it can be consumed by micro-organisms (biodegradation). In the opinion of the applicants, that additive therefore makes it possible for the plastic into which it has been incorporated to be converted into biodegradable materials. |

| 8 | On 5 June 2019, Directive 2019/904 was adopted. |

| 9 | In accordance with recital 15 of that directive:  ‘… 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. …’ |

| 10 | Article 5 of Directive 2019/904, entitled ‘Restrictions on placing on the market’, provides:  ‘Member States shall prohibit the placing on the market of the single-use plastic products listed in Part B of the Annex and of products made from oxo-degradable plastic.’ |

II. Forms of order sought

| 11 | The applicants claim that the Court should:   | – | find the European Parliament, the Council of the European Union and the European Commission to be non-contractually liable in accordance with the second paragraph of Article 340 TFEU and/or Article 41(3) of the Charter of Fundamental Rights of the European Union (‘the Charter’), by adopting Article 5 and recital 15 of Directive 2019/904, in so far as they apply to oxo-biodegradable plastic; |  | – | order the Parliament, Council and Commission to compensate them for damage suffered (including any additional damage suffered during the course of the proceedings) and/or likely foreseeable damage, together with interest payable, at an amount and rate to be determined in the course of the proceedings; |  | – | in the alternative, order the Parliament, Council and Commission to submit to the Court, within a reasonable period of time after the date of delivery of the judgment in the present case, the detailed calculation of the amount of the compensation agreed by the parties or, in the absence of agreement, order them to submit their quantified proposals to the Court within the same period; |  | – | in any event, order the Parliament, Council and Commission to pay the costs. | |

| 12 | The Parliament and the Council contend that the Court should:   | – | dismiss the action; |  | – | order the applicants to pay the costs. | |

| 13 | The Commission contends that the Court should:   | – | dismiss the action as inadmissible in so far as it concerns it and, in any event, as unfounded; |  | – | order the applicants to pay the costs. | |

III. Law

| 14 | By the present action, the applicants seek compensation for damage they claim to have suffered on account of the prohibition on the placing on the market of products made from oxo-degradable plastic, laid down in Article 5 of Directive 2019/904, in so far as the prohibition applies to products made from plastic which they classify as oxo-biodegradable. Oxo-biodegradable plastic is a type of plastic, to which a pro-oxidant additive is added, such as that contained in their d2w masterbatch, so that it biodegrades more quickly than oxo-degradable plastic. By failing to distinguish between oxo-degradable plastic and oxo-biodegradable plastic, and by extending, as the case may be, the prohibition on products made from oxo-degradable plastic to products made from oxo-biodegradable plastic, the three institutions concerned have committed a sufficiently serious breach of a number of rules of law intended to confer rights on individuals. In so doing, they have caused damage to the applicants. In the applicants’ view, there is a sufficiently direct causal link between that damage and the unlawful conduct of the institutions. |

| 15 | The three institutions concerned submit that none of the three conditions for the non-contractual liability of the European Union to be incurred have been satisfied and they contend that the action should be dismissed. They submit, in particular, that no distinction should be made between oxo-degradable plastic and oxo-biodegradable plastic. In their view, those two terms refer to one and the same type of plastic, namely conventional plastic incorporating an additive which accelerates its fragmentation or chemical decomposition into very small pieces through oxidation. That type of plastic does not biodegrade properly within a reasonable time frame. |

A. The application for omission of certain information vis-à-vis the public

| 16 | By separate document lodged at the Registry of the General Court on 21 December 2020, the applicants requested the omission of certain information vis-à-vis the public, in accordance with Article 66 of the Rules of Procedure of the General Court, in order to ensure the protection of business secrets as regards their own data and data belonging to third parties. |

| 17 | By separate document lodged at the Court Registry on 23 June 2021, the applicants submitted a second application for omission of certain information vis-à-vis the public, in accordance with Article 66 of the Rules of Procedure. That application concerns data mentioned in their replies and also seeks to ensure the protection of business secrets as regards their own data and data belonging to third parties. |

| 18 | By those applications, the applicants seek, in essence, to have the following types of information omitted:   | – | the consequences for their customers of the prohibition on the placing on the market of products made from oxo-degradable plastic, as evidenced, in particular, by statements from staff members; |  | – | the assessment of the amount of damage alleged to have been suffered as a result of that prohibition, as well as the data on which that assessment is based, that is to say, in particular, how their profits and losses, their market shares and the value of their shares have evolved; |  | – | the text of European, United States, British and international standards on biodegradation, oxo-degradation and composting of plastic, as well as a glossary relating to the degradation and biodegradation of plastic. | |

| 19 | Contrary to the application for omission of the first two categories of data referred to in paragraph 18 above, which, according to the applicants, is aimed at protecting their own data, the application for omission of the third category of data seeks to protect data over which third parties have property rights. |

| 20 | In that regard, it should be borne in mind that, in reconciling the need to make judicial decisions public, on the one hand, and the right to protection of personal data and of business secrets, on the other, the court must seek, in the circumstances of each case, to find a fair balance, having regard also to the public’s right of access, in accordance with the principles set out in Article 15 TFEU, to judicial decisions (judgment of 27 April 2022, Sieć Badawcza Łukasiewicz – Port Polski Ośrodek Rozwoju Technologii v Commission, [T‑4/20](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AT%3A2022%3A242&locale=en), [EU:T:2022:242](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AT%3A2022%3A242), paragraph [29](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AT%3A2022%3A242&anchor=#point29)). |

| 21 | In the present case, the present judgment does not contain data falling within the first two categories referred to in paragraph 18 above. |

| 22 | As regards the data in the third category, the present judgment contains only the data also referred to in a study published on the Commission’s website, namely the study carried out by Eunomia Research & Consulting Ltd for the Commission’s Directorate-General for the Environment, entitled ‘The Impact of the Use of “Oxo-degradable” Plastic on the Environment’ dated April 2017 (‘the Eunomia study’). Since the data mentioned in that study are already public, it is not necessary for the protection of business secrets to omit them, contrary to the applicants’ assertions. |

| 23 | There is therefore no legitimate reason to grant the applicants’ applications. |

B. Preliminary observation

| 24 | Before analysing the admissibility and substance of the action, a comment on terminology should be made. |

| 25 | The parties to the dispute apply different classifications to plastic to which a pro-oxidant additive, such as that contained in the d2w masterbatch, has been added. The applicants classify it as ‘oxo-biodegradable plastic’, which should be distinguished, in their view, from oxo-degradable plastic, which biodegrades much more slowly. The Parliament, in its written pleadings, also uses the expression ‘oxo-biodegradable plastic’, but takes care to state that that expression refers to the plastic which the applicants claim is biodegradable, a claim which it does not support. The Council uses the term ‘PAC plastic’ to refer to ‘pro-oxidant additive containing plastic’. The Commission refers to ‘oxo-(bio)degradable plastic’, suggesting, by the use of brackets, its doubts regarding the biodegradability of that type of plastic. |

| 26 | The choice of expression used to designate the type of plastic in question is not neutral, since it may imply that a view has been taken on the biodegradability of that type of plastic. It is therefore appropriate to use, in the present judgment, the most neutral term possible. Therefore, with the exception of the passages setting out the arguments of the parties, in which the terminology chosen by them will be retained, and the references to Article 5 of Directive 2019/904, which will use the expression ‘oxo-degradable plastic’ used in that article, the expression ‘plastic containing a pro-oxidant additive’ will be used. |

C. Admissibility

| 27 | Although it has not formally raised a plea of inadmissibility pursuant to Article 130(1) of the Rules of Procedure, the Commission submits that the action is inadmissible in so far as the action is directed against it. |

| 28 | The Commission, supported by the Council, submits that any unlawfulness of the prohibition on the placing on the market of products made from oxo-degradable plastic laid down in Article 5 of Directive 2019/904 is not attributable to it. It submits that (i) in accordance with Article 192(1) TFEU, Directive 2019/904 is an act adopted by the Parliament and by the Council, not by the Commission through the ordinary legislative procedure and (ii) that prohibition was not included in the proposal for a directive which it submitted to the Parliament and the Council on 28 May 2018 (COM(2018) 340 final – 2018/0172(COD), ‘the proposal for a directive’), but was introduced by an amendment to the proposal by the Parliament, to which the Council gave its agreement. The Commission also states that it could not withdraw its proposal, since the conditions for such withdrawal are not satisfied in the present case. |

| 29 | Lastly, in the view of the Commission, neither the fact that it instituted and terminated the restriction procedure laid down in Articles 68 to 73 of 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 2006 L 396, p. 1](./../../../legal-content/EN/AUTO/?uri=OJ:L:2006:396:TOC); ‘the REACH Regulation’), nor the fact, even if proven, that the impact assessment was limited and defective and that it failed to comply with its obligations as regards the gathering and assessment of evidence, can result in the prohibition on placing on the market laid down in Article 5 of Directive 2019/904 being attributable to the Commission. |

| 30 | The applicants dispute that inadmissibility. |

| 31 | According to the case-law, whereas actions for annulment and for failure to act seek a declaration that a legally binding measure is unlawful or that such a measure has not been taken, an action for damages seeks compensation for damage resulting from a measure or from unlawful conduct, attributable to an EU institution or body (judgments of 20 September 2016, Ledra Advertising and Others v Commission and ECB, [C‑8/15 P to C‑10/15 P](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AC%3A2016%3A701&locale=en), [EU:C:2016:701](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AC%3A2016%3A701), paragraph [55](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AC%3A2016%3A701&anchor=#point55), and of 23 May 2019, Steinhoff and Others v ECB, [T‑107/17](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AT%3A2019%3A353&locale=en), [EU:T:2019:353](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AT%3A2019%3A353), paragraph [51](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AT%3A2019%3A353&anchor=#point51)). |

| 32 | Therefore, since Directive 2019/904 was, in accordance with Article 294 TFEU, adopted by the Parliament and the Council, it is irrelevant that the Commission has not adopted a legally binding act. For the Commission to be regarded as having rendered the European Union liable, or having contributed to the liability of the European Union, it is sufficient that an unlawful act, even one that is not legally binding, or unlawful conduct, is attributable to it. |

| 33 | It is true that no such act or conduct can be identified in the proposal for a directive. That proposal provided solely, in Article 5 thereof, that ‘Member States shall prohibit the placing on market of the single-use plastic products listed in Part B of the Annex’, and Part B of that annex made no reference to oxo-degradable plastic. |

| 34 | Nevertheless, the applicants criticise the Commission for its conduct by which, in the context of the interinstitutional compromise of 19 December 2018, it stated that it ‘accept[ed] all the amendments’ made to its proposal for a directive. In that regard, it should be noted that it was amendment No 83 put forward by the Parliament to the proposal for a directive on 24 October 2018 (COM(2018) 0340 – C8-0218/2018 – 2018/0172 (COD) (‘the Parliament’s amendment’), which introduced the prohibition of oxo-degradable plastic products into that proposal. The three institutions concerned then agreed, within that compromise, to incorporate that amendment into the text of the future directive. It was at that point that the Commission stated that it accepted all the amendments. |

| 35 | The applicants also criticise the Commission for having, by letter of 30 April 2019 (‘the letter of 30 April 2019’), requested the European Chemicals Agency (ECHA) to close its ongoing restriction procedure relating to plastics containing a pro-oxidant additive. According to the applicants, if the ECHA had completed that procedure and if it had, in particular, compiled a dossier, as provided for in Article 69(1) of the REACH Regulation, the additional information thereby brought to the attention of the three institutions concerned would have led them to adopt measures other than a prohibition on placing on the market in respect of plastic containing a pro-oxidant additive, or not to adopt any measure. |

| 36 | Lastly, the applicants complain that the Commission failed to carry out an impact assessment relating specifically to plastic containing a pro-oxidant additive and products made from that type of plastic, and for not having sought, or having failed to take into account, relevant evidence concerning that plastic and the risk it posed to the environment and human health. In the applicants’ view, in possession of additional evidence, the three institutions concerned modified their assessment. |

| 37 | The question whether the conduct referred to in paragraphs 34 to 36 above is unlawful and whether, in the absence of such conduct, the Parliament and the Council would still have prohibited the placing on the market of plastic products made from plastic containing a pro-oxidant additive involve the existence of an event giving rise to liability and of a causal link between that event and the alleged damage. The questions relating to the examination of the conditions necessary for the non-contractual liability of the European Union to be incurred, such as the existence of an event giving rise to liability and of a causal link, relate to the examination of the substance of the present action and are therefore irrelevant to the assessment of whether it is admissible (see, to that effect and by analogy, judgment of 23 May 2019, Steinhoff and Others v ECB, [T‑107/17](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AT%3A2019%3A353&locale=en), [EU:T:2019:353](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AT%3A2019%3A353), paragraphs [42](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AT%3A2019%3A353&anchor=#point42) to [47](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AT%3A2019%3A353&anchor=#point47)). |

| 38 | Consequently, it is necessary to reject the Commission’s argument seeking to have the action declared inadmissible in so far as it is directed against it. |

D. Substance

| 39 | As a preliminary point, it should be recalled that, pursuant to the second paragraph of Article 340 TFEU, in the case of non-contractual liability, the European Union is to, in accordance with the general principles common to the laws of the Member States, make good any damage caused by its institutions or by its servants in the performance of their duties. |

| 40 | According to settled case-law, the Court of Justice notes that the European Union may incur non-contractual liability only if a number of conditions are fulfilled, namely the existence of a sufficiently serious breach of a rule of law intended to confer rights on individuals, the fact of damage and the existence of a causal link between the breach of the obligation resting on the author of the act and the damage sustained by the injured parties (see judgment of 10 September 2019, HTTS v Council, [C‑123/18 P](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AC%3A2019%3A694&locale=en), [EU:C:2019:694](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AC%3A2019%3A694), paragraph [32](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AC%3A2019%3A694&anchor=#point32) and the case-law cited). |

| 41 | If any one of those conditions is not satisfied, the action must be dismissed in its entirety and it is unnecessary to consider the other conditions for non-contractual liability on the part of the European Union. Nor are the EU Courts required to examine those conditions in any particular order (see, to that effect, judgments of 9 September 1999, Lucaccioni v Commission, [C‑257/98 P](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AC%3A1999%3A402&locale=en), [EU:C:1999:402](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AC%3A1999%3A402), paragraphs [13](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AC%3A1999%3A402&anchor=#point13), [63](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AC%3A1999%3A402&anchor=#point63) and [64](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AC%3A1999%3A402&anchor=#point64), and of 5 September 2019, European Union v Guardian Europe and Guardian Europe v European Union, [C‑447/17 P and C‑479/17 P](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AC%3A2019%3A672&locale=en), [EU:C:2019:672](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AC%3A2019%3A672), paragraph [148](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AC%3A2019%3A672&anchor=#point148)). |

| 42 | As regards the first of those conditions, the Court of Justice has stated that a sufficiently serious breach of a rule of law intended to confer rights on individuals is established where the breach is one that implies that the institution concerned manifestly and gravely disregarded the limits set on its discretion, the factors to be taken into consideration in that connection being, inter alia, the degree of clarity and precision of the rule breached and the measure of discretion left by that rule to the EU authority (judgments of 30 May 2017, Safa Nicu Sepahan v Council, [C‑45/15 P](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AC%3A2017%3A402&locale=en), [EU:C:2017:402](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AC%3A2017%3A402), paragraph [30](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AC%3A2017%3A402&anchor=#point30), and of 10 September 2019, HTTS v Council, [C‑123/18 P](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AC%3A2019%3A694&locale=en), [EU:C:2019:694](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AC%3A2019%3A694), paragraph [33](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AC%3A2019%3A694&anchor=#point33)). |

| 43 | In that regard, it must be pointed out, in the context of the present case, that a possible sufficiently serious infringement of the rule of law at issue must be based on a manifest and serious failure to have regard to the limits of the broad discretion enjoyed by the EU legislature when exercising its powers on environmental matters under Articles 191 and 192 TFEU. The exercise of that discretionary power implies, first, the need for the EU legislature to anticipate and evaluate ecological, scientific, technical and economic changes of a complex and uncertain nature, and, second, the balancing and arbitration by that legislature of the various objectives, principles and interests set out in Article 191 TFEU (judgment of 2 March 2010, Arcelor v Parliament and Council, [T‑16/04](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AT%3A2010%3A54&locale=en), [EU:T:2010:54](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AT%3A2010%3A54), paragraph [143](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AT%3A2010%3A54&anchor=#point143)). |

| 44 | It is necessary to assess, first of all, whether the first condition for the European Union to incur liability is satisfied. |

| 45 | In that regard, the applicants raise five pleas of illegality alleging sufficiently serious breaches, first, of Articles 68 to 73 of the REACH Regulation, second, of paragraphs 12 and 14 to 16 of the Interinstitutional Agreement between the [Parliament], the [Council] and the [Commission] on Better Law-Making of 13 April 2016 ([OJ 2016 L 123, p. 1](./../../../legal-content/EN/AUTO/?uri=OJ:L:2016:123:TOC); ‘the Interinstitutional Agreement’), third, of the general principle of proportionality, enshrined in Article 5(4) TEU, and of Article 191 TFEU as well as manifest errors of assessment, fourth, of the general principle of equal treatment and, fifth, of Articles 16 and 17 and Article 41(1) of the Charter and of Article 49 TFEU. |

1.
 
The first plea of illegality, alleging infringement of Articles 68 to 73 of the REACH Regulation

| 46 | By their first plea of illegality, the applicants maintain that the prohibition on placing on the market products made from oxo-degradable plastic laid down in Article 5 of Directive 2019/904 was adopted by circumventing the restriction procedure set out in Articles 68 to 73 of the REACH Regulation. They state, in that regard, that a restriction procedure was ongoing before the ECHA when, without taking any account of that procedure, the Parliament adopted the amendment which added oxo-biodegradable plastic products to those products which the proposal for a directive prohibited from being placed on the market. That restriction procedure was still ongoing when the Parliament and the Council gave their consent to the amendment and when the Parliament adopted a legislative resolution on that amendment. |

| 47 | Therefore, the applicants’ view is that Article 5 of Directive 2019/904 was adopted without the three institutions concerned having assessed properly whether oxo-degradable plastic constitutes an ‘unacceptable risk to human health or the environment … which needs to be addressed on a [European Union]-wide basis’, without ‘tak[ing] into account the socio-economic impact of the restriction, including the availability of alternatives’ as required by Article 68(1) of the REACH Regulation, and without them being invited to submit comments to the ECHA pursuant to Article 69(6) of the REACH Regulation. Consequently, the adoption of that prohibition was premature and unlawful. |

| 48 | In the view of the applicants, by circumventing the restriction procedure laid down in Articles 68 to 73 of the REACH regulation – when solely the ECHA has the technical competence to investigate and determine whether oxo-degradable and oxo-biodegradable plastic are environmentally justified – the three institutions concerned have, in the applicants’ opinion, committed a sufficiently serious breach of Articles 68 to 73 of the REACH Regulation. Lastly, the applicants state that the REACH Regulation confers rights on individuals, since Article 69(1) thereof provides that the ECHA is to invite all interested parties to submit comments on dossiers and the suggested restrictions, and to provide it with a socio-economic analysis. |

| 49 | The Parliament, Council and Commission dispute the arguments put forward by the applicants. |

| 50 | In that regard, it should be noted that, under Article 68(1) of the REACH Regulation, where there is an unacceptable risk to human health or the environment, arising from the manufacture, use or placing on the market of a substance, which needs to be addressed on an EU-wide basis, such manufacture, use and placing on the market may be subject to restrictions. Those restrictions are set out in Annex XVII to that regulation. |

| 51 | To that end, Article 69 of the REACH Regulation allows the Commission to ask the ECHA to prepare a dossier. If that dossier shows that action on an EU-wide basis is necessary, the ECHA is to propose restrictions within 12 months of receipt of the Commission’s request. The dossier is then published on the ECHA’s website, together with the restriction proposals made by the ECHA, and interested parties are invited to submit their comments to the ECHA. |

| 52 | The dossier is then the subject, within 9 months of its publication, of an opinion of the ECHA Committee for Risk Assessment and, within 12 months of its publication, of an opinion of the ECHA Committee for Socio-economic Analysis, in accordance with Articles 70 and 71 of the REACH Regulation. Those two opinions are submitted to the Commission and published on the ECHA’s website, in accordance with Article 72 of that regulation. |

| 53 | If the conditions laid down in Article 68(1) of the REACH Regulation have been fulfilled, the Commission is to prepare a draft amendment to Annex XVII to that regulation, in accordance with Article 73(1) of that regulation. The final decision is to be taken in accordance with the procedure in the regulation with scrutiny in accordance with Article 73(2) and Article 133(4) of that regulation. |

| 54 | In the present case, such proceedings have been initiated but have not been concluded. |

| 55 | By letter of 22 December 2017, the Commission invited the ECHA to prepare a dossier concerning oxo-degradable plastics, in accordance with Article 69(1) of the REACH Regulation. The Commission and the ECHA then agreed to postpone the presentation of that dossier until the end of July 2019, in order to allow interested parties to submit further information to the ECHA, as demonstrated by an email sent to the applicants by an ECHA staff member on 30 October 2018. However, as referred to in paragraph 35 above, the Commission then, by the letter of 30 April 2019, requested the ECHA to close the preparation of the dossier in question, on the ground that intervention under the REACH Regulation was no longer necessary because, on 19 December 2018, an interinstitutional compromise had been found when preparing the directive on the reduction of the impact of certain plastic products on the environment, in order to prohibit the placing on the market of products made from oxo-degradable plastic. |

| 56 | As stated in the preamble to Directive 2019/904, the prohibition on the placing on the market of products made from oxo-degradable plastic was adopted in accordance with the ordinary legislative procedure laid down in Article 294 TFEU. |

| 57 | The applicants submit that, by adopting the prohibition laid down in Article 5 of Directive 2019/904 without waiting for the outcome of the ongoing restriction procedure, the three institutions concerned circumvented Articles 68 to 73 of the REACH Regulation. That prohibition was adopted prematurely and unlawfully, without the ECHA, which, unlike those institutions, has scientific expertise in the field, being able to bring the information which it had gathered to the attention of those institutions and without hearing the applicants. Such conduct constitutes a sufficiently serious breach of Articles 68 to 73 of the REACH Regulation, those articles being intended to confer rights on individuals. |

| 58 | Such an argument cannot be accepted because, first, no infringement of Articles 68 to 73 of the REACH Regulation has been committed and, second, those articles do not constitute rules of law intended to confer rights on individuals. |

| 59 | First, it cannot be considered that the prohibition on the placing on the market of products made from oxo-degradable plastic had to be adopted in accordance with the restriction procedure laid down in Articles 68 to 73 of the REACH Regulation. |

| 60 | Directive 2019/904 was adopted in accordance with the ordinary legislative procedure laid down in Article 294 TFEU. In addition, the preamble to that directive indicate that its legal basis is Article 192(1) TFEU. That article provides that the Parliament and the Council are to act in accordance with that procedure. |

| 61 | In addition, Article 2(4) of the REACH Regulation provides that that regulation ‘shall apply without prejudice to … [EU] … environmental legislation, including’ a number of directives which it lists. That regulation therefore makes express provision for the application of acts of EU law relating to the protection of the environment. It is true that Directive 2019/904 is not one of the provisions listed in Article 2(4) of the REACH Regulation. However, that directive was adopted after that regulation was adopted. In addition, the use of the term ‘including’ indicates that the list set out in that article is not exhaustive. |

| 62 | Second, it also cannot be held that the three institutions concerned were required, if not to follow the restriction procedure under Articles 68 to 73 of the REACH Regulation, at least to await the outcome of the ongoing restriction procedure before adopting the prohibition laid down in Article 5 of Directive 2019/904. |

| 63 | The power of legislative initiative accorded to the Commission by Article 17(2) TEU and Article 289 TFEU means that it is for the Commission to decide whether or not to bring forward a proposal for a legislative act and to determine the subject matter, objective and content of the proposal (judgment of 6 September 2017, Slovakia and Hungary v Council, [C‑643/15 and C‑647/15](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AC%3A2017%3A631&locale=en), [EU:C:2017:631](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AC%3A2017%3A631), paragraph [146](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AC%3A2017%3A631&anchor=#point146)). |

| 64 | In addition, the Parliament and Council’s legislative power conferred in Article 14(1) and Article 16(1) TEU means that it is for those institutions alone to decide the content of a measure (judgment of 21 June 2018, Poland v Parliament and Council, [C‑5/16](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AC%3A2018%3A483&locale=en), [EU:C:2018:483](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AC%3A2018%3A483), paragraph [84](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AC%3A2018%3A483&anchor=#point84)). |

| 65 | Consequently, to require the Commission, the Parliament and the Council to await the outcome of the restriction procedure laid down in Articles 68 to 73 of the REACH Regulation before adopting, respectively, the proposal for a directive and the amendment introducing into that proposal the prohibition on the placing on the market of products made from oxo-degradable plastic, would be tantamount to limiting the power of legislative initiative of the Commission and the legislative power of the Parliament and the Council. |

| 66 | Third, the legality of Directive 2019/904 cannot be assessed in the light of the REACH Regulation. |

| 67 | In accordance with case-law, the substantive legality of an EU act cannot be examined in the light of another EU act of the same status in the hierarchy of legal rules, unless the former has been adopted pursuant to the latter or unless it is expressly provided, in one of those two acts, that one takes precedence over the other (judgment of 22 February 2022, Stichting Rookpreventie Jeugd and Others[C‑160/20](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AC%3A2022%3A101&locale=en), [EU:C:2022:101](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AC%3A2022%3A101), paragraph [38](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AC%3A2022%3A101&anchor=#point38)). |

| 68 | It is apparent from Article 289(1) and (3) TFEU that legal acts adopted in accordance with the ordinary legislative procedure constitute legislative acts. That is so, as stated in paragraph 56 above, with regard to Directive 2019/904. The legal basis of the REACH Regulation is Article 95 EC which provided for the co-decision procedure described in Article 251 EC to apply. The ordinary legislative procedure defined in Article 294 TFEU reproduces, in essence, the co-decision procedure (order of 6 September 2011, Inuit Tapiriit Kanatami and Others v Parliament and Council, [T‑18/10](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AT%3A2011%3A419&locale=en), [EU:T:2011:419](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AT%3A2011%3A419), paragraph [61](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AT%3A2011%3A419&anchor=#point61)), with the result that the REACH Regulation can also be regarded as a legislative act. Consequently, Directive 2019/904 and the REACH Regulation must be regarded as being of the same status in the hierarchy of legal rules (see, by analogy, judgment of 22 February 2022, Stichting Rookpreventie Jeugd and Others, [C‑160/20](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AC%3A2022%3A101&locale=en), [EU:C:2022:101](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AC%3A2022%3A101), paragraph [38](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AC%3A2022%3A101&anchor=#point38)). |

| 69 | Moreover, Directive 2019/904 was not adopted pursuant to the REACH Regulation. |

| 70 | In addition, in so far as, as stated in paragraph 61 above, Article 2(4) of the REACH Regulation indicates that it is to apply without prejudice to EU environmental legislation, it is clear that that regulation does not state that it takes precedence over those provisions, such as Directive 2019/904. Furthermore, that directive also does not state that the REACH Regulation takes precedence over its provisions. |

| 71 | It follows from paragraphs 59 to 70 above that the three institutions concerned did not infringe Articles 68 to 73 of the REACH Regulation. |

| 72 | In the absence of an infringement of those provisions, there is no need to examine whether that infringement is sufficiently serious, as required by the case-law relating to the first condition for the liability of the European Union to be incurred, cited in paragraph 42 above. |

| 73 | In any event, Articles 68 to 73 of the REACH Regulation cannot be regarded as being rules of law intended to confer rights on individuals. |

| 74 | In that regard, the applicants rely on Article 69(6) of the REACH Regulation, which provides that the ECHA is to invite all interested parties to submit, within six months of publication of the dossier, their comments on the dossier and on the proposed restrictions, as well as a socio-economic analysis, or any information that may contribute to such an analysis. In the applicants’ view, that provision confers a right on individuals to be heard prior to a restriction being introduced. |

| 75 | In addition, under Article 71(1) of the REACH Regulation, the ECHA is to invite interested parties to submit their comments on the draft opinion of the Committee for Socio-economic Analysis. |

| 76 | It is true that the right to be heard is a rule of law intended to confer rights on individuals (judgment of 28 October 2021, Vialto Consulting v Commission, [C‑650/19 P](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AC%3A2021%3A879&locale=en), [EU:C:2021:879](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AC%3A2021%3A879), paragraph [140](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AC%3A2021%3A879&anchor=#point140)). |

| 77 | However, no provision in Articles 68 to 73 of the REACH Regulation guarantees, in the strict sense, interested parties a right to be heard. In particular, the fact that Article 69(6)(a) and Article 71(1) of that regulation provide for a public consultation does not call into question the fact that neither the ECHA nor the Commission are required to hear an individual who is concerned by the amendment of Annex XVII to the REACH Regulation in addition to that public consultation (see, to that effect and by analogy, judgment of 25 September 2015, VECCO and Others v Commission, [T‑360/13](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AT%3A2015%3A695&locale=en), [EU:T:2015:695](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AT%3A2015%3A695), paragraphs [81](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AT%3A2015%3A695&anchor=#point81) and [82](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AT%3A2015%3A695&anchor=#point82)). |

| 78 | Consequently, the first plea of illegality must be rejected. |

2.
 
The second plea of illegality, alleging a sufficiently serious breach of paragraphs 12 and 14 to 16 of the Interinstitutional Agreement

| 79 | By their second plea of illegality, the applicants maintain that, by failing to conduct an impact assessment in relation to the prohibition on the placing on the market of products made from oxo-degradable plastic laid down in Article 5 of Directive 2019/904, the three institutions concerned infringed paragraphs 12 and 14 to 16 of the Interinstitutional Agreement. The impact assessment accompanying the proposal for a directive concerned only fishing gear and single-use plastics listed in Part B of the annex to that proposal, which do not include oxo-degradable plastics. In the view of the applicants, the Parliament and the Council infringed paragraph 15 of the Interinstitutional Agreement, and the Commission infringed paragraph 16, by failing, respectively, to carry out an impact assessment of the amendment made by the Parliament to the proposal for a directive and to supplement the initial impact assessment. |

| 80 | The applicants acknowledge that the Parliament and the Council are not bound by the Commission’s impact assessment and that the three institutions concerned have a certain margin of discretion to establish whether a supplementary impact assessment is necessary when amendments are made to a proposal for a directive presented by the Commission. They observe, however, that failing to carry out an impact assessment is the exception and that carrying one out is the norm. In the present case, the three institutions concerned ought to have carried out an impact assessment in relation to oxo-degradable plastic since they did not have sufficient scientific evidence. Consequently, those institutions committed a sufficiently serious breach of the Interinstitutional Agreement, which confers rights on individuals. |

| 81 | The Parliament, Council and Commission dispute the arguments put forward by the applicants. |

| 82 | The applicants’ line of argument cannot be accepted. First, there has been no infringement of the Interinstitutional Agreement and, second, the provisions of that agreement cannot be regarded as being intended to confer rights on individuals. |

| 83 | In that regard, in the first place, the Court observes that the Commission carried out an impact assessment in relation to its proposal for a directive. However, that impact assessment does not cover oxo-degradable plastic. |

| 84 | It is not disputed that the adoption of the Parliament’s amendment was not accompanied by an impact assessment covering that type of plastic. |

| 85 | It must therefore be examined whether paragraphs 12 and 14 to 16 of the Interinstitutional Agreement required the three institutions concerned, or one or other of them, to carry out an impact assessment specifically covering the Parliament’s amendment. |

| 86 | It is clear from the wording of those paragraphs that that was not the case. |

| 87 | Indeed, paragraph 12 of the Interinstitutional Agreement states, inter alia, that impact assessments are a tool to help the three institutions reach well-informed decisions and not a substitute for political decisions within the democratic decision-making process. |

| 88 | Paragraph 13 of the Interinstitutional Agreement states that the Commission will carry out impact assessments, in particular, of legislative initiatives which are expected to have significant economic, environmental or social impacts. |

| 89 | Paragraph 14 of that agreement states that the Parliament and the Council will take full account of the Commission’s impact assessments. |

| 90 | However, according to the case-law, an impact assessment is not binding on either the Parliament or the Council, with the result that the EU legislature remains free to adopt measures other than those which were the subject of that impact assessment (judgment of 4 May 2016, Pillbox 38, [C‑477/14](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AC%3A2016%3A324&locale=en), [EU:C:2016:324](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AC%3A2016%3A324), paragraph [65](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AC%3A2016%3A324&anchor=#point65)). |

| 91 | In addition, in accordance with paragraph 15 of the Interinstitutional Agreement, the Parliament and the Council will, when they consider that to be appropriate and necessary for the legislative process, carry out impact assessments in relation to their substantial amendments to the Commission’s proposal. That paragraph 15 states that the definition of a ‘substantial’ amendment should be for the respective institution to determine. |

| 92 | However, according to the case-law, paragraph 15 of the Interinstitutional Agreement does not contain a definite obligation for the Parliament and the Council. That paragraph provides only for the option to carry out an update of the impact assessment where the Parliament and the Council ‘consider this to be appropriate and necessary for the legislative process’ (judgment of 13 March 2019, Poland v Parliament and Council, [C‑128/17](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AC%3A2019%3A194&locale=en), [EU:C:2019:194](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AC%3A2019%3A194), paragraph [43](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AC%3A2019%3A194&anchor=#point43)). |

| 93 | In the present case, both the Parliament and the Council submit that they had sufficient scientific information and that such an update was therefore not necessary. Consequently, they cannot be criticised for failing to carry out an impact assessment of the Parliament’s amendment. |

| 94 | As regards the Commission’s alleged wrongful failure to act, it should be noted that paragraph 16 of the Interinstitutional Agreement states that the Commission ‘may’, on its own initiative or on the invitation of the Parliament or the Council, complement its own impact assessment or undertake other analytical work it considers necessary. It is clear from the wording of that paragraph 16 that it does not contain any obligation for the Commission to carry out an update of the impact assessment. Therefore, it cannot be criticised for failing to do so in order to take account of the Parliament’s amendment. |

| 95 | It follows from the foregoing that the three institutions concerned have not infringed paragraphs 12 and 14 to 16 of the Interinstitutional Agreement. |

| 96 | In the absence of such an infringement, there is no need to examine whether such infringement is sufficiently serious, as required by the case-law relating to the first condition for the liability of the European Union to be incurred, cited in paragraph 42 above. |

| 97 | In the second place, and in any event, paragraphs 12 and 14 to 16 of the Interinstitutional Agreement cannot be regarded as being intended to confer rights on individuals, since, as stated in paragraph 12 of that agreement, impact assessments are a tool to help the three institutions concerned reach well-informed decisions. |

| 98 | Accordingly, the second plea of illegality must be dismissed. |

3.
 
The third plea of illegality, alleging a sufficiently serious breach of the general principle of proportionality, enshrined in Article 5(4) TEU and Article 191 TFEU, as well as manifest errors of assessment

| 99 | By their third plea of illegality, the applicants submit that, in so far as it applies to oxo-biodegradable plastic, the prohibition laid down in Article 5 of Directive 2019/904 is contrary to the general principle of proportionality, enshrined in Article 5(4) TEU, and Article 191 TFEU, and is based on manifest errors of assessment. Therefore, in the applicants’ view, by adopting that prohibition, the three institutions concerned have committed a sufficiently serious breach of a rule of law intended to confer rights on individuals. |

| 100 | That plea is divided into three parts. |

| 101 | By the first part, the applicants submit that the three institutions concerned did not have at their disposal a thorough scientific assessment of the risks posed by oxo-degradable plastic and that, therefore, the prohibition laid down in Article 5 of Directive 2019/904 is in itself contrary to the general principle of proportionality, enshrined in Article 5(4) TEU, and Article 191 TFEU, and that it is based on manifest errors of assessment. |

| 102 | According to the applicants, those institutions could not adopt such an intrusive measure without the benefit of evidence which would have been gathered during the restriction procedure provided for in Articles 68 to 73 of the REACH Regulation. The three institutions concerned should also have had at their disposal an impact assessment relating specifically to oxo-degradable plastic and any other scientific assessment of the advantages and disadvantages of that type of plastic. By prohibiting the placing on the market of that type of plastic without such information, those institutions followed a purely hypothetical approach to the risks that it posed. |

| 103 | The applicants point out that the fact that the three institutions concerned enjoy a broad margin of discretion in environmental matters does not exempt them from the obligation to take all relevant factors into account. The scientific evidence on which those institutions claim, in their defences, to have relied in order to adopt the prohibition on the placing on the market of products made from oxo-degradable plastic does not make a distinction between oxo-degradable plastic and oxo-biodegradable plastic and does not advocate a total prohibition on oxo-biodegradable plastic. In addition, the three institutions concerned did not, inter alia, take into account the economic and social impacts of that prohibition. Lastly, there is sufficient evidence to call into question the proportionality of that prohibition. |

| 104 | By the second part of their third plea, the applicants maintain that the three institutions concerned have failed, either sufficiently or at all, to establish that there is a rational connection between the prohibition on the placing on the market of products made from oxo-degradable plastic and the aims of Directive 2019/904, namely the protection of the environment and human health. Consequently, that prohibition is contrary to the general principle of proportionality, enshrined in Article 5(4) TEU. |

| 105 | The applicants’ view is that none of the four assertions in recital 15 of that directive is substantiated. |

| 106 | First, the assertion that oxo-degradable plastic does not biodegrade properly is not based on any evidence, since such evidence ought to have been adduced in the restriction procedure under Articles 68 to 73 of the REACH Regulation. The scientific studies on which the three institutions concerned claim to have relied did not conclude that oxo-degradable plastic does not biodegrade properly, but simply that there is no conclusive evidence of its biodegradability. In addition, the applicants’ view is that that assertion is contradicted by other scientific studies and laboratory tests which establish that oxo-biodegradable plastic biodegrades properly. |

| 107 | Second, according to the applicants, the assertion that oxo-degradable plastic is not compostable is incorrect. In addition, the three institutions concerned have not indicated how the fact that oxo-biodegradable plastic is not compostable is harmful to the environment or to human health, or why that fact justifies the prohibition on oxo-biodegradable plastic when conventional plastic, which is also not compostable, is not prohibited. |

| 108 | Third, the parties submit that, as regards the assertion that oxo-degradable plastic has a negative impact on the recycling of conventional plastics, the scientific studies on which the three institutions concerned claim to have relied do not deny that oxo-degradable plastic can be recycled and indicate that the use of stabilisers can prevent that type of plastic from negatively affecting the recycling of conventional plastics. According to the applicants, other studies establish, that oxo-biodegradable plastic can be recycled in the same way as conventional plastic. |

| 109 | Fourth, the applicants’ view is that the assertion that oxo-degradable plastic fails to deliver a proven environmental benefit is not based on any scientific study. |

| 110 | By the third part of the third plea, the applicants submit, in essence, that the total prohibition on placing on the market goes beyond what is necessary in order to achieve the objective pursued by Directive 2019/904 and that less restrictive alternative measures exist. Consequently, that prohibition is contrary to the general principle of proportionality, enshrined in Article 5(4) TEU. |

| 111 | In support of that third part, the applicants submit that it was possible to exclude oxo-biodegradable plastic from the prohibition in question, to require tests to be carried out in accordance with a recognised standard in order to assess, in particular, its biodegradability, to require it to contain markers allowing automatic sorting prior to recycling, to include oxo-biodegradable plastic in one of the non-prohibition measures set out in Articles 4, 7, 8 and/or 10 of Directive 2019/904, or to require specific labelling to avoid consumer confusion. The applicants also submit that, instead of an outright prohibition on the placing on the market, the three institutions concerned ought to have provided for a transition period. |

| 112 | The Parliament, Council and Commission dispute the arguments put forward by the applicants. |

| 113 | The Court observes that, while infringement of Article 191 TFEU is alleged in relation to the first part of the third plea of illegality alone, by contrast, breach of the general principle of proportionality, enshrined in Article 5(4) TEU, is alleged in relation to all three parts of that plea. Therefore, it is appropriate to group those three parts together and to examine, first, the infringement of Article 191 TFEU and, second, the infringement of Article 5(4) TEU. |

(a)
 
The first part, in so far as it alleges a sufficiently serious breach of Article 191 TFEU

| 114 | As a preliminary point, it should be recalled that, as stated in paragraph 43 above, the EU legislature enjoys a broad discretion when exercising its powers in environmental matters under Articles 191 and 192 TFEU. |

| 115 | Therefore, review by the EU Courts has to be limited to verifying whether the exercise of such powers has been vitiated by a manifest error of assessment or a misuse of powers, or whether the EU legislature has manifestly exceeded the limits of its discretion (judgment of 8 July 2010, Afton Chemical, [C‑343/09](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AC%3A2010%3A419&locale=en), [EU:C:2010:419](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AC%3A2010%3A419), paragraph [28](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AC%3A2010%3A419&anchor=#point28)). |

| 116 | In addition, according to Article 191(2) TFEU, EU policy on the environment is to be based, inter alia, on the precautionary principle. According to Article 191(3) TFEU, in preparing that policy, the European Union is to take account, inter alia, of available scientific and technical data. |

| 117 | The precautionary principle means that where there is uncertainty as to the existence or extent of risks, including risks to the environment or human health, protective measures may be taken without having to wait until the reality and seriousness of those risks become fully apparent. Where it proves to be impossible to determine with certainty the existence or extent of the alleged risk because the results of studies conducted are inconclusive, but the likelihood of real harm to the environment or public health persists should the risk materialise, the precautionary principle justifies the adoption of restrictive measures (judgment of 6 May 2021, Bayer CropScience and Bayer v Commission, [C‑499/18 P](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AC%3A2021%3A367&locale=en), [EU:C:2021:367](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AC%3A2021%3A367), paragraph [80](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AC%3A2021%3A367&anchor=#point80)). In that regard, the institutions may not take a purely hypothetical approach to risk and may not base their decisions on a level of ‘zero risk’ (see, by analogy, judgments of 9 September 2003, Monsanto Agricoltura Italia and Others, [C‑236/01](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AC%3A2003%3A431&locale=en), [EU:C:2003:431](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AC%3A2003%3A431), paragraph [106](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AC%3A2003%3A431&anchor=#point106); of 12 December 2014, Xeda International v Commission, [T‑269/11](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AT%3A2014%3A1069&locale=en), not published, [EU:T:2014:1069](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AT%3A2014%3A1069), paragraphs [55](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AT%3A2014%3A1069&anchor=#point55) and [56](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AT%3A2014%3A1069&anchor=#point56); and of 17 March 2021, FMC v Commission, [T‑719/17](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AT%3A2021%3A143&locale=en), [EU:T:2021:143](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AT%3A2021%3A143), paragraph [69](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AT%3A2021%3A143&anchor=#point69)). |

| 118 | Consequently, if it is not to adopt arbitrary measures, which cannot in any event be rendered legitimate by the precautionary principle, the competent public authority must ensure that any measures that it takes, even preventive measures, are based on as thorough a scientific risk assessment as possible, account being taken of the particular circumstances of the case at issue (see, to that effect, judgment of 8 July 2010, Afton Chemical, [C‑343/09](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AC%3A2010%3A419&locale=en), [EU:C:2010:419](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AC%3A2010%3A419), paragraph [60](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AC%3A2010%3A419&anchor=#point60); see also, by analogy, judgment of 12 December 2014, Xeda International v Commission, [T‑269/11](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AT%3A2014%3A1069&locale=en), not published, [EU:T:2014:1069](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AT%3A2014%3A1069), paragraph [57](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AT%3A2014%3A1069&anchor=#point57)). |

| 119 | That scientific assessment should be based on the best scientific data available and should be undertaken in an independent, objective and transparent manner (see, by analogy, judgment of 17 March 2021, FMC v Commission, [T‑719/17](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AT%3A2021%3A143&locale=en), [EU:T:2021:143](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AT%3A2021%3A143), paragraph [70](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AT%3A2021%3A143&anchor=#point70)). It must give the competent public authority sufficiently reliable and cogent information to allow it to understand the ramifications of the scientific question raised and decide upon a policy in full knowledge of the facts (see, by analogy, judgments of 14 November 2013, ICdA and Others v Commission, [T‑456/11](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AT%3A2013%3A594&locale=en), [EU:T:2013:594](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AT%3A2013%3A594), paragraph [52](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AT%3A2013%3A594&anchor=#point52), and of 17 March 2021, FMC v Commission, [T‑719/17](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AT%3A2021%3A143&locale=en), [EU:T:2021:143](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AT%3A2021%3A143), paragraph [71](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AT%3A2021%3A143&anchor=#point71)). |

| 120 | Therefore, the adoption of the prohibition on placing on the market, laid down in Article 5 of Directive 2019/904, presupposed that, on the basis of a scientific assessment of the risks posed by products made from plastic containing a pro-oxidant additive which was as through as possible, the three institutions concerned could, without making a manifest error of assessment, come to the conclusion that there was a risk to the environment or to human health. It should also be recalled that, in accordance with the case-law cited in paragraph 42 above, the non-contractual liability of the European Union is incurred only where the breach of the rule of law at issue is sufficiently serious. |

| 121 | In that regard, the Court considers that, contrary to the applicants’ assertions, neither the fact that no impact assessment was carried out in respect of products made from plastic containing a pro-oxidant additive, nor the fact that the Commission terminated the restriction procedure laid down in Articles 68 to 73 of the REACH Regulation and that, therefore, the three institutions concerned had at their disposal neither a dossier prepared by the ECHA nor a proposal for a restriction, nor opinions of the Committee for Risk Assessment and of the Committee for Socio-economic Analysis provided for by the REACH Regulation, establish that the prohibition on those products, laid down in Article 5 of Directive 2019/904, was adopted in the absence of a scientific assessment of the risks they pose, which was as thorough as possible. It is apparent from paragraphs 78 and 98 above that those institutions were not required either to carry out such an impact assessment or to follow the procedure laid down in Articles 68 to 73 of the REACH Regulation in order to adopt that prohibition. In order to satisfy the requirements of the case-law cited in paragraphs 118 and 119 above, it is sufficient that the three institutions concerned had at their disposal, during the legislative procedure, sufficiently reliable and cogent information to allow them to understand the ramifications of the scientific question raised and to decide upon their policy in full knowledge of the facts, irrespective of the origin and form of such information. |

| 122 | Recital 15 of Directive 2019/904 justifies the extension of the prohibition laid down in Article 5 thereof to products made from oxo-degradable plastic by the fact that, first, that type of plastic does not properly biodegrade and thus contributes to microplastic pollution in the environment, second, it is not compostable, third, it negatively affects the recycling of conventional plastic and, fourth, it fails to deliver a proven environmental benefit. |

| 123 | Consequently, it is necessary to examine whether, although no impact assessment was carried out and the restriction procedure provided for in Articles 68 to 73 of the REACH Regulation was not completed, each of those four assertions is nevertheless based on a scientific assessment of the risks posed by products made from plastic containing a pro-oxidant additive which was as thorough as possible and whether, on the basis of such an assessment, the three institutions concerned could, without committing manifest errors of assessment, conclude that there were risks to the environment and human health. |

(1) The assertion that plastic containing a pro-oxidant additive does not biodegrade properly

| 124 | As regards the assertion that plastic containing a pro-oxidant additive does not biodegrade properly, it should be noted, as a preliminary point, that according to a definition which is not disputed by the parties and is contained in a report from the Commission to the Parliament and the Council on the impact of the use of oxo-degradable plastic, including oxo-degradable plastic carrier bags, on the environment (COM(2018) 35 final) of 16 January 2018 (‘the report of 16 January 2018’), biodegradation is the process by which material disintegrates and is decomposed by microorganisms into elements that are found in nature, that is to say, carbon dioxide, biomass and water. Biodegradation can occur in an oxygen-rich environment (aerobic biodegradation) or in an oxygen-poor environment (anaerobic biodegradation). |

| 125 | In their defences, the three institutions concerned claim to have relied on the following evidence in order to conclude that plastic containing a pro-oxidant additive did not biodegrade properly: the Eunomia study, referred to in paragraph 22 above; the report of 16 January 2018, referred to in paragraph 124 above; a report from the Ellen MacArthur Foundation entitled ‘Oxo Statement’ dated 6 November 2017 (‘the Oxo Statement’); a study carried out by S. Deconinck and B. De Wilde for PlasticsEurope AISBL, a European association of plastic producers, entitled ‘Benefits and challenges of bio- and oxo-degradable plastics’ dated 9 August 2013 (‘the De Wilde study’), and a study carried out by the University of Loughborough (United Kingdom) for the Department for Environment, Food and Rural Affairs of the United Kingdom Government, entitled ‘Assessing the Environmental Impacts of Oxo-degradable Plastics Across Their Life Cycle’ dated January 2010 (‘the Loughborough University Study’). |

| 126 | First, the Eunomia study clarifies that it will not use the term ‘oxo-biodegradable’ plastic, since it is used by plastic manufacturers to market their products as biodegradable, but rather the expression ‘containing a pro-oxidant additive’, since that simply describes a physical feature of the plastic at issue without indicating whether it is biodegradable. |

| 127 | It is apparent from the Eunomia study that the biodegradation of plastic containing a pro-oxidant additive is not possible unless there is a first phase where it is exposed to ultraviolet radiation and heat. The aim of that first phase is to reduce, by oxidation, the molecular mass of the plastic so that it is fragmented into very small pieces. That study indicates that, without that prior phase, biodegradation does not occur, or occurs over a much longer period, because the plastic has not reached a sufficient degree of fragmentation to be consumable by micro-organisms. As light and heat vary according to local conditions, it is very difficult to estimate the time and degree of fragmentation necessary for biodegradation to be able to occur. However, the pro-oxidant additive accelerates the fragmentation of the plastic during that first phase, so that the plastic containing such an additive is fragmented more quickly than conventional plastic when exposed to ultraviolet radiation and heat. |

| 128 | As regards the subsequent phase, namely biodegradation itself (consumption by microorganisms), it is apparent from the Eunomia study that biodegradation in an open environment of plastic containing a pro-oxidant additive has been demonstrated only in part. While it appears that that plastic can degrade in an open environment, it is not certain that it will degrade completely and within a reasonable time. Indeed, it was only in laboratory experiments that satisfactory biodegradation (almost complete, within two years, the shortest observed) was obtained. Such biodegradation has never been observed in a real-world situation. In addition, while it is possible to regard the biodegradation, in an open environment, of plastic containing a pro-oxidant additive as being much faster than that of conventional plastic, the negative impact on the environment could be even greater during that biodegradation phase. |

| 129 | As regards the biodegradation of plastic containing a pro-oxidant additive when it is put into landfill, the Eunomia study concludes that the hypothesis that biodegradation does not take place is substantiated. According to that study, while biodegradation may take place in the higher levels of the landfill, where the plastic is exposed to oxygen (aerobic biodegradation), by contrast, biodegradation is low to non-existent in the deep levels of the landfill, where there is little oxygen. However, in those deep levels, anaerobic biodegradation is possible. Anaerobic biodegradation produces methane, a greenhouse gas 25 times more harmful than carbon dioxide produced by aerobic biodegradation. Consequently, plastic containing a pro-oxidant additive is marginally worse than conventional plastic because, unlike conventional plastic, it can lead to emissions of greenhouse gas. |

| 130 | Lastly, according to the Eunomia study, the available scientific data are insufficient to establish whether or not there is biodegradation of plastic containing a pro-oxidant additive in the marine environment. That study states, however, that the results of certain experiments suggest that, in a marine environment, that type of plastic fragments more quickly than conventional plastic, but that it biodegrades at a considerably slower pace than in land-based open environments, which means that very small pieces could remain in the environment indefinitely or for a sufficiently long period to cause serious harm to the environment. |

| 131 | Second, according to the report of 16 January 2018, which sets out the findings of the Eunomia study, prior exposure of plastic containing a pro-oxidant additive to heat and/or ultraviolet radiation is a necessary condition for biodegradation to occur in the next phase. It is also apparent from that report, in the first place, that there is no reason to conclude with certainty that biodegradation in an open environment of that type of plastic actually occurs in a real-world situation. In the second place, once more in accordance with that report, the biodegradation of plastic containing a pro-oxidant additive in landfill is possible in the higher levels of the landfill, but is low to non-existent, in the deep levels, where that type of plastic is more problematic than conventional plastic from the point of view of greenhouse gases. In the third place, that report states that the available data do not make it possible to maintain with certainty that there is biodegradation in the marine environment within a reasonable period of time and that, in any event, biodegradation would probably be much slower than in land-based open environments, and would cause significant environmental damage. |

| 132 | Both the Eunomia study and the report of 16 January 2018 were at the disposal of the three institutions concerned when Directive 2019/904 was being drawn up and adopted. It was on 16 January 2018, that is to say, before the adoption on 5 June 2019 of that directive, that that report was submitted by the Commission to the Parliament and the Council, pursuant to Article 20a(2) of Directive 94/62/EC of the European Parliament and of the Council of 20 December 1994 on packaging and packaging waste ([OJ 1994 L 365, p. 10](./../../../legal-content/EN/AUTO/?uri=OJ:L:1994:365:TOC)), as amended by Directive (EU) 2015/720 of the European Parliament and of the Council of 29 April 2015 ([OJ 2015 L 115, p. 11](./../../../legal-content/EN/AUTO/?uri=OJ:L:2015:115:TOC)). The Eunomia study is the basis for the report of 16 January 2018, which refers frequently to that study. It follows that that study was also available to the three institutions concerned before 5 June 2019. |

| 133 | Third, the Oxo Statement confirms that it has not been established that plastic containing a pro-oxidant additive biodegrades properly within a reasonable period of time. That statement, signed by numerous undertakings and professional organisations, non-governmental organisations, institutions, research bodies, scientists and members of the European Parliament, appears on the website of the Ellen MacArthur Foundation, the purpose of which is to promote the circular economy. It follows that plastic containing a pro-oxidant additive is incorrectly (i) marketed as being the solution to plastic pollution and (ii) presented as being biodegradable within a reasonable period of time. After that plastic has fragmented into very small pieces, biodegradation depends on the environmental conditions, which are variable, and it often takes longer, or much longer, than a few months or even several years. During that period, fragments persist in the environment, which may have a negative impact on the environment and on human health. |

| 134 | It is irrelevant that the initial version of the Oxo Statement, published on 6 November 2017 and summarised in the preceding paragraph, was removed in June 2018 from the website of the Ellen MacArthur Foundation in order to enable that foundation to examine a third-party complaint, or that that statement was amended before being reposted online in May 2019. The amendments made in 2019 clarify the content of that statement, but do not change its meaning. |

| 135 | First, the Oxo Statement was published on the website of the Ellen MacArthur Foundation, that is to say, it is in the public domain. Second, such publication, whether of the initial version or of the amended version of the Oxo Statement, pre-dates the adoption, on 5 June 2019, of Directive 2019/904. |

| 136 | In addition, the report of 16 January 2018, which was established in paragraph 132 above as having been accessible to the three institutions concerned, refers to the Oxo Statement. |

| 137 | Consequently, the Oxo Statement must be regarded as having been in the public domain and therefore accessible to the three institutions concerned when Directive 2019/904 was being drawn up and adopted (see, to that effect, judgment of 8 July 2010, Afton Chemical, [C‑343/09](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AC%3A2010%3A419&locale=en), [EU:C:2010:419](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AC%3A2010%3A419), paragraph [39](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AC%3A2010%3A419&anchor=#point39)). |

| 138 | Fourth, the De Wilde study also bears out the conclusions of the Eunomia study and of the report of 16 January 2018 regarding the biodegradation of plastic containing a pro-oxidant additive. |

| 139 | As the Commission states, it is apparent from the De Wilde study that, although two articles, one by Jakubowicz, I., Yarahmadi, N., and Arthurson, V., entitled ‘Kinetics of abiotic and biotic degradability of low-density polyethylene containing prodegradant additives and its effect on the growth of microbial communities’ published in May 2011 (‘the 2011 Jakubowicz study’), and the other by Chiellini, E., Corti, A., and Swift, G., entitled ‘Biodegradation of Thermally oxidised, Fragmented Low-density Polyethylenes’ in 2003 (‘the Chiellini and Corti study’), reported a significant percentage of biodegradation in respect of that type of plastic, all the other articles available reported a (very) low level of biodegradation or none at all. That study concludes that the level of biodegradation which plastic containing a pro-oxidant additive can achieve is the subject of debate. |

| 140 | Contrary to the applicants’ assertions, the mere fact that the De Wilde study dates from August 2013 is not sufficient to establish that that study is out of date. In fact, the applicants do no more than make a general, unsubstantiated assertion in that regard, and make no reference to specific passages in that study. |

| 141 | In addition, the conclusion of the De Wilde study as to the low, or non-existent, level of biodegradation achieved by plastic containing a pro-oxidant additive cannot be invalidated by the fact that the tests on which it is based were carried out in a laboratory and not in a real-world environment. Indeed, that fact was taken into account by that study. In addition, it is apparent, in particular, from paragraphs 127 and 133 above that environmental conditions are variable and therefore difficult to reproduce in a laboratory. |

| 142 | Lastly, on the one hand, the De Wilde study was published on the internet, as demonstrated by the hyperlink in the footnote to the Commission’s defence, that is to say, it is in the public domain. On the other hand, the Eunomia study, which was established in paragraph 132 above as having been accessible to the three institutions concerned before the adoption of Directive 2019/904, refers to the De Wilde study. It follows that, in accordance with the case-law cited in paragraph 137 above, the De Wilde study was also accessible to those institutions when that directive was being drawn up and adopted. |

| 143 | Fifth, the Loughborough University study also supports the conclusions of the Eunomia study and of the report of 16 January 2018 regarding the biodegradation of plastic containing a pro-oxidant additive. |

| 144 | As the Parliament points out, it is apparent from that study that the fragmentation of that type of plastic into very small parts depends on environmental conditions and that it is therefore impossible to assess the time needed for that fragmentation, but that it nevertheless appears to take, in an open environment and in the conditions of the United Kingdom, between two and five years. According to the same study, the biodegradation of plastic containing a pro-oxidant additive, which can take place only after that fragmentation, occurs very slowly, with the result that the term ‘biodegradable’ is virtually meaningless, unless it is accompanied by a reference to the rate of biodegradation and the conditions under which it occurs, preferably with reference to a widely recognised standard. The Loughborough University study recommends further studies to determine whether there is full biodegradation and, if so, over what timescale. |

| 145 | Contrary to the applicants’ assertions, it cannot be inferred that the Loughborough University study is out of date simply because it dates from January 2010. In that regard, the applicants do no more that make a general assertion, without specifying which aspects of that study are out of date or providing evidence in support of their assertion. Moreover, the fact that the Loughborough University study is referred to repeatedly in the Eunomia Study, which dates from April 2017, tends, on the contrary, to suggest that it remains up to date. |

| 146 | In addition, the conclusion of the Loughborough University study as to the uncertainty surrounding the biodegradation of plastic containing a pro-oxidant additive cannot be called into question by the document entitled ‘OPA Response to Loughborough Report’, which the applicants adduced as an annex to their replies to the Parliament and the Council. According to that document, that study confused oxo-biodegradation with hydro-biodegradation. |

| 147 | In that regard, it must be recalled that the principle which prevails in EU law is that of the unfettered evaluation of evidence, which governs appeal proceedings, and that it is only the reliability of the evidence before the Court which is decisive when it comes to the assessment of its value. In addition, in order to assess the probative value of a document, regard should be had to the credibility of the account it contains and, in particular, to the person from whom the document originates, the circumstances in which it came into being, the person to whom it was addressed and whether, on its face, the document appears to be sound and reliable (judgment of 16 May 2019, GMPO v Commission, [T‑733/17](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AT%3A2019%3A334&locale=en), [EU:T:2019:334](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AT%3A2019%3A334), paragraph [60](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AT%3A2019%3A334&anchor=#point60)). |

| 148 | As the Parliament submits, without being contradicted, the author of the document referred to in paragraph 146 above is the Oxo-Biodegradable Plastics Association (OPA), the only active executives of which are the managing director and director of Symphony Environmental. In addition, that document is not accompanied by any evidence supporting the assertions contained within it. |

| 149 | Therefore, the document in question has little probative value (see, by analogy, judgment of 14 March 2017, Bank Tejarat v Council, [T‑346/15](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AT%3A2017%3A164&locale=en), not published, [EU:T:2017:164](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AT%3A2017%3A164), paragraphs [85](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AT%3A2017%3A164&anchor=#point85) and [86](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AT%3A2017%3A164&anchor=#point86)). |

| 150 | Lastly, on the one hand, the Loughborough University study is available on the website of the Department for Environment, Food and Rural Affairs of the United Kingdom Government. On the other hand, that study is cited repeatedly in the Eunomia study, which was established in paragraph 132 above as having been available to the three institutions concerned before Directive 2019/904 was adopted. It follows that, in accordance with the case-law cited in paragraph 137 above, the Loughborough University study was also accessible to those institutions. |

| 151 | It follows from paragraphs 124 to 150 above that, when Directive 2019/904 was drawn up and adopted, the three institutions concerned had at their disposal a thorough scientific assessment of the risk that plastic containing a pro-oxidant additive does not biodegrade properly, and that they could, without making a manifest error of assessment, regard such a risk as having been established. |

| 152 | That conclusion cannot be called into question by the applicants’ argument that the Eunomia study, the report of 16 January 2018 and the Oxo Statement do not take account of the distinction between oxo-degradable plastic and oxo-biodegradable plastic. As stated in paragraph 14 above, the much faster biodegradation of oxo-biodegradable plastic and, therefore, the existence of a distinction between oxo-degradable plastic and oxo-biodegradable plastic is, according to the applicants, established by various items of evidence, and they criticise the three institutions concerned for failing to take that evidence into account. The items of evidence in question are as follows: (i) paragraphs 23 and 24 of the witness statement of the Chief Executive Officer (‘CEO’) of the applicants dated 16 December 2020 (‘the witness statement of the applicants’ CEO’); (ii) an opinion on oxo-biodegradable plastic technology of 2 November 2018 (‘the opinion of 2 November 2018’); (iii) the study carried out by Queen Mary University, London, entitled ‘Microbial Degradation of Plastic in Aqueous Solutions Demonstrated by CO2 Evolution and Quantification’, published in 2020 (‘the Queen Mary University study’); (iv) the report from the Laboratoire d’Océanographie Microbienne de Banyuls-sur-Mer (France), dated 4 September 2020; (v) the reply by Mr Ignacy Jakubowicz dated 21 August 2017 to a document from the Ellen MacArthur Foundation concerning the oxo-degradable and photodegradable additives contained in plastics (‘Mr Jakubowicz’s reply to the Ellen MacArthur Foundation’); (vi) the witness statement of the senior scientist of Symphony Environmental dated 23 June 2021 (‘the witness statement of Symphony Environmental’s senior scientist’) and, (vii) the study carried out by the Laboratoire d’Océanographie Microbienne de Banyuls-sur-Mer, entitled ‘Degradation, Biodegradation and toxicity of Oxo-biodegradable Plastics in the oceans’, dated 10 March 2021 (‘the Oxomar study’). |

| 153 | First, as regards paragraphs 23 and 24 of the witness statement of the applicants’ CEO, the CEO states therein, as regards the biodegradation of plastic containing a pro-oxidant additive that (i) the three institutions concerned had not demonstrated that that type of plastic would not biodegrade properly, (ii) a total prohibition on placing on the market would therefore not be justified, (iii) those institutions did not assess sufficiently the economic, social and environmental consequences of their intervention, and (iv) they have not established that plastic products containing a pro-oxidant additive are among the waste most commonly found on beaches. The applicants’ CEO also states that the three institutions concerned took no account of the opinion of the ECHA, which was not convinced that that plastic fragmented into microplastics. |

| 154 | However, the legality of an EU measure must be assessed on the basis of the facts and the law as they stood at the time when the measure was adopted. In particular, the complex assessments made by the author of that measure must be examined solely on the basis of the information available to it at the time when those assessments were made (see, by analogy, judgment of 11 September 2018, Apimab Laboratoires and Others v Commission, [T‑14/16](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AT%3A2018%3A524&locale=en), not published, [EU:T:2018:524](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AT%3A2018%3A524), paragraphs [124](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AT%3A2018%3A524&anchor=#point124) and [137](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AT%3A2018%3A524&anchor=#point137)). |

| 155 | Consequently, the three institutions concerned cannot be criticised for having failed to take account of the witness statement of the applicants’ CEO, since that testimony was drawn up specifically for the present action and therefore post-dated the adoption of Directive 2019/904. |

| 156 | Furthermore, the witness statement in question was made by the CEO of the applicants. Therefore, in accordance with the case-law cited in paragraphs 147 and 149 above, its author cannot be classified as being independent of the applicants and that witness statement therefore has little probative value. |

| 157 | It is true that, in support of his assertions, the applicants’ CEO refers to three documents annexed to his witness statement, namely, (i) a study carried out by Eunomia Research & Consulting, entitled ‘Analysis of Branded Items found on UK Beaches’ dated 9 May 2019, (ii) an email from a member of ECHA staff to the applicants dated 30 October 2018 and, (iii) the letter of 30 April 2019, referred to in paragraphs 35 and 55 above. |

| 158 | As regards the study referred to in paragraph 157 above, the applicants’ CEO states that that study did not find any product made from plastic containing a pro-oxidant additive among the waste found on the beaches of the United Kingdom. However, it must be stated that the sole purpose of that study is to identify the brands of the various objects found on those beaches, in order to determine which undertakings placed those objects on the market. Therefore, that study does not specify the types of plastic, if any, which those objects comprise. |

| 159 | As regards the email referred to in paragraph 157 above, it is sufficient to note that in that email, the ECHA indicates that it is ‘not yet convinced that microplastics are formed’ from plastic containing a pro-oxidant additive – it being noted that the term ‘microplastics’ generally refers to fragments below 5 mm, which tend to accumulate in the environment rather than biodegrading within a reasonable period of time. Therefore, that email cannot be regarded as the ECHA having adopted a firm position. On the contrary, in so far as the ECHA states in that letter that it needs more time in order to determine whether the information received demonstrates that microplastics are formed and that it intends to request further information from the applicants, that email illustrates the ECHA’s doubts regarding that point. |

| 160 | As regards the letter of 30 April 2019, it should be recalled that in that letter the Commission requested the ECHA to close the restriction procedure initiated under Articles 68 to 73 of the REACH Regulation. However, that letter cannot be regarded as an expression of the Commission lacking interest in obtaining scientific data, since, as is apparent from paragraph 121 above, it may collect scientific data from other sources. |

| 161 | Consequently, the three institutions concerned cannot be criticised for having failed to take into account paragraphs 23 and 24 of the witness statement of the applicants’ CEO. |

| 162 | Second, as regards the opinion of 2 November 2018, the applicants indicate that they rely on the evidence cited in that opinion. That involves, first, a study carried out by Mr Eyheraguibel and others, entitled ‘Characterisation of oxidised oligomers from polyethylene films by mass spectometry and NMR spectroscopy before and after biodegradation by a Rhodococcus rhodochrous strain’ dated 23 May 2017, which establishes a biodegradation rate of 95% for a sample of high density polyethylene containing a pro-oxidant additive, after exposure to a specific soil bacterium for 240 days. Second, according to the opinion of 2 November 2018, a study carried out by Mr Dussud and others, entitled ‘Colonisation of Non-biodegradable and Biodegradable Plastics by Marine Organisms’ dated 18 July 2018, concludes that the colonisation of samples of plastic containing a pro-oxidant additive is, after 6 weeks of exposure to certain marine bacteria, 30 times higher than colonisation of samples of conventional plastic. |

| 163 | In that regard, while the body of the application may be supported and supplemented on specific points by references to extracts from documents annexed thereto, a general reference to other documents, even those annexed to the application, cannot make up for the absence of the essential element in law, which, in accordance with Article 21 of the Statute of the Court of Justice of the European Union and Article 76 of the Rules of Procedure of the General Court, must appear in the application. Thus, it is not for the Court to seek and identify in the annexes the pleas and arguments on which it may consider the action to be based, since the annexes have a purely evidential and instrumental function (judgments of 11 September 2014, MasterCard and Others v Commission, [C‑382/12 P](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AC%3A2014%3A2201&locale=en), [EU:C:2014:2201](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AC%3A2014%3A2201), paragraphs [40](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AC%3A2014%3A2201&anchor=#point40) and [41](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AC%3A2014%3A2201&anchor=#point41), and of 15 October 2020, Zhejiang Jiuli Hi-Tech Metals v Commission, [T‑307/18](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AT%3A2020%3A487&locale=en), not published, [EU:T:2020:487](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AT%3A2020%3A487), paragraph [239](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AT%3A2020%3A487&anchor=#point239)). |

| 164 | In the present case, the only reference in the application to the opinion of 2 November 2018 is a reference in a footnote to the 14-page annex containing that opinion. In that footnote, the applicants simply state the following: ‘See, for example, the evidence cited within [the opinion of 2 November 2018]’. At most, the applicants observe, in the same footnote, that that opinion strengthens their conclusion that the ‘… basis of the Article 5 prohibition [is flawed and/or insufficiently founded] in so far as it applies to oxo-biodegradable plastics’, and that it illustrates ‘the matters which should have been taken into account’. In their replies to the Parliament, the Council and the Commission, the applicants simply make a general reference to the annex containing the opinion of 2 November 2018, and a reference to six pages of that opinion, without specifying the relevant argument within those six pages. |

| 165 | Furthermore, since that opinion was drawn up by a lawyer with no scientific training, it cannot be included among the best scientific data available within the meaning of the case-law cited in paragraph 119 above. In addition, while that lawyer states that he was encouraged to act as an independent decision-maker and to express his reservations when drafting his opinion, the fact remains that he is instructed and paid by Symphony Environmental Technologies to draft that opinion. Therefore, according to the case-law cited in paragraphs 147 and 149 above, little probative value can be attributed to the opinion in question. |

| 166 | That is all the more so since the evidence cited in the opinion of 2 November 2018 is not adduced as an annex to that notice. The second study, namely the study by Mr Dussud and others, is not included in the dossier, whereas the first study, namely the study by Mr Eyheraguibel and others, is included in the dossier only because the applicants adduced it at the stage of the reply. Consequently, it is not possible to verify accurately the reliability of that opinion. |

| 167 | Therefore, the three institutions concerned cannot be criticised for having failed to take account of the opinion of 2 November 2018. |

| 168 | Third, as regards the Queen Mary University study, the applicants rely on a passage from that study, from which it is apparent that, in an aqueous solution, that type of plastic degrades 90 times faster than conventional plastic. |

| 169 | In that regard, it should be noted that the Queen Mary University study states that it applied a new method to test the biodegradability of a sample of plastic containing a pro-oxidant additive. That new method does not consist of placing that sample in soil, that is to say, in an environment for which neither the bacterial concentration nor the type of bacteria contained are known, but rather consists of depositing a specific bacterium on the sample. Applying that method, Queen Mary University states that it found that for such a sample, which was exposed to ultraviolet radiation for 450 hours and then to a specific soil bacterium, after 35 days the biodegradation was 90 times greater than that of a sample of conventional plastic subjected to the same treatment. |

| 170 | However, the three institutions concerned did not take account of the Queen Mary University study which was not available at that time, but did at least take account of its content. Indeed, the Eunomia study refers to information provided by Dr R. Rose, one of the authors of the Queen Mary University study. In that regard, the Eunomia study states that the method used by Queen Mary University is far from the accepted standard, and that it is not certain that the results observed in a laboratory by that university can be obtained in a real-world situation. |

| 171 | In addition, the Queen Mary University study post-dates the adoption of Directive 2019/904, since it dates from August 2019 and was published in 2020. Consequently, in accordance with the case-law cited in paragraph 154 above, the three institutions concerned cannot be criticised for having failed to take that study into account. |

| 172 | Fourth, as regards the report of the Banyuls-sur-Mer laboratory, the applicants note that it indicates that plastic containing a pro-oxidant additive, in particular the additive produced by the applicants, biodegrades in the marine environment much more effectively than conventional plastic. |

| 173 | However, the report of the Banyuls-sur-Mer laboratory, which is dated 4 September 2020, post-dates the adoption of Directive 2019/904. Therefore, in accordance with the case-law cited in paragraph 154 above, it could not be taken into account by the three institutions concerned. In any event, that report is not a scientific study presenting the results of tests undertaken, but rather a one-and-a-half-page document presenting a project known as Oxomar. |

| 174 | Fifth, the applicants rely on the reply of Mr Jakubowicz, associate professor of the Research Institutes of Sweden (RISE), to the Ellen MacArthur Foundation. He states that, in his view, ‘the degradation process [of plastic containing a pro-oxidant additive] is not only a fragmentation, but is an entire change of the material from a high molecular weight polymer to monomeric and oligomeric fragments, and from hydrocarbon molecules to oxygen-containing molecules which can be bioassimilated’. |

| 175 | In that regard, it is sufficient to state that Mr Jakubowicz’s reply to the Ellen MacArthur Foundation is merely a one-and-a-half-page statement, which does not refer to any scientific study. Even if, as the Commission notes, that response is based on two earlier articles, namely the 2011 Jakubowicz study and the Chiellini and Corti study, it has been stated in paragraph 139 above that, according to the De Wilde study, only those two articles express that opinion. In addition, those articles are duly referred to in the Eunomia study. |

| 176 | Consequently, the three institutions concerned cannot be criticised for having failed to take account of Mr Jakubowicz’s reply to the Ellen MacArthur Foundation. |

| 177 | Sixth, as regards the witness statement of Symphony Environmental’s senior scientist, in the first place, the applicants rely on it in order to respond to the evidence adduced by the three institutions concerned in their defences, that is to say, in order to establish that there is a distinction between oxo-degradable plastic and oxo-biodegradable plastic. Symphony Environmental’s senior scientist states, first, that the TR 15351 standard, drawn up by the European Committee for Standardisation (CEN) and cited in the Eunomia study, distinguishes oxo-degradation, defined as ‘degradation resulting from oxidative cleavage of macromolecules’, from oxo-biodegradation, defined as ‘degradation resulting from oxidative and cell-mediated phenomena either simultaneously or successively’. Second, the chemical composition of oxo-degradable plastic differs from that of oxo-biodegradable plastic, as the pro-oxidant additive contained in the latter enables it to meet the definition of oxo-biodegradation under the TR 15351 standard. Third, although there is no European standard for oxo-biodegradation, various national standards and methods make a distinction between oxo-degradable plastic and oxo-biodegradable plastic. Fourth, various scientists support the existence of such a distinction. |

| 178 | In the second place, the applicants rely on that witness statement in order to establish that plastic containing a pro-oxidant additive is biodegradable. Symphony Environmental’s senior scientist submits, first, that the Eunomia study acknowledges that the crucial question is not whether that type of plastic undergoes total biodegradation, but whether the time needed for total biodegradation can be regarded as acceptable. Second, the biodegradability of plastic containing a pro-oxidant additive is established by numerous items of evidence. Third, it is impossible to test biodegradation in the real-world environment and laboratory conditions are generally less favourable to biodegradation than real-world conditions. Fourth, various studies demonstrate the biodegradability of that plastic in the marine environment. |

| 179 | It should be noted that the witness statement of Symphony Environmental’s senior scientist is provided by an employee of one of the applicants, who is responsible for the d2w product, that it was drawn up at the request of the applicants and specifically for the present action, and that it seeks to defend their interests. Consequently, in accordance with the case-law cited in paragraphs 147 and 149 above, it has little probative value. In addition, since that testimony post-dates the adoption of Directive 2019/904, in accordance with the case-law cited in paragraph 154 above, the three institutions concerned cannot be criticised for having failed to take it into account. |

| 180 | It is true that the statements made by Symphony Environmental’s senior scientist are supported by documents annexed to his witness statement and that, in their replies, the applicants rely on three of those annexes, namely: in the first place, the report prepared by the Intertek laboratory for the ECHA, entitled ‘Oxo-biodegradable plastics and the microplastics: towards a logical approach’ dated 24 May 2018 (‘the Intertek laboratory report’); in the second place, a contribution made by a scientist, entitled ‘Evidence in Response to the UK Government’s July 2019 Call for Evidence on Standards for Bio-Based, Biodegradable and Compostable Plastics’ dated 7 October 2019 (‘the contribution of 7 October 2019’); and, in the third place, the result of a test carried out by the Eurofins laboratory on 25 July 2017 (‘the Eurofins laboratory test of 25 July 2017’). |

| 181 | However, and in any event, none of those three annexes to the witness statement of Symphony Environmental’s senior scientist supports the arguments of the applicants. |

| 182 | As regards the Intertek laboratory report, which states, in particular, that ‘whatever the speed of degradation [of oxo-biodegradable plastics], it is faster than that of conventional plastics’ and that ‘the different findings of the limited research that has been carried out to date are simply a matter of degree’, it must be pointed out that that report was prepared at the request of Symphony Environmental. Therefore, in accordance with the case-law cited in paragraphs 147 and 149 above, that report can be regarded only as having little probative value. |

| 183 | As regards the contribution of 7 October 2019, which concludes that ‘microplastic formation is highly unlikely in the case of oxo-biodegradable plastics’, it must be stated that it post-dates the adoption of Directive 2019/904. In accordance with the case-law cited in paragraph 154 above, the institutions cannot be criticised for having failed to take that into account. In any event, the contribution of 7 October 2019 is not a scientific study presenting test results, but a simple six-page statement drafted in response to a call for evidence by the United Kingdom Government on standards for bio-based, biodegradable and compostable plastics. |

| 184 | As regards the Eurofins laboratory test of 25 July 2017, which was carried out on a sample of plastic containing the applicants’ d2w masterbatch, that test demonstrates a biodegradation rate of 88.86%, obtained in 121 days. However, it should be pointed out that the fragmentation and assimilation of plastic by microorganisms depend on environmental conditions. As is apparent, in particular, from paragraphs 127 and 133 above, those conditions are variable and do not correspond to the conditions of a laboratory test. Consequently, the fact that a biodegradation rate of 88.86% was obtained in a laboratory does not establish that the same rate will be obtained, within the same period, in a real-world situation. |

| 185 | Consequently, the three institutions concerned cannot be criticised for having failed to take into account the witness statement of Symphony Environmental’s senior scientist, the Intertek laboratory report, the contribution of 7 October 2019 and the Eurofins laboratory test of 25 July 2017. |

| 186 | Seventh, as regards the Oxomar study, which was annexed to the witness statement of Symphony Environmental’s senior scientist, the authors of that study conclude that certain factors tend to demonstrate that plastic containing a pro-oxidant additive biodegrades in the marine environment. However, they could not comment on its complete biodegradation. |

| 187 | Furthermore, the Oxomar study, which dates from 10 March 2021, post-dates the adoption of Directive 2019/904. In accordance with the case-law cited in paragraph 154 above, the institutions cannot be criticised for having failed to take that into account. |

| 188 | In addition, that study does not establish that plastic containing a pro-oxidant additive undergoes complete biodegradation in the marine environment within two years. A finding therefore cannot be made that it invalidates, inter alia, the conclusions of the Eunomia study on that point. |

| 189 | It should be noted that, in support of their argument referred to in paragraph 152 above, the applicants also submit that the standard most commonly used in Europe in order to test the biodegradability of plastic, namely the EN 13432 standard, is not relevant for plastic containing a pro-oxidant additive. |

| 190 | In that regard, the applicants do not argue that the plastic containing their d2w masterbatch complies with the EN 13432 standard, in relation to which the Eunomia study states that, for aerobic composting, a rate of conversion into carbon dioxide and biomass of at least 90% within a maximum period of 6 months is required. |

| 191 | They claim that the EN 13432 standard assesses the biodegradation of a sample of plastic under specific conditions, namely industrial composting conditions. From that, they infer that, in so far as the plastic containing the d2w masterbatch is not intended to be composted and is not marketed as being compostable, the EN 13432 standard is not relevant for assessing its biodegradation. It is the US ASTM D 6954 standard which should used to measure the biodegradation of that type of plastic, since it is designed to biodegrade in an open environment, and not in the specific conditions of industrial composting. |

| 192 | It is true that the Eunomia study indicates that, at EU level, there is not one, but rather a number of standards which allow for the assessment of the biodegradability of plastic, that some of them are simple methods, that some are national methods and that they are constantly evolving. |

| 193 | It is also true that, since each environment (industrial composting, freshwater, marine environment, soil and landfill) has its own conditions, the standards for measuring biodegradation in a given environment do not allow for biodegradation in other environments to be measured. Accordingly, the Eunomia study states that the standards applicable to biodegradation via composting, which include EN 13432, differ from the standards for measuring biodegradation in fresh water, in the marine environment or in the soil, and from the standards designed to measure the degradation of plastic containing a pro-oxidant additive. The latter have recently undergone some evolution. They include the US standard ASTM D 6954, British standard BS 8472:2011 and the French standard AC T 51-808. The same study states that the evolution of standards specifically measuring the degradation of plastic containing a pro-oxidant additive is explained by the fact that none of the other standards requires the sample to first be exposed to ultraviolet radiation and/or heat, whereas, where there is no such prior exposure, it is almost certain that the sample will not biodegrade. |

| 194 | The Eunomia study also states that producers of plastic containing a pro-oxidant additive do not market that plastic as being compostable, in accordance with the EN 13432 standard, but rather indicate that it is not suitable for composting. |

| 195 | Lastly, when questioned by means of a measure of organisation of procedure, the three institutions concerned agreed that the EN 13432 standard was relevant for assessing the biodegradation of plastic in industrial composting, but that other standards could, depending on the intended use, be relevant for assessing its biodegradation. |

| 196 | However, as the Eunomia study points out, the only environment the conditions of which can be satisfactorily reproduced in a laboratory is composting, because it is an industrial process which occurs in a controlled environment. Consequently, for other environments, the results of laboratory tests cannot necessarily be reproduced in a real-world situation. Accordingly, even if a sample of plastic containing a pro-oxidant additive were tested in order to assess its biodegradation in conditions other than industrial composting, in accordance with a standard other than EN 13432, for example the ASTM D 6954 standard, the result of that test, carried out in a laboratory, could not necessarily be reproduced in a real-world situation. As stated in paragraph 184 above, while the outcome of the test carried out on 25 July 2017 by the Eurofins laboratory indicates that the plastic sample containing the d2w masterbatch complies with the ASTM D 6954 standard, since it has reached a biodegradation rate of 88.86%, that does not demonstrate that the same rate will be obtained in a real-world situation. |

| 197 | In addition, it should be observed that, as the Parliament indicated in response to the measure of organisation of procedure referred to in paragraph 195 above, there is no unified standard at EU level which makes it possible to assess the biodegradation of plastic containing a pro-oxidant additive, but only national standards, the criteria and thresholds of which differ. For example, according to the Eunomia study, while the US ASTM D 6954 standard uses a threshold of 60% degradation, the British BS 8472 standard defines a threshold of 50% of the carbon content having evolved. |

| 198 | Lastly, it is apparent from the Eunomia study that industrial composting is, of all environments, the most aggressive, that is to say, the most favourable to biodegradation. Consequently, it is unlikely that a sample of plastic containing a pro-oxidant additive which does not biodegrade properly in industrial composting conditions and does not comply with the EN 13432 standard will biodegrade properly in other environments, for example in soil or in the marine environment. It cannot therefore be found that the EN 13432 standard is entirely irrelevant for assessing the biodegradation of that type of plastic in conditions other industrial composting conditions. |

| 199 | Therefore, it must be held that, in coming to the conclusion, on the basis of studies carried out pursuant to the EN 13432 standard, that plastic containing a pro-oxidant additive did not biodegrade properly, the three institutions concerned did not exceed the limits of the broad discretion which, in accordance with the case-law cited in paragraph 115 above, they enjoy in environmental matters. |

| 200 | Consequently, the applicants’ arguments summarised in paragraph 152 above cannot be accepted. |

| 201 | Therefore, it follows from paragraphs 124 to 200 above that the three institutions concerned had at their disposal a scientific assessment of the risk that plastic containing a pro-oxidant additive does not biodegrade properly which was as thorough as possible and that they did not make a manifest error of assessment in finding that such a risk existed. |

(2) The assertion that plastic containing a pro-oxidant additive is not compostable

| 202 | As regards the assertion in recital 15 of Directive 2019/904 that oxo-degradable plastic is not compostable, it should be stated that the report of 16 January 2018 indicates that composting is enhanced biodegradation under managed conditions, predominantly characterised by forced aeration and natural heat production resulting from the biological activity taking place inside the material. |

| 203 | In their defences, the Commission and the Parliament state that they relied on the Eunomia study, the report of 16 January 2018, the Oxo Statement and the De Wilde study in coming to the conclusion that plastic containing a pro-oxidant additive was not compostable. |

| 204 | As indicated in paragraphs 132, 135 and 142 above, those documents were available to the three institutions concerned when Directive 2019/904 was being drawn up and adopted. |

| 205 | It is apparent from the Eunomia study that plastic containing a pro-oxidant additive is not suitable for any form of composting and that it does not comply with the EN 13432 standard, which, as stated in paragraph 190 above, requires 90% biodegradation within six months. The Eunomia study points out, in that regard, that the highest percentage of biodegradation obtained in a scientific study is well below 90% and that it was obtained within a much longer time frame than those used in industrial composting, thus giving rise to a risk that fragmented plastics could be applied to land. As stated in paragraph 194 above, that study also indicates that most manufacturers of that type of plastic do not claim that it is compostable. |

| 206 | The report of 16 January 2018 confirms that, according to the available data, oxo-degradable plastics do not appear to be suitable for any form of composting or anaerobic digestion and will not meet the current standards for packaging recoverable through composting in the European Union. That report also states that the plastic fragments generated by the process might adversely affect the quality of the compost. |

| 207 | The Oxo Statement also states that plastic containing a pro-oxidant additive does not meet any standards applicable to plastic packaging or the recovery of plastic, because its biodegradation takes too long and plastic fragments can remain in the compost and therefore have an impact on the quality of the compost or be spread in the environment. |

| 208 | Similarly, the De Wilde study concludes that plastic containing a pro-oxidant additive does not meet the various standards for industrial or domestic composting. |

| 209 | It follows from paragraphs 202 to 208 above that when Directive 2019/904 was drawn up and adopted, the three institutions concerned had at their disposal a thorough scientific assessment of the risk that plastic containing a pro-oxidant additive might not be compostable, and that they could, without making a manifest error of assessment, regard such a risk as having been established. |

| 210 | That conclusion cannot be called into question by the applicants’ argument that the three institutions concerned failed to take account of evidence which, in their view, demonstrates that plastic containing a pro-oxidant additive is compostable and that it does not constitute a risk, namely, (i) paragraphs 23 and 24 of the witness statement of the applicants’ CEO, (ii) paragraphs 56 and 58 of the witness statement of Symphony Environmental’s senior scientist, (iii) the Eurofins laboratory test of 25 July 2017 and, (iv) a proposal of the European Committee of the Regions to amend Article 3 of Directive 2019/904. |

| 211 | It should be noted that, in paragraphs 23 and 24 of his witness statement, the applicants’ CEO merely asserts that, first, the three institutions concerned failed to demonstrate why composting of oxo-degradable plastic is desirable and, second, those institutions did not state the reasons why the fact that that type of plastic is not compostable poses a threat to the environment or human health sufficient to justify its prohibition. |

| 212 | Similarly, in paragraphs 56 and 58 of his witness statement, Symphony Environmental’s senior scientist claims that plastic containing a pro-oxidant additive was not designed to comply with the EN 13432 standard, that, for many reasons, it is not necessary for that type of plastic to be compostable and that the fact that it is not compostable does not justify prohibiting it. |

| 213 | However, the three institutions concerned cannot be criticised for having failed to take account of paragraphs 23 and 24 of the witness statement of the applicants’ CEO and paragraphs 56 and 58 of the witness statement of Symphony Environmental’s senior scientist, for the reasons stated, respectively, in paragraphs 155 and 156 and in paragraph 179 above. |

| 214 | In addition, the applicants cannot, in order to demonstrate that the plastic containing their d2w masterbatch is compostable, argue that it was successfully tested in accordance with the ISO 14855 standard, namely, in particular, the Eurofins laboratory test of 25 July 2017. It is apparent from paragraph 184 above that the fact that a certain rate of biodegradation was obtained in a laboratory does not establish that the same rate will be obtained, within the same period, in a real-world situation. |

| 215 | Furthermore, the three institutions concerned cannot be criticised for having failed to take account of the proposal of the European Committee of the Regions, during the travaux préparatoires for Directive 2019/904, to amend Article 3 of that directive such that certain synthetic polymers, namely those considered to be biodegradable according to the ASTM D 6002 standard, would not be regarded as ‘plastic’. That concerned synthetic polymers which ‘are capable of undergoing biological decomposition in a compost site … at a rate consistent with known compostable materials’. It does not follow from that proposed amendment that plastic containing a pro-oxidant additive is one of the synthetic polymers which may undergo such decomposition. |

| 216 | Lastly, the Court notes that the applicants contradict themselves as regards the compostability of plastic containing a pro-oxidant additive. They assert, in the application, that ‘in fact, oxo-biodegradable plastic is compostable’. However, they nevertheless acknowledge, in their replies, following a comparison between that type of plastic and conventional plastic, that conventional plastic is ‘also not’ compostable and, in their reply to the measures of organisation of procedure, that plastic containing a pro-oxidant additive ‘is not intended for processing in controlled waste treatment plants’. |

| 217 | As regards the applicants’ argument that the non-compostability of plastic containing a pro-oxidant additive does not pose a threat to the environment or to human health, it must be pointed out that the non-compostability of that type of plastic, taken together with the fact that it does not biodegrade properly, that it is not suitable for recycling and that it fails to deliver a proven environmental benefit, has the consequence that, left in an open environment, it will fragment into microplastics which will persist in the environment before possibly biodegrading. It must be held that, in accordance with the case-law cited in paragraph 115 above, the question whether, having regard, in particular, to the fact that it does not biograde properly, the non-compostability of plastic containing a pro-oxidant additive constitutes a threat to the environment or to human health falls within the discretion of the three institutions concerned. |

| 218 | It follows from paragraphs 202 to 217 above that the three institutions concerned had at their disposal a scientific assessment of the risk that plastic containing a pro-oxidant additive would not be compostable which was as thorough as possible and that they did not make a manifest error of assessment in finding that such a risk existed. |

(3) The assertion that plastic containing a pro-oxidant additive negatively affects the recycling of conventional plastic

| 219 | As regards the assertion in recital 15 of Directive 2019/904 that oxo-degradable plastic negatively affects the recycling of conventional plastic, it should be noted that, in their defences and rejoinders, the three institutions concerned state that they relied on the Eunomia study, the report of 16 January 2018, the Oxo Statement and the Loughborough University study in support of that assertion. |

| 220 | As indicated in paragraphs 132, 135 and 142 above, those documents were at the disposal of the three institutions concerned when Directive 2019/904 was being drawn up and adopted. |

| 221 | According to the Eunomia study, the evidence gathered suggests that the technologies currently available do not make it possible to identify plastic containing a pro-oxidant additive in order to separate it from other plastics. It is therefore recycled with conventional plastics. That affects the quality of recycled plastic. While the use of stabilising compounds makes it possible, in certain cases, to avoid such deterioration in the quality of recycled plastic, it is nevertheless difficult to determine the quantity of stabilisers needed, which depends on the concentration and type of pro-oxidant additive used. |

| 222 | In addition, the Eunomia study indicates that the degradation, before recycling, of plastic containing a pro-oxidant additive appears to have an impact on the physical qualities and on the life of the recycled plastic. That study concludes that recycled plastic is not suitable for all end uses and that, in particular, it should not be used for long-life products. However, it is possible to produce recycled plastic which can be used for shorter-life products. The Eunomia study concludes that, where recycled plastic contains plastic containing a pro-oxidant additive, that negatively affects the marketability of recycled plastic, its quality and price. |

| 223 | The report of 16 January 2018, which sets out the conclusions of the Eunomia study, states that the technologies currently available do not allow reprocessors to identify and sort plastic containing a pro-oxidant additive and that it will therefore necessarily be recycled with conventional plastic, which may result in a deterioration of the quality of recycled materials. It is difficult to know the correct dose of stabilising compounds which could prevent such deterioration. In addition, according to that report, it is impossible to control the level of ageing experienced by plastic containing a pro-oxidant additive before it is recycled. The report of 16 January 2018 highlights the negative effect of those factors on the price of recycled plastic and concludes that plastic containing a pro-oxidant additive is not suitable for recycling. |

| 224 | The Oxo Statement also states that current technologies do not allow plastic containing a pro-oxidant additive to be separated from conventional plastic and that it is difficult to assess both the degree of ageing and the extent of stabilising compounds needed to prevent the degradation of recycled plastic. That statement infers therefrom that plastic containing a pro-oxidant additive is not suitable for recycling at scale. |

| 225 | Similarly, the Loughborough University study indicates that plastic containing a pro-oxidant additive is not suitable for recycling due to the presence in recycled material of pro-oxidant additives which will accelerate its degradation. The addition of stabilising compounds is delicate because of the uncertainty regarding the quantity of stabilisers needed and the degree of oxidation already achieved. |

| 226 | It follows from paragraphs 219 to 225 above that when Directive 2019/904 was being drawn up and adopted, the three institutions concerned had at their disposal a thorough scientific assessment of the risk that plastic containing a pro-oxidant additive would negatively affect the recycling of conventional plastic, and that they could, without making a manifest error of assessment, regard such a risk as having been established. |

| 227 | That conclusion cannot be called into question by the applicants’ argument that those institutions failed to take account of the following documents: (i) the report of the Austrian laboratory TCKT entitled ‘Effect of mechanical recycling on the properties of films containing oxo-biodegradable additive’ of 17 March 2016 (‘the TCKT laboratory report of March 2016’); (ii) another report from the same laboratory, entitled ‘Weathering study on LDPE (with and without d2w/oxo-biodegradable additive)’ of 27 July 2016 (‘the TCKT laboratory report of July 2016’); (iii) a report of the South African laboratory Roediger entitled ‘Recycling report on d2w oxo-biodegradable plastics’ of 21 May 2012 (‘the Roediger laboratory report’); (iv) a study by Samper, M.D. and others, entitled ‘Interference of Biodegradable Plastics in the Polypropylene Recycling Process’ of 2018 (‘the Samper study’); and, (v) paragraphs 48 to 52 of the witness statement of Symphony Environmental’s senior scientist. |

| 228 | It is true that it is apparent from the TCKT laboratory report of March 2016 that recycled material obtained from plastic containing the d2w masterbatch may be used for short-life products, such as rubbish bags or shopping bags. In addition, it is apparent from the report of the same laboratory of July 2016 – the purpose of which was to examine whether plastic shopping bags containing a pro-oxidant additive can be recycled to make thick plastic products from them which are intended for long-term use – that, while the presence in recycled material of plastic containing a pro-oxidant additive may have negative effects, such as increased surface cracking, such negative effects would not occur once a stabilising compound is added. The Roediger laboratory report also states that the presence of plastic containing the d2w masterbatch is of no significant detriment to the recycled product. |

| 229 | However, reference is made to both the TCKT laboratory report of March 2016 and the Roediger laboratory report in the Eunomia study. As indicated in paragraph 132 above, that study was available to the three institutions concerned when Directive 2019/904 was being drawn up and adopted. The institutions cannot therefore be criticised for having failed to take those two reports into account. |

| 230 | In addition, it is apparent from the Eunomia study that the TCKT laboratory report of March 2016 and the Roediger laboratory report were both commissioned by the plastic (containing a pro-oxidant additive) industry. In addition, it is apparent from the TCKT laboratory report of July 2016 that it was drawn up at the request of the applicants. Therefore, in accordance with the case-law cited in paragraphs 147 and 149 above, those three reports, in particular the TCKT laboratory of July 2016, can be regarded as having little probative value only. |

| 231 | Lastly, the Eunomia study notes an inconsistency in the results recorded in the Roediger laboratory report, without that report explaining that inconsistency. The study also states that it is difficult to give weight to the conclusions of the TCKT laboratory report of March 2016, given concerns regarding the lack of clarity in relation to, in particular, trends between the various samples, since each contains a different percentage of plastic containing a pro-oxidant additive. |

| 232 | As regards the Samper study, it should be noted, as the Commission does, that it does not cover the recycling of plastic containing a pro-oxidant additive, but rather the recycling of biodegradable polymers. From the fact that the placing on the market of the type of plastic which is the subject of the Samper study was not prohibited even though it was unsuitable for recycling, it cannot be inferred that the placing on the market of plastic containing a pro-oxidant additive also ought not to be prohibited. According to the case-law cited in paragraph 115 above, determining the risk represented by each type of plastic falls within the discretion of the three institutions concerned. |

| 233 | Lastly, as regards the witness statement of Symphony Environmental’s senior scientist, it is true that paragraphs 48 to 52 thereof, to which the replies refer, state, inter alia, that plastic containing a pro-oxidant additive can be recycled in the same way as conventional plastic and that it is not necessary to separate it from conventional plastic in order to recycle it. However, for the reasons set out in paragraph 179 above, the three institutions concerned cannot be criticised for having failed to take into account paragraphs 48 to 52 of the witness statement of Symphony Environmental’s senior scientist. |

| 234 | It follows from paragraphs 219 to 233 above that the three institutions concerned had at their disposal a scientific assessment of the risk that plastic containing a pro-oxidant additive would negatively affect the recycling of conventional plastic which was as thorough as possible and that they did not make a manifest error of assessment in finding that such a risk existed. |

(4) The assertion that plastic containing a pro-oxidant additive fails to deliver a proven environmental benefit

| 235 | As regards the assertion in recital 15 of Directive 2019/904 that oxo-degradable plastic fails to deliver a proven environmental benefit, the Parliament and the Commission state that they relied on the Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions of 16 January 2018 entitled ‘A European strategy for plastics in a circular economy’ (COM(2018) 28 final) and on the De Wilde study. |

| 236 | The De Wilde study, the purpose of which was to evaluate, in particular, the advantages and disadvantages of oxo-degradable plastics compared with the advantages and disadvantages of plastics said to be biodegradable, merely concludes that oxo-degradable plastics are not biodegradable, without highlighting any proven benefits. Above all, the Commission communication referred to in the preceding paragraph indicates, on page 17, that ‘some alternative materials claiming biodegradability properties, such as “oxo-degradable plastics”, have been found to offer no proven environmental advantage over conventional plastics, while their rapid fragmentation into microplastics cause concerns’. Moreover, it is not apparent from the scientific assessments of biodegradation, composting and recycling of plastic containing a pro-oxidant additive, referred to in paragraphs 124 to 234 above, that that type of plastic has a proven benefit in any of those respects. |

| 237 | However, first, the applicants claim that those institutions ought to have taken account of the opinion of the Parliament’s Committee on Fisheries on the proposal for a directive, which recommended that biodegradable plastic be defined clearly. |

| 238 | Second, the applicants regard it to be particularly telling that, in their opinions on the proposal for a directive of 3 and 11 October 2018 respectively, the Committee on Agriculture and Rural Development and the Committee on the Environment, Public Health and Food Safety of the Parliament proposed prohibiting the placing on the market of products made from oxo-degradable plastic, without, however, putting forward any justification in that regard. |

| 239 | According to Article 59(1) of the Rules of Procedure of the Parliament ([OJ 2019 L 302, p. 1](./../../../legal-content/EN/AUTO/?uri=OJ:L:2019:302:TOC)), the Parliament’s position within the meaning of Article 294(3) TFEU is to be adopted by a vote in plenary session and not by the opinion of one of its committees. It therefore counts for little that a committee, such as the Committee on Fisheries, has an opinion which differs from that adopted in plenary session. A fortiori, it counts for little that a committee, such as the Committee on Agriculture and Rural Development and the Committee on the Environment, Public Health and Food Safety, does not provide a justification for its opinion. Consequently, the Parliament, still less the Council and the Commission, cannot be criticised for having failed to take such opinions into account. |

| 240 | It follows from paragraphs 235 to 239 above that the three institutions concerned had at their disposal a scientific assessment of the possible environmental benefits of plastic containing a pro-oxidant additive which was as thorough as possible and that they could, without making a manifest error of assessment, conclude that there were no proven benefits. |

| 241 | Consequently, those institutions had at their disposal a scientific assessment of the risks referred to in recital 15 of Directive 2019/904 which was as thorough as possible, namely that plastic containing a pro-oxidant additive does not properly biodegrade, is not compostable, negatively affects the recycling of conventional plastic and fails to deliver a proven environmental benefit. Those institutions were therefore entitled, without making a manifest error of assessment, to find that those risks were serious. |

(5) The list annexed to the replies, which lists all the documents which the three institutions concerned allegedly failed to take into account

| 242 | Lastly, it should be stated out that the applicants have adduced, as an annex to the replies, a list of all the documents which, according to the applicants, the three institutions concerned failed to take into account (‘the list annexed to the replies’). |

| 243 | Most of the documents on that list have already been examined above. |

| 244 | Of those which have not been the subject of such an examination, some post-date the adoption of Directive 2019/904, namely: (i) British standard PAS 9017:2020, which dates from October 2020; (ii) the study by Babetto, A.S., Antunes, M.C., Bettini, S.H.P., and Bonse, B.C., entitled ‘A Recycling-Focused Assessment of the Oxidative Thermomechanical Degradation of HDPE Melt containing Pro-oxidant’, published on the internet on 21 December 2019; (iii) the study by Saikrishnan, S., Jubinville, D., Tzoganakis, C., and Mekonnen, T.H., entitled ‘Thermo-mechanical degradation of polypropylene (PP) and low-density polyethylene (LDPE) blends exposed to simulated recycling’, published in December 2020; and (iv) the study by Åkesson, D., Kuzhanthaivelu, G., and Bohlén, M., entitled ‘Effect of a Small Amount of Thermoplastic Starch Blend on the Mechanical Recycling of Conventional Plastics’, published on 24 October 2020. In accordance with the case-law cited in paragraph 154 above, the three institutions concerned cannot be criticised for having failed to take those four documents into account. |

| 245 | One of the documents on the list annexed to the replies is mentioned in the Eunomia study, which was accessible to the three institutions concerned when Directive 2019/904 was drawn up and adopted. They therefore took it into account. The document in question is the study by Jakubowicz, I. and Enebro, J., entitled ‘Effects of Reprocessing of Oxobiodegradable and Non-degradable polyethylene on the durability of recycled materials’, dated March 2012. |

| 246 | The application contains simply a general reference to another of the documents on the list annexed to the replies, namely Annex A.27 to the application, which comprises letters sent by scientists to the ECHA concerning oxo-biodegradable plastic. The application merely states that those letters were sent in response to the public call for evidence issued by the ECHA concerning that type of plastic and that the authors of those letters opposed its prohibition. In accordance with the case-law cited in paragraph 163 above, it is not for the Court either to identify which of the letters in Annex A.27, which comprises 100 pages and more than 30 letters, are relevant, reliable and documented, or to determine which of the applicants’ arguments they support. The replies themselves do no more than make a general reference to that annex. There is, however, an exception, which concerns a letter from Dr R. Rose dated 3 May 2018. That letter is specifically referred to in the application and the replies. It is, however, cited in support of the fourth plea of illegality and will therefore be examined in the context of that plea. |

| 247 | Lastly, one of the documents on the list annexed to the replies is not referred to in the application or the replies. The document in question is the study by Jin, H., Gonzalez-Gutierrez, J., Oblak, P., Zupančič, B., and Emri, I., entitled ‘The effect of extensive mechanical recycling on the properties of low-density polyethylene’ dated November 2012. Only the witness statement of Symphony Environmental’s senior scientist, which is itself annexed to the replies, refers to that study. The case-law cited in paragraph 163 above also applies to the reply (judgment of 11 July 2018, Europa Terra Nostra v Parliament, [T‑13/17](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AT%3A2018%3A428&locale=en), not published, [EU:T:2018:428](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AT%3A2018%3A428), paragraph [86](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AT%3A2018%3A428&anchor=#point86)). Therefore, the Court cannot take that study into account. |

| 248 | Consequently, the three institutions concerned cannot be criticised for having failed to take account of the documents on the list annexed to the replies. |

| 249 | It must therefore be concluded that, as stated in paragraph 241 above, the applicants err in claiming that the three institutions concerned made a manifest error of assessment, first, by adopting the prohibition on the placing on the market of products made from plastic containing a pro-oxidant additive even though they did not have at their disposal a scientific assessment of the risks posed by that type of plastic which was as thorough as possible and, second, by finding that those risks were established. |

| 250 | Since the EU legislature’s power under Article 191 TFEU is, in accordance with the case-law cited in paragraph 115 above, subject to review of whether there has been a manifest error of assessment, it must be concluded that the three institutions concerned have not infringed that provision. |

| 251 | In the absence of an infringement of Article 191 TFEU, there is no need to examine whether that infringement is sufficiently serious, as required by the case-law relating to the first condition for the liability of the European Union to be incurred, cited in paragraph 42 above. |

| 252 | The first part of the third plea of illegality must therefore be rejected, in so far as it alleges a sufficiently serious breach of Article 191 TFEU and manifest errors of assessment. |

(b)
 
Whether the breach of the general principle of proportionality, enshrined in Article 5(4) TEU, is sufficiently serious

| 253 | By the second and third parts and, in part, by the first part of their third plea of illegality, the applicants maintain that the prohibition on the placing on the market of products made from oxo-degradable plastic, laid down in Article 5 of Directive 2019/904, is contrary to the general principle of proportionality enshrined in Article 5(4) TEU. |

| 254 | As a preliminary point, it must be recalled that the principle of proportionality requires that acts of the EU institutions be appropriate for attaining the legitimate objectives pursued by the legislation at issue and do not go beyond what is necessary in order to achieve those objectives; when there is a choice between several appropriate measures, recourse must be had to the least onerous, and the disadvantages caused must not be disproportionate to the aims pursued (judgment of 13 March 2019, Poland v Parliament and Council, [C‑128/17](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AC%3A2019%3A194&locale=en), [EU:C:2019:194](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AC%3A2019%3A194), paragraph [94](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AC%3A2019%3A194&anchor=#point94)). |

| 255 | With regard to the judicial review of whether that principle has been observed, in an area of evolving and complex technology, the EU legislature has a broad discretion, in particular as to the assessment of highly complex scientific and technical facts in order to determine the nature and scope of the measures that it adopts, whereas review by the EU judicature has to be limited to verifying whether the exercise of such powers has been vitiated by a manifest error of appraisal or a misuse of powers, or whether the legislature has manifestly exceeded the limits of its discretion. In such a context, the EU judicature cannot substitute its assessment of scientific and technical facts for that of the EU legislature on which the Treaty has conferred that task (judgment of 13 March 2019, Poland v Parliament and Council, [C‑128/17](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AC%3A2019%3A194&locale=en), [EU:C:2019:194](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AC%3A2019%3A194), paragraph [95](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AC%3A2019%3A194&anchor=#point95)). |

| 256 | In the light of those considerations, it is necessary to examine whether the applicants are correct in submitting, by the second part of their third plea of illegality, that, in so far as it applies to oxo-biodegradable plastic, the prohibition laid down in Article 5 of Directive 2019/904 is not appropriate for attaining the objective of that directive, and then whether, as they maintain in the third part of that plea, that prohibition goes beyond what is necessary in order to achieve that objective. |

| 257 | As regards the first part of the third plea, it should be recalled that that part alleges, in part, that the prohibition in question is disproportionate merely on account of there being no scientific assessment of the risks posed by oxo-degradable plastic to the environment and human health. It must be observed that the applicants thus claim, in essence, that, since the existence of such risks has not been established, that prohibition cannot be appropriate for protecting against those risks. The first part, in so far as it is based on that argument, is therefore indissociable from the second part and will be examined with it. |

(1) The second part, alleging that, in so far as it applies to oxo-biodegradable plastic, the prohibition laid down in Article 5 of Directive 2019/904 is not appropriate for attaining the objective of that directive, and the first part, in so far as it is based on the same argument

| 258 | It follows from paragraphs 124 to 249 above that the three institutions concerned did not make a manifest error of assessment in finding that plastic containing a pro-oxidant additive posed a threat to the environment and human health, since it did not biodegrade properly, was not compostable, negatively impacted the recycling of conventional plastic and failed to deliver a proven environmental benefit. |

| 259 | Consequently, in accordance with the case-law cited in paragraph 255 above, a measure prohibiting the placing on the market of products made from plastic containing a pro-oxidant additive must be regarded as appropriate for attaining the objective of protecting the environment and human health, set out in recital 36 and Article 1 of Directive 2019/904. |

(2) The third part, alleging that, in so far as it applies to oxo-biodegradable plastic, the prohibition laid down in Article 5 of Directive 2019/904 goes beyond what is necessary in order to achieve the objective pursued by that directive

| 260 | By the third part of the third plea of illegality, the applicants maintain that, in so far as it applies to oxo-biodegradable plastic, the measure provided for in Article 5 of Directive 2019/904 exceeds the limits of what is necessary in order to achieve the objective of protecting the environment and human health pursued by that directive. |

| 261 | In the first place, the applicants submit that there are other measures less onerous than an outright prohibition on placing on the market, namely: first, excluding oxo-biodegradable plastic from the definition of ‘oxo-degradable plastic’ in point 3 of Article 3 of that directive and, consequently, from the scope of Article 5 thereof; second, requiring oxo-biodegradable plastic to be tested in accordance with the US ASTM D 6954 standard or a comparable standard; third, requiring oxo-biodegradable plastic to contain a marker which makes possible automatic sorting prior to recycling; fourth, including such plastic within the scope of Articles 4, 7, 8 and/or 10 of Directive 2019/904; or, fifth, requiring labelling which avoids any risk of confusion on the part of consumers. |

| 262 | However, none of the five measures suggested by the applicants makes it possible to attain the objectives pursued by Directive 2019/904. |

| 263 | First, as regards the applicants’ suggestion of excluding oxo-biodegradable plastic from the definition of ‘oxo-degradable plastic’ in point 3 of Article 3 of Directive 2019/904, it has already been observed, in the examination of the first part of the present plea, that the three institutions concerned did not make a manifest error of assessment in finding that plastic containing a pro-oxidant additive does not biodegrade properly within a reasonable time and that, therefore, no distinction should be made between oxo-degradable plastic and oxo-biodegradable plastic. Consequently, to exclude plastic containing a pro-oxidant additive from the definition of ‘oxo-degradable plastic’ in point 3 of Article 3 of Directive 2019/904 would amount to limiting the scope of the prohibition laid down in Article 5 of that directive to the single-use plastic products listed in Part B of the annex to that directive, which would run counter to the very wording of that article. |

| 264 | Second, as regards the applicants’ suggestion of requiring plastic containing a pro-oxidant additive to be tested in accordance with the US ASTM D 6954 standard or a comparable standard, it has already been found in paragraph 197 above that, in so far as there is no unified standard at EU level which makes it possible to assess the biodegradation of that plastic, but only national standards, the three institutions concerned did not go beyond the limits of their discretion by not relying on the ASTM D 6954 standard or on a comparable standard. |

| 265 | Third, as regards the applicants’ suggestion of requiring plastic containing a pro-oxidant additive to also contain a marker which makes it visible to an automatic sorting machine so that it is separated from conventional plastics and is not recycled with them, it is apparent from the Eunomia study that the current technology does not allow automatic sorting of plastic containing a pro-oxidant additive, and from the report of 16 January 2018 that ‘currently available technology can … not ensure identification and separate sorting of oxo-degradable plastic by re-processors’. |

| 266 | The Commission points out, in that regard, that conventionally used automated separation techniques, such as infrared spectroscopy, do not allow plastic containing a pro-oxidant additive to be detected and that, therefore, new automatic sorting machines would have to be developed for that purpose, but that that is not an economically feasible option for the recycling industry. The applicants simply assert that the development of new automatic sorting machines is economically feasible, without adducing any evidence in support of such an assertion or demonstrating that it is in fact possible to put in place the marker which they suggest. |

| 267 | Fourth, the applicants suggest including plastic containing a pro-oxidant additive within the scope of Articles 4, 7, 8 and/or 10 of Directive 2019/904, which allow Member States to adopt the following measures: measures to reduce consumption (Article 4); measures providing for the affixing of marks informing consumers, first, of appropriate waste management options for the product in question or waste disposal means to be avoided for that product and, second, of the presence of plastics in the product and the negative impact of inappropriately disposing of waste resulting from it (Article 7); measures providing for extended producer responsibility schemes in respect of the placing on the market of plastic products containing a pro-oxidant additive (Article 8); awareness-raising measures seeking to inform consumers and incentivise responsible consumer behaviour (Article 10). |

| 268 | However, in the light of the broad discretion, referred to in paragraph 255 above, which the EU legislature has in order to determine the nature and scope of the measures which it adopts, it cannot be considered that the three institutions concerned went beyond the limits of such a discretion in coming to the conclusion, having regard to the risks posed by plastic products containing a pro-oxidant additive, in particular the risk that they do not biodegrade properly, that their placing on the market should be prohibited, rather than subjecting them to one or other of the measures referred to in Articles 4, 7, 8 and/or 10 of Directive 2019/904, which are, moreover, capable of varying from one Member State to another. |

| 269 | Fifth, as regards the applicants’ suggestion of requiring labelling of products made from plastic containing a pro-oxidant additive which prevents any risk of confusion on the part of consumers, that accords with their proposal to make those products subject to the measures laid down in Article 7 or 10 of Directive 2019/904. It must therefore, for the reasons set out in paragraph 268 above, be rejected. |

| 270 | In the second place, the applicants maintain that, instead of imposing an outright prohibition on the placing on the market of products made from plastic containing a pro-oxidant additive, the three institutions concerned ought to have provided for a transition period, as the ECHA did in its proposal for a restriction on intentionally added microplastics. |

| 271 | That argument cannot be accepted. |

| 272 | It is true that the ECHA communication entitled ‘Restriction proposal on intentionally added microplastics – questions and answers’ of September 2020, adduced by the applicants, indicates that that agency proposed a restriction under the REACH Regulation, in which it recommends that the placing on the market of microplastics used in cosmetic products be prohibited, but provides for a transition period of four to eight years. |

| 273 | However, it must be pointed out that the period for transposing Article 5 of Directive 2019/904, which was adopted on 5 June 2019, expires, according to Article 17(1) thereof, on 3 July 2021 and that such a period could be regarded as equivalent, in practice, to a transition period of two years accompanying the prohibition on the placing on the market of products made from plastic containing a pro-oxidant additive. In addition, the transition periods recommended by the ECHA for microplastics intentionally added to cosmetic products do not apply in all cases. Accordingly, they do not apply to cosmetic products containing microbeads because they can easily be replaced by natural substances such as ground almond, coconut shell or olive seeds. Lastly, as the Commission maintains, having regard to the non-complex uses of plastic containing a pro-oxidant additive, it must be found that the three institutions concerned did not go beyond the limits of their discretion in coming to the conclusion that products made from that type of plastic had to be prohibited without providing for a transition period. |

| 274 | Consequently, the applicants cannot rely on the transition periods recommended by the ECHA for intentionally added microplastics in order to argue that an outright prohibition on products made from plastic containing a pro-oxidant additive, without a transition period, is disproportionate. |

| 275 | In the third place, the applicants submit that the disadvantages caused by the prohibition on the placing on the market of products made from plastic containing a pro-oxidant additive are disproportionate to the aims pursued, in so far as the three institutions concerned failed to assess the social and economic impact of that prohibition. |

| 276 | The protection of human health takes precedence over economic considerations and protection of the environment constitutes one of the essential objectives of the European Union. The importance of such objectives may justify even substantial negative economic consequences for certain operators (judgment of 12 December 2014, Xeda International v Commission, [T‑269/11](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AT%3A2014%3A1069&locale=en), not published, [EU:T:2014:1069](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AT%3A2014%3A1069), paragraph [138](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AT%3A2014%3A1069&anchor=#point138)). |

| 277 | In addition, the applicants merely assert that the three institutions concerned failed to assess the social and economic impact of the prohibition laid down in Article 5 of Directive 2019/904. They do not explain the nature of the alleged social and economic disadvantages posed by the prohibition, but merely refer, without substantiating that argument, to the impediments to developing a more efficient oxo-biodegradable technology. |

| 278 | It must therefore be concluded that the prohibition on the placing on the market of products made from plastic containing a pro-oxidant additive does not go beyond what is necessary to achieve the objective of protecting the environment and human health pursued by Directive 2019/904. |

| 279 | Therefore, it follows from paragraphs 259 and 278 above that that prohibition does not infringe the general principle of proportionality, enshrined in Article 5(4) TEU. |

| 280 | In the absence of a breach of that principle, there is no need to examine whether that principle is sufficiently serious, as required by the case-law relating to the first condition for the liability of the European Union to be incurred, cited in paragraph 42 above. |

| 281 | It is therefore necessary to reject the second and third parts of the third plea of illegality, and the first part thereof, in so far as it alleges a sufficiently serious breach of the general principle of proportionality, enshrined in Article 5(4) TEU. |

| 282 | Consequently, the third plea must be rejected in its entirety. |

4.
 
The fourth plea of illegality, alleging a sufficiently serious breach of the principle of equal treatment

| 283 | By their fourth plea of illegality, the applicants submit that the three institutions concerned breached the general principle of equal treatment, first, by prohibiting the placing on the market of products made from oxo-biodegradable plastic, but not products made from conventional plastic, with the exception of nine single-use products and, second, by prohibiting the placing on the market of products made from oxo-biodegradable plastic, but not products made from plastics marketed as ‘compostable’. |

| 284 | As regards, in particular, the difference in treatment of products made from oxo-biodegradable plastic and products made from conventional plastic, with the exception of nine single-use products, the applicants submit that it has not been demonstrated that oxo-biodegradable plastic would cause more harm to the environment than oxo-degradable plastic or conventional plastic. Oxo-biodegradable plastic does not fragment into microplastics and it biodegrades more quickly than conventional plastic. Oxo-biodegradable plastic is not more likely to be the subject of littering than conventional plastic. Oxo-biodegradable plastic can be recycled in the same way as conventional plastic. As regards, further, the difference in treatment of products made from oxo-biodegradable plastic and products made from conventional plastic, with the exception of nine single-use products, the applicants also submit that there is no justification for prohibiting only nine single-use products made from conventional plastic, whereas all products made from oxo-biodegradable plastic are prohibited. |

| 285 | In the alternative, the applicants maintain that the prohibition laid down in Article 5 of Directive 2019/904 results in a distortion of competition between different types of biodegradable plastic. |

| 286 | The Parliament, Council and Commission dispute the arguments put forward by the applicants. |

| 287 | As a preliminary point, it should be borne in mind that, according to settled case‑law, the principle of equal treatment is infringed only where comparable situations are treated differently or different situations are treated in the same way, unless such difference of treatment is objectively justified (see judgment of 5 December 2013, Solvay v Commission, [C‑455/11 P](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AC%3A2013%3A796&locale=en), not published, [EU:C:2013:796](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AC%3A2013%3A796), paragraph [77](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AC%3A2013%3A796&anchor=#point77) and the case-law cited). |

| 288 | The comparability of different situations must be assessed having regard to all the elements which characterise them. Those elements must, in particular, be determined and assessed in the light of the subject matter and purpose of the EU act which makes the distinction in question. The principles and objectives of the field to which the act relates must also be taken into account (judgments of 16 December 2008, Arcelor Atlantique et Lorraine and Others, [C‑127/07](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AC%3A2008%3A728&locale=en), [EU:C:2008:728](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AC%3A2008%3A728), paragraph [26](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AC%3A2008%3A728&anchor=#point26), and of 19 December 2019, HK v Commission, [C‑460/18 P](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AC%3A2019%3A1119&locale=en), [EU:C:2019:1119](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AC%3A2019%3A1119), paragraph [67](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AC%3A2019%3A1119&anchor=#point67)). |

| 289 | It is necessary to examine, first, whether the three institutions concerned have breached the general principle of equal treatment by prohibiting the placing on the market of products made from oxo-biodegradable plastic, but not products made from conventional plastic, with the exception of nine single-use products, and then, second, whether they breached that principle by prohibiting the placing on the market of products made from oxo-biodegradable plastic, but not products made from plastics marketed as ‘compostable’. |

| 290 | As regards, in the first place, the first of the two infringements referred to in paragraph 289 above, the Court considers that products made from plastic containing a pro-oxidant additive cannot be regarded as being in a situation comparable to that of products made from conventional plastic. |

| 291 | First, it follows from the examination of the third plea of illegality that, on the basis of the scientific risk assessment available to the three institutions concerned at the time when Directive 2019/904 was being drawn up and adopted, it cannot be ruled out that plastic containing a pro-oxidant additive may, at least in certain respects relating, in particular, to its recycling and its biodegradation in landfill, be more problematic than conventional plastic. |

| 292 | In that regard, it is apparent from paragraphs 129 and 131 above that, according to the Eunomia study and the report of 16 January 2018, in the event of biodegradation in the deep levels of a landfill, plastic containing a pro-oxidant additive would be slightly more problematic than conventional plastic from the point of view of greenhouse gases. |

| 293 | In addition, as stated in paragraph 234 above, plastic containing a pro-oxidant additive cannot be recycled with conventional plastic without affecting the quality of the recycled material. |

| 294 | Lastly, it is apparent from paragraphs 127 to 131 above that, according to the Eunomia study and the report of 16 January 2018, plastic containing a pro-oxidant additive fragments faster than conventional plastic, but that it cannot be ruled out that that faster fragmentation of plastic containing a pro-oxidant additive would have the consequence that, both in an open environment and in the marine environment, its negative impact on the environment would be increased, because it is concentrated over a shorter period. |

| 295 | That is emphasised in Section 4.3 of the report of 16 January 2018, which states ‘as oxo-degradable plastic is likely to fragment quicker than conventional plastic, the negative impacts associated with the presence of microplastics in the marine environment are concentrated within a shorter period of time. This could ultimately be worse than spreading out the impacts over a longer period, due to an increase in the proportion of individuals, species and habitats affected, as well as the burden of impacts for an individual’. |

| 296 | That is also highlighted by the Eunomia study as regards biodegradation in the open environment. According to that study, ‘it can be believed that degradation periods for [plastic containing a pro-oxidant additive] can be much shorter than should be expected for the degradation of conventional plastic, but consideration should be given to whether there are increased negative environmental impacts during this time frame compared to counterfactual situations’. |

| 297 | The applicants cannot, in order to refute the observations in paragraphs 291 to 294 above, rely on the letter sent by Dr R. Rose – the author of the Queen Mary University study – to the ECHA on 3 May 2018. It is true that, in that letter, Dr R. Rose states that she is ‘surprised that the European Union [are] proposing to ban a product that is certainly no worse than the unmodified [low-density polyethylene, namely, conventional plastic] that is not subject to the same action’ and that ‘legislating against a single form of plastic is not the way to resolve the accumulation of many forms of poly hydrocarbon’. However, that letter alludes to the use of the new method developed by Queen Mary University, which, as stated in paragraph 170 above, was far from being the accepted standard and that it is not certain that it would enable results to be obtained which could be reproduced in a real-world situation. |

| 298 | Nor can the applicants, in order to refute the observations in paragraphs 291 to 294 above, rely on paragraphs 19(c) and 47(b) of the witness statement of Symphony Environmental’s senior scientist. It is true that in that statement, that scientist states, first, that conventional plastic fragments into microplastics which persist in the environment for decades or hundreds of years and, second, that consumers who abandon plastic waste often do not care whether or not it is biodegradable. However, it must be recalled that, as stated in paragraph 179 above, little probative value can be attributed to that witness statement. That is all the more so since the only evidence which Symphony Environmental’s senior scientist cites in support of his claims is the Intertek laboratory report, which, as stated in paragraph 182 above, was prepared at the request of Symphony Environmental. |

| 299 | Lastly, in so far as the applicants seek to derive an argument from paragraphs 25 and 26 of the witness statement of the applicants’ CEO, in which the latter emphasises, without however referring to a scientific study, the inconsistent nature of Directive 2019/904, which prohibits oxo-biodegradable plastic, but not conventional plastic or compostable plastic, even though they do not, inter alia, biodegrade properly in an open environment and fail to deliver a proven environmental benefit, it is sufficient to recall that, as stated in paragraph 156 above, little probative value can be attributed to that witness statement. |

| 300 | Second, it is apparent from recital 36 of Directive 2019/904 that its objective is, inter alia, to prevent and reduce the impact of certain single-use plastic products, products made from oxo-degradable plastic and fishing gear containing plastic on the environment and human health. That directive does not therefore seek to cover all plastic products which may pose a risk to the environment and human health, but to focus efforts where they are most needed, as stated in recital 7thereof in relation to single-use plastic products. Article 1 of Directive 2019/904 confirms that its purpose is, inter alia, to prevent and reduce the impact of ‘certain’ plastic products on the environment, in particular the aquatic environment, and human health. |

| 301 | It has been established in the analysis of the third plea of illegality that the three institutions concerned did not make a manifest error of assessment in finding that the products made from oxo-degradable plastic had an impact on the environment and human health. |

| 302 | Since, according to the case-law cited in paragraph 288 above, the comparability of different situations must be assessed in the light of the subject matter and purpose of the EU act which makes the distinction in question, it cannot be found that products made from oxo-degradable plastic, in relation to which Directive 2019/904’s subject matter and purpose is to prevent and reduce the impact on the environment and human health, are in a situation comparable to that of products made from conventional plastic. |

| 303 | Therefore, the three institutions concerned did not breach the general principle of equal treatment by prohibiting the placing on the market of products made from plastic containing a pro-oxidant additive, but not the placing on the market of products made from conventional plastic, with the exception of nine single-use products. |

| 304 | It is not possible to accept the applicants’ argument that those institutions breached the general principle of equal treatment by prohibiting the placing on the market of ‘all’ products made from plastic containing a pro-oxidant additive, but only the placing on the market of ‘certain’ single-use products made from conventional plastic. It is apparent (i) from recital 36 of Directive 2019/904 that the objective of that directive is, inter alia, to prevent and reduce the impact of ‘certain’ single-use plastic products on the environment and human health, and (ii) from recital 7 of that directive that, in order to focus efforts where they are most needed, the directive should cover only those single-use plastic products that are found the most on beaches in the European Union, namely those listed in Part B of the annex to that directive. Consequently, in accordance with the case-law cited in paragraph 288 above, it cannot be considered that single-use products made from conventional plastic which are not found on the list annexed to Directive 2019/904 are in a situation comparable to that of products made from plastic containing a pro-oxidant additive. Therefore, by prohibiting the placing on the market of products made from plastic containing a pro-oxidant additive, but not of single-use products made from conventional plastic, the three institutions concerned did not breach the general principle of equal treatment. |

| 305 | Lastly, in so far as the applicants’ argument that the prohibition on placing on the market laid down in Article 5 of Directive 2019/904 results in a distortion of competition between different types of oxo-degradable plastic must be understood as alleging that by prohibiting not only products made from oxo-degradable plastic but also those made from plastic which the applicants classify as ‘oxo-biodegradable’, the three institutions concerned breached the general principle of equal treatment, that argument cannot be accepted. It has already been found, in the examination of the third plea of illegality, that those institutions did not make a manifest error of assessment in finding that plastic containing a pro-oxidant additive did not biodegrade properly and that no distinction should be made between oxo-degradable plastic and oxo-biodegradable plastic. Therefore, it cannot be maintained that by treating products made from oxo-degradable plastic differently from those made from plastic which the applicants classify as ‘oxo-biodegradable’, those institutions breached the general principle of equal treatment. |

| 306 | In the second place, as regards the breach of the general principle of equal treatment resulting from the prohibition on the placing on the market of products made from oxo-biodegradable plastic, but not of products made from plastic marketed as ‘compostable’, the Court considers that those two categories of products are not in a comparable situation. |

| 307 | It follows from the examination of the third plea of illegality that the three institutions concerned did not make a manifest error of assessment in finding that there is a risk that plastic containing a pro-oxidant additive is not compostable, which, as stated in paragraph 216 above, the applicants have acknowledged. Lastly, in accordance with the case-law cited in paragraph 288 above, account must be taken of the fact that, while the subject matter and purpose of Directive 2019/904 is to prevent and reduce the impact of products made from oxo-degradable plastic, products made from plastic marketed as ‘compostable’ do not fall within its subject matter and purpose. |

| 308 | It follows from paragraphs 303, 306 and 307 above that the three institutions concerned did not breach the general principle of equal treatment by prohibiting the placing on the market of products made from plastic containing a pro-oxidant additive, but not the placing on the market of products made from conventional plastic, with the exception of nine single-use products, or those made from plastic marketed as ‘compostable’. |

| 309 | In the absence of a breach of that principle, there is no need to examine whether that breach is sufficiently serious, as required by the case-law relating to the first condition for the liability of the European Union to be incurred, cited in paragraph 42 above. |

| 310 | Accordingly, the fourth plea of illegality must be dismissed. |

5.
 
The fifth plea of illegality, alleging a sufficiently serious breach of Articles 16 and 17 and Article 41(1) of the Charter and Article 49 TFEU

| 311 | The fifth plea of illegality comprises two parts. By the first part, the applicants maintain that by adopting the prohibition laid down in Article 5 of Directive 2019/904, the three institutions concerned restricted their freedom to conduct a business, enshrined in Article 16 of the Charter, their right to property, laid down in Article 17 of the Charter, and their freedom of establishment, referred to in Article 49 TFEU. The prohibition at issue prevents them from placing on the EU market products containing their d2w masterbatch. By the second part, the applicants submit that that prohibition was adopted contrary to their right to sound administration, laid down in Article 41 of the Charter, in so far as the three institutions concerned failed to take account of relevant evidence and did not follow proper procedures. |

| 312 | The Parliament, Council and Commission dispute the arguments put forward by the applicants. |

(a)
 
The first part of the fifth plea, alleging a sufficiently serious breach of Articles 16 and 17 of the Charter and of Article 49 TFEU

| 313 | It is necessary to examine whether the three institutions concerned committed a sufficiently serious infringement of (i) Article 16 of the Charter, (ii) Article 17 of the Charter and (iii) Article 49 TFEU. |

| 314 | The Court finds that that is not so. |

| 315 | As regards, in the first place, the infringement of Article 16 of the Charter, relating to the freedom to conduct a business, it should be noted that the protection afforded by that provision covers the freedom to exercise an economic or commercial activity, freedom of contract and free competition (judgment of 21 December 2021, Bank Melli Iran, [C‑124/20](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AC%3A2021%3A1035&locale=en), [EU:C:2021:1035](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AC%3A2021%3A1035), paragraph [79](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AC%3A2021%3A1035&anchor=#point79)). In addition, freedom of contract includes, in particular, the freedom to choose with whom to do business and the freedom to determine the price of a service (judgment of 22 January 2013, Sky Österreich, [C‑283/11](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AC%3A2013%3A28&locale=en), [EU:C:2013:28](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AC%3A2013%3A28), paragraph [43](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AC%3A2013%3A28&anchor=#point43)). |

| 316 | However, the freedom to conduct a business enshrined in Article 16 of the Charter does not constitute an absolute prerogative, but, first, must be viewed in relation to its function in society and, second, be weighed in the balance with other interests protected by the EU legal order and the rights and freedoms of others (judgment of 21 December 2021, Bank Melli Iran, [C‑124/20](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AC%3A2021%3A1035&locale=en), [EU:C:2021:1035](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AC%3A2021%3A1035), paragraph [80](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AC%3A2021%3A1035&anchor=#point80)). |

| 317 | Having regard to the wording of Article 16 of the Charter, which provides that the freedom to conduct a business is recognised in accordance with EU law and national laws and practices and thus differs from the wording of the other fundamental freedoms laid down in Title II thereof, yet is similar to that of certain provisions of Title IV of the Charter, that freedom may therefore be subject to a broad range of interventions on the part of public authorities which may, in the public interest, limit the exercise of economic activity (judgment of 21 December 2021, Bank Melli Iran, [C‑124/20](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AC%3A2021%3A1035&locale=en), [EU:C:2021:1035](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AC%3A2021%3A1035), paragraph [81](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AC%3A2021%3A1035&anchor=#point81)). |

| 318 | That circumstance is reflected, in particular, in the way in which EU legislation and national legislation and practices should be assessed in the light of the principle of proportionality under Article 52(1) of the Charter. In accordance with the latter provision, any limitation on the exercise of the rights and freedoms recognised by the Charter must be provided for by law and respect the essence of those rights and freedoms and, in compliance with the principle of proportionality, must be necessary and actually meet objectives of general interest recognised by the European Union or the need to protect the rights and freedoms of others (judgments of 22 January 2013, Sky Österreich, [C‑283/11](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AC%3A2013%3A28&locale=en), [EU:C:2013:28](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AC%3A2013%3A28), paragraphs [47](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AC%3A2013%3A28&anchor=#point47) and [48](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AC%3A2013%3A28&anchor=#point48), and of 21 December 2021, Bank Melli Iran, [C‑124/20](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AC%3A2021%3A1035&locale=en), [EU:C:2021:1035](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AC%3A2021%3A1035), paragraphs [82](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AC%3A2021%3A1035&anchor=#point82) and [83](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AC%3A2021%3A1035&anchor=#point83)). |

| 319 | In the present case, the prohibition laid down in Article 5 of Directive 2019/904 entails a limitation on the exercise by the applicants of their freedom to conduct a business. First, the applicants market products made from plastic containing the d2w masterbatch, such as rubbish bags and freezer bags, which the prohibition at issue now prohibits them from doing. Second, that prohibition is capable of affecting the applicants’ main activity, namely the manufacture and marketing of the d2w masterbatch. That main activity is related to the activity of placing on the market products made from oxo-degradable plastic, with the result that the prohibition of the latter could have economic consequences for the former and affect the applicants’ decision to continue it (see, by analogy, judgment of 10 March 2020, IFSUA v Council, [T‑251/18](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AT%3A2020%3A89&locale=en), [EU:T:2020:89](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AT%3A2020%3A89), paragraphs [150](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AT%3A2020%3A89&anchor=#point150) and [151](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AT%3A2020%3A89&anchor=#point151)). |

| 320 | However, that restriction is provided for by law, namely Directive 2019/904. In addition, it does not affect the essence of the applicants’ freedom to conduct a business, since only the placing on the EU market of products made from plastic containing a pro-oxidant additive, is prohibited, but not their production. Therefore, the applicants may continue to manufacture such products in order to place them on the market in third countries. They may also continue to manufacture their d2w masterbatch and sell it to customers who will use it in the manufacture of products which they intend to place on the market in third countries. Lastly, as found in the examination of the third plea of illegality, that restriction is necessary, proportionate and meets an objective of general interest recognised by the European Union, namely the protection of the environment and human health. |

| 321 | As regards, in the second place, the infringement of Article 17 of the Charter, Article 17(1) thereof provides that everyone has the right to own, use, dispose of and bequeath his or her lawfully acquired possessions and no one may be deprived of his or her possessions, except in the public interest and in the cases and under the conditions provided for by law, subject to fair compensation being paid in good time for their loss. Furthermore, the use of property may be regulated by law in so far as is necessary for the general interest. |

| 322 | However, according to the case-law, no economic operator can claim a right to property in a market share, even if that operator held it at the time before the introduction of a measure affecting the market, since such a market share constitutes only a momentary economic position exposed to the risks of changing circumstances. Nor can an economic operator claim an acquired right or even a legitimate expectation that an existing situation which is capable of being altered by measure taken by the EU institutions within the limits of their discretion will be maintained (judgment of 12 July 2005, Alliance for Natural Health and Others, [C‑154/04 and C‑155/04](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AC%3A2005%3A449&locale=en), [EU:C:2005:449](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AC%3A2005%3A449), paragraph [128](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AC%3A2005%3A449&anchor=#point128)). |

| 323 | In the present case, it follows from the case-law cited in paragraph 322 above that the applicants cannot claim protection under Article 17(1) of the Charter with regard to their right to place the d2w masterbatch on the EU market (see, by analogy, judgment of 3 September 2015, Inuit Tapiriit Kanatami and Others v Commission, [C‑398/13 P](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AC%3A2015%3A535&locale=en), [EU:C:2015:535](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AC%3A2015%3A535), paragraph [60](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AC%3A2015%3A535&anchor=#point60)). |

| 324 | It is not possible to accept the applicants’ argument that the prohibition on the placing on the market of products made from oxo-degradable plastic, laid down in Article 5 of Directive 2019/904, is contrary to Article 17(2) of the Charter, under which ‘intellectual property shall be protected’, because it reduces considerably the value of the intellectual property right which they hold over the formulation of the d2w masterbatch. Although the applicants have stated that that masterbatch was protected by a trade mark right and the know-how necessary for its production, they have continued not to state how such rights are infringed. |

| 325 | In any event, it must be stated that it is not apparent from Article 17 of the Charter or from case-law that the protection of intellectual property rights must be protected as an absolute right (see, by analogy, judgment of 29 July 2019, Spiegel Online, [C‑516/17](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AC%3A2019%3A625&locale=en), [EU:C:2019:625](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AC%3A2019%3A625), paragraph [56](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AC%3A2019%3A625&anchor=#point56)). Any limitation on Article 17(2) of the Charter must be imposed in accordance with Article 52(1) of that charter. In the present case, any limitation of the exercise of the intellectual property right which the applicants hold over the d2w masterbatch, even if established, would be provided for by law. It would not adversely affect the essence of that right, since the manufacture of products made from plastic containing a pro-oxidant additive and their sale on the market of third countries is not prohibited, nor is the manufacture and placing on the EU market of such an additive. As observed in the examination of the third plea of illegality, such a limitation meets an objective of general interest recognised by the European Union, namely the protection of the environment and human health, and does not go beyond what is necessary. |

| 326 | As regards, in the third place, the infringement of Article 49 TFEU, it is sufficient to state that the applicants do not indicate the reasons why the prohibition on the placing on the market of plastic containing a pro-oxidant additive would impede their freedom of establishment. |

| 327 | It follows from paragraphs 313 to 326 above that the three institutions concerned have not infringed Article 16 of the Charter, Article 17 thereof or Article 49 TFEU. |

| 328 | In the absence of an infringement of those articles, there is no need to examine whether that infringement is sufficiently serious, as required by the case-law relating to the first condition for the liability of the European Union to be incurred, cited in paragraph 42 above. |

| 329 | The first part of the fifth plea of illegality must therefore be rejected. |

(b)
 
The second part of the fifth plea, alleging a sufficiently serious breach of the right to sound administration, enshrined in Article 41 of the Charter

| 330 | By the second part of their fifth plea of illegality, the applicants maintain that the prohibition laid down in Article 5 of Directive 2019/904 was adopted contrary to their right to sound administration, enshrined in Article 41 of the Charter. They submit that the three institutions concerned failed to take account of the relevant evidence and did not follow the appropriate procedures. |

| 331 | That line of argument cannot be accepted. |

| 332 | It is sufficient, in that regard, to state that, according to the case-law, the right to sound administration, as it results from Article 41 of the Charter, does not cover the process of enacting a legislative act, such as Directive 2019/904 (see, to that effect, judgments of 14 October 1999, Atlanta v European Community, [C‑104/97 P](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AC%3A1999%3A498&locale=en), [EU:C:1999:498](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AC%3A1999%3A498), paragraph [37](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AC%3A1999%3A498&anchor=#point37), and of 12 June 2015, Health Food Manufacturers’ Association and Others v Commission, [T‑296/12](./../../../legal-content/EN/AUTO/?uri=ecli:ECLI%3AEU%3AT%3A2015%3A375&locale=en), [EU:T:2015:375](./../../../legal-content/EN/TXT/PDF/?uri=ecli:ECLI%3AEU%3AT%3A2015%3A375), paragraph [98](./../../../legal-content/EN/TXT/HTML/?uri=ecli:ECLI%3AEU%3AT%3A2015%3A375&anchor=#point98)). |

| 333 | Consequently, the three institutions concerned did not infringe Article 41 of the Charter. |

| 334 | Where there has been no breach of that article, there is no need to examine whether that breach is sufficiently serious, as required by the case-law relating to the first condition for the liability of the European Union to be incurred, cited in paragraph 42 above. |

| 335 | The second part of the fifth plea of illegality and, therefore, the fifth plea in its entirety must therefore be rejected. |

| 336 | It follows from all the foregoing that each of the five pleas of illegality must be rejected and that the applicants have failed to demonstrate that there is a sufficiently serious breach of a rule of law intended to confer rights on individuals. |

| 337 | Since the conditions for the non-contractual liability of the European Union to be incurred are, as stated in paragraph 41 above, cumulative, the present action must be dismissed on that basis, without it being necessary to examine the conditions for there to be actual and certain damage or a causal link. |

IV. Costs

| 338 | Under Article 134(1) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Since the applicants have been unsuccessful, they must be ordered to pay the costs, in accordance with the form of order sought by the Parliament, the Council and the Commission. |

|  | On those grounds,  THE GENERAL COURT (First Chamber, Extended Composition)  hereby: |

|  | | 1. | Dismisses the action; | |

|  | | 2. | Orders Symphony Environmental Technologies plc and Symphony Environmental Ltd to pay the costs. | |

|  |  |
| --- | --- |
|  | Van der Woude  Spielmann  Gâlea  Delivered in open court in Luxembourg on 31 January 2024.  V. Di Bucci  Registrar  S. Papasavvas  President |

Table of contents

|  |  |
| --- | --- |
|  | I. Background to the dispute |
|  | II. Forms of order sought |
|  | III. Law |
|  | A. The application for omission of certain information vis-à-vis the public |
|  | B. Preliminary observation |
|  | C. Admissibility |
|  | D. Substance |
|  | 1. The first plea of illegality, alleging infringement of Articles 68 to 73 of the REACH Regulation |
|  | 2. The second plea of illegality, alleging a sufficiently serious breach of paragraphs 12 and 14 to 16 of the Interinstitutional Agreement |
|  | 3. The third plea of illegality, alleging a sufficiently serious breach of the general principle of proportionality, enshrined in Article 5(4) TEU and Article 191 TFEU, as well as manifest errors of assessment |
|  | (a) The first part, in so far as it alleges a sufficiently serious breach of Article 191 TFEU |
|  | (1) The assertion that plastic containing a pro-oxidant additive does not biodegrade properly |
|  | (2) The assertion that plastic containing a pro-oxidant additive is not compostable |
|  | (3) The assertion that plastic containing a pro-oxidant additive negatively affects the recycling of conventional plastic |
|  | (4) The assertion that plastic containing a pro-oxidant additive fails to deliver a proven environmental benefit |
|  | (5) The list annexed to the replies, which lists all the documents which the three institutions concerned allegedly failed to take into account |
|  | (b) Whether the breach of the general principle of proportionality, enshrined in Article 5(4) TEU, is sufficiently serious |
|  | (1) The second part, alleging that, in so far as it applies to oxo-biodegradable plastic, the prohibition laid down in Article 5 of Directive 2019/904 is not appropriate for attaining the objective of that directive, and the first part, in so far as it is based on the same argument |
|  | (2) The third part, alleging that, in so far as it applies to oxo-biodegradable plastic, the prohibition laid down in Article 5 of Directive 2019/904 goes beyond what is necessary in order to achieve the objective pursued by that directive |
|  | 4. The fourth plea of illegality, alleging a sufficiently serious breach of the principle of equal treatment |
|  | 5. The fifth plea of illegality, alleging a sufficiently serious breach of Articles 16 and 17 and Article 41(1) of the Charter and Article 49 TFEU |
|  | (a) The first part of the fifth plea, alleging a sufficiently serious breach of Articles 16 and 17 of the Charter and of Article 49 TFEU |
|  | (b) The second part of the fifth plea, alleging a sufficiently serious breach of the right to sound administration, enshrined in Article 41 of the Charter |
|  | IV. Costs |

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(
[\*1](#c-ECR_62020TJ0745_EN_01-E0001)
) Language of the case: English.

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