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Das Bulletin zur Arzneimittelsicherheit informiert aus beiden Bundesoberbehörden zu aktuellen Aspekten der Risikobewertung von Arzneimitteln. Ziel ist es, die Kommunikation möglicher Risiken von Arzneimitteln zu verbessern und die Bedeutung der Überwachung vor und nach der Zulassung (Pharmakovigilanz) in den Blickpunkt zu rücken. In der aktuellen Ausgabe finden Sie folgende Themen: Editorial: Wechsel im PRAC – doch Expertise bleibt. BfArM und Paul-Ehrlich-Institut vertreten Deutschland weiterhin mit Erfahrung und Fachwissen Methadon/Levomethadon: Neurologische Entwicklungsstörungen bei Kindern, deren Mütter während der Schwangerschaft wegen Opioidabhängigkeit mit Methadon behandelt wurden Medikationsfehler mit Salbutamol-Druckgasinhalatoren Anwendung von kombinierten hormonalen Kontrazeptiva in Deutschland Meldungen aus BfArM und PEI PRAC-Empfehlungen im Rahmen von EU-Referral-Verfahren – Januar bis März 2026 Neufassung des Wortlauts der Produktinformationen – Auszüge aus den Empfehlungen des PRAC zu Signalen Hinweise auf Rote-Hand-Briefe und Sicherheitsinformationen Das Bulletin ist auf den Webseiten des BfArM und des PEI abrufbar.

Bei ifosfamidhaltigen Arzneimitteln zur parenteralen Anwendung handelt es sich um Arzneimittel zur Behandlung lebensbedrohlicher Erkrankungen. Eine alternative gleichwertige Arzneimitteltherapie steht nicht zur Verfügung. Diese Feststellung ermöglicht es den zuständigen Behörden der Länder, nach Maßgabe des § 79 Absatz 5 und 6 AMG im Einzelfall ein befristetes Abweichen von den Vorgaben des AMG zu gestatten. Das Bundesministerium für Gesundheit (BMG) wird bekanntmachen, wenn der Versorgungsmangel nicht mehr vorliegt. Die Bekanntmachung kann auf der Webseite des Bundesanzeigers abgerufen werden.

BERLIN Friedrichstraße 134 10117 Berlin BONN Ubierstraße 71–73 53173 Bonn Pharma Deutschland e. V. info@pharmadeutschland.de www.pharmadeutschland.de BRÜSSEL Rue Marie de Bourgogne 58 1000 Brüssel Ihre Ansprechpartner in der Pharma Deutschland-Pressestelle: Hannes Hönemann Leiter Abteilung Presse- und Öffentlichkeitsarbeit M: +49-171-5618203 hoenemann@pharmadeutschland.de Anna Frederike Gutzeit CvD Presse- und Öffentlichkeitsarbeit M: +49-170-4548014 gutzeit@pharmadeutschland.de Pressemitteilung Kommissionsvorschläge sind kurzsichtig und kontraproduktiv Pharma Deutschland vermisst bei den Vorschlägen der Finanzkommission Gesundheit differenzierten Blick auf die möglichen wirtschaftlichen und gesamtgesellschaftlichen Folgen Berlin (30. März 2026) – Pharma Deutschland vermisst bei den heute von der Finanzkommission Gesundheit vorgelegten Vorschlägen einen differenzierten Blick auf die möglichen wirtschaftlichen und gesamtgesellschaftlichen Folgen. Es zeigt sich, dass der Auftrag der Kommission zu einseitig auf Einsparungen und wenig auf strukturelle Verbesserungen ausgerichtet ist. Dass wirtschaftspolitische Aspekte unberücksichtigt bleiben, ist die große Schwäche der Vorschläge. Insbesondere im Arzneimittelbereich drohen schwerwiegende Folgen für Versorgungssicherheit, Innovationskraft sowie Therapieeinschränkungen. Die Vorschläge für Arzneimittel unter Patentschutz sind kurzsichtig und stehen im offenen Widerspruch zum erklärten Ziel, Forschung und Entwicklung für den Bereich innovativer Arzneimittel zu stärken. Die Erhöhung des Herstellerabschlags, der Ausbau von Wettbewerb unter Patentarzneimitteln, Nachschärfungen bei Preis- Mengen-Regelungen, die Abschaffung des Orphan Drug Privilegs: alle diese Vorschläge eint, dass sie die Rahmenbedingungen für Hersteller massiv verschlechtern würden. Mit einer Anhebung des Herstellerabschlags werden völlig falsche Signale gesendet. Beitragssatzentlastungen werden mit massiven Einbußen am Standort für forschende und produzierende Unternehmen erkauft, deren gesamtwirtschaftliche Folgekosten weit über den damit erzielten Einsparungen liegen. Gerade vor dem Hintergrund des Pharmadialogs wäre es widersprüchlich, wenn die Bundesregierung einerseits die Bedeutung der pharmazeutischen Industrie für Krisensicherheit und Unabhängigkeit sowie mailto:hoenemann@pharmadeutschland.de 2 Wirtschaftswachstum betont, andererseits aber durch zusätzliche Belastungen die Umsetzung untergräbt und das Bereithalten von Investitionen in Forschung, Produktion und Lieferketten schwächt. Aus Sicht von Pharma Deutschland braucht es eine Rückkehr zu einer nutzenbasierten Preisfindung und verlässliche industriepolitische Rahmenbedingungen, statt immer neuer Sonderabgaben und Automatismen zulasten der Hersteller. Auch die Vorschläge zu mehr Wettbewerb unter patentgeschützten Arzneimitteln über Selektivverträge würden die Versorgung von Patientinnen und Patienten in Deutschland massiv verschlechtern. Die ärztliche Therapiefreiheit würde massiv eingeschränkt werden. Die Entscheidung darüber, welches Arzneimittel eingesetzt wird, würde nicht von der medizinischen Entscheidung, sondern von den Regeln der Krankenkassen abhängen. Der Vorschlag fördert zudem eine Zwei-Klassen-Medizin. Letztendlich stellt er aber vor allem eines dar: eine klare Rationierungsmaßnahme. Dorothee Brakmann, Hauptgeschäftsführerin von Pharma Deutschland, erklärt dazu: „Die Vorschläge der Kommission greifen zu kurz und verstärken die aktuellen strukturellen Defizite. So ist eine erneute Erhöhung des Herstellerabschlags wirtschaftspolitisch widersprüchlich und kurzsichtig. Man kann nicht ausschließlich den Standort mit zusätzlichen Sonderabgaben strangulieren, wenn man im internationalen Wettbewerb steht. So zerstört man Vertrauen, Investitionsbereitschaft und am Ende auch Versorgungssicherheit.“ Die Finanzkommission hat eine langfristige Stärkung der Prävention unterstrichen. Dennoch konterkarieren die kurzfristigen Maßnahmenvorschläge zu Impfungen dieses Ziel grundlegend. Pharma Deutschland kritisiert auch die von der Finanzkommission vorgeschlagene Streichung der Erstattung homöopathischer Leistungen im Rahmen von Satzungsleistungen deutlich. Zusammengenommen bedeuten die Entscheidungen für die Bürgerinnen und Bürger weniger Innovationsdynamik und Sicherheit in der Versorgung. Die negativen Effekte der Vorschläge gehen weit über die Pharmaindustrie hinaus ohne Lösungsansätze für die strukturellen Defizite des GKV-Systems zu bieten. _______________ Der Pharma Deutschland e.V. ist der mitgliederstärkste Branchenverband der Pharmaindustrie in Deutschland. Er vertritt die Interessen von rund 400 Mitgliedsunternehmen, die in Deutschland ca. 80.000 Mitarbeiterinnen und Mitarbeiter beschäftigen. Die in Pharma Deutschland e.V. organisierten Unternehmen tragen maßgeblich dazu bei, die Arzneimittelversorgung in Deutschland zu sichern. So stellen sie fast 80 Prozent der in Apotheken verkauften rezeptfreien und fast zwei Drittel der rezeptpflichtigen 3 Arzneimittel sowie einen Großteil der stofflichen und dentalen Medizinprodukte für die Patientinnen und Patienten bereit. Unter www.pharmadeutschland.de gibt es mehr Informationen zu Pharma Deutschland. http://www.pharmadeutschland.de/

Die Vorschläge für Arzneimittel unter Patentschutz sind kurzsichtig und stehen im offenen Widerspruch zum erklärten Ziel, Forschung und Entwicklung für den Bereich innovativer Arzneimittel zu stärken. Die Erhöhung des Herstellerabschlags, der Ausbau von Wettbewerb unter Patentarzneimitteln, Nachschärfungen bei Preis-Mengen-Regelungen, die Abschaffung des Orphan Drug Privilegs: alle diese Vorschläge eint, dass sie die Rahmenbedingungen für Hersteller massiv verschlechtern würden. Mit einer Anhebung des Herstellerabschlags werden völlig falsche Signale gesendet. Beitragssatzentlastungen werden mit massiven Einbußen am Standort für forschende und produzierende Unternehmen erkauft, deren gesamtwirtschaftliche Folgekosten weit über den damit erzielten Einsparungen liegen. Gerade vor dem Hintergrund des Pharmadialogs wäre es widersprüchlich, wenn die Bundesregierung einerseits die Bedeutung der pharmazeutischen Industrie für Krisensicherheit und Unabhängigkeit sowie Wirtschaftswachstum betont, andererseits aber durch zusätzliche Belastungen die Umsetzung untergräbt und das Bereithalten von Investitionen in Forschung, Produktion und Lieferketten schwächt. Aus Sicht von Pharma Deutschland braucht es eine Rückkehr zu einer nutzenbasierten Preisfindung und verlässliche industriepolitische Rahmenbedingungen, statt immer neuer Sonderabgaben und Automatismen zulasten der Hersteller. Auch die Vorschläge zu mehr Wettbewerb unter patentgeschützten Arzneimitteln über Selektivverträge würden die Versorgung von Patientinnen und Patienten in Deutschland massiv verschlechtern. Die ärztliche Therapiefreiheit würde massiv eingeschränkt werden. Die Entscheidung darüber, welches Arzneimittel eingesetzt wird, würde nicht von der medizinischen Entscheidung, sondern von den Regeln der Krankenkassen abhängen. Der Vorschlag fördert zudem eine Zwei-Klassen-Medizin. Letztendlich stellt er aber vor allem eines dar: eine klare Rationierungsmaßnahme. "Die Vorschläge der Kommission greifen zu kurz und verstärken die aktuellen strukturellen Defizite." Dorothee Brakmann Hauptgeschäftsführerin "So ist eine erneute Erhöhung des Herstellerabschlags wirtschaftspolitisch widersprüchlich und kurzsichtig. Man kann nicht ausschließlich den Standort mit zusätzlichen Sonderabgaben strangulieren, wenn man im internationalen Wettbewerb steht. So zerstört man Vertrauen, Investitionsbereitschaft und am Ende auch Versorgungssicherheit“, Brakmann weiter. Die Finanzkommission hat eine langfristige Stärkung der Prävention unterstrichen. Dennoch konterkarieren die kurzfristigen Maßnahmenvorschläge zu Impfungen dieses Ziel grundlegend. Pharma Deutschland kritisiert auch die von der Finanzkommission vorgeschlagene Streichung der Erstattung homöopathischer Leistungen im Rahmen von Satzungsleistungen deutlich. Zusammengenommen bedeuten die Entscheidungen für die Bürgerinnen und Bürger weniger Innovationsdynamik und Sicherheit in der Versorgung. Die negativen Effekte der Vorschläge gehen weit über die Pharmaindustrie hinaus ohne Lösungsansätze für die strukturellen Defizite des GKV-Systems zu bieten.

Preisentwicklung auf dem Arzneimittelmarkt bis Februar 2026 GKV-Arzneimittelindex Impressum Die vorliegende Publikation ist ein Beitrag des Wissenschaftlichen Instituts der AOK (WldO). Preisentwicklung auf dem Arzneimittelmarkt bis Februar 2026 Berlin, März 2026 Salka Enners, Prof. Dr. Michael Thiede Wissenschaftliches Institut der AOK (WIdO) im AOK-Bundesverband eGbR – Arbeitsgemeinschaft von Körperschaften des öffentlichen Rechts Rosenthaler Str. 31, 10178 Berlin Geschäftsführender Vorstand: Dr. Carola Reimann (Vorsitzende) Jens Martin Hoyer (stellv. Vorsitzender) http://www.aok-bv.de/impressum/index.html Registergericht Berlin (Charlottenburg), GsR 634 B Aufsichtsbehörde: Senatsverwaltung für Gesundheit, Pflege und Gleichstellung –SenGPG– Oranienstraße 106, 10969 Berlin Satz: Anja Füssel Titelfoto: KomPart Nachdruck, Wiedergabe, Vervielfältigung und Verbreitung (gleich welcher Art), auch von Teilen des Werkes, bedürfen der ausdrücklichen Genehmigung. E-Mail: wido@wido.bv.aok.de Internet: http://www.wido.de http://www.aok-bv.de/impressum/index.html http://www.wido.de/ Inhalt Einleitende Hinweise ............................................................................................................. 4 Teil I: Preisindex im Arzneimittelmarkt.................................................................................. 5 Gesamtmarkt ............................................................................................................................... 5 Festbetrags- und Nicht-Festbetragsmarkt ................................................................................... 8 Preisentwicklung nach Arzneimittelgruppen ............................................................................. 11 Teil 2: Kennwerte der Preisveränderung im Arzneimittelmarkt ........................................... 13 Einzelne Marktsegmente ........................................................................................................... 14 Vergleich der Marktsegmente ................................................................................................... 18 Arzneimittelgruppen .................................................................................................................. 20 Allgemeine methodische Hinweise ...................................................................................... 21 Datenbasis ................................................................................................................................. 22 4 GKV-Arzneimittelindex – Preisinfo 2/2026 Einleitende Hinweise Die vorliegende Publikation stellt die Preisentwicklung im Fertigarzneimittelmarkt mit zwei möglichen Berechnungsansätzen dar. Damit wird ermöglicht, dass bei der Dar- stellung der aktuellen Preisentwicklung einerseits die Verordnungsmengen eines fes- ten Warenkorbs und andererseits aktuelle Marktbewegungen auf Produktebene stärker fokussiert werden. In Teil 1 wird der Preisindex eines definierten Warenkorbs nachgezeichnet. Dabei wer- den die Preise aller Arzneimittel entsprechend ihrer Verordnungshäufigkeit im Vorjahr bis zum aktuellen Monat verglichen. Damit ein Arzneimittel hier berücksichtigt wird, muss es also sowohl im Vorjahr (Basiszeitraum) als auch aktuell (Betrachtungszeit- raum) auf dem Markt verfügbar gewesen sein. Dabei wird der Effekt umso stärker ge- wichtet, je häufiger es verordnet wurde. Aktuelle Marktentwicklungen werden damit auf Preisebene, nicht aber auf Produktebene nachvollzogen. In Teil 2 werden die Preise aller aktuell verordnungsfähigen Arzneimittel als ungewich- tete Mittelwerte der Marktsituation der Vormonate gegenübergestellt. Aktuelle Markt- entwicklungen werden sowohl auf Preisebene als auch auf Produktebene (einschließ- lich der aktuellen Markteintritte und Marktaustritte und deren individuelle Preise) nachvollzogen. Dies geschieht unabhängig von der Verordnungshäufigkeit in einem definierten Zeitraum. Die Analysen basieren auf allem verkehrsfähigen, rezeptpflichti- gen Arzneimittel, für die eine Preisangabe vorliegt. Diese Arzneimittel können sowohl von ambulant tätigen Kassenärzten verordnet werden wie auch im Krankenhaus ein- gesetzt werden. GKV-Arzneimittelindex – Preisinfo 2/2026 5 Teil I: Preisindex im Arzneimittelmarkt Gesamtmarkt Im Folgenden wird der Preisindex im gesamten Arzneimittelmarkt dargestellt. In Abbildung 1 wird die Preisentwicklung gegenüber Januar 2024 als Preisindex darge- stellt. Der Preisindex berechnet sich auf der Grundlage der monatlichen Steigerungen. In Abbildung 2 wird der prozentuale Anstieg zwischen zwei aufeinanderfolgenden Mo- naten dargestellt. Mit der Aktualisierung des Warenkorbes können die Werte von vorangegangenen Pub- likationen abweichen. Die Tabelle 1 beinhaltet neben den Preisindizes die Änderungswerte gegenüber dem Vormonat (vgl. Abbildung 1) und dem Monat des Vorjahres. Abbildung 1: Preisindex im Gesamtmarkt für Fertigarzneimittel Quelle: GKV-Arzneimittelindex im WIdO 2026 90 91 92 93 94 95 96 97 98 99 100 101 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 2024 2025 2026 Preisindex (Jan 2024= 100) Gesamtmarkt 6 GKV-Arzneimittelindex – Preisinfo 2/2026 Abbildung 2: Preisentwicklung im Gesamtmarkt gegenüber Vormonat in Prozent Quelle: GKV-Arzneimittelindex im WIdO 2026 -3,0 -2,5 -2,0 -1,5 -1,0 -0,5 0,0 0,5 1,0 1,5 2,0 2,5 3,0 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 2024 2025 2026 GKV-Arzneimittelindex – Preisinfo 2/2026 7 Tabelle 1: Ausgewählte Indikatoren der Preisentwicklung von Januar 2025 bis Februar 2026 für Fertigarzneimittel Jahr Monat Preisindex Preisanstieg gegenüber Januar 2024 = 100 Vorjahr in % Vormonat in % 2025 Januar 98,9 -1,1 0,0 Februar 98,8 -1,3 -0,1 März 98,7 -1,4 -0,1 April 98,7 -1,2 0,0 Mai 98,7 -0,8 0,0 Juni 98,6 -0,7 -0,1 Juli 98,8 -0,8 0,2 August 98,8 -0,8 0,0 September 98,7 -0,7 0,0 Oktober 98,7 -0,5 0,0 November 98,6 -0,4 -0,1 Dezember 98,5 -0,5 -0,1 Jahresdurchschnitt 98,7 -0,8 0,0 2026 Januar 98,4 -0,5 -0,1 Februar 98,4 -0,4 0,0 Jahresdurchschnitt 98,4 -0,4 0,0 Quelle: GKV-Arzneimittelindex im WIdO 2026 8 GKV-Arzneimittelindex – Preisinfo 2/2026 Festbetrags- und Nicht-Festbetragsmarkt Im Folgenden werden die oben beschriebenen Analysen für den Markt der Festbetrags- arzneimittel vorgestellt. Stichtag zur Abgrenzung beider Marktsegmente ist der jewei- lige 1. des Analysemonats. Durch Änderungen der Festbetragsfestlegungen kann die Warenkorbabgrenzung von der in vorangegangenen Publikationen abweichen. Die Monatswerte werden auf der Grundlage der aktuell gültigen Festbetragsgruppen auch rückwirkend neu berechnet. In Abbildung 3 ist die monatliche Preisentwicklung nach den Marktsegmenten Festbe- tragsmarkt, Nicht-Festbetragsmarkt und Gesamtmarkt als Preisindex dargestellt. Die Tabelle 2 beschreibt die Indexwerte nach den Marktsegmenten Festbetragsmarkt, Nicht-Festbetragsmarkt und Gesamtmarkt. Die monatliche Preisentwicklung im Vergleich zum Vorjahresmonat für die Marktseg- mente sind in der Tabelle 3 aufgeführt. Abbildung 3: Preisindex für Fertigarzneimittel nach Marktsegmenten (entsprechend § 35 SGB V) Quelle: GKV-Arzneimittelindex im WIdO 2026 92 93 94 95 96 97 98 99 100 101 102 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 2024 2025 2026 Preisindex (Jan. 2024 = 100) Nicht-Festbetragsmarkt Festbetragsmarkt Gesamtmarkt GKV-Arzneimittelindex – Preisinfo 2/2026 9 Tabelle 2: Preisentwicklung für Fertigarzneimittel nach Marktsegmenten (entsprechend § 35 SGB V) von Januar 2024 bis Februar 2026 Jahr Monat Gesamtmarkt Festbetragsmarkt* Nicht- Festbetragsmarkt* 2024 Januar 100,0 100,0 100,0 Februar 100,1 100,2 100,1 März 100,1 100,1 100,0 April 99,8 99,6 99,9 Mai 99,5 99,5 99,5 Juni 99,3 99,5 99,2 Juli 99,6 98,2 100,2 August 99,6 98,1 100,3 September 99,4 98,1 100,0 Oktober 99,2 97,6 99,9 November 99,0 97,6 99,6 Dezember 98,9 97,6 99,6 Jahresdurchschnitt 99,5 98,8 99,9 2025 Januar 98,9 97,6 99,5 Februar 98,8 97,6 99,4 März 98,7 97,5 99,3 April 98,7 97,1 99,4 Mai 98,7 97,0 99,5 Juni 98,6 97,0 99,4 Juli 98,8 96,9 99,7 August 98,8 96,9 99,6 September 98,7 96,9 99,6 Oktober 98,7 96,8 99,5 November 98,6 96,7 99,5 Dezember 98,5 96,8 99,3 Jahresdurchschnitt 98,7 97,1 99,5 2026 Januar 98,4 96,7 99,2 Februar 98,4 96,7 99,2 Jahresdurchschnitt 98,4 96,7 99,2 * Die Veränderungswerte sind dann nicht unmittelbar mit den Angaben der Vorperioden vergleichbar, wenn neue Festbetragsfestlegungen gelten. In den Teilmärkten werden die jeweils aktuellen Marktanteile zu- grunde gelegt, d. h. die Veränderungswerte basieren damit auf den jeweils aktuellen Marktverhältnissen und werden rückwirkend neu berechnet Quelle: GKV-Arzneimittelindex im WIdO 2026 10 GKV-Arzneimittelindex – Preisinfo 2/2026 Tabelle 3: Preisentwicklung für Fertigarzneimittel nach Marktsegmenten (entsprechend § 35 SGB V) im Vergleich zum Vorjahr in Prozent Jahr Monat Gesamtmarkt in % Festbetragsmarkt* in % Nicht-Festbetrags- markt* in % 2025 Januar -1,1 -2,4 -0,5 Februar -1,3 -2,6 -0,7 März -1,4 -2,6 -0,8 April -1,2 -2,5 -0,5 Mai -0,8 -2,6 0,0 Juni -0,7 -2,5 0,2 Juli -0,8 -1,2 -0,6 August -0,8 -1,2 -0,7 September -0,7 -1,2 -0,4 Oktober -0,5 -0,8 -0,4 November -0,4 -0,9 -0,1 Dezember -0,5 -0,9 -0,3 Jahresdurchschnitt -0,8 -1,8 -0,4 2026 Januar -0,5 -0,9 -0,3 Februar -0,4 -0,9 -0,1 Jahresdurchschnitt -0,4 -0,9 -0,2 * Die Veränderungswerte sind dann nicht unmittelbar mit den Angaben der Vorperioden vergleichbar, wenn neue Festbetragsfestlegungen gelten. In den Teilmärkten werden die jeweils aktuellen Marktanteile zu- grunde gelegt, d. h. die Veränderungswerte basieren damit auf den jeweils aktuellen Marktverhältnissen und werden rückwirkend neu berechnet Quelle: GKV-Arzneimittelindex im WIdO 2026 GKV-Arzneimittelindex – Preisinfo 2/2026 11 Preisentwicklung nach Arzneimittelgruppen In Abbildung 4 ist die Preisentwicklung der Arzneimittelgruppen entsprechend dem ak- tuellen Stand der ATC-Klassifikation des GKV-Arzneimittelindex im Vergleich zum Vorjahresmonat dargestellt. Hierbei werden die 20 umsatzstärksten Arzneimittelgrup- pen berücksichtigt. Tabelle 4 zeigt die Preisentwicklung gegenüber dem Vorjahresmo- nat, den Umsatzanteil im Gesamtmarkt des Jahres 2024 und die Preisentwicklung ent- sprechend der aktuellen Festbetragseinstufung in den Arzneimittelgruppen. Abbildung 4: Preisentwicklung Februar 2026 im Vergleich zum Vorjahresmonat in % nach Arz- neimittelgruppen Quelle: GKV-Arzneimittelindex im WIdO 2026 -0,4 -11,5 -4,7 -3,0 -1,7 -1,5 -1,4 -1,4 -1,1 -0,8 -0,7 -0,5 -0,1 -0,1 0,0 0,1 0,6 0,6 0,8 2,1 2,6 -14 -13 -12 -11 -10 -9 -8 -7 -6 -5 -4 -3 -2 -1 0 1 2 3 4 Gesamtmarkt Andere Mittel für das Nervensystem Endokrine Therapie Antivirale Mittel zur systemischen Anwendung Antineoplastische Mittel Analgetika Immunsuppressiva Antibiotika zur systemischen Anwendung Psycholeptika Mittel, die den Lipidstoffwechsel beeinflussen Mittel mit Wirkung auf das Renin-Angiotensin-System Andere Dermatika Psychoanaleptika Antithrombotische Mittel Andere Mittel f. d. alimentäre System und d. Stoffwechsel Ophthalmika Immunstimulanzien Antihämorrhagika Immunsera und Immunglobuline Mittel bei obstruktiven Atemwegserkrankungen Antidiabetika 12 GKV-Arzneimittelindex – Preisinfo 2/2026 Tabelle 4: Preisentwicklung in % nach Arzneimittelgruppen für Februar 2026 im Vergleich zum Vorjahresmonat ATC Code Arzneimittelgruppe nach 2. Ebene der ATC-Klassifikation Umsatzanteil im Jahr 2024 in % Gesamt- markt Festbetrags- markt* Nicht-Festbe- tragsmarkt* A10 Antidiabetika 8,4 2,6 -0,3 3,0 R03 Mittel bei obstruktiven Atemweg- serkrankungen 4,6 2,1 2,3 2,1 J06 Immunsera und Immunglobuline 1,6 0,8 - 0,8 B02 Antihämorrhagika 2,0 0,6 0,0 1,0 L03 Immunstimulanzien 1,5 0,6 -2,5 1,2 S01 Ophthalmika 3,3 0,1 -0,2 0,2 B01 Antithrombotische Mittel 1,8 0,0 -2,2 0,1 A16 Andere Mittel für das alimentäre System und den Stoffwechsel 6,7 -0,1 -0,2 0,0 D11 Andere Dermatika 1,9 -0,1 -0,1 -0,4 N06 Psychoanaleptika 1,7 -0,5 - -0,5 C09 Mittel mit Wirkung auf das Renin- Angiotensin-System 3,8 -0,7 -0,6 -0,9 C10 Mittel, die den Lipidstoffwechsel beeinflussen 2,1 -0,8 -0,8 -0,8 N05 Psycholeptika 1,7 -1,1 -0,1 -2,4 J01 Antibiotika zur systemischen An- wendung 1,4 -1,4 -2,6 1,7 L04 Immunsuppressiva 16,5 -1,4 -1,2 -1,5 N02 Analgetika 3,9 -1,5 -1,4 -2,0 L01 Antineoplastische Mittel 7,7 -1,7 -2,1 -1,7 J05 Antivirale Mittel zur systemischen Anwendung 2,3 -3,0 -3,0 -3,0 L02 Endokrine Therapie 3,1 -4,7 -37,4 -0,3 N07 Andere Mittel für das Nervensys- tem 1,4 -11,5 -1,6 -12,6 Alle 20 Arzneimittelgruppen 77,1 -0,7 -1,3 -0,5 Gesamtmarkt 100,0 -0,4 -0,9 -0,1 * Die Veränderungswerte sind dann nicht unmittelbar mit den Angaben der Vorperioden vergleichbar, wenn neue Festbetragsfestlegungen gelten. In den Teilmärkten werden die jeweils aktuellen Marktanteile zu- grunde gelegt, d. h. die Veränderungswerte basieren damit auf den jeweils aktuellen Marktverhältnissen und werden rückwirkend neu berechnet Quelle: GKV-Arzneimittelindex im WIdO 2026 GKV-Arzneimittelindex – Preisinfo 2/2026 13 Teil 2: Kennwerte der Preisveränderung im Arzneimittelmarkt Im Folgenden wird die Preisveränderung für den Gesamtmarkt, den Markt der patent- geschützten Arzneimittel und für neu eingeführte, patentgeschützte Arzneimittel für den Zeitraum der letzten 24 Monate inklusive des aktuellen Analysemonats dargestellt. Die Analysen basieren auf den Apothekenverkaufspreisen (AVP). Ist für ein Arzneimit- tel kein AVP gemeldet, wird ersatzweise der Apothekeneinkaufspreis oder der Herstel- lerabgabepreis genutzt. Berücksichtigt werden jeweils alle verkehrsfähigen, rezept- pflichtigen Arzneimittel, für die eine Preisangabe vorliegt. In Abbildung 5 sind die monatlichen arithmetischen Mittelwerte und die Mediane für den Gesamtmarkt angegeben. In Tabelle 5 werden die zehn teuersten Arzneimittel des aktuellen Monats mit ihren Preisen aufgelistet. Abbildung 5: Preisveränderung im gesamten Arzneimittelmarkt Quelle: GKV-Arzneimittelindex im WIdO 2026 0 500 1000 1500 2000 2500 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 2024 2025 2026 D ur ch sc hn itt sp re is in E ur o Arithmetisches Mittel Median 14 GKV-Arzneimittelindex – Preisinfo 2/2026 Tabelle 5: Die zehn teuersten Arzneimittel* im Februar 2026 Rang Handelsname ATC Code Arzneimittelgruppe nach 2. Ebene der ATC-Klassi- fikation Hauptindikationsgruppe Preis (in Euro) 1 Upstaza A16 Enzymersatzmittel Seltene Stoffwechselkrank- heiten 3.000.000 2 Hemgenix B02 Antihämorrhagika Erkrankungen des Blutsys- tems 2.482.100 3 Libmeldy A16 Enzymersatzmittel Seltene Stoffwechselkrank- heiten 2.125.000 4 Zolgensma M09 Antiarthrotika/andere Mittel Erkrankungen des Muskel- und Skelettsystems 1.385.000 5 Carvykti L01 Antineoplastische Mittel Krebserkrankungen 285.000 6 Luxturna S01 Ophthalmika Erkrankungen von Auge und Ohr 280.000 7 Tecartus L01 Antineoplastische Mittel Krebserkrankungen 271.000 8 Idefirix L04 Immunsuppressiva Immuntherapie 249.510 9 Kymriah L01 Antineoplastische Mittel Krebserkrankungen 239.000 10 Yescarta L01 Antineoplastische Mittel Krebserkrankungen 226.990 * aufgeführt ist die teuerste, sich in Vertrieb befindende Packung des Arzneimittels Quelle: GKV-Arzneimittelindex im WIdO 2026 Einzelne Marktsegmente Tabelle 6 enthält die Durchschnittswerte entsprechend der Abbildung 5 und zusätzlich die Preisveränderung für die preiswertesten und die teuersten Produkte am Markt. Ta- belle 7 beschreibt die aktuelle monatliche Preisveränderung im patentgeschützten Markt, Tabelle 8 für die neu eingeführten Patent-Arzneimittel. Im Warenkorb sind alle Neueinführungen der zu jedem dargestellten Monat vorangegangenen 36 Monate ent- halten. Dies entspricht beispielsweise für Februar 2026 dem Warenkorb der Neueinfüh- rungen zwischen Februar 2023 und Februar 2026. Aufgrund der geringen Anzahl von Produkten wurde die Anteilsgrenze in Tabelle 8 auf 5 % gesetzt. GKV-Arzneimittelindex – Preisinfo 2/2026 15 Tabelle 6: Veränderung der durchschnittlichen Preise für verschreibungspflichtige Fertigarz- neimittel (in Euro) Jahr Monat Preis- werteste Produkte (1%) Preis- werteste Produkte (25%)* Arithmeti- sches Mittel Teuerste Produkte (25%)** Teuerste Produkte (1%)** 2024 März 12,52 18,64 1.806,78 7.057,01 142.672,58 April 12,56 18,64 1.779,23 6.948,50 139.624,53 Mai 12,55 18,66 1.775,85 6.933,53 139.422,17 Juni 12,55 18,66 1.760,44 6.871,39 137.712,93 Juli 12,57 18,66 1.735,77 6.773,79 134.712,65 August 12,56 18,69 1.740,32 6.784,29 134.779,61 September 12,59 18,74 1.743,62 6.799,72 133.137,76 Oktober 12,59 18,75 1.745,97 6.809,00 133.261,34 November 12,59 18,79 1.743,25 6.798,71 131.451,78 Dezember 12,61 18,81 1.743,82 6.794,84 131.475,50 2025 Januar 12,61 18,83 1.738,87 6.774,20 131.398,82 Februar 12,64 18,86 1.732,43 6.752,08 131.852,08 März 12,63 18,89 1.710,13 6.663,07 129.385,69 April 12,63 18,90 1.968,96 7.695,86 153.101,73 Mai 12,67 18,96 1.973,16 7.714,10 155.181,01 Juni 12,68 19,00 1.978,31 7.732,02 155.308,33 Juli 12,74 19,04 1.972,25 7.708,55 155.227,03 August 12,75 19,07 1.943,73 7.595,40 151.933,72 September 12,74 19,09 1.946,61 7.602,87 150.440,43 Oktober 12,76 19,13 1.948,04 7.609,35 150.229,76 November 12,75 19,16 1.951,40 7.619,84 150.642,80 Dezember 12,77 19,19 1.956,69 7.640,52 150.910,28 2026 Januar 12,77 19,19 1.980,46 7.733,57 153.071,90 Februar 12,77 19,19 1.977,69 7.724,05 152.940,01 * ungewichtete Durchschnittspreise der preiswertesten Arzneimittel entsprechend dem angegebenen Anteil ** ungewichtete Durchschnittspreise der teuersten Arzneimittel entsprechend dem angegebenen Anteil Quelle: GKV-Arzneimittelindex im WIdO 2026 16 GKV-Arzneimittelindex – Preisinfo 2/2026 Tabelle 7: Veränderung der durchschnittlichen Preise für patentgeschützte verschreibungs- pflichtige Fertigarzneimittel (in Euro) Jahr Monat Preis- werteste Produkte (1%) Preis- werteste Produkte (25%)* Arithmeti- sches Mittel Teuerste Produkte (25%)** Teuerste Produkte (1%)** 2024 März 20,35 140,68 22.697,82 86.291,46 1.380.000,00 April 20,28 138,23 22.257,43 84.557,67 1.338.333,33 Mai 20,28 140,57 22.075,17 83.854,84 1.338.333,33 Juni 20,28 142,72 21.704,25 82.346,75 1.315.833,33 Juli 20,47 145,99 21.226,10 80.120,81 1.266.166,67 August 20,54 150,54 21.109,57 79.616,09 1.266.166,67 September 20,54 147,70 20.917,27 79.025,50 1.266.166,67 Oktober 20,54 148,25 20.755,74 78.221,13 1.266.166,67 November 20,54 149,91 20.588,71 77.560,05 1.266.166,67 Dezember 20,54 149,84 20.584,12 77.559,27 1.266.166,67 2025 Januar 20,54 162,13 21.183,45 79.660,06 1.266.166,67 Februar 20,54 162,11 21.010,55 78.983,93 1.266.000,00 März 20,54 161,01 20.549,36 77.580,01 1.266.000,00 April 20,54 167,73 24.072,24 91.139,56 1.558.333,33 Mai 20,54 170,35 23.931,01 90.802,29 1.558.333,33 Juni 20,54 174,15 23.834,99 90.276,10 1.558.333,33 Juli 20,85 177,50 23.871,29 90.258,93 1.558.333,33 August 20,85 178,67 23.346,74 88.521,78 1.516.666,67 September 20,85 183,59 23.176,66 87.569,79 1.516.666,67 Oktober 20,85 186,16 23.030,86 86.954,05 1.516.666,67 November 20,85 185,71 22.951,03 86.746,31 1.516.666,67 Dezember 20,85 182,86 22.497,58 84.891,43 1.516.666,67 2026 Januar 20,85 170,66 22.594,21 85.688,54 1.554.758,35 Februar 21,67 169,93 22.544,97 85.086,76 1.371.364,30 * ungewichtete Durchschnittspreise der preiswertesten Arzneimittel entsprechend dem angegebenen Anteil ** ungewichtete Durchschnittspreise der teuersten Arzneimittel entsprechend dem angegebenen Anteil Durch monatliche Patentausläufe und damit verbundene Klassifikationsänderungen kann die Marktabgrenzung zwischen patentgeschütztem Markt und generikafähigem Markt von Monat zu Monat differieren. Die Zuschrei- bung zu einem der Marktsegmente erfolgt einheitlich auch rückwirkend. Ein Vergleich der vorgestellten Analysen mit vorherigen Publikationen ist daher nur bedingt aussagekräftig, da immer die aktuelle Klassifikation zugrunde gelegt wird. Quelle: GKV-Arzneimittelindex im WIdO 2026 GKV-Arzneimittelindex – Preisinfo 2/2026 17 Tabelle 8: Veränderung der durchschnittlichen Preise der Marktneueinführungen im Markt der patentgeschützten verschreibungspflichtigen Fertigarzneimittel (in Euro) Jahr Monat Preis- werteste Produkte (5 %)* Preis- werteste Produkte (25 %)* Arithmeti- sches Mittel Teuerste Produkte (25 %)** Teuerste Produkte (5 %)** 2024 März 46,65 234,59 59.398,20 229.652,33 1.044.733,24 April 41,34 232,09 57.263,49 216.265,47 965.685,57 Mai 40,43 243,18 56.698,96 215.800,28 965.685,57 Juni 41,06 248,70 39.809,24 151.198,40 637.958,89 Juli 46,87 268,35 39.944,52 150.447,36 605.498,07 August 50,85 312,75 39.277,27 145.953,49 605.498,07 September 46,40 283,78 38.041,14 141.731,35 605.498,07 Oktober 47,33 330,46 38.950,56 146.158,75 605.498,07 November 47,12 333,70 37.704,68 141.521,75 602.916,66 Dezember 46,13 355,51 37.957,08 141.521,75 602.916,66 Januar 52,96 389,78 39.062,77 145.325,34 602.023,80 2025 Februar 53,19 371,45 38.183,86 141.997,10 575.725,69 März 53,36 390,01 39.081,49 147.324,13 575.725,69 April 53,36 432,18 53.903,96 206.133,81 857.023,80 Mai 53,51 456,66 53.294,56 200.669,08 857.023,80 Juni 53,51 441,49 52.533,31 200.982,43 857.023,80 Juli 53,51 453,92 53.631,77 200.897,40 857.023,80 August 53,64 447,88 50.661,19 193.187,82 821.309,52 September 62,65 464,23 27.574,79 101.349,76 399.440,02 Oktober 59,24 476,17 25.579,83 93.745,08 371.726,79 November 59,44 506,13 25.822,35 93.840,56 364.890,53 Dezember 64,66 358,59 24.236,14 87.514,87 364.890,53 2026 Januar 86,09 286,28 24.327,56 89.582,66 351.635,70 Februar 91,20 276,39 24.304,77 89.075,25 351.635,70 * ungewichtete Durchschnittspreise der preiswertesten Arzneimittel entsprechend dem angegebenen Anteil ** ungewichtete Durchschnittspreise der teuersten Arzneimittel entsprechend dem angegebenen Anteil Quelle: GKV-Arzneimittelindex im WIdO 2026 18 GKV-Arzneimittelindex – Preisinfo 2/2026 Vergleich der Marktsegmente In Abbildung 6 wird die monatliche Veränderung der ungewichteten durchschnittlichen Preise im Gesamtmarkt, im patentgeschützten Markt und für die Marktneueinführun- gen dargestellt. Abbildung 6: Preisveränderung nach Marktsegmenten in Euro Quelle: GKV-Arzneimittelindex im WIdO 2026 0 10.000 20.000 30.000 40.000 50.000 60.000 70.000 80.000 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 2024 2025 2026 D ur ch sc hn itt sp re is in E ur o Patentmarkt Neue Markteinführungen Gesamtmarkt GKV-Arzneimittelindex – Preisinfo 2/2026 19 Abbildung 7 zeigt die Verteilung der Arzneimittelpreise im Gesamtmarkt, im Patent- markt und im Markt neu eingeführte Arzneimittel im patentgeschützten Markt für den aktuellen Monat. Abbildung 7: Preisverteilung nach Marktsegmenten nach Perzentilen * logarithmische Skalierung zur Basis 10 Quelle: GKV-Arzneimittelindex im WIdO 2026 1 10 100 1.000 10.000 100.000 1.000.000 10.000.000 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 95 100 D ur ch sc hn itt sp re is in E ur o* Neueinführungen Patent Gesamt (n = 7.988) (n = 146) (n = 601) 20 GKV-Arzneimittelindex – Preisinfo 2/2026 Arzneimittelgruppen Die 20 Arzneimittelgruppen, die die höchste prozentuale Dynamik der Durchschnitts- preise im Vergleich zum Vorjahresmonat erkennen ließen, werden in Abbildung 8 aus- gewiesen. Dabei werden die Gruppen entsprechend dem aktuellen Stand der ATC- Klassifikation des GKV-Arzneimittelindex berücksichtigt, wenn mindestens zehn un- terschiedliche Präparate am Markt vertreten waren. Abbildung 8: Änderungen der ungewichteten Durchschnittspreise für Fertigarzneimittel im Februar 2026 im Vergleich zum Vorjahresmonat in % getrennt nach Arzneimittelgruppen Quelle: GKV-Arzneimittelindex im WIdO 2026 14,2 -28,6 -21,7 -15,8 -11,2 -11,2 -10,2 -10,0 -9,9 9,9 16,6 18,4 21,6 24,1 27,5 51,5 95,0 141,1 162,5 2.091,3 3.575,2 -500 500 1.500 2.500 3.500 Gesamtmarkt Gallen- und Lebertherapie Corticosteroide zur systemischen Anwendung Endokrine Therapie Mittel gegen Protozoen-Erkrankungen Andere Mittel für das Nervensystem Antineoplastische Mittel Immunsera und Immunglobuline Mittel mit Wirkung auf das Renin-Angiotensin-System Andere Dermatika Antidiabetika Aknemittel Antidiarrhoika und intestinale Antiphlogistika/Antiinfektiva Rhinologika Psychoanaleptika Andere Hämatologika Gichtmittel Mittel, die den Lipidstoffwechsel beeinflussen Herztherapie Antihämorrhagika Schilddrüsentherapie GKV-Arzneimittelindex – Preisinfo 2/2026 21 Allgemeine methodische Hinweise Die vorliegenden Analysen ermöglichen einen Überblick über die Preisentwicklung im deutschen Markt der rezeptpflichtigen Arzneimittel. Im Wesentlichen werden dafür zwei Gruppen von Kennzahlen für verschiedene Marktsegmente ermittelt und monat- lich zur Verfügung gestellt. Die Preisindices werden nach der Laspeyres-Formel berechnet. Bei der Indexberech- nung werden nur solche Artikel berücksichtigt, die im Warenkorb des Basisjahres 2024 enthalten sind. Dabei werden in der vorliegenden Publikation alle Arzneimittel berück- sichtigt, die sich in der Basis- und Berichtsperiode im Abverkauf befinden. Eventuelle indirekte Preiserhöhungen im Zusammenhang mit Produktvariationen im Berichtszeit- raum werden nicht erfasst. Insbesondere werden auch neue Präparate, deren Marktein- tritt nach der Erhebung des Warenkorbes liegt, nicht berücksichtigt, da noch keine ent- sprechenden Verordnungsdaten vorliegen. Neben der Berechnung der Indices werden ergänzend Preisanalysen angeboten. Für die Berechnung der reinen Preisentwicklung werden alle Präparate – also insbesondere auch neue Produkte und Produktvariationen – zum Zeitpunkt des Berichtsmonats be- rücksichtigt. Diese Analysen können ohne Berücksichtigung der Abverkaufszahlen als Lageparameter für die diskutierten Marktsegmente erstellt werden. Bei der Interpretation der Ergebnisse ist auf die unterschiedliche Aussagekraft der bei- den Betrachtungen zu achten. Während der Preisindex als Maß für die Teuerung für einen definierten Warenkorb interpretiert werden kann, zeigen die Lageparameter, wie sich die Verteilung der Preise unabhängig von einem Warenkorb in dem Betrachtungs- zeitraum verändert. Durch monatliche Klassifikationsänderungen kann die Abgrenzung zwischen einzel- nen Marktsegmenten von Monat zu Monat differieren. Ein Vergleich der Analysen mit denen aus vorherigen Publikationen ist daher nur bedingt aussagekräftig, da immer die aktuelle Klassifikation zugrunde gelegt und die zurückliegenden Zeiträume entspre- chend neu berechnet werden. 22 GKV-Arzneimittelindex – Preisinfo 2/2026 Datenbasis Preise Das GKV-Abrechnungsverzeichnis Arzneimittel enthält Informationen zu über 80.000 Fertigarzneimitteln, die zu Lasten der Gesetzlichen Krankenversicherung abgerechnet werden können. Preisänderungen werden monatlich berücksichtigt und im GKV-Arz- neimittelindex historisiert. Stichtag der monatlichen Indexangaben ist der Erste eines Monats. Jahresdurchschnitte der Preisindices werden als ungewichtete arithmetische Mittel der Monatswerte errechnet. Die Analysen basieren auf den Apothekenverkaufs- preisen (AVP). Die ungewichteten Durchschnittspreise in Teil 2 werden mit den Durchschnittswerten für ein Arzneimittel mit allen Produktvariationen berechnet. Ist für ein Arzneimittel kein AVP gemeldet, wird in Teil 2 ersatzweise der Apothekeneinkaufspreis oder der Herstellerabgabepreis genutzt. In diesen Fällen blieben die Aufschläge der Handelsstu- fen und die Mehrwertsteuer unberücksichtigt. Anders als in Teil 1 werden in Teil 2 ab dem Preisinfo 10/2019 auch Klinikpackungen berücksichtigt. Die Analysen basieren so- mit auf allen verkehrsfähigen befindlichen, rezeptpflichtigen Arzneimitteln mit Preis- angabe. Warenkorb Warenkorbänderungen für die Indexberechnung erfolgen jährlich. Den gegenwärtigen Warenkorb bilden die gesamten GKV-Arzneimittelverordnungen des Jahres 2024. Mit der Aktualisierung des Warenkorbes können sich andere Steigerungsraten ergeben, als sie auf der Basis älterer Warenkörbe ausgewiesen wurden. Diese Differenzen sind je- doch in aller Regel nur geringfügig. Umbasierung Um die aktuellen Indices mit denen älterer Veröffentlichungen zu vergleichen, ist der aktuelle Index mit der Basis Januar 2024 = 100 auf die damals gültige Basis Januar 2023 = 100 umzurechnen. Der anzuwendende Faktor errechnet sich aus dem Quotien- ten des Preisindexes des aktuellen Basisjahres (Januar 2024 = 100,1) und der damals gel- tenden Basis (Januar 2023 = 100). 100,1 = 1,001 100 Eine Umrechnung des Preisindexes für Februar 2026 auf Basis Januar 2023 führt zu ei- nem Preisindex von 98,4 * 1,001 = 98,5. Einleitende Hinweise Teil I: Preisindex im Arzneimittelmarkt Gesamtmarkt Festbetrags- und Nicht-Festbetragsmarkt Preisentwicklung nach Arzneimittelgruppen Teil 2: Kennwerte der Preisveränderung im Arzneimittelmarkt Einzelne Marktsegmente Vergleich der Marktsegmente Arzneimittelgruppen Allgemeine methodische Hinweise Datenbasis

Künstliche Intelligenz (KI) ist aus einer zukunftsorientierten Gesundheitsversorgung nicht mehr wegzudenken. Sie beeinflusst zunehmend alle Bereiche der Therapieentwicklung und ‑anwendung, von Forschung über Zulassung bis hin zur Versorgung. Für Pharma Deutschland bedeutet dies, KI in sämtlichen Aufgabenfeldern systematisch zu monitoren, zu analysieren und aktiv zu begleiten, um die Interessen unserer Mitgliedsunternehmen optimal zu unterstützen. Im KI HUB von Pharma Deutschland werden die KI-Anwendungsfelder umfassend beleuchtet und wir freuen uns, Sie für die nächste Sitzung des KI HUB einzuladen, die am Montag, 04. Mai 2026 von 13:00 – 16:00 Uhr online via Teams stattfinden wird. Im Bereich der medizinischen Versorgung wird Dr. Carsten Dochow, Leiter der Rechtsabteilung der Bundesärztekammer, Perspektiven zur „KI und Ärztliches Berufsrecht. Gefährdet KI die ärztliche Therapiefreiheit?“ geben. Darüber hinaus wird Max Sieg, Co-Founder von caidera, Einsatzmöglichkeiten von KI im Pharma‑Marketing darstellen. Sie können sich schon jetzt für die Veranstaltung anmelden .

Die Ministerin kündigte an, die Vorschläge auszuwerten und bis spätestens zur Sommerpause einen Gesetzgebungsvorschlag ins Kabinett einzubringen, um die finanzielle Stabilität der gesetzlichen Krankenversicherung kurz- und mittelfristig zu sichern. Kritisch seitens Pharma Deutschland wird gesehen (nicht abschließend): Einführung dynamisierter Herstellerabschlag (für das Jahr 2027 auf 14 %, ab dem Jahr 2028 eine Dynamisierung des Herstellerabschlag, durch Kopplung der Ausgabenentwicklung an die Einnahmeentwicklung) Nachschärfung der Preis-Mengen-Regelung Selektivverträge für therapeutisch gleichwertige Arzneimittel (auch unter Patent) Abschaffung des Orphan-Drug-Privilegs Streichung der Kostenübernahme für homöopathische Leistungen Wiedereinführung apothekenbezogener Zytostatika-Ausschreibungen Ausweitung der Regulierungsmöglichkeiten für die Preise von Schutzimpfungen Die vorgelegten Vorschläge zeigen in Teilen auch in die richtige Richtung, insbesondere dort, wo strukturelle Effizienzreserven adressiert werden. Wie z.B. Einführung einer gestaffelten Steuer auf zuckergesüßte Erfrischungsgetränke, Höherbesteuerung von Alkohol und Tabak, Stärkung der Prävention, obligatorische Zweitmeinung und zur Finanzierung der Beiträge von Bürgergeldbeziehenden in der GKV aus Steuermitteln. Eine Senkung der Umsatzsteuer wurde ebenso ausgeklammert wie das Thema Anhebung der Beitragsbemessungsgrenze. Die Reformmaßnahmen werden in drei Kategorien eingeteilt: A*, A und B. Priorität haben Maßnahmen der Kategorie A* und A, während Kategorie B politisch besonders abgewogen werden muss. Die ausführlichen Ergebnisse der GKV-Finanzkommission (Empfehlungen und Management Summary) finden Sie im Detail auf der BMG-Webseite. Entscheidend wird jedoch sein, wie die Maßnahmen im Detail gesetzgeberisch ausgestaltet werden. Pharma Deutschland setzt darauf, dass die Regierungskoalition im weiteren Prozess auf eine ausgewogene und nachhaltige Lösung hinarbeitet, die sowohl die Finanzierbarkeit des Systems als auch die Innovationskraft der Branche berücksichtigt. Pharma Deutschland wird im morgigen Newsletter „Pharma Deutschland aktuell“ ausführlich zu den einzelnen Maßnahmen im Bereich der Arzneimittelpolitik sowie zu den zentralen gesundheitspolitischen Forderungen berichten.

Mit dem 1. April 2026 tritt eine aktualisierte Fassung des Rahmenvertrags über die Arzneimittelversorgung nach § 129 Absatz 2 SGB V in Kraft. Im Fokus der Änderungen steht die Regelung zum Biosimilaraustausch. Der Auswahlbereich wird nun konsequent an der Biosimilarregelung des Gemeinsame Bundesausschuss (G-BA) ausgerichtet. Sobald der G-BA eine Austauschbarkeit festgestellt hat, sind Apotheken verpflichtet, preisgünstige Biosimilars abzugeben. Rabattverträge behalten Vorrang, sofern die Substitution nicht ausgeschlossen hat. Die Anlage 1 des Rahmenvertrages, in der sog. Bioidentical definiert wurden, wurde aufgehoben bzw. ist nun unbesetzt. Zur Umsetzung der Austauschverpflichtungen des Rahmenvertrages bedarf es aus Sicht von Pharma Deutschland weiterer Änderungen der Arzneimittel-Richtlinie, insbesondere Regelungen zu austauschbaren Darreichungsformen.

DG ENV, Unit B01 March 2026 Packaging and Packaging Waste Regulation (PPWR) Frequently Asked Questions EUROPEAN COMMISSION Directorate-General for Environment Directorate ENV.B — Competitive Circular Economy & Clean Industrial Policy Unit ENV.B.1 — Bioeconomy & Sustainable Materials Contact: Unit B.1 E-mail: ENV-B01-ARES@ec.europa.eu European Commission B-1049 Brussels EUROPEAN COMMISSION Directorate-General for Environment 2026 Packaging and Packaging Waste Regulation (PPWR) Frequently Asked Questions Manuscript completed in March 2026 1st edition This document has been prepared for the European Commission however it reflects the views only of the authors, and the European Commission is not liable for any consequence stemming from the reuse of this publication. It is intended to assist economic operators, national authorities and citizens in the application of the PPWR. Luxembourg: Publications Office of the European Union, 2026 © European Union, 2026 The reuse policy of European Commission documents is implemented by Commission Decision 2011/833/EU of 12 December 2011 on the reuse of Commission documents (OJ L 330, 14.12.2011, p. 39). Unless otherwise noted, the reuse of this document is authorised under a Creative Commons Attribution 4.0 International (CC BY 4.0) licence (https://creativecommons.org/licenses/by/4.0/). This means that reuse is allowed provided appropriate credit is given and any changes are indicated. For any use or reproduction of elements that are not owned by the European Union, permission may need to be sought directly from the respective rightholders. PDF ISBN 978-92-68-37678-2 doi:10.2779/6056528 KH-01-26-006-EN-N https://creativecommons.org/licenses/by/4.0/ 2 Table of Contents I. Introduction on the subject matter and scope .................................................................. 5 II. Definitions ............................................................................................................................ 6 III. Substances of concern ....................................................................................................... 10 IV. Recyclability ...................................................................................................................... 15 V. Recycled content in plastic packaging ............................................................................. 19 VI. Compostability .................................................................................................................. 23 VII. Packaging minimisation ................................................................................................... 24 VIII. Labelling ............................................................................................................................ 27 IX. Environmental claims ....................................................................................................... 28 X. Obligations of manufacturers .......................................................................................... 29 XI. Empty space....................................................................................................................... 31 XII. Bans and the use of certain packaging ............................................................................ 32 XIII. Reuse and refill .................................................................................................................. 35 XIV. Plastic carrier bags ........................................................................................................... 40 XV. Assessment of the conformity of packaging .................................................................... 41 XVI. Waste prevention .............................................................................................................. 45 XVII. Extended producer responsibility .................................................................................... 47 XVIII. Return and collection systems .......................................................................................... 49 XIX. Deposit and return systems .............................................................................................. 50 3 Abbreviations CMO: Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products DfR: Design for recycling DRS: Deposit and Return System DSA: Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a Single Market for Digital Services ECHA: European Chemicals Agency EO: Economic Operator EPR: Extended Producer Responsibility EPS: Expanded Polystyrene ESPR: Regulation (EU) 2024/1781 of the European Parliament and of the Council of 13 June 2024 establishing a framework for the setting of eco-design requirements for sustainable products FCM: Food-contact material, as regulated under Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food FIBC: Flexible Intermediate Bulk Container HoReCa: Hotel, Restaurant and Catering IBC: Intermediate bulk containers JRC: Joint Research Centre NACE: Statistical classification of economic activities / classification of economic activities in the European Union (EU) OJEU: Official Journal of the European Union PFAS: Per-and polyfluoroalkyl substances PPWD: European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste PPWR: Regulation (EU) 2025/40 of the European Parliament and of the Council of 19 December 2024 on packaging and packaging waste PRO: Producer Responsible Organisation REACH: 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 SoC: Substances of Concern SUPD: 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 4 TRIS: Procedure under Directive 2015/1535 to prevent creating barriers in the internal market WFD: Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste XPS: Extruded Polystyrene 5 I. INTRODUCTION ON THE SUBJECT MATTER AND SCOPE Regulation (EU) 2025/40 (1) establishes a harmonised legal framework for packaging and packaging waste across the European Union. Its primary objective is to ensure the smooth functioning of the internal market while significantly reducing the environmental and health impacts associated with packaging throughout its life cycle. By replacing Directive 94/62/EC (2), this regulation introduces clearer, stricter, and more uniform requirements for all economic operators and Member States, fostering a transition towards a circular economy. The scope of the Regulation is comprehensive. It applies to all packaging placed on the EU market, whether empty or filled, regardless of the material used, and whether produced within the Union or imported from third countries. It also covers all packaging waste generated within the EU. Packaging is defined broadly, as any item intended for containment, protection, handling, delivery, or presentation of products, including its components. However, items that form an integral part of a product and are disposed of together with it are excluded. Through these provisions, Regulation (EU) 2025/40 seeks to harmonise national measures on packaging, prevent market fragmentation, and promote sustainable practices. It introduces obligations such as recyclability and reuse targets, restrictions on hazardous substances, and requirements for eco-friendly design and labelling. In doing so, it not only addresses pressing environmental challenges but also creates a level playing field for businesses operating across multiple Member States. The PPWR entered into force on 11 February 2025, and its general application date is 12 August 2026, but certain provisions apply later (e.g., recyclability, recycled content targets, packaging bans and reuse targets by 2030). Some of the main provisions of the PPWR are: - Waste Prevention Targets: 5% by 2030, 10% by 2035, 15% by 2040 (compared to 2018 levels) (Article 43). - Recyclability: All packaging must be recyclable in an economically viable way by 2030 (Article 6). - Reuse Targets: For transport, e-commerce, and beverage packaging (Article 29). - Restrictions: Ban on certain single-use formats from 1 January 2030 (Article 25 and Annex V); PFAS in food contact packaging prohibited from 12 August 2026 (Article 5(5)). - Empty Space threshold: Max 50% for grouped, transport, and e-commerce packaging (Article 24). - Mandatory Deposit-Return Systems: For beverage cans and plastic bottles (Article 50). - Labelling: Harmonised sorting labels for all packaging (Article 12(1)). - Extended Producer Responsibility (EPR): Strengthened obligations for producers (Articles 44–47). This document clarifies some issues and answers questions that have been received by DG Environment since the adoption of the Regulation. This document complements the Commission Notice - Guidance document for Regulation 2025/40 (EU) on packaging and packaging waste (hereinafter ‘Commission guidance document’). (1) Regulation (EU) 2025/40 of the European Parliament and of the Council of 19 December 2024 on packaging and packaging waste, amending Regulation (EU) 2019/1020 and Directive (EU) 2019/904, and repealing Directive 94/62/EC (OJ L, 2025/40, 22.1.2025). (2) European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste (OJ L 365 31.12.1994, p. 10). 6 II. DEFINITIONS 1) Does the wording packaging ‘…whether empty or with a product…’ modify the definitions of packaging and of manufacturer under the PPWR? Article 3(1), point (1), contains a definition of packaging, which remained largely unchanged compared to the packaging definition in the Directive 94/62/EC. However, the new definition contains the new wording ‘…whether empty or with a product…’. This new wording does not modify the definition of packaging or the definition of manufacturer but is intended to cover all different factual situations and types of packaging that come within the scope of the PPWR. For further information on the packaging definition, please consult the Commission guidance document. 2) Why does the definition of packaging for tea and coffee mention ‘machine use’ only in point (g) and not in point (f) of Article 3(1)? The wording indicates the difference between systems for filter coffee/tea bags and those for coffee extraction machines. Machine use is one of the key criteria to decide if a tea/coffee capsule falls under Article 3(1), point (1)(f), or point (1)(g). Permeability is another element that needs to be considered. This distinction is important in relation to the compostability requirements in Article 9. Permeable tea, coffee or other beverage bags, or soft after-use system single-serve units that contain tea, coffee or another beverage, which are intended to be used and disposed of together with the product (point (1)(f)), are mandatorily compostable. Non-permeable tea, coffee or other beverage system single- serve units intended for use in a machine, and which are used and disposed of together with the product (point (1)(g)) are not. However, Member States may decide to make the latter mandatorily compostable on their territories, under certain conditions, such as the existence of an appropriate collection and waste treatment infrastructure for bio-waste. Member States cannot ban or require compostability as regards metal capsules. 3) Why does the wording ‘making available on the market’ sometimes refer to the Union market and other times to the territory of a Member State? The definitions ‘making available on the market’ (Article 3(1), point (9)) and ‘placing on the market’ (Article 3(1), point (10)) refer to the Union market. These definitions apply throughout the PPWR reflecting the harmonisation of requirements that apply directly to economic operators. However, in the provisions on waste management, such as waste reduction and recycling targets, separate collection and extended producer responsibility, the requirements are mainly addressed to Member States. To reflect the territorial scope of the above-mentioned requirements, the Regulation uses the term ‘making available on the territory of a Member State’ (Article 3(1), point (11)). The definition has the same meaning as the definition of ‘making available on the market’, the only difference being that it circumscribes the actions to the territory of a Member State instead of the Union market. 4) How can producers know if a packaged product is made available to an end user or whether it is made further available? A product is considered to have been made available on the market when it is supplied for distribution, consumption, or use in the course of a commercial activity. An end user, whether a consumer or a professional end user, is a person or entity to whom a product is made available and who does not make that product further available on the market in the form in which it was supplied. 7 The determining factor is therefore not the legal status of the recipient, but how the product is used. A professional end user is considered as an end user where it uses the product on its own operations or production process and does not resell or otherwise place the product back on the market in the same form. A producer of a packaged product should be able to determine, based on the nature of the packaging and the chosen marketing and distribution channels, whether the intended recipient is an end user (consumer or professional), or a commercial buyer who will resell the packaged product in another Member State. It should be noted that logistics companies that receive packaged goods, such as imported products from third countries, and perform handling activities (e.g., unpacking, repacking, or dividing products into smaller quantities) are not considered end users. 5) Is a farmer producer for the purpose of EPR obligations? Whether a farmer is a ‘producer’ will depend on the specific situation. There is no general exemption for specific sectors such as farmers in terms of extended producer responsibility obligations since all economic operators making packaging available on the territory of a Member State for the first time will have to comply with these obligations. The following examples show some typical examples of when a farmer would normally be considered a producer and when it would not. • If a farmer packs a few apples in a container (sales packaging) and sells it under its own name or trademark to a retailer or consumer in the same Member State, the farmer is a producer. • If the farmer sells the packed apples under its own name or trademark in another Member State, the farmer is only the producer if the recipient is the end user of the apples. This means that the farmer is not the producer if it sells the apples to a retailer in another Member State. • If the farmer is a micro-enterprise, which is often the case, and the supplier of the apple container is established in the same Member State, such supplier becomes the producer in the Member State where the farmer and supplier are located. • If the container is produced under the name or trademark of an agricultural cooperative of which the farmer is part, then this cooperative, and not the individual farmer, is the producer. • If the farmer delivers apples in bulk in large containers (transport packaging) to a agricultural cooperation, who then packs the apples into containers (sales packaging) under the name or trademark of the cooperative, the agricultural cooperative is the producer. 8 The producer definition addresses packaging used in primary production. ‘Primary production’ is to be understood as ‘the production, rearing or growing of primary products including harvesting, milking and farmed animal production prior to slaughter’ (3). Packaging material, for example foil or straps used for hay bales, is only considered to be made available on the market, and thereby packaging, when the bales are placed on the market and not when it is used in a production process, in this case on the same farm. 6) When is packaging considered ‘composite packaging’? If the total mass of materials which are different from the main packaging material constitutes more than 5% of the total mass of the packaging unit, such packaging is composite packaging, regardless of whether the total mass of each other packaging material is less than 5% of the total mass of the packaging unit (Article 3(1), point (24)). An example of composite packaging is a multilayer flexible packaging of which the main material is Polypropylene (PP) (83–90%) used for the structural layer and printability. Such packaging usually uses a barrier layer of aluminium foil or metallized PET (3–4%) to provide oxygen and a light barrier to preserve freshness. It may also have a barrier made of low-density polyethylene (LDPE) or ethylene vinyl acetate (EVA) (3–4%) that ensures heat-sealing for airtight closure. Printing inks and bonding adhesives used for branding and lamination are also used in such packaging and constitute 1–2% of the total mass. However, they are not taken into account to determine whether something constitutes composite packaging. This type of packaging consists of one main packaging material, in terms of weight, and additional materials which, taken together constitute more than 5% of the total mass of the packaging unit. It therefore qualifies as composite packaging within the meaning of Article 3(1), point (24), even where all packaging materials are plastics. In this context, the notion ‘different materials’ should be understood as referring to different material categories or functional layers (e.g. barriers), rather than to variants within the same polymer family. For example, polymer grades or variants within (3) Article 3(17) of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 031 1.2.2002) 9 polyethylene (such as LDPE, LLDPE or HDPE) would normally be considered the same material for the purposes of this assessment, whereas the combination of polypropylene with polyethylene layers, aluminium foil or metallised materials would constitute the use of different materials. This interpretation is without prejudice to the classification of packaging formats set out in Annex II, Table 1, which serves a different purpose and does not limit the scope of the legal definition of composite packaging laid down in Article 3. Further details will be provided in the implementing legislation under Article 7(8). If the packaging consists of components of different materials that can be manually separated, it is not considered a composite packaging. The definition of composite packaging is without prejudice to Directive (EU) 2019/904 (4). 7) Are crown corks for beverage bottles an integrated or separate component? Crown corks for glass bottles are considered separate components, as per Article 3(1), point (44), of the Regulation. Such closures, which are not permanently attached to the bottle, need to be separated completely and permanently from the main packaging unit in order to access the product and, therefore, to ensure the functionality of the packaging unit. The future delegated act on design for recycling (DfR) will further specify the rules for integrated and separate components. 8) Are the derogations provided for in Directive 2008/68/EC (5) applicable to all packaging that is used for the transport of dangerous goods? Are the derogations also applicable to the transport of non-dangerous goods? The provisions on recyclability, recycled content and reuse targets contain specific exemptions for packaging used for transport of dangerous goods. If the packaging is used for transport of dangerous goods in accordance with Directive 2008/68/EC, even though it does not require UN approval, e.g. packaging used under limited quantities (LQ) marking, the PPWR derogations are applicable. For UN approved packaging used for the transport of non-dangerous goods, the PPWR derogations do not apply, which means the general rules apply. (4) 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 (SUPD). (5) Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods (OJ L 260, 30.9.2008, pp. 13–59). 10 III. SUBSTANCES OF CONCERN 1) In the definition of Substances of Concern (SoC), which refers to the ESPR, should the conditions in Article 2(27) points (a), (b), (c), (d) of the ESPR be considered as cumulative? How should the wording ‘negatively affects the reuse and recycling of materials in the product in which it is present’ be understood? It is sufficient that only one of the conditions under points (a) to (d) of Article 2(27) ESPR is fulfilled for a substance to be considered as a SoC (6). As regards the meaning of the wording ‘negatively affects the reuse and recycling…’ the Commission and the European Chemicals Agency (ECHA) are currently conducting a study on identifying the SoC that could affect human health and impact packaging reusability and recyclability. 2) What is the difference between substances and substances of concern (SoC)? Does the Ecodesign for Sustainable Products Regulation (ESPR) and the PPWR address substances of concern (SoC) in the same manner? The definition of substances of concern (SoC) refers to the ESPR (Article 3(1), fourth paragraph of the Regulation), which means that substances of concern are defined in the same manner in the PPWR and the ESPR. The ESPR establishes the criteria for identification of substances of concern. They are mainly based on their hazardous properties and classification in accordance with the CLP Regulation (7) but also include a reference to negative effects on the reuse and recycling of materials in the product in which they are present (8). The conditions are not cumulative, which means that if one of the conditions is fulfilled, the substance is considered as SoC. 3) How will the PPWR deal with the addition of substances of concern (SoC) and the use of recyclates? The objective of the Regulation is the minimisation of the presence of SoC in packaging. This will be done via the identification of substances of concern, as a first step, and their limitation, if they (6) The ESPR FAQ can be found here: Circabc. (7) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31/12/2008, p. 1–1355). (8) According to Article 2, point (27) of ESPR, ‘a substance of concern’ means a substance that: a) meets the criteria laid down in Article 57 of Regulation (EC) No 1907/2006 and is identified in accordance with Article 59(1) of that Regulation; b) is classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 in one of the following hazard classes or hazard categories: a. carcinogenicity categories 1 and 2; b. germ cell mutagenicity categories 1 and 2; c. reproductive toxicity categories 1 and 2; d. endocrine disruption for human health categories 1 and 2; e. endocrine disruption for the environment categories 1 and 2; f. persistent, mobile and toxic or very persistent, very mobile properties; g. persistent, bioaccumulative and toxic or very persistent, very bioaccumulative properties; h. respiratory sensitisation category 1; i. skin sensitisation category 1; j. hazardous to the aquatic environment — categories chronic 1 to 4; k. hazardous to the ozone layer; l. specific target organ toxicity — repeated exposure categories 1 and 2; m. specific target organ toxicity — single exposure categories 1 and 2. c) is regulated under Regulation (EU) 2019/1021; or d) negatively affects the reuse and recycling of materials in the product in which it is present. https://circabc.europa.eu/ui/group/418195ae-4919-45fa-a959-3b695c9aab28/library/25c48e7c-9ce3-41cb-96ac-d2942a8a29d6/details?download=true 11 are relevant for recycling, via the DfR criteria, to be adopted under Article 6(4) PPWR, or via the update of REACH restrictions for substances that affect human health or the environment. The identification of the relevant substances is on-going via a study lead by the Commission and the European Chemicals Agency (ECHA). 4) How many substances could fall under the definition of substances of concern (SoC)? There is no definite number or list of substances of concern (SoC) in packaging. The study, which the Commission and ECHA are undertaking to comply with its implementation obligation established in Article 5(2), will look into this issue and will provide a list of SoC on the basis of the information currently available about packaging manufacturing and waste treatment. There are several sources of information that can be consulted for each criterion listed in Article 2(27) of Regulation (EU) 2024/1781 (ESPR) to identify Substances of Concern (e.g. the ‘Candidate list of Substances of very high concern for Authorisation’ managed by ECHA (9); Annex VI of Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (10) could be also used as a source for identifying SoCs. 5) How is the supplier of packaging obligated to comply with the data requirements of substances of concern (SoC)? Obligations of packaging suppliers are detailed in Article 16 PPWR. Accordingly, suppliers must provide the manufacturer with all the information and documentation necessary for the manufacturer to demonstrate the conformity of packaging and the packaging materials with this Regulation, either in paper or in electronic format. Manufacturers need this information from suppliers of packaging materials or converters in order to identify PFAS or other SoC present in packaging and draft the declaration of conformity demonstrating compliance with Article 5 PPWR. 6) At which value are the concentration limits for SoC set? The Regulation includes an obligation to minimise the SoC content in material and emissions. The main driving principle is that human health and environment are protected, i.e. unacceptable adverse effects should be avoided. The Regulation does not set a general concentration limit for SoC. Nevertheless, specific concentration limits are established for certain substances (e.g. PFAS and certain heavy metals). More information and knowledge on SoC are expected to come from the on-going Commission and ECHA-led study. But substances meeting the substances of concern (SoC) criteria can already be identified by the manufacturer based on the existing definition of SoC. The SoC criteria refer mainly to hazardous properties but also include, on a case-by-case basis, considerations related to recycling and re-use. The possibility to establish new concentration limits for SoC in packaging may result from the evaluation to be carried out by the Commission by 2033, which will consider if the Regulation has sufficiently contributed to minimising the presence and concentration of SoC in packaging. Moreover, the Commission may adopt delegated acts in accordance with Article 6(4) to limit the presence of SoC that negatively affect recycling. 7) What is the implementation date for Article 5(1) PPWR? (9) https://echa.europa.eu/candidate-list-table. (10) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, pp. 1–1355). https://echa.europa.eu/candidate-list-table 12 The Regulation and therefore the obligation to minimise SoC content will apply from 12 August 2026. Already PPWD contained the obligation to minimise substances of concern with regards to their presence in emissions, ash or leachate when packaging or its packaging waste residues are incinerated or landfilled and has set specific concentration limits for four heavy metals (lead, cadmium, mercury and hexavalent chromium). 8) Is the harmonised standard, EN 13428:2004 still applicable to ensure conformity with the requirements as regards SoC? These requirements concerning SoCs have been strengthened in the PPWR. Under the PPWR, packaging must be manufactured so that the ‘presence and concentration of substances of concern’, both in the material itself and in emissions or waste outcomes, is minimised. It also explicitly ties these requirements to effects on reuse, recycling and chemical safety rather than merely end-of-life disposal. EN 13428 focuses primarily on minimising dangerous substances in emissions and disposal, not on the holistic lifecycle impacts, as required by Article 5 of the PPWR. Furthermore, the standard does not reflect the expanded hazard scope of the PPWR covering SVHCs under REACH, CLP hazard classes and recyclability impacts. Therefore, Annex C of the existing harmonised standard, EN 13428:2004(11) related to the ’minimisation of dangerous substances or preparations and demonstration of conformity’, ca therefore no longer create a presumption of conformity after 12 August 2026. The report on the presence of substances of concern in packaging, under preparation by the European Chemicals Agency (ECHA), will help packaging manufacturers to identify substances of concern in packaging and minimise their presence in packaging’. 9) Does the obligation to minimise the presence of substances of concern (SoC) in packaging apply to all economic operators? The obligation applies to all packaging placed on the market, according to the definition in the Regulation (Article 3(1), point (10)). The manufacturer placing packaging on the market or a supplier, in case a manufacturer is a microenterprise, must make sure that the provisions are complied with. 10) When does the obligation on minimisation of substances of concern (SoC) start to apply for packaging that is not food-contact sensitive? The general obligation to minimise SoC in Article 5(1) and the limits on four heavy metals in Article 5(4) apply to all packaging from 12 August 2026. The limits set in Article 5(5) for PFAS will apply to food-contact materials only. 11) Member States may submit data on a substance they believe to be of concern before 31 December 2025. If Member States inform the Commission about new substances of concern, will this information be accessible before the Commission delivers its report in 2026? According to Article 5(2) of the PPWR, Member States should inform the Commission about relevant information on SoC before 31 December 2025. This information will be considered in the development of the study. The monitoring of SoC is a permanent task for the Commission. (11) Harmonised standards published in Commission communication in the framework of the implementation of the European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste (OJ C 44 of 19 February 2005), EN 13428:2004 ‘Packaging – Requirements specific to manufacturing and composition – Prevention by source reduction’. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52005XC0219(02) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52005XC0219(02) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52005XC0219(02) 13 12) Does the derogation for glass packaging introduced by Commission Decision 2001/171/EC (12) in relation to heavy metal concentration levels in packaging and packaging waste continue to apply? Commission Decision 2001/171/EC continues to apply and has not been repealed by the PPWR. This means that the packaging may exceed the concentration limit of 100 ppm by weight for the sum of lead, cadmium, mercury and hexavalent chromium, when this exceedance is due to the addition of recycled glass. No lead, cadmium, mercury or hexavalent chromium is allowed to be intentionally introduced during the manufacturing process. The Commission may adopt delegated acts to amend the limit established in Article 5(4), but only to lower the permitted sum of concentration levels. The Commission is not empowered to extend the application date of the heavy-metal restrictions laid down in the PPWR. 13) Will Regulation (EC) 1935/2004 on food contact materials, Regulation (EU) 10/2011 (13) on plastic articles intended to come into contact with food, Regulation (EU) 2019/1021 on persistent organic pollutants and the REACH regulation be amended by reference to the PPWR's ban on PFAS? The PPWR does not establish a PFAS ban but rather sets maximum concentration levels. Also, it is not provided that the PFAS limits in the PPWR would be taken over into other, ‘vertical’, EU legislations. Based on Article 5(5), the Commission will carry out an evaluation to assess the need to amend or repeal the PFAS restriction in the PPWR in case of identified overlaps with restrictions or prohibitions on the use of PFAS under the FCM Regulation, the REACH Regulation or the POPs Regulation. 14) Do the PFAS restrictions in Article 5(5) apply both to intentionally added and unintentionally present PFAS? The PFAS restriction adopted by the PPWR does not differentiate between intentionally added and unintentionally present PFAS. Therefore, the provisions in Article 5(5) apply to both. To be noted, preliminary PFAS laboratory analyses results on a number of selected packaging (14) showed that in practice only packaging where PFAS have been intentionally added would give results above the PFAS limit values. 15) Do the restrictions apply only to materials used in packaging manufacturing or also to the materials and the associated inks, varnishes, glues and adhesives? The limits apply to the packaging unit as a whole, including the associated inks, varnishes, glues and adhesives placed on the market by the manufacturer. The latter is the person responsible for drawing the technical documentation needed to prove compliance (for further information, see Commission guidance document). 16) Will a list of the PFAS concerned by the ban (with CAS numbers for identification) be published? A list of PFAS subject to this restriction will not be published. The limits apply to all PFAS falling under the definition provided in the PPWR and possibly contained or contaminating the packaging. (12) Commission Decision of 19 February 2001 establishing the conditions for a derogation for glass packaging in relation to the heavy metal concentration levels established in Directive 94/62/EC on packaging and packaging waste (OJ L 62, 2.3.2001, pp. 20–21). (13) Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (OJ L 012 15.1.2011) (14) Skedung L.1 and Bjarnemark F.1: A Harmonized Workflow for PFAS Compliance Testing under EU Packaging and Packaging Waste Regulation and Emerging Universal Restrictions: A Food Contact Packaging Case Study. 1RISE Research Institutes of Sweden 14 17) How will the PFAS limits be enforced, considering there are no harmonised methodologies for PFAS in food-contact packaging at EU level? As explained in the Commission guidance document, the Commission is striving to ensure a harmonised approach of the national market surveillance authorities for the enforcement of the PFAS limits. There are intense works ongoing involving industrial stakeholders, civil society associations and the competent authorities in the Member States aiming to deliver a harmonised testing protocol for PFAS in food-contact packaging. This work stream includes engaging with the EURL on Food Contact Materials, which coordinates the network of national reference laboratories for food contact materials. 18) As the starting point for enforcement of the PFAS limits seems to be the total fluorine analysis, what laboratories offer such testing methodology? There are already plenty of commercial and university laboratories offering Total Fluorine / Total Organic Fluorine analysis. It can be expected that many other commercial and accredited laboratories will in view of the PPWR PFAS limits invest into testing capacities, and that those already doing it increase theirs. 15 IV. RECYCLABILITY 1) In the context of recyclability performance grade assessment: • how is a packaging unit defined, • what is the difference between integrated and separate components, and • what is the main body of the packaging unit? A ‘unit of packaging’ is defined in Article 3(1), point (45), of the Regulation as a unit, including any integrated or separate components, which as a whole serves a packaging function, such as the containment, protection, handling, delivery, storage, transport or presentation of products. A unit of packaging is independent from units of grouped or transport packaging where the latter are discarded prior to the point of sale. The term ‘unit of packaging’ should be considered equal to ‘packaging unit’, which is a term also used in the PPWR. Integrated and separate components are also defined in the Regulation, in Article 3(1), points (43) and (44), respectively. An illustrative example of a packaging unit is a plastic ketchup bottle made available to consumers at the point of sale. Such a ketchup bottle consists of the following packaging components: plastic bottle, removable lid (i.e. peelable foil), which is typically fully removed by consumers to access the product, label, and the closure system. If a removable lid needs to be fully completely and permanently separated by consumers to access the ketchup, then it should be considered as a separate component. As regards the closure system, it typically does not need to be completely and permanently separated by consumers and is thus disposed of together with the ketchup bottle. Assuming that the closure system on a ketchup bottle is not meant to be separated by consumers, it should be considered as an integrated component. As for the label, it is typically attached to the plastic bottle and disposed of together with a ketchup bottle. Hence, it is considered an integrated component; in this context, the plastic bottle itself is the main body of the packaging unit. Against this background, it could be considered that the main body of the packaging unit is the packaging part of the packaging unit with the highest share, by weight, except closure on flexible packaging. According to Article 6(9), ‘where a unit of packaging includes integrated components, the assessment of compliance with the design for recycling criteria and with the recycled-at-scale requirements shall include all integrated components. A separate assessment shall be carried out for integrated components that can become separated from each other as a result of mechanical stress during transportation or sorting’. 2) If there is no recyclable alternative for a specific packaging or its components on the market, could such packaging or its component get an exemption under Article 6? The exemptions from the recyclability obligations are listed in Article 6(11). The Commission is not empowered to grant any further exemptions. However, in case of innovative packaging, as brought to the attention of the competent authorities in the Member States, the Commission must assess the requests from the competent authorities and update or adopt new delegated acts under Article 6(4). Innovative packaging is defined as ‘packaging that is manufactured using new materials, resulting in a significant improvement in the functions of the packaging, such as the containment, protection, handling, or delivery of products, and in overall demonstrable environmental benefits, with the exception of packaging that is the result of modification to existing packaging for the main purpose of improving the presentation of products and marketing’ (Article 3(1), point (46)). 16 The Commission will monitor the impact of the derogations contained in Article 6(11) and derogations as regards innovative packaging contained in Article 6(10), and may propose amendments to the Regulation, if necessary. Therefore, if a packaging or its components does not fall under the established exemptions in Article 6(11), and does not qualify as innovative packaging, the manufacturers must improve packaging design to be compliant with the DfR guidelines from 2030 or two years after the entry into force of the delegated acts adopted under Article 6(4), specifying DfR requirements. Non- recyclable integrated components may lower the recyclability grade of a unit of packaging or may even make the entire packaging unit non-compliant. 3) What is the process for granting the derogation and what are the expected timelines for its completion? What specific criteria does the Commission use to assess innovativeness? The process is outlined in Article 6(10). Member States enjoy a margin of discretion implement the process in their national legislation while respecting the rules outlined in that provision. The criteria are outlined in Article 3(1), point (46), and the Commission is currently not envisaging the adoption of further guidance in this regard. Manufacturers using this exemption from the recyclability requirements must evidence compliance with these criteria in the technical documentation. 4) Can Member States apply their own eco-modulation criteria? Under Article 6(4)(d), the Commission will outline a framework concerning the modulation of financial contributions based on the packaging recyclability performance grades to be paid by producers to comply with their EPR obligations set out in Article 45(1). This harmonised framework is necessary to ensure the proper functioning of EU internal market, by preventing regulatory fragmentation and ensuring legal uncertainty for economic operators, in particular those placing packaging on the market in several Member States, while at the same time incentivising more sustainable packaging design. Divergent national eco-modulation schemes based on recyclability performance could otherwise create obstacles to trade and distort competition within the internal market. The harmonised framework will not set the actual amounts of such fees but will instead harmonise the criteria for the modulation of EPR fees based on the recyclability performance grade obtained through the recyclability assessment. Until the entry into force of the harmonised eco-modulation rules, Member States will remain able to eco-modulate fees based on the recyclability of packaging in accordance with their national provisions adopted under the PPWD. In doing so, Member States must consider the potential impact of such measures on the internal market. Where national eco- modulation measures constitute technical regulations or rules affecting products, they must be notified to the Commission in accordance with Directive (EU) 2015/1535 (15) through the TRIS notification system. Following the entry into force of the delegated act on design for recycling, which will establish a harmonised framework for eco-modulation of EPR fees based on packaging recyclability performance grade, Member States will be required to apply this harmonised framework. This obligation aims to ensure the consistent application of eco-modulation rules across the Union and to safeguard the free movement of goods. (15) Directive (EU) 2022/2555 of the European Parliament and of the Council of 14 December 2022 on measures for a high common level of cybersecurity across the Union, amending Regulation (EU) No 910/2014 and Directive (EU) 2018/1972, and repealing Directive (EU) 2016/1148, (OJ L 333 27.12.2022) 17 However, Member States will continue to be able to eco-modulate financial contributions of producers on the basis of other criteria, such as recycled content, the presence of substances of concern, or the reusability of packaging. If Member States decide to introduce eco-modulation based on the presence of recycled content in plastic packaging, they will be required to take into account sustainability criteria of recycling technologies and the environmental cost, which are to be developed by the Commission under Article 7(9) by the end of 2026. 5) If Member States do not reach the recycling targets, is there any mechanism foreseen to take this into account in the recyclability ‘at scale’ assessment? The ‘at scale’ assessment will be based on a recycling target of 55% (16) to be achieved at EU level per packaging categories listed in Table 2 of Annex II. The Commission is empowered to amend the list of these categories to adapt them to the technical and scientific developments regarding packaging and packaging waste management. The ‘at scale’ assessment is not based on the recycling rates achieved at national level and therefore there is no need for a specific mechanism in the recyclability at scale assessment, which would take into account the fact that a specific Member State did not reach specific recycling targets. However, it is important that all Member States strive to optimise their collection, sorting and recycling systems to improve the overall recycling rate at the Union level and the availability of secondary feedstock. The Regulation provides for several support measures, such as the obligation to set up deposit and return systems, mandatory harmonised waste sorting labels, the obligation on Member States to establish mandatory collection targets, and the prohibition to landfill or incinerate recyclable packaging. The implementation of these requirements will help increase the overall recycling rate in the EU and thus allow economic operators to fulfil the recycling ‘at scale’ requirement. 6) What is the scope of the exemption under Article 6(11)(e) for baby food? The exemption for baby food as referred to in Regulation (EU) No 609/2013 (17) should be understood in line with the definition given in its Article 2(2f). Therefore, the exemption should not be understood as covering all fruit juices and purees and other products that are marketed for consumption by babies. 7) Will the recyclability ‘at scale’ assessment be based on all packaging waste generated regardless of its origin, sector or type? The recyclability ‘at scale’ assessment and the related 55% recycling target for all packaging materials and 30% for wood indeed refers to all plastic packaging waste generated and recycled in the EU, regardless of its origin (household, commercial and industrial waste), sector or type. Calculation of the recycling rate should be based on the existing rules for the calculation of recycling rates laid down in Commission Decision 2005/270, as amended, which will be replaced by a new decision under Article 56(7) PPWR. 8) Does Article 6 apply to reusable sales and transport packaging placed on the EU market prior to the entry into force of the requirements under Article 6(1) PPWR? (16) For all materials except for wooden packaging, where it is 30%. (17) Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, pp. 35–56) 18 Recital (14) explains that ‘packaging should be placed on the market only if it complies with the sustainability requirements and labelling requirements laid down in or pursuant to this Regulation’ (emphasis added). Packaging already placed on the Union market before the date of application of relevant requirements, including packaging in the stocks, does not need to meet the sustainability and labelling requirements laid down in or pursuant to this Regulation and does not need to be withdrawn. Article 6(2) requires that all packaging placed on the market 24 months from the date of entry into force of the delegated acts adopted pursuant to Article 6(4) is recyclable according to the DfR principles laid down therein. This obligation refers to every type of packaging, regardless of whether it is reusable or single-use, or sales, grouped or transport packaging. Therefore, since the delegated acts under Article 6(4) are to be adopted by 1 January 2028, reusable or transport packaging which manufacturers will have placed on the market before 1 January 2030, can stay on the market even if it is not compliant with the recyclability requirements. Placing on the market refers to every single packaging unit and not to the packaging design. 9) Are the exemptions from the recyclability requirements for packaging made from cork, lightweight wood, textile, ceramics rubber, porcelain and wax valid until 2035? Article 6(1) requires that all packaging be recyclable. Article 6(11) establishes exemptions from this requirement for certain packaging materials and sectors. The Commission will review these exemptions by 1 January 2035 to consider if it is appropriate to maintain them. Based on this assessment, it may propose to amend or remove them. The exceptions for packaging made from cork, lightweight wood, textile, ceramics rubber, porcelain and wax apply only to sales packaging and mean that such packaging will not have to undergo the recyclability assessment for the purpose of determining if it can be placed on the market. However, the obligation to adjust the EPR fees based on the recyclability performance will apply also to such sales packaging. The recyclability assessment for such packaging will thus be carried out only for the purpose of determining the EPR fee modulation. 19 V. RECYCLED CONTENT IN PLASTIC PACKAGING 1) How should compliance with the recycled content requirements be demonstrated? Compliance with the recycled content targets in the PPWR must be demonstrated in the technical documentation for the packaging as specified in Annex VII. Compliance with the recycled content requirements can be exemplified as follows. An economic operator places a plastic tray made of polyethylene (PET) with a peelable lid made of polypropylene (PP) on the market. In this case, we could assume that the PET tray and PP lid are manufactured in different manufacturing plants within the EU and supplied to the economic operator who assembles the packaging components into a tray with a lid, fill it with product, and eventually places it on the market. The two manufacturing plants which manufacture, respectively, the tray and the lid must each disclose information about the compliance with the minimum recycled content requirements for their components, as provided for in Article 7(2). Based on the information from these manufacturing plants, the economic operator who eventually places the tray with the lid on the market (i.e. the manufacturer), must draw up the technical documentation that demonstrates compliance with the legal requirements for recycled content. The same principle applies to intermediate plastic packaging components, empty plastic packaging or filled plastic packaging imported into the EU. The economic operator must also ensure that the requirements for the recycled content meet the sustainability and equivalence criteria, which will be set out in the implementing acts pursuant to Article 7(9) and (10), respectively. 2) What is to be understood by ‘average per manufacturing plant and year’ in the context of recycled content in plastic packaging? A manufacturing plant must be understood as the industrial facility in which packaging is manufactured. An average per year refers to the amount of recyclates (recycled content) in each plastic packaging type and format over the period of a calendar year, produced for each manufacturer in a specific manufacturing plant. The manufacturing plant will have to provide documentation demonstrating that the average supply per year to the specific manufacturer fulfils the targets for recycled content. Manufacturers usually produce several packaging formats in one manufacturing plant and will therefore have to calculate the recycled content targets for each packaging type and format. The implementing act to be adopted under Article 7(8) will outline the rules on how to calculate and verify the recycled content in plastic packaging. 3) Are adhesives, paints and inks covered by the recycled content requirements for plastic packaging? Adhesives, paints and inks are not deemed plastic under the PPWR and therefore do not need to fulfil the recycled content requirements. This is regardless of whether they represent less than 5% of the packaging unit. 4) Are environmental claims on recycled content in plastic packaging allowed? Environmental claims on recycled content in plastic packaging are allowed where the recycled content exceeds the applicable minimum requirements set out in Article 7(1) and (2) of the PPWR. Article 14 specifies that the economic operator is allowed to make environmental claims for a packaging unit, the part of the packaging unit that contains the recycled content, or all packaging placed on the market over a calendar year by the economic operator. This is exemplified in the table below. 20 Example PPWR recycled content requirements Environmental claim for: Allowed environmental claim PET plastic bottle with a closure system made of PP PET bottle: 30% PP closure: 10% Packaging unit (bottle and a closure system) The recycled content exceeds 30% for the PET bottle or 10% for the PP closure system. Regardless of the choice to make environmental claims or not, compliance with the legal requirements must be demonstrated in the technical documentation. 5) How do economic operators know which recycled content requirements to fulfil? The recycled content requirements apply to sales, grouped, and transport plastic packaging. Firstly, the economic operator must determine whether the packaging is contact-sensitive. Secondly, the economic operator must determine what polymer the packaging is made from. Based on this information, the economic operator can then determine what recycled content requirements to fulfil. This logic is illustrated in the following table. Packaging format 1st step: Is the packaging contact- sensitive? 2nd step: What is the polymer made from? 2030 applicable target Example A Pallet wrapping film to transport goods Non-contact sensitive Other than PET Art. 7(1)(d), 35% Example B Beverage carton Contact-sensitive Other than PET Art. 7(1)(b), 10% Example C Single-use plastic beverage bottle: Contact-sensitive PET Art. 7(1)(c, 30% 6) Do the requirements for recycled content apply to packaging placed on the market before 2030? The recycled content requirements apply only to packaging placed on the market from 1 January 2030 or three years after entry into force of the implementing act in Article 7(8), whichever is the latest. However, no exhaustion of stocks is envisaged for packaging supplied to manufacturers and not yet placed on the market by the latter before the due date. 7) Will also a plastic cap and a label on a glass bottle need to comply with the recycled content requirements? Article 7(5)(b) exempts plastic parts that represent less than 5% of the total weight of a packaging unit from the recycled content requirements. This exemption applies exclusively to plastic parts and does not extend to non-plastic materials. By way of example, in the case of a glass bottle with a metallic cap and a label, the metallic cap is not a plastic part and therefore falls outside the scope of the recycled content requirements. A 21 plastic label, however, is exempted only if its weight accounts for less than 5% of the total weight of the packaging unit, the bottle. 8) Recycled plastic in plastic caps is mandatory for milk but not for infant formula packaging. Must an economic operator that uses the same caps for these products meet the targets for recycled plastic content to comply with the requirements for milk packaging? As of 2030, manufacturers must ensure that the plastic part of the packaging placed on the market is compliant with the recycled content targets of Article 7(1). Milk is not exempted from the recycled content requirements. Therefore, a manufacturer must ensure that plastic caps that are used for the milk packaging fulfil the recycled content requirements. On the other hand, plastic caps for instant baby formula are not required to include recycled content due to the exemption set out in Article 7(4), point (g). 9) Is there a difference between ‘contact-sensitive plastic packaging’ and ‘immediate packaging’ as used in the exemptions of Article 7? The term ‘immediate packaging’ refers to the ‘(…) packaging immediately in contact with the medicinal product’ (18), whereas according to Article 3(1), point (49), of the PPWR contact- sensitive packaging means packaging that is intended to be used for food and medicinal products. In the context of medical devices and other medicinal products ‘immediate packaging’ will generally qualify as ‘contact-sensitive plastic packaging’ according to Article 3(1), point (49), of the PPWR, and while the concepts are not identical, they should be understood in the same way for the purpose of implementation of Article 7 of the PPWR. 10) Could the Commission clarify the reporting obligations related to recycled content under the PPWR and SUPD and their interplay? Article 6(5), points (a) and (b) of SUPD (i.e. recycled content targets for beverage bottles listed in Part F of Annex to SUPD), and Article 13(1)(e) on related Member States’ reporting remain in force until 1 January 2030 or 3 years after the entry into force of the implementing act on the calculation of recycled content referred to in Article 7(8). There are some differences in scope between the PPWR and the SUPD, which should be taken into account: • In the SUPD, the target is at Member State level, whereas the PPWR sets the. requirements per packaging type/format, calculated as an average per manufacturing plant and year. • There is no minimum threshold in the SUPD for composite materials, whereas the PPWR contains an exemption for the plastic part if it represents less than 5% of packaging unit weight. • There is no exemption regarding compostable plastic packaging in the SUPD. 11) Recycled content requirements for imported plastic packaging Regulation (EU) 2022/1616 and its provisions (especially Article 6) apply to all recycled plastics for food contact materials placed on the EU market, including imported packaging. Therefore, importers of plastic materials with recycled content that intend to use this material as food-contact material, including food-contact packaging, should ensure that these materials comply (18) Article 1(23) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311 28.11.2001, p. 67) 22 with the requirements outlined below. If not compliant, these materials may not be placed on the market for food contact applications, including food-contact packaging. However, they may be used for other purposes. Article 6 of that Regulation mandates the following: • Separate collection of plastic waste; • A certificate obtained with third-party certification of the pre-processing activities in accordance with Article 6, including all activities from sorting to recycling of plastic waste; • Proof that the recyclates have been produced in accordance with Regulation (EU) 10/2011. 23 VI. COMPOSTABILITY 1) Article 9(1) mandates a compostability requirement for certain packaging types. Will these packaging types be allowed in the bio-waste stream even before 12 February 2028? Indeed, the Regulation changed the definition of packaging to include tea and coffee bags which are not left empty after use. Such new packaging items will be classified as packaging when the Regulation becomes applicable, that is on 12 August 2026. As Article 9 on compostability applies from 12 February 2028, Member States are not required to accept such packaging in the bio-waste steam before that date, but they are encouraged to accept them. 2) How should manufacturers deal with the fact that not all industrial composting facilities operate in accordance with EN 13432:2000? Will waste management operators in all Member States have to accept compostable packaging if it is certified according to the harmonised standard EN 13432:2000? While the Regulation does not state explicitly that composting facilities must operate in accordance with the harmonised standard, the Commission expects that this will indeed be the case. For example, Article 9(2) conditions the Member States’ flexibility to add additional packaging items to the national lists of mandatorily compostable packaging to the existence of ‘appropriate waste collection schemes and waste management infrastructure to ensure that compostable packaging enters the bio-waste management stream’. The Commission will ensure that associations representing industrial composting will be fully involved in the development of the updated industrial compostability standards. 3) If a product is nowadays compostable, and on the market, can economic operators continue to market it after the Regulation has entered into force and become applicable? The answer is ‘yes’, if there is a clear legal requirement in the territory of a Member State where the economic operator is marketing their products that a particular packaging format must be compostable. As explained in point 8 of the Commission guidance document, Member States have the possibility until 12 August 2026 to decide that packaging formats additional to items listed in Article 9(1) and 9(2)(a) must be compostable on their territories. 24 VII. PACKAGING MINIMISATION 1) Do both Article 10(1) and (2) on packaging minimisation apply by 1 January 2030? Yes. Both Article 10(1) and (2) apply by 1 January 2030. Until the end of 2029, the essential requirements from the PPWD continue to apply and thus also the existing standard EN 2004:13428. This results from Article 70(1)(b) of the Regulation. 2) How should the term ‘increase the perceived volume of the product’ in Article 10(2) be understood? The use of certain packaging characteristics, such as double walls or false bottoms, is not allowed when the perceived volume of the product is increased. An illustrative example below is provided to help better understanding. Example Packaging minimisation Choices that might increase the perceived volume of the product Plastic or glass 50 ml jar for facial cream Plastic or glass jars are reduced to the minimum volume necessary to protect the product inside Use of double walls or false bottoms to make it appear that the content of the cream as more than 50 ml Use of cardboard boxes around the jar which make it appear that the content of the cream larger than 50 ml Moreover, the Impact Assessment that supported the legislative proposal of the PPWR outlines a few examples on ‘increase the perceived volume of the product’ (19). Overall, the economic operator must prove that double walls, false bottoms, frontal flaps and additional layers are used only in circumstances where the packaging functionality cannot be ensured otherwise and/or in cases where these components add legitimate functionality to the packaging. This will have to be demonstrated via tests and proven in the technical documentation, by providing a sufficient justification. 3) How will the requirements of packaging minimisation be enforced for other than the most common packaging types and formats? By 12 February 2027, the Commission will request the European standardisation organisations to prepare or update, as appropriate, harmonised standards laying down the methodology for the calculation and measurement of compliance with the minimisation requirements. These standard(s) will be an update of the existing standard EN 13428:2004 to account for the changed performance criteria set out in Annex IV of the Regulation and will outline the methodology for demonstrating compliance with the minimisation requirements for all packaging. Once adopted, economic operators will be able to use the updated standard and thus benefit from the presumption of conformity with the minimisation requirement. (19) Assessment of options for reinforcing the Packaging and Packaging Waste Directive’s essential requirements and other measures to reduce the generation of packaging waste - Publications Office of the EU, page 26: an identical packaging format in terms of size, weight and volume is used to pack different amounts of the same type of screws. In the first case, the packaging fits 100 screws, whereas in the second case the same packaging contains 20 screws of the same size. Therefore, the second case (i.e. pack of 20 screws) is considered over-packaged, both in terms of the volume and weight of the pack. https://op.europa.eu/en/publication-detail/-/publication/bdacd175-a0a9-11ed-b508-01aa75ed71a1 https://op.europa.eu/en/publication-detail/-/publication/bdacd175-a0a9-11ed-b508-01aa75ed71a1 https://op.europa.eu/en/publication-detail/-/publication/bdacd175-a0a9-11ed-b508-01aa75ed71a1 25 In addition, for the most common packaging types and formats, the Commission will request the European standardisation bodies to prepare standard(s) specifying the maximum adequate weight and volume limits and, where appropriate, wall thickness and maximum empty space. 4) What are the ‘most common packaging types and formats’ mentioned in Article 10(3)? The Commission will identify the ‘most common packaging types and formats’ in its forthcoming standardisation request pursuant to Article 10(3) PPWR. These types and formats will be identified in collaboration with the industry and other stakeholders and be based on the available market data in terms of units placed on the market, on a level of granularity which accounts for the packaging functionality, packaging material and shape, as well as the packaged product. The potential for minimisation will also be considered in the framing of the standardisation request. 5) Which packaging is exempted from the minimisation requirements? The following packaging is excluded from the minimisation requirements (Article 10(2)): Packaged products or beverages that benefit from a geographical indication protected under Union law, such as under Regulation (EU) No 1308/2013 for wine, Regulation (EU) 2019/787 for spirit drinks or Regulation (EU) 2023/2411 for craft and industrial products or is covered by a quality scheme as referred to in Regulation (EU) 2024/1143. If packaging design is protected by a Community design pursuant to Council Regulation (EC) No 6/2002 (64) or by design rights falling within the scope of Directive 98/71/EC of the European Parliament and of the Council (65), including international agreements having effect in one of the Member States. For the exemption to apply, the packaging design must be protected before 11 February 2025, and the application of the minimisation requirements affect the packaging design in a way that it would alter its novelty and its individual character If packaging shape is a trademark falling within the scope of Regulation (EU) 2017/1001 (66) or Directive (EU) 2015/2436 (67), including trademarks registered under international agreements having effect in one of the Member States. For the exemption to apply, the trademark must be protected before 11 February 2025, and the application of the minimisation requirements affect the packaging in a way that the trademark can no longer distinguish the marked product from those of other undertakings. If the economic operator wants to use these exemptions, it will need to provide evidence related to them in the technical documentation. It will not be sufficient to provide a licencing number. It will also be necessary to demonstrate the existence and assessment of other conditions. 6) How will the packaging ’shape’ affect the packaging minimisation assessment? Firstly, the economic operator will have to consider if its packaging is covered by the exemption in Article 10(2)(a) related to shapes which are protected trademarks and if the conditions set out in that provision for exemption from the minimisation requirements are fulfilled. The verification of said conditions needs to be demonstrated by the economic operator. If the packaging is not covered by the exemption, economic operators will apply the updated harmonised standard on the methodology for packaging minimisation assessment to be requested by the Commission pursuant to Article 10(3). This updated harmonised standard will take the packaging shape into account in its methodology. For example, if a specific shape is necessary to provide packaging for the packaging functionality, such as safe-handling design, child resistance, anti-tamper, anti-theft, anti-counterfeit, hazard warnings, or specific product characteristics. 7) What is the relationship between the minimisation requirement in the PPWR and the ones in the ESPR? https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202500040#ntr64-L_202500040EN.000101-E0064 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202500040#ntr65-L_202500040EN.000101-E0065 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202500040#ntr66-L_202500040EN.000101-E0066 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202500040#ntr67-L_202500040EN.000101-E0067 26 The general principle is that acts under the ESPR only take the lead on regulating products when their environmental sustainability dimensions either cannot or have not been fully and appropriately addressed by other instruments. This principle applies also to packaging. As explained in Recital 25 of the ESPR, if needed, the ESPR may complement the PPWR by setting product-based requirements that focus on the packaging of specific products. The ESPR will not, however, set general eco-design or sustainability requirements for packaging as a product group because these requirements are laid down in PPWR. 27 VIII. LABELLING 1) Will labelling requirements for reusable packaging under Article 12(2) apply at the level of each individual packaging? Reusable packaging must be designed to ensure a minimum number of rotations, which will be established in the delegated act to be adopted under Article 11(2). The obligation to calculate and report on the number of rotations for reusable transport packaging will depend on the type of reuse system. Namely, open-loop reuse systems without a system operator are exempted from this obligation and from the obligation to bear a reusable packaging label and a QR code. According to Article 12(2), reusable transport packaging circulating within closed-loop systems will have to bear a reusable packaging label and a QR code or another standardised open digital data carrier that will allow for tracking of the individual packaging and the calculation of its rotations. The detailed rules, including the label informing consumers that a packaging is reusable, will be clarified in the implementing act to be adopted under Article 12(6). This act will also specify situations when it is considered that an individual QR code and tracking of rotations is not feasible and the calculation of rotations can thus be made based on an average estimation. 2) Under what circumstances are labels, marks, symbols, or inscriptions considered misleading? Marks, symbols, labels, or inscriptions should not mislead consumers regarding sustainability requirements of packaging such as its recyclability, recycled content, reusability, compostability, bio-based content, hazardous substances content or waste management options (Article 12(8)). To further understand the notion of misleading claim please refer to Directive (EU) 2024/825 (20) ‘Empowering Consumers for the Green Transition’. Claims are considered misleading if they cause the consumers to make decisions that they would not otherwise make. 3) Should a packaging bear a national DRS label when it is imported from one Member State to another? Labelling of packaging covered by the mandatory deposit and return systems has not been harmonised in the PPWR. Therefore, products will have to comply with the DRS label of the Member State where they are made available on the market. Member States may require that such packaging be marked with a ‘harmonised colour label’ as specified in Article 12(1), fourth subparagraph. If products are imported in the context of private imports, i.e. directly by the end user and with no intention to commercialise them, this is not considered ‘making available on the market’. Member States cannot prohibit the affixing of DRS labels in place in other Member States. 4) Which are the substances of concern that need to be identified by the labelling requirements in Article 12(7), second subparagraph? The European Chemicals Agency (ECHA) is currently conducting a study to identify the substances of concern (SoC) in packaging that could affect human health and those that can impact packaging reusability and recyclability. Based on this input, the Commission will develop an implementing act establishing the methodology for labelling of SoC by means of digital labelling. (20) Directive (EU) 2024/825 of the European Parliament and of the Council of 28 February 2024 amending Directives 2005/29/EC and 2011/83/EU as regards empowering consumers for the green transition through better protection against unfair practices and through better information (OJ L, 2024/825, 6.3.2024) 28 IX. ENVIRONMENTAL CLAIMS 1) Will businesses be allowed to make environmental claims about features that are equivalent to those established by the Regulation? Article 14 applies only to ‘properties for which legal requirements are set out in this Regulation’. Environmental claims and sustainability labels related to, e.g., recyclability, compostability, recycled content, reusability, weight and volume minimisation, fall under the PPWR and manufacturers will need to make sure that such claims comply with Article 14, i.e. relate to properties that go beyond minimum requirements set by the PPWR and specifies if the claim refers to the whole packaging unit or a specific part of it. As regards environmental claims related to sustainability requirements outside the scope of this Regulation, for example recycled content in aluminium packaging, they must comply with the existing EU rules on environmental claims, in particular the Empowerment of Consumers Directive (EU) 2024/825, which amends the Unfair Commercial Practices Directive (2005/29/EC) and the Consumer Rights Directive (2011/83/EU). For further information on the relationship between the Unfair Commercial Practices Directive and other legislation, please, consult the Commission Guidance document on its interpretation (21), in particular parts 1.2.1. on relationship with other EU legislation and part 4.1.1.1 on the Interplay with other EU legislation on environmental claims, which explains that lex specialis (e.g. PPWR) prevails over lex generalis (UCPD) in case of conflict. 2) In case the manufacturer wants to make a claim about the share of recycled content on the packaging unit, which threshold should be considered as the minimum requirement established by law? Will it be possible to make claims about 10, 20 or 50% of recycled content in each unit? In case a manufacturer makes a claim about the share of recycled content in packaging placed on the market, the applicable minimum targets (calculated as an average per manufacturing plant and per year), will apply and the manufacturers will be allowed to make the claim only if the recycled content exceeds those targets. For recycled content, the calculation and verification methodology will be established by 31 December 2026 in an implementing act, and environmental claims will need to comply with these rules. The voluntary label for recycled content will be developed by the Commission. 3) Does Article 14 apply only for environmental claims which refer to requirements stated in the PPWR (e.g. recyclability) or also for any other kind of environmental claims on sustainable packaging? Article 14 applies only to ‘properties for which legal requirements are set out in this Regulation’. Therefore, as regards environmental claims which are not regulated under the PPWR, e.g. related to recycled aluminium content, they must comply with the existing EU rules on environmental claims, in particular the Empowerment of Consumers Directive (EU) 2024/825. (21) Commission Notice – Guidance on the interpretation and application of Directive 2005/29/EC of the European Parliament and of the Council concerning unfair business-to-consumer commercial practices in the internal market (OJ C 526, 29.12.2021, pp. 1–129). https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52021XC1229%2805%29&qid=1640961745514 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52021XC1229%2805%29&qid=1640961745514 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52021XC1229%2805%29&qid=1640961745514 29 X. OBLIGATIONS OF MANUFACTURERS 1) Article 15(1) states that manufacturers must place on the market only packaging which complies with the requirements set out in Articles 5 to 12. Does this obligation apply exclusively to packaging manufacturers? The obligation to place on the market only compliant packaging does not apply only to economic operators defined as the manufacturer, but also to importers and distributors. Pursuant to Article 15(1), ‘manufacturers shall only place on the market packaging which is in conformity with the requirements laid down in or pursuant to Articles 5 to 12.’ The conformity assessment procedure (Article 38) can be carried out by the manufacturer or by someone else on their behalf (e.g. a laboratory or a certification scheme), in accordance with Article 15(2). The EU declaration of conformity (Article 39) must be drafted by the manufacturer, based on the information and documentation provided by suppliers pursuant to Article 16(1), or by an authorised representative, appointed by the manufacturer by a written mandate pursuant to Article 17. This means that the manufacturer is the sole economic operator bearing legal responsibility for packaging compliance with the sustainability and labelling requirements, regardless of the fact who might have actually drafted the EU declaration of conformity or parts of it. 2) When is the effective date of application of Articles 15 and 18 of the PPWR on obligations of importers and manufacturers? PPWR will become applicable on 12 August 2026, and this includes provisions on the obligations of manufacturers and importers. However, these provisions must be read in conjunction with the substantive obligations, as defined in various provisions of the Regulation, notably in Articles 5 – 12. Some substantive provisions have different application dates, which are often linked to the adoption of a specific implementing measure by the Commission. For example, as regards recyclability, manufacturers must comply with the recyclability requirements and perform the conformity assessment procedure in accordance with Article 38 and Annex VII of the PPWR only two years from the adoption of the delegated act on design for recycling requirements. On the assumption that this delegated act will be adopted by the Commission in January 2028 and will fully harmonise design for recycling requirements and the related assessment methodology, the binding recyclability performance criteria will only apply from 1 January 2030 or two years from the date of entry into force of the delegated act. Other effective dates of application of sustainability and other key requirements under PPWR: - Recycled content in plastic packaging: 1 January 2030 or three years from the date of entry into force of the implementing act referred to in Article 7(8) PPWR. - Minimisation (Article 10(1) – (2)): 1 January 2030. - Void space requirement for transport, grouped and e-commerce packaging: from 1 January 2030 or three years after the entry into force of the implementing act under Art. 24(2); as regards void space in sales packaging, see Art. 10. - Reusable packaging (Art. 11): from the date of entry into force of the Regulation (11 February 2025), but minimum number of rotations will have to be complied with depending on the date that will be specified in the implementing act referred to in Article 11(2) to be adopted by 12 February 2027. - Reuse targets: from 1 January 2030 or 18 months from the date of entry into force of the implementing act on the calculation of reuse targets, referred to in Article 30(3), to be adopted by 30 June 2027. 30 3) Should suppliers be required to mark ‘plain’ packaging, such as plastic carrier bags, with a serial number? Suppliers of packaging or packaging material are not manufacturers according to the definition of manufacturer in Article 3(1), point (13), except when the ‘manufacturer’ is a microenterprise and the supplier is located in the same Member State. The Regulation does not require that suppliers of packaging are identifiable on the packaging or via a data carrier. They must only ensure that the manufacturer has all the information and documentation necessary to demonstrate packaging conformity. The Regulation does not require either that suppliers identify packaging with a type, batch or a serial number; this is an obligation that falls on manufacturers. However, in practice, it may well be that it will be the suppliers of packaging who will ensure that packaging is identifiable, as this is often done at the production stage. 4) Do importers or distributors who supply packaging materials need to comply with any requirements in the Regulation? Suppliers do not have the legal responsibility to comply with the Regulation. However, their clients who place packaging or packaged products on the EU market (manufacturers, importers) will need to ensure that that they use compliant packaging or packaging material. It is therefore normal to assume that suppliers that sell non-complaint packaging will lose their clients. 31 XI. EMPTY SPACE 1) Who is the obligated party to comply with the empty space requirements under Article 24? Article 24(1) establishes maximum empty space ratio for grouped, transport and e-commerce packaging which needs to be met by the economic operator who fills such packaging. This may be the manufacturer as defined in Article 3(1), point (13), as well as other economic operators who make packaged products available on the market. 2) How should the term ‘minimum necessary’ in Article 24(4) be understood? The empty space ratio for sales packaging means the difference between the total internal volume of the sales packaging and the volume of the packaged product. For assessing compliance with this paragraph, space filled by filling materials, such as paper cuttings, air cushions, bubble wraps, sponge fillers, foam fillers, wood wool, polystyrene or styrofoam chips, shall be considered as empty space. For empty space ratio in sales packaging, there is no maximum threshold established in the PPWR; instead, it is left to the relevant economic operator who fills sales packaging to minimise the empty space and to demonstrate this in the technical documentation. This provision should be read in conjunction with Article 10 on packaging minimisation. 3) Are the design patents covered by the 50% empty space ratio requirement? Contrary to Article 10 on packaging minimisation, Article 24 does not have specific exemptions for packaging covered by packaging design rights or trademarks. However, the 50% threshold applies only to grouped packaging, transport packaging and e-commerce packaging (Article 24(1)). 4) How will round products and other irregular shapes be addressed by the methodology for the calculation of the empty space? By 12 February 2028, the Commission shall adopt implementing acts to establish the methodology for the calculation of the empty space ratio for grouped packaging, transport packaging and e- commerce packaging (Article 24(2)). That methodology shall consider the special characteristics of packaging which needs to be placed in an empty space that is large enough to comply with the applicable legal requirements or to protect the product. The methodology shall take into account packaged products of irregular shape, packaging containing more than one sales packaging or product, packaging containing liquid products, packaged products the content of which can easily be damaged and packaged products that can be damaged by larger products due to their small dimensions, and the minimum space on the transport packaging to enable shipment labels to be affixed. Economic operators will need to comply with the empty space ratio threshold by 1 January 2030 or 3 years after the entry into force of this implementing act. The methodology will be based on a wide range of examples, including irregular shapes. 32 XII. BANS AND THE USE OF CERTAIN PACKAGING 1) What instruments are available to ensure legal harmonisation and predictability of the implementation of Annex V? The Regulation empowers the Commission to adopt guidelines by February 2027, in consultation with Member States and EFSA (European Food Safety Authority), to explain Annex V in more detail, including examples of packaging formats in scope, and any exemptions from the restrictions, and provide a non-exhaustive list of fruits and vegetables that are excluded from point 2 of Annex V (Article 25(6) PPWR). The Commission has started preparatory works for the guidelines and intends to ensure that these guidelines are based on science and on the latest technological developments. The intention is to ensure a common understanding and the equal implementation of the packaging formats in scope, and any exemptions from restrictions. While the Regulation does not empower the Commission to harmonise the list of exempted fruits and vegetables via an implementing or delegated act, the Commission, together with EFSA, has been working hard to ensure a solid scientific basis for the future guidelines, and expects that Member States will follow the guidelines, once published. Finally, the Regulation contains a specific review clause requiring the Commission to assess, by 2032, the packaging bans and empowering it to propose new restrictions or to amend the existing derogations and exemptions. 2) What do the terms ‘unprocessed fresh fruits and vegetables’ and ‘demonstrated need’ in point 2 of Annex V mean? The terms ‘unprocessed fresh fruits and vegetables’ and ‘demonstrated need’ will be further clarified after the formal consultation with the related stakeholders and EFSA, in the context of the development of the Commission guidelines. The term ‘unprocessed fresh fruits and vegetables’ refers to fresh fruit and vegetables that have not been altered. When such fruits and vegetables weigh less than 1,5 kg, they cannot be prepacked. The Commission will develop guidelines explaining, based on scientific studies, which unprocessed fresh fruit and vegetables are appropriate for exemptions. 3) Is it possible to extend the scope of the illustrative formats and products covered by point 4 of Annex V to additional sectors (e.g. schools), beyond the exemptions explicitly listed? Point 4 of Annex V concerns single-use plastic packaging for condiments, preserves, sauces, coffee creamer, sugar and seasoning in the HORECA sector. It expressly exempts only (a) take-away ready-prepared food intended for immediate consumption and (b) the healthcare sector. The illustrative formats will be developed in the guidelines. The PPWR does not provide a legal basis to enlarge the list of exemptions to other sectors. 4) How shall the term ‘necessary to facilitate handling’ under point 1 of Annex V to be understood? The restriction in question concerns ‘single- use plastic grouped packaging used at the point of sale (…), designed as convenience packaging to enable or encourage consumers to purchase more than one product’. What is targeted is unnecessary single-use plastic grouped packaging designed for ease of use and portability, and which also incites consumers to buy more. Both conditions should be fulfilled for the ban to apply. The most common examples of such packaging are collation films and shrink wraps, grouping two or more stock keeping units (SKUs). 33 Other examples and other guiding principles will be provided in the guidelines. As regards B2B situations, they are not covered by the ban. The Commission guidelines will further specify how the term ‘necessary to facilitate handling’ will be operationalised, through illustrative examples. 5) Are biodegradable or compostable bags banned by Annex V, point 6? All very lightweight plastic carrier bags (thus including compostable or biodegradable bags) are banned under Annex V, point 6. However, if such bags are needed for hygiene purposes or provided as sales packaging for loose food to prevent food waste, they are excluded from this harmonised ban. Very lightweight plastic carrier bags, which are needed for hygiene purposes or provided as sales packaging for loose food to prevent food waste’, although not banned by Annex V, point 6, are in principle included in the 40% reduction target set out in Article 34(1) PPWR for all lightweight plastic carrier bags. However, Member States may decide to exempt that specific type of bag from the reduction target (Article 34(4) PPWR). To reach the 40% target, Member States may decide to ban very lightweight plastic carrier bags, including compostable or biodegradable bags, which are needed for hygiene purposes or provided as sales packaging for loose food to prevent food waste However, marketing restrictions (bans) by Members States must be proportionate and non- discriminatory (Article 34(2) PPWR). 6) Can hotel miniature cosmetics be available on demand? Can we expect derogations for products packaged for hygienic reasons, such as toothbrush and cotton pads? Annex V, point 5, refers to ‘single-use accommodation sector packaging intended for an individual booking’. The Regulation does not define the terms ‘cosmetics, hygiene and toiletry product’, nor does it exempt miniature packaging available on demand or purchased at the hotel premises, but only those intended for an individual booking. To ensure a harmonised approach, the Commission is mandated to explain Annex V in more detail, including examples of the packaging formats in scope, and any exemptions from the restrictions, by publishing guidelines by 12 February 2027 (Article 25(6) PPWR). The timely adoption of the Commission guidelines will ensure that the scope of the provision is sufficiently clear almost three years ahead of the application date. The Commission intends to consult the relevant stakeholders, including the hospitality sector, before publishing them. Furthermore, it should be recalled that only packaging is banned and not products as such, which could therefore still be made available without packaging. 7) Will single-use plastic food and beverage packaging be banned from entertainment and sporting events and festivals? Sport and entertainment venues and festivals are included in the ‘HORECA’ definition (Article 3(1), point (35)), which refers to ‘Accommodation and Food Service Activities according to NACE Rev. 2 – Statistical classification of economic activities. NACE Rev. 2 includes guidance which explains that the decisive element is that meals, including beverages, fit for immediate consumption are offered at the facility, and not the kind of facility providing them. However, establishments in the HORECA sector that do not have access to drinking water are expressly exempted from the ban, pursuant to Annex V, point 3. 8) Is hotel room service covered by the ban in Annex V, point 3? How about if a hotel delivers food outside the restaurant’s premises? The packaging ban in Annex V, point 3, applies to the HORECA sector, which should be understood in line with the definition in Article 3(1), point (35), which in turn refers to NACE Rev. 2. Hotels are included in the HORECA sector, which means that room service falls under the ban. 34 However, if a hotel delivers food and beverages in packaging outside their premises, then such packaging is not banned under Article 25 and Annex V, point 3. However, in that case, the obligations relating to refill and re-use in the take-away sector, as specified under Articles 32 and 33, apply. 9) Is the list of examples outlined in the ‘illustrative example’ column of Annex V exhaustive? The list is not exhaustive, as its wording (‘illustrative example’) demonstrates. The formats that fall within the scope of the bans will be further explained in the Commission guidelines to be developed by 12 February 2027, as mentioned in the answers to the previous questions. 35 XIII. REUSE AND REFILL Reusable packaging (Article 11) 1) How will the rotations or trips of reusable packaging be calculated? Reusable packaging must be designed to ensure a minimum number of rotations, which will be established in the delegated act to be adopted under Article 11(2). The obligation to calculate and report on the number of rotations for reusable transport packaging will depend on the type of reuse system. In particular, open-loop reuse systems without a system operator are exempted from this obligation (Annex VI, Part A, section 1 (i)). Closed-loop reuse systems with system operators must report on the number of rotations or trips for each individual reusable packaging, or for an average estimation if the calculation for each individual reusable packaging is not feasible. The detailed rules on the calculation of the achievement of the re-use targets contained Article 30 will be clarified in the implementing act to be adopted under Article 12(6). This act will also specify the situations where it is considered that an individual QR code and tracking of rotations is not feasible and the calculation of rotations can be made based on an average estimation. Manufacturers need to demonstrate that the design of reusable packaging and the related system for reuse allow packaging to comply with the minimum number of rotations requirement. This will need to be done at the time of placing packaging or a packaged product on the market in the technical documentation and applies both to reusable packaging circulating in open loop and closed loop reuse systems. According to Article 27 and Annex VI, reuse systems must be designed to ensure that reusable packaging rotating within them completes at least the minimum intended number of rotations as set out in the delegated act. This will be verified by the Member States’ market surveillance authorities (Article 62(1), point (h)). Reuse systems 2) What is an ‘open loop’ reuse system and what are some concrete examples of such systems? Open loop reuse systems are characterised by interoperability where reusable packaging can circulate across different companies, locations, product categories, or sectors rather than being returned to the single system operator. Open loop reuse systems do not necessarily mean that reusable packaging becomes the property of the consumer once paid for; this will depend on the business model. Such reuse systems are normally characterised by using standardised packaging, shared infrastructure (e.g. for collection, washing and redistribution), and are often coordinated by a system operator, who manages the logistics and ensures quality, even if the existence of a system operator is not a legal requirement under the PPWR. Under the PPWR, open-loop systems without a system operator are exempted from the reuse labelling requirements and from the reporting on the number of rotations achieved. Examples of open loop systems without a system operator are the following: The 0.33-liter longneck reusable bottle system (in Germany): this system is mostly used by brewers, but also by mineral water companies and other carbonated soft drink producers. Although there is a standard for the bottle issued by the German Brewers Association and a licensing system for participants, there is no system operator. The Euro Pallet: this system has a standard for the pallets, and licensees for production are issued, but there is no system operator or system management, even though an association (i.e., EPAL) is responsible for licensing and some other services. 36 3) How can economic operators using reusable packaging ensure that a proper reuse system is in place? According to Article 27 PPWR, economic operators using reusable packaging must participate in one or more re-use systems and ensure that these systems comply with the requirements laid down in the PPWR, Part A of Annex VI. Economic operators also have the possibility to set up their own re-use system, which must comply with Annex VI. The PPWR establishes the minimum requirements for the reuse systems in its Annex VI, and the sector needs to find ways to cooperate and find the most appropriate solutions, depending on their respective products and the local circumstances, to optimise the functioning of the reuse system. 4) Does a reuse system need to be open for all end users? Re-use systems can vary in size and geographical coverage and range from smaller local systems to larger systems that may span over one or several Member States’ territory. Reuse systems do not have to cover the entire MS. They must however provide equal access and fair conditions to the end users in the area in which they operate. Reuse targets for transport packaging 5) Would the exemption for cardboard boxes from the reuse targets for transport packaging cover interlayers and corrugated cardboard? Article 29(4)(d) exempts cardboard boxes from the scope of the reuse targets. This should be understood as including corrugated cardboard boxes. However, the list of exemptions contained in Article 29(4) must be understood strictly and is limitative, in terms of material, format and use. Therefore, the exemption of cardboard refers only to cardboard boxes and does not include interlayers. Nevertheless, since they are also not a format that is explicitly listed in Article 29(1) and therefore, interlayers are also not concerned by the reuse targets in the first place. 6) What packaging formats are covered by the exemption for flexible formats for transport packaging? Article 29(4)(c) excludes from the targets transport packaging flexible packaging formats that are used for transportation and that are in direct contact with food and feed, as defined in Article 2 and in Article 3, point (4), of Regulation (EC) No 178/2002 or with food ingredients as defined in Article 2(2), point (f), of Regulation (EU) No 1169/201. Therefore, all flexible formats, such as big bags or flexible intermediate bulk containers, as listed in Article 29(1), which are not used for direct contact with food and feed, and also not used for the transportation of dangerous goods (exemption envisaged under Article 29(4)(d)), and not custom- designed for the transportation of large-scale machinery (exemption envisaged under Article 29(4)((b)) should comply with the reuse targets set forth in Article 29(1) to (3). These will be further specified in the context of the Implementing Act under Article 30 on the rules on the calculation of the achievement of the re-use targets. 7) Do ‘pallet wrappings and straps’ count as one format or two separate formats? Pallet wrappings and straps are different packaging formats, but they may be part of the same transport unit for the purpose of calculating compliance with reuse targets under Article 29. This will be further clarified in the implementing act under Article 30 on the rules on the calculation of the achievement of the re-use targets. 37 8) If a format is not indicated in Article 29(1), can it still be in the scope of the reuse targets for transport packaging? Are all flexible packaging formats, such as sealed bags, in that scope or only those formats listed in paragraph 1? Article 29(1) lays down an exhaustive list of packaging formats covered by reuse targets, including their flexible formats. If a sealed bag is an intermediate bulk container, it is within the scope of the reuse targets, unless it is in direct contact with food and feed, as specified in Article 29(4)(c), in which case it is exempted. 9) What is the definition of a transport unit? The term is not defined nor used in the Regulation, but it might be defined in the future for the purpose of the rules on the calculation of the achievement of the re-use targets in the implementing act to be adopted under Article 30(3). Reuse targets for beverages 10) Do the reuse targets for beverages apply to non-alcoholic and alcoholic beverages individually considered or are they joint targets? The reuse target for beverages provided for in Article 29(6) applies to both alcoholic and non- alcoholic beverages. Final distributors, such as retailers, bars and restaurants, can decide what type of beverages (alcoholic, non-alcoholic or both) they offer for sale to consumers in reusable packaging in order to fulfil the reuse target. Final distributors shall, however, ensure that beverages of their own brand contribute on a fair and proportionate basis towards the achievement of the reuse target. 11) What beverages fall under the scope of the reuse targets for beverages? The beverages within the scope of the reuse targets for beverages in Article 29(6) will be clarified in Commission guidelines to be adopted by 12 February 2027. The guidelines will be developed in consultation with the Member States and other relevant stakeholders. Article 29(7) specifies that certain beverages are exempted from the reuse targets. This includes: • Beverages which are highly perishable within the meaning of Article 24 of Regulation (EU) No 1169/2011 (22). • Milk and milk products listed in Part XVI of Annex I to Regulation (EU) No 1308/2013 (23) and their dairy analogies falling within codes 2202 99 11 and 2202 99 15 of the Combined Nomenclature (CN) in Annex I to Council Regulation (EEC) No 2658/87 (24). Categories of grapevine products listed in points 1, 3 to 9, 11, 12, 15, 16 and 17 of Part II of Annex VII to Regulation (EU) No 1308/2013.Aromatised wine products as defined in Regulation (22) Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (OJ L 304 22.11.2011, p. 18) (23) Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (OJ L 347, 20.12.2013, pp. 671–854) (24) Regulation (EU) 2018/196 of the European Parliament and of the Council of 7 February 2018 on additional customs duties on imports of certain products originating in the United States of America ((OJ L 044 16.2.2018, p. 1) 38 (EU) No 251/2014 of the European Parliament and of the Council. Products that are similar to wine products and aromatised wine products and that are obtained from fruit other than grapes and vegetables, and other fermented beverages falling within CN code 2206 00. Alcohol-based spirituous beverages corresponding to CN heading 2208. 12) Can Member States set national reuse targets for beverages? By 2030, Member States shall fulfil the waste prevention targets specified in Article 43(1). Member States may need to complement the harmonised EU measures with national measures, as specified in Article 51(2)(c). Member States may increase the harmonised reuse targets set forth in Article 29(6) or set reuse targets for other beverages. This may include beverages that are expressively exempted under Article 29(7). To implement national reuse targets, a Member State needs to prove that this is necessary to meet the waste prevention targets, so as to avoid compromising the objective of market harmonisation. The targets will need to be notified to the Commission via the TRIS procedure, since such measures are technical regulations. Member States can keep existing national reuse obligations in force until 1 January 2030, but from this date onwards the reuse targets in the PPWR will prevail. For further information on under what conditions that Member States can set national reuse targets, please consult the Commission guidance document. 13) Are operators of restaurants or bars covered by the 10% reuse obligation set on beverages? All final distributors, including the ones in the HORECA sector, are obliged to fulfil the reuse targets for beverages provided for in Article 29. However, to minimise burdens on smaller businesses, final distributors with a sales area of less than 100 m2 are exempted from this obligation by Article 29(6). Final distributors which make less than 1000 kg of packaging available on the territory of the Member State per year and fall under the definition of a micro-enterprise, are also exempted from the reuse target for beverages by Article 29(13)(a). 14) Is single use beverage packaging exempted from the reuse targets for beverages if it is part of a deposit and return system? The obligation to fulfil the reuse targets for beverages in Article 29(6) applies to final distributors such as retailers and restaurants. The PPWR does not contain a general exemption for single-use beverage packaging in a deposit and return system, but it provides a large number of exemptions and flexibilities. These includes: o All final distributors with a sales area under 100 m2 are fully exempted (Article 29(10)) o Member States can exempt final distributors on small islands with less than 2000 habitants (Article 29(11)) o Member States can exempt final distributors if their sales area is located in a municipality with population density of less than 54 persons/km2. However, the targets will apply to final distributors with a sales area in population centres with more than 5000 inhabitants (Article 29(11)). o Member States can allow final distributors to form pools for the purpose of meeting their reuse obligations jointly. This means that up to 5 final distributors, for example in densely and remote areas, can share the reuse obligation (Article 29(12)). 39 o All final distributors, who are micro-enterprises and do not make more than 1000 kg. of packaging available in a Member State a year, are fully exempted (Article 29(13)) o Member States can provide further exemptions for final distributors under certain conditions according to Article 29(14) and specified in point 25 of the Commission guidance document. If all exemptions and flexibilities are fully applied in a Member State, the number of final distributors that are required to fulfil the reuse targets for beverages, will be limited. These final distributors would enjoy a high degree of flexibility in meeting the targets ensuring that national circumstances can be taken into consideration. 15) The reuse targets for beverages apply from 2030, which allows time to make the necessary adjustments to apply to the 10 % target. The Commission will review the reuse targets in 2034 in the light of the experiences gained. Under what circumstances will the Commission use its empowerment to exempt certain packaging formats or economic operators from the reuse targets? The Regulation empowers the Commission to adopt delegated acts supplementing the harmonised reuse targets for transport packaging, grouped packaging and beverages provided for in Article 29. Such delegated acts can be adopted under strict legal conditions, and only if it is necessary to take account of the latest scientific and economic developments. The empowerment to adopt delegated acts can only be used to exempt economic operators who face particular economic constraints, or specific packaging formats where achievement of the reuse targets is hindered due to either hygiene and food safety issues or environmental issues following the proper impact assessment as specified under the better regulation guidelines (Better regulation: guidelines and toolbox). https://commission.europa.eu/law/law-making-process/better-regulation/better-regulation-guidelines-and-toolbox_en https://commission.europa.eu/law/law-making-process/better-regulation/better-regulation-guidelines-and-toolbox_en 40 XIV. PLASTIC CARRIER BAGS 1) Are compostable waste bags considered lightweight plastic carrier bags? No. Only sales bags (i.e. carrier bags) are covered by the definition of ‘packaging’ in Article 3(1), point (1), and the definition of ‘plastic carrier bags’ in Article 3(1), point (55). Waste bags or doggy bags are products, not packaging, and therefore not covered by PPWR. 2) Can a Member State ban all very lightweight plastic carrier bags? Very lightweight plastic carrier bags that are needed for hygiene purposes or provided as sales packaging for loose food to prevent food wastages are not banned under Article 25 PPWR. Member States may nevertheless decide to ban such bags to meet the sustainable reduction target for lightweight plastic carrier bags under Article 34(1). However, Article 34(2) requires Member States to consider the environmental impact of bags when they are manufactured, recycled or disposed of, and their intended use. Any bans (market restrictions) should also be proportionate and non-discriminatory. Member States must report to the Commission on the consumption of all very lightweight plastic carrier bags, even those which are excluded from the EU-wide or the national bans. 3) What are the requirements for compostable plastic carrier bags under the PPWR? Compostable bags are exempted from the general packaging ban under Article 25, Annex V, point 6, if they are very lightweight plastic carrier bags and needed for hygiene reasons or for loose food to prevent food wastage. The use of other very lightweight or lightweight plastic carrier bags is not banned under Article 25 and Annex V but could be subject to national bans, and other marketing restrictions, adopted under Article 34(2). Member States may also decide that very lightweight plastic carrier bags or lightweight plastic carrier bags that have not been banned at EU or national level should be compostable, under the conditions set out Article 9(2)(a). 41 XV. ASSESSMENT OF THE CONFORMITY OF PACKAGING 1) From which date will companies have to carry out the conformity assessment procedure mandated by the PPWR? In general, the Regulation applies from 12 August 2026 (Article 71). However, certain key provisions will apply only from the date specified therein. In several cases, the entry into force of the obligation is linked to the expiry of a certain time after the adoption of the necessary implementing or delegated acts. This will give stakeholders and Member States sufficient time to adapt. When a relevant provision does not specify a specific date for its entry into application, the general application date applies, and companies will thus have to carry out the conformity assessment procedure by 12 August 2026. 2) Annex VII refers to packaging ‘type’. Does this wording mean the same as ‘types’ in Annex II, table 1? The word ‘type’ referred to in Annex VII concerning the conformity assessment procedure is not the same as the packaging types referred to in Annex II. Annex VII refers to each packaging format or each packaging batch/series and not to packaging materials, which are used for recyclability assessment. 3) What is meant by ‘the unique identification of the packaging’ referred to in Annex VIII? Is the normal product traceability enough? The Regulation does not define ‘unique identification of the packaging”. This wording, referred to in Annex VIII, means that the packaging itself needs to be identified in terms of the type, batch, or serial number. 4) Is it sufficient that a single declaration of conformity is drawn up for packaging or a packaged product? Or is it required that a dossier of all required declarations of conformity is drawn up as a single document? When a packaged product is subject to more than one Union act requiring an EU declaration of conformity, such as the declaration of compliance under Article 15 of Regulation (EU) 10/2011 on plastic materials and articles intended to come into contact with food or Article 16 of Regulation (EC) No 1935/2004 on food contact materials, a single EU declaration of conformity may be drawn up for all Union acts. That declaration must state the Union acts concerned and their publication references. It may consist of a dossier of relevant individual EU declarations of conformity. Therefore, manufacturers have a margin of discretion in assessing the necessity of drawing up a single declaration of conformity. However, in case a single declaration of conformity is drawn up, it must clearly distinguish the packaging from the packaged products. The manufacturer may decide whether the single declaration of conformity is presented as a dossier with different declarations of conformity or as a single document. If they are presented as a single document, the conformity assessment for the packaged product and the packaging should still be done and presented separately. 5) Is the assessment of conformity to be drawn up for each part of the packaging, such as a bottle, closure and label, or for the entire packaging unit? The assessment of conformity must be performed, and the declaration of conformity must be drawn up, for the entire packaging unit. The assessment should include all integrated and separate components. 6) Is a conformity assessment procedure required for the exemptions set out in Article 6 on recyclability and in Article 7 on recycled content? 42 Compliance with the exemptions set out in Article 6 on recyclability and in Article 7 on recycled content should indeed be assessed and be included as part of the technical documentation referred to in Annex VII. 7) The wording ‘type, batch or serial number or other element’ in Article 15(5) suggests that manufacturers can choose to only indicate one of these. Which one? The wording should be understood as a type, batch or serial number or other element allowing the identification of the packaging in question. Manufacturers can choose freely among these. 8) Is a manufacturer obliged to contact the competent authorities in each Member State where its packaging could end up? There are similar obligations for manufacturers in Article 15(8) and distributors in Article 19(5) to inform the authorities if they suspect non-compliance in the countries where they have made the packaging or the packaged product available. The obligation of the manufacturer is to inform the competent authority in the country or countries where it had made the packaging or packaged product available on the market for the first time. In cases where a manufacturer delivers products from one Member State to the warehouse of a distributor in another Member State, and the latter serves different national markets from the warehouse, it is the obligation of the distributor to inform the competent authority in each of those Member States. 9) Can packaging that was placed on the market before the date of application of the Regulation or of the relevant provisions remain on the market? In general, packaging which was lawfully placed on the market before 12 August 2026, or otherwise before the date of application of a specific provision, may remain on the market without having to be brought into compliance, withdrawn or recalled. As an exception to this rule, for reusable packaging the cut-off date is 11 February 2025 (Article 15(9) PPWR), which means that packaging placed on the market before this date can remain on the market without having to be brought into compliance, withdrawn or recalled. 10) How should a presumption of conformity be construed in relation to the harmonised EU standards? The PPWD sets out a number of requirements for placing packaging on the market (essential requirements). These can be considered as predecessors of the sustainability requirements in the PPWR. Under the PPWD, compliance with these essential requirements was presumed if packaging was compliant with the harmonised standards published in the Official Journal of the European Union (25). Under the PPWR, the existing harmonised standards can be used only as guidance (see Recital 58), which means that there can no longer be a presumption of conformity based on these standards. The only exception to this is laid down in Article 70(1), point (b), in relation to the essential requirements on packaging minimisation of the PPWD, which applies until end of 2029. This means that the related harmonised standard can be used for the presumption of conformity until that date. (25) EN 13427:2004 ‘Packaging – Requirements for the use of European Standards in the field of packaging and packaging waste’ EN 13429:2004 ‘Packaging – Reuse’; EN 13430:2004 ‘Packaging – Requirements for packaging recoverable by material recycling’; EN 13431:2004 ‘Packaging – Requirements for packaging recoverable in the form of energy recovery, including specification of minimum inferior calorific value’; EN 13428:2004 ‘Packaging – Requirements specific to manufacturing and composition – Prevention by source reduction’; EN 13432:2000 ‘Packaging – Requirements for packaging recoverable by composting and biodegradation’. 43 The Commission will consider taking formal measures to repeal the list of the old, harmonised, standards before the PPWR becomes applicable, to avoid any confusion (26). Presumption of conformity with new or revised harmonised standards in support of PPWR will again be possible from the date when a Commission decision listing the relevant harmonised standards will be published in the Official Journal of the European Union. This publication of references will allow the presumption of conformity to apply from that date onwards. 11) If a packaging is made from the same materials, but has different sizes, should a declaration of conformity be drawn up for all sizes of or is just one declaration for all sizes enough? According to Annex VII, the manufacturer must draw up a written declaration of conformity for each packaging type. The declaration of conformity must identify the packaging for which it has been drawn up. The documentation shall make it possible to assess the packaging’s conformity with the sustainability requirements, laid down in Article 5 – 12. The technical documentation must specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture, use and operation of the packaging. For example, the assessment of the minimisation requirement will depend on the packaged product whereas the assessment of recycled content might depend on the weight of the packaging. It follows that the declaration of conformity should be drafted at the level where packaging has the same characteristics in view of the applicable requirements and the packaged products. Therefore, if the products differ, a manufacturer should not draft a single declaration of conformity for all packaging placed on the market. Concretely, if bottles are of different sizes and contain the same product, and the difference in size does not affect compliance with any of the requirements in Article 5 – 12, then the manufacturer may draft a single declaration of conformity for the bottles. Manufacturers must ensure that the series production of packaging remains in conformity with the Regulation. They must consider if changes in packaging design or in its characteristics, as well as changes in harmonised standards or other rules by reference to which conformity is declared or verified, require reassessment. 12) Does transport packaging also require a conformity assessment and a declaration of conformity? There is no exemption for transport packaging. Indeed, completely different packaging types, such as pallets, pallet collars, wrappings and straps, must undergo separate assessments and must have separate declarations of conformity. 13) Who will monitor if the recyclability assessment carried out by the manufacturer is correct? The manufacturer is obliged to carry out the recyclability performance grade assessment. The result of this assessment must be included in the technical documentation before the packaging is placed on the market. Market surveillance authorities will carry out checks based on their national plans and should apply penalties set at national level in accordance with Article 68. 14) Will economic operators face fines in case they place on the market packaging that is PPWR-compliant but does not comply with national requirements? (26) In case of safety legislation with harmonised standards, the harmonised standards cited in the Official Journal of the European Union under repealed legislation remain valid for the purpose of the presumption of conformity if these references are not withdrawn from the OJEU. This interpretation comes from ECJ ruling T-474/15, Global Garden Products vs. Commission. 44 To reply to this question, it is necessary to distinguish between: 1) additional national requirements adopted pursuant to Article 4(3) and 2) additional national requirements explicitly allowed in specific articles of the PPWR. In the case under point 1), fines are not allowed as they have a deterrent effect on the economic operators and may create market barriers. In the case under point 2), fines are allowed, given that the Regulation explicitly empowers Member States to go beyond the Regulation. However, such national fines still must comply with the general rules of the Treaty, in particular proportionality, which is for Member States to demonstrate. This evidence is to be provided at the time of the TRIS notification. 45 XVI. WASTE PREVENTION 1) How are the packaging waste reduction targets going to be implemented? The implementation of packaging waste reduction targets is the responsibility of each Member State. It is Member States’s responsibility to reach the target and put in place the waste reduction measures necessary to reach the targets set out in Article 43. While the Regulation harmonises several packaging waste prevention measures, such as laying down reuse targets, refill and reuse obligation for take-away sector, packaging bans, and minimisation of packaging requirements, including empty space thresholds, it is up to the Member States to implement some of these harmonised measures, as well as to lay down possible additional national waste prevention measures necessary to reach the targets set out in Article 43(1). National measures which are applied in addition to the EU harmonised measures may include, but are not limited to, economic incentives, EPR schemes, and public awareness campaigns, as this is outlined in Article 43(5). The measures may also include additional obligations on economic operators, such as higher or additional reuse targets, subject to the conditions under Article 29(15) and -(16) as explained also in the Commission guidance document. Pursuant to Article 43(5), national implementing measures must be proportionate and non-discriminatory and be designed to avoid barriers to trade or distortions of competition. They must not lead to a shift to lighter packaging material, which does not comply with other sustainability requirements, such as recyclability, being used to fulfil the goal of the packaging waste reduction. 2) What happens if a Member State does not reach the waste prevention targets? Each Member State must reduce the packaging waste generated per capita, as compared to the packaging waste generated per capita in 2018 and as reported to the Commission in accordance with Decision 2005/270/EC, by at least 5% by 2030, 10% by 2035 and 15% by 2040. The Commission will monitor the implementation of these targets based on the data on packaging waste generated reported by Member States. A Member State’s failure to meet the targets is susceptible to lead to appropriate enforcement action by the Commission. 3) Does the waste reduction target cover all packaging waste generated in a Member State or only household packaging waste? The PPWR applies to all packaging and to all packaging waste, whether it originates from industry, other manufacturing, retail or distribution, offices, services or households. The provisions related to the calculation of the packaging waste generated (see Article 53(2)) cover all packaging waste generated on the territory of a Member State. Therefore, the statistical data on packaging waste generated, as reported by Member States to the Commission, cover all packaging waste generated on the territory of a Member State. It is up to Member States to decide how they implement Article 43 and what measures they take to meet the waste reduction targets established in that provision. Member States can exclude certain types of waste from the national waste prevention targets and focus merely on the household packaging waste, if they consider that this will be sufficient to meet the targets. Member States may maintain the established separate systems for the management of household packaging waste, on the one hand, and for industrial and commercial packaging waste, on the other hand (Article 43(3)). 4) Will Member States be obliged to notify the national rules they wish to introduce to achieve the waste reduction targets via the TRIS? 46 Directive (EU) 2015/1535 (27) imposes an obligation on the Member States to notify to the Commission all draft technical regulations concerning products (and Information Society Services) before they are adopted in national law. The term ‘technical regulation’ should be understood broadly. It means technical specifications, other requirements or rules on Information Society services which are laid down by the Member States, the observance of which is compulsory, de jure or de facto, for the marketing or use of a product, for the provision of a service or the establishment of a service operator. It covers also regulations or administrative provisions prohibiting the manufacture, importation, marketing or use of a product or prohibiting the provision or use of a service, or establishment as a service provider. Therefore, all new draft implementing measures, which are technical regulations, must be notified in the Technical Regulations Information System (TRIS) (28). Member States do not need to re- notify under the TRIS notification procedure their existing national measures which are compliant with the Regulation. Notifications by Member States are made at the draft stage, that is, at a stage of preparation at which substantial amendments can still be made (Article 1(1)g) of Directive (EU) 2015/1535). National technical regulations which were not notified can be declared inapplicable to individuals by the national courts (29). 5) Obligation for the Member States to ensure that their national measures that were adopted to achieve the packaging waste reduction targets do not ‘lead to a shift to lighter packaging material being used to fulfil the goal of packaging waste reduction’ and that such measures also ‘reduce the quantity of plastic packaging waste generated’. This obligation is placed on the Member States, and they must inform on how they achieve this result in their waste prevention programmes adopted under Article 42(2) PPWR and in the TRIS notification procedure. The Commission has a general monitoring competence and may also decide to help Member States by giving additional guidance. However, the Commission does not have a specific empowerment to provide guidance on the implementation of this provision. (27) Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17/09/2015, p. 1–15). (28) TRIS - European Commission. (29) ’CIA-Security’ (Case C-194/94). https://technical-regulation-information-system.ec.europa.eu/en/search 47 XVII. EXTENDED PRODUCER RESPONSIBILITY 1) Are micro-enterprises exempted from Extended producer responsibility (EPR) obligations? There is no general exemption for micro-enterprises from EPR obligations in the PPWR or Directive 2008/98/EC (Waste Framework Directive (WFD)). All producers are responsible for waste management of the packaging that they make available on the territory of a Member State for the first time. This includes registering in and reporting to that Member State’s register of producers according to Article 44. To minimise administrative burdens on small producers, the PPWR sets fewer reporting obligations on producers who make less than 10 tonnes a year of packaging available on the market of a Member State. Furthermore, Member States and producer responsibility organisations (PRO) must ensure equal treatment of producers regardless of their origin or size and must not place disproportionate burdens on small producers. Member States continue to have the right to invoke lower administrative fees for smaller producers as established in the WFD after the application of PPWR. WFD establishes that were justified by the need to ensure proper waste management and the economic viability of the extended producer responsibility scheme, Member States may, provide that: • in the case of extended producer responsibility schemes established to attain waste management targets and objectives established under legislative acts of the Union, the producers of products bear at least 80% of the necessary costs; • in the case of extended producer responsibility schemes established on or after 4 July 2018 to attain waste management targets and objectives solely established in Member State legislation, the producers of products bear at least 80% of the necessary costs; • in the case of extended producer responsibility schemes established before 4 July 2018 to attain waste management targets and objectives solely established in Member State legislation, the producers of products bear at least 50% of the necessary costs; • and provided that the remaining costs are borne by original waste producers or distributors. This derogation may not be used to lower the proportion of costs borne by producers of products under extended producer responsibility schemes established before 4 July 2018. The PPWR establishes that the producer is either the manufacturer, importer or distributor of packaging – depending on the context and whether the packaging is transport, sales, grouped, primary or service packaging. If a manufacturer is a micro-enterprise and that manufacturer is also the producer of the packaging, it will be exempted from its EPR-requirements when the supplier of the packaging materials is established in the same Member State. 2) To what extent does the PPWR harmonise national EPR schemes? The PPWR harmonises certain administrative EPR obligations to lower the administrative burden for economic operators selling packaging or packaged products in multiple Member States. These requirements are related to registration, reporting deadlines and frequency, and the granularity of the data that needs to be reported. The PPWR also harmonises who the producer is in a Member State. It is the packaging type and selling technique that determine whether a company is responsible for EPR obligations. Further information on how the definition of the producer applies, can be found under point II of this document. Finally, the PPWR also harmonises the criteria for eco-modulation of EPR-fees. The eco- modulation will be based on the recyclability performance grades set in Article 6. Member States 48 are allowed to use additional criteria, such as reusability and recycled content, when they apply the framework for eco-modulation in their national EPR schemes. In other areas, Member States continue to have a wide flexibility to organize EPR systems and waste management according to the national conditions and legal settings. 3) Which is the first calendar year that producers must report to the register of producers? All Member States shall establish a register of producers that producers must register in and report to. By February 2026, the Commission shall adopt an implementing act laying down the format for EPR registering in and reporting to the EPR register (Article 44(14) PPWR). Member States will have 18 months to establish the register after the adoption of the act (Article 44(1) PPWR). Producers shall report by June for each full preceding calendar year, and producers will therefore have to report to the national EPR registers according to the new harmonised rules for the first time by 1 June 2029. 4) What is the scope of the activities that online platforms can fulfil on behalf of their sellers? Based on a written mandate by producers, online platforms can offer to pay the EPR fees in each Member State where the packaging or packaged products are made available on the market directly to consumers (Article 45(4) PPWR). However, only the producer, or its PRO or authorised representative, is responsible for the EPR registration and reporting. An online platform cannot fulfil these obligations on their behalf unless the producer has chosen to appoint the platform as an authorised representative. 5) Does an online platform need to check every producer before allowing them to use the platform? To prevent free riding as regards EPR obligations, and in line with the obligations in the Digital Services Act (DSA) (30), the PPWR provides that online platforms that allow consumers to conclude distance contracts with producers shall obtain information from producers that they are registered in the EPR register in the Member State where the consumer resides and a self- certification confirming that their EPR-obligations for packaging are fulfilled. The online platform shall obtain this information prior to allowing the producers to use the platform’s services. The online platform shall make best efforts to assess whether the information provided is reliable and complete, by using or verifying freely available online databases and online interfaces (Article 45(6) PPWR). This may include requesting the producers to provide supporting documents (Article 45(8) PPWR). Making best efforts usually requires the verification of the information provided by the producer with the data in the register of producers. (30) Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a Single Market For Digital Services and amending Directive 2000/31/EC (OJ L 277, 27.10.2022, pp. 1– 102) 49 XVIII. RETURN AND COLLECTION SYSTEMS 1) How will priority access for recycled materials work in practice? Collection systems and recycling facilities may provide priority access to recycled materials for use in applications where the distinct quality of the recycled material is preserved or recovered in such a way that it can be recycled further and used in the same way and for a similar application with minimal loss of quantity, quality or function (Article 48(2) PPWR). The objective of this provision is to help economic operators comply with their recycled content requirements for plastic packaging under the PPWR. Therefore, Member States may establish such systems with regards to plastic packaging. If such systems are established, priority access to the plastic recycled materials should be granted at market prices. The quantity of recyclates to which priority access is given should correspond to the quantity of packaging made available on the territory of the Member State by the economic operator within a specified timeframe. It is Member States who decide to establish such priority access systems must ensure that these conditions are complied with and monitored and shall notify such systems via TRIS. 2) What does it mean that packaging is separately collected? Separate collection is defined in the WFD as ‘the collection where a waste stream is kept separately by type and nature so as to facilitate a specific treatment’. Member States must ensure that systems and infrastructure are set up to provide for the separate collection of packaging waste in accordance with the waste hierarchy, and to facilitate its preparation for re-use and high-quality recycling. More generally, Member States must ensure that the collection of the packaging materials is sufficient to achieve the recycling targets laid down in Article 52 and they must establish mandatory collection objectives for this purpose. The requirements for separate collection vary. For example, separate collection of single-use beverage packaging of plastic and aluminium in Article 50 refers to collection in a deposit and return system. Calculation and reporting requirements for separate collection for the purpose of complying with the separate collection requirement under Article 50(1), and for the purpose of establishing the ‘at scale’ methodology, will be specified in an implementing act to be adopted by 12 February 2027 under Article 56(7). 3) How is composite packaging accounted for in the calculation of recycling targets? According to Article 53(3), Member States must calculate recycling targets for composite packaging based on all materials contained in the packaging unit. Pursuant to Article 53(4), Member States may derogate from this requirement where a given material constitutes an insignificant part of the packaging unit, and in no case more than 5% of the total mass of the packaging unit. The 5 % threshold applies to the total mass of the packaging unit. 4) Are the terms ‘ferrous metal’, ‘ferrous metal (including tinplate)’ and ‘steel’ all synonymous for ‘ferrous metal including tinplate’? The terms ‘ferrous metal (including tinplate)’ is used in the PPWR only in the context of Member States’ reporting on reusable packaging. It is also referred in Table 1 of Annex II regarding materials and formats for which DfR criteria will be established. In the interest of coherence, the terms ‘steel’ in Table 3 of Annex XII and the term ‘ferrous metals’ used in Article 52(1)(b) and (d), and in Table 1 of Annex XII, also include tinplate. 50 XIX. DEPOSIT AND RETURN SYSTEMS 1) Does the exemption from setting up a deposit and return systems (DRS) apply to the two beverage packaging types separately? The 90 % separate collection targets for single-use plastic beverage bottles and metal beverage containers are two separate collection targets that apply by 1 January 2029. An exemption from the requirement to be part of a DRS would therefore need to be obtained separately for each format. Article 50(5) establishes that Member States which collect more than 80% of all single-use plastic beverage bottles or metal beverage containers within the scope of the PPWR by 2026 may be exempt from the obligation to set up a DRS. Member States would also have to show with concrete measures how they will reach 90% separate collection targets by 2029 without setting up a DRS when notifying the Commission about their request for an exemption. 2) Can a Member State set additional national requirements for DRS? Pursuant to Article 50(9) PPWR, Member States may adopt provisions for DRS which go beyond the minimum requirements set forth in Article 50 and in Annex X, while observing the Treaty on the functioning of the EU and acting in accordance with the PPWR. For example, Member States are encouraged to establish or maintain DRS for single-use glass beverage bottles and beverage cartons and may include beverages which are not required to be part of a DRS under Article 50(4), such as wine, spirits or milk-based products, as well as for other products. They should, however, be mindful of the negative impact on the internal market of such rules and should take account of the recommendations in the Communication from the Commission — Beverage packaging, deposit systems and free movement of goods (2009/C 107/01). Member States should encourage DRS for reusable packaging, in particular for reusable glass beverage bottles. Member States must ensure that the return of packaging is convenient for end users and may establish additional minimum requirements to ensure that the objectives of the Regulation are met and to increase the purity of the collected packaging waste and reduce litter (Article 50(9) PPWR). 3) What is to be understood by ‘high transboundary business’ in Annex X? Annex X requires that Member States with regions with high transboundary business ensure that the DRS allow for collection of packaging from other Member States’ DRS at designated collection points and that they must endeavour to enable the possibility of return of a deposit that was charged to the end user when purchasing the packaging. Member States will need to assess if this requirement applies when ensuring compliance with the minimum requirements in Annex X. The minimum requirements apply to DRS established after 11 February 2025, whereas for the existing DRS, Member States must only apply the requirements from 1 January 2035 if the 90% separate collection targets are not reached by 1 January 2029 (Article 50(11) PPWR). Given that an increasing number of Member States is establishing DRS, the need for transboundary collaboration between the DRS’ is likely to increase to ensure separate collection of beverage packaging. The Commission must assess best practice of such measures by 2038 in collaboration with Member States to strengthen interoperability of DRS from different Member States (Article 50(11) PPWR). 4) Do all DRS have to be non-profit? A DRS for single-use beverage bottles of plastic and metal containers established after 11 February 2025 must be non-profit, as specified in the minimum criteria set out in Annex X, point f. 51 DRS established before 11 February 2025 are required to be non-profit by 1 January 2035 only if the Member State does not reach the 90% separate collection targets when they are first reviewed or at the latest by 1 January 2029 (Article 50(11) PPWR). 5) Is packaging of milk, wine and spirits also exempted from the 90% separate collection targets? According to Article 50(4), single-use plastic beverage bottles and metal containers with milk and milk-products, wine or products similar to wine and spirits are exempted from the requirement to be part of a DRS. However, such products must be included in the calculation of the separate collection targets under Article 50(1). Moreover, Member States have flexibility on whether or not to include the packaging for these products in their DRS. 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