PPWR — Article 71

European Union and repealing Decision 2014/335/EU, Euratom (OJ L 424, 15.12.2020, p. 1). (6) OJ C 465, 17.11.2021, p. 11. (7) Regulation (EU) 2024/1781 of the European Parliament and of the Council of 13 June 2024 establishing a framework for the setting of ecodesign requirements for sustainable products, amending Directive (EU) 2020/1828 and Regulation (EU) 2023/1542 and repealing Directive 2009/125/EC (OJ L, 2024/1781, 28.6.2024, ELI: http://data.europa.eu/eli/reg/2024/1781/oj). and repealing Directive 2009/125/EC (OJ L, 2024/1781, 28.6.2024, ELI: http://data.europa.eu/eli/reg/2024/1781/oj). (8) Directive (EU) 2019/904 of the European Parliament and of the Council of 5 June 2019 on the reduction of the impact of certain plastic products on the environment (OJ L 155, 12.6.2019, p. 1). (9) Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4). to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4). (10) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1). 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1). (11) 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). (12) Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants (OJ L 169, 25.6.2019, p. 45). (13) Commission Decision 2001/171/EC 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, p. 20). concentration levels established in Directive 94/62/EC on packaging and packaging waste (OJ L 62, 2.3.2001, p. 20). (14) Commission Decision 2009/292/EC of 24 March 2009 establishing the conditions for a derogation for plastic crates and plastic pallets in relation to the heavy metal concentration levels established in Directive 94/62/EC of the European Parliament and of the Council on packaging and packaging waste (OJ L 79, 25.3.2009, p. 44). (15) 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). (16) Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43). of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43). (17) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1). (18) Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176). medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176). (19) 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, p. 35). (20) 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, p. 13). and of the Council of 24 September 2008 on the inland transport of dangerous goods (OJ L 260, 30.9.2008, p. 13). (21) Contact-sensitive packaging refers to plastic packaging of products covered by Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29), 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 (OJ L 338 13.11.2004, p. Council of 27 October 2004 on materials and articles intended to come into contact with food (OJ L 338 13.11.2004, p. 4), Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC (OJ L 229, 1.9.2009, p. 1), Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59), Regulation (EU) 2017/745, Regulation (EU) 2017/746, Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed, amending Regulation (EC) No 183/2005 of the European Parliament and of the Council and repealing Council Directive 90/167/EEC (OJ L 4, 7.1.2019, p. 1), Regulation (EU) 2019/6, Directive 2001/83/EC and Directive 2008/68/EC. (22) OJ L 39, 16.2.1993, p. 3. (23) OJ L 179, 23.6.1998, p. 3. (24) OJ L 171, 27.6.1981, p. 13. (25) OJ L 186, 5.8.1995, p. 44. (26) Commission Regulation (EU) 2022/1616 of 15 September 2022 on recycled plastic materials and articles intended to come into contact with foods, and repealing Regulation (EC) No 282/2008 (OJ L 243, 20.9.2022, p. 3). intended to come into contact with foods, and repealing Regulation (EC) No 282/2008 (OJ L 243, 20.9.2022, p. 3). (27) Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12). 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12). (28) 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, p. 671). Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (OJ L 347, 20.12.2013, p. 671). (29) Regulation (EU) 2019/787 of the European Parliament and of the Council of 17 April 2019 on the definition, description, presentation and labelling of spirit drinks, the use of the names of spirit drinks in the presentation and labelling of other foodstuffs, the protection of geographical indications for spirit drinks, the use of ethyl alcohol and distillates of agricultural origin in alcoholic beverages, and repealing Regulation (EC) No 110/2008 (OJ L 130, 17.5.2019, p. 1). of agricultural origin in alcoholic beverages, and repealing Regulation (EC) No 110/2008 (OJ L 130, 17.5.2019, p. 1). (30) Regulation (EU) 2023/2411 of the European Parliament and of the Council of 18 October 2023 on the protection of geographical indications for craft and industrial products and amending Regulations (EU) 2017/1001 and (EU) 2019/1753 (OJ L, 2023/2411, 27.10.2023, ELI: http://data.europa.eu/eli/reg/2023/2411/oj). (EU) 2017/1001 and (EU) 2019/1753 (OJ L, 2023/2411, 27.10.2023, ELI: http://data.europa.eu/eli/reg/2023/2411/oj). (31) Regulation (EU) 2024/1143 of the European Parliament and of the Council of 11 April 2024 on geographical indications for wine, spirit drinks and agricultural products, as well as traditional specialities guaranteed and optional quality terms for agricultural products, amending Regulations (EU) No 1308/2013, (EU) 2019/787 and (EU) 2019/1753 and repealing Regulation (EU) No 1151/2012 (OJ L, 2024/1143, 23.4.2024, ELI: http://data.europa.eu/eli/reg/2024/1143/oj). repealing Regulation (EU) No 1151/2012 (OJ L, 2024/1143, 23.4.2024, ELI: http://data.europa.eu/eli/reg/2024/1143/oj). (32) Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to-consumer commercial practices in the internal market and amending Council Directive 84/450/EEC, Directives 97/7/EC, 98/27/EC and 2002/65/EC of the European Parliament and of the Council and Regulation (EC) No 2006/2004 of the European Parliament and of the Council (‘Unfair Commercial Practices Directive’) (OJ L 149, 11.6.2005, p. 22). of the European Parliament and of the Council (‘Unfair Commercial Practices Directive’) (OJ L 149, 11.6.2005, p. 22). (33) 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, ELI: http://data.europa.eu/eli/dir/2024/825/oj). (34) Commission Decision 97/129/EC of 28 January 1997 establishing the identification system for packaging materials pursuant to European Parliament and Council Directive 94/62/EC on packaging and packaging waste (OJ L 50, 20.2.1997, p. 28). (35) Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36). of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36). (36) Directive (EU) 2015/720 of the European Parliament and of the Council of 29 April 2015 amending Directive 94/62/EC as regards reducing the consumption of lightweight plastic carrier bags (OJ L 115, 6.5.2015, p. 11). (37) Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82). (38) Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, p. 1). and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, p. 1). (39) 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 (Digital Services Act) (OJ L 277, 27.10.2022, p. 1). (40) Directive (EU) 2018/852 of the European Parliament and of the Council of 30 May 2018 amending Directive 94/62/EC on packaging and packaging waste (OJ L 150, 14.6.2018, p. 141). (41) Commission Implementing Decision (EU) 2019/1004 of 7 June 2019 laying down rules for the calculation, verification and reporting of data on waste in accordance with Directive 2008/98/EC of the European Parliament and of the Council and repealing Commission Implementing Decision C(2012)2384 (OJ L 163, 20.6.2019, p. 66). Parliament and of the Council and repealing Commission Implementing Decision C(2012)2384 (OJ L 163, 20.6.2019, p. 66). (42) Regulation (EC) No 1013/2006 of the European Parliament and of the Council of 14 June 2006 on shipments of waste (OJ L 190, 12.7.2006, p. 1). (43) Regulation (EU) 2024/1157 of the European Parliament and of the Council of 11 April 2024 on shipments of waste, amending Regulations (EU) No 1257/2013 and (EU) 2020/1056 and repealing Regulation (EC) No 1013/2006 (OJ L, 2024/1157, 30.4.2024, ELI: http://data.europa.eu/eli/reg/2024/1157/oj). (44) Commission Decision 2005/270/EC of 22 March 2005 establishing the formats relating to the database system pursuant to Directive 94/62/EC of the European Parliament and of the Council on packaging and packaging waste (OJ L 86, 5.4.2005, p. 6). 94/62/EC of the European Parliament and of the Council on packaging and packaging waste (OJ L 86, 5.4.2005, p. 6). (45) Commission Implementing Decision (EU) 2018/896 of 19 June 2018 laying down the methodology for the calculation of the annual consumption of lightweight plastic carrier bags and amending Decision 2005/270/EC (OJ L 160, 25.6.2018, p. 6). annual consumption of lightweight plastic carrier bags and amending Decision 2005/270/EC (OJ L 160, 25.6.2018, p. 6). (46) Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, p. 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, p. 1). (47) Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65). (48) Directive 2014/25/EU of the European Parliament and of the Council of 26 February 2014 on procurement by entities operating in the water, energy, transport and postal services sectors and repealing Directive 2004/17/EC (OJ L 94, 28.3.2014, p. 243). (49) Commission Implementing Regulation (EU) 2015/2447 of 24 November 2015 laying down detailed rules for implementing certain provisions of Regulation (EU) No 952/2013 of the European Parliament and of the Council laying down the Union Customs Code (OJ L 343, 29.12.2015, p. 558). (50) OJ L 123, 12.5.2016, p. 1. and of the Council laying down the Union Customs Code (OJ L 343, 29.12.2015, p. 558). (50) OJ L 123, 12.5.2016, p. 1. (51) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). (52) OJ L 124, 17.5.2005, p. 4. (53) Regulation (EU) 2021/1119 of the European Parliament and of the Council of 30 June 2021 establishing the framework for achieving climate neutrality and amending Regulations (EC) No 401/2009 and (EU) 2018/1999 (‘European Climate Law’) (OJ L 243, 9.7.2021, p. 1). and amending Regulations (EC) No 401/2009 and (EU) 2018/1999 (‘European Climate Law’) (OJ L 243, 9.7.2021, p. 1). (54) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1). (55) Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights, amending Council Directive 93/13/EEC and Directive 1999/44/EC of the European Parliament and of the Council and repealing Council Directive 85/577/EEC and Directive 97/7/EC of the European Parliament and of the Council (OJ L 304, 22.11.2011, p. 64). Directive 85/577/EEC and Directive 97/7/EC of the European Parliament and of the Council (OJ L 304, 22.11.2011, p. 64). (56) Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29). (57) Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC (OJ L 229, 1.9.2009, p. 1). (58) Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59). of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59). (59) Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed, amending Regulation (EC) No 183/2005 of the European Parliament and of the Council and repealing Council Directive 90/167/EEC (OJ L 4, 7.1.2019, p. 1). (60) Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51). (61) Commission Decision (EU) 2023/1809 of 14 September 2023 establishing the EU Ecolabel criteria for absorbent hygiene products and for reusable menstrual cups (OJ L 234, 22.9.2023, p. 142). the EU Ecolabel criteria for absorbent hygiene products and for reusable menstrual cups (OJ L 234, 22.9.2023, p. 142). (62) Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control) (OJ L 334, 17.12.2010, p. 17). (63) Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources (OJ L 328, 21.12.2018, p. 82). (64) Council Regulation (EC) No 6/2002 of 12 December 2001 on Community designs (OJ L 3, 5.1.2002, p. 1). (65) Directive 98/71/EC of the European Parliament and of the Council of 13 October 1998 on the legal protection of designs (OJ L 289, 28.10.1998, p. 28). Parliament and of the Council of 13 October 1998 on the legal protection of designs (OJ L 289, 28.10.1998, p. 28). (66) Regulation (EU) 2017/1001 of the European Parliament and of the Council of 14 June 2017 on the European Union trade mark (OJ L 154, 16.6.2017, p. 1). (67) Directive (EU) 2015/2436 of the European Parliament and of the Council of 16 December 2015 to approximate the laws of the Member States relating to trade marks (OJ L 336, 23.12.2015, p. 1). (68) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). (69) 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). (70) Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1). of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1). (71) Regulation (EU) No 251/2014 of the European Parliament and of the Council of 26 February 2014 on the definition, description, presentation, labelling and the protection of geographical indications of aromatised wine products and repealing Council Regulation (EEC) No 1601/91 (OJ L 84, 20.3.2014, p. 14). (72) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30). (73) Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumption (OJ L 435, 23.12.2020, p. 1). of the Council of 16 December 2020 on the quality of water intended for human consumption (OJ L 435, 23.12.2020, p. 1). (74) Commission Implementing Regulation (EU) 2023/595 of 16 March 2023 establishing the form for the statement relating to the own resource based on non-recycled plastic packaging waste pursuant to Council Regulation (EU, Euratom) 2021/770 (OJ L 79, 17.3.2023, p. 151). (75) Regulation (EU) 2019/1150 of the European Parliament and of the Council of 20 June 2019 on promoting fairness and transparency for business users of online intermediation services (OJ L 186, 11.7.2019, p. 57). ANNEX I Indicative list of items in the scope of the definition of packaging in Article 3(1), point (1) A. Article 3(1), point (1)(a) list of items in the scope of the definition of packaging in Article 3(1), point (1) A. Article 3(1), point (1)(a) 1. Items that are packaging: Sweet boxes Film overwrap around a CD case Mailing pouches for catalogues and magazines (with a magazine inside) Cake doilies sold with a cake Rolls, tubes and cylinders around which flexible material (e.g. plastic film, aluminium or paper) is wound, except rolls, tubes and cylinders intended as parts of production machinery and not used to present a product as a sales unit Flower and plant pots, including seed trays, intended to be used only for selling and transporting Glass bottles for injection solutions CD spindles (sold with CDs, not intended to be used as storage) Clothes hangers (sold with a clothing item) Matchboxes Sterile barrier systems (pouches, trays and materials necessary to preserve the sterility of the product) Refillable steel cylinders used for various kinds of gas, excluding fire extinguishers Tea and coffee foil pouches Boxes used for toothpaste tubes for various kinds of gas, excluding fire extinguishers Tea and coffee foil pouches Boxes used for toothpaste tubes 2. Items that are not packaging: Flower and plant pots, including seed trays, used in business-to-business relations throughout different stages of production or intended to be sold with the plant Tool boxes Wax layers around cheese Sausage casing skins Clothes hangers (sold separately) Cartridges for printers CD, DVD and video cases (sold together with a CD, DVD or video inside) CD spindles (sold empty, intended to be used as storage) Soluble bags for detergents Graveside lights (containers for candles) Mechanical quern (integrated in a refillable recipient, e.g. refillable pepper mill) B. Article 3(1), points (1)(b) and (c) quern (integrated in a refillable recipient, e.g. refillable pepper mill) B. Article 3(1), points (1)(b) and (c) 1. Items that are packaging: Labels hung directly on or attached to a product including sticky labels attached to fruits and vegetables Mascara brush which forms part of the container closure Sticky labels attached to another packaging item Staples Plastic sleeves Device for measuring dosage, which forms part of the container closure for detergents Mechanical quern (integrated in a non-refillable recipient, filled with a product, e.g. pepper mill filled with pepper) 2. Items that are not packaging: Radio frequency identification (RFID) tags Tyre labels in the form of stickers in accordance with Regulation (EU) 2020/740 of the European Parliament and of the Council (1) C. Article 3(1), points (1)(d) and (e) with Regulation (EU) 2020/740 of the European Parliament and of the Council (1) C. Article 3(1), points (1)(d) and (e) 1. Items that are packaging, if designed and intended to be filled at the point of sale: Paper or plastic carrier bags Disposable plates and cups Cling film Sandwich bags Aluminium foil Plastic foil for cleaned clothes in laundries 2. Disposable plates and cups Cling film Sandwich bags Aluminium foil Plastic foil for cleaned clothes in laundries 2. Items that are not packaging: Stirrer Disposable cutlery Wrapping paper (sold separately to consumers and business operators) Paper baking cases (sold empty) Cake doilies sold without a cake Disposable plates and cups not intended to be filled at the point of sale (1) Regulation (EU) 2020/740 of the European Parliament and of the Council of 25 May 2020 on the labelling of tyres with respect to fuel efficiency and other parameters, amending Regulation (EU) 2017/1369 and repealing Regulation (EC) No 1222/2009 (OJ L 177, 5.6.2020, p. 1). parameters, amending Regulation (EU) 2017/1369 and repealing Regulation (EC) No 1222/2009 (OJ L 177, 5.6.2020, p. 1). ANNEX II Categories and parameters for assessment of recyclability of packaging Table 1 Indicative list of packaging materials, types and categories referred to in Article 6 Category No Predominant packaging material Packaging type Format (illustrative and non-exhaustive) Colour / Optical transmittance 1 Glass Glass and composite packaging, of which the majority is glass Bottles, jars, flacons, cosmetics pots, tubs, ampoules, vials made of glass (soda lime silica), aerosol cans — 2 Paper/cardboard Paper/cardboard packaging Boxes, trays, grouped packaging, flexible paper packaging (e.g. films, sheets, pouches, lidding, cones, wrappers) — 3 Paper/cardboard Composite packaging of which the majority is paper/cardboard Liquid packaging board, and paper cups (i.e. packaging of which the majority is paper/cardboard Liquid packaging board, and paper cups (i.e. laminated with polyolefin and with or without aluminium), trays, plates and cups, metallised or plastic laminated paper/cardboard, paper/cardboard with plastic liners/ windows — 4 Metal Steel and composite packaging of which the majority is steel Rigid formats (aerosols cans, cans, paint tins, boxes, trays, drums, tubes) made of steel, including tinplate and stainless steel — 5 Metal Aluminium and composite packaging of which the majority is aluminium – rigid Rigid formats (food and beverage cans, bottles, aerosols, drums, tubes, cans, boxes, trays) made of aluminium — 6 Metal Aluminium and composite packaging of which the majority is aluminium – semi-rigid and flexible Semi rigid and flexible formats (containers and trays, tubes, foils, flexible foil) made of aluminium — 7 Plastic PET – rigid Bottles and flasks Transparent clear / coloured, opaque 8 Plastic PET – rigid Rigid formats other than bottles and flasks (including pots, tubs, jars, cups, mono- and multilayer trays and containers, aerosol cans) Transparent clear / coloured, opaque 9 Plastic PET – flexible Films Natural / coloured 10 Plastic PE – rigid Containers, bottles, trays, pots and tubes Natural / coloured 11 Plastic PE – flexible Films, including multilayer and multi-material packaging Natural / coloured 12 Plastic PP – rigid Containers, bottles, trays, pots and tubes Natural / coloured 13 Plastic PP – flexible Films, including multilayer and multi-material packaging Natural / coloured 14 Plastic HDPE and PP – rigid Crates and pallets, corrugated board plastic Natural / coloured 15 Plastic PS and XPS – rigid Rigid formats (including dairy packaging, trays, cups and other food containers) Natural / coloured 16 Plastic EPS – rigid Rigid formats (including fish boxes / white goods and trays) Natural / coloured 17 Plastic Other rigid plastics (e.g. formats (including fish boxes / white goods and trays) Natural / coloured 17 Plastic Other rigid plastics (e.g. PVC, PC) including multi-materials – rigid Rigid formats, including. intermediate bulk containers, drums — 18 Plastic Other flexible plastics including multi-materials – flexible Pouches, blisters, thermoformed packaging, vacuum packaging, modified atmosphere/modified humidity packaging, including flexible intermediate bulk containers, bags, stretch films — 19 Plastic Biodegradable plastics (1) – rigid (e.g. PLA, PHB) and flexible (e.g. bulk containers, bags, stretch films — 19 Plastic Biodegradable plastics (1) – rigid (e.g. PLA, PHB) and flexible (e.g. PLA) Rigid and flexible formats — 20 Wood, cork Wooden packaging, including cork Pallets, boxes, crates — 21 Textile Natural and synthetic textile fibres Bags — 22 Ceramics or porcelain stoneware Clay, stone Pots, containers, bottles, jars — Table 2 Indicative list of packaging materials and categories referred to in Article 6 Materials Categories Link to Table 1, Annex II Plastic PET rigid categories 7, 8 PE rigid, PP rigid, HDPE and PP rigid categories 10, 12, 14 Films/flexible categories 9, 11, 13, 18 PS, XPS, EPS categories 15, 16 Other rigid plastics category 17 Biodegradable (rigid and flexible) category 19 Paper/cardboard Paper/cardboard (except liquid packaging board) categories 2, 3 Liquid packaging board category 3 Metal Aluminium categories 5, 6 Steel category 4 Glass Glass category 1 Wood Wood, cork category 20 Others Textile, ceramics/porcelain and others categories 21, 22 Table 3 Recyclability performance grades Packaging recyclability shall be expressed in the performance grades A, B or C. 3 Recyclability performance grades Packaging recyclability shall be expressed in the performance grades A, B or C. From 2030, recyclability performance is based on design for recycling criteria. The design for recycling criteria shall ensure the circularity of the use of the resulting secondary raw materials of sufficient quality to substitute the primary raw materials. The assessment based on design for recycling criteria shall be carried out for each packaging category listed in Table 1, taking into account the methodology established under Article 6(4) and the related delegated acts, as well as the parameters established in Table 4. After weighing the criteria per packaging unit, it will be classified into categories A, B or C. in Table 4. After weighing the criteria per packaging unit, it will be classified into categories A, B or C. When a packaging unit’s recyclability performance grade is below 70 %, it is considered to be non-compliant with the recyclability performance grades and therefore the packaging will be considered technically non-recyclable and its placing on the market shall be restricted. From 2035, a new factor shall be added to the assessment of the packaging recyclability, which is the recycled-at-scale assessment. Consequently, a new assessment shall be carried out based on the quantity (weight) of the material effectively recycled from each of the packaging categories in accordance with the methodology established in the implementing acts adopted under Article 6(5). categories in accordance with the methodology established in the implementing acts adopted under Article 6(5). The thresholds related to the annual recycled packaging materials for compliance with the recycled-at-scale assessment shall be defined taking into account the targets set in Article 3(1), point (39). with the recycled-at-scale assessment shall be defined taking into account the targets set in Article 3(1), point (39). 2030 2035 2038 Recyclability performance grade Design for recycling (DfR) Assessment of recyclability per unit, in terms of weighting Recyclability performance grade (for DfR) Design for recycling (DfR) Assessment of recyclability per unit, in terms of weighting Recyclability performance grade (for recycled-at-scale assessment) Recyclability performance grade Design for recycling (DfR) Assessment of recyclability per unit, in terms of weighting Recyclability performance grade (for recycled-at-scale assessment) Grade A higher or equal to 95 % Grade A higher or equal to 95 % Grade A RaS Grade A higher or equal to 95 % Grade A RaS Grade B higher or equal to 80 % Grade B higher or equal to 80 % Grade B RaS Grade B higher or equal to 80 % Grade B RaS Grade C higher or equal to 70 % Grade C higher or equal to 70 % Grade C RaS Grade C CANNOT BE PLACED ON THE MARKET higher or equal to 70 % Grade C RaS TECHNICALLY NON-RECYCLABLE lower than 70 % TECHNICALLY NON-RECYCLABLE lower than 70 % NOT RECYCLED AT SCALE (below thresholds of Article 3(1), point (39). 70 % TECHNICALLY NON-RECYCLABLE lower than 70 % NOT RECYCLED AT SCALE (below thresholds of Article 3(1), point (39). TECHNICALLY NON-RECYCLABLE lower than 70 % NOT RECYCLED AT SCALE (below thresholds of Article 3(1), point (39). Table 4 Non-exhaustive list of parameters for setting design for recycling criteria under Article 6 The list in this Table shall be used as a basis when defining design for recycling criteria, as set out in Article 6(4). The design for recycling criteria shall then be used in order to set the calculations leading to the performance grades listed in Table 3. criteria shall then be used in order to set the calculations leading to the performance grades listed in Table 3. In addition, the assessment of the parameters set out in that list shall consider: — separability of any component of packaging, either manually by end users or in processing plants, — efficiency of sorting and recycling processes, for example yield, — evolution of sorting and recycling technologies (to address the aspect if the packaging cannot be sorted today, but it might be sortable in 2 years), and — preservation of functionality of secondary raw materials enabling the substitution of primary raw materials. The packaging functionality that the following parameters provide to the packaging shall be factored-in in the setting of design for recycling criteria. the following parameters provide to the packaging shall be factored-in in the setting of design for recycling criteria. Parameters for design for recycling criteria Parameter’s relevance Additives Additives refer often to substances added to materials to confer specific properties. The presence of additives in the packaging containers can result in incorrect sorting of the packaging materials during the sorting process and can contaminate the obtained secondary raw materials. Labels Coverage rate of labels can affect the efficiency of the sorting process. Material from which the label is made and type of glue or adhesive also affect the quality of the secondary raw material. Sleeves Coverage rate of the sleeve on the main packaging body affects the possibilities for sorting. In addition, the use of sleeves can affect the ability to separate them from the main packaging body. for sorting. In addition, the use of sleeves can affect the ability to separate them from the main packaging body. The material from which the sleeve is made can affect both the sortability and the recyclability of the packaging. Closures and other small packaging components Closures refer to components used to close or seal the packaging. There may be different types of closures, rigid or flexible, such as tamper-evident shrink wrap, linings, caps, lids, seals, valves, etc. The material from which the closures is made can affect both the sortability and the recyclability of the packaging. Closures that are not firmly attached to the packaging can increase litter. Small packaging components attached to the main packaging body can affect the separability and the recyclability of the packaging. In addition, the components can be lost in the sorting and recycling process. and the recyclability of the packaging. In addition, the components can be lost in the sorting and recycling process. Adhesives Adhesives can be used in such a way that they can be easily separated in the recycling process or by the end user or in a way that they do not affect the efficiency of the sorting and recycling processes. The presence of adhesive residues on the packaging can downgrade the quality (purity) of the secondary raw materials. Washable adhesives can ensure the separation from the main packaging body and that no adhesive residue remains in the secondary raw material. Colours Colours are substances that impart colour to the packaging material. Heavily dyed materials in paper or plastics can cause problems with regard to sorting and can downgrade the quality of secondary raw materials. paper or plastics can cause problems with regard to sorting and can downgrade the quality of secondary raw materials. Material composition Use of mono-materials or material combinations that permit easy separation and ensure high yield of secondary raw materials is preferable. Barriers / coatings The material or substance added to confer barrier properties (barrier), or a variety of materials applied on the surface to impart other properties (coating). The presence of barriers or coatings within the packaging can make recycling more difficult. Combinations that ensure high yield of secondary raw materials are preferable. can make recycling more difficult. Combinations that ensure high yield of secondary raw materials are preferable. Inks and lacquers / printing/ coding Inks and lacquers are mixtures of colorants with other substances applied onto the material by a printing or coating process (ink) or a protective coating made of resin or cellulose ester, or both, dissolved in a volatile solvent (lacquer). Coding refers to printing applied directly to sales packaging for the purpose of batch coding and other information and branding. The use of inks with substances of concern hinders recycling, as those packaging units cannot be recycled. Printing inks when released can contaminate the recycling stream through the washing water. Likewise, printing inks which are not released can impair the transparency of the recycling stream. the washing water. Likewise, printing inks which are not released can impair the transparency of the recycling stream. Product residues / ease of emptying Residues of the content of the packaging can affect the sortability and the recyclability of the packaging. The design of the packaging should enable the easy emptying of its content and when disposed of should be in a fully drained condition. Ease of dismantling Components that are firmly attached to each other can affect the sortability and the recyclability of the packaging. Packaging design can facilitate the possibility of separating different components into different material streams. Packaging design can facilitate the possibility of separating different components into different material streams. (1) Please note that this category contains plastics that are readily biodegradable (meaning a proven ability to convert >90 % of the original material into CO2, water and minerals by biological processes within 6 months) and regardless of the feedstock used for their production. Biobased polymers that are not readily biodegradable are covered under the other relevant plastic categories. Biobased polymers that are not readily biodegradable are covered under the other relevant plastic categories. ANNEX III Compostable packaging Conditions to be considered when mandating or introducing the use of compostable packaging format: (a) it could not have been designed as reusable packaging or the products could not be placed on the market without packaging; (b) it is designed to enter the organic waste stream at the end of its life; (c) it is of such biodegradable nature that it allows the packaging to undergo physical or biological decomposition, including anaerobic digestion, resulting ultimately in conversion into carbon dioxide and water, new microbial biomass, mineral salts, and, in the absence of oxygen, methane; (d) its use significantly increases the collection of organic waste compared to the use of non-compostable packaging materials; (e) its use significantly reduces the contamination of compost with non-compostable packaging and does not cause any problems in bio-waste processing; (f) its use does not increase the contamination of non-compostable packaging waste streams. in bio-waste processing; (f) its use does not increase the contamination of non-compostable packaging waste streams. ANNEX IV Methodology for packaging minimisation assessment Part A Performance criteria 1. Product protection: packaging design shall ensure protection of the product, from the point of packaging or filling until its end use, with a view to preventing significant product damage, loss, deterioration or waste. Requirements may consist of protection against mechanical or chemical damage, vibration, compression, humidity, moisture loss, oxidation, light, oxygen, microbiological infection, pest, deterioration of organoleptic properties, etc. and include references to specific Union law setting out requirements on product quality. organoleptic properties, etc. and include references to specific Union law setting out requirements on product quality. 2. Packaging manufacturing processes: the packaging design shall be compatible with the packaging manufacturing and filling processes. The packaging manufacturing processes may determine packaging design elements, such as the shape of a container, thickness tolerances, size, feasibility of tooling, or specifications minimising waste in manufacturing. The processes operated by manufacturer of products may also require certain design elements of packaging, such as impact and stress resistance, mechanical strength, packing line speed and efficiency, stability in conveying, heat resistance, effective closing, minimum headspace, or hygiene. line speed and efficiency, stability in conveying, heat resistance, effective closing, minimum headspace, or hygiene. 3. Logistics: the packaging design shall ensure adequate and safe distribution, transport, handling and warehousing of the packaged product. Requirements may consist of dimensional coordination for optimum space utilisation, compatibility with palletising and de-palletising systems, handling and warehousing system, and packaging system integrity during transport and handling. 4. Packaging functionality: the packaging design shall ensure its functionality, taking into account the purpose of the product and particularities giving rise to its sale, such as sales for gift purposes, or on the occasion of seasonal events. and particularities giving rise to its sale, such as sales for gift purposes, or on the occasion of seasonal events. 5. Information requirements: the packaging design shall ensure that any necessary information regarding the packaged product itself, its use, storage and care, including safety instructions, can be provided to end users. Requirements may include providing product information, instructions for storage, application and use, bar codes and the best before date. 6. Hygiene and safety: the packaging design shall ensure user and consumer safety as well as product safety and hygiene throughout the distribution, end use and disposal of the packaged product. Requirements may include those on safe handling design, child resistance, anti-tamper, anti-theft, anti-counterfeit, hazard warnings, clear identification of content, safe opening device or pressure-release closure. anti-counterfeit, hazard warnings, clear identification of content, safe opening device or pressure-release closure. 7. Legal requirements: the packaging design shall ensure that the packaging and packaged product can comply with applicable law. 8. Recycled content, recyclability and re-use: the packaging design shall ensure reusability, recyclability and inclusion of recycled content as required under this Regulation. If the packaging is intended for re-use, it shall fulfil the requirements laid down in Article 11(1). This means that the packaging weight or volume may have to be increased beyond what would otherwise be possible under the other performance factors in order to enable for example a higher number of trips or rotations, to facilitate inclusion of recycled content or to enhance recyclability (for example when moving to a mono-material or post-consumer recycled content). content or to enhance recyclability (for example when moving to a mono-material or post-consumer recycled content). Part B Assessment methodology and determination of the minimum packaging volume and weight The assessment of the minimum packaging volume and weight necessary to ensure the packaging functionality as described in Article 3(1), point (1), shall be explained in the technical documentation and shall include at least: (a) the description of the outcome of the assessment, including the details of the calculation of the minimum necessary weight and volume for the packaging; possible variations between production batches for a same packaging shall be taken into account and documented; (b) for each performance criterion as listed in Part A, a description which explains the design requirement that prevents further reduction of the packaging weight or volume without endangering the packaging functionality, including safety and hygiene, for the packaged product, packaging and user; the method used for the identification of these design requirements shall be described, and the reasons preventing further reduction of the packaging weight or volume shall be explained; all reduction opportunities with a given packaging material shall be investigated, such as the reduction of any superfluous layer which does not perform a packaging function; substitution of one packaging material with another shall not be considered sufficient; (c) any test results, market research or studies that have been used for the assessment conducted under points (a) and (b). test results, market research or studies that have been used for the assessment conducted under points (a) and (b). ANNEX V Restrictions on use of packaging formats Packaging format Restricted use Illustrative example 1. Single-use plastic grouped packaging Single-use plastic packaging used at the point of sale to group goods sold in bottles, cans, tins, pots, tubs, and packets designed as convenience packaging to enable or encourage consumers to purchase more than one product. This excludes grouped packaging necessary to facilitate handling. Collation films, shrink wrap more than one product. This excludes grouped packaging necessary to facilitate handling. Collation films, shrink wrap 2. Single-use plastic packaging for unprocessed fresh fruit and vegetables Single-use plastic packaging for less than 1,5 kg pre-packed fresh fruit and vegetables. Member States may set up exemptions in respect of this restriction if there is a demonstrated need to avoid water loss, or turgidity loss, microbiological hazards or physical shocks, oxidation, or if there is no other possibility to avoid commingling of organic fruits and vegetables with non-organic fruits and vegetables in compliance with requirements in Regulation (EU) 2018/848 of the European Parliament and of the Council (1) on certification or labelling, without entailing disproportionate economic and administrative costs. Nets, bags, trays, containers or labelling, without entailing disproportionate economic and administrative costs. Nets, bags, trays, containers 3. Single-use plastic packaging Single-use plastic packaging for foods and beverages filled and consumed within the premises in the HORECA sector, which include all eating areas inside and outside a place of business, covered with tables and stools, standing areas, and eating areas offered to the end users jointly by several economic operators or a third party for the purpose of food and drinks consumption. Establishments in the HORECA sector that do not have access to drinking water are exempted. Trays, disposable plates and cups, bags, boxes HORECA sector that do not have access to drinking water are exempted. Trays, disposable plates and cups, bags, boxes 4. Single-use plastic packaging for condiments, preserves, sauces, coffee creamer, sugar, and seasoning in HORECA sector Single-use plastic packaging in the HORECA sector, containing individual portions or servings, used for condiments, preserves, sauces, coffee creamer, sugar and seasoning, except in the following cases: (a) such packaging is provided together with take-away ready-prepared food intended for immediate consumption without the need of any further preparation; (b) such packaging is required to ensure safety and hygiene in establishments where there is a medical requirement for individualised care, such as hospitals, clinics or nursing homes. Sachets, tubs, trays, boxes a medical requirement for individualised care, such as hospitals, clinics or nursing homes. Sachets, tubs, trays, boxes 5. Single-use accommodation sector packaging intended for an individual booking Single-use packaging for cosmetics, hygiene and toiletry products for the use in the accommodation sector, as described in NACE Rev. 2 – Statistical classification of economic activities, intended for an individual booking only and intended to be discarded before the next guest arrives. Shampoo bottles, hand and body lotion bottles, sachets around bar soap 6. Very lightweight plastic carrier bags Very lightweight plastic carrier bags, except for very lightweight plastic carrier bags required for hygiene reasons or provided as sales packaging for loose food when this helps to prevent food wastage. required for hygiene reasons or provided as sales packaging for loose food when this helps to prevent food wastage. Very thin bags provided for bulk groceries (1) Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (OJ L 150, 14.6.2018, p. 1). and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (OJ L 150, 14.6.2018, p. 1). ANNEX VI Requirements specific to re-use systems and refill stations For the purposes of this Annex, the following definitions apply: (a) ‘governance guidelines’ means the governance structure of a re-use system that defines the role of system participants, ownership and any envisaged transfer of ownership of packaging, as well as other relevant governance elements of the re-use system as defined in this Annex; (b) ‘closed loop system’ means a re-use system in which reusable packaging is circulated by a system operator or a co-operating group of system participants without the change of the ownership of packaging; (c) ‘open loop system’ means a re-use system in which reusable packaging circulates amongst an unspecified number of system participants, and the ownership of the packaging changes at one or more points in the re-use process; (d) ‘system operator’ means any natural or legal person who is a system participant and manages a re-use system; (e) ‘system participant’ shall mean any natural or legal person who participates in a re-use system and performs at least one of the following actions: collects the packaging either from end users or from other system participants, reconditions it, distributes it among system participants, transports it, fills it with products, packs it or offers it to end users; a re-use system can comprise one or more system participants. it with products, packs it or offers it to end users; a re-use system can comprise one or more system participants. Part A Requirements for re-use systems 1. General requirements for re-use systems All re-use systems shall: (a) have a clearly defined governance structure as described in the governance guidelines; (b) have a governance structure that: (i) ensures that the objectives of the system in the governance guidelines and, if applicable, the re-use targets and any other objectives of the system can be met; (ii) allows for equal access and fair conditions of all economic operators wishing to become a part of the system; (iii) allows for equal access and fair conditions for all end users; (c) 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 adopted pursuant to Article 11(2); (d) have rules defining their functioning, including requirements for packaging use, that are accepted by all system participants and which: (i) specify types and design of packaging allowed to circulate in the system; (ii) describe the products intended to be used, filled or transported through the system; (iii) specify the terms and conditions for proper handling and packaging use; (iv) specify detailed requirements for packaging reconditioning; (v) specify the requirements for packaging collection; (vi) specify the requirements for packaging storage; (vii) specify the requirements for packaging filling or uploading; (viii) specify rules to ensure the effective and efficient collection of reusable packaging, including by providing for incentives for end users to return the packaging to the collection points or grouped collection system; (ix) specify rules to ensure equal and fair access to the re-use system, including for vulnerable consumers; (e) have a system operator that controls the proper functioning of the system and verifies whether re-use is properly enabled; (f) have reporting rules allowing to access data on the number of fillings or re-uses (i.e. re-use is properly enabled; (f) have reporting rules allowing to access data on the number of fillings or re-uses (i.e. rotations per category) and rejects, collection rate (i.e. return rates), sales units or equivalent units, including the material and per category, or an average estimation if the calculation is not feasible, number of units of reusable or refillable packaging added to the system, and number of units of packaging that have been handled by the end-of-life plan; (g) ensure that the design of the packaging is laid down in accordance with mutually agreed specifications or standards; (h) ensure a fair distribution of costs and benefits for all system participants; (i) ensure the implementation of the extended producer responsibility obligations for reusable packaging used in the system and that has become waste. the extended producer responsibility obligations for reusable packaging used in the system and that has become waste. The open loop systems which do not have a system operator shall be exempt from points (b)(i), (e), (f) and (h). Open loop systems established prior to the entry into force of this Regulation shall be exempt from the requirements under points (a), (b)(i) and (ii), (e), (f) and (h). force of this Regulation shall be exempt from the requirements under points (a), (b)(i) and (ii), (e), (f) and (h). 2. Requirements for closed loop systems In addition to the general requirements for re-use systems listed under point 1, closed loop systems shall satisfy the following requirements: (a) the system has reverse logistics facilitating transfer of the packaging from the end users back to the system participants; (b) the system ensure the collection, reconditioning and redistribution of packaging; (c) system participants are obliged to take the packaging back from the collection point if it has been used, collected and stored in accordance with the system rules. packaging back from the collection point if it has been used, collected and stored in accordance with the system rules. 3. Requirements for open loop systems In addition to the general requirements for re-use systems listed under point 1, open loop systems shall satisfy the following requirements: (a) after packaging is used, the system participant decides whether to re-use the packaging or to pass it to another system participant for re-use; (b) the system ensures that the collection, reconditioning and redistribution of packaging are in place and are generally available; (c) reconditioning meeting the requirements under Part B is part of the system. Part B Reconditioning available; (c) reconditioning meeting the requirements under Part B is part of the system. Part B Reconditioning 1. The reconditioning process shall not create risks for the health and safety of those responsible for carrying out the reconditioning of the packaging and shall minimise the impact of that process on the environment. It shall be operated in accordance with applicable laws on contact-sensitive materials, waste and industrial emissions. It shall be operated in accordance with applicable laws on contact-sensitive materials, waste and industrial emissions. 2. Reconditioning shall cover the following operations adapted to the reusable packaging format and its intended use: (a) assessment of the condition of the packaging; (b) removal of damaged or non-reusable components of the packaging; (c) conveyance of removed components of the packaging to an appropriate recovery process; (d) cleaning and washing the packaging according to required hygiene conditions; (e) repair of the packaging; (f) inspection and assessment of fitness-for-purpose of the packaging. 3. Where necessary, cleaning and washing processes shall be carried out at different stages of the reconditioning and repeated. necessary, cleaning and washing processes shall be carried out at different stages of the reconditioning and repeated. 4. The reconditioned product shall meet health and safety requirements applicable to it. Part C Requirements for refill Refill stations shall satisfy the following requirements: (a) the refill station displays clear and precise information on: (i) the hygiene standards that the end user’s container must meet in order for it to be used to purchase products at the refill station; (ii) the types and features of containers that can be used to purchase products through refill; (iii) the contact details of the final distributor to ensure compliance with hygiene standards under applicable law; (b) the refill station comprises a measuring device or provides alternative means of ensuring that the end user can choose a specified quantity of product for purchase; (c) the price paid by end users does not include the weight of the container. ANNEX VII Conformity assessment procedure Module A Internal production control not include the weight of the container. ANNEX VII Conformity assessment procedure Module A Internal production control 1. Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4 and ensures and declares on his sole responsibility that the packaging concerned satisfies the requirements of Articles 5 to 12 of this Regulation that apply to it. 2. Technical documentation The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the packaging’s conformity with the applicable requirements, and shall include an adequate analysis and assessment of the risks of non-conformity. with the applicable requirements, and shall include an adequate analysis and assessment of the risks of non-conformity. The technical documentation shall specify the applicable requirements and shall cover, as far as relevant for the assessment, the design, manufacture and operation of the packaging. and shall cover, as far as relevant for the assessment, the design, manufacture and operation of the packaging. The technical documentation shall contain, wherever applicable, at least the following elements: (a) a general description of the packaging and its intended use; (b) conceptual design, manufacturing drawings and materials of components; (c) descriptions and explanations necessary for the understanding of the drawings provided under point (b) and the schemes and operation of the packaging; (d) a list of: (i) the harmonised standards, referred to in Article 36, applied in full or in part; (ii) the common specifications, referred to in Article 37, applied in full or in part; (iii) other relevant technical specifications used for measurement or calculation purposes; (iv) in the event of partly applied harmonised standards or common specifications, an indication of the parts which have been applied; (v) in the event of harmonised standards or common specifications not being applied, a description of the solutions adopted to meet the requirements referred to in point 1; (e) a qualitative description of how the assessments provided for in Articles 6, 10 and 11 have been carried out; and (f) test reports. description of how the assessments provided for in Articles 6, 10 and 11 have been carried out; and (f) test reports. 3. Manufacturing The manufacturer shall take all measures necessary so that the manufacturing process and the monitoring thereof ensure compliance of the manufactured packaging with the technical documentation referred to in point 2 and with the requirements referred to in point 1. packaging with the technical documentation referred to in point 2 and with the requirements referred to in point 1. 4. Declaration of conformity The manufacturer shall draw up a written declaration of conformity for each packaging type and keep it together with the technical documentation at the disposal of the national authorities for 5 years after single-use packaging has been placed on the market, and 10 years after reusable packaging has been placed on the market. The declaration of conformity shall identify the packaging for which it has been drawn up. A copy of the declaration of conformity shall be made available to the relevant authorities upon request. drawn up. A copy of the declaration of conformity shall be made available to the relevant authorities upon request. 5. Authorised representative The manufacturer’s obligations set out in point 4 as regards keeping the technical documentation may be fulfilled by its authorised representative, on its behalf and under its responsibility, provided that those obligations are specified in the mandate. ANNEX VIII EU declaration of conformity No (*1) … 1. No … (unique identification of the packaging): 2. Name and address of the manufacturer and, where applicable, the manufacturer’s authorised representative: 3. This declaration of conformity is issued under the sole responsibility of the manufacturer. 4. Object of the declaration (identification of the packaging allowing traceability): description of the packaging: Object of the declaration (identification of the packaging allowing traceability): description of the packaging: 5. The object of the declaration referred to point 4 is in conformity with the relevant Union harmonisation legislation: … (reference to the other Union acts applied). 6. References to the relevant harmonised standards or the common specifications used or references to the other technical specifications in relation to which conformity is declared: 7. Where applicable, the notified body … (name, address, number) … performed … (description of intervention) … and issued the certificate(s): … (details, including the date of the certificate(s), and, where appropriate, information on the duration and conditions of validity). the date of the certificate(s), and, where appropriate, information on the duration and conditions of validity). 8. Additional information: Signed for and on behalf of: (place and date of issue): (name, function) (signature): (*1) (identification number of the declaration) ANNEX IX Information for registration and reporting to the register referred to in Article 44 Part A Information to be submitted upon registration and reporting to the register referred to in Article 44 Part A Information to be submitted upon registration 1. The information to be submitted by the producer or its authorised representative for extended producer responsibility shall include: (a) name and brand names (if available) under which the producer makes its packaging, including packaging of packaged products, available on the territory of the Member State and address of the producer, including postal code and place, street and number, country, telephone, if any, web address and e-mail address, indicating a single contact point; (b) where a producer has authorised an authorised representative with carrying out the extended producer responsibility obligations on its behalf, in addition to the information referred in point (a): name and address including postal code and place, street and number, country, telephone and e-mail address of the authorised representative; (c) national identification code of the producer, including its trade register number or equivalent official registration number and the European or national tax identification number; (d) a declaration on how the producer meets its responsibilities under Article 45, including a certificate issued by the producer responsibility organisation where Article 46(1) applies. Article 45, including a certificate issued by the producer responsibility organisation where Article 46(1) applies. 2. Where a producer responsibility organisation is entrusted with carrying out the extended producer responsibility obligations, the information to be provided by the producer shall include the name and contact details, including postal code and place, street and number, country, telephone, web address and e-mail address and the national identification code of the producer responsibility organisation, including the trade register number or an equivalent official registration number and the European or national tax identification number of the producer responsibility organisation, the represented producer’s mandate, and a statement by the producer or, where applicable, producer’s authorised representative for the extended producer responsibility or the producer responsibility organisation stating that the information provided is true. producer responsibility or the producer responsibility organisation stating that the information provided is true. 3. Where a producer responsibility organisation that has been entrusted with carrying out the extended producer responsibility obligations by the producer as referred to in Article 46(1), carries out the obligation to register set out in Article 44, it shall, in addition to the information required under point 1 of this Part, provide: (a) the names and contact details, including postal codes and places, streets and numbers, countries, telephones, web addresses and e-mail addresses of the producers represented; (b) the mandate of each represented producer, where applicable; (c) where the producer responsibility organisation represents more than one producer, a separate indication of how each one of the represented producers meets the responsibilities set out in Article 45. Part B Information to be submitted for reporting producers meets the responsibilities set out in Article 45. Part B Information to be submitted for reporting 1. Information to be submitted for reporting in accordance with Article 44(7): (a) national identification code of the producer; (b) reporting period; (c) quantities by weight of packaging categories as set out in Table 1 of Annex II that the producer makes available on the territory of the Member State for the first time or that the producer unpacks without being an end user; (d) arrangements to ensure the producer responsibility regarding the packaging made available for the first time on the territory of the Member State or from which packaged products are unpacked by a producer who is not an end user. 2. the territory of the Member State or from which packaged products are unpacked by a producer who is not an end user. 2. Information to be submitted for reporting in accordance with Article 44(8): (a) national identification code of the producer; (b) reporting period; (c) information on packaging types set out in Table 1 of this point; (d) arrangements to ensure the producer responsibility regarding the packaging made available for the first time on the territory of the Member State or from which packaged products are unpacked by a producer who is not an end user. Table 1 Quantities by weight made available on the territory of the Member State or unpacked Glass Plastic Paper/cardboard Ferrous metal Aluminium Wood Other Total 3. of the Member State or unpacked Glass Plastic Paper/cardboard Ferrous metal Aluminium Wood Other Total 3. Information to be submitted for reporting in accordance with Article 44(10): (a) quantities, by weight, per category of packaging waste, as defined in Table 2 of Annex II, collected in the Member State and sent for sorting; (b) quantities, by weight, per category of packaging waste recycled, recovered and disposed of within the Member State or shipped within Union or in a third country as set out in Table 3 of Annex XII; (c) quantities, by weight, of separately collected single-use plastic beverage bottles with a capacity of up to three litres and single-use metal beverage containers with a capacity of up to three litres, as set out in Table 5 of Annex XII. and single-use metal beverage containers with a capacity of up to three litres, as set out in Table 5 of Annex XII. ANNEX X Minimum requirements for deposit and return systems For the purpose of this Annex, the following definition applies: ‘system operator’ means any natural or legal person who is entrusted with a responsibility to establish or operate a deposit and return system in a Member State. person who is entrusted with a responsibility to establish or operate a deposit and return system in a Member State. Minimum general requirements for deposit and return systems Member States shall ensure that the deposit and return systems established on their territories meet the following minimum requirements: (a) a single system operator is established or licenced or, in the case there is more than one system operator, Member State shall adopt measures to ensure coordination between the different system operators; (b) the governance and related operational rules of the system allow for equal access and fair conditions of all economic operators wishing to become part of the system, provided they make available on the market packaging that belongs to a packaging type or category included in the system; (c) control procedures and reporting systems are set up allowing the system operator to obtain data on the collection of packaging covered by the deposit and return system; (d) a minimum deposit level is established, which is sufficient to achieve the required collection rates; (e) minimum requirements on the financial capacity of the system operator are established allowing the system operator to perform its functions; (f) the system operator is a non-profit and independent legal entity; (g) the system operator performs exclusively roles arising from the rules of this Regulation, and any additional roles related to the coordination and operation of the deposit and return system as established by the Member States; (h) the system operator coordinates the functioning of the deposit and return system; (i) the system operator keeps in writing: (i) a statute establishing the internal organisation of the system; (ii) evidence of the funding system of the system; (iii) a statement proving the compliance of the system with the requirements laid down in this Regulation, as well as any additional requirements established in the Member State in which it operates; (j) a sufficient amount of the annual turnover of the system operator is used for public awareness campaigns on the management of packaging waste; (k) system operators provide any information requested by the competent authorities of a Member State in which the system operates, for the purposes of monitoring compliance with the requirements in this Annex; (l) Member States shall ensure that final distributors are obligated to accept the deposit bearing packaging of the packaging material and format that they distribute and to provide end users with redeemed deposits when the deposit bearing packaging is returned, unless end users have equally accessible means to redeem the deposit after the use of the deposit bearing packaging, through one of the collection channels that, for food packaging, ensure food grade recycling and that are authorised for that purpose by the national authorities. for food packaging, ensure food grade recycling and that are authorised for that purpose by the national authorities. This obligation does not apply where the sale surface area does not make possible for end users to return deposit bearing packaging. However, final distributors will always have to accept the return of the empty packaging of products they sell; (m) the end user is able to return the deposit bearing packaging without the need to purchase any goods; deposit shall be redeemed to the end user; (n) all deposit bearing packaging that is to be collected by a deposit and return system is clearly labelled, so that the end users can easily identify the need to return such packaging; (o) fees are transparent. labelled, so that the end users can easily identify the need to return such packaging; (o) fees are transparent. In addition to the minimum requirements, Member States may set additional requirements, as appropriate, in order to ensure the fulfilment of the objectives of this Regulation, in particular to increase the purity of the collected packaging waste, reduce litter or promote other circular economy objectives. Member States with regions with high transboundary business shall ensure that the deposit and return systems allows for collection of packaging from other Member States’ deposit and return systems at designated collection points and shall endeavour to enable the possibility of return of a deposit that was charged to the end user when purchasing the packaging. to enable the possibility of return of a deposit that was charged to the end user when purchasing the packaging. ANNEX XI Implementation plan to be submitted pursuant to Article 52(2), point (d) The implementation plan to be submitted pursuant to Article 52(2), point (d), shall contain the following: (a) assessment of the past, current and projected rates of recycling, landfilling and other treatment of packaging waste and the streams of which it is composed; (b) assessment of the implementation of waste management plans and waste prevention programmes in place pursuant to Articles 28 and 29 of Directive 2008/98/EC; (c) reasons for which the Member State considers that it might not be able to attain the relevant target laid down in Article 52(1), point (b) or (d), within the deadline set therein and an assessment of the time extension necessary to meet that target; (d) measures necessary to attain the targets set out in Article 52(1), point (b) or (d), of this Regulation that are applicable to the Member State during the time extension, including appropriate economic instruments and other measures to provide incentives for the application of the waste hierarchy as set out in Article 4 of Directive 2008/98/EC; (e) a timetable for the implementation of the measures identified in point (d), determination of the body competent for their implementation and an assessment of their individual contribution to attaining the targets applicable in the event of a time extension; (f) information on funding for waste management in line with the polluter pays principle; (g) measures to improve data quality, as appropriate, with a view to better planning and monitoring performance in waste management. to improve data quality, as appropriate, with a view to better planning and monitoring performance in waste management. ANNEX XII Data to be included by Member States in their databases on packaging and packaging waste (in accordance with Tables 1 to 4) 1. For sales, grouped and transport packaging: (a) quantities, for each packaging categories of packaging generated within the Member State (tonnage produced, imported and stored, less tonnage exported) (Table 1); (b) quantities of reusable packaging (Table 2). produced, imported and stored, less tonnage exported) (Table 1); (b) quantities of reusable packaging (Table 2). 2. For sales, grouped and transport packaging waste: (a) for each packaging category (Table 3): (i) quantities of packaging made available on the territory of the Member State for the first time or of packaging from which products were unpacked by a producer who is not an end user; (ii) quantities of generated packaging waste; (iii) quantities of packaging disposed of, recovered, and recycled; (b) the annual consumption of very lightweight plastic carrier bags, lightweight plastic carrier bags and thick plastic carrier bags per capita, separately for each category, as laid down in Article 56(1), point (b), (Table 4); (c) separate collection rate of the packaging formats covered by the deposit return systems, as laid down in Article 50(1), (Table 5). Table 1 Quantity of packaging (sales, grouped and transport) generated on the territory of the Member State Tonnage produced – Tonnage exported + Tonnage imported + Tonnage stored = Total Glass Plastic Paper/cardboard Ferrous metal Aluminium Wood Other Total Tonnage imported + Tonnage stored = Total Glass Plastic Paper/cardboard Ferrous metal Aluminium Wood Other Total Table 2 Quantity of total reusable packaging (sales, grouped and transport) made available on the territory of the Member State for the first time Tonnage of packaging made available on the territory of the Member State for the first time Reusable packaging Reusable sales packaging Tonnage Percentage of total reusable packaging Tonnage Percentage of total reusable sales packaging Glass Plastic Paper/cardboard Ferrous metal (including tinplate) Aluminium Wood Other Total sales packaging Glass Plastic Paper/cardboard Ferrous metal (including tinplate) Aluminium Wood Other Total Table 3 Quantity per packaging category, as defined in Table 2 of Annex II, of: packaging made available on the territory of the Member State for the first time; packaging from which products were unpacked by a producer who is not an end user; generated packaging waste; and packaging waste disposed of, recovered and recycled on the territory of the Member State and exported Material Category Packaging made available on the territory of the Member State for the first time or unpacked (t) Packaging waste generation (t) Total packaging waste disposed of (t) Total packaging waste recovered (t) Total packaging waste recycled (t) Total packaging waste disposed of (t) Total packaging waste recovered (t) Total packaging waste recycled (t) On the territory of the Member State Outside the territory of the Member State Plastic PET rigid PE rigid, PP rigid, HDPE and PP rigid Films/flexible PS, XPS, EPS Other rigid plastics Biodegradable (rigid and flexible) Paper/cardboard Paper/cardboard (except liquid packaging board) Liquid packaging board Metal Aluminium Steel Glass Glass Wood Wood, cork Others Textile, ceramics/porcelain and others packaging board Metal Aluminium Steel Glass Glass Wood Wood, cork Others Textile, ceramics/porcelain and others Table 4 Quantity of very lightweight plastic carrier bags, lightweight plastic carrier bags, thick plastic carrier bags, and very thick plastic carrier bags per capita, consumed on the territory of the Member State Plastic carrier bags consumed on the territory of the Member State Number per capita Tonnes per capita very lightweight plastic carrier bags plastic carrier bags with a wall thickness below 15 microns lightweight plastic carrier bags plastic carrier bags with a wall thickness below 50 microns thick plastic carrier bags plastic carrier bags with a wall thickness between 50 and 99 microns below 50 microns thick plastic carrier bags plastic carrier bags with a wall thickness between 50 and 99 microns Table 5 Separate collection rate of packaging formats covered under the deposit return systems, as laid down in Article 50(1) Packaging made available on the territory of the Member State for the first time (t) Collected separately on the territory of the Member State by the deposit and return system (t) Single-use plastic beverage bottles with a capacity of up to 3 litres Single-use metal beverage containers with a capacity of up to 3 litres ANNEX XIII