第5条 包装中の物質に関する要件

1. Packaging placed on the market shall be so manufactured that the presence and concentration of substances of concern as constituents of the packaging material or of any of the packaging components is minimised, including with regard to their presence in emissions and any outcomes of waste management, such as secondary raw materials, ashes or other material for final disposal, and to the adverse impact on the environment due to microplastics.

2. The Commission shall monitor the presence of substances of concern in packaging and packaging components and shall take, where appropriate, the relevant follow-up measures.

By 31 December 2026, the Commission, assisted by the European Chemicals Agency, shall prepare a report on the presence of substances of concern in packaging and packaging components, to determine the extent to which they negatively affect the re-use and recycling of materials or impact chemical safety. That report may list the substances of concern present in packaging and packaging components and indicate the extent to which they could present an unacceptable risk to human health and the environment.

The Commission shall submit the report to the European Parliament, to the Council and to the committee referred to in Article 65 of this Regulation setting out its findings and shall consider appropriate follow-up measures, including:

(a)for substances of concern in packaging materials which primarily affect human health or the environment, the use of the procedures referred to in Article 68(1) and (2) of Regulation (EC) No 1907/2006 to adopt new restrictions;

(b)for substances of concern that negatively affect the re-use and recycling of materials in the packaging in which they are present, the establishment of restrictions as a part of design for recycling criteria in accordance with Article 6(4) of this Regulation.

If a Member State considers that a substance negatively affects the re-use and recycling of materials in the packaging in which it is present, it shall, by 31 December 2025, supply such information to the Commission and the European Chemicals Agency and, where available, refer to the relevant risk assessments or other relevant data.

3. Member States may request the Commission to consider restricting, pursuant to Article 6(4), point (a), the use of substances of concern that potentially negatively affect the re-use and recycling of materials in packaging in which they are present, for reasons other than those related primarily to the chemical safety of those substances. Member States shall accompany such requests with a report documenting the identity and uses of the substances and a description of how the use of the substances in packaging hinders recycling, for reasons other than those related primarily to chemical safety. The Commission shall evaluate the request and present the results of that evaluation to the committee referred to in Article 65.

4. Without prejudice to the restrictions on chemicals set out in Annex XVII to Regulation (EC) No 1907/2006 or, where applicable, to the restrictions and specific measures on food-contact materials and articles in Regulation (EC) No 1935/2004, the sum of the concentrations of lead, cadmium, mercury and hexavalent chromium resulting from substances present in packaging or packaging components shall not exceed 100 mg/kg.

5. From 12 August 2026, food-contact packaging shall not be placed on the market if it contains per- and polyfluorinated alkyl substances (PFAS) in a concentration equal to or above the following limit values to the extent that the placing on the market of packaging containing such a concentration of PFAS is not prohibited pursuant to another Union legal act:

(a)25 ppb for any PFAS as measured with targeted PFAS analysis (polymeric PFAS excluded from quantification);

(b)250 ppb for the sum of PFAS measured as the sum of targeted PFAS analysis, where applicable with prior degradation of precursors (polymeric PFAS excluded from quantification); and

(c)50 ppm for PFASs (including polymeric PFAS); if total fluorine exceeds 50 mg/kg the manufacturer, importer or downstream user as defined respectively in Article 3, points (9), (11) and (13) of Regulation (EC) No 1907/2006 shall, upon request, provide to the manufacturer or the importer as defined respectively in Article 3(1), points (13) and (17), of this Regulation proof of the quantity of fluorine measured as content of either PFAS or non-PFAS in order for them to draw up the technical documentation as referred to in Annex VII to this Regulation.

‘PFAS’ means any substance that contains at least one fully fluorinated methyl (CF 3 -) or methylene (-CF 2 -) carbon atom (without any H/Cl/Br/I attached to it), except substances that only contain the following structural elements: CF 3 -X or X-CF 2 -X′, where X = -OR or -NRR′ and X′ = methyl (-CH 3), methylene (-CH 2 -), an aromatic group, a carbonyl group (-C(O)-), -OR′′, -SR′′ or –NR′′R′′′; and where R/R′/R′′/R′′′ is a hydrogen (-H), methyl (-CH 3), methylene (-CH 2 -), an aromatic group or a carbonyl group (-C(O)-).

By 12 August 2030, the Commission shall carry out an evaluation to assess the need to amend or repeal this paragraph in order to avoid overlaps with restrictions or prohibitions on the use of PFAS laid down in accordance with Regulations (EC) No 1935/2004, (EC) No 1907/2006, or (EU) 2019/1021.

6. Compliance with the requirements set out in paragraphs 4 and 5 of this Article shall be demonstrated in the technical documentation drawn up in accordance with Annex VII.

7. In order to take account of scientific and technical progress, the Commission may adopt delegated acts in accordance with Article 64 to amend this Regulation in order to lower the sum of the concentrations of lead, cadmium, mercury and hexavalent chromium resulting from substances present in packaging or packaging components referred to in paragraph 4 of this Article.

8. In order to take account of scientific and technical progress, the Commission may adopt delegated acts in accordance with Article 64 to supplement this Regulation in order to determine the conditions under which the sum of the concentrations referred to in paragraph 4 of this Article shall not apply to recycled materials or to product loops which are in a closed and controlled chain, as well as to determine the packaging types or formats of packaging, based on the packaging categories listed in Table 1 of Annex II to this Regulation, which shall be exempted from the requirements laid down in that paragraph. Such delegated acts shall be justified on the basis of a case by case analysis, time-limited, provide for appropriate marking and information requirements, and contain requirements for regular reporting in order to ensure that the exemption is regularly reviewed. Delegated acts adopted in accordance with this paragraph shall only be adopted to amend derogations established in Decisions 2001/171/EC and 2009/292/EC.

9. By 12 August 2033, the Commission shall carry out an evaluation to assess whether this Article and the design for recycling criteria set out in accordance with Article 6(4) have contributed sufficiently to minimising the presence and concentration of substances of concern as constituents of packaging materials.