PPWR Article 5: Substances of Concern, Heavy Metals, and PFAS Restrictions

Authors

Conor O’Donoghue

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This blog was originally posted on 14th September, 2026. Further regulatory developments may have occurred after publication. To keep up-to-date with the latest compliance news, sign up to our newsletter.

AUTHORED BY CONOR O’DONOGHUE, REGULATORY COMPLIANCE SPECIALIST, ADHERENT

Key Insight

Article 5 of the EU Packaging Regulation (PPWR) governs substance restrictions in packaging. There are multiple parts to Article 5 which primarily relate to:

Substances of concern in packaging;
Concentration limits for heavy metals in packaging; and
PFAS in food-contact packaging.

These provisions generally apply from 12 August 2026.

Substances of Concern
Heavy Metal Restrictions
PFAS
Next Steps
FAQ

Substances of Concern

Firstly, Article 5(1) requires ‘substances of concern’ in packaging to be minimised during the manufacturing process. This would include the presence of these substances “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.” There are currently no specific concentration limits under this provision for substances of concern.

The meaning of a ‘substance of concern’ is defined under Article 2(27) of the Ecodesign for Sustainable Products Regulation (ESPR). If any of the below criteria are met, then the substance is considered to be a ‘substance of concern’:

(a) the substance 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) the substance is classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 in one of the following hazard classes or hazard categories:
- (i) carcinogenicity categories 1 and 2;
- (ii) germ cell mutagenicity categories 1 and 2;
- (iii) reproductive toxicity categories 1 and 2;
- (iv) endocrine disruption for human health categories 1 and 2;
- (v) endocrine disruption for the environment categories 1 and 2;
- (vi) persistent, mobile and toxic or very persistent, very mobile properties;
- (vii) persistent, bioaccumulative and toxic or very persistent, very bioaccumulative properties;
- (viii) respiratory sensitisation category 1;
- (ix) skin sensitisation category 1;
- (x) hazardous to the aquatic environment — categories chronic 1 to 4;
- (xi) hazardous to the ozone layer;
- (xii) specific target organ toxicity — repeated exposure categories 1 and 2;
- (xiii) specific target organ toxicity — single exposure categories 1 and 2;
(c) the substance is regulated under Regulation (EU) 2019/1021; or
(d) the substance negatively affects the reuse and recycling of materials in the product in which it is present.

According to the Commission’s PPWR FAQ Document, manufacturers are to prove compliance with Article 5(1) by assessing in line with Annex C (Minimisation of Dangerous Substances or Preparations and Demonstration of Conformity) of the existing harmonised standard EN 13428-2004.

Furthermore, the Commission has stated in the FAQ Document that “Annex C of the existing harmonised standard EN 13428:2004 related to the ’minimisation of dangerous substances or preparations and demonstration of conformity’ can no longer create a presumption of conformity with the new rules concerning SoCs. However, until the updated harmonised standard becomes available, the existing standard EN 13428:2004 can be used.”

Secondly, Article 5(2) obligates the EU Commission to “monitor the presence of substances of concern in packaging and packaging components and shall take, where appropriate, the relevant follow-up measures.” This process would include the preparation of a report, in conjunction with the European Chemicals Agency, which would determine the impact of substances of concern on the re-use and recycling of materials or chemical safety. Follow-up measures may include new restrictions on certain substances. According to the FAQ Document, this process is currently ongoing.

The FAQ Document also states that “there is no definite number or list of substances of concern (SoC) in packaging. The study… will provide a list of SoC on the basis of the information currently available about packaging manufacturing and waste treatment.”

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Heavy Metal Restrictions

Article 5(4) restricts the sum of the concentrations of lead, cadmium, mercury and hexavalent chromium resulting from substances present in packaging or packaging components to a maximum of 100 mg/kg. This is without prejudice to the restrictions on chemicals set out in Annex XVII to Regulation (EC) No 1907/2006 or to the restrictions and specific measures on food-contact materials and articles in Regulation (EC) No 1935/2004.

Compliance with this restriction is to be demonstrated in the technical documentation drawn up in accordance with Annex VII. The Commission has recommended using CEN report CR 13695-1/2000 to demonstrate compliance.

The Commission has also confirmed that Decision 2001/171/EC (which contains a derogation for glass packaging in relation to heavy metal concentration levels in packaging and packaging waste) continues to apply. So, packaging may exceed the concentration limit for the sum of lead, cadmium, mercury and hexavalent chromium, when this exceedance is due to the addition of recycled glass.

PFAS

Article 5(5) prohibits the placing on the market of food-contact packaging if it contains 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:

25 ppb for any PFAS as measured with targeted PFAS analysis (polymeric PFAS excluded from quantification);
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
50 ppm for PFASs (including polymeric PFAS);

In their PPWR Guidance Document, the Commission has recommended the following approach to PFAS testing:

Total Fluorine (TF) quantification (step 1): If TF is below 50 mg/kg ( 16), sample could be considered compliant.
If TF is above 50 mg/kg, methods such as pyrolysis-GC/MS can be used to confirm whether the fluorine is organic (PFAS) or inorganic in step 2. If the organic fluorine is below 50 mg/kg, the sample could be considered compliant.
Direct TOP (total oxidizable precursors) analysis is recommended to check compliance with the 25 μg/kg ( 17) and 250 μg/kg concentration limit in step 3.

It is important to emphasise that this provision only applies to food-contact packaging and creates concentration limits, rather than outright banning PFAS in food-contact packaging.

The Commission has also noted in their FAQ Document that Article 5(5) “does not differentiate between intentionally added and unintentionally present PFAS. Therefore, the provisions in Article 5(5) apply to both.” According to the Commission, initial testing has indicated that only packaging containing intentionally added PFAS would exceed the allowed limits.

Again, compliance with this requirement is to be demonstrated in the technical documentation drawn up in accordance with Annex VII.

Next Steps

Much like many requirements emanating from the PPWR, we are awaiting the publication of numerous documents relating to Article 5, such as:

Follow-up measures relating to Article 5(2) on substances of concern (already mentioned above).
Commission’s evaluation and potential amendment or repeal of the PFAS restrictions to avoid overlaps with other EU Regulations. This is due by 12 August 2030.
The creation of a harmonised testing protocol for PFAS in food-contact packaging.
Potential adoption of delegated acts to lower the heavy metal concentration limits or to provide for exemptions from these limits.

Want to learn more about the PPWR? Download our expert guide.

FAQ

What does Article 5 of the EU Packaging Regulation (PPWR) govern?
Article 5 of the EU Packaging Regulation (PPWR) governs substance restrictions in packaging. There are multiple parts to Article 5 which primarily relate to: Substances of concern in packaging; Concentration limits for heavy metals in packaging; and PFAS in food-contact packaging.
What are the heavy metal concentration limits under Article 5?
Article 5(4) restricts the sum of the concentrations of lead, cadmium, mercury and hexavalent chromium resulting from substances present in packaging or packaging components to a maximum of 100 mg/kg.
Does Article 5 ban PFAS in food-contact packaging?
It is important to emphasise that this provision only applies to food-contact packaging and creates concentration limits, rather than outright banning PFAS in food-contact packaging.
Do the PFAS provisions apply to unintentionally present PFAS?
The Commission has also noted in their FAQ Document that Article 5(5) “does not differentiate between intentionally added and unintentionally present PFAS. Therefore, the provisions in Article 5(5) apply to both.”