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COMPLIANCE PACKAGING WITH SUBSTANCE RESTRICTIONS

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Packaging Substance Restrictions

Due to the heavy concentration of metals that they may contain, compliance of packing should be tested and assessed against substance restrictions such as the following chemicals:

  • lead and lead compounds;
  • mercury and mercury compounds;
  • cadmium and cadmium compounds;
  • hexavalent chromium.
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Model Toxics in Compliance Packaging Legislation

This Model Legislation first appeared in 1989 and was known as the Coalition of Northeastern Governors (CONEG) legislation. Overall, their main objective was to reduce the presence of these four heavy metals and their compounds in packaging and its components. Thus, they intended for all the US states to adopt this legislation. However, only 19 adopted it as of 2021. These are the 19 member states of the Toxics in Packaging Clearinghouse (TPCH).

The Model Legislation also took hold in the EU where, for example, the packaging and packaging waste Directive 94/62/EC was instated.

Generally, the requirements for these regulations are to prohibit the intentional use of the four metals in any amount. Additionally, any incidental use of these metals cannot surpass a cumulative sum of 100 ppm by weight (0.01% w/w).

EU Packaging Substance Restrictions and Compliance with Directives 94/62/EC, 2018/852, and the PPWR

European Union RoHS Flag

The European Union’s packaging and packaging waste regulations play a central role in its transition toward a circular economy. Directive 94/62/EC, its 2018/852 amendment, and the Packaging and Packaging Waste Regulation (PPWR), effective February 11, 2025, govern packaging substance restrictions and waste management.

Key Compliance Requirements:

1. Management of Declarations of Conformity:

Importers and manufacturers collect and manage declarations of conformity from packaging suppliers. These documents confirm compliance with the EU’s stringent substance restrictions and environmental criteria.

2. Extended Producer Responsibility (EPR):

Importers and manufacturers of goods:

  • Register with national authorities in each Member State where they market their products.
  • Subscribe to a compliance scheme, which includes reporting packaging quantities placed in every Member State.
  • Finance the recycling and disposal of packaging waste, following national regulations and targets the PPWR sets.

 

3. Provisions in the PPWR:

The PPWR strengthens measures to reduce the environmental and health impacts of packaging waste. These measures include:

  • Waste reduction targets.
  • Restrictions on excessive packaging, particularly in e-commerce.
  • Improvements in recyclability increased recycled content and the elimination of harmful substances such as PFAS (per- and poly-fluoroalkyl substances).

 

4. Appointment of an Authorized Representative (AR):

Producers appoint an Authorized Representative (AR) to act on their behalf in the EU. One AR represents producers across all EU Member States. These AR obligations align with those for battery waste management but differ from WEEE (Waste Electrical and Electronic Equipment) regulations.

The PPWR harmonizes national regulations and ensures sustainable management of packaging and packaging waste across the EU.

Key Changes in the EU Packaging Regulation:

Limits on Heavy Metals

Article 5(4) of EU 2025/40 (PPWR) maintains the total concentration limit of 100 ppm for lead (Pb), cadmium (Cd), mercury (Hg), and hexavalent chromium (Cr(VI)) in packaging materials. This requirement remains unchanged from the previous directive.

PFAS Restrictions for Food-Contact Packaging

Article 5(5) sets strict limits on PFAS concentrations in food-contact packaging, prohibiting market placement if PFAS exceeds:

  • 25 ppb for individual PFAS tested using target analysis (excluding polymeric PFAS).
  • 250 ppb for the sum of individual PFAS, where applicable with prior degradation of precursors (excluding polymeric PFAS).
  • 50 ppm for total PFAS, including polymeric PFAS. If total fluorine content exceeds 50 mg/kg, manufacturers provide technical documentation (Annex VII) to confirm whether fluorine originates from PFAS or non-PFAS sources.

 

Labeling and Marking Requirements

To enhance sorting and recycling, Article 12 mandates:

  • A harmonized label indicating the material composition of packaging by 12 August 2028 or 24 months after the relevant implementing acts come into force, whichever is later.
  • Standardized digital markings for packaging containing Substances of Concern (SoC).
  • A defined digital marking format under delegated acts, including the name and concentration of any SoC(s) present in each material within a packaging unit.

 

Mandatory Recyclability and Reuse Standards

PPWR enforces binding recyclability criteria, requiring electronics manufacturers to:

  • Use packaging with a minimum recycled content.
  • Meet reusability targets for specific packaging types.

 

Increased Reporting and Compliance Obligations

Companies selling in the EU market submit detailed packaging composition reports and demonstrate compliance with recyclability and reuse criteria. Stricter supply chain documentation impacts manufacturers’ sourcing of packaging from multiple suppliers.

 

Declaration of Conformity (DoC) Requirements

Per Article 39 & Annex VIII, manufacturers provide a Declaration of Conformity (DoC) confirming compliance with the regulation. The DoC includes:

  • Packaging identification, manufacturer details, and a statement of responsibility.
  • Relevant EU legislation and standards applied.
  • Any certifications issued by a notified body (if applicable).

If packaging or the packaged product falls under multiple EU regulations requiring a DoC, manufacturers prepare a single DoC covering all relevant Union acts or compile individual declarations into a compliance dossier.

PPWR’s Impact on Electronics Manufacturers

The Packaging and Packaging Waste Regulation (PPWR) imposes additional compliance requirements on electronics manufacturers, including:

  • Providing technical documentation for SoC restrictions and labeling requirements.
  • Reassessing packaging materials for recyclability and compliance.
  • Collaborating with suppliers to obtain verified compliance documentation.
  • Updating regulatory reporting processes to align with EU-wide standards.
 

United States Toxics in Packaging

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The toxics in packaging legislations in the US are:

  • TPCH Section 95G of the Revised Code of Washington.
  • The Model Legislation, USA Coalition of Northeastern Governments, known as CONEG.

These laws diverge in the allowable exemptions they allow and the enforcement of their requirements. However, state laws are always precedent over the original Model Legislation.

Additional Requirements to TPCH

In February 2021, the US updated the Model Toxics in Packaging Legislation. The legislation now includes the following substances:

  • Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS);
  • Ortho-Phthalates, (commonly known as phthalates).

 

Additionally, they introduced new criteria and processes for regulating and identifying other concerning chemicals in packaging.

Each state will need to adopt these changes within its local laws or issue a new regulation addressing toxic substances in packaging.

China Packaging National Standards

China RoHS Flag

GB/T 16716 Packaging and the environment is a Chinese national standard related to packaging and pollution prevention. Initially implemented in 2008, the standard aims to reduce environmental impacts by regulating packaging materials, their design, production, utilization, and disposal. According to the standard, the combined amount of lead, cadmium, mercury, and hexavalent chromium in packaging and packaging materials should not exceed 100 mg/kg. Furthermore, the standard outlines strict labeling requirements, ensuring that information about packaging composition, recyclability, and environmental impact is communicated to consumers.

Notably, China has similar standards for packaging used in various applications. For instance, GB 43352-2023 limits heavy metals used in express and mail packaging made of paper, plastic, and textile fibers.

Compliance Packaging with Substance Restrictions: How to be Toxics-Free?

Packaging Substance restrictions

We recommend you contact your supply chain and verify whether it meets the strictest obligations in terms of heavy metals limit in packages, i.e.:

  1. The regulated metals –  lead, mercury, cadmium, and hexavalent chromium – were not intentionally added to any package or packaging component during the manufacturing process;
  2. The sum of the incidental concentration levels of lead, mercury, cadmium, and hexavalent chromium present in any package or package component does not exceed 100 parts per million by weight;
  3. Adequate documentation is maintained for inspection upon request.

To do so, you can use the free EPEC Enviropass Product Environmental Compliance Form.

EPR Packaging Laws in the United States: What You Need to Know

With increasing concerns about packaging waste, several states in the U.S. have introduced Extended Producer Responsibility (EPR) packaging laws. These laws aim to hold producers responsible for the entire lifecycle of their packaging, from production to disposal. The goal? To reduce packaging waste, promote recycling, and relieve local governments of the financial burden of managing waste.

Under EPR laws, producers must:

  • Join a Producer Responsibility Organization (PRO) to manage recycling and waste.
  • Report packaging data and pay fees based on packaging volume and sustainability.
  • Adopt eco-friendly packaging to reduce waste and minimize costs.
 

These laws are currently in place in California, Colorado, Maine, Minnesota, and Oregon. While each state has a unique approach, they share the goal of reducing waste and increasing recycling rates. For example, California’s Senate Bill 54 aims to recycle 65% of single-use plastics by 2032, and Colorado’s House Bill 22-1355 mandates that producers fund a statewide recycling program.

By complying with these laws, businesses can avoid penalties, reduce environmental impact, and benefit from a more sustainable brand image.

If you’re unsure of your compliance obligations or need help navigating these regulations, Enviropass can provide expert guidance and support.

Recycling Symbols on Packaging

Packaging should have recycling symbols. The recycling marking discloses whether the packaging is recyclable and provides information about the packaging materials. The table below summarizes different recycling markings used for various types of materials.

Material Name

Recycling Marking

Description

Paper

Applicable to products such as paper boxes, paper crates, and molded pulp forms. May be labeled as “Paper” on the lower portion of the marking.

Plastic

The recycling symbol contains a code identifying the material used. Examples are:

  • 01 – Polyethylene terephthalate (PET)
  • 02 – High-density polyethylene (HDPE)
  • 03 – Polyvinyl chloride (PVC)
  • 04 – Low-density polyethylene (LDPE)
  • 05 – Polypropylene (PP)
  • 06 – Polystyrene (PS)

Aluminum

May be labeled as “Aluminum” on the lower portion of the marking.

Iron

May be labeled as “Iron” on the lower portion of the marking.

Triman Logo

Notably, countries around the world may require additional recycling symbols and information. For instance, France uses the Triman logo along with product recycling.

Other obligations, like EU REACH on Substances of Very High Concern (SVHC) and Permanent Organic Pollutants (POP), also apply to packages. You can use the EPEC form to cover all Packaging, REACH, TSCA-PBT, California Proposition 65, and POP requirements.

Ask Enviropass to perform compliance assessments for the packaging you use on your behalf, whether it is about labeling, technical documentation maintenance, or simply following up with suppliers.

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