As of 12 August, companies in the Life Science, Healthcare and Food sectors must be able to demonstrate the compliance of their packaging and the existence of a credible implementation plan in place.
Acting late exposes companies to urgent, often costly interventions that are difficult to manage, with possible repercussions on business continuity.
Regulatory context
The Packaging and Packaging Waste Regulation repeals the former Directive 94/62/EC and affects multiple business functions, including:
It is not just a “quality issue”; it requires cross-functional coordination.
Without genuine coordination between these areas, the risk is inefficiencies and delays.
Regulatory Requirements
The regulation introduces stringent requirements at every level of the supply chain which, depending on the product and packaging category, include:
Restrictions on substances
New restrictions on PFAS, BPA and metals, with a direct impact on packaging material selection.
Waste reduction and recyclability
Minimum recycled-content percentages and design-for-recyclability requirements for specific packaging types.
Harmonised labelling
New requirements calling for updates to packaging materials and consumer-facing claims.
Format and material restrictions
Specific restrictions on formats that may affect the design of existing and in-development packaging.
What should not be underestimated
Many companies are still addressing the PPWR in a fragmented way. This can lead to significant operational, economic and reputational consequences.
Misinterpretation of exemptions
Exemptions for the pharmaceutical sector are not automatic: they require technical and regulatory assessments supported by robust technical justification, and do not cover secondary or tertiary packaging.
Urgent, costly adaptations
Acting late turns a structured compliance plan into an operational emergency, with costs often significally higher than a preventive approach.
Market launch delays
Delays in placing products on the market, resulting in lost revenue and a
competitive position that is difficult to recover.
Supplier and material challenges
The transition requires supply chain alignment, which takes time and advance planning involving procurement and suppliers.
MOCA / PPWR misalignment
For food supplements and food products, the new PPWR restrictions on PFAS add to the existing MOCA (Materials in Contact with Food) requirements, requiring more in-depth checks on the safety, migration and suitability of materials.
For companies operating in the food and packaging sectors, Neagea – the PTM Group company specializing in this field – supports compliance with the PPWR using the same structured approach.
Loss of competitiveness
Companies that adapt in time can turn compliance into a strategic advantage. Those who delay risk penalties, inefficiencies and a competitive disadvantage.
How we support companies
We support companies in the Life Science, Healthcare and Food sectors with a dedicated service to address the PPWR in a structured, strategic way.
We analyse the packaging portfolio to identify the relevant categories, the scope of the assessment and the current compliance level of primary, secondary and tertiary materials.
We correctly interpret PPWR requirements and the exemptions applicable to the specific product and market context, assessing the interaction with MOCA regulations for the food and food-supplement sector.
We assess risks and opportunities across the entire product portfolio, identifying impacts on existing and in development packaging, including an assessment of the effect on industrial costs and the supply chain.
We define compliant, long-term sustainable compliance strategies, coordinating the company functions involved — regulatory affairs, quality, R&D, packaging, procurement and supply chain.
We support companies in proactively identifying critical issues, updating labels and claims, and managing the impact on go-to-market timelines.
PTM Consulting’s advisory service enables you to:
Reduce compliance costs through structured, early planning ahead of the deadline
Reduce compliance costs through structured, early planning ahead of the deadline
Improve packaging sustainability and strengthen competitive market positioning
Our Methodology
Our structured approach covers every critical aspect of the compliance process.
 Area |
 PTM Approach |
 Benefit |
|---|---|---|
| Area: Packaging portfolio mapping |
PTM Approach: Systematic analysis of primary, secondary and tertiary packaging across all products |
Benefit: Clear understanding of the scope of intervention |
| Area: Regulatory interpretation and exemptions |
PTM Approach: Technical and regulatory review of sector-specific requirements |
Benefit: Correct application of available exemptions |
| Area: MOCA / PPWR integration |
PTM Approach: Joint assessment of MOCA and PPWR requirements for food and food supplements |
Benefit: Avoiding misalignments and duplicate documentation |
| Area: Material impact assessment |
PTM Approach: Safety, migration and suitability analysis of packaging materials |
Benefit: Compliant and sustainable material choices |
| Area: Supply chain and suppliers |
PTM Approach: Identification of impacts on industrial costs, suppliers and procurement |
Benefit: Operational continuity and a resilient supply chain |
| Area: Labelling and claims |
PTM Approach: Updating labels in line with the new harmonised requirements |
Benefit: Point-of-sale compliance and reduced legal risk |
| Area: Go-to-market timelines |
PTM Approach: Assessment of impacts on launch plans for products in development |
Benefit: Reduced time-to-market risk |
| Area: Cross-functional coordination |
PTM Approach: Structured involvement of regulatory, quality, R&D, procurement and commercial teams |
Benefit: Elimination of inefficiencies and delays caused by organisational silos |
The deadline to meet
12 August 2026
By this date, companies must be able to demonstrate a clear understanding of their compliance level and have a clear implementation strategy.
Effectively addressing the PPWR requires a structured approach based on technical and regulatory analysis. It is not simply a matter of verifying formal compliance, but of thoroughly understanding how each packaging component fits within the new requirements.
Contact a PTM consultant now
We can discuss the specific implications for your sector and work with you to assess the most suitable strategy.
Fill in the contact form and one of our PPWR specialists will call you back.
Via Roma, 24 – 42049 S.Ilario d’Enza (RE) Italy
