August 12th, 2026 marked a regulatory milestone in the EU with the implementation of Regulation (EU) 2025/40 on packaging (PPWR). This regulation replaces the previous directive and introduces immediate requirements regarding chemical safety, minimization, and technical documentation. We explain how the cosmetics, pharmaceutical, aerosol, and nutraceutical sectors can adapt without disrupting industrial operations.
Substance Restrictions and Chemical Safety
Effective August 12th, the PPWR prohibits the sale of food-contact packaging that exceeds the limits for perfluoroalkyl and polyfluoroalkyl substances (PFAS). It also establishes a maximum limit of 100 mg/kg for the sum of heavy metals such as lead, cadmium, mercury, and hexavalent chromium.
This measure requires manufacturers of aerosol formulations, cosmetics, and nutraceuticals to verify the composition of their containers and internal coatings. Ensuring that these materials are free of persistent contaminants is an essential technical requirement for operating in the EU market.
Declaration of Conformity and Technical Documentation
One of the most demanding new requirements is the obligation to have a Declaration of Conformity (Annex VIII) and a detailed technical file (Annex VII) for each type of packaging placed on the market. The assessment is based on internal production control (Module A).
To comply with these regulations, companies take the lead in managing documentation related to their products. It is essential to support the principles of minimization and security with information provided by suppliers. Keeping this record up to date for five years will ensure success and peace of mind in the event of any routine audit.
European Harmonization and Extended Producer Responsibility
As a regulation, the PPWR applies directly in all 27 Member States without the need for national transposition. This eliminates regulatory fragmentation and requires mandatory registration in the producer registry in order to operate legally under the Extended Producer Responsibility (EPR) scheme.
The definition of “producer” is expanded to include manufacturers, importers, and distributors who place the product on the market for the first time. For regulated sectors such as pharmaceuticals and cosmetics, switching to technically stable packaging materials like aluminum—which is infinitely recyclable—facilitates compliance with circular economy standards.
Practical Application: Steps to Ensure Industrial Compliance
To bring industrial operations into compliance with current PPWR requirements, we recommend implementing the following technical roadmap:
- Supplier Audit: Request safety data sheets and analytical reports certifying the absence of PFAS and compliance with heavy metal limits in coatings.
- Consolidation of the technical dossier: Organize the folders containing documentary evidence (Annex VII) and sign the Declarations of Conformity (Annex VIII) for each active product.
- Review of Producer Registration: Verify registration in the appropriate national registries to ensure compliance with RAP obligations.
The implementation of the PPWR should be viewed as a strategic opportunity to consolidate sustainable and transparent industrial processes. Keeping documentation up to date and working in partnership with approved suppliers ensures operational continuity without commercial friction, guaranteeing the full technical compliance of every container on the European market.
