PPWR regulation and the significance of CPSR documentation - Safety-relevant packaging information under the EU Cosmetics Regulation

1. Regulation (EC) No 1223/2009 on cosmetic products (Cosmetics Regulation)

Article 10 – Safety assessment

“In order to demonstrate that a cosmetic product complies with Article 3, the responsible person shall, prior to placing a cosmetic product on the market, ensure that the cosmetic product has undergone a safety assessment on the basis of the relevant information and that a cosmetic product safety report is set up in accordance with Annex I.”

Annex I – Cosmetic Product Safety Report

Part A requires, as a minimum:

“Impurities, traces, information about the packaging material”

Specifically: the purity of substances and mixtures; evidence of technical unavoidability of traces of prohibited substances; and “the relevant characteristics of the packaging material, in particular purity and stability.”

This is limited to aspects relevant to the safety of the finished cosmetic product for human health (primarily primary packaging in direct contact with the formulation, including potential migration).

Source: Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products and its subsequent consolidations.

Reference to Regulation EC No 1223/2009 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02009R1223-20260518 

2. Commission Implementing Decision 2013/674/EU – Guidelines on Annex I

This is the key European Commission guidance interpreting Annex I of Regulation 1223/2009.

Section 3.4.3 – The relevant characteristics of packaging material

“Packaging material means the container (or primary packaging) that is in direct contact with the formulation. The relevant characteristics of packaging materials in direct contact with the final product are important for the safety of the cosmetic product. Reference to Regulation (EC) No 1935/2004 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02004R1935-20210327

The combination of packaging material, formulation of the cosmetic product and contact with the external environment may have an impact on the safety of the finished product, due to the following factors: (a) interaction between the product and the packaging material; (b) barrier properties of the packaging material; (c) substance migration from/to the packaging material.

The information on relevant characteristics of the packaging materials in direct contact with the product should allow an estimation of potential risks.

The guidance focuses exclusively on safety (migration, compatibility, purity, stability). It does not require recyclability data, recycled-content percentages, PPWR Declarations of Conformity, or other sustainability/waste metrics.

Source: 2013/674/EU: Commission Implementing Decision of 25 November 2013 on Guidelines on Annex I to Regulation (EC) No 1223/2009,

Reference to Guidelines https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32013D0674

3. Regulation (EU) 2025/40 – Packaging and Packaging Waste Regulation (PPWR)

Article 4 – Packaging shall only be placed on the market if it complies with this Regulation.

Article 15 (and related) – Obligations of manufacturers: ensure packaging complies, prepare technical documentation (Annex VII), carry out conformity assessment, and draw up the EU Declaration of Conformity.

Article 39 and Annex VIII – EU Declaration of Conformity for packaging (model structure required; covers Articles 5–12 requirements on substances, recyclability, recycled content, minimisation, labelling, other matters)

Article 5 – Requirements for substances in packaging (heavy metals limit of 100 mg/kg; minimisation of substances of concern).

Article 3(1)(49) – Defines “contact-sensitive packaging” as including packaging intended for products within the scope of Regulation (EC) No 1223/2009 (cosmetics).

The PPWR creates independent obligations (Declaration of Conformity PLUS technical documentation under Annexes VII/VIII). It does not amend Regulation 1223/2009 or require its data to be inserted into the CPSR (Cosmetic Product Safety Report) /PIF (Product Information File).

Note: Where recycled content or substance restrictions under PPWR affect chemical safety/migration into the cosmetic product, those safety aspects must still be assessed under Annex I of 1223/2009 (as confirmed by the 2013 Guidelines and general safety obligations in Article 3 of the Cosmetics Regulation).

Source: Regulation (EU) 2025/40 of the European Parliament and of the Council of 19 December 2024 on packaging and packaging waste.

Reference to PPWR https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025R0040

Note: it applies generally from 12 August 2026, with phased later dates for specific provisions.

4. Other European Commission materials

• Commission Guidance on PPWR (published March 2026 by DG Environment) and associated FAQs clarify manufacturer obligations, definitions (including contact-sensitive packaging), PFAS restrictions mainly food-contact (also Substances of Very High Concern (SVHCs) under REACH), recyclability, and EPR (Extended Producer Responsibility), but do not require integration into the CPSR.

Reference to the guide on the European Commission Environment page - https://ec.europa.eu/commission/presscorner/detail/en/ip_26_664 

Reference to EPR https://environment.ec.europa.eu/topics/waste-and-recycling/packaging-waste/extended-producer-responsibility-packaging-small-businesses_en 

5.  Currently, no Commission guidance or legal text links the full set of PPWR sustainability/waste data recyclability grades, recycled-content targets for EPR purposes, sorting labels, the PPWR DoC (Document of Conformity) itself, and others as a mandatory element of the CPSR under Annex I of Regulation 1223/2009.

6.  Summary of requirements under EU law

• CPSR (Annex I of 1223/2009 along with 2013/674/EU Guidelines) take into consideration packaging data relevant to human health safety (migration, purity, compatibility, stability of primary packaging).

• PPWR (2025/40) is a separate technical documentation and Declaration of Conformity (DoC) for packaging sustainability and waste rules.

  • PPWR primarily addresses environmental protection and sustainability of packaging across its life cycle, while also covering aspects of chemical safety that can affect human health and the environment. It is not a pure “chemical safety” regulation like REACH, but it intersects with REACH on substances of concern.

• Overlap exists only where PPWR measures (e.g., recycled plastics) create potential safety/migration issues that must be evaluated in the CPSR.