Regulatory compliance for packaging: where to start?
Packaging compliance does not rely on a single regulation or one specific document. Depending on the material, intended use, packaged product and target market, different requirements may apply: consumer safety, food contact, chemical substances, environmental obligations or Extended Producer Responsibility.
With the application of the European Packaging and Packaging Waste Regulation, the PPWR (EU) 2025/40, since 12 August 2026, companies must also integrate new requirements into their compliance strategy. The Regulation notably covers environmental sustainability and packaging labelling, waste prevention, reuse, recycling and Extended Producer Responsibility.
Faced with this wide range of requirements, how can companies structure their packaging regulatory compliance approach effectively?
1. Clearly identify the packaging and its intended use
The first step is to clearly determine what needs to be assessed. The applicable regulatory framework may depend on several factors:
the nature and composition of the material;
the type of packaging;
the packaged product;
the intended conditions of use;
the markets where the product is placed on the market.
For example, packaging intended to come into contact with food will not be assessed in the same way as cosmetic packaging.
This initial characterisation helps define the relevant regulatory scope and identify the information that needs to be collected from suppliers.
2. Secure the information provided by suppliers
Packaging compliance largely depends on the quality of the information available on the materials and substances used in its composition. Collecting documentation from suppliers is therefore a key part of the assessment process.
Depending on the type of packaging, this information may include:
material composition;
available declarations of compliance;
restrictions applicable to certain substances;
intended conditions of use;
test results or data supporting the safety assessment of the packaging.
Appropriate supplier questionnaires can help structure this information-gathering process and identify missing data before the assessment continues.
3. For food packaging, assess food contact compliance
Materials and articles intended to come into direct or indirect contact with food are regulated at European level by Regulation (EC) No 1935/2004.
This Regulation notably establishes the principle that materials must not transfer their constituents to food in quantities that could endanger human health, result in an unacceptable change in the composition of the food or cause a deterioration in its organoleptic characteristics.
For plastic materials and articles, Regulation (EU) No 10/2011 sets out specific requirements, notably concerning composition, substance restrictions and migration limits. In this context, the compliance assessment may require:
reviewing supplier documentation;
reviewing or drafting declarations of compliance;
identifying substances subject to restrictions;
assessing the conditions of contact;
carrying out or coordinating overall or specific migration testing where necessary.
The declaration of compliance is notably an important element for plastic materials covered by Regulation (EU) No 10/2011. It helps provide the necessary information to operators throughout the supply chain to demonstrate the compliance of the material or article.
4. For cosmetic packaging, assess container-content interactions
For cosmetic products, packaging assessment must also take into account potential interactions between the container and the product.
The objective is to identify substances that may interact with the formulation or migrate from the packaging material, and then assess their relevance under the product’s actual conditions of use.
This approach may include:
collecting and reviewing supplier data;
identifying relevant substances;
risk assessment;
exposure assessment based on consumer use;
coordinating compatibility testing adapted to the product and its packaging.
The assessment should therefore focus on the container-content combination, rather than on the packaging material alone.
5. Integrate environmental requirements: PPWR and EPR
Packaging compliance is no longer limited to safety considerations. Regulation (EU) 2025/40 on packaging and packaging waste introduces a harmonised European framework covering the entire packaging life cycle. It notably introduces requirements relating to environmental sustainability and labelling, as well as provisions on packaging waste prevention, reuse, recycling and Extended Producer Responsibility.
Some obligations are associated with specific implementation timelines and implementing acts. Compliance therefore does not simply consist of assessing packaging at a given point in time: companies must also monitor regulatory deadlines and additional texts that progressively clarify the practical implementation of the Regulation.
For companies operating in several markets, Extended Producer Responsibility obligations must also be assessed according to the countries concerned.
6. Build a packaging compliance roadmap
When several packaging references, suppliers or markets are involved, managing each regulatory question separately can quickly become difficult.
A structured approach can include:
listing the packaging references and markets concerned;
identifying the applicable regulations;
checking the available documentation;
identifying gaps or missing information;
prioritising the necessary actions;
monitoring regulatory developments and upcoming deadlines.
A compliance audit or dashboard can then help centralise this information and provide a clear regulatory roadmap.
Compliance must be monitored over time
Packaging regulatory compliance is not a one-off exercise. Regulations evolve, new requirements gradually become applicable, and information relating to materials may also change. Regulatory monitoring tailored to the markets concerned therefore helps identify developments that may impact packaging already on the market or currently under development.
At CEHTRA, our experts support manufacturers, suppliers and packaging users with different aspects of regulatory compliance: regulatory monitoring, PPWR and Extended Producer Responsibility, food contact compliance, cosmetic packaging assessment, supplier dossier review, testing and training.
Would you like to assess the regulatory compliance of your packaging or identify the next steps to take?
