The food supplement sector does not only compete on formulation; packaging also plays a key role. With the entry into force of EU Regulation 2025/40 on packaging and packaging waste, the rules of the game are changing for all companies that manufacture, market or simply use packaging to transport and distribute their products. At Lleó Productos Naturales, we are closely monitoring these regulatory developments because they directly affect how we design and manufacture products for our clients.
A Regulation, Not a Directive: Direct Application Across the EU
Unlike the former Directive 94/62/EC, which each country had to transpose into its own national legislation, the new legislation takes the form of a Regulation. This means that it applies directly and uniformly across all Member States, with no scope for differing national
interpretations. In Spain, the national framework established by Royal Decree 1055/2022 is undergoing a comprehensive reform to fully adapt and align with the requirements of the new European legislation before its full application.
Who Does It Really Affect?
This is one of the aspects that most surprises brands: the regulation is not aimed solely at packaging manufacturers. Any company that uses packaging to transport or distribute its products — even if it does not manufacture the packaging itself — also assumes certain
obligations.
In other words, if your supplement brand outsources production to a third party, responsibility for the packaging remains an issue that needs to be addressed.
The Developments with the Greatest Practical Impact
- Packaging minimisation: from 2030, weight and volume must be reduced to the minimum functionally necessary, with elements such as double walls and false bottoms prohibited.
- Mandatory recyclability: all packaging must be recyclable from 2030 and recyclable on a large scale from 2035.
- Minimum recycled content: mandatory percentages of recycled plastic are being established, with increasingly ambitious targets through to 2040.
- Substance restrictions: from August 2026, the presence of PFAS and heavy metals in packaging that comes into contact with food will be restricted, a particularly sensitive issue for food supplements.
Why Is It Advisable to Anticipate These Changes Now?
Although the regulation will be fully enforceable from August 2026, adapting formats, materials and manufacturing processes is not something that can be done immediately.
Reviewing a product’s packaging today — its composition, weight or recyclability — helps to avoid rushed redesigns and last-minute costs.
At Lleó Productos Naturales, we also support brands in this aspect of product development, integrating regulatory requirements from the initial design of the appropriate format through to final production.
For more information on how Lleó can help develop supplements that meet market
demands, visit us and get in touch.
Further information: https://lleo.es
