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Supplement sector calls for delay to new EU packaging laws

Medicine, pill, health care concept
With new regulations surrounding PFAS and recyclable packaging looming, the supplement industry is concerned about whether the given timelines will allow companies to reach compliance on time. (Getty Images)

The European Federation of Associations of Health Products Manufacturers (EHPM) is calling for a temporary derogation of new packaging laws for food supplements amid concerns around implementation timelines.

The calls have come as a result of two proposed changes under the new Packaging and Packaging Waste Regulation (PPWR), including new rules on PFAS (per- and polyfluoroalkyl substances), or ‘forever chemicals’, and product recyclability.

While the EHPM supports the objectives of these policies, the trade association highlighted that the timeline provided by the European Commission is not sufficient.

Valérie Vercammen, managing director of Be-sup, the Belgian trade association for the food supplement industry, told delegates at the EHPM’s inaugural Food Supplement Summit (Jun. 23) that a ‘transitional approach’ is therefore needed.

“Sustainability, product integrity and consumer protection should not be competing objectives—they must go hand-in-hand and reinforce each other,” she told delegates. “As a sustainable industry, we are ready to innovate, we are investing, and we want to comply, but implementation must follow realistic timelines. This is why EHPM is asking for science-based, proportionate implementation of the PPWR.”

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New regulations on PFAS coming into force on Aug. 12

The PPWR is designed to prevent unnecessary packaging waste and promote reuse, refill and recycling to contribute to the circular economy and climate neutrality by 2050.

The regulations were also put in place to harmonize national measures as packaging regulations were previously determined by individual countries. This has historically caused problems with relabeling for different markets and created barriers for cross-country trade.

While the objectives of the regulation have been widely supported, there has also been pushback from many food business operators (FBOs) including calls for regulatory clarity and a push for grace periods.

For the supplement industry, there are two key areas of concern. The first is related to PFAS—widely used synthetic chemicals which are often employed in flexible plastic packaging and blister packs. These chemicals are highly persistent in the environment and can also increase the risk of several cancers, inflammatory bowel disease and pregnancy outcomes.

Next month (Aug. 12), all food-contact packaging containing a certain level of PFAS will be banned, and every piece of packaging on the EU market will be legally required to have its own declaration of conformity.

PFAS limits

The PPWR bans food-contact packaging containing PFAS above these limits:

  • 25 ppb (parts per billion) for any single PFAS compound
  • 250 ppb for the total of all PFAS compounds combined
  • 50 ppm (parts per million) for total fluorine, unless companies can prove the fluorine comes from a non-PFAS source

Vercammen said that while the EHPM supports the European Commission’s plans to restrict PFAS, significant practical challenges remain.

“There is no fully harmonized analytical methodology […], and it is quite difficult to find a laboratory that is able to test PFAS, yet in less than two months we will be required to have certificates," she said. “Suppliers are struggling too, still evaluating their packaging portfolios. Companies will not only have to assess the packaging itself but also assess inks, coatings and additives—every other component."

Vercammen also raised concerns about packaging which is found to contain PFAS retrospectively. FBOs will have to identify an alternative supplier and test the material to validate its properties. New stability studies will also be required in order to issue a declaration of conformity.

“It’s not an overnight switch,” she said. “This is why EHPM is asking for a pragmatic, transitional approach.”

Design for Recycling (DFR) requirements to come in by start of 2030

The other challenge facing FBOs is the new Design for Recycling (DFR) requirements which are due to come into effect in 2030. These new regulations will require packaging to achieve recycling grades A, B or C.

Recycling Grades

  • Grade A (≥ 95%): Highly recyclable. Meets the highest thresholds and pays the lowest eco-modulated EPR (Extended Producer Responsibility) fees.
  • Grade B (≥ 80%): Moderately recyclable. Functions within standard systems.
  • Grade C (≥ 70%): Marginally recyclable. It acts as a temporary pass, meaning FBOs will have to improve recyclability by 2038 when Grade C will be prohibited.
  • Grades D/E (< 70%): Considered technically non-recyclable.

The DFR criteria, however, is yet to be established. As they are not expected to be published until 2028, Vercammen expressed concerns that FBOs will not have sufficient time to complete the necessary testing before compliance with the new regulations becomes mandatory.

“Stability validation typically requires 24 to 36 months,” she said. “Once the criteria has been established, companies will have to find compliant packaging solutions. They will need to test them, validate them and generate stability data. So, the question is, if the final criteria arrives in 2028, and if stability studies require between 24 to 36 months, how can you be fully compliant by January 2030? The math does not work.”

Vercammen highlighted that these new packaging laws could also create problems for certain type of supplements, including probiotics, omega-3s, minerals and botanicals, which are all sensitive to moisture, oxygen and light.

Without adequate packaging, the quality of these products could become compromised, shelf life will shorten, product waste will increase, and consumers will not be protected.

“Take the example of blister packs for probiotics,” she said. “Many probiotic products rely on blisters because of its high barrier performance. Today, recyclable alternatives are under development, but many solutions still lack long-term validation under real commercial conditions. Before we as companies can switch, we must be sure that our products will remain stable for their entire shelf life—this is absolutely critical. Packaging is not marketing for us, it is part of product performance.”

The EHPM is therefore calling for a temporary derogation until 2035 for food supplements, recognizing them as stability-critical products. Specific exemptions have already been granted to the pharmaceutical industry, which relies on blister packs, vials and ampoules to protect medicines from contamination, degradation and moisture.

The trade body is also asking the European Commission for greater legal certainty regarding packaging stocks to ensure they do not need to be thrown away—something which would create more waste and run counter to the regulation’s objectives.

“We are not asking for less sustainability,” Vercammen said. “On the contrary, we are asking for implementation measures that are technical, feasible, economical, realistic and compatible with consumer protection.”

FBOs continue to push for timeline extensions

Other FBOs and trade organizations are also lobbying for leeway, including the International Probiotics Association (IPA).

“The regulation on packaging and waste is a challenge because its set very strict requirements for recycling,” said Rosanna Pecere, executive director of IPA Europe, during the the 19th International Scientific Conference on Probiotics, Prebiotics, Gut Microbiota, and Health (IPC), held last week in Krakow, Poland.

“The fact is the probiotic sector is not able to meet these requirements because of the characteristics of the product—we need specific packaging to keep the product alive. We have extended a request to the EC for an extension to the deadline for the probiotics sector, and the objective is to be vocal to hopefully be given a longer period for application of the regulation.”

In the coming days, EHPM will publish an official position paper outlining the practical implications of the legislation for the food supplement sector, highlighting the importance of ensuring that environmental objectives are implemented in a way that remains proportionate and workable for businesses.