5 min read
Introduction
Ever-changing regulations are indeed one of the factors that formulate the food and dietary supplement industries to ensure public health safety. For instance, certain botanical species containing hydroxyanthracene derivatives (HADs) will be banned in 2025. As a proposal from the European Commission (EC), the amendment to Regulation (EC) No. 1925/2006 has an objective to address health concerns arising from these substances.
This blog delves into the history of this regulatory shift, the botanical species affected, what it means to manufacturers, and how one can get compliance in the EU market.
1. Background on Hydroxyanthracene Derivatives
Hydroxyanthracene derivatives are natural compounds that occur in plants and have been used since antiquity, mostly for their laxative effects. They have been introduced in food supplements and herbal medicines since time immemorial due to stimulating bowel movement effects.
However, concerns over the safety of HADs have increased in the past decade. The EFSA has, in fact, issued an opinion that puts forward health risks from potential long-term exposure to the compounds. Specifically, it talked of genotoxicity, carcinogenicity, and gastrointestinal problems, which have alarmed health regulators. The EC has taken action, therefore, to now ban the use of HAD-containing botanicals in food products in order to prevent them from entering the consumers' markets.
2. Botanical Species Affected by the Amendment
The upcoming ban specifically targets certain botanical species that are known to contain hydroxyanthracene derivatives. These species include:
- Rheum palmatum (Chinese rhubarb);
- Rheum officinale (Turkey rhubarb);
- Rhamnus purshiana (Cascara sagrada);
- Rhamnus frangula (Alder buckthorn); and
- Cassia senna (Senna).
These botanicals have been widely used in the production of food supplements for their natural laxative effects. However, their continued use will be prohibited unless manufacturers can prove the analytical absence of hydroxyanthracene derivatives in their products by 2025.
3. Details of the Amendment
Here, the draft amendment to Regulation (EC) No. 1925/2006 clearly defines the specifications for manufacturers interested in distributing products containing these botanicals within the European market. Some of the specific features of the amendment are:
- Ban on Certain Botanicals: The five (05) species of botanicals having hydroxyanthracene derivatives will be restricted from use in dietary supplements if proof is found to be lacking for those compounds.
- Proof of Absence: Manufacturers must demonstrate, through validated analytical testing, that hydroxyanthracene derivatives are not present in the raw materials or finished products. In the absence of this proof, the products cannot be legally sold in the EU market.
Effective Date: The ban is likely to start in the first quarter of 2025, so manufacturers will have a period to reformulate or phase out affected products.
4. Manufacturer and Brand Owners Implications
The hydroxyanthracene derivatives ban will have deep effects on the manufacturers and brand owners in the food supplement market. The following are key affected areas:
a. Product Reformulation
For businesses that currently include these botanical species in their formulations, reformulation will be essential to comply with the new regulations. This could involve sourcing alternative ingredients that offer similar benefits without the health risks associated with hydroxyanthracene derivatives. Finding such alternatives may require significant research and development, adding to the cost of compliance.
b. Supplier Engagement
Manufacturers will have to collaborate with suppliers for products free of raw materials that contain hydroxyanthracene derivatives. This requires documentation and testing results from the suppliers that prove the absence of the substances. This will thus disrupt the existing supply chain since a company may have to source supplies from different firms or install new quality control measures.
c. Testing and Quality Assurance
Companies need to put in stringent testing procedures to be able to confirm the absence of hydroxyanthracene derivatives in their commodities. This includes embracing analysis techniques that the regulatory authorities permit and introducing testing procedures in the control of quality methods. Manufacturers are likely to incur higher operation costs on both infrastructure and talent to carry out these tests.
d. Labeling and Advertising Changes
EU marketability will now be denied for the products that continue using banned botanicals unless reformulated. The eventual implication is an upgrade in labelling, marketing materials, and product description.This action is necessary to avoid infractions, strictly speaking, in the realms of regulation, and allows consumers to have proper information on the products.
5. Impact on the Food Supplements Industry
The ban on hydroxyanthracene derivatives will reshape the food supplement industry in several ways:
a. Market Access and Product Availability
Many products, currently available, contain hydroxyanthracene derivatives, often marketed for their laxative effect. With a ban on these compounds, their products will either need to be re-formulated to cease operations or at least significantly reduced in the marketplace, which could make it difficult for manufacturers to maintain sales in some instances by changing formulations or creating new products.
b. Supply Chain Disruptions
It may be challenging for SMEs to source compliant raw materials free from hydroxyanthracene derivatives. Whenever manufacturers find alternative suppliers, shortfalls in the supply chain combined with high demand for compliant ingredients may result in shortages and unavailability besides modifying the price of products.
c. Higher Compliance Costs
This will increase costs for manufacturers in terms of reformulation, testing, and quality assurance. SMEs will be hardest hit by this because absorbing these costs may be very challenging for them. Prices would, therefore, rise for end users or businesses may suffer low profit margins. Larger firms might be in a better position to bear these challenges but it will still attract a high cost burden.
6. Future Trends in Botanical Regulation
Hydroxyanthracene derivatives banned
The ban on hydroxyanthracene derivatives seems to signal an overall regulatory trend in the EU's scrutiny of botanical ingredients used for food supplements. With greater public awareness of the safety of ingredients and continued prioritization of consumer health by regulators, it will likely be that even more botanical substances are placed under review. Companies must remain vigilant in current regulations with preparedness for probable future regulatory revisions. Proactive monitoring of EU legislation, coupled with a commitment to innovation in product formulation, will be key to maintaining compliance and market relevance.
7. How Can Freyr Help?
Regulatory changes are complex issues for companies that work with multiple market requirements. Freyr is a company that carries significant expertise in regulatory affairs to ensure manufacturers meet the new requirements on hydroxyanthracene derivatives. Our list of services includes:
- Consultation regarding the regulatory impact of the ban on your product as well as the consultative approach to reformulation.
- Supplier verification: We help in assessing suppliers for the suitability of raw materials to adhere to regulation requirements.
- Testing Protocols: Freyr will assist manufacturers in developing testing protocols to confirm the absence of hydroxyanthracene derivatives.
- Labeling and Marketing Compliance: We ensure all product labels and other materials are in full compliance with the EU regulations to avoid costly recalls or penalties.
- Partnerships with Freyr will ensure their business stays compliant, safe about their products, and not easily disrupted.
Conclusion
The upcoming ban on hydroxyanthracene derivative-containing botanicals is a significant regulatory change for the EU food supplement industry. While the ban aims to protect consumer health, it presents numerous challenges for manufacturers, from product reformulation to supply chain management. Companies that prepare early, adopt stringent testing protocols, and engage with trusted regulatory partners like Freyr will be well-positioned to navigate these changes successfully.
For more details on the regulatory implications of this amendment and how to ensure compliance, feel free to reach out to Freyr’s regulatory experts.
