Hylobates España

22/12/2025

Hylo's Luca Bucchini as ESSNA Chair on what the future holds for Sports Nutrition

This year marked major shifts in sports nutrition, driven by accelerated EU regulatory activity on Maximum Permitted Levels (MPLs) and an intense public debate on ultra-processed foods (UPFs). Looking ahead to 2026, the sector faces evolving challenges around EU–UK alignment, Single Market integra...

19/12/2025

Hylo's Luca comments on 50 probiotic strains declared not novel or not novel in Food Supplements on December 17th. An interesting present from the EC and the Member States for the FS industry

The European Commission has updated its Novel Food Catalogue to add 34 probiotic strains considered ‘not novel’ when used in food or food supplements.

02/12/2025

Find Luca's comments in the new NutraIngredients article regarding the European Food Safety Authority (EFSA)'s suggested safe consumption limit of 1 μg/kg of body weight for the combined intake of delta-8 and delta-9 THC from food.


By Nikki Hancocks

The European Food Safety Authority (EFSA) has released a new scientific opinion on delta-8-tetrahydrocannabinol (THC), updating the acute reference dose (ARfD) to include delta-8 alongside delta-9-THC. This revision prompts the European Commission and Member States to consider regulatory measures to...

01/12/2025

The Ministry of Health has recently published the new version of the Guidelines on Foods for Special Medical Purposes (FSMP) – revision of July 15, 2025.

The category of Foods for Congenital Metabolic Diseases (CMD) is introduced, with warnings regarding excess vitamins and minerals, and the categories of FSMPs (nutritionally complete, incomplete, adapted) have been updated. Specific warnings are provided for patients with renal insufficiency or CMD: for example, evaluating the additional intake of sodium, potassium, and phosphorus in patients with aminoacidopathies, or monitoring dysphagia and the risk of malnutrition in patients on levodopa therapy.

Freeze-dried and homogenized meals can no longer be classified as FSMPs in the context of dysphagia; ready-to-eat meals must state dilution instructions according to the IDDSI framework and indicate whether they are intended for adults, children, or both.

In the new version, labeling must clearly indicate the medical condition for which the product is intended, the risks for individuals for whom the product is not intended, and the statement “must be used under medical supervision,” a concept reiterated and expanded upon with the term “dietary management” for non-autonomous patients. The prohibition on using nutrition and health claims remains confirmed.

In this context of continuous updates and sector progress, Hylobates offers support and guidance to clients in the management of FSMPs, from classification and labeling to notification.

25/11/2025

AFMS Ruling: Stop Repetitive Nutrition Facts on FOP!

A recent ruling clarifies the labeling of Foods for Special Medical Purposes (AFMS), according to the AFMS Regulation!

The AFMS Regulation requires a description of the product's properties related to the disease/condition being treated (e.g., 'for dysphagia').

The Case: A company (Nestlé) used this space to include nutritional claims on the FOP (Front-of-Pack), such as "X fiber per serving."

The Ruling: These nutritional claims (e.g., amount of fiber or protein) on the AFMS FOP are not permitted and are considered impermissible repetitions (Art. 6.2 AFMS Regulation).

Key Points to remember:

No more "per serving" on the FOP: Even if the nutritional information in the table is per 100g, reporting the same information (e.g., fiber, protein) on the FOP per serving is still an unauthorized repetition (this reinforces an existing interpretation).

No more "disguised claims": Repetitions "disguised as claims" (e.g., "20g of protein per serving") are considered unauthorized repetitions.

➡️ In Summary: Nutritional information such as the amount of fiber or protein cannot be included on the FOP of AFMS. This is different from the provisions of EU Regulation 1169/2011 for traditional foods, where some repetitions are permitted (Art. 30.3).

24/11/2025

The Swiss Federal Food Safety and Veterinary Office (FSVO) recently issued Signal Report ADURA F-2024-021 regarding the trend of "microdosing", The termis is used for the consumption of minute quantities of psychotropic substances like psilocybin or L*D in foodstuffs, a Silicon valley trend.
The FSVO notes adverse events linked to microdosing and availability of products on the Swiss and EU market. Under Swiss law, they say, psychotropic substances are governed exclusively by the Narcotics Act. Consequently, they are statutorily excluded from the definition of "food." Contrary to online claims, there is no regulatory "grey zone" here.
Similar rules apply in the EU. Article 2 of Regulation (EC) No 178/2002 (General Food Law) defines "food". Paragraph (g) explicitly excludes "narcotic or psychotropic substances." In other words, a psilocybin gummy is not a "food supplement" under Directive 2002/46/EC because it cannot be food. Further rules in the Member States may reinforce this principle. For food business operators observing US trends, Hylo's Luca says, microdosing belongs to narcotics legislation, not food law.
*D

20/11/2025

The European Council has agreed to move forward with the elimination of the €150 customs threshold, so-called "de minimis". Recently, this threshold has been used by Chinese companies to ship low cost parcels to the EU, directly from China (according to the Commission, 90% of such parcels are from China). This rise in direct shipping has also raised compliance concerns in terms of EU rules on safety and the environment. New rules are expected to come into force within a year. The new rules may slow the extension of this business model to food supplements and other food products on top of other regulatory restrictions, says Hylo's Luca, although many will lament the pace of EU action

13/11/2025

Find Luca Bucchini's comment on the 'Risk Free Guarantee' for CBD products in the new NutraIngredients article.

The European Food Safety Authority (EFSA) has once again issued a negative opinion on the use of synthetic cannabidiol (CBD) in food supplements, leading to further questions over the future of the market.

05/11/2025

The regulatory fate of Hydroxyanthracene Derivatives (HADs) remains in legal limbo after the initial EU ban, applied in March 2021 due to concerns over the substance's genotoxicity, was formally annulled by the General Court in late 2024. The Court ruled the European Commission failed to establish a consumption threshold for the ban, but the Commission successfully kept the restriction in force while appealing. EFSA supports the ban, arguing that the risk is purely intrinsic and no safe level can be set for genotoxic substances, rendering a consumption threshold irrelevant. This unprecedented legal fight is poised to redefine the regulatory landscape for all naturally-derived substances in the EU. Your company can rely on Hylobates Consulting Srl's expertise to navigate this complex and evolving legal landscape, ensuring your products remain fully compliant.

04/11/2025

France is clarifying the classification of ethanol used for sealing capsules. French Agency for Food, ANSES (French food safety agency) has issued a crucial technical opinion which defines the classification of ethanol: It is identified as a "wetting agent" and falls into the residual category of other processing aids. This category, as such, would not require prior authorisation. However, the Agency highlights that ethanol is classified as a Group 1 carcinogen (IARC), a factor that demands utmost caution. This is not a green light. In the same document, ANSES has issued clear recommendations for the industry:
- Minimise Residues: Drying processes must be optimised to ensure the lowest possible level of ethanol in the finished product.
- Assess Exposure: Manufacturers must rigorously assess consumer exposure to such residues.
- Check for Neo-formed Compounds: It must be ensured that the ethanol does not react with the capsule's ingredients, creating degradation or neo-formed compounds.
What does this mean for food supplement manufacturers? The French Competent Authority must now decide on the final regime (whether a notification will suffice or if an authorisation will be required) by balancing the technical function, as defined by ANSES, with the toxicological risk profile. The advice to companies is not to wait: start validating your drying processes and gathering analytical data on residues now. Compliance and consumer safety remain the priority.

03/11/2025

For the first time ever, Notices of Violation (NOVs) have been filed under Proposition 65 for the alleged failure to warn consumers about aflatoxins. This represents a significant shift in enforcement, targeting common food such as chilli powders, corn flour, and almond butter. California’s Proposition 65 (enacted in 1986) is a “right-to-know” law that requires businesses to provide a “clear and reasonable warning” before exposing Californians to any of the more than 900 chemicals identified by the state as causing cancer or reproductive toxicity. Failure to warn can expose companies to costly private enforcement actions. Aflatoxins are natural mycotoxins that can contaminate crops like corn, peanuts, tree nuts, and spices. Although listed as carcinogens under Proposition 65 since 1988, this is their first enforcement action. Unlike most listed chemicals, aflatoxins have no OEHHA-established safe harbour level, and meeting FDA limits does not ensure compliance with Proposition 65. Food and Drug Administration (FDA) has issued an aflatoxins action level of

29/10/2025

🚨Regulation Alert: Food Supplements in France!

The DGAL (General Directorate for Food) updated its dedicated webpage for food supplements on September 24, providing crucial clarifications on European and national regulations (definition, composition, placing on the market).
👉 Key Changes and Takeaways:

- Simplified Compliance and Notification: A direct link to the Compl'Alim tool is now available to verify product compliance and submit notifications.
(Note: Even the labeling example provided by the DGAL contains a non-compliance regarding Reference Intakes. Double-check is essential!)

- Prior Authorizations (Arts. 17 & 18): New details on the prior authorization procedure when your ingredients exceed regulatory limits.
Procedure: Requires Anses opinion (takes about 5 months).
Control: These applications will be subject to a systematic administrative review (vs. targeted/random review for general notifications - Art. 15).

- Transparency of Declarations: The notification database is also accessible (around 1600/month, updated until June 2025).

🔎 Action for Professionals: Immediately check the DGAL page and use Compl'Alim to ensure your products are 100% compliant and properly notified, especially if you use ingredients at maximum doses!
Need help navigating these new requirements? At Hylobates, we can guide your company through the entire process!