Hylobates

05/11/2025

Il destino normativo dei Derivati dell'idrossi antracene (HAD) rimane nel limbo legale dopo che il divieto iniziale dell'UE, applicato nel marzo 2021 a causa delle preoccupazioni sulla genotossicità della sostanza, è stato formalmente annullato dal Tribunale generale alla fine del 2024. La Corte ha stabilito che la Commissione europea non ha definito una soglia di consumo per il divieto, ma la Commissione ha mantenuto con successo la restrizione in vigore presentando ricorso. L'EFSA sostiene il divieto, argomentando che il rischio è puramente intrinseco e che non è possibile stabilire alcun livello sicuro per le sostanze genotossiche, rendendo irrilevante una soglia di consumo. Questa lotta legale senza precedenti è destinata a ridefinire il panorama normativo per tutte le sostanze di origine naturale nell'UE. La vostra azienda può contare sull'esperienza di Hylobates per navigare in questo panorama legale complesso e in evoluzione, assicurando che i vostri prodotti rimangano pienamente conformi.

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

31/10/2025

Intelligenza Artificiale e Nutraceutico: Pronti per il futuro? 🤖

🚨 NUOVO ARTICOLO SU NUTRA HORIZONS!

Luca Bucchini di Hylo, interviene con un'analisi fondamentale sull'impatto dell'Intelligenza Artificiale e sulle sfide degli aspetti regolatori che stanno ridefinendo l'intero settore nutraceutico.
Dalla Ricerca & Sviluppo alla conformità, come sta cambiando il panorama?

➡️ Scopri il parere completo di Luca di Hylo. Link in bio!

INTELLIGENZA ARTIFICIALE, ASPETTI REGOLATORI NEL SETTORE NUTRACEUTICO INTRODUZIONE Si parla ancora di Intelligenza Artificiale (IA) come una prospettiva per il futuro. A fronte degli incredibili investimenti di Big Tech, sicuramente le opportunità e le sfide della IA sono solo all’inizio. Tuttavi...

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!

21/10/2025

The European Parliament has approved an amendment to the Common Market Organisation ( ) regulation that would ban plant-based and lab-grown foods from using meat- or animal-related terms such as “ ,” “ ,” “ ,” “ ,” “ yolk,” and “egg white.” The proposal, introduced by French Céline Imart, is intended to prevent consumer confusion and protect traditional meat producers, but it still needs to pass through negotiations with the European Commission and EU governments before becoming law. Supporters claim the measure will safeguard product integrity and transparency, while critics argue it is unnecessary, protectionist, and inconsistent with the EU’s sustainability ambitions. According to Hylo’s Armando, the rule could force plant-based brands to rebrand, increasing and making their products less recognizable to consumers. From a regulatory perspective, existing labeling laws already prevent misleading claims, and clearer standards could ensure transparency without restricting innovation or limiting consumer choice.

10/10/2025

Luca Bucchini chair of European Specialist Sports Nutrition Alliance (ESSNA) and managing director of Hylobates Consulting Srl, is featured in a Vitafoods Insights article discussing the Channel 4 documentary, Joe Wicks: Licensed to Kill.
Luca highlights the need for a balanced, evidence-based discussion on Ultra-Processed Foods (UPFs). He emphasizes the UK's rigorous food safety standards and the science that underpins food processing.
The piece reinforces ESSNA's commitment to clear, evidence-based communication on sports nutrition and food regulation.

➡️ Read the full article here: https://www.vitafoodsinsights.com/sports-nutrition/experts-criticise-joe-wicks-protein-bar-documentary-for-scaremongering-

Nutrition experts and industry leaders have criticised Joe Wicks’ protein bar documentary for “scaremongering” and “demonising” UPFs.

18/09/2025

Find Luca Bucchini's reaction to the topic of vitamin D recommendations in Germany in the latest article by Nikki Hancocks of NutraIngredients

A new risk assessment from the German Federal Institute for Risk Assessment (BfR) suggests a low daily limit for vitamin D as a result of health concerns related to intermittent ‘bolus’ dosing.

09/09/2025

Find Luca's new article on REGULATORY CHALLENGES related to PERSONALIZED NUTRITION and NUTRACEUTICS in the new issue of NUTRA HORIZON.

INTRODUZIONE La nutraceutica -termine senza un preciso riferimento normativo ma sufficientemente preciso per l’industria - è un campo in continua evoluzione. La nutrizione personalizzata non è un’idea nuova; si tratta di un’evoluzione dell’idea della nutrizione di precisione, ed ha una sto...

05/09/2025

The European Commission has clarified that both the fruiting body of Ophiocordyceps sinensis (Berk.) G.H. Sung, J.M. Sung, Hywel-Jones & Spatafora (best known as Cordyceps sinensis (Berk.) Sacc.) and Samsoniella hepiali Q.T. Chen & R.Q. Dai (best known as Paecilomyces hepiali Q.T. Chen & R.Q. Dai are NOT novel when used in food supplement. While P. hepiali has been the dominant source of Cordyceps in the EU for a long time, its regulatory status was unclear. Now, we have legal certainty on this species, and authorities are calling for proper labelling of fungal species in food supplements. "Mushrooms, algae and micro-organisms have long and complex taxonomic and use histories. Specialist expertise is required to clarify their legal status and allow market expansion" says Hylo's Luca Bucchini.

03/09/2025

Hylo's Luca points to issues with the article 4 process to determine novel food status


By Olivia Haslam

Article 4 of the EU Novel Food Regulation helps determine if an ingredient requires authorization, but experts warn it may be misused to delay competitors. Food safety consultant Luca Bucchini calls for more transparency and centralized oversight to prevent manipulation.

02/09/2025

Read Hylo's Luca Bucchini comments in Nutraingredients' new article on children's magnesium gummies that contain unauthorized melatonin in the UK

By Olivia Haslam

UK brand Nutrition Ignition’s magnesium glycinate gummies for children were found to contain unauthorized melatonin (1.5–1.7mg), prompting MHRA intervention and full product withdrawal from all sales channels. According to experts, the contamination is suspected to be either a serious manufactur...