Hylobates

Hylobates 💊 Hylobates Consulting srl is a scientific and regulatory consulting firm specialising in food and cosmetic product compliance

At Hylobates Consulting srl we specialize in risk assessment, scientific and regulatory consulting in the food and cosmetic sectors. Since 2003, our clients are offered the most advanced scientific and regulatory applied knowledge in food safety, on labeling and health claims for food supplements, dietetic products and common foods, as well as regulatory dossiers on ingredients and claims. While w

e are leading consultants in Italy for dietary supplements for sports, we are helping several European and international food supplement manufacturers comply with relevant European and Italian regulations, including botanicals and multivitamins. We are involved in several research projects in nutrition and food risk analysis. Our research consulting group tackles complex food risk assessments, policy issues and health burden estimates

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Noi di Hylobates Consulting siamo specializzati in valutazione del rischio e consulenza scientifico-regolatoria in ambito alimentare e cosmetico. Dal 2003, offriamo ai nostri clienti le conoscenze scientifiche e regolatorie più avanzate nel campo della sicurezza alimentare, dell’etichettatura degli alimenti e dei claim, delle procedure tecniche ed amministrative per integratori, prodotti dietetici e loro ingredienti. Siamo consulenti leader nel campo dell’integrazione per lo sport e il supporto privilegiato per accedere al mercato nazionale per tutti gli integratori alimentari per operatori comunitari. Siamo esperti dell’ambito regolatorio nazionale, mentre lavoriamo direttamente con le autorità di diversi altri paesi comunitari. Investiamo consistentemente nella ricerca sia in campo nutrizionale che nel campo dell’analisi del rischio. La nostra componente di ricerca affronta i temi più complessi di valutazione e politica del rischio e di valutazione dell’impatto sanitario

EU: Herring roe oil is not a NovelOn March 20, 2026, following a consultation procedure initiated by the Norwegian Food ...
14/04/2026

EU: Herring roe oil is not a Novel

On March 20, 2026, following a consultation procedure initiated by the Norwegian Food Safety Authority under Article 4 of Regulation (EU) 2015/2283, it was officially established that oil extracted from herring roe (Clupea harengus L.) is classified as a non-Novel Food. This decision definitively clarifies the ingredient's regulatory status, removing the requirement for prior authorization for its commercialization within the European Union. The most relevant technical aspect of the evaluation concerned the production method. The oil is extracted from wet frozen herring roe through a process involving the extraction of the lipid fraction with ethanol. Although the use of ethanol as a sole solvent was not identified as a traditional method before May 1997, the authorities concluded that it does not cause chemical changes in the extracted lipids. Furthermore, this process does not lead to significant changes in the composition or structure of the fat fraction compared to the original raw material. Do you want to be sure your product does not contain a Novel Food? Ask our team to provide you with a detailed assessment to assist you in complying with the Novel Food regulation.

PPWR: Operational Guidance from the European CommissionThe roadmap toward the full implementation of the new Packaging a...
13/04/2026

PPWR: Operational Guidance from the European Commission

The roadmap toward the full implementation of the new Packaging and Packaging Waste Regulation (EU) 2025/40 (PPWR) has reached a turning point. On March 30, 2026, the European Commission released an official communication along with 131 FAQs to clarify its interpretation. These include the definition of manufacturer, fundamental instructions for managing PFAS substances in food-contact packaging, and exemptions regarding minimum recycled content. We are available to assess how this regulation affects your product lines and to assist you in correctly preparing the required documentation.

China: Upcoming national standard for probiotics and new ingredient assessment.China’s regulatory landscape is undergoin...
13/04/2026

China: Upcoming national standard for probiotics and new ingredient assessment.

China’s regulatory landscape is undergoing a crucial transformation toward a more scientific and structured approach. In late March 2026, the National Technical Committee for Special Foods Standardization officially opened a public consultation (active until May) on the draft national standard specifically for probiotics within the Health Food category. This initiative aims to ensure high standards across the entire supply chain—from strain identification to post-market surveillance—setting rigorous criteria for stability and safety. In parallel, during March 2026, the National Health Commission (NHC) accelerated the review process for several "Novel Ingredients." Three new food ingredients have been officially accepted for evaluation: glucuronolactone, N-acetylglucosamine, and yerba mate. Navigating these regulations requires precision and deep knowledge of local processes. If you are planning to launch your products in China, we are available to analyze these opportunities with you and define the most effective compliance strategy for your brand.

Food businesses face penalties for mislabelling products as Canadian.  Since April 1, 2025, the Canadian Food Inspection...
02/04/2026

Food businesses face penalties for mislabelling products as Canadian.
Since April 1, 2025, the Canadian Food Inspection Agency (CFIA) has imposed monetary penalties totalling $47,000 for inaccurate or misleading origin claims.
Origin declarations must be truthful, substantiated, and compliant with applicable legislative requirements. Food business operators are responsible for ensuring that all products they sell, whether domestically produced or imported, comply with regulations. The CFIA conducts inspections, both in response to complaints and proactively, covering labels, advertising, and in-store communications. Controls include: documentary verification, assessment of business processes, and requests for corrective actions. Enforcement measures are determined based on the level of risk, the impact of the non-compliance, and the operator’s compliance history.
Accurate labelling is a fundamental requirement for consumer protection and fair market practices.
Should you require any clarification, please do not hesitate to contact Hylobates.

Luca Bucchini's view on EFSA and berberine.By Nikki Hancocks
12/03/2026

Luca Bucchini's view on EFSA and berberine.

By Nikki Hancocks

Experts have warned the future for berberine containing plants looks bleak after EFSA published a draft opinion questioning their safety, with a stakeholder consultation now open until May. 4.

Hylo's Luca Bucchini discusses MartinBauer’s strategic shift in the botanical world in latest NutraIngredients feature.B...
06/03/2026

Hylo's Luca Bucchini discusses MartinBauer’s strategic shift in the botanical world in latest NutraIngredients feature.

By Nikki Hancocks

MartinBauer's new nutraceutical unit integrates research, formulation and analytics to innovate botanical products, addressing fragmented health claims, regulatory scrutiny and consumer demand for scientific backing. The unit aims to consolidate production and supply, enhance speed to market and exp...

La pianta Garcinia cambogia, già recentemente vietata in Francia negli integratori alimentari. A seguito del parere dell...
11/02/2026

La pianta Garcinia cambogia, già recentemente vietata in Francia negli integratori alimentari. A seguito del parere della Commissione belga per le piante, che ha concluso che la sicurezza di questo ingrediente non può essere garantita, le autorità hanno già sospeso l'accettazione di notifiche per prodotti che contengono questa pianta, in attesa dell'aggiornamento della norma nazionale. Sebbene in questi casi sia previsto un periodo di transizione di due anni per i prodotti già in commercio, non è più possibile immettere sul mercato belga nuovi prodotti contenenti questa pianta.

Allattamento e fieno greco: ANSES conferma l’avvertenza .L’ANSES ha valutato la richiesta di esenzione dall’avvertenza p...
06/02/2026

Allattamento e fieno greco: ANSES conferma l’avvertenza .
L’ANSES ha valutato la richiesta di esenzione dall’avvertenza per le donne che allattano relativa a un integratore alimentare contenente polvere di semi di Trigonella foenum-graecum L.. L’ Agenzia ha confermato che l’esenzione non è giustificata. Pur autorizzati negli integratori alimentari e tradizionalmente usati come galattogeni, i semi di fieno greco non hanno evidenze scientifiche sufficienti a dimostrarne la sicurezza durante l’allattamento. La valutazione ha considerato studi preclinici, dati clinici e segnalazioni di nutrivigilanza, evidenziando lacune metodologiche e dati insufficienti dal richiedente. Non sono disponibili studi sugli effetti a lungo termine su madre e neonato. ANSES ribadisce quindi la necessità di mantenere l’avvertenza, indipendentemente da dose o forma, in linea con le raccomandazioni europee e il principio di prudenza.
Il nostro team è disponibile a fornire consulenza sulle avvertenze per i prodotti botanici sul mercato francese.

Hylo's China team informs that SAMR has published Announcement No. 58/2025, expanding the technical scope for Coenzyme Q...
22/01/2026

Hylo's China team informs that SAMR has published Announcement No. 58/2025, expanding the technical scope for Coenzyme Q10 and Melatonin under the Filing (Beian) pathway. The update authorizes new dosage forms—specifically Oral Liquids (Kǒufú Yè) for both ingredients and Powders for CoQ10—previously restricted to the slower Registration track. It also establishes a specific positive list of excipients for these new formats. These changes apply to single-ingredient Health Foods (Baojian Shipin) and are effective from March 1, 2026, offering a significantly faster market entry route for liquid health products.

Il team di Hylobates dedicato al mercato cinese informa che il SAMR ha pubblicato l'Annuncio n. 58/2025, ampliando l'ambito tecnico per il Coenzima Q10 e la Melatonina sotto la procedura di notifica (Filing). L'aggiornamento autorizza nuove forme di dosaggio – nello specifico Liquidi Orali (Kǒufú Yè) per entrambi gli ingredienti e Polveri per il CoQ10 – precedentemente limitate al più lento percorso di Registrazione. Viene inoltre stabilita una lista positiva specifica di eccipienti per questi nuovi formati. Tali modifiche si applicano agli Health Foods (Baojian Shipin) monocomponente e saranno applicabili dal 1° marzo 2026, offrendo una via di accesso al mercato significativamente più rapida per i prodotti liquidi.

Find Luca's predictions for 2026 in HBW Insight!By Tom Gallen
21/01/2026

Find Luca's predictions for 2026 in HBW Insight!

By Tom Gallen

HBW Insight’s panel of food supplement experts highlight key regulatory and legislative changes manufacturers need to keep a close eye on in 2026.

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

Hylo's Luca comments on 50 probiotic strains declared not novel or not novel in Food Supplements on December 17th. An in...
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.

Indirizzo

Via Guido Rattoppatore 59
Rome
00135

Orario di apertura

Lunedì 08:00 - 16:30
Martedì 08:00 - 16:30
Mercoledì 08:00 - 16:30
Giovedì 08:00 - 16:30
Venerdì 08:00 - 16:30

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