Hylobates España

18/02/2026

The halfway mark of the transition period for the major GB 7718-2025 and GB 28050-2025 standards updates, released in March 2025, is approaching. These standards introduce stricter compliance requirements, most notably making allergen labeling mandatory and standardizing the format for best before dates. Hylo's China Team recommends that all operators use this remaining period to conduct a thorough compliance review of their labels and packaging to align with these new technical standards, ensuring full compliance by the mandatory enforcement date.

11/02/2026

Crucial updates for food supplements in Belgium:
Garcinia cambogia, following the French ban, the Belgian Botanical Commission has recently also concluded that the safety of this ingredient can no longer be guaranteed. Consequently, authorities have already suspended the issuance of notification receipts for products containing this plant. Although the updated regulation that will soon follow provides a two-year transition period for products already on the market, it is no longer possible to notify new products containing this plant in Belgium.

06/02/2026

Breastfeeding and Fenugreek: ANSES Confirms the Warning.
ANSES evaluated a request for exemption from the warning for breastfeeding women regarding a food supplement containing Trigonella foenum-graecum L. seed powder. The Agency confirmed that the exemption is not justified. Although fenugreek seeds are authorized in food supplements and traditionally used as galactagogues, there is insufficient scientific evidence to demonstrate their safety during lactation. The assessment considered preclinical studies, clinical data, and nutrivigilance reports, highlighting methodological gaps and insufficient data provided by the applicant. No studies are available on the long-term effects on mother and infant. ANSES therefore reiterates the need to maintain the warning, regardless of dose or formulation, in line with European recommendations and the precautionary principle.
Our team is available to advise on warnings for botanicals in the French market.

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.

21/01/2026

Find Luca Bucchini'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.

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