China Blue Hat & SAMR Registration Consultancy

The Blue Hat (蓝帽子) is the official mark carried by products approved as health food (保健食品) in China. It is the only route to legally making a health function claim on a supplement sold through general trade. Without it, a product is a normal food or an imported personal-use item, and it cannot claim to support immunity, sleep, memory or any other regulated function.

SAMR, the State Administration for Market Regulation, through its Special Food Safety Supervision and Administration Department, with technical review by the Center for Food Evaluation. NMPA has no role in health food. NMPA sits under SAMR administratively but handles drugs, medical devices and cosmetics. A great deal of English-language guidance still says "NMPA Blue Hat", which is a holdover from the pre-2018 CFDA system that was never corrected.

It depends entirely on your formula. If every ingredient appears in the SAMR raw material catalogue, at catalogue dosages and in an approved dosage form, you can use the filing route (备案), which is faster, cheaper and produces a certificate with no expiry. If even one ingredient falls outside the catalogue, or your claim cannot be covered by a filing, you must go through full registration (注册). This is the first question we answer for any new client, because it determines everything downstream.

Filing typically runs in months. Registration is far longer than the statute suggests. The regulation allows 80 working days for technical and administrative review, but that clock covers only the review itself, not the safety and function evidence you must generate first. Realistic end to end for a registration, including trials and dossier preparation, is 18 months to three years. Any consultant quoting you six months for a full registration is quoting the review window and ignoring the science.

We do not quote a single figure, and we would treat anyone who does with caution. There is no current published official government fee schedule for registration, and the real cost sits in testing, toxicology and function trials, not in administrative fees. That means the number depends on your formula, how many ingredients need evidence, and which route you qualify for. A filing is a fraction of a registration. We cost the project after the route assessment, not before.

The 保健食品原料目录 is the list of ingredients that can be used through the fast filing route, at fixed dosages. It has two parts: nutrient supplements, meaning vitamins and minerals, and a much shorter list of functional ingredients. Ten functional ingredients are currently filable: coenzyme Q10, broken-wall reishi spore powder, spirulina, fish oil and melatonin since March 2021, soy protein isolate and whey protein since September 2023, and ginseng, American ginseng and lingzhi effective May 2024. Dosages are fixed, not indicative. Coenzyme Q10 is capped at 30 to 50 mg per day, melatonin at 1 to 3 mg per day, fish oil at no more than 4 g per day.

No. The three ingredients added to the catalogue in May 2024, ginseng, American ginseng and lingzhi, may be filed only as single-ingredient formulations. A combination formula containing them has to go through full registration. This catches out a lot of traditional-formula brands who assume the catalogue addition opened the fast route for their existing SKU.

China permits a closed list of 24 health functions, set by the 2023 catalogue issued jointly by SAMR, the National Health Commission and the National Administration of Traditional Chinese Medicine. It was reduced from 27: improving growth and development, promoting lactation, and improving skin oil content were removed for lack of scientific consensus, with a five-year transition running to 2028. The wording of each permitted function is legally binding, so you cannot paraphrase one into more attractive marketing language. Claiming or implying disease treatment or prevention is prohibited on every channel.

Yes, through cross-border e-commerce. CBEC goods are treated as personal imports, so there is no Blue Hat requirement, no GACC label registration and no Chinese label needed on the product itself. Tmall Global, JD Worldwide and bonded warehouse models all work this way. The trade-off is that you cannot make any of the 24 health function claims, and you are limited to online cross-border channels only.

Purchases are capped at RMB 5,000 per transaction and RMB 26,000 per person per year. The product must appear on the cross-border positive list, and ingredients classed as drugs in China are excluded. You also cannot sell through offline retail, pharmacies or chain distribution on this route. The point to convert to general trade with a Blue Hat is when volume outgrows those caps, when you need physical distribution, or when a function claim becomes necessary to compete.

A registration certificate is valid for five years and must be renewed, with the renewal application filed six months before expiry. A filing certificate has no expiry. This is one of the practical advantages of qualifying for the filing route that brands rarely factor into their comparison.

GB 7718-2025, the prepackaged food labelling standard, was issued in March 2025 and becomes mandatory on 16 March 2027, with early adoption permitted. It bans "zero added" and "no added" style claims unless the content is genuinely zero, makes allergen labelling mandatory rather than voluntary, requires expiry to be shown as a specific date, and adds a dedicated chapter covering imported prepackaged food labels. Two years sounds generous until you count artwork revision cycles and existing stock rotation.

Not in the way most brands plan to. Livestream e-commerce measures effective 1 February 2026 ban natural persons who are not the goods operator, meaning KOLs, influencers and livestream hosts, from promoting or selling health food in livestreams. A further rule effective 20 March 2026 sets out categories of food banned from livestream sale, including special foods lacking the required qualification. If your China launch plan is built around Douyin or Xiaohongshu livestream seeding for a Blue Hat product, it needs rewriting, and that is a conversation to have before you commit budget.

Yes, and it is a separate obligation from the Blue Hat. GACC Decree 280 replaces Decree 248 and takes effect on 1 June 2026, governing the registration of overseas manufacturers of food exported to China. Health food sits in the higher-risk category that requires an official recommendation from your home country competent authority, which means a health food manufacturer can no longer self-register through CIFER. Blue Hat approves your product to be sold and to make a claim. Decree 280 approves your factory to export at all. You need both, and they run on different clocks.