- A foreign dairy or beverage producer building a plant in China needs a locally incorporated entity that obtains a Food Production Licence (SC licence); for infant formula it must also obtain SAMR formula registration before production or import.
外资乳品或饮料企业在华建厂须设立本地实体并取得《食品生产许可证》（SC证）；婴幼儿配方乳粉还须取得SAMR配方注册方可生产或进口。- In 2026, several provinces grade SC licensing by product risk: health food, special medical, infant formula, infant supplements and salt are reviewed by the provincial bureau; dairy and other special diets by the municipal bureau; ordinary food by the county bureau, with first applications subject to on-site audit.
2026年多省按产品风险分级SC许可：保健食品、特医、婴配、婴辅、食盐由省局审查；乳制品及其他特膳、食品添加剂由市局；普通食品由区县局，首次申请全部现场核查。- Infant formula powder formula registration (issued by MOJ on 19 May 2026) caps each enterprise at three series / nine formulas, with a five-year certificate and strict “no misleading origin / no health claim” labelling.
婴幼儿配方乳粉产品配方注册（2026年5月19日司法部发布）限定每企业原则上不超过三个系列九种配方，证书五年，标签严禁模糊产地与保健声称。- Infant formula liquid milk is now the strictest segment: SAMR’s January 2026 review rules prohibit contract manufacturing and repackaging, require complete in-house processes, and set high staff qualifications.
婴幼儿配方液态乳现为最严细分：SAMR 2026年1月审查细则禁止委托与分装生产，要求完整自有工艺，并对人员资质设高门槛。- Beverage plant setup is faster when paired with local government service: Swire Coca-Cola’s Kunshan plant signed in Jan 2023 and produced by May 2026, with the SC licence issued in five working days after expert on-site review.
饮料建厂配合地方政府服务可提速：太古可口可乐昆山工厂2023年1月签约、2026年5月投产，SC证经专家现场核查后5个工作日核发。- Imported dairy still requires GACC official-recommended registration (dairy is one of the 17 listed categories); combining an imported line with a local plant needs both the GACC number and the SC licence.
进口乳品仍须GACC官方推荐注册（乳品为17类之一）；进口与本地建厂并行须同时具备GACC编号与SC证。
Foreign dairy and beverage producers building plants and market access in China (2026) | 2026 外资乳品
Overview
For foreign dairy and beverage groups, China is both a vast market and a demanding manufacturing jurisdiction. Building a local plant (rather than only importing) brings tariff, freshness and cost advantages, but triggers a layered permit stack: entity formation, environmental and site approvals, the Food Production Licence (SC licence), and — for infant formula — SAMR formula registration. This article sets out the 2026 pathway, the risk-graded licensing, and the special dairy rules.
Market context
China regulates food manufacturing through the SC licence administered by market-regulation authorities, with risk-based grading increasingly applied at provincial, municipal and county levels. Special foods — health food, special medical foods, infant formula powder and liquid — sit under SAMR’s special-food supervision and require registration/filing on top of the SC licence. Imported dairy remains under GACC’s overseas-establishment registration (dairy is one of the 17 official-recommended categories under Decree No. 280). A foreign producer can thus run three models: import-only, local plant-only, or a hybrid.
Key 2026 developments
Risk-graded SC licensing. Taking Zhejiang’s 2026 practice as a marker, licensing is tiered by product risk: health food, special medical food, infant formula, infant supplementary food and salt are reviewed by the provincial bureau; dairy, other special diets, other foods and additives by the municipal bureau; ordinary food by the county bureau, with all first-time applications subject to on-site audit. The standard process runs: prepare (business licence, fit-out, equipment, systems, trial batches) → online application → acceptance → on-site verification by ≥2 officers (first application always audited; pass rate generally ≥85%) → approval and electronic SC certificate.
Beverage plant example — Swire Coca-Cola Kunshan. Signed in January 2023 and producing in May 2026, the Kunshan plant is a “smart factory” with 13 planned lines, ultimate capacity exceeding 1.6 million tonnes/year and about RMB 1.2 billion in annual sales. Phase I has four lines (up to 400,000 tonnes/year, ~1 million bottles/day) producing sodas, sports drinks and 100+ SKUs. Local government compressed the SC licence review to five working days after expert on-site verification, illustrating how proactive provincial service shortens time-to-market.
Infant formula powder registration (MOJ, 19 May 2026). The *Measures for the Administration of Infant Formula Milk Powder Product Formula Registration* govern both domestic production and import. An applicant must be a production enterprise intending to produce and sell in China, or an overseas producer intending to export. Each enterprise is generally capped at three formula series and nine formulas (stage 1/2/3). The registration certificate is valid for five years (electronic equals paper). Labels must meet strict rules: no vague origin claims such as “imported milk source” or “ecological pasture”; no disease-prevention, immunity or intelligence claims; no “no added / zero added” emphasis for substances not permitted.
Infant formula liquid milk — the strictest regime. Following the September 2025 Food Safety Law amendment (effective 1 December 2025) that brought liquid infant formula into the registration system, SAMR issued the *Detailed Rules for the Review of Production Licences for Infant Formula Liquid Milk* on 29 January 2026. The rules forbid contract manufacturing and repackaging; a site with only packaging, process or equipment but no complete production process is not licensed; using the same formula for different brands is prohibited; and producing liquid formula from reconstituted powder is barred. Requirements include an independent air-handling system for clean zones, cooling raw milk to 0–4°C within two hours of milking, metal detection, and high staff qualifications (director/officer/R&D bachelor’s or above; production technicians college or above plus three years’ experience).
Imported dairy under GACC. Dairy is one of the 17 categories requiring official-recommended registration under GACC Decree No. 280 (effective 1 June 2026). A foreign dairy plant exporting to China must be recommended by its home authority and hold a China registration number printed on the label. A hybrid producer (local plant plus imports) needs both the SC licence and the GACC number.
Labelling and advertising. All products must meet GB 7718 and GB 28050; dairy and formula carry additional label rules (formula registration number, origin truthfulness, prohibition of therapeutic or health claims). Advertising must comply with the Advertising Law — no disease-treatment or unsubstantiated function claims.
Practical steps
- Incorporate a China entity (WFOE) to hold the SC licence and act as the producer of record.
- Secure site and environment approvals early; design the plant to the risk tier (dairy/infant formula → provincial/municipal scrutiny, stricter build standards).
- Apply for the SC licence with complete layouts, process flows, equipment lists, systems and trial-batch reports; budget for on-site audit.
- For infant formula, file SAMR formula registration (powder: three-series/nine-formula cap; liquid: no contract/repackaging, full in-house process) before any production or import.
- If importing dairy, complete GACC official-recommended registration and print the China number on labels.
- Build compliant labels (GB 7718/28050 + formula rules) and advertising review to avoid claims that trigger enforcement.
Related reading
- Imported food and health-food registration, filing and labelling (see article 155).
- Supply-chain localisation and central-kitchen compliance for chain restaurants (see article 156).
Sources
- 司法部 — 《婴幼儿配方乳粉产品配方注册管理办法》（2026-05-19）
- China Briefing — China’s New Production Licensing Rules for Infant Formula Liquid Milk（2026-01）
- 国家市场监督管理总局 — 官方网站（食品生产许可 / 特殊食品监管）
- 浙江食品生产许可证（SC证）办理条件及流程（2026年分级实践）
2026 外资乳品
概述
对外资乳品与饮料集团而言，中国既是庞大市场，也是严苛的制造法域。本地建厂（而非仅进口）带来关税、鲜度与成本优势，但触发多层许可组合：实体设立、环评与选址审批、《食品生产许可证》（SC证），以及——对婴幼儿配方——SAMR配方注册。本文梳理2026年路径、风险分级许可与乳品特别规则。
市场背景
中国通过市场监管部门管理的SC证规制食品制造，并按产品风险在省、市、县层级分级审查。特殊食品——保健食品、特殊医学用途食品、婴幼儿配方粉与液态乳——归SAMR特殊食品监管，须在SC证之上另行注册/备案。进口乳品仍受GACC境外生产企业注册约束（乳品为第280号令17类官方推荐类别之一）。外资生产者可运行三种模式：仅进口、仅本地建厂，或二者混合。
2026年核心进展
风险分级SC许可。 以浙江2026实践为标志，许可按风险分级：保健食品、特医食品、婴配、婴辅、食盐由省局审查；乳制品、其他特膳、其他食品、食品添加剂由市局审查；普通食品由区县局审查，首次申请全部现场核查。标准流程：筹备（营业执照、装修、设备、制度、试制）→网报→受理→≥2人现场核查（首次必查，得分率一般≥85%）→审批发电子SC证。
饮料建厂案例——太古可口可乐昆山。 2023年1月签约、2026年5月投产的昆山工厂是”智慧工厂”，规划13条产线，达产年产能超160万吨、年销售额约12亿元。一期4条线（最大40万吨/年、日产约100万瓶），生产汽水、运动饮料等100多个品类。地方政府将SC证审查在专家现场核查后压缩至5个工作日，体现主动服务如何缩短上市周期。
婴幼儿配方粉注册（司法部，2026年5月19日）。 《婴幼儿配方乳粉产品配方注册管理办法》规制境内生产销售与进口。申请人应为拟在华生产销售的生产企业，或拟出口的境外生产企业。每企业原则上不超三个配方系列九种产品配方（1/2/3段）。注册证书有效期五年（电子与纸质同效）。标签须严守：不得含”进口奶源””生态牧场”等模糊产地；不得涉疾病预防、增强免疫力等声称；不得对不允许的物质强调”不添加/零添加”。
婴幼儿配方液态乳——最严制度。 继2025年9月《食品安全法》修正（2025年12月1日生效）将液态婴配纳入注册体系后，SAMR于2026年1月29日发布《婴幼儿配方液态乳生产许可审查细则》。细则禁止委托生产与分装；仅有包装场地、工序、设备而无完整生产工艺者不予许可；同一配方生产不同品牌被禁；以乳粉复原生产液态婴配被禁。要求清洁作业区独立空气净化系统，生乳挤出后2小时内降温至0–4℃，金属异物检测，并对人员资质设高门槛（总监/员/研发本科及以上；生产技术人员大专及以上且3年以上经验）。
GACC下的进口乳品。 乳品为第280号令（2026年6月1日施行）17类须官方推荐注册之一。出口中国的外资乳品厂须由所在国主管当局推荐并取得在华注册编号，印于标签。混合生产者（本地建厂+进口）须同时具备SC证与GACC编号。
标签与广告。 所有产品须符合GB 7718与GB 28050；乳品与配方另有标签规则（配方注册号、产地真实、禁治疗/保健声称）。广告须符合《广告法》——不得疾病治疗或未经证实的功能声称。
实务步骤
- 设立中国实体（WFOE）以持有SC证并作为记录生产者。
- 尽早取得选址与环评，按风险层级设计工厂（乳制品/婴配→省/市严审，建造标准更高）。
- 申请SC证，备齐布局图、工艺流程图、设备清单、制度与试制报告；预留现场核查时间。
- 婴配须申报SAMR配方注册（粉：三系列九配方上限；液态：禁委托/分装、须完整自有工艺）后方可生产或进口。
- 若进口乳品，完成GACC官方推荐注册并将在华编号印于标签。
- 制作合规标签（GB 7718/28050+配方规则）并做广告审查，避免触发执法的声称。
延伸阅读
- 进口食品与保健食品注册、备案及标签合规（参见155篇）。
- 外资连锁餐饮供应链本地化与中央厨房合规（参见156篇）。
来源