A comprehensive guide to certifications and standards relevant to food and cosmetics OEM manufacturing — from HACCP, ISO 22000, FSSC 22000, JFS Standard and Organic JAS, to Cosmetics GMP, the Pharmaceutical Affairs Act and COSMOS. Includes cost estimates, typical timelines and comparison tables to help you choose.
Major certifications and standards relevant to food OEM manufacturing — from mandatory HACCP compliance, international standards such as ISO 22000 and FSSC 22000, to Japan's own JFS Standard.
A hygiene management methodology that analyses biological, chemical and physical hazards in the food manufacturing process and sets Critical Control Points (CCPs) for continuous monitoring. As of June 2021, HACCP-based hygiene management is mandatory in principle for all food business operators in Japan.
Authority / certifier
Ministry of Health, Labour and Welfare (MHLW)
Scope
All food business operators (manufacturing, processing, cooking, sales) in principle
Estimated cost
In-house: JPY 0.5M–2M / With consultant: JPY 1M–5M
Typical timeline
3–12 months (depends on operation size)
An international standard that combines HACCP principles with the ISO 9001-style management system approach. It targets food safety management across the entire food supply chain and can be obtained by any organisation involved in the food chain.
Authority / certifier
ISO (International Organization for Standardization) / certification bodies such as JQA, BSI, SGS
Scope
Food manufacturers, processors, packaging material makers, logistics operators, etc.
Estimated cost
Initial certification: JPY 1M–3M / Annual maintenance: JPY 0.3M–0.8M
Typical timeline
6–18 months
A stricter food safety standard that adds ISO/TS 22002-1 (prerequisite programmes) and FSSC-specific extra requirements to ISO 22000. Recognised by GFSI (Global Food Safety Initiative) and frequently required by global food companies of their suppliers.
Authority / certifier
FSSC Foundation / certification bodies
Scope
Food manufacturers, packaging material makers
Estimated cost
Initial: JPY 1.5M–4M / Annual: JPY 0.5M–1M
Typical timeline
8–18 months
A food safety management standard developed by the Japan Food Safety Management Association (JFSM). It comes in three tiers (A / B / C) designed for gradual level-up. JFS-C obtained GFSI recognition in 2018.
Authority / certifier
JFSM (Japan Food Safety Management Association)
Scope
Food manufacturers (choose A–C by company size)
Estimated cost
JFS-A: JPY 0.1–0.3M / JFS-B: JPY 0.3–1M / JFS-C: JPY 1–3M
Typical timeline
JFS-A: 1–3 months / JFS-B: 3–6 months / JFS-C: 6–12 months
An organic food certification scheme administered by the Ministry of Agriculture, Forestry and Fisheries (MAFF). By law, you must hold Organic JAS certification to label or sell products as 'organic'. Covers organic farm produce, organic processed foods, organic livestock products and more.
Authority / certifier
Ministry of Agriculture, Forestry and Fisheries (MAFF) / accredited certifiers
Scope
Manufacturers, processors and importers of organic foods
Estimated cost
Initial: JPY 0.2–0.5M / Annual: JPY 0.1–0.3M
Typical timeline
3–6 months
Licensing regime required for food manufacturing, processing and sales. The June 2021 amendment of the Food Sanitation Act reorganised licensed business categories into 32 categories. Operators in non-licensed categories must still file a notification.
Authority / certifier
Local public health centres
Scope
All food manufacturers, processors and sellers
Estimated cost
Application fee: JPY 10,000–30,000 (varies by category / region)
Typical timeline
2–4 weeks (including site inspection)
The Food Labeling Act consolidates labeling provisions previously split across the Food Sanitation Act, JAS Act and Health Promotion Act. Processed foods must show product name, ingredients, additives, allergens, net content, best-before date, storage conditions, manufacturer name and more.
Authority / certifier
Consumer Affairs Agency (CAA)
Scope
All food manufacturers, processors and sellers
Estimated cost
Labeling consultancy: JPY 50K–200K / Nutrition analysis: JPY 10K–50K
Typical timeline
Label design: 2–4 weeks
Two schemes allow health-related claims on Japanese foods. FOSHU (Tokuho) requires individual review and approval by the Consumer Affairs Agency — expensive and slow. The FFC scheme is notification-based and lets operators make functional claims with relatively short timelines and lower cost.
Authority / certifier
Consumer Affairs Agency (CAA)
Scope
Manufacturers and sellers of health and functional foods
Estimated cost
Tokuho: JPY tens of millions to hundreds of millions / FFC: JPY 2M–10M (including SR)
Typical timeline
Tokuho: 2–5 years / FFC: 6–12 months (until accepted)
Permits, certifications and standards relevant to cosmetics OEM manufacturing — from statutory requirements such as cosmetics manufacturing licences, to quality and organic standards including GMP (ISO 22716) and COSMOS.
International standard covering quality management throughout cosmetics manufacturing — from raw material receipt through manufacturing, packaging, storage and shipping. Not legally required in Japan, but de-facto industry standard often demanded by major brands for OEM partnerships.
Authority / certifier
ISO (International Organization for Standardization) / certification bodies
Scope
Cosmetics manufacturers
Estimated cost
Initial: JPY 1M–3M / Annual: JPY 0.3M–0.8M
Typical timeline
6–12 months
Authorisation required to put cosmetics on the market (manufacture and sell). It covers responsibility for quality and safety management, and is mandatory if you sell under your own brand. Either the OEM client or the OEM manufacturer must hold this licence.
Authority / certifier
Local prefecture (Pharmaceutical Affairs Division)
Scope
Operators putting their own-brand cosmetics on the market
Estimated cost
Application fee: ~JPY 40,000 / Preparation: JPY 0.5–1M
Typical timeline
3–6 months (including preparation)
Licence required for each manufacturing site that actually produces cosmetics. Comes in two categories: 'General' (manufacture / pack / label / store) and 'Packaging-only' (pack / label / store only). The OEM manufacturer holds this licence; the OEM client usually does not need it.
Authority / certifier
Local prefecture (Pharmaceutical Affairs Division)
Scope
Operators manufacturing cosmetics (per site)
Estimated cost
Application fee: ~JPY 30,000 / Facility setup: varies
Typical timeline
2–4 months
Approval required to market medicated cosmetics (quasi-drugs). Each product needs approval from the Minister of Health (operationally PMDA) for the active ingredients and claimed effects. Applies to products claiming whitening, acne prevention, hair growth and similar effects.
Authority / certifier
MHLW / PMDA (Pharmaceuticals and Medical Devices Agency)
Scope
Operators marketing medicated cosmetics / quasi-drugs
Estimated cost
Application: JPY 0.5–2M (including testing)
Typical timeline
6–12 months (until approval)
The core law governing the manufacture, sale and advertising of cosmetics. It defines cosmetics, labeling rules (full ingredient disclosure) and advertising rules (allowed claims). Cosmetics may only claim effects from the official list of 56 — anything beyond constitutes a violation.
Authority / certifier
MHLW (Ministry of Health, Labour and Welfare)
Scope
All operators involved with cosmetics
Estimated cost
Legal counsel: JPY 50K–200K / Ad review: depends on case
Typical timeline
-
International guideline defining natural-origin and organic-origin raw materials and methods to calculate natural and organic indices. It is not a certification scheme but a calculation standard, used to substantiate claims like 'X% natural-origin ingredients'.
Authority / certifier
ISO (International Organization for Standardization)
Scope
Operators marketing natural / organic cosmetics
Estimated cost
Standard purchase + calculation work: JPY 100K–300K
Typical timeline
1–2 months (calculation / implementation)
International certification standard for organic / natural cosmetics jointly developed by ECOCERT, BDIH, Cosmebio, ICEA and Soil Association. Comes in two levels — COSMOS ORGANIC and COSMOS NATURAL — with strict criteria for ingredients, manufacturing and packaging.
Authority / certifier
COSMOS-standard AISBL / certification bodies (ECOCERT etc.)
Scope
Operators of organic / natural cosmetics
Estimated cost
Initial: JPY 0.5–1.5M / Annual: JPY 0.2–0.5M
Typical timeline
3–6 months
Compare the key food safety certifications at a glance. Choose what fits your business size and your customers' requirements.
| Certification | Level | Estimated cost | Typical timeline | International recognition | GFSI recognition |
|---|---|---|---|---|---|
| HACCP | Basic (mandatory) | 50〜500万円 | 3〜12ヶ月 | 高 | Not recognised |
| ISO22000 | Intermediate | 100〜300万円 | 6〜18ヶ月 | 高 | Not recognised |
| FSSC22000 | Advanced | 150〜400万円 | 8〜18ヶ月 | 最高 | Recognised |
| JFS-A | Other | 10〜30万円 | 1〜3ヶ月 | 低 | Not recognised |
| JFS-B | Basic | 30〜100万円 | 3〜6ヶ月 | 中 | Not recognised |
| JFS-C | Advanced | 100〜300万円 | 6〜12ヶ月 | 高 | Recognised |
| 有機JAS | Specialty | 20〜50万円 | 3〜6ヶ月 | 高 | Not recognised |
About GFSI (Global Food Safety Initiative): GFSI is run under the Consumer Goods Forum (CGF) and benchmarks (recognises) food safety standards. GFSI-recognised standards are widely required by global companies such as Walmart, Nestlé and Danone of their suppliers. FSSC 22000 and JFS-C are GFSI-recognised.
Compare cosmetics OEM permits and certifications at a glance. Understand mandatory legal requirements and voluntary certifications to plan accordingly.
| Certification / Licence | Category | Estimated cost | Typical timeline | Scope |
|---|---|---|---|---|
| 化粧品製造販売業許可 | Mandatory | 50〜100万円 | 3〜6ヶ月 | 市場出荷 |
| 化粧品製造業許可 | Mandatory | 設備による | 2〜4ヶ月 | 製造所 |
| GMP（ISO22716） | Recommended | 100〜300万円 | 6〜12ヶ月 | 品質管理 |
| 医薬部外品承認 | Other | 50〜200万円 | 6〜12ヶ月 | 薬用品目 |
| COSMOS認証 | Optional | 50〜150万円 | 3〜6ヶ月 | オーガニック |
| ISO16128 | Optional | 10〜30万円 | 1〜2ヶ月 | 自然由来指数 |
What OEM clients should know: Cosmetics Manufacturing Licences are held by the OEM manufacturer (the plant), so OEM clients usually do not need to obtain one themselves. However, you do need a Cosmetics Marketing Authorisation when selling under your own brand. Picking an OEM manufacturer that already holds the marketing authorisation can save the client from acquiring it.
Obtaining food-safety or quality-management certification typically follows these five steps. The timeline depends on the certification and your business size, but the basic flow is shared.
Compare your target certification's requirements with your current operations to surface gaps. Engaging a consultant is also effective.
Build the management system the certification requires and prepare documents such as procedures and records. Define staff roles and accountability.
Train staff on the documented system. Run a trial period in real operations to surface issues and improvement points.
Run an internal audit to check conformance with the standard, then have leadership review the results and direct improvements. This is the final check before the external audit.
Be audited by the certification body. Audits are typically two stages: documentation review (Stage 1) and on-site audit (Stage 2).
OEM JAPAN lets you search for OEM manufacturers holding HACCP, ISO 22000, FSSC 22000, GMP and similar certifications. Filter by certification to find partners with strong quality management.
Disclaimer: This page is compiled from public materials of each authority and certifier, but the details, cost and timeline of certification schemes may vary by period and certifier. For the latest accurate information, please check the relevant authority's or certifier's official site. Costs are estimates and vary significantly with business size, scope and use of consultants.
OEM JAPAN allows you to search and compare food and cosmetics OEM manufacturers for free. Many manufacturers offering small lot options are listed.