Ahead of Taiwan's Full PIF Mandate, BAYCOSMETICS Launches OEM Service Covering Manufacturing to PIF Compliance

BAYCOSMETICS Co., Ltd. announces the launch of a new one-stop service to support Product Information File (PIF) preparation, safety assessment, and local regulatory submission for Taiwan and ASEAN markets, effective from July 1, 2026—the date of enforcement for the third phase of Taiwan's PIF (Product Information File) regulation. This integrated system allows brands to outsource manufacturing to BAYCOSMETICS and receive full PIF compliance as part of the same service. This comprehensive approach—where a cosmetics OEM/ODM manufacturer assumes full responsibility for PIF compliance as part of manufacturing—is unprecedented among domestic manufacturers in Japan (based on company research as of June 2026). Brands will no longer need to separately outsource PIF preparation to regulatory consulting firms, eliminating a major bottleneck in overseas expansion.

Background

Taiwan's PIF Regulation Expands to All Cosmetics on July 1, 2026

Under Taiwan's Cosmetic Health and Safety Management Act, enacted in 2019, the PIF system has been introduced in phases since July 2024. After Phase 1 (sunscreen, hair dyes, etc.) and Phase 2 (products for infants, lip/eye area, etc.), Phase 3—effective July 1, 2026—will mandate PIF creation and retention for all general cosmetics, excluding solid hand soaps.

A PIF is a comprehensive product safety dossier containing 16 technical documents, including full ingredient concentrations, toxicological data, stability test reports, preservative efficacy testing, and GMP compliance certificates. Non-compliance may result in fines of NT$10,000 to NT$1,000,000 (approximately 47,000 to 4.7 million JPY), and serious violations could lead to business suspension.

The 'Formulation Data Barrier' Facing Japanese Companies

The biggest challenge Japanese cosmetic brands face in complying with Taiwan's PIF requirements is obtaining accurate formulation data.

While the PIF requires disclosure of precise ingredient concentrations (formulation ratios), Japan's cosmetic labeling regulations do not mandate such disclosure. As a result, many brands that outsource manufacturing to OEM suppliers lack access to exact formulation ratios. Moreover, OEM manufacturers often refuse to share data citing 'trade secrets,' causing numerous PIF preparation efforts to stall.

Additionally, the limited number of authorized safety assessors (signatories) in Taiwan has led to a surge in demand ahead of Phase 3 enforcement, resulting in wait times of several months just to secure a signature.

Limitations of Existing Support Systems

Currently, PIF compliance support in Taiwan is primarily provided by consulting and regulatory affairs firms. While these firms possess strong regulatory expertise, they lack manufacturing capabilities, meaning formulation data acquisition must still be coordinated separately between the brand and the OEM manufacturer.

Conversely, while OEM manufacturers excel in production, PIF preparation and overseas regulatory compliance are typically outsourced. According to our research, no other OEM manufacturer in Japan currently offers an integrated in-house service covering 'OEM manufacturing + PIF creation + local regulatory submission.'

Overview of the Integrated PIF Compliance Service

Three Reasons Why 'Outsource Manufacturing, Get PIF Compliance Included'

Products manufactured by BAYCOSMETICS will receive full PIF compliance as part of the manufacturing service, with no additional outsourcing required. This seamless integration is made possible by our structural advantage as the manufacturer.

1. No Formulation Data Barrier—The Manufacturer Owns All Data

For all products we manufacture, we internally hold all PIF-required data, including ingredient ratios, manufacturing processes, and raw material specifications. Brands no longer need to negotiate with OEM factories for data access, enabling immediate PIF preparation.

This eliminates the major hurdle brands face when outsourcing PIFs: OEM manufacturers refusing to disclose data due to trade secret concerns. By choosing BAYCOSMETICS as the manufacturing partner, this structural issue is resolved.

2. Zero Back-and-Forth on Formula Changes and PIF Updates

When formula adjustments are needed due to overseas regulatory restrictions, traditional processes involve multiple parties—brand → consultant → OEM → consultant → brand—leading to delays. At BAYCOSMETICS, formula changes and PIF updates are handled simultaneously in-house, significantly accelerating response times.

3. Integrated Acquisition of Safety Assessments and Test Data

We coordinate all required testing for PIFs, including stability testing (accelerated testing for 3+ months), microbiological testing, and preservative efficacy testing (challenge testing). We also arrange for authorized safety assessors (signatories), minimizing administrative burden on the brand.

Service Coverage

Covered Items

Details

PIF Document Preparation

Creation of all 16 technical documents in Chinese or English

Full Ingredient Data Provision

Complete disclosure of formulation ratios, raw material specifications, and manufacturing processes

Safety Testing

Conducting and obtaining stability tests, microbiological testing, and preservative efficacy testing

Toxicological Data Collection

Collection and organization of toxicological research data for all ingredients

Safety Assessment

Safety evaluation and signing by a Taiwan-authorized assessor

GMP Compliance Certification

Issuance of GMP compliance documentation for our in-house manufacturing facility

Regulatory Submission Support (Taiwan)

Support for cosmetic notification (registration) procedures

Target Regions (Expanding Gradually)

Taiwan: Service available starting July 2026

ASEAN Countries (Singapore, Malaysia, Thailand, Indonesia, Vietnam, Philippines): Gradual rollout planned

We are building a one-stop compliance system aligned with the ASEAN Cosmetic Directive (ACD), preparing for upcoming regulatory tightening across ASEAN nations in 2025–2026—including Indonesia's mandatory halal certification, Vietnam's new regulations, and updates to the ACD ingredient list.

Growth Opportunities in ASEAN and Taiwan Markets

Japan's cosmetic exports have traditionally focused on China and Hong Kong. However, with slowing growth in China, expansion into ASEAN and Taiwan is accelerating.

ASEAN Cosmetic Market

Projected to reach approximately USD 9.5 billion in 2025

Expected to grow to USD 36.9 billion by 2034 (CAGR ~15.8%)

Taiwan Cosmetic Market

Market size of approximately TWD 214.6 billion (JPY 103.17 billion)

※ Annual growth of 3.5–4.3%

Key Markets

Indonesia (CAGR 16.52%, halal demand)

Vietnam (high trust in Japanese brands, young population)

By removing entry barriers to these high-growth markets, we aim to accelerate our clients' overseas expansion.

Integration with 'Bay Bridge Project'—Comprehensive Overseas Expansion Support

Starting June 2026, BAYCOSMETICS will launch the 'Bay Bridge Project,' a new program offering end-to-end support for cosmetic manufacturers—from product development and manufacturing to local market entry (press release issued May 18, 2026).

Under the Bay Bridge Project, brands that outsource manufacturing to us will receive full support to achieve sales success overseas, including overseas-compliant formulation development, local regulatory compliance, packaging localization, retail shelf placement negotiations, and local marketing via KOLs and social media. All support—including marketing strategy, regulatory compliance, and shelf negotiations—is provided free of charge. Brands are only responsible for manufacturing (OEM) costs.

This integrated PIF compliance service enhances and expands the regulatory capabilities of the Bay Bridge Project. For brands expanding via the Bay Bridge Project, PIF preparation will be included at no additional cost as part of the OEM manufacturing service.

About BAYCOSMETICS—From Manufacturing Partner to Strategic Partner

BAYCOSMETICS Co., Ltd. Representative Director: Sota Kato

Established in December 2023 as a 100% subsidiary of MD Co., Ltd., a marketing consulting firm, BAYCOSMETICS is a cosmetics OEM/ODM manufacturer. Guided by the concept 'From Manufacturing Partner to Strategic Partner,' we provide end-to-end support—from product planning and development to manufacturing, sales support, and overseas expansion.

Six-Phase Support System

Initial Consultation

Confirm business goals, budget, and target audience; propose optimal product strategy based on market data

Planning & Development

Utilize cosmetic formulation AI (analyzing ~6,000 formulation datasets) to design formulas in as little as 5 minutes

Manufacturing

Flexible scheduling aligned with promotional plans; full proposals including fixtures, containers, packaging, and design

Delivery Speed

Fast delivery in 2–3 months; rapid and flexible response via in-house manufacturing

Sales & Growth

Post-delivery sales support, including EC sales packages, in-store shelf placement, and live commerce

Overseas Expansion

End-to-end support from market selection to local launch strategy, including PIF compliance

Our Capabilities

Cosmetic Formulation AI: Real-time analysis of ~6,000 formulation trial datasets, enabling formula design in ~5 minutes

In-house Brand Experience: Products available in over 10,000 online and offline stores

Dedicated Marketing Team: Consistently develops 30+ campaigns monthly

AI Development: Cosmetic formulation AI, Pharmaceutical Affairs Law compliance AI, co-development of proprietary ingredients with universities

Distribution Network: Shelf presence at Don Quijote, @cosme, Loft; live commerce on Qoo10 and TikTok Live

Product Categories

Skincare, Haircare, Bodycare, Oral Care, Makeup, Fragrance, Hygiene Products, Organic Products, Professional Spa Cosmetics, Health Supplements

Future Outlook

Starting with our integrated PIF compliance service, BAYCOSMETICS will progressively build regulatory support systems for ASEAN countries, creating an environment that enables Japanese cosmetic brands to rapidly expand overseas. We will continue to transcend the role of a traditional OEM/ODM manufacturer and serve as a 'strategic partner for overseas expansion' for our clients.

Company Overview

Company Name: BAYCOSMETICS Co., Ltd.

Representative Director: Sota Kato

Founded: December 2023

Capital: 15 million JPY

Headquarters & Factory: 3-3-27 Shimokawaya, Izumisano City, Osaka Prefecture

Tokyo Office: 6-9-4 Shimbashi, Minato-ku, Tokyo, 4F Shimbashi Rokuchome Building

Business: Cosmetics OEM/ODM / Supplement OEM

URL: https://baycosme.com

Media & Inquiry Contact

Daisuke Shimizu, Public Relations BAYCOSMETICS Co., Ltd. TEL: 03-6823-7543 E-mail: contact@baycosme.com