This week for OEM / ODM manufacturers

The revision of 21 March 2025 amended 15 general test methods and 222 ingredient specifications. From 30 September 2026, the new specifications apply unless a minor change notification allowing continued use of the old specifications was filed before September.

What to do: Companies manufacturing or selling quasi-drugs (medicated cosmetics) for Japan should review their raw material specifications.

Source: Pharmaceutical Affairs Notice No. 0321-1 (March 21, 2025) · A related notice was also issued on the same day: Drug Administration and Review Notice No. 0321-1

The US Food and Drug Administration (FDA) published the FY2027 OTC Monograph Drug User Fee (OMUFA) rates on 29 July 2026: USD 47,891 for monograph drug facilities (MDF) and USD 31,927 for contract manufacturing organisations (CMO), about 149% higher than in FY2026 (FY2026 was an unusually low point following a one-off statutory reserve adjustment). The payment date moves from June to October, with two equal instalments due on 1 October 2026 and 1 February 2027.

What to do: Contract manufacturers producing OTC monograph drugs for US brands (e.g. acne products containing salicylic acid or benzoyl peroxide, and sunscreens) must pay the official CMO fee of USD 31,927, with the first half (USD 15,963.50) due on 1 October 2026. The fee should be factored into the cost of US OTC business. Non-OTC product lines are not affected.

Source: FDA OMUFA

Under Regulation No. 25/2025 of the Indonesian Food and Drug Authority (BPOM): 101 substances are newly prohibited (including Quaternium-15, D4, 2-chloroacetamide and chlorophene); homosalate is restricted to face products (excluding sprays); and benzophenone-3 is restricted by product category. Products containing newly prohibited substances may not be renewed or sold.

What to do: Products on sale in, or being notified for, Indonesia should be checked against the new lists immediately; products that exceed the limits must be reformulated and re-notified.

Source: PerBPOM 25/2025

What to do: Under the EU REACH Regulation, companies should check whether formulations and packaging materials contain perfluorohexanoic acid (PFHxA) or its salts.

Source: REACH

Confirmed by two official sources, the Halal Product Assurance Agency (BPJPH) and the Indonesian Food and Drug Authority (BPOM); the head of BPJPH told parliament there will be no postponement. Imported and domestic products are subject to the same deadline, with no differential treatment. Legal basis: Law No. 33/2014 and Government Regulation No. 42/2024.

What to do: According to a clarification by Indonesia's Minister of Trade on 17 September 2026, halal certification is not an import restriction: goods can clear customs, but a certificate is required for products to be distributed on the market. Indonesian buyers are expected to require manufacturers to provide certification. As of September 2026, Indonesia had signed mutual recognition agreements (MRAs) with 116 foreign halal certification bodies, and certification through an MRA body is generally faster than a new application. Options include: (1) certification by a foreign body that has signed an MRA (first verify that it is on the list); (2) commissioning an Indonesian halal inspection body (LPH) to audit the factory in China. Factories that already hold a halal certificate should also verify that the issuing body is on the MRA list.

Source: Official BPJPH / BPOM

Decree No. 284 of the General Administration of Customs of China (GACC), published on 6 May 2026, takes effect on 1 December 2026. It also abolishes consignee filing for imported cosmetics and the designated storage site requirement. Pre-export declarations must state that the company holds a production licence and include label samples with Chinese translations. Customs clearance will be considerably simpler, but companies bear greater primary responsibility.

What to do: Exporters can streamline their procedures accordingly, while ensuring that their quality management systems remain effective.

Source: General Administration of Customs Order No. 284 (Issued on May 6, 2026)

Under WAC 173-339-110, 25 formaldehyde-releasing substances will be banned in cosmetics. The list includes DMDM hydantoin, imidazolidinyl urea, diazolidinyl urea and bronopol, which are widely used as low-cost preservatives in products such as cotton pads, wet wipes and sheet-mask essences, so these categories are the most affected. A new definition of 'intentionally added' takes effect on the same date.

What to do: Products sold in Washington State, and products using a single US-wide formula, should switch preservative systems before 1 January 2027 (alternatives include phenoxyethanol with ethylhexylglycerin, caprylyl glycol and hydroxyacetophenone). Preservative changes involve formulation and stability work with long lead times, so brands and manufacturers should start early.

Source: WAC 173-339-110

The Oregon Health Authority (OHA) must review and revise its list of high-priority chemicals every three years, so the list is a living one and one-off compliance will not remain valid.

What to do: Companies should monitor updates to the OHA list of high-priority chemicals.

Source: Oregon SB 546