CIRS Regulatory Newsletter | August 2026 – Regulatory Updates (II) - Newsletter

From registrations for pesticides and chemical substances, to sunscreen testing, and food labeling, regulators around the world are continuing to introduce changes that could have a direct impact on market access.

In this issue, we highlight some of the most important recent developments across China, South Korea, the EU, the U.S., and beyond, with practical takeaways for businesses navigating evolving requirements in chemicals, agrochemicals, cosmetics, and food.

⭐Editor’s picks – key regulatory developments

Comprehensive Analysis: Key Points of the Draft Data Requirements for Pesticide Registration in China

China’s MARA has issued a sweeping draft revision of pesticide‑registration data requirements, tightening risk‑based evaluations for new active ingredients, expanding metabolite testing, raising botanical‑pesticide obligations, and simplifying TC and similar‑formulation pathways after data‑protection expiry. Microbial‑pesticide registration shifts to species‑level management, designated adjuvants gain new data duties, and all submissions move to fully digital dossiers. These changes significantly lower barriers for off‑patent TCs while raising scientific rigor for new actives. ➡️Read more

China: Four Key Changes as New Chemical Substance Filing Converts to Registration

With the Ecological and Environmental Code in force, China has abolished the filing pathway for new chemical substances and fully transitioned to registration. From August 15, 2026, the MEE system accepts only registration applications, each covering a single substance, with mandatory disclosure of applied use and—where confidentiality is sought—a necessity statement for information protection. Overseas entities can no longer act as applicants. Enterprises should review ongoing filings, prepare use descriptions, and update documentation to ensure a smooth compliance transition.➡️Read more

South Korea's MFDS Proposes Introducing In Vitro Test Methods for Sunscreen Cosmetics

South Korea’s MFDS has proposed major updates to functional‑cosmetics review rules, introducing ISO‑recognized in vitro SPF and PA test methods to reduce reliance on human studies and accelerate sunscreen development. The draft also narrows data‑exemption criteria—requiring full ingredient alignment except for minor changes in fragrances, preservatives, and colorants—and clarifies substantiation standards for labeling and advertising sun‑protection claims. With comments due September 18, companies should review formulation strategies and testing plans early.➡️Read more

South Korea Revised the Labeling Standards for Genetically Modified Foods

South Korea’s MFDS has revised its GM food labeling standards, requiring mandatory labeling for soy sauce, sugars, and edible oils and fats produced using GM ingredients, even when GM components are not detectable in the final product. The change significantly broadens labeling obligations and follows earlier industry consultations and WTO notification. The rules take effect on December 31, 2026, with sugars and edible oils subject to a one‑year delayed implementation until December 31, 2027. ➡️Read more

🔎What’s covered in this issue – at a glance

💻Free webinars

Introduction on Hair Care Damage Models & Efficacy Evaluation

🌱Agrochemical news

Comprehensive Analysis: Key Points of the Draft Data Requirements for Pesticide Registration in China

🧪Chemical news

💄Cosmetic news

🍽Food and food contact material (FCM) news

Free Webinar

Introduction on Hair Care Damage Models & Efficacy Evaluation

In the competitive global cosmetics market, substantiating your hair care product’s repair claims with robust, scientifically valid data is no longer optional—it’s a regulatory and commercial necessity. This webinar, led by Marcy Liang, delivers a deep dive into the establishment of standardized hair damage models and the cutting-edge evaluation methods used to quantify repair efficacy. ➡️Read more and register here

Agrochemical news

Comprehensive Analysis: Key Points of the Draft Data Requirements for Pesticide Registration in China

Chemical news

EU Proposes Significant Tightening of Chemical Controls in Toys

The EU’s draft directive revising Annex II of the Toy Safety Directive introduces sweeping chemical‑safety updates: Lilial will be fully prohibited, BPA’s migration limit will drop nearly tenfold to 0.005 mg/L, and phenol and BIT requirements will shift to new EN 71‑17/18/19 standards with updated content and migration limits. Member States must transpose the directive within 12 months of publication, with rules applying 12 months thereafter. Toy manufacturers should begin reformulation and testing reviews now. ➡️Read more

South Korea's NICS Proposes Prescribed Quantity Thresholds for 38 New Hazardous Chemicals

South Korea’s NICS has proposed revisions to prescribed‑quantity rules under the Chemicals Control Act, setting thresholds for 38 newly designated hazardous chemicals, adding strengthened low‑diffusion quantities for seven substances, and correcting five existing entries. These thresholds determine whether a substance triggers permission, reporting, or facility‑management duties, making early review essential for chemical holders. With the rule expected to take effect on August 7, 2026, companies should assess inventory impacts and submit comments before August 19. ➡️Read more

China: Four Key Changes as New Chemical Substance Filing Converts to Registration

How Exactly Will the EU PPWR Be Enforced? Official Answers to 11 FAQs

The EU Packaging and Packaging Waste Regulation becomes applicable on August 12, 2026, with the Commission clarifying that non‑compliant packaging will first receive corrective‑action warnings rather than immediate market bans. Stock produced before the deadline need not be destroyed, and EPR duties fall primarily on producers and EU importers. The FAQ outlines requirements for unique identifiers, PFAS testing, heavy‑metal verification, and whole‑unit conformity assessments. Companies must prepare accurate DoCs and align packaging portfolios with Articles 5–12.➡️Read more

South Korea to Refresh Chemical Classification and Labeling Regulation

South Korea’s NICS has proposed amendments to the Regulation on the Classification and Labeling of Chemical Substances, incorporating GHS classifications for 38 newly designated hazardous chemicals and revising nine existing entries, including updates to lead compounds, cyanides, mercury, strychnine, hydantoins, and several UN numbers. Because these classifications directly determine on‑pack labels and SDS content under the Chemicals Control Act, companies must review substance‑level impacts and plan timely relabeling before the July 1, 2027 transition deadline. . ➡️Read more

PPWR Officially Takes Effect: Chemical Export Enterprises Please Note

The EU PPWR became applicable on August 12, 2026, requiring chemical exporters to verify packaging compliance across manufacturer identification, heavy‑metal and PFAS testing, Declaration of Conformity, and full technical documentation. EPR duties depend on who places the packaged product on the EU market—typically the importer, unless the exporter supplies directly to an end‑user factory. Dangerous‑goods packaging is exempt only from recyclability and recycled‑content rules. Companies should begin testing, documentation, and producer‑status determinations immediately. ➡️Read more

South Korea Proposes to Ban PET Cans from January 1, 2028

South Korea’s MCEE has proposed banning PET containers joined with metal lids that cannot be separated by hand, targeting PET cans that disrupt food‑grade PET recycling. The rule, effective January 1, 2028, will impact roughly 11,000 coffee outlets and related manufacturers, all of whom must transition to separable PET bottles. Regulatory analysis shows added annual material costs of KRW 8.03 billion (approx €4,923,399/$5,756,474) but significant recycling‑system benefits. Companies should assess packaging separability and plan replacements ahead of the deadline. ➡️Read more

EU Notifies WTO of Major CLP Regulation Revision Draft

The European Commission’s draft CLP revision integrates GHS Revisions 8–11, introducing a new “chemicals under pressure” hazard class, updated aerosol and explosives criteria, and tiered non‑animal assessment approaches for skin corrosion/irritation, eye damage, sensitisation, and acute toxicity. Precautionary statements are extensively rationalised, with new and consolidated codes. After publication, the rules become mandatory in 24 months, with a 48‑month sell‑through period for existing labels. Exporters should begin reviewing classifications, SDSs, and hazard communication now.➡️Read more

Cosmetic news

Effective from January 1, 2028, Mandatory National Standard Cosmetics-General Safety Requirements Officially Issued

China’s new mandatory standard, GB 7916‑2026 Cosmetics – General Safety Requirements, consolidates and elevates national cosmetic safety rules, replacing the 1987 hygiene standard. It introduces stricter microbial limits for children’s and eye‑area products, unified definitions for prohibited and permitted substances, tighter heavy‑metal controls, and clearer impurity‑management principles. The standard also reduces industry burden by harmonizing requirements and providing a transition period through 2028. Companies should begin formula reviews, testing updates, and compliance alignment now. ➡️Read more

South Korea Exempts Rinse-free Shampoos from Labeling and Adds Usage Precautions for Benzophenone-3

South Korea’s MFDS has amended its cosmetic precaution and allergen‑labeling requirements, introducing a key exemption that allows dry and rinse‑free shampoos to omit the warning about hair loss or discoloration. The update also adds mandatory usage precautions for Benzophenone‑3 above 2.4%, effective September 2, 2026, with a six‑month grace period for existing packaging. These changes refine risk communication and reduce unnecessary labeling burdens. Companies should update formulas, artwork, and compliance checks promptly.➡️Read more

China's NIFDC Solicits Comments on Cosmetics Ingredients and Testing Methods in STSC

China’s NIFDC has released nine draft updates to the Safety and Technical Standards for Cosmetics, proposing to prohibit Trisodium NTA, Methyl Pyrrolidone, and Ethyl Butylacetylaminopropionate; restrict Kojic Acid to 1% in face and hand products; lower the formaldehyde‑labeling threshold to 0.001%; and expand CI colorant uses with EU‑aligned purity limits. The skin‑sensitization test method is also modernized to match OECD TG 406. Companies should assess formulation impacts, labeling changes, and testing adjustments early. ➡️Read more

South Korea MFDS Releases Draft Guidelines on Braille Labeling for Cosmetics

South Korea’s MFDS has released draft Guidelines on Braille Labeling and Accessibility QR Codes for cosmetics, establishing standardized methods, specifications, and placement rules to support visually and hearing‑impaired consumers. The draft outlines braille size and spacing requirements, preferred embossing methods, and tactile‑bordered QR codes that provide full product information, including ingredients, usage, batch data, and precautions. With comments due August 31, 2026, cosmetic manufacturers and responsible sellers should review packaging designs and prepare for compliance.➡️Read more

Summary Report on China Cosmetic Supervision and Sampling Inspection – July 2026

Cosmetic regulators in Guangdong and Guizhou reported nine non‑compliant batches, mainly sunscreen and hair‑care products, with issues ranging from microbial exceedances to illegal ingredients and preservative misuse. Guangdong also suspended nine manufacturers for severe production‑quality management failures, later allowing operations to resume after rectification. Concurrently, SAMR advanced revisions to China’s product‑quality random‑inspection measures, and Shandong conducted targeted inspections on perfume and floral‑water products. Enterprises should strengthen raw‑material control, formula review, and full‑chain compliance.➡️Read more

Global Cosmetics Regulatory Updates – Vol. 41 (July 2026)

July 2026 saw sweeping cosmetic regulatory activity worldwide. China advanced multiple NMPA and NIFDC initiatives, expanded personalized‑cosmetics pilots, and issued new standards and provincial reform measures. The EU updated fragrance‑allergen rules, proposed amendments to Annexes II–V, and saw Sweden move toward a national PFAS ban. The US progressed formaldehyde and allergen‑labeling rules, while Illinois enacted a 24‑ingredient ban. Australia tightened controls on retinal, and South Korea and ASEAN advanced safety‑assessment and standards updates. ➡️Read more

South Korea MFDS Proposes to Introduce In Vitro Test Methods for Sunscreen Cosmetics

Sunscreen SPF & UVA in the EU, UK and China: A Practical Guide

In this article, Zeynep Gudum dives into the scientific and regulatory complexities behind SPF and UVA claims, explaining why sun protection testing must be tailored to each market. While the EU and UK rely on ISO methods and emerging in‑vitro alternatives, China treats sunscreens as special cosmetics requiring accredited‑lab testing, CSAR registration, and PA‑grade labeling. Because permitted filters, testing protocols, and classifications differ significantly, brands should confirm requirements early to avoid costly reformulation and delays. ➡️Read more.

Food and food contact material (FCM) news

UK Food Standards Agency Releases Updated Allergen Guidance for Food Businesses

The UK FSA’s July 2026 update reinforces strict allergen‑management rules, requiring clear emphasis of 14 regulated allergens on prepacked and PPDS labels, and written allergen information for non‑prepacked foods. Businesses must maintain full allergen‑traceability records, verify supplier documentation, and implement robust cross‑contamination controls. Allergen‑free claims now require comprehensive evidence covering raw materials, segregation, and hygiene practices. Exporters should update labels, strengthen documentation, and prepare standardized allergen disclosures for UK partners. ➡️Read more

FSANZ Released New Guidance Clarifying the Definitions of GM Food

FSANZ’s updated guidance clarifies how GM food and novel DNA definitions apply under the Australia–New Zealand Food Standards Code, outlining four GM‑food categories and key exemptions for additives, processing aids, grafted plants, and null segregants. The update emphasizes that GM classification depends on source materials and production processes, not solely on detectable DNA. Developers using gene editing, synthetic biology, precision fermentation, or cell‑culture systems should conduct early regulatory assessments and maintain robust technical documentation. ➡️Read more

How to Legally Export New Food Ingredients to the US: FAQs on GRAS Notice

U.S. FDA compliance for new food ingredients follows four pathways – GRAS, NDI, FAP, and CAP, each tied to intended use and technical function. GRAS status has no expiry but must be updated when use conditions or manufacturing change, and GRAS alone does not authorize dietary‑supplement use without evidence of commercial marketing. Ingredients not in the GRAS inventory require either NDI notification or GRAS plus subsequent NDI exemption. FDA is expected to introduce a simplified transition for existing Self‑GRAS filings.➡️Read more

FDA Released Proposed Rule on Mandatory GRAS Notification—120-Day Comment Period Opens

The U.S. HHS and FDA have released a proposed rule that would formally end the Self‑GRAS pathway and mandate FDA‑submitted GRAS notices for all GRAS determinations. The proposal, open for comment until December 9, 2026, marks a major shift toward greater regulatory oversight of food‑ingredient safety. Companies should evaluate existing Self‑GRAS positions, identify dossier gaps, and consider whether early voluntary submission offers a competitive advantage. CIRS’s U.S. toxicology team is supporting clients through this transition. ➡️Read more

In-Depth Analysis of the FDA’s Proposed Rule: How Long Can Self-GRAS Continue?

The U.S. HHS has issued a proposed rule to replace voluntary GRAS notifications with a mandatory system, directly targeting the Self‑GRAS pathway. Companies with urgent commercialization timelines may still pursue Self‑GRAS while preparing FDA submissions, whereas others can move directly to FDA review. The proposal also affects animal‑food GRAS, with exemptions via AFIC and certain AAFCO listings. NDI exemptions remain available only when GRAS ingredients have been marketed in conventional foods. Businesses should begin adjusting regulatory strategies now. ➡️Read more

South Korea Revised the Labeling Standards for Genetically Modified Foods

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