Whether you are preparing a new substance registration or fulfilling regulatory obligations under China REACH, LAUS supports you with high-quality testing services covering the full range of regulatory requirements according to the principles of Good Laboratory Practice (GLP). Our experts work closely with you to develop efficient testing programs that meet the expectations of Chinese regulatory authorities.

Please, take a look at the data requirements further down.

Time-sensitive regulatory update: China REACH / New Chemical Substance Registration

Proposed changes may affect non-Chinese companies exporting chemical substances to China

On 11 June 2026, China’s Ministry of Ecology and Environment (MEE) published a draft revision of the rules governing the registration of new chemical substances, currently set out in MEE Order No. 12 and often referred to as China REACH.

The draft is open for public comment until 12 July 2026 and has not yet been finalized. If adopted as currently drafted, the revised rules are expected to take effect on 15 August 2026, when MEE Order No. 12 would be repealed.

Key proposed change: applicant role for overseas companies

A key proposed change concerns the role of overseas companies.

Under the draft, the existing model under which a non-Chinese company acts as the registration applicant through a Chinese local representative would no longer be available. Instead, the applicant would need to be an enterprise or institution registered in mainland China and engaged in producing or importing the new chemical substance.

This proposed change could be particularly relevant for companies that currently export, or plan to export, chemical substances to China and either hold, rely on, or plan to obtain a China new chemical substance record notification or registration.

Potential relevance for specific sectors

The draft may also be relevant for companies in sectors such as pharmaceuticals, pesticides, veterinary drugs, cosmetics, food, food additives, feed, feed additives and fertilizers. For these sectors, the regulatory scope may need to be reviewed more carefully under the draft, depending on the substance and its use.

Points companies may wish to review

Companies with current or planned exports of chemical substances to China may wish to consider the following questions:

• Do you currently export, or plan to export, chemical substances to China, either as such or in mixtures?
• Do you currently hold, rely on, or plan to obtain a China new chemical substance record notification or registration for exports to China?
• If the current overseas applicant model is no longer available, could this affect your compliance route, supply-chain setup or protection of confidential business information for exports to China?

Early review recommended

As the draft includes a short timeline and may affect existing or planned China market-entry strategies, companies potentially affected by the proposed changes may wish to review their situation promptly.

For questions or an initial assessment, please contact us to discuss whether your substances, supply chain or project status may be affected.

China REACH

The MEP Order No. 7 (Measures on Environmental Administration of New Chemical Substance) came into force on October 15, 2010 and due to its similarity to the European model it is referred to as China REACH. On January 1, 2021 this was replaced by the Chinese Ministry of Ecology and Environment with MEE Order No.12 (Measures for the Environmental Management Registration of New Chemical Substances).

New Substances are substances, that are not listed in the Chinese Inventory of Existing Chemical Substances manufactured or imported in China (IECSC). These must be registered regardless of the production volume. Substances with a change in the intended use must also be registered.

A Regular Registration is required for substances that are manufactured or imported in quantities> 10 t / a. A Simplified Registration is sufficient for substances that are manufactured or imported in quantities of 1-10 t / a. For substances that are manufactured or imported in quantities <1 t / a or for polymers that meet PLC criteria (Polymers of Low Concern) a Record Notification is sufficient. In contrast to EU REACH, polymers have to be registered.

The competent authority is the Solid Waste and Chemical Management Center (SCC) of the State Environmental Protection Administration (SEPA). Registration must take place prior to production or import.

The MEE Order No.12 has resulted in the following changes in the data requirements:

• Physico-chemical test data from non-Chinese laboratories are accepted
• In-vitro skin and eye irritation studies are accepted if the results are conclusive
• Additional requirements based on P and B potential (Persistence and Bioaccumulation), e.g. toxicological data, sediment chironomid test, etc.

Data requirement:

Physico-chemical Properties: Simplified Registration and Regular Registration

Physico-chemical Properties	Test Method OECD	Simplified Registration (1 t/a ≤ Q < 10 t/a)			Regular Registration (Q ≥10 t/a)
		Gas	Liquid	Solid	Gas	Liquid	Solid
Spectrogram		x	x	x	x	x	x
Melting point/Freezing point	102		x	x		x	x
Boiling point	103		x			x
Density	109		x	x		x	x
Vapor pressure	104		x			x
Water solubility	105	x	x	x	x	x	x
n-octanol/water partition coefficient	107		x	x		x	x
pH			x			x
Granulometry	110			x			x
Surface tension	115		x			x
Critical point		x			x
Dissociation constant (pKa)	112					x	x
Henry’s law constant					x	x	x

x = required

Ecotoxicology: Simplified Registration (1 t/a ≤ Q < 10 t/a) and Regular Registration (Q ≥ 10 t/a)

Ecotoxicology	Test Method OECD	Basic Simplified Data (non-P and non-B; P or B)	Special Simplified Data (P and B)	Basic Regular Data (non-P and non-B)	Special Regular Data (P or B)
Algal growth inhibition toxicity	201	x	x	x	x
Daphnia acute toxicity	202	x	x	x	x
Fish acute toxicity / Fish short-term toxicity test on embryo yolk-sac absorption stages	203	*	*	*	*
Activated sludge respiration inhibition toxicity	209			*	*
Adsorption/desorption	121/106			x	x
Degradability	301/310	*	*	*	*
Earthworm acute toxicity test	207			x	x
Daphnia reproduction test	211		x	x	x
Bioaccumulation	305	*	*	*	*
Fish chronic toxicity test	210/212/215		*	*	*
Seed germination and root elongation test or Terrestrial plants growth test					x
Enchytraeid reproduction test or Earthworm reproduction test					x
Benthos chronic toxicity					x

x = required; * = mandatory test in China; P = persistence; B = bioaccumulation

Toxicology: Regular Registration (Q ≥ 10 t/a)

Toxicology	Test Method OECD	Basic data (non-P and non-B)	Special Data 1 (P or B)	Special Data 2 (P and B)
Acute toxicity (oral + dermal + inhalation)	423, 402, 403	x	x	x
Skin corrosion/irritation	431/435/439 in-vitro (in-vivo 404)**	x	x	x
Eye irritation	492/437 in-vitro (in-vivo 405)**	x	x	x
Skin sensitization	in-vitro 442C/D/E (in-vivo 406/429)**	x	x	x
Mutagenicity	471, 473/487, 476 (in-vitro/in-vivo)	x	x	x
Repeated dose toxicity (oral/dermal/inhalation, 28days/90days)	407/410/412 (28 days); 408/409, 411, 413 (90 days)	x (28 days)	x (90 days)	x (90 days)
Reproductive/ developmental toxicity	421/422	x	x	x
Toxicokinetics	417			x
Chronic toxicity	452			x
Carcinogenicity	451/453		x	x
Other		x	x	x

x = required; P = persistence; B = bioaccumulation

**If no conclusion can be drawn from in-vitro test data, in-vivo test data must be provided.

If you are affected by China REACH, please contact us to discuss the test strategy.