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.