China Hazardous Chemical Registration for Flavors and Fragrances

(Originally published on REACH24H official website, translated and edited by Jane Zhou)

1. Legal basis

Required by Decree 591, China’s overarching legislation on management of hazardous chemicals, and detailed by the Measures for the Administration of Hazardous Chemicals Registration (SAWS Order 53), companies are obliged to register at the local administrations of work safety to manufacture and/or import hazardous chemicals.

2. Scope of hazardous chemicals

For some historical reasons, many industry stakeholders mistakenly take highly toxic chemicals or chemical dangerous goods with assigned UN numbers as hazardous chemicals. Actually, according to Article 3, Decree 591, “hazardous chemicals refer to highly toxic and other chemicals hazardous to the human body, facilities and the environment which have toxic, corrosive, explosive, combustive, combustion-supporting, etc. properties.” In other words, chemicals with certain hazard properties are deemed as hazardous chemicals.

The specific hazard properties/ categories are further specified by the Inventory of Hazardous Chemicals (2015). The Inventory adopts 81 categories out of the total 95 hazard categories from 28 classes in line with the 4^th revision of UN GHS (2011), meaning that chemicals classified to any of the 81 categories belong to hazardous chemicals in addition to the specifically listed 2827 chemicals.

3. Hazardous chemicals in flavors and fragrances

Some typical wood distillates and flavors and fragrances are incorporated in the Inventory:

SN in the Inventory	Chinese Name (Alias)	English Name	CAS No.	HS Code
983	1,8-环氧对孟烷（桉叶油醇）	1,8-Epoxy-p-menthane; Cineole	470-82-6
1232	2-莰醇（冰片；龙脑）	BORNEOL FLAKES	507-70-0	2906190090
1233	莰烯（樟脑萜；莰芬）	Camphene	79-92-5	2902199090
1576	迷迭香油	Rosemary oil	8000-25-7	3301299999
1603	α-蒎烯（α-松油萜）	α-Pinene	80-56-8	2902191000
1604	β-蒎烯	β-Pinene	127-91-3	2902191000
1949	生松香（焦油松香；松脂）	Raw rosin	/	1301904010
2097	松焦油	Pine tar	8011-48-1	3807000000
2098	松节油	Turpentine oil	8006-64-2	3805100000
2099	松节油混合萜（松脂萜；芸香烯）	Terebene	1335-76-8	3805100000
2100	松油	Pine oils	8002-09-3	3805901000
2101	松油精	Rosin oil	8002-16-2	2942000000
2124	萜品油烯（异松油烯）	Cyclohexene, 1-methyl-4-(1-methylethylidene)-; Terpinqlene	586-62-9	2942000000 2901299090
2125	萜烃	Terpene hydrocarbons, n.o.s.	63394-00-3
2751	樟脑油（樟木油）	Camphor oil	8008-51-3

In addition to the listed ones, there are other chemicals not listed in the Inventory that are also regarded as hazardous chemicals and thus require hazardous chemical registration.

Different compositions and concentration ranges lead to different hazard categories. For example, the 60% (v/v) and 80% (v/v) spearmint oils are the most common commercial concentrations used in products on the market and their GHS classification results differ:

Spearmint Oil	60%	80%
Hazard categories	Flammable liquid, Cat.4	Flammable liquid, Cat.4
	Acute toxicity – Oral, Cat.5	Acute toxicity – Oral, Cat.5
	Aspirational hazard, Cat.1	-
	Skin irritation, Cat.2	Skin irritation, Cat.3
	Skin sensitization, Cat.1	Skin sensitization, Cat.1
	Hazardous to the aquatic environment – Acute, Cat.2	Hazardous to the aquatic environment – Acute, Cat.3
	Hazardous to the aquatic environment – Chronic, Cat.2	Hazardous to the aquatic environment – Chronic, Cat.3

In transportation, spearmint oil 60% is classified as Class 9 (Miscellaneous Dangerous Goods), while spearmint oil 80% is considered to be non-dangerous. From a manufacturing or importation perspective, both products require hazardous chemical registration under SAWS Order 53.

The classification results of the same 60% spearmint oil could also differ in different countries due to different building block strategies. Comparing China’s classification with that in the European Union:

Spearmint Oil 60%	China	EU
Hazard categories	Flammable liquid, Cat.4	-
	Acute toxicity – Oral, Cat.5	-
	Aspirational hazard, Cat.1	Aspirational hazard, Cat.1
	Skin irritation, Cat.2	Skin irritation, Cat.2
	Skin sensitization, Cat.1	Skin sensitization, Cat.1
	Hazardous to the aquatic environment – Acute, Cat.2	-
	Hazardous to the aquatic environment – Chronic, Cat.2	Hazardous to the aquatic environment – Chronic, Cat.2

This also accounts for why some products are considered non-hazardous in EU but are hazardous in China. Though many Chinese importers ask for the (M) SDSs of chemical products from their European suppliers, direct translation of the CLP-compliant SDS is usually unacceptable under China’s regulatory regimes. The following table shows some of the major flavors and fragrances not specifically listed in the Inventory but with suspected hazards and require further identification due to the fact that concentrations and/or impurities may vary.

SN	Chinese name	English name	HS Code
1	松香水	White spirits	27100014
2	4-烷基双环己烷	4-Alkyl-4’-alkyl-bicyclohexyl	29021920
3	其他环烷烃；其他环烯及环萜烯	Other cyclanes, cyclense and cycloterpenes	29021990
4	二硝基甲苯	Dinitrotoluene	29042030
5	甘露糖醇	Mannitol	29054300
6	山梨醇	Sorbitol	29054400
7	薄荷醇	Menthol	29061100
8	萜品醇	Terpineols	29061910
9	其他环烷醇、环烯醇及环萜烯醇	Other cyclanic, cyclenic or cycloterpenic	29061990
10	其他芳香醇	Other aromatic alcohols	29062900
11	2-苯基乙醇	2-Phenyl alcohol	29062910
12	1烷氧基4（4乙烯基环己基）2，3二氟苯	1-alkoxylate-4(4-vingl cyclohexyl)-2,3-difluoro henzene	29093010
13	其他芳香醚及其卤化、磺化、硝化或亚硝化衍生物	Other aromatic ethers and its halogenated, sulphonated, nitrated or nitrosated derivatives	29093090
14	香草醛（3-甲氧基-4-羟基苯甲醛）	Vanillin(4-hydroxy-3-methoxybenzaldehyde)	29124100
15	未列名醛醚、醛酚及含其他含氧基的醛	Aldehyde ethers not otherwise specified,	29124900 29124990
16	樟脑	Camphor	29142100 29142910
17	水杨酸的其他酯及其盐	Other esters of salicylic acid and their salts	29182300
18	香豆素、甲基香豆素及乙基香豆素	Coumarin, methylcoumarins and ethylcoumarins	29322010 29322100
19	3，4－亚甲二氧基苯甲醛（胡椒醛）	3,4-Methylene-dihydroxybenzaldehyde (Piperonal)	29329300
20	香柠檬油（佛手油）	Bergamot oil	33011100
21	橙油	Orange oil	33011200
22	柠檬油	Lemon oil	33011300
23	其他柑桔属果实精油	Essential oils of other citrus fruit	33011900
24	白柠檬油（酸橙油）	Lime oils	33011910
25	茉莉油	Jasmine oil	33012200
26	熏衣草（包括杂种熏衣草）油	Lavender (inc. lavandin) oils	33012300
27	胡椒薄荷油	Peppermint oils	33012400
28	其他薄荷油	Essential oils of other mints	33012500
29	岩兰草油	Vetiver oil	33012600
30	香茅油	Citronella oil	33012920
31	茴香油	Aniseed oil	33012930
32	桂油	Cassia oil	33012940
33	山苍子油	Litsea cubeba oil	33012950
34	桉叶油	Eucalyptus oil	33012960
35	老鹳草油（香叶油）	Geranium oil	33012991
36	未列名非柑桔属果实精油	Other essential oils other than those of citrus fruit	33012999
37	其他香膏	Other resinoids	33013090
38	提取的油树脂	Extracted oleoresins	33019010
39	酒精浓度≤0.5%以香料为基本成份的饮料原液	Preparations based on odoriferous substances, of a kind used for the manufacture of beverages, alcoholic strength by volume not exceeding 0.4% vol	33021010
40	松香	Rosin	38061010
41	酯胶	Ester gums	38063000
42	妥尔油脂肪酸	Tall oil fatty acids	38231300

4. Industry obligations

If products manufactured in or imported to China are listed in the Inventory of Hazardous Chemicals, stakeholders should:

Classify chemicals according to GB 30000 standards, prepare China GHS-compliant SDSs and precautionary labels, and provide emergency telephone number.
Register hazardous chemicals at local administrations of work safety and acquire hazchem registration certificate.
Apply for safe manufacturing permit or safe operation permit from the local administrations of work safety.

If the products are highly toxic or fall into the scope of explosive precursors, etc., other administrative approvals are required, as well as the requirement to archive all information for subsequent inspection by law enforcement.

Chemicals not in the list and with unknown hazards are subject to hazard identification. Accredited identification institutes will issue the identification report and a conclusion on hazchem registration requirements. If the chemical is exempted from registration, the company should apply for a negative certification statement from NRCC, informing work safety administrators of the exemption status. Multiple companies can collaborate to identify the same product and share costs via joint identification.

5. Hazchem registration procedures

Hazchem registration requires both online application and paper material submission. The detailed procedures are as follows:

Carry out hazard identification of chemicals and determine chemicals subject to hazchem registration;
Apply for hazchem registration via online system
After the application has passed review by provincial registration office and NRCC, submit paper materials to the provincial office to apply for the registration certificate.

The hazchem registration system requires input of basic company information and detailed data on the intrinsic properties of the chemicals, major hazard installations and major hazardous chemical engineering processes. Lack of necessary data and wrong or inconsistent information will definitely lead to failure. Expert advice will make this process easier and more efficient.

About the author

Lora Chen
Senior consultant, Global GHS compliance, Industrial Chemical Division of REACH24H Consuling Group

Ms. Lora Chen specializes in GHS consulting services for chemical companies and pharmaceutical companies. She has very rich experience in global SDS compilation, label preparation, language translation, China hazardous chemical registration and training.