1
 3
 General Explanation of Draft Version of paragraph  15 and paragraph  1 
Table1 and paragraph  4 Table 4 of the Guidelines on Regulated Toxic 
Chemical Substances and the Management of Their Handling  
 
The Toxic Chemical Substances Control Act was revised and 
promulgated on December 11, 2013. In accordance with Article 7 of this 
Act, the central comp etent authority shall officially announce toxic 
chemical substances as Class 1, Class 2, Class 3 or Class 4 toxic chemical 
substances when the toxicological characteristics of chemical substances 
conform to the toxic chemical substance classification defin itions 
prescribed in Article 3 of this Act. Furthermore, according to Article 11, 
Paragraph 1 of the Toxic Chemical Substances Control Act, unless other 
regulations apply, the handling of toxic chemical substances shall be 
conducted in compliance with meth ods announced or approved by the 
central competent authority, which may also authorize the announcement 
of toxic chemical substance control concentration standards and 
large -scale handling standards in accordance with management needs.  
In view of the recen t occurrence of food safety incidences and the 
introduction of illegal chemical substances into the food supply that affect 
people’s health, this announcement has added regulation s for 
strengthened controls for the eight major handling activities of 
manufa cturing, import ing, export ing, sell ing, transport ing, using, stor ing, 
and dispos ing and for strengthening  the packag e labeling for 13 types of 
toxic chemical substances , including malachite green,  that present food 
safety risks, for which there is concern of endangerment to human health, 
and that are Class 4 toxic chemical substances as announced pursuant to 
the Toxic Chemical Substances Control Act.  Furthermore , the Chinese 
substance name for chromium carbonyl has been changed from  and the 
control standard has been amended to chromium concentration 1% or 
more . The summary of amendments is as follows:  2
 3
 1. Added Paragraph 15: Apart from requiring relevant markings in 
accordance with the " Toxic Chemical Substances Labeling and 
Materials Safety Data Sheets Regulations " and other relevant 
regulations, "Not for use in foods" must be marked on container 
packaging when handling malachite  green, maleic acid, maleic 
anhydride, dulcin, potassium bromate, dimethyl fumarate, benzyl 
viologen  4B, metanil yellow, rhodam ine B, butter yellow , sodium F , 
melamine, and coumarin . 
2. Revision of Paragraph 1 Table 1: 
(1) Addition of malachite green , maleic acid , maleic anhydride , dulcin , 
potassium bromate , dimethyl fumarate , benzyl viologen  4B, 
metanil yellow , rhodamine B , butter yellow , sodium F , melamine , 
and coumarin  as Class 4 toxic chemical substances with control 
concentration standards of 1%  or more . 
(2) The Chinese substance name for chromium carbonyl has been 
changed and the chromium content control concentration standard 
has been amended to chromium concentration 1% or more . 
3. Revision of Paragraph 4 Table 4: Addition of summary table of 
improvement deadlines for malachite green, maleic acid, maleic 
anhydride, dulcin, potassium bromate, dimethyl fumarate, benzyl 
viologen  4B, metanil yellow, rhodamine B, butter yellow, sodium F, 
melamine, and coumarin .  3
 3
 Draft Version of Item 15 and Paragraph 1 Table1 and Paragraph 4 Table 4 of the Guidelines on Regulated Toxic Chemical 
Substances  and the Management of Their Handling  
 
Announcement  Explanation  
15. Apart from requiring relevant markings to adhere to the " Toxic Chemical Substances 
Labeling and Materials Safety Data Sheets Regulations " and other relevant 
regulations, "Not for use in foods" must be marked on container packaging when 
handling malachite green, maleic acid, maleic anhydride, dulcin, potassium bromate, 
dimethyl fumarate, benzyl viologen  4B, metanil yellow, rhodamine B, butter yellow, 
sodium F, melamine, and coumarin . The characters of such markings must be clearly 
rendered on a visible area of the largest external surface area of containers, and the 
markings shall be primarily  in Chinese. The area of the markings may not be smaller 
than 35% of the surface area, and the color of the markings must contrast with the 
background color.  
 Addition of official announcement concerning 
13 toxic chemical substances, including 
malachite green, that pose a food safety risk 
and are suspect ed of being hazardous to 
human health. Apart from being announced as 
Class 4 toxic chemical substances subject to 
increased control in accordance with these 
Guidelines , also strengthens  packaging 
marking requirements and adds a warning that 
the substances may not be used in foods.  
Table 1 Summary table of announced toxic chemical substances and their control 
concentration standards and large -scale handling standards  
 
 
Listed 
No. Series 
No. Chinese Name  English Name  Chemical  
Formula  CAS. Number  control 
concentration 
standard  
w/w %  large -scale 
handling 
standard  
Kg
  Toxicity  
Classify  Announce d Date  
055 24 
  Chromium carbonyl  Cr(CO) 6 13007 -92-6 chromium 
concentration 
1% or more  500 2 85.05.31  
88.07.19  
88.12.24  
89.10.25  
106.
 .
 
175 01 
  Malachite green  C23H25ClN2 569-64-2 1 
  4 106.
 .
 
176 01 
  Maleic acid  C4H4O4 110-16-7 1 
  4 106.
 .
 
176 02 
  Maleic anhydride  C4H2O3 108-31-6 1 
  4 106.
 .
 
177 01 
  (4-Ethoxyphenyl)urea
  
Dulcin  C9H12N2O2 150-69-6 1 
  4 106.
 .
 
178 01 
  Potassium bromate  KBrO 3 7758 -01-2 1 
  4 106.
 .
 
179 01 
  Dimethyl fumarate 
(DMF)  C6H8O4 624-49-7 1 
  4 106.
 .
 
180 01 
  Benzyl violet 4B  C39H40N3NaO 6S2 1694 -09-3 1 
  4 106.
 .
 
181 01 
  Metanil yellow  C18H14N3NaO 3S 587-98-4 1 
  4 106.
 .
 
182 01 
 B Rhodamine B  C28H31ClN 2O3 81-88-9 1 
  4 106.
 .
 
183 01 
  Butter yellow  C14H15N3 60-11-7 1 
  4 106.
 .
 
184 01 
  Sodium F  CH 7NaO 5S 6035 -47-8 1 
  4 106.
 .
 
185 01 
  Melamine  C3H6N6 108-78-1 1 
  4 106.
 .
 
186 01 α-
  Coumarin  C9H6O2 91-64-5 1 
  4 106.
 .
 1. The Chinese substance name for 
chromium carbonyl has been changed and 
the chromium content control 
concentration standard has been amended 
to chromium concentration 1% or more . 
2. Addition of the 13 chemical substances 
malachite green, maleic acid, maleic 
anhydride, dulcin, potassium bromate, 
dimethyl fumarate, benzyl viologen  4B, 
metanil yellow, rhodamine B, butter  
yellow, sodium F, melamine, and 
coumarin , which are suspected of po sing a 
food safety risk and may be hazardous to 
human health, and are therefore listed as 
Class 4 toxic chemical substances.  
 
 
 
 
 
 
 
 
 
 
Table 4 Summary table of improvement deadlines for handling of announced toxic 
chemical substances  
 
Summary table of improvement deadlines for malachite green, maleic acid, maleic 
anhydride, dulcin, potassium bromate, dimethyl fumarate, benzyl viologen  4B, metanil 
yellow, rhodamine B, butter  yellow, sodium F, melamine, and coumarin  
 
Toxic chemical substa nce 
Item Improvement deadlines for malachite green, maleic acid, maleic anhydride, dulcin, 
potassium bromate, dimethyl fumarate, benzyl viologen  4B, metanil yellow, rhodamine B, 
butter  yellow, sodium F, melamine, and coumarin  
Production of h andling records, release quantity records, 
and regular reports in accordance with regulations.  Begin recording and reporting in accordance with regulations starting on February  15, 
2018.  
Completion of containers, packaging, and handling 
premise and facility markings and preparation of 
material safety data sheets.  Complete improvements before Ju ly 15, 2018.  
Acquisition of manufacture, import, sale, use, storage, 
and export approval documents in accordance with 
regulations.  Obtain before January  15, 201 9. 
Other matters not listed in this table.  Handle in accordance with relevant re gulations starting from February  15, 2018.  
 Addition of a summary table of improvement 
deadlines for Class 4 toxic chemical 
substances malachite green, maleic acid and 
maleic anhydride, dulcin, potassium bromate, 
dimethyl fumarate, benzyl viologen  4B, 
metanil yellow, rhodamine B, butter yellow, 
sodium F, melamine , and coumarin .