Page 1 of 9 GUIDELINES  ON REGULATED  TOXIC  CHEMICAL   SUBSTANCES 
AND THE MANAGEMENT OF THEIR HANDLING  
General information on the revision  draft of Paragraph 4, Paragraph 1 6, 
Paragraph 1 Table  1, Paragraph 2 Table  2, Paragraph 3 Table  3 and 
Paragraph 4 Table 4  
 
The Guidelines on Regulated Toxic Chemical Substances and the 
Management of Their Handling was announced and implemented in 2007. 
The Official Announcement has gone through 10 revisions throu ghout the 
past 10 years. Based on Article 7 and Article 11 of the Toxic Chemical 
Substances Control Act, the central competent authority has been authorized, 
based on its management requirements, to release a list of toxic chemical 
substance control concen tration standards and large -scale handling 
standards.  
Fourteen toxic chemical substances, including Sudan dyes, have been 
classified as Class 4 toxic chemical substances under the specifications of 
this Official Announcement. These classifications were mad e in light of a 
number of food safety incidents in recent years, in response to illegal 
chemical substances entering the food supply chain and being mixed in with 
food products or animal feed, and in consideration of food safety risks that 
endanger the pub lic health. Furthermore, in response to international 
regulatory trends, pentachlorophenyl laurate has been classified as a Class 1 
and a Class 3 toxic chemical substance, and perflurooctanoic acid as a class 
4 toxic chemical substance. The controlled conc entration level of 
perfiuorooctane sulfonic acid has also been revised. Based on the revision 
draft of the Official Announcement, the key revisions are as follows:  
I. Corrected the wording in order to return to the original purpose of the 
legislation. (Revis ed of Paragraph 4 ) 
II. Added Sudan 1, Sudan 2, Sudan 3, Sudan 4, Sudan Red G, Sudan 
Orange G, Sudan Black B, Sudan Red 7B, Diethyl yellow/ Solvent Page 2 of 9 yellow 56, Basic Orange 2, Auramine, Red No. 2, Azorubine, and 
Orange 2 as Class 4 toxic chemical substances; in addition, the 
containers of these substances must have a label stating "Not for use 
in foods and animal feed" and "The area of the markings may not be 
smaller than 35% of the surface  area." (Revised of  Parag raph 1 6) 
III. Added pentachlorophenyl laurate as a Class 1 and Class 3 toxic 
chemical substance; Sudan 1, Sudan 2, Sudan 3, Sudan 4, Sudan Red G, 
Sudan Orange G, Sudan Black B, Sudan Red 7B, Diethyl 
yellow/ Solvent yellow 56, Basic Orange 2, Auramine, Red No. 2, 
Azorubine and O range 2 and perflurooctanoic acid a s Class 4 toxic 
chemical substances. With the exception of pentachlorophenyl laurate  
and perflurooctanoic acid  which ha ve the controlled concentration 
standards of 0.01%  or more , and p erfiuoroocta ne sulfonic acid  which 
has corrected  the controlled concentration standards more rigorous of 
0.01% or more , all others on the list have a controlled concentration 
standards of 1%  or more. (Revised of Paragraph 1 Table 1)  
IV. Added the prohibited handling of pentachlorophenyl laurate. (Revised 
of Paragraph 2 Table 2) 
V. Added the intended use of pentachlorophenyl laurate. (Revised of 
Paragraph 3 Table 3) 
VI. Added the pentachlorophenyl laurate  and perfiuorooctane sulfonic 
acid with the controlled concentration standards of 0.01%  or more , 
Sudan 1, Sudan 2, Sudan 3, Sudan 4, Sudan Red G, Sudan Orange G, 
Sudan Black B, Sudan Red 7B, Diethyl yellow/ Solvent yellow 56, 
Basic Orange 2, Auramine, Red No. 2, Azorubine , Orange 2 and 
perflurooc tanoic acid to the summary table of improvement deadlines. 
(Revised of Paragraph 4 Table 4 item (II) and (III) ) Page 3 of 9 Revision draft comparison table for Paragraph 4 and Paragraph 1 6 of 
the Guidelines on Regulated Toxic Chemical Substances and the 
Management of  Their Handling  
 
Proposed Revision   Current Measure  Explanation  
Announcement details:  
4. Handlers who have already used 
these substances prior to the 
official announcement made by 
the central competent authority 
declaring them as toxic chemical 
substances must complete all  
relevant items specified in Table 
4 within the established  
deadline.  Announcement details:  
4. Handlers who have already used 
these substances prior to the 
official  announcement made by 
the central competent authority 
declaring them as toxic chemical 
substances must complete all 
improvement measures specified 
in Table 4 within the established 
deadline.  The use of "improvement 
deadlines" is inconsistent with the 
use of "deadlines for making 
improvements" in Chapter IV of 
the Toxic  Chemical Substances 
Control Act. To avoid confusion, 
the wording has been modified to 
"must complete all relevant items 
within the established deadline" in 
order to return to the original 
purpose of the legislation.  
16. Apart from requiring relevant 
markings to adhere to the 
"Toxic Chemical Substances 
Labeling and Materials Safety 
Data Sheets Regulations" and 
other relevant regulations, it 
must be marked on container 
packaging when handling  
Sudan 1, Sudan 2, Sudan 3, 
Sudan 4, Sudan Red G, Sudan 
Orange  G, Sudan Black B, 
Sudan Red 7B, Diethyl 
yellow/Solvent yellow 56, 
Basic Orange 2, Auramine, 
Red No. 2, Azorubine  and 
Orange 2 . The characters of 
such markings must be clearly 
rendered on a visible area of 
the largest external surface 
area of containers:  
(I)  "Not for use in foods and 
animal feed ", and the 
markings shall be 
primarily in Chinese.  
(II) The area of the markings 
may not be smaller than 
35% of the surface  area. 
(III)  The color of the markings 
must contrast with the 
background color.   I. Added this item.  
II. The 14 toxic chemical 
substances, including the 
Sudan dyes, are substances 
which impact food safety and 
can be harmful to the public 
health. Therefore, in order to 
tighten controls over these 
substances, they have been 
listed as Class 4 toxic chemical 
substances under the 
specifications of this Official 
Announcement.  
III. As a result of multiple cases 
involving Sudan dyes being 
mixed in illegally with animal 
feed, specifications related to 
package labels have been 
revised and reinforced by 
adding " Not for use in foods  
and animal feed" and the 
wording has been modified 
accordingly.  
IV. The definition of the labeling 
area has been modified to the "  
surface  of area of the mai n 
display ." 
 
 Page 4 of 9 Paragraph 1 Table  1 revision draft comparison table  
Proposed Revision   Current Measure  Explanation  
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 No.  Controlled 
Concentrati
on standard  
 (w/w % ) Large -scale 
Handling 
Standard
（Kg） Toxicity 
Classify  Announce d 
Date 
007 02 月桂酸五氯苯酯  Pentachlorophenyl 
laurate  C18H23Cl5O2 3772 -94-9 0.01 50 1,3 107.○○.○○  
169 01 全氟辛烷磺酸  Perfiuorooctane 
sulfonic acid (PFOS)  C8HF 17O3S 1763 -23-1 0.01 50 1.2 99.12.24  
107.○○.○○  
169 04 全氟辛酸  Perflurooctanoic acid 
(PFOA)   C8HF 15O2 335-67-1 0.01 50 4 107.○○.○○  
187 01 蘇丹 1號 Sudan 1  C16H12N2O 842-07-9 1% － 4 107.○○.○○  
187 02 蘇丹 2號 Sudan 2  C18H16N2O 3118 -97-6 1% － 4 107○○.○○  
187 03 蘇丹 3號 Sudan 3  C22H16N4O 85-86-9 1% － 4 107.○○.○○  
187 04 蘇丹 4號 Sudan 4  C24H20N4O 85-83-6 1% － 4 107.○○.○○  
187 05 蘇丹紅 G Sudan Red G  C17H14N2O2 1229 -55-6 1% － 4 107.○○.○○  
187 06 蘇丹橙 G Sudan Orange G  C12H10N2O2 2051 -85-6 1% － 4 107.○○.○○  
187 07 蘇丹黑 B Sudan Black B  C29H24N6 4197 -25-5 1% － 4 107.○○.○○  
187 08 蘇丹紅 7B Sudan Red 7B  C24H21N5 6368 -72-5 1% － 4 107.○○.○○  
188 01 二乙基黃  Diethyl yellow/Solvent 
yellow 56  C16H19N3 2481 -94-9 1% － 4 107.○○.○○  
189 01 王金黃 (塊黃 ) Basic orange 2  C12H13ClN 4 532-82-1 1% － 4 107.○○.○○  
190 01 鹽基性芥黃  Auramine  C17H22ClN 3 2465 -27-2 1% － 4 107.○○.○○  
191 01 紅色 2號 Red No.2  C20H11N2Na3O10S3 915-67-3 1% － 4 107.○○.○○  
192 01 氮紅  Azorubine  C20H12N2Na2O7S2 3567 -69-9 1% － 4 107.○○.○○  
193 01 橘色 2號 Orange2  C16H11N2NaO 4S 633-96-5 1% － 4 107.○○.○○  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 No.  Controlled 
Concentrati
on standard  
 (w/w % ) Large -scale 
Handling 
Standard
（Kg） Toxicity 
Classify  Announce d 
Date 
169 01 全氟辛烷磺酸  Perfiuorooctane 
sulfonic acid  C8HF 17O3S 1763 -23-1 1 50 1.2 99.12.24  I. In conjunction with the addition of 
pentachlorophenyl laurate into 
Annex A (Elimination) of the 
Stockholm Convention on 
Persistent Organic Pollutants and 
the management of international 
controlled substance list, as well as 
to conform with the Class 1 and 
Class 3 toxic chemical properties of 
the Toxic Chemical Substances 
Control Act, pentachlorophenyl 
laurate has been listed as a Class 1 
and Class 3 toxic chemical 
substance with a controlled 
concentration standard  of 0.01%.  
II. Currently, the controlled 
concentration standard  of 
perfiuorooctane sulfonic acid 
(Listed No. 169, Series No. 01) is 
1%. In order to strengthen the 
control over toxic substances, the 
controlled concentration standard  
has been revised to 0.01%.  
III. Current deli berations of the 
Stockholm Convention on 
Persistent Organic Pollutants have 
included perflurooctanoic acid as a 
controlled substance. Although the 
deliberations have not concluded, in 
consideration of the fact that the 
Convention has already completed 
its yearly deliberation procedures 
related to perflurooctanoic acid, 
which will most likely be included 
in the Convention in the near 
future, we are making an advanced 
announcement to classify 
perflurooctanoic acid as a Class 4 
toxic chemical substance.  
IV. Added 14 chemical substances, 
including the Sudan dyes (Sudan 1, 
Sudan 2, Sudan 3, Sudan 4, Sudan 
Red G, Sudan Orange G, Sudan 
Black B, Sudan Red 7B), Diethyl 
yellow/Solvent yellow 56 , Basic 
Orange 2, Auramine, red No. 2, 
Azorubine, and orange No. 2.  
V. Sudan dyes have been listed as 
Class 4 toxic chemical substances Page 5 of 9 due to food safety concerns which 
may endanger public health and due 
to the fact that certain metabolites 
of Sudan dyes have been classified 
as group 2B carcinogens by the 
IARC, which meets the screenin g 
and identification standards of 
Class 4 toxic chemical substances 
specified within the “Screening and 
Identification Principles of Toxic 
Chemicals Established by the 
Environmental Protection 
Administration, Executive Yuan.”  
 Page 6 of 9 Paragraph 2 Table  2 revision draft comparison table  
Proposed Revision   Current Measure  Explanation  
Table  2  Summary table of the prohibited use of controlled toxic chemical substances  
 
 
Listed 
No. Series 
No. Chinese Name of 
the Chemical  Prohibited Handling Details  
007 02 月桂酸五氯苯酯  Manufacturing , importing , selling , and using  are strictly prohibited. However, for 
research, testing, and educational purposes, these restrictions do not apply.  
 Table   2  Summary table of the prohibited use of controlled toxic chemical substances  
 
 
Listed 
No. Series 
No. Chinese Name of 
the Chemical  Prohibited Handling Details  
 By referencing Annex A (Elimination) 
of the Stockholm Convention on 
Persistent Organic Pollutants as well as 
the management practices of 
international regulations, prohibited 
handling details for pentachlorophenyl 
laurate were added.  
 
 
 Page 7 of 9 Paragraph 3 Table  3 revision draft comparison table  
Proposed Revision   Current Measure  Explanation  
Table  3  Summary table of intended uses for controlled toxic chemical substances  
 
Listed 
No. Series 
No. Chinese Name of 
the Chemical  Intended Use  
007 02 月桂酸五氯苯酯  1. Research, testing, and education.  
 Table  3  Summary table of intended uses for controlled toxic chemical substances  
 
Listed 
No. Series 
No. Chinese Name of 
the Chemical  Intended Use  
 
 Pentachlorophenyl laurate may be used 
for research, testing, and education.  
 
 
 Page 8 of 9 Paragraph  4 Table  4 revision draft comparison table  
Proposed Revision   Current Measure  Explanation  
Table 4 Summary table of improvement deadlines for handling  of announced toxic 
chemical substances  
 
(I)Summary table of improvement deadlines for  malachite green, maleic acid, maleic 
anhydride, 4 -Ethoxyphenyl urea, potassium bromate, dimethyl fumarate (DMF), benzyl 
violet, methyl yellow, rhodamine B, dimethyl yellow, sodium hydroxymethanesulfinate, 
melamine, and coumarin  
 
Toxic Chemical Substances  
Item Improvement deadlines for  malachite green, maleic acid, maleic 
anhydride, 4 -Ethoxyphenyl urea, potassium bromate, dimethyl fumarate 
(DMF), benzyl violet, methyl yellow, rhodamine B, dimethyl yellow, 
sodium hydroxymethanesulfinate, melamine, and coumarin  
Production of handling records, release quantity 
records, and regular reports in accordance with 
regulations.  Begin recording and reporting in accordance with reg ulations 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 July 15, 2018.  
Acquisition of manufacture, import, sale, use, 
storage, and export approval documents in 
accordance with regulations.  Obtain before  January 15, 2019.  
Other matters not listed in this table.  Handle in accordance with relevant regulations starting from February 
15, 2018.  
 
 
(II)Summary table of improvement deadlines for  pentachlorophenyl laurate and 
perfiuorooctane sulfonic acid (with a concentration standard  greater than 0.01% and 
less than 1%)  
 
Toxic Chemical Substances  
Item Improvement deadlines for  pentachlorophenyl laurate and 
perfiuorooctane sulfonic acid (with a concentration standard  greater 
than 0.01% and less than 1%)  
Production of handling records, release quantity 
records, and regular reports in accordance with 
regulations.  Begin recording and reporting in accordance with regulations starting 
on January 1, 2018.  
As specified under the regulations, hazard 
prevention and response plans are to be submitted.  Reports are to be filed before January 1, 2019.  
Completion of containers, packaging, and handling 
premise and facility markings and preparation of 
material safety data sheets.  Complete improvements before  January 1, 2019.  
Transporting toxic chemical substances.  To be processed according to the regulations before July 1, 2019.  
The prepara tion of emergency response tools and 
equipment.  Improvement measures shall be completed by January 1, 2019.  
As specified under the regulations, reports on 
response equipment and the setup/operating plans 
of detection/alert systems shall be submitted.  Repo rts are to be filed before April 1, 2019.  
As specified under the regulations, a toxic 
chemical substance defense organization shall be 
established  To be completed before April 1, 2019.  
Complete the setup of detection and alert systems.  Setup shall be completed before July 1, 2019.  
Perform thorough investigations on the 
implementation of hazard prevention and response 
plans.  To become effective on July 1, 2019.  
Deployment of professional technical management 
personnel.  Setup shall be completed before July 1, 2019.  
Acquisition of manufacture, import, sale, use, 
storage, and export approval documents in 
accordance with regulations.  Obtain before  July 1, 2019.  
Other matters not listed in this table.  Handle in accordance with relevant regulations starting from January 1, 
2018.  
 
 
 
 Table 4 Summary table of improvement deadlines for handling of announced toxic 
chemical substances  
 
(I) Summary table of improvement deadlines for malachite green, maleic acid, maleic 
anhydride, 4 -Ethoxyphenyl urea, potassium bromate, dimethyl fumarate (DMF), 
benzyl violet, methyl yel low, rhodamine B, dimethyl yellow, sodium 
hydroxymethanesulfinate, melamine, and coumarin  
 
Toxic Chemical Substances  
Item Improvement deadlines for malachite green, maleic acid, maleic 
anhydride, 4 -Ethoxyphenyl urea, potassium bromate, dimethyl fumarate 
(DMF), benzyl violet, methyl yellow, rhodamine B, dimethyl yellow, 
sodium hydroxymethanesulfinate, melamine, and coumarin  
Production of handling records, release quantity 
records, and regular reports in accordance with 
regulations.  Begin recording and rep orting 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 July 15, 2018.  
Acquisition of manufacture, import, sale, use, 
storage, and export approval documents in 
accordance with regulations.  Obtain before  January 15, 2019.  
Other matters not listed in this table.  Handle in accordance with relevant regulations starting from February 
15, 201 8. 
 I. Added a list of relevant items which 
shall be completed within the 
specified deadline for  
pentachlorophenyl laurate, 
perflurooctanoic acid, and 
perfiuorooctane sulfonic acid  (with a 
concentration standard  greater than 
0.01% and less than 1%).  
II. The wording for improvement 
deadlines in the header is 
inconsistent with the deadline for 
making improvements specified 
within Chapter 4 on penalties. In 
order to avoid complications, the 
wording has been modified to "must 
complete all relevant items withi n 
the established deadline" in order to 
return to the original purpose of the 
legislation.  
III. Added Sudan 1, Sudan 2, Sudan 3, 
Sudan 4, Sudan Red G, Sudan 
Orange G, Sudan Black B, Sudan 
Red 7B, Diethyl yellow/Solvent 
yellow 56 , Basic Orange 2, 
auramine, Red No. 2, Azorubine, and 
Orange No. 2 as Class 4 toxic 
chemical substances; a summary 
table for relevant items which shall 
be completed within the specified 
deadline; minor changes to the 
wording.  Page 9 of 9 (III)Summary table of improvement deadlines for  Sudan 1, Sudan 2, Sudan 3, Sudan 4, 
Sudan Red G, Sudan Orange G, Sudan Black B, Sudan Red 7B, Diethyl 
yellow/Solvent yellow 56 , Basic Orange 2, Auramine, Red No. 2, Azorubine, Orange 
No. 2, and perflurooctanoic acid  
 
Toxic Chemical Substances  
Item Relevant items which shall be completed within the specified deadline for  
Sudan 1, Sudan 2, Sudan 3, Sudan 4, Sudan Red G, Sudan Orange G, Sudan 
Black B, Sudan 7B, Diethyl yellow/Solvent yellow 56 , Basic Orange 2, 
Auramine, Red No. 2, Azorubine, and Orange No. 2  
Production of handling records, release quantity 
records, and regular reports in accordance with 
regulations.  Begin recording and reporting in accordance with regul ations starting on 
January 1, 2018.  
Completion of containers, packaging, and handling 
premise and facility markings and preparation of 
material safety data sheets.  Complete improvements before January  1, 2019.  
Acquisition of manufacture, import, sale, use, 
storage, and export approval documents in 
accordance with regulations.  Obtain before  July 1, 2019 . 
Other matters not listed in this table.  Handle in accordance with relevant regulations starting from January 1, 2018.