Updates to the Annexes of the ASEAN Cosmetic Directive (ACD) adopted at 28th ACC Meeting

Updates to the Annexes of the ASEAN Cosmetic Directive (ACD) adopted at 28th ACC Meeting

   1. The following information is to update the industry on the decisions adopted at the ACC Meeting.
   2. The industry may provide your feedback on the implementation dates by 30 June 2018.
   3. The entry number may be subject to further changes.
Summary of changes to cosmetic ingredient lists at 28th ACSB Meeting (May 2018)


 Type of       Annex of    Entry No. /Ref.   Description of changes                                                                                   Reference   Implementation
 change        the ACD     No.                                                                                                                        table       date

 Amendment     Annex II    307               To revise the description of the substance to “Sulphanilamide and its derivatives obtained by            Table 1     -
                                             substitution of one or more H-atoms of the -NH2 groups, and their salts”
 Amendment     Annex III   2a                To revise the text “Percentages calculated as total thioacids, i.e., either singly (thiolactic acid or   Table 2     -
                                             thioglycolic acid alone) or combination of thiolactic acid and thioglycolic acid in a given formula.”
                                             under column D to “For general use of hair waving or straightening products the maximum
                                             concentration for combination of Thioglycolic acid and Thiolactic acid must not exceed 8%
                                             calculated as Thioglycolic Acid.”

 New Entry     Annex III   8c                A new entry of N,N′-Bis(2-Hydroxyethyl)-2-Nitro-p-Phenylenediamine                                       Table 2     1st Dec 2019

 New Entry     Annex III   9b                A new entry of 2,6-Dihydroxyethylaminotoluene                                                            Table 2     1st Dec 2019

 New Entry     Annex III   314               A new entry of Di[2-[4-[(E)-2-[4- [bis(2-hydroxyethyl)aminophenyl]vinyl]pyridin-1-ium]                   Table 2     1st Dec 2019
                                             butanoyl]aminoethyl] di-sulfanyl dichloride (HC Red No 17)

 New Entry     Annex III   315               A new entry of Di[2-[4-[(E)-2- [2,4,5-trimethoxyphenyl]vinyl] pyridinin-1-ium]                           Table 2     1st Dec 2019
                                             butanoyl]aminoethyl]disulfanyl dichloride (HC Yellow No 17)

 New Entry     Annex III   316               A new entry of 1H-Pyrazole-4,5- diamine, 1- hexyl-, sulfate (2:1) (1-Hexyl 4,5- Diamino Pyrazole         Table 2     1st Dec 2019
                                             Sulfate)

 New Entry     Annex III   317               A new entry of 4-Hydroxy-2,5,6- triaminopyrimidine sulfate (2,5,6-Triamino- 4-Pyrimidinol)               Table 2     1st Dec 2019

 New Entry     Annex III   318               A new entry of 302 2-[(3-Aminopyrazolo[1,5-a]pyridin-2-yl)oxy]ethanol hydrochloride                      Table 2     1st Dec 2019
                                             (Hydroxyethoxy Aminopyrazolopyridine HCl)

 New Entry     Annex III   319               A new entry of Phenol, 3-amino- 2,6-dimethyl (3-Amino-2,6- Dimethylphenol)                               Table 2     1st Dec 2019

 New Entry     Annex III   320               A new entry of 2-Naphthalenaminium, 8-[(4- amino-3-nitrophenyl)azo]-7-hydroxy-N,N,N-                     Table 2     1st Dec 2019
                                             trimethyl-, chloride (Basic Brown 17)
 New Entry     Annex III   321               A new entry of 3-Amino-7-(dimethylamino)-2-methoxyphenoxazin-5-ium chloride (Basic Blue                  Table 2     1st Dec 2019
                                             124)
 New Entry     Annex III   322               A new entry of Peanut oil extracts and derivatives                                                       Table 2     1st Dec 2019
New Entry   Annex III   323   A new entry of Hydrolyzed wheat protein                                                                  Table 2   1st Dec 2019

Amendment   Annex III   A9    To revise the text “Percentages calculated as total thioacids, i.e., either singly (thiolactic acid or   Table 2   -
                              thioglycolic acid alone) or combination of thiolactic acid and thioglycolic acid in a given formula.”
                               under column D to “For general use of hair waving or straightening products the maximum
                              concentration for combination of Thioglycolic acid and Thiolactic acid must not exceed 8%
                              calculated as Thioglycolic Acid.”
Table 1: Changes to List of Prohibited Ingredients (Annex II)

                                                   Substance                                                                  CAS Number                         Ref. No
 Sulphanilamide and its derivatives obtained by substitution of one or more H-atoms of the -NH2 groups, and                     63-74-1                           307
 their salts




Table 2: Changes to List of Restricted Ingredients (Annex III)

Ref No                 Substance                                                    Restrictions                                         Conditions of use and warnings which
ACD #                                                                                                                                    must be printed on the labels
(EU #)                                        Field of application and/or use      Maximum authorized Other limitations and
                                                                                   concentration in ready requirements
                                                                                   for use preparation
    A                       B                                    C                            D                           E                                  F
    2a     Thioglycolic acid and its salts    (a) Hair waving or straightening     (a)                      (a) (b) (c)                  (a)
                                                  products:
                                                                                   1.    8% ready for       The directions for use       1.
                                                  1. General use                         use at pH 7 –      drawn up in the national or
                                                                                         9.5                official language(s) must         Contains thioglycolate
                                                                                                            obligatorily incorporate the      Follow the instructions
                                                  2. Professional use                                                                         Keep out of reach of children
                                                                                                            following sentences:
                                                                                   2.    11% ready for
                                              (b) Depilatories                           use at pH 7- 9.5
           CAS No 68-11-1
                                                                                                               Avoid contact with       2.

                                              Other hair care products which are                                eyes
                                                                                                               In the event of               For professional use only
                                              removed after application
                                                                                                                contact with eyes,            Contains thioglycolate
                                                                                                                rinse immediately             Follow the instructions
                                                                                   (b)   5% ready for           with plenty of water          Keep out of reach of children
                                                                                             use at             and seek medical
                                                                                         at pH 7-12.7           advice.
                                                                                                               Wear suitable gloves
                                                                                                                (a) and (c) only.
                                                                                                                                         (b) and (c)
Ref No               Substance                                                      Restrictions                                     Conditions of use and warnings which
ACD #                                                                                                                                must be printed on the labels
(EU #)                                       Field of application and/or use      Maximum authorized Other limitations and
                                                                                  concentration in ready requirements
                                                                                  for use preparation
                                                                                  (c)   2% ready for                                     Contains thioglycolate
                                                                                        use at pH 7-9.5                                  Follow the instructions
                                                                                                                                         Keep out of reach of children

                                                                                  For general use of
                                                                                  hair waving or
                                                                                  straightening
                                                                                  products the
                                                                                  maximum
                                                                                  concentration for
                                                                                  combination of
                                                                                  Thioglycolic acid and
                                                                                  thiolactic acid must
                                                                                  not exceed 8%
                                                                                  calculated as
                                                                                  Thioglycolic Acid.




   8c    Ethanol, 2,2′-[(2- nitro-1,4-       (a)Hair dye substance in oxidative                           (a) After mixing under     (a) To be printed on the label:
         phenylene)diimino]bis- (9CI)        hair dye products                                            oxidative conditions the   The mixing ratio.
                                                                                                          maximum concentration
                                                                                                          applied to hair must not
                                                                                                          exceed 1%                        “Hair colourants can cause severe
         N,N′-Bis(2-Hydroxyethyl)-2-Nitro-   (b)Hair dye substance in non-                                                           allergic reactions.
                                                                                  (b) 1.5%                                           Read and follow instructions.
         p-Phenylenediamine                  oxidative hair dye products
                                                                                                                                     This product is not intended for use on
                                                                                                          For (a) and (b)            persons under the age of 16.

                                                                                                          The direction for use “wear Temporary ‘black henna’ tattoos may
         CAS No. 84041-77-0                  Use for dyeing eyelashes and                                                             increase your risk of allergy.
                                                                                                          suitable gloves” must be
                                             eyebrows is not permitted.
                                                                                                                                     Do not colour your hair if:
Ref No              Substance                                                Restrictions                                       Conditions of use and warnings which
ACD #                                                                                                                           must be printed on the labels
(EU #)                                    Field of application and/or use   Maximum authorized Other limitations and
                                                                            concentration in ready requirements
                                                                            for use preparation
                                                                                                 included in label or leaflet   -   you have a rash on your face or
                                                                                                 text.                              sensitive, irritated and damaged
                                                                                                                                    scalp,
                                                                                                                                -   you have ever experienced any
                                                                                                   Do not use with                 reaction after colouring your hair,
                                                                                                    nitrosating agents          -   you have experienced a reaction to a
                                                                                                                                    temporary ‘black henna’ tattoo in the
                                                                                                                                    past.
                                                                                                   Maximum nitrosamine
                                                                                                                                (a) and (b)
                                                                                                    content: 50 μg/kg(21)
                                                                                                                                Do not use to dye eyelashes or
                                                                                                                                eyebrows.”
                                                                                                   Keep in nitrite-free
                                                                                                    containers




   9b    1-Methyl-2,6-bis- (2-            Hair dye substance in oxidative                        After mixing under             To be printed on the label:
         hydroxyethylamino)-benzene       hair dye products                                      oxidative conditions the       The mixing ratio.
                                                                                                 maximum concentration
                                                                                                 applied to hair must not
                                                                                                 exceed 1%                          “Hair colourants can cause severe
         2,6-Dihydroxyethylaminotoluene                                                                                       allergic reactions.
                                                                                                 The direction for use “wear Read and follow instructions.
                                          Use for dyeing eyelashes and                           suitable gloves” must be     This product is not intended for use on
                                          eyebrows is not permitted.                             included in label or leaflet persons under the age of 16.
         CAS No 149330-25-6                                                                      text.
                                                                                                                              Temporary ‘black henna’ tattoos may
                                                                                                                              increase your risk of allergy.
                                                                                                   Do not use with
                                                                                                                                Do not colour your hair if:
                                                                                                    nitrosating agents
                                                                                                                                - you have a rash on your face or
                                                                                                                                   sensitive, irritated and damaged
                                                                                                                                   scalp,
                                                                                                   Maximum nitrosamine
                                                                                                    content: 50 μg/kg(21)
Ref No             Substance                                               Restrictions                                       Conditions of use and warnings which
ACD #                                                                                                                         must be printed on the labels
(EU #)                                  Field of application and/or use   Maximum authorized Other limitations and
                                                                          concentration in ready requirements
                                                                          for use preparation
                                                                                                                              -   you have ever experienced any
                                                                                                                                  reaction after colouring your hair,
                                                                                                 Keep in nitrite-free        -   you have experienced a reaction to a
                                                                                                  containers                      temporary ‘black henna’ tattoo in the
                                                                                                                                  past.

                                                                                                                              Do not use to dye eyelashes or
                                                                                                                              eyebrows.”


  314    Di[2-[4-[(E)-2-[4- [bis(2-         Hair dye substance in non-                         — Do not use with              Do not use to dye eyelashes or
         hydroxyethyl)aminophenyl]vinyl]p oxidative hair dye products    0.5%                  nitrosating agents             eyebrows
         yridin-1-ium] butanoyl]aminoethyl]
         di-sulfanyl dichloride             Use for dyeing eyelashes and
                                            eyebrows is not permitted.
                                                                                               — Maximum nitrosamine
 (298)                                                                                         content: 50 μg/kg(21)
         HC Red No 17


                                                                                               — Keep in nitrite-free
         CAS No 1449471-67-3                                                                   containers



                                                                                               The direction for use “wear
                                                                                               suitable gloves” must be
                                                                                               included in label or leaflet
                                                                                               text.
Ref No               Substance                                                          Restrictions                                    Conditions of use and warnings which
ACD #                                                                                                                                   must be printed on the labels
(EU #)                                        Field of application and/or use          Maximum authorized Other limitations and
                                                                                       concentration in ready requirements
                                                                                       for use preparation
  315    Di[2-[4-[(E)-2- [2,4,5-              Hair dye substance in             non-                        The direction for use “wear To be printed on the label:
         trimethoxyphenyl]vinyl] pyridinin-   oxidative hair dye products              0.5%                 suitable gloves” must be
         1-ium]                                                                                             included in label or leaflet
         butanoyl]aminoethyl]disulfanyl                                                                     text.                              “Hair colourants can cause severe
                                              Use for dyeing eyelashes and                                                               allergic reactions.
         dichloride                           eyebrows is not permitted.                                                                 Read and follow instructions.
 (299)                                                                                                                                   This product is not intended for use on
                                                                                                                                         persons under the age of 16.

         HC Yellow No 17                                                                                                                Temporary ‘black henna’ tattoos may
                                                                                                                                        increase your risk of allergy.

                                                                                                                                        Do not colour your hair if:
         CAS No 1450801-55-4                                                                                                            - you have a rash on your face or
                                                                                                                                           sensitive, irritated and damaged
                                                                                                                                           scalp,
                                                                                                                                        - you have ever experienced any
                                                                                                                                           reaction after colouring your hair,
                                                                                                                                        - you have experienced a reaction to a
                                                                                                                                           temporary ‘black henna’ tattoo in the
                                                                                                                                           past.

                                                                                                                                        Do not use to dye eyelashes or
                                                                                                                                        eyebrows.”


  316    1H-Pyrazole-4,5- diamine, 1-         Hair dye substance in oxidative                               After mixing under          To be printed on the label:
         hexyl-, sulfate (2:1)                hair dye products                                             oxidative conditions the
                                                                                                            maximum concentration
                                                                                                            applied to hair must not          “Hair colourants can cause severe
 (300)                                        Use for dyeing eyelashes and                                                              allergic reactions.
                                              eyebrows is not permitted.                                    exceed 1%
         1-Hexyl 4,5- Diamino Pyrazole                                                                                                  Read and follow instructions.
                                                                                                                                        This product is not intended for use on
         Sulfate
                                                                                                                                        persons under the age of 16.
Ref No               Substance                                              Restrictions                                     Conditions of use and warnings which
ACD #                                                                                                                        must be printed on the labels
(EU #)                                   Field of application and/or use   Maximum authorized Other limitations and
                                                                           concentration in ready requirements
                                                                           for use preparation
                                                                                                The direction for use “wear Temporary ‘black henna’ tattoos may
                                                                                                suitable gloves” must be     increase your risk of allergy.
         CAS No 1361000-03-4                                                                    included in label or leaflet
                                                                                                                             Do not colour your hair if:
                                                                                                text.
                                                                                                                             - you have a rash on your face or
                                                                                                                                sensitive, irritated and damaged
                                                                                                                                scalp,
                                                                                                                             - you have ever experienced any
                                                                                                                                reaction after colouring your hair,
                                                                                                                             - you have experienced a reaction to a
                                                                                                                                temporary ‘black henna’ tattoo in the
                                                                                                                                past.

                                                                                                                             Do not use to dye eyelashes or
                                                                                                                             eyebrows.”


  317    4-Hydroxy-2,5,6-                Hair dye substance in oxidative                        After mixing under           To be printed on the label:
         triaminopyrimidine sulfate      hair dye products                                      oxidative conditions the
                                                                                                maximum concentration
                                                                                                applied to hair must not           “Hair colourants can cause severe
 (301)                                   Use for dyeing eyelashes and                                                        allergic reactions.
                                         eyebrows is not permitted.                             exceed 0.5%
         2,5,6-Triamino- 4-Pyrimidinol                                                                                       Read and follow instructions.
                                                                                                                             This product is not intended for use on
                                                                                                                             persons under the age of 16.
                                                                                                The direction for use “wear Temporary ‘black henna’ tattoos may
         CAS No 1603-02-7                                                                       suitable gloves” must be     increase your risk of allergy.
                                                                                                included in label or leaflet
                                                                                                text.                        Do not colour your hair if:
                                                                                                                             - you have a rash on your face or
                                                                                                                                sensitive, irritated and damaged
                                                                                                                                scalp,
                                                                                                                             - you have ever experienced any
                                                                                                                                reaction after colouring your hair,
Ref No              Substance                                              Restrictions                                    Conditions of use and warnings which
ACD #                                                                                                                      must be printed on the labels
(EU #)                                  Field of application and/or use   Maximum authorized Other limitations and
                                                                          concentration in ready requirements
                                                                          for use preparation
                                                                                                                           -   you have experienced a reaction to a
                                                                                                                               temporary ‘black henna’ tattoo in the
                                                                                                                               past.

                                                                                                                           Do not use to dye eyelashes or
                                                                                                                           eyebrows.”


  318    302 2-[(3-Aminopyrazolo[1,5-   Hair dye substance in oxidative                        After mixing under          To be printed on the label:
         a]pyridin-2-yl)oxy]ethanol     hair dye products                                      oxidative conditions the
         hydrochloride                                                                         maximum concentration
                                                                                               applied to hair must not          “Hair colourants can cause severe
 (302)                                  Use for dyeing eyelashes and                                                       allergic reactions.
                                        eyebrows is not permitted.                             exceed 2.0%
                                                                                                                           Read and follow instructions.
                                                                                                                           This product is not intended for use on
         Hydroxyethoxy                                                                                                     persons under the age of 16.
         Aminopyrazolopyridine HCl
                                                                                               The direction for use “wear Temporary ‘black henna’ tattoos may
                                                                                               suitable gloves” must be     increase your risk of allergy.
                                                                                               included in label or leaflet
                                                                                               text.                        Do not colour your hair if:
         CAS No 1079221-49-0
                                                                                                                            - you have a rash on your face or
                                                                                                                               sensitive, irritated and damaged
                                                                                                                               scalp,
                                                                                                                            - you have ever experienced any
                                                                                                                               reaction after colouring your hair,
                                                                                                                            - you have experienced a reaction to a
                                                                                                                               temporary ‘black henna’ tattoo in the
                                                                                                                               past.

                                                                                                                           Do not use to dye eyelashes or
                                                                                                                           eyebrows.”
Ref No              Substance                                                         Restrictions                                    Conditions of use and warnings which
ACD #                                                                                                                                 must be printed on the labels
(EU #)                                      Field of application and/or use          Maximum authorized Other limitations and
                                                                                     concentration in ready requirements
                                                                                     for use preparation
  319    Phenol, 3-amino- 2,6-dimethyl      Hair dye substance in oxidative                               After mixing under          To be printed on the label:
                                            hair dye products                                             oxidative conditions the
                                                                                                          maximum concentration
                                                                                                          applied to hair must not          “Hair colourants can cause severe
 (303)                                      Use for dyeing eyelashes and                                                              allergic reactions.
         3-Amino-2,6- Dimethylphenol        eyebrows is not permitted.                                    exceed 2.0%
                                                                                                                                      Read and follow instructions.
                                                                                                                                      This product is not intended for use on
                                                                                                                                      persons under the age of 16.

         CAS No 6994-64-5                                                                                 The direction for use “wear Temporary ‘black henna’ tattoos may
                                                                                                          suitable gloves” must be     increase your risk of allergy.
                                                                                                          included in label or leaflet
                                                                                                          text.                        Do not colour your hair if:
                                                                                                                                       - you have a rash on your face or
                                                                                                                                          sensitive, irritated and damaged
                                                                                                                                          scalp,
                                                                                                                                       - you have ever experienced any
                                                                                                                                          reaction after colouring your hair,
                                                                                                                                       - you have experienced a reaction to a
                                                                                                                                          temporary ‘black henna’ tattoo in the
                                                                                                                                          past.

                                                                                                                                      Do not use to dye eyelashes or
                                                                                                                                      eyebrows.”


  320    2-Naphthalenaminium, 8-[(4-        Hair dye substance in             non-                        The direction for use “wear Do not use to dye eyelashes or
         amino-3-nitrophenyl)azo]-7-        oxidative hair dye products              2.0%                 suitable gloves” must be     eyebrows
         hydroxy-N,N,N-trimethyl-, chloride                                                               included in label or leaflet
                                            Use for dyeing eyelashes and                                  text.
                                            eyebrows is not permitted.
 (304)   Basic Brown 17
Ref No               Substance                                                    Restrictions                                    Conditions of use and warnings which
ACD #                                                                                                                             must be printed on the labels
(EU #)                                  Field of application and/or use          Maximum authorized Other limitations and
                                                                                 concentration in ready requirements
                                                                                 for use preparation



         CAS No 68391-32-2




  321    3-Amino-7-(dimethylamino)-2-   Hair dye substance in             non-                        — Do not use with           To be printed on the label:
         methoxyphenoxazin-5-ium        oxidative hair dye products              0.5%                 nitrosating agents
         chloride
                                                                                                                                        “Hair colourants can cause severe
                                        Use for dyeing eyelashes and                                                              allergic reactions.
                                        eyebrows is not permitted.                                                                Read and follow instructions.
                                                                                                      — Maximum nitrosamine
 (305)                                                                                                                            This product is not intended for use on
         Basic Blue 124                                                                               content: 50 μg/kg(21)
                                                                                                                                  persons under the age of 16.

                                                                                                                                  Temporary ‘black henna’ tattoos may
                                                                                                                                  increase your risk of allergy.
         CAS No 67846-56-4                                                                            — Keep in nitrite-free
                                                                                                      containers                   Do not colour your hair if:
                                                                                                                                   - you have a rash on your face or
                                                                                                                                      sensitive, irritated and damaged
                                                                                                                                      scalp,
                                                                                                      The direction for use “wear - you have ever experienced any
                                                                                                      suitable gloves” must be        reaction after colouring your hair,
                                                                                                      included in label or leaflet -  you have experienced a reaction to a
                                                                                                                                      temporary ‘black henna’ tattoo in the
                                                                                                      text.
                                                                                                                                      past.

                                                                                                                                  Do not use to dye eyelashes or
                                                                                                                                  eyebrows.”


  322    Peanut oil extracts and                                                                      Maximum concentration of
         derivatives                                                                                  peanut proteins: 0.5 ppm
Ref No              Substance                                                 Restrictions                              Conditions of use and warnings which
ACD #                                                                                                                   must be printed on the labels
(EU #)                                     Field of application and/or use   Maximum authorized Other limitations and
                                                                             concentration in ready requirements
                                                                             for use preparation
 (306)   Arachis Hypogaea Oil

         Arachis Hypogaea Seedcoat
         Extract

         Arachis Hypogaea Flour

         Arachis Hypogaea Fruit Extract

         Arachis Hypogaea Sprout Extract

         Hydrogenated Peanut Oil

         Peanut Acid

         Peanut Glycerides

         Peanut Oil PEG-6 Esters

         Peanutamide MEA

         Peanutamide MIPA

         Potassium Peanutate

         Sodium Peanutamphoacetate

         Sodium Peanutate

         Sulfated Peanut Oil

         CAS Nos
         8002-03-7/8002-03-7/8002-03-7
         8002-03-7/68425-36-5
         91051-35-3/91744-77-3
         68440-49-3/93572-05-5
Ref No                Substance                                                  Restrictions                                       Conditions of use and warnings which
ACD #                                                                                                                               must be printed on the labels
(EU #)                                      Field of application and/or use    Maximum authorized Other limitations and
                                                                               concentration in ready requirements
                                                                               for use preparation
         61789-56-8/61789-57-9/73138-
         79-1

  323    Hydrolyzed wheat protein                                                                     Maximum molecular
                                                                                                      weight average of the
                                                                                                      peptides in hydrolysates:
                                                                                                      3.5 kDa
 (307)   CAS Nos 94350-06-8 / 222400-
         28-4 / 70084-87-6 / 100209-50-5
   A9    Thiolactic acid and its salts     (a) Hair waving or straightening   (a) 8.5% ready for      For (a), (b) and (c):         (a), (b) and (c)
                                               products                           use at pH
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