Republic of the Philippines Department of Health FDA, FOOD AND DRUG ADMINISTRATION Fos ee ES 14 April 2015 FDA CIRCUL. No. 2013-008 SUBJECT: A ic Dit five (ACD) In the interest of service, and for the information of all, the Food and Drug Administration (FDA) hereby provides the Reports of the 21" ASEAN Cosmetic Committee (ACC), 20" and 21" ASEAN Cosmetic Scientific Body (ACSB), and 4" ASEAN Cosmetic Testing Laboratory Committee (ACTLC) Meetings as attachments. Noting the importance of the grace periods in the industry activities, including reformulation, development, initiation of product phase-outs, among others, the FDA has consulted representatives of the different cosmetic industries via the regular regulatory update meetings. As a result, adjusted grace periods as presented below are hereby adopted: Amendments BER Agreed Grace Period ‘Annex II = 1374-1378 | Existing products can be in the market until December 31st 2015 ‘Annex IIT la Immediate effect [PTs aa 286 Until July Ist 2015 or earlier for produets to be placed in the market and 287 December Ist 2015 for existing products in the market. ‘Annex IV. | CL 77510 Immediate effect ‘Annex VI 12 and 12a Local grace period/timeline will be moved to “until end of to March 2016, and for existing products in the market will be end of September 2016” 25, End of December 2015 but subject to review at the next ACSB meeting 39 Local grace period/timeline will be moved fo “until Oct Ist 2015 or 37 earlier, for products to be placed in the market and July 2016 for existing products in the market” 39 Immediate effect Annex Vit = 29 [Immediate effect Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines ‘Trunk Line +63 2.857 1900 Fax +63 280700751 Website: wwwfda.goviph Email info@fda.govphThe FDA hereby reiterates that companies, as well as individuals who are responsible for placing cosmetic products in the market are responsible for continually checking updates and amendments to the ACD. You are also hereby directed to take note of the abovementioned grace periods. Furthermore, previous reports of the following meetings are hereby republished in the FDA website for everyone’s perusal: ACC — 18" to 20" meetings ACSB ~ 17" to 19 meetings ACTLC - 3" meeting For updates and amendments, please visit the following websites: www.fda.gov.ph aseancosmetics.org www.asean.org This order shall take effect immediately. a © ATTY. NICOLAS B. LUTERO III, CESO III OIC-Director IV, Food dnd Drug AdministrationHighlights of the Meeting A. 21° ACSB (Manila, Philippines) 1, Amendments to the ASEAN Cosmetic Ingredient Annexes ‘The summary of the amendments to the ASEAN Cosmetic Ingredient Annexes are presented below: a. Amendments to Annex II ‘Substances CAS Number Rene 2RCpH isomerate INCI nose yertn Satur ate Sata ct —— a ~ sobutyl4hycronbenzoat (INC: sobuyparaben) ee ee Sodium salto Sl of nobuybaraben e4s00-15-4 Pheny-tysronbenzoate (INCI Phenyparaben) 17606-62.7 1876 Benzyl nydronbenzone (NCI Benzyparaben) 4108 ‘877 Pent yéronbenzoate (NCI Penvparaben) es2i285 1378 b._ Amendments to Annex IIL Reatvictions rere | Substance | Field ofapplication | Waximum authorised concentration in | Other limitations Conditions of uso ‘and warning which or tates ein ‘andlor we ‘Refnshed comet produc” | andrequremere | Muse pind on we] Bocas — wy Tale Tal By RTS we BOVE I) TATE NATO DE | TAIT Natt be | tomes ana | Usedin | edn prods or ‘eraborates predicts or | een under 3 | with the | children under | years of age Steen o Syear ofage | '2 Nottobe Stbetance 2iNetto be | used on peeing oF Novieein Usedon peeing | tated skin nvext orate an ite (014, Notte (b) 0.19% (by massimass as boric acid) ‘concentration | swallowed Stree soe |" D Notto be (&) Produc or Sorates used in roa for Srainypione | (o) 9%(by massa bore act) | excoeds 15% | chitrenunder3 Ceymesemase | Your orape selon 208) (0). Netto be used (©) tne prods (0) Nottobeuses_ | Inprosues tor (escudeg bath Irproduesfor_| cxiren under 2 | produ ana Ghisrenunder_| year of age faving Syearsofape | "2: Noto be used | rates cngeingor | ‘ested | | | | [et Notto be. | ein roi foe Chien under | Sears of soe 2 hottobe bon peatingifite ‘concentration of fee soluble borates ‘exceeds 1.5% (by massimass ‘aeborie acid) | | | Asset foe annexe Vi Part | SIN 5B 286" | Cie (a) Rinse-off hair | (a) 28 % forthe individual For purposes other | ‘atytinethyla | products ‘Soncenratons oe sum of the than iting the mmenuim Indvaval concentrations of cetimonium | development of chionde ‘horde and steartimonium chionde. | micro organisms in the product The Gr. | (©) Leave-onnair | (b) 0% forthe naval purpose has tobe SHynimetya | Goss rare aes of he Sean! om ne mmenum | indivua eoneertratens of cetimonium | presentaton of fe crore” | Gilde and stearimonium chioide | product. [ra roms | 0)05 fore mau As a preservative, ‘oncentratons o he sum ofthe see Annex Vi Part + | Indivisual concentrations of cetimonium | Ref No. 44 (horse and stearimonum chionde BP oe Ta) Rinse hair | (a) 50% forthe ncvidual conceriation | For purposes ober ‘alkytrimetnyla | products ‘of behentrimonium chionde orthe sum | than inhibiting the renin ofthe mdivdua!concervatons of development of chionde fetimenium enionge, steartimonum | mio: organisms in | Chloride and behentrimonium chloride, | the product The While atthe same time respecting the | purpose hasto be relevant maximum concentraton forthe | apparent from the um of cetrimanium eniorde and Presentation ofthe Stoartimonium ehiorde set outin entry | product. 286. ‘Asa preservative, (©) Leavecon hair | (b)3.0.% forthe invita concentration | see Annex VI Pat 1 Products ff behentrimonium chlonde or the sum | Ref. No. 44 fhe indiveiual concentrations of Cetimonium chirde, steartimonium éhloride and behentrimonium chloride, ‘while a the same me respecting the Felevant maximum concentration forthe sum of cetrimonium chloride and Steartrimonium chicde set out in entry 286. | | [recone | 20% rbot canton | ana nun cies stanean | ‘timonium chiorde, steatrimonium Chloride and behentrimonium ehide, ‘while atthe same time respecting the | Felevant maximum concentration forthe | ‘sum of cetmonium chloride and ‘Steartimonium chloride set out in entry 286, | ct the naval concetatons of | *Post-meeting Update from the Secretary of ACSB: Reference Numbers 286 and 287 have yet to be incorporated in the Updated Ingredient Annex III, due to discrepancies found in the reference numbers used versus available reference numbers in Annex IIL The FDA noting the importance of such information being disseminated to stakeholders hereby includes the abovementioned restriction in this update. Please take note that Reference Numbers 286 and 287 may be presented differently when an updated Ingredient Annex III has been released,c._ Amendment to Annex IV Colour index Number or | _ Colour Fie of application ‘ther imitations and requirements ‘Denomination 71213 Ls 77510 bie [x Free fom eyanie on d. Amendments to Annex VI Conaions of ase and Rete aoe Monin autores Uimiatonsana | cameras, rm ‘concentration requirement mings which mut 72 [pipsonpbensoe aod ands [096 av an or sng ete Itetye ana ety esters and [oem te ax) for manures ne sans tNcl) Jntcrs MINES epoh ote estar in mature |4-Hydroxybenzoic acid; CAS No. Joannot exces Le loo 3-7 tempparaben, CaS No 29°05 petassum eoyparaten; CAS Ro sessr otaseum paraben; CAS No ‘eraaoe eeu matparaben; CAS No. see ecu etnparaben CAS No, Sens o8. etyperaben, CaS No 0.3 sci paraben; CAS No. 114 es potassium methyparaben; CAS o"ssit2r Jeskium praten CAS No eeououseo 72a [buy yeronberaoate and fs |0,18 (es 008) or the sum offi o be usedinleave-on [For maveon pros sats Propyayarontenzote |e mahal concentatons|poaicedesgneater ”|gengned or caren under land's cate nes (mncks tr moauecet [ovieaton rte napoy _ |tves years ofage'Do |Butyiparaben; CAS No. 94.26-8; |substances mentioned in entry |@”€2 of children under three Juse on the nappy area” |Propylparaben; CAS No, 94-13-3|12 and 12a, where the sum of |Y€ars of age. oct propyparaben CaS no [te rewaal concentaton [ss206-c0 $codium buty- and propypareben and S259 soda sasr. Ines Soe tat oxcoee Ea oa caesium tutyparaben, CAS Ko. sesee se 6 potassium propyaraben, CAS No. 8000- ee B | somone @ 0% ci Stored) penal a sa wen Bay soapelSnoner Teelosan (0) Beton (non. CASH 3380345 seen Foe pores and Bemsheorcealos Nat procul fr fegemate snd tears etre he Sepoaten or 02% (&) Mouthwashes39 [Miure of S:chioro-2metny- | 0.0015 % (ofa mixture in the | Rinse-o products lsothiazot3(2H}-one and 2- | rato 3:1 of §-chioro-2- IMethyisctrazol-3(2H}-0ne | metnyiisotiazol 372H}-one Jancs) and 2-methylisothiazok3 (2Hyoney IMethychlroisothiazotnone, (and) Metnyteothiazotnone”” IcAS No. 26172-55-4, 2682-20-4, \55055-84.9 ‘ST [2-Methy-2H-eothiazol- Sone 001 cry IMetnysothiazotnone"® JCAS No.2582-20-4 9 [1 28-Propaneticarboxyic aod, | 02% corresponding to [Noto be used mn hydroxy, monohyarate and" | 0.002% 9 of siver oral products and eye 1 2.5-Propaneticarboxyic act products" Xhydroxysver 1+) sa, lmononyarate (INCI) cite acid (and) Siner ctrate TB) Wethviscthiazoinone fe also regulated i entry 57. The two erties are mutually ruse He use ofthe mibture oF Metnyleniroisciiazoinane (and) Methyisobiazoinone is incompatible withthe use of Methylisthiazoinone alone inthe same product (14) Methytsothiazolinone i also regulated in entry 39 in a mixture with Methyicloroisotniazolinone. The two entries are mutually ‘exclusive the use ofthe mature of Methylchioroisothiazolnone (and) Methylisthiazoinone is incompatibie with the use of Metnylisothiazatnone alone in the same product e._ Amendment to Annex VII ‘Conditions of use and Reference Maximum authorized | Other limitations and Substance ‘warnings which must be Number ‘concentration requirements inted on the label 29 _([ias-Tiazne 24,686 [1,7- 70% Noto be used in eprays. bioneny-4-y, induding as [Only nanomaterials having Inanomateri (INCI Name : Tris Ite folowing characterises phenyl triazine Ti-bipheny! late alowed Itiazine (nano)} CAS No. 21274- raz |— median primary particle size > 80 rm, |—Punty 2 98 %: | Uncoated 2. Inclusion of the Strongly Recommended warning in the ASEAN Sunscreen Labeling Strongly recommended warning: Re-apply frequently to maintain protection, especially after sweating, swimming or toweling; The use of sunscreens is one way to reduce the dangers from sun exposure; Instruction for use to ensure that sufficient quantity is applied, e.g pictogram, illustration, ete; Over-exposure to the sun is a serious health threat; 3. Adoption of the final revision of Pilot risk assessment of botanical ingredients The document is uploaded in the FDA website (www.fda.gov.ph) under ASEAN Cosmetic Harmonization,