Objective and Scope
- The Circular provides updates and amendments to the ACD as adopted during the 28th ACC meeting and related meetings.
- It covers all cosmetic products made available in the Philippine market.
- It applies to establishments involved in manufacturing, importation, exportation, sale, distribution, donation, transfer, and where applicable, use, testing, promotion, advertising, or sponsorship of cosmetic products.
Updates and Amendments to the ACD Ingredient Annexes
- The Circular highlights updates to cosmetic ingredient annexes with revisions accessible on the FDA website.
- Annex A includes a table of new and modified ingredient entries and grace periods.
Thioglycolic Acid and Thiolactic Acid
- Updated restriction clarifies combination use in hair waving or straightening products.
- Maximum concentration for combined use set at 8%, calculated as Thioglycolic acid.
EU 2013/344 Chemical Restrictions
- No changes made to Annex III entries Ref. Nos. 103 to 184 and 186.
- These fragrance ingredients are controlled by IFRA standards or covered under existing annexes.
EU 2017/237 Additions to Annex III
- New chemical entries including various dyes and compounds (Ref. Nos. 8c, 9b, 314-321) adopted.
- Compliance mandatory from 1 December 2019; non-compliant products to be withdrawn.
EU 2017/1410 Adoption and Implementation
- Inclusion of Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde (Lyral), Atranol, and Chloroatranol into Annex II.
- Indonesia initially delayed adoption but later aligned with other AMS.
- Ban effective 23 August 2021 for products containing these banned substances.
Zinc Oxide Restriction
- New restriction prohibits use in applications leading to inhalation exposure.
- Expert risk assessment required to determine exposure risk.
Clarification on Sulphonamides (Annex II Ref. No. 307)
- Revised definition to clearly include sulphanilamide derivatives and salts.
EU 2017/2228 Additions
- Inclusion of Peanut Oil and Hydrolyzed Wheat Protein in Annex III.
- Compliance required by 1 December 2019; non-compliant products must be withdrawn.
Trace Impurity Limit for 1,4-Dioxane
- Maximum allowable trace limit set at 25 parts per million (ppm) in finished cosmetic products.
- ASEAN Guideline for Limits of Contaminants updated accordingly and posted online.
ASEAN Cosmetic Methods (ACM)
- First eight ACMs revised and uploaded on ASEAN Trade Repository and ASEAN Secretariat websites.
- ACM 009 (Determination of Salicylic Acid by HPLC) to be published shortly.
Updated List of Cosmetic Accredited Laboratories
- List available at the Department of Trade and Industry - Philippine Accreditation Bureau website.
- Includes scope of accreditation and links to National Accreditation Bodies in ASEAN.
Question and Answer on Specific Provisions of the ACD
- Q&A document on ACD provisions uploaded on ASEAN and FDA websites for stakeholder guidance.
Penalty Clause
- Violations of the FDA rules on cosmetic products subject establishments to sanctions as prescribed under Republic Act No. 9711 (FDA Act of 2009).
Effectivity
- The Circular is effective immediately upon filing.
- Grace periods apply to ingredient annex updates as specified.
- Entries without specified grace periods are effective immediately.