Asia-Pacific Update: ASEAN Updates to Nano, Sun Care, Trace Limits and More

Changes to the European Union’s Cosmetic Directive 76/768/EEC were a main topic of discussion at the meeting of the ASEAN Cosmetic Scientific Body (ACSB) and the ASEAN Cosmetic Council (ACC), which took place in Cambodia on July 11-12, 2012. There were suggestions to adopt parts of the Cosmetic Directive, which will be repealed for Regulation (EC) No 1223/ 2009 on July 11, 2013. Namely, the two groups are interested in the regulation’s treatment of nanomaterials and teeth whitening products. Also discussed were trace limits and sunscreen labeling, and member states are to review these suggestions and give their comments and feedback on the contents by the end of 2012.

EU Updates and Adaptations

Nanomaterials: In July 2013, nanomaterials must be declared in the notification to authorities as part of 1223/2009 when placing a cosmetic product on the market. The ASEAN region is considering adopting this regulation, which would require labeling of nanomaterials such as nano-sized titanium dioxide on existing and new products. The ASEAN Cosmetic Association (ACA) has been tasked with drafting a working definition and safe use of nanomaterials in cosmetics for the next ACSB meeting.

Teeth Whitening: There were also further discussions on adoption of Council Directive 2011/84/EU, which amends Annex III of Directive 76/768/EEC due to technical progress. Specifically discussed was Annex III Part 1, Ref. 12, wherein consultation would need to be made with the national dental association on usage of hydrogen peroxide at 6–35% in teeth whitening products. The limitations highlighted in the 2011/84/EU referring to tooth whitening or bleaching products allows 0.1-6% hydrogen peroxide, and the usage age is limited to those over 18. While concentration of hydrogen peroxide less than 0.1% can be present and released in oral care products, Annex III Part 1 further states that greater concentration up to 6% should be obtained only through a qualified dental practitioner and not for direct sale to general public. Those with concentration of 6-35% hydrogen peroxide are to be strictly used only by a qualified dental practitioner.

Adaptation of EU annexes: Agreement was reached in Europe on extending the deadline to June 2013 for three ingredients per Annex III Part 2, and the ASEAN region is also extending this deadline. Namely, the deadline is extended for HC Red No. 10, HC Red No. 11 and its salts (Ref. 50) and hydroxyethyl-2-nitro-p-toluidine and its salts (Ref. 10).

Maximum Trace Limits

On maximum trace limits for chromate Ions in CI 77288 and CI 77289, members of the ACC may adopt the U.S. Food and Drug Administration’s limits as a guideline for Post Market Surveillance activities. Maximum limits set were 0.075% chromate ion in 2% sodium hydroxide for CI 77288 and 0.1% chromate ion in 2% sodium hydroxide for CI 77289. Further, the FDA’s limit for cyanide ion in CI 77510, <10 ppm of cyanide ion in CI 77510, may be adopted as a guideline for Post Market Surveillance.


Proposal for mandatory labeling for sunscreen products was made during the tenth ACSB meeting. It has been implemented in Indonesia, Malaysia and the Philippines, and remaining member states were reminded of the need for this implementation. In addition, member states were to review the printing of warning “Do not stay too long in the sun, even while using a sunscreen product.” The classification was also amended for sunscreen labeling guidelines (see Table 1) due to grey areas in SPF levels and a desire for higher SPF values.

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