Adoption of ASEAN Cosmetic Regulatory Scheme

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DOH ADMINISTRATIVE ORDER NO. 2005-0015: Adoption of ASEAN Cosmetic Regulatory Scheme

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Title Supreme Court: Adoption of ASEAN Cosmetic Regulatory Scheme

Law: Doh Administrative Order No. 2005-0015

Decision Date: Apr 21, 2005

DOH Administrative Order No. 2005-0025 aligns the Philippines' cosmetic regulations with the ASEAN Harmonized Cosmetic Regulatory Scheme, aiming to protect public health and facilitate the transition to international standards, with specific guidelines for registration, labeling, and post-market surveillance.

cosmetic regulations

A

Statement of Policy

DOH supports cosmetic industry members entering ASEAN and global markets via the harmonized scheme.
Encourages SMEs to upgrade technologies to ASEAN standards.
Promotes regular dissemination of technical information through BFAD and cosmetic industry associations.

Objectives

Formally integrate ASEAN Harmonized Regulatory Scheme and Common Technical Documents into Philippine National Requirements.
Facilitate coordinated transition from previous regulations to the ASEAN Harmonized Cosmetic Regulatory Scheme for BFAD and cosmetic industry.

Scope of Application

Applicable to all cosmetic manufacturers, traders, exporters, and importers of cosmetic products within the Philippines.

Definition of Terms

Terms shall follow ASEAN Cosmetic Directive and Common Technical Documents definitions.
Philippine national laws prevail if there are conflicts with ASEAN definitions.

Implementing Guidelines

A. Adoption of the ASEAN Harmonized Cosmetic Regulatory Scheme

DOH adopts ASEAN Mutual Recognition Arrangement for product registration approvals, consistent with national laws.
Schedule A and B from the ASEAN Harmonized Cosmetic Regulatory Scheme Agreement incorporated.

B. Adoption of the ASEAN Technical Documents

DOH adopts seven ASEAN Technical Documents, including definitions, ingredient listings, labeling requirements, claims guidelines, registration and import/export requirements, and GMP guidelines.
Appendices I to VII incorporated.
Documents accessible through BFAD.

C. Authority of the Bureau of Food and Drugs (BFAD)

BFAD authorized to issue detailed implementation directives.
Directive must allow transition period for compliance with ASEAN labeling requirements until 31 December 2007.
Regular seminars, workshops, and information exchange mandated to ensure clarity and uniform implementation.

Repealing and Separability Clause

All existing administrative issuances inconsistent with this Order are repealed.
Provisions found unconstitutional or contrary to law shall not affect the rest of the Order.

Effectivity

The Order takes effect 15 days after publication in a newspaper of general circulation.

END