For the effective implementation of A.O. No. 2005-0025 (Subject: Implementation of the ASEAN Harmonized Cosmetic Regulatory Scheme and ASEAN Common Technical Documents), BC No. 2006-001 is hereby amended as follows:


A. The Documentary and Technical Requirements for Products for Notification are hereby amended as follows:

1. Documentary Requirements

a. Forms to be accomplished correctly and completely

- Revised Assessment Slip (Ref. BC 20 s. 2005: Subject Revised Assessment Slips)

- Two (2) copies of the Notarized Cosmetic Product Notification Form and Declaration using the revised form (Annex A^* hereof).

- PART I ONLY of the BFAD Worksheet.

b. Attachments

• For Manufacturers- With reflected or attached List of Cosmetic Trader/s and List of Product Lines.
  
  
• For Traders -  with reflected or attached List of Toll Manufacturer  and List of Product Lines.
  
  
• For Importer/Distributor - With reflected or attached List of Product  Source of imported cosmetic products as well as actual manufacturer of the product.
  
  
• For Wholesaler/Distributor -  With reflected or attached List of Product Source.

2. Technical Requirements

• Test for Heavy Metals done on the finished products (Ref. BC No. 13 s. 2006, Subject: Amendment to Bureau Circular No. 17 s. 2005)
  
  
• Two (2) copies of unattached specimen of all labeling materials [(outer, immediate, package insert (if applicable)] in commercial presentation which shall be legible, comprehensible and indelible.
  
  
• Two (2) copies of unattached Facsimile of the labeling materials complying with the ASEAN Labeling Requirements contained in the ASEAN Harmonized Regulatory Scheme (For products with non-complying labels with ASEAN), which shall  be legible, comprehensible, and indelible.
  
  
• Specimen of the finished commercial product (One specimen to represent the pack size) or digital picture/s (at least 5 x 5 1/4 in size) of these samples showing the container and actual content of the product/s.

B. Paragraph B of BC No. 2006-001 (Products for Notification under the ASEAN MRA) is hereby deleted.

C. The Documentary and Technical Requirements for Cosmetic Products for Regular Registration is hereby amended as follows:

1. Documentary Requirements


- The legalized documents required to be submitted for imported cosmetic products in BC No. 2006-001 remain effective

2. Technical Requirements

• Finished Product Specification
  
  
• Test for Heavy Metals done on the finished products (Ref. BC No. 13 s. 2006, Subject : Amendment to Bureau Circular No. 17 s. 2005)
  
  
• Test Methods (when requested or necessary)

c.     ˜   Unattached specimen of all labeling materials [outer, immediate, package insert (if applicable)] in commercial presentation which shall be legible, comprehensible, and indelible.

˜  Unattached Facsimile of the labeling materials complying with the ASEAN Labeling Requirements contained in the ASEAN Harmonized Regulatory Scheme (For products with non-complying labels with ASE- AN), which shall be legible, comprehensible and indelible.

d. Specimen of the finished commercial product (One specimen to represent the pack size) or digital picture/s (at least 5 x 5 1/4 in size) of these samples showing the container and actual content of the product/s.

e. Attestation to support special product claims (Ref. BC No. 5 s. 2005, Subject: Consolidation and Update of Permissible Cosmetic Claims)

D. Products for Export only shall be subject to the same regulations applicable to locally marketed cosmetics as stipulated in A.O. 2005-0025.


The Procedure laid down in BC No. 2006-001 is hereby amended as follows:

1. Paragraphs 1 and 2 of BC No. 2006-001 remain effective.

2. Paragraph 3 of BC No. 2006-001 is deleted.

3. Arrange the documents according to the checklist of requirements in an expandable color-guided long folder using the following legend:

Green : Notification
Yellow: Regular Registration
Blue : Export

In arranging the documents, put identifying markers/separators in between sections, indicating the type of documents as per application requirements.

4. Paragraphs 4 and 5 of BC No. 2006-001 remain effective

5.  For Product Notification Applications, the BFAD shall stamp as received the Revised Cosmetic Product Notification Form (Annex A), upon submission by the applicant of the required documents, to acknowledge receipt thereof instead of issuing a Certification. Notwithstanding the acknowledgement of receipt of the required documents, the BFAD reserves the right to further issue a letter/notice to the company in case of clarification or when the cosmetic product subject of the application failed to conform to any of the existing standards or specifications set by the Bureau.

Items III and IV are hereby added to BC No. 2006-001, to read as follows:


To Align with the ASEAN Harmonized Cosmetic Regulatory Scheme (AHCRS) the following rules shall apply to any changes on the particulars as reflected in the initial product notification form.

a. Types of changes for Product Notification that require letter of request and the necessary documents that affect the change(s)

1. Product Presentation (single product, palettes in a range, etc.)
2. Name and/or address of company without change of distribution rights
3. Person representing the company
4. Pack sizes, packaging materials and labels.

b.  Types of changes that require new product notification in accordance with A.O. 2005-0025

1. Product name, brand name or variant name
2. Company change due to change of distribution rights
3. Product types
4. Intended use
5. Change or addition of claims
6. Formulation
7. Manufacturer and/or assembler (name and/or address)

The following changes shall require an amendment of Certificate of Product Registration (CPR) following the list of requirements listed in PSD-CSA-03 (Worksheet for Amendment).

1. Change in Manufacturing site
2. Change of Manufacturer
3. Change of Packer/Repacker
   

The following changes shall require re-issuance of new CPR

1. Change in product name, brand name or variant name
2. Change in Business name and/or address of company
3. Change in ownership
   

Requests for Amendments and re-issuance of new CPR will be submitted and received at the Public Assistance, Information and Compliance Section (PAICS) during Thursdays only.

This Circular shall take effect on 01 January 2007.

Adopted: 18 Dec. 2006