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FDA LABELLING REQUIREMENTS

Aside from avoiding using banned chemicals in your beauty products, brand owners and manufacturers should also ensure compliance with the Philippine FDA's labelling requirements. The Philippine FDA follows the ASEAN Cosmetic Directive guidelines and recalls products that fail to follow its instructions. To avoid costly recalls and brand damage, below are the mandatory texts that should be found in the packaging of your beauty products.

Scope and definitions

1) Name of the cosmetic product means the name given to a cosmetic product, which may be an invented name, together with a trade mark or the name of the manufacturer;

 

2) Immediate packaging means the container or other form of packaging immediately in contact with the cosmetic product;

 

3) Outer packaging means the packaging into which is placed the immediate packaging;

 

4) Labelling means information written or printed or graphic matter on the immediate or outer packaging and any form of leaflets;

 

5) Registration holder means the holder of the authorization for the cosmetic products.

 

Labelling of cosmetic products

 

1. The following particulars shall appear on the outer packaging of cosmetic products or, where there is no outer packaging, on the immediate packaging of cosmetic products.

 

a) the name of the cosmetic products and its function, unless it is clear from the presentation of the product;

 

b) instructions on the use of the cosmetic products, unless it is clear from the product name or presentation;

 

c) full ingredient listing. The ingredients must be declared in descending order of weight at the time they are added. Perfume and aromatic compositions and their raw materials may be referred to by the word “perfume”, “fragrance”, “aroma” or “flavor”. Ingredients in concentrations of less than 1% may be listed in any order after those of concentration of more than 1%. Coloring agents may be listed in any order after the other ingredients, in accordance with the color index number or denomination adopted in Annex IV. For decorative cosmetic products marketed in several color shades, all coloring agents used in the range may be listed, provided that the terms “may contain” or “+/-“ be added.

The ingredients shall be specified by using the nomenclature from the latest edition of standard references (Refer to appendix A) Botanicals and extract of botanicals should be identified by its genus and species. The genus may be abbreviated; The following shall not, however, be regarded as ingredients;

- impurities in the raw materials used;

- subsidiary technical materials used in the preparation but not present in the final product;

- materials used in strictly necessary quantities as solvents, or as carriers for perfume and aromatic compositions.

 

d) country of manufacture

 

e) the name and address of the company or person responsible for placing the product on the local market ;

 

f) the contents given by weight or volume, in either metric or both in metric and imperial system;

 

g) the manufacturer's batch number;

 

h) the manufacturing date or expiry date of the product in clear terms (e.g. month/year);

 

i) special precautions to be observed in use, especially those listed in the column “Conditions of use and warnings which must be printed on the label in Annexes ____”, which must appear on the label as well as any special precautionary information on the cosmetic products.

 

Member countries may require specific warnings based on local needs e.g. declaration of ingredients from animal origin. In this case:

 

(i) There must be a statement (of any format) on the product label that declares the presence of ingredients from animal origin

(ii) For ingredients from bovine and porcine origin, the exact animal must be declared.

(iii) Ingredients from human placenta must be declared specifically on the product label.

 

j) registration number from the country of origin (manufacture) or the country of registration.

 

2. In cases where the size, shape or nature of the container or package does not permit the particulars laid down in para 1 (a) - ( i ) to be displayed, the use of leaflets, pamphlets, hang tags, display panel, shrink wrap etc. shall be allowed. However, the following particulars at least shall appear on small immediate packaging :

 

  • the name of the cosmetic products;

  • the manufacturer's batch number

 

3. The particulars referred to in para 1 and para 2 shall be easily legible, clearly comprehensible and indelible.

 

4. The particulars listed in para 1 shall appear in English and/or National Language and/or language understood by the consumer where the product is marketed.

 

Appendix A

 

List of Standard References to be use for Cosmetic Ingredient Nomenclature

 

1.         International Cosmetic Ingredient Dictionary

2.         British Pharmacopoeia

3.         United States Pharmacopoeia

4.         Chemical Abstract Services

5.         Japanese Standard Cosmetic Ingredient

6.         Japanese Cosmetic Ingredients Codex

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