COSMETICS

Regulation of Cosmetic Products in the Andean Community

Decision 516 regulates Andean Community trade in cosmetic products. It was adopted in March 2002 by the trade and health authorities of the CAN Member Countries with the assistance of the General Secretariat.   

The basic principles of the Decision are:

1. To establish a uniform platform among the Andean Community Member countries in order to guarantee fair and transparent trade in cosmetic products.

2. To seek a balance between public health safeguards and the free circulation of cosmetic products in the Andean subregion. 

3. To promote the principle of good faith based on mutual trust among Member Country authorities committed to technical and administrative cooperation and the exchange of information for effective post-trade control; also to trust in the good faith of the interested party, which agrees to inform authorities about any changes made to its product in the market (incorporations, brands, alterations, etc.).

4. To prioritize post-trade, rather than pre-trade, monitoring of cosmetic products in order to effectively verify the sanitary quality of the product when in the market. 

5. To adopt Good Manufacturing Practices as a means for ensuring the sanitary quality of the cosmetic products throughout the entire production process. 

6. To simplify administrative procedures in order to facilitate free trade in cosmetic products among Andean Community Member Countries, without threatening their sanitary quality in so doing.   

Application of Decision 516

What is a Compulsory Sanitary Notification?

A Compulsory Sanitary Notification (CSN) is a communication, in the capacity of an affidavit, through which the manufacturer or marketer informs the Competent National Authority about its intention to market a cosmetic product within the territory of any Andean Community Member Country (Dec. 516, Art. 6). 

What cosmetic products may have recourse to Decision 516?

Decision 516 is applicable to all cosmetic products that are marketed in the Andean Community, whether they originated in any of the five Member Countries or in third countries (Dec. 516, Art. 2).

What is the procedure for marketing a cosmetic product in the CAN?

1. A Compulsory Sanitary Notification must be submitted to the Competent National Authority before a cosmetic product can be marketed (Dec. 516, Art. 5)

2. If the product is manufactured in the subregion, the Member Country where it is produced must be notified.  If it is imported, the CSN must be presented to the first Member Country where the product is to be marketed.  (Dec. 516, Art. 5)

3. The CSN must be presented to the Competent National Authority together with a series of general and technical documents and information.  (Dec. 516, Arts. 5 and 7).

4. On receiving the CSN, the Competent National Authority shall check to see that the required documentation is complete.  If so, the CSN will immediately be assigned a code number. If the information is not complete, the Authority will let the interested party know without delay what is lacking.  (Dec.516, Arts. 8 and 9).

5. The CSN and accompanying documents shall be received and a code assigned or the missing information reported immediately and without any unnecessary delay or need for an administrative resolution to be issued or compliance with any other formality.

Once these steps have been taken, the product will be ready for marketing in the country where the Compulsory Sanitary Notification was presented.   

How does the automatic recognition operate in Decision 516?

The CSN code granted by the first Member Country is accepted by all other CAN Member Countries.   

Once an interested party has a CSN code, all it must do to market its product in the rest of the Andean Community is to present a copy of its CSN with its code and to attach the necessary documents for monitoring and control purposes.  Presentation of the copy together with the complete documents authorizes the interested party to immediately market its product in the Member Countries where these formalities were completed.  (Dec. 516, Arts. 8 and 23)

The other Competent National Authorities may not, under any circumstances, repudiate the first Member Country’s Compulsory Sanitary Notification.

What ingredients can be used to manufacture the cosmetic products?

The ingredients that can be used or not used in the cosmetic products, together with their corresponding restrictions or terms of use are included on the international lists of the following entities: the United States Food & Drug Administration, the Cosmetics Toiletry & Fragrance Association (CTFA), and the European Cosmetic Toiletry and Perfumery Association (Colipa) and in the Guidelines of the European Union (Dec. 516, Art. 3)

Each country’s authorities can decide to either include or exclude an ingredient after consulting among themselves and with the General Secretariat, provided they have clear evidence or scientific proof that the ingredient in question could be harmful to people’s health. (Dec. 516, Art. 4)

How can doubts about the Decision’s application be resolved? 

If doubts arise among the Competent National Authorities about any aspect of Decision 516, they can turn to consultations, the exchange of information and mutual cooperation (Dec 516, Art. 30).

Furthermore, both those authorities and the Decision’s users can request a technical opinion from the General Secretariat of the Andean Community.

If a dispute must be submitted to a Member Country judicial authority, the trial court judge (either on his/her own initiative or at the request of one of the parties) may ask the Andean Court of Justice of the Cartagena Agreement for a binding legal interpretation by means of a simple communication stating the key points of the case and the decision to be interpreted.  The national judge, with that interpretation, shall then decide the case.    

What will happen in the event of noncompliance with Decision 516?

Member Country authorities and natural and artificial persons whose rights have been impaired by failure to comply with an Andean Decision may submit their claim to the General Secretariat, as provided for in the Treaty Creating the Andean Community Court of Justice and in Decision 425.