The demand for cosmetic products market in Chile is increasing day by day and it has become a necessity. So products with such importance must be highly regulated to ensure its safe, effective and quality release to market. The regulatory authority of Chile is the Institute of Public Health (ISP). The National Agency for Medicines (ANAMED), coming under ISP, is responsible for the regulation of cosmetics.
Continue to read to know about Chile cosmetic registration, labelling requirements, import of cosmetics & more.
Definition Of Cosmetics According To Chile Cosmetic Regulations
Preparations ordained for external application on human body for beauty purposes, physical aspect modification, and conservation of the normal, physical or chemical condition of the skin, hair, mucous membrane, nails, outer genital region and teeth.
The Legislation Distributes Cosmetics In Two Categories
High Risk Cosmetics: These include colored makeup, sanitizers, body lotions/treatments, insect repellent, anti-ageing treatments etc.
Low Risk Cosmetics: These include-Nail cosmetics such as nail removers, nail enamel; hair cosmetics such as body hair remover wax, shampoos, sprays, conditioners; sanitary pads(disposable) and tissues; perfumes and toiletries such as deodorants, eau de toilettes, perfumes; mouthwash and shaving products.
Chile Regulatory Authorities For Cosmetics
- INSTITUTE OF PUBLIC HEALTH (ISP)-Cosmetics in Chile are registered at National Regulatory Agency INSTITUTE OF PUBLIC HEALTH (ISP).
- AGENCIA NACIONAL DE MEDICAMENTOS (ANAMED) – Under ISP the cosmetics registration and notification process is done by ANAMED. ANAMED when translated to English is The National Agency for Medicines.
Chile Regulatory Process By ISP And ANAMED
The registration process is carried out by Chilean regulatory entity (ISP) so that products can be marketed and distributed in the country. The validity of registration is of 5 YEARS. At the end of this period the company must re-register the product. Only legally established local companies can carryout the registration or notification of cosmetic products in Chile.
For cosmetic registration- The name, cosmetic purpose, formula of product and legal status of the applicant must be verified.
If the evaluation request is positive the registration resolution can be issued which include the detailed about the conditions under which the product can be marketed but on the other hand if the registration by ISP is denied the product cannot be marketed.
If foreign company want to import and register then their products should be manufactured in independent lab, should have pharmaceutical consulting company, law firm or they should appoint a representative to operate the registration process. Also, the company should have pharmacist in their staff.
Chile Cosmetics Registration Fee Structure
Some of the fee applicable to cosmetic products are given below:
| Type | Fee in dollar |
| Cosmetic product registration certificate (per product) | 160,027+ VAT |
| Formula modification of cosmetic product variety | 34,293+ VAT |
| Cosmetic product registration certificate (For hygiene, low risk & odorizing, by list) (per product) | 70,431+ VAT |
| Renewal of cosmetic product registration, per product | 336,327+ VAT |
| Export certificate for cosmetic products | 126,786+VAT |
| Sanitary registration certificate – cosmetic product with formula (each product) | 285,758+VAT |
**Note that the fees are subjected to change with time and are not fixed. Please refer to the official Institute of Public Health, Chile official website to know the current exact payment depending on your product type.**
Items Given To ISP For Registration Are-
- Sample of the product to be marketed,
- Complete ingredient list and formula used for manufacturing product,
- Quality specifications,
- QC and QA tests reports,
- Labels written In Spanish,
- Certificate of free sale given by state or federal authority in US
Stages For Cosmetics Registration in Chile
Stage 1 – Registration and Notification with the ISP
After the completion of making stable formula by QF or cosmetic lab pharmacist (here stable formula represents that the product is free from microbes, has standard pH, accepted viscosity and solubility, etc. company has to make agreement with cosmetic laboratory, ware house rental agreement.
Further company has to cancel the tariff in the ISP of the notification and registration.
Stage 2 – Process of purchasing the elements necessary for elaboration of cosmetic product
After obtaining the notification from ISP company will buy raw materials from the cosmetic suppliers and containers exactly same which were sent to the agreement laboratory.
Later the labelling should be done with the registration number which was provided by the ISP.
Stage 3 – Start manufacturing the product to be distributed and marketed in the country
The lab delivers the product already filled and labelled which is to be dispatched to the warehouse as indicated by the client. The remaining raw materials and containers and cosmetic formula will be used to manufacture further batches of cosmetic.
Registration Certificate For Cosmetic Product: Step by Step Process
- Request for access credentials for GICONA, the electronic processing system. Ignore this if you already have an access key.
- All the required documents must be gathered and be made digital.
- After making sure that all the documents are available in digital form, the next step is to log in to the GICONA system.
- Once you have logged in to the system, according to the service you wish to request, select the appropriate link followed by the relevant service code.
- An electronic form must be completed and in the end all the documents that are required must be uploaded in the digital format indicated. To select the required document click on the “browse” button.
- After uploading all the documents, the system will direct you to a shopping cart that has the list of all submitted requests. From there you have 2 options. One is to enter another request, and the next one is to make payment for the submitted requests.
- Select the payment method and complete the payment. Once the request has been evaluated and processed an email notification will be received indicating the completion of the processing.
- A resolution approving or rejecting the request will be received.
Cosmetics Import Regulations In Chile
The cosmetic products imported for distribution or marketing within the national territory must have a health registration. Finished product when imported into Chile, its original label must have the conditions specified in Article 40 (f through j) of Decree 239, Chilean Law. If the original label lacks this information, they might be received in the authorized warehouses and the missing information must be added before distribution.
Once the processing of cosmetics has been completed and a certificate is issued by the National Custom Service, the products will be removed from the premises of customs. It will then be under the consignee responsibility.
Now the consignee must not sell, use, distribute, market, consume, transfer or even dispose them without gaining an authorization from ISP. This authorization should be issued within 3 business days from the date the interested party notifies the authority on the product entry into their storage location. It must be accompanied with
- A copy of the Health Service certificate which authorized their transfer to that facility.
- An analysis report from the foreign manufacturer or from a Chilean quality control lab specifically referring to that batch to be imported.
Cosmetics Labelling Regulations In Chile
Cosmetics products are mandatory to have all the labelling of containers and packaging in Spanish language only. Information to be given on the product is given below:
- Name of the product
- Cosmetic formula given according to INCI nomenclature of cosmetic ingredients. Order should be in descending concentration.
- Duration of the product to be used or expiration date.
- Any warnings, indications or instructions to be given for use storage or conservation.
- Quantity of the product in metric units.
- Production or batch number code or key.
- Name and address of the registration holder and producer or importer.
- The phrase to be written in children cosmetics stating that product is permitted only for children younger than 6 years of age (“permitido su uso en niños menores de 6 años”).
- In sun screening products, SPF factor to be written in accordance with certain parameters and other information.
Cosmetic soaps which contain ingredients like triclosan or triclocarbon should not make any direct or indirect therapeutic claims on their labels by using the terms such as antiseptic, disinfecting or any claims on personal hygiene.
Animal Testing per Cosmetic Regulations In Chile
As per the Law 21646 of the Chilean Ministry of Health, testing of safety and efficacy of cosmetics on animals are prohibited. The products such as cosmetic, hygiene, personal fragrance products, each of their ingredients, combination of ingredients or final products are also prohibited. Since animal testing has been prohibited it doesn’t mean that no testing must be carried out. Alternative methods of testing devoid of animals should be used and it must be recognized by the Organization of Economic Corporate and Development or the Institute of Public Health.
Animal testing prohibitions can have exemptions if the Public Health Institute allows in cases where all these cumulative conditions are met
- No alternative testing methods exist other than the use of animals to prove safety that is Public Health Institute recognized.
- The ingredients are subjected to concentration restriction for cosmetic use.
- The cosmetic ingredient is widely used, and no other ingredients are available for fulfilling a similar function.
New animal derived scientific evidence can be used when:
- No alternative tests devoid of animals are available
- There is documented evidence that the safety and efficacy testing of the ingredient is done other than those for cosmetic, hygiene, personal fragrance products. In addition to this it must have a history of use of at least one year out of the cosmetic industry.
- Data from animal tests that are authorized by the concerned agency.
Cancellation Of Health Registration
Health registration for cosmetics can be cancelled under the following conditions:
- If requested by the registration holder
- If any of the declarations submitted to request registration is found with deception or falsification
- If any qualitative, negative changes or significant quantitative ingredient changes are found in the registration.
- If any serious violations of health regulations happens
- If one of the products ingredients is such that
- It is of limited use
- The concentration is limited
- Is removed from the authorized list of ingredients that can be used for cosmetic products or is included in the prohibited list of ingredients for cosmetic products.
For any assistance with cosmetic regulatory affairs, import in Chile
Cosmetovigilance Requirements in Australia
Just like pharmacovigilance focuses on the side effects of medicines, cosmetovigilance deals with monitoring the safety of cosmetic products. It involves detecting, collecting, evaluating, and preventing any unwanted effects that may occur when cosmetics are used as intended. These reactions can range from mild allergies to, in rare cases, serious or life-threatening conditions. Below are the steps for reporting such adverse reactions.
- Visit ispch, then click on cosmetics.
- In the cosmetovigilance page that has shown up, click on the notification of adverse reaction to cosmetics.
- Next click on the Adverse Reaction Notification Form and fill out the form. Make sure to include the following details
- Name of the product
- ISP registration and batch number
- Details of the patient
- Adverse reaction description
- Onset time and other relevant details
- After completing the form send it to cosmetovigilancia@ispch.cl
Conclusion
Even though it might seem as cosmetic regulation is not as strong as pharmaceuticals, the regulatory side for each product is taken seriously by the authorities. For the authorities, everything relating to the safety, quality and effectiveness matters and will always be their top priority. So, they always look for better ways for improvement when coming to these areas. As a result, stringent regulations, testing requirements and other standards must be fulfilled to make a product entry.
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Artixio, with 20+ years of experience, is here to help you. Region specific advice from our regional experts along with product specific strategic solutions will guide you to a streamlined and expedited market entry of cosmetics. For any assistance with cosmetic regulatory support in Chile, please reach out to info@artixio.com
FAQ’s
Q. What is the Integrated Surveillance System (ISS) of Chile?
A. The ISS or integrated Surveillance System of the ISP of Chile is a single portal that allows for the monitoring of cosmetics. The healthcare professionals can report the adverse reactions of the cosmetic product electronically. It allows reporting the adverse effects from different users so that the ISP can evaluate adverse effects and thereby help prevent them.
Q. What is the GICONA System?
A. It stands for Information Management and National Coordination System. GICONA is an administrative system utilized by the ISP, Chile for managing the matters concerning cosmetics, pharmaceuticals and medical devices.
Q. Do I need to register my cosmetic product for exporting purposes?
A. Cosmetic products intended exclusively for export will not require to register their cosmetic products. The institute must be notified by the designated laboratories like the laboratories that are authorised for manufacture of hygiene or low-risk production products.
Q. When a “cruelty free” or “not tested on animals” logo cannot be used on cosmetics?
A. A “cruelty free” or “not tested on animals” logo on label or packaging cannot be used if:
1. The safety and efficacy details of the product, its ingredients or combination, are derived by testing it on animals after the law came into effect. It doesn’t matter if it was contracted by the manufacturer or by another producer within the production chain. 2. The manufacturer, to demonstrate the safety and efficacy of the product, has relied on the data or evidence obtained from tests as mentioned above.
