Thứ Hai, 30 tháng 5, 2016

Q&A ON COSMETICS REGULATIONS IN VIETNAM

There have been a number of questions arisen after the Webinar on Cosmetic Regulations in Vietnam on May 27th, 2015 and we would like to address those questions as following:

1. Has Vietnam fully implemented the ASEAN Harmonized Cosmetic Directive (ACD)? Yes. Vietnam authorities regularly issue official letters giving instructions and guidance to Department of Health of Cities and Provinces in Vietnam on the application of the decision of the ASEAN’s cosmetics committee. We are of opinion that Vietnam regulations are built toward complying with regulations in other ASEAN countries
2. Does Vietnam vary from the Regulation in any way(s)? Vietnam authorities regularly issue official letters giving instructions and guidance to Department of Health of Cities and Provinces in Vietnam on the application of the decision of the ASEAN’s cosmetics committee. We are of opinion that Vietnam regulations are built toward complying with regulations in other ASEAN countries
3. Does Vietnam require notification numbers on cosmetic packages?
No. The following contents must be presented on the label:
– The product’s name and function,
– The usage instruction,
– The full formula ingredients:
– The country where the product was made;
– The name and the address of organizations or individuals who are responsible for placing products on market (written fully in Vietnamese according to the business registration certificate or the investment license);
– Weight or volume,
– The manufacture lot number;
– The manufacture day or the expiry must be clearly presented (i.e.: day/month/year). The “expiry” or “the best using before date” can be exerted, if necessary, can add the instructed condition needs obey to make sure of the product’s stability.
– Warning about safety for usage;

4. Prior to exporting cosmetics to Vietnam, do we need to get a license or certificate for importing? If necessary, what are the requirements to obtain it? The party placing the products on the market need to do the product proclamation procedures.
5. As Vietnam is part of the ASEAN, electronic notification is therefore part of the cosmetics’ registration process. Nevertheless, a Free Sale Certificate can be still requested by the Vietnamese authorities. What is the reason of being for such a document? Mutual recognition has no more meaning in this kind of registration process.In the other hand, a Free Sale Certificate is a document provided to a responsible person (the person who place the product on the market), however some Vietnamese officials are expecting a Free Sale Certificate to be issued by the “made in” country’s authorities… what can be impossible in some cases, when the responsible person has no address in that typical country!
For the first problem, the competent agencies have not yet implemented the procedure of electronic notification.
For second problem, as per Chapter 1, Article 2, Clause 19: Certificate of free sale (CFS) is a certificate issued by an authority agency in the export country for the export domestics trader stated in CFS to confirms that the cosmetic is freely produced and sold in the export country. The export domestic trader may be manufacturers or other traders not manufacturer.
This CFS is mandatory.
For the procedure of proclamation, the organization, individual that is responsible for placing imported cosmetic product into Vietnam shall be organization, individual who registered for business in competent agency of Vietnam. They must present CFS to competent agency.

6. Can you tell us if this document is really mandatory and if so what should be its format for products manufactured abroad? Same as above
7. What activities will be taken during the post-market surveillance in Vietnam? By whom? Would they inspect some documents of the product? If yes, what documents?
Authority will be checking and inspecting the compliance of laws on the cosmetic production and the trading:
– The compliance of principles and standards of “cosmetic good manufacturing practice” of the Asian Southeast Association Nations (CGMP-ASEAN) or equivalence which are admitted by the ASEAN Cosmetic Association;
– The label writing;
– The Product Information File (PIF) regulated by the ASEAN;
– The cosmetic advertising.
Authority
– The Cosmetic Quality Checking Central agency is the Drug Administration department – the Ministry of Health;
– The local cosmetic quality-checking agency is the Health department of cities and provinces.
For documents of the product inspected:
As above mentioned, one of inspecting and checking contents is about Product Information File. The Product Information File involves of the following 04 parts:
– Part 1: Administrative documents and a summary of product;
– Part 2: Material quality;
– Part 3: Product quality;
– Part 4: Safety and efficiency.
Part 1 of the Product Information File must immediately be presented when required; others, if inefficiently, must be presented within 15-60 days since the consideration day in regard to the Functional agency’s request.

8. Will there be changes to the regulations in the coming months and what will these regulations be? As Vietnam is developing regulations to implement the ASEAN’s treaty, there could be changes that further align the Vietnam regulations with ASEAN’s regulations.
9. If so, are these strict regulations to discourage importation? There are no law that discourage of importation. The importer just has to follow the regulations at importation.
10. Free Sale Certificates have to be obtained from the country of manufacturer in Vietnamese regulations. The EU defines the ‘manufacturer’ as the Responsible Person who puts the product on to the open market, this means if the Responsible Person company is from the United Kingdom, the Free Sale Certificate should be issued by the United Kingdom’s health body. Why is there such a difference between the two regulations?
Obtaining country of origin FSC can be costly and time consuming; where as a UK Free Sale Certificate is free and quick. According to Vietnam regulations, “Certificate of free sale (CFS) is a certificate issued by an authority agency in the export country for the export trader.”
Besides, Vietnam also provides that CFS must be made on white paper, A4 size, in English and include minimum information as following:
a) Name of issuing authority;
b) Reference number of CFS;
c) Date of issuance;
d) Name of issued product, good;
đ) Type or group of issued product, good;
e) Name and address of manufacturer;
g) CFS must define clearly that product, good are manufactured and free to sell in market of exported state;
h) Full name, signature, position of person who issue the CFS and stamp of issuing authority.

11. What are the health bodies Vietnam’s authorities will accept for country of origin Free Sale Certificates in China and Thailand? (we don’t understand the question, please clarify)
Some countries Free Sale Certificates will not allow artwork names to be used, only a production name, can we use a Product Technical File to prove that the product is the same? Vietnam regulations do not have regulations or instructions on artwork names on CFS.
Besides, Vietnam also provides that CFS must be made on white paper, A4 size, in English and include minimum information as following:
a) Name of issuing authority;
b) Reference number of CFS;
c) Date of issuance;
d) Name of issued product, good;
đ) Type or group of issued product, good;
e) Name and address of manufacturer;
g) CFS must define clearly that product, good are manufactured and free to sell in market of exported state;
h) Full name, signature, position of person who issue the CFS and stamp of issuing authority.

12. If a product has an artwork name change, however, the product itself remains the same from when it was first registered (ingredients), can the previous Free Sale Certificate be used to register the product’s name change again? Vietnam regulations do not have regulations or instructions on artwork names on CFS.
Besides, Vietnam also provides that CFS must be made on white paper, A4 size, in English and include minimum information as following:
a) Name of issuing authority;
b) Reference number of CFS;
c) Date of issuance;
d) Name of issued product, good;
đ) Type or group of issued product, good;
e) Name and address of manufacturer;
g) CFS must define clearly that product, good are manufactured and free to sell in market of exported state;
h) Full name, signature, position of person who issue the CFS and stamp of issuing authority.

13. If a product is manufactured in Vietnam, the business wishing to sell the product in Vietnam buys the product, however due to logistics it has to be exported out to the UK, then sent back to Vietnam to sell, do we need to provide documents such as a Vietnam country of origin Free Sale Certificate? In our opinion, in this case CFS will be issued by country of export: UK. According to Vietnam regulations, CFS is a certified document issued in the export country (not country of manufacturer) to the export trader to confirm the product is allowed to be sold in such country.
14. Could you please precise if the banned/restricted/admitted ingredients in the Official Letter 6577/QLD are the same as the one published in the ASEAN Cosmetic directive? The content of ingredients provided in Official Letter 6577/QLD is based on recently updated regulations of ASEAN Cosmetic Committee.
15. How are hair dyes classified in Vietnam? Hair dyes are classified into hair care products according to Annex No. 01 of Circular 06/2011/TT-BYT
16. How long does it take to receive the registration certificate for cosmetics in Vietnam? Within 03 working days since receiving the regular dossier and fee as provided.
17. What are the specificities for cosmetic product regulation in Vietnam in comparison to ASEAN Cosmetic Directive? No specificities for cosmetic product regulation in Vietnam in comparison to ACD. Vietnam authorities regularly issue official letters giving instructions and guidance to Department of Health of Cities and Provinces in Vietnam on the application of the decision of the ASEAN’s cosmetics committee. We are of opinion that Vietnam regulations are built toward complying with regulations in other ASEAN countries.

18. Are there claims allowed in other ASEAN countries that are not allowed in Vietnam? Vietnam authorities regularly issue official letters giving instructions and guidance to Department of Health of Cities and Provinces in Vietnam on the application of the decision of the ASEAN’s cosmetics committee. We are of opinion that Vietnam regulations are built toward complying with regulations in other ASEAN countries.
19. Is Free Sale Certificate required? Yes, CFS is required for application of product proclamation in Vietnam.
20. If our company wants to send some samples to customers in Vietnam, do we have to apply for a proclamation or is there an exemption? There are cases which cosmetics sample imported into Vietnam are exempted from proclamation which are categorized under following purposes: research, gift, and display at fair/exhibition. However other procedures might be applicable depending on the specific cases.
21. What about safety data based on alternatives to animal testing? Are they recognised by the Vietnam authorities or do we need to do it the regular way?

22. I wanted to clarify a question and answer that was raised during the Vietnam Cosmetics Regulation webinar. It is in regards to Free Sale Certificates (FSC) and where they should come from.
Currently we are obtaining country of origin FSC for our products where they were manufactured. As an example, if a product was made in Poland, we would obtain a Polish FSC, for our franchise business to register in Vietnam to sell.
During the webinar there was discussion of the FSC coming from the ‘export trader’ or the responsible person. As Marks and Spencer is the responsible person in the United Kingdom, and the products are shipped from the United Kingdom to our franchise business under a different name ‘Central Retail Group’ in Vietnam, would a United Kingdom FSC be accepted by the Vietnamese authorities?

Country of origin FSC from Poland, China and Thailand can be quite expensive and take a long time to obtain, however, a United Kingdom FSC is free of charge and easier to obtain.
According to Vietnam regulations, “Certificate of free sale (CFS) is a certificate issued by an authority agency in the export country for the export trader.”
Besides, Vietnam also provides that CFS must be made on white paper, A4 size, in English and include minimum information as following:
a) Name of issuing authority;
b) Reference number of CFS;
c) Date of issuance;
d) Name of issued product, good;
đ) Type or group of issued product, good;
e) Name and address of manufacturer;
g) CFS must define clearly that product, good are manufactured and free to sell in market of exported state;
h) Full name, signature, position of person who issue the CFS and stamp of authority.

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