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Cosmetics filing

Shanghai Pudong New District Pilot Implementation of Importation of Non-Special Purpose Cosmetics

Since March 1, 2017, all imported non-special-purpose cosmetics imported from the port of Pudong New DistrictArea of Shanghai and registered in the Pudong New Area District of Shanghai have been readjusted from the current approval management to the record management. The domestic responsible person can submit relevant business activities after submitting the relevant materials to the record in accordance with the filing management requirements. After the products were filed, the supervision department found violations of laws and regulations and corrected or punished according to law. The pilot program is a system innovation based on product management methods without reducing the requirements for product safety supervision. It will adjust the focus of the supervision from approval to approval to strengthen post-event supervision.

Special-purpose cosmetics: Hair care, hair dyeing, perming, hair removal, beauty milk, body building, deodorant, freckle, sunscreen cosmetics
Non-special purpose cosmetics: products other than the above-mentioned special-purpose cosmetics
* special or non-special according to product efficacy , Non-product form (face mask, cream, gel, mousse, etc.)

First, the process

table of Contents project confirm
0 Early preparation (time determined by the customer, generally takes 2 days to 7 days)  
  Product Information Form/Company Business License, External Trader's Trade Record Form → Customer Provided OK
  Outer Packaging Auditing →Customer Provides HD Scanning Parts - Our Company's Audit Meets Chinese Advertising Law and Commodity Inspection Requirements  
  Formula auditing →Customer-supplied - Our company checks whether the raw material complies with the cosmetic specification (2015) / Cosmetics used raw materials list  
1 Authorized notarization (time determined by the customer, generally takes 3 days to 2 weeks)  
  Power of Attorney + Notarization + Embassy Certification → Our company provides template - Customer is ready as soon as possible  
  Domestic acceptance of authorization + official seal + original business license + original legal representative ID card → legal person needs to go in person, notarized and notarized  
2 Registration for registration (7 days)  
  User name registration application → Our company provides sample-signature and seal  
  certificate  
  Business license - customer provides, business license requires three words of cosmetics  
3 Sample testing (2 months)  
  Import non-special-purpose cosmetics filing application form → our company completed  
  Product name of the Chinese name is based on the name of the customer  
  Samples/Product samples→30 batches of commercial products  
4 Submit your license (3 days)  
  Product formula/formula list → Our company finished by our company  
  Product original packaging (including product label, product manual) picture → completed by our company  
  Product quality safety control requirements/product safety and quality control → Our company provides sample  
  Product production process description / production flow chart and brief → Our company provides sample  
  Production and sales certification documents (original) / The certificate of free sale (ORIGIN) → Customer provide / Our company checks each letter  
  Certification documents for production quality management of overseas manufacturing companies /copy of ISO certificate →Customer supply/ Our company checks each letter  
  Product technical requirements → prepared by our company  
  The inspection report and relevant materials issued by the cosmetics administrative license inspection agency → completed by our company  
  The relevant safety assessment data of safety risk substances may exist in the product → completed by our company  
  The raw materials and raw materials for cosmetics meet the requirements for the prohibition of high-risk substances in the mad cow disease epidemic area → completed by our company  
  Refer to the “Regulations for the Acceptance of Cosmetics Administrative Licensing Reports” for other information that may contribute to the filing.  

Second, the cost

Test items Hair supplies Skin Care Makeup products Finger (Toe) Supplies Aromatic products
General skin care products Eye-friendly skin care products General cosmetics Eye makeup products Lip protection and lip makeup products
microorganism Ο Ο Ο Ο Ο Ο Ο  
Lead, mercury, arsenic, cadmium Ο Ο Ο Ο Ο Ο Ο Ο
Dioxane                
Methanol               Ο
α-hydroxy acid, pH                
Antibiotics, metronidazole                
Anti-dandruff agent                
asbestos                
Acute skin irritation test Ο           Ο Ο
Eye irritation test Ο   Ο   Ο      
Multiple skin irritation tests   Ο Ο Ο Ο Ο    
Human trial                
Detection period (days) 60 60 60 60 60 60 60 60
Sample quantity (copies) 10 10 10 10 10 10 8 8
Cost (yuan) 7300 6300 8300 6300 8300 6300 5300 4500

All charges come from the relevant departments of the National Health Inspection and Quarantine. In addition to the company's agency service fees, all are paid to related departments. If the country adjusts fees, the company has the right to make corresponding adjustments.

The product containing the sum of ethanol and isopropanol content ≥10% needs to measure methanol, and measure methanol plus 1,000 yuan; the formula contains dioxane as a dangerous substance, and dioxane plus 1,000 yuan; the formula contains phenol, a dangerous substance, and phenol plus 1000. Yuan; formula containing acrylamide as a risk substance, measuring acrylamide plus 1,000 yuan; formula containing pesticide residue risk substances, measuring pesticide residues plus 2,000 yuan; and claiming dandruff products, measuring dandruff adding 1,000 yuan; Product, test plus 1,000 yuan; for products that claim to contain fruit acids or that do not contain fruit acids but have an acid content of ≥3%, add 1100 yuan for acid and PH; if the product contains UV absorber ≥0.5%, Adding UV absorbers, skin allergy tests and skin phototoxicity tests, plus 6,000 yuan.

If you need to identify the SPF value, you need to pay for the SPF value. The SPF value is calculated by the higher of the declared value and the measured value.

Third, data preparation

First, the production company needsproducers need to provide the following information:

Producers needs to provide the following information:

1. Product formula (including percentage content, purpose of use, mixed raw material should be written in the form of mixed components, and the proportion of each single component)

Product formula( Percentage of content,the mixed materials should be offered in mixed form, and, contain each unit's proportion.)

2. Finished product quality standard (signed and approved by relevant person in charge of Quality Criterion)

The product's quantity Criterion(the Quality Criterion should have the responsible person's signature.)

3. Samples for inspection (The quantity required for the inspection shall be determined according to the specifications of the product, and more than 30 ml requires 18 samples and the same batch number)

Product samples (the number of tests need to be based on product specifications, 30 ml need more than 18 samples)

4. Production and sales certification documents (CFS) issued by industry associations or official agencies of the country of origin (domestic commissioned foreign production does not require)

The local Industry Association or official agency issue the free sale certificate.

5, finished product production process and description

production flow chart and brief.

6, other materials that help review. (such as the certification of the quality specifications of some raw materials, the extraction process of plant raw materials, etc.)

Other information which is useful, such as formula's specifications proof、the plant material’s extraction process.

7, power of attorney and authorized signature.

Authorization and authorization signature book.

 

Commissioned processing:

OEM:

1. Original copy of the commission processing agreement between the entrusting party and the entrusted party

Offer the original commission processing agreement.

2. The entrusted party passes the certification documents of good production specifications such as ISO or GMP.

The commissioned party should offer their company's ISO or GMP, or other good manufacturing practice documents.