Is it enough to prepare all the necessary documents?However,80% of mouthwash importers fail to meet the hidden requirements of ingredient review.Last week,a client engaged in cross-border cosmetics business contacted me,saying that a batch of mouthwash produced in the European Union was detained at Shanghai Port because the added amount of "chlorhexidine" did not comply with Chinese regulations.The "Safety Technical Specifications".He repeatedly emphasized that "the bill of lading,certificate of origin,and health certificate are all in place",but he completely failed to realize that as a sub-category of "oral hygiene cosmetics",the review standards for the ingredient list of mouthwash are three times stricter than those for ordinary skincare products.Even if the concentration of "chlorhexidine" exceeds the standard by 0.05%,the entire batch of goods will be deemed "exceeding the ingredient standard",resulting in the return of the entire shipment.

The two underlying logics of mouthwash imports: Why are ingredients more crucial than regulatory documents?

The core conflict in the import of mouthwash lies in the information gap between "product attributes" and "regulatory requirements".

1.Classifying and qualifying are prerequisites: According to the "Cosmetics Classification Rules and Classification Catalogue",mouthwashes with the functions of "antibacterial,anti-moth,and anti-dental plaque" are classified as "special-purpose cosmetics",and applicants must obtain a "Special Cosmetics Certificate" (which takes 6-12 months to process); while ordinary cleansing mouthwashes are classified as "ordinary cosmetics",and applicants only need to file for recordation (which takes 1-3 months).Many importers skip this step and declare the products as "ordinary goods",only to have their shipments detained and face the requirement to obtain the necessary certificates.

2.Ingredient review is a red line: The ingredients of mouthwash must comply with both the "Technical Specifications for Cosmetic Safety (2015 Edition)" and the "General Technical Requirements for Oral Hygiene Care Products (GB 22115-2008)",such as chlorhexidine ≤ 0.2%,fluoride ≤ 0.15% (calculated as fluoride),and cetrimonium chloride ≤ 0.05%.These "numerical thresholds" are the red lines for customs clearance and there is no room for negotiation.

MouthwashFull Process SOP: Five Key Steps from Pre-Audit of Ingredients to Customs Clearance

Step 1: Conduct "Product Classification and Characterization" first to avoid wrong approval paths

Output:

• Checkthe"ClassificationRulesandCatalogofCosmetics(2021Edition)":Iftheproductclaimsto"antibacterial,anti-moth,andanti-dentalplaque",itbelongstoSpecial-purposecosmeticsToselloralcareproducts,itisnecessarytoapplyfora"SpecialCosmeticsLicense".Iftheproductisonlyadvertisedas"oralcleansing",itisclassifiedasOrdinarycosmeticsDothe"filingcertificate".

Step 2: Pre-audit of ingredients — Use "third-party reports" to eliminate loopholes in customs clearance

Output:

• WhenlookingforAtestinginstitutionaccreditedbyCNASorCMA,issuing2corereports:

① "Cosmetics Ingredient Testing Report": Test the actual content of restricted ingredients such as chlorhexidine,fluoride,and cetrimonium chloride;

② "Cosmetic Ingredient Safety Assessment Report": It proves that the ingredients comply with the requirements of Chinese regulations.

Step 3: Prepare core documents—don’t miss the "Evidence for Efficacy Claims"

Output:

• Basicdocuments:Billoflading,commercialinvoice,packinglist,certificateoforigin(subjecttonotarization),andhealthcertificate(issuedbytheEUorUSauthorities).
• SpecialDocuments:Approvalnumberforspecial-purposecosmetics(orordinarycosmeticfilingcertificate),ingredienttestreport,andingredientsafetyassessmentreport;
• Supplementarydocuments:Iftheproductclaimstobe"moth-proof"or"anti-allergic",themanufacturermustprovidecorrespondingevidencetosupporttheseclaims.Effectivenessclaimsbasedon(e.g.clinicaltrialreportsorauthoritativeliterature).

Step 4: "Real-time Communication" in Customs Declaration - Avoid Cargo Detention Due to Information Gaps

Output:

• Confirmwiththecustomsdeclarationagencyinadvance:theHScodeofthemouthwash(itisrecommendedtouse3306900090,"Otheroralcleaningproducts"),toavoidclassificationerrors;
• Whengoingthroughcustomsclearance,ifthecustomsrequiresa"reinspectionofingredients",immediatelyasktheinspectionagencytoissuea"supplementaryexplanationletter"(whichneedstobestamped)andsubmititwithinoneworkingdaytoavoidthegoodsbeingdetainedforalongtime.

Don’t ignore "Reverse Verification of Label Filing"—hidden bombs that explode after clearance

Many importers think that "everything is fine after customs clearance",but the most tragic case I’ve ever encountered was this: A company that had completed customs clearance three months earlier was notified by the customs that their labels were "non-compliant" - the reason was that the label stated "fluoride content 0.1%",but the actual test report showed 0.12%.Even with a mere 0.02% difference,the company was deemed to have "made false labeling declarations",and was required to recall the entire batch of goods and pay a fine of 200,000 yuan.

Key Reminder:When designing labels,it is necessary to let the inspection agencies verify the "ingredient order" and "content marking".For example,if "Chlorhexidine" is listed as the fifth ingredient in the ingredient list,it must also be listed as the fifth ingredient on the label.The "fluoride content" indicated on the label must be exactly the same as that in the test report,with an error margin of no more than 0.01%.

3 things you can do this afternoon—nip the risk in the bud

• 1.Pullouttheingredientlistsofthelast3batchesofmouthwashandcheckifthecontentofchlorhexidineandfluoridecomplieswithGB22115-2008;
• 2.Contactthecustomsbrokerandrequestachecklistoftheimportdeclarationdocumentsformouthwash.Then,compareyouractualdocumentswiththechecklisttoidentifyandrectifyanyomissionsorinaccuracies.
• 3.FindtwoCNAS-accreditedtestinginstitutionsandinquireabouttheprocessingperiod(usually5-7workingdays)andcost(about2000-5000yuanperreport)ofthe"IngredientSafetyAssessmentReport".