Imported Cosmetics Registration

Understanding China Regulation for Imported CosmeticsBefore customs clearance and free sales in China, all imported cosmetics must be approved by CFDA (China Food and Drug Administration).In China, according to "Cosmetics Health Supervision Regulations", cosmetics are daily used chemical products applied on the surface of any part of the human body surface (skin, hair, nails and lips etc.) by way of smearing, spraying or other similar methods to keep the body clean, to get rid of undesirable smell, to protect the skin, to make up the face and to increase the beauty of the appearance.According to this definition, mouthwash, toothpaste etc. are not cosmetics.It is remarkable that actually toothpaste is regarded as cosmetics now in China, but approval from CFDA is not needed. For solid soap which belongs to cosmetics, approval from CFDA is generally not needed either.In China, cosmetics are classified into two types and managed as such: Special use cosmetics (special cosmetics) and non-special use cosmetics (non-special cosmetics, normal cosmetics). Special cosmetics refer to cosmetics used for hair nourishment, hair-dye, hair perm, hair removing, breast massage, body building, deodorization, speckle removal (including whitening products) and anti-sunburn. The other cosmetics belong to non-special cosmetics.In the draft "Cosmetics Health Supervision Regulations" (revision version), definition of cosmetics are defined as 'products that are applied to human body surface (skin, hair, nails and lips etc.), tooth and oral mucosa for the purpose of cleaning, protecting, beautifying, modifying and keeping them in good conditions'; special cosmetics refer to hair-dye, hair perm, whitening, antisunburn cosmetics, and other cosmetics products which CFDA considers necessary to manage as special cosmetics.Currently, imported cosmetics shall be evaluated and approved by China Central FDA (CFDA) --- Imported Cosmetics Registration, which can be called as Cosmetics registration in CFDA, China domestic special cosmetics shall also be evaluated and approved by CFDA, but China domestic non-special cosmetics are evaluated by China local FDA (L-FDA) --- it can be called as Cosmetics registration in China FDA.Registration formality of special cosmetics and imported non-special cosmetics is very similar. The major difference is the difference on test items.Notification of China domestic non-special cosmetics is called 'Record Notification': in principle, L-FDA is not responsible for quality evaluation of notification dossier, the notification to L-FDA is for formality check to see whether required documents are missed and whether there are critical or obvious incompliance.It is planed that evaluation of imported non-special cosmetics be transferred to China local FDA.The chart bellows illustrates relation of different cosmetics.The registrant of cosmetics shall be the cosmetics manufacturer. For tolling manufacturing, if the last production step of contacting cosmetics content is inside China, then the cosmetics belong to China domestic cosmetics. If the last step is outside China, then the cosmetics belong to imported cosmetics.Overseas manufacturer cosmetics shall appoint a China local company as its representative responsible for the cosmetics registration in China.Approval of cosmetic evaluated and approved by CFDA is valid for 4 years. Extension of the approval shall be applied four months before the expiry date.Some tests shall be performed for registration of cosmetics, including microbiology test, sanitary chemistry and toxicology test. Animal tests (e.g. eye irritation test, as part of toxicology test) by accredited Chinese labs are mandatory for registration of special use cosmetics (imported or China domestic). Animal tests for by accredited Chinese labs for registration of imported non-special use cosmetics currently is still mandatory, although tests for China domestic non-special use cosmetics are already optional.According to Randis experience, the registration of imported non-special use cosmetics takes 4-6 months and the registration of special use cosmetics takes approximately 8-12 months. The registration time includes two parts, one is sample test by accredited labs, one is for CFDA evaluation and approval.The necessary fee of cosmetics registration includes fee for lab tests, fee for notarizations (appointment of China Representative, free sales certificate, GMP or ISO certification, etc.) fee and other fees e.g. translation fee. The amount of sample test fee vary on cosmetics types and cosmetics ingredients. Test items of different types of cosmetics maybe different (table below as example). Specifically, some tests on human body could be needed for some special use cosmetics, for example human skin patch test for speckle removal cosmetics.  Some special ingredients requires extra tests. For example, the ingredient phenoxyethanol require to detect the concentration of phenol and dioxane in cosmetics. Test Items for Non-special Use CosmeticsTest ItemsHair Use ProductsSkin Care productsMake-up ProductsNail ProductsPerfumeGeneral Skin ProductsAccessible Eye Skin CareRinse-off Clean productsLeave-on Clean productsGeneral Make-up ProductsMake-up Products for EyeMake-up Products for LipNail PolishNail Varnish RemoverMicroorganism√√√√√√√√√　√Lead, Mercury, Arsenic√√√√√√√√√√√Methanol　　　　　　　　　　√Acute Skin Irritation√　√　　　　√√Acute Eye Irritation√√√√　√　　　　Repeated skin irritation　√√　√√√√　　　Test Items for Special Use CosmeticsTest Itemshair nourishmentbody buildinghair-dyehair permanti-sunburndeodorizationspeckle removalhair removingMicroorganism√√√√Lead, Mercury, Arsenic√√√√√√√√Chlormethine,Cantharidin√Oxidation Hair Dye√Thioglycolic Acid√√Hormone√√Methanal√Phenol, Hydroquinone√Suncream Agent√pH√√√Acute Eye Irritation√√√Acute Skin Irritation√Repeated Skin irritation√√√√√Skin Sensitisation Test√√√√√√√√Skin Phototoxicity Test√√√Salmonella Typhimurium/Reverse Mutation Assay√√√In Vitro Mammalian Cells Chromosome Aberration Test√√√Tests of Cosmetics on Human Body√√√√√√√√