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FDA Registration – Cosmetics 化妆品注册

美国食品和药物管理局要求境内外所有在美生产, 包装或销售的企业, 都要进行自主申报注册。此外, 企业也可以将产品的成分配方信息在FDA进行备案。

产品注册备案：

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企业注册备案：

美国加州第2762号众议院法案（化妆品安全）

对《健康与安全法规（Health and Safety Code)》进行修订

24种化学成分被禁用

根据化妆品成分禁令，从2025年1月1日起，制造商和零售商将不能再制造或销售含有以下微量元素的化妆品：邻苯二甲酸二丁酯（DBP）、邻苯二甲酸二己酯（DEHP）、甲醛、多聚甲醛、二甲二醇、四元数-15、汞、尼泊金异丁酯、尼泊金异丙酯、间苯二胺及其盐类、邻苯二胺及其盐类、以及十三种长链单氟和多氟烷基物质（PFASs）及其盐类。

什么是化妆品：

FDA 将化妆品定义为旨在用于人体清洁、美化、提高吸引力或改变外观的产品（不包括纯肥皂）。提供进口到美国的化妆品必须遵守与在美国国内生产的相同的 FDA 法律和法规。
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进口时会验证哪些化妆品要求：
FDA 进行现场检查并收集化妆品样品，以验证产品和成分是否适合并安全地用于其预期用途（例如，眼影中的颜色添加剂已获准在眼睛周围使用）。

如果化妆品含有需要认证的颜色添加剂，FDA 将验证颜色识别码 (CIN)。

如果化妆品企业自愿注册并提供注册号，则将进行验证。

FDA 如何验证是否符合化妆品要求：
FDA入境审查员经过培训，使用进口商入境传输中提供给FDA的信息来验证是否符合化妆品要求，例如：

声明制造商
申报进口商/收货人
产品描述
合规性确认（A of C）
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这些入境声明与FDA内部数据系统中的信息进行比较。提交正确和准确的输入数据以及相关的A of C代码将有助于加快输入审查过程。准确提供这些信息增加了货物以电子方式处理而不是人工审查的可能性，因为FDA的筛选工具PREDICT可以根据FDA的内部数据系统验证声明的信息。

化妆品标签：
对产品标签和/或标签进行审查，以确保所需信息存在并正确声明，信息丰富且真实，并且是英语（或波多黎各的西班牙语）。此外，如果标签和/或标签包括治疗或预防疾病或以其他方式影响身体结构或任何功能的声明，则可能导致该产品被视为药物。
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颜色添加剂：
只有当FDA批准这些添加剂用于预期用途时，才允许在化妆品中使用颜色添加剂。如果化妆品含有色素添加剂，则必须遵守FDA的批准，认证，身份和规范以及使用和限制的法律和要求。FDA将批准的颜色添加剂分为两类：需要认证的颜色和不需要认证的颜色。对于需要认证的颜色添加剂，FDA将在进口时验证颜色识别号（CIN）。

自愿化妆品注册计划：
FDA 的自愿化妆品注册计划Voluntary Cosmetic Registration Program (VCRP) 是一个报告系统，供在美国进行商业分销的化妆品制造商、包装商和分销商使用。 VCRP 向 FDA 提供有关化妆品和成分、使用频率以及参与其制造和分销的公司的信息，以评估市场上的化妆品。

化妆品合规规范的确认：
合规代码的确认（A of C）是在进口时可以提供的三个字母代码，以方便FDA审查。化妆品不强制要求提交A of C代码，但是，自愿提交A of C代码可能会加快对入境产品的初步筛选和审查。

如果您不确定某个产品是化妆品还是药品，珩渥检测将会对你的产品进行评估鉴定，并提供全方面服务，让您的产品更快通过FDA的法规进入美国市场。

如何确定化妆品是否列在进口警报中：
FDA 提供了按行业划分的进口警报清单。以下为进口化妆品警报清单

Import Alert Number	Import Alert Type	Publish Date	Import Alert Name
17-04	DWPE	12/10/2020	"Detention Without Physical Examination Bulk Shipments of High-Risk Bovine Tissue from BSE-Countries--Bovine Spongiform Encephalopathy"
45-02	DWPE	08/04/2022	"Detention Without Physical Examination and Guidance of Foods Containing Illegal and/or Undeclared Colors."
53-04	DWPE	10/29/2021	"Detention Without Physical Examination of Eyelash and Eyebrow Dyes Containing Coal-Tar"
53-06	DWPE	08/03/2022	"Detention Without Physical Examination Of Cosmetics That are Adulterated and/or Misbranded Due to Color Additive Violations"
53-10	DWPE	12/10/2020	"Detention Without Physical Examination of Cosmetic Products Containing Methylene Chloride as an Ingredient"
53-16	DWPE	12/10/2020	"Detention Without Physical Examination of Rio Hair Naturalizer"
53-17	DWPE	06/13/2022	"Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination"
53-18	DWPE	06/08/2022	"Detention Without Physical Examination of Skin Whitening Creams Containing Mercury"
53-19	DWPE	06/21/2022	"Detention Without Physical Examination of Henna Based Skin Color"
54-15	DWPE	07/27/2022	DETENTION WITHOUT PHYSICAL EXAMINATION OF DIETARY SUPPLEMENTS AND BULK DIETARY INGREDIENTS THAT ARE OR CONTAIN MITRAGYNA SPECIOSA OR KRATOM
66-40	DWPE	08/04/2022	"Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs"
66-41	DWPE	08/01/2022	Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
66-66	DWPE	07/19/2022	"APIs That Appear To Be Misbranded Under 502(f)(1) Because They Do Not Meet The Requirements For The Labeling Exemptions In 21 CFR 201.122"
66-74	DWPE	07/18/2022	"Detention Without Physical Examination Of Dentifrice Products Containing Diethylene Glycol(DEG)"
66-78	DWPE	05/26/2022	"Detention Without Physical Examination of Drugs, Based Upon Analytic Test Results"
66-79	DWPE	07/12/2022	"Detention Without Physical Examination of Drugs From Foreign Establishments Refusing FDA Inspection"
68-19	DWPE	08/03/2022	"DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS"
89-04	DWPE	06/27/2022	"Detention Without Physical Examination of Devices from Firms that Have not met Device Quality System Requirements"
89-08	DWPE	08/04/2022	"Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
99-19	DWPE	08/03/2022	"Detention Without Physical Examination Of Food Products Due To The Presence Of Salmonella"
99-32	DWPE	12/06/2021	"DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS FROM FOREIGN ESTABLISHMENTS REFUSING FDA INSPECTION"
99-34	DWPE	07/22/2022	DETENTION WITHOUT PHYSICAL EXAMINATION OF DRUGS OR MEDICAL DEVICES FROM FIRMS WITHOUT A VALID DRUG OR MEDICAL DEVICE REGISTRATION
99-39	DWPE	08/04/2022	Detention Without Physical Examination of Imported Food Products appear To Be Misbranded

已经被FDA允许的化妆品添加剂清单

Common name	Botanical name of plant source
Alfalfa herb and seed	Medicago sativa L.
Allspice	Pimenta officinalis Lindl.
Ambrette seed	Hibiscus abelmoschus L.
Angelica	Angelica archangelica L. or other spp. of Angelica.
Angelica root	Do.
Angelica seed	Do.
Angostura (cusparia bark)	Galipea officinalis Hancock.
Anise	Pimpinella anisum L.
Anise, star	Illicium verum Hook. f.
Balm (lemon balm)	Melissa officinalis L.
Basil, bush	Ocimum minimum L.
Basil, sweet	Ocimum basilicum L.
Bay	Laurus nobilis L.
Calendula	Calendula officinalis L.
Camomile (chamomile), English or Roman	Anthemis nobilis L.
Camomile (chamomile), German or Hungarian	Matricaria chamomilla L.
Capers	Capparis spinosa L.
Capsicum	Capsicum frutescens L. or Capsicum annuum L.
Caraway	Carum carvi L.
Caraway, black (black cumin)	Nigella sativa L.
Cardamom (cardamon)	Elettaria cardamomum Maton.
Cassia, Chinese	Cinnamomum cassia Blume.
Cassia, Padang or Batavia	Cinnamomum burmanni Blume.
Cassia, Saigon	Cinnamomum loureirii Nees.
Cayenne pepper	Capsicum frutescens L. or Capsicum annuum L.
Celery seed	Apium graveolens L.
Chervil	Anthriscus cerefolium (L.) Hoffm.
Chives	Allium schoenoprasum L.
Cinnamon, Ceylon	Cinnamomum zeylanicum Nees.
Cinnamon, Chinese	Cinnamomum cassia Blume.
Cinnamon, Saigon	Cinnamomum loureirii Nees.
Clary (clary sage)	Salvia sclarea L.
Clover	Trifolium spp.
Coriander	Coriandrum sativum L.
Cumin (cummin)	Cuminum cyminum L.
Cumin, black (black caraway)	Nigella sativa L.
Elder flowers	Sambucus canadensis L.
Fennel, common	Foeniculum vulgare Mill.
Fennel, sweet (finocchio, Florence fennel)	Foeniculum vulgare Mill. var. duice (DC.) Alex.
Fenugreek	Trigonella foenum-graecum L.
Galanga (galangal)	Alpinia officinarum Hance.
Geranium	Pelargonium spp.
Ginger	Zingiber officinale Rosc.
Grains of paradise	Amomum melegueta Rosc.
Horehound (hoarhound)	Marrubium vulgare L.
Horseradish	Armoracia lapathifolia Gilib.
Hyssop	Hyssopus officinalis L.
Lavender	Lavandula officinalis Chaix.
Linden flowers	Tilia spp.
Mace	Myristica fragrans Houtt.
Marigold, pot	Calendula officinalis L.
Marjoram, pot	Majorana onites (L.) Benth.
Marjoram, sweet	Majorana hortensis Moench.
Mustard, black or brown	Brassica nigra (L.) Koch.
Mustard, brown	Brassica juncea (L.) Coss.
Mustard, white or yellow	Brassica hirta Moench.
Nutmeg	Myristica fragrans Houtt.
Oregano (oreganum, Mexican oregano, Mexican sage, origan)	Lippia spp.
Paprika	Capsicum annuum L.
Parsley	Petroselinum crispum (Mill.) Mansf.
Pepper, black	Piper nigrum L.
Pepper, cayenne	Capsicum frutescens L. or Capsicum annuum L.
Pepper, red	Do.
Pepper, white	Piper nigrum L.
Peppermint	Mentha piperita L.
Poppy seed	Papayer somniferum L.
Pot marigold	Calendula officinalis L.
Pot marjoram	Majorana onites (L.) Benth.
Rosemary	Rosmarinus officinalis L.
Saffron	Crocus sativus L.
Sage	Salvia officinalis L.
Sage, Greek	Salvia triloba L.
Savory, summer	Satureia hortensis L. (Satureja).
Savory, winter	Satureia montana L. (Satureja).
Sesame	Sesamum indicum L.
Spearmint	Mentha spicata L.
Star anise	Illicium verum Hook. f.
Tarragon	Artemisia dracunculus L.
Thyme	Thymus vulgaris L.
Thyme, wild or creeping	Thymus serpyllum L.
Turmeric	Curcuma longa L.
Vanilla	Vanilla planifolia Andr. or Vanilla tahitensis J. W. Moore.
Zedoary	Curcuma zedoaria Rosc.

[42 FR 14640, Mar. 15, 1977, as amended at 43 FR 3705, Jan. 27, 1978; 44 FR 3963, Jan. 19, 1979; 50 FR 21044, May 22, 1985; 61 FR 14246, Apr. 1, 1996]

§182.20 Essential oils, oleoresins (solvent-free), and natural extractives (including distillates).

Essential oils, oleoresins (solvent-free), and natural extractives (including distillates) that are generally recognized as safe for their intended use, within the meaning of section 409 of the Act, are as follows:

Common name	Botanical name of plant source
Alfalfa	Medicago sativa L.
Allspice	Pimenta officinalis Lindl.
Almond, bitter (free from prussic acid)	Prunus amygdalus Batsch, Prunus armeniaca L., or Prunus persica (L.) Batsch.
Ambrette (seed)	Hibiscus moschatus Moench.
Angelica root	Angelica archangelica L.
Angelica seed	Do.
Angelica stem	Do.
Angostura (cusparia bark)	Galipea officinalis Hancock.
Anise	Pimpinella anisum L.
Asafetida	Ferula assa-foetida L. and related spp. of Ferula.
Balm (lemon balm)	Melissa officinalis L.
Balsam of Peru	Myroxylon pereirae Klotzsch.
Basil	Ocimum basilicum L.
Bay leaves	Laurus nobilis L.
Bay (myrcia oil)	Pimenta racemosa (Mill.) J. W. Moore.
Bergamot (bergamot orange)	Citrus aurantium L. subsp. bergamia Wright et Arn.
Bitter almond (free from prussic acid)	Prunus amygdalus Batsch, Prunus armeniaca L., or Prunus persica (L.) Batsch.
Bois de rose	Aniba rosaeodora Ducke.
Cacao	Theobroma cacao L.
Camomile (chamomile) flowers, Hungarian	Matricaria chamomilla L.
Camomile (chamomile) flowers, Roman or English	Anthemis nobilis L.
Cananga	Cananga odorata Hook. f. and Thoms.
Capsicum	Capsicum frutescens L. and Capsicum annuum L.
Caraway	Carum carvi L.
Cardamom seed (cardamon)	Elettaria cardamomum Maton.
Carob bean	Ceratonia siliqua L.
Carrot	Daucus carota L.
Cascarilla bark	Croton eluteria Benn.
Cassia bark, Chinese	Cinnamomum cassia Blume.
Cassia bark, Padang or Batavia	Cinnamomum burmanni Blume.
Cassia bark, Saigon	Cinnamomum loureirii Nees.
Celery seed	Apium graveolens L.
Cherry, wild, bark	Prunus serotina Ehrh.
Chervil	Anthriscus cerefolium (L.) Hoffm.
Chicory	Cichorium intybus L.
Cinnamon bark, Ceylon	Cinnamomum zeylanicum Nees.
Cinnamon bark, Chinese	Cinnamomum cassia Blume.
Cinnamon bark, Saigon	Cinnamomum loureirii Nees.
Cinnamon leaf, Ceylon	Cinnamomum zeylanicum Nees.
Cinnamon leaf, Chinese	Cinnamomum cassia Blume.
Cinnamon leaf, Saigon	Cinnamomum loureirii Nees.
Citronella	Cymbopogon nardus Rendle.
Citrus peels	Citrus spp.
Clary (clary sage)	Salvia sclarea L.
Clover	Trifolium spp.
Coca (decocainized)	Erythroxylum coca Lam. and other spp. of Erythroxylum.
Coffee	Coffea spp.
Cola nut	Cola acuminata Schott and Endl., and other spp. of Cola.
Coriander	Coriandrum sativum L.
Cumin (cummin)	Cuminum cyminum L.
Curacao orange peel (orange, bitter peel)	Citrus aurantium L.
Cusparia bark	Galipea officinalis Hancock.
Dandelion	Taraxacum officinale Weber and T. laevigatum DC.
Dandelion root	Do.
Dog grass (quackgrass, triticum)	Agropyron repens (L.) Beauv.
Elder flowers	Sambucus canadensis L. and S. nigra I.
Estragole (esdragol, esdragon, tarragon)	Artemisia dracunculus L.
Estragon (tarragon)	Do.
Fennel, sweet	Foeniculum vulgare Mill.
Fenugreek	Trigonella foenum-graecum L.
Galanga (galangal)	Alpinia officinarum Hance.
Geranium	Pelargonium spp.
Geranium, East Indian	Cymbopogon martini Stapf.
Geranium, rose	Pelargonium graveolens L'Her.
Ginger	Zingiber officinale Rosc.
Grapefruit	Citrus paradisi Macf.
Guava	Psidium spp.
Hickory bark	Carya spp.
Horehound (hoarhound)	Marrubium vulgare L.
Hops	Humulus lupulus L.
Horsemint	Monarda punctata L.
Hyssop	Hyssopus officinalis L.
Immortelle	Helichrysum augustifolium DC.
Jasmine	Jasminum officinale L. and other spp. of Jasminum.
Juniper (berries)	Juniperus communis L.
Kola nut	Cola acuminata Schott and Endl., and other spp. of Cola.
Laurel berries	Laurus nobilis L.
Laurel leaves	Laurus spp.
Lavender	Lavandula officinalis Chaix.
Lavender, spike	Lavandula latifolia Vill.
Lavandin	Hybrids between Lavandula officinalis Chaix and Lavandula latifolin Vill.
Lemon	Citrus limon (L.) Burm. f.
Lemon balm (see balm)
Lemon grass	Cymbopogon citratus DC. and Cymbopogon lexuosus Stapf.
Lemon peel	Citrus limon (L.) Burm. f.
Lime	Citrus aurantifolia Swingle.
Linden flowers	Tilia spp.
Locust bean	Ceratonia siliqua L,
Lupulin	Humulus lupulus L.
Mace	Myristica fragrans Houtt.
Mandarin	Citrus reticulata Blanco.
Marjoram, sweet	Majorana hortensis Moench.
Maté	Ilex paraguariensis St. Hil.
Melissa (see balm)
Menthol	Mentha spp.
Menthyl acetate	Do.
Molasses (extract)	Saccarum officinarum L.
Mustard	Brassica spp.
Naringin	Citrus paradisi Macf.
Neroli, bigarade	Citrus aurantium L.
Nutmeg	Myristica fragrans Houtt.
Onion	Allium cepa L.
Orange, bitter, flowers	Citrus aurantium L.
Orange, bitter, peel	Do.
Orange leaf	Citrus sinensis (L.) Osbeck.
Orange, sweet	Do.
Orange, sweet, flowers	Do.
Orange, sweet, peel	Do.
Origanum	Origanum spp.
Palmarosa	Cymbopogon martini Stapf.
Paprika	Capsicum annuum L.
Parsley	Petroselinum crispum (Mill.) Mansf.
Pepper, black	Piper nigrum L.
Pepper, white	Do.
Peppermint	Mentha piperita L.
Peruvian balsam	Myroxylon pereirae Klotzsch.
Petitgrain	Citrus aurantium L.
Petitgrain lemon	Citrus limon (L.) Burm. f.
Petitgrain mandarin or tangerine	Citrus reticulata Blanco.
Pimenta	Pimenta officinalis Lindl.
Pimenta leaf	Pimenta officinalis Lindl.
Pipsissewa leaves	Chimaphila umbellata Nutt.
Pomegranate	Punica granatum L.
Prickly ash bark	Xanthoxylum (or Zanthoxylum) Americanum Mill. or Xanthoxylum clava-herculis L.
Rose absolute	Rosa alba L., Rosa centifolia L., Rosa damascena Mill., Rosa gallica L., and vars. of these spp.
Rose (otto of roses, attar of roses)	Do.
Rose buds	Do.
Rose flowers	Do.
Rose fruit (hips)	Do.
Rose geranium	Pelargonium graveolens L'Her.
Rose leaves	Rosa spp.
Rosemary	Rosmarinus officinalis L.
Saffron	Crocus sativus L.
Sage	Salvia officinalis L.
Sage, Greek	Salvia triloba L.
Sage, Spanish	Salvia lavandulaefolia Vahl.
St. John's bread	Ceratonia siliqua L.
Savory, summer	Satureia hortensis L.
Savory, winter	Satureia montana L.
Schinus molle	Schinus molle L.
Sloe berries (blackthorn berries)	Prunus spinosa L.
Spearmint	Mentha spicata L.
Spike lavender	Lavandula latifolia Vill.
Tamarind	Tamarindus indica L.
Tangerine	Citrus reticulata Blanco.
Tarragon	Artemisia dracunculus L.
Tea	Thea sinensis L.
Thyme	Thymus vulgaris L. and Thymus zygis var. gracilis Boiss.
Thyme, white	Do.
Thyme, wild or creeping	Thymus serpyllum L.
Triticum (see dog grass)
Tuberose	Polianthes tuberosa L.
Turmeric	Curcuma longa L.
Vanilla	Vanilla planifolia Andr. or Vanilla tahitensis J. W. Moore.
Violet flowers	Viola odorata L.
Violet leaves	Do.
Violet leaves absolute	Do.
Wild cherry bark	Prunus serotina Ehrh.
Ylang-ylang	Cananga odorata Hook. f. and Thoms.
Zedoary bark	Curcuma zedoaria Rosc.

Sample for reference 参考图片:

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FDA Registration – Cosmetics 化妆品注册

§182.20 Essential oils, oleoresins (solvent-free), and natural extractives (including distillates).