Product Compliance
Test/Filing/Registration
Recently, a piece of official information on ordinary cosmetics suspected of special-use cosmetics, caused a hot discussion among the industry.
According to the opinion of the review department, there are ordinary cosmetics added with phenethyldiphenylene catechol (commonly known as 377 in the industry), while the copywriting declared "brightening and snow-white skin" etc., which is suspected of special-use cosmetics for whitening.
Recently, the food and drug administration has ordered spot check the filing data of the new platform. It is very concerned about ordinary cosmetics containing whitening ingredients such as phenethyl resorcinol (commonly known as 377 in the industry) and claiming brightening and snow-white skin. The product is suspected special-use cosmetics for whitening. The filing applicant shall strictly check the filing materials, prohibit excessive use of restricted or permitted raw materials, and prohibit illegal claims and exaggerated publicity.
Reference : Announcement of The NMPA on the Approval of 4-(1-phenylethyl)-1, 3-resorcinol as cosmetic raw materials (Announcement No. 71, 2012 of the NMPA), phenethyl resorcinol is used for whitening skin and inhibiting the formation of melanin by inhibiting the activity of tyrosinase. Usage limit :0.5%."
Enterprises have received the review opinions as follows:
When companies file for ordinary cosmetics, if they use common chemical anti-freckle and whitening ingredients(chemical category), zoop reminds everyone pay attention to the safe use of concentration, at the same time the product declaration that cannot use the vocabulary of alleged or hinted whitening or spot , to avoid being ordered to correct and even be canceled for the filing. If the products are classified as special-use products, according to the "Regulations on supervision and Administration of Cosmetics" (hereinafter referred to as the "Regulations"), the production, operation or import of unregistered special-use cosmetics will face severe penalties.
The current regulations clearly stipulate that freckle-removing and whitening products are special-use cosmetics, which can only be produced, sold or imported after obtaining the registration certificate in accordance with the registration process of the NMPA. The approval number format is: (domestic products) "国妆特字 + four-digit number of year + the order number of registered products in this year", such as "国妆特字G20219977", imported products are "国妆特进字+ four-digit number of year + the order number of registered products in this year", such as "国妆特进字J20219988".
In addition, if it is a whitening product with only physical cover, and the name and label have declared "whitening" , also belongs to special-use cosmetics, must apply for a special-use cosmetics registration certificate, but compared with the addition of chemical freckle & whitening ingredients, the detection cycle is fast with low cost.
For the filing of ordinary cosmetics, Zoop suggested that in addition to the careful selection of the above risk categories of raw materials in the formula, attention should also be paid to the truthful declaration of the label , so as to make sure that the declaration should conform to the declaration category of ordinary cosmetics.
In fact, in October 2021, the national bureau launched the special action for "Online Net and Offline Clean Source"for cosmetics, which clearly mentioned the issue that caused everyone's heated discussion. One: Clean up and rectify cosmetics with illegal label declaration: including label content that is inconsistent with registered or filed materials, false or misleading, expressly implying medical effects, and illegal declaration of cosmeceuticals, stem cells, brush acid, medical skin care products, etc. Two: 2: Clean up and rectify cosmetics with quality and safety risks: including illegally added, manufactured with prohibited raw materials, and manufactured with restricted ingredients that exceed the scope or limit, and focus on children's cosmetics, freckle & whitening cosmetics, etc.
Prior to this, there have also been many cases of companies being punished for claiming violations of ordinary cosmetics, which has sounded a wake-up call for the entire industry. How to achieve legal compliance with the declaration of ordinary cosmetics is an issue that enterprises should pay attention to. Below are two cases of penalties for violation declaration.
A Shanghai company used "whitening, hydrating, moisturizing, pore shrinking, anti-wrinkle, lifting and firming", "fading fine lines, moisturizing, removing dark circles, removing eye pouches,moisturizing, whitening, nourishing" and "replenishing, removing freckles, moisturizing, lifting, tightening, repairing, soothing skin, anti-wrinkle, whitening, and moisturizing". It has been verified that the three products sold by the company in the online store are all imported from abroad, and the products have also obtained the filing credential for imported non-special use cosmetics. They are imported non-special use cosmetics and do not contain whitening, freckle-removal and other related ingredients. The three products do not have the effect of whitening and freckle-removal, which are false declaration and illegal declaration. Finally to be investigated and punished.
A company in Guangdong province posted a product introduction page on its website, claiming that the product contains "rich plant extracts such as polygonum multiflorum, rosemary and ginseng. Gently care hair, nourish hair, give hair sufficient nutrients, prevent hair loose. After use, hair will be smooth, shiny and fragrant."It is promoted that the product has the effect of special-use cosmetics for preventing hair loss and hair growth, and the actual product sold declare to "gently care for the hair, nourish the hair, give the hair sufficient nutrients, and make the hair soft, shiny and fragrant after use, and the product does not contain Polygonum multiflorum and ginseng ingredients. The propaganda do not tally with the actual product function, composition, constitute false advertising, and alleged violations. Finally, they were investigated and punished.
Punishments for the production, operation or import of unregistered special-use cosmetics shall be explained in accordance with Article 61 of the Regulations:
The department responsible for drug supervision and administration shall confiscate illegal income, illegal production and operation of cosmetics, and raw materials, packaging materials, tools, equipment and other items specially used for illegal production and operation;Where the value of cosmetics illegally produced and operated is less than 10,000 yuan, a fine of more than 50,000 yuan but less than 150,000 yuan shall be imposed; If the value of goods exceeds 10,000 yuan, a fine between 15 and 30 times the value of goods shall be imposed; If the circumstances are serious, it shall be ordered to suspend production or business operations,If the circumstances are serious, it shall be ordered to suspend production and business, the filing department shall cancel the filing or the original issuing department shall revoke the cosmetics license, and shall not handle the cosmetics filing or accept the cosmetics administrative license application submitted by it within 10 years, the legal representative or the main person in charge, the directly responsible person in charge and other directly responsible persons of the illegal unit shall be fined not less than 3 times but not more than 5 times of the income they obtained from the unit in the previous year, and shall be prohibited from engaging in cosmetics production and business activities for life; Constitute a crime, be held criminally responsible.
The year 2020 is known as the first year of new regulations on cosmetics. Up to now, many new regulations and management methods have been released. The new regulations have higher requirements for the registration of cosmetics.
The road is long and not easy to walk on. Let's work together.
Reference content
1. State Drug Administration Rational understanding and use of freckle whitening cosmetics
2.The State Food and drug administration carries out cosmetics Online net and offline Qingyuan Special action
3.Min City case supervision office Zi 2017 The first1202016201910number
4.Decision on administrative penalty-Suiyun municipal supervision office Zi[2021]1393number