Wang Shuai

Qingyan Network Technology (Wuhan) Co.,Ltd.,China

On June 18,2021,following the May 31 release of the first “Survey on the Consumer Safety Perception of Children’s Cosmetics” (hereinafter referred to as the Survey) by the Department of Cosmetics Regulation of National Medical Products Administration of China (hereinafter referred to as NMPA),the “Regulations on the Supervision and Administration of Children’s Cosmetics (An Exposure Draft)” (hereinafter referred to as the Exposure Draft)was officially released and opinions from the public were openly solicited.The deadline for feedback is July 31,2021.It is worth mentioning that the Exposure Draft is also the first regulatory document in China issued specifically for the supervision of children’s cosmetics.Many people in the industry have made positive comments after reading it,like “Support! Children’s cosmetics deserves to be properly regulated” and “The supervision of children’s cosmetics can’t be overemphasized.”

Banning the use of new ingredients and simplifying formulas

From an overall point of view,the full text of the Exposure Draft contains 22 provisions,which include the definition of children’s cosmetics,labeling requirements,formulation principles,safety assessment requirements,production/operation(including online) requirements,registration and filing management,production/operation supervision,sampling and monitoring,and other links related to children’s cosmetics.First of all,the Exposure Draft clarifies the range of children’s cosmetics as cosmetics for children under 12 years old (including 12 years old).It also points out that the cosmetics registrant and recorder are responsible for the quality safety and efficacy claims of the children’s cosmetic products.In addition,the Exposure Draft also stipulates the functional categories of children’s cosmetics,which mainly include cleansing,moisturizing,body conditioning,sun protection,etc.

The Exposure Draft stipulates that the formulation of children’s cosmetics should follow three major principles.First,the number of types of ingredients used in the formula should be reduced;second,the use of ingredients intended for spot removing,whitening,dealing with acne,hair removal,deodorization,anti-dandruff,anti-hair loss,hair dyeing and perm,etc.is not allowed.If these ingredients with the above-mentioned effects have to be used for other purposes,the necessity and safety of using them in children’s cosmetics should be evaluated.Third,it is recommended to use cosmetic ingredients with a history of safe use,while it is not permitted to use new ingredients that are still in the monitoring period and ingredients whose safety to children remains unclear.

In terms of safety assessment requirements for children’s cosmetics,it is required that children’s cosmetics should be evaluated for product safety through safety assessments and toxicological tests.When the cosmetics registrant and recorder conduct safety assessments of children’s cosmetics,they shall consider the physiological characteristics of children in the process of hazard identification and exposure calculation.

Children’s cosmetics must not be similar to foods and medicines to prevent accidental ingestion and misuse

It is worth mentioning that the Exposure Draft also proposes that cosmetics registrants,recorders,and entrusted manufacturers should take measures to avoid confusion between children’s cosmetics and food,drugs,and other products in terms of characteristics and appearances,so as to prevent accidental ingestion and misuse.In this regard,an engineer from a baby cosmetics company suggests,“We can add bittering agents to children’s cosmetics (except for lip moisturizers) in an appropriate amount,and specify the specific bittering agents and the minimum amount to be added,so that we can place another layer of protection through the bitter taste.”

In addition,the Exposure Draft also stipulates that ordinary cosmetic products with labels like “suitable for all skin types,” “can be use by the whole family,”or the use of trademarks,patterns,homophones,letters,Chinese pinyin,numbers,symbols,packaging,etc.to imply that the target users include children that fail to comply with the filing of children’s cosmetics will be handled in accordance with Article 65 of the Cosmetic Supervision and Administration Regulation,Article 58 and Article 59 of the Administrative Measures for the Registration and Filing of Cosmetics as well as other laws and regulations.

According to Article 65 of the Cosmetic Supervision and Administration Regulation,if false information is provided during filing,the filing department shall cancel the filing and impose a fine of 3 to 10 times the value of the goods;if the circumstances are serious,the person in charge of the enterprise shall be prohibited from engaging in activities of cosmetics production and business within five years.

The Administrative Measures for the Registration and Filing of Cosmetics clearly states that those filed materials of the registered cosmetics and new cosmetic ingredients that do not meet the requirements should be ordered to make corrections within a time limit.Among them,if the filed materials that do not meet the requirements are related to safety concerns,the related products can at the same time be ordered to be suspended from sales and use;if the product does not belong within the scope of cosmetics filing,such filing shall be cancelled.

Products need to be marked with the sign of “Children’s Cosmetics”

It is worth noting that when the NMPA conducted the Survey at the end of May,it included a question asking “Is it necessary to design a special sign for children’s cosmetics?” At that time,many people in the industry believed that the setting of this question indicated that the NMPA had intended to use a special sign to distinguish children’s cosmetics from other products.

Unsurprisingly,the Exposure Draft clearly states that children’s cosmetics should be labelled with the Children’s Cosmetics sign (to be decided) stipulated by the NMPA in a prominent position on the display surface of the sales package,and the standard number that the product complies with should be marked right below the sign.It also emphasizes that “non-children’s cosmetics must not be marked with the Children’s Cosmetics sign.”

At the same time,the NMPA has also publicly solicited ideas for the Children’s Cosmetics sign from the public,and issued the “Children’s Cosmetics Sign Collection Requirements” (hereinafter referred to as the Requirements).The Requirements stipulate that the content of the entries should be positive and healthy,and must not contain any content that violates relevant laws and regulations;it must reflect the characteristics of children’s cosmetics;in terms of means of expression and techniques,the design must be suitable for use on various occasions and carriers,including websites,documents,letterheads,promotional materials,and other media use.

The NMPA announced that it will organize experts to select the collected children’s cosmetics signs,and the results of the selection will be made public.In this regard,one engineer engaged in the R&D and production of children’s cosmetics said,“It is necessary for the country to use children’s cosmetics standards to differentiate such products.I only hope that the business cost of companies can be taken into consideration and the cost of those companies will not increase for this reason.”

Six major encouragements

It is worth noting that in the Exposure Draft,China’s NMPA also put forward six “encouragements”:first,cosmetics producers and operators are encouraged to use information technology to collect and store production and operation information,and establish a quality safety traceability system for children’s cosmetics;second,cosmetic registrants and recorders are encouraged to use anti-counterfeiting technologies on product labels to facilitate consumers to identify and choose legal products;third,cosmetic registrants and recorders are encouraged to formulate product implementation standards that are stricter than mandatory national standards for children’s cosmetics;fourth,cosmetics company employees are encouraged to report non-compliance or irregularities found in their work;fifth,cosmetics operators are encouraged to display children’s cosmetics in independent areas,and publicize children’s cosmetics signs in sales areas;sixth,when selling children’s cosmetics,cosmetic business are encouraged to actively remind consumers to inquire about product registration information.

Focused supervision and severe penalties

The Exposure Draft mentions that the National Medical Products Administration will organize a cosmetic technical evaluation agency to formulate specific guidelines for the examination and evaluation of special cosmetics for children and to strictly review and approve the registration applications submitted by the applicants.

In addition,the supervision of children’s cosmetics will be strictly handled.For example,the Exposure Draft states that the cosmetics filing management department should conduct technical verification of all the filing materials of children’s cosmetics,focusing particularly on the verification of product safety materials.If any product is found to be inconsistent with the regulations,it shall be dealt with strictly in accordance with the law.

The Exposure Draft also stipulates that the provincial medical products supervision and administration departments shall,in accordance with the principles of risk management and in view of local conditions,list children’s cosmetics registrants,record holders,domestic responsible persons,and entrusted manufacturing enterprises as key targets for supervision and clarify supervision measures.The departments in charge of medical products supervision and management should also follow the principles of risk management and combine with local conditions to implement key supervision and inspection on cosmetics operators who have concentrated behavior of selling children’s cosmetics.

The Exposure Draft also specifically states that in investigating and dealing with illegal acts of children’s cosmetics,should the departments in charge of drug supervision and administration find acts like “use of ingredients prohibited for the production of cosmetics and new ingredients that should be registered but not registered for the production of children’s cosmetics”or “illegal addition of substances that may harm human health to children’s cosmetics,” such acts shall be deemed to be a serious situation as stipulated in the Cosmetic Supervision and Administration Regulation,and a heavier fine shall be imposed in accordance with the law.