Suggestion and Current Situation of Ordinary Cosmetics Label Management Under New Regulations

Hu Chunli,Gu Yu

Liaoning Inspection,Examination &Certification Centre,China

Abstract Sorted out the legal system of cosmetics registration and filing,mainly adopted on the Regulations on the Supervision and Administration of Cosmetics,Administrative Measures for Registration and Filing of Cosmetics,Regulations on the Administration of Cosmetics Registration and Filing Documents ,analyzed and summarized the relevant laws and regulations related to the management of cosmetics label,and discussed the background and significance of Measures for the Management of Cosmetics Label in detail.On the basis of summarizing and analyzing the problems and current situation faced by the current label management,this paper put forward reasonable suggestions to the filer and regulatory authorities,so as to provide certain guiding significance for the declaration and evaluation of ordinary cosmetics labels.

Key words surfactant;standardization;development

1 Overview of cosmetic registration and filing legal system

The cosmetic registration and filing regulatory management system is roughly divided into four levels,forming a regular triangle of regulations.It mainly includesThe Criminal Law of the People's Republic of China,The Product Quality Law of the People's Republic of China,The Advertisement Law of the People's Republic of China,The Anti-Unfair Competition Law of the People's Republic of China,etc,at the top legal level;Regulations on the Supervision and Administration of Cosmetics(Regulations for short hereinafter),at the level of administrative regulations;Administrative Measures for Registration and Filing of Cosmetics(Measures for short hereinafter)andAdministrative Measures for Production and Operation of Cosmetics,at the level of departmental rules;as well as the standards and technical specifications at the bottom of the triangle,such asSafety Technical Specifications for Cosmetics,Regulations on the Administration of Cosmetics Registration and Filing Documents(Administration Regulations for short hereinafter),Measures for the Management of Cosmetics Labels(Label Management Measures for short hereinafter),and so on.Based on the regulations,the author analyzes and summarizes the relevant laws and regulations related to the management of cosmetics labels,the problems faced by the current review,hoping to be helpful to the future supervision.

1.1 Regulations on the supervision and administration of cosmetics

Firstly,the Regulation gives a complete description on cosmetic definition from four aspects:the use-method(wiping,spraying or other similar methods),the use-part(human body surface),the use-purpose(cleaning,protection,beautification and modification),and the product attribute(daily chemical industrial products).Non-cosmetic products such as pharmaceutical related products and general industrial products are excluded.

Secondly,the regulations encourage cosmetics to adopt advanced technology and management norms,and carry out innovation in combination with characteristic plant resources.Ⅰnnovation can be specifically understood as the innovation of cosmetic raw materials,formulas,processes,equipment,packaging,or product safety,efficacy,skin feeling,experience and convenience.The cosmetic innovation in R &D technology will eventually be reflected in the product declaration.Therefore,the moderate and reasonable standardization of product label management will give enterprises the driving force and space for innovation[1].However,we should not only exaggerate the publicity or innovate business concepts,such as marketing the efficacy the cosmetics don’t have.

Third,the classification of special cosmetics is changed from 9 categories(Regulations Concerning the Hygiene Supervision over Cosmetics(Supervision for short hereinafter))to 5 + 1 categories.According to the normative documentClassification Rules and Catalogue of Cosmetics,it is necessary to code and classify the cosmetics according to the efficacy,usepart,dosage form,users,use-method and other factors.New efficacy cosmetics with letters in the code need to be registered.It should be noted that,the products of domestic non-special purpose cosmetics used in pregnant women and lactating women are no longer within the filing scope of ordinary cosmetics.

Fourth,efficacy claim and social co-governance.The efficacy claim should have sufficient scientific basis and pay attention to the reality of the product.For one thing,urge enterprises pay attention to technology research,the quality of their own products,and form a good industry atmosphere[2];for another,compulsory disclosure of efficacy test methods and literature data ensures the consistency between the claims of cosmetics and the application materials,and ensures the consumers’ right to know.

Fifth,the filing materials should be unified.Compared with the Regulations,the filing materials have changed greatly,adding very important contents such as product implementation standards,label samples,safety evaluation materials and so on.However,due to the new content,the pressure of filing products becomes greater for some filers.

1.2 Administrative measures for registration and filing of cosmetics

The measures clarify once again that the cosmetic filer should clear and definite the product implementation standard.The product implementation standard is consistent with the product filing number.The standard has mandatory force,one product one standard.The product implementation standard integrates the product quality and safety control requirements,product technical requirements and mandatory national standards in the old regulations,and add quality control at the same time.The standard aims to better meet the needs of the industry and improve the quality control level of cosmetics[3].The filer needs to fully understand and evaluate the control measures of relevant indicators of his own products to ensure that the standards are consistent with the actual operation,so that the standard can fully ensure the safety and controllability of the products.At the same time,Measures also leave some transition space for filers:For the products that have been filed,the standard,label samples,formulas and other contents shall be submitted before May 1st,2022.For ordinary cosmetics that have been filed for more than one year,an annual report shall be submitted in the first quarter of each year,which includes the implementation of mandatory national standard.

1.3 Regulations on the administration of cosmetics registration and filing documents

According to the Administration Regulations,the product implementation standard has added quality control for microorganisms and physical&chemical indicators,storage conditions,compared with the original technical requirements.In addition to uploading the sales package and manual,the product label item also needs to fill in the content of the product label sample,such as net content,etc.Even if there is no mandatory requirement to mark ‘storage conditions’ on the label,it will be controlled in the product implementation standard to ensure the quality.The above two parts of information will be publicized on the website of NMPA for consumers to inquire,ensuring consumers’ right to know.

2 Background and significance of measures for the management of cosmetics labels

2.1 Background of the label management measures

in the past,there was no corresponding label management measures under the old regulations.The management of cosmetics labels was mainly based onAdministrative Provisions on Cosmetic Labeling(No.100 order)(issued by General Administration of Quality Supervision,Inspection and Quarantine),Regulations on the Naming of Cosmetics(issued by SFDA)and the mandatory national standardGB5296.3 General Label for Cosmetics.Since the Regulations came into effect on January 1st,2021,the Label Management Measures came into being.The Label Management Measures have integrated and standardized the previous regulations from the aspects of label definition,content,naming,legal liability and so on.It also leaves enough transition period for the filer.Cosmetics that apply for filing before May 1st,2022 must update the labels before May 1st,2023 to make it comply with the requirements of the Label Management Measures.Meanwhile,Regulations on the supervision and administration of children’s cosmetics,which will come into force on January 1st,2022,has made specific provisions on the words,patterns and warning words of children’s products.For example,words such as ‘food grade’,‘edible’ or food related patterns can’t be marked;children’s cosmetics signs must be marked on the display surface of sales packaging.

2.2 Significance of the label management

The label of cosmetics is an important consideration for consumers to recognize products.Through the labels,consumers can understand the key information such as product composition,safety information,efficacy claim,use-method and validity period,so as to buy their favorite products.Labels are the direct source for consumers to obtain basic product information.Regulators ensure the legal compliance by managing cosmetics labels[1];meanwhile,the label can be understood as a part of the contract and the key evidence to safeguard consumer benefits.Therefore,label management is also one of the administrative means to implement the main responsibility of enterprises.

3 Problems encountered in label management

Compared with the old regulations,theLabel Management Measuresare more strict in terms of definition,consistency with the filed materials,Chinese labels,common names,guiding words.The labels of many filed labels need to be redesigned.At present,the main problems which should be brought to the attention of relevant filers are as follows:

3.1 The definition of cosmetic label

Label Management Measuresclarify the definition of cosmetic label for the first time,which refers to the words,symbols,numbers,patterns and other marks used to identify the basic information,attribute characteristics and safety warnings of products on the product sales package,as well as the packaging containers,packaging boxes and instructions with identification information.It indicates that the cosmetic labels include words,picture information and packaging carriers.In the past,the label evaluation in our province was also handled in this way,the newLabel Management Measuresclarified for the first time.For some transboundary products,such as **rabbit joint lipstick,air cushion and mask made by a food company,and some co-branded product such as **tea[4],has to pay special attention to the label management regulations and avoid misleading consumers.

3.2 Consistency between labels and filed materials

The filer shall be responsible for the label.The label shall be consistent with the relevant filed materials,which is actually consistent with the label sample and the product implementation standards.All contents marked on the labels shall be accurately filled in the relevant forms of the label samples,including some pattern information with special meanings.The most important thing is that the declaration and efficacy part of the label should correspond to the efficacy declaration and product name in the filing application form.At present,the most common problems found in the filing review is that the content of efficacy declaration is inconsistent with the label declaration.For example,the efficacy declaration is moisturizing,but the product function of the label is moisturizing and repair;the product is named **repair,but the label claims to be nourishing and repair effects.

3.3 Labels and packaging in direct contact with contents

According to theLabel Management Measures,except for registered trademarks,the font size of other characters shall be less than or equal to the corresponding standardized Chinese characters on the same visual surface;the Chinese name shall be marked on the visible surface of the sales package;for products with packages boxes,the Chinese name and validity period shall also be marked on the packaging containers that directly contact with contents.

Many products filed in the past have these problems.For example,there are only foreign fonts on one visual surface,the corresponding Chinese fonts are on another visual surface;the trademark name and attribute name are separated,or multiple trademarks are printed,the consumers can’t confirm the product name at the first time;the packaging containers of domestic cosmetics that directly contact with the contents are generally marked with Chinese name,but the imported products are not,they often marked on the labels of the smallest sales unit.How to design and mark the imported products in the future may still be considered by the filers.

3.4 Raw materials in common name and product efficacy

The label management measures requires that if the general name uses the specific raw materials or words indicating the category of raw materials,it shall be consistent with the ingredients of the product formula,and the efficacy of the raw materials in the products shall be consistent with the product efficacy claim.This is more stringent than the previous filing standards.Special attention should be paid to the use of valuable plant or a specific raw material as the common name among the filed products,such as ** hyaluronic acid mask,the product labels in the efficacy claimed for repair,acne and so on,or ** rose sunscreen which mainly used for sunscreen.

3.5 Guiding language

Label management measures require that the guide words of Chinese name of the product,the filer/domestic responsible filer/production enterprise,ingredients,executive standard number,net content,usage period,safety warnings should be accurately marked.If it’s necessary to mark the use-method of the product,it shall be marked on the visible surface of the sales packages or in the instruction attached to the product.However,the Regulations clearly require the use-method to be marked in the label,which seems to be contradictory.It may be explained by NMPA how to implement it.

4 Suggestion and current situation of ordinary cosmetics label management

4.1 The filers should be familiar with the regulations as soon as possible

From the promulgation of the Regulations to the operation of the new filing system( National Drug intelligent supervision platform),it is a huge challenge for both filers and supervisors.There are great difficult in completing the filing,reviewing and mastering the operation of the system,it also takes a considerable period of time to adopt and adjust the transition.The filers needs to be familiar with the regulations as soon as possible and fill in truthfully according to the actual product operation;fill in the technical data and effi-cacy declaration accurately;try to refer to the system operation manual and Q&A to solve related system problems.

4.2 Label defects leave fault tolerance space for enterprises

In the previous cosmetic filing system,the Provincial Bureau will give the filing number and publicize it after the review is completed within 5 working days,while the new filing system will apply for the filing number in advance,and the product will be filed upon submission.According to the notice of strengthening the filing management of ordinary cosmetics issued by NMPA,labels shall comply with the preliminary review standard when data sorting,that is ‘the key contents of preliminary review’ in the notice.Therefore,some filers are worried that according to the preliminary review standard,the label has not been strictly reviewed by regulatory authorities.If there is any problem,the subsequent economic loss would be relatively large.On one hand,enterprises should strengthen their own capacity-building,study the regulations carefully and declare in compliance;on the other hand,the regulations also give enterprises an outlet,which is to clarify the concept of label defect(according to the Measures for Supervision and Administration of Cosmetics Production and Operation),leaving fault tolerance space for enterprises.If it doesn’t affect the quality and safety of the products and will not mislead consumers,it may have the opportunity to order correction.But it may bear corresponding economic losses.

4.3 Regulatory review should be fair and impartial

It is suggested that the review should respect the fact but not over-correct.According to the quality supervision documents of NMPA,the quality supervision will be carried out every quarter,and the feedback opinions will be fed back to the provincial supervision departments.Reviewing the opinions of previous quality supervision,some other opinions by other provinces need to be discussed,such as the marking method of usage-period.The filers marked the production date and validity period of the product,and marked the batch NO.at the same time,which was also raised as a problem.Personally,I think the Regulation stipulate the contents that should be marked and be prohibited from marking,but it doesn’t mention that other contents can’t be marked.Therefore,other contents allowed by regulations should not be raised as a problem.In addition,it is suggested that the previous quality spot check standards should be sorted and made public on the official website in time,which is also convenient to guide the filer to declare.

4.4 The evaluation standard should be clarified as soon as possible

At present,there isn’t any clear evaluation standard in the documents review stage.It is suggested that the corresponding evaluation standard should be clarified by NMPA as soon as possible,or collect problems regularly and form unified standard after discussion and distribute to provinces;clarify quantitative and hierarchical management as soon as possible to avoid multiple and repetitive reviews;unify the provincial evaluation criteria through policy interpretation,joint meetings and other means[5].