FUSO TEIYAKU (Qingdao) Co.,Ltd.,China

Abstract The present situation of cosmetic raw materials has been introduced,mainly includingthe measures of risk analysis and quality control for cosmetic raw materials.Through the inspection of cosmetic raw materials,the formulation design and development,and the incoming management,the departments in the enterprise have worked together to achieve the risk analysis and quality control of cosmetic raw materials,to ensure the quality and safety of cosmetics.

Key words cosmetic raw material; risk analysis; quality control; cosmetic quality

Since the entry into the 20th century,the safety of cosmetics has become increasingly prominent.The occurrence of some safety incidents attracts the attention of the whole industry,government regulatory departments and even the whole society,who start to care about the safety of cosmetics.And the causes of such issues always relate to cosmetic raw materials.The former Food and Drug Administration introduced papers to stress the responsibility subject while the State Drug Administration gradually released methods to test the asbestos,formaldehyde,hormone components in cosmetic raw materials,which were included into theTechnology Regulation on Cosmetics (2015 edition).A series of relevant policies and regulations all highlight the significance of risk analysis and quality control of cosmetic raw materials.

Some people say that “the quality control of materials is a double-edge sword which may be detrimental to business and may also be contributing to the elevation of product quality and brand value.”In my opinion,despite that the quality control of raw materials is bound to bring about an increase in costs,it is the only way to improve product quality and plays a vital role in adding brand value.

There are a variety of cosmetic raw materials.A total of 8 783 cosmetic raw materials have been included in theList of Used Cosmetic Raw Materials(2015 edition).And a total of 1 290 kinds of banned cosmetics,98 kinds of banned cosmetic plants(animal) raw materials,47 cosmetic limited raw materials,51 kinds of cosmetic quasi-preservatives,27 kinds of cosmetic quasi-sun screening agent as well as 157 cosmetic quasi-colorant have been included inTechnical Specification for Cosmetic Safety (2015 edition).Cosmetics is a mixture made from different raw materials with different functions according to a certain formula proportion and production process.Although there are many factors affecting product quality,raw materials remain one of the key factors of product quality control as the basic substance of cosmetics.

At the current stage,cosmetics raw materials are confronted with the following problems: the lack of unified quality standards for cosmetics raw materials,especially for plant extracts; cosmetics enterprises lack systematization for the assessment of risk substances brought by raw materials; part of cosmetic production enterprises break law to add raw material and lack necessary procedures of inspection and acceptance.Systematic management of supplier audit and convenient traceability mechanism for cosmetics raw materials are also lacked.

Facing so many cosmetic raw materials,how could we manage the use of raw material in the upper stream entering the cosmetic production businesses and safeguard the legal rights and interests of consumers? It is essential to effectively improve the safety of cosmetics and strengthen the quality control of cosmetics,which is closely related to the raw materials of cosmetics.We can adopt the following measures focusing on the control of cosmetic raw materials: select cosmetic raw materials in a scientific way; improve the purity of cosmetic raw materials;avoid the allergic synergism during the distribution of raw materials; strengthen the inspection of raw materials to be introduced to factories; consolidate the management of cosmetics after entering factories.

With an aim to better manage cosmetic raw materials,cosmetic enterprises have established a series of process management to ensure the smooth implementation of cosmetic raw materials from investigation to final transformation,production and use.The process management of cosmetics can be divided into four stages in general: pre-audit by supplier; development of formula design; supplier audit; quality management.

We can see that the process management of cosmetic raw materials needs the coordination and collaboration among different departments so as to analyze the risk and control the quality of cosmetics.The following are the specific descriptions.

1 The cosmetic raw material review is the foundation

Cosmetic raw material audit includes two stages: supplier pre-audit and supplier audit.There are different subjects to serve.Supplier pre-audit is helping research and development staff to predict or do pre-research.Supplier audit is to provide service for quality control personnel to carry out cosmetic raw material inspection.

1.1 Pre-audit by cosmetic raw material supplier

The pre-audit of cosmetic raw material suppliers is connected to the internal control requirements of cosmetic enterprises.The purchasing or R＆D personnel of cosmetic enterprises require the manufacturers or agents of cosmetic raw materials to provide the performance inspection report and safety assessment materials of raw materials,so that the R＆D personnel can carry out pre-judgment or preresearch on raw materials.

1.2 Pre-audit of cosmetic raw material supplier

Cosmetic production enterprises ensure the quality inspection of supplier is the first step to guarantee the raw materials entrance into factories.The former State Food and Drug Administration released the paper of No.186 [2011] in 2011 which identified the screening requirement of supplier and raw material: the quality of supplier including the licence of business,legal production and management certificates,etc; the paper of quality management system of supplier; the instruction of raw material production; quality,specification of raw material,safety evaluation material,self-inspection report of businesses or effective inspection report issued by quality inspection organizations.The R＆D personnel refer to such standards,together with the audit material,to map out the inspection standard for raw material entrance into factories,which could serve as the basis of the final inspection for the entrance into factories.

2 Cosmetic formula design and development is the key

We need to analyze the following five aspects in the phase of cosmetic formula design and development: raw material compliance assessment;raw material risk assessment; assessment of limited substance use; raw material safety assessment;raw material compatibility and contraindications assessment.Based on the above research,we could evaluate the influence of raw materials on compliance,safety and stability.

2.1 The raw material compliance assessment of raw material

The raw material compliance assessment should be in line with both the domestic regulations and foreign regulations.The cosmetic raw material must conform to theTechnical Specification for Cosmetic Safety (2015 edition)andthe List of Used Cosmetic Raw Materials (2015 edition)and should be cosmetic raw materials inthe List of Used Cosmetic Raw Materials (2015 edition).The raw materials not included inthe List of Used Cosmetic Raw Materials(2015 edition)should be applied and reviewed by China Food and Drug Administration before use.

The foreign rules and regulations are often used as reference to predict the trend of cosmetic raw materials.The R＆D personnel should focus on the trends of regulations in key areas like America,the EU and Japan.In 2019,the NDRC issued theList of Industrial Structural Adjustment Guidance (2019 edition)which pointed out that the daily chemical products including plastic beads would be banned for sale before December 31st,2022.As early as 2015,America introduced the2015 Plastic Micro-beads Protection Actwhich required that all manufacturers would no longer be able to produce and introduce any rinsed cosmetics containing plastic microbeads and would forbid the sale of products involving micro plastic beads[1]with a purpose to protect the water environment in America.This act would take effect on July 1st2018.Companies and the industry as a whole will benefit if researchers can make predictions and adjust their research direction earlier.

From the above measures,it is obvious that we should set up the dynamic inclusion mechanism of business internal raw materials so as to make sure companies are looking forward to the future of the raw material compliance.In this way,we could help businesses to make prediction and adjustment of the development of cosmetic raw materials which have been used.

2.2 Raw material risk assessment

A number of domestic cosmetics enterprises started late in the assessment of the risk substances of cosmetic raw materials,while as early as the 1970s,the European Union and the United States began to study it.It has its limitation to cosmetic raw material research only according to theTechnical Specification for Cosmetic Safety (2015 edition).However,the Risk Assessment Guidance on Possible Risky Contents in Cosmetics describes four aspects in detail which mentions that the basis procedures of the risk evaluation include danger recognition,the description of danger characteristics,exposure assessment as well as risk characteristics.Cosmetics R＆D personnel need to deeply understand the structural synthesis process stability conditions and other information of cosmetic raw materials in order to analyze the risk substances that cosmetic raw materials may introduce.For example,polyacrylamide may include acrylamide monomer while phenoxyethanol may introduce two risk matters of phenol and dioxane.To do a good job in the analysis of the risk substances of cosmetic raw materials is conducive to the establishment of the control standard of the risk substances in cosmetic raw materials.

With the development of technology and inspection level,the risky matters in cosmetic raw materials have been gradually recognized.Enterprises should constantly update the risk assessment of cosmetic raw materials and continuously monitor the risk.Also,they should analyze the risk scale of the risky matters in cosmetic raw materials,so as to prevent the risk from emerging after the launch of cosmetics.Meanwhile,we need to predict the risk of launched cosmetics and design plans to deal with it accordingly.

2.3 Evaluation of the amount of restricted substances

In terms of the amount of restricted cosmetic raw materials,R＆D personnel should focus on 47 types of restricted groups of cosmetics,51 quasipreservatives,27 quasi-sun screening agents and157 quasi-colorants listed in theTechnical Specification for Cosmetic Safety (2015 edition).Besides,we should know the requirements of foreign rules and regulations on restricted substances.For example,Technical Specification for Cosmetic Safety (2015 edition)requires that the maximum allowed fortified concentration of salicylic acid in rinsing hair products is 3% and in other products and skin-use products is 2%.However,the amount of salicylic acid is safe within 0.5% when used in lotions-eye shadow,mascara,eyeliner,lip balm and deodorants according to the science committee from the EU.The amount here refers to the total amount of salicylic acid with all functions as mentioned above.[2]The change of limited cosmetics raw materials mainly hinges on the limited requirements of restricted cosmetics raw materials.It should be stressed that cosmetic developers tend to ignore the restricted substances contained in the compound components of cosmetic raw materials,which leads to the exceeding of the restricted substances in the final products.

2.4 Evaluation of the safety of raw materials

The R＆D personnel conduct a series of safety evaluation in terms of raw materials involving the application of raw materials (scope,amount and people),toxicological information,acceptable maximum,daily intake and actual estimated intake and carry out collection of and evaluation on the safety data of cosmetic raw materials.In case of insufficient safety data of raw materials,it is necessary to carry out acute oral toxicity test,acute percutaneous toxicity test,skin irritation and other toxicological tests,as well as human-body skin patch test.We also need to pay attention to the quasi-preservatives not mentioned in theTechnical Specification for Cosmetic Safety (2015 edition).This kind of non-quasi-use preservatives as anti-corrosion function need to do a systematic safety assessment to reduce the occurrence of risks.

2.5 Evaluation of raw materials compatibility

In terms of the raw materials compatibility of cosmetics,we could refer to the formula compatibility and taboo of cosmetics.[3]The poor compatibility of raw materials is often reflected in the turbidity of precipitation crystals and other aspects,such as the poor pre-treatment of methyl propyl allantoin and other raw materials in the actual product development process,which may result in the crystallization precipitation; we also need to be careful in the use of Ca2+-containing formulations where insoluble calcium salts may precipitate; in face of improper selection of emulsifier,the product was separated into different layers.Only by solving the compatibility of raw materials can the occurrence of cosmetic risk events be further reduced.

3 Quality management of cosmetic raw materials to enter factory

The management process of cosmetics raw materials entering the factory usually involves three parts: raw material code entering the factory;quality department inspection and document filing;warehouse management.The business guarantees the quality management of cosmetic raw materials based on the process of factory management,establishes the correlation mechanism between raw materials and finished products,and responds to the unexpected situation of the market,so as to realize the traceability of cosmetic problems.

3.1 Raw material code entering factory

It is good for the inspection and tracing of the raw materials after entry into factory if the codes of cosmetic raw materials enter the factory.The code is like the ID of raw materials,linking raw materials and the finished products together.At the same time,it combines the coding information of raw materials and finished products and manufacturers with internet technology to realize the one-code query of the whole production process information of products.In case of adverse reaction complaints in the market,the one-itemone-code traceability mechanism can be utilized to quickly analyze and find the root causes of emergent problems.

3.2 Quality department review and filing

As the last key “l(fā)ine of defense” before raw materials enter the factory,the risk analysis of cosmetic raw materials in the early stage paved the way for the formulation of quality standards and in-factory inspection of cosmetic raw materials.Internal quality control standards for cosmetic raw materials are usually combined with inspection reports and inspection methods offered by cosmetic raw materials suppliers.And the industrial standards are established on such basis along withChinese Pharmacopoeia.It remains a crucial step to review key projects (impurity,risky substance,amount of active matters,etc.) and focus on the entering of raw materials into factory,in order to guarantee the quality of finished products of cosmetics.Enterprises should integrate internal and external inspection means to ensure that raw materials meet the quality standards of raw materials.

3.3 management

The main point is to store well those cosmetic raw materials after their entry into factory.Many businesses tend to ignore it.The condition of storage could refer to the requirements inChinese Pharmacopoeia(2015 edition).And the management of them could refer to partial requirements inThe 105 Points for Inspection of Production License for Cosmetics.The labeling of the expiry date of the re-inspection period of raw materials must be clearly marked to avoid the conflict between the expiry date of raw materials and the actual disposal measures.

4 Conclusion

In summary,the analysis and quality control of cosmetic raw materials is a kind of knowledge which is in need of the joint efforts from different departments; in the selection process of cosmetic raw materials,the purchasing personnel should keep their eyes open,the R＆D personnel should do a great job in the assessment of raw material compliance,the assessment of limiteduse risk substances,the assessment of limited-use substances,the safety assessment of raw materials and the study of raw material compatibility,and the quality management personnel should do a good job in the inspection of raw materials’ incoming quality standards and the management of raw materials after entering the factory.Meanwhile,company’s legal personnel should do a good job in the legal risk elimination and protection mechanism,so as to avoid the occurrence of risk events caused by cosmetics raw materials as much as possible,and at the same time to prevent the fatal impact following the occurrence.