One  Guidelines for Research and Determination of Safe Use History of New Cosmetics Ingredients trial  What is the background of its formulation

according to Regulations on the Supervision and Administration of Cosmetics ,When applying for registration or filing of new cosmetic ingredients,New raw material safety assessment materials should be submitted.of which,For new ingredients that have a sufficient history of safe use in cosmetics,Can waive some toxicology test items.

To implement the National Medical Products Administration Several regulations supporting innovation in cosmetic raw materials ,Strengthen the utilization of existing data,Organized and formulated by the Central Inspection Institute Guidelines for Research and Determination of Safe Use History of New Cosmetics Ingredients trial   hereinafter referred to as guide  ,Collect historical data related to safe use Provide technical guidance for judgment and application in security assessment.

Two Do new raw materials to be registered and filed need to be completely consistent with the raw materials in the history of safe use

New raw material registrant Filing person Hereinafter referred to as the preparer Should be sourced from raw materials Production process Raw material composition Conduct consistency analysis of raw materials in terms of quality specifications and other aspects.For new raw materials with a clear single chemical structure,The molecular formula should be ensured Consistent key information such as structural design Due to the improvement of raw material quality Adjustments to production processes due to environmental friendliness and other reasons,Should take into account the process adjustment situation,Regarding the content of raw materials purity  Comprehensive analysis of impurity composition and other possible changes.For other types of new raw materials,Like plant extracts Microbial fermentation products High molecular weight polymers, etc,It should be ensured that the raw materials cited in the safety use history proof materials are consistent with the new raw materials to be registered and filed.

in addition,For those sold in a complex form in practice,Other components in the composite raw materials should be analyzed for their impact on efficacy Possible impacts on safety, etc,Fully consider the scientific rationality of the historical basis for the safe use of new raw materials for registration and filing.

Three What are the requirements for marketed cosmetics in the historical proof of safe use

The marketed cosmetics in the historical proof of safe use should comply with the definition of cosmetics in Chinese regulations.When the product is not managed as a cosmetic overseas but meets the definition of cosmetics in China,The regulatory background of relevant products overseas should be provided Regulatory requirements and product efficacy Relevant information on the mechanism of action, etc,And analyze and explain the relevant situations that meet the definition of cosmetics in China.in addition,The concentration of raw materials used in marketed cosmetics Used Part The usage method should be able to support the applicable or usage scope filled in the registration and filing materials Information related to safe usage and other related factors.

Four What are the requirements for the launch time and quantity of cosmetics already on the market

The marketed cosmetics should have been on the market for no less than3year,It can be the same product that has been sold continuously3Year and above,Or multiple products have accumulated continuous sales of at least3Year and above.If the product is launched earlier,The reliability and traceability of relevant information should be fully considered.

in addition,It should be ensured that the relevant products have sufficient usage quantities.in principle,If using terminal retail cosmetics sales quantity The actual quantity purchased by consumers ,standard3The annual cumulative sales quantity shall not be less than10000piece,Among them, the annual minimum shall not be less than3000piece If indirect sales data is used,Such as the factory output of cosmetics production enterprises Distributor sales volume, etc,standard3The annual cumulative sales quantity shall not be less than100000piece,Among them, the annual minimum shall not be less than30000piece.

Five How should new raw material preparers conduct safety usage analysis

New raw material preparation personnel should conduct comprehensive research,Provide a detailed explanation of the channels and methods for collecting adverse reaction events,And whether there have been any records of adverse reactions or other related reports on the harm to human health caused by the use of this ingredient in cosmetics since their launch,And conduct necessary analysis.On this basis,Considering the overall situation of the raw material's market use,Scientific and reasonable evaluation of the usage history of new raw materials,Formulate a clear conclusion on whether the raw material has caused serious adverse reactions or group adverse events, and whether it may pose a risk to human health.

For new raw materials with spot removing and whitening functions,Attention should also be paid to the safety risks of long-term effects on human skin,For example, providing no less than100Long term famous consumers 1Year and above Related situations of continuous use of the same product.If unable to provide relevant information,Long term human trial safety tests can also be conducted as an option,Provide relevant research data.

Six What are the format requirements for using historical proof materials

The person responsible for preparing new raw materials should follow the basic requirements of safety use history certification documents,Collect relevant materials and information arrange Analyze and summarize,Overview of the history of safe use of new raw materials,Please find attached the relevant appendix See example guide attached table1 outside3 ,And provide traceable relevant proof materials.

Considering the retention of product sales records in various countries There are different regulations and customs regarding traceability and other aspects, guide No specific restrictions have been imposed on the form of proof materials.New raw material preparation personnel should fully grasp the actual situation,And based on its sales Specific ways of use,Organize and form supporting documents on your own.The provided supporting documents should have relevance Traceability,And reflect necessary key information such as production and operation.If the marketed cosmetics are produced by non new raw material injection personnel,The source of information should be explained and appropriate authorization should be obtained.

Q&A on the "Guidelines for Historical Research and Determination of Safe Consumption of New Cosmetics Ingredients (Trial)"

One  Guidelines for Historical Research and Determination of Safe Consumption of New Cosmetics Ingredients trial  What is the background of its formulation

according to Regulations on the Supervision and Administration of Cosmetics ,When applying for registration or filing of new cosmetic ingredients,New raw material safety assessment materials should be submitted.of which,For new ingredients with a sufficient history of safe consumption,Can waive some toxicology test items.

To implement the National Medical Products Administration Several regulations supporting innovation in cosmetic raw materials ,Strengthen the utilization of existing data,Organized and formulated by the Central Inspection Institute Guidelines for Historical Research and Determination of Safe Consumption of New Cosmetics Ingredients trial   hereinafter referred to as guide  ,Collection of historical data related to safe consumption Provide technical guidance for judgment and application in security assessment.

Two What are the requirements for the source of historical proof of safe consumption

The historical proof of safe consumption should come from food sources agriculture Supervision and management departments in the fields of health and other related areas,Or technical institutions with functions or technical capabilities related to food safety risk assessment,Should have a certain level of authority,And generally it should be publicly released data information As announced notice Technical standards, etc .of which,The supervisory and management departments in our country should be at the provincial or ministerial level or above Foreign supervisory and management departments should be at the national level Technical institutions should be internationally recognized authoritative institutions or organizations.

in addition,When using historical proof of safe consumption,The background of the cited materials should also be considered Specific information content Comprehensive analysis of requirements related to food safety supervision,Fully explain the relevant information on safe consumption.

Three What consistency or correlation should be observed between the newly registered raw materials and the food raw materials listed in the history of safe consumption

The new raw materials to be registered and filed should have consistency or correlation with the food raw materials stated in the historical proof of safe consumption,New raw material registrant Filing person Hereinafter referred to as the preparer Analysis should be conducted based on the historical proof of safe consumption and the relevant information of new raw materials to be registered and filed.

It should be pointed out that,If the processing method is inconsistent with the food consumption processing method If using other solvents for extraction, etc ,Should be combined with specific process types,Regarding the composition and enrichment situation Analyze residual solvents, etc New raw materials for biological fermentation,Relevant proof that the final fermented product obtained is safe for consumption should be provided.

Four What are the common historical proof materials for safe consumption

The common history of safe consumption mainly comes from ordinary food ingredients Local specialty food ingredients New food ingredients Medicinal and edible raw materials of the same origin Raw materials for health food, etc.To guide new raw material preparers in collecting and utilizing relevant information,exist guide Some common proof materials and their basic requirements are listed in the document.

of which,Considering that some common food ingredients may lack official published evidence,The person responsible for preparing new raw materials can explain the relevant situation,Provide relevant proof materials that have been listed and sold as ordinary food ingredients within the territory of China,And analyze and explain the situation of safe consumption, etc.The provided supporting documents should have relevance Traceability,And it can accurately reflect the consistency or relevance with the new raw materials to be registered and filed.

Five Can relevant certification materials issued by foreign regulatory agencies or technical institutions be used

Using information related to safe edible raw materials released by foreign regulatory authorities or authoritative technical institutions as proof of safe consumption history,In addition to complying with relevant principles and requirements,Relevant background information should also be provided,Including publishing countries area  Regulatory authorities/Background information of technical institutions Release time Publish complete information content Specific application of food safety supervision Background information on safety assessment, etc.

Six How to conduct safety risk assessment on new cosmetic ingredients with a history of safe consumption

There are clear consumption limits or other restrictions in food,It should be based on the applicability or scope of use of the new raw materials Information on safe usage, etc,Evaluate the safety of using new ingredients in cosmetics Without clear consumption limits,Can be combined with the dietary habits of the population Regular consumption amount and other information,Conduct a reasonable evaluation.Further processing of raw materials,In the form of plant extracts,Necessary conversions should be considered.

According to the consumption limit or regular consumption amount,Unable to meet the demand for the use of new ingredients in cosmetics,Can supplement repeated dose toxicity test data and other necessary data,Scope of use of new raw materials Evaluate safety usage and other factors,Simultaneously provide complete information Standardized toxicology test report.

in addition,The safe consumption history is mainly used to reduce the toxicity related test projects of the system,For new raw materials with spot removing and whitening functions,It cannot be ruled out that there is a safety risk of long-term use of it as a cosmetic ingredient on human skin,Necessary data or experimental research should be supplemented.