Three major cosmetic regulations drafts are released! Pay attention to 10 change

The "Opinion Draft" is the moment when the industry needs a voice most! On September 28, the official website of the State Food and Drug Administration issued three items: "Cosmetic Production Quality Management Standards (Draft for Comments)", "Management Measures for Adverse Reaction Monitoring of Cosmetics (Draft for Comments)" and "Management Rules for Cosmetic Sampling Inspection (Draft for Comments)" Documents, solicit opinions from the public.

The content of "Cosmetics Production Quality Management Regulations (Draft for Comment)" (hereinafter referred to as "Specifications") basically follows the guidelines on the cosmetics production process in the 2015 "Announcement on Matters Concerning Cosmetics Production Licensing" (hereinafter referred to as "Article 105") The control requirements have been supplemented and improved in conjunction with the new "Regulations on Supervision and Administration of Cosmetics."

The release of the "Measures for the Monitoring and Management of Cosmetic Adverse Reactions" (draft for comments, hereinafter referred to as the "Measures") indicates that companies need to spend more energy on the monitoring and management of cosmetic adverse reactions! If this area could be done by hospitals and other institutions before, now companies are encouraged to do it independently. Not only that, cosmetic operators and e-commerce platforms also have the obligation to monitor and report cosmetic adverse reactions.

The promulgation of the "Cosmetics Sampling Inspection Management Regulations (Draft for Comment)" means that the state will have to be more detailed and strict in the inspection of certain prohibited ingredients, and products that have been tested for loopholes may be hit in the future. Not only that, the scope of producers and operators has expanded, and relevant persons responsible have increased, and all persons responsible for products will become "grasshoppers on a rope."

Through interviews with professionals, "Cosmetics News" sorted out the following 10 key points.

01 The monitoring of cosmetic adverse reactions is done by the company

Knocking on the blackboard: cosmetics adverse reaction monitoring and reporting will be completed by cosmetics companies. Article 23 of the "Measures" stipulates the means for the registrant and the filing person to report.

The “Measures” clearly stipulates that cosmetics registrants, recorders, and domestic responsible persons shall register as users of the National Cosmetic Adverse Reaction Monitoring Information System, and actively maintain their user information. After discovering or learning about adverse reaction information that may be related to their marketing cosmetics, Submit reports through the information system in a timely manner, and continue to track and process monitoring information. Cosmetics registrants, recorders, and domestic responsible persons shall publish effective contact information such as telephone numbers and e-mail addresses to the public, designate contact persons, and actively collect reports from entrusted manufacturers, cosmetics operators, medical institutions, consumers, etc. of their listed cosmetics Adverse reaction information.

An industry insider told reporters that the national cosmetics adverse reaction monitoring information system has been in existence for a long time, but it was not enforced before the "Measures". Standardized large enterprises are doing better in self-discipline, but for small and medium-sized enterprises, it is New challenges: Although the cosmetics adverse reaction information is completely controlled within the regulatory department and will not be publicized, because it is more negative information about the brand or product, the enthusiasm of the company in this area has not been high. Even some companies are worried that adverse reaction reports may affect the subsequent cosmetic registration and filing approval. These voices have greatly affected the enthusiasm of companies.

Is that OK? Although the "Measures" does not provide penalties, but in light of Article 52, Article 62 and Article 70 of the "Regulations on Cosmetics Supervision and Administration" that have been promulgated, those who fail to monitor and report cosmetic adverse reactions in accordance with the regulations will not only face several problems. An administrative penalty of 100,000 yuan will be "suspended production and business" at the highest level.

The above-mentioned industry insiders have judged that the hospital's adverse reaction monitoring will not stop, but if the draft opinion is passed, the company should actively monitor and report.

02 E-commerce platforms are under supervision, and e-commerce platforms such as JD’s self-operated/Tmall supermarkets need to pay attention

The "Administrative Measures for the Monitoring of Adverse Reactions in Cosmetics" (draft for comments, hereinafter referred to as "Measures") incorporates e-commerce platforms into key supervision. Its Article 19 stipulates that when a cosmetics e-commerce platform operator receives a cosmetic adverse reaction report, it shall record and timely transfer it to the cosmetic operator on the platform for processing, and supervise the cosmetic operator on the platform to perform the adverse reaction report obligation of the cosmetic operator. Moreover, if a cosmetics e-commerce platform operator conducts self-operating business on its platform, the self-operated cosmetics shall perform the adverse reaction reporting obligation of the cosmetics operator.

Industry insiders believe that this includes not only JD’s self-operated, but also Tmall Supermarket. E-commerce platforms shall fulfill the adverse reaction reporting obligations of cosmetics operators.

03 How long should the monitoring records of adverse reactions be kept?

Article 41 provides for "monitoring records". Cosmetic registrants, record holders, domestic responsible persons, entrusted production enterprises, cosmetics operators and monitoring bases, monitoring sentinels, and medical institutions shall establish and maintain cosmetic adverse reaction monitoring records or report records. The record retention period shall not be less than 1 year after the expiration of the product use period; if the product use period is less than 1 year, the record retention period shall not be less than 2 years. The operator of the cosmetics e-commerce platform shall establish and keep records of the transfer of cosmetic adverse reactions in the last 3 years.

04 Non-cosmetics produced in cosmetics workshops need to provide relevant reports

Article 67 of the original 105 stipulates that the raw materials and packaging materials to be manually managed by enterprises should be stored separately to ensure that there is no cross-contamination between the materials, and no non-cosmetic raw materials shall be stored in the raw material warehouse. Article 30 of the new "Specifications" completes the above regulations and mentions that non-cosmetic products that adversely affect the quality of cosmetics should not be produced in the cosmetics production workshop, and the raw materials used in non-cosmetic products meet the requirements and quality specifications of the relevant laws and regulations on cosmetic raw materials. It can be produced on-line with cosmetics, but a management system and risk analysis report to ensure the safety of cosmetics must be provided.

05 Clarify the sanitation indicators of clean area, quasi-clean area and general area

Article 39 of the original Article 105 stipulated that the production workshop should be divided into a clean area, a quasi-clean area and a general area according to the requirements of product process environment control, but no specific requirements other than "pressure difference" were specified. Article 105 and Article 40 stipulate that the filling room and the storage room of clean containers for the production of skin care products for eyes and skin care products for babies and children shall meet the requirements of 300,000 class cleanliness. The production area should maintain a corresponding pressure difference according to the process quality assurance requirements, and the clean area and other production areas should maintain a certain positive pressure difference.

In addition, on the basis of the original 105, the new "Specifications" require that the storage, filling, and storage of clean containers and tools of toothpaste, eye skin care cosmetics, and infant and children skin care cosmetics must be carried out in a clean area; Toothpaste, eye skin care cosmetics, infant and children skin care cosmetics weighing, preparation, buffering, dressing process, and other semi-finished products storage, filling, cleaning containers and tools storage, weighing, preparation, and buffering , The changing process must be carried out in a quasi-clean area.

It should be pointed out that the requirement for a 300,000 class clean room is that the number of planktonic bacteria per cubic meter cannot exceed 1000, and the new "Code" limits the number of planktonic bacteria to 500, which also means higher production cleanliness Degree requirements.

06 The threshold of the person in charge of the production department has become higher, and these three people must pay special attention

Article 105 of the original Article 5 stipulates: The person in charge of production of an enterprise shall have corresponding production knowledge and experience. Article 11 of the new "Code" stipulates that: the person in charge of the production department should have a college degree or above in cosmetics-related majors, have knowledge of cosmetics production and regulations, and have more than 3 years of cosmetics and related industry production or quality management experience.

In addition to the higher threshold for the person in charge of the production department, cosmetics companies also need to set up a person in charge of quality and safety and a person in charge of the quality department, who will assist the person in charge of quality and safety in quality management. In addition, the person in charge of the quality department and the person in charge of the production department shall not concurrently serve each other, and the person in charge of quality and safety and the person in charge of the production department shall not concurrently serve each other.

So, the person in charge of quality and safety and the person in charge of the quality department can be the same person?

07 Risk management from recommended items to required items

The original 105 stipulates: Enterprises should implement quality risk management, and conduct quality risk assessments on materials, production processes, storage and other links. This item was previously only a recommendation, not a mandatory requirement for on-site inspection. However, in the new "Specifications", Article 15 clearly requires that: companies should implement quality and safety risk management and conduct quality risk assessments on key links in the production process. Changes related to product quality and safety should be evaluated in advance, and major changes can only be implemented with written approval by the person in charge of quality and safety.

08 Refine raw material procurement specifications, and focus on animal and plant raw materials

Article 49 of the new "Specifications" specifically mentions that when purchasing raw materials, when using cosmetic raw materials of animal and plant origin, companies should clarify the source, preparation process, and location of use; use animal organ tissues and blood products or extract raw materials , The enterprise should clarify its source and preparation process, and must not use such raw materials that are not approved for use in the country of origin.

In addition, Article 49 also mentions that companies should establish and implement an inspection record system for raw materials and packaging materials that directly contact cosmetics. Check the supplier’s qualifications and effective certification documents related to material quality and safety, truthfully record purchase and sales information, and keep relevant ticket documents. For enterprises purchasing semi-finished products directly for filling, the manufacturer of the semi-finished products purchased shall obtain a cosmetics production license, and overseas production enterprises shall obtain the relevant qualification certification of the production quality management system of the local regulatory agency.

09 The batch number and production date of materials and finished products cannot be changed at will

As new content, Article 17 of the “Specifications” emphasizes that: the batch number and production date of materials and finished products must not be changed at will. If it is really necessary to change, it must be approved in writing by the person in charge of quality and safety, and the change and reason shall be recorded and stored. Relevant records before the change.

In addition, compared with Article 105, the new "Specifications" refines the traceability management system, requiring companies to establish and implement a traceability management system, formulate clear batch number management rules for materials and finished products, and each batch of products should have a corresponding batch number and production Inspection records to ensure traceability of product production, quality control, storage and logistics activities.

10 Self-examination of the enterprise, at least once a year

Article 20 of the new "Code" requires: Enterprises should regularly conduct self-inspection of the implementation of this code at least once a year. The self-inspection can be conducted by a qualified third party. After the self-inspection is completed, a report shall be formed. The content of the report shall include the problems found, safety evaluation and rectification suggestions. After the self-inspection report is approved by the person in charge of quality and safety, it shall be reported to the legal representative of the enterprise and fed back to the relevant departments.

The enterprise shall propose necessary corrective and preventive measures for the problems found in the self-inspection, and complete the rectification within a reasonable time, and the effect shall be evaluated by the quality department. The self-inspection plan, report and related records of rectification and evaluation shall be kept for more than 2 years.

At present, despite the rapid development of cosmetics manufacturers in my country, a number of well-known brands have emerged, and the market share has increased significantly. The production quality management system of some small and medium-sized enterprises is still not perfect, and the problems of low product quality control are still widespread, especially The company's integrity management and product safety awareness of the main responsibility needs to be improved.

The latest draft of production quality management specifications covers all the requirements of the "ISO 22716 Good Manufacturing Practices for Cosmetics" issued by the International Organization for Standardization, which will guide domestic cosmetics manufacturers to integrate with international standards. In addition, the draft opinion highlights the main responsibility of the enterprise, and clearly requires the cosmetics registrant, recorder, and entrusted manufacturer to establish a cosmetics production quality management system in accordance with the requirements of this specification to realize the entire process of cosmetics material procurement, production, inspection, storage, sales and recall The control and traceability ensure the continuous and stable production of cosmetics that meet the quality and safety requirements and predetermined efficacy.