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Rejected the record, "no preservative" cosmetics to cool? Claim that "no preservative" does not mean no preservative system

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"The formula is unreasonable, no preservatives."

"Aqueous cosmetics were rejected for filing because they did not add preservatives".

Interview object for map

A few days ago, the news that the above several cosmetics records were rejected circulated in the industry, causing heated discussions. Cosmetics Observation immediately sought confirmation from relevant persons. The person in charge of an enterprise in Guangdong clearly stated, "There is no antiseptic now, and the record is not given."

Does this mean that the main "preservative-free" natural cosmetics on the market will be cold?

01 No preservative was added, and many records were rejected.

According to the above-mentioned person in charge of an enterprise in Guangdong, the filing of a new aqua product of the company, "XX rejuvenation and skin rejuvenation solvent solution", was rejected. According to the audit opinion, one of the reasons is that the product "is formulated as a water matrix, but no preservative is added, which may lead to the risk of spoilage and deterioration of the product during the shelf life. Please provide relevant supporting materials that can ensure the quality of the product during the shelf life".

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In the view of the person in charge, this means that "there is no preservative in the formula, and the record has not been given at all".

It should be noted that many people in the industry emphasized that the "preservative" mentioned in the filing rejection opinion refers to "permitted preservatives".

In December 2015, the State Food and Drug Administration issued the "Cosmetic Safety Technical Specification" (2015 Edition) (hereinafter referred to as the "Specification"), in which the list of preservatives used in Table 4 of Chapter III contains a total of 51 kinds of preservatives, and clearly stipulates the variety, maximum allowable concentration, scope of use, restrictions and labeling of preservatives.

At present, the main natural cosmetics on the market claim that "no preservatives are added", which mainly means that the above-mentioned preservatives are not added, but in fact, the products are added with off-the-table preservatives with preservative effect.

According to the filing opinion, if such "formula does not add preservative to be used", an anti-corrosion challenge test report shall be submitted for filing to prove that the product will not deteriorate during the validity period.

In addition, if the packaging materials have anti-corrosion effect of products, or the main disposable products, "like the sub-throwing products, it is enough to submit the production environment and related equipment to meet the aseptic process requirements, as well as the certification materials that the factory sampling and inspection are qualified," an industry insider said.

In response to the fact that the record was refuted without adding preservatives, many practitioners revealed that this is not an example, and many places have begun to implement it. "These requirements are actually not excessive, after all, did not add the traditional quasi-use preservatives, how to prove that your product can be anti-corrosion?" The industry insiders said bluntly.

A brand research and development engineer believes that in the past, many products did not have on-balance sheet preservatives, and most of them can pass. Now the filing is stuck, which means that the regulatory authorities will strictly control off-balance sheet preservatives in the future.

02 burst red "no preservative" cosmetics antiseptic?

In the popular science article "Correct Understanding of Preservatives" published by China Food and Drug Network in 2021, it was pointed out that preservatives refer to a class of raw materials that can inhibit or prevent the growth and reproduction of microorganisms, thereby preventing product corruption. The rational and standardized use of anti-corrosion system is one of the important links in the production process of cosmetics.

However, although there is a lot of popular science on preservatives, many consumers still "talk about decay" because preservatives are the second largest cause of cosmetic allergy and contact dermatitis ". In the post-epidemic era, consumers' pursuit of natural and pure skin care products has added fire to cosmetics that claim to be "preservative-free" or "zero-added.

Cosmetics Observation searched for the key word "no preservative" in Little Red Riding Book and found that there were 200000 relevant notes, almost all of which were cosmetics-related contents such as "preservative-free facial mask" and "preservative-free facial cream. On Taobao, Pinduo, Jingdong and other major e-commerce platforms, cosmetics labeled "no preservative" and "preservative 0 added" can be found everywhere, including well-known brands at home and abroad, with a large number of single products selling more than 10,000 a month.

China Medical News once published a popular science video "Talking about corruption, are you afraid of cosmetic preservatives?" it is pointed out that at present, cosmetics that claim to be preservative-free mainly have the following two situations: first, the products do not contain preservatives, and most of them are disposable packaged products (such as secondary throwing and capsules) and products that are not easy to breed microorganisms (such as perfume, dry powder, etc.); second, unapproved preservatives, that is, off-balance sheet preservatives, are used. According to the report, "some of these belong to the concept of stealing or misleading propaganda".

According to industry sources, in fact, there is still a third situation, in which preservatives are actually added to the formula, but they claim "zero addition", which may be suspected of false propaganda.

Cosmetic observation and combing found that the second type of product is the most common in the current market.

Take a maternity skin care brand as an example. Its Tmall flagship store sells the product "xx Moisturizing 3-piece Set". The product details page clearly states, "Refuse to add ingredients for pregnant women with caution" and "No preservatives, flavors and alcohol". According to the filing number "Guangdong G Zhuang Wang Beizi 2021092639", the new filing platform shows that the product has not yet been fully recorded, while the old platform shows that its components include "1,2-pentanediol", "p-hydroxyacetophenone", "1,2 hexanediol" and so on.

An engineer pointed out that "although these ingredients are not in the list of preservatives to be used in the specification, they can play a certain anti-corrosion effect through reasonable collocation, but there are also certain risks."

However, with the rejection of cosmetics filings with "no permitted preservatives" in many places, this behavior may not work.

03 Tighter supervision, dynamic adjustment of the list of permitted preservatives

It is understood that the current common types of "off-the-table preservatives" include p-hydroxyethanone, organic acids (such as caprylyl hydroxamic acid, anisic acid), polyols (such as pentanediol, butanediol), medium carbon chain polar amphiphiles (such as ethyl hexyl glycerol, glycerol caprylate), etc.

"There is no evidence that off-balance sheet preservatives are safer than permitted preservatives." A senior regulatory expert in an industry pointed out that cosmetic preservatives have a scientific and rigorous management system in my country. In addition to list management, it also stipulates specific use. In comparison, the safety risk of off-balance sheet preservatives is greater.

"What is certain is that the regulatory authorities do not respect off-balance sheet preservatives." The above-mentioned brand R & D engineers also believe that off-balance sheet preservatives may not be ideal in terms of safety and effect. "If the conditions can be met and the relevant technical requirements can be met, Will be included in the" Code ".

This is not without precedent. On December 28, 2020, the State Drug Administration issued the Announcement on the Approval of the Use of 4 Raw Materials such as Lauroyl Acine Ethyl HCl as Cosmetic Raw Materials, approving the use of Lauroyl Acine Ethyl HCl as a cosmetic preservative, and incorporating the list of cosmetics permitted preservatives in Chapter 3 of the Cosmetic Safety Technical Specifications.

It is worth mentioning that in May 2021, the State Food and Drug Administration also issued the Announcement on Updating the List of Prohibited Raw Materials for Cosmetics, updating the list of prohibited raw materials for cosmetics, and listing benzachlorophenol, formaldehyde, and paraformaldehyde previously used as preservatives as prohibited raw materials, which will come into effect on the date of release.

In other words, up to now, there are 49 kinds of preservatives for cosmetics in China.

"It is quite normal that the preservatives to be used in the" Cosmetic Safety Technical Specifications "should be included in new ingredients, and outdated ingredients should also be eliminated," said Huang Gong, a senior R & D engineer in the industry.

The article "Correct Understanding of Preservatives" also pointed out that the current "Code" only stipulates the maximum allowable concentration for single preservatives. It is suggested that in addition to timely revision of the list of permitted preservatives, the regulatory authorities should also carry out safety assessment on the addition of multiple preservatives at the same time, and improve the testing standards and regulations of "off-balance sheet preservatives", so as to reduce their safety risks.

With the tightening of filing and supervision in various places, cosmetics enterprises can only avoid stepping on the pit by raising their quality awareness, reasonably using the anti-corrosion system, and making standard claims. At the same time, the regulatory authorities should continue to increase science popularization. Only when consumers stop "talking about corruption" and blindly believe in "no anti-corrosion" can market chaos be curbed.

Preservatives, Cosmetics, Products, Safety, Specification

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