Li Zhongrui

Intertek Testing Services Shenzhen Ltd., China

Feng Huanhuan

Intertek Testing Services Shanghai Ltd., China

Introduction

Along considering with the rapid development of the cosmetics industry and the strengthened self-protection awareness of the consumers, the cosmetics quality has been attracting great attention from all walks of life. Since late 1980s, a series of cosmetics laws and regulations, technical standards, requirements and normative documents have been promulgated successively in China. Since 2016, China Food and Drug Administration (CFDA) has started to put forward stricter requirements for the cosmetics regulations and the related enterprises (manufacturing enterprises and operating enterprises), expecting to maximize the product safety, thus protecting the consumer health. The paper summarized and reviewed the updated cosmetics industry regulations in 2016 and the results of spot check by the regulators, providing more detailed regulations to support and reference for the cosmetics related enterprises.

Technical Specification for Safety of Cosmetics (2015)

Technical Specification for Safety of Cosmetics (2015)[1](hereinafter referred to as TSSC) is the revised edition of Hygienic Specification for Cosmetics[2](hereinafter referred to as HSC). In November 2015, TSSC was passed at the plenary meeting of cosmetics standard expert committee, promulgated by CFDA and implemented as of Dec 1, 2016.

Introduction

TSSC includes eight chapters. Chapter I involves the overview, including scope, terms and definitions and general requirements for cosmetics safety; Chapter II involves the requirements for banned and restricted components of cosmetics, including requirements for 1,388 banned components and 47 restricted components of cosmetics; Chapter III involves the requirements for permitted components of cosmetics, including requirements for 51 permitted preservations, 27 permitted sun-screening agents, 157 permitted colorants and 75 permitted hair dyes; Chapter IV involves the physical and chemical test methods, recording 77 methods; Chapter V involves the microbial test methods, recording 5 methods;Chapter VI involves the toxicological test methods,recording 16 methods (on November 11, 2016, CFDA released the Announcement No. 147,[3]adding in-vitro 3T3 NRU photo-toxicity test method of chemical raw materials for cosmetics); Chapter VII involves the human safety test methods, recording 2 methods; Chapter VIII involves the human efficacy evaluation and test methods,recording 3 methods.

TSSC has identified several important definitions and terms, such as new raw materials for cosmetics, which refers to the natural or artificial raw materials used in the cosmetics production for the first time in China, and from the point of view of industrial practice, those not listed in the Name Directory of Raw Materials Used in Cosmetics[4](2015); it shall be deemed as new raw materials; the banned components that shall not be used as the raw materials for cosmetics, it may be understood that banned components cannot be added intentionally, but may exist as impurities(safe risk materials) upon risk assessment and confirmation as being safe, rather than illegal substances as deemed by some insiders or media; for the restricted components, they must meet the restricted conditions in the TSSC before being used as the raw materials for cosmetics.

Requirements for raw materials

TSSC are significant update of HSC upon implementation for 9 years. HSC makes reference to the requirements of EU cosmetics directive 76/768EEC,[5]while TSSC do not make reference to the requirements of EU cosmetics regulation EC 1223/2009, however, make reference to the requirements of Japanese, Korean and other national relevant regulations and standards for the banned and restricted substances. It can be said that TSSC is a very strict regulation so far in the world in terms of requirements for raw materials of cosmetics.

TSSC points out that safety risk materials are produced or brought during the production, transportation and storage of raw materials and packaging materials of cosmetics, which might cause potential hazard to human health when exposed to human body. Such materials may be evaluated by reference to the draft version of Guideline for Cosmetics Safety Risk Evaluation.[6]As earmarked in the new specification, packaging material which is in direct contact with cosmetics shall be safe, shall not have chemical reaction with cosmetics, and shall not migrate or release any poisonous and harmful compounds hazardous for human body. At present, there are no test standards and methods specific to packaging materials in the cosmetics industry,but reference to the requirements and test methods for food contact materials and drug packaging materials is made to control the safety.

Cosmetics standards and specifications of China are updated at one time or on a staged basis, while cosmetics standards and specifications of EU and other countries and regulations are updated on a sustainable basis. For example, EU Scientific Committee on Consumer Safety(SCCS) will publish the safety evaluation opinions or guidelines on a monthly basis, and EU cosmetics regulation EC 1223/2009[7]will update the directory of banned and restricted substances on an irregular basis. Such sustainable updating allows the enterprises to understand and predict the ideas and plans of the competent organizations in a timely manner, so that they can adjust the products with ease. At present, China’s disposal on of the banned and restricted substances is still based on the introduction of international standards, in lack of independent risk assessment; therefore, updating at one time might be more adaptive to the national conditions at the present stage.

Counter measures

To ensure the smooth implementation of TSSC, CFDA released the Announcement on Related Matters about Implementation of TSSC for Safety of Cosmetics (2015)(2016 N0. 108).[8]Such announcement is the specific interpretation of requirements for the transitional period of TSSC and the product information change. Since implementation of the new specification, many smalland medium-sized enterprises (SMEs) have encountered the problem of product formula updating and upgrading.In particular, the preservative systems and product labels shall be updated, and generally, it shall take half a year to replace the raw material suppliers and to develop the new products; therefore, the SMEs must to complete the product upgrading.

Two-in-one license

To further strengthen the cosmetics production supervision and to guarantee the cosmetics quality safety, CFDA released the Notice on Relevant Work of Cosmetics Production Permit,[9]requiring the cosmetics production enterprises holding the original National Industrial Product Production License and Cosmetics Manufacturing Enterprise Hygiene License must obtain the new version of Cosmetics Production License within the period from January 1, 2016 to December 31, 2016,and since January 1, 2017, the enterprises without the Cosmetics Production License shall not continue the production. Such new specification is called “two-in-one license” in a nutshell.

As requested by the new license, 105 items shall be inspected for the cosmetics production license, including 26 key items, 71 general items and 8 recommended items.Such items are by reference to the ISO 22716 and the Good Manufacture Practice of Cosmetics (GMPC). It can be said that the new production license after the “two-in-one license” is the Chinese GMPC certificate. As mentioned in Article I (5) of Work Specification for Cosmetics Production License, enterprises engaging in cosmetics production shall meet the relevant specifications of national industrial policy. Such article is specific to the toothpaste products. At present, toothpaste industry is one of the national regulatory industries, and it is difficult for such industry to obtain the approval.

“QS” mark on the cosmetics labels

Before institutional reform of the State Council,Administration of Quality and Technology Supervision was responsible for management of cosmetics production and issuance of production license, and the products may be indicated with “QS” mark. However, after institutional merger, Administration of Quality and Technology Supervision would not issue the production license, the “QS”mark lost the legal perspective. Cosmetics terminal operating enterprises such as supermarkets and department stores were not aware of the institutional function adjustments and new requirements of the State Council, and still compulsively required the cosmetics enterprises to print the “QS” mark on the packages when the products are marketed in such places,causing troubles to many cosmetics enterprises.

On June 1, 2016, CFDA stipulated in the Reply on the Relevant Problems of Cosmetics Identification(S.Y.J.B.Y.H.J.H. (2016) No.386) and the Announcement on the Relevant Matters of Cosmetics Production License(2015 CFDA Announcement No. 265) that from July 1,2017, the cosmetics produced must use the new packaging identification indicated with the information of the Cosmetics Production License, and the new packaging identification shall not be indicated with the “QS” mark anymore. Original packaging identification of cosmetics manufacturing enterprises can be used until June 30,2017, and the cosmetics produced with the original packaging identification before then may still be marketed within the shelf life.[10]

It is clearly indicated in the Document No. 386 that“QS” is not a compulsive identification anymore, which plays a positive role in normalizing the industries and identifying the obligations.

Sunscreen effect identification

On June 1, 2016, to further normalize the sunscreen effect identification management of sunscreen cosmetics,CFDA developed the Requirements for Sunscreen Effect Identification Management of Sunscreen Cosmetics.[11]Since December 1, 2016, for the sunscreen cosmetics under application for administrative license, the sunscreen effect identification shall meet the requirements in the Announcement. For the sunscreen products that have obtained the approval number before then, the product packages may be used until June 30, 2017, and the related products may be marketed until the shelf life.

The claims in the sunscreen products shall be consistent with the results of the sunscreen test methods in the TSSC. The new specification has pointed out that the maximum SPF identification may be up to 50+, while the maximum SPF identification previously was 30+ only; the PA identification has been also changed, the maximum identification is “PA++++”. At present, the identification of sunscreen products sold in the foreign markets has been up to SPF 50+ and even SPF 70+, and many consumers are praising the products with high SPF; it is of slight significance to purely restrict the SPF identification of domestic products.Therefore, such updating conforms to the international trend, creating a fair competition environment.

Naming of cosmetics

On April 15, 2016, Guangdong Food and Drug Administration (GFDA) stipulated in the notice on forwarding the Reply of CFDA on Relevant Matters about Naming of Domestic Cosmetics for Non-special Purpose[12]that the cosmetics under new application for filing shall not be named with “doctor” and other related words, and that the filed cosmetics that have used “doctor” and other related words in this vein shall be canceled before December 31, 2016, and it is not allowed to continue the production.

There is no concept of “cosmeceuticals” in the cosmetics regulation system of China. On July 11,2011, CFDA clearly stipulated in the Notice on Further Strengthening the Illegal Cosmetics Identification Supervision and Inspection[13]that: Identifications and claims of “cosmeceuticals”, “medical skin-care products”and other exaggerated propagandas and medical terms in the product labels, small packages or package inserts shall be deemed as illegal behaviors. Therefore, any indicated or implied “medical” or “medicinal” efficacy claims shall be deemed as illegal propagandas.

Results of spot check by cosmetics regulators in China

Announcement of CFDA on the spot check results

With respect to the sunscreen cosmetics, CFDA announced in July 2016, that three batches of non-conforming products(the restricted sun-screening agents) were not conforming to the requirements in the HSC (2007), announced in August 2016 that 84 batches of products were found to contain inconsistent sun-screening agent ingredients with the approvals and the identified ingredients, announced in September 2016 that 79 batches of products were found to contain inconsistent sun-screening agent ingredients with the approvals and the identified ingredients, and announced in October 2016 that 156 batches of products were found to contain inconsistent sun-screening agent ingredients with the approvals and the identified ingredients, including many famous brands at home and abroad.[14～17]Special purpose cosmetics are sunscreen cosmetics and the production of cosmetics for special purpose must obtain the approval of CFDA. The products shall obtain the approval number before production. The above-mentioned sun-screening agent ingredients were not conforming to the product approvals and the identified ingredients, inconsistent with the Regulations Concerning the Hygiene Supervision over Cosmetics, the Regulations for Cosmetics Identification Management and other relevant regulations.

These four announcements involved many products and brands, reflecting many common problems in the industry. It takes at least one year to obtain the product license or approval for production of cosmetics for special purpose, and the cosmetics industry is a FMCG industry or a fashion industry in itself, where the product upgrading is fast. The approval time should not exceed one year. In the US, sunscreen products are OTC(over the counter), under strict supervision, but FDA has developed a monograph for sunscreen products,stipulating the requirements for active matter category and concentration and for product labeling. As long as the enterprise’s formula design meets the requirements in the monograph, the products may be directly marketed upon SPF test without approval. Competent organizations of China may organize the experts to develop a monograph for the sunscreen products or other cosmetics for special purpose by reference to the requirements of the FDA,so that the approval time can be shortened greatly.On the other hand, the supervision and punishment shall also be strengthened, and the enterprises shall be guided to conduct legal production, so as to promote the development of the industry.

In March 2016, CFDA released the 2016 Announcement No. 26 to make public the spot check results of cosmetics supervision, 39 batches of mask cosmetics had the problem of illegal addition of banned substances, and the products of 11 enterprises were detected to contain the banned substance clobetasol propionate (glucocorticoid).[18]On November 4, 2016, CFDA released the 2016 Announcement No. 140[19]again to make public that 50 batches of mask cosmetics had the problem of illegal addition of banned substances, and that all the non-conforming products were detected to contain clobetasol propionate, betamethasone,triamcinolone acetonide, triamcinolone acetonide 21-acetate,betamethasone dipropionate, beclomethasone dipropionate,betamethasone 17-valerate or other glucocorticoids.

Glucocorticoids are banned substances. The detected banned substances in the products might be added by the enterprises intentionally, but more often, they are brought by the raw materials due to non-strict control of the enterprises over the raw material suppliers. Therefore,glucocorticoids and other banned substances shall be controlled in the raw materials, particularly the functional raw materials.

Announcement of GFDA on the spot check results

At the beginning of 2016, Guangdong FDA released the Announce-ment on the Non-conforming Cosmetics,[20,21]67 batches had the problem of illegal addition of banned substances and 15 batches had the problem of illegal use of restricted substances, including OOS of heavy metals(mercury) and illegal use of glucocorticoids (dexamethasone,dexamethasone acetate, clobetasol propionate, betamethasone and betamethasone 17-valerate) and antibiotics(metronidazole, chloram-phenicol and ofloxacin). In the middle of 2016, Guangdong FDA released the Announcement on the Non-conforming Cosmetics[22]again, 2 batches had excessive content of heavy metals (mercury).On October 26, 2016, Guangdong FDA released the Announcement on the Non-conforming Cosmetics[23]21 batches had illegal addition of heavy metals (mercury),antibiotics (metronidazole and chloramphenicol) and glucocorticoids (beclomethasone and triamcinolone acetonide).

In fact, the problems of non-conforming cosmetics mainly include excessive content of heavy metals and illegal use of antibiotics and glucocorticoids. It is stipulated in HSC and TSSC that antibiotics, glucocorticoids, mercury and mercury compounds are banned components;phenylmercuric salts (including phenylmercuric borate)and merthiolate are restricted components, the maximum allowable concentration thereof in cosmetics is 0.007%(calculated by mercury), and if mixed with other mercury compounds allowed to be used in the TSSC, the maximum allowable concentration thereof is still 0.007%,and they are only used in eye cosmetics and eye makeup removers and must be indicated on the labels; if mercury is impurity, the restricted value in cosmetics is 1mg/kg.

It is pointed out in the Guangdong Cosmetics Safety Risk Management Annual Report (2015-2016) released by Guangdong FDA[24]that in the supervisory testing of cosmetics commercially available in Guangdong in 2015(non-random, targeted in the spot check), 48 out of 135 batches of whitening, freckle removing and acne removing products had illegal addition (accounting for 35.6%). In the supervisory testing of functional cosmetics (online) in Guangdong in 2015 (non-random), 22 out of 81 batches of acne removing, freckle removing and whitening products had illegal addition (accounting for 27.2%). It can be seen that rapid whitening, acne removing and freckle removing products propagandized online or offline have high risk,consumers shall be cautious when purchasing.

With respect to the cosmetics manufacturing enterprises and operating enterprises, in the Announcement of Guangdong FDA on the Supervision and Inspection Results of Guangdong Cosmetics Enterprises, 35 cosmetics manufacturing enterprises and 51 cosmetics operating enterprises failed to perform the entity responsibility for quality safety.[25,26]With respect to the product filing of cosmetics operating enterprises, as announced in the Document, a few enterprises failed to verify the product filing.[27]On November 2, 2016, Guangdong FDA asked for opinions on the Measures for Online Operation, Supervision and Management of Cosmetics in Guangdong (draft version),focusing on the responsibilities and obligations of cosmetics operating platforms.[28]

Summary

In 2016, Guangdong FDA and GuangdongFDA made repeated announce-ments on spot check of cosmetics and cosmetics enterprises, indicating that the cosmetics supervision was increasingly strengthened, and that the spot check was more targeted and scientific. The implementation of TSSC and the exchange of Cosmetics Production License had the greatest effect on the entire industry, constituting significant challenges to the product formula redesign and the production condition. In 2017, along with the advancement of revision of Regulations Concerning Supervision and Management of Cosmetics and Guideline for Cosmetics Safety Risk Evaluation, inclusion of simplified application for new raw materials of plant cosmetics and more alternative methods in the TSSC might become an important event that influences the entire cosmetics industry.

[1] CFDA. Technical Specification for Safety of Cosmetics (2015),2015.

[2] National Health and Family Planning Commission. Hygienic Specification for Cosmetics (2007), 2007.

[3] CFDA. CFDA Announcement on Inclusion of In-vitro 3T3 NRU Phototoxicity Test Method of Chemical Raw Materials for Cosmetics in Technical Specification for Safety of Cosmetics(2015) (2016, No. 147). http://www.sda.gov.cn/WS01/CL0087/166246.html?from=groupmessage&isappinstalled=0. 2016.

[4] CFDA. CFDA Announcement on Release of Name Directory of Raw Materials Used in Cosmetics (2015, No. 105). http://www.sda.gov.cn/WS01/CL0087/140365.html. 2015.

[5] European Union. Council Directive of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (76/768/EEC). Official Journal of the European Union, 1976, L 262, 169-200.

[6] CFDA. Department of Drug and Cosmetics Registration asked for opinions on the Guideline for Cosmetics Safety Risk Evaluation. http://www.sda.gov.cn/WS01/CL0781/134401.html. 2005.

[7] European Union. Regulation (EC) No 1223/2009 of the European parliament and of the council of 30 November 2009 on cosmetic products. Official Journal of the European Union,2009, L 342, 59-209.

[8] CFDA. CFDA Announcement on Relevant Matters about Implementation of Technical Specification for Safety of Cosmetics (2015) (No. 108). http://www.sfda.gov.cn/WS01/CL1870/154563.html. 2016.

[9] CFDA. Announcement on Relevant Matters of Cosmetics Production License (No. 265). http://www.sfda.gov.cn/WS01/CL0087/138486.html. 2005.

[10] CFDA. Reply on Relevant Problems of Cosmetics Identification (S.Y.J.B.Y.H.J.C.H. (2016) No. 386). http://www.sfda.gov.cn/WS01/CL0846/154561.html. 2016.

[11] CFDA. Announcement on Release of Requirements for Sunscreen Effect Identification Management of Sunscreen Cosmetics (2016, No. 107). http://www.sda.gov.cn/WS01/CL1272/154562.html. 2016.

[12] GFDA. Notice on forwarding the Reply of CFDA on Relevant Matters about Naming of Domestic Cosmetics for Non-special Purpose. 2016.

[13] CFDA. Notice on Further Strengthening the Illegal Cosmetics Identification Supervision and Inspection (S.Y.J.B.B.H. [2011]No.108). http://www.sda.gov.cn/WS01/CL0846/64012.html. 2015.

[14] CFDA. CFDA Announcement on 3 Batches of Non-conforming Sunscreen Cosmetics (2016, No.110). http://www.sfda.gov.cn/WS01/CL1753/160115.html. 2016.

[15] CFDA. Announcement on Non-conformance of Actually Detected Sun-screening Agent Ingredients in 84 Batches of Sunscreen Cosmetics to Product Approvals and Identified Ingredients (2016, No.116), 2016.

[16] CFDA. Announcement on Non-conformance of Actually Detected Sun-screening Agent Ingredients in 79 Batches of Sunscreen Cosmetics to Product Approvals and Identified Ingredients (2016, No.125), 2016.

[17] CFDA. Announcement on Non-conformance of Actually Detected Sun-screening Agent Ingredients in 156 Batches of Sunscreen Cosmetics to Product Approvals and Identified Ingredients (2016, No.137). http://www.sfda.gov.cn/WS01/CL1753/165163.html. 2016.

[18] CFDA. Announcement of CFDA on 39 Batches of Nonconforming Mask Cosmetics from 11 Enterprises including Ailushi Cosmetics Factory, 2016.

[19] CFDA. Announcement on 50 Batches of Non-conforming Mask Cosmetics (No. 140). http://www.sfda.gov.cn/WS01/CL1753/165941.html. 2016.

[20] CFDA. Annoucement on Non-conforming Cosmetics (2015,Issue 9) (Y.S.Y.J.J.Z. (2015) No.170). http://www.gdda.gov.cn/publicfiles/business/htmlfiles/jsjzz/s7494/201601/316066.htm. 2016.

[21] CFDA. Announcement of GFDA on Non-conforming Cosmetics (2016, Issue 1) (Y.S.Y.J.J.Z. (2016) No.12). http://www.gdda.gov.cn/publicfiles/business/htmlfiles/jsjzz/hzpxfjg/201601/316838.htm. 2016.

[22] CFDA. Announcement on Non-conforming Cosmetics (2016,Issue 2) (Y.S.Y.J.J.Z. (2016) No.87). http://www.sfda.gov.cn/WS01/CL1754/156861.html. 2016.

[23] CFDA. Announcement on Non-conforming Cosmetics (2016,Issue 3) (Y.S.Y.J.J.Z. (2016) No.188) http://www.gdda.gov.cn/publicfiles/business/htmlfiles/jsjzz/s10778/201610/330893.htm. 2016.

[24] CFDA. New Edition of Cosmetics Risk Management Annual Report issued by GFDA. http://www.gdda.gov.cn/publicfiles/business/htmlfiles/jsjzz/pzxdt/201606/323927.htm. 2016.

[25] CFDA. Announcement on Supervision and Inspection Results of Cosmetics Manufacturing Enterprises (Y.S.Y.J.J. [2015]No.168). http://www.gdda.gov.cn/publicfiles/business/htmlfiles/jsjzz/s7494/201601/316067.htm. 2016.

[26] CFDA. Announcement on Supervision and Inspection Results of Cosmetics Operating Enterprises (2016, Issue 1) (Y.S.Y.J.J.Z.(2016) No.11). http://www.gdda.gov.cn/publicfiles/business/htmlfiles/jsjzz/s7494/201601/316875.htm. 2016.

[27] CFDA. Announcement on Supervision and Inspection Results of Cosmetics Operating Enterprises (2016, Issue 2) (Y.S.Y.J.B.Z.(2016) No.262). http://www.gdda.gov.cn/publicfiles/business/htmlfiles/jsjzz/s7494/201606/324341.htm. 2016.

[28] CFDA. An Announcement for opinions asking for the Measures for Online Operation, Supervision and Management of Cosmetics in Guangdong (draft version), 2016.