News-Beijing Alan-China CFDA registration and approval, sanitary license, cosmetics and more

Beijing Alan keeps our clients updated with the latest industry news...

Going paperless?

Issued on Fri, November 02 2018

In order to further optimize the port business environment and promote cross-border trade facilitation, the General Administration of Customs and the State Drug Administration have announced on Oct. 29, 2018 to implement electronic data networking verification for seven kinds of regulatory documents, including the Import Drug Customs Declaration and Hygiene Permit for both special and non-special imported cosmetics (Announcement No. 148th, 2018). From now on, the two administrations will coordinate tightly and share their respective information synchronously. The purpose of this policy is accord with spirit of the governmental restructuring which had taken place several months ago that multiple administrations would apply the “single window” to operate together. Thanks to this policy, importers and other end users of the customs system will be able to enjoy a more expedited and simplified customs process in the future.   Source: http://www.customs.gov.cn/customs/302249/302266/302269/2064608/index.html 

The Current Status of the Notification Process for Imported Non Special Cosmetics

Issued on Thu, November 01 2018

Since March 12, 2018 this year, CFDA has extended the pilot cites where imported non special cosmetics can be registered through the notification system. So far, a total of 109 companies, with a total of 1745 cosmetic products have completed the notification process through Shanghai Pudong New District, which has tripled the number compared to last year. While for the rest 9 cites, there is only one company with one product registered through Zhejiang and one company with 7 products registered through Guangdong. Imported cosmetics notification is viewed as a long-term development strategy as part of the governmental restructuring in China. Products registered through the notification system can start importing prior to technical review. Notification permit also does not require renewal every four years. Whereas the traditional registration method can only grant product entry post technical review approval, which can prolong the process by up to three months. Products registered with traditional method also will be required to have administrative renewal in every four years. Once matured, the notification system will offer a more simplified entry process with faster speed. However, the notification system is still in the process of becoming fully streamlined in reality. The lack of systematic and complete guidance is viewed as a main obstacle for products that are seeking to take advantage of the new system. Currently China government is keeping both the registration and notification systems. Foreign brands are free to weight between the pros and cons of the dual systems and choose the most ideal method for their product’s legal entry into China. Reference:http://ft.zybh.gov.cn/province/webquery/list.jsp http://www.gov.cn/xinwen/2018-03/13/content_5273664.htm   

CFDA’s latest official replies to common questions in the cosmetics registration process

Issued on Mon, August 13 2018

CFDA recently published its replies to some common questions regarding the cosmetics registration process in an update on its official website. Frequently raised questions and other practical major concerns such as formula and label requirements, testing methods of specific category products, ingredients that require physical and chemical testing and other important issues were covered in the replies. Each reply from CFDA is of guiding significance, and shall be regarded as potential standard for the future cosmetics registration process. Highlight: New regulatory requirements demands more tests to be done in order to obtain registration. For example, for special use cosmetics could contain ingredients such as Benzophenone-2 , Diethylamino hydroxybenzoyl hexyl benzoate,  Diethylhexyl butamido triazone, Benzylidene camphor sulfonic acid as UV filter, which now will need to be tested on its actual content through test. This could affect new products in process, and or also products in renewal process with the CFDA. Detailed replies may be found in the following link: http://www.zybh.gov.cn/n?menu=12&key=%E5%A4%96%E9%83%A8%E7%BD%91%E7%AB%99-%E5%8C%96%E5%A6%86%E5%93%81&from=timeline&isappinstalled=0 

No more Animal Testing?

Issued on Fri, July 27 2018

China require animal testing on all imported cosmetics. This applies to all categories from creams, sun block, skin whitener hair dye to deodorants. This is a mandatory requirement by the law. It is a controversial topic that present difficulties for European exporters wishing to access the Chinese market.  Following the complete ban of animal testing in Europe, China is looking into alternative methods, but the current stand remains the same. There are reported news channels that say that China will have animal free testing pilot program, but there is no official statement or regulation published of such for imported cosmetic products. China has waived, but not banned, animal testing for domestically produced non-special use cosmetics, like nail polish and perfume. It can either be manufactured in China, or formulations can be imported in bulk into China and then packed. Semi manufacturing would be considered as domestically produced making it possible to waive the animal testing. 

ALAN regulatory presentation at Beauty Cluster Barcelona

Issued on Wed, June 20 2018

On June 13, 2018 The Beauty Cluster in Barcelona held a session about Registration of Cosmetic in China and market Data. ALAN attended as speaker and talked about the challenges that comes with sanitary permit, the regulatory barriers, and procedures and timelines. More than 80 professionals of the sector attended the event. Publication: http://beautyclusterbarcelona.com/es/celebrada-la-sesion-registro-cosmeticos-china/ 

Institutional Restructuring For CFDA

Issued on Thu, June 07 2018

On March 13th, The State Council has announced the passing of a proposal for institutional restructuring during the First Annual Session of the 13th National People's Congress. According to this proposal, China Food and Drug Administration (CFDA), together with three other administrations will be reorganized into the new State Administration for Market Regulation (SAMR). The new SAMR will take over the responsibility of registration and approval of cosmetics and special food products. Source:http://samr.saic.gov.cn/jg/zjzz/ 

Alan's Korean Branch

Issued on Thu, April 26 2018

Alan's Korean branch, ALAN KOREA CO.,LTD. has now been officially and legally established. More details: 조선 알란그룹, "국내 화장품 업체들과의 소통 창구 역할" 위해 한국에 지사 설립 http://danmee.chosun.com/site/data/html_dir/2018/04/26/2018042601672.html     동아 알란 그룹 한국지사 설립…“한국기업의 중국 CFDA 인증 도움줄 것” http://bizn.donga.com/3/all/20180426/89808013/2     한국경제 중국 CFDA 화장품-건강기능식품 허가인증 1위 ‘알란그룹’ 국내 진출한다 http://news.hankyung.com/article/201804259435q     bnt뉴스 중국 화장품 위생허가 및 건강기능식품 인증허가업체 ‘알란그룹’ 국내 진출 http://bntnews.hankyung.com/apps/news?popup=0&nid=03&c1=03&c2=03&c3=00&nkey=201804251718033&mode=sub_view 

CFDA restructured as National Market Supervision Administration?

Issued on Thu, March 15 2018

China’s State Council on Tuesday draft plan to consolidates Bureau government ministries organizational structure, with the China Food and Drug Administration (CFDA), along with several other administrations, restructured as the National Market Supervision Administration. The draft would mean the State Council will be composed of 26 ministries and commissions. The CFDA would no longer be a standalone department but will be part of a larger integrated administration. It is expected not to have affect on the day-to-day work. National legislators are scheduled to vote on the draft plan on Saturday. 

10 more cities to process Imported regular use cosmetics notifications

Issued on Mon, March 12 2018

The regulator is extending 10 more Pilot free trade zones that can register Imported Non Special Cosmetics through a Notification process. It is following the pilot notification system in Shanghai Pudong District Free Trade Zone since last year. The government is opening up TianJin, LiaoNing, ZheJiang, FuJian, HeNan, HuBei, GuangDong, ZhongQing, SiChuan and ShaanXi starting March 12 to December 21 this year 2018. You will need to appoint a local responsible entity to process and held accountable for the notifications. Be mindful when choosing to go for notification process the imported cosmetics may be only imported through the specific trade zone you processed the registration. Reference: http://www.sfda.gov.cn/WS01/CL0087/226149.html 

More market inspection testing?

Issued on Fri, February 09 2018

Starting September this year inspecting government organizations have the legal tools and testing capability to more strictly regulate cosmetics. A list of 20 new test standards for cosmetic ingredients and its raw material criteria will be enforced. For example, when importing  cosmetics, it may happen that a cosmetic would be tested on banned substances, such as 20 dyeing ingredients. Or may test up to 20 whitening ingredients in cosmetics. Or for exporting cosmetics the whitening ingredients test could serve as efficiency report. It is unsure if the CFDA registration process would enforce these standards at the same time. http://www.sac.gov.cn/, http://news.sina.com.cn/c/2018-02-09/doc-ifyrkzqr0215935.shtml  

CFDA solicits public consultation on a new cosmetic classification system

Issued on Thu, January 18 2018

Issued on January 17 CFDA published a draft for comments regarding a renewed cosmetic category system. CFDA followed principles as used in the European Union and USA categorizing cosmetics on basis of claims, usage instruction such as which part of the body to be used, how to use it, and its users group. The drafts recommends the use of systematic codes in order to determine the categories. Opinions and suggestions may reach CFDA through official website, mail or fax.     Source and draft available: http://www.sda.gov.cn/WS01/CL0050/222862.html  

CFDA announces to increase and tighten market inspections

Issued on Thu, January 18 2018

Issued on January 9 All provinces related FDA departments are to follow the guidelines issued on cosmetic inspections. With the cosmetic market expanding in China, the role for government to regulate and control is becoming more demanding as well. For details please see the source : http://www.sda.gov.cn/WS01/CL0846/222100.html  

Pilot program Non-special use cosmetics

Issued on Wed, January 03 2018

Since March 3, 2017, governmental departments in China have made it possible with a pilot program for implementing a registration process for non-special use cosmetics imported into Pudong New District of Shanghai. So far, a total of 42 companies, with a total of 676 cosmetic products have completed the notification process through this pilot. Mostly large brands such as Shiseido, Lancôme, Chanel, and Guerlain with color cosmetics, make-up and lip products are the majority. The total amount of participating products is low compared to the cosmetic applications for approval certificate registration received annually by the CFDA in Beijing. Companies participating the pilot must have a local responsible entity registered in Shanghai Pudong New District, and are restricted only to be imported through the port of Shanghai. There is also a mandatory market inspection that could be a barrier for participating the pilot. In order to increase the participants, officials have announced that the scope for local responsible entity would be expanded to not only Pudong New District, but also Jingan district. Next year government will issue a further guidance on the pilot program.  

CFDA releases announcement on registering and filing of cosmetics products

Issued on Thu, December 07 2017

In order to ensure that the information of cosmetics manufacturer on the new Cosmetics Production Licence is consistent with th recorded registration information, CFDA has released official annoucement (2017 No. 195) on the relevant matters . Source: http://www.sfda.gov.cn/WS01/CL0050/218065.html 

China to lower import duties on some consumer goods.

Issued on Wed, November 29 2017

Starting December 1st 2017 China will reduce import tariffs on a selection of consumer goods. Import tariffs will be cut from an average 17.3% to 7.7% on products including cosmetics, food, health food products, medicines, clothes etc. and other daily goods.   The reduction follows since the last import duties reduction in 2015, with increasing demand for imported consumer goods. This latest reduction is said to be made in response to the rising demand for quality goods (amongst the success of Single's day 11/11 and Black Friday) that cannot currently be met domestically and would allow for increased consumer choice.   Link to government notice: http://gss.mof.gov.cn/zhengwuxinxi/zhengcefabu/201711/t20171123_2755506.html   Source: http://www.gov.cn/xinwen/2017-11/25/content_5242090.htm 

CFDA solicits public consultation on the Regulations for Legislation Procedures of CFDA (Draft)

Issued on Tue, November 21 2017

In order to further standardize the procedures of legislation, ensure the quality and improve the efficiency of legislation, CFDA has drafted the Regulations for Legislation Procedures of  CFDA (Draft) and is now openly soliciting consultation from the public. Opinions and suggestions may reach CFDA through official website, mail or fax.     Source: http://www.sda.gov.cn/WS01/CL0783/217012.html 

CFDA issues the Methods of Supervision and Administration of Food Safety and Online Catering Services

Issued on Tue, November 14 2017

In order to strengthen the supervision and administration of food safety and online catering services, regulate the operation of online catering services and ensure food safety and public health, China Food and Drug Administration (CFDA) issued the Methods of Supervision and Administration of Food Safety and Online Catering Services  (CFDA Order No. 36) on November 6, 2017. The Methods comprises 49 articles and will come into effect as of January 1, 2018. Source: http://www.sda.gov.cn/WS01/CL1199/216689.html 

CFDA has drafted the Guidelines for Safety Risk Assessment of Cosmetics (consultation paper)

Issued on Mon, November 13 2017

In order to  standardize and guide the safety risk assessment work and ensure the safety of cosmetics consumption, the department of drug and cosmetics registration and administration of CFDA has drafted the Guidelines for Safety Risk Assessment of Cosmetics (consultation paper). It is now open for pulic comments, suggestions and advice. Source:http://www.sda.gov.cn/WS01/CL1172/134401.html 

CFDA seeks advice from the public on its Amendment to the Provisions for Health Food Registration and Filing.

Issued on Mon, November 06 2017

In order to implement and further carry out the reform of administrative approval system, standardize and strengthen the management of health food registration and filing, and improve efficiency of review and approval, CFDA is now seeking advice from the public on its Amendment to the Provisions for Health Food Registration and Filing. The newly-drafed Amendment comprises  74 articles in 8 chapters, aiming to provide relief for the renewal of registration and filing. The public may send suggestions and advice to CFDA from now till November 20, 2017 through the following email address: jinfb@cfda.gov.cn Source: http://www.sda.gov.cn/WS01/CL0050/216307.html   

CFDA issues Amendment to the Provisions for In-vitro Diagnostic Reagent Registration

Issued on Thu, February 09 2017

China Food and Drug Administration (CFDA) issued the Amendment to the Provisions for In-vitro Diagnostic Reagent Registration (CFDA Order No. 30) on January 25, 2017, which shall come into effect as of the date of promulgation. Source:http://eng.sfda.gov.cn/WS03/CL0757/169410.html 

CFDA issues the Provisions for Formula Registration of Infant Formula Milk Powder

Issued on Mon, June 13 2016

In accordance with the requirements of the newly revised Food Safety Law of China, China Food and Drug Administration (CFDA) issued the Provisions for Formula Registration of Infant Formula Milk Powder (CFDA Order No. 26) on June 6, 2016. The Provisions comprises 49 articles in six chapters, and will come into effect as of October 1, 2016. The formula registration management of infant formula milk powder will further urge enterprises to scientifically develop and design product formulas, improve their R&D, production and inspection capacities to ensure the quality and safety of infant formula milk powder. Source:http://eng.sfda.gov.cn/WS03/CL0757/155700.html 

CFDA issues Provisions for Routine Supervision and Inspection of Food Production and Food Business Operation

Issued on Wed, March 09 2016

In order to intensify the routine supervision and inspection to food production and food business operation, fulfill the main responsibilities of food producers and business operators, ensure food safety, the Provisions for Routine Supervision and Inspection of Food Production and Food Business Operation was promulgated on March 4, 2016 as CFDA Order No. 23. The Provisions comprises 36 articles in five chapters, and will be put into force as of May 1, 2016. Source:http://eng.sfda.gov.cn/WS03/CL0757/146608.html   

CFDA issues Provisions for Health Food Registration andfiling

Issued on Wed, March 02 2016

In order to implement the new modes and requirements of the newly revised Food Safety Law on health food registration and filing, further carry out the reform of administrative approval system, standardize and strengthen the management of health food registration and filing, the Provisions for Health Food Registration and Filing was promulgated on February 26, 2016 as CFDA Order No. 22. The Provisions comprises 75 articles in 8 chapters, and will come into force as of July 1, 2016. Source: http://eng.sfda.gov.cn/WS03/CL0757/145740.html 

Supervision of Antibacterial agents and disinfectants label claims

Issued on Mon, November 23 2015

The National health and Family Planning Commission (NHFPC) has warned manufacturers to avoid unacceptable label functional claims. The NHFPC has received complaints about exaggerating product claims of antibacterial agents. Products are not allowed to include label claims outside the scope of the registration, such as cure of certain diseases, or to be used illegally in medical institutions. Antibacterial agents are tested per its function prior to market sales, and not all antibacterial agents are allowed to be used in medical institutions. ONLY with the registered approval of the Health Safety Evaluation Report a product is allowed to be sold on the Chinese market. The NHFPC has issued a notice to work together with the provincial Food Drug Administrations (and local FDA's) to strengthen the supervision and to investigate and punish illegal behavior. See reference: http://www.nhfpc.gov.cn/zhjcj/s9139/201510/5e6398aa1a9d45398c501036f0c628af.shtml,and http://www.nhfpc.gov.cn/zhjcj/s9139/201511/cef85199970e453bb20f0811e22cf1f3.shtml For more information about antibacterial and or disinfection product registration, please contact intl@alanbj.com.     

Stricter policy use of extreme language in advertisements

Issued on Tue, September 08 2015

After The New Advertising Law came into force on September 1 there has been a lot of confusion about the definition of extreme language. According to the New Law when extreme language is being used in advertisement there could be a fine of at least 200,000 Yuan which is the triple fee of the former penalty fee. The law specifically forbids extreme words such as “National grade, Best grade, the Best etc. related words". The latter “etc. related words” has left room for much imagination. Online bloggers are concerned about this specific provision and have been discussing all sorts of related  words that could be also considered as "National grade", or "The Best", such as: national level, global level, the highest level, the biggest, the first, the only, the initial, the first choice, the first-rate, the largest, precise, the top level, the tallest, the most advanced, the greatest extent,Number 1, Top 1, brand leader etc. brand being called out. As currently known, these extreme languages should not appear on the product list page, product headline, subhead, master graph or detail pages, product package and etc. For example an online web shop could be punished with a fine more than 200,000 Yuan or less than 1000,000, for using extreme language or in worst case scenario close down the shop. Whether there is actually “extreme” language will be reviewed case by case by the Industrial and commercial administrative department. However, it is still important for sellers to self -implement inspection and correction, conduct timely modification and changes in order to avoid any punishment. 

Comparison between new and old Cosmetic Health Standard

Issued on Wed, September 02 2015

In recent years, different safety problems have been found in cosmetics, such as excessive heavy metal, forbidden ingredient and etc. which has drawn consumers ‘increasing attention to the safety use of cosmetics. In the meantime, China is gradually conducting stricter market safety supervision and regulation of cosmetics. China Food and Drug Administration (hereinafter referred to as CFDA) published <Cosmetic Safety Technical Standard> (hereinafter referred to as Draft Standard) on its official website to invite opinions. It has updated the name and content to the former <Cosmetic Health Standard (version 2007)> (hereinafter referred to as Current Standard). We will analyze the stricter measures for the CFDA to regulate cosmetics in the new standard by the following four aspects. 1) Overall improvement in definitions: The comparison shows an improvement completing the basis of the Current Standard in order to further increase the accuracy and comprehensiveness on technical matters. Meanwhile, the Draft Standard assimilates <Cosmetic Health Supervision Regulation> and other regulation documents. It also adds definitions, such as the definitions of 9 special use cosmetics, and Draft Standard also gives clear and accurate definitions of former ambiguous definitions, such as colorant, hair dye and etc. The more accurate and comprehensive definitions of common terms are beneficial for guidance on all aspects in cosmetic registration and production; it can give proof to industry insiders as well. 2) Large adjustment to the forbidden cosmetic raw materials and stricter supervision: Draft Standard includes stricter regulation on forbidden and restricted cosmetic ingredients, both of which are adjusted in different extent. It also revises some of the forbidden and restricted ingredient names. It will be important to focus on the changes of the ingredients when preparing registration documents in order to ensure efficient and accurate information. When comparing we can see the difference between Draft Standard and Current Standard. Stricter supervision is the general trend. For example, Draft Standard increases forbidden ingredient quantity and decreases substances of hair dye, preservative and etc. which are not safe for human body. See below specific data: (i) The forbidden ingredients quantity is increased by 6.62% from 1208 to 1288, adding 80 new ingredients. (ii) The forbidden plant and animal origin ingredients quantity is increased by 25.64% from 78 to 98, adding 20 new ingredients, which shows CFDA’s stricter supervision on forbidden cosmetic ingredients. (iii) The restricted preservative quantity is decreased by 8.93% from 56 to 51, which will have certain effect on the preservative manufacturers, who need to adjust their production line in advance according to Draft Standard. (iv) The restricted sun screening agent quantity is decreased by 3.57% from 28 to 27. Draft Standard sets the rule that Aminobenzoic acid can no longer be used as sun screening agent. (v) There is no change on restricted colorant quantity, it is still 156. However Draft Standard does adjust some colorant names and restricted requirements. (vi) The restricted hair dye quantity is decreased by 21.51% from 93 to 73, deducting 20 hair dye ingredients, which is a big adjustment. (vii) The quantity of other restricted ingredient is decreased by 35.61% from 73 to 47, deducting 26 ingredients, which is also a big adjustment. 3). Extra Physical and chemical testing method an operation enhancement: Plenty of additional cosmetic testing and evaluation methods are added to Draft Standard. The quantity is sharply adjusted, which is increased by 177.78% from 27 to 73, amongst total 48 testing methods are added under condition of physical and chemical testing methods for strontium and total fluorine deducted from former testing methods. In the meantime, Draft Standard has more detailed and more precise clarification on testing methods, providing better operations of each testing method including sharing demand reagent, sample pretreatment, device, chromatographic condition and standard atlas. Test organizations could easily establish the testing method based on Draft Standard in case a respective testing method is missing. When comparing, we can see the difference between the cosmetic testing and evaluation methods in Draft Standard and Current Standard. Testing and evaluation methods quantity addition is the general trend with different extent of different ingredient groups. See below specific data: (i) The quantity testing method for forbidden ingredients is increased by 155.55% from 9 to 23, adding 14 testing methods. (ii) The quantity of testing method for restricted ingredients is increased by 133.33% from 6 to 14, adding 8 testing methods. (iii) The quantity of testing method for preservative is increased by 400% from 2 to 10, adding 8 testing methods. (iv) The quantity of testing method for sun screening agent is increased by 900% from 1 to 10, adding 9 testing methods. (v) Current Standard does not have any relative testing method for colorant. Technical Standard has 3 testing methods for colorant which is available for testing of 22 colorants. (vi) The quantity of testing method for hair dye is increased by 100.00% from 1 to 2, adding 1 testing method, which is available for testing of 32 ingredients. (vii) Testing method of anti-dandruff agent is adjusted. The testing method in Current Standard is appropriate for 4 kinds of anti-dandruff agents, one more agent- pyrithione zinc is added in Draft Standard. Besides, parameter of the testing method is adjusted accordingly such as testing wave length and etc. while standard atlas is accordingly revised as well. (viii) The quantity of testing method for anti-infection drug is increased by 200.00% from 1 to 3, adding 2 testing methods, which is available for testing of 19 ingredients. (ix) The quantity of testing method for hormone is increased by 100.00% from 1 to 2, adding 1 testing method, which is available for testing of 7 other ingredients. (x) Current Standard does not have any relative testing method for organic solvent. Draft Standard has 1 testing method for organic solvent which is available for testing of 15 organic solvent. (xi) The quantity of other testing method is increased by 250.00% from 2 to 7, adding 5 testing methods, which is available for testing of 24 other ingredients. From the adjustment proportion, we can see that CFDA has stricter supervision on cosmetics, which should prevent manufacturers from randomly adding forbidden ingredients to cosmetics. Some relative testing measures could trace the finished product which largely increases the supervision strength. In addition, the added ingredients could be tested in officially designated testing center or third party testing institutions. In case the testing center lacks respective testing method, it can establish relative testing method based on Draft Standard, building its relevant testing ability. 5) Small adjustment on testing method of microorganism and other substances: In Draft Standard, testing methods for microorganism, toxicology, human safety and human efficacy did not go through significant amendments, for example, it slightly adjusts the general principal of microorganism testing method, supplements pressure parameter etc. but the overall method does not change a lot. From the wide adjustment in Draft Standard, it shows CFDA’s resolution to carry out stricter supervision towards cosmetics. Although it is only a draft for opinions, it has great reference value. Build on experience from previous years, the final version should not change a lot from this draft. Therefore, for to cosmetic registration applications should prepare for these new methods and plans in advance until the final version comes in force. Source: Beijing Daily Chemical Association 2015-09-02    

Trademark registration “Qiaodan” don’t infringe on Michal Jordan’s famous brand.

Issued on Fri, August 21 2015

The basketball legend has been suing the Qiaodan Sports Chinese Company for years using his unique Chinese name and jumping man logo.   The former Chicago Bull is arguably the most popular international basketball star in China and is known in China as “Qiaodan”. However, the ruling of the Beijing court dismissed the trademark case brought by the USA basketball superstar against the Chinese company using similar name and logo to his Nike-produced brand. China has constantly been criticized by its trade partners over lax protection of intellectual property rights. The law in China only protects registered trademarks. In case your trademark is not registered, the law does NOT protect unregistered trademarks. A strategic move in the trademark system could be carefully considered.  If someone else registered the Chinese version of your international brand name as their company name and trademark, you will be playing catch up (negatively), such as Micheal Jordan’s case. There was a similar case happened to the  popular drug Viagra, before it even hit the Chinese market, the popular Chinese translation for it was already registered by a third party.   Should you need our help with your trademark application, please contact intl@alanbj.com for more information.  

New Draft on Cosmetic Label Management Measures

Issued on Mon, December 01 2014

CFDA recently posted a new draft to further strengthen cosmetic market supervision and especially ensure consumers’ legal rights; the draft is called “Cosmetic Label Management Measures”. The new draft sets sail to protect consumers and to provide an information system that would provide clear and accurate label standards and regulation. New measurements are suggested to control the current cosmetic market and abolish those labels that are not compliant. Should the new draft be enforced major consequences are: -Name and address of the Chinese responsible entity must be included in the label; previously it was optional if the distributor information had been included. -CFDA will take charge of label compliance, and regularly by online platform publish label information of registered cosmetic. Previously labels had to be recorded with the Inspection and Quarantine bureau. -CFDA will crack down on changed packaging that included additional functions not part of the registration submission. -a new detailed requirement for label font and label size and position; Chinese characters size must always supersede the original text. -CFDA will take extra control on the use of unsuitable and prohibited terms for cosmetic, such as medical and/or false exaggerating advertising. With this new draft CFDA wants to uniform and standardize label requirements as it has been for the domestic cosmetic labeling. With a new public integrating label system it is said to prevent labels for being changed approval. Contact intl@alanbj.com for a copy and translation of the CFDA’s the prohibited terms. Reference: http://www.sda.gov.cn/WS01/CL0781/109234.html       

CFDA announces further 22 governmental sanctioned testing institutes for health food products

Issued on Fri, October 18 2013

From 2013, October 1st additional 22 governmental testing institutions are allowed to test health food products. CFDA has selected and added 22 governmental testing centers for testing of the 27 health claims under Chinese regulations. The additional 22 testing agencies will be responsible for evaluation and testing of both domestic and imported health foods. Each testing facility will be accredited to carry our testing for a period of 5 years. Per testing center testing capabilities could differ, so it is dependent on the specific claim being tested certain test centers will be only sufficient. China required pre-market approval of health food by CFDA  and only testing reports from CFDA accredited agencies will be accepted for registration. The extra test institutions will bring solution to the increased demand of imported health food product testing.   The official announcement of CFDA web link: http://www.sda.gov.cn/WS01/CL0847/83064.html 

CFDA to revise the Leading Legislative Cosmetics Regulation

Issued on Mon, September 23 2013

On 11 September of 2013 China State Food Drug Administration has published a notice to invite public opinions, comments and amendments on the revision of “Regulations Concerning The Hygiene Supervision over Cosmetics”. Public commentary is invited before 10 November of 2013. “The Regulations Concerning The Hygiene Supervision over Cosmetics” (1 January of 1990) has been implemented for 23 years and so far has never been revised. As China’s cosmetics industry is rapidly developing as one of the world’s largest cosmetics markets, regulators have decided to revise the Regulation to meet the demands of China’s current market. The Public notice is the first round of opinion-soliciting prior to amendment, designed to get stakeholders’ feedback and promote industry involvement throughout legislative process. Stakeholders are encouraged to make proposal on specific articles in the regulation and submit to CFDA. The CFDA will start the legislative revision process by taking into consideration suggestions made during this consultation period. The draft of this regulation will most likely be available at the end of 2012, and its release will open the second round public consultation. It is uncertain to say, but there has been rumors that China plans to tighten the control over cosmetics that have efficacy claims, such as skin-whitening an anti-wrinkle cosmetic products.     The public notice can be downloaded here: http://www.cfda.gov.cn/WS01/CL0781/92497.html The complete “Regulations Concerning the Hygiene Supervision over Cosmetics” can be downloaded here: http://www.gov.cn/banshi/2005-08/01/content_19081.htm 

SFDA change name into CFDA

Issued on Mon, April 01 2013

On 2013, March 22 State Food Drug Administration  known as “SFDA” has been placed back as a ministerial-level agency directly under the State Council, which is China’s highest administrative body. From now on “SFDA” will be continue as the “CFDA” which stands for China Food Drug Administration.   

CFDA Campaign to Regulate TCM Material Market

Issued on Wed, May 23 2012

  The CFDA has ordered a special crackdown on counterfeit materials used in traditional Chinese medicine (TCM) as well as illegal actions such as artificial dyeing and weight-increasing. The move was announced on May 23rd by the administration as part of a six-month campaign to regulate the TCM materials market and ensure public health. The administration has urged both regular and non-scheduled inspections for the TCM materials market as well as stricter management over the quality of TCM products and the licenses of sellers. The campaign will also focus on illegal practices, including using cheaper materials, dyeing materials to make them look more appealing and artificially increasing the weight of these materials, which are usually sold by the kilogram. According to the CFDA, violators will be warned and urged to rectify their practices. In serious cases, relevant markets will be forced to close. The administration also urged local drug watchdogs to set up an effective mechanism to regulate the TCM material market once the campaign is over. Last week, a joint proposal created by 14 government authorities was released to boost the development of TCM. The proposal includes a five year period to establish a TCM trade and management system and a marketing strategy that is in line with China will also encourage qualified TCM institutions and enterprises to set up overseas branches by establishing joint ventures with foreign companies. Ten TCM institutions are expected to establish such branches by 2015 in South East Asia, Europe, North America and the Middle East.The CFDA has ordered a special crackdown on counterfeit materials used in traditional Chinese medicine (TCM) as well as illegal actions such as artificial dyeing and weight-increasing.   The move was announced on May 23rd by the administration as part of a six-month campaign to regulate the TCM materials market and ensure public health. The administration has urged both regular and non-scheduled inspections for the TCM materials market as well as stricter management over the quality of TCM products and the licenses of sellers. The campaign will also focus on illegal practices, including using cheaper materials, dyeing materials to make them look more appealing and artificially increasing the weight of these materials, which are usually sold by the kilogram. According to the CFDA, violators will be warned and urged to rectify their practices. In serious cases, relevant markets will be forced to close. The administration also urged local drug watchdogs to set up an effective mechanism to regulate the TCM material market once the campaign is over. Last week, a joint proposal created by 14 government authorities was released to boost the development of TCM. The proposal includes a five year period to establish a TCM trade and management system and a marketing strategy that is in line with China will also encourage qualified TCM institutions and enterprises to set up overseas branches by establishing joint ventures with foreign companies. Ten TCM institutions are expected to establish such branches by 2015 in South East Asia, Europe, North America and the Middle East.   

China’s CFDA watchdog reports about contaminated drug capsules

Issued on Fri, April 20 2012

  On April 16, 2012 CFDA suspend the sales and consumption of 13 kinds of drugs packed in capsules confirmed to have excessive levels of chromium. After China Central Television (CCTV) reported in a program on quality issues some capsule medication contain excessive amount of chromium, which is harmful to human health. A total of 13 commonly used drugs were packed into capsules with excessive levels of chromium. CFDA has published the list of drugs and related companies and has given public notice to hold all sales and production until further investigation. CFDA has ordered its provincial-level bureaus to investigate the cases. After investigation results in the eastern province of Zhejiang CFDA has revoked the production license of several capsule producers in the eastern province involved in the scandal of contaminated capsules. References: <http://www.cfda.gov.cn/WS01/CL0844/70817.html> <http://www.cfda.gov.cn/WS01/CL0051/70973.html> <http://www.cfda.gov.cn/WS01/CL0051/70969.html>   

Beijing Alan holds seminar on CFDA registration

Issued on Fri, April 20 2012

  Beijing Alan held a seminar about CFDA (State Food Drug Administration) related health food and cosmetics on April 12, 2012 in partnership with The Korean Chamber of Commerce (Shanghai). Shelly Yuan, director of Beijing Alan Business Solutions, talked about the recent developments and difficulties around CFDA health food registration. Jae Lee discussed the CFDA process for approving cosmetics. Korean skincare and food products in mainland China are rapidly increasing, therefore Beijing Alan hosted in partnership with the Korean Chamber Commerce this seminar to create more understanding about CFDA product registration permit. Ms. Shelly Yuan opened stage giving an overview about CFDA regulations for exporters and manufacturers. She explained how the CFDA is continuing to increase its oversight of regulated domestic and imported products and discussed a range of concerns companies face when preparing their products for sale in mainland China; including product labeling, prior notice, Chinese Agent, and registration requirements. Mr. Jae Lee closed the seminar by discussing the latest issues in the cosmetic and personal care products industry, covering the regulatory compliance for these products. He explained how to differentiate cosmetic ingredients and how to process the registration. Beijing Alan Business Solutions Inc. ©   

China's CFDA starts overseas inspection

Issued on Wed, November 16 2011

  China's State Food and Drug Administration (CFDA) has started to inspect overseas manufacturing facilities in yet another sign of the agency's efforts to bring its practices in line with international standards. The move is increasingly important given the burgeoning growth in the domestic Chinese pharmaceutical market, which is tipped to increase from $40 billion at present to $100 billion in 2015 and $200 billion in 2020, at which point it will become the largest drug market in the world. At the same time, the proportion of imported medicines is also expected to increase, from a current level of around 20%, with domestic producers currently meeting around 50% of demand and joint ventures with foreign drugmakers another 30%. The start-up of overseas inspections - the first block are due to be carried out this month - comes on the tail of a dramatic revision of China's regulations on Good Manufacturing Practice (GMP), which became effective on March 1, 2011 and are due to be universally adhered to in 2015. New pharmaceutical facilities have had to require with the new GMPs from 1 March of this year, with sterile product manufacturers having a compliance deadline of 31 December, 2013. All other organisations must be in adherence by December 31, 2015. Part of that effort has included a revision of its inspection practices, with a shift towards standardized practices, certification procedures and new approaches to the recruitment, training and evaluation of its inspection teams. The overall aim was to bring GMP in line with other developed countries with the introduction of concepts accepted elsewhere, such as the pivotal role of the qualified person (QP) within an organisation's quality department and the use of a risk-management approach in inspections, rather than the old 'checklist' system. The CFDA says 5 to 10 overseas site visits are due to take place over the coming weeks in five countries, with many of the companies involved volunteering for inspection in order to help the agency refine and improve its procedures.   

Evelyn Lauder of cosmetics group dies

Issued on Tue, November 15 2011

NEW YORK — Evelyn Lauder, who with her husband Leonard helped build the Estee Lauder Companies into a global cosmetics giant, has died at the age of 75, the company announced. The New York firm said Evelyn Lauder, who also helped created the "pink ribbon" symbolizing the battle against breast cancer, died Saturday at the age of 75 from complications of non-genetic ovarian cancer. "My mother carried the torch of our company heritage and the values that were passed to her by my grandmother, Mrs. Estee Lauder," said William Lauder, her son. "My mother and father were life partners as well as business partners. They nurtured the culture and growth of the Estee Lauder Companies, and as we grew, my mother was our creative compass and pillar of strength. Together my family and the company celebrate the beautiful person she was." Evelyn Lauder was born in Vienna, Austria, and came to New York when her parents fled from Europe with her during the Nazi occupation. She graduated from New York City public schools and from Hunter College, part of the City University of New York. After receiving her college degree, she was a public school teacher in New York City for several years. In college she met Leonard Lauder, the older son of Estee and Joseph Lauder, owners of a small family cosmetics company, and they married in 1959. That same year she joined the family business. She had many roles including serving as new product director and marketing director. She also measured color standards in makeup, sold products in stores, and made numerous personal appearances. Evelyn Lauder also worked for a number of philanthropic causes in health and human services, education and inner-city schools, the environment, women's causes, and the arts and in 1992, co-created the Pink Ribbon, now recognized as the worldwide symbol of the fight against breast cancer. Copyright © 2011 AFP. All rights reserved.  

베이징 알란 국제부 론칭

Issued on Tue, October 25 2011

베이징 알란 비지니스 솔루션: 국제부 런칭   중국 화장품 위생허가 및 제조약, 의료기기, 건강식품등의 인허가증에 대한 수요와 문의 증가로 국제부를 만들기로 결정했습니다. 이에 인해   한국, 미국, 그리고 유럽의 손님들이 언어 장벽 없이 저희 북경 본사와 소통을 할 수 있게 되었습니다. 중개인을 통하지 않고 저희에게 직접 문의 하실수 있습니다. (비용 절감) 중개인을 통하지 않으므로 시간을 절약하실수 있습니다. 이 분야의 가장 오래된 경험으로 구축된 저희 유통망을 이용하실 수 있습니다.   전 세계 유명회사들이 저희를 믿고 애용해 주시어 이 분야의 선두자로 굳혀진 이미지를 더욱 크게 키워나가겠습니다.  

CFDA Issues An Urgent Notice for Strictly Inspection of PAEs Contained Products

Issued on Tue, August 12 2008

During the inspection of PAEs illegal accession action in Taiwan, related department inspected PAEs from the 8 products in the above 4 companies. CFDA requests the catering services at all levels food safety control sector to strengthen inspection and examination, the products which have been purchased should be stored immediately, and the company should actively cooperate with related department for theproduct treatment and recall working. The Notice also requests the catering services at all levels food safety control sector should report to local government and local control sector when find the questioned products above.   

The CFDA published a listing of approved test institutes for cosmetic testing

Issued on Tue, August 12 2008

Issued in February 2011 (Circular No. 18/2011) The CFDA approved 11 institutes the microorganism, sanitary chemistry and toxicity tests required in the cosmetic testing standard for the application of cosmetic administrative licenses. They are as follows: The Institute of Environmental Health and Related Product Safety (China Center for Disease Control), Beijing CDC, Liaoning CDC, Shanghai CDC, Jiangsu CDC, Zhejiang CDC, Guangdong CDC, Sichuan CDC, Beijing institute for Drug Control, Shanghai institute for Food and Drug Control and the Guangdong institute for Drug Control. In addition, 6 other institutes have been approved to perform the human safety and human sun block effect tests required in the standard. They are The General Hospital of Chinese People's Liberation Army Air Force, Shanghai Skin Disease Hospital, The third Affiliated Hospital of San Yat-sen University, West China Hospital of Sichuan University, The first hospital of China Medical University and the Kin Disease Hospital of Chinese Academy of Medical Sciences. The announcement will come into effect on June 1 2011 and will be valid for 4 years. All the tests for cosmetics products and new cosmetic raw materials must be performed in these approved institutes. The CFDA will supervise the test quality by requiring monthly report and annual reports from the institutes, in addition to non-scheduled on-site inspections. The previous list of 13 test institutes approved by (MoH) was still accepted by CFDA.   

CFDA Moving Notice

Issued on Sun, August 10 2008

Issued in February 2011 (Circular No. 18/2011) The State Food and Drug Administration (CFDA) will move from A38, Beilishi Road, Xicheng District, Beijing to Building 2, No.26 Xuanwumen West Street, Xicheng District, Beijing (not including the Administrative Service Center of CFDA) between December 11 and December 14, 2010. The new address will take effect from December 13, 2010. The official website of CFDA and the service of the Administrative Service Center of CFDA will be temporarily closed from 8:00, December 11, 2010 to 8:00, December 22, 2010. We are sorry for all the inconveniences brought about by the moving. New address: Building 2, No.26 Xuanwumen West Street, Xicheng District, Beijing Postcode: 100053 Telephone: +86 10 6831 3344   

Specification for Cosmetic Product Technical Requirements Issued

Issued on Sat, August 09 2008

Issued in February 2011 (Circular No. 18/2011) he State Food and Drug Administration recently issued the Specification for Cosmetic Product Technical Requirements to further standardize the administrative licensing for cosmetics, improve control over the cosmetics hygiene, quality and safety, strengthen the hygiene supervision on cosmetics production and distribution, and direct the formulation of cosmetic product technical requirements. The Specification will come into force on April 1, 2011.  

 

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