Cosmetics

On 06.11.2019, the China NDRC (National Development and Reform Commission) announced (No.20-2019) the prohibition of daily chemical articles containing plastic microbeads for production after December 31, 2020, and for sale after December 31, 2022.Microbeads are small plastic particles, mostly included in cosmetic and cleaning products, and are known to cause water pollution to the marine and freshwater environments. Currently, 14 states have already taken action towards the ban on microbeads. Although the details of the ban for production and sales in China is still subject to further refinement, brands and manufacturers are expected to reformulate their products containing microbeads, while some have already replaced microbeads with natural abrasives as an alternative in daily chemical articles.The announcement (No.20-2019) is based on the Industrial Structure Adjustment Guidance Catalogue (2019 Edition) that was approved at the 2nd committee meeting on 27.08.2019, and has replaced the 2011 version since 01.01.2020.

On 22.11.2019, China's NMPA (National Medical Products Administration) announced a draft regulation concerning overseas inspection for cosmetic products, and launched the public consultation to receive feedback.According to the proposed regulation, it aims to introduce, standardize and optimize the inspection process. Once adopted, inspections on foreign manufacturers are required to be conducted by Chinese authorities from NMPA, which includes on-site inspections for any overseas facilities involved with the manufacturing process of cosmetic products that are intended to be sold in the China market.China NMPA will continue to solicit public opinions until 22.12.2019.

On 10.09.2019, the NMPA (National Medical Products Administration) announced changes to the procedures regarding cosmetics sample tests in China (No. 72-2019), followed by an interpretation of their announcement on 12.09.2019. Laboratories - that perform sample tests for cosmetics NMPA approval - need to re-apply for their qualification as a testing institutions because the relevant qualification will be automatically suspended on 01.11.2019. Until then - during the transitional period - there are two possible methods for managing tests. Cosmetics enterprises can follow the original procedures offline, as well as apply for sample tests online. Starting on 01.11.2019, however, laboratories have to be newly accredited. Furthermore, cosmetics enterprises and their NMPA Legal Agents will only be able to apply for and manage tests, which are related to cosmetics registration/filing, online.1) The goal is to improve the testing workflow, to standardize the test project requirements, to improve the efficiency of tests, and to provide strong technical support for cosmetics safety supervision.2) The prerequisite for testing institutions is to submit relevant information and obtain a new certification from the CMA (China Inspection Body and Laboratory Mandatory Approval).3) New guidelines for testing institutions include that testing must not be subcontracted, quality management system has to be ensured, testing work procedures for cosmetics registration and documentations have to be standardized, the facilities and equipment have to meet requirements.4) In order to improve work efficiency, an “Inspection Information System” was introduced to optimize the workflow of testing institutions. Via the online system, cosmetics manufacturers select a testing institution, submit relevant product information and apply for testing. The testing institution can then accept the test application and issues the test report online after testing.5) Changes in managing test samples include:Firstly, rather than regulatory authorities performing the on-site test sample sealing, the testing insitution seals the test samples. This change only applies to domestic “special” cosmetics.Secondly, laboratories accept samples produced for the purpose of testing if the product is not sold yet. (Please note, however, that the NMPA requires a product to be already sold in the country of origin.)6) The test requirements are changed to emphasize the safety of products during evaluation and some test items will be adjusted to better reflect the safety situation of products; for instance, by measuring dioxane.7) During the transition period – until 31.10.2019:Firstly, testing institutions should apply for their qualification because on 1 November, the old ones will be terminated.Secondly, already approved cosmetics, whose tests do not comply with the new specifications anymore, have to undergo supplementary testing a year of the announcement.Third, cosmetics manufacturers can follow the old (offline) way of applying for and managing tests, as well as the new “online” way.

On 01.08.2019, the NMPA released a notice changing the consultation service of the “National Institute for Food and Drug Control” regarding cosmetics approval applications (No. 245-2019).1) Questions regarding the technical review of cosmetics, on-site consultation is available every Tuesday afternoon.2) Questions regarding the administrative/format review of cosmetics, telephone consultation is available all day on Tuesdays and Thursdays.

On 10 July 2019, the Italian association for cosmetics industry (Cosmetica Italia) hosted a seminar on the regulatory environment of cosmetics in China. The seminar was held in collaboration with Cisema, which is specialised in the registration and certification of cosmetics in China.Following the seminar, Miriam Bandinelli, a Cisema business consultant, shared her knowledge in 2B2 interviews with individual member companies. The response was very positive: 50 Italian companies attended the event in person and via webinar. This shows the great interest of Italian companies in China, one of the main markets of the cosmetics industry.

Simplified Registration of Cosmetics.The registration procedure for conventional cosmetics at Shanghai FDA has been simplified.In February 2017 NMPA published two new regulations, i.e. NMPA Ann, . # 7, 2017 (Filing Management of First Import Non-special Use Cosmetics through Shanghai Pudong) and NMPA Ann. #10, 2017 (Procedures for Filing Management of First Import Non-special Use Cosmetics through Shanghai Pudong)Based on these regulations, which are preliminarily valid for a test period (01.03.2017 to 21.12.2018) a simplified filing process for conventional cosmetics is applicable.The new regulations are only valid for cosmetics imported through Shanghai Pudong New Area. The so-called China-Responsible is a new concept in cosmetics management aspect. The China-Responsible, who has to be registered in the Shanghai Pudong New Area, is not just a legal agent for filing, but also functions as importer and distributor.The advantage of this new procedure is that the filing for conventional cosmetics at SH FDA can be made in one day, whereas the official way through NMPA registration may take up to three months. On top, the certificate issued by SH FDA does not have to be renewed after four years.Further information on the above topic can be obtained from:Cisema GmbHTel.: +49 89 4161 7389 – 00Fax: +49 89 7484 9956info@cisema.dewww.cisema.com

NMPA – New Application Deadlines for Cosmetics. As of Sept.1^st, 2017 the deadlines for the application of certificate renewals or changes will be as follows:

• Renewal application must be submitted six months before expiry and not four months as before
• Certificate changes, completions or corrections must be applied for ten months before expiry now. Renewal and change applications can be submitted at the same time.
• The technical review by NMPA for a certificate renewal will take three months counting from the acceptance date of the application.

Further information on the above topic can be obtained from:Cisema GmbHTel.: +49 89 4161 7389 – 00Fax: +49 89 7484 9956info@cisema.dewww.cisema.com