Abbott Fined Nine Million Yuan for the Detection of Vanillin in Stage 1 Infant Formula

Takehome: The tiny amount of vanillin detected in the involved batch of Abbott’s stage 1 infant formula is mainly the residues in pipeline after the production of another batch of products. In 2019, 13 domestic infant formula companies in China initiated an “Anti-flavoring Action” and promised to rule out the use of flavorings in infant formula products. On May 6, 2021, Shanghai State Administration of Market Regulation (SAMR) issued the decision to fine Abbott Laboratories Trading (Shanghai) Co,.Ltd. over 9.09 million yuan (around USD 1.4 million dollars) for the detection of vanillin, a food flavoring, in its stage 1 infant formula. Besides, a total of 3.43 million yuan of illegal income would be confiscated as well. The reason behind this penalty is that according to the regulations1 in China, vanillin is a forbidden substance in stage 1 infant formula (for infants from 0-6 months) and can only be used in stage 2 and 3 infant formula products (for babies from…

May. 25th, 2021

China Introduces Transitional Arrangements Concerning the Change of Cosmetics Registration and Notification Information Management Platforms

The transitional arrangements mainly clarify matters related to the acceptance, review, and approval of cosmetic registration and notification during the transitional period between the previous and the new cosmetics registration and notification information management platforms. To ensure smooth and orderly progress of cosmetics registration and notification work during the transition period between the old and new cosmetic regulations, China National Medical Products Administration (NMPA) released a set of transitional arrangements on May 7, 2021. 1 Specifics are as follows: The new cosmetics registration and notification information management platform (“new platform”) officially put into service on May 1, 2021. Cosmetics registrants, notifiers, and domestic responsible persons can apply for special cosmetic registration and general cosmetic notification through the new platform. As of May 1, 2021, the original cosmetics administrative licensing and notification information management system (“original platform”) no longer accepts special cosmetics registration or general cosmetics notification. ● For special cosmetics whose registration applications…

May. 19th, 2021

China Implemented New Fertilizer Marking Standard Starting from May 1

From May 1, 2021, China began to carry out a new national standard of fertilizer markings “GB 178382-2021 Fertilizer Marking—Presentation and declaration”. The mandatory standard applies to both homemade and imported fertilizers circulated in China, playing an effective role in protecting farmer’s interests and promoting legitimate businesses. Fertilizer marking is the illustration of product characteristics and quality commitment made by its producers and mainly consists of 3 parts: mandatory contents to be labeled on marking, rules and specification, and prohibited contents. The mandatory content includes 8 items and the key points are summarized as follows:

May. 17th, 2021

Korean MSDS Submission

On January 15 of 2019, the Ministry of Employment and Labor (MoEL) made a comprehensive amendment to the Occupational Safety and Health Act (OSHA). Compared with the previous act, three new regulations were proposed for MSDS submission, CBI application, and agent appointment will be officially implemented on January 16 of 2021. Manufacturers outside South Korea can appoint domestic agents in Korea who meet the requirements of the Ministry of Employment and Labor to complete related matters of MSDS submission and CBI application. Korean MSDS Submission Chemical substances subject to MSDS Substances/mixtures containing harmful factors (Article 104 of the OSHA) are referred to as Chemical substances subject to MSDS, and an MSDS must be prepared and submitted. Hazardous chemicals are belong to harmful factors. Subjects and materials of MSDS submission Submission Body Submission material 1)  Manufacturers/importers in Korea 2) Agents in Korea appointed by overseas manufacturers (OR) 1) Products’ MSDS 2)…

Apr. 23rd, 2021

Attention! Netherland launched Regulatory Inspection and Enforcement

In March 2021, the Dutch authorities officially launched the regulatory inspection and enforcement which required OR and the enterprises to cooperate and complete the enforcement inspection. Characteristic of Regulatory Inspection and Enforcement Function Making decisions on whether compliance has been achieved or whether action is required per the legislation or regulations. Actions could include sending letters indicating remedial steps to be taken, enforcing penalties, filing charges through the court system, and shutting down non-compliant operations. In a departure from previous years, the Dutch authorities will not only be comparing customs data with companies\’ trade data and required to provide relevant qualification documents. Instead, they are asking companies to provide all trade records for the substances they spot check for any given year REACH24H reminds all enterprises that need to export to Europe, please follow the standard use of number of registration dossiers and strengthen supervision over the administration of importers. Contact…

Mar. 30th, 2021

Breaking News! China to Exempt Animal Testing for Imported General Cosmetics on May 1

Background Last August and November, China released the first and second draft Instructions for Cosmetic Registration and Notification Dossiers which proposed that general cosmetics could be exempted from animal testing. General cosmetics refer to all the products complying with the definition of cosmetics within the Cosmetic Supervision and Administration Regulation (CSAR), except for the special cosmetics namely hair dyes, hair perming products, freckle-removing and whitening products, sunscreens, anti-hair loss products and cosmetics claiming new efficacy. On Mar. 4, 2021, China NMPA finally released the finalized Instructions for Cosmetic Registration and Notification Dossiers (renamed as Provisions for Management of Cosmetic Registration and Notification Dossiers). As per the finalized regulation, imported general cosmetics will be permitted to exempt from animal testing from May 1, 2021.But it should be noted that there are two preconditions and three exceptions for the animal testing exemption: Two Preconditions Three Exceptions Only by fulfilling both of the following two conditions can companies of general cosmetics apply for the exemption…

Mar. 04th, 2021

Proya: A Company Perspective on Ingredient Management under China’s New Cosmetic Regulations

On Dec 8, 2020, speaking at the CRAC-HCF 2020 Virtual Forum by REACH24H, Mr. Ligang Jiang, the Chief R&D Officer from Proya Cosmetics Co., Ltd, analyzed how cosmetic enterprises should manage ingredients under the Cosmetic Supervision and Administration Regulation (CSAR) [1]. During the speech, Mr. Jiang summarized the key provisions related to ingredients in CSAR and its subsidiary regulations and their impact, hotly discussed issues in the industry, and his thoughts and recommendations on ingredient management from the enterprise perspective. NMPA Supervision Scope Extends to Ingredient Manufacturer – Introduction of Ingredient Submission Code According to Mr. Jiang, a considerable improvement of the CSAR is that the NMPA has extended the supervision scope to the cosmetic ingredient manufacturers. Instructions for Cosmetic Registration and Notification Dossiers stipulated that when notifying or registering cosmetics, the ingredient sources, quality specifications, quality and safety documents, etc., should be submitted. But the ingredient quality and safety documents are so…

Dec. 29th, 2020

MOT Official Addresses Industry Concerns over Road Transport of Dangerous Goods Packed in LQ and EQ

On December 1st, 2020, Mr. Wu Jinzhong from the Highway Research Institute under the Ministry of Transport (MOT) introduced the highlights of the Measures for Safety Administration of Road Transport of Dangerous Goods [1], which was introduced in late 2019 and took effect on January 1st this year (for more details, see CL news [2]), at CRAC-HCF 2020 [3]. Notably, he laid particular emphasis on the exemption granted to dangerous goods packed in limited quantities (LQ) and excepted quantities (EQ) in the Measures. In recent years, the transport of dangerous goods with low hazards and in small quantities has always been a topic of heated discussion in the industry. If such goods can be transported using reliable and durable packages or following certain conditions, they will pose much less danger. In response to such discussions, the Measures authorities state that “dangerous goods can be transported as general goods if the number of packages of dangerous goods packed…

Dec. 29th, 2020

China Heads Towards Risk-oriented Registration of Hazardous Chemicals, Says MEM Official

On November 30th, 2020, at the CRAC-HCF 2020 Virtual Forum [1] by REACH24H, Mr. Chen Jun, an official from the National Registration Center for Chemicals (NRCC) of the Ministry of Emergency Management (MEM), unfolded a roadmap of the reform of the registration framework regulating hazardous chemicals and relevant businesses. Mr. Chen Jun had also previously responded to comments on the proposed revisions to the Implementation Guidance of the 2015 Inventory of Hazardous Chemicals as seen here. China has been practicing the registration management of hazardous chemicals for nearly a decade. According to the Regulations on the Control over Safety of Hazardous Chemicals (State Council Decree No. 591) [2], enterprises that manufacture or import hazardous chemicals should register the hazardous chemicals with the authority for the registration of hazardous chemicals under the State Council. The system primarily aims to ensure the safety of workplaces involving hazardous chemicals, and prevent and reduce hazardous chemicals-related accidents. Mr. Chen…

Dec. 29th, 2020

MEM Official Responds to Comments on Proposed Revision to the Implementation Guidance of the 2015 Inventory of Hazardous Chemicals

On November 30th, 2020, Mr. Chen Jun, official from the National Registration Center for Chemicals (NRCC) of the Ministry of Emergency Management (MEM), articulated informative responses to the solicited comments on the proposed revisions to the Implementation Guidance of the 2015 Inventory of Hazardous Chemicals [1] during the CRAC-HCF 2020 [2] by REACH24H. Mr. Chen reviewed the background and rationales of the proposed revision, which was released in August this year, and detailed major adjustments made in it (see CL news [3] for more details). He noted that the consultation held among emergency management administrations at various levels as well as central enterprises and industry associations, collected more than 200 pieces of comments and recommendations, over 70 of which concerned the hazard classification of chemicals. Click here to read the five most talked-about comments and responded to each one of them as these comments are some of the greatest concerns…

Dec. 28th, 2020
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