On May 23-24, the 2017 Global Chemical and Material Compliance Seminar held by REACH24H Consulting Group was successfully concluded in Taipei. 130 enterprise representatives from internationally renowned enterprises like Taiwan Taiyo Ink Co.,Ltd., attended the seminar.

This seminar was the first large-scale conference organized by REACH24H and jointly held by the Taiwan Medical Quality Assurance Association, Taipei Import and Export Business Association, Taipei Chemical Raw Materials Business Association and the Mader Kay Sonko Limited, and Plastic Industrial Technology Development Center Co. The seminar mainly aims at the two major industries of chemicals and materials, starting from the latest developments of global laws and regulations, and carrying out thorough analysis of laws and regulations and key points of compliance for enterprises to solve practical problems enterprise encounter during compliance work.

A Review of Chemicals Management in Taiwan

Mr. Ray Huang, Senior Regulatory Consultant, from REACH24H Consulting Group Taiwan office, comprehensively introduced Taiwan chemicals management. He maintains that Taiwan enterprises should pay more attention to the management of chemical substances and toxic hazard in Taiwan general regulations as well as chemical registration. The timing of compliance is the top priority. Take the four registration standards REACH24H received as an example, for these enterprises wish to complete a first-degree standard (including time need for testing) need to set aside a year’s time, the relevant enterprises should prepare early, so as not to affect the trading and business process.

Mr. Ray Huang, Senior Regulatory Consultant, REACH24H Consulting Group

At the end of 2016, in response to the Food Safety Five Policy and to strengthen Taiwan’s management of chemical substances, the executive department of Taiwan EPA Poison and Chemical Management Bureau was formally established, mainly responsible for the assessment of management, operation management, and hazard control. The establishment of Drug Authority will further promote the sound management of chemicals in Taiwan. Dr. Liu Gengyan, deputy director of the Taiwan Environmental Protection Department Chemical Registration Center introduced in details the progress and status quo of Taiwan chemical management of new chemical substances and chemical substances regulations.

Dr. Liu, Gengyan

The Measures for Environmental Management of New Chemical Substances Registration and the Measures for Existing Substances Notification have been officially implemented more than 2 years. During this period, the characteristics of Taiwan chemical information and registration bring great challenges to the domestic and foreign enterprises. Especially in practice, enterprises encounter different problems, such as the summary of key information and filling rules for CHEMIST, CNS15030 classification standard, the chemical exposure assessment, and evaluation report points. REACH24H Senior Regulatory Consultant Mr. Guozhao Xiang has many years of experience in dealing with compliance and to sum up Taiwan new chemicals and existing chemical registration compliance points and he shared experience received great feedback as many enterprises experienced similar obstacles in the registration and notification process.

Mr. Xiang, Guozhao, Senior Regulatory Consultant, REACH24H Consulting Group

On January 1, 2016 Taiwan implemented the GHS system and offered institutions one year of buffer period, so far the buffer deadline has been in the past half a year. Then, what are the challenges Taiwan enterprises met during the comprehensive compliance process? The regulations REACH24H regulatory consultant Ms. Qian, Meili help enterprises better understand the key points of Taiwan GHS implementation, and according to the international trade business in Asia Pacific region, Europe and the countries in the GHS classification, exemption details, label size, SDS update cycle and CBI information protection and other aspects of the differences are analyzed. Ms. Qian used an example case analysis to help enterprises to further understand the compliance requirements and key points of Taiwan GHS.

Ms. Qian, Meili, Senior Regulatory Consultant, REACH24H Consulting Group

An Overview of Regulations in Asia-Pacific

The Asia Pacific region has one of the world’s most promising chemicals markets, and the dynamics of its chemicals management have attracted much attention. Because of language barriers, the Asia Pacific region chemicals management regulations cannot be delivered timely for understanding, therefore in the Asia Pacific region in chemical production and imports of chemical enterprises, how to improve the legal framework and to ensure the production and trade stability remain challenging for enterprises. REACH24H regulatory consultant for Ms. Chen, Ying presented the chemicals management in the Asia Pacific region, especially the mainland China, Japan Thailand, Malaysia and Philippines.

Ms. Chen, Ying, Senior Regulatory Consultant, REACH24H Consulting Group

For a long time, in the assessment of the industrial chemicals, drugs, cosmetics, using the animal in vivo testing is the mainstream method to understand the safety and toxicity of chemical substances. In recent years, research on animal welfare 3R and alternative methods – in vitro methods and alternative methods raise attention in various countries. The National Environment the National Institutes of Health, National Medical Research Institute, National Research Center of Forest and Environmental toxins and deputy director Lin, Binbin presented on the 3R application of animal and alternative methods in international and Taiwan chemicals registration application for the enterprises.

Ms. Lin, Binbin

Europe, America and Korea Regulation Diagnosis

With the registration deadline of existing chemical substances in 2018 for EU REACH regulations approaching, the pre-registration number will no longer be a “temporary pass” access to the EU market, which means official registration will become the only way to open EU market.

REACH24H Consulting Group regulatory consultant Mr. William Zhou presented on the registration process and the costs for such services in detail. At the same time, based on years of experience in compliance service, William explained for the enterprise the joint registration data, artificial audit, obligations for supply chain information transfer, material and portfolio assessment and review SME.

How would it impact the enterprise when the dossier was manually audited? Is it necessary to transfer SDS/eSDS? What substances are officially evaluated and how should they be addressed? How to determine enterprise size and how to deal with SME review? For these enterprises concerned about the topic, Mr. Zhou Wei made in-depth answers to provide guidance for corporate compliance work.

Mr. William Zhou, Senior Regulatory Consultant, REACH24H Consulting Group

After the TSCA Act is amended, the U.S. Environmental Protection Agency (EPA) has more power to control the commercial chemicals, and in the TSCA regulatory framework released under the TSCA directory, resetting the administrative fee adjustment, material classification screening, and regulating risk assessments. REACH24H regulatory consultant Ms. Tang, Linlin made a detailed introduction to the TSCA Act, and the regulations of TSCA points of reform are summarized and further analysis, help enterprises understand the potential impact of regulatory reform of chemical exports to the U.S. market.

In June 2017, the U.S. EPA will publish the implementation of the three regulations, then the enterprises will face new reporting regulations in effect of existing chemical substances in the first ten years of production and import duty activities. After the declaration process has been classified as active labels of the material will be further screening and evaluation, enterprises under the new version of the regulations can also initiate risk assessment independently, and pay assessment fees. Existing substances that are not declared by the enterprise will not be able to continue on the American market.

Ms. Tang Linlin, Senior Regulatory Consultant, REACH24H Consulting Group

An Interpretation of Food Contact Materials Regulations

With long carbon chain oil proof agent, bisphenol A, two-methyl-phthalate compounds, fluorescent whitening agent, heavy metal exceeding the standard and other food contact safety problems undermining human health and environmental safety, the world of food contact materials is under increasingly strict supervision.

On the afternoon of May 24th, Mr. Xu, Huiming from the Technology Development Center of Taiwan Institute of Plastics Industry, introduces the management policies and measures of the current Taiwan food contact materials, including the Taiwan Food Safety Law, materials and products labelings, current health standards, registration system and regulations and criterion on food hygiene (GHP). At the same time, he shared with the audience the development of food contact plastic raw materials security verification and share implementation verification system and supply chain management, in order to ensure the safety of food industry is easy to obtain safe material, regular self-inspection and management, to create a positive industrial environment.

Plastic Industry Development Center Mr. Huiming Xu

Mr. Jay Cang, REACH24H Consulting Group Senior Consultant, explained in details the differences and similarities between the Euro-American and Chinese food contact materials regulations and compliance strategies. The regulating ideas and patterns of food contact materials of the United States and the European Union have been influencing the legislation and regulation revision of other countries, and affecting how related enterprises develop new markets. Mr. Cang Yunlong introduced the European regulations for food contact materials supervision system and logistics behind related regulations. He made two comparisons between the regulating system in Europe and in the United States regarding food contact materials. In addition, he explained the general situation and requirements, regulations for new chemical notification processes, helping enterprises to better respond to markets in the United States and the European Union.

Mr. Jay Cang, , Senior Regulatory Consultant, REACH24H Consulting Group

On November 18, 2016, Chinese Planning Commission official website released the GB 4806.1-2016 “food contact materials and products of general safety requirements” and GB9585-2016 “standard” for uses of additives in food contact materials and products such as 53 varieties of food related standards. This marks the establishment of China’s food contact materials regulatory system, which means that food contact materials compliance after this regulation, need to meet the corresponding standards and the new regulatory requirements. Food contact material enterprises at home and abroad are very concerned about the 53 recently issued national standards, and desperately want to get the latest information and insights. Mr. Jay Cang provided a detailed introduction on the new national standard system of Chinese food contact materials. To take plastic products as an example, he introduced the compliance strategy under the new national standard system from the industry’s perspective.

This seminar was a meeting of science and technology. Through this seminar, REACH24H shared many years of valuable project experience with enterprises, to solve their practical questions, thereby helping them further understand the laws and regulations in Taiwan, and to understand the dynamic compliance regulations. In the future, REACH24H will keep our professional advantage and to provide efficient technical supports for enterprises to successfully carry out business.