August 30, 2012

In general, (M)SDS writing norms in these three countries or areas, EU, China and USA, are based on the United Nations’ GHS standard. Both the EU and China maintain all 16 sections in a complete Safety Data Sheet consistent with the UN GHS, while the US SDS adopts only 12 sections, i.e. Section 12/13/14/15 are not so mandatory as the other ones.

In general, (M)SDS writing norms in these three countries or areas, EU, China and USA, are based on the United Nations’ GHS standard. Both the EU and China maintain all 16 sections in a complete Safety Data Sheet consistent with the UN GHS, while the US SDS adopts only 12 sections, i.e. Section 12/13/14/15 are not so mandatory as the other ones.

In the product stewardship of a hazardous chemical product, when asked “what is your principal regulatory duty”, most clients immediately think of a Safety Data Sheet or a chemical precautionary Label based on local standards. Yet not so many come to realize your hazard classification is actually the real pre-requisite that underlines all the other GHS compliance activities.

August 29, 2012

In China, seven CRC-MEP drafted national standards on ecotoxicological testing have entered into force since 1st this August. The seven GB/T (nationwide recommended) standards respectively specify the testing methods of ready biodegradability, degradation screening, biodegradation screening, soil Koc estimation using HPCL, arobic and anerobic transformation in soil and aquatic sediment systems, and fish acute toxicity.

An approval notice of 5 new food additives for use and an adjustment for other 28 food additives was currently released by MOH.

27 August, 2012

5 new food additives have been approved for use by the Ministry of Health (MOH) in accordance with the Food Safety Law (Order of the President No.9) and Administrative Measures for New Food Additives (Order No.73 of MOH). Along with the approval notice released on 27 August 2012, MOH also approved an expansion of use scope and dosage for other 13 food additives, 5 food processing aids, and 8 nutritional fortification substances, besides, a supplement of quality specifications for GDL(Glucono–δ—Lactone) and raw materials sources for Protease. For detailed functions, use scope, dosage, quality specifications (production process, technical requirements, sensory requirements, physic-chemical index, etc.) and test methods of the corresponding food additives please refer to Appendix to the notice.

August 24, 2012

The State Food and Drug Administration (SFDA) solicits opinions on the Measures for the Inspection of the Overseas Pharmaceutical Manufacturers (draft), hereafter referred as the Measures. This draft will be open for public comments until 8 October 2012. According to the Measures, any pharmaceutical manufacturers fail the on-site inspection will face a severe penalty that the drug registration application will be suspended and the drug export to China will be ordered to stop.

Subtle changes made to the policy of emergency phone service for China’s new hazardous chemicals registration are making some registrants confused: How do I arrange my emergency phone service in view of China’s new hazardous chemicals registration?

August 24, 2012

SAWS to Enforce More Severe Punishment for Non-Compliance of the Revised HC Registration Measures

August 23, 2012

On August 20, 2012, SFDA started to seek public comments on a notice concerning a newly-added licensing procedure to further regulate the format and content of submitted application dossiers.

22 August 2012

Under the notice, SFDA will issue a new result “recommend approval after information supplementation”, if the following situations occur:

20 August 2012

According to the notice, cosmetic manufacturers that already obtain the hygiene license or record keeping certificate from SFDA, are allowed to apply for one-time modification of names, addresses, responsible agents in China together with product information that is under processing. Documents that have been submitted before need not submitting repeatedly.