Industrial Chemical

Format Auditing tightens as CRC requests

The chemical registration center (CRC) has now become more aware of its auditing procedure towards all the notification materials handed over to them. The increasingly stricter examination calls for keener attention from all the notifiers to be well-prepared and detail-oriented before hand over their materials. This would certainly save both cost and time.  

2012-09-27

Industrial Chemical

Practical guidance regarding CBI claims on EU REACH

The European Chemicals Agency (ECHA) announced on 24 July that starting in November 2012, it will make more safety data sheet (SDS) information from dossiers submitted in IUCLID5.4 available on its website. The decision of publishing more registration information from SDS of registered chemicals will influence the chemical trade in Europe, even in the world. It not only notices the enterprises to consider whether or not to request confidentiality on their registration information, but also gives the information that the process of compliance with REACH for enterprises is sustainable  

2012-09-26

Industrial Chemical

12 New Regular Notifications to be Approved under China REACH

MEP releases the 2nd batch of Regular Notifications: 12 new substances registered through regular notification under China REACH will be approved soon.   31 August 2012   12 new chemical substances registered through regular notification under China New Chemical Substance Notification (China REACH) will be soon approved if no dissenting opinion is raised during the period of 30 August to 3 September. According to the China MEP announcement on 30 August, two of the published substances have been registered through joint notification of the special regular notification submission.

2012-08-31

Industrial Chemical

MEP Publishes New China REACH Statistics in the First Half 2012

China MEP declares 1,474 substances registered in the type of Simplified Notification and 13 substances registered through Regular Notification during the first half 2012.   August 31, 2012   China’s Ministry of Environmental Protection (China MEP) yesterday published two statistic diagrams for the registered new chemical substances between January and June, 2012. During the first half 2012, nine registrant companies now are formally granted the registration certificate for 13 substances, in the type of new substance Regular Notification, following a MEP demonstration announcement three months ago (see REACH24H news on May 30); and in total 1,474 substances are announced registered in the type of new substance Simplified Notification (SN).

2012-08-31

Industrial Chemical

Compare SDS writing norms under China GHS, EU CLP and US HCS

This article compares three localized SDS writing rules under China GHS, the EU CLP regulation and the US OSHA HCS.   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.

2012-08-30

Industrial Chemical

Compare SDS writing norms under China GHS, EU CLP and US HCS

This article compares three localized SDS writing rules under China GHS, the EU CLP regulation and the US OSHA HCS.   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.

2012-08-30

Industrial Chemical

GHS Classification Comparison - UN/EU/China/USA

How different do you know about the hazard classification for chemicals under UN GHS/EU CLP/China GHS/US HCS(Hazard Communication Standard)? 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.

2012-08-30

Industrial Chemical

11 CRC Drafted GB/T Standards on Ecotox Testing in Force from this August

In China, seven CRC-MEP drafted national standards on ecotoxicological testing have entered into force since 1st this August.   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.

2012-08-29

Food

5 New Food Additives are Approved for Use

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.

2012-08-28

Food

Overseas Pharmaceutical Manufacturers to Face On-site Inspection

The opinion draft of on-site inspection for overseas pharmaceutical manufacturers is open for public comments. According to the draft Measures, if failing the inspection, the drug will be blocked outside China until it passes the next on-site inspection.   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.

2012-08-28