Monday, October 24, 2011

Draft regulation of 3rd ATP to CLP regulation published.

5 Oct 2011, The European Commission published a draft Regulation amending the Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures. This is the third adaptations progress (ATPs) to the CLP regulation.

The 3rd ATP will update the classifications of 16 substances (for example, 2-ethoxyethanol) in Tables 3.1 and 3.2 of Annex VI of CLP regulation. The draft regulation is expected to come into force on 1 June 2013. However, companies can adopt those updates on a voluntary basis prior to 1 June 2013.
The technical annexes of CLP Regulation, as well as certain articles, will be updated from time to time to ensure they are kept as comprehensive and accurate as possible – this is done through the EU comitology process. The amendments are known as adaptations to technical progress (ATPs) to the Regulation.
Use of harmonised classification and labelling set out in Tables 3.1 and 3.2 of Annex VI of CLP regulation is mandatory in Europe. It is very important that companies follow the updates of CLP regulation to ensure that they are using up-to-date classification criteria or harmonized classifications. The previous two adaptations are listed as follows:

First adaptation to technical progress

The 1st Adaptation to Technical Progress (1st ATP) is laid down in COMMISSION REGULATION (EC) No 790/2009. The regulation was issued on 10th Aug 2009 and entered into force on 01st Dec 2010. The regulation brings the entries from the 30th ATP & 31st ATP of Directive 67/548/EEC into Annex VI of CLP, resulting in the update of harmonized classifications in annex VI of CLP.

Second adaptation to technical progress

The 2nd Adaptation to Technical Progress (2nd ATP) to the CLP Regulation is laid down in Commission Regulation (EU) No 286/2011 which entered into force on 19 April 2011. It includes various scientific-technical changes to the Annexes to the CLP Regulation. The main purpose of this regulation is to align CLP regulation with the 3rd revised edition of UN GHS. The changes relate, inter alia, to the labelling provisions, new sub-categories for respiratory and skin sensitisation, the revision of the classification criteria for long-term hazards (chronic toxicity) to the aquatic environment and the hazard class for substances and mixtures hazardous to the ozone layer.


The technical annexes of CLP Regulation(for example, Annex VI), as well as some articles, need to be updated from time to time to ensure they are kept as comprehensive and accurate as possible. The amendments are known as adaptations to technical progress (ATPs) to the Regulation. CLP regulation has gone through 7th amendments. 

 - See more at: http://www.chemsafetypro.com/Topics/EU/CLP_Regulation_EC_No_1272_2008.html

Tuesday, October 18, 2011

Occupational Exposure Limits in China - GBZ 2.1-2007 - Occupational exposure limits for hazardous agents in the workplace

An occupational exposure limit is an upper limit on the acceptable concentration of a hazardous substance in workplace air for a particular material or class of materials.
In China, Occupational Exposure Limits(OELs) for hazardous chemicals is set by GBZ 2.1-2007 - Occupational exposure limits for hazardous agents in the workplace. The standard was revised by the Ministry of Health in 2007 and implemented from 1 Nov 2007.
There are three types of OELs for hazardous chemicals in China:
  • Maximum allowable concentration (MAC); other countries might call it the ceiling value.
  • Permissble concentration-time weighed average(PC-TWA): the maximum average concentration of a chemical in air for a normal 8-hour working day and 40-hour week;
  • Permissble concentration-short term exposure limit(PC-STEL): the maximum average concentration to which workers can be exposed for a short period (usually 15 minutes);
The standard has set occupational exposure limits for 339 hazardous chemicals, 47 kinds of dust and 2 types of bacteria. The standard methods of monitoring the concentration of hazardous chemicals in workplace are defined in national standards GBZ 159-2004 and GBZ/T 160-2004.

Related Occupational Exposure Limits(OELs)

  • Types of Occupational Exposure Limits
  • OSHA Permissible Exposure Limits (PELs)
  • California OSHA Permissible Exposure Limits (PELs)
  • ACGIH Threshold Limit Values (TLVs)
  • NIOSH Recommended Exposure Limits (RELs)
  • AIHA Workplace Environmental Exposure Levels (WEELs)
  • Occupational Exposure Limits in Europe
  • GESTIS: International Occupational Exposure Limit Database

  • Pesticides Regulations - Revised Pesticide Management Ordinance in China

    In 2010, the Ministry of Agriculture of China took the lead to amend the currently most effective pesticide management laws, the administrative regulations – "Pesticide Management Ordinance", and handed in the "Pesticide Management Ordinance (Revised)" in July 2010 for the comments of the relevant pesticide management ministries, and in October 2010 submitted the "Pesticide Management Ordinance (Revised Draft to the State Council Legislative Affairs Office, who will solicit the opinions of relevant ministries.
    Compared to the previous one issued in 1997, the amended pesticide regulation includes the following changes:
    • Pesticide Registration System
      • Temporary registration is cancelled;
      • In case of registration of pesticide of the same active substance or change of applicable scope, method of use and dose level, one company can share other companies' data with authorization;
      • Update of registration certificate is required in case of the change of active substance, applicable scope, method of use ,dose level, and country of origin;
      • Registration information will be made public by the government.
    • Production of Pesticides
      • Manufacturer shall apply for a production license. A registration certificate must be obtained first.
      • Both manufacturers and contracted manufacturers need to register and obtain production license;
      • Labels for pesticides shall be consistent with the registration and shall not include misleading information;
    • Operation and Sales of Pesticides
      • An operating license must be obtained first.
      • Sellers need to comply with the requirements of ;
      • Sellers' record-keeping obligations are strengthened;
      • Management of import/export of restricted pesticides is strengthened. Clearance notification is required.
    Pesticide GHS labels

    Regulations for The Administration of Precursors and Chemicals Used in Production of Narcotic Drugs and Psychotropic Substances in China– 2005

    In China, the main legislation regulating precursor chemicals is the Regulations for The Administration of Precursors and Chemicals Used in Production of Narcotic Drugs and Psychotropic Substances, which came into force in Nov 2005.

    The purpose of the legislation is to strengthen the administration of drug precursor chemicals, regulating the production, distribution, purchase, transportation and import and export of precursor chemicals, preventing precursor chemicals from being used in manufacturing drugs and psychotropic substances.

    Updated in 2015: http://www.chemsafetypro.com/Topics/China/Drug_Precursor_Chemicals_List.html

    Catalog and Classification of Precursor Chemicals

    The precursor chemicals are classified into three categories. Category I includes the major materials that can be used for producing drugs. Categories II and III include the chemical agents that can be used for producing drugs. The detailed classification and types of precursor chemicals are shown as below:
    Category I
    1. 1-phenyl-2-propanone
    2. 3,4-Methylenedioxyphenyl-2-propanone
    3. piperonal
    4. safrole
    5. sassafras oil
    6. iso-safrole
    7. n-acetyl o-amino benzoic acid
    8. o-amino benzoic acid
    9. ergotic acid*
    10. ergotamine*
    11. ergobasine*
    12. ephedrine, pseudo ephedrine, mesoephedrine, phenylpropanolamine, methylephedrine, ephedrine extractum, ephedrine extractum powder and other ephedrine substances
    Category II
    1. phenyl acetic acid
    2. acetic oxide
    3. chloroform
    4. aether
    5. piperidine
    Category III
    1. toluene
    2. acetic oxide acetone
    3. methyl ether ketone
    4. polsassium permanganate
    5. sulphuric acid
    6. hydrochloric acid
    Notes:
    1. The saline chemicals that may exist in the substances as listed in Category I or II shall be brought into control.
    2. The types marked with "*" are precursor chemicals under the item of pharmaceuticals in Category I, which include the pharmaceutical raw materials and the single preparation thereof