Chinese Chemicals Regulation and the influence from EU REACH

Chinese Chemicals Regulation and the influence from EU REACH Jim Wei Hangzhou RUIO Technology Co., Ltd Tyre Industry Regulatory Dialogue Brussels, October 26, 2010 Hangzhou RUIO Technology Co., Ltd www.reach24h.cn

Contents Contents Chinese Chemical Regulations Toxic chemicals Hazardous chemicals New Chemicals Influence from EU REACH China REACH & EU REACH RUIO Technology Co., Ltd Introduction Hangzhou RUIO Technology Co., Ltd www.reach24h.cn Tyre Industry Regulatory Dialogue

Chinese Chemical Regulations Chinese Chemical Regulations Toxic chemicals (1994) Regulations on Environmental Administration of the First Import of Chemicals and the Import & Export of Toxic Chemicals (1994) Hazardous chemicals(1987) hazardous chemicals Safety management legislation(1987) New Chemicals(2003) Measures of Environmental Management of New Chemical Substances- China REACH (2003)

Toxic Chemicals Background of Regulations on Environmental Administration of the First Import of Chemicals and the Import & Export of Toxic Chemicals Regulation of Environmental Management on the First Import of Chemicals and the Import and Export of Toxic Chemicals [Came into force in 1994]; Decision on The Cancellation of Administrative Projects of Examination and Approval by the State Council, First Catalogue [2002]; CRC will not accept applications for the Environmental Management Registration on the First Import of Chemicals Circular No. 46 2005, by SEPA and General Administration of Customs of P.R.C.[2005] List of Toxic Chemicals Severely Restricted on the Import and Export in China.,Circular No. 65 2005, by SEPA and General Administration of Customs of P.R.C. Amendment List of Toxic Chemicals Severely Restricted on Import and Export in China, Circular No. 80 2006, by SEPA and General Administration of Customs of P.R.C.[2006] Directions for the Registrations of Environmental Management on Import and Export of Toxic Chemicals

Toxic Chemicals Procedures of Reviewing & Approving the Registration of Import & Export of Toxic Chemicals

Notification platform: -------Notification system for Environmental Management on Import/Export of toxic Chemicals

Contents Contents Chinese Related Chemical Legislations Toxic chemicals Hazardous chemicals New Chemicals Influence from EU REACH China REACH & EU REACH RUIO Technology Co., Ltd Introduction Hangzhou RUIO Technology Co., Ltd www.reach24h.cn Tyre Industry Regulatory Dialogue

Hazardous Chemicals February 17, 1987, the State Council promulgated the hazardous chemicals safety management legislation January 26, 2002, the State Council promulgated the new version of Hazardous chemicals safety management legislation November 15, 2002, the Measures of Environmental Management of hazardous Chemical Substances came into force under the supervision of the State Economic and Trade Commission promulgated February 29, 2008, the Measures of Environmental Management of hazardous Chemical Substances (draft) was promulgated by the State Council Legislative Affairs Office June 8, 2009, Measures of Environmental Management of hazardous Chemical Substances (draft) was submitted to the State Council executive meeting for their review

Hazardous Chemicals According to the existing national standard GB6944-2005, hazardous chemicals are divided into the following nine categories: : Explosives; : Gases; : Flammable liquid; : Flammable solids, substances liable to spontaneous combustion, water emit flammable gases ; : Oxidizing substances and organic peroxides; : Toxic and infectious substances; : Radioactive material; : Corrosive substances; : Others dangerous substances and articles

New Chemicals Approved Proclaimed 01/04/2003 12/09/2003 15/10/2003 Effective Approved 30/12/2009 Effective Proclaimed 19/01/2010 Existing Version---Measures on the Environmental Management of New Chemical Substances, China(Environmental Protection Department Order No. 17) Revised Version---Measures on the Environmental Management of New Chemical Substances, China 2010(draft, Environmental Protection Department Order No. 7)

New Chemicals What is China REACH The notification must be done before a new chemical substance can be manufactured, imported or placed on the market. How to do The legal entities need to submit the notification documents to Chemical registration center of MEP (CRC). What is the new chemical substance The substance which is not covered by IECSC. Who can be a notifier The legal entity should be registered within Chinese territory.

IECSC IECSC : Inventory of Existing Chemical Substances in China IECSC covered the substances which have been placed on the market for commercial purposes between January 1, 1992 to October 10, 2003. Include elements, compounds (including one of the additives and impurities), byproducts, reaction intermediates, polymer, but does not include the mixture and articles. The following types which managed by other departments are also not included in IECSC: 1 Pesticide 2 Tobacco and tobacco products 3 Radioactive substances 4 Military products 5 Food, food additives, pharmaceuticals and cosmetics

IECSC Update The core IECSC compiled in 1995 (1995 IECSC) The first IECSC supplement notification in period of 1996-1997 (IECSC official version) The second IECSC supplement notification in period of 1999-2000 (2000 IECSC) The third IECSC supplement notification in period of 2001-2002 (2002 IECSC) The forth IECSC supplement notification in 2003 (2003 IECSC) The fifth IECSC supplement notification in period of 2003-2004 (2004 IECSC) The case supplement in period of 2004-2005 by MEP (2005 IECSC) According to the 12 document issued by MEP, the supplement list in period of 2006 to the end of Aug. 2007 (2007 IECSC) According to the 12 document issued by MEP, the supplement list in period of 2007 to the end of Dec. 2008 (2008 IECSC) According to the 12 document issued by MEP, the supplement list in period of 2008 to the end of Oct. 2009 (2009 IECSC)

IECSC = The substances which CAS No. are required confidentiality or do not have the CAS No. show the four-digit serial number! This Means one can not found the confidential substance in PC version. http://www.crc-mep.org.cn/iecscweb/

IECSC There are 45,355 chemical substances totally, 37,291 with CAS Number 8,064 without CAS Number (or unknown). For substances without or unknown CAS number, an unique serial number was given in IECSC. There are 3,088 confidential substances. The Chinese and English preferred names of these substances are not published. As a new feature, there are 32,557 chemicals have their formula structures pictures.

Notification types Regular Notification Serial Notification Joint Notification Joint serial Notification Repeat Notification Re-notification for the amount increase Re-notification for uses change Simplified Notification Scientific Research Record Notification

Data Requirements The higher volume, the more requirements for testing data: <1 t/y, 1-10 t/y, 10-100 t/y, 100-1000 t/y and 1000+ t/y The Eco-toxicological Data are mandatorily carried out in China

The China REACH Guidelines of hazard assessment,glp and test New chemicals

China REACH & EU REACH --Influence from EU REACH EU REACH China REACH Scope Apply for Registrant/Notifier Deadline Registration/Notification form Obligations after registration/notification Phase in substance & non New chemical substance phase-in substance; Annual volume> 1 t/a (Not on the IECSC list) No tonnage band limit Substance, Substance Preparation Preparation Article Article Natural person within EU Legal entity within CN Legal entitywithin EU deadline(2010,2013,2018) No deadline Transitional period No transitional period SIEF/Consortium/LR Please refer to Page 33 Update the dossier when amount and usage change Update the dossier when amount and usage change Inform the status of risk control Inform the usage direction of the product

China REACH & EU REACH The Scope of Applicable Chemical Substances China REACH New Substance not listed in Inventory of Existing Chemical Substances in China EU REACH Non Phase-In Substance (New Substance) Phase-In Substance Hangzhou RUIO Technology Co., Ltd www.reach24h.cn Tyre Industry Regulatory Dialogue

China REACH & EU REACH CHINA REACH The management of pharmaceuticals, pesticides, veterinary medicine, cosmetics, food addictives, feed addictives etc... shall comply with other relevant laws and regulations. However, environmental risk management for the new chemical substances used as raw materials and intermediates for the production of the aforementioned products shall comply with the Measures. Hangzhou RUIO Technology Co., Ltd www.reach24h.cn Tyre Industry Regulatory Dialogue

China REACH & EU REACH EU REACH Substances contained within products falling into scope Medicinal products Food and Feedingstuffs Plant Protection Products exempted from the following parts of REACH: Title II (Registration); Title V (Downstream Users); Title VI (Evaluation); Title VII (Authorisation) Hangzhou RUIO Technology Co., Ltd www.reach24h.cn Tyre Industry Regulatory Dialogue

China REACH & EU REACH The Applicant CHINA REACH CN Manufacturer CN Importer Non- CN legal entity(should appoint an Agent in CN) EU REACH EU Importer; EU Manufacturer Non-EU manufacturer (should appoint Only Representative in EU ) Hangzhou RUIO Technology Co., Ltd www.reach24h.cn Tyre Industry Regulatory Dialogue

China REACH & EU REACH The requirements of agents --China REACH An agent is a Chinese registered organization which has already passed the annual inspection of the industrial and commercial bureau. It shall already have permanent office and staff the professional person who is familiar with the notification flow of the new chemical substances; its registered capital is over 1000 thousands CNY. An agent is required to have sufficient background in the practical handing of substances and the information related to them it should be always under the supervision and inspection of Ministry of Environmental Protection Agency of China and shows no records of punishment for violation the measures within the consecutive three years. Hangzhou RUIO Technology Co., Ltd www.reach24h.cn Tyre Industry Regulatory Dialogue

China REACH & EU REACH The requirements of only representative --EU REACH An only representative is a legal entity established in the EU which has sufficient background in the practical handling of substances and the information related to them to be able to fulfil the obligations of importers. Hangzhou RUIO Technology Co., Ltd www.reach24h.cn Tyre Industry Regulatory Dialogue

China REACH & EU REACH Type of Notification(Registration) CHINA REACH Regular Notification Simplified Notification Scientific Research Record Notification EU REACH Registration Intermediate Registration PPORD Notification OR Hangzhou RUIO Technology Co., Ltd www.reach24h.cn Tyre Industry Regulatory Dialogue

China REACH & EU REACH Notification Approach CHINA REACH EU REACH Serial Notification Joint Notification Repeat Notification Individual Submission Joint Submission A B C D OR A B C Hangzhou RUIO Technology Co., Ltd www.reach24h.cn Tyre Industry Regulatory Dialogue

China REACH & EU REACH Data Requirement CHINA REACH EU REACH Truthfully Increase by tonnage grade Date Sharing (Encourage) Data of testing report priority Perform eco-toxicological tests within territory of China Testing is the last resort Ecotoxicological and toxicological tests should comply with GLP The higher tonnage, the more data Hangzhou RUIO Technology Co., Ltd www.reach24h.cn Tyre Industry Regulatory Dialogue

China REACH & EU REACH Polymer CHINA REACH Polymer,as substance The definition of polymer Polymer not included in IECSC - new substance 2% principle & polymer of lower concern Regular Notification and Simplified Notification EU REACH The definition of polymer Polymer is exempted from registration monomer 2% principle Hangzhou RUIO Technology Co., Ltd www.reach24h.cn Tyre Industry Regulatory Dialogue

China REACH & EU REACH Risk Assessment CHINA REACH EU REACH Risk Assessment Report Substances >1 tonne per year Only brief guide Chemical Safety Report Substances > 10 tonne per year Detailed guidance More supporting software Hangzhou RUIO Technology Co., Ltd www.reach24h.cn Tyre Industry Regulatory Dialogue

China REACH & EU REACH Supervise CHINA REACH Information communication with DU Activity report (first time/every time) Annual Report and Annual plan EU REACH Supply Chain Communication(SDS) Uses covered The obligation of DU Enforcement Hangzhou RUIO Technology Co., Ltd www.reach24h.cn Tyre Industry Regulatory Dialogue

Company Introduction Who We Are Full service provider for Regulatory Affairs We are the most professional agency for chemical regulation services in China EU REACH CLP BPD China REACH China GHS TSCA CEPA

Company Introduction What We Have Done Activities EU REACH technical support, consultation Date May, 2010; Customers Comments The signing ceremony of REACH project between CNPC and RUIO marked the REACH regulation entering a new stage within Chinese enterprises.

Company Introduction What We Have Done Activities EU REACH technical cooperation Date July, 2010 Partners Comments DR. KNOELL CONSULT and RUIO will cooperate and support each other in the field of Regulatory Affairs and related consulting services provided to their customers.

Company Introduction What We Have Done Activities EU REACH technical cooperation Date March, 2010; Customers CCCMC Comments RUIO cooperates with CCCMC. Both sides reached consensus on assist domestic enterprises to comply with REACH regulation.

Company Introduction What We Have Done Activities Conduct the 1st Stakeholders' Workshop on China REACH Date June, 2010 Partners Comments June 25, 2010, RUIO associated with China Petroleum and Chemical Industry Association (CPCIF) successfully held the "China REACH Seminar 6 comments supporting documents."

Company Introduction What We Have Done Activities Conduct the 1st China REACH Workshop on China REACH Date October, 2010 Partners Comments REACH24H Group, cooperating with Dr. KNOELL CONSULT GmbH, will hold the "China REACH Workshop, Brussels 2010" in Brussels on November 3 rd, 2010. At the workshop, the officer of the Chemical Registration Centre, Ministry of Environmental Protection of the PRC will make a speech on "Introduction and Enforcement of China REACH".

Workshop and contract photos

Company Organization REACH24h Group Separate legal entities RUIO REACH24h China RCS REACH24h Ireland RNAS REACH24h Canada

Hangzhou RUIO Technology Co., Ltd www.reach24h.cn Tyre Industry Regulatory Dialogue