Chemical Regulations in CHINA - Actions needed to become compliant -
Existing regulations, expected changes
Key Regulations Measures on Environmental Management of New Chemical Substances 2010 (nicknamed China REACH ) Regulations on Safe Management of Hazardous Chemicals in China (1994, amended several times, latest amendment expected to be in force 1.12.2011) China GHS, standards on the Classification, Labeling and Packaging of Chemicals and Chinese SDS (2011) Note: other product specific regulations / measures may apply Provision on the First Import of Chemicals and the Import and Export of Toxic Chemicals (1994) Regulation on the Labor Protection in Workplace Handling Toxic Materials (2002) Measure for supervision of imported and exported cosmetics (2011) Measure for administration of pesticide (2007) Measure for the administration of pharmaceutical precursor chemicals (2010)
Measures on Environmental Management of New Chemical Substances 2010- (nicknamed China REACH )
China REACH 2010 - Scope In Nutshell China REACH: A system of notification obligations applicable to the manufacture, import, processing and use of new chemical substances in the territory of China. Applies to all new substances (=not in Inventory of Existing Chemical Substances Produced or Imported in China, IECSC) irrespective of annual tonnage Substances manufactured or imported, in preparations or in articles (substances intended to be released), Substances used as ingredients / intermediates in pharma, pesticudes, cosmetics, food and more
China REACH 2010 - Scope in Nutshell Notification prior to manufacture or import : No notification, no market Existing penalties: If you fail to submit notification Warning Fines Directed to stop manufacture / import Notification prevented within next 3 years Chinese Authorities: Chemical registration Centre of the Ministry of Environmental Protection (CRC-MEP)
China REACH 2010 Scope in nutshell: Definition of New Substance Starting point: Inventory of existing Chemical Substances Produced or Imported in China (IECSC) Latest release 6 dec 2010 Covers 45 602 substances 37 427 substances with CAS number 8 175 without CAS number, identification includes technical work 3 166 substances are confidential (can not be seen by accessing CRC s list), access only through the authority => Formal check agaist IECSC is necessary If not included in IECSC, new substance => notifiation
China REACH 2010 Scope In Nutshell: Definition of New Substance Special case, new substances manufactured or imported in China before Oct 15th, 2003: Only application for IECSC inclusion
China REACH 2010 - Scope compared with REACH IECSC is not EINECS: 103.000 substances in EINECS and 146.000 substances preregistered as phase-in substances under REACH compared with 45 602 substances in IECSC Hits manufacturers/exporters of speciality chemicals and also manufacturers/exporters of mixtures. Chinese domestic manufacturers in many cases focus on bulk chemicals
China REACH - Exemptions Four major categories of chemical substances exempted: 1. Chemicals subject to other existing laws and regulations; Radioactive substances, military industry products, pyrotechnics, biotic substances, pesticides, veterinary drugs, pharmaceuticals, cosmetics, foods, food additives, feed, feed additives, tobacco and tobacco products. 2. Substances existing in nature Substances that are unprocessed, or that are manufactured or processed only through the methods listed below: 1) Manual; 2) Mechanical; 3) Gravitational; 4) Soluble in water; 5) Floatation in water; 6) Heat dehydration. Extracted from the atmosphere through various means; Natural polymers, except for ones that are chemically modified;
China REACH - Exemptions 3. Substances of noncommercial purpose or unintentionally produced 1. Impurities; 2. Products of random reactions; 3. Products of random reactions that occur when a chemical substance, mixture, or article is in storage; 4. Products of reactions that occur when a chemical substance, mixture, or article is in final use; 5. Waste water, waste gas, solid waste, and by-products. 4. Special categories 1 Glass; 2.Frit; 3. Pottery raw materials and ceramic ware; 4. Steel and steel products; 5. High-alumina cement; 6. Portland cement; 7. Articles; 8. Homogeneous and heterogeneous alloys, except for metal compounds and precisely defined intermetallic compounds 9. Non-isolated intermediates.
China REACH - Notification by Whom Manufacturer or importer of the substance in China Foreign companies: Case 1: Foreign company acting in China Notification by themselves Notification by an appointed local Chinese agent Case 2: foreign company not acting in China Notification requires appointment of a local agent (several requirements apply (next slide) The appointment letter (Power of Attorney) needs to be submitted to the Chemical Registration Centre
China REACH: Requirements for China REACH Representative The Representative needs to: Be a company registered in mainland China which has passed annual industrial and commercial inspections. Have an office address, a fixed place of work in mainland China (not just a mailbox address). Have a share capital of over RMB 3,000,000 (about 300,000 euros)
China REACH: Requirements for China REACH Representative The representative needs to: Have personnel with professional experience of the regulation Be capable of fulfilling the regulatory obligations on behalf of the non-chinese manufacturer Accept to be subject to supervision and inspection of the Ministry of Environmental Protection (MEP) Have no record of penalties for violation of China REACH within a period of 3 years Not have officers of MEP, the Expert Evaluation Committee or other relevant authorities as staff members
China REACH Types of Notification (4) 1. Normal notification New substance manufactured or imported > 1 tonne / year 2. Simplified notification New substance manufactured < 1 tonne / year 3. Simplified notification under specific conditions New substance Only export < 1 tonne / year For scientific reseach 0.1 1 tonne / year For technical reseach < 10 tonne / year Polymers with all monomers already included in IECSC Polymers containing less than 2 % new substances (weight) Low concern polymers
China REACH Type of Notification (4) 4. Scientific research record Substances only for scientific research and Annual volume < 0.1 tonne / year Or if the sample is to be tested in Chinese laboratories
China REACH: Start Notification Process (Data Requirements and Our Services Later in the Presentation) Define your substances and collect data needed for information form Fill and submit information form IECSC check if new substance (by authority) Our practice Typical Notification Simplified notification Scientific record IECSC inclusion application No notification General Specific Case study
China REACH Normal Notification: Data Requirements Form Chinese SDS Classification and labeling according to Chinese GHS Test report: Physico-chemical properties, toxicity and ecotoxicity Four levels, the higher the tonnage band, the more data required Risk assessment report Qualification of used laboratories Other related documents Takes from 4 to over 15 months
China REACH Simplified Notification: Data Requirements Under basic conditions: Form 1-3 eco-toxicological tests must be carried out in China Takes 4-6 months Under specific conditions: Form For polymers, composition data about monomer, GPC data, and polymerization mechanism shall be given. No test data is required Takes 2-3 months
China REACH Scientific Research Record Form No test data is required Takes only 5-10 working days Results published by MEP regularly
China REACH Notification: Review Expert Review Committee on Environment Management of New Chemical Substances of the Ministry of Environmental Protection ( Expert Review Committee ) carries out a review Sends it to the Ministry of Environmental Protection (MEP) Depending on the assessment, MEP issues a certificate on registration of the substance ( Registration Certificate ).
China REACH: Data requirements and the process compared with REACH Data requirements, key differences: Toxicological as well as ecotoxicological tests are in some cases more demanding than under REACH Example: data needs in lower tonnage bands 1-10 tonne/ year The process, key differences You have to submit new substances notification before starting export! Applies under 1 tonne / year Use of Chinese labs (appointed by Chinese authorities)
China REACH - Costs Data cost Depending on the tonnage band, data cost can vary from 10.000 to over 100.000 Service cost No administrative costs
China REACH - Post Notification Obligations Simplified Notification Submit annual plan (for next year); Keep documents on file for over 10 years; Scientific Research Record Requirements of professionals and facilities; General new chemical substances Communicate MSDS to downstream users; Implement risk management measures; Submit first-activity report; Keep documents on file for over 10 years; Do not sell chemicals to downstream users who are not capable of implementing risk management measures; Submit updates if new hazard arises;
China REACH - Post notification obligations - additional Hazardous New Chemical Substances Submit annual report (for previous year); Comply with The Measures for The Administration of Registration of Hazardous Chemicals Priority hazardous new chemical substances for environmental management Submit report on disposal information;
China REACH - Special Cases Serial notification applies when Similar molecular structure Identical or similar uses Similar test data Joint notification Typical notification or serial notification Jointly submitted by two or more notifiers Independent registration certificate for each notifier
Regulations on Safe Management of Hazardous Chemicals in China (1994, amended several times, latest version to be in force from 1.12.2011) and Chinese GHS 2011
Regulations on Safe Management of Hazardous Chemicals in China Key issue: If your substances are listed in IECSC then the China REACH does not apply to them but they may be affected by Regulations on Safe Management of Hazardous Chemicals in China (2011) Requires the use of Chinese GHS compliant SDS and labelling Registration of hazardous chemicals and license for operation needed in certain situations Coverage Hazardous chemicals, currently 3789 substances (since 2002) The substance list is being updated, and speculated to increase to over 7000 substance before the end of 2011 Regulates production and storage, use, sales and marketing, as well as the transportation of hazardous substances
Main Requirements of the Regulation For companies in China Production permit Transportation permit Use permit Operating licenses for sales and marketing Registration of hazardous chemicals by manufacturers and importers Labelling and SDS Safety management system Qualified professionals Other requirements For foreign companies Labelling and SDS compliant with Chinese GHS national standards
Penalties Offences Penalties No proper operating license RMB 100,000 to 200,000 No SDS or label; SDS and label do not comply with national standards RMB up to 50,000; Repeated infringement up to RMB 100,000 Manufacturers and importers fail to register hazardous chemicals RMB up to 50,000; Repeated infringement up to RMB 100,000
China GHS Background and Current Status Several compulsory (GB) and recommended (GB/T) national standards enterd into force 2006: 26 new national standards, directly from GHS 1st of May 2010: General rules for classification and hazard communication of Chemicals (GB 13690-2009), mandatory standard Current status: Companies selling to China are required to adopt these standards
China GHS vs CLP Items China GHS EU CLP UN version UN GHS 2003+2007 UN GHS 2009 3rd Rev Hazard classes 26 classes, no aspiration hazard 28 classes, aspiration hazard, hazardous to ozone layer Unique features Acute Toxicity, Cate. 5 Acute Aquatic Cate. 2&3 Flammable Liquids Cate. 4 Skin Corrosion/Irritant 3 Serious eye damage/eye irritation, Cate. 2B (Do not exist in CLP) H304: May be fatal if swallowed and enters airways H335: STOT Single Exposure Category 3, Respiratory tract irritation H336: STOT Single Exposure, Category 3, Narcosis Euxx: Hazardous to the ozone layer and other supplemental hazards (Do not exist in China GHS) Pictogram Frame: Both red and black Frame: Red; Minimum size requirement Acute Toxicity for Gases Cate. 4 Inhalation (Gas) LC50>2500 ppm, <5000 ppm Simplified label Yes No H332: Inhalation (Gas) LC50>2500ppm, <20000ppm
Provisions on the First Import of Chemicals and the Import and Export of Toxic Chemicals (1994) License to operate with toxic chemicals on Chinese market
Obligations Foreign Exporter Apply for Regisration Certification Note: Issued for only one type of toxic chemical, to only one foreign company, with only one Chinese company as trader, limited quantity limit, valid for two years Chinese Importer Apply for Import Clearance notification Chinese Exporter Apply for Export Clearance notification
Regulations on Safe Management of Hazardous Chemicals in China: Application Foreign Exporter 1. Application form 2. Contract, information about two years 3. Verification documents (right to export) Fee: $10.000 Next steps by Authorities CRC or MEP The latest list of toxic chemicals contains 156 substances.
Compliance. Sustained. Our process and services for Chinese Regulations, our offering, services and case studies
Our process and offering for China REACH To remember: Working with regulations should include two different view angles, which will be addressed in our offering: Technical angle, e.g.: scientific process Data requirements, test Business risk mitigation angle, e.g.: Minimizing market risk, program for continuous compliance What kind of model for notification (local agent / own subsidiary) Skills to be developed in own organisation Use of external resources, choice of supplier Cost level control Management of CBI
Our process and offering for China REACH Overview, for more information, contact us Steps / our service: Step 1: Chinese compliance check Examples on delivery, content, outcome, comments 1. Substance validation, 2. Check againts IECSC, 3. Required notification type for each substance / no notification document Note: fixed pricing / substance Step 2: Chinese notification service Step 3: Post notification compliance service (note, depending on selected oper. Model) 1. Selection of working model (own subsidiady REACHLaw as local agent) 2. REACH dossier evaluation against China REACH 3. Data collection, dossier generation 4. Executing / submission of notifications Note: Fixed prices for each notification type 1. Hazard updates 2. MSDS communication to DU s / DU control 3. First activity report 4. Annual reports / annual plan / substance flow chart 5. Filing of documents Note: Fixed price fort each service component
China REACH How to proceed? If you don t know exactly your substances and chinese notification requirements Chinese compliance check for your substances, We send supporting documents REACHLaw offering If you know exactly your substances and chinese notification requirements Directly to selection of operational model and notification REACHLaw offering