Do you have a plan for global compliance? Are your products market ready? Are the parts of your business working together for EH&S excellence?
To discuss those questions and more, join us at ChemADVISOR’s free annual regulatory event on May 28, 2015, in Brussels, Belgium at the Hilton Brussels Grand Place.
You will receive updates on the latest global regulatory trends in:
- Biocides authorization and registration
- International Material Data Systems (IMDS) end of life vehicle directive
- Market readiness
- Regulatory updates in Canada, China, Turkey, Russia and more!
Event handouts will be provided. You will have an opportunity to network with our guests and ChemADVISOR experts.
by Tammy J. Murphy
The February 11, 2015 Canada Gazette, Part II brought about the long awaited amendment to the Hazardous Products Act (HPA) and laid out the path to GHS implementation in Canada. Subsequently, the new Hazardous Products Regulations (HPR; SOR/2015-17) details revisions to Canada’s hazard communication and classification system. The new Regulations incorporate Revision 5 of the United Nations’ Globally Harmonized System of Classification and Labelling of Chemicals (GHS) and aligns Canada, to a degree, with the US OSHA Hazard Communication Standard 2012 (HazCom 2012). With this revision of Canada’s Workplace Hazard Materials Information System (WHMIS), the level of safety measures in place for workers has not only been maintained but has also been enhanced.
The HPA establishes the standard in regards to chemical classification and hazard communication within Canada. The HPA requires suppliers of hazardous products to provide accurate and current labels and Safety Data Sheets (SDSs) for all hazardous products imported, manufactured or sold for use in the workplace.
The HPR, issued under the HPA, defines conditions for exemption, form and content of labels, arrangement of SDS content and hazardous product criteria. The HPR also repeals and replaces the Controlled Products Regulations (CPR) and repeals the Ingredient Disclosure List (IDL). Similar to classification under the CPR, the HPR criteria requires consideration be given to all available and relevant data when classifying hazardous products. The GHS ‘building block’ approach to the classification of hazardous products is incorporated in the HPR. The HPR also introduces two main types of hazards to be regulated, physical hazards and health hazards, including physical hazards not otherwise classified (PHNOC) and health hazards not otherwise classified (HHNOC), as well as minimum “prescribed classifications” for certain substances.
The HPR is divided into 9 Parts and 5 Schedules:
Part 1 of the HPR provides definitions for terms found throughout the Regulations.
Part 2 of the HPR provides the requirements for product, mixture, material and substance classification. This includes both general information and specific rules. It also introduces “bridging principles” in relation to the classification of mixtures and “prescribed classifications,” per Schedule 4, are also defined. Even though these Schedule 4 substances have a given classification, only certain endpoints are addressed, and the identified substances must still be evaluated according to the criteria of the other hazard classes.
Part 3 of the HPR details labelling requirements for hazardous products. Schedule 3 provides symbols and pictograms while Schedule 5 gives information elements, such as symbol, signal word and hazard statement for certain categories of substances.
Part 4 of the HPR details the Safety Data Sheet (SDS) requirements for hazardous products. It also details the additional requirements for hazardous products classified as Biohazardous Infectious Materials. Schedule 1 gives the information elements for the SDS while Schedule 2 details the information elements for a Biohazardous Infectious Material appendix to the SDS.
Part 5 of the HPR describes exceptions and provides detailed information and definitions. It includes, but is not limited to, exceptions for laboratory samples, mixtures of radioactive nuclides, small-capacity containers, confidentiality protection, importation for use in own workplace, hazardous products in transit and so forth.
Part 6 of the HPR details additional requirements, including disclosure of information to health professionals, inspectors, etc. It also describes the language requirements (bilingual) for both labels and SDSs.
Part 7 and Part 8 of the HPR provides specific information for Physical and Health Hazard Classes, respectively. Each part is divided into subparts and each subpart provides a definition for the specific hazard class as well as information about “Classification in a Category of the Class.” Part 8 also includes tables with the specific criteria for mixture classification.
Physical Hazard Classes include: Explosives, Flammable Gases, Flammable Aerosols, Oxidizing Gases, Gases Under Pressure, Flammable Liquids, Flammable Solids, Self-Reactive Substances and Mixtures, Pyrophoric Liquids, Pyrophoric Solids, Self-Heating Substances and Mixtures, Substances and Mixtures Which (in Contact with Water), Emit Flammable Gases, Oxidizing Liquids, Oxidizing Solids, Organic Peroxides, Corrosive to Metals, Combustible Dusts, Simple Asphyxiants, Pyrophoric Gases and Physical Hazards Not Otherwise Classified.
Health Hazard Classes include: Acute Toxicity (Oral Exposure Route, Dermal Exposure Route and Inhalation Exposure Route), Skin Corrosion/Irritation, Serious Eye Damage/Eye Irritation, Respiratory or Skin Sensitization, Germ Cell Mutagenicity, Carcinogenicity, Reproductive Toxicity, Specific Target Organ Toxicity – Single Exposure, Specific Target Organ Toxicity – Repeated Exposure, Aspiration Hazard, Biohazardous Infectious Materials and Health Hazards Not Otherwise Classified.
Part 9 of the HPR provides miscellaneous information, including but not limited to amendments to the Food & Drugs Act, Consumer Containers and Chemicals Regulations, etc. It also addresses transitional provisions, repeals of the CPR and IDL and the coming into force of the HPR.
There are transition periods associated with the adaptation of the HPR. The transition periods (termed “Phase 1,” “Phase 2,” “Phase 3” and “Completion”) are dependent on whether an “entity” is a manufacturer and/or importer, distributor or employer:
- “Phase 1” begins from the coming into force of the HPR and ends on June 1, 2017
- During “Phase 1,” all entities may use the CPR or HPR requirements.
- “Phase 2” begins June 1, 2017 and ends June 1, 2018
- During “Phase 2,” manufacturers and importers must use the HPR requirements while distributors and employers may use either the CPR or HPR requirements.
- “Phase 3” begins June 1, 2018 and ends December 1, 2018
- During “Phase 3,” manufacturers and importers as well as distributors must use the HPR requirements while employers may use either the CPR or HPR requirements.
- “Completion” begins December 1, 2018
- From “Completion” on, all entities will be required to use the HPR requirements.
- There is an exception for employers who have products that are in compliance under the CPR requirements in their warehouses as of December 1, 2018. In addition, employers will be able to use any products that comply with the CPR requirements and that are already within the workplace as of December 1, 2018, until June 1, 2019.
Compliance has to be either completely with the CPR requirements and the ‘old’ HPA or completely with the HPR requirements and the amended HPA, dependent on the transition phase and the entity. There cannot be a “mixing” of the two sets of requirements.
Note that although the HPR seeks to align as close as possible with the 5th Revision of the “Purple Book” and the US HazCom 2012, the new Regulations and corresponding amendments are NOT direct adaptations of either one. Compliance must be with Canadian requirements.
Additional information can be found on Health Canada’s WHMIS site. The full text of the publications should be consulted for complete details.
Health Canada’s Workplace Hazardous Materials Information System: http://www.hc-sc.gc.ca/ewh-semt/occup-travail/whmis-simdut/index-eng.php
Canada Gazette, Part II, February 11, 2015 edition: http://canadagazette.gc.ca/rp-pr/p2/2015/2015-02-11/pdf/g2-14903.pdf
By Patricia Manteghi
The Turkish Ministry of Customs & Trade published the Notice on Market Supervision and Control for Hazardous Chemical Content of Some Consumer Products on January 14, 2015.
The aim of this Notice is to design procedures and guidelines on restriction of usage of the hazardous chemicals, specified in Annex I of this Notice, which are supplied as final products to the market and are used in some consumer products.
The Notice is enforced by the Turkish Ministry of Customs & Trade as of the date of publication, January 14, 2015, except for rows 4-10 of Annex I which will take effect on May 21, 2015.
Turkish Ministry of Customs & Trade, “Notice on, Market Supervision and Control for Hazardous Chemical Content of some Consumer Products” Turkish Gazette 29236 (January 14, 2015).
By Martina Schneider, PhD
According to the REACH regulation (No 1907/2006), ECHA must perform a compliance check for at least 5% of the registration dossiers for each tonnage band. The compliance check reviews whether the information in the dossier fulfills the legal requirements and if the provided safety information is appropriate and complete.
Priority is given to substances which have suspected data gaps in the higher tier human health or environment endpoints and a high potential for exposure of humans or environment, e.g. a broad spectrum of use and high volumes. The method for selecting a substance is in line with the approach that is used for the selection of substances for evaluation.
Possible outcomes of a compliance check may be no action needed by the registrant, a request for additional information, or a quality observation letter that would point out any inconsistency not directly related to missing information, e.g. inappropriate risk management measures.
To increase transparency of compliance checks, ECHA has published a list of substances for which a compliance check will probably be conducted in 2015. This gives registrants a chance to update the dossier in advance and, if available, add any new information. The list will be updated a few times per year and is only “indicative and non-exhaustive,” therefore compliance checks can still be performed on any dossier at any time and without prior notice to the registrants.
In addition to the substances on the recently published list, compliance checks are usually conducted for substances which are on the Community Rolling Action Plan (CoRAP) list.
ECHA press note
List of substances potentially subject to compliance check during 2015