Posts Tagged ‘REACH compliance’

All products used in the workplace must have an MSDS accessible for employees to understand the proper use and safety measures needed when using a product or in case of an accident. It is the responsibility for the employer to ensure that there is an MSDS sheet for every product being used in their facility, but these MSDSs are typically provided by the supplier of the product.

An MSDS sheet is a go-to document for all persons who may come into contact with a particular chemical or mixture. It explains the relevant physical properties, hazardous information and safety procedures. Every country/jurisdiction has its own regulations that must be followed when preparing an MSDS for a product, specifying what information must be disclosed on the document.

Nexreg Compliance Inc. is a regulatory company that specializes in MSDS preparation. Nexreg offers MSDS authoring for the E.U. (SDS), NAFTA (U.S., Canada and Mexico), OSHA/WHMIS (U.S. and Canada), OSHA (U.S.) and WHMIS (Canada). The type of MSDS you require will depend on where your product will be used. Because of the many different legislations regulating MSDS preparation, choosing a professional service like Nexreg Compliance is a safe way to ensure that your MSDS will be compliant with all necessary documents.

Nexreg offers services for MSDS preparation from 2 weeks standard time to a 24-hour rush depending on your companys needs. Nexreg will determine the hazardous properties and classifications for your product from the formulation and prepare the appropriate MSDS accordingly. We also offer translations if you require your MSDS in another language besides English. Our team also offers services to update or reformat existing MSDSs your company may have that are expired or need to be used in a different jurisdiction.
If you have any questions or are interested in finding out more about Nexreg Compliance Inc.s services, feel free to contact us:

Nexreg Compliance, Inc.
Toll Free: (866) 361-3032
Phone: (519) 488-5126
Fax: (519) 488-5217
Web: www.nexreg.com

For further information on MSDS sheet and MSDS preparation please visit http://www.nexreg.com/

The Workplace Hazardous Materials Information System (WHMIS) requires labels on controlled materials from the supplier and at the workplace. Health and safety officers may check the containers of controlled products in your workplace to ensure they have supplier labels with the special hatched border (illustrated in Appendix II). These labels must have the following information enclosed in the border:

a product identifier

a hazard symbol or symbols to correspond to risk phrases (standard pictograms for WHMIS)

risk phrases describing the nature of the hazard and possible consequences of product misuses (e.g. eye irritant

precautionary measures to be taken to ensure the safe use of the product (e.g. keep away from acids)

first aid measures (e.g. in case of skin contact, flush immediately with plenty of water)

a supplier identifier

a reference to the Material Safety Data Sheet (e.g. see MSDS)

Any containers that have a quantity of 100 mL or less need to only display a product identifier, the hazard symbol(s), the supplier identifier and some reference to the MSDS. All supplier labels must be in English and French.

Workplace labels must contain the following information:

clearly identify the product

identify essential information for safe use and handling of the product

indicate whether a MSDS is available (ex. if a consumer product is being used, a MSDS may not be available)

Contrary to the supplier label, the workplace label is performance oriented and therefore, its appearance, wording and arrangement are not restricted. Regardless, the workplace label must provide enough information to depict the precautions that must be taken to prevent injuries or accidents. Word, symbols, or other modes of communication can be used to convey the possible health and environmental hazards, but it must be combined with worker education to make certain that the worker has all the necessary information for safe handling and storage of the chemical.

For further information on WHMIS and MSDS please visit http://www.nexreg.com/

REACH stands for the Registration, Evaluation and Authorization of Chemicals of the European Union (EU). The new law came into existence on June 1, 2007, simplifying the 40 existing pieces of legislation into a single system of regulations for all chemicals. It provides information regarding chemicals acute and long-term effects. REACH has five main components: pre-registration, registration, evaluation, authorization, and restriction.

Pre-Registration
In order to continue manufacturing/importing substances on the EU market after December 1, 2008, manufacturers and importers mustve pre-registered these chemicals between June 1 and December 1, 2008. The Pre-registration data includes your identity and contact information, the estimated imported tonnage and expected registration deadline, and the EINECS and CAS numbers for each substance. This data will be used by the European Chemicals Agency (ACHA) to allow companies registering the same substances to share the relevant data.

Registration
Any manufacturers and importers of chemical substances that exceed 1 ton/year are required to obtain information regarding the physiochemical, toxicological and environmental properties of these substances and use it to ascertain the safest ways to utilize the product. Each manufacturer and importer must submit a registration dossier stating this information and providing guidance on the safe use of the substance. By pre-registering, the deadline for the registration process is spread out; if no pre-registration was completed, the importation or manufacturing of the substance is banned until the registration is completed.

Evaluation
The ECHA will perform evaluations to determine whether the submitted registration dossiers are complete and to provide direction on what further tests should be administered to ensure a full-bodied data set is available for the substance.

Authorization
Substances of very high concern to human health would include carcinogens, mutagens, reproductive toxins, and persistent, bioaccumulative and toxic substances. Any companies that have a product containing one of these substances will be required to obtain authorization. These companies must demonstrate that they have sufficiently controlled the risks associated with the substance, or that the socioeconomic benefits from use of the substance outweigh the risks. REACH aims to slowly replace the use of substance of very high concern with substances that pose a lesser risk; therefore, applicants must also investigate the possibility or substituting these substances with safer alternatives.

Restriction
The EU can prohibit or impose restrictions on the market or use of certain dangerous substances when intolerable risks to the environment or humans have been identified.

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For further information on MSDS, EU SDS and REACH compliance please visit http://www.nexreg.com/

According to WHMIS classifications, Class D (Poisonous and Infectious Material) has 3 divisions. Two of these divisions also havesubdivisions.

Class D1 represents “Materials Causing Immediate and Serious Toxic Effects at greater than or equal to one percent”. This category is further broken up into Class D1A (Very Toxic Material at greater than or equal to one percent) and Class D1B (Toxic Material at greater than or equal to one percent). If a product fits the criteria for a certain TDG Class, Packing group, or falls into the assigned levels for oral, dermal or inhalation toxicity for one of these two classes, it would fall into that class.

Class D2 represents “Materials Causing Other Toxic Effects”. Class D2A (Very Toxic Material at greater than or equal to 0.1 percent) applies to any substance that contains an ingredient which has demonstrated aspects of carcinogenicity, reproductive toxicity, teratogenicity, embryotoxicity, mutagenicity or respiratory sensitization. Class D2A (Very Toxic Material at greater than or equal to one percent) would also include any substance which has been found to have chronic toxic effects in small doses which threatens life or causes serious impairment of cardiovascular or nervous systems, or bodily organs. Class D2B (Toxic Material at greater than or equal to one percent) would incorporate any chemical that has been found to have chronic toxic effects in larger doses (than D2A), mutagenicity, skin sensitization or skin and/or eye irritation.

Please note that for the classes which have a percentage assigned to them, the chemical in question must be present in the mixture in a concentration falling within the range given in order to be classified.

Finally, Class D3 represents “Biohazardous Infectious Material”. Any organism that has been shown to cause or is reasonably believed to cause disease in persons or animals would be classified under this division. Any organisms classified into Risk Group 2, 3, and 4 as determined by the Medical Research Council of Canada (MRCC) or the World Health Organization (WHO) would also be classified as a Class D3 substance.

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A Drug Identification Number (DIN) is an 8-digit number assigned by Health Canada to a drug product (both over-the-counter and prescription-only) under the Food and Drugs Act (FDA). All drug products that fall under the FDA must be assigned a DIN before market in Canada. The DIN guarantees the drug has been evaluated and authorized for sale in Canada by the Canadian government. The DIN is assigned a random number in order to follow-up on the drug once it gets on the Canadian market. This is particularly important for product recalls, inspections and quality monitoring since it uniquely identifies the product and proves Health Canada approved the drug for sale. A drug product in Canada that does not have an associated DIN is not compliant under Canadian law.

The first thing a manufacturer (supplier) must do to receive a DIN from Health Canada is submit the DIN Application Data, which describes in great detail the drug products complete chemical formulation, consumer label and instructional use to ensure it meets all regulations in Canada. The application must be as detailed and up to date as possible. Once Health Canada receives the application data they begin the Screening phase where completeness and quality is of the essence. This is a good reason why initially filling out the application with as much detail as possible can pay off.

If Health Canada wants clarification in response to the DIN application they can issue a Clarifax (clarification issued to the manufacturer by means of fax mail). The Clarifax can lead to the issue of a Safety, Efficacy, and Quality Review, a Notice of Deficiency (NOD) or Screening Deficiency Notice (SDN), or a Screening Rejection Letter (SRL) or Notice of Deficiency - Withdrawal (NOD/w). The NOD, SDN, SRL and NOD/w are all for additional information because of incorrect or insufficient reporting. If any of these are issued to the manufacturer they must respond with the requested information and the product can re-enter the screening process for the DIN.

A Safety, Efficacy, and Quality Review is the third step in receiving DIN assignment. The review assesses the benefits and risks of the product. A Clarifax can again be issued in response to a NOD or NOD/w, or Notice of Non-compliance (NON) or Notice of Non-compliance-Withdrawal (NON/w). From here the drug application can either be rejected or withdrawn from the DIN application or be accepted for DIN registration.

If the application is completed successfully a DIN is issued for the drug product which authorizes sale in Canada.

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MSDS stands for Material Safety Data Sheets that are essentially documents of a special type. These documents are expected to usher in a new world, a world free from incidents and accidents resulting from chemicals of a hazardous kind. These documents are to be raised for each hazardous chemical that could harm the individual or the environment in any way. Therefore, incendiaries, inflammable chemicals or chemicals that could be sensitive to initiation that could cause an explosion and corrosive chemicals or chemicals that could be toxic or carcinogenic in nature are all covered. The stress is on thorough documentation and total training of personnel who are involved in handling such chemicals in any way whether in production, packing, testing, transporting or in demolition.

MSDS is important from the point of view of total safety due to awareness. All personnel who are involved with such hazardous chemicals would be aware as to how to handle any incident or accident involving such chemicals. Thus, if such a chemical is being transported and there is a spill the personnel accompanying and the safety operators would be aware of the measures that were required to be taken to combat any risk from fire or explosion that may arise. They would have the necessary safety gear and would be competent to handle such incidents to a safe conclusion.

The documents also lay down some important physical data such as the vapor pressure, the associated odor, the boiling point and the degree to which the chemical reacts with other substances. There are several regulatory bodies for MSDS such as the National Institute for Occupational Safety and Health or NIOSH, the Occupational Safety and Health Administration or OSHA and the Environment Protection Agency or EPA. There are some competent agencies as well that offer services towards MSDS authoring in respect of the data sheets in the United States, Canada and Mexico besides some other countries. With this new form of documentation it is hoped that there would be a global reduction in incidents and accidents involving hazardous chemicals and as a result there would be greater health and security in the new world.

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There are a large number of chemicals that are hazardous in nature. These chemicals could be explosive in nature or inflammable or both. They could also be toxic, carcinogenic or corrosive. Therefore, the need was felt to document such chemicals on standardized Material Safety Data Sheets or MSDS. The idea of such documentation is hardly new. Such an idea existed during the time of Imhotep - the Egyptian physician some 4 thousand years ago. He would place every detail regarding his prescription on record. Such details included materials used, their sources and names and how they were prepared. The method of storage was on record as well as the application. Warnings were detailed concerning incorrect use.

Modern times have made the introduction of MSDS absolutely imperative. Every hazardous chemical will henceforth need to be catalogued in a standard manner. In order to improve the safety and health conditions of personnel engaged in the processing of such chemicals it’s essential that all personnel involved in the production, storage, packing, testing, transportation and destruction of these chemicals are to be fully equipped and trained in the very nature of these chemicals.

The MSDS will need to display complete particulars concerning the hazardous chemicals. The particulars will include the names of the chemicals and the full particulars and address of the supplier as well as the producer. The constituents will have to be detailed together with important physical data such as the boiling point, vapor pressure and the odor besides the degree to which the chemical might react with other substances. The sensitivity to explosion and the degree to which the chemical is inflammable are both most pertinent. The protective and safety gear to be used and the first aid measures that may be required are to be clearly stipulated.

Finally, there are regulatory bodies for MSDS. Some of these bodies are the National Institute for Occupation Safety & Health or NIOSH, the Occupational Safety & Health Administration or OSHA and EPA or the Environment Protection Agency. There are competent agencies in the US, Canada, Mexico and some other countries that offer competent services towards MSDS authoring.

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The United Nations introduced the concept of Globally Harmonized System or GHS as an attempt to classify all hazardous chemicals in a uniform manner for information and consultation. The United Nations Economic and Social Council subsequently endorsed this concept in July 2003. The method classifies the hazardous chemicals based on the hazard types that they are associated with.

Till the introduction of GHS every independent country had its own method of classification of hazardous chemicals, their labeling and symbols defining the nature and class of associated hazard that could be fire, explosion or both besides toxicity. Therefore, when such chemicals were transported through other countries there was an absolute lack of awareness of the manner in which a spillage was to be tackled or a conflagration and/or explosion. There was no common directive to define the precautions that were to be considered, or the manner in which a particular type of incident or accident was to be handled.

With the introduction of GHS, a commonality is being established globally. The intention of establishing such a commonality is ultimately to bring in a global improvement in health and safety standards, especially in a field that is so hazardous. The approach adopted is to establish a relationship between the classification and the associated hazard criteria. Subsequently, the link is to be communicated down the line to all the dealing personnel on the hazards, the protective measures that were necessary and the methodology of labeling that was to be adopted. The labeling could be an SDS (Safety Data Sheet). Companies dealing in such chemicals would need the services of a competent GHS consultant.

The new system is not legally binding though it’s an international agreement. It’s also not a standard nor is it a regulation. There is no deadline stipulated for implementation. However, there are immense benefits to the society in general and the industry in particular from its implementation. It is hoped that with the spread of awareness about the associated hazards there will be a dramatic fall in the rate of accidents globally bringing in an improvement in productivity and cost effectiveness besides ensuring better health conditions.

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All materials or chemical substances that are hazardous in nature are to be documented in Material Safety Data Sheets or MSDS. This concept of documentation is not new and goes back in time to thousands of years ago when the great Egyptian physician Imhotep would record the particulars concerning his prescription. The raw materials used in these medications were defined in terms of their names, concentrations and their sources. The method of preparation was detailed along with the manner in which these formulations were to be stored and applied. The warnings against wrong use or application were stipulated clearly. In more recent times, say about a hundred years ago, chemists have used Chemical Data Sheets.

There is a thrust once again in modern times to drive to a standard wherein every hazardous chemical is duly catalogued in the appropriate MSDS. All personnel involved in the production or storage, testing or handling, disposal or transportation of these hazardous chemicals are to be fully aware of the hazards involved. This is a global thrust to ensure that the culmination is in total health and safety both for the society and the environment.

The scope of these data sheets is to display the full particulars related to the name of the hazardous chemical, its producer’s particulars as well as those of the supplier. Such particulars will include the complete postal address and telephone numbers. All the constituents of the hazardous product are to be detailed in addition to their physical data. Such data will include vapor pressure, odor, boiling point and the degree of its reactivity with other substances. The degree of inflammability and tendency to explode must be clearly stipulated. The various safety and protective gear that are to be used must be spelt out besides the first aid measures that will be needed and the health factors that may be involved. The degree to which the product is carcinogenic also needs to be defined.

MSDS has regulatory bodies such as NIOSH or the National Institute for Occupational Safety and Health and OSHA or the Occupational Safety and Health administration besides EPA, the Environment Protection Agency.

For further information on MSDS authoring and MSDS please visit http://www.nexreg.com/

MSDS is an abbreviation that stands for Material Safety Data Sheets that envelop all the chemicals that are hazardous. The concept actually dates back to some 4000 years ago during the period of the ancient Egyptians. Then physicians made it a point to document various details related to the prescriptions. Such details would be the various materials that were used in making the prescription, the names of these materials as well as the sources from which these were made available. The method of producing the prescription was accurately documented as well as the way it was to be stored and the manner in which these were to be applied and the precautions that were to be taken in the application. There were warnings pertaining to improper usage or application as well.

Even a hundred years ago chemists were using chemical data sheets. In modern times, it has become absolutely essential that all personnel who are involved in either the production, the handling or storage and transportation or the testing and the destruction of these hazardous chemicals should be totally aware of the dangers involved, the protection that was to be taken and the equipment that was to be used to contain the conflagration resulting from such chemicals. The world now truly needs MSDS again more than ever before. The global effort has already started to ensure a complete documentation of all chemicals that are hazardous. The implementation of these data sheets will ensure an all round improvement in both safety and health.

All hazardous chemicals will be under the purview of MSDS. Establishments dealing with such chemicals will need to display details concerning the name of the chemical and particulars of both manufacturer and supplier including their addresses and contact numbers. All ingredients need to be specified as well as physical particulars that include odor, vapor pressure, boiling point and reactivity with other substances. All precautions are to be detailed concerning the control of spillage and fire and use of protective gear, first aid measures and disposal of waste. Regulatory bodies have been appointed and the world is now getting ready for a safer tomorrow.

For further information on GHS and MSDS please visit http://www.nexreg.com/