What is the functionality of REACH compliance?

REACH (Registration, Evaluation, Authoring and Restriction of Chemicals) compliance is a new European Community Regulation on chemicals and their safe use (EC1907/2006).The main goal of this regulation is to improve the protection of human health and the environment while identifying the properties of chemical substances in an appropriate manner.

Manufacturers and importers will be required to gather information on the properties of their chemical substances, which will allow their safe handling. The chemical substance must be registered with the central database run by the European Chemicals Agency (ECHA) in Helsinki in order to be legally used on the market. The Agency will act as the central point in the REACH system. It will manage the databases necessary to operate the system, co-ordinate the in-depth evaluation of suspicious chemicals, and run a public database in which consumers and professionals can find hazard information.

The Regulation also calls for the progressive substitution of the most dangerous chemicals when suitable alternatives have been identified. One of the main reasons for developing and adopting the REACH Regulation was that a large number of substances have been manufactured and placed on the market in Europe for many years, sometimes in very high amounts, and yet there is insufficient information on the hazards that they pose to human health and the environment.

It has been known and accepted since the drafting of REACH that the need to fill the data gaps would result in an increased use of laboratory animals for the next 10 years. At the same time, in order to minimize the number of animal tests, the REACH compliance Regulation provides a number of possibilities to adapt the testing requirements and use existing data and alternative assessment approaches instead.

How is the EU SDS “Sustainable Development Strategy” implementing the “Kyoto Protocol” towards “Climate Change”?

The implementation of the EU SDS “Sustainable Development Strategy” enforces its regulation towards “Climate Change” with one very important tool which is the “Kyoto Protocol”. “Kyoto Protocol” entered into force on the 16th of February, 2005 in Rome, with an aim to combat Global Warming. The entry into force of the protocol and its provisions today will not only oblige industrialized countries to reduce their emission of greenhouse gases, but also enhance EU SDS in developing countries.

The “Kyoto Protocol” provides mechanisms that will encourage investment in climate-friendly projects, which will contribute to reducing greenhouse gas emissions and at the same time promote the EU SDS in developing countries. However, in order for the EU SDS to take its effect, several different policies have been developed. Developed countries will pay for carbon emission offsets, which will help finance adaptation activities to assist highly-vulnerable developing countries to cope with the challenges of climate change. The FAO “Food and Agriculture Organization of the United Nations” will support vulnerable countries in identifying and formulating projects that will enable them to receive such investments.

Measures include the use of bioenergy, reforestation, and the adoption of improved agricultural practices that help reduce emissions from agriculture while increasing production. With more investment in increasing bioenergy generation and use, carbon emissions could be reduced by 5 to 25 percent of the projected fossil fuel emissions for the year 2050, according to the Intergovernmental Panel on Climate Change (IPCC). Under the Kyoto Protocol, FAO aims to identify, develop and promote these practices so that developing countries may gain additional income from selling carbon credits, while improving the livelihoods of farmers through enhanced soil fertility and higher crop production.

What is the goal of (GHS) Globally Harmonized System and why is it necessary?

GHS – Globally Harmonized System of Classification and Labeling of Chemicals is a system which defines and classifies hazards, and communicates health and safety information on labels and material safety data sheets (called Safety Data Sheets, or SDSs, in GHS regulations).

The main goal of GHS is to enhance the protection of human health and the environment by providing an internationally comprehensive system for hard communication. This is to be achieved by adopting the same set of rules for classifying hazards and using the same format and content for labels and SDSs around the world.

“Global Harmonization” is necessary because presently many different countries have varying systems for classification and labeling of chemicals. In addition, several different systems can even exist within the same country. One problem many countries have come across is that their old systems have been too expensive for their governments to regulate and enforce. This has become costly for companies who have to comply with many different systems, as well as confusing for workers who need to understand the hazards of a chemical in order to work safely.

GHS will provide guidance on classifying pure chemicals and mixtures, according to its criteria. An SDS author must properly classify a compound in order for the target audiences (workers, transport workers, emergency responders and consumers) to understand the authored documents.

What must be disclosed on an MSDS if the chemical has been accepted as a trade secret?

Section 26 of the Controlled Products Regulations states what must be disclosed on an MSDS when the chemical formula is accepted as “trade secret”.

(1) A supplier who, pursuant to subsection 11(1) of the Hazardous Materials Information Review Act, files a claim for exemption from a requirement to disclose information in respect of a controlled product on a MSDS or on a label shall, in respect of the sale or importation of the controlled product or any controlled product having the same product identifier, disclose on the MSDS and, where applicable, on the label of the controlled product or container in which the controlled product is packaged the date that the claim for exemption was filed and the registry number assigned to the claim under the HMIRA.

(2) The requirements of subsection (1) apply in respect of a supplier who receives notice of a decision that the claim for exemption is valid
(a) if there is no appeal of the decision under subsection 20(1) of the HMIRA for a period not exceeding 30 days after the expiry of the appeal period; and
(b) if there is an appeal of the decision under subsection 20(1) of the HMIRA, for a period not exceeding 30 days after the expiry of all periods for the making of an appeal or an application for judicial review in respect of the decision on appeal.

How to author a GHS MSDS?

MSDS usually referred in the GHS regulation as SDS (Safety Data Sheet) should be prepared for all substances and mixtures which meet the harmonized criteria for physical, health or environmental hazards under the GHS and for all mixtures which contain ingredients that meet the criteria for carcinogenic, toxic to reproduction or target organ toxicity in concentrations exceeding the cut-off limits.

The writer of the SDS needs to keep in mind that an SDS must inform its audience of the hazards of a substance or a mixture and provide information on the safe storage, handling and disposal of the substance or a mixture. An SDS contains information on the potential health effects of exposure and how to work safely with the substances or mixtures. When writing the SDS, information should be present in a consistent and complete form, with the workplace audience firmly in mind. However, it should be considered that all or part of the SDS can be used to inform workers, employers, health and safety professionals, emergency personnel, relevant government agencies, etc.

Language used in the SDS should be simple, clear and precise; vague and misleading expressions should not be used. If it is stated that a particular hazard does not exist, the SDS should clearly differentiate between cases where no information is available to the classifier and cases where negative test results are available.

The data of issue of the SDS should be stated and be very apparent. The data of issue is the data the SDS version was made public. Revised SDS’s should clearly state the date of issue as well as a version number, revision number, or some other indication of what version is replaced.

For further information on GHS MSDS, visit www.nexreg.com

What are the WHMIS classifications, and their symbols?

There are 6 different WHMIS classifications, which are depicted by classes A through F. Several of these have multiple sections and subsections. They are as follows:

Class A. Compressed Gas
Materials which are normally gases, contained under pressure.

Class B. Flammable/Combustible Material
Flammable materials burn at temperatures below 37.8 °C (100°F). Combustible materials burn at temperatures of 37.8°C–93.3°C (100°F–200°F). Reactive flammable materials spontaneously combust when combined with air/water, or react with air/water to make flammable gases.
B1. Flammable Gases
B2. Flammable Liquids
B3. Combustible Liquids
B4. Flammable Solids
B5. Flammable Aerosols
B6. Reactive Flammable Materials

Class C. Oxidizing Material
Contributes to the combustion of another material by producing oxygen or another oxidizing agent,regardless of whether the material itself is combustible;
or the material is an organic peroxide that contains the bivalent O-O structure.

Class D. Poisonous and Infectious Material
Class D1. Materials Causing Immediate and Serious Toxic Effects
Effects to health are usually fast-acting, but can also be long-term.
D1A. Very Toxic Material
D1B. Toxic Material
Class D2. Materials Causing other Toxic Effects
Effects are usually slow acting and may be temporary.
D2A. Very Toxic Material
D2B. Toxic Material
Class D3. Biohazardous Infectious Materials
An organism that causes disease in humans and animals.

Class E. Corrosive Material
Causes severe burns to human tissue, and other materials including metals.

Class F. Dangerously Reactive Material
A material that undergoes vigorous polymerization, decomposition or condensation; reacts with water to release a toxic gas; or self-reacts under shock, increased pressure or temperature.

What information must be disclosed in an OSHA MSDS?

Under the Occupational Safety and Health Administration (OSHA) all hazardous chemicals within the United States must have an associated MSDS. There is no mandatory format for the OSHA MSDS, it does however require specific information to be present. This information is stated in the OSHA Hazard Communication Standard (HCS) 1910.1200, which is as follows:

1. The chemical’s identity as stated on the product label
2. Physical and chemical characteristics
3. Physical hazards, including fire, explosion and reactivity potential
4. Health hazards
5. The primary route(s) of entry into the body
6. Exposure limit values
7. If listed on the National Toxicology Program (NTP) Annual Report On Carcinogens or International Agency for Research on Cancer (IARC) Monographs as a potential carcinogen
8. Precautions for safe handling and procedures for clean-up of spills and leaks
9. Control measures including engineering controls, work practices, and personal protective equipment
10. Emergency and first add procedures
11. Preparation date of OSHA MSDS
12. Name, address and telephone number of chemical manufacturer

There is a suggested eight section OSHA MSDS format in the OSHA Form 174, which does not necessarily have to be followed as long as the required information is present within the document. In fact the ANSI format, which contains sixteen specific sections, is now becoming more widely used for OSHA standards.

Can we use GHS in Europe on our SDSs and labels right away?

Can we use GHS in Europe on our SDSs and labels right away? If not, when can we prepare a GHS MSDS or SDS for use in Europe?

The short answer is 'yes', the EU implementation of GHS, known as CLP (Classification, Labelling and Packaging of chemical substances and mixtures) allows for early adoption of GHS for both SDSs and labels, though the rules differ between pure substances and mixtures.

Mixtures - The new classification system is not required for mixtures until June 1, 2015. Companies are free to adopt the new CLP rules on their SDSs and labels for mixtures any time before that date.

Substances - Between December 1, 2010 and June 1, 2015 companies are required to use both the existing classification system and the CLP system on their labels and SDSs - that is, substances will be 'double classified'. After June 1, 2015 only the CLP system is required. Companies are free to adopt the CLP system prior to December 1, 2010, so long as they follow the 'double classification' provisions required between December 1, 2010 and June 1, 2015.

Note that, unlike REACH, there is no one tonne exemption under CLP.

What are the obligations of non-EU companies towards the REACH Regulation?

According to the REACH Regulation, companies of the non-EU countries do not have direct obligations under the REACH Regulation. However, it is the importer who needs to comply with the REACH obligations. According to the Article 3(11) of the REACH Regulation, importer means any natural or legal person established within the Community who is responsible for import. On the other hand, according to Article 3 (9) of the REACH Regulation, a manufacturer means any natural or legal person established within the Community who manufactures a substance within the Community.

Non-EU companies exporting chemical substances on their own are not obligated to appoint an “only representative” according to the Article 8 of the REACH Regulation to fulfill the obligations of importers. However as a non-EU company such industries still need to take the REACH Regulation into observation. Why? Although you may be established in a non-EU country, you have to take into observation that some of your business partners might be based in the European Union. Even though, placing REACH Regulation into action it might be out of your direct line of sight, but you still have to pay attention to the details of the REACH Regulation. If not, someone downstream in your industry sales chain will be affected which will have a major impact on your industry as well.

For further information on REACH compliance, You may visit http://www.nexreg.com/

Do MSDSs prepared under U.S. OSHA Hazard Communication Standard (HCS) meet Canadian requirements?

No. The WHMIS supplier MSDS and label requirements are more prescriptive than those set out under HCS. However, the WHMIS and OSHA closely parallel one another; the main difference between those two regulations is the criteria for updating and MSDS.

In Canada under WHMIS regulations an MSDS is required by law to be updated every three years or in case there is a change in the formulation, which in that case might lead to a new WHMIS classification. On the other hand, OSHA requires an update only in the case if there is a change in formulation or health information. If a manufacturer, supplier or an importer is shipping his product to Canada they must have an MSDS dated with three years and the document must be in the two official languages English and French.

One of the main differences between the two standards is the actual style format in which the information is being presented, such as hazardous ingredients and hazard identity information. WHMIS regulations specifically require a 9 section format MSDS, which are as follows:

Hazardous Ingredients
Preparation Information
Product Information
Physical Data
Fire or Explosion Hazard
Reactivity Data
Toxicological Properties
Preventive Measures
First Aid Measures

OSHA MSDS suggests that an MSDS follows the 16 section format established by the American National Standards Institute (ANSI) standard for preparation of MSDSs (Z400.1), which are as follows:

Identification
Hazard(s) identification
Composition/information on ingredients
First-aid measures
Fire-fighting measures
Accidental release measures
Handling and storage
Exposure controls/personal protection
Physical and chemical properties
Stability and reactivity
Toxicological information
Ecological information
Disposal considerations
Transport information
Regulatory information
Other information

However, since WHMIS regulations were passed, several agencies have made suggestions and approved the 16 section standards and that under one condition that it follows the Canadian WHMIS regulations, in order to meet Canadian requirements.

How many products have been recalled for CCCR violations in 2009?

There have been 11 sets of products recalled for CCCR violations in 2009. This does not include all the products that were simply removed from store shelves until the labels are made compliant; Health Canada does not release statistics on removals.

The products that received a full public recall in 2009 (as of July 2009) are as follows:

Jul. 2009: toilet bowl cleaner (lacking child-resistant container)
May 2009: fire fuel (lacking child-resistant container)
May 2009: jewelry cleaner (lacking child-resistant container, flammability and corrosive warnings)
May 2009: spray deodorant (lacking flammability and explosive warnings)
May 2009: chafing fuel (flammability)
May 2009: 14 cleaning chemicals (lacking child-resistant container)
May 2009: 13 pool chemicals (lacking child-resistant container)
Apr. 2009: 3 hair care products (lacking flammability and explosive warnings)
Feb. 2009: shaving cream (lacking flammability and explosive warnings)
Feb. 2009: jewelry cleaner (lacking child-resistant container, flammability and corrosive warnings)
Jan. 2009: 3 brake cleaners (flame projection too long)
We expect this list to increase in 2009, to match the approximately two dozen recalls in 2008.

What products are subject to WHMIS supplier MSDS requirements?

A manufacturer/supplier who plans to sell a product to be used in a workplace environment in Canada is required to classify the chemical merchandise. The chemical product must under go a comparison of physical, chemical and toxic properties with a detailed list of WHMIS criteria. The list can be found in Part IV of the Controlled Products Regulations CPR act. In case the product is determined to meet at least one of the following WHMIS criteria:

1. Compressed Gas
2. Flammable Gases/Liquids/Solids & Aerosol
3. Combustible Liquids
4. Reactive Flammable Materials
5. Oxidizing material
6. Poisonous and Infectious Material
7. Biohazardous Infectious Material
8. Corrosive Material
9. Dangerously Reactive Material

The product becomes automatically a WHMIS controlled product and therefore subject to the WHMIS requirements.

Before the chemical product under goes the comparison of physical, chemical and toxic properties, manufacturer/supplier wants to make sure that the chemical product is excluded under Section 12 of the Hazardous Products Act HPA. Products that are excluded are exempted from both federal and provincial WHMIS requirements, which are:

1. Consumer Products
2. Cosmetics
3. Dangerous Goods in Shipment
4. Explosives
5. Food and Drugs
6. Hazardous Waste
7. Manufactured Articles
8. Pesticides
9. Radioactive Materials
10. Tobacco and Tobacco Products
11. Wood and Wood Products

In this case manufacturer/supplier has classified the chemical product to be WHMIS controlled product, his duty is to properly label the product with a WHMIS label, prepare and provide the customer with an MSDS. An MSDS must be reviewed to ensure that it is still compliant. Further, under WHMIS regulations the MSDS must be reviewed every three years.

What does a GHS label look like?

Examples of Arrangement of the GHS Label Elements are given in Annex 7 of the Second Revised Edition of the Globally Harmonized System of Classification and Labelling of Chemicals - GHS (also known as 'The Purple Book'). The following siz graphical examples are given:

1. Combination packaging for a Category 2 flammable liquid

2. Combination packaging for a Category 1 specific target organ toxicant and Category 2 flammable liquid

3. Combination packaging for a Category 2 skin irritant and Category 2A eye irritant

4. Single packaging (200 l drum) for a Category 2 flammable liquid

5. Single packaging for a Category 1 specific target organ toxicant and Category 2 flammable liquid

6. Single packaging for a Category 2 skin irritant and Category 2A eye irritant.

The common label elements to each of these examples are: Product identifier, Signal Word, Hazard Statements, Precautionary Statements and Supplier Identification. When GHS is adopted at the country level, each particular country made require additional elements that must appear on the label or may not use all of the GHS elements. Label authors need to be familiar with both the purple book version of GHS as well as the regulations specific to the country they are authoring the label for.

Are there any exemptions under the CCCR?

There are a number of classes of products that are not required to have their labels be CCCR compliant in Canada.

The first set of products are those which are given an exemption undersection 3 of the Hazardous Products Act. They are as follows:

- cosmetics

- drugs

- explosives

- food

- medical devices

- nuclear substances

- pest control products

- tobacco products

Section 2 of the CCCR-2001 lists 3 classics of products that arespecifically exempt because they follow under other regulations:

- portable petroleum containers

- lighters

- fire extinguishers.

Under section 2, products are also exempt if there is no reasonableexpectation that the consumer could be exposed to the hazardous chemicalsinside.

Finally, products are excluded if they are used exclusively in theworkplace, as workplace chemicals are governed under WHMIS. Note thatif a product is available for sale to the general public, then it must meetthe CCCR-2001 requirements, even if it is primarily used in a workplacesetting. The Health Canada Guide to the CCCR-2001 notes that "[s]tatementssuch as "For Industrial Use Only" on the label do not remove consumerproducts from the requirements of the CCCR-2001."

WHMIS MSDS

One question we are often asked at Nexreg is "if I have a Canadian WHMIS MSDS prepared, do I need to have it in both French and English?" To answer that, let's look at the regulations.

Section 24(2) of Canada's Controlled Products Regulations states:"Where a supplier transmits a material safety data sheet in respect of a controlled product, the information shall be disclosed on the material safety data sheet in English or in French, or both, in accordance with the request of the person to whom the controlled product is sold or, where the person does not specify the language in which the information shall be transmitted, the information shall be transmitted in English or in French, whichever is used in the course of the sale between the supplier and the person."In practical terms, a supplier needs to have MSDSs prepared in both English and French by the time they begin selling in Canada, as they need to have both of these MSDSs available upon request.For the WHMIS supplier label, the required information needs to be presented in both English and French - no exceptions. The English and French text can be in the same WHMIS border or within two separate WHMIS borders, but if the latter, the hazard symbols must also appear in both WHMIS borders.