Dr. Luc and his team often receive questions, here are his answers to some of the most commonly asked questions. If you have a question for Dr. Luc, please do not hesitate to send it in.
Dr. Luc: Keeping up with global regulations is a challenge all companies face; unfortunately, there is no such thing as a central repository of regulations that covers all the regions you ship to. Further, the regulations provided by country governments are usually in the language of that country.We update our regulatory data bases on a quarterly basis to ensure the documents we generate for our clients meet the country specific regulations for any region you need.
Dr. Luc: Due to the ever changing regulatory landscape, keeping your documents in compliance for the many regions you ship to is a daunting task. KMK has many options to help our clients not only meet the country requirements but also lower their cost of compliance long term. Our long term compliance (document maintenance) updates all of the documents we have created at a substance level. This solution ensures your compliance and real peace of mind.
Dr. Luc: Under GHS and CLP in Europe these types of products are recognized as “articles” and do require the proper documentation. This new regulation is complex since calculations are made on the various chemicals needed in that machinery based on the concentration of each ingredient in that mixture. Our authors have a great deal of expertise with this new requirement.
Dr. Luc: Years ago, European authorities were more flexible with compliance to local and international regulations. As of 2007, REACH and GHS/CLP was implemented in Europe and is now supported by all regulatory bodies and in many Asian countries. The newly adopted regulations now supports Directive 1272/2008 for GHS and to the Directive 453/2010 to support the CLP (Classification, Labelling and Packaging) format, has also provided the border authorities with the ability to hold product from entering the country and even levy fines to companies that do not comply with regulations or even proper language of the regulated documents. SDS must be language and country specific.
Dr. Luc: Japan, as well as many other countries all over the world, adopted the GHS classification system. The system governs the disclosure of hazardous ingredients under multiple conditions (hazards, hazard levels, concentration, physical state etc.) and so even if you would prefer to disclose all of your ingredients, we would always first recommend that you ONLY disclose the ones that are mandatory by law. The concentration of water in your product is not yet mandatory to declare.
Dr. Luc: KMK provides in-house expertise in many areas including transportation. KMK supports all of its clients, with answers to these types of questions as part of our service agreement. Since we position ourselves as an extension of your own regulatory group, you can always count on our staff to answer your questions and work with your group as regulatory partners.
Dr. Luc: CLP stands for Classification Labelling and Packaging and it is ONLY valid in Europe. As per the recently adopted Directive 1272/2008 and Directive 435/2010, we now MUST ALWAYS use the CLP format for all of European SDSs, and we also have to ALWAYS show the GHS classification for substance’ SDSs since December 1st, 2010. In the case of mixtures, we suggest our customers to show BOTH the Risk and Safety (Dangerous Preparation Directive) statements and symbols TOGETHER WITH the GHS that to ease the transition for their distributors, importers and customers, between both systems.
Dr. Luc: Software, implementation, maintenance, support and the expert staff to generate the compliant documents is a costly solution. Even with the very best and cutting edge software applications available, experts with regulatory knowledge in all the regions of your distribution chain must be able to understand and interpret the rules and regulations that drive the classifications. Interpreting the results of the calculations is critical to avoid the cost of non-compliance, fines and delays at the borders. KMK can be your regulatory experts. We will provide an unbiased appraisal of your needs for a full suite of software products, data etc., versus the KMK service offering. Contact us and we help you make an informed decision.
Dr. Luc: Yes you can, BUT you would risk not being in compliance. The reason being the language is only ONE part of the compliance, the other part remains the classification and the entire statements to be applicable to the country where you ship or sell your product. A case in point would be to translate a US compliant MSDS into German to ship to Germany. US and Germany have two distinct systems to classify chemicals, the German authorities will likely BLOCK your shipment at the border, until you send them a CLP-GHS German language compliant SDS.
Dr. Luc: The cost of compliance can be prohibitive if you have many products being distributed into many countries and this can be punctuated if sales of a particular product are low. Whenever possible we encourage our clients to use our grouping (Generic names or Derivative documents) options to combine multiple products onto a single document or to derive similar documents based on a given master SDS, at a much lower cost of production. These options greatly reduce the total cost of compliance. Contact us directly, so we can help you evaluate the potential of lowering your project costs.
Dr. Luc: Many of our clients use pre-printed labels; we supply them with the data (content) that must be reflective of the classifications of the corresponding (M) SDS documents. We have the capabilities of delivering the data in many different formats including: XML, HTML, simple Text… and ultimately a closely acceptable Word document conversion allowing our clients to import the content directly into their label writer.
Dr. Luc: Since Belgium is a French (and Dutch) speaking country, GHS requires all regulated documents be produced in EU French (OR Dutch). However, we do produce documents in 45+ languages and will produce a Belgium compliant document in English in conjunction with the French document and meet Belgium language requirements.
Dr. Luc: Many solutions and solution providers are available to manage both your in-bound and out-bound documents. These documents can be indexed for quick and easy searching and reporting capabilities. We provide an integrated solution that can support your needs and ensures your total compliance long-term. Maintaining the compliance of all your documents is the most cost effective solutions to lowering the high cost of compliance and greatly reduces your exposure in the marketplace. Our solutions provide the most advanced technology to store, display, access and print your active regulated documents.
Dr. Luc: No, HAZCOM 2012 and GHS Canada will not cover consumer products. These are in each country’s respective consumer product regulation (CPSC in the US and CCCR in Canada). They are totally different and require a specific set of hazard symbols. The logic behind it is in the nature of the “hazard” being more of a “risk”, since they are used in small quantities, by an untrained person, over a small period of time. Therefore one must continue to issue a consumer label for what we expect will be many years to come.
Dr. Luc: For now, the Biohazard symbol will keep its “WHMIS-like” black and white circle. It’s possible that in the future, Canada will propose that the United Nations adopt a “Square to the Point” red border symbol, but as of now we have no indication from any official representative.
Dr. Luc: At the time when the final version of the HPR (Hazard Product Regulation) comes out, this should be confirmed. We already know that it should follow the US GHS content and that it will be bilingual (English-French), so unless we have a big surprise, we can already foresee pretty much what it will look like and contain. KMK will offer a webinar on labels so we cover that topic extensively.
Dr. Luc: This is an interesting option to consider. HMIS and NFPA have been in use for many years, but there is a paradigm shift in thinking versus the GHS hazards: NFPA and HMIS have a 0 to 4 increasing hazard levels where 0 is less hazardous than 4, while GHS is more about categories where Category 1 is more hazardous than Category 5. We warn our customers not to show these side by side unless their end-users have been trained on that particular topic to avoid possible confusion.
Dr. Luc: Absolutely! There is no room to keep both systems. The GHS has its own set of criteria, symbols and mandatory H and P phrases so in no way will we have authorization to put both on the same document (SDS or label).
Dr. Luc: It was never mentioned that “Pure substances”, followed by “mixtures” in phases would be adopted. Because of the late adoption and the will of Health Canada to mirror the US, we believe the enforcement will apply to all industrial products together from day one.
Dr. Luc: Yes, Canada has two official languages, English and French and since no one knows who will read the regulated document it will need to contain both languages. It is not the same thing for (M)SDS where the law requires that the language version requested by the workers must be available on-demand, so in cases where only English workers are found, having an English SDS would be in compliance.
Dr. Luc: No, the European Union adopted the same basic GHS for all of its members, but there are local regulations that need to be considered and applied when applicable(Country-specific OELs and other regulations such as GWK in Germany for example) . Also, languages of each of the EUROPEAN country must be adopted for the regulated documents circulated with products
The EU adopted different GHS building blocks from the ones in use in the US, where some health hazard cut-off concentrations are higher (1% level in Europe) compared to the 0.1% level in the US, so be careful not to send a US GHS SDS into Europe. There are significant differences from one side of the Atlantic to the other!
Dr. Luc: Until Health Canada releases the final Gazette on or before Dec 1st 2014 GHS regulated documents cannot be used, workers have not yet been trained to recognize the GHS symbols and classification.
Dr. Luc: The Environmental Hazards are not enforced under HAZCOM 2012 and the upcoming Canadian GHS. The non-enforcement of these hazards would impact your SDS and Labels if they don’t identify the specific Signal Words, H and P Phrases and all symbols related to these hazard classifications, this includes pictogram. In fact, the whole classification can be left out for now. At the present time, we are working with a number of OSHA representatives to clarify the information regarding when EPA (US) or CEPA (Canada) will start regulating these hazards specifically.
Dr. Luc: This is a question and concern we hear on a regular basis, as we all need to identify the ingredients’ full disclosure to perform classification calculations. Once a compliant HAZCOM 2012 format SDS is available, we will be able to “see” the Trade Secret hidden name and concentration contributing to the final hazard. It remains a very complex endeavour. KMK has proposed to OSHA that Section 3 also identify the ingredient hazard to cover for this situation and were told it might be confusing, but we believe, as per the EU regulation, it would give valuable information. KMK is in active discussion with OSHA representatives to identify and amend this perplexing question during our next meeting in September 2014. For now, it remains a concern. To add to the possible repercussions, some manufacturers/suppliers/blenders are not particularly “in a rush” to provide HAZCOM 2012 format SDS, waiting for that June 2015 deadline. As you know, nowadays Supply Chain is a series of moveable parts. Every supplier/manufacturer/blender that delays or waits for the last minute to complete their GHS transition will affect their clients’ own supply chain. We expect some difficult times in the coming months for those manufacturers/suppliers/blenders that do not respond to the new regulations with alacrity.
Dr. Luc: This is an important confirmation we are all waiting on. We will keep an attentive eye out and will communicate the final Hazardous Product Regulations (HPR) release as soon as it’s confirmed.
Dr. Luc: NJTS is still ‘In use’ for now. As a state regulation NJTS conflicts with the newly adopted GHS in the United States. Raw Material providers will need to review all their SDS documents to ensure the latest rules have been applied regarding OSHA’S guidelines (Name, concentration in ranges must be shown).
One must remember the requirement from HAZCOM 2012 on Confidential Business Information (CBI) refers to disclosure of the hazardous ingredients being disclosed by a CBI (Trade Secret) in terms of masking the chemical name and exact concentration by ‘synonyms and concentration range’. KMK is concerned that these will not show their specific hazard contribution to the mixture they are part of… This topic will be discussed in more details in a coming webinar.
Dr. Luc: We were told there would be no change in the Canadian HMRIC submission process, so the fee structure will unfortunately remain.
Ask Dr. Luc is a service providing answers to complex regulatory questions sometimes needing an informed judgment call. Dr. Luc will provide answers to the best of his professional and expert ability. In case of error or omissions, Dr. Luc or KMK Regulatory Services cannot be held responsible or assume any liability.