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.
Question: As the only Regulatory professional in the company where I work, I find it increasingly more difficult to stay in compliance with all of the changes that are occurring to regulations. Is there single source of data that can help me stay apprised, we ship to many countries in Europe and Asia.
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.
Question: We recently had some of our products delayed at an EU border, seems the SDS we produced was outdated.What should I do to have my documents updated?
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.
Question: We produce hardware (medical device) that requires some liquid product (lubricants) to be shipped with the hardware, I’m told I need to produce an MSDS to ship this product, is that true?
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.
Question: We ship our products to Europe using our US MSDS in English, why is this a problem?
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.
Question: Do we have to declare all the ingredients in our products when shipping to Japan? Even water?
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.
Question: How do I know if a product can be shipped by air or not?
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.
Question: When do we need to include CLP on our regulated documents? And should CLP be added to other non-EU states i.e. Korea?
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.
Question: Services vs. software, when should we buy commercial software?
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.
Question: Can we go to a translation company to convert our documents to another language?
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.
Question: We have a lot of products; I don’t see how we could ever afford to buy documents for each one. Many are very similar, sometimes only the color changes. Why should I have to buy a document for each product name?
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.
Question: We have pre-printed labels, can I use these if the regulations change?
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.
Question: My client in Belgium speaks English, can I provide them the MSDS in English?
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.
Question: We’re supposed to manage the documents that come from our suppliers, what do companies do to update and view these documents electronically?
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.
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.