Ask Dr.Luc

KMK Regulatory Services’s CEO and Chief Science Officer, Dr Luc Séguin, Ph. D., Chemist, will be pleased to answer your questions regarding global regulatory issues, (M)SDSs, labels, GHS, REACh as well as local and international regulations that drive substance classifications.

Please fill your question and information in the box hereinafter (500 characters max.) and Dr. Luc will get back to you in a timely manner. Please note that confidentiality will be respected at all times and that no answer(s) will be published without your formal agreement and permission.

Q: Our US based company exports products to a number of EU countries. Our EU SDSs comply with the EU DSD and DPD and we have always provided them in English only without any problems. Recently we were told that we must supply them in the language of each of the country we export to. Is it true or false?

A: Article 31(5) of REACH specifies that "The safety data sheet shall be supplied in an official language of the Member State(s) where the substance or preparation is placed on the market, unless the Member State(s) concerned provide otherwise." It is then for you to enquire on the official language(s) spoken in each of the country you are exporting to.

Q: Is it possible and do you recommend writing MSDSs to cover many countries, if so which ones?

A: One must make sure that all countries shown on the same MSDS are under compatible legislation and regulatory requirements. For example Canada and the United States are governed by two distinct legislations (WHMIS and CPR in Canada versus OSHA Hazard Communication System in the US) but both systems are 'mainly' compatibles. There are some differences in the concentration cut-off of some hazards related to the classification of mixtures, but fundamentally both systems are lying on the same 'philosophy' so could lead to the same adapted MSDS. Also very important in that example is that both countries officially accept the same MSDS Standard (American National Standard Institute – ANSI – Z400.1) to govern the content and format of the MSDSs, this being critical in that regard.

On the other end, the recent obligations of the REACH European legislation makes it almost impossible to group European countries on the same SDS and that not because the systems are different from one country to the other but rather because the SDS MUST by law, be written in a language spoken in the country where it is used. Considering the numerous languages in used, it is somehow more complicated to group the 'few countries' speaking the same language (French speaking countries, German speaking countries) then to clearly analyze the sales potential of your product in each and every country of Europe and to dedicate an exclusive language specific SDS.

Q: Is it possible to have a Global Harmonized System MSDS authored today for any given country?

A: This is a question we get each and every day! Could we ask you for ONE WORLDWIDE GHS compliant (M)SDS for our products? Unfortunately the answer is NO. And this is really not to push back against that extremely important milestone in the world regulatory arena but again, because your (M)SDS MUST COMPLY with the adopted law in the country it will be used. This being said we, at KMK adopted as NUMBER ONE PRIORITY to offer GHS-Ready products, documents and services, in compliance with the adopted legislations, worldwide. For instance, Japan adopted GHS back in December 2007 and we are pleased to write Japan-GHS MSDS in Japanese language for all our customers, no question at! More recently (January 20th, 2009), Europe via the REACH legislation opened the door to GHS for substances and mixtures, allowing the SDSs to carry BOTH the former-actual DSD;DPD Directives using the Risk (R-) phrases and squared orange symbols, TOGETHER WITH the GHS classes, categories and symbols, in Section 15 of the SDS. The essence in understanding the universality of GHS is to know that each country MAY ADOPT all or part of it and may also add country specifics, which make the system, rather disharmonized, as I mention in a 2009 to be published paper!

Q: Avec la mise en oeuvre du SGH (3) et de REACH (2) en Europe, est-ce que les phrases de risque (1) vont disparaître des fiches de données de sécurité européennes ?

A: Une période de transition réglementaire a été promulguée pour les produits purs (substances) qui va du 20 janvier 2009 à décembre 2010, et pour les mélanges (préparations) qui s’étend du 20 janvier 2009 à décembre 2015. Pendant cette période, les fiches émises sur le territoire doivent, ou bien montrer la plus récente classification avec les phrases R et S, ou bien celle-ci avec EN PLUS la classification et les phrases de précautions selon le SGH tel qu’appliqué en Europe (c’est-à-dire par exemple sans la catégorie 5 de l’irritation de la peau, etc.). À la fin des périodes de transition (2010 ou 2015) SEULES les classifications, symboles et énoncés de précautions selon le SGH version Europe, seront permises, d’où à ce moment, la disparition des énoncés de précautions, des phrases de risques et de leurs symboles associés.