With the first deadline (1 December 2010) for registering chemical substances under Europe’s REACH (Registration, Evaluation, Authorisation and Restriction of Chemical Substances) legislation, manufacturers and importers are under increasing pressure to comply with the new requirements for Safety Data Sheets preparation.
The new regulation for SDS formatting applies to chemicals and chemical substances that are to be shipped to the European Union and/or placed for direct sale on its market.
Safety Data Sheets are reviewed upon import and chemical substances producers and importers whose SDS do not comply with the latest regulatory requirements will not be permitted to distribute or sell their products on the EU market.
One of the main differences between the Material Safety Data Sheets previously used and the Safety Data Sheets currently applicable under REACH is the requirement that a SDS (including Exposure Scenario) should be supplied in an official language of the Member State(s) on whose market the substance or preparation is placed (unless the Member State(s) concerned indicate otherwise).
The aforementioned EU legislative amendment will require that companies operating in the chemical industry use professional language translation providers.
A translation company should be familiar with the new REACH Regulation, Annex II (which provides a guide to preparing Safety Data Sheets) and translate all SDS and MSDS required in accordance with this.
Since SDS need to be authored in the official language(s) of the country they are intended for and comply with the laws of the jurisdiction of the member state in which they are to be used, direct translation of the documents is rarely sufficient.
Rather than translating SDS or MSDS directly from the source to the target language, a translation company can take the existing document and author a new set of data sheets in the necessary language(s) that are compliant with the local regulations.
To perform the task of MSDS authoring, a translation services company shall have an in-house pool of translators with senior qualifications in industrial chemistry and hygiene.
Furthermore, translators should be experts in data sheet translations and familiar with the local industry-specific regulations and national legislation.
The proper and accurate localisation and translation of MSDS or Safety Data Sheets will ensure that all official translations as published in the EU Official Journal are used (i.e. mandatory heading titles, proper classification, hazard statements, risk and safety phrases, Exposure Scenario, Risk Management Measures, Toxicological and Ecological information, etc). In addition, SDS will be accurately localised for national occupational exposure limits, hazard classifications and other regional requirements.
The format and content of the original data sheet often need to be modified. A translation company shall have the resources to support different formats, conversions and produce SDS in PDF format to facilitate distribution via e-mail and the internet.
ECHA (European Chemicals Agency) amended the requirements for Safety Data Sheets under REACH Annex II, which covers the introduction of Classification, Labelling and Packaging (CLP) information into the Safety Data Sheet.
The deadline of 1 December 2010 applies to substance classification in accordance with the European Community Regulation on Classification, Labelling and Packaging of Substances and Mixtures (CLP).
This Regulation aligns previous EU legislation with the United Nations’ Globally Harmonised System of Classification and Labelling of Chemicals (GHS) and aims to ensure that hazards are described and labelled in the same way all over the world.
Any manufacturer, importer, distributor or user of chemical substances and mixtures must classify, label and package any substance or mixture in accordance with the CLP and only those labels and packages which comply with the CLP Regulation rules will be accepted in the EU.
Here, the role of a translation company is to:
• Translate product labels in accordance with the regulations of the local marketplace.
• Ensure language translation and localisation of hazard labels and packaging in accordance with the GHS system.
Although many pictograms are similar to the existing EU system, they have been redesigned and new signal words have been introduced, along with new packaging requirements. Any translation company worth its salt shall be up to date with those changes and, if necessary, assist its clients in complying with the latest regulations.
• Offer desktop publishing solutions and, if required, be able to produce the final, clear and legible layout of labels and packages, including attention to wording, spelling, font size and design. After all, labels are supposed to be read and used in adverse conditions, which makes design and word selection extremely important.
The aforementioned legislative amendments only apply to cases of import into the European Union, but it is believed that within the next 5 years every Material Safety Data Sheet (MSDS) or Safety Data Sheet will need to be re-written in order to comply with the GHS system.
European translation companies shall specialise in conversions from different national standards formats to the Globally Harmonized System (e.g. from the American National Standards Institute (ANSI) format to GHS).
To ensure access to their products, it is critical that companies operating in the chemical industry create SDS, product labels and packaging that meet the requirements of the country for which the product is intended (whether within or outside the European Union).
SDS and labels must also be written in the official language of this market and properly localised.
Most chemical companies operate on multiple markets and require multilingual translation services. Furthermore, some countries have more than one official language (e.g. Dutch and French in Belgium; English and French in Canada).
Working with a professional and highly reputable language translation company is the solution.