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LangJonathan BW
Jon Lang, Emergency Responder and Chemical Regulatory Consultant

Keeping your SDS updated and compliant

14/09/2016

The National Chemical Emergency Centre receives and deals with 100s of safety data sheets (SDS) every week. Be that via our emergency response centre, our SDS authoring service or consulting as experts in the field. This exposure shows us the wide variety in the interpretations of SDS within the chemical industry. Where some companies are monitoring changes in classification, updating their SDS and remaining compliant, many are falling short.

The SDS is the main instrument for providing information on the safe use of chemical substances and mixtures to users. The REACH legislation (EC/1907/2006 and amendments) is the current legal basis for the compilation of this document in Europe. For substances registered under REACH in quantities of 10 tonnes or more each year per registrant, various exposure scenarios must be compiled. These are then annexed to the extended SDS (eSDS). Exposure scenarios are required for all identified uses that may lead to an exposure. They are also required for substances that meet the criteria of article 14 (4) of REACH or are identified as PBT or vPvB. For each exposure scenario the relevant operational conditions and risk management measures (RMM) that are necessary for safe use need to be described. However, a study undertaken in 2012 by the Finish authorities reported that 49% of eSDS had inconsistencies in the RMM between the main text of the SDS and the exposure scenarios.

Due to the importance of SDS in occupational health and safety obligations the Dutch Inspectorate of Social Affairs and Employment (Inspectie SZW) created a review to shed light on the number of companies that are not fully compliant with REACH legislation. A systematic assessment of SDS collected from downstream users during a REACH enforcement project involving over 500 SMEs showed certain shortcomings.

For nearly half of the concerned SDS there were strong indications that they were not up to date, or in some instances manufacturers had no SDS to provide. The problems identified were related to the use of the correct Member State language (Dutch); incomplete or no specifications on skin protection and SDSs that pre-dated regulations. Any SDS dated before 2011 (for substances) or before July 2011 (mixtures) were considered not up-to-date due to the regulation changes since then.

It was reported that 75% of the SDS contained inconsistencies in section 7, section 8 and the annexed exposure scenarios. There were indications that the classification listed on the SDS, and those considered in the exposure scenarios, did not match. Sometimes SDS lacked exposure scenarios for substances where they would be expected. A third of the evaluated SDS did not mention Occupational Exposure Limits (OELs) and they were often without Derived No Effect Levels (DNELs). Additionally, appropriate technical measures were not reported in almost half of the studied SDS.

None of the collected documents were found to be in full compliance with all requirements of the legislation. Only for one of the SDS were the issues considered not to seriously limit the use of the SDS. With ECHA continuing to improve its enforcement around REACH and CLP legislation the risk of non-compliance is growing. In the Netherlands, under the economic offences act, the fines for non-compliance can be up to €18,500, or for certain infringements a fine of up to €74,000 and possible imprisonment. 

A key notion is that the studied SDS were selected up to two years ago. The question is whether the conclusions presented here are still representative of the current situation. In recent years ECHA has deployed initiatives to improve the quality of the SDS. The Inspectie SZW has itself created an integrated website (https://www.chemischestoffengoedgeregeld.nl/) which leads you through a roadmap to meet the legal requirements of REACH. The specific focus of the website is to make REACH more effective and useful, especially for SMEs and in a manner that yields cost savings in the implementation of the REACH obligations.

For more information on how NCEC can support you with SDS regulations please contact Jonathan.Lang@ricardo.com

For information on the NCEC SDS authoring service please click here

The full Inspectie SZW report can be found here

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