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Targeted implementation of REACH and GHS with TÜV SÜD

The pre-registration period for chemicals under REACH expired in December 2008, and the new GHS regulation has been in effect since January 2009. Chemicals must now be registered, evaluated, assessed and labelled in phase-in periods. To ensure certain and cost-effective compliance with these more complex requirements, TÜV SÜD assists companies throughout all steps of REACH and GHS implementation.

The EU regulations REACH and GHS have established new legal requirements for chemicals which bring greater responsibility for industry in their wake. "The regulations largely transfer the responsibility for the safe handling of chemicals from official authorities to their producers, importers, downstream users and retailers", explains Dr Dieter Reiml, REACH expert at TÜV SÜD Industrie Service GmbH. Numerous companies across all sectors of industry must comply with strict requirements in both the timely registration and the classification and labelling of substances. The new regulations are both complex and extensive. "We support companies throughout all steps of REACH and GHS implementation", emphasizes Dr Reiml. "This enables risks to be reliably minimized and potential for optimization to be identified." Here it must be taken into account, he notes, that the chemicals legislation is not a stand-alone legislation but includes cross-references to other areas, including occupational health and safety, waste legislation and industrial safety.

Efficient implementation improves market opportunities

"Companies efficiently implementing REACH and GHS improve their market opportunities compared to competitors", explains Dr Fritz Prechtl, REACH Manager at TÜV SÜD Industrie Service. When registering a substance, the producers or importers must include the substance's intended use by downstream users. The information included in the registration dossier – such as information about the classification and labelling – will later be included in the safety data sheets. A systematic approach to implementation therefore makes good sense. "While the areas regulated by REACH and GHS are not identical, the regulations include numerous interfaces", explains Dr Prechtl. "GHS therefore should not be regarded on its own, but in interaction with REACH." As the expert and reliable partner of both industry and trade, TÜV SÜD advises companies on the integrated implementation of the two regulations.

REACH: registration, evaluation, authorization and restriction

Through registration, evaluation, authorization and restriction of chemicals, the REACH regulation aims at preventing possible adverse effects on people and the environment. "For many chemicals currently available on the markets, no exact information about their hazard and risk potential as yet exists", notes Dr Prechtl. While the pre-registration period expired in December 2008, the regulation provides for phase-in periods for substances not registered so far. Depending on their quantity and harmful effects, chemicals must be registered by 30 November 2010, 31 May 2013 or 31 May 2018. "In contrast to pre-registration, the actual registration of substances is both complex and time-consuming", warns the TÜV SÜD expert. "Strict compliance with the periods is a must."

Following expiry of the relevant period, any chemicals not registered may no longer be placed on the market in the European Union. Apart from some exceptions, registration is compulsory for all substances produced or imported into the EU in quantities totalling over one tonne per year per company. Further requirements may apply, inter alia, for quantities exceeding ten tonnes per year. In this case, the producer or importer must submit a chemical safety report which includes the identified use of the substance. "Many chemicals suppliers from third-party countries use the possibility to rely on TÜV SÜD as their 'only representative' to register the substances they import into the EU", reports Dr Prechtl. "Our international REACH network places us in a position to support companies throughout the world." Currently, communication in the SIEF is at the centre of interest, he adds, as it conceals a multitude of financial and legal pitfalls.

GHS: classification and labelling

Providing a globally standardized system for the risk classification of chemicals, GHS is geared to harmonizing the classification of hazardous substances and mixtures and improving risk communication. The new regulation replaces the classification and labelling system as per the substances and the preparations directives. According to the new regulation, substances and mixtures must now be re-classified and their labels changed within certain deadlines: In many cases, particularly those involving more complex assessments (toxicology, ecotoxicology), the GHS regulation makes explicit provision for expert judgements", explains Dr Reiml. In everyday life, GHS implementation also imposes strict requirements on market players, including comprehensive communication throughout the supply chain, which is in turn governed by separate deadlines. Gradual revision of safety data sheets and the corresponding alignment of the instructions for use are also necessary. "The duties and consequences are not always clear at first sight", notes the TÜV SÜD expert. GHS defines transitional periods until December 2010 and June 2015 for the re-classification and labelling of substances and mixtures.

Further information about the services provided by TÜV SÜD are available at www.tuev-sued.de.