Global Chemical Labeling Requirements

Kallik minimizes the impact of staying compliant with current and forthcoming chemical regulations

What Are the Requirements?

The Globally Harmonized System of the Classification and Labelling of Chemicals (GHS) forms the basis for a worldwide consistent approach to health and safety information on the packaging of chemicals. CLP (Classification, Labelling and Packaging of Chemical Substances and Mixtures) regulations harmonized to GHS have been adopted by EU member states, whilst HCS (Hazard Communication Standard) 2012 applies in the US.

How Does Kallik Help with the Chemical Regulations?

Kallik helps chemicals manufacturers ensure their products are correctly labelled ensuring compliance with the latest CLP and GHS regulations to avoid costly product recalls and potential harm to human and animal life.

  • Perform labeling changes quickly and cost effectively within timescales set by regulatory authorities and ensure alignment across labeling content and Chemical Safety Data Sheets
  • Stay compliant with EU, US and other country specific applications of the GHS standards as applicable to product and package labeling
  • Gain complete transparency from formulations and processes to finished products with rapid traceability of affected products to perform labeling changes
chemicals

Timeline of Chemical Requirements

2003: First Edition of GHS Published

The first edition of the GHS, which was intended to serve as the initial basis for the global implementation of the system, was adopted in December 2002 and published in 2003. Since then, the GHS has been updated, revised and improved every two years as needs arise and experience is gained in its implementation. The eighth revised edition of the GHS (GHS Rev.8), published in 2019, is the most recent revised edition.

June 2007: REACH Entered Into Force

REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) applies to all chemical substances; not only those used in industrial processes but also in our day-to-day lives. Therefore, the regulation has an impact on most companies across the EU. REACH places the burden of proof on companies. To comply with the regulation, companies must identify and manage the risks linked to the substances they manufacture and market in the EU.

January 2009: CLP Entered Into Force

European Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures came into force on 20 January 2009 in all EU Member States, including the UK. It is known by its abbreviated form, ‘the CLP Regulation’ or just plain ‘CLP’. The CLP Regulation adopts the United Nations’ Globally Harmonized System on the classification and labelling of chemicals (GHS) across all European Union countries, including the UK.

March 2012: HCS Entered Into Force

On March 26, 2012, Occupational Safety and Health Administration (OSHA) modified its Hazard Communication Standard (HCS) to conform to the United Nations’ (UN) Globally Harmonized System of Classification and Labeling of Chemicals (GHS). The revisions will improve consistency and quality of information that is provided to both employers and employees concerning chemical hazards and protective measures related to chemical hazards.

How To Be Compliant

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Ensure Consistency and Robustness

Establish a global source of labeling truth backed up by digital signatures and comprehensive audit trails that all market-facing product information and materials flow from to deliver process transparency and simplify proof of compliance.

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Embrace Cloud Technologies

Eliminate multiple siloed systems by moving to a centralized cloud-based solution will improve visibility, control and co-ordination making it easier to identify and updated impacted labels whilst demonstrating compliance

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Harmonize Your Processes

Unite dispersed teams and eliminate disjointed processes resulting from use of spreadsheets, documents, emails and localized desktop solutions that otherwise make identification of all impacted labels an almost impossible task.

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Improve Insights

Identify opportunities to maximize operational gains across multiple contract manufacturing and supply chain partners by standardizing content and layout for multiple packaging processes and graphic elements across global supply chain partners.

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Ensure Data Integrity

Data integrity plays a key role in all areas of GMP compliance including labeling and FDA expects data to be meaningful, taking into consideration the design, operation, and monitoring of systems and controls based on risk to patient, process, and product.

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Optimize Print and Packaging

Ensure the quality, format and positioning of linear and 2D serialization barcodes contained within multiple types of print and packaging labeling are detectable to the range of optical and scanning devices used throughout the supply chain.