Regulatory compliance for chemical, cosmetic and biocidal products.
CHEMICALS
Classification according the Globally Harmonised System - GHS
Services
Alchemy Compliance can provide consultancy in the area of the GHS system, to enable companies to assess the impact of re-classification of chemical products, and the effects of re-classification on downstream processes, such as labelling and workplace risk assessment.
Alchemy Compliance has extensive experience in the classification of chemical substances according. We can advise on the GHS classification using available data, such as study reports, literature searches, and structure–activity relationships.
Alchemy Compliance can also classify preparations, either from test data, or by calculation according to the GHS.
Further information
The Globally Harmonised System for Classification
The United Nations (UN) has concluded that small and medium enterprises (SMEs) are effectively precluded from international trade in chemicals due to the burden of regulatory compliance. A primary concern for many chemical companies is the classification and labelling of chemical products for supply. This is the set of criteria for determining the hazard class (eg flammable, irritant) of chemical substances and preparations, and also subdivisions within each class (eg very toxic, toxic, harmful for acute toxicity). This classification is highly visible to the customer as symbols and hazard phrases, directly affects marketing strategy, and has a substantial knock-on effect for downstream operations such as worker safety, provision of safety data sheets (SDSs), and waste management. For instance, preparations containing substances that are classified as carcinogenic, mutagenic, or toxic reproduction cannot be marketed to the general public.
However, chemicals may have different official classifications in different regulatory jurisdictions, such as the EU and US. Furthermore, when official classifications of chemicals do not exist, manufacturers have to classify their own products according to criteria that may also differ from country to country. What is toxic in the EU may not necessarily be toxic in the US. Further complications are the different systems of classification for supply and transport, and between product types such as industrial chemicals and biocides. Finally, even within the EU, individual Member States can add their own restrictions and requirements on the marketing of dangerous chemicals. This diversity of regulation means that chemical companies often face complex compliance issues, which can lead to delays in marketing, product withdrawals, and reduced profitability.
The UN does have a partial solution to these woes. They have published the Globally Harmonised System of Classification and Labelling of Chemicals (GHS), with the intention of reducing costs of global trade in chemicals through harmonising the classification criteria across product types and geographical regions, harmonising the hazard communication elements (labelling and Safety Data Sheets), and extending the scheme to those countries that do not have a developed chemical control system. The GHS should also offer better protection to man and the environment through an increased coherency, and also because of the efforts of the UN to prepare easily understood symbols and readily translatable warning statements.
The GHS was designed to take the best elements of the most widely used systems for chemical classification: those in the US, Japan, Australia, Canada and the EU, plus the harmonised system already in place for the classification of substances and preparations for transport. The UN required that the new system would not lead to a reduction in safety standards, with a consequence that the most stringent aspects of each scheme were taken on board. When the Globally Harmonised System is adopted, we will see more chemical products requiring a classification, and some of the currently classified chemicals with a more severe classification.
EU Implementation of the GHS
The current EU system for classification and the GHS are similar in scope, covering classification, packaging and hazard communication (SDSs and labelling) of both neat substances and preparations (‘mixtures’ in GHS terminology). However, some of the criteria for classification are changed. The most noticeable changes for chemical users will be new hazard symbols and labelling phrases on packaging of chemical products.
The current OECD or EU test methods do not always yield data that converts easily into the GHS system of classification. As an example, the OECD method for testing the flammability of a solid requires measurement of the time taken to burn along a trail of the powdered substance. For classification under the GHS, additional information is required about the ability of the substance to burn through a wetted zone. Secondly, the currently preferred acute oral toxicity test is the B.1 tris (acute toxic class) method, which requires dosing at the current EU classification thresholds of 25, 200 and 2000 mg/kg, while the GHS thresholds are 5, 50, 300, and 2000.
While using older test data to classify substances under the GHS might be difficult, the classification of preparations under the GHS would be a major headache, especially if only the current classification were available, as is usually the case, rather than quantitative test results. The GHS proposal in Annex VII contains a provision for conversion tables from classification according to current practices (under 67/548/EEC and 99/45/EC) to the proposed GHS Regulation. However, these tables are not yet published. Annex VIII of the GHS, however, does give a useful table to reference categories of danger from the older system to the new.
The EU Commission has stated its intention for adopting the GHS system at the same time as the REACH legislation. A proposed Regulation was put out for consultation with a deadline for comments of October 2006.
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