On June 27, 2007, the European Commission introduced proposed amendments to the current European system of classification and labeling, in order to align with the United Nation's Globally Harmonized System of Classification and Labeling (GHS). The new proposed Regulation complements the recently implemented REACH regulation by working in conjunction with it. The proposed Regulation takes over from REACH, requirements for notification of new classifications, the establishment of a new harmonized list of classifications, and the creation of a classification and labeling inventory.
The new proposed Regulation takes a five part approach to protecting human health and the environment. It harmonizes classification, labeling and packaging requirements; obliges industry to properly classify their own products; requires notifications to the European Union and the public of new classifications; establishes a new harmonized list of classified substances (similar to the current Annex I list); and establishes a new classification and labeling inventory of the notified classifications and the harmonized classifications.
Some of the features the new Regulation includes are:
- Aerosols will have their own hazard class.
- Industry will continue to be required to classify their products for environmental hazards, but under new GHS hazard criteria.
- Rules for child-proof fastenings and tactile warnings of danger are included.
- Special labeling for plant protection products is included.
- A list of harmonized GHS hazard statements, and extra statements for hazards not part of the GHS (R phrases from current system now called 'EUH-Statements'), are included.
- A new list of harmonized classifications of pure substances is included. Substances on the list mainly include carcinogens, germ cell mutagens, reproductive toxins category 1A or 1B, and respiratory sensitizers. Once the list has been finalized, other substances can be added provided the additions are justified.
- 'Translation' tables are included. These tables are for substances and mixtures already classified and labeled under the current system where a simple equivalence can be established between the current system and the new GHS style system. Suppliers have the option of using the translation tables to classify and label their product under the new Regulation, or perform a full re-classification.
The European Union has estimated that the number of pure substances regulated under the new GHS Regulation will be roughly the same as those that are regulated under the current EU system. However, the EU estimates that more mixtures, currently considered non-dangerous, will become regulated under the new GHS Regulation as a result of changes in cutoff values and calculation methods.
Every label for supply in Europe will have to be modified to align with the new Regulation. However, during transition periods, businesses will be allowed to use either, the current classification and labeling system, or the new GHS Regulation.
The proposed new regulation must now go through the European 'co-decision' process that exists between the European Parliament and Council. Once the co-decision process has been completed and the entry into force date is set, the proposed deadlines for substance re-classifications is December 1, 2010, and for mixtures, June 1, 2015. The European Chemicals Agency will be preparing guidance documents and tools in order to assist industry with re-classifications and new labeling
For more information contact Envision Compliance at 1-800-318-7090.
