At the end of March, the European Commission published the 12th adaptation to technical progress (ATP) to 1272/2008 the Classification, Labelling and Packaging (CLP) regulation under REACH. This update brings the CLP regulation in line with the 6th and 7th revisions of the UN GHS Purple Book. What was published in the ATP should come as no surprise for those who are familiar with these changes to the Purple Book. Since there were some significant modifications to the regulation, there is a slight delay in the applicable date to allow for transition to the new requirements. The published changes are set to apply as of October 17, 2020. It is important to understand the CLP changes to determine how they may impact your products that are sold into the EU market. We have provided a summary below of the most significant changes to the regulation that help with this effort.
In the published amendments, Annexes I through VI all had changes. A few of the major amendments that would have the most significant impact on a product’s classifications, SDSs and labels are outlined below.
Annex I – Classification and Labelling Requirements for Hazardous Substances and Mixtures
- Table 1.1 – Generic cut-off values – this table was amended to include cut-off values of 1% for the Specific target organ toxicity, single exposure, Category 3 hazard class and Aspiration toxicity. This cut-off value and further amendments to the Specific target organ toxicity, single exposure and aspiration toxicity sections officially add the concept of additivity and relevant ingredients to these hazard classes and categories when classifying mixtures.
- Brand new hazard class for desensitized explosives (section 2.17)
- The Flammable gases (including chemically unstable gases) section is now called Flammable Gases and was updated to include a new category for pyrophoric gas and clarification for how the flammable gas classifications and hazard communication elements (pictograms, hazard statements and precautionary statements) are applied for the chemically unstable gases that are also a part of this hazard class.
- Slight modifications to the category 3 criteria for substances and mixtures which in contact with water emit flammable gases
- The definitions of skin corrosion, skin irritation, serious eye damage and eye irritation all had the text that included time of application removed and replaced by the word exposure.
- Change to the concentration limit for elicitation that is used for determining both when an SDS is required and special labelling requirements for sensitizers (specifically for substances that have specific concentration limits). The concentration limit for elicitation is set at one tenth of the specific concentration limit.
Annex II – Special Rules for Labelling and Packaging of Certain Substances and Mixtures
- EUH001 – “Explosive when dry” is deleted.
- Change to the text which determines when EUH210 ‘Safety data sheet available on request’ is required on the label.
Annex III – List of Hazard Statements, Supplemental Hazard Information and Supplemental Label Elements
- This portion of the text is a reference of sorts and the changes reflected here include various amendments and updates are associated with the changes to the Flammable Gases section and the addition of the new desensitized explosives hazard class. If these classification changes impact your products we would recommend at least skimming this section for the changes.
Annex IV – List of Precautionary Statements
- Along with changes corresponding to the addition of desensitized explosive and modifications to flammable gases, the text of the following existing precautionary statements have been modified – P103, P280.
- A new precautionary statement P503 (for explosives) has been added.
- A few p-statements also had the Conditions for use that were associated to them updated as well.
Annex VI – Harmonised Classification and Labelling for Certain Hazardous Substances
Fortunately in this round of changes there were no amendments to classifications found in Annex VI (table 3).
Long story short – it’s time to make plans to review the product classifications, SDSs and labels against the updated requirements for substances and mixtures sold into the EU market prior to October 2020. At a minimum it would be good to plan to review products that meet any of these criteria:
- Flammable or pyrophoric gas
- Any material that has EUH001 – these could be desensitized explosives
- Any mixture that has substances that are classified as either specific target organ toxicity, single exposure, Category 3 or aspiration toxicity and present in >=1% in a mixture – new classifications could be applicable
- Any mixture containing a sensitizer that has a specific concentration limit (these might have changes to the requirement to have an SDS and also the label statements)
- Materials that are explosives (addition of P503)
Official Text of the changes can be found here. A consolidated version of the regulation including the amendments in ATP 12 has not yet been published.