EU Amends CLP Regulation on Substances and Mixtures
The EU has recently published an adaption of technical and scientific progress to the CLP Regulation. The new law for substances in Table 3.1, where classification and labelling are stipulated in the CLP Regulation, will take effect on March 1, 2018.
In January 2016, we  informed you that the World Trade Organization circulated a proposal from the European Union (EU) to amend Regulation (EC) 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures (CLP Regulation).
On July 20, 2016, Regulation (EU) 2016/1179 was published in the Official Journal of the EU (OJEU). This is the 9th adaption to technical and scientific progress (ATP-9) to the CLP regulation and contains important changes to Table 3.1 of Part 3 of Annex VI to the CLP Regulation. These include:
- Deleting Tinurin 123 (EC number 406-750-9 and Index number 607-331-00-5) and Direct Blue FC 57087 (EC number 418-870-9 and Index number 609-066-00-0).
- Updating the classification and labelling requirements for 22 existing entries, including those for bisphenol A (BPA, EC number 201-245-8) and diisobutyl phthalate (DIBP, EC number 201-553-2).
- Creating 26 new entries, including those for lead powder and dicyclohexyl phthalate (DCHP).
It is interesting to note that BPA has been reclassified from Repr. 2 to Repr. 1B and the specific concentration limits for DIBP have been deleted.
ATP-9 also deletes the list of substances in Table 3.2 as the harmonized classification and labelling of these substances were based on the criteria set out in Annex VI to Directive 67/548/EEC (Dangerous Substances Directive, DSD). The DSD has been repealed by the CLP Regulation since June 2015.
The new law has 2 effective dates:
- June 1, 2017 for the deletion of Table 3.2
- March 1, 2018 for Table 3.1
The new law will have a pronounced effect on products that are classified as substances, mixtures, or articles such as toys within the meaning of Directive 2009/48/EC.
Highlights of BPA on classification and labelling under the new law and Regulation (EU) 758/2013 are summarized in Table 1.
Table 1: Comparison of BPA under ATP-9 to the CLP Regulation and Regulation (EU) 758/2013
|Regulation (EC) 1272/2008 (CLP)|
|Regulation (EU) 2016/1179 (ATP-9)||Regulation (EU) 758/2013|
|Substance||4,4-Isopropylidenediphenol (Bisphenol A, BPA)||4,4-Isopropylidenediphenol (Bisphenol A, BPA)|
|CAS No. (EC No.) [Index No.]||80-05-7 (201-245-8) [604-030-00-0]||80-05-7 (201-245-8) [604-030-00-0]|
|Classification for hazard class and category code||Repr. 1B||Repr. 2|
STOT SE 3, Eye Dam. 1,
|STOT SE 3, Eye Dam. 1, |
Skin Sens. 1
|Classification for hazard statement code||H360F||H361f***|
|H317, H318, H335||H317, H318, H335|
|Labelling for pictogram, signal word code||GHS05, GHS07, GHS08, Dgr||GHS05, GHS07, GHS08, Dgr|
|Labelling for hazard statement code||H360F||H361f***|
|H335, H318, H317||H335, H318, H317|
|Specific concentration limits, M-factors||None||None|
|Effective date||March 1, 2018||In force|
Table 2: Abbreviations/Definitions
|2||Eye Dam||Serious eye damage|
|3||Repr||Reprotoxic (toxic for reproduction)|
|4||Skin Sens.||Skin sensitization|
|5||STOT SE||Specific target organ toxicity – single exposure|
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