SAFEGUARDS | Consumer Products NO. 136/16

SafeGuardS chemical substance

The EU has recently published an adaptation 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 [1] 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 [2] was published in the Official Journal of the EU (OJEU). This is the 9th adaptation 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 The DSD has been repealed by the CLP Regulation since June 2015.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,
Skin Sens. 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

Item Abbreviation Definition
1 Dgr Danger
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

Throughout our global network of laboratories, we are able to provide a range of services, including analytical testing and consultancy for restricted substances, safety data sheets (SDSs), as well as chemical safety assessments (CSAs) for the EU and international markets. Please do not hesitate to contact us for further information.

For enquiries, please contact:

Hing Wo Tsang
t: +852 2774 7420

Stay on top of regulatory changes within your industry: subscribe to SafeGuardS!

© SGS Group Management SA - 2016 - All rights reserved - SGS is a registered trademark of SGS Group Management SA. This is a publication of SGS, except for 3rd parties’ contents submitted or licensed for use by SGS. SGS neither endorses nor disapproves said 3rd parties contents. This publication is intended to provide technical information and shall not be considered an exhaustive treatment of any subject treated. It is strictly educational and does not replace any legal requirements or applicable regulations. It is not intended to constitute consulting or professional advice. The information contained herein is provided “as is” and SGS does not warrant that it will be error-free or will meet any particular criteria of performance or quality. Do not quote or refer any information herein without SGS’s prior written consent.