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SAFEGUARDS | Toys & Juvenile Products NO. 141/17

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The European Rapid Alert System for dangerous non-food products has reported a number of notifications involving DIBP in toys. New requirements for DIBP under the CLP Regulation will become effective in March 2018.

The European Toy Safety Directive 2009/48/EC (TSD [1]) is a comprehensive piece of legislation in meeting modern-day toy safety requirements. Unless specifically exempted, the use of substances or mixtures that are classified as carcinogenic, mutagenic or reprotoxic (CMR) category 1A, 1B or 2 under Regulation (EC) 1272/2008, the so-called CLP Regulation [2], is strictly prohibited in toys, toy components or micro-structurally distinct parts of toys.

Since 2015, the European Rapid Alert System for dangerous non-food products [3] has reported a number of notifications for violation of diisobutyl phthalate (DIBP, CAS 84-69-5) as a CMR substance in toys falling under the TSD. DIBP has two categories for its classification as a reprotoxic substance under Regulation (EC) 790/2009 [4], the first adaptation to technical and scientific progress (ATP-1) to the CLP Regulation. These are:

  • Reprotoxic category 1B when the specific concentration limit (SCL) is 25% or more

  • Reprotoxic category 2 when the SCL is equal to or more than 5% but less than 25%

In August 2016, SGS reported [5] the publication of Regulation (EU) 2016/1179 in the Official Journal of the European Union (OJEU). This piece of legislation was the ninth adaptation to technical and scientific progress (ATP-9) to the CLP Regulation. This ATP contains a number of important changes, including an update on the classification and labeling requirements for bisphenol A (BPA) and DIBP. While DIBP remains a reprotoxic category 1B substance for the purpose of classification, its SCLs have been deleted. In the absence of a SCL, the generic concentration limit (GCL) of 0.3% in the CLP regulation would apply. ATP-9 to the CLP Regulation will become effective on March 1, 2018. 

In addition to being regulated as a CMR substance in the TSD, DIBP is also regulated under the following pieces of legislation:

  • REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) – a substance of very high concern (SVHC) on the Candidate List for Authorization [6] since January 2010 

  • REACH – an SVHC on the Authorization List (Annex XIV [7]) since February 2012

  • Rohs Recast – a restricted substance in electrical and electronic equipment (EEE) under Directive (EU) 2015/863 [8], amending Directive 2011/65/EU. The restriction of DIBP in (electric) toys will become effective on July 22, 2019

Highlights of a comparison of DIBP falling under ATPs 1 and 9 to the CLP Regulation are summarized in the table below.

Regulation (EC) 1272/2008 (CLP Regulation)


Regulation (EU) 2016/1179
(ATP-9 to CLP)
Regulation (EC) 790/2009
(ATP-1 to CLP)

Substance
Diisobutyl phthalate (DIBP)
Diisobutyl phthalate (DIBP)
CAS No. (EC No.)
[Index No]

84-69-5 (201-553-2)
[607-623-00-2]
84-69-5 (201-553-2)
[607-623-00-2]
Classification for hazard class and category code
Repr 1B
Repr 1B
Classification for hazard statement code
H360Df
H360Df
Labeling for pictogram, signal word code
GHS08
Dgr
GHS08
Dgr
Labeling for hazard statement code
H360Df
H360Df
Specific concentration limit (SCL)
None

≥ 25% for Repr. 1B
≥ 5% but < 25% for Repr. 2

Effective Date
March 1, 2018
In Force
Note
Dgr = Danger, Repr =Reprotoxic (Toxic to reproduction)

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.

NEXT STEP:

Stakeholders are advised to comply with the latest requirements for DIBP and other toy safety requirements for the EU market.

For enquiries, please contact:

Hingwo Tsang
Global Information and Innovation Manager
t: +852 2774 7420

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