EU – CLP Regulation to Lower Concentration Limits for Certain Boron Compounds Amended

Vol. 1257 | 09 Jul 2021

On 28 May 2021, the European Commission has published Commission Delegated Regulation (EU) 2021/849 to amend the CLP Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures. The amendment shall enter into force on 17 June 2021 and apply from 17 December 2022.

The regulation has amended Table 3 (List of harmonised classification and labelling of hazardous substances) of Part 3 of Annex VI to the CLP Regulation, to remove the specific concentration limits (SCL) of 7 boron compounds. The generic concentration limit (GCL) for Repr. 1B substances, i.e. 0.3%, shall then apply for these boron compounds. The presence of boron at or above this limit in another substance or in a mixture as an identified impurity, additive or individual constituent leads to the classification of the substance or mixture as hazardous.

The Toy Safety Directive 2009/48/EC prohibits the use of CMR substances (substances that are classified as carcinogenic, mutagenic or toxic for reproduction) in toys. By way of derogation, substances or mixtures classified as CMR may be used in toys provided these substances and mixtures are contained in individual concentrations equal to or smaller than the relevant concentrations in the CLP regulation, for the classification of mixtures containing these substances.

Therefore, the concentration limit for those boron compounds in toys or in components of toys shall become 0.3%, which is generic concentration limit triggering classification of a mixture for Repr. 1B substances.

(Note: Toys or components of toys shall also comply with the migration limits for boron (B) as laid down in Point 13 of Part III of Annex II to the Toy Safety Directive 2009/48/EC.)

The related boron compounds are listed as below:

Index No	Chemical Name	CAS No	Hazard Class and Category Code(s)	Concentration limit in toy components
				Current	New (Apply from 17 December 2022)
005-007-00-2	boric acid	10043-35-3; 11113-50-1	Repr. 1B	5.5 %	0.3%
005-008-00-8	diboron trioxide	1303-86-2	Repr. 1B	3.1%	0.3%
005-011-00-4	tetraboron disodium heptaoxide hydrate	12267-73-1	Repr. 1B	4.5%	0.3%
	disodium tetraborate anhydrous	1330-43-4
	orthoboric acid sodium salt	13840-56-7
	disodium tetraborate decahydrate	1303-96-4		8.5%
	disodium tetraborate pentahydrate	12179-04-3		6.5%

Boron compounds have been used in the raw materials for producing slime and putty toys to make them more elastic and stretchable. Ingestion of boron compounds, in medium to high dosage, may induce nausea and vomiting and, in the long term, has an adverse effect on the fertility. Manufacturers shall control the boron compounds content in toy products to safeguard the safety of children.

Apart from boron compounds, the Regulation (EU) 2021/849 also added, amended and deleted other substances in Table 3 of Part 3 of Annex VI of the CLP regulation. For detailed list of substances, please refer to link below:

Regulation (EU) 2021/849

https://eur-lex.europa.eu/eli/reg_del/2021/849/oj

For more information:

Erik Chen
erik.chen@intertek.com

Pako Chan
pako.chan@intertek.com