SAFEGUARDS | Consumer Products NO. 069/15

The European Union (EU) has expanded the scope of restriction of lead to articles or accessible parts of articles for the general public if such articles or components may be placed in the mouth by children.  The enforcement date will be 1 June 2016. 

In October 2014, we informed you that the European Commission (EC) notified the World Trade Organisation (WTO) of a proposal[1] to amend the restriction of lead under ANNEX XVII of REACH.

On 23 April 2015, Regulation (EU) 2015/628[2] was published in the Official Journal of the European Union (OJEU) to expand the scope of lead restriction from jewellery articles to articles or accessible parts of articles for the general public if such products or components may be placed in the mouth by children during normal or reasonably foreseeable use.  An article or an accessible part of article may be placed in the mouth by children if it is less than 5 cm (< 5 cm) in one dimension or has a detachable or protruding part of that size.

The new law places a restriction of no more than 0.05% lead content in the new scope of products or components. It also provides a number of exemptions, including a migration limit of 0.05 µg/cm2 per hour (equivalent to 0.05 µg/g/h) as an alternative to the lead content limit.

According to the new legislation, guidelines identifying products that are inside and outside the scope of the Regulation should be developed to assist economic operators and enforcement authorities.  

Highlights of the existing Regulation (EU) 836/2012[3] and the new Regulation are summarised in Table 1.

Table 1

Lead under Entry 63 in ANNEX XVII of REACH





Enforcement Date

Regulation (EU) 836/2012

  • Jewellery
  • Components to manufacture jewellery
  • Crystal glass under Annex I (categories 1-4) of Directive 69/493/EEC
  • Precious and semi-precious stones (CN Code 7103) under Regulation 2658/87 unless treated with lead
  • Enamels

≤ 0.05%

9 October 2013

Regulation (EU) 2015/628

  • Articles for the general public or accessible parts thereof which may be placed in the mouth by children during normal or reasonably foreseeable conditions of use

≤ 0.05% or

 ≤ 0.05 µg/cm2 per hour (equivalent to 0.05 µg/g/h)

1 June



Regulation (EU) 2015/628 also exempts the following:

  • Articles placed on the market for the first time before 1 June 2016
  • Articles or parts of articles comprising alloys provided the brass alloy is no more than 0.5% lead
  • Jewellery under Regulation (EU) 836/2012
  • Keys and locks, including padlocks
  • Musical instruments
  • Portable zinc-carbon batteries and button cells
  • Religious articles
  • Tips of writing instruments
  • Articles within the scope of:
    • Packaging Directive 94/62/EC
    • Food Contact Regulation (EC) 1935/2004
    • Toy Safety Directive 2009/48/EC
    • RoHs Recast Directive 2011/65/EU

Throughout our global network of laboratories, we are able to provide a range of services, including analytical testing and consultancy, for lead and restricted substances in consumer products for the EU and international markets. Please do not hesitate to contact us for further information.

For enquiries, please contact:

Hing Wo Tsang
Global Toys and Juvenile Products
t: +852 2774 7420

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