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Heavy Metal Index

EU Regulation 2015/628 - lead in mouthable consumer articles

Regulation

Scope The restriction covers articles supplied to the general public, or accessible parts of such articles, that may during normal or reasonably foreseeable use be placed in the mouth by children.

Page snapshot
Referenced by10 pages
JurisdictionEU
Effective2015-05-13

Scope

The restriction covers articles supplied to the general public, or accessible parts of such articles, that may during normal or reasonably foreseeable use be placed in the mouth by children. The instrument excludes jewellery already covered by paragraph 1 of REACH entry 63, toys, food-contact materials, RoHS electrical/electronic equipment, and several listed article or material categories.

Exact limit and units

metalmatrixlimitunitbasis
Lead, expressed as metalArticle or accessible part supplied to the general public and mouthable by children0.05percent by weightConcentration in the article or accessible part
Lead releaseArticle or accessible part supplied to the general public and mouthable by children0.05ug/cm2 per hourAlternative release demonstration; not converted to ug/kg
Lead, expressed as metalBrass alloy article or part under the derogation0.5percent by weightConcentration in the brass alloy

How tested

The regulation allows the concentration restriction not to apply where the lead release rate from the article or accessible part, whether coated or uncoated, does not exceed 0.05 ug/cm2 per hour and coated articles maintain that release rate for at least two years of normal or reasonably foreseeable use.

Enforcement posture

This is a directly applicable EU regulation amending REACH Annex XVII. It is binding in its entirety and directly applicable in all Member States.

History of changes

The regulation was done at Brussels on April 22, 2015 and published in the Official Journal on April 23, 2015. Article 2 states that it enters into force on the twentieth day following publication; paragraph 10 states that paragraph 7 does not apply to articles first placed on the market before June 1, 2016.

How it compares

The primary content threshold is 0.05 percent by weight, equal to 500 mg/kg or 500,000 ug/kg. The brass-alloy derogation is ten times higher at 0.5 percent by weight, while the release-rate path is a surface-flux criterion and is not directly comparable to ug/kg limits.

Sources

Update history

The five most recent substantive edits to this page, classified major (evidence or structure moved), correction (a published value or statement was wrong and has been fixed), or minor (narrative rewritten without changing the underlying evidence). Each description is derived from what the edit did to this page; the linked commit is the authoritative record, routine regeneration passes are excluded, and the full version history lives in git. When DOI minting comes online (see schema docs), each entry below will also link to a version-pinned DataCite DOI.

CommitDateChangeDescription
a8052bb2026-08-09major1 source added; contamination-profile values revised; 7 sections added