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Lead Severely Restricted in Several Consumer Products as of June This Year

On 1 June 2016, a new law which bans products that contain lead over a certain threshold entered into effect. The law, which was published on 23 April 2015 in the EU’s Official Journal as Commission Regulation 2015/628, has been incorporated into the EU’s complex body of chemicals law, commonly known as the REACH Regulation.

The new law restricts lead and its compounds in a vast number of widely used consumer articles. Hong Kong companies selling any such articles – including, e.g., clothing and fashion accessories – to consumers throughout the EU will have to comply with the newly implemented rules, or else face the possibility of sanctions.

According to the law, articles or individual parts of articles that can be mouthed by children and which contain over a minimum threshold of lead (0.05%) will not be allowed on the EU market. The restriction has permitted traders to benefit from a period of adjustment in order to get rid of existing stock. Even though it was published more than a year ago, the new law has not applied to articles placed on the market for the first time before 1 June 2016.

It is pointed out in Regulation 2015/628 that, on 21 December 2012, Sweden submitted a dossier to the European Chemicals Agency (ECHA) highlighting that, due to their mouthing behaviour, children, especially those under 36 months, may be repeatedly exposed to lead released from consumer articles containing lead or lead compounds. Lead and lead compounds are said to be present in consumer articles as intentionally added metallic lead, as an impurity or additive of metal alloys (particularly in brass), as a pigment and as a stabiliser in polymers (particularly in PVC).

The articles addressed in this restriction are articles intended for consumer use, and for which it is likely that small children can put in their mouths. Examples of such articles are clothes, shoes, related accessories, interior decorations, articles for sports and leisure, and stationery. This list is by no means exhaustive.

Hong Kong sellers will likely be aware that clothes and fashion accessories are examples of articles where lead can be found in a variety of materials in the articles. Metallic parts, such as buttons, buckles, zippers and the like, can be manufactured from alloys containing lead. Lead pigments are used for colouring of the textiles or polymer material as well as in paints on the surface of metal or in polymer details.  

The law highlights that repeated exposure to lead from mouthing of articles that contain lead or its compounds can result in severe and irreversible neurobehavioural and neurodevelopmental effects to which children are particularly sensitive. The placing on the market and use of lead and its compounds in articles that are supplied to the general public, and which can be placed in the mouth by children, should therefore be prohibited if the concentration of lead (expressed as metal) in that article, or even just a part of the article, exceeds the threshold laid down in the Regulation.

In short, the relevant legal text states that lead and its compounds shall not be placed on the market, or used in articles supplied to the general public if the concentration of lead (expressed as metal) in those articles or accessible parts thereof is equal to or greater than 0.05% by weight, and those articles or accessible parts thereof may, during normal or reasonably foreseeable conditions of use, be placed in the mouths of children.

The limit shall not apply if it can be demonstrated that the rate of lead release from an article, or any accessible parts of an article, whether coated or uncoated, does not exceed 0.05 μg/cm2 per hour (equivalent to 0.05 μg/g/h). For coated articles, the lead restriction limit does not apply if this release rate is not exceeded for a period of at least two years of normal or reasonably foreseeable conditions of use of the article.

For the purposes of the restriction, it is considered that an article or accessible part of an article may be placed in the mouth by children if it is smaller than 5 cm in one dimension or has a detachable or protruding part of that size.

Hong Kong traders will see that due to its broad scope, a wide variety of articles are covered by the new Regulation. It nonetheless sets out a number of exempted articles. Thus, due to the expected migration level being low, crystal glass, enamels and precious and semi-precious stones (unless lead is intentionally used) will be exempted; or where, due to their small size, exposure to lead is minimal, such as in the case of tips of writing instruments.

Keys, locks, padlocks and musical instruments, all of which can potentially be mouthed by children, are also exceptionally exempted, as there seems to be a lack of suitable alternatives to lead in the manufacturing of these articles. Portable zinc-carbon batteries and button cell batteries are also exempt, at least for now, as the impact of applying the restriction to them has not been fully assessed. Traders should view the Regulation itself for the full list of exemptions.

The restriction, and exemptions in respect thereof, amend Entry 63 in Annex XVII of the REACH Regulation. Lead is already the subject of Entry 63, prohibited in any individual part of jewellery articles, if the concentration of lead (expressed as metal) in such a part is equal to or greater than 0.05% by weight.

Hong Kong businesses can click on the following to carefully examine the restriction and evaluate its impact on their supply chain: Regulation 2015/628.

Content provided by Picture: HKTDC Research
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