24 June 2016
Official Guidelines Published on Newly Introduced Lead Restrictions
On 25 May 2016, the European Chemicals Agency (ECHA) published a set of guidelines to aid businesses in navigating the new lead restriction provisions found in Commission Regulation 2015/628. These provisions were incorporated into the EU’s body of chemicals law, the REACH Regulation. The new restrictions came into effect on 1 June 2016 (see: Lead Severely Restricted in Several Consumer Products as of June This Year, for details of the actual rules).
ECHA’s guidelines on Regulation 2015/628 clarify the terminology used within it. Certain phrases like “accessible part of articles”, “normal conditions of use” and “foreseeable conditions of use” are explained more clearly so that companies may take necessary precautions when manufacturing, labelling and packaging articles. Additionally, and no doubt of interest to Hong Kong manufacturer-exporters, the guidelines provide a non-exhaustive list of article types and sub-types which fall within, and outside, the scope of the lead restrictions. Helpfully, pictures and diagrams are included which identify referenced article parts.
In brief, Regulation 2015/628 prohibits lead and its compounds from being placed on the market or used in articles supplied to the general public. An article or part of an article is banned when it meets three conditions:
(1) it is supplied to the general public and contains lead or lead compounds at concentrations of lead, expressed as metal, equal to or greater than 0.05% by weight;
(2) it may be placed in the mouth by small children during normal or reasonably foreseeable conditions of use; and
(3) it is not covered under the list of stated exemptions.
If certain size and shape criteria are fulfilled, then an article is accessible and may be placed in the mouth of a child. Looking specifically at part of the second condition above, “may be placed in the mouth” refers to articles or parts of articles that are smaller than 5 cm in one dimension, or which have a detachable or protruding part of that size.
Further guidance on what constitutes an accessible article follows the definitional method laid down in clause 8.10 of European standard EN 71-1 on toy safety. “Small children” refers to the primary group at risk from lead exposure: children between 6 and 36 months of age. The mouthing behaviour of this age group is thus especially relevant for Hong Kong manufacturers and exporters of consumer goods placed on the EU market.
The more complicated portion of the second condition above is “during normal or foreseeable conditions of use.” Normal conditions of use are conditions associated with the main function of the article. Where an article’s supplier has, in writing (e.g. on the label), clearly recommended avoiding a particular use or manner of use, such use is by definition excluded from normal conditions of use.
Reasonably foreseeable conditions of use refer to conditions that can be anticipated because of either the function or appearance of the article. Whether the small child may mouth the article or part of the article is determined on a case by case basis considering the nature and function of the article. For example, certain articles are manifestly dangerous (e.g. flammable) and thus found almost exclusively in areas out of reach of children. Thus, mouthing by a child is not foreseeable.
In the same vein of logic, various categories of articles are excluded by their nature or availability. Articles that are not supplied to the general public are not within the scope of the restrictions. Articles intended exclusively for professional or industrial uses are also excluded.
Additionally, the ECHA guidelines provide a list – that is non-exhaustive – of articles and their status under the new restrictions. Categories generally within the scope include:
Clothing and accessories:
- garments including those made of cotton, wool, fine animal hair or manmade fibres,
- metal or plastic details like buttons and zippers, fastenings or decorative details,
- footwear, outdoor and indoor,
- accessories like sunglasses, spectacles, belts, bags, badges, hygiene tools and kits.
- rubber erasers,
- writing instruments (except tips of writing instruments),
- binding materials such as notebook rings of metal and plastic.
- curtains, table cloths and their weights,
- household articles and toilet articles made of plastics, porcelain or china,
- interior textiles (pillows, blankets, etc.),
- artificial foliage and fruits and their parts,
- frames, figurines and other ornamental articles made of plastics, metals, wood, ceramic, porcelain and other materials.
- baby carriages and parts of pushchairs,
- inflatable mattresses.
Articles evaluated on a case by case basis include:
- outdoor use items,
- sport and water-proof footwear,
- any coated articles (including those mentioned in the above categories, like spectacles), although, to fall outside the scope, they must have coating where the migration of the lead is below the limit value (0.05 µg/cm2 per hr) after being subjected to wear test simulating at least two years of normal use.
Articles generally outside the scope include:
- brass alloys if the concentration of lead does not exceed 0.5%,
- keys, locks,
- musical instruments,
- crystal glass, enamels, precious and semiprecious stones,
- religious articles for consumer use like crosses, rosaries,
- tips of writing instruments,
- portable zinc-carbon batteries and button-cell batteries,
- internal hinges in frames,
- non-toy figures, tin based figures as well as ship miniatures intended for collectors above a certain age or for museum exhibitions.
Articles already covered by EU-specific legislation are exempted, such as articles intended to come in contact with food (utensils, cookware), electronic articles, toys, jewellery and packaging materials.
Please click on the following for the ECHA guidelines. Hong Kong businesses may also wish to more carefully examine the original text of the restrictions and evaluate its impact on their supply chain by clicking on Regulation 2015/628.