Lead Regulation (EU) No. 2015/628

A new European regulation restricting the amount of lead in articles may have implications for shoemakers.

by Martin Heels

Historically, lead and lead compounds have been utilised in many applications. Some lead compounds, such as lead chromate, are brightly coloured and, as a result, were used as pigments in paints and plastics. Tetraethyl lead was added to petrol as an anti-knocking agent (to combust the air/fuel mixture correctly in the engine) and lead pipes were used in domestic plumbing up until the early 20th century. In fact, 'plumber' is derived from the Latin word for lead – 'plumbum'.

However, lead has been proven to be a toxic substance and is poisonous to humans in high concentrations. The use of lead in these historical contexts has been restricted in many regions of the world for many years and, as the health risks associated with lead have been uncovered, more restrictions have followed. This latest restriction – Commission Regulation (EU) No 2015/628, published on 22nd April 2015 – is applicable to articles that may, during normal or foreseeable conditions of use, be placed in the mouth by children.

This regulation has amended the existing text in REACH (Regulation (EC) No. 1907/2006) Annex XVII entry number 63, in which the lead restriction is only applicable to the use of this substance in jewellery. The April 2015 regulation comes into force for articles placed onto the market after 1st June 2016.

The dangers of lead

Lead accumulates in the body, so repeated exposure to even low levels of lead can eventually endanger health. In the body, lead can result in severe and irreversible neurobehavioural and neurodevelopmental effects. This can result in symptoms such as memory problems, tremors and involuntary limb movements. Children are particularly sensitive to lead in the body, given that their central nervous system is still under development. The amount of lead in children’s products on the market in the USA has been restricted since 2008 by federal legislation. Regulation (EU) No. 2015/628 is intended to protect the general public from exposure to lead by limiting the total amount of lead to below 0.05 per cent (500 parts per million) in articles or accessible parts of an article that may be placed in the mouth by children under normal or foreseeable conditions of use.

However, the total amount of lead may exceed 0.05 per cent if the rate of lead release is sufficiently slow, which will be discussed later in this article. For the purposes of this regulation, an article or accessible part of an article is included in the statement 'may be placed in the mouth by children' if it is smaller than 50mm in one direction or has a detachable or a protruding part of that size. This means that items of less than 50mm in any direction which are intended for very young children will have to comply with these regulations. Items that foreseeably may be mouthed by children also need to comply, even if they are not intended for very young children.

The requirements in Regulation (EU) No. 2015/628 are separate legislation to the existing requirements for extractable lead in the Toy Safety Directive (2009/48/EC). These are mandatory for children’s toys on the market in Europe, and are generally viewed as appropriate for due diligence purposes in the footwear industry for young children’s footwear and the footwear that young children may foreseeably encounter.
Relevance to footwear

Footwear intended for children under the age of 36 months has a relatively high likelihood of being placed in the mouth by the wearer. Although the whole footwear may not have a dimension of less than 50mm, parts of the product (such as fastening straps, buckles, and heel loops) will probably fall within this size. Other footwear cannot be ignored (for example, plush slippers that are novelty- or character-based), as even those available in adult sizes could be considered appealing to children.

Whether Regulation (EU) No. 2015/628 is considered as being applicable will need to become part of a risk assessment for a specific footwear style, in the same way that the Toy Safety Directive is currently used for children's footwear. However, the text of the regulation states that 'guidelines regarding articles that fall within and outside the scope of this restriction should be developed to assist with the implementation of this regulation'. It is our expectation that these guidelines will be produced by the European Commission and will contain specific examples to interpret which articles are expected to meet these lead limits.

Why might lead be present?

Lead compounds might be present in polyvinyl chloride (PVC) and other plastics such as pigments or stabilisers, to make the plastic more resistant to degradation by heat, light and ultraviolet (UV) radiation. Metallic trims could potentially be made from alloys in which lead is a constituent. However, from a performance perspective, it is unlikely that such alloys would be selected for footwear components.

Rate of lead release

The regulation states the maximum lead concentration of 0.05 per cent shall not apply where it can be demonstrated that the lead release does not exceed 0.05µg per cm² per hour. This is stated in the regulation as being equivalent to 0.05µg per gram per hour. The rationale behind the equivalence provision is taken from background studies surrounding the lead in jewellery restrictions, where the general assumption was used that the ratio of the surface area (in cm²) to the weight of the item (in g) was 1:1. Relating the surface area to mass is dependent upon the specific shape of the item and the density of the material, so this equivalence rate will not be true in the vast majority of cases. Therefore, it would be prudent to express the lead release rate in terms of surface area rather than article (or part of article) weight.

The regulation is silent on specifying any test method that should be used to demonstrate compliance. However, EN 71-3:2014 – the procedure to demonstrate compliance to the Toy Safety Directive – determines the amount of extractable metals if the toy material is sucked, licked, chewed or swallowed. Comparing the lead release rates in both pieces of legislation, the maximum allowable limit of lead in the Toy Safety Directive (2009/48/EC) for Category III items is 160mg/kg. Although Categories I and II have lower limits, materials used in shoemaking are unlikely to fall into these categories (which are defined as ‘brittle, powder-like pliable materials’ for Category I and ‘sticky materials’ for Category II). Using
the equivalence rate as an illustration to compare these two requirements, the maximum allowable limit of 160mg/kg is the same as 80µg per gram per hour. This is because the extraction period defined in EN 71-3:2014 is two hours and mg/kg is the same as µg per gram.

SATRA's recommendation

These maximum allowable rates of lead release have a huge difference of 1,600 times. This creates an interesting discussion point for footwear as to which extraction rate should be achieved by children’s footwear. It is SATRA's recommendation that footwear or parts of footwear that may be considered to fall under the definitions of these regulations should contain less than 0.05 per cent of lead, and hence the lead release rate would be irrelevant. The vast majority of footwear is unlikely to contain lead above this concentration. However, SATRA's chemical and analytical team can test materials and components to clarify whether or not they fall outside the amended restriction.

Exempted articles

There are exemptions where the total lead concentration is allowed to be greater than 0.05 per cent, and the rate of lead release can exceed 0.05µg per cm² per hour. Specific articles – including crystal glass, musical instruments and batteries – are not included in the scope of Regulation (EU) No. 2015/628. A lack of suitable alternatives to lead in the manufacture of these articles is cited as the justification for their exemption. Articles that fall within the scope of the restriction of certain hazardous substances in electrical and electronic equipment (RoHS – 2011/65/EU), the Packaging and Waste Directive (94/62/EC) or the Toy Safety Directive (2009/48/EC) also do not fall within the lead regulation. When the Toy Safety Directive is referred to as an appropriate due diligence assessment, the view could be taken that meeting those requirements for lead would suffice. As mentioned earlier, SATRA's recommendation is for those articles, or parts of articles that may fall within the scope of these regulations, to not contain more than 0.05 per cent of lead.

In summary

Commission Regulation (EU) No. 2015/628 should be considered as part of a footwear style's risk assessment. However, it is primarily relevant for very young children's footwear. Adult’s plush slippers, which could be considered to have play value for young children, may contain parts that are defined as accessible under this regulation, and SATRA recommends that these types of items meet the requirements of this legislation for total lead.

Generally speaking, adult outdoor footwear is not likely to be affected when this new regulation comes into force on 1st June 2016. Although no test procedures are referenced to quantify the amount of lead or the lead release from components, the well-established American methods CPSC-CH-E1001-08.2, E1002-08.2 and E1003-09.1 to determine total lead are commonly used by chemical testing laboratories and would be appropriate procedures to compare against the 0.05 per cent requirement.

Publishing Data

This article was originally published on page 16 of the September 2015 issue of SATRA Bulletin.

Other articles from this issue »

---