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Lead and its compounds in jewellery
a summary of the situation and response to the French Annex XV report

The issue of lead, and the potential danger of ingestion of lead from children’s fashion jewellery, has regularly been highlighted in the International Press. France has prepared a report (an Annex XV report) proposing to restrict lead and its compounds in jewellery under the REACH Regulations.

POTENTIAL EFFECTS OF LEAD INGESTION:
Lead is a metal which is toxic even at very low levels of exposure. It may be present in jewellery as part of the metal alloy itself, or as solder. Certain lead compounds may be used as pigments in the coating and so both metallic and non-metallic jewellery are potential sources of exposure to lead.

Lead accumulates in the body, and regular exposure to even very low quantities may badly damage intellectual and behavioural development of infants and young children. Lead also has a variety of adverse health effects on adults, but children are the most at risk. Products intended for children therefore carry a higher safety risk, particularly as young children are likely to suck or chew items.

CURRENT LEGISLATION:
While there is currently no specific legislation regarding the use of lead and its compound in jewellery (neither fashion nor precious jewellery) in the Europe, there are regulations in relation to lead, and other toxic elements, in toys (i.e. Safety of Toys – BS EN 71-3:1995 – Migration of certain elements) and electro-technical products (EU RoHS Directive).
NB:  fashion jewellery intended for children is exempted from the new Toy Safety Directive 2009/48/EC2. Canada and the USA have now imposed specific restrictions on lead in children’s jewellery. 

LEAD - THE HAZARD:
The scientific community generally recognizes a level of 10 micrograms of lead per decilitre of blood (10μg/dL) as a threshold level of concern with respect to lead poisoning. Children who wear metal jewellery containing accessible lead can ingest the lead by handling jewellery and putting their hands in their mouths, by putting jewellery directly in their mouths, or by ingesting either parts or whole pieces of the jewellery. This is behaviour that may occur regularly over time (e.g. every day that a child has access to an item) and so results in chronic exposure.

Extensive test data developed by American and European researchers led them to believe that the amount of lead that would be absorbed by ingesting an item of jewellery would be much greater than the amount of lead that would be absorbed by sucking or handling the same piece. Accordingly, they believed that keeping lead content low enough will give reasonable protection against excess exposure by ingestion, and will provide even greater protection against the possibility of excess exposure through sucking.

WHAT LEVEL OF LEAD CONTENT OR RELEASE IS CONSIDERED TO BE “SAFE”?
Scientists from the US Consumer Product Safety Commission recommend that children should not ingest more than 175μg of accessible lead in a short period of time.
When scientists from the US Consumer Product Safety Commission evaluated the data on total lead content and leachable lead obtained from analysis of children’s metal jewellery, they determined that jewellery items that contained greater than 0.06% lead (600 parts per million) were associated with an increased likelihood of a result greater than 175μg lead in the leachable test, while items containing 0.06% lead or less were not associated with acid extraction results greater than 175μg.

USA
USA Children’s Jewellery Regulations (Ref. CPSC Section 101) – Children’s jewellery must not contain more than 0.03% (300ppm) lead. The limit goes down to 100ppm from August 14, 2011, unless the Commission determines that it is not technologically feasible to have this lower limit. The lead in paint limit is 90ppm.

According to the findings of the Scientists of the US Consumer Product Safety Commission, in the case of metallic items, there is no reason to test both content and release if the total lead content is less than 0.03%. Retailers who have very tight supply chains or manufacture the product themselves and know that their sources for raw materials do not contain lead will consider a lead content test sufficient. If the concentration of lead is less than 0.03% (i.e. a threshold level of concern with respect to lead poisoning), then they can logically assume that their product is safe. 

CANADA
The Canadian Authorities have also considered the possibility of ingestion of lead by children handling jewellery and putting their hands in their mouths afterwards, or physically chewing or sucking jewellery – a situation which may commonly occur with a necklace or pendant.

Unlike the Americans the Canadian Authorities have given equal importance to both situations and have imposed a limit for total lead content and a limit for leachable lead:

Canadian Regulations - Limit 600mg/Kg (equivalent to 0.06%, or 600ppm) total lead and 90 mg/Kg (0.009%, 90ppm) leachable lead.

The Canadian Regulations encompass both the US Children’s jewellery regulations and the European Safety of Toys Regulations.

EUROPE
Europe: BS EN 71-3:1995 – Safety of toys (Part 3: Migration of certain elements) specifies the requirements and test methods for migration of various toxic elements (including lead) from toys. Simulates action of digestive acid and quantitatively determines element migration (including lead) from test component. Limit 90 mg/Kg (equivalent to 0.009%, or 90ppm) leachable lead.

Although BS EN 71-3 relates to toy safety, it is a recognized European standard intended to ensure the safety of children’s products and would seem to present the most suitable approach currently available under European testing regimes. BS EN 71-3 requires all  decorative and protective coatings such as paints, varnishes, lacquers, printing inks and similar coatings to be removed from the article by scraping with a sharp blade or similar and then to be tested as a separate component.  The test identifies the level of leachable lead in each component

FRENCH PROPOSAL
France has prepared a report (an Annex XV report) proposing to restrict lead and its compounds in jewellery under the REACH Regulations. With the proposed restriction, jewellery which has a lead migration rate greater than 0.09 micrograms per square centimetre per hour (µg/cm²/hr) would be prohibited from being produced and/or placed on the EU market. The proposed restriction would apply to all jewellery, both precious and fashion jewellery, to jewellery intended for adults as well as for children. The lead migration limit should be considered for each individual part of the jewellery. In order to test the migration rate it is proposed to use the available standard EN 71-3 which is already used for testing the migration of certain elements from toys. The restriction would apply 6 months after the entry into force of the amendment of REACH Annex XVII.

To summarise, although there are no specific laws or limits for lead in jewellery, or specifically children’s jewellery in the EU and given the fact that lead is considered as a non-threshold toxic substance for neurotoxic effects, exposure to this substance should be avoided as much as possible.

In order to protect consumers and to address the legal implications, The Birmingham Assay Office believes that EU suppliers need to adopt “due diligence” procedures to demonstrate that they have taken “all reasonable steps” to ensure that their products are safe.  Part of this may be in the specification to the manufacturer or wholesaler, but it is recommended that some independent testing be carried out on high risk products.

EXAMINING THE FRENCH PROPOSAL FOR AMENDMENTS TO THE “REACH” REGULATIONS
The French proposal is based on the lead migration rate and draws from parallel experience with developing the approach to measuring nickel release in EN 1811. Indeed, studies suggest that as with nickel there is no correlation between the lead content of jewellery and the quantity of lead that migrates from the jewellery.
Lead content is the quantity of lead that is present in the jewellery materials composition, whereas the lead migration rate is the quantity of lead which can be released by the jewellery during a certain period of time, generally under acidic conditions, simulating the use or misuse of the jewellery (e.g. mouthing or ingestion).
As a consequence, the proposed restriction is targeted to limit the lead migration rate as it is considered to be the most relevant indicator of potential exposure. The Birmingham Assay Office supports this approach.

Several suitable testing methods are available for the measurement of the lead migration rate from various products. The quantity of lead is measured without any distinction of the origin of lead (present as metallic lead, or as part of an inorganic or organic compound). In selecting which testing option to use, the supplier should consider the product and the market.  For items which are to be sold within Europe it makes sense to adopt a method recognized by a European Standard, particularly when It is already being used for regulatory purposes (in the framework of the Toy Directive 2009/48/EC).

Please note that toys are not usually tested according to EN 71-3 if they are not supposed to be ingested by children, i.e. if they do not fit entirely the so-called “small parts cylinder” which is a device that approximates the size of the fully expanded throat of a child under three years old. However, the health risks identified considered in the French report deal not only with the accidental ingestion of jewellery, but also with the mouthing of jewellery. As the latter activity may be performed by the child irrespective of the size of the jewellery, it is necessary to test all jewellery according to this standard. Indeed, a toy (and possibly jewellery) which is too large to be swallowed may clearly be mouthed/sucked which may result in chronic lead poisoning. As larger jewellery items need to be tested using EN 71-3, it may be necessary to adapt the quantities of aqueous solution of hydrochloric acid. For information, US CPSC indicates that the amount of acid solution added should be equivalent to fifty times the weight of the jewellery item.

It is acknowledged that while mouthing jewellery, children will deteriorate the article and thus they will remove some parts of the coating, thus making the material underneath accessible. Consequently, the jewellery should be tested after removal of any coating in accordance with appropriate section (ref. 8.1.1) of 71-3 and the coating which should scraped off (wherever possible) and tested as a separate component (section 8.1.2).

Articles tested by EN 71-3:1995 are considered safe if a level of leachable lead from both coating and metal/non-metal beneath respectively is found to be equal to/or less than 90 mg/Kg (0.009%, 90ppm). The French proposal suggest that although the coating(s) and metal/non-metal beneath will be tested separately as individual components, but in such a situation, the sum of the two migration rates (coating alone plus jewellery without its coating) should not exceed the limit proposed in the restriction. The Birmingham Assay Office has no objection to the proposal, but the proposed limit to be applied to the individual coating and metal/non-metal beneath and pass/fail of the item should be decided accordingly.

Metallic articles with a metallic coating which it is not physically practical to remove during testing (e.g. rhodium plating and hard gold plating) should be tested as individual components; the metallic coating is unlikely to contain lead, but the base material underneath must be safe when the protective layer eventually wears away. European standard, EN 12472, is available for the simulation of wear and corrosion of coated items. It was originally developed for the regulation which addresses health risks related to nickel in jewellery articles. The suitability of this method to the issue of lead and its compounds in jewellery is however unknown. Analytical tests would probably be needed to assess its relevance.

Again where there are decorative and protective coatings such as paints, varnishes, lacquers, printing inks and similar coatings which can be removed by scraping, the coating should be removed and its lead content tested separately.

The French proposal is that the lead content of individual metal components/coating is to be established by ICP-OES.  Please note that the report does not precisely specify the analytical method to be used in order to measure the lead’s migration rate. It simply says that the inductively coupled plasma spectroscopy (ICP) and the flame atomic absorption spectrometry are suitable techniques.

Whatever the technique, the proposed lead migration rate of 0.09μg/cm2/hr is very low and depending on the size of the sample, may present difficulties in measuring accurately, depending on the equipment. The closer to the detection limit of the measuring equipment, the precision and reliability of the measurement decrease significantly. It may only be possible to detect such a low limit using ICP-MS, which is more costly, more restrictive, and will increase turnaround times.

BIRMINGHAM ASSAY OFFICE RECOMMENDATION

1. Precious metal jewellery alloys, including children’s jewellery, are unlikely to contain any lead as it would cause the items to fracture during manufacturing.  Enamels etc. used for decoration are also lead-free as they would pose serious health issues during firing. The Birmingham Assay Office is of the opinion that precious metal products should be exempted from testing (as they are in the USA), however, non-metallic decorative coatings should be tested.

1. The migration rate is defined in μg/cm²/hr in the French proposal and the proposed limit is 0.09 μg/cm2/hr.  This implies that the surface of the jewellery tested will have to be measured. For this measurement, the proposal recommends the use of the method proposed in European standard EN 1811. The facility and experience to measure the surface area of complex jewellery items is available with the majority of metal testing laboratories, but experience suggests that EN 1811 is contested regularly for its non-repeatability of results. One of the reasons for non-repeatable results is attributed to the measurement of surface area, as by its very nature it seems to lead to a great variation in test results.To overcome this problem, The Birmingham Assay Office recommends that the test to evaluate the lead migration rate of jewellery items is the same one which is used for the Toy regulations in the standard EN 71-3 (Part 3: Migration of some compounds) simulating the ingestion of a toy by a child. The limit set by the Toy regulation is 90 mg/kg. Therefore the suggested unit in the Toy regulations (mg/kg) is more appropriate than the one suggested in the French restriction project which corresponds to a combination of the Toy and Nickel in jewellery regulations. In the interests of consistency, repeatability and accuracy there seems no reason to treat jewellery any differently from toys.

1. Experts at The Birmingham Assay Office believe that if the lead migration rate is measured per surface area unit, disputes will arise due to the associated uncertainty of the test method itself. It appears as though the French proposal originates from using surface area as in EN 1811 (nickel), but we are unable to see any sound scientific justification supporting this approach. Measuring the surface area of crystals is particularly difficult and may introduce substantial variation between different laboratories results. The Birmingham Assay Office takes the view that either sound technical reason(s) for reporting results in μg/cm²/hr are provided as part of this proposal or the unit in the Toy regulations (mg/kg) is implemented. We would like to have sight of the data and reasoning in supporting the proposal.

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