The AnchorCert Protect methodology identifies the allergenic potential of metal elements present in products and allows only those products deemed to ‘Pass’ to enter the marketplace which considerably reduces the risk of a product causing an allergic reaction to human skin. The ‘Pass’ result from the AnchorCert Protect testing methodology indicates that the component is kind to skin, and it is less likely to cause metal-induced Allergic Contact Dermatitis (ACD) commonly known as skin allergy to an already sensitised individual; thus, preventing both induction and elicitation phase. This means complete freedom from metal allergy.The AnchorCert Protect test methodology measures the release concentration of the potentially known 16 metallic skin sensitisers and provides an accurate measurement of their sensitisation potential based upon their reaction with novel artificial sweat and the formation of soluble metal ions.

‘Pass’ results indicate that the component is kind to skin, and it is less likely to cause metal-induced Allergic Contact Dermatitis (ACD) commonly known as skin allergy to an already sensitised individual; thus, preventing both induction and elicitation phase. This means complete freedom from metal allergy.

A ‘Fail’ result indicates that the component parts may not be suitable for contact with human skin and may cause metal-induced Allergic Contact Dermatitis (ACD).

Jewellery and similar items complying with the AnchorCert Protect threshold release limits can be classed and marketed as AnchorCert Protect Compliant.

The test procedure also ensures that the test sample identified as compliant by AnchorCert Protect methodology shall also be compliant for nickel when tested by EN1811 + A1:2015 method. The success rate has been above 99%.

More than 99% of articles passing AnchorCert Protect will also comply with the requirements of the latest version of EN 1811 / EN 12472 and comply with the Nickel Directive. This is a highly acceptable level of certainty from a scientific point of view.

Leaching or release of metal ions from metal objects (alloys) in contact with sweat is a multifactorial event that defeats prediction. It depends on several factors, including electrochemical characteristics of the metals /alloys, the supply of sweat and its composition, pH of perspiration (acidity/ alkalinity), temperature conditions, metal element’s ability to form coordinate/ covalent bond and associated bond energy etc. In addition to these properties, other factors such as the size and, in particular, the specific surface area of the metal in contact with skin, the length of time over which exposure takes place, and, of course, the mass or surface area loading of the substance will all play a part in determining the level of soluble metal ions at the metal-skin interface. This is what we call a favourable condition that must exist at the metal-skin interface for the metal to produce biologically active soluble metal ions and trigger skin allergy reaction.

Aside from the above immediate environmental factors, the microenvironment (grain size) within the particular alloy in contact with a conducting medium (electrolyte, e.g., sweat) is a principal determinant due to the action of electromotive forces prevailing at the interface of atoms with differing electromotive potential.

It is impossible to change the immediate environmental factors/conditions on the metal-skin interface when the metal object touches consumers' skin. However, the skin allergy could be prevented if we devise a mechanism to control metal release below the safe threshold level; this is possible by adopting the correct metallurgical approach during the manufacturing of the metal objects.

Listed below are the possible explanations as to why what appears to be variations in metal release results sometimes occur:

Each individual case must be viewed independently, but in general, variations in the amount of metal released during an Anchorcert Pro/EN 1811:2015 test may be influenced by several factors as follows:

• Due to the corrosion/wear/immersion process changing the surface characteristics of the item, it is not possible to test exactly the same article more than once, so direct comparisons in results for exactly the same item cannot be made. Samples from the same batch may be tested and results compared, but they are all individual samples.

• If articles are plated, particularly with an intermediate interlayer, variable metal release may be observed due to the products themselves being non-uniformly produced as a result of the plating process itself.

• Differences in use and efficiency of the masking agents used to ‘stop off’ any areas of the item from the test, judged not to be in direct and prolonged contact with the skin.

• A ‘fail’ result may be obtained for an article to which no allergen metal has been deliberately added because of contamination by allergen metals or other interfering elements during the fabrication process, for example drawing a wire through a stainless-steel die; nickel present in steel die could go onto the surface of wire which apparently had no nickel added during manufacturing. The wire may fail for nickel due presence of nickel which got embedded on the wire during wire drawing process.

• Surface finish - ranging from highly polished to matt finishes can significantly influence nickel release.

• Differing surface characteristics, such as discontinuities and porosity.

• The presence/absence of other elements in the material, such as sulphur can influence surface reactivity and hence metal particularly nickel release.

• Metallurgical treatments, such as annealing, anodising etc.

Please note that the rate of allergen metal release from an allergen metal containing material could easily be changed by altering the metallurgical/mechanical properties. The treatment such as annealing at different temperatures for different periods of time can influence the allergen metal release rate. If the material has been properly heat treated and all of the metallurgical aspects which could influence metal release have been considered, then this may cause the material to release metal at below the recommended threshold level, when otherwise it would be expected to fail.

We can confirm that, to the best of our knowledge, no other laboratory in the world is offering a similar or matching test. However, to verify our claim concerning minimising skin allergy related incidences even in already sensitised individuals, thus preventing both sensitisation and elicitation phase, you may wish to undertake trials yourselves and compare results findings obtained from AnchorCert Analytical via the AnchorCert Protect Test with results of items from other laboratories if you believe they offer a similar test.

The Patch testing is used frequently by dermatologists to identify the cause of allergic reaction to human skin. ESSCA (the European Surveillance System on Contact Allergies) is an EU network; they collect data on patch-tested patients across Europe. A recent analysis by the European Surveillance System on Contact Allergy (ESSCA) network based on 2002–2010 patch test data across Europe, showed a high frequency of skin allergy:

• 23.4% of the EU population is sensitised to Nickel

• 9.3% to Cobalt

• 5.6% to Chromium

Similarly, the North American Contact Dermatitis Group (NACDG) reported positive responses to Nickel in 19.5%, Cobalt in 8.4% and Chromium in 4.1% of the 5,085 patch-tested subjects.

The science of nickel sensitisation is well established and understood, but the science of other metal(s) induced allergic contact dermatitis are not well understood. ANCHORCERT PRO RESEARCH PROJECT UNDERTAKEN BY ANCHORCERT GROUP IS ADDRESSING THIS ISSUE.

Unlike EN1811:2015, which is applicable to metallic components only, the AnchorCert Protect test is applicable to all components made of polymeric1, metallic2 and inorganic non-metallic materials3 including textile and leather intended to come into direct and prolonged contact with the skin or those inserted into pierced parts of the human body.

Note1*: Polymer materials include polyethylene, polyvinyl chloride (PVC), epoxyresin, polyamide (e.g., nylon), and polystyrene, rubber etc.

Note2**: Metallic materials may be precious metal alloys, ferrous metal alloys, and non-ferrous metal alloys etc.

Note3***: Inorganic non-metallic materials may be glass and ceramics etc.

AnchorCert Protect test methodology covers the metallic & non-metallic parts of the following:

• Jewellery (fashion/precious), Body Piercings & Accessories

• Embellishments on Clothing,

• Finishing Components, including Zips, Poppers, Clasps, Buttons,

• Decorative parts of garments, other buttons, clothing hooks (such as bra hooks), pins, hair slides, hairgrips, hair clasps, pendants, toe rings,

• Wrist-watch cases, watch straps, Activity trackers, their straps, and tighteners

• Belts and belt buckles

• Metallic/ non-metallic accessories used in textile products, footwear, or leatherwear such as snap hooks, buckles, fastening, padlocks, frames (handbags), buttons, rivets, broaches, eyelets, chains, post assemblies, pins, rings, handles, handbag holders, zips, zip sliders, sequins etc.

• Cutlery, items of personal hygiene, keyrings, umbrellas, walking sticks, smoking accessories, item of stationery, electronic articles, and mobile phone etc

MACD is a disease with the economic and psychological impact on society. It could be damaging for brand reputation, consequences are:

• Disruption to Business,

• Negative Publicity,

• Reputational Damage to Brand,

• Loss of Consumer Trust and Confidence,

• Significant Cost Impact: managing the failure, recalling the product, legal settlements, extra testing, loss of sales. If it goes wrong – it will be made public

MACD has a non-reversible effect; this means once allergic, a person would be likely to continue to be allergic throughout their life. Prevention & Proactive Intervention is the best way forward. AnchorCert Protect is addressing this issue by minimising skin allergy related incidences thereby reducing the economic and psychological impact on society.

In our opinion, at least one sample from every batch to be tested and each batch identity to be traceable. It is frequently noticed that although the materials are apparently homogeneous, the test results still vary significantly between batches. In other words, the results obtained for a determinate batch (having an exact and discernible form) are neither representative of, nor can be extrapolated, for other different batches. It is therefore suggested that the samples to be tested must be identified by a code/ batch number that can be traced to the batch. The test certificate, which accompanies the shipping documentation, must make a reference to this code. This is the only way to guarantee the authenticity and traceability between the goods and their associated certificates.

In compliance with the GPSD Directive, the supply chain must ensure that only safe consumer products are sold in the European Union (EU); consumers must be informed of the risks that are not immediately perceptible via the use of a suitable warning, e.g.

CONTAINS COBALT, CAUSES SENSITISATION TO THE SKIN (H 317).

Sections 28, 29 and 30 of Annex XVII of REACH clearly states that the entire supply chain, including consumers, must be notified, (within 45 days, if requested), if CMR (Carcinogenic, Mutagenic and Repro-toxins) substances are present in an article in quantity exceeding: 0.1% by mass of the mixture.

Members of the supply chain must be able to prove to the regulatory body (e.g., TS) responsible for overseeing market discipline:

• That they have ordered products or components free of problems.

• That they have received products or components free of problems.

• That they have made sure that they have verified the absence of the problem, this is possible if exposure is adequately controlled to as low a level as is reasonably practicable.

In the above example, Cobalt as the metal itself is a CMR. When present in jewellery, watches & in similar products, it may form CMR substances such as chlorides or oxides of cobalt due to its migration on contact with body sweat. Such exposure presents the greatest risk to human health if the rate of metal release exceeds the already accepted threshold values set out for those metals in EU/US regulations (safe harbour limit).

The AnchorCert Protect test methodology has been validated in such a way that it’s ‘compliance report’ would ensure that that any metal allergens and their compounds, if present or formed during the end use of the product would cause less risk to human and comply with the requirements of General Product Safety Directive (GPSD) from a ‘Skin-Sensitisation’ point of view.

Nickel is a common metal often combined with other metals to create alloys with increased hardness and resistance to corrosion. However, the presence of nickel in certain products which are intended to come into direct and prolonged skin contact may cause sensitisation of humans to nickel and may lead to allergic reactions. Nickel released is regulated under EC 1907/2006 REACH Annex XVII, Item 27. The latest version of EN 1811 is to be used to verify the conformity of the products to the regulation.

Anyone wishing to place items on the market must recognise that they have a legal obligation to ensure that items meet the requirements of the REACH regulation. The responsibility for ensuring that all items conform is placed upon retailers, importers, wholesalers, and manufacturers.

It is a defence for a person charged (for ‘product liability’ & breach of statutory duty) to show that he took –

• All reasonable steps; and

• Exercised all due diligence to avoid committing the offence.

All reasonable steps - these are proactive precautions, e.g., setting up systems/procedures of control.

Exercising all due diligence - this is reactive and means making sure the systems work.

The onus is on the seller to prove “all due diligence”. The seller needs to be able to prove, through a paperwork audit trail that they have complied with legislation. This will entail obtaining certification from suppliers to guarantee compliance and also “appropriate” random testing of the products being sold.

The supplier of a product which is found not to comply with the nickel regulation is committing an offence under the Consumer Protection Act. Penalties can be up to six months imprisonment or fines of up to £5000. Also, there are likely to be far higher financial penalties in terms of personal injury claims and damage to the reputation of the business.

The General Product Safety Directive (GPSD) EC/2001/95 exists to ensure that only safe consumer products are sold in the European Union (EU). The GPSD covers the provisions for consumer products in its finished state that are not covered by specific sector legislation. For example, Cobalt as metal is a known allergen but it is not covered by any specific EU legislation. In such situation skin allergy due to cobalt will be monitored according to provisions of the General Product Safety Directive (GPSD) EC/2001/95 which advocates that only safe products enter the market.

Consumers must be provided with the information required to evaluate the risks of the product during its normal period of use. The jewellery product must be free of CMR substances. The supply chain is responsible for assessing the risks and they must be guaranteed that the safe product has been placed on the market by test certificates from an accredited laboratory. All written information related to manufactured items must be filled and available to the authority that requires it.

Other consequences are:

• Disruption to Business,

• Negative Publicity,

• Reputational Damage to Brand,

• Loss of Consumer Trust and Confidence,

• Significant Cost Impact: managing the failure, recalling the product, legal settlements, extra testing, loss of sales. If it goes wrong – it will be made public (e.g., Argos, Reebok, Mattel cases)

Prevention & Proactive Intervention is the best way forward. AnchorCert Protect addresses this issue by minimising skin allergy related incidences thereby reducing the economic and psychological impact on society.

In court, there is no need for the prosecution to prove an intention to commit an offence. Onus is on defendant to prove that he/she took all reasonable steps and showed all due diligence to avoid committing the offence. There are no written rules as to what this means for an organisation, what is reasonable depends on the size and resources of the business. A large business, for example, must do more [Ref.: Garrett v Boots the Chemist].

• A company with many shops must exercise control at all levels. The directors speak and act as the company their subordinates do not [Tesco Supermarkets Ltd v Nattrass].

• Relying on the reputation and experience of wholesalers is not a precaution - elementary testing was (Sherratt v Geralds the American Jewellers).

• Even in a fair and proper relationship with the enforcing authority, it is not possible to ‘shuffle off’ responsibility onto a friendly enforcement officer. Failure to test imports was not ‘reasonable’ (Taylor v Lawrence Fraser (Bristol) Ltd).

• Control systems must include adequate checks, that are recorded, with instructions given to staff and staff training given in the systems (Baxters Butchers v Manley)

• TESTING (Rotherham Metropolitan Borough Council v Raysun):

• The number of tests must be sufficient.

• Test results must be reported, and they must be considered.

• Blanket assurances from a supplier are not enough, there must be positive acts to justify the defence (Riley v Webb)

• Can be delegated, key criteria are: Competence & Independence (Amos v Melcom)

• In contract

• In negligence

• In ‘product liability.’

• Breach of statutory duty

In ‘product liability’ it was irrelevant whether the hazard had come to the notice of the producer before the incident occurring (Abouzaid v Mothercare (UK) Ltd)

In deciding what is reasonable for due diligence, the following needs to be considered:

• Risk assess the product – likely use, potential danger and what potential harm could it do?

• Risk assess the supplier – established record or unknown, QMS, accredited, recommended, type of business, other customers?

• Consider previous test results – high rate of failure?

• Create a decision tree for your business to assess each product or supplier against, grade them to quantify risk.

• Establish a sampling plan with different levels according to risk, based on both product and supplier

Nickel is the most common cause of Allergic Contact Dermatitis of the skin. This may cause minor allergic irritation for most individuals, but some people may experience a severe significant reaction.

The main problem with nickel arises for nickel sensitised patients who develop dermatitis. Nickel can easily permeate through the skin resulting in a perpetuation of dermatitis. As nickel is such a universally found substance, it is almost impossible for sufferers to avoid contact with nickel. As a result, long-term side-effects occur.

The purpose of the Nickel Regulations is twofold:

To prevent people from becoming sensitised to nickel.

To reduce the risk of prolonged and direct contact with articles with a high level of nickel release which could trigger an allergic reaction.

It is estimated that 15% of people in Europe are nickel-sensitised, so the danger of a Customer suffering bad reactions from a non-conforming product is significant. Subsequent legal action is almost inevitable.

To ensure that products comply, they must be tested to the relevant British Standards stipulated in the legislation i.e., BS EN 1811 and BS EN 12472. Other screening tests are a useful part of a due diligence procedure, but legally all items must pass the relevant test stipulated in the Regulations.

No limit has been set for the nickel content of items in direct and prolonged contact with the skin.

The requirements in the Regulations refer only to Nickel release.

There is no simple relationship between Nickel content and nickel release, so it is not possible to state which alloys will be compliant, based on their composition alone.

The amount of nickel released from a Nickel-containing alloy depends on several factors, such as the thickness/uniformity/porosity in plating and metallurgical aspects including homogeneity etc. Providing the plating is sufficient to prevent nickel being released at below the figures quoted in the Regulations - for post assemblies, they will be compliant if they release nickel at less than 0.2 µg/cm2week (<0.35 data-preserve-html-node="true" µg/cm2week with 46% uncertainty), and for other products, in order to be compliant, the rate of nickel release from each individual part of the item coming into direct and prolonged contact with the skin must be equal to or less than 0.5 µg/cm2/week (<0.88 data-preserve-html-node="true" µg/cm2week with 46% uncertainty), then the actual nickel content is not the determining factor.

It is, therefore, necessary to test finished items containing Nickel, in order to establish the level of Nickel release and hence compliance or otherwise.

The assumption made by anyone that item will fail to comply with the REACH Nickel regulation without testing the items for Nickel release is not professional or acceptable in the eye of law. Items must be tested by EN1811:2011 + A1:2015 method and if it fails due to the presence of Nickel in the alloy then legal action could be taken but not until failure is proven.

We can help ensure that you conform to REACH regulation. Our UKAS accredited laboratory offers all necessary REACH tests, and our professional staff are experts in this field and closely involved in the latest developments. AnchorCert Group, which is part of the Birmingham Assay Office, is involved in these developments and commits itself to keep our Customers up to date with any changes they need to be aware of.

The General Product Safety Directive (GPSD) EC/2001/95 ensures that only safe consumer products are sold in the European Union (EU). The GPSD covers the provisions for consumer products in its finished state that are not covered by specific sector legislation. Consumers must be provided with the information required to evaluate the risks of the product during its normal period of use.

Anyone wishing to place items for sale on the market must recognise that they have a legal obligation to ensure that items are safe during the intended use by the consumer and meet the applicable requirements of the EU Regulations. The responsibility for ensuring that all items conform is placed upon retailers, importers, wholesalers, and manufacturers.

There is a growing concern within the EU and worldwide about skin sensitisation of the general population from exposure to metallic elements present in jewellery, watches, eyewear, piercing, dental implants alloy materials and also from metallic elements present in chemicals used in textile and leather articles, such as clothes and footwear. Once a person is sensitised to an allergen, they must avoid exposure to the allergen for the rest of their life in order to prevent allergic reactions. Furthermore, data show that there is no difference in the prevalence of contact allergy between children and adults. This means that a person can get sensitised at a very young age and can be affected during their entire life.

If the skin sensitisation is caused by its exposure to metal allergens, then it is termed as Metal Induced Allergic Contact Dermatitis’ (MACD) which is a disease with an economic and psychological impact on society. It could be damaging for brand reputation and the potential consequences of are disruption to business, negative publicity, reputational damage, loss of consumer trust and confidence and trust as well as a significant cost impact from managing the failure, recalling the product, legal settlements, extra testing, loss of sales. If it goes wrong – it will be made public.

MACD has a non-reversible effect; this means once allergic likely to continue to be allergic throughout life. Prevention & Proactive Intervention is the best way forward.

Sensitisation to nickel (Ni) is the main cause of metal induced Allergic Contact Dermatitis (ACD). However, there are several other transition metals that are now of growing concern amongst dermatologists for their capability to act as allergens under certain circumstances. The research undertaken by AnchorCert Analytical on the sensitisation and contact dermatitis, along with In-vitro tests carried out in-house suggest that in addition to Nickel (Ni), Chromium (Cr) and Cobalt (Co), Allergic Contact Dermatitis (ACD) could also be initiated by other elements such as Aluminium (Al), Gold (Au), Beryllium (Be), Copper (Cu), Iron (Fe), Mercury (Hg), Manganese (Mn), Molybdenum (Mo), Palladium (Pd), Tin (Sn), Titanium (Ti) and Zinc (Zn) providing favourable conditions existed. None of these potential allergens, other than Nickel, is covered by EU legislations.

The AnchorCert Protect test methodology measures the release concentration of the known 16 potential metallic skin sensitisers (Ni, Cr, Co, Au, Hg, Be, Pd, Pt, Mn, Al, Cu, Fe, Mo, Sn, Ti, Zn) and provides an accurate measurement of their sensitisation potential based on their reaction with a novel artificial sweat and the formation of soluble metal ions. The test procedure also ensures that the test sample identified as compliant by AnchorCert Protect –shall also be compliant for Nickel when tested by EN1811 + A1:2015 method.

The purpose of the AnchorCert Protect test methodology is fourfold:

• To prevent people from becoming sensitised to sixteen potentially known metal allergens.

• to reduce the risk of prolonged and direct contact with articles with a high level of metal release from sixteen known metal allergens which could trigger an allergic reaction.

• To ensure product conforms to entry 27, Annex XVII (REACH) which imposes restrictions on the use of Nickel in all post assemblies which are inserted into pierced parts of the human body and articles intended to come into direct and prolonged contact.

• The compliance from AnchorCert Protect method also implies that the product meets the General Product Safety Regulation 2005 from a skin allergy point of view.

The AnchorCert Protect test methodology has been validated in such a way that it’s ‘compliance report’ would ensure that that sixteen potential metal allergens, if present or formed during the end use of the product would cause less risk to human from a ‘Skin-Sensitisation’ point of view. The AnchorCert Protect compliant product will also meet the General Product Safety Directive (GPSD) EC/2001/95 requirements from a ‘Skin-Sensitisation’ point of view.

Contrary to EN1811:2015 which is applicable to metallic components, the AnchorCert Protect test is applicable to all components made of polymeric, metallic, and inorganic non-metallic materials including textile and leather that are intended to come into direct and prolonged contact with the skin or those inserted into pierced parts of the human body.

The compliance results from the AnchorCert Protect test methodology implies that in the majority of people, the article will not trigger an allergic reaction even in an already sensitised individual, thus preventing both induction and elicitation phase. This means complete freedom from metal allergy in the majority population. No other currently known method has such a distinction.

The purpose of the General Product Safety Directive (GPSD) EC/2001/95 is to ensure that only safe consumer products are sold in the European Union (EU): The GPSD covers the provisions for consumer products in its finished state that are not covered by specific sector legislation. Consumers must be provided with the information required to evaluate the risks of the product during its normal period of use.

Anyone wishing to place items on the market must recognise that they have a legal obligation to ensure that items are safe during the intended use by the consumer and meet the applicable requirements of the EU Regulations. The responsibility for ensuring that all items conform is placed upon retailers, importers, wholesalers, and manufacturers.

Those who are responsible for enforcing the legislation will focus their attention on EU importers, wholesalers and retailers who must ensure their products comply and are safe. If one of your products causes a problem in the future, you will need to be able to prove that you took “all reasonable steps” and exercised “all due diligence” to avoid committing an offence. Note the word “all” in these statements.

Carrying out a few tests at random or the production of an unaccredited test certificate will not be accepted as fulfilling the requirements of ‘Due Diligence’, if a product sold by you is subsequently found not to meet the criteria set out in the legislation.

It is only possible to establish a ‘Due Diligence Defence’ if all the following criteria are met:

• The defendant has a Preventative System in place to demonstrate that all reasonable and practical steps have been taken to ensure that products comply with legislation and are safe during their intended use. This should include clear specifications of your requirements and some product testing to ensure products conform.

• The defendant can demonstrate that the Preventative System has been regularly monitored to ensure that it remains effective in order to avoid an offence being committed.

• There is a reasonable and innocent explanation as to how the offence occurred.

There cannot be any certainty that a product does not contain any known metal allergens and conforms to the REACH Regulations without it undergoing full testing. However, if you have full knowledge of the components and methods of production, these guidelines may be used as an indication of which products does or does not contain metal allergens and are most likely to conform to REACH or other relevant legislation. Please note that the AnchorCert Analytical does not take any responsibility for the interpretation of these guidelines or any subsequent consequences arising from this information.

Yellow Carat Gold Alloys are likely to conform, as metal allergens including Nickel are not normally present as a deliberate addition in EU. However, Nickel, Cobalt or Palladium may be present in the traditional plating solution used to “flash plate” so beware.

White Gold Carat Alloys may not conform as nickel or palladium can be deliberately added to “whiten” the alloy. Rhodium plating can reduce the amount of Nickel or Palladium being released but this depends upon the plating being of a sufficient thickness and can also be affected by other factors e.g., porosity in the plating.

Platinum Alloys are unlikely to be a problem. Platinum is a highly reactive transitional metal which easily complexes with donor groups in amino acids to form a complete antigen. The platinum compounds eliciting hypersensitivity are confined to a small group of ionic complexes containing reactive halogen ligands.

Silver Alloys commonly used in jewellery articles in themselves are likely to conform, as any known metal allergens including Nickel are not normally present as a deliberate addition. However, if a Nickel or Palladium diffusion barrier has been used beneath a top layer of fine silver, then the final product may not conform depending upon the thickness of the layer etc. If Silver is plated with Cobalt to give an antique look, then it is highly likely it may cause skin allergy if conditions are favourable.

Costume Jewellery could contravene the regulations if nickel is used as a plated layer beneath the surface layer, or if nickel is present in the plating solution used to plate the surface layer. Other known metal allergens covered under ‘AnchorCert Protect’ test methodology if present may potentially cause skin allergy if conditions are favourable.

Watches will depend upon the materials selected for the components and any subsequent treatments.

Although contact allergy to Gold is frequent, complex interplay between gold and the human body sweat is still poorly understood. The ionisation of elemental gold is essential to induce contact allergy and to elicit Allergic Contact Dermatitis (ACD). It is understandable that gold when present in a solution as a soluble or complex ion may cause contact dermatitis. However, keeping the electrochemical nobility of gold in mind, it is not clear how metallic gold or gold alloys present in jewellery and similar products would react with body sweat at a rate sufficient to elicit an allergic reaction in gold-sensitised people.

In a double-blinded study where 60 individuals with gold contact allergy were instructed to wear for 8 weeks either gold-coated (n = 30) or titanium nitride (n = 30) earrings, there was a significantly higher number that developed ear lobe reactions to the gold-coated earrings (12 vs 5). In ear lobe dermatitis caused by gold, scanning electron microscopy and X-ray microanalysis had shown small dense fragments containing gold.

During the AnchorCert Protect research study we observed that the gold plating of gold-plated articles tends to react with artificial sweat and produce soluble gold ions when it is not in perfect uncharged equilibrium with its substrate, due to the difference in electrode potential. Soldered/welded assemblies of non-plated jewellery items introduce the macro potential difference between solder and gold base alloy which could also cause the release of gold ions into sweat.

Gold, due to its nobility, hinders the production of significant amounts of soluble gold ions. If the quantum of gold release will be above or below the threshold limit required to trigger an allergic reaction in gold sensitised individuals, will depend on the size of potential difference which in turn depends on the size of macro defects.

We have scientific evidence to prove that gold does release into novel artificial sweat, but we are unable to fully characterised its mechanism and exact conditions under which such release take place. There is a need for a scientific investigation to understand better the formation of soluble gold ion in sweat solution, gold allergy and allergic contact dermatitis induced by gold.

We are continuing broader studies, conducted more rigorously, which are needed to firmly answer the questions raised in our paper titled “Gold Allergy: Differentiating Myth from Reality” written by Dippal Manchanda regarding the condition & mechanism of Gold dissolution in bodily fluids.

Platinum is a highly reactive transitional metal which easily complexes with donor groups in amino acids to form a complete antigen. The Platinum compounds eliciting hypersensitivity are confined to a small group of ionic complexes containing reactive halogen ligands.

Look for the AnchorCert Protect sticker on the product or request information from the seller or supplier. A list of high street retailers granted a licence to sell AnchorCert Protect’ compliant jewellery available on our website www.anchorcertprotect.com.

AnchorCert Protect test methodology offered by the Anchorcert Protect Laboratory of the Birmingham Assay Office has been witnessed by Assessors from the United Kingdom Accreditation Service (UKAS) and been seen to meet the requirements of ISO 17025 – ‘General requirements for the competence of testing and calibration laboratories’ and has therefore been included on our scope of accreditation. The test results will be supplied as a full Report on a UKAS accredited certificate. These certificates will be accepted throughout the EU to meet nickel regulation requirements.

The Anchorcert Group Laboratory is accredited by UKAS (the United Kingdom Accreditation Service) to ISO 17025 standard and follows rigorous Quality Assurance and Quality Control Practices.

EN1811/ or AP Test: One finished article as it will be displayed or sold. However, in case of earring, minimum two pairs of earrings to meet the surface area requirements.

AP-Pb-Cd/ or AP-RoHS test: Two finished article as it will be displayed or sold.

Any of the signatory of the test report.