EU Nickel Directive Research Articles

Prevalence of contact allergy to metals: nickel, palladium, and cobalt in Southern Sweden from 1995-2016.

In 2001, the EU nickel directive was introduced to prevent contact allergy to nickel. Contact allergy to palladium and/or cobalt is often seen together with contact allergy to nickel. To compare the contact allergy prevalence of nickel, palladium, and cobalt allergy before and after the introduction of the EU nickel directive in consecutive patients with dermatitis. A retrospective analysis of patch test results from 1995-2016 was performed (n = 18 264). Chi-square tests were used to examine trends for nickel, palladium, and cobalt across test years. Logistic regression was used for associations. The prevalence of nickel allergy decreased significantly in the youngest age group (6-30 years) for both female and male patients from 1995-1999 to 2012-2016: females: 33.4% to 19.1% (P < .001); males: 5.9% to 2.1% (P < .05). The concomitant reactions between nickel and palladium and nickel and cobalt among young females, respectively, also decreased significantly. Isolated palladium and cobalt allergy remained stable (1.4% and 2.3%, respectively) during the same time period for both men and women. The prevalence of nickel has decreased among young females and males suspected of contact allergy in Southern Sweden after the introduction of the EU nickel directive. There has been no change in isolated palladium or cobalt allergy.

Prevalence of nickel allergy in Europe following the EU Nickel Directive - a review.

Nickel contact allergy remains a problem in EU countries, despite the EU Nickel Directive. To study the prevalence of nickel allergy in EU countries following the implementation of the EU Nickel Directive, we performed a systematic search in PubMed for studies that examined the prevalence of nickel allergy in EU countries published during 2005-2016. We identified 46 studies: 10 in the general population and 36 in patch tested dermatitis patients. A significantly lower prevalence of nickel allergy after than before the implementation of the EU Nickel Directive was found in women aged 18-35 years (11.4% versus 19.8%) (p = 0.02), in female dermatitis patients aged ≤17 years (14.3% versus 29.2%) (p < 0.0001), and in dermatitis patients aged 18-30 years (women: 20.2% versus 36.6%) (p < 0.0001) (men: 4.9% versus 6.6%) (p < 0.0001). Overall, the prevalence was higher in southern than in northern EU countries, and generally remained high, affecting 8-18% of the general population. A consistent pattern of decreasing prevalence of nickel allergy in some EU countries was observed, although the prevalence among young women remains high. Steps should be taken for better prevention of nickel allergy in EU countries.

Nickel allergy in a Danish population 25 years after the first nickel regulation.

Nickel in metallic items has been regulated in Denmark since 1990; however, 10% of young Danish women are still sensitized to nickel. There is a need for continuous surveillance of the effect of regulation. To identify current self-reported metallic exposures leading to dermatitis in nickel-allergic patients, and the minimum contact time needed for dermatitis to occur. A questionnaire was sent to all patients who reacted positively to nickel sulfate 5% pet. within the last 5 years at the Department of Dermatology and Allergy, Gentofte Hospital. The response rate was 63.2%. Earrings were the foremost cause of dermatitis after the EU Nickel Directive had been implemented, followed by other jewellery, buttons on clothing, belt buckles, and wrist watches. Dermatitis reactions within 10 min of contact were reported by 21.4% of patients, and dermatitis reactions within 30 min of contact were reported by 30.7% of patients. Nickel exposures that led to the implementation of a nickel regulation seem to persist. The durations of contact with metallic items to fall under the current REACH regulation of nickel correspond well with the results of this study.

Nickel and cobalt release from metal alloys of tools--a current analysis in Germany.

The former 'EU Nickel Directive' and, since 2009, the REACH Regulation (item 27 of Annex XVII) do not include all metallic objects. The nickel content of tools is not regulated by the REACH Regulation, even if they may come into in prolonged contact with the skin. Tools might be possible sources of nickel and cobalt sensitization, and may contribute to elicitation and maintenance of hand eczema. To perform a current analysis of the frequency of nickel or cobalt release from new handheld tools purchased in Germany. Six hundred unused handheld tools from the German market were investigated with the dimethylglyoxime test for nickel release and with disodium-1-nitroso-2-naphthol-3,6-disulfonate solution for cobalt release. Nickel release was detected in 195 of 600 (32.5%) items, and cobalt in only six (1%) of them. Positive nickel results were nearly twice as frequent in tools 'made in Germany' than in tools without a mark of origin. Tools made in other European countries did not release nickel. Cobalt release was only found in pliers and a saw. A correlation was found between price level and nickel release. Among toolkits, 34.2% were inhomogeneous concerning nickel release. The German market currently provides a large number of handheld tools that release nickel, especially tools 'made in Germany'. For consumer protection, it seems appropriate to include handheld tools in the REACH Regulation on nickel.

Influence of shape and finishing on the corrosion of palladium-based dental alloys.

PURPOSEThe purpose of this study was to evaluate the effects of the surface treatment and shape of the dental alloy on the composition of the prosthetic work and its metallic ion release in a corrosive medium after casting.MATERIALS AND METHODSOrion Argos (Pd-Ag) and Orion Vesta (Pd-Cu) were used to cast two crowns and two disks. One of each was polished while the other was not. Two as-received alloys were also studied making a total of 5 specimens per alloy type. The specimens were submersed for 7 days in a lactic acid/sodium chloride solution (ISO standard 10271) and evaluated for surface structure characterization using SEM/EDAX. The solutions were quantitatively analysed for the presence of metal ions using ICP-MS and the results were statistically analysed with one-way ANOVA and a Tukey post-hoc test.RESULTSPalladium is released from all specimens studied (range 0.06-7.08 µg·cm-2·week-1), with the Pd-Cu alloy releasing the highest amounts. For both types of alloys, ion release of both disk and crown pairs were statistically different from the as-received alloy except for the Pd-Ag polished crown (P>.05). For both alloy type, disk-shaped pairs and unpolished specimens released the highest amounts of Pd ions (range 0.34-7.08 µg·cm-2·week-1). Interestingly, in solutions submerged with cast alloys trace amounts of unexpected elements were measured.CONCLUSIONShape and surface treatment influence ion release from dental alloys; polishing is a determinant factor. The release rate of cast and polished Pd alloys is between 0.06-0.69 µg·cm-2·week-1, which is close to or exceeding the EU Nickel Directive 94/27/EC compensated for the molecular mass of Pd (0.4 µg·cm-2·week-1). The composition of the alloy does not represent the element release, therefore we recommend manufacturers to report element release after ISO standard corrosion tests beside the original composition.

Alergia de Contacto a Metais num Período de 20 Anos no Centro de Portugal: Implicações das Directivas Europeias

Metals are a common cause of allergic contact dermatitis. After the introduction of the EU Nickel Directive (1994/27/CE; 2004/96/EC) and, more recently, the Cement Directive (2003/53/EC) there has been a significant decrease in sensitization to metals mainly in the Nordic countries. The applicability of these directives and their impact in the Portuguese population is unknown. A retrospective study (1992-2011) was carried out in our patch test clinic to assess the temporal trend of metal sensitization (nickel [Ni], cobalt [Co] and chromium [Cr]) along the last 20 years, particularly considering age, sex and its relation with occupational activity. Out of 5 250 consecutively patch-tested patients, 1 626 (31%) were reactive to at least one metal (26.5% to Ni; 10.0% to Co and 7.9% to Cr). Women had a higher prevalence of sensitization to Ni (34.4% vs 8.9%) whereas men were more reactive to Cr (11.5% vs 5.0%). Nickel sensitization did not decrease significantly over the years, although in recent years among women sensitized to nickel the percentage of younger patients (16-30 years-old) is significantly lower (p < 0.001). Chromium sensitization significantly decreased, particularly in men (r = -0.535), and mainly in the construction workers (r = -0.639). Chromium reactivity associated with the shoe dermatitis has remained stable. We emphasize the higher and stable percentage of nickel sensitized individuals suggesting, so far, a low impact from the EU Ni directive, although a decreasing percentage in the the younger group among Ni sensitized women may suggest a beneficial effect is becoming evident is this age group. On the contrary, the impact of the directive regarding the modification of Cr in cement seems to be effective. There is now a need to regulate chromium content in leather products, namely in shoes. The regulation of interventional measures related either to the manufacture and trade of adornments or professional use will better protect the population of allergy to metals.

Decrease in nickel allergy in women after the second EU nickel directive

Decrease in nickel allergy in women after the second <scp>EU</scp> nickel directive

Usage test with palladium‐coated earrings in patients with contact allergy to palladium and nickel

Since the EU Nickel Directive came into force, concern has been raised that palladium may increasingly replace nickel in alloys used in jewellery and dentistry, and that it may cause as many allergy problems as nickel. (i) To investigate the clinical relevance of contact allergy to palladium resulting from the wearing of palladium-coated earrings, and (ii) to evaluate the concordance in test results between palladium chloride (PdCl2 ), sodium tetrachloropalladate (Na2 PdCl4 ), and nickel(II) sulfate hexahydrate (NiSO4 .6H2 O), as well as variability in patch test reactivity. Forty female patients with pierced earlobes and previously known contact allergy to palladium and nickel were patch tested with dilution series of nickel and palladium salts. They wore earrings covered with palladium and titanium for 9 weeks to monitor the appearance of any clinical manifestations. There is a low risk of eczema in palladium-allergic and nickel-allergic individuals when they wear jewellery coated with pure palladium, but further studies are needed to determine whether palladium, when present in alloys, could cause allergic reactions. PdCl2 , like NiSO4 .6H2 O, shows variability in patch test reactivity over time. Furthermore, Na2 PdCl4 seems to be a more sensitive test substance than PdCl2 for the detection of palladium allergy.

Contact allergy to metals in adolescents. Nickel release from metal accessories 7 years after the implementation of the EU Nickel Directive in Poland

Contact allergy among adolescents is an important issue. To assess the prevalence of contact allergy to metals in adolescents aged 15 years and nickel release from metal accessories that are in direct contact with the skin. Three hundred and nine females and 219 males, all 15 years old, from randomly selected secondary schools were examined and patch tested with nickel sulfate, cobalt chloride, palladium chloride, and potassium dichromate. Three hundred and ninety-nine metal accessories were tested with the dimethylglyoxime (DMG) test. 'Metal dermatitis' was reported by 19.4% of females and 0.5% of males. Positive patch test reactions were found in 8.5% of the adolescents (12.9% in females; 2.3% in males), namely to: nickel (12.3% of females; 1.4% of males); palladium (5.2% of females; 0.5% of males); cobalt (3.2% of females; 1.4% of males); and chromium (1.3% of females; 0.9% of males). Allergic contact dermatitis caused by metals was diagnosed in 9.7% of females and in 0.5% of males. Of the metal items, 26.1% gave positive DMG test results: 10.0% of earrings, 11.4% of snaps, and 56.2% of belt buckles. Despite the implementation of the Nickel Directive in Poland, nickel still remains an important causal factor for allergic contact dermatitis. Numerous metal accessories do not comply with the Directive.

The EU Nickel Directive revisited – future steps towards better protection against nickel allergy

The EU Nickel Directive revisited – future steps towards better protection against nickel allergy

Excessive nickel release from mobile phones-a persistent cause of nickel allergy and dermatitis

Despite the political intention to limit nickel allergy and dermatitis in Europeans, nickel allergy remains frequent. There are several explanations for the persistence of nickel allergy and dermatitis, including the increasing use of mobile phones. Before regulation of nickel release from mobile phones, we showed that eight (19.5%) of 41 mobile phones marketed in Denmark between 2003 and 2007 released nickel in concentrations that may result in nickel allergy and dermatitis. In 2009, the EU Nickel Directive was revised to include nickel-releasing mobile phones. To investigate the proportion of mobile phones sold in Denmark that release nickel after regulation. Metallic parts from 50 randomly selected mobile phones currently for sale in Denmark were tested for nickel release by use of the dimethylglyoxime (DMG)-nickel spot test. Nine (18%) phones showed at least one positive DMG test reaction and two phones had more than one DMG test-positive spot. Apparently, the proportion of mobile phones with significant nickel release remains unchanged, despite the 2009 revision of the EU Nickel Directive. We encourage manufacturers to measure nickel release from metallic components used in the assembly of mobile phones to ensure safe products.

Nickel and cobalt allergy before and after nickel regulation – evaluation of a public health intervention

Over the 20th century, the frequent use of nickel in consumer products resulted in an increasing prevalence of nickel allergy. Risk items included suspenders in the 1950s-1960s; buttons, zippers and rivets in the 1970s; and ear-piercing jewellery in the 1980s. When subjects allergic to nickel were exposed to nickel in high concentrations, it often resulted in allergic nickel contact dermatitis and hand eczema. In 1990, the Danish government began to regulate consumer nickel exposure as a response to the increasing nickel allergy problem. In 1994, the EU Nickel Directive was passed, a regulation that was based on the Danish and Swedish nickel regulations. These major public health interventions were expected to change the epidemiology of nickel allergy and dermatitis in Europe. Furthermore, it was debated whether nickel would be replaced by cobalt in inexpensive jewellery and result in higher prevalence of cobalt allergy. An evaluation of the possible effects of the European nickel regulations is of importance to ensure protection of consumers and dermatitis patients. This doctoral thesis aimed to evaluate the effects of regulatory interventions on nickel exposure by investigating the development of nickel allergy and dermatitis before and after nickel regulation. Furthermore, a change in the association between nickel allergy and hand eczema was evaluated. The nickel spot test was validated to determine its value when used for screening purposes. Possible explanations for the persistence of nickel allergy were explored including genetic predisposition and consumer nickel exposure from jewellery and accessories. A cobalt spot test was developed and validated. Finally, it was evaluated whether a cobalt allergy epidemic had replaced the nickel allergy epidemic after nickel regulation in terms of increasing cobalt sensitization and cobalt exposure. The thesis showed that the prevalence of nickel allergy decreased significantly after nickel regulation in young Danish women from the general population (18-35 years) and in young Danish female dermatitis patients from a university patch test clinic (0-30 years). Stratification by ear-piercing status revealed that women ear pierced before 1990 had a significantly higher prevalence of nickel allergy and dermatitis than women ear pierced after 1990. Furthermore, the association between hand eczema and nickel allergy decreased in young women aged 18-35 years when a comparison was made between women who were patch tested and questioned in, respectively, 1990 and 2006. Despite the decreasing prevalence of nickel allergy, this condition remains prevalent in young Danish women, as about 10% are nickel allergic. Genetic predisposition to nickel allergy was evaluated by investigating the possible association between filaggrin null mutation status and nickel allergy. A positive association was found but it was also concluded that environmental nickel exposure is of much greater importance. Thus, of 354 consumer items purchased from 36 different stores in Copenhagen, 22% released nickel in concentrations that may result in nickel dermatitis in sensitized subjects. Therefore excessive consumer nickel exposure remains common in Denmark and may be an important explanation for the persistence of nickel allergy. Excessive nickel release was also frequent when samples of earrings purchased in Warsaw and London were examined with the nickel spot test, in particular earrings purchased from street markets and shops with independent ownership. Only very weak indications of an emerging cobalt allergy epidemic were found, as the prevalence of cobalt allergy has not yet increased in young people and only four of 354 consumer items purchased in Copenhagen released cobalt in concentrations that may result in cobalt dermatitis in sensitized individuals. The specificity of the nickel spot test was 98% and the sensitivity 59%. Also, a cobalt spot test was developed and validated and seemed to be a useful diagnostic tool. In conclusion, the Danish nickel regulation and the EU Nickel Directive have changed the epidemiology of nickel allergy in Denmark. However, the Nickel Directive and its reference methods need to be revised to better protect consumers and dermatitis patients.

Nickel on the Dutch market: 10 years after entry into force of the EU Nickel Directive

dimethylglyoxime test;EUlegislation;nickelallergy;NickelDirective;prevention;TheNetherlands.Theprevalenceofnickelallergyinthegeneralpopulationisapproximately 9%,17%inwoman and 3%inmen(1).Consumer items are important for sensitization to nickeland for elicitation of nickel dermatitis. The EU NickelDirective, limiting nickel release from certain items,may have had beneficial health effects(2–5). Studieson nickel release from consumer items have beenperformed(6–10). The aim of this study was to estimatethe percentage of products in The Netherlands that didnotmeetthecriteriaoftheEUNickelDirective.

The EU Nickel Directive revisited-future steps towards better protection against nickel allergy

In July 2001, the EU Nickel Directive came into full force to protect European citizens against nickel allergy and dermatitis. Prior to this intervention, Northern European governments had already begun to regulate consumer nickel exposure. According to part 2 of the EU Nickel Directive and the Danish nickel regulation, consumer items intended to be in direct and prolonged contact with the skin were not allowed to release more than 0.5 µg nickel/cm2/week. It was considered unlikely that nickel allergy would disappear altogether as a proportion of individuals reacted below the level defined by the EU Nickel Directive. Despite this, the EU Nickel Directive part 2 was expected to work as an operational limit that would sufficiently protect European consumers against nickel allergy and dermatitis. This review presents the accumulation of epidemiological studies that evaluated the possible effect of this major public health intervention. Also, it evaluates recent exposure assessment studies that have been performed using the dimethyl glyoxime test. It is concluded that the EU Nickel Directive has started to change the epidemiology of nickel allergy in Europe but it should be revisited to better protect consumers and workers since nickel allergy and dermatitis remain very frequent.

Excessive nickel release from earrings purchased from independent shops and street markets – a field study from Warsaw and London

Nickel allergy is frequent and cause morbidity and increased health care costs. The aim of this study was to determine the proportion of inexpensive earrings randomly purchased from stores and street markets in two capitals that gave positive dimethylglyoxime (DMG) test reactions and to determine whether the degree of nickel release was related to shop category. Random inexpensive metallic earrings were purchased from stores and vendors in London and Warsaw. A qualitative investigation of nickel release by using the DMG test was performed. DMG testing revealed that respectively 15.1% (n=205) and 18.4% (n=206) of earrings purchased in London and Warsaw released nickel as indicated by positive test outcomes. Stratification by store category showed that DMG test-positive jewellery were mainly purchased from street markets and from stores that were not part of national or international chains. Despite the EU Nickel Directive having resulted in decreasing prevalence of nickel allergy, a large proportion of inexpensive earrings still release nickel in concentrations that may result in nickel allergy and dermatitis. Authorities should prioritize information campaigns and random inspections as a legislation that is not followed is of limited value.

Nickel on the Swedish market: follow-up 10 years after entry into force of the EU Nickel Directive

The EU Nickel Directive, aimed at primary and secondary prevention of nickel allergy by limitation of nickel release from certain items, came fully into force in July 2001. To assess the prevalence on the market of items with nickel release and to compare the outcome with previous studies performed in Sweden in 1999 and 2002-2003. Nickel release from 659 items covered by the EU Nickel Directive was assessed with the dimethylglyoxime (DMG) test. Special attention, as compared with the previous surveys, was given to cheap jewellery in street markets and sewing materials in haberdashery shops. Nickel release was shown for 9% of the tested items, all of which were intended for direct and prolonged contact with the skin. A high proportion of items bought at haberdashery shops and street markets, 34% and 61%, respectively, showed nickel release. The Swedish market for products intended for direct and prolonged contact with the skin has largely adapted to the Nickel Directive. It is suggested that authorities should monitor the market regularly and give attention to areas where compliance with the requirements is poor, for protection of public health.

Identification of metallic items that caused nickel dermatitis in Danish patients

Nickel allergy is prevalent as assessed by epidemiological studies. In an attempt to further identify and characterize sources that may result in nickel allergy and dermatitis, we analysed items identified by nickel-allergic dermatitis patients as causative of nickel dermatitis by using the dimethylglyoxime (DMG) test. Dermatitis patients with nickel allergy of current relevance were identified over a 2-year period in a tertiary referral patch test centre. When possible, their work tools and personal items were examined with the DMG test. Among 95 nickel-allergic dermatitis patients, 70 (73.7%) had metallic items investigated for nickel release. A total of 151 items were investigated, and 66 (43.7%) gave positive DMG test reactions. Objects were nearly all purchased or acquired after the introduction of the EU Nickel Directive. Only one object had been inherited, and only two objects had been purchased outside of Denmark. DMG testing is valuable as a screening test for nickel release and should be used to identify relevant exposures in nickel-allergic patients. Mainly consumer items, but also work tools used in an occupational setting, released nickel in dermatitis patients. This study confirmed 'risk items' from previous studies, including mobile phones.

Cobalt release from inexpensive jewellery: has the use of cobalt replaced nickel following regulatory intervention?

Before the introduction of the EU Nickel Directive, concern was raised that manufacturers of jewellery might turn from the use of nickel to cobalt following the regulatory intervention on nickel exposure. The aim was to study 354 consumer items using the cobalt spot test. Cobalt release was assessed to obtain a risk estimate of cobalt allergy and dermatitis in consumers who would wear the jewellery. The cobalt spot test was used to assess cobalt release from all items. Microstructural characterization was made using scanning electron microscope (SEM) and energy-dispersive spectroscopy (EDS). Cobalt release was found in 4 (1.1%) of 354 items. All these had a dark appearance. SEM/EDS was performed on the four dark appearing items which showed tin-cobalt plating on these. This study showed that only a minority of inexpensive jewellery purchased in Denmark released cobalt when analysed with the cobalt spot test. As fashion trends fluctuate and we found cobalt release from dark appearing jewellery, cobalt release from consumer items should be monitored in the future. Industries may not be fully aware of the potential cobalt allergy problem.

Sensitivity and specificity of the nickel spot (dimethylglyoxime) test

The accuracy of the dimethylglyoxime (DMG) nickel spot test has been questioned because of false negative and positive test reactions. The EN 1811, a European standard reference method developed by the European Committee for Standardization (CEN), is fine-tuned to estimate nickel release around the limit value of the EU Nickel Directive from products intended to come into direct and prolonged skin contact. Because assessments according to EN 1811 are expensive to perform, time consuming, and may destruct the test item, it should be of great value to know the accuracy of the DMG screening test. To evaluate the sensitivity and specificity of the DMG test. DMG spot testing, chemical analysis according to the EN 1811 reference method, and X-ray fluorescence spectroscopy (XRF) were performed concomitantly on 96 metallic components from earrings recently purchased in San Francisco. The sensitivity of the DMG test was 59.3% and the specificity was 97.5% based on DMG-test results and nickel release concentrations determined by the EN 1811 reference method. The DMG test has a high specificity but a modest sensitivity. It may serve well for screening purposes. Past exposure studies may have underestimated nickel release from consumer items.

Contact dermatitis caused by nickel release from hair clasps purchased in a country covered by the EU Nickel Directive

Contact dermatitis caused by nickel release from hair clasps purchased in a country covered by the EU Nickel Directive