Certottica: study of nickel release standard specifically for optical products
Together with a TC 170 “Spectacle Frames” delegation in Brussels, Certottica met the European Commissioner and Enterprise and Industry policy director to explain the peculiarities of optical products with regard to the reference test method for nickel release.
At the meeting, a detailed description was given of the requirements and peculiarities of frames and sunglasses and why standard EN1811 is inadequate for testing such articles, which gave the Commission a fuller understanding of the problems linked to the product.
Standard EN1811:1998 is the reference method for evaluating whether objects in direct and prolonged contact with the skin meet the requirements established in Nickel Directive 76/769/EEC. This standard is being revised by CEN/TC 347 “Methods for analysis of allergens” Task Group 1 and the new version should come into force June 2011.
Frames and sunglasses are included in EN1811:1998 with regard to the evaluation of any release of nickel. However, both the current and the revised versions cover a huge range of products that are very different in terms of materials, surface treatments and interaction with the skin.
Nickel release standard EN 1811 refers to all products that come into direct and prolonged contact with the skin, but there are various types of exposure, such as penetrating, or piercing, open, objects or liquids in temporary contact such as metal coins, eyeglasses, occluded, objects in close and continuous contact such as rings, belts, and oral, food and dentures.
Clinical studies have demonstrated that different exposures have different thresholds regarding sensitivity or the activation of allergies and standard EN1811 has the same procedure for testing all products, without taking substantial differences into account.
The nickel release procedure is inadequate for testing frames and sunglasses because they are hardly ever in direct and prolonged contact with the skin: the only parts that are typically in contact are the end pieces and the nose pads, and it is well-known that these are made in plastic.
In addition, the surfaces of all the articles are treated and therefore they are subjected to wear and corrosion simulation in accordance with standard EN 12472. The effectiveness of this procedure varies greatly depending on the shape of the article and the increased uncertainty of the final measurement is not taken into consideration. Moreover, frames have a complex shape and the calculation of the surface of the tested articles always leads to considerable errors.
Because of these elements, the uncertainty of the measurement for articles with surface coatings makes the procedure totally inadequate and manufacturers do not know if their products conform or otherwise to the Directive.
It is therefore necessary to create a specific Harmonized Standard which takes the peculiarities of optical products into account.
The Working Group of the “RESTRICTIONS ON THE MARKETING AND USE OF DANGEROUS SUBSTANCES AND PREPARATIONS” Commission met to examine the “Nickel Directive” should this regulation become part of REACH.
The Commissioner briefly described the limitations of standard EN 1811 which make it inadequate for testing eyeglasses and sunglasses: it will then be necessary to develop a specific standard for these articles.
It was requested that the study of this standard should be carried out by CEN TC 170 experts. Until an ad hoc nickel release standard for sunglasses and eyeglasses has been prepared, standard EN1811:1998 will remain in force.
