M/448 - Spectacle frame and sunglasses
Standardisation mandate assigned to CEN concerning the revision of methods of analysis to detect the release of nickel from spectacle frames and sunglasses (Revision of EN 1811:1998)
Mandate M/448 assigns CEN the task of revising the methods of analysis to detect nickel release from spectacle frames and sunglasses, updating the existing standard EN 1811:1998. This revision aims to ensure improved safety and compliance with regulatory requirements concerning nickel release in these products. The mandate involves the development of standardized testing methods to accurately assess nickel release, thereby supporting consumer protection and harmonizing safety standards across the European market. The decision is recorded in resolution CEN/BT C01/2010.
Purpose
The mandate M/448 aims to revise and update existing European standards related to the analysis methods for detecting nickel release from spectacle frames and sunglasses. This is focused on ensuring that the methods used are accurate, reliable, and reflect current scientific and technological developments.
Standardisation request
The European Commission has assigned this mandate to CEN (European Committee for Standardization) to revise EN 1811:1998. This standard currently specifies the test methods for determining the release of nickel from spectacle frames and sunglasses, which is important due to nickel's potential to cause allergic reactions in sensitive individuals.
Expected deliverables
- A revised version of the EN 1811 standard that improves or updates the analytical methods for nickel release detection in spectacle frames and sunglasses.
- The updated standard should provide clear, validated, and harmonized test procedures suitable for regulatory and market surveillance purposes within the EU.
- The amendment is expected to facilitate compliance with related EU legislation on product safety and consumer protection.
Context
Nickel is a common cause of allergic contact dermatitis, and its release from consumer products such as spectacle frames and sunglasses is regulated under EU legislation. EN 1811:1998 currently sets the methodology for nickel release detection, but advances in science and technology as well as changes in regulatory requirements necessitate its revision to maintain consumer safety standards. The CEN/BT C01/2010 resolution pertains to the approval process of this mandate.
This mandate covers the revision of standard analysis methods to detect the release of nickel from spectacle frames and sunglasses. The focus is on ensuring safety by updating the testing procedures for nickel release in these specific eyewear products.
General Information
This document specifies the reference method for the testing of spectacle frames, ready-to-wear near-vision spectacles, sunglasses and spectacle frames used for eye and face protection for nickel release.
The reference method supports the demonstration of conformity with the limit value for nickel release of 0,5 µg·cm−2·week−1 set forth by European Regulation.
The reference method involves the procedural steps shown in Figure 1 and described in Clause 4.
This document applies to those parts of metal spectacle frames and those metal parts of combination spectacle frames that are intended to come into direct and prolonged contact with the skin of the wearer. This document also applies to those relevant metal parts of ready-to-wear near-vision spectacles, sunglasses and spectacle frames used for eye and face protection.
NOTE The reference method for articles apart from spectacle frames, ready-to-wear near-vision spectacles, sunglasses and spectacle frames used for eye and face protection is specified in EN 1811.
- Standard49 pagesEnglish languagee-Library read for1 day
This document specifies the reference method for the testing of spectacle frames, ready-to-wear near-vision spectacles, sunglasses and spectacle frames used for eye and face protection for nickel release.
The reference method supports the demonstration of conformity with the limit value for nickel release of 0,5 µg·cm−2·week−1 set forth by European Regulation.
The reference method involves the procedural steps shown in Figure 1 and described in Clause 4.
This document applies to those parts of metal spectacle frames and those metal parts of combination spectacle frames that are intended to come into direct and prolonged contact with the skin of the wearer. This document also applies to those relevant metal parts of ready-to-wear near-vision spectacles, sunglasses and spectacle frames used for eye and face protection.
NOTE The reference method for articles apart from spectacle frames, ready-to-wear near-vision spectacles, sunglasses and spectacle frames used for eye and face protection is specified in EN 1811.
- Standard49 pagesEnglish languagee-Library read for1 day
This European Standard specifies the reference method for the testing of spectacle frames, ready-to-wear spectacles, sunglasses and other items for eye and face protection for nickel release.
The reference method supports the demonstration of conformity with the limit value for nickel release of 0,5 µg/cm2/week set forth by European Regulation.
The reference method involves the procedural steps shown in Figure 1 and described in Clause 4.
This document applies to those parts of metal spectacle frames and those metal parts of combination spectacle frames that are intended to come into direct and prolonged contact with the skin of the wearer. This document also applies to those relevant metal parts of ready-to-wear spectacles, sunglasses and other items for eye and face protection.
NOTE The reference method for articles apart from spectacle frames, ready-to-wear spectacles, sunglasses and other items for eye and face protection is specified in EN 1811.
- Standard35 pagesEnglish languagee-Library read for1 day
This document specifies the reference method for the testing of spectacle frames and sunglasses for nickel release.
The reference method supports the demonstration of conformity with the limit value for nickel release of 0,5 µg/cm2/week set forth by European Regulation and makes provision for a uniform application and control of the European legislation in all member states.
The reference method involves the following procedural steps (see also Clause 4):
- Simulation of wear and corrosion;
- EIS coating test (optional);
- Laboratory test: Release of nickel and its quantitative analytical detection.
This document applies to those parts of metal spectacle frames and those metal parts of combination spectacle frames that come into direct and prolonged contact with the skin of the wearer. This document also applies to those relevant metal parts of articles for eye and face protection, including sunglasses.
The EIS coating test method can be applied only to metal parts which have been coated with an organic, electrically insulating, layer.
This document does not apply to products other than spectacle frames and articles for eye and face protection, which includes sunglasses.
NOTE The reference method for products other than spectacle frames and of articles for eye and face protection, including sunglasses is specified in EN 1811:2011.
- Technical specification33 pagesEnglish languagee-Library read for1 day
This European Standard specifies a method for simulating the release of nickel from those parts of spectacle frames and sunglasses intended to come into direct and prolonged contact with the skin in order to determine whether they release nickel at a rate greater than 0,5 µg/cm2/week.
NOTE 1 This European Standard, EN 16128, has been prepared in reply to the European Commission's Mandate M/448 addressed to CEN. From the technical point of view, this European Standard provides an unchanged re-publication of the technical requirements that had previously been specified in EN 1811:1998, but restricted in scope to apply only to spectacle frames and sunglasses.
NOTE 2 Users of this European Standard may wish to note that, also in reply to the European Commission's Mandate M/448, this European Standard is currently subject to review with the objective of developing a new standardized method to supersede this European Standard when the new method becomes available.
NOTE 3 Nickel release testing of products other than spectacle frames and sunglasses is specified in prEN 1811:2009.
- Standard17 pagesEnglish languagee-Library read for1 day
This European Standard specifies the reference method for the testing of spectacle frames, ready-to-wear spectacles, sunglasses and other items for eye and face protection for nickel release.
The reference method supports the demonstration of conformity with the limit value for nickel release of 0,5 µg/cm2/week set forth by European Regulation.
The reference method involves the procedural steps shown in Figure 1 and described in Clause 4.
This document applies to those parts of metal spectacle frames and those metal parts of combination spectacle frames that are intended to come into direct and prolonged contact with the skin of the wearer. This document also applies to those relevant metal parts of ready-to-wear spectacles, sunglasses and other items for eye and face protection.
NOTE The reference method for articles apart from spectacle frames, ready-to-wear spectacles, sunglasses and other items for eye and face protection is specified in EN 1811.
- Standard35 pagesEnglish languagee-Library read for1 day
This document specifies the reference method for the testing of spectacle frames and sunglasses for nickel release.
The reference method supports the demonstration of conformity with the limit value for nickel release of 0,5 µg/cm2/week set forth by European Regulation and makes provision for a uniform application and control of the European legislation in all member states.
The reference method involves the following procedural steps (see also Clause 4):
- Simulation of wear and corrosion;
- EIS coating test (optional);
- Laboratory test: Release of nickel and its quantitative analytical detection.
This document applies to those parts of metal spectacle frames and those metal parts of combination spectacle frames that come into direct and prolonged contact with the skin of the wearer. This document also applies to those relevant metal parts of articles for eye and face protection, including sunglasses.
The EIS coating test method can be applied only to metal parts which have been coated with an organic, electrically insulating, layer.
This document does not apply to products other than spectacle frames and articles for eye and face protection, which includes sunglasses.
NOTE The reference method for products other than spectacle frames and of articles for eye and face protection, including sunglasses is specified in EN 1811:2011.
- Technical specification33 pagesEnglish languagee-Library read for1 day
This European Standard specifies a method for simulating the release of nickel from those parts of spectacle frames and sunglasses intended to come into direct and prolonged contact with the skin in order to determine whether they release nickel at a rate greater than 0,5 µg/cm2/week.
NOTE 1 This European Standard, EN 16128, has been prepared in reply to the European Commission's Mandate M/448 addressed to CEN. From the technical point of view, this European Standard provides an unchanged re-publication of the technical requirements that had previously been specified in EN 1811:1998, but restricted in scope to apply only to spectacle frames and sunglasses.
NOTE 2 Users of this European Standard may wish to note that, also in reply to the European Commission's Mandate M/448, this European Standard is currently subject to review with the objective of developing a new standardized method to supersede this European Standard when the new method becomes available.
NOTE 3 Nickel release testing of products other than spectacle frames and sunglasses is specified in prEN 1811:2009.
- Standard17 pagesEnglish languagee-Library read for1 day
Frequently Asked Questions
A European Standardization Mandate is a formal request from the European Commission to the European Standardization Organizations (CEN, CENELEC, and ETSI) to develop European standards (ENs) in support of EU legislation and policies. Mandates are issued under Regulation (EU) No 1025/2012 and help ensure that products and services meet the essential requirements set out in EU directives and regulations.
M/448 is a European Standardization Mandate titled "Standardisation mandate assigned to CEN concerning the revision of methods of analysis to detect the release of nickel from spectacle frames and sunglasses (Revision of EN 1811:1998)". Standardisation mandate assigned to CEN concerning the revision of methods of analysis to detect the release of nickel from spectacle frames and sunglasses (Revision of EN 1811:1998) There are 8 standards developed under this mandate.
Standards developed in response to a mandate and cited in the Official Journal of the European Union become "harmonized standards". Products manufactured in compliance with harmonized standards benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation, facilitating CE marking and market access across the European Economic Area.