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According to European regulations transposed into enforceable French law :

  • Spectacle frames are considered to be medical devices and,
  • Sunglasses are considered to be individual protective equipment.

Substantiating these texts, standards are technical documents that enable the CE compliance of these products to be verified.


For all information on regulations concerning eyewear, contact: the A.LU.TEC Laboratory.

CE labelling

This is the ‘passport' allowing free movement of products throughout the entire territory of the European Union and enabling them to be launched on the market. CE labelling certifies the compliance of products with essential health and safety requirements set out by the European directive. The verification procedures are described in the European standard(s) specific to each product. The test reports drawn up on completion of testing comprise the technical dossier that certifies CE compliance of the product, thus authorising CE labelling.

The main references in terms of legal texts and standards

94/27/EC, the "Nickel" directive

European Directive 94/27/EC concerning dangerous substances and referred to as the "Nickel Directive" came into force on 1st February 1995 and was transposed into French law by the order of 18th July 2000. The Member States of the European Union transposed this regulation into national law in different ways. In France, verification of nickel discharge applied in particular to prescription frames or sunglasses is restricted to the parts that come into direct and prolonged contact with the skin.
Reference standards: EN 12472:2005 + EN 1811:1998

Directive 93/42/EC on Medical Devices

This directive came into force on 14th June 1998 and was transposed into French law by decree No. 95-292 of 16th March 1995. Product standards of reference for the "Medical Devices" Directive:

  • Concerning optical frames: ISO EN NF 12870:2005 (ISO 12870:2004 + corrigendum Nov04)
  • Concerning corrective lenses: ISO EN NF 8980 -1 and -2: 2004; -3 and -5:2005; -4:2000 ISO EN NF 14889:2003
  • Concerning magnifying or reading glasses: ISO 16034:2002 EN NF 14139:2003

Directive on 89/686/EEC "Individual Protection Equipment"

This directive came into force on 1st July 1995 and was transposed into French law by decree No. 94-689 of 5th August 2004 modified by the French Code of Sports.

Product standards of reference for the "I.P.E" Directive:

  • Concerning sun lenses and sunglasses EN NF 1836:2007 (or EN 1836:2005 +A1 2007)
  • Concerning ski goggles EN NF 174:2001
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