Compliance is usually treated as paperwork that arrives after the deal is done. In eyewear it works the other way round. The certificates a supplier can produce determine which markets you are allowed to sell into, and a quotation that looks competitive without them is not a quotation — it is a placeholder. This article sets out which standard applies to which product, what each standard actually tests, and the exact files to request before you sign a purchase order.

Start with the product, not the country

The most common mistake buyers make is asking "do you have CE?" without saying what they are buying. Three products that look similar on a shelf fall under three different rules in the European Union, and the document you need for one is useless for another.

Product	EU legal basis	Harmonised standard	Conformity route
Spectacle frames (delivered as a component to be glazed by an optician)	No dedicated EU directive; quality verified against the harmonised standard	EN ISO 12870:2016	Manufacturer's test report + declaration of conformity
Sunglasses and fashion eyewear (non-corrective)	PPE Regulation (EU) 2016/425, Category I	EN ISO 12312-1	Internal production control (Module A), EU Declaration of Conformity, CE marking
Ready-to-wear reading spectacles	Same PPE logic where applicable; product-specific spec otherwise	EN 14139	Test report + declaration
Prescription spectacles supplied complete to a patient	Medical Device Regulation (EU) 2017/745, custom-made Class I	EN ISO 12870 for the frame	Technical documentation + statement for custom-made devices

The practical consequence: if you import frames only, your supplier should give you an EN ISO 12870 test report and a declaration referencing it. If you import finished sunglasses, you need an EU Declaration of Conformity citing EN ISO 12312-1 plus CE marking on the product. Asking a frame factory for a sunglasses DOC — or the reverse — is the fastest way to get a document that will not survive a customs check.

What EN ISO 12870 actually covers

The standard is titled "Ophthalmic optics — Spectacle frames — Requirements and test methods". It is a test standard: it does not certify a company, it certifies that a specific frame model survived a specific list of tests. That distinction matters, because a test report issued three years ago for model 2820 tells you nothing about model 2823.

The test battery

•Dimensional requirements — lens aperture, bridge width and temple length measured against the marked values on the frame. Tolerances here are what make a frame glazeable without rework.

•Resistance to perspiration — the frame is exposed to an artificial sweat solution at elevated temperature, then inspected for coating loss, discolouration and surface degradation. This is the test that separates a well-cured lacquer from a cheap one.

•Resistance to ignition — the frame must not continue to burn after a heated rod is applied; the standard sets a burn-rate expectation rather than full non-combustibility.

•Resistance to optical radiation — exposure to a xenon-arc source to simulate solar ageing, checking for colour shift and material embrittlement.

•Bridge deformation — a defined load applied to the bridge, with a permanent-set limit afterwards.

•Temple deformation — same principle applied to the temple, verifying it springs back rather than staying bent.

•Hinge and temple fatigue — repeated opening and closing cycles, after which the temple must retain retention and alignment.

•Resistance to impact — a drop-ball test using a steel ball of defined mass dropped from a defined height onto a mounted assembly.

•Nickel release — assessed for metal parts in prolonged skin contact, using the reference method in EN 16128.

What it does not cover

EN ISO 12870 says nothing about lens optical quality, UV filtering, or chemical content beyond nickel. If your buyer questionnaire asks for UV400 or for a full REACH declaration, those are separate documents from separate test routes. Treating a 12870 report as a blanket "the product is safe" pass is the single most common compliance error in this category.

The CE technical file behind the marking

CE marking is a declaration that a technical file exists, not a certificate issued by anyone. For sunglasses falling under the PPE Regulation, Category I, the manufacturer performs internal production control and draws up the file themselves. The file is what an authority would ask for if a shipment were challenged. It should contain:

1.Product description and identification, including model numbers, materials and intended use.

2.Design and manufacturing drawings with the dimensions that the standard references.

3.Risk assessment for the intended use.

4.List of harmonised standards applied, with version years.

5.Test reports from a laboratory accredited to ISO/IEC 17025 for the relevant standard.

6.EU Declaration of Conformity, signed, naming the product and the standards.

7.Instructions and labelling, in the language of each destination market.

Note the wording risk. A supplier writing "CE approved" or "CE certified" is using language that does not exist in the regulation, which is itself a signal that the declaration was drafted by someone unfamiliar with the process. The correct phrasing is "EU Declaration of Conformity".

United States entry: FDA, not CE

The United States does not recognise CE marking. Eyeglasses and sunglasses are regulated by the Food and Drug Administration as Class I medical devices, which brings three distinct obligations.

Establishment registration

Under 21 CFR 807, a foreign establishment that manufactures a device for US import must register with FDA, list its devices, and designate a US agent. Registration is annual and carries a fee that FDA revises each fiscal year — always confirm the current figure against FDA's published fee schedule rather than a figure quoted by a supplier. Registration is not approval; it is a record that the establishment exists and can be reached.

Impact-resistant lenses

21 CFR 801.410 requires that lenses for eyeglasses and sunglasses be impact resistant. The reference test drops a steel ball of roughly 5/8 inch diameter, weighing about 0.56 ounces, from a height of about 50 inches onto the mounted lens. The rule applies to the finished lens, not to the frame — but because most eyewear is imported assembled, the practical burden lands on the exporter. Where an impact-resistant lens is genuinely unsuitable, the regulation provides a narrow exception requiring a written determination and a documented waiver from the patient.

Labelling

US labelling rules require the name and address of the manufacturer, packer or distributor on the label. For imported goods the country of origin must also appear. In practice this is where private label orders most often fail, because the artwork was set up for EU requirements and never re-checked for US ones.

REACH and restricted substances

For the EU, chemical content is governed by REACH rather than by the product standard. The entries that most often affect eyewear are:

Substance	REACH Annex XVII entry	Limit for consumer articles	Where it appears in eyewear
Nickel release	Entry 27	0.5 µg/cm²/week for articles in direct and prolonged skin contact	Metal cores, hinges, pad arms, end tips, plating on metal frames
Lead	Entry 63	0.05 % by weight where an article may be placed in the mouth by children	Decorative elements, paints and coatings on children's frames
Cadmium	Entry 23	0.01 % by weight in certain plastics and painted articles	Pigments and stabilisers in plastics
Phthalates DEHP, DBP, BBP, DIBP	Entries 51 and 52	0.1 % by weight individually in toys and childcare articles	Soft PVC pads, flexible end tips, printed logos
Substances of very high concern (SVHC)	Article 33	Communication required above 0.1 % w/w	Any component; a supplier declaration is the practical route

Two things to watch. First, a "REACH compliant" statement with no supporting test data is an assertion, not evidence — ask for the underlying report or a restricted-substance declaration naming the entries tested. Second, nickel release is measured on the finished article as placed on the market, so a frame that passed with one plating may fail with another. If you change the colour way, the certificate does not travel with it.

The documents to request before signing a PO

The table below is the checklist to send to a supplier in parallel with your quotation request. Requiring it early does two things: it filters out factories that cannot produce it, and it stops the late-stage scramble where a container is built and the paperwork is not.

Market	Mandatory	Document to request	What to verify on the document
EU — frames	Standard compliance	EN ISO 12870:2016 test report	Model numbers match your order; lab accreditation; report date within a reasonable window
EU — sunglasses	CE marking	EU Declaration of Conformity + EN ISO 12312-1 test report	Standard cited with year; filter category stated; signed by an authorised person
EU — all	Chemical content	Nickel release report (EN 16128) and REACH / SVHC declaration	Plating or colour way named; entries listed individually
US — all	Registration	FDA establishment registration number and US agent details	Number is current for the fiscal year; agent is named and reachable
US — finished eyewear	Lens safety	Impact resistance test records per 21 CFR 801.410	Test parameters stated; covers the lens material in your order
US — children's	Product safety	Children's Product Certificate and third-party test report	Age grading stated; lab is CPSC-accepted
Retail programmes	Chain requirement	Proposition 65 assessment and any buyer-specific questionnaire	Dated; covers the article as shipped

A request list you can paste into your next email

The wording below works because it asks for documents by name rather than asking whether the supplier "has certificates".

·       Please provide the EN ISO 12870:2016 test report for models [list], issued by an ISO/IEC 17025 accredited laboratory.

·       Please provide the nickel release test report per EN 16128, stating the plating or colour way tested.

·       Please provide the EU Declaration of Conformity for the sunglasses models, citing EN ISO 12312-1 and the filter category.

·       Please provide your FDA establishment registration number, listing status, and US agent contact.

·       Please provide impact resistance test records for the lens material used, per 21 CFR 801.410.

·       Please provide a REACH and SVHC declaration covering the materials and coatings used in this order.

·       For children's models, please provide the Children's Product Certificate and the supporting third-party test report, stating the age grading applied.

Frequently asked questions

Does a spectacle frame require CE marking?

A frame supplied as a component for glazing is not covered by a directive that compels CE marking. In practice buyers require an EN ISO 12870 test report and a declaration referencing it, because it is the only shared evidence of frame quality. Finished non-corrective sunglasses, by contrast, do require CE marking under the PPE Regulation.

Can one test report cover a whole colour way?

Depends on the test. Mechanical and dimensional tests are generally frame-shape specific, so one report can cover a model. Colour- and coating-dependent tests such as perspiration resistance and nickel release need the worst-case or the specific colour way to be named in the report. Ask the laboratory to state which colour was tested.

Is FDA registration the same as FDA approval?

No. Registration records the establishment and its devices; it is not an assessment of safety or efficacy. Class I spectacle devices are normally exempt from premarket notification, so registration is the operative requirement.

Who signs the EU Declaration of Conformity?

The manufacturer, or an authorised representative established in the Union. If your supplier signs only as a factory and the brand is yours, clarify in writing who is the legal manufacturer before the order is placed, because that party carries the declaration duty.

How often should reports be refreshed?

Refresh whenever the model, material, plating, coating or supplier changes. A report is evidence about a specific article as tested; it does not have an expiry date printed on it, which is exactly why buyers need to track changes instead.