Compliance · By market
Sunglasses Standards by Market: EU, US, Australia and New Zealand
Which standard applies where, what the lens category number actually means, and what has to appear on the label before a pair can legally be sold.
Why it matters
The same pair of sunglasses is a different product in each market
Sunglasses are regulated as consumer products in most markets and as protective equipment in some. The physical product can be identical; what changes is the conformity route, the label and the paperwork.
Getting this wrong is expensive in two ways. A shipment can be refused at the border, and a product can be sold legally but carry a label that does not meet the standard — which is the more common failure, and the one that surfaces in a retail audit rather than at customs.
European Union
European Union: EN ISO 12312-1 and when CE applies
EN ISO 12312-1 is the reference standard for sunglasses and related eyewear in the EU. It covers optical requirements, transmittance, robustness and labelling.
Whether CE marking is required depends on how the product is sold:
| How it is sold | Regulatory route | CE marking |
|---|---|---|
| Fashion or sports sunglasses, sold as a consumer product | General Product Safety Regulation; EN ISO 12312-1 as the reference standard | Not mandatory, but the standard still defines what a compliant product looks like |
| Sunglasses sold as protective equipment (occupational, or marketed for eye protection) | PPE Regulation (EU) 2016/425 | Mandatory, with the conformity assessment route for the PPE category |
| Prescription sunglasses | Medical Device Regulation (EU) 2017/745 | CE marking as a medical device |
The distinction is the claim, not the product. The same frame sold as a fashion accessory and as safety eyewear falls under two different regimes — and the marketing copy is part of what decides which.
Categories
Lens filter categories, and why the number must match the label
Both EN ISO 12312-1 and AS/NZS 1067 use a filter category scale based on visible light transmittance. The category must be determined by measurement, not estimated from the tint.
| Category | Light transmission | Typical use | Notes |
|---|---|---|---|
| 0 | 80–100% | Very low light, indoor | Almost clear |
| 1 | 43–80% | Overcast, low light | — |
| 2 | 18–43% | General purpose, mixed conditions | The most common general-purpose category |
| 3 | 8–18% | Bright sun, driving in daylight | The most common category for sports sunglasses |
| 4 | 3–8% | High altitude, glacier, water sports | Not permitted for road use or driving |
Mirrored and photochromic lenses still carry a category. A photochromic lens has a range, and both ends of that range should be documented.
Labelling
What has to appear on the label
EN ISO 12312-1 requires the category to be marked, and expects specific warnings to travel with the product. These are the ones that most often go missing:
- The filter category number.
- A warning that the eyewear is not suitable for direct observation of the sun.
- A warning that it is not suitable for protection against artificial light sources such as solaria.
- A warning that it is not suitable for use as eye protection against mechanical impact hazards, where that applies.
- The manufacturer or supplier identification.
These warnings are not decorative. A retailer auditing a supplier will check for them, and their absence is a straightforward non-conformity that is entirely avoidable at the packaging stage.
Australia and New Zealand
Australia and New Zealand: AS/NZS 1067
AS/NZS 1067.1 covers sunglasses and fashion spectacles and is the standard Australian and New Zealand buyers will ask about. It uses the same category scale as the European standard, but the labelling and performance requirements are set out separately.
For a supplier shipping to Australia, three things are worth confirming before production:
- Which revision of AS/NZS 1067 the test report cites — reports referencing a superseded edition are frequently rejected by retail compliance teams.
- Whether the report covers the exact lens and frame combination being ordered, not a similar one.
- Whether the labelling artwork has been checked against the standard, not just the product.
United States
United States: what actually applies
The US route is different again, and it is the one most often misunderstood.
| Product | Status | What it means |
|---|---|---|
| Non-prescription sunglasses | Not a medical device by default | No FDA premarket submission. FTC labelling rules and state law apply. |
| Sunglasses making therapeutic claims (e.g. for a medical condition) | Regulated as a medical device | Claims trigger regulation. Wording on the packaging is what decides this. |
| Prescription sunglasses | Class I medical device | Establishment registration and device listing apply; most prescription eyewear is 510(k) exempt. |
ANSI Z80.3 is the voluntary industry standard for non-prescription sunglasses. It is not legally mandatory, but large US retailers commonly require conformance as a condition of supply — which in practice makes it mandatory for anyone selling through them.
Checklist
Six things to confirm before you place an order
- Which market the product is for, and which standard that market references.
- Whether the product will be sold as a consumer product or as protective equipment — the marketing claim decides the route.
- That the test report names the exact lens and frame combination being ordered.
- That the report cites the current edition of the standard.
- That the lens category on the label matches the measured transmittance.
- That the required warnings are on the packaging artwork, not just in the plan.
Most compliance problems are paperwork and labelling problems, not product problems. Both are cheap to fix before production and expensive to fix after.
Tell us the market and we will tell you what is needed
Destination country, product type and how you intend to sell it — that is enough to set out the conformity route and the label requirements.