Cosmetic Packaging Artwork Approval: A Pre-Print Checklist

Most artwork errors are not design errors. The designer reproduces whatever text they were given, and the mistake was already in that text: an ingredient list retyped from an old formula, a net content that changed after the fill decision, a distributor address for a company that is not the responsible person. This checklist is about catching those errors while they are still a file revision and not a pallet of cartons.

It sits at one step in a longer sequence. Format and component choice come first, and our guide to contract cosmetic packaging explains why. Whether the formula is compatible with the pack is a separate question with its own evidence, covered in packaging compatibility testing. What each country requires on the label is compared in cosmetic labeling requirements by market. This article assumes those decisions are made and asks one question: is this artwork file ready to print?

Scope: skincare, hair care, body care and colour cosmetics packed by an OEM for a brand. Products that are also drugs, such as sunscreens sold as OTC drugs in the US, carry drug labeling requirements on top of these and are out of scope.

Three Kinds of Requirement, and Why the Checklist Labels Them

An artwork review mixes three different kinds of rule, and treating them as one causes arguments at sign-off. Each line in the checklist below is tagged with one of them.

• Law. Text and placement that a regulation requires. For the EU, the core list is Article 19 of Regulation (EC) No 1223/2009. For the US, the FDA's Cosmetics Labeling Guide sets out the requirements of the FD&C Act, the Fair Packaging and Labeling Act and 21 CFR 701 and 740. Other markets have their own rules; check them in the market comparison linked above.
• Customer requirement. Something your retailer, marketplace or distributor requires as a condition of listing, such as a barcode specification. Not legally mandatory, but the product will not sell without it.
• Recommended practice. Controls that prevent common failures, such as version fields, proof sign-off and golden samples. No regulation requires them. Skipping them is how errors get through.

The distinction matters at sign-off. A legal line cannot be traded away for design reasons. A customer line can be negotiated with that customer. A recommended-practice line can be adjusted if the risk is understood and accepted in writing.

Who Signs What

Regulation decides who carries compliance responsibility for the label. It does not decide who signs the artwork internally. In the EU, compliance ultimately sits with the designated responsible person, whose name and address Article 19 requires on the label. In the US, the label must identify the manufacturer, packer or distributor. Neither rule sets out an artwork sign-off procedure, and there is no single global rule for one.

So the sign-off roles are something the brand, the responsible person or importer, the OEM, the designer and the printer agree between them, by market and by contract. A workable split looks like this. It is recommended practice, not a legal requirement, and the exact allocation belongs in your supply agreement.

The OEM is responsible, to the extent agreed in the contract, for the data it supplies and for confirming that the artwork can be manufactured. That does not automatically make it the party responsible for market compliance on the brand's behalf. Our EU private label guide explains what the responsible person role involves.

The Pre-Print Checklist

Run this against the final artwork on the final dieline, for each SKU and each market version. Each line needs evidence, meaning the source document it was checked against. A tick on its own is not evidence.

1. Ingredient list (INCI review)

• Law (EU): preceded by the word "Ingredients"; in descending order of weight at the time of addition, with ingredients below 1% allowed in any order after those above 1%; names from the common ingredient name glossary; perfume shown as "parfum" or "aroma", with the Annex III substances required in the "Other" column listed as well; nanomaterials followed by "(nano)"; colorants by CI number. The ingredient list may appear on the outer packaging alone.
• Law (US): descending order of predominance, with the exceptions the FDA guide sets out; names as specified in 21 CFR 701.3(c); letters at least 1/16 inch high, or 1/32 inch where the total surface available for labeling is under 12 square inches.
• Shade ranges: both the EU and US rules provide a "may contain" route for colorants across a shade range, under different conditions. Confirm that the route matches the rule for the market on this pack. Our colour cosmetics guide covers pigment listings.
• Recommended: paste the list from the manufacturer's formula data, and record which formula version and document revision it came from. Never let a designer retype it. A transcription error on a printed carton is a reprint.

2. Net content

• Law (EU): nominal content at the time of packaging, by weight or volume. Exceptions apply to packs under 5 g or 5 ml, free samples and single-application packs.
• Law (US): on the principal display panel, generally in the bottom 30% (waived for panels of 5 square inches or less); fluid measure for liquids and weight for solids, semi-solids and viscous products; minimum type height set by panel area (1/16 inch up to 5 sq in, 1/8 inch over 5 to 25, 3/16 inch over 25 to 100, 1/4 inch over 100). Metric units may be added.
• Recommended: check the figure against the agreed fill specification, not the component's nominal capacity. A 50 ml bottle filled to 45 ml is a 45 ml product.

3. Responsible entity and origin

• Law (EU): name or registered name and address of the responsible person. Where several addresses are shown, highlight the one where the product information file is kept. Country of origin for imported products.
• Law (US): name and place of business of the manufacturer, packer or distributor. If it is not the manufacturer, use wording such as "Manufactured for" or "Distributed by". Street address, city, state and ZIP code, with limited exceptions. Imported products state the English name of the country of origin. For the MoCRA obligations that sit with the labelled party, see our MoCRA compliance guide.
• Recommended: confirm that the named entity has agreed in writing to that role. A distributor's logo on the pack does not make it the responsible person.

4. Warnings, precautions and function

• Law (EU): particular precautions for use, including at least those required by Annexes III to VI for the ingredients present; the product's function unless obvious from its presentation. Where precautions or ingredients cannot practically fit, Article 19(2) allows an enclosed or attached leaflet, label, tape, tag or card, referenced on pack by abbreviated information or the symbol in point 1 of Annex VII.
• Law (US): a warning statement wherever necessary or appropriate to prevent a health hazard (21 CFR 740), plus the specific statements that part prescribes for certain product types. Warnings must be conspicuous: bold type on a contrasting background, at least 1/16 inch high.
• Language: in the EU, the language of the content, durability, precaution and function information is set by each Member State where the product is sold. In the US, required statements must be in English; if the label carries foreign-language representations, the required statements must appear in that language too.

5. Durability and opened-life symbols

• Law (EU): a date of minimum durability, preceded by the symbol in point 3 of Annex VII or the words "best used before the end of", is required where minimum durability is 30 months or less. Above 30 months, show the period after opening with the symbol in point 2 of Annex VII, unless opened life is not relevant.
• Recommended: confirm which applies with whoever holds the stability evidence. That decision determines whether the pack needs a printed date in the variable area. The period-after-opening figure is static artwork; a durability date is variable data.

6. Batch/lot coding area and other variable information

• Law (EU): the batch number or a reference that identifies the product must appear on both the container and the packaging, in indelible, easily legible and visible lettering. It may appear on the packaging only where the product is too small for practical reasons.
• Law (US): the Cosmetics Labeling Guide does not list a batch or lot code among the mandatory label elements. Brands usually carry one anyway, because recalls, complaints and most retailers depend on tracing a unit to its batch.
• Recommended: mark the coding area on the dieline with its dimensions and position, and agree it with the filling line. It should be a plain area the coder can print on and the code can be read from, not over a seam, a curve the print head cannot reach, an embossed area or a finish the ink will not hold to. Do not put the only code on a separable part such as a cap. Agree the code format, including date format, in writing.

7. Barcode

• Customer requirement: neither Article 19 of Regulation 1223/2009 nor the FDA Cosmetics Labeling Guide lists a barcode as a label element. Retailers and marketplaces set the requirement, and their specification governs the number, size and placement. Some destination markets add their own rules; check the market comparison before you lock the panel.
• Recommended: confirm that the number belongs to this SKU and size, not a sibling variant. Check the barcode with a scanner on the printed proof, at final size, on the final substrate, not on screen.

8. Claims and remaining copy

• Law (EU): Article 20 prohibits text, names, trade marks, pictures and figurative or other signs that imply characteristics or functions the product does not have. That covers the whole pack, including images and the product name.
• Recommended: match every claim on the pack to the support file that substantiates it, and check whether wording that is fine in one market reads as a drug claim in another. Our claims compliance guide sets out the boundaries.

9. Physical layout

• Law (US): required information must be on a panel shown under customary conditions of purchase. Bottom panels are generally excluded unless the product is very small and customarily picked up for inspection. Text must not be obscured by designs or crowding.
• Recommended: confirm that the dieline revision matches the current component specification; that no required text sits in a fold, glue flap, seal area or label overlap; and that minimum type sizes are still met after any scaling for smaller sizes in the range. Compliance on screen proves nothing if the file is scaled down for a 15 ml version.

Version Fields Every Artwork File Should Carry

Most packaging errors that reach market are version errors, not content errors. The correct file existed, but a superseded file was sent to the printer. These fields are recommended practice. Put them in an approval record or in the slug area outside the trim, and make sure they never print on the pack itself.

A copy-ready sign-off record

One record per component, per market version. Fill it in before the print order is released.

Status: draft, under review, approved for print, or withdrawn. List any open risks accepted in writing, such as approval on a digital proof only.

Regulatory version control is more than housekeeping. Under Article 11 of the EU regulation, the product information file must be updated as necessary and kept for ten years after the last batch is placed on the market. Knowing which artwork version each batch carried makes that record, complaint handling and any recall far easier, in any market.

Proofs and the Golden Sample

Approval happens in stages, and each stage checks something the previous one could not. None of this is legally required. It is how most reprints are avoided.

1. Digital proof. The print-ready PDF on the printer's dieline. Check every text line against its source, and check the version fields. This is where the content checklist is completed.
2. Physical proof or pre-production sample. On the production substrate where possible. Check colour, legibility of small type, barcode scanning, and whether the coding area takes ink. A digital proof cannot show whether 1/16 inch type survives a textured paperboard or a curved tube.
3. First production run sign-off. Check units from the first approved run, filled, coded and packed, against the approved proof.
4. Golden sample. Keep signed, dated reference units from the first approved run, with copies held by the brand and the OEM, and record the artwork version on the sample. Later runs are compared against it for colour, text and code placement. Replace it when the artwork version changes.

If you sign a digital proof and skip the physical one, write down the accepted risk: colour and small-type legibility have not been confirmed on the real substrate.

Change Control After Approval

Approved artwork stays approved only while everything it was checked against stays the same. Treat each of these as a trigger to reopen the checklist:

• A formula change, including a supplier change that alters an INCI name or order
• A fill specification change, which changes the net content
• A component or dieline change, even "the same bottle from a new supplier"
• A new market, or a change to the responsible person, distributor or address
• A regulatory change: a new restriction, a new warning requirement, or a new edition of a standard you labeled against
• A new claim, or a claim being withdrawn

For each change, record the new version, what changed, who re-approved it, the first batch to carry it, and what happens to old printed stock: use it up, overlabel it, or scrap it. Deciding what happens to old stock is a commercial and regulatory call for the brand. Make it before the new print order is placed, not after the cartons arrive.

Common Failures

• Retyped INCI. The designer copies the list from an email or an older carton. Paste it from formula data, and record the source and revision in the version fields.
• Net content from the catalogue. The figure comes from the component's capacity, not the fill specification.
• No room for the code. The batch area sits under foil, varnish or a seam, or was never reserved. The first production run finds this out.
• Code on the cap only. Under EU rules the batch reference belongs on the container and the packaging. A cap can be separated from the bottle.
• Approved on screen, failed in print. Type that passes at 100% on screen fails after a file is scaled for a smaller size, or blurs on a textured substrate.
• Wrong barcode. A sibling variant's number, or a barcode scaled below the retailer's specification.
• Two live versions. An old PDF still in the printer's folder. Status fields and a single file owner prevent this.
• No golden sample. When run three looks different from run one, there is nothing signed to compare against.

Frequently Asked Questions

Who is responsible for artwork approval in a private label project?

There is no single global rule. Regulation sets who carries compliance responsibility: in the EU it ultimately sits with the designated responsible person, and in the US the label identifies the manufacturer, packer or distributor. Who signs the artwork internally is agreed between the brand, the responsible person or importer, the OEM, the designer and the printer, by market and by contract. The OEM is responsible, as agreed, for the data it supplies, such as the ingredient list, net content and coding area, and for confirming manufacturability. That does not automatically make it the brand's market compliance party.

Is a batch or lot code legally required on cosmetic packaging?

In the EU, yes: Article 19(1)(e) of Regulation 1223/2009 requires a batch number or identifying reference on both the container and the packaging, or on the packaging only where the product is too small. The FDA Cosmetics Labeling Guide does not list it as a mandatory US label element, but brands normally carry one for traceability, recalls and retailer requirements.

Should the ingredient list come from the factory or the designer?

From the manufacturer's formula data, pasted into the artwork and checked against that data. The designer places the text but should not type it. Record the source document and its revision so that a formula change can be traced to the artwork that needs updating.

What is a golden sample?

A signed, dated reference unit taken from the first approved production run, with copies held by the brand and the manufacturer. Later runs are compared against it. It is a recommended practice, not a legal requirement, and it should be replaced whenever the artwork version changes.

Does a component change mean new artwork approval?

It means reopening the checklist. A new component can change the dieline, the printable area or the coding area even when the capacity is the same. Whether the formula still performs in the new component is a separate question. See packaging compatibility testing.

Is a digital proof enough to approve packaging artwork?

It is enough to approve the content. It cannot confirm colour, legibility of small type on the real substrate, barcode scanning or whether the coding area takes ink. If you approve on a digital proof alone, record that those points have not been confirmed.

Before You Release the Print Order

Every check here costs a file revision before printing and a print run after it. The aim is to make sure the only version that reaches the press has been checked against its sources and signed by the right people. Packaging and labeling sit inside our OEM service: we supply the formula and fill data the artwork depends on, and the coding area should be agreed with us before files go to print. If you have artwork waiting for sign-off, send the SKU list and target markets through our quote request form.