Four Types of EU Compliance Requirements for Cosmetic Packaging: REACH / EC 1223/2009 / 94/62/EC / EN 13427 Explained in One Article

Last year, a client who packages essential oils asked me: “We produce bottles and outer boxes for a French essential oil brand. The client sent us a 30-page compliance requirements list densely packed with REACH, EC 1223/2009, 94/62/EC, and EN 13427. I work in packaging—which of these regulations are actually directly relevant to me?”

Behind this issue lies a genuine pain point: many printing companies that produce packaging for cosmetics exports treat these regulations as “documents provided by the client” rather than “laws for which they are directly responsible.” When problems arise, the brand owner shifts the blame to the printer, only for the printer to realize that it has been operating without legal safeguards all along. This article clearly explains the “direct liability boundaries of printing companies” under 4 categories of regulations.

Regulation 1: REACH — “Chemical Disclosure” for Packaging Materials

The core of REACH is chemical registration, evaluation, authorization, and restriction. Its impact on packaging factories is reflected primarily in high-concern substances (SVHC) in materials.

Specifically, if inks, adhesives, or plastic components contain substances on the REACH Candidate List (such as certain plasticizers, flame retardants, or heavy metal compounds) at concentrations exceeding 0.1%(w/w), the packaging supplier is obligated to disclose this to the brand owner.

Where did a lipstick tube packaging customer get burned last year? His lipstick tubes were made of ABS plastic, and the supplier failed to disclose that ABS contains short-chain chlorinated paraffins (SCCPs), a substance restricted under REACH. After the customer exported the tubes to Germany, customs selected them for testing and detected excessive SCCPs. The entire shipment of lipstick tubes was returned, and the brand owner’s finished lipsticks were pulled from the market as a result. The printing company paid 870,000 in compensation.

The only way to truly shield the printing plant from liability is to request a REACH compliance statement from the raw material supplier. The statement must specify whether the product contains any SVHC substances, their concentrations, and whether they are included in the restricted list. Each raw material must be covered by a separate statement; a single generalized certification is not acceptable.

The REACH candidate list is updated twice a year (January and July) and currently contains 240+ substances. Printing plants do not need to memorize the list, but they should establish a three-way tracking table linking raw materials, substances, and list versions to ensure that, whenever the list is updated, they can quickly determine whether their raw materials are affected.

Regulation 2: EC 1223/2009 — “Indirect Requirements” for Packaging under the Cosmetics Regulation

EC 1223/2009 is the EU Cosmetic Products Regulation. It governs cosmetic products themselves, but imposes 3 types of indirect requirements on packaging:

First, packaging materials must not affect changes in cosmetic components. In other words, the packaging must not allow harmful substances to migrate into the contents. This requirement is consistent with the approach of food packaging GB 4806.

Second, the packaging must carry a PAO (Period After Opening) mark, indicating the period of use after opening (for example, “12M” means it should be used within 12 months after opening). This mark is usually printed on the carton or bottle, with a font height of no less than 1.2mm.

Third, the packaging design must comply with Child-Resistant Packaging (CRP) requirements. If cosmetics may be accessed by children (such as perfume or body lotion), the opening and closing mechanism should make it difficult for children under 5 to open within 5 minutes, while allowing adults to open it normally.

The most common pitfall for printing plants is PAO labeling: the font is too small, the print position is incorrect, or the color clashes with the brand logo and makes it difficult to see. EU customs authorities inspect PAO markings very strictly; any font smaller than 1.2mm results in immediate detention of the goods. Last year, one of our customers exported a serum gift box to Italy. The PAO marking had been printed on the bottom inside of the box, and Italian customs ruled that it was "not visible to consumers." The entire shipment was detained for 21 days, missing the Christmas sales peak.

Regulation 3:94/62/EC — the “four heavy metals” in packaging waste

94/62/EC is the EU Directive on packaging and packaging waste. Its core requirement for packaging is the 「total heavy-metal limit for the four regulated metals」:

The total amount of the four heavy metals lead (Pb), cadmium (Cd), hexavalent chromium (Cr6+), and mercury (Hg) must not exceed 100 ppm (i.e., 0.01%).

This requirement may appear simple, but the point where printing plants often make mistakes is heavy metals in inks. Gold, red, and black inks, in particular, contain lead and cadmium at levels 5-10 times higher than typical inks.

Last year, a customer producing Christmas gift boxes exported to the Netherlands used extensive hot stamping and red printing on the boxes. A spot check by Dutch customs found the lead content to be 180 ppm, nearly twice the permitted limit. The reason was that the hot-stamping foil supplier used domestically produced gold foil from a small factory that did not control for heavy metals. The customer was required by the Dutch buyer to pay €120,000 in compensation.

A compliant approach for printers is to have the ink supplier provide an EN 71-3 or heavy metal test report, with each color tested separately; it is not acceptable to make a blanket statement that “the inks comply with EU standards.” At the same time, avoid high-risk color combinations: be especially vigilant when large areas of gold foil, bright red, and black are used together.

Regulation 4:EN 13427 — “Self-Assessment” for Packaging Recovery

EN 13427 is one of the European Union’s series of standards for packaging recyclability. Although it is not a mandatory regulation in itself, many EU brand customers include it in procurement contracts and require printing plants to provide a self-assessment report on packaging recyclability.

Specific evaluation criteria: whether the packaging is recyclable, whether it is made of a single material, whether it is easy to separate, and whether it contains components that impede recycling (such as metal foil, composite materials, or PVC).

The packaging type most likely to cause problems at printing plants is composite-material gift boxes: paper + plastic lamination + hot foil stamping + UV. In the eyes of EU customers, however, this “luxurious” combination is instead considered “non-environmentally friendly” because composite materials are costly to recycle and have low recycling value.

The packaging that truly earns a high EN 13427 score is “single material + minimalist design”: a pure white carton + single-color printing + a removable insert. Last year, a customer producing a gift box for a Nordic hand cream brand changed the original “paper + film lamination + hot foil stamping + magnet” structure to “paper only + soy-based ink + removable paper insert.” Its recyclability rating rose from C to A, while the customer’s unit price increased by 15% and sales doubled.

Print Factory Directly Liable vs. Merely Informed

After reviewing the 4 categories of regulations, let us return to the core question: the printing plant bears direct liability vs. merely being notified.

The printing plant directly assumes responsibility under REACH and 94/62/EC—if an issue arises, the printing plant is the party bearing legal liability, and the brand owner may seek compensation from the printing plant.

The printing plant only needs to be informed of EC 1223/2009 and EN 13427—these regulations govern the cosmetics themselves and brand practices. As a supplier, the printing plant should cooperate by providing compliance support, but is not legally the primary responsible party.

In practice, printers often assume excessive responsibility under EC 1223/2009 and EN 13427 because they do not understand the regulatory boundaries. The solution is to include a clear "compliance responsibility-sharing clause" in the purchase contract with the brand owner, specifying which responsibilities belong to the brand owner, which belong to the printer, who bears the testing costs, and how liability is apportioned if a problem arises.

Further Reading

Three Compliance Hurdles for Packaging Exported to the United States: What Do FDA, Prop 65, and CPSIA Each Regulate, and How Can You Clear All Three in One Go?

Practical Guide to GB 4806 Testing for Food Contact Packaging: 5 Commonly Challenging Test Items + 3 Remedies for Nonconformance

GB 4806.1 to 4806.11 Explained in One Article: How to Use the 5 Core Standards for Food Contact Packaging

3 Types of Mandatory Requirements for Packaging Factories Under the ISO 22000 Food Safety Management System