Cosmetic prepackages - what you need to consider

Cosmetic prepackages need to meet international standards to reach compliance with regional jurisdiction (e.g., in Europe or the USA). Common denominator of most national or regional regulations are the standards set by the International Organization for Standardization (ISO 22715). The following is a summary of what you need to consider for packaging and labelling.

Why is the ISO 22715 important

While ISO 22715 is not legally binding, it is however, the common denominator of most of the national regulations that apply to the packaging and labeling of cosmetic products. Country regulators refer to ISO standards as guidelines to best practices for the various sectors for which they apply. Often, in order to comply with a local regulation, an individual, business or manufacturer must comply with the applicable ISO standard(s).

The following sections shed light on the important points that need to be considered, when pre-packaging cosmetic containers compliant to the ISO 22715.

Pre-Package Requirements

If you have visions of entering the cosmetics industry, you must conform with standards set by ISO 22715. This organization defines what must appear on cosmetic packaging. For labelling purposes, ISO 22715, section 2.3 states: "pre-package packaging at the point of sale, containing similar or different products with similar or different functions."

One of the main concerns that industry authorities have about packaging in general is that it is done safely so that it doesn't allow for unsanitary conditions that can lead to health problems. Products must be free of dirt and filth. Consumers also have a right to know product ingredients.

ISO ISO 22715, section 4.2.4 Specifics

Information must be positioned so that it is easy to read. The message must be legible and visitor to customers at a store. Product information, however, only needs to be on secondary packaging. In situations where lack of information may cause confusion for customers on how to use the product, more explanation are necessary on the primary packaging.

It's important to make it clear to the buyers what the number of units are within the package. So if it's not visible to the customer, the number of units should be indicated on the outer package. These considerations are the minimum requirements for distributing free samples.

FDA and EU Labelling Requirements

While FDA approval is not necessary to put a cosmetic product on the market, it's still critical for vendors to follow its rules established by the Federal Food, Drug and Cosmetic Act (FD&C Act). This law laid out the basics for how cosmetic products must be labelled. The label must include important information and be attached to the outer package. Even though there is no FDA requirement that a cosmetic product must be licensed, the manufacturer still has a responsibility to make sure the product is safe. In the EU, manufacturers must give notification of their cosmetic products via the EU Cosmetic Products Notification Portal (CPNP).

U.S. federal requirements for ingredients used to make cosmetic products are not specific, except that certain chemicals must be listed. Any type of chemicals that affect hair color, such as dyes and additives, are subject to FDA requirements and safety inspections. The FDA reserves the right to deny cosmetic imports, but usually does not closely monitor the industry, due to limited resources. In the EU, colorants, preservatives and UV-filters (including those comprising nanomaterials) must be approved. When products include nanomaterials the ingredients must be labeled with the word "nano" in brackets after the name of the substance, such as "titanium dioxide (nano)"

Here are key requirements to keep in mind when packaging cosmetic products in compliance to both regulations:

cosmetic packaging must preserve quality of the product
labels must contain contact information of the manufacturer, packer and distributor
labels must contain accurate information and avoid any type of deception
certain chemicals can be grouped under one name
net contents must be listed and must be in a conspicuous place
statement of how the product is intended to be used
warning about what the consumer should do if the product is misused

Essentially, the product must be protected from mechanical, thermal, biological, chemical and tampering damage when it leaves the factory. The packaging must be strong enough to resist environmental factors while stored in the supply chain or on display at stores. If the FDA or EU determine that a product is misbranded, the responsible company may face violations.