EU Labeling Requirements

HSA Labeling Requirements

Language of the Information

Product Information must be available in the national language or languages

of the State concerned, or in a language readily understood by the competent

authorities

 

Language of the Information

Labels/labeling statements must be in English. Other languages if any may be present on the label.

 

 

Label Display

Prominently and conspicuously displayed on the product at the point of sale. If the size, shape or nature of the container or package does not permit all the required information to be specified on the container or package, the use of leaflets, pamphlets, hang tags, display panels etc are allowed. However, the name of the cosmetic product and the batch reference must be displayed on the container or package.

Location of Product Information

 

The information should be available at a single place within the EU, with the

address listed on the product. The address may appear in complete or

abbreviated form.

 

 

 

 

Fragrance(s)

Where a substance is used solely to impart an odour to the product, the substance shall be specified on list of ingredients by the word 'fragrance'. The plural 'fragrances' may be used if more than one fragrance is used. The ingredients(s) in the fragrance or fragrances may be also be listed.

Address of Manufacturing or Initial Importation Premises:

 

Manufacturers, agents, and marketers must notify competent authorities of

the Member States of place of manufacture of cosmetics products on the

European market

 

 

 

 

Product Range

Where items in a range of cosmetic products which are similar in composition and produced by the same manufacturer, and which are intended for the same use and available in different shades (e.g. lipsticks, eye shadows or nail polish but not composite packs of different types), the ingredient disclosure may include all the colour additives used in all the items of the range of cosmetic products. In such cases, the colour additives, which are contained in the entire range of related products, may be identified after the phrase 'may contain' or words to that effect.

Product Information to be made Available

 

For checks by national authorities, each manufacturer, importer or marketer

of a cosmetic product must keep certain elements of Product Information

accessible, including:

Product Composition

Physico-Chemical and Microbiological Specifications of Raw

Materials and Finished Product

Method of Manufacture

Safety Assessment

Information on the Safety Assessor

Undesirable Effects on Human Health

Proof of Effect

 

Product  Information to be made Available

Manufacturers or importers may apply for the approval of an ingredient to be specified as 'other ingredient' if the disclosure of the ingredient would prejudice a trade secret and on the provision that the inclusion of such an ingredient would not harm the consumer.

 

 

Exemption from Ingredient Listing

 

Ingredients that have no technical or functional effect in the cosmetic products and are present in a cosmetic product at insignificant levels need not be specified. However an ingredient which has a technical or functional effect must be declared regardless of the concentration of the ingredient in the cosmetic product.

Mandatory information on the product

Language

Indelible, easily legible and visible lettering.

 

Language

Labels must be clearly legible.

Product Identity

Name of cosmetic product

 

Product Identity

Name of cosmetic product

 

Name and address of manufacturer or importer or distributor of

product

 

Name and address must be within EU.

Name and address of manufacturer or importer or distributor of

product

 

Must include the name and address of local manufacturer or importer.

Weight or volume of content

Nominal content at time of packaging

 

 

Durability

 

Date of minimum durability (only when shelf life is < 30 months)

 

 

 

Precautions

 

Particular precautions to be observed in use (if regulated in Annexes of

Cosmetic Directive)

 

Precautions

Include any available precaution

Product function

 

Required unless clear from presentation

 

 

 

Batch Reference

Reference for identifying the goods

Batch Reference

Reference for identifying the goods

List of Ingredients

 

 

Found on packaging only, not on the container. Listed in descending order of weight at time added.

List of ingredients

 

All cosmetic products must be labeled with the ingredients contained in the product. The quantity or percentage of each ingredient in the cosmetic product need not be disclosed.

 

The ingredients should be listed in descending order by either mass or volume; or by using the following format:

-Ingredients(except colour additives) in concentrations of 1% or more shall be listed in descending order by mass or volume;

- Ingredients (except colour additives) in concentrations of less than 1% being listed in any order; and

- Colour additives in any order.

 

Nomenclature of Ingredients

 

Based on INCI, the International Nomenclature for Cosmetic Ingredients. It is a common

nomenclature to identify each ingredient used in a cosmetic product and has

been developed by the European and American cosmetic industries.

Nomenclature of Ingredients

 

Based on the most recent edition of the International Cosmetic Ingredient Dictionary, Chemical Abstracts Service, Japanese Cosmetic Codex, British Pharmacopoeia and United States Pharmacopoeia, or other references approved by the Health Sciences Authority.