Cosmetics labeling requirements EU

EU REGULATION 1223/2009

© CE.way Regulatory Consultants Ltd

LEGISLATION
• EU cosmetic regulation 1223/2009 (replacing
directive 76/768/EC)
• Applicable: July 2013 onwards
• Other legislation may also apply


PACKAGING GLOSSARY
• Container
• Outer packaging


LABELLING REQUIREMENTS
ALL THE INFORMATION MENTIONED ON THE
FOLLOWING SLIDES HAS TO BE MENTIONED:

• On both container and outer packaging
• Lettering has to be:
 Indelible
 Easily legible
 Visible


NAME AND ADDRESS OF THE RESPONSIBLE
PERSON

• What does “responsible person” mean?
Click here to find out or watch our clip
• “EU responsible person: ...” or highlight the
address where the product information file is
readily accessible (if multiple addresses are
listed)

PRODUCT’S COUNTRY OF ORIGIN

• For cosmetic products imported into the EU
• Example: “Made in USA”


NOMINAL CONTENT (QUANTITY)

• Nominal content at the time of packaging, given by
weight (i.e. g, kg...) or volume (i.e. ml, l...)
• Exceptions:
 Packaging containing less than 5g or 5ml
 Free samples
 Single application packs
 In certain cases it can be replaced by stating the number
of items in the packaging
• “℮” sign can be put on the label if the requirements
of the directive 76/211/EEC are met

EXPIRATION DATE

• Date of minimum durability
 “Date of minimum durability symbol” + expiration date
OR “best use before the end of”
 If necessary, conditions which must be satisfied to guarantee
the stated durability shall be mentioned
 Not mandatory for products with a minimum durability of
more than 30 months
• Period of time after opening (PAO)
 For products with expiration date of more than 30 months
 “PAO symbol” + number of months/years the product is still
safe to use after it has been opened
• For some products PAO is not relevant


PARTICULAR PRECAUTIONS FOR USE

• At least:
 Those listed in Annexes III to VI
 Precautions for use mentioned in the safety
assessment
 Special precautionary information on cosmetic
products for professional use
• Example: “Avoid contact with eyes”


BATCH NUMBER

• Or the reference for identifying the cosmetic
product
• If the product is too small, batch number
may appear only on the outer packaging


FUNCTION OF THE COSMETIC PRODUCT

• Unless it is clear from the product’s
presentation
• Example: nail lacquer, soap etc.


LIST OF INGREDIENTS

• The list shall be preceded by the term
“ingredients”
• May be indicated on the outer packaging
alone


• INCI denomination
• Order of listing ingredients:
 In descending order of weight
 Ingredients with a concentration of less than 1% may be
listed in any order after those with a concentration of
more than 1%
 Colorants may be listed in any order after the other
cosmetic ingredients
• Nanomaterials: [nano]
• Perfumes and aromatic compositions: “parfum” or
“aroma”
• Colorants: CI (Colour Index) nomenclature shall be
used


CERTAIN EXCEPTIONS
IMPOSSIBLE TO MENTION INFORMATION ON THE LABEL?

• Where it is impossible for practical reasons to put the
particular precautions for use and list of ingredients on
the label (for example, because the product is too small)
the following applies:
 Information shall be mentioned on an enclosed or
attached leaflet, label, tape, tag or card
 “Open book symbol” shall be put on the container and/or
on the outer packaging
 If it is impossible to mention the list of ingredients on a
leaflet, label, tag, tape or card, it shall appear on a notice
in the immediate proximity to the container


LANGUAGE REQUIREMENTS
The following information has to be translated
into the required language(s) of the country(ies)
where the product is to be sold:
• Nominal content
• Expiration date (if wording “best before the
end of” is used)
• Particular precautions for use
• Function of the cosmetic product


LANGUAGE REQUIREMENTS
• Which languages the previously mentioned
information has to be translated into is
determined by the law of the individual
Member States
• Contact CE.way to find out more about which
languages are required in different countries


CLAIMS
• “In the labelling, making available on the
market and advertising of cosmetic products,
text, names, trademarks, pictures and
figurative or other signs shall not be used to
imply that these products have characteristics
or functions which they do not have”
(Regulation 1223/2009, Article 20.1)
• Therefore proof of the effect claimed for the
claims that appear on the labels must be
provided


LABELLING REQUIREMENTS SUMMARY

• Name and address of the responsible person
• Product’s country of origin (if non-EU)
• Nominal content (quantity)
• Expiration date
• Particular precautions for use
• Batch number
• Function of the cosmetic product
• List of ingredients


www.ceway.eu
info@ceway.eu

Cosmetics labeling requirements EU

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