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Labeling compliance for Europe

The Cosmetic Regulation applies to finished cosmetic products, and sets up requirements for the brand who intends to place a cosmetic product on the EU market. One of the key steps of cosmetic compliance is making sure that labels are compliant. Follow our checklist and get full compliance for your artwork and packs.

The EU Cosmetic Regulation


Enforced in 2013, the EU Cosmetic Regulation 1223/2009 concerns 31 European countries (28 countries of the EU + Norway + Iceland + Lichtenstein). The Cosmetic Regulation is the main regulatory framework for finished cosmetic products when placed on the EU market. It ensure that cosmetic placed through the EU market are safe for the consumer

To successfully place your cosmetic product on the European market read our article: “5 steps to successfully place a cosmetic product on the EU market”.


Definitions

Cosmetic product: “Means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours".


Labeling: Mandatory requirements


Article 19 of the EU cosmetic regulation defines the rules for a compliant cosmetic label.

Here is the mandatory information that must be printed in “indelible, easily legible and visible lettering”:


  1. Name and address of the Responsible Person: If you don’t know the role of the Responsible Person (RP), please read our quick definition or our article on the subject. If you’re outside the EU, it is mandatory to designate a RP based in Europe in order to market your product. If you’re a cosmetic brand based in the EU, you will be acting as the RP by default, unless you designate someone else.
  2. Country of origin: Add the words: “Made in XXXXX” unless the product is made in Europe in which case this is not mandatory. Note: the “Made in” expression does not need any translation.
  3. Nominal content: The nominal content must appear in grams (g) or milliliter (ml) and in first position. You can add additional measurement units if you wish, e.g. oz.
  4. Date of minimum durability (DOMD) & Period after opening (PAO): If the DOMD (defined by the stability test) is inferior or equal to 30 months, you need to indicate it using the “hour glass” symbol and print date (MMYYYY or MMYY or DDMMYYYY or DDMMYY). If the DOMD is superior to 30 months then you must indicate the PAO, defined by the challenge test. You’ll need to print the “open jar” symbol with the number of months (M) or year (Y) inside or next to the open jar.
  5. Particular precautions of use and warnings: Depending on the type of cosmetic product, some particular precautions of use and warnings might be useful to consumers or even mandatory in certain cases, e.g. avoid contact with the eyes.
  6. Batch number: is mandatory, and no particular format is required.
  7. Product function: The function of the product must be clearly indicated, e.g. hand moisturizer so as to prevent any misuse.If you have any doubt about the primary function of your product, please consult our article on how to classify borderline cosmetics.
  8. List of ingredients: In decreasing order of weight, except for ingredients below 1%.

Please note:


  • Translation: The EU Cosmetic Regulation applies to 31 EU countries representing more than 24 different official languages. You must translate the function of the product, the precautions of use and warnings but also the nominal content in the language of the country you export to. Note that Austria, Bulgaria, France, Poland, Portugal and Slovakia, request full translation of the label, i.e. even the marketing content and claims.
  • All elements above must be on the labels. When it is impossible to print the mandatory information for practical reasons, i.e. not enough space because your product is too small, then you can use a leaflet for specific information only. A leaflet is an enclosed or attached leaflet, label tape, tag or card. In this case, the information shall be referred to on the primary packaging (PP) and/or secondary packaging (SP) by the « hand-in-book » symbol.

Symbols requirements


The hour-glass symbol to illustrate the Date of Minimum Durability (DOMD) when equal or below 30 months. The DOMD is defined by the stability test. You must add the date near the symbol


If the DOMD exceeds 30 months, the open-jar symbol will indicate the period after opening "PAO” defined by the combination of the stability test and challenge test.


The hand-in-book symbol will indicate to the consumer that a card, tag or leaflet is enclosed with the product with more regulatory information.



Example of a compliant label



Claims


Cosmetic product claims are mentioned in article 20 of Regulation 1223/2009 but also in a specific regulation dedicated to claims EC No. 655/2013. This regulation aims to ensure that the information conveyed to the end users through claims is useful, understandable and reliable. It must enable them to make informed decisions and to choose the product that best suits their needs and expectations.

Cosmetic claim are usually used to market the final product. Claims will appear on the label but also on ads, magazines, etc. They:

  • Describe the effects of a product
  • Help consumers/users choose a product
  • Make the product seem more appealing than the competition

6 common criteria

  1. Legal compliance
  2. Truthfulness
  3. Evidential support
  4. Honesty
  5. Fairness
  6. Informed decision-making

For more information on cosmetic claims, read our expert advice on making claims in Europe.


EcoMundo's services


Contact us



Do not hesitate to contact our expert Sylvain De Backer by phone on +33 (0)1 83 64 20 54 for Europe and for North America please dial + 1 (778) 231-1607 or send an email at [email protected].



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Comments

  • Ryan
    Commentaire

    Hi there, during the product lifecycle, if the labelling or packaging is updated / changed what needs to happen in terms of assessment? Thanks!

    Tue 16/08/2016 - 17:56
  • Sabine Ashfaq
    Commentaire

    Hi Ryan

    If you only change the label you don't need to redo the safety assessment. If you decide to change the primary packaging then, you'll need to reassess your product and carry out a new safety assessment.

    Sabine

    Wed 17/08/2016 - 00:36
  • Marilyn E.
    Commentaire

    Hi Sabine for some reason our safety assessor in EU, is advising these conversion are wronged.

    as an example: 0.09 fl oz= 2.66 ml. To her 2.7ml.
    and,
    0.04 oz= should be 1.13g.

    My question is, is there specific requirements in rounding off no. in the EU under cosmetic packaging/labeling regulation and if so, please send me the link information?

    Thank you,
    Marilyn E

    Thu 03/11/2016 - 22:41
  • Sabine Ashfaq
    Commentaire

    Hi Marilyn,

    My colleague called you last week and I hope you are satisfied with her answer, we also sent you our fact sheets :)

    Let us know if you have any other question, we'll be happy to assist you

    Sabine

    Fri 18/11/2016 - 00:45
  • Anonyme
    Commentaire

    Hello,

    Rosk is an international cosmetic integration company who works with various laboratories, primarily in the USA, to fulfill orders of cosmetics for international clients.

    Labeling in the US and EU markets are obvisously different, so we are looking for a company who has the expertise to evaluate the content of our products and ensure that the various label requirements are met for each regulatory body.

    Lastly, we want to establish a long term consultancy agreement so that we stay ahead of regulatory and compliance issues both domestically in the USA, and abroad.

    I look forward to your reply.

    Regards,

    Robert C. Ferguson

    Sun 10/09/2017 - 19:21

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