Key Differences Between US and EU Cosmetic Labelli
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Key Differences Between US and EU Cosmetic Labelli

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Key Differences Between US and EU Cosmetic Labelli
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posted in Recent jobs and industry news by Gary Lovell on 13:20 Jan 19th, 2019

 Both the US and the European Union have a cosmetic regulation outlining labelling requirements for cosmetic products. Here we explain the key differences so that you’re fully aware of labelling compliance on either side of the Atlantic. Being informed means being cmpliant and this blog will help you.

The cosmetics distributed in the US must comply with the Cosmetic Labeling Guide published by the FDA under the authority of the FD&C Act. Labeling means all labels and other written, printed or graphic matter on or accompanying a product.

The main requirements are: identity statement which is the common or usual name, descriptive name, fanciful name, Illustration, prominence, and placement; net quantity - which is the quantity of the contents, in terms of weight, measure, and numerical count; warning -  If the cosmetic product contains an ingredient for which adequate substantiation of safety has not been obtained, a warning must be placed on the PDP like “Warning - the safety of this product has not been determined”. Also note that the label statements required under the authority of the FD&C Act must appear on the inside as well as any outside container or wrapper.

The information panel of the label must include the following:

·         statements required by law or regulation must be in English

·         Name and place of Business: Corporate name, Manufactured for XXX, Distributed by XXX, Address, Principal place of business

·         Distributor statement: Add manufactured for XXX or Distributed by XXX, if relevant (see above)

·         Cosmetic Warning Statements: The FD&C Act and related regulation specify warning and caution statements related to specific products. Cosmetics that may be hazardous to consumers must be bear appropriate label warnings. E.g.: Flammable cosmetics such as aerosols.

·         Ingredients declaration: Ingredients must appear clearly and intelligibly, so that an ordinary person under normal conditions of purchase can understand. If you do not have sufficient space for such declaration, you may use a tag, tape or card firmly affixed on the package.

·         Ingredients name: You may use INCI name or in absence, you should use the name given by the United States Pharmacopeia, National Formulary, Food chemical Codex, USAN, and the USP dictionary of drugs names

 

·         Ingredients listing: They must be listed in descending order of predominance

·         Material facts: You should reveal material facts (e.g.: directions for safe use), or your product will be considered as misbranded or adulterated.

 

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”:

·         Name and address of the Responsible Person: If you’re a cosmetic brand based in the EU, you will be acting as the RP by default, unless you designate someone else.

·         Country of origin: Add the mention: “Made in XXXXX” unless the product is made in Europe in which case such mention is not mandatory. Note: the “Made in” expression does not need any translation.

·         Nominal content: The nominal content must appear in grams (g) or milliliter (ml) and in first position.

·         Date of minimum durability (DOMD) & Period after opening (PAO): If the durability is inferior or equal to 30 months, you need to indicate the “hour glass” symbol and print date (MMYYYY or MMYY or DDMMYYYY or DDMMYY). If the durability is superior to 30 months, then you must indicate the PAO. 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.

·         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.

·         Batch number: is mandatory, although no particular format is required.

·         Product function: The function of the product must be clearly indicated, e.g.: hand moisturizer as to prevent any misuse.

·         List of ingredients: In decreasing order of weight, except for ingredients below 1%.

 

At LabelSevice, we keep track of and are experts in regulatory needs of labelling. We take this very seriously so that we can consult with our customers on compliance before we print your labels.

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