International Cosmetic Laws

flagsWhile most of my writing has been on the subject of United States regulations, the truth is that nearly all major countries have very comparable laws when it comes to labeling soap and cosmetics. The US is a bit more lenient when it comes to soap, and to registration and pre-approval.

The reason for the similarities in labeling laws is the International Cooperation on Cosmetics Regulation, a group made up of regulatory bodies from the US, Canada, Japan, Brazil and the European Union which meets annually. Their purpose is to:

“maintain and enable the highest level of global consumer protection by working towards and promoting regulatory convergence, while minimizing barriers to international trade.”

In other words, they meet to work out ways that they can make the regulations in each country similar enough so that regulations make sure that consumers are protected (safety) and companies can sell products internationally without having to change labels and formulations country to country.

They are currently working on issues such as nanotechnology, animal testing, allergens, lead, product preservation and trace contaminants.  Labeling and good manufacturing practices were addressed in 2008 – 2010.

Similarities and Differences

 The following information is a general overview and should not be considered a complete list of all applicable laws/regulations in each country.

Almost All Major Countries

Almost all major countries, including those participating in the ICCR as well as Australia, require the following information on cosmetic products:

  • Identity and/or function of the product, AND
  • Net weight, AND
  • Name and address of responsible party, AND
  • Ingredients:
    • May be listed
      • in descending order of predominance
      • all ingredients present at 1% or greater in descending order of predominance, followed by ingredients present at less than 1% listed in any order
    • May use a specific term to denote fragrance materials (depends on country)

United States

  • Use “fragrance” in ingredient list to fragrance materials.
  • Names used to list botanical ingredients should be the common English name , rather than the Latin name used in the INCI listings.
  • Products must not be adulterated or misbranded.
  • It is the responsibility of the manufacturer to determine safety (only a few ingredients are specifically prohibited or restricted by regulation or law)
  • Only approved color additives may be used in cosmetics.
  • Soap is exempt from the definition of a cosmetic under certain circumstances.
  • Net contents must also be listed in fluid ounces for liquid products or avoirdupois (by weight) ounces for solid/semi-solid products.
  • Registration for cosmetic manufacturers voluntary

Regulatory body:  Food and Drug Administration

Primary applicable laws: Food, Drug and Cosmetic Act and the Fair Packaging and Labeling Act.

European Union

  • Label requires:
    • Date until which the cosmetic product will continue to fulfil its initial function
    • Batch number
    • “Parfum” or “aroma” to denote fragrance materials.
    • Certain substances must be listed in ingredient declaration if present, even if only as constituents of other ingredients (i.e. some essential oil constituents)
  • Prior to marketing, a notification must be give to the Commission
  • There is a list of prohibited and restricted substances for use in cosmetics (long lists!).
  • The is a list of acceptable colorants and preservatives, and only those may be used.
  • Animal testing is prohibited
  • Nano materials subject to limitations and specific labeling requriements

Regulatory Body: European Commission – Cosmetics

Primary applicable laws: EC No 1223/2009 (as amended)

Member states may have additional laws, regulations and/or requirements.

Canada

  • Labeling:
    • Information must be shown in both English and French (except for the INCI name)
    • Botanical ingredients must be listed with at least the genus and sepcies portions of the INCI name.
    • Fragrance may be listed as “parfum”; Flavor may be listed by “aroma”.
  • At least 10 days before a cosmetic product is sold, the manufacturer or importer must notify Health Canada.  Information required on the form includes name of manufacturer, name, form  and function of cosmetic, list of ingredients with amounts (ranges are acceptable, using provided chart). Changes must be notified within 10 days.

Regulatory body: Health Canada

Primary applicable laws: Food and Drugs Act and Cosmetic Regulations

Australia

  • Labeling is virtually identical to US.
  • Soap and cosmetic manufacturers must register with the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) (Annual fee)

Regulatory bodies:


If you have more information about the laws or regulations in Canada, European Union or Australia, from EU member states, or from other countries, please add it to the comments or email me directly so I can include it here.

Comments

  1. Hi!
    It is interesting. I make natural cosmetics and soaps in the Czech Republic. We have so many troubles here. For example, we can not use our own herbs we grow, we have to buy them with certificate. If we make a jam from our fruits and herbs, we do not need any specifications or MSDSs here. But if I make soaps, I need to have so many papers here. We need to label allergens from essenial ois. So there are usually 3 – 8 another names that discourage people. The evanuation of the safety of every single product is very expensive. Plus the norms (another two papers). Then you can not make cosmetic at home. You need to have approved spaces. One room for stroring materials, one for made products, one for drying soaps (paradox is that this room should not have windows that can be opened, only a fan), another room for packing.
    It is so complicated to start a cosmetic business here. What is more, the ingredients are much more expensive. I buy oils mainly in USA and it is still cheaper with the shipping price, tax 21% and clearing 7%, money conversion. Finally, I can not sell the soap for a high price. Nobody would buy it here. Normal price is 6USD for 130g of soap.

    1. Author

      I am sorry to hear that you have so many hurdles to jump in order to make and sell handcrafted soap in your country.

      Since the Czech Republic is part of the European Union, your national regulations are supposed to be in accordance with the EU Cosmetics regulations. As with many cosmetic regulations, it looks like the implementation is intended for large companies rather than smaller businesses with handcrafted products. The space requirements (a room for storing, one for made products, room for drying soap with no windows, etc) are interpretations and implementations of ISO 22716 – the standard for Good Manufacturing Practices for cosmetic manufacture.

      Have you been able to meet all of the regulatory requirements?

  2. In Canada how do we label beer on ingredient list. How do we label calenda infused oils or tea? Thanks!

    1. Author

      Beer is probably lited as “beer” since it isn’t really a “blended ingredient” … once the beer-making process is complete it is a new substance.

      An infused oil or tea IS a blended ingredient – you would list the liquid(s) as one ingredient and then “____ extract” as a separate ingredient. The amount of the extract is probably very small, so it would be most likely be listed with the ingredients present at 1% or less (which may be listed in any order after the ingredients present at more than 1%). That’s the same as the US.

  3. Do the notifications for Health Canada and the Registration for Australia apply to US makers that ship internationally? I have a business in the US and am trying to get labels ready for international customers…holy cow this is complicated! Thank you for your help!

    1. Author

      I am not very familiar with the Canadian and Australia regulations, but I did find some applicable information:

      Canada

      See: https://www.canada.ca/en/health-canada/services/consumer-product-safety/cosmetics/notification-cosmetics.html

      Quote from that page:

      As per section 30 of the Cosmetic Regulations, manufacturers and importers must notify Health Canada within 10 days after they first sell a cosmetic in Canada. Failure to notify may result in a product being denied entry into Canada or removed from sale.

      So importers do need to register with Health Canada.

      Australia
      See: https://www.nicnas.gov.au/cosmetics-and-soaps/cosmetics-and-therapeutic-goods

      Quote from that page:

      All importers of cosmetics or cosmetic ingredients and/or manufacturers of cosmetic ingredients must be registered with NICNAS.

      So in Australia you apparently need to be registered with NICNAS. There are also other regulations for whether other import restrictions apply, based on the ingredients in the product. You can find links on the page linked to above.

      Hope that helps.

  4. I have an Etsy shop and sell cosmetics internationally. I read all the FDA articles and yours, because they are really thorough and helpful. Could FDA send me a warning letter even though my shop is in Europe? I try to coply with FDA policies, but I ask just in case to be able to sleep better 🙂 Thank you so much for all your extra clarifying answers!

    1. Author

      The FDA regulates products that are sold in the US. If you are listed on Etsy and ship from Europe, and you sell to a US customer, I don’t think it’s interpreted that you are selling in the US. Even so, the labeling laws in Europe are actually stricter than they are in the US, and if you are selling in Europe (even if you ship to the US), you should be following those laws.

      If you sell products WHOLESALE to a reseller in the US, then they are importing your products to be sold here … and the FDA has the right to inspect and deny entry of the products if they don’t meet the US requirements.

  5. Hi Marie! I have an Etsy shop with cosmetics and try to comply with FDA regulation, even though I live in Greece, because there are many articles (including yours) that help me clarify what I am permitted to say in my products’ description. I was wondering if FDA send warning letters also to websites that are not located to USA. Does it matter that I ship internationally or it matters where my base is? Thank you a million times for your extra clarifying answers!

    1. Author

      What is permitted in the descriptions is pretty much the same from country to country — all don’t allow medical claims, but some have more specific guidelines than the US. I’m not sure about what governs Greece. You would need to check since the products are actually being made and sold there.

      The FDA does send warning letters to countries outside the US, but the only ones I have seen are for drug manufacturers and they have been for pretty bad violations. If you send a product in to the US that was purchased by an individual, then it is not coming in to the US for resale … so I don’t think the FDA inspects or regulates. If you were to send in products that you wholesaled to a company that was going to retail them here, then the FDA has the right to inspect (and refuse entry) to the products if they don’t meet the correct labeling requirements for the US.

      1. Thank you for your answer Marie! I had asked you in another article about selling sunscreens. So, since I am in Europe and in Europe sunscreens are cosmetics and not drugs, I guess I can sell them to my USA customers in my Etsy shop. Most of my clients are from USA. I really appreciate your quick and clear answers!

      2. Author

        I BELIEVE that if the product is legally manufactured in your country, you can send it to a person in the US who has purchased the product (unless the product is specifically disallowed in the US). I can’t guarantee that, though.

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