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MARKET ENTRY

U.S. LABELING REQUIREMENTS FOR COSMETIC PRODUCTS

How are cosmetic products and labels defined under the U.S. law?

Cosmetics under the U.S. law are products such as skin creams, lotions, perfumes, lipsticks, fingernail polishes, eye and facial make-up preparations, shampoos, permanent waves, hair colours, toothpastes, deodorants, and any material intended for use as a component of a cosmetic product. Even raw materials used in the cosmetic products are considered as cosmetics in the U.S. law. Here’s the definition: “A cosmetic is a product, except soap, intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance”. Labelling under U.S. law is defined as: “All labels and other written, printed or graphic matter on or accompanying a product”.

What competent authorities and laws you must comply with when exporting cosmetics to the U.S.?

In order to protect U.S. consumers from deceptive and/or unsafe packaged or labelled cosmetic products, foreign companies must comply with the following laws and authorities when exporting their cosmetics to the U.S.: • Federal Food, Drug, and Cosmetic (FD&C) Act • The Fair Packaging and Labelling (FP&L) Act • Regulations published by the Food and

Drug Administration (FDA) under the above-mentioned laws.

What mandatory information you must display in your cosmetics’ labels?

1. Identity of the Product: it entails what the product in question is, for example mascara, perfume, and so on. It is an essential piece of information to display as consumers must clearly understand what type of cosmetic product is and what it is used for. The identity of the commodity may be expressed in terms of the common or usual name of the cosmetic, a descriptive name, or when the nature of the cosmetic is obvious. It may also be expressed in form of an illustration. The product identity information must be displayed on the front/ principal display of the label/package. 2. Net Contents: net content advises the consumers how much content the cosmetic product contains. Net content statements must be in terms of weight, measure, numerical count, or a combination of numerical count and weight or measure. Statements of net content must be on the bottom area of the front panel in line generally parallel to the base on which the package rests, and in a type size commensurate with the size of the container. 3. Ingredient Declaration: it tells the consumer what the cosmetic product is made of. Such a declaration must be contained only in cosmetic products intended to be sold to final consumers for their personal use. Therefore, cosmetic products used by professionals at the workplace such as hairdressers do not need to display the ingredient declaration (unless the products are then sold to consumers at the salon).

The ingredient declaration may appear on any information panel of the package, i.e., the folding carton, box wrapping if the immediate container is so packaged, and may also appear on a firmly affixed tag, tape or card. All ingredients in a cosmetic must be declared on the label in descending order of predominance (i.e. the ingredient present at the highest percentage is listed first, the next highest percentage second, etc.). 4. Any required warning labels: warning labels are required for cosmetics whose use may cause hazard to consumers’ health. Therefore, statements must include information on how to safely use the cosmetic product. Moreover, they must be easily identified by the consumer and it must stand out from other statements, word or design (the warning statement must be in bold type). Example of a cosmetic label in the U.S. including special symbols’ meaning

1. Product identity 2. Net contents 3. Ingredients in descending order of predominance 4. Direction of use 5. Name and location of the manufacturer or distributor 6. Country of origin 7. The symbol tells the consumer the recommended number of months within which the product should be used after being opened 8. The symbol denotes that the company contributes to

European programs for the proper disposal and recycling of all packing components 9. Warning statement 10. The symbol tells the customer to look elsewhere in the packing for additional information, for example in a leaflet, card or tag

MARKET ENTRY

First Step for Exporting to the U.S. – FDA Facility Registration

If you’re an Irish company producing food or drink and interested in exporting to the U.S., the first step is to register your facility with the Food and Drink Administration (FDA). FDA Facility Registration is mandatory for all food and drinks companies, is relatively straightforward and generally takes 2-3 weeks. Do I need to be FDA Registered to ship food and drink to the U.S.?

Yes. To send food or drink to the U.S., exporters must be FDA Registered and file a ‘Prior Notice’ with the FDA prior to shipping. What is a ‘Prior Notice’?

A Prior Notice is a notification to the FDA that is required in order for the shipment to pass through customs. The Prior Notice filing Includes information about the product, quantity, and packaging, and related facilities, such as the manufacturer, shipper, owner, and ultimate consignee. Who needs to register their Facility with the FDA?

FDA Facility Registration is obligatory for Irish companies that manufacture, process, pack or hold food or drink for consumption in the United States.

Am I required to register a facility every two years? Yes. All food facilities need to register every two years. I use a contract manufacturer, do I need to register? Contact your manufacturer and ask if they are already registered. If they aren’t registered, you’ll need to ask them to register or register on their behalf. Are foreign food facilities required to have an agent in the U.S.? Yes. U.S. law requires that all foreign facilities must appoint a U.S. agent who is a U.S. based individual or company who serves as a point of contact for the FDA. I only use my facility for storage; do I still need to register? Yes. You’ll register your facility even if you just store / pack the goods at the facility. The responsibilities of the U.S. agent include:

• Assisting FDA in communications with the facility. • Responding to questions concerning the facilities products that are imported or offered for import into the United

States.

• Verifying the facilities details. • U.S. point of contact on behalf of the facility. FDA Facility Registration is relatively quick and easy, provided you have a U.S. Agent. Be aware a number of companies can charge up to $750 to process it for you. World Trade Center Dublin offers completely free, expedited FDA registration and U.S. agent services to our members.

MARKET ENTRY

Attention Spirits Companies: Expanding into the German Market?

Read below and find out Germany’s main strengths and growth opportunities for your business!

• Population is 83.9 million people • Europe’s largest economy and the 4th largest in the world • Europe’s largest consumer market • Second largest e-commerce market in

Europe • €29 billion German/Irish bilateral trade • Ireland’s 4th largest market for merchandise exports in 2019 • 3rd largest online retail market in

Europe Selling online: Germany’s online market is highly developed and could prove to be a useful channel. Be aware that German sites don’t always accept credit cards. Ensure your site is equipped for alternative payment forms.

What’s the recent spirits and wine consumption in Germany?

Consumption of wines and spirits in Germany is stable as shown in the below

graph. (Source: Statista 2021)

What are the main channels to the German market?

Commercial agents: working with a commercial agent or distributor can reduce the risks for an Irish company by providing a presence on the ground. Distributors: The German consumer market is robust. It will be necessary to use a national distributor. You may need to incentivize large, broad-based distributors to promote your product over an established comparable brand in their portfolio. An alternative to using a large distributor is to select a small niche distributor. Germany remains the primary EU market in terms of volume of consumption of spirits, with annual consumption of around 5.4 Litres per inhabitant. The per capita consumption of alcoholic beverages in Germany amounted to 128.5 litres in 2019. The country had a per capita wine consumption of 20.1 litres that year. Brandy is the largest category in value terms in the German spirits sector.

Hypermarkets & supermarkets accounted for the leading share in the distribution of spirits in the country. As it is a member state of the European Union, Germany is a market that is relatively easy to get access to. However, there are few regulatory differences on topics such as spirit labelling or even packaging management.

What’s Germany’s import share for spirits and other drinks and what were its main trading partners in 2020?

• Ireland with a share of 2.54% (217 million

US$) • Italy with a share of 20% (1.76 billion

US$) • France with a share of 17.6% (1.5 billion

US$) • Austria with a share of 10.6% (907 million US$) • Netherlands with a share of 7.63% (651 million US$) • Spain with a share of 6.74% (575 million

US$) • United Kingdom with a share of 4.74% (405 million US$) • Belgium with a share of 4.57% (390 million US$) • Denmark with a share of 3.13% (267 million US$)

What are the main growth forecasts in the Spirits industry?

Revenue in the Spirits segment amounts to US$8 billion in 2021. The market is expected to grow annually by 8.66% (CAGR 20212025). By 2025, 38% of spending and 14% of volume consumption in the Spirits segment will be attributable to out-of-home consumption (e.g., in bars and restaurants).

In the Spirits segment, volume is expected to amount to 510.1 Millilitres by 2025. The market for Spirits segment is expected to show a volume growth of 4.0% in 2022. The average volume per person in the Spirits segment is expected to amount to 5.70 Litres in 2021.