As of December 13, 2024, the new General Product Safety Regulation (GPSR) has come into force in the European Union, establishing updated safety requirements for consumer products sold on EU markets, including platforms like Etsy, eBay, and Amazon.

This regulation replaces the previous General Product Safety Directive and aims to enhance product safety standards. Its primary objective is to ensure a higher level of consumer protection by improving labelling requirements, product traceability, and introducing new obligations for manufacturers and sellers.

The new rules apply to both new and second-hand non-food products. They introduce additional responsibilities for sellers and manufacturers, who are now required to ensure their products meet safety requirements and maintain clear documentation regarding product origin.

For entrepreneurs trading on online marketplaces such as Amazon, Etsy, or eBay, it is crucial to be prepared for these new requirements. They apply to both large corporations and small businesses selling products in the EU.

In this article, we will explore the key changes for businesses operating in the European market and how to ensure product compliance with the new GPSR requirements.

For more detailed information about the GPSR regulation and its requirements, you can read the document here.

Countries covered by the GPSR Regulation

The new General Product Safety Regulation (GPSR) applies to all European Union countries, as well as Northern Ireland.

Due to Brexit, the United Kingdom is no longer part of the EU, and therefore, the GPSR does not apply to products sold in England, Wales, and Scotland. However, Northern Ireland remains subject to the regulation.

As a result, manufacturers in Great Britain (England, Wales, and Scotland) must comply with the UK General Product Safety Regulations (UK GPSR) instead.

Products covered by the GPSR Regulation

The General Product Safety Regulation (GPSR) applies to non-food consumer products sold in the EU market, including new, second-hand, repaired, or refurbished items. This includes products such as electronics, furniture, clothing and footwear, toys, car parts, sports equipment, and more.

However, there are specific exemptions where the new requirements do not apply, including:

• Medicinal products
• Food and animal feed
• Live animals and plants
• Genetically modified organisms (GMOs) and microorganisms
• Animal by-products
• Plant protection products (pesticides)
• Products of plant and animal origin related to reproduction
• Antiques
• Certain types of aircraft
• Tourism-related equipment operated by a service provider for consumer transportation
• Products explicitly marked as requiring repair, refurbishment, or reprocessing before use

For these categories, specific regulatory frameworks and safety standards apply, depending on the nature and classification of the product.

Key requirements of the GPSR

In this section, we will outline the general GPSR requirements applicable to all sellers, as well as specific obligations for those selling on Amazon, Etsy, and eBay.

General GPSR requirements

1. Compliance with labelling and traceability requirements
   Sellers must ensure that all products sold in the EU and Northern Ireland comply with GPSR labelling and traceability requirements.
2. Appointment of a responsible person
   If the manufacturer is not based in the EU, a Responsible Person must be designated within the EU. This person is responsible for ensuring product compliance and coordinating cooperation with market surveillance authorities.

Who can be a responsible person:

• The manufacturer, if based in the EU
• The importer, if the product is sourced from outside the EU
• An Authorized Representative – a natural or legal person registered in the EU, appointed by the manufacturer via a formal agreement
• A fulfillment service provider, if based in the EU

Responsibilities of the responsible person:

• Maintaining technical documentation and providing it to authorities upon request
• Ensuring compliance with specific information requirements, including:
• Product type, batch number, serial number, or other unique identifier
• Manufacturer’s details: name, registered trade name or trademark, and contact information
• Clear instructions and safety information in a language easily understood by consumers
• Notifying authorities about dangerous products and incidents
• Cooperating with authorities and ensuring corrective actions are implemented

3.     Product labelling requirements

• Marking products with the contact information of the Responsible Person, manufacturer, and, where applicable, the importer
• Displaying product type, batch number, or serial number
• Providing safety information and warnings in the official language(s) of the country of sale
• Listing the Responsible Person’s and manufacturer’s name and contact details in product listings
• Including product photos and relevant identification details
• Displaying safety warnings and information in the listing’s language

After reviewing the core GPSR requirements, it is essential to consider the specific compliance procedures for each marketplace, such as Amazon, Etsy, and eBay. In addition to general requirements, each platform has its own regulated processes that sellers must follow to ensure compliance.

Amazon

In addition to the general GPSR requirements, Amazon sellers must follow these specific procedures:

Removing Non-GPSR-Compliant Products

• If you do not plan to continue selling products in EU marketplaces due to non-compliance with GPSR, remove the affected products from your inventory using the Manage Inventory panel or FBA Dashboard.

Adding Responsible Person and Manufacturer Information to Listings

• Details of the Responsible Person and manufacturer, along with relevant images and safety documents, will appear in product listings within 24 hours after confirmation.

Submitting Compliance Data on Amazon

• Use the Add compliance information widget in Manage Your Compliance Dashboard to submit the required data.
• Provide Responsible Person and manufacturer details for the following markets: France (FR), Germany (DE), Italy (IT), and Spain (ES).

This information serves as a guideline and does not replace legal advice. For specific compliance questions, consult your legal advisor.

Etsy

For sellers on Etsy, in addition to the general compliance steps, it is also important to add an Economic Operator:

• If you sell to EU countries and qualify as a “trader” (e.g., a registered business or professional seller), you may need to appoint an Economic Operator to comply with the Digital Services Act. This can be a manufacturer, importer, authorized representative, or fulfillment service provider.
• To add Economic Operator information, go to Etsy.com → Shop Manager → Settings → Partners you work with. Click Add economic operator, enter the required details (name, address, and contact information), then click Save operator. You can edit this information in the same section by clicking the pencil icon.

Important: Etsy does not provide legal advice regarding the need to appoint an Economic Operator. If you are unsure, consult a local legal advisor. Additionally, note that adding or editing Economic Operator information is currently unavailable via the Etsy Seller App.

eBay

For sellers on eBay, compliance with general GPSR requirements is essential for continuing operations in EU markets. To assist with appointing a Responsible Person, eBay provides a list of partner organizations that sellers can choose from:

• Webinterpret
• Cert-Rep
• Obelis
• Eucerep (ebay_support@eucerep.com)

This recommendation is intended to help sellers find individuals or companies that can assist in ensuring compliance with EU product safety regulations. It is important to assess whether these services meet your specific needs. Please note that eBay does not assume responsibility for the quality of services provided by these third-party partners.

Consequences of Non-Compliance with GPSR

If a product does not meet GPSR requirements, it may be classified as a “dangerous product”, leading to corrective actions such as fines, sales bans, or market withdrawals.

For online marketplaces like Amazon, Etsy, and eBay, GPSR non-compliance carries serious consequences:

●      Amazon:

As of December 13, 2024, all products on Amazon must comply with the General Product Safety Regulation (GPSR). If a product does not meet the requirements, it may be removed from the platform, and participation in Lightning Deals will no longer be possible.

●      Etsy:

If Etsy receives a notification about a product’s non-compliance with GPSR, the platform may remove the product or suspend the seller’s account. Information about a product subject to corrective actions by a market surveillance authority in an EU Member State will be published in the Safety Gate – the EU Rapid Alert System for dangerous non-food products. This may lead to other authorities requiring similar actions within their jurisdictions. This could lead to similar enforcement actions by other authorities.

●      eBay:

On eBay, products that do not comply with GPSR requirements may become unavailable to buyers in the EU and Northern Ireland, directly impacting sales. Non-compliance with GPSR can lead to legal consequences, lost sales, and reduced consumer trust.

Conclusion

Compliance with the GPSR regulation is mandatory for sellers operating in EU markets and plays a crucial role in ensuring product safety and mitigating legal risks. Key steps, such as meeting labeling and traceability requirements and appointing a Responsible Person, must be implemented to minimize potential sanctions. Sellers on platforms like Amazon, Etsy, and eBay should closely monitor the regulation’s requirements and adjust their listings to align with the new safety standards.

Successful preparation and implementation of these requirements require a systematic approach and timely execution of all necessary steps. This not only helps avoid fines but also prevents product bans or market withdrawals, account deactivation or removal, and listing suspensions on marketplaces. Ultimately, compliance with GPSR strengthens brand trust and ensures product safety for consumers.

If you have any questions or concerns regarding GPSR compliance, it is advisable to seek guidance from qualified legal or professional consultants to properly execute procedures and prevent potential complications. If you need support in preparing for compliance, Disqover Agency specialists are ready to assist with product format selection for international sales, documentation preparation, account registration, and listing creation on Amazon, Etsy, and eBay. We ensure full compliance at every stage and facilitate a successful entry into international marketplaces.

Amazon Kindle Direct Publishing (KDP) is a platform for self-publishing books and is part of Amazon, one of the largest retailers in the world. As an integrated part of Amazon, KDP provides authors with the opportunity to publish their books independently, ensuring access to a global audience. With Amazon’s vast customer base, authors can effectively promote and sell their books using the platform’s tools.

Amazon KDP operates on a print-on-demand model. This means that you upload the electronic format to the KDP bookshelf, create listings, launch sales, and promote your product. When a printed format is purchased, Amazon prints and ships the book to the buyer.

This platform opens limitless opportunities for authors and entrepreneurs, especially for those who aim to enter the international market. For Ukrainian entrepreneurs, this platform can be the key to global success. Let’s explore why KDP is worth your attention and how this platform can boost your business.

Opportunities for Ukrainian Entrepreneurs on Amazon Kindle Direct Publishing

High demand for new content: European and American markets constantly need new books and ideas. Ukrainian authors have the chance to impress foreign readers with their unique stories and perspectives.

Economic benefits: Starting a book business on Amazon through the KDP platform has significantly lower barriers in terms of investments. There are no registration fees on KDP, and printing and logistics costs are automatically deducted from the price of your book only upon purchase. This is particularly important for startups and small businesses.

Entering the International Market: Advantages for Authors on Amazon

Wide audience reach: Amazon has over 300 million active users worldwide. By entering the international market through KDP, you gain access to a vast base of potential customers.

Growth of the e-book market: The self-publishing market is growing much faster than the traditional publishing market: in one year, the self-publishing market grew by 17% compared to the traditional publishing market, which grew by only 1%. Therefore, now is the ideal time to enter this market.

Royalties up to 70%*: Amazon KDP offers some of the highest royalties in the industry, allowing authors to earn up to 70% from e-book sales and 60% from print book sales.

• “Royalties up to 70%” means the share of sales that the author receives from each copy of their book sold through Amazon KDP. Royalties are the portion of the profit that goes to the author after accounting for costs and commissions specified by the platform or publisher.

Advantages of Amazon Kindle Direct Publishing Platform

Full control over the publishing process: KDP allows you to manage all aspects of your book’s publication, from uploading the file to creating the cover and choosing categories.

Ease of use: An intuitive interface and step-by-step instructions make the publishing process quick and easy.

Scalability: Whether you are publishing one book or an entire series, KDP provides opportunities for growth and expansion.

Free promotion through KDP Select: Participation in the KDP Select program allows your book to be exclusively available on Kindle Store for 90 days with the possibility of automatic renewal, providing additional promotion opportunities.

Statistics

Market growth: From 2018 to 2023, the number of self-published books on KDP increased by 264%.

Amazon’s dominance: Amazon holds 83% of the e-book market in the USA and controls over 70% of the print book market in the USA.

Popular genres: The most popular book categories on KDP include Fiction (science fiction, fantasy, romance) and Non-fiction (biographies, business, cooking).

Steps to Start a Business on Amazon KDP

Our experienced experts have a step-by-step plan that has helped many entrepreneurs successfully start their business on Amazon KDP. This plan carefully considers all aspects – from account registration to active product promotion, and provides an effective strategy for launching and developing your brand in the international e-book market.

4 steps to launching a business on Amazon KDP:

1. Registration and research: We will register your account and conduct in-depth market research. This will allow you to understand what product the market needs, expected sales volumes, competitive pricing, promotion strategies, and more.
2. Creation and adaptation: Based on our experts’ recommendations, you will create or adapt a book for the market. This may include the book’s content, cover, title, and other aspects.
3. Product launch: We develop visual and textual content optimized for market needs, fill it with keywords, and create an attractive listing.
4. Promotion and development: We actively promote your product in the market and develop your position as an author in the relevant niche; we also analyze the market according to your requests and offer opportunities to expand the range.

Niche Analysis on Amazon KDP

The first step to success on Amazon KDP is understanding your target audience and competitors. Our specialists will help you conduct a deep niche analysis to explore your product in the market, key competitors, and promotion methods. We research the market, analyze competitors’ sales, and provide detailed recommendations on optimizing your offer.

Registration

1. Registering a KDP account: Start with the standard registration process on the KDP platform.
2. Email confirmation: Confirm your email address for further communication.
3. Linking the account to a phone number: Protect your account by linking it to your phone number.
4. Entering bank details: Add your banking information to receive payments.
5. Entering tax information: Complete the tax information to comply with regulations.

Our specialists are ready to help you at every stage of this process to ensure smooth registration and a quick start to your business.

Promotion on Amazon KDP

Promotion is a crucial component of success on Amazon KDP as it increases the visibility of your book among millions of others. What are the promotion opportunities for books:

KDP Select: A program for free promotion of e-books on Amazon, lasting 90 days (with the possibility of renewal).

Author Central: Creating an author page that helps readers easily find your books.

Amazon Ads: Using various types of ads, such as Sponsored Products, Sponsored Brands, and Lockscreen Ads.

External promotion: Increasing recognition and visibility in the market through external promotion channels.

Conclusion

Amazon Kindle Direct Publishing provides unique opportunities for Ukrainian entrepreneurs looking to enter the international market. Given the large customer base, high royalties, and ease of use of the platform, KDP is an ideal tool for developing your business. Don’t put off until tomorrow what you can do today – start your path to international success with Amazon KDP now.

The enrichment of Europeans’ cultural experience leads to a diversity of tastes, preferences, and lifestyle perspectives. This, in turn, poses a challenge for businesses — understanding and adapting their strategies to the unique needs of each country and consumer group.

Economists and marketers have long been studying and analyzing consumer habits of potential clients, as this helps businesses tailor their products and marketing strategies to the preferences of each region. Therefore, before expanding a business into any marketplace, we recommend conducting an in-depth marketing analysis.

What specific aspects are important when analyzing consumer habits in different European countries? How does this influence the market selection for businesses operating in Europe?

In this blog, we will examine how the diversity of consumer habits in European countries influences consumer choices and market dynamics, drawing on research and our team’s experience with the most popular marketplace in Europe – Amazon.

Amazon has the largest number of buyers and ranks first among marketplaces in many European countries. Therefore, by analyzing it, one can more easily notice the main differences between consumer habits in various European countries.

When comparing European countries by the average purchase amount for the same shopping list on Amazon, the following statistics emerge:

• Spain: €3,149
• United Kingdom: €3,127
• France: €3,120
• Italy: €3,050
• Germany: €3,004

To better understand consumer habits in these countries, we will provide some insights about each of them.

Germany -> Amazon.de

• Amazon is the number one marketplace in Germany 500 million visits per month on average
• $33.6 billion in revenue in 2022.

Consumer Behavior:

• Key Purchase Motivation: Price-quality ratio
• Prolonged Decision-Making Process: Expectation of exceptional products at reasonable prices
• Pre-Purchase Research: German consumers actively seek out extensive information about products, including their features, origin, and other details, beyond just the price.

According to research, German consumers are considered some of the most discerning in the world, willing to spend more on high-quality products. They are open to products from international companies and show brand loyalty if the products meet high-quality standards. Approximately 60% of the population is willing to purchase the same brand multiple times if the products are of high quality.

Environmental awareness is prevalent among German consumers and is reflected in their preference for organic and vegan products that utilize minimal energy and other sustainable practices. Most German consumers actively support and choose products that meet sustainable development and environmental conservation standards.

These trends indicate that a successful business in Germany must be prepared to meet high quality standards, be open to foreign brands, and address consumer environmental consciousness. Specifically, we recommend emphasizing product quality and providing comprehensive information about product origin and eco-friendliness to attract German demand.

Popular Product Categories:

• Clothing
• Books
• Health Products
• Cosmetics and Body Care
• Home Electronics
• Bags and Accessories
• Pet Products
• Food and Beverages

In Germany, online shopping has become the norm, making the country the largest online market in Europe. Although Germany has one of the largest and most promising markets in Europe, most sellers remain competitive by offering lower prices and operating under the strategy of “lower prices, higher sales.”

United Kingdom -> Amazon.co.uk

• Amazon: The number one marketplace in the UK
• Average Monthly Visits: 400 million
• Revenue in 2022: $30 billion
• Amazon Usage: 90% of the adult population in the UK uses Amazon
• Amazon Prime Membership: 40% use Amazon Prime for fast, free delivery and additional benefits

Consumer Behavior:

• 60% of purchases on Amazon UK are driven by lower prices compared to other online stores.
• 60% of consumers shop on Amazon UK because they cannot find the desired product in any physical offline store.
• 40% of buyers cannot find their desired product on other websites.

The consumers mentioned above (who shop on Amazon for various reasons) prefer searching for products such as electronics, household appliances, and clothing online rather than visiting physical stores (57% versus 21%, respectively).

Popular Product Categories:

• Clothing
• Books
• Food and Beverages
• Cosmetics and Body Care
• Bags and Accessories
• Home Electronics
• Health Products
• Accessories
• Pet Products

France -> Amazon.fr

• Amazon: The number one marketplace in France
• Average Monthly Visits: 164 million
• Revenue in 2022: $5.4 billion

The French population is characterized by a high and varied level of mass consumption. For most French people, consumption is synonymous with enjoyment and the pleasure of life. Thus, travel, dining, sports, culture, entertainment products, and services play an important role in their daily lives.

However, in recent years, there has been a shift in consumer behavior in France. Consumers now strive to make more responsible consumption decisions, paying attention to quality, traceability, composition, authenticity, transparency, and environmental sustainability.

Particular interest is shown in products that are organic, local, natural, and free from parabens and preservatives, indicating an increase in consumer awareness about consumption issues (according to Greenflex & Ademe Barometer 2021). They demonstrate a more mature understanding of the importance of choosing products that align with their values and provide greater benefits for their health and the environment.

Popular Product Categories:

• Clothing
• Books
• Cosmetics and Body Care
• Bags and Accessories
• Home Electronics
• Pet Products
• Accessories
• Food and Beverages
• Health Products

Italy -> Amazon.it

• Average Monthly Visits: 162.3 million
• Amazon Revenue: $5.28 billion
• Amazon Usage: 96% of Italian consumers have ordered from Amazon at least once

Italian consumers have high standards for product quality, paying more attention to the quality of goods and customer service than promotional offers.

Foreign goods are quite popular, especially in the categories of footwear and streetwear. Italians value new arrivals, particularly in the fashion sector. Most consumers prefer shopping with mass retailers and large companies, especially in metropolitan areas.

Research indicates that 85% of buyers believe that eco-friendly products are of higher quality and more innovative. In a study conducted by Bord Bia during the first half of 2021, 90% of Italian consumers stated that they made an effort to purchase products with higher welfare standards over the past 12 months, and more than half recognized the importance of sustainability when choosing food and beverages.

Popular Product Categories:

• Clothing
• Books
• Cosmetics and Body Care
• Health Products
• Bags and Accessories
• Home Electronics
• Pet Products
• Accessories
• Toys and Children’s Products

Spain -> Amazon.es

• Average Monthly Visits: 131.1 million
• Revenue in 2022: $5.55 billion
• Amazon Usage: 8 out of 10 Amazon buyers place orders at least once a month

Due to the economic crisis and high unemployment rate, price has become a key factor influencing purchases in Spain. Ease of payment, promotions, and efficient customer service also determine consumer choice.

Against this backdrop, there is an active development of responsible consumption in Spain. The number of consumers paying attention to production responsibility, demanding traceability, and high quality is growing. Additionally, the second-hand market is gaining popularity among Spanish buyers, becoming an alternative to new purchases and promoting sustainable consumer behavior.

Popular Product Categories:

• Electronics
• Clothing and Footwear
• Home
• Books, Movies, and Music
• Toys and Games
• Sports
• Stationery
• Beauty and Health Products
• Jewelry

Conclusions

Evaluating the general consumer trends in the aforementioned countries, it is easy to notice that Europeans mainly prefer quality products and conscious consumption. Factors such as the Covid epidemic, the war in Ukraine, and the rise in energy prices across Europe have greatly influenced this. Thus, in recent years, consumers in European countries have reconsidered their purchases and strive to consume less but better and more sustainably.

For Ukrainian entrepreneurs dreaming of entering the European market, the good news is the loyal attitude toward foreign goods among European countries. Therefore, do not be afraid to explore new horizons. The main thing is to prepare carefully and analyze the market before entering. Our team is ready to become an indispensable assistant for you in this! Let’s conquer Europe together!

Amazon founder Jeff Bezos chose to focus on e-commerce as early as 1994. In 2024, he is considered one of the richest people in the world, with a fortune estimated at $37 billion.

Today, Amazon offers millions of products in various categories, including electronics, fashion, groceries, and much more. Amazon is not just an online store; it is a large retail giant that has changed the way we buy and sell goods. In this article, we will explore what makes Amazon such a successful marketplace and why it is one of the most popular places for e-commerce.

Why Amazon?

Amazon is a global leader in e-commerce, opening up endless possibilities for businesses. This marketplace is a powerful tool for business development, regardless of the size of your company: whether you are a small entrepreneur looking for ways to grow, or a large corporation seeking to expand your audience. In either case, Amazon can become your best ally.

To better understand the importance of Amazon for business, let’s look at some statistics:

• Amazon has a 37.8% market share in e-commerce in the US.
• This marketplace controls 10.4% of the total retail market share in the US.
• Worldwide, Amazon accounts for over 20% of all online store visits from personal computers.
• Global sales on Amazon amount to nearly $700 billion.
• Small businesses in the United States sell over 4,000 items per minute on Amazon.

How to Start Selling on Amazon: Tips for Beginners

If you are considering starting a business on Amazon, here are a few useful tips:

1. Before starting sales on Amazon, it is important to thoroughly research your niche and competitors. This step is crucial to save your business money and nerves. Entrust this stage to professionals from Disqover Agency, who will conduct a deep niche analysis and help create a step-by-step plan for entering Amazon.
2. Be patient when registering an account on Amazon. This stage is not always easy for beginners, but the effort is worth it. This marketplace will open up international trade and a solvent audience for you.
3. Optimizing product listings plays a major role in attracting customers’ attention. Ensure that your listings are attractive and informative.
4. Use various Amazon advertising tools to attract new customers and increase your product sales.

5 Benefits for Business on Amazon

Amazon is one of the most popular marketplaces, where 56% of consumers start searching for the necessary product. Using Amazon offers numerous benefits that make it attractive for business:

1. Large Consumer Base: Amazon has a huge audience, providing a high level of consumer trust. This allows you to reach a wider audience for your brand.
2. All-in-One Dashboard: Statistics, advertising dashboard, invoices, CRM integrations, customer communication, and even payments are available in one dashboard. This simplifies business management.
3. Quick Response to Consumer Trends: Marketplaces allow quick response to changing consumer trends and easy tracking, enabling you to stay informed about market changes.
4. Personalized Shopping Experience: Amazon offers a personalized shopping experience, enhancing consumer loyalty to your brand.
5. Access to International Markets: Using Amazon is a relatively cheaper way to enter international markets, providing 24/7 availability for your products.

Brand Registry: Additional Opportunities for Business

One of the other great opportunities on Amazon is the Brand Registry program, which allows you to take advantage of brand benefits within Amazon and enhance seller competitiveness.

For Brand Registry owners, the following business benefits open up:

1. Proactive Trademark Protection: A registered trademark in one country does not guarantee its protection in others.
2. Enhanced Content Creation: A+ Content includes spreading information about the brand’s history and product features. Images on pages and texts improve conversion rates. This helps increase traffic and, consequently, sales.
3. Analytics: Amazon provides a wide range of tools for obtaining analytics, including customer behavior reports and keyword analysis. This allows for making successful strategic decisions.
4. Bonuses for New Sellers: By just connecting your brand to the platform, you can receive discounts and bonuses

What to Do Next?

If you have not yet considered Amazon as a platform for your business, now is the time to start. This platform is a full-fledged tool for business development and growth.

Use all the opportunities Amazon offers to grow your business and achieve successful sales. Don’t waste time; start your journey to success on Amazon today!

Disqover Agency specialists have been helping Ukrainian entrepreneurs achieve success in sales on Amazon every day for 5 years: from the necessary documents for exporting products abroad and registering an account to creating listings and setting up effective advertising. Let’s grow in the global market together!

The FDA has established new requirements for the import of cosmetic products into the United States, which must be met by July 1, 2024. Let’s take a look at all the nuances of the new regulation.

General Overview

Today, the United States has several restrictions on the composition of cosmetic products. Eleven ingredients and their compounds are prohibited for use in cosmetics, and most others require certification from the FDA. These restrictions apply to both colorants and fragrances used in cosmetic products. Therefore, cosmetics manufacturers must comply with the established rules to be able to sell their products on the US market.

To successfully import cosmetic products into the United States, two important steps must be taken. The first step is to determine whether the product and its manufacturer are subject to registration with the FDA. The second step is to ensure that the product complies with the FDA’s labeling requirements.

Background Information on MoCRA and Cosmetics Direct

MoCRA (Cosmetic Regulatory Modernization Act) implements new standards for the regulation of cosmetics in the United States. The program requires owners or responsible persons of businesses engaged in the manufacture or processing of cosmetic products to register their businesses and all cosmetics they manufacture for sale in the United States.

With the new Cosmetics Direct portal, cosmetics manufacturers will have a user-friendly interface for registering MoCRA-compliant facilities and products. 

Explanation of the New Rules

With the adoption of the MoCRA in 2022, the FDA gained significantly more authority to regulate cosmetic products. According to MoCRA, owners or operators of facilities that manufacture or process cosmetic products for distribution in the United States must register their facilities and cosmetic products.

If a company has a contract manufacturer that produces the products on its behalf, only the contract manufacturer needs to be registered. The company will be listed as the responsible person and will be solely accountable for the products.

However, it is important to note that there are exceptions. Small businesses with average annual gross sales of cosmetic products in the U.S. for the preceding three-year period of less than $1,000,000, adjusted for inflation, may be exempt from FDA manufacturer and cosmetic product registration. Nevertheless, their product labeling must meet certain standards.

Regardless of average annual gross sales, all businesses engaged in the manufacture or processing of the following products are not exempt from manufacturer and product registration:

• Cosmetics that usually come into contact with the mucous membrane of the eye (e.g., eye makeup removers, liquid eyeliner, glue for false eyelashes).
• Cosmetics that are injected (e.g., tattooing).
• Cosmetics intended for internal use.
• Cosmetics intended to change appearance for more than 24 hours (e.g., certain nail polishes like gel polishes, certain hair products like dyes and colorants, certain eyebrow dyes, and certain leave-on skincare products like SPF).

If a company manufactures one or more of the above products, it is required to register the manufacturer and all products it plans to sell in the United States under any circumstances.

Compliance with the new rules is critical for cosmetics manufacturers, as failure to comply can have serious consequences, including fines and even a ban on importing products into the US market.

Responsible Person of the FDA Cosmetic Product

The Responsible Entity (i.e., the entity named on the product label) must register all cosmetic products with the FDA and submit comprehensive information about each product. This includes the product name, brand, responsible person on the label, product manufacturer, ingredient list, and label file, which includes product ingredients. It is also necessary to update the information about the company annually and in case of data changes. Additionally, the relevance of the manufacturer and product data must be confirmed at the end of each year by December 31, though updates can be made at any time.

A responsible person may be a manufacturer, packager, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with Section 609(a) of the FD&C Act or Section 4(a) of the Fair Packaging and Labeling Act.

Source: https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products

Conclusions

The new rules for importing cosmetics into the United States are designed to ensure control over manufacturers and the safety of cosmetic products for consumers. According to these rules, manufacturers or responsible persons must comply with FDA and MoCRA requirements regarding product registration and labeling. Adhering to these requirements will ensure the quality and safety of cosmetic products for consumers in the United States.

If you have any questions regarding compliance with FDA and MoCRA requirements or the cosmetic registration process, please contact our experts.

Approximately 91% of Amazon sellers express satisfaction with the prompt delivery of their products globally. This efficiency is primarily attributed to the FBA (Fulfillment by Amazon) service – a specialized logistics program by Amazon enabling sellers to stock their goods in Amazon warehouses.

What advantages do sellers gain by utilizing FBA? Amazon warehouses are strategically positioned across the globe. Storing your products in these warehouses allows for expedited delivery to customers, emerging as a pivotal factor in fostering customer loyalty.

Furthermore, utilizing FBA presents the opportunity to economize on storage expenses, owing to the absence of external cross-border fees. FBA facilitates payment solely for domestic shipping fees in the countries where the Amazon warehouses housing your products are situated.

FBA Changes in the USA

Amazon has recently implemented alterations to the payment structure for FBA commissions in the United States. These changes will occur in three phases:

1. First Commission Rate: Until January 15, all commissions will be maintained at the rates applicable during the period of October to December 2023.

2. Second Commission Rate: Starting from January 15, 2024, the rates for all products will be sustained as per the previous year, reflecting the period from January to September 2023.

3. Third Commission Rate: The first significant tariff adjustment is scheduled for February 5, 2024. Amazon intends to modify the intervals for categorizing products based on weight:

• For Small Standard Size, products will be categorized by 2 ounces, with the commission calculation commencing at 2 ounces. In 2023, the minimum weight was 4 ounces, and categorization was done in 4 ounces. This change, however, does not apply to clothing.
• For Large Standard Size, the ranking intervals will be 4 ounces for products weighing 1 to 20+ pounds, increasing the number of rates from 9 to 13.
• Amazon is introducing a new size category called Large Bulky, encompassing products weighing 20 to 50 pounds.
• All other products in the Oversize category will retain their current parameters but will now be referred to as Extra-Large.

Accordingly, the fees will undergo changes on February 5:

 Commissions for Regular Products:

• Small Standard Size:  The lowest remains at 3.22, and the highest increases to 3.82. Compared to the period before February 5, the smallest commission remains the same, while the largest commission has increased by 0.05.
• Large Standard Size:  The smallest commission stays the same as in the previous period at 3.86, and the largest commission will increase to 7.25, up by 0.08.
• For All Large Bulky and Extra-Large Products:  The smallest commission remains the same as in the previous period at 9.73, and the largest will increase to 194.95 from 158.49.

 For Clothing:

• Small Standard Size:  The lowest commission is 3.43, and the highest is 4.15.
• Large Standard Size:  The smallest commission remains the same as in the previous period at 4.43, and the largest commission will increase to 7.17.
• For All Large Bulky and Extra-Large Products:  The smallest commission remains the same as in the previous period at 9.73, and the largest will increase to 194.95.

This ranking and commission change are beneficial only to sellers whose products had a lower weight than the maximum weight that Amazon previously ranked. In conclusion, starting February 5, 2024, Small Standard Size and Large Standard Size products will be ranked in smaller intervals (2 and 4 ounces, respectively), resulting in a total of 21 fees instead of 13. This change may reduce fulfillment fees for product owners with weights within the new intervals.

4th Tariff:

The 2nd significant change is scheduled for April 15. Amazon plans to reduce the commissions for Small Standard Size and Large Standard Size products.

This reduction will result in lower commissions for:

 Regular Products:

• Small Standard Size:  A reduction of 15-17 cents. The lowest rate is 3.06 cents, and the highest is 3.65 cents.
• Large Standard Size:  A reduction of 17-33 cents, reaching 3.68 for the smallest rate and 6.92 for the largest.

 For Clothing:

• Small Standard Size:  A reduction of 15-17 cents. The lowest rate is 3.27, and the highest is 3.98.
• Large Standard Size:  A reduction of 17-25 cents, reaching 4.25 at the lowest rate and 6.92 at the highest.

 For Hazmat:

• Small Standard Size:  A reduction of 15-17 cents. The lowest rate is 4.03, and the highest is 4.47.
• Large Standard Size:  A reduction of 17-33 cents, reaching 4.5 for the smallest tariff and 7.38 for the largest.

In conclusion, starting April 15, 2024, sellers of Small Standard Size products may experience a reduction in commissions by 15-17 cents, and Large Standard Size products by 17-33 cents.

Changes to the Monthly Storage Fee

The Monthly Storage Fee, which is the charge for storing products in Amazon warehouses, calculated for each unit separately and debited monthly, is also undergoing changes, but these changes won’t apply universally.

Effective April 1, 2024, the Monthly Storage Fee for Small and Large Standard Size products will undergo a reduction of $0.09 per cubic foot. It’s important to note that this adjustment is applicable exclusively during the off-peak sales period, spanning from January to September.

The revised fee structure is as follows:

• Previous Rate:  $0.87 per cubic foot
• New Rate:  $0.78 per cubic foot

It’s crucial to emphasize that all other storage fees will remain unchanged, ensuring stability in cost structures for various product categories.

Storage Utilization Fee Changes

Commencing April 1, 2024, Amazon will implement modifications to the storage utilization fee, introducing charges for products with a storage utilization index of 22 weeks or more. This marks a reduction from the previous threshold of 26 weeks. Previously, these fees were differentiated based on size and categorized into four tariffs (up to 26 weeks, 26-39, 39 weeks and more, for new sellers). The updated structure will now feature additional tiers (up to 22, 22-28, 28-36, 36-44, 44-52, 52+, for new sellers).

In essence, it can be inferred that this adjustment will result in increased fees for all sellers, and sellers with an index of less than 22 weeks will now be obligated to pay this fee.

Aged Inventory Fee Adjustments

Effective February 15, 2024, Amazon will implement changes to the aged inventory fee for products stored in Amazon’s warehouses for a duration of 271 to 365 days. It is important to note that this adjustment does not impact clothing and accessories, and for inventory with a shorter storage duration, the fees will remain unchanged.

In summary, the commission will experience an increase ranging from $1.65 to $1.7 compared to the previous period until February 15, 2024:

• Term 271-300 days:  Increasing by $1.65, from $3.8 to $5.45.
• Term 301-330 days:  Increasing by $1.7, from $4 to $5.7.
• Term 331-365 days:  Increasing by $1.7, from $4.2 to $5.9.

FBA Removal, Disposal, and Liquidation Order Fee Adjustments

The expansive and financially robust US market beckons entrepreneurs, but anyone harboring dreams of establishing their business here must acquaint themselves with the FDA and its requirements.

The FDA, also known as the Food and Drug Administration, wields authority over the safety of food, drugs, cosmetics, and medical devices within the United States.

While the temptation to turn to Google for FDA registration guidance is strong, the vast expanse of the internet is riddled with inaccuracies and misinformation that can easily bewilder or, even worse, discourage you from venturing into the US market.

With over 5 years of experience, during which we’ve assisted countless clients with FDA registration, we’ve pinpointed three prevailing myths that frequently ensnare entrepreneurs navigating the intricate landscape of the FDA.

Myth #1: FDA Certification of Companies and Products

Let’s clear the air on this common misconception! The FDA doesn’t certify companies or products. As a federal executive agency, its role involves inspecting products and facilities, establishing exacting standards, and strongly encouraging adherence to these standards.

To effectively manage the vast US market, the FDA requires businesses engaged in the production of food and drugs to REGISTER with their database. By doing so, you receive a unique registration number that allows you to import regulated goods into the United States.

While your registration allows the FDA to gain a better understanding of your imported products, it’s crucial to note that there can be significant variations in FDA requirements based on the manufacturer or the specific nature of its product. So, it’s not a one-size-fits-all scenario!

Myth #2: The FDA Registration Agent – A Special Representative?

Let’s debunk another myth! Contrary to popular belief, a registration agent isn’t an official representative of the FDA. In fact, anyone residing in the US can step into this role.

The FDA mandates that foreign companies appoint a US resident as their registration agent. This individual’s duty is to serve as a communication bridge between the importer and the FDA. Importantly, they don’t need to be affiliated with an FDA support agency, dispelling the notion of “special representation.”

The registration agent’s responsibilities include establishing contact with relevant parties, coordinating inspections for the importer, and ensuring the seamless transmission of necessary documents to meet FDA requirements.

If you have a US resident at your disposal, the FDA registration process can be streamlined. However, should you require a registration agent, we’re here to offer recommendations.

Myth #3: Bypassing the FDA – A False Notion

Let’s address another common misconception: the idea that you can outsmart the FDA. This notion is far from the truth!

The FDA maintains a watchful eye over the domain of food, drugs, cosmetics, and medical devices. Depending on the nature of the product, the FDA employs several stringent control methods:

Customs Vigilance: This involves a thorough examination of products, including checking for Prior Notice (a notification of Goods Arrival in the USA), confirming the manufacturer’s registration in the FDA database, scrutinizing labels, evaluating product ingredients for safety, and verifying that the product possesses FDA marketing authorization.

On-Site Inspections: The FDA conducts inspections at the points of sale and storage facilities.

Post-Consumer Complaint Inspections: If a consumer raises concerns, the FDA investigates.

In any scenario, the FDA wields the authority to remove or recall products, even going so far as to send them back to their country of origin. Hence, when a seller peddles products with prohibited ingredients or lacking proper licenses, it’s merely a matter of time before it faces consequences.

The cost of the financial and reputational fallout for a brand caught in this web of non-compliance can be far greater than if they had proactively tested their products and met the FDA’s requirements. Remember, compliance is the key to success in the market. Shortcuts simply don’t pay off in the long run!

Conclusion

For any aspiring entrepreneurs eyeing to tap the vast US market, here’s a crucial principle to incorporate into your business strategy: If your export portfolio includes food, drugs, cosmetics, or medical devices, gearing up for FDA registration is likely to be a part of your playbook. Attempting to sidestep this requirement can spell serious trouble, especially on the financial front.

FDA registration isn’t merely an entry point into the US market; it also functions as a badge of product quality and a trust-boosting tool for consumers.

A crucial prerequisite for FDA registration is the appointment of a US resident registration agent. Should you encounter difficulties in securing such an agent, don’t worry! We stand ready to provide our expertise and suggest reliable agents who can fulfill this role.

Navigating the FDA registration process is not a daunting endeavor when you have the right guidance. Get in touch with us, and we’ll guide you through the process, ensuring you secure your registration number with the Food and Drug Administration effortlessly! Your journey into the US market awaits.

Account Registration and Verification

• Data verification is critical in the registration process, often requiring documentation to support the provided information. However, this step can be time-consuming and can often be complex.
• Amazon may reject a registration, even if all submitted documents meet their requirements. For more information on account verification, please refer to our article: https://disqover.agency/yak-zareyestruvatisya-i-prodavati-na-amazon-instrukciya/ .
• Sometimes, a rejection seems arbitrary, necessitating a thorough investigation as to what the underlying cause is.
• During the video verification process, unexpected questions about your business may arise.
• Securing utility bill information and an official address card can be challenging, particularly if your company lacks access to an official address or does not operate from one. Meeting these requirements with the correct documentation can be extremely complicated.