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Cosmetics Regulatory Compliance

Turn to professionals who know your industry's regulatory compliance needs.

All cosmetic products must be manufactured, labeled, registered, and sold in compliance with the cosmetic laws under the authority of both the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). If a product will be exported then it must also follow international regulations. Regulatory consultants offer a full range of regulatory solutions to assist firms in complying with those requirements. Regulatory compliance consultants will review your cosmetic products to ensure that all claims are permissible for cosmetics and that all required information is present on labels and that ingredient listings are provided in the required formats. It is important that therapeutic claims do not appear on the labels of cosmetic products or the product could be classified as a drug or natural health product.

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Manufacturers and brand owners of cosmetics must comply with MoCRA as of December 29, 2023. it sets new requirements for cosmetics sold in the USA. Obelis USA is here to support you! If you are in the USA or abroad, we can be your professional consultant or US Agent. We take care of all regulatory requirements: FDA registrations, adverse events, safety substantiation, labelling, and much more.

location_on Cincinnati, United States
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As the world’s leading testing, inspection and certification company, we can assist you in navigating and complying with national and international standards across all your key risk areas. SGS is the only provider able to offer a comprehensive range of quality, safety, sustainability, security and social expertise to help our partners efficiently and effectively manage operational risk.

location_on Rutherford, United States
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Cosmeservice arose from the experience of highly qualified professionals in Cosmetic Safety and Regulation. We offer comprehensive advice/service to cosmetic manufacturers and distributors in compliance with the regulatory requirements of the European Regulation. The purpose of Cosmeservice is to actively contribute to the consolidation of manufacturers and distributors in the European cosmetic market. We opera

location_on Jerez de la Frontera, Spain
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Founded in 2007, Pharmadocx is an India based consultation firm providing services to Cosmetics & Ayurvedic Industries. We provide: Technical Consultation for Setting up Cosmetics & Ayurvedic manufacturing facilities, our package include designing of layout, in autocad format, MEP Designing, providing list & sources of Machinery, Turnkey Project. We also provide regulatory services for grant of cosmetics License

location_on Sonipat, India
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If you are thinking of hiring a consulting firm to be your quality and regulatory solutions provider, we are the right fit. Our experience affords us many connections in an ever-growing network. We keep our operations lean and efficient, and continuously fine-tune our processes without sacrificing service quality. Fast Projects Completion! One-Stop Shop! Our History Is In Compliance but we are much moree.

location_on Burlington, Canada
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Celmark International is a leading, FDA compliant, contract manufacturer of topical skincare, beauty products, and liquid nutritional supplements for the international Health, Beauty and Accessories (“HBA”) and Vitamins, Minerals, and Supplements (“VMS”) industries. Manufacturing, operations, and offices are located in Orlando, Florida.

location_on Orlando, United States
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We are a professional consultancy that provides regulatory services to international manufacturers who intend to import cosmetics into Italy and throughout Europe. We offer regulatory advice to provide solutions for the importation and the sales of cosmetic products.

location_on Rome, Italy
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We help companies around the world to market and export their cosmetic products while complying with applicable regulations in more than 30 countries, including Europe, the United States, the United Kingdom and Canada. We work easily, quickly and in a didactic way, adding value to society in each project.

location_on Barcelona, Spain
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Producing High-Quality Bulk Cosmetics of International Standards Thincen Cosmetics: Your Quality Partner for Global Beauty Brands Global reach in 120+ countries, including US, UK, and EU Adherence to strict regulatory and quality standards Unwavering commitment to quality from raw materials to final inspection Rigorous quality control process exceeding industry benchmarks Dedicated account and after-sales managers for personalized support Comprehensive �babysitting service� for attention to detail and communication Bulk manufacturing for new product lines or expanding existing ranges Trusted

location_on shenzhen, China
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Obelis has over 25 years of Regulatory Expertise pertaining to the European Community and serving as a professional EU "responsible person" in accordance with Cosmetics Regulation EC 1223/2009. Services: PIF compilation, Pre-Market Notification (Registration), Safety Assessment, EU Safety Testing, EU Address, Ongoing EU Regulatory Strategy, Regulatory Updates, and more. Let us be your gateway to the EU Market!

location_on Brussels, Belgium
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Personal Care Regulatory Ltd. is a proud service provider for overseas brands who need EU/UK compliance and responsible person service. We provide fast efficient and affordable RP service for brands who want to assure compliance in the UK/EU. Services: Safety assessment report (CPSR); Responsible Person (RP); Producing PIF; label review to ensure EU/UK complaince; Testings.

location_on cambridge, United Kingdom
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Ithos Global is an IT organization with extensive knowledge of compliance for the cosmetic and nutrition industries, providing companies with the ability to search through regulations, generate compliance reports, access and organize supplier documentation and information, visualize work-flows, and more so that they can expand into new and existing markets, all while ensuring compliance.

location_on TROY, United States
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Colella Legal Studio is a boutique business and trademark law firm with a concentration on beauty-based businesses. The firm helps beauty brands with brand protection, contracts, corporate matters and regulatory matters.

location_on Haverford, United States
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Ingredient SAFETM is a regulatory reporting system designed to simplify the compliance reporting process needed to commercialize products across multiple jurisdictions. Register to Ingredient SAFETM and start streamlining your compliance reporting today.

location_on TROY, United States
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Whether you want to develop a range of face care, body care or hair care products, we offer you our expertise and adaptability. Each of our products is uniquely developed in accordance with your specifications. We assure the highest level of quality and deliver at your earliest convenience.

location_on La Seyne-sur-Mer, France
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Industry leading experts in Regulatory Affairs & Quality Assurance for Cosmetics, OTC Drugs and Natural Health Products in United States and Canada. We can assist you in product registration, testing, clinical trials, labeling, ingredient and advertising compliance, NHP and DIN approvals, claims management and GMP audits. We work with small, medium and large corporations, as well as with industry associations and governments.

location_on East Mississauga, Canada

Entering the Cosmetic Business is possible if you understand how it works and you establish clear goals.

The Cosmetic Business is divided up into several general areas:

Please read along about the first steps in Lone Star Laboratories Cosmetics, or you can directly browse the information categories in the top menu.

These products can be produced for you by companies that specialize in one or several of these areas. If you want a line of products with your label on the package you have two potential directions: Private Label and Contract Filler.

If your quantities are really small, you might even want to consider making your own blends and filling your own bottles. It all depends on what quantity of each product you want and how "custom" the products need to be. Generally, if the quantity is small and you are willing to accept the product types and packaging that already exists - your choice would be a Private Label house. The Private Label company maintains a ready supply of components and finished goods. By using different variations and combinations, and applying your custom labeling or decoration, you can usually find a satisfactory "custom" look.

Once your quantity requirements get larger (several thousand per item) a Contract Filler might be a better choice. You become responsible for providing the packaging components, labels, etc., and the Filler makes the formula and fills your components. What you get is a truly custom product from formula to packaging, but a lot more depends on you.

In both cases, selling products under your name makes you legally responsible for the product in all areas including labeling (regulated by the FDA) and product claims. And the FDA has determined that your claims include not only what you say on the label but what you say in any brochures or other advertising material. You will also be the first one contacted if a consumer experiences any adverse reactions to your product. This means you should educate yourself about such things as stability, shelf life, and Product Liability Insurance.

CosmeticIndex.com has several resources that can provide orientation about Lone Star Laboratories Cosmetics. Check out Industry Resources and Trade Associations. ICMAD (Independent Cosmetic Manufacturers and Distributors) is the appropriate trade association for companies entering the industry. ICMAD can provide general guidance on regulations and government support and even has a Group Products Liability Policy for members.

Private Label: Getting finished products made with your label in small quantities.

Ideal for

Quantities: a few pieces up to several hundred of each product
What you need: almost nothing but money and an idea of the types of products you want.
Advantages: gets you into the business fast without large startup or inventory costs
Disadvantages: you are limited to the shades, products, and packaging carried by the supplier.

Contract Filling: Getting products made with your label in larger quantities.

Ideal for

Quantities: usually 5000 pieces with the exception of shaded items which are usually 2000 pieces per shade.
What you need: packaging, artwork, displays and possibly consultants in marketing and product design.
Advantages: Custom made products from the ground up, and lower per piece cost.
Disadvantages: requires a large investment and support staff.
Alternative suggestions: If you don't have expertise in the Cosmetic Industry consider using consultants. Some can act as your marketing and product development staff. Some specialize in technical, formulation and regulatory issues. Some, called Full Service Development Companies can put together an entire line of products using their knowledge and experience, and will arrange for everything from formulation development to the final package.
Special note on Fragrances: To produce a custom fragrance in small quantities is a difficult task. You must first work with one of the essential oil houses who will blend the ingredients according to your guidelines. Then you must locate a filler who will do the rest of the steps necessary to bring the essential oils into a finished product like a perfume, cologne, etc.
Accessories and Displays: Accessories such as brushes, applicators, etc. as well as counter displays, tester displays, can be bought in both small and large quantities.

If you are thinking about starting your own cosmetics line, and would like to receive quotations for your ingredients, packaging, labels, etc, please browse the categories in the left menu and contact the companies in the appropriate category. This would be a starting point to learn about Lone Star Laboratories Cosmetics.

If you want to advertise your cosmetics company, you can sign up below, for free, and get a listing in one of our supplier categories. This way you will be able to find you when they search for "Lone Star Laboratories Cosmetics".