Deciphering FDA cosmetic regulations is a bit like solving a puzzle. There are clear directives guiding the manufacture and packaging of a cosmetic product, others to prevent misbranding, adulteration, or the use of certain banned substances. But deciding whether a product is a cosmetic or a drug — and which regulations apply to which product — can be like trying to fit jagged pieces together while blindfolded and with one hand tied behind your back.
The t... Continue reading
Directive 76/768/EEC has been governing the composition, labeling, and packaging of finished cosmetic products in the European Union (EU) since 1976 and required that manufacturers keep a record of all pertinent product information. In 2003, the Directive was revised to include new requirements for a more detailed product information file (PIF) and a cosmetic safety assessment.
In 2009, Regulation (EC) N° 1223/2009 was adopted, becoming the primary regulatory standard for cosmetic products created and proposed for sale on the EU market. This regulation gre... Continue reading
If you manufacture or market a cosmetic product that exposes individuals to potentially hazardous chemicals, then you are legally required to inform them of these hazards. This is the idea behind a Safety Data Sheet (SDS).
A Safety Data Sheet gives information about the chemical composition, physical and chemical properties, and associated health risks to individuals and the environment. If you manufacture or market beauty or skincare products, an SDS is necessary in order fo... Continue reading
Many health benefits and uses of CBD oil are being explored, however, conclusive research is still required in many of these areas. Cannabidiol (CBD) oil is quickly becoming more popular in the beauty industry. The movement has been gaining momentum for a long time but is now starting to take off in popularity after the legalization of marijuana in certain states. Still, navigating a regulatory minefield is a necessity to marketing a CBD oil product successfully and avoiding any unwanted state or federal level scrutiny. It is critical to have a clear understanding of a product's claims and its intended benefits since t... Continue reading
ECHA continues to move forward with formally establishing a ban on silicone materials D4, D5, D6, which are widely used in cosmetic products within the EU. Existing as of today, REACH Annex XVII restricted substances (EU) 2018/35 released January 10, 2018, states cosmetic products containing D4 and D5 shall not be placed on the market in wash-off cosmetic products in a concentration equal to or greater than 0.1% by weight of either substance after January 31, 2020. This restriction allows for the presence of these substances at less than 0.1% within the final formulation as residual material only and not intentionally... Continue reading
The FDA issued the Sunscreen Drug Products for Over-the-Counter Human Use Proposed Final Monograph on February 26, 2019, which categorizes the most current Sunscreen Active Ingredients as Category 3 (additional data needed). It calls for several new tests on sunscreen active ingredients in order for them to be reinstated to Category 1 (generally recognized as safe and effective).
I... Continue reading
New York has introduced Assembly Bill 6295 to amend the Environmental Conservation Law in regards to prohibiting the use of 1,4-Dioxane in personal cosmetic products and household cleansing products, which is designed to help prevent water contamination from this ingredient.
The Environmental Protection Agency (EPA) identifies 1,4-Dioxane as a "likely carcinogen to humans," which is currently found in cosmetics, detergents, deodorants and shampoos. Once used by consumers, the ingredient ends up washed down the drain and enters local water sy... Continue reading
With initial guidance documents now available in regards to how manufacturers list nutrition information on their products, the Food and Drug Administration (FDA) hopes to eliminate consumer’s misperceptions around what exactly they’re putting in their bodies.
For manufacturers, this means increased specificity in listing nutrition information, a nutrition label redesign, rethinking the portion sizes of their produ... Continue reading
Businesses and manufacturers in California face stricter regulations around how they create and place product warning labels on their products. This bill, known as California Proposition 65, is poised to clear up ambiguity and hold corporations accountable for potentially exposing their customers to any naturally occurring or synthetic chemicals in their goods that are known to the state of California to cause cancer, congenital disabilities, or to harm the reproductive process.
What is Prop 65?
The cosmetics industry is facing some major regulation changes within the EU in 2019 and awareness is key to staying ahead of the game in terms of compliance. Among these changes should be some form of final outcome regarding Brexit and potential separation from the EU. Clarity is certainly needed to mitigate considerable disruption to companies intending to do business in the UK.
The EU industry's inspection priorities have been identified by the Health Authorities. These include Nanomaterials, Organic & Natural claims, Metrology contr... Continue reading
Ithos Global has created the full-service software Ingredient Search, providing customers with the ability to explore INCI ingredients, associated Raw Materials that contain these INCI substances and determine potential regulated restrictions on a worldwide scale.
General substance information and regulatory data are now available for over 24,000 INCI level substances spanning more than 50 countries. In order to simplify the INCI search process, Ithos Global has incorporated a variety of search capabilities — from application requireme... Continue reading
California legislatures recently introduced AB-1080 and SB-54 — known as the California Circular Economy and Plastic Pollution Reduction Act — that is meant to establish a comprehensive plan to "reduce and recycle" 75 percent of single-use plastics by 2030.
By January 1, 2022, the bill calls for manufacturers of single-use plastic packaging or products distributed and sold in California to exhibit a recycling rate of at least 20 percent. By 2026, the recycling rate increases to at least 40 percent, and by 2030, all products would need t... Continue reading
Discussions continue to happen around the future of sunscreen and what's permitted in product formulations. The FDA and ingredient committees have plans to meet on a continual basis to discuss which ingredients should be protected vs. which ingredients should be removed from use. Experts are included in these conversations to help determine the appropriate path for sunscreen. The FDA in this Proposed Final Monograph is focused on collecting more safety data,... Continue reading
Earlier this year, AB No. 495 was introduced to amend the California Safe Cosmetics Act (CSCA) of 2005. The CSCA would require cosmetics manufacturers selling products in California subject to FDA regulation to provide the Division of Environmental and Occupational Disease Control with a list of all cosmetic products that contain an ingredient identified as a chemical that causes cancer or birth defects.
The purpose of AB No. 495 is to enforce the California Legislature's intent to enact legislation that would improve the oversight of "harmfu... Continue reading
Ithos Global will announce its strategic partnership with Delphic HSE at In-Cosmetics Global in Paris, France at stand R111. The companies are creating a commercialization partnership to heighten the value provided to clients in the cosmetics industry and foster the successful management of global registrations for new products.
This partnership provides a full-service regulatory system for companies looking to commercialize products by combining the global regulatory managed content solutions and services from Ithos Global, with the global toxicology, product safety and compliance knowledge... Continue reading
In the past, makeup companies have raised concerns among consumers and regulatory agencies in regards to possible health and safety concerns. However, in the last decade, work has begun to ensure the safety of consumers.
With a consumer driven need for more stringent cosmetic regulations on products, the beauty industry is taking steps to respond to these concerns. Consumer driven marketing for more products with natural or organic claims or those t... Continue reading
Put into force in 2018, Canada's Cannabis Act states that one year following its passage, the sale of "edibles containing cannabis" and "cannabis concentrates" is legally authorized. Because of this, amendments to the Cannabis Regulations are required to manage the public health and public safety risks of these new classes of cannabis, as well as a proposed order amending Schedule 4 of the Cannabis Act, both of which were published for consultation in the Canada Gazette on December 22, 2018.
Note that this proposed regulation has not yet gon... Continue reading
On February 26, 2019, the FDA published a new version of the Sunscreen Tentative Final Monograph (TFM) , which applies to nonprescription, over-the-counter (OTC) sunscreen products. This version addresses previous issues such as active ingredients, dosage forms, and SPF maximum value that were covered in the Unified Agenda, as well as new and significant changes of additional safety data required to establish that ingredients are GRASE.
In November 2018, the Andean Community passed Decision 833 “Harmonization of legislation on cosmetic products,” which establishes requirements and regulations for cosmetic products manufactured in Bolivia, Ecuador, Peru, and Columbia.
Decision 833 regulates production, storage, implementation, and commercialization of cosmetic products within the Andean Community, which goes into effect November 2019. In addition, cosmetic products must be manufactured in conformance with Good Manufacturing Practices (GMP) which will have a specific Andea... Continue reading
In a statement, Key West Mayor Teri Johnston said it's the commission's "obligation" to protect the Florida Reef – a beautiful ecosystem that stretches almost 150 miles and is the only living coral barrier reef in the continental United States.Sunscreen Bans in the U.S. and Beyond
States such a... Continue reading
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