What is it?

New York now requires manufacturers (including importers or first domestic distributors) of children’s products containing certain toxic chemicals to disclose information on their use at practical quantification limits (PQLs).

The signed senate bill adds Title IX “Toxic Chemicals in Children’s Products” to Article 37 of the Environmental Conservation Law, in relation to regulation of toxic chemicals in children’s products. New York’s Environmental Conservation Law (ECL) Article 37 Title 9 establishes an ingredient disclosure program and prohibits certain chemicals in children’s products, which includes cosmetics marketed to children. This will establish a children’s product safety council and reorganize the regulatory framework for the New York State Department of Environmental Conservation (NYSDEC) to designate chemicals of concern (CoC) and high-priority chemicals (HPC).

The original law contains an initial list of 103 entries for CoC and a list f 9 entries for “dangerous chemicals” (DCs), which the NYSDEC published on their NYSDEC website. “These lists are reviewed periodically and reporting requirements for children’s products containing a DC or CoC at PQLs levels within 12 months after a DC has been added to the list and fee requirements, and waivers for reporting. Additionally, children’s products containing specific DCs will be prohibited from January 1, 2023.

What’s the impact?

Manufacturers and distributors must disclose if they are using certain chemicals in children’s products at PQLs. Some children may have been harmed from products that contained toxic chemicals that were not disclosed earlier.

When is it happening?

The original Act became effective on March 1st, 2020. On February 7th, 2020, the governor signed into law SB S501-B regarding toxic chemicals in children’s products. The law requires DEC to promulgate lists of chemicals of concern and high-priority chemicals that must be disclosed if present in children’s products by March 1, 2022. This law also prohibits the sale of children’s products containing benzene, asbestos, or tris (1,3-dichloro-2-propyl) phosphate by January 1, 2023.

After a period of public comment, this law is still being reviewed. From the NY DEC website, “NY DEC is in the the process of developing a rule to implement portions of the law. The rule is expected to address the specific product categories that are covered, what chemicals and supporting information must be disclosed, details on how to obtain a waver from reporting or the sales prohibition, and the fees associated with reporting and applying for a waiver.”

What are the next steps?

The new law aims to increase consumer awareness of the listed chemicals of concern with the goal of reducing potential childhood exposure. As consumer transparency requirements increase and there becomes more awareness on how to avoid products with these chemicals, manufacturers are likely to reformulate and redesign to remove the concerning chemicals and materials used in such products.

Do you have questions about the impact of this law on your products? Looking for help with compliance documentation? The Ithos Information Network Software (IIN) can save valuable time and money. Contact us for a free demo.

What is it?

The International Fragrance Association published its 50th Amendment, addressing “the prohibition of use for the fragrance material Mintlactone. According to IFRA’s Expert Panel for Fragrance Safety Rationale “The material Mintlactone has been reviewed by the Expert Panel for Fragrance Safety with the conclusion that it cannot be safely used as a fragrance ingredient. If the substance is found as an impurity in other fragrance ingredients, please check the latest version of the Guidance to the IFRA Standards for the respective IFRA procedure.”

This amendment comes in addition to previous Amendments to the IFRA Code of Practice. As a consequence, all elements of the 49th Amendment, as notified January 10, 2020, addressing other fragrance materials, remain unchanged and in place.

What’s the impact?

As of August 30, 2021, no new fragrances may contain Mintlactone. As of July 30, 2022, existing fragrances cannot include the ingredient. Fragrance houses that formulate with Mintlactone must comply with this new IFRA 50 standard. As seen with other previous fragrance ingredient bans, reformulating multiple fragrances could prove a costly endeavor.

When is it happening?

By August 30, 2021, all standards entering into force for new creations (fragrance mixtures only, not the finished product) needed to comply with IFRA 50. By July 30, 2022, all standards entering into force for existing creations (fragrance mixtures only, not the finished product) must comply with IFRA 50.  Finished product impacts will be tracked as this ban may be picked up by various regulatory bodies in the EU.

What are the next steps?

Ithos is currently ensuring all clients are aware of and fully understand the new IFRA 50 Standard, including the impact on finished goods. If you currenly formulate with Mintlactone, contact us to set up a time to review the document and impact on your products.

What is it?

The FDA has published a new draft guidance document updating the OTC reporting requirements. The March 2020 Coronavirus Aid, Relief, and Economic Security Act (CARES Act) includes a requirement for annual reporting on the amount of each listed drug product that was manufactured, prepared, propagated, compounded, or processed for commercial distribution.

This guidance is officially called “Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act.”

Action: Stakeholders in OTC manufacture should read the Guidance Document and Technical Conformance Guide to better understand the new reporting obligations.

What’s the impact of FDA’s new OTC Reporting requirements?

“This draft guidance is intended to assist registrants of drug establishments in submitting to FDA reports on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution, as required by section 510(j)(3) of the FD&C Act. The draft guidance addresses the content of reports, the timing of reports, and the process for report submission.”

In summary, this draft guidance will change the method in which Drug Listings are performed. The CARES Act “included authorities to enhance FDA’s ability to identify, prevent, and mitigate possible drug shortages, among other things, improving FDA’s visibility into drug supply chains.”

When is it happening?

The CARES Act was enacted on March 27th, 2020. The Guidance Document was published on November 1st, 2021, and distributed for public comments, ending January 3rd, 2022. 

What are the next steps?

The final version of the Guidance Document is expected sometime in 2022. Although OTC reporting is required annually, the FDA suggests reporting the amount of drug releases each month. 

Have cosmetic compliance questions about your products, formulas, or ingredients? Looking to bring products to new markets? We can help. Contact us today.

As of January 1, 2022, New York State has banned all but trace amounts of 1,4 Dioxane in cosmetics, personal care, and cleaning products. The ban starts with a phase-down schedule: permissible levels of the substance will start at 10 parts per million (ppm) for cosmetics, going down to 1ppm for certain personal care and cleaning products by the end of 2023.

Though the 1,4 Dioxane is not added directly to consumer product formulas, the synthetic industrial chemical can be introduced as a trace contaminant in certain ingredients, most significantly detergents, foaming agents, emulsifiers and solvents. They are identifiable as:

  • PEG
  • Polyethylene
  • Polyethylene Glycol
  • Polyoxyethylene
  • -eth
  • -oxynol
  • POE

The law has separate limitations for three categories of consumer products: cosmetics, personal care, and household products. The latter two are known to generally contain higher levels of 1,4 Dioxane. 

How to Comply with 1, 4 Dioxane Ban, Suggested Next Steps, and Tips

To meet the law’s phase-down schedule, Ithos recommends the following:

  1. Determine the specification of 1,4 Dioxane in your raw materials, especially the ones that fall into the above categories. This should be based on a guaranteed maximum specification and not a one time test level.
  2. Review each formula and determine/calculate the total 1,4 Dioxane content in ppm.  Analytical testing on certain bases or formulas can also help to get an idea of levels of 1,4 Dioxane. Remember that levels can vary lot to lot.
  3. Compare the result in Step 2 to the product category and the maximum allowable limit for the relevant product classification.
  4. Work with your raw material supplier to try to set a lower maximum level if possible.
  5. Update your internal ingredient policy and train internal technical teams, suppliers, and third party manufacturers on the updates to the policy.
  6. Reformulate as required. Utilize restages where possible to formulate without sulfates.

Have questions?  Contact us.

Manufacturers may apply for a one-year waiver for a specific product if they are able to submit proof that they have taken steps to reduce the presence of 1,4 Dioxane and are still unable to meet the statutory limits. 

Upon the expiration of a waiver, any product that contains 1,4-dioxane in excess of the maximum trace concentrations in the law cannot be sold in the State.
Non-compliance with this law can result in these civil penalties:

  • $1000 per day per violation
  • $2500 per day per violation for second violations

More detail about the 1,4 Dioxane ban

The law describes cosmetics as any article intended to be rubbed, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for beautifying, promoting attractiveness, or altering the appearance, as well as any substance intended for use as a component of a cosmetic product

Personal care products will be defined under the new New York State law as any product intended for cleaning or cleansing any part of the body, such as the skin and hair, and including but not limited to, hair shampoo, hair conditioner, soap, bath gels and other bath products. This does not include any products that require a prescription for distribution. 

The law also sets limits for 1,4 Dioxane in household cleaning products, which includes soaps and detergents containing a surfactant as an emulsifying agent, and used primarily for domestic or commercial cleaning purposes.

Timeline

  • March 2019: New York State bill is introduced.
  • June 2019: Bill passed by NY State Assembly and Senate.
  • December 2019: Signed into law by Governor Cuomo.
  • January 1, 2022: Law goes into effect. The maximum amount of 1,4 Dioxane allowed will be: 
    • Cosmetics: 10 ppm by December 31, 2022.
    • Personal care and household cleaning products:  2 ppm by December 31, 2022, further reduced to 1 ppm by December 31, 2023.

Every two years after the bill goes into effect, trace concentration thresholds will be reviewed and determined whether such concentration needs to be lowered to better protect human health and the environment.

This is not the first time 1,4 Dioxane has become subject to regulation. In California, the substance is on the CA Prop 65 list and may be entered into raw material attributes in the IIN, if applicable.

1,4 Dioxane has an NSRL (no significant risk level) of 30 micrograms/day. To ensure full compliance with CA Prop 65 labeling requirements, a calculation should be done to determine the micrograms/day of exposure based on the 1,4 Dioxane level and reasonably expected maximum daily use of the product.

Please watch the Ithos Newsletter for any updates. Please contact Ithos if you need assistance with the NYS 1,4 Dioxane waiver process.

For more information on the 1,4 Dioxane ban, visit the New York State Department of Environmental Conservation.  

Part 1: Understanding Key Regulations and Regulatory Agencies

The cosmetics industry is thriving, largely unaffected by fluctuations in global or local economies. Every week, it seems, new products are introduced to the market to help keep skin smooth, hair silky, teeth gleaming, and beards trimmed. Cosmetic usage is consistently increasing across demographic groups, and shows no signs of slowing down, with a projected worldwide revenue of $860 billion USD by 2024. Not too bad for an industry with so many regulatory hurdles to clear on the way to the product launch finish line. With that in mind, it’s important to understand cosmetic regulations and the EU for brands that wish to expand into Europe.

But with all that glorious capital comes responsibility, and cosmetic manufacturers in the E.U. are held to a set of standards to ensure that the products they sell are safe for consumers to use. Cosmetic regulations in the E.U. are similar to the U.S. in that they ensure product safety but differ when it comes to banning certain chemicals and restricting the type of testing done to assess product and ingredient safety. E.U. cosmetic regulations are usually more prescriptive and require more regimented documentation from manufacturers and suppliers before a product can be released to the market. 

Cosmetic Regulations and the EU – Key Things You Should Know

Regulation (EC) N° 1223/2009 is the primary legislation for cosmetic products created and proposed for sale in the European market, greatly reinforcing product safety by ensuring that manufacturers maintain proper records for the cosmetics they develop, namely a more detailed cosmetic safety assessment and a complete product information file. 1223/2009 also provides clearer direction on the definition of a cosmetic product and introduces the concept of a responsible person named as the owner and primary contact for the product.

1223/2009 defines cosmetic products as “any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.” Manufacturers are encouraged to check with their designated competent authority to verify how a cosmetic is defined in a given area, as it may vary slightly. 

It is also important to note that many products that are considered OTC drugs in the United States by definition are cosmetics in the EU. These include sunscreens, antiperspirants, shampoos, and toothpastes. Anti-acne products, however, fall under the Medicines Directive (Directive EU2001/83/EC and Regulation EC 726/2004.

Because consumers are presented with a variety of claims as to the effect a product will have on their bodies, 1223/2009 clarifies requirements for product labelling and mandates that any product claims must be substantiated with evidence. Regulation (EU) No 655/2013 expands on this requirement by establishing common criteria for cosmetic product claims. These criteria do not specify the exact wording to be used in a product claim but require that all messaging remain compliant and that the responsible person maintains documented evidence to support posted claims. A technical document on Cosmetic Claims was developed as a tool to help guide advertisers, but ultimately, the local competent authorities are responsible for providing more clarity and direction. 

These regulations are enforced at the national and regional level by competent authorities, named by member states to monitor compliance. These authorities act on behalf of government in compliance with E.U. laws and perform post-market surveillance of products. In addition, the European Commission (EC) communicates with stakeholders at the national and international levels to streamline the exchange of information and ensure smoother implementation of requirements across the industry.

Non-Governmental Regulatory Agencies

EC legislation is not the only source of cosmetic regulation. Member states often enact their own laws regarding cosmetics, relying heavily on input from industry groups and independent organizations. It is therefore advantageous for cosmetic manufacturers to collaborate with these organizations when developing new products in order to avoid stumbling over a last-minute hurdle:

  • Scientific Committee on Consumer Safety – The SCCS reviews cosmetic ingredients and determines whether the ingredient is safe to use and at what level.
  • International Fragrance Association  – IFRA is a trade association who sets standards for its members, which often become law. Perfumes not meeting the standard can’t be compounded or purchased after the determined cut-off date.
  • Cosmetic, Toiletry and Perfumery Association – The CTPA is the leading trade association for cosmetic manufacturers in the U.K., publishing a wealth of cosmetic safety information on their website.
  • Cosmetics Europe  – Formerly COLIPA, is an umbrella trade association. CE works with many different entities and produces guidance and interpretation of regulations and legislation, as well as lobbying for or against legislation.
  • Medical Products Agency – This Swedish agency promotes alignment with E.U. regulations but has also adopted tougher standards for preservatives.

Prohibited Substances and Practices

E.U. cosmetics regulations prohibit the use of over 1,000 substances, the vast majority of which have never been used – or considered for use – in products made in the E.U. This ban also applies to products imported from other countries that still allow the use of the prohibited ingredients.

One of the great recent advances in cosmetic technology is the development of nanomaterials. These microparticles have made inroads into multiple products, and the E.U. has strict regulations regarding their use. All nanomaterials – other than previously approved colorants, preservatives, and UV filters – must be authorized by the EC prior to use, and finished products containing nanomaterials must be presented to the Commission for review six months in advance of market release.

1223/2009 implemented a comprehensive ban on the testing of ingredients and finished cosmetics on animals in 2013. Cosmetic manufacturers can no longer use animal testing as part of their safety assessment for new ingredients, nor can they use suppliers who perform animal testing on ingredients after the cut off date (2009 or 2013 depending on the test) and must rely on alternative testing methods to validate the safety of their products.  

Clearing Hurdles to Success

Like their counterparts in the U.S. and elsewhere, cosmetic manufacturers in the European Union strive to provide safe products to consumers and make substantial investments in evaluating and documenting the safety of their products. As the industry continues to innovate new products and expand into new markets, cosmetics will remain one of the most tightly regulated products sold in the E.U., leaving manufacturers racing along the regulatory track while striving to remain profitable. But clearing the regulatory hurdles means that cosmetics released to market will remain one of the safest products available to consumers, fostering faith in the products and establishing long-term loyalty to brands they know and trust.

Part 2: Cosmetic Product Development and the Key Phases of Compliance

Despite the many regulatory challenges that present themselves when trying to bring a product to market, cosmetic manufacturers are committed to providing safe products to consumers. But identifying the key cosmetic regulations and becoming acquainted with the various governmental and industry agencies are only the first stages of ensuring compliance during the cosmetic product development process. Everyone involved in the product development and supply chain has a role in achieving compliance and should have a solid understanding of the regulations associated with each step.

Role of the Responsible Person

The EU cosmetics directive introduced the concept of a designated Responsible Person to be in charge of overall compliance. A Responsible Person should be defined as a “Natural or legal person designated within the Community” that represents all countries within the EU per Article 4 of the Cosmetic Regulation (EC) No 1223/2009. The Responsible Person can be a consulting firm, manufacturer, importer, or distributor. This designee serves as the primary contact for all external communication regarding the product, its safety and its functions, and is the gatekeeper for all documentation associated with the cosmetic product development process. This designee serves as the primary contact for consumer and local health authority questions or complaints, oversees all cosmetic product development testing, and ensures that the cosmetic product development process aligns with good manufacturing practices (GMP) at the production level and incorporates animal testing restrictions where applicable.

This designated person is responsible for ensuring the development and maintenance of the product information file (PIF) and ensuring that the cosmetic safety assessment has been performed by an appropriately qualified and credentialed assessor. The Responsible Person is accountable for substantiation of any product claims, the compliance and accuracy of cosmetic product labels, and communication of any undesirable effects to the European Commission. The responsible person is charged with submitting the pre-market notification to the EU’s Cosmetic Product Notification Portal (CPNP), the last step required before releasing the product for sale.

The role of the Responsible Person can be challenging due to the long list of compliance obligations, therefore any candidate for the role should be appropriately credentialed and have the appropriate experience and in-depth knowledge of the cosmetics industry and all applicable regulations. Note that these responsibilities can be delegated within the company, or a “third party” can be hired as the Responsible Person.

What Does PIF Mean?

The product information file (PIF) is a primary responsibility for the designated Responsible Person. EU Cosmetic Regulation 1223/2009 states “when a cosmetic product is placed on the market the Responsible Person shall keep a product information file for it.” It is important for the manufacturer to ensure PIF information is prepared during cosmetic product development so the Responsible Person can perform responsibilities in accordance with EU safety standards and industry best practices.

The PIF is a detailed accounting of product development and must contain the list of ingredients, product claims, and any use precautions or possible side effects that may occur, in addition to the following elements:

  • Detailed description of the cosmetic product
  • Complete Cosmetic Safety Report (including a full cosmetic safety assessment)
  • Description of the production process
  • A statement of compliance with good manufacturing practices
  • Proof of the effects claimed for the cosmetic product
  • Evidence of compliance related to any animal testing performed on a cosmetic product or its ingredients
  • Product labeling, which includes primary and secondary packaging
  • Other elements as indicated in Article 11 of the Cosmetics Regulation 1223/2009

The Responsible Person is accountable for the creation, storage, and maintenance of this mandatory file, which is comprised of documents from multiple stakeholders and must be kept on file for 10 years following placement of the last batch of products on the market. The Responsible Person must have a complete copy of the PIF available for review at any time by the local competent authority, in a language the authority in the designated location,underlined if multiple addresses  are on the label, can interpret. As a point of information, authorities are supposed to ask for specific information, not the entire PIF, if an issue comes up.

Product Formulation

One of the key pieces of information in the PIF is the cosmetic product formulation, and achieving compliance at this stage requires careful sourcing of raw materials. As a first step, developers should check the International Nomenclature Cosmetic Ingredient (INCI) database, which lists the universal industry names of raw materials and other ingredients that may contain INCI substances. 

Next, each potential ingredient needs to be screened for compliance with all regional and local regulations, including restrictions and prohibitions in the Cosmetic Regulation 1223/2009 annexes, and some ingredients – especially those on the Substances of Very High Concern list – must be checked for European Chemicals Agency (ECHA) registration status. Some substances on the SVHC list require authorization by ECHA prior to use and may have concentration restrictions limiting their use. Other ingredients may be used, however, it is wise to ensure INCI Dictionary and COSING listings.

The finished product must also demonstrate similar compliance, adhering to the same cosmetic regulations as raw materials. The Responsible Person must have documented evidence of safety, performance claim, and any relevant development testing of the finished product on file.

Compliant Labeling

Cosmetic labels are strictly regulated and must contain the following information, as laid out in Regulation (EC) N° 1223/2009:

  • Name and address of the designated Responsible Person 
  • County of origin (unless the product was made in Europe)
  • Nominal Content (metric)
  • Product function
  • Date of minimum durability or Period After Opening (PAO)
  • Use precautions and warnings (if any)
  • Batch number
  • List of ingredients
  • Languages required are determined by the law of the Member States in which the product is available to the end user

The cosmetics directive also states that any information posted on a cosmetic label must be legible and may not contain any false, misleading, or incomplete information. Standards for the use of the terms “natural” and “organic” have been developed by trade organizations and industry authorities, but none are backed by specific legislation.

CPNP Notification

The Cosmetic Product Notification Portal (CPNP) is an online portal where manufacturers notify the market that a new product has been proposed for release. The Responsible Person posts an electronic notification to the portal that contains pertinent launch and import information  related to the product – including the product formulation – and serves are the official notice to the European Commission and E.U. member states of a product’s planned release.

The information posted to the CPNP is available to competent authorities for the purpose of market surveillance and analysis, evaluation, and collection of consumer information, and may also help competent authorities to screen for counterfeit or illegally imported products. Poison Centers may also require access to the CPNP for purposes of medical treatment.

The CPNP has a separate module for the reporting of cosmetic products containing nanomaterials. This is a separate submission dossier and may trigger the Scientific Committee on Consumer Safety to order a risk assessment, depending on the nature of the nanomaterials used. Submission of information regarding the use of nanomaterials in a product must be made six months in advance of the planned market release.

 Compliance is Everyone’s Responsibility

While most of the compliance obligations fall on the designated Responsible Person, compliance is still an organizational responsibility. Departmental teams are accountable for ensuring that their piece of the cosmetic product development process is completed in alignment with all applicable regulations. Organizations that invest in a robust compliance management system and encourage a culture in which every employee is accountable for compliance can reap the benefits and enjoy a streamlined path to product approval and market release.

Are you currently involved in the new product introduction process or working to remain compliant with existing products in the E.U.? Contact us to discuss your compliance hurdles and for improved agility bringing new products to market: Contact Ithos Global Today.

Cosmetic and beauty trends can change on a dime, as new technologies are developed and consumer tastes and loyalties shift. Most recently, the trend has been toward clean cosmetic brands that appeal to the newest generation of customers. These socially responsible consumers are choosing brands that are organic, sustainable and eco-friendly, causing more traditional manufacturers to put increased focus on ingredient transparency in order to remain competitive.

This trend is having an impact on major retailers as well, as they move to check the ingredients in cosmetics they sell, ensuring that a good portion of the products on their shelves can be classified as “clean” under their particular definition of this product category. It should be noted however, that as of today there is no established legal definition for “clean cosmetics” that is currently recognized by any authoritative body. Industry harmonization for this category is lacking at the moment as retailers vary in terms of how they define a “clean cosmetic”, although there are many similarities. This is a quickly growing trend that is truly consumer driven and retailers are responding to their specific demographic needs. This drive toward healthy cosmetics is expected to have a significant impact on industry growth overall. Retailers and manufacturers alike are investing in the development of plant-based ingredients and preservatives to meet the growing need for clean cosmetics that are free of chemicals that are perceived or deemed to be harmful to humans, the environment, or both.

Growth of The Clean Cosmetic Trend in 2019

This clean cosmetic movement is motivating consumers to take a closer look at what is in the products they use. Market research has shown that cosmetic consumers now place more emphasis on natural ingredients and reducing the impact on the environment than they do on name brand recognition. Niche retailers like Sephora are making this movement for safe cosmetics the cornerstone of their business. Even mass-market stores like Target and Ulta Beauty are moving toward incorporating cosmetic brands that consider their products as non-toxic, assuming they meet the specific retailer definition of a “clean cosmetic”.

Sephora is clearly leading the clean cosmetic charge with new healthy cosmetic product lines and clean beauty initiatives. They have developed an elaborate restricted substance list (RSL) for their private label Sephora Collection line that extends beyond the 1,300 plus ingredients restricted by the E.U. Sephora has doubled down on the demand for natural beauty brands by launching their Clean at Sephora line, which includes only those cosmetics, skincare, hair care and fragrance products that adhere to Sephora clean beauty standards. Any product labelled as clean must be “formulated without” more than 50 banned ingredients including beta hydroxy acid (BHA), mercury and mercury compounds, sodium lauryl sulfate (SLS), sodium laureth sulfate (SLES), parabens, formaldehyde, phthalates and mineral oils. Sephora has also taken the unprecedented step of requiring that – beginning in 2020 – all manufacturers of products sold in the Clean at Sephora line disclose ingredient information to the company to further ensure that the products they sell can truly be labelled clean.

Larger retailers wanting to capitalize on the clean cosmetic trend are making changes of their own. Target has been revising its clean cosmetics strategy, placing the Target Clean logo on more than 30 natural beauty brands and 4,000 products, including Target’s private label brands Goodfellow & Co and Smartly, as well as brands such as Unilever’s Love, Beauty and Planet lines.Target’s sales of beauty, personal care products, and household essentials approached $18 billion in 2018, or 24% of Targets total sales. Keeping on top of this cosmetic trend by moving to products that meet a “clean” definition by Target’s standards and expanding the retail space available for beauty products is imperative to Target’s continued success.

Smaller, boutique-style cosmetic retailers are not immune to this trend, and in many ways have pioneered the transition to “clean cosmetics” by carefully curating their products and attracting a dedicated base of eco-conscious consumers. Credo actively promotes and displays their mission to discover the cleanest ingredients available and to provide the largest collection of beauty products they consider to be, clean, safe and sustainable.Their Credo Clean Standard promises that all their products are free of “Credo Dirty List” ingredients, cruelty-free, and have documented evidence of compliance and claim substantiation. 

Follain takes a similar approach, basing their entire business on the clean cosmetic model, posting their product approval process and extensive list of Follain-prohibited ingredients on their website. Credo and Follain – and other niche retailers like them – make it clear that they are targeting the socially aware, environmentally conscious clients who have propelled the healthy cosmetic trend to center stage for the industry.

The Challenges of Creating Clean Cosmetics

While retailers and consumers have been quick to jump on the clean cosmetic bandwagon, manufacturers know that achieving a clean labelled product is complicated. Again, the definition of the term “clean” is unclear, with no specific regulation defining proper use. While the idea of using completely natural and sustainable ingredients may be popular, natural replacements do not yet exist for some chemical ingredients, and preservatives are proving especially difficult to replace.  

Nonetheless, manufacturers have been finding ways to use biological processes to replace petroleum-based chemicals. Last year, bioengineering company Genomatica introduced a natural butylene glycol – used as a moisturizing ingredient – created through fermentation of sugar using genetically modified E. coli bacteria, making the butylene glycol sustainable and environmentally friendly. Manufacturers are also investigating natural replacements such as clay and starches for emulsifiers and surfactants that can irritate the skin.

Personal care products are typically stored in bathrooms, where the warm and humid environment allows microbial growth to thrive. Preservatives extend the shelf life of products, but antimicrobial compounds used to preserve cosmetics – often parabens and formaldehyde – are considered by some to be harmful to humans in spite of regulatory agency use restrictions to what is considered a safe level. Researchers are looking at ways to modify chemical molecular structures to optimize the antimicrobial benefits while minimizing the toxic properties, making preservatives that can be used in clean cosmetics.  

Consumer education will play a big role in the transition to cleaner cosmetic ingredients. Anyone reading a product label with butylene glycol will naturally think that the product has a chemical considered to be toxic, so manufacturers will need to be clear about the source of ingredients they use.

Further challenging cosmetic manufacturers is the standardized naming convention for cosmetic ingredient names – the International Nomenclature of Cosmetic Ingredients (INCI). Using standardized ingredient names does make it easier for global cosmetic trade and compliance, but consumers may continue to think that any ingredient that is unfamiliar or difficult to pronounce is harmful. For example, the INCI name for red clay is montmorillonite, and the term for shea butter is butyrospermum parkii. Both are typically natural ingredients, but to the uneducated eye, both label names potentially read or are perceived as chemicals to the consumer and must therefore be dangerous to use. Manufacturers and retailers alike will need to continually educate their customers on label names and clarify that some unpronounceable terms are actually common healthy and natural ingredients, assuming they are sourced correctly.

Supporting the Growing Trend

Cosmetic and beauty product sales are expected to grow globally by about 6% per year through 2020, driven largely by the natural beauty trend. The trend for safe cosmetics will carry on, and cosmetic science will continue to identify new ingredients to replace existing hot-button ingredients with the potential for risk to human health or the environment.

But as consumer demand for eco-friendly and clean cosmetics grows, manufacturers will be hard-pressed to demonstrate compliance with the various retailer standards that allow them to produce a clean label for their products. 

Ithos Global Solutions is the one-stop resource for all pertinent ingredient, product and label regulatory compliance information. Contact Ithos Global to help meet your retailer “clean” requirements.  

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 greatly reinforced product safety by ensuring that manufacturers create and maintain proper records for the cosmetics they develop. 1223/2009 provides clearer direction for the content and format of the PIF file and requires a full cosmetic safety report in place of the previously accepted assessment. The new standard also introduces a requirement for a responsible person to be named as the owner and primary contact for the file.  

What is the Meaning of the Product Information File?

The product information file is a detailed account of the manufacture, testing, and composition of a cosmetic product. The PIF formally documents the complete safety profile and efficacious properties for a cosmetic product within a standardized file format. This mandatory file – which may include electronic records as well as hard copy – is a compilation of technical documents that must be kept on record for 10 years following the release of the last batch of product placed on the market for sale.  

The file contains specific information about the product that would be of interest to the consumer, including the identity and description of the product, the list of ingredients, and any use precautions or possible side effects that may occur. The information in the file is comprised of documents from several stakeholders such as suppliers, testing laboratories, and safety assessors.

The PIF must be available for review by the regional competent authorities at any time, but manufacturers are under no obligation to provide the public access to the files. Competent authorities from other countries or member states do not have the right to access to the PIF and can only request verification of compliance from the regional competent authorities.

Documents Included in the PIF File

Detailed description of the cosmetic product: This allows the file to be clearly linked to the product and should include the exact product name and a description of the product’s function.

Complete Cosmetic Product Safety Report (CPSR): The requirements for the product safety assessment are outlined in the next section.

Description of the production process: This should include an overview of the manufacturing process, including bulk storage and filling and references to all manufacturing documentation. This description must be applicable to all manufacturing sites.

Evidence of compliance with good manufacturing practices (GMP): A statement of compliance with GMP must be included in the file. Compliance is presumed if the product is manufactured in accordance with a relevant standard such as EN ISO 22716:2007.

Proof of the effects claimed for the cosmetic product: Where justified by the nature or the effect of the product, proof of effects claimed for the cosmetic product must be supported with evidence and all technical data kept within the file, or clearly referenced.

Statement on testing cosmetic products on animals: Any animal testing performed by the manufacturer, their agents or suppliers must be documented in the file. This applies to both ingredients and the finished product. Details of any animal testing performed in compliance with legislative or regulatory requirements of countries outside the EU should also be included if the product is to be sold in those countries.

Product labelling, which includes primary and secondary packaging: The name and address of the responsible person must be posted on all packaging in indelible and clearly legible lettering.

Cosmetic Product Safety Report

While Directive 76/768/EEC required a cosmetic safety assessment, Regulation (EC) N° 1223/2009 expanded the requirement to a complete cosmetic product safety report as part of the product information file. The safety report is intended to collect the necessary data to justify the safety of the cosmetic product.

 Part A – Cosmetic Safety Information

The cosmetic product safety report is formatted similarly to a chemical Safety Data Sheet (SDS) and must contain the following information at a minimum:

  • Qualitative and quantitative composition of the cosmetic product
  • Physical and chemical characteristics and stability
  • Microbiological quality
  • Impurities, traces, and information about packaging
  • Normal and reasonably foreseeable use

Additional data that may be collected as part of the safety report includes:

  • Data on exposure to the cosmetic product
  • Data on exposure to the substances
  • Toxicological profile of all substances
  • Undesirable effects and serious undesirable effects 

Part B – Cosmetic Safety Assessment

The assessment must be performed by a qualified assessor with a diploma in theoretical and practical study in pharmacy, toxicology, medicine, or a similar discipline, and is required to contain a review of products intended for use on children under the age of three and for those products intended exclusively for use in external intimate hygiene.

The safety assessment includes:

  • Assessment Conclusions
  • Instructions for Use and labelled warning
  • Reasoning
  • Safety Assessor’s credentials and approval

Role of the Responsible Person

Regulation (EC) N° 1223/2009 mandates that a responsible person be named in the PIF as a primary contact for the competent authorities. The responsible person should have access to a file for every product placed onto the market and be able to produce that file at any time upon request, in a language easily understood by the regional competent authority. The responsible person must be available to answer inquiries and be able to demonstrate that the product complies with the regulations.

The responsible person is tasked with maintaining the file in accordance with the regulations, as well as ultimately ensuring that the product is safe for human health under normal or reasonably foreseeable use. This means that the responsible person of record must ensure that the safety assessment has been performed by an appropriately qualified and credentialed assessor and that all product performance claims can be substantiated by the data on file.

Next Steps

The regulations that govern the creation of cosmetic products are designed to ensure that manufacturers create products that are safe for consumers to use. The product information file is a manufacturer’s best option for documenting development in accordance with EU cosmetic safety standards and industry best practices. Investing in the development of a complete PIF file streamlines a product’s path to approval by the competent authorities and the ability to bring a product to market.

Contact us to discuss your products, formulas, and ingredients for compliance – and for improved agility bringing new products to market: Contact Ithos Global Today.

2019 ushered in a new age for the hemp and cannabidiol industries. The Agricultural Improvement of 2018 (Farm Bill) removed hemp from the Controlled Substances List, which legalized the growth of industrial hemp provided the requirements within the Act are met. As a result of this legislation, cannabidiol (CBD) has been introduced to the cosmetic market where it has begun to appear in skin care, shampoo, and other personal care products. 

CBD is derived from the hemp plant, a variety of the same Cannabis sativa plant that produces marijuana. Hemp and CBD can contain relatively low levels of the psychoactive substance tetrahydrocannabinol (THC) but conventional wisdom considers them safe for topical use, particularly if the Farm bill mandated 0.3 maximum THC content limit is met. However, very few studies have been done to validate CBD efficacy as a cosmetic ingredient and so the regulatory landscape remains uncertain. The FDA published both a series of warning letters, and separately, it’s views and concerns about cannabis derivatives. 

Despite the Pandora’s box of concerns, CBD is being branded as the next big thing for the cosmetic industry. The global market for CBD skin care is forecasted to reach $1.7 billion by 2025 thanks to the consumers hungry for plant-based wellness and beauty products. As a result, many cosmetic and personal care brands are basing their marketing and product development strategies on CBD products and transforming this well-known but little understood substance into the key industry driver for the foreseeable future. 

CBD in Cosmetics – Will the Trend Continue? 

The humble hemp seed has long been a staple of natural beauty products, appearing in mass-market skin care products since the 1970s. But it’s upstart cousin CBD is suspected of having even greater anti-oxidizing, anti-inflammatory and oil-balancing properties and as a result is attracting a tremendous amount of attention from the cosmetic industry regardless of whether formal clinical substantiation exists or not for these benefits. 

CBD does sound like a wonder substance, if the hype is to be believed, and can therefore be an easy entry point for cosmetic brands looking to enter the sustainable, natural and plant-based beauty markets. It is also promoted as a drug-free antidote to stress and anxiety, another boon for manufacturers looking to cash in on the booming holistic, whole-body wellness trend although again this has yet to be clinically proven.

It is unlikely that this trend will slow down any time soon. Key retailers CVS and Walgreens announced in April 2019 that they would start offering non-ingestible CBD products for topical use. The FDA has not endorsed cannabidiol as generally recognized as safe (GRAS) in food or as a dietary supplement. Thus CBD and similar hemp derivatives are not allowed to be used in food or dietary supplements in the United States. It cannot be promoted as a medical treatment or cure, unless a new drug application is approved. There is no federal regulation to date limiting the use of CBD in cosmetics, assuming the material being sourced complies with the 2018 Farm Bill and it meets all other regulations pertaining to cosmetics. As a result, CBD has become the go-to ingredient for almost every type of cosmetic product, despite little solid evidence to support the miraculous claims made about its benefits. 

To Regulate or Not to Regulate 

The FDA is currently undecided about the efficacy of CBD and has expressed concerns about the risks associated with long-term use. Although the industry is full of anecdotal claims about the benefits of cannabidiol, there is very little substantive data supporting its use and limited information on how long-term cannabidiol use can affect the body. The FDA has posted an information forum and FAQs to inform consumers of the potential health risks of using CBD and the lack of controlled study data supporting the growing list of stated benefits, but these potential risks may or may not be more applicable to ingestion than topical application. 

The FDA has been keeping a keen eye on manufacturers of ingestible CBD products who are making curative medical claims about their CBD products, which is illegal under the Food, Drug and Cosmetic Act. And while hemp seed oil and CBD oil are similar, they are not the same substance, and some companies are using the terms interchangeably, misleading consumers and opening themselves and their products to closer scrutiny by regulators. 

However, the agency has publicly acknowledged the consumer interest in CBD oil as a green and natural beauty product ingredient, and regulatory focus has yet to impact the use of CBD by the cosmetic industry. The FDA guidelines define cosmetics as any product applied to the body for the purposes of cleansing or beautification, and there are no limitations on the use of cannabis or cannabis-derived 

ingredients at this time, except for those that prove to be harmful with use. The agency does keep a weather eye on manufacturers who play fast and loose with concentrations, promoting a product as having a level of CBD that it just does not have, which is considered misbranding under the FD&C Act. 

The regulatory landscape surrounding the use of cannabidiol is not much clearer in Europe. The European Cosmetic Regulation No 1223/2009 prohibits the use of cannabis and cannabis-derived extracts in cosmetics, but the directive does not specifically call out CBD. As a result, the EC clarified the difference between synthetic and plant-based CBD and allowing use only of the synthetic or hemp-derived CBD. 

In both the US and EU, individual states have implemented their own CBD standards but are looking to the national agencies to issue more definitive clarification on the acceptable uses of cannabidiol in order to streamline business for this new and fast-growing segment of the cosmetic industry. 

Currently, CBD is not allowed in Cosmetics in Canada.Tetrahydrocannabinol; delta-9-tetrahydrocannabinol; Cannabidiol; Cannabinol; Cannabis Sativa Flower Extract; Cannabis Sativa Flower/Leaf/Stem Extract are prohibited in Cosmetics. Cannabis sativa seed oil; Hemp seed oil; Hydrolyzed Hemp seed protein are allowed if they follow guidelines and contain less the .0010% THC. The Cannabis Act as amended October 17, 2019 specifies other uses of marijuana and derivatives. 

Various states of the United States of America have regulations affecting the use of these products. Growers and producers of derivatives require licenses, the Farm Bill allowance of hemp derived products are not incorporated into laws of Idaho, and Nebraska, and there is still uncertainty as to CBD status in South Dakota. California recently listed THC as a developmental toxic substance, without a safe harbor level (no effect) listed. This could affect the use of CBD and other derivatives with any THC present. 

What This Means for CBD in Cosmetics 

The CBD cosmetic market remains an open market, as long as the Farm act and State regulations are followed. Otherwise, CBD is treated as any other cosmetic ingredients, many of which do have certain restrictions. Consumers need to be aware of vagaries surrounding the use of CBD in personal care products and should thoroughly research a brand and product before making a purchase decision. Going forward, cosmetic manufacturers, regulators and potentially legislators will need to reach a consensus regarding definitions, efficacy, dosages and provenance if the cosmetic market is to continue to ride the CBD wave to projected success. 

Starting a new makeup line may seem like a straightforward and almost fool-proof endeavor. The industry is thriving, with a global makeup market currently valued at $5.87 billion USD and forecast to nearly double in sales by 2023. And the cosmetic industry remains largely unaffected by fluctuations in the economy, so logic – and history – indicate that launching a new makeup brand should be a resounding success for any company looking to enter the space. How to start a makeup line? Make a business plan, find a few suppliers, generate an eye-catching logo, connect with investors, create the initial market offering, and voila – you have created your own makeup line. 

Unfortunately, it is not quite that easy. Cosmetic products may be thriving, but they are also one of the most tightly regulated commodities on the market. Cosmetic manufacturers of all sizes are held to a stringent set of compliance standards designed to ensure product safety. Both US and EU cosmetic regulations place the responsibility for compliance squarely on the shoulders of the manufacturer, so even small cosmetic companies need to have a regulatory plan and strategy in place to ensure compliance and avoid unnecessary and unforeseen expenses. But with careful attention to compliance details, even small manufacturers can easily solve the regulatory puzzle, bringing all the pieces together and clearing the pathway to successful commercialization. 

How to Start a Makeup Line? How Much Will it Cost?

The initial research and information-gathering on how to start a makeup line may not cost anything, but there are quite a few expenses that will need to be covered well in advance of creating the first batch of product. These expenses may vary slightly by product and by production location, but a small-scale makeup business should budget between $17,500 and $62,550 in up-front expenses, including (but not limited to): 

Establishing legal business entity and other legal fees 

Brand website and logo 

Licenses, permits and insurance 

Signage, advertising, business cards 

Rental or purchase of office and/or lab and production facilities 

Ingredients and other materials to create product 

Packaging and Labeling requirements 

Regulatory Compliance 

Miscellaneous 

The total upfront expense can climb to over $150,000 for a medium-sized makeup brand, and large name-brand or luxury niche companies can spend several million dollars to start a new line. However, this list does not include any expenses that may be incurred while achieving necessary regulatory compliance of the production facility, ingredients, final formula and packaging so that will need to be taken into consideration when determining how much it will cost to start a makeup line. 

Define the New Product Development Process 

New companies may balk at the idea of allocating precious capital on compliance, but non-compliance can cost a company much more in product reformulations, product artwork revisions, documentation changes and fines, and in order to sell a product, it has to be compliant. Whether an organization has 15 employees or 15,000, establishing the compliance needs for each phase of the new product development process early on will keep the new makeup line fully compliant and on budget as it moves from ideation to commercialization. 

To help keep costs in line and compliance front-of-mind, cosmetic companies of all sizes should clearly define each stage of their new product development process. A clearly defined process will ensure that everyone within the organization knows what deliverables need to be completed for each stage, who is responsible for what deliverable, and – more importantly – what the compliance requirements are for each phase of the process. You can access more information here on the cost of compliance versus non-compliance in the Cosmetic industry. 

There are six key stages – or gates – in the new product development process: 

The marketing brief contains the market analysis for a proposed product, defines the initial product concept, and identifies the 

targeted niche for the product. 

The product formulation lists the ingredients used to create the cosmetic product and must take into consideration any ingredient restrictions for each targeted jurisdiction. 

Sourcing of ingredient suppliers also has a regulatory component. Any third-party supplier must be able to demonstrate 

compliance with good manufacturing practices (GMP) and provide documentation of compliance for any ingredients they supply. 

Regulatory & Quality Compliance should be part of the development process from the very start. The EU requires the designation of an assigned person to be the regulatory and technical contact, and this person has oversight of the entire regulatory compliance process. 

Packaging/Artwork is also guided by regulatory requirements that define what must be included on a product label, including 

product name, performance claims, name and address of the assigned person, and any necessary precautions and warnings. 

Product Validation serves to substantiate the safety and any performance claims for the product, while ensuring that the 

formulation produces no adverse effects.Microbiological, Product Stability and Safety testing should be completed as is appropriate for the product and formula. In most jurisdictions, animal testing is prohibited or severely restricted, so testing must be completed 

with human test subjects (as allowed) or via other approved methods. 

Understanding U.S. Cosmetic Regulations 

Cosmetic manufacturers are responsible for ensuring the safety of their products and compliance with all local, regional or international standards. The regulations may seem overwhelming to a startup trying to determine exactly how to start a makeup line, but the strict standards help maintain the quality of the products, resulting in very few cosmetic adverse events. 

In the United States, both federal and state governments have detailed cosmetic regulations guiding the introduction of a new cosmetic product. The Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA) are the two most 

important pieces of legislation pertaining to cosmetic products sold in the U.S. with oversight of product safety, labelling and the restriction of ingredients. The FDA does not require cosmetics gain pre-market clearance or mandate specific product validation analysis, but their regulations do provide for routine inspection of manufacturing facilities. In addition, FDA regulations prohibit or restrict the use of several ingredients and require warning statements on the labels of certain types of cosmetics. 

Several states have also implemented their own regulations further restricting the use of some ingredients, and California’s Prop 65 has had far-reaching impact on the industry and manufacturers looking to market their products in the state. 

Understanding EU Cosmetic Regulations 

European Union cosmetic regulations are like those in the U.S. in that they ensure product safety but are much more stringent and require much more documentation overall from manufacturers before a product can be released to the market. 

Regulations (EC) N° 1223/2009 and No 655/2013 are the primary pieces of EU legislation for cosmetic products sold on the European market. These standards clarify the rules for product labelling, define the substantiation of product claims, establish requirements for the product information file (PIF) and mandate the designation of an assigned person to be the primary regulatory and technical contact for the product. 1223/2009 also implemented a comprehensive ban on the testing of ingredients and finished cosmetics on animals, so cosmetic manufacturers must rely on alternative testing methods to validate the safety of their products. 

EU member states often enact their own laws regarding cosmetics, so it is recommended that all cosmetic manufacturers fully research the regulations for each targeted jurisdiction defined in the marketing brief to ensure that the product will be compliant when released to the market. 

Bringing it All Together 

Starting your own makeup line can be exhilarating and demanding, requiring the development of new skills in order to successfully bring a product to market. The costs can seem steep, the compliance process overly complex and the myriad other challenges can cause an unprepared makeup brand to lose their way. For those determined to understand how to start a makeup line successfully, making the investment in compliance can lead to commercial and financial success. 

The European Commission has published an amendment, as of May 26, 2021, to the European Cosmetics Regulation (EU) No 2021/850. It amends and corrects Annexes II, III, IV, and VI of the European Cosmetic Regulation. The effective date is October 1, 2021.

Changes to annex II include the following listings to Annex II:

  • Cobalt 
  • Metaldehyde (ISO); 2,4,6,8-tetramethyl- 1,3,5,7-tetraoxacyclooctane 
  • Methylmercuric chloride 
  • Benzo[rst]pentaphene 
  • Dibenzo[b,def]chrysene; dibenzo[a,h]pyrene
  •  Ethanol, 2,2′-iminobis-, N- (C13-15-branched and linear alkyl) derivs. 
  • Cyflumetofen (ISO); 2-methoxyethyl (RS)-2- (4-tert-butylphenyl)-2-cyano-3-oxo-3-(α,α,α-trifluoroo-tolyl)propionate 
  • Diisohexyl phthalate 
  • halosulfuron-methyl (ISO); methyl 3-chloro-5-{[(4,6- dimethoxypyrimidin-2-yl) carbamoyl] sulfamoyl}-1- methyl-1H-pyrazole-4- carboxylate 
  • 2-methylimidazole 
  • Metaflumizone (ISO); (EZ)-2′-[2-(4-cyanophenyl)-1-(α,α,α -trifluoro-m- tolyl)ethylidene]-[4-(trifluoromethoxy)phenyl] carbanilohydrazide [E-isomer ≥ 90 %, Z-isomer ≤ 10 % relative content]; [1] (E)-2′-[2-(4-cyanophenyl)- 1-(α,α,α -trifluoro-m-tolyl) ethylidene]-[4-(trifluoromethoxy)phenyl] carbanilohydrazide 
  • Dibutylbis(pentane-2,4- dionato-O,O’)tin

Also entry 1427, corresponding to the substance nickel bis(tetrafluoroborate) (CAS number: 14708-14-6), is deleted.

The following changes have been made to the other listed annexes:

Annex III

  • Salicylic Acid is now allowed at 0.5% in body lotion, eye shadow, mascara, eyeliner, lipstick, roll-on deodorant
  • Titanium dioxide in powder form containing 1 % or more of particle with aerodynamic diameter ≤ 10 μm are not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation’

Annex IV (Colorants) & Annex V (UV Filters)

  • Titanium Dioxide entries are aligned to the above Annex III restrictions.

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