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9.5: Regulation of Cosmetics - Biology


You might be surprised to learn that the FDA has regulatory oversight over cosmetics. You may be even more surprised to know that this oversight is largely self-regulated! The FDA acts with hazardous products – but the remainder of the control is by the companies themselves. The other area the FDA does scrutinize heavily is misbranding. Many companies have recently moved to market their cosmetics with drug language – such as "anti-aging cream." https://www.fda.gov/cosmetics

Some of the areas the FDA looks at when considering cosmetics is:

  • regulations and policy governing the safety of cosmetic ingredients and finished products
  • regulations, policy, and other activities dealing with proper labeling of cosmetics
  • regulatory and research programs to address possible health risks associated with chemical or biological contaminants
  • post-market surveillance and related compliance activities ✓ industry outreach and consumer education

As with foods, the complexity of the cosmetic industry and the technologies and ingredients used in the production of cosmetics is overwhelming. A global cosmetics industry has increased the calls for safety oversight since products and components enter the U.S. from many countries with different regulatory and safety standards. Some of the current areas of focus for cosmetics include:

  1. microbiological contaminants
  2. chemical contaminants
  3. drug vs. cosmetic products
  4. use of nanoscale materials as ingredients
  5. botanical ingredients
  6. alternatives to animal testing

What is a Cosmetic?

The Federal Food, Drug, and Cosmetic Act (FD&C Act) define cosmetics as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance" (FDA.gov). Lipstick, nail polish, moisturizers all are examples of cosmetics that would meet this definition.

The FDA excludes “soap” as a cosmetic – but this is a complicated and tricky topic. Soaps that are composed of fat and alkali (ex. Vegetable oil and lye) are not regulated at all by the FDA – but rather are under the purview of the Consumer Product Safety Commission. Soap that is advertised to cleanse, or beautify in any way, is regulated as a cosmetic. Moreover, soap that has a treatment claim, such as an anti-bacterial soap, is a drug! Whew!

Is it a Cosmetic, Drug, or Both?

One of the biggest issues with cosmetics is determining Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)

Whether a product is a cosmetic or drug primarily depends on its intended use. Different laws (above) come into play, depending on the use of the product. A product can be considered both a cosmetic and a drug when it is used to diagnose or treat a disease or disorder and to beautify. An excellent example of this would be dandruff shampoo – it is used to both clean the hair as well as treat a disorder. Ultimately, which regulations apply to depend on labeling and marketing.

Good Manufacturing Practice for Cosmetics

The FDA provides CGMPs for cosmetic products – however, there are no requirements in the FD&C Act for cosmetic products to be manufactured under CGMPs. Many legislative attempts have been made to change this, but so far, none has passed. The industry does provide many of its manufacturing guidelines; some follow the international Guidance’s provided in ISO 22716.

Adulteration of Cosmetics

One of the FDA enforcement areas is of facility and product inspection. Specifically, the FDA is looking for:

  1. A poisonous or deleterious substance that may injure the customer under regular use
  2. Filthy, putrid or decomposed substance (including microorganism contamination)
  3. Packaging under unsanitary conditions
  4. The container is composed of a poisonous or deleterious substance
  5. The product contains an unsafe (or unapproved) color additive
  6. Any outlawed ingredient (ex. Mercury, lead, zirconium, chlorofluorocarbons)
  7. Prohibited cattle material (brain, skull, spinal cord)

FDA's Enforcement Tools for Food and Cosmetic Products

For food and cosmetics, the FDA focuses on:

  • inspection of establishments
  • collection and analysis of samples
  • monitoring of imports
  • monitoring of adverse event reports and consumer complaints
  • premarket review (e.g., food and color additives)
  • notification programs (e.g., food contact substances, infant formula)
  • regulations/agreements (e.g., memoranda of understanding)
  • determine the health effects of food and cosmetic contaminants
  • determine the effects of processing on food composition and allergenicity
  • determine the health effects of dietary factors
  • determine skin penetration of cosmetic ingredients and contaminants

Cosmetics

Francisca Rodrigues , . Antonio Segura Carretero , in Polyphenols: Properties, Recovery, and Applications , 2018

1 Introduction

The cosmetic industry is a prosperous global business. According to the Cosmetics Europe—The Personal Care Association, 450 million of Europeans daily use a wide variety of cosmetic products, such as soap, shampoo, hair conditioner, toothpaste, deodorant, shaving cream, skincare, perfume, or make-up ( COLIPA, 2015 ). Innovation is one of the basic principles in this field. Over the past 20 years, the innovation in cosmetic industry is enormous, resulting in a wide range of products to protect and moisturize skin as well as to combat inflammation and age signals. Also, consumers are more concerned about their appearance, trying to accept the new society paradigms. On the other hand, the demand for natural cosmetics is stronger than ever, being now widely considered a serious threat to the worldwide economy and society. These new concepts had improved the use of natural extracts as active ingredients in cosmetics, leading to the reuse of old-style active ingredients obtained from natural sources, as well as to new green compounds obtained considering sustainable principles. Inside these large groups of active ingredients, polyphenols could be considered the oldest one, being obtained from diverse sources such as plants or even food by-products ( Nunes et al., 2017 Rodrigues et al., 2016b ).

Since ancient times, phytochemicals are widely used in topical preparations. This large group of compounds is defined as bioactive nutrients from plants, indeed phyto is derived from the Greek word phyto, which means plant ( Huang et al., 2010 ). Most phytochemicals are substances of low molecular weight, named as secondary plant metabolites, which are nonessential for the survival of the plant, but exert a substantial number of principal functions. This kind of compounds is present in a large variety of food matrix, including fruit, vegetables, cereals, nuts, and cocoa/chocolate as well as in beverages derived from them, such as juice, tea, coffee, and wine ( Liu, 2003 Si and Liu, 2014 ). Among the high structural diversity of phytochemicals, phenolic compounds or polyphenols have attracted considerable interest and represent one of the main groups of secondary metabolites in plants ( Han et al., 2007 Tsao, 2010 ). Nowadays, most of the attention that has attracted these compounds is justified mainly due to their wide range of bioactivities. Particularly in humans, they have demonstrated a large diversity of beneficial health effects, such as anticarcinogenic ( Franceschi et al., 1998 Pauwels, 2011 ), antidiabetic ( van Dam and Hu, 2005 ), antioxidant ( van Dam and Hu, 2005 ), antiobesity ( Evans et al., 2006 ), cardioprotective ( Hertog et al., 1993, 1995 Knekt et al., 1996 ), or neuroprotective ( Dai et al., 2006 Kelsey et al., 2010 Letenneur et al., 2007 Singh et al., 2008 ) activities, among others. In the cosmetic field, polyphenol-enriched extracts can be effective for the prevention and therapy of premature skin aging provoked by oxidative stress. The beneficial properties of polyphenols, which are mostly relevant with topical application, are antioxidant activity, protective action against ultraviolet (UV) damages, inhibition of dermal proteinases, antimicrobial activity, and anticarcinogen action ( Joshi and Pawar, 2015 Thring et al., 2009 Zillich et al., 2015 ).

The term “polyphenols” includes a large group of substances, which all have more than one phenolic hydroxyl group, bounded to one or more benzene ring systems. Among the best sources of phenolic antioxidants is possible to identify tea (Camellia sinensis L.), wine (Vitis vinifera), olive, sesame as well as other oilseeds (such as sunflower), oak (Quercus robur), pine (Pinus maritime), cinnamon (Cinnamomum zeylanicum), or even food by-products (such as grape or olive by-products as well as coffee by-products) ( Braga et al., 2014 Nunes et al., 2017 Rodrigues et al., 2015a, 2017 ).

Thus, the aim of this chapter is to describe some of the most important polyphenols sources for the cosmetic industry, particularly focusing on their skin effects, as well as to analyze the most recent patents on the cosmetic industry regarding polyphenols.


9.5: Regulation of Cosmetics - Biology

Regulatory agencies have been putting increasing emphasis in the need of supporting any health claim with significant scientific evidence. In the European Union, health claims made in relation to food products require authorisation by the EFSA under the EC Regulation 1924/2006 before they can be used in the labelling and marketing of these products. In the United States, dietary supplements do not require approval from the FDA, but any health claim must be widely accepted by the scientific community or else the product may be withdrawn from the market.

Similar requirements have been adopted in regards to cosmetics products in order to protect the consumer. The EU Regulation No 655/2013 clearly states that “claims for cosmetic products, whether explicit or implicit, shall be supported by adequate and verifiable evidence”. Moreover, the amendments to the old cosmetics Directive (76/768/EEC) and the entry in force of the new EC Regulation (1223/2009) introduced new challenges in the development of cosmetics by putting an end to animal testing.

This new scenario has created a need for suitable methods to study safety and efficacy of cosmetic and nutraceutical products in human health. With this goal in mind, Anaxomics assists nutraceuticals and cosmetics companies in obtaining scientific fundamentals for their health and consumer care claims. Anaxomics has developed Therapeutic Performance Mapping System (TPMS) proprietary technology, which employs the latest advances in Systems Biology to generate virtual models of human physiology. TPMS can realistically simulate the response to an active ingredient or the therapeutic effect of a supplement.

  • Efficacy and safety assessment: learn how to maximize the results of your research.
    • Synergic combinations of active compounds to increase their efficacy or safety
    • List of potential cosmetic indications prioritized according to the predicted efficacy
    • Mechanism of action that justify the efficacy of your active compound
    • Patient stratification to guarantee a successful outcome of your studies in humans

    Check our article on the utilization of systems biology approaches to select nutraceutical treatments for NAFLD based on their mechanism of action


    China Finalizes Cosmetic Supervision Legislation

    On June 29, 2020, the updated cosmetic legislation, 'Cosmetic Supervision and Administration Regulation (CSAR),' was officially published by the Chinese State Council. According to a report by Chemlinked, provisions for ingredient management, safety assessment and efficacy claims are among the most notable changes.

    The CSAR will replace the existing Cosmetics Hygiene Supervision Regulations (CHSR), which originally was released in 1989. The new regulation is effective as of January 1, 2021.

    Major updates to the new regulation include the following:

    • Products defined as cosmetics now include those to "eliminate unpleasant odor," referring products to be applied to skin, hair, nails, lips, etc., by spreading, spraying or other similar ways for the purpose of cleansing, protecting, beautifying and modifying.
    • Toothpaste will be managed in line with general cosmetics. In relation, efficacy claims (such as "anti-caries," "inhibiting plaque," etc.) are permitted after conducting efficacy evaluations following the national or industrial standards.
    • Soaps are considered outside the scope of the CSAR regulation, except for those with special cosmetic efficacy.
    • Cosmetic ingredients are now classified as "new" and "used" ingredients. New ingredients with high risk require registration while other new cosmetic ingredients are subject to filing management.
    • New ingredients with high risk such as preservatives, sunscreens, colorants, hair dyes and whitening agents must register with the National Medial Products Administration (NMPA) and obtain approval. Other new ingredients must file with NMPA before use.
      • New ingredient filings/registrations must include: name, address and contact information of registration applicant or filer R&D report research materials on manufacturing process, stability and quality control standards and safety assessment dossiers.

      New provisions to the CSAR include:

      • The registration applicant and filer of new ingredients and cosmetics should carry out the safety assessment or entrust a professional institution prior to registration and filing. Personnel engaged in safety assessments should have professional knowledge related to cosmetics quality and safety, and have more than five years of relevant work experience.
      • Cosmetic efficacy claims must include sufficient scientific evidence including relevant literature, research data or efficacy evaluation documents, which will be made available to the public on the NMPA's website for social supervision.
      • Imported cosmetics also require the submission of certifications relating to manufacturing quality control of the overseas manufacturers, and supporting documents that prove those products have been put into market in the country (region) where those products are manufactured. For products specially produced for China's market without the supporting documents, the applicant must submit related research and test data for Chinese consumers.
      • Regarding the dossiers, the information provided must include: 1) name, address and contact information of registration applicant or filer 2) name, address and contact information of manufacturer 3) product name 4) product formula or a full list of ingredients 5) the standards adopted 6) a sample manuscript of the label 7) testing reports 8) safety assessment dossiers and 9) other documents required to prove product safety.

      According to Chemlinked, given the CSAR's number of new requirements for cosmetics, a five-year grace period was granted for already-registered hair growth, hair removal, breast beauty, slimming and deodorant cosmetics from the date of implementation of this regulation to ensure a smooth transition. The production, import and sale of these products are prohibited after the transition period.


      Regulation & Safety of Cosmetics

      The development and marketing of cosmetic and toiletry products involves complex formulation and ingredient selection to ensure that the final product not only works as it is supposed to, but also provides the end consumer protection from possible harm when using the product.

      One of the key drivers for the European Union to recast its existing cosmetic directive (76/768/EEC) into a regulation (EC/1223/2009) was to further improve the protection of human health across the cosmetic and toiletry industry. The regulation has introduced a number of new requirements, such as EU pre-market notification and Responsible Person status, and provides a more prescriptive mechanism for carrying out Cosmetic Product Safety Reports (CPSRs) and the generation and management of the Product Information Files (PIFs).

      Exponent has a long history of providing expert consultancy service and providing the very best care for its business partners.

      To help the personal care industry meet its regulatory requirements and to help exceed customer expectations Exponent offers the following services:

      • Responsible Person dossier preparation and management in compliance with EC/1223/2009
      • Cosmetics Product Safety Reports part A&B (CPSR EC/1223/2009)
      • Product Information File creation/reviewing/auditing
      • Cosmetic labeling reviews and advice
      • Borderline advice
      • Claim substantiation
      • Advice on New Product Development and ingredient selection
      • SCCS submissions/raw material support
      • Ingredient safety assessments
      • Global registration/notification of cosmetic products
      • Global regulatory advice and compliance support

      Many of our highly experienced consultants have worked for industry, with trade associations, as government regulators, or for contract research organizations, giving us unparalleled expertise with solving complex regulatory and scientific problems.

      Our Cosmetic Regulatory Team has over 20 years of experience working across all areas of the personal care industry including product development, distribution, and manufacturing of cosmetic and toiletry products. Based in the UK, the Exponent Regulatory Team can act as your Responsible Person for all your cosmetic and toiletry needs or provide contract and ad-hoc regulatory services.

      If you want to import cosmetics and toiletries into the EU or are a manufacturer, distributor, or retailer within the EU, then our team will help you address compliance with all relevant regulations so you are able to confidently offer your customers high quality, safe and sustainable products.


      9.5: Regulation of Cosmetics - Biology

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      Looking Back to the Future of Regulating New Technologies: The Cases of Nanotechnologies and Synthetic Biology

      2 For further detail, see Stokes , Elen , “ Nanotechnology and the Products of Inherited Regulation ”, 39 ( 1 ) Journal of Law & Society ( 2012 ), pp. 92 – 112 CrossRefGoogle Scholar .

      4 For instance, consumer products containing nanomaterials have been described as “virtually unregulated”, see European Parliament Debate No. 4, Thursday, 28 September 2006, MEP Hiltrud Breyer.

      5 See, for example, Davies , Clarence J. , Managing the Effects of Nanotechnology ( Washington, DC : Project on Emerging Nanotechnologies , 2006 )Google Scholar Taylor , Mike , Regulating the Products of Nanotechnology: Does FDA Have the Tools It Needs? ( Washington, DC : Project on Emerging Nanotechnologies , 2006 )Google Scholar Frater , Lori , Stokes , Elen , Lee , Robert , Oriola , Taiwo , An Overview of the Framework of Current Regulation affecting the Development and Marketing of Nanomaterials: A Report for the DTI ( London : DTI , 2006 )Google Scholar Ludlow , Karinne , Bowman , Diana M. and Hodge , Graeme A. , A Review of the Possible Impacts of Nanotechnology on Australia's Regulatory Framework ( Melbourne : Monash University , 2007 )Google Scholar and European Commission , Regulatory Aspects of Nanomaterials ( Brussels : European Commission , 2008 )Google ScholarPubMed .

      6 NICNAS , Guidance on new chemical requirements for notification of industrial nanomaterials ( Canberra : Australian Government , 2010 )Google Scholar .


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