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Related Concept Videos

Drug Regulation01:25

Drug Regulation

Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
Impact01:30

Impact

Impact occurs when two bodies collide, leading to the application of impulsive forces between them. Analyzing impact mechanics involves considering two colliding particles moving along a line known as the line of impact, which passes through their centers and is perpendicular to the contact plane.
When particles with different initial velocities collide, they induce deformation by applying equal and opposite impulses. At the point of maximum deformation, the particles move together with...
FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
Effects of Chemicals: Overview01:27

Effects of Chemicals: Overview

Drugs, encompassing various chemical compounds from natural sources, lab synthesis, or genetic engineering, elicit different biological responses in living organisms. Some of these responses are desirable or therapeutic, while others are undesirable. The primary goal of administering a drug is to achieve a therapeutic effect, that is, to address a specific disease or health condition. Any concurrent effects outside of this therapeutic outcome are considered undesirable. These undesirable...
Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
Drug Control Governance: Regulatory Bodies and Their Impact01:03

Drug Control Governance: Regulatory Bodies and Their Impact

Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with a...

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REACH: impact on the US cosmetics industry?

Anne Pouillot1, Barbara Polla, Ada Polla

  • 1Alchimie Forever Sàrl, Geneva, Switzerland. anne@forever-beauty.com

Journal of Cosmetic Dermatology
|March 3, 2009
PubMed
Summary

The European Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation impacts the cosmetics industry, particularly for US exporters. While partially exempt, compliance is mandatory for market access.

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Area of Science:

  • Chemical Regulation
  • Environmental Policy
  • Cosmetic Science

Background:

  • The European Union enacted REACH to safeguard human health and the environment from chemical risks.
  • REACH mandates a precautionary principle, requiring data and action when uncertainty arises regarding chemical safety.
  • Existing regulations on cosmetic ingredients mean the cosmetics sector is only partially subject to REACH's full scope.

Purpose of the Study:

  • To analyze the implications of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation on the cosmetics industry.
  • To identify potential benefits and drawbacks of REACH for cosmetic manufacturers, including those in the US.
  • To clarify the extent of REACH's applicability to cosmetic ingredients and finished products.

Main Methods:

  • Review of the European Union's REACH regulation text.
  • Analysis of existing directives and agencies governing cosmetic ingredients.
  • Assessment of the impact of REACH on innovation and international trade within the cosmetics sector.

Main Results:

  • Cosmetic ingredients are subject to REACH registration and evaluation but likely not authorization or restriction due to pre-existing regulations.
  • REACH may enhance consumer confidence and industry image but could also stifle innovation.
  • US cosmetics manufacturers exporting to Europe must comply with REACH requirements.

Conclusions:

  • REACH presents a mixed impact on the cosmetics industry, offering reputational benefits but posing innovation challenges.
  • Compliance with REACH is essential for US companies to maintain access to the European market.
  • The regulation underscores the importance of chemical safety and transparency in the global cosmetics trade.