A cosmetic product intended for use on infants should be safe for his or her health when it is being used under normal and foreseeable conditions, taking into consideration the physiological characteristics, application area and infant-specific behaviors that may increase exposure to certain substances or to their toxic effects

Safe Cosmetics for Young Children

The cosmetic product should contain no more than a strict minimum number of ingredients; the following substances (including impurities) should not be present:

  • substances with carcinogenic or mutagenic properties or substances that are toxic for reproduction (CMR),
  • substances with endocrine disrupting activity,
  • substances that are candidates for inclusion in Annex XIV of Regulation (EC) No. 1907/2006 (REACH),
  • substances that are potent allergens

We offer the following services for cosmetic industries:

  • ISO 22716 and FDA compliance evaluations
  • Global regulatory strategies, FDA 21 CFR, parts 710 & 720
  • Registering cosmetic manufacturing and/or packaging establishments with USFDA
  • Filing Cosmetic Product Ingredient Statements (CPIS)
  • Amending or Discontinuing a Product Formulation
  • Regulatory Consulting, Product Notifications
  • Cosmetics Testing
  • Compilation of Product Information File (PIF)
  • Cosmetic Safety Assessment Report (CPSR)
  • Product Labelling Review & Support
  • EC 1223/2009 (CPR) compliance through the following services
  • A comprehensive review of product portfolios and current certificate expiry dates
  • Gap assessment
  • Remediation and implementation of an EC 1223/2009 compliance plan
  • Compiling application form with declaration to secure LTO from Philippines FDA (AO-2016-0003)
  • Preparation & Review of Risk Management Plan
  • Preparation & Review of Site Master File (SMF)
  • Product Notification (ASEAN Cosmetic Directive)
  • Review of product labelling
  • Review of cosmetic ingredients (IFRA Standards)

Consultation certification for manufacturers

  • Good Manufacturing Practices Certification (ASEAN Guideline)
  • ISO 22716 Certifications
  • ISO 9001:2015 Certifications
  • IFRA Certification
  • IFRA Allergen Certification
  • HACCP Certification

Post Approval support

  • Root cause investigation
  • Corrective and preventive action support
  • Complaint handling
  • Recall management

Need help cosmetic regulatory services?

Our Regulatory professional bring direct experience in cosmetics development and manufacturing to help you understand and address regulatory needs at every stage of product. We offer regulatory services for cosmetic industries across the globe

FWQRC has a proven track record in facilitating success for numerous organisations.

Contact us to learn more and get the conversation started

Call Now Button