Cosmetic Safety Assessment & CPSR/PIF Services

At Makrolife Biotech, we provide professional cosmetic safety assessments in compliance with the EU Cosmetics Regulation 1223/2009.
As qualified experts (biochemist with toxicological and pharmaceutical experience), we prepare CPSRs (Cosmetic Product Safety Reports) and structured PIFs (Product Information Files) for cosmetics, perfumes, and cosmetic end products.

Our mission: to deliver toxicological evaluations, safety reports, and compliance services that enable manufacturers, importers, and brands to achieve fast and audit-proof market approval in the EU.

Do you need assistance with legal issues relating to safety assessments?
Our Safety Team will be happy to help:

Email: info@Makrolife-Biotech.com
Tel:   +49 176 92 67 888 6

Our Services

• Preparation and signature of CPSR (Part A & B – Cosmetic Product Safety Report)
• Compilation and approval of PIFs (Product Information File)
• Toxicological assessment of ingredients and fragrance oils (including IFRA compliance)
• Evaluation of CMR substances and nanomaterials in cosmetics
• Legally compliant authority statements (SCCS, BfR, DGK)
  

Kosmetik-Sicherheitsbewertung & CPSR/PIF Services

Relevante Richtlinien in Deutschland

Product & Formulation Assessment

Safety reports for cosmetic products and perfumes

INCI review & Annex check (bans, restrictions, maximum levels)

Assessment of impurities and residues (PAHs, heavy metals, solvents)

Exposure assessments for leave-on, rinse-off, and multi-use products

Consulting & Support

Regulatory consulting for cosmetics in line with EU 1223/2009

Development of practical SOPs and checklists for manufacturers and importers

Supply chain validation (COA, SDS, IFRA, allergen reports)

• Training & workshops on cosmetic safety and EU compliance

Testing & Validation (Assessment)

Evaluation of stability and compatibility tests

Microbiological risk assessment (challenge tests, microbial counts)

Review of analytical data (preservative efficacy, pH, viscosity, residues)

Claim plausibility checks (“dermatologically tested”, “hypoallergenic”)

Bewertungen

Borderline assessments (cosmetic vs. medical device or biocide)

Preparation of international cosmetic dossiers (UK SCPN, MENA, ASEAN)

Pre-compliance audits at manufacturers or contract manufacturers

Claim substantiation and study design consulting for marketing claims

Wolfgang Steiner

Makrolife Biotech develops, analyzes, markets, and supports successful product and market positioning, ensures legally compliant health claims, and guarantees the scientific validity and effectiveness of your products—for sustainable success on the market. An ingenious service, especially when everything comes from a single source and we have one point of contact.

CEO, Aquapharma