Makrolife Biotech – Your In-House Toxicology and Regulatory Laboratory for CPSR, PIF and complete EU cosmetic market approval. From lab to launch — all under one roof.

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

• CPSR Preparation (Parts A & B) – full toxicological safety assessment by qualified safety assessors according to EU Regulation (EC) 1223/2009
• PIF Creation & Management – complete setup and maintenance of Product Information Files compliant with EU regulatory requirements
• CPNP Notification – product registration in the EU Cosmetic Products Notification Portal including Responsible Person data management
• INCI Lists & Ingredient Compliance – legally compliant ingredient labeling and allergen declarations according to Annex III
• Label Compliance & Artwork Review – regulatory verification and approval of all mandatory packaging and labeling elements
• IFRA & Fragrance Compliance Assessments – verification of IFRA certificates, QRA documentation and fragrance concentration limits
• Toxicological Evaluation Services – ingredient safety reviews, exposure assessments and Margin of Safety (MoS) calculations
• Claims Compliance Review – legal evaluation of marketing claims according to EU Regulation (EU) 655/2013
• Packaging & Migration Assessments – regulatory safety review of glass, plastic and elastomer packaging components
• Animal Testing Declarations – preparation of legally compliant statements under Article 18 of Regulation (EC) 1223/2009
• Batch Traceability Systems – setup of traceability and lot documentation systems for market surveillance readiness
• Regulatory Project Management – end-to-end coordination of all regulatory approval activities
• Supplier Documentation Management – direct communication with fragrance and packaging suppliers to obtain QRA, IFRA and conformity documents
• Portfolio Registration & Scaling – regulatory processing of single products and large multi-SKU cosmetic portfolios
• Regulatory Authority Liaison – professional communication with market surveillance authorities and regulators
  

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”)

Assessments

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