The safety report a physician signs.

REGULARUS builds your Product Information File and safety report (CPSR Parts A & B) under EU Regulation 1223/2009. The software structures your formulation, calculates margins of safety and checks limits - Dr. med. Rosemarie Klotz reviews every assessment and signs it personally.

  • Start without a credit card
  • Drafts and review requests are free
  • Credits never expire

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Formulations assessed

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Active customers

Safety Assessor

Scientific accountability - by name.

"Safety assessment is not about ticking boxes - it is about knowing what is in the product and what consequences that brings for humans and skin. Every CPSR is a physician's responsibility."

Dr. med. Rosemarie Klotz

Specialist in Internal Medicine · Safety Assessor

Dr. Klotz personally signs off on every CPSR generated in REGULARUS - with over 30 years of medical and toxicological experience. Every safety report carries her name, her qualification, and her signature; the underlying assessment follows SCCS Notes of Guidance, 12th Revision, and EU Regulation 1223/2009 Annex I.

Dr. med. Rosemarie Klotz

Compliance engine

What the software checks automatically.

Every formulation passes a regulatory pre-check before the medical review - with documented sources instead of a black box.

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Allergen detection per EU 2023/1545

Detects declarable fragrance allergens - thresholds 0.001 % (leave-on) and 0.01 % (rinse-off), including inside fragrance blends.

CAS verification against PubChem

Every CAS number is checked forward and reverse: INCI to CAS and CAS to synonyms. Divergences are flagged, never overwritten.

MoS calculation per substance

Margin of safety from NOAEL, dermal absorption and category exposure data - target MoS ≥ 100 per SCCS.

Annex III/V/VI thresholds

Limits for restricted substances, preservatives and UV filters are checked against the use concentrations in your formulation.

INCI label per Annex VIII

Blends are resolved, identical INCIs summed, sorted descending - allergens are appended at the end of the list by convention.

Smart upload

Upload your formulation as XLSX, CSV, PDF or photo - the composition is extracted and prefilled automatically.

Everything authorities want to see

Structured along Annex I of the EU Cosmetics Regulation. Every required field, every editing step logged.

Complete PIF

Product description, formulation, physico-chemical and microbiological specs, packaging, exposure.

CPSR Parts A & B

Data part + assessment part with the qualified Safety Assessor’s conclusion. Name and signature are added after review.

GMP per ISO 22716

Manufacturing method, batch traceability, equipment and supplier qualification.

Full audit log

Who changed what, when - 10-year retention per Art. 11. Per-formulation versioning.

CPNP notification helper

Structured PDF with every mandatory field of the EU notification portal - copy-paste ready for manual entry at webgate.ec.europa.eu/cpnp.

Multi-tenant

Multiple brands, contract manufacturers and external customers in one account - cleanly separated.

Four steps to the PIF

01

Create or upload formulation

Manually or via smart upload: XLSX, CSV, PDF or photo - the composition is extracted automatically and mapped against the INCI catalogue.

02

Add data

Stability, microbiology, packaging, exposure. Templates and supplier datasheets speed up entry.

03

Request assessment

Qualified Safety Assessor reviews. Name and signature are added once review is complete.

04

Export PIF

Print-ready CPSR PDF for authority inspection plus a CPNP notification helper for EU portal entry.

CONIUNCTA® HQ · Breslauer Strasse 350 · 90471 Nürnberg

CONIUNCTA® HQ · Breslauer Strasse 350 · 90471 Nürnberg

CONIUNCTA

From practice. For practice.

REGULARUS is an entity of CONIUNCTA®.

CONIUNCTA® is a large-scale combined-chemistry operation - extract specialist, training, researching, patenting. REGULARUS was born from our daily reality of certified cosmetic manufacturing (DIN EN ISO 9001 + 22716, COSMOS/NATRUE, EFfCI, IFS HPC): so our customers can move faster from idea to compliant product - without PID bureaucracy standing between innovation and market.

Compliant or certified per

DIN EN ISO 9001DIN EN ISO 22716DIN EN ISO 16128EFfCICOSMOS/NATRUE (IFOAM)Regulation (EU) 2018/848 (organic)EC 178/2002 + 852/2004 + 1169/2011IFS HPC

Who can see your data?

Strictly separated access - three roles, nothing more.

Access to your formulations, ingredients and assessments is limited to three clearly defined roles. There is no admin mode that reads across customer boundaries - not even for REGULARUS staff.

You + your team

Tenant-isolated access

Only your own user accounts see your formulations and ingredients. Each account belongs to exactly one tenant; switching is not supported. Other customers on the same platform never see your data - not even aggregated.

Safety Assessor

Only on your explicit request

The Safety Assessor (Dr. med. Rosemarie Klotz) receives a single signed token link by email - only after you click "Request review". The link is valid for 14 days. Once approved or expired, access ends. Every action is logged.

REGULARUS team

No access. Not even for support.

We do not see your formulations, compositions or assessment contents. Support requests are answered based on the error description you send - without database access. A technical exception would show up in the audit log immediately.

Our security commitment

Your formulation stays your trade secret.

Data stays in the EU
Your formulation data is stored and processed in the EU - GDPR-compliant, with no transfers to third countries.
Strict separation per customer
Your data is technically separated from every other customer - there is no shared pool in which formulations could mix.
Protected access
Access only through personal accounts with encrypted sign-in. Sessions expire automatically instead of staying open for weeks.
Traceable for inspection
Every change is recorded with person and timestamp and retained for 10 years - exactly as Art. 11 of the Cosmetics Regulation requires for authority inspection.
Encrypted throughout
Your data is encrypted along the entire transmission path - from your browser to storage.
No trackers, no sharing
There are no analytics or advertising trackers inside the application. Your data is never sold, shared or mined.

On request we provide a data processing agreement (Art. 28 GDPR), TOM description and sub-processor list.

Transparent pricing

Self-service platform: you maintain ingredients, formulation and datasheet status, REGULARUS provides tox auto-extraction, CAS verification, signed Safety Assessor and audit log. Drafts and review requests are free. Pack credits never expire. Net prices, VAT applied per country.

1 credit = 1 signed CPSR - only consumed at final sign-off by Dr. Klotz.

One-time packs

Single use

1 CPSR

249 €

249 € per CPSR

1 CPSR. Best for a single product to test the market.

5-pack

5 CPSR

995 €

199 € per CPSR

5 CPSRs. 20 % off vs. single use.

Recommended

10-pack

10 CPSR

1.690 €

169 € per CPSR

10 CPSRs. 32 % off. For growing brands.

50-pack

50 CPSR

5.950 €

119 € per CPSR

50 CPSRs. 52 % off. For contract manufacturers with many variants.

Subscription

6-month minimum term. Unused credits roll over.

Monthly

5 CPSR / month

495 €/month

99,00 € per CPSR

5 CPSRs per month. 6-month minimum. Unused credits roll over indefinitely. Best per-CPSR price.

FAQ

Frequently asked questions

The most common questions on assessment, pricing and data access.

Ready for your first signed CPSR?

Create an account, upload a formulation, review the draft for free. You only pay when Dr. Klotz signs.

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