REGULARUS

Cosmetics compliance without compromise.

REGULARUS prepares your Product Information File and safety report (CPSR Parts A and B) fully in line with EU Regulation 1223/2009 and the current SCCS guidelines. You send us your formulation, our team handles assessment, documentation and release. Every report is reviewed and personally signed by a qualified safety assessor.

  • Quote is free and non-binding
  • Binding fixed-price quote up front
  • Reply usually within two working days

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Years of experience

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Formulations assessed

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Units produced

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Active customers

Assessment team

Scientific accountability, by name.

"A safety report is not a formality. It has to stand up professionally: to authorities, to trade partners and above all to the people who use the product."

Dr. med. Rosemarie Klotz

Specialist in Internal Medicine · Safety Assessor

Behind every report stands the REGULARUS team for regulatory affairs and toxicology. It structures the formulation, calculates margins of safety, checks limits and allergen obligations and documents everything in line with Annex I. Final release is given by one of our qualified safety assessors per Art. 10. Every assessment follows the SCCS Notes of Guidance, 12th Revision. Every report carries the name, qualification and signature of the releasing assessor.

Dr. med. Rosemarie Klotz

Compliance engine

What we check for every formulation.

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

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Allergen detection per EU 2023/1545

Detects declarable fragrance allergens, including inside fragrance blends. Thresholds: 0.001 % (leave-on) and 0.01 % (rinse-off). More than 80 fragrance allergens become subject to labelling under Regulation (EU) 2023/1545; products newly placed on the market must comply from 31 July 2026.

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 intake of your formulation

Your formulation as Excel, CSV, PDF or photo is enough. We read the composition in a structured way and check it against the INCI catalogue.

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

Structured notification helper with every mandatory field of the EU portal. On request we handle the submission entirely.

Cleanly separated

Every customer is kept in their own isolated tenant, multiple brands and product lines included.

Four steps to the PIF

01

Send your inquiry

Briefly describe your product in the inquiry form. You can attach your formulation right away (Excel, CSV, PDF or photo).

02

Receive your quote

You usually receive a binding fixed-price quote within two working days. Free and non-binding.

03

We prepare and review

We structure your formulation, calculate margins of safety and check limits. A qualified safety assessor reviews every assessment personally. We contact you directly with any questions.

04

Receive your signed CPSR

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 is limited to the people working on your order. There is no admin mode that reads across customer boundaries.

You

Your formulation remains your property

Every customer is kept in their own isolated tenant. Other customers never see your data, not even aggregated. Your formulation is used exclusively for your order.

Safety Assessor

Review via a single signed link

The safety assessor receives a single signed token link by email, only once your documents are fully prepared. The link is valid for 14 days. Once approved or expired, access ends. Every action is logged.

REGULARUS team

Access for your order only

Your formulation is handled exclusively by the people preparing your PIF, under contractual confidentiality. No disclosure to third parties, no use for any other purpose. Every action is recorded in the audit log, retained for 10 years.

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.
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 formulation data is never sold, shared or mined for advertising.

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

Service catalogue

From the first label to ongoing market care

CPSR and PIF are the core. Beyond that, we handle everything your cosmetic product needs before and after market entry.

Market entry

Ready to sell

  • Label and artwork review

    We check your final label and artwork against Art. 19: mandatory particulars, INCI order, allergens, warnings and symbols.

  • CPNP notification

    On request we handle the complete notification of your product in the EU portal, not just the preparation.

  • UK SCPN (optional)

    For the British market: notification via the UK portal SCPN, aligned with your EU documents.

Representation

Responsible Person as a service

  • EU Responsible Person

    We act as the responsible person per Art. 4 with an EU address, keep your PIF available for authorities and remain reachable for them.

  • UK Responsible Person (optional)

    For sales into Great Britain: appointment of a UK Responsible Person, together with the SCPN notification.

Ongoing operations

Your product stays compliant

  • Annual PIF maintenance

    We keep your Product Information File current: new regulatory states, SCCS assessments and document updates on a yearly cycle.

  • Change service

    Formulation changed, new packaging or shifted legislation: we assess the impact and update CPSR, PIF and label.

  • Authority requests and cosmetovigilance

    As a retainer: we answer authority requests, document undesirable effects per Art. 23 and keep reporting channels ready.

All services can be booked individually or as a package. Simply state in the inquiry form what you need.

One fixed price per product

You receive a binding fixed-price quote for your product up front. The price depends on product type and formulation, with no hidden costs.

  • Quote is free and non-binding, reply usually within two working days
  • Follow-up questions and change loops until sign-off included
  • Several products or variants: lower price per product

Quote

Fixed price

binding quote up front, net per product

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Quote is free and non-binding

FAQ

Frequently asked questions

The most common questions on process, price and confidentiality.

Ready for your first signed CPSR?

Send an inquiry, receive a quote, share your formulation. We take care of the rest. Free and non-binding, you only pay after placing the order.

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