Native Formulas Limited

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Everything You Need to Know

1.What cosmetic regulatory services does Native Formulas provide?

We provide CPSRs, PIF preparation and review, label and CLP compliance checks, SCPN/CPNP notifications, and ongoing regulatory support for UK and EU cosmetic businesses.

2.What is a CPSR?

A CPSR (Cosmetic Product Safety Report) is a legally required safety assessment confirming a cosmetic product is safe for use before being placed on the market.

3.What is a custom CPSR?

A custom CPSR is prepared for a unique formulation that has not been previously assessed and is specific to your product.

4.What is a CPSR variant?

A variant applies when products share the same base formulation but differ only in aspects such as Additional ingredients/ingredients, fragrance or colour, within approved limits.

5.What is not considered a variant?

Changes to product type, intended use, target population, or major formulation changes require a new custom CPSR.

6.What is a Product Information File (PIF)?

A PIF is a mandatory regulatory file containing the CPSR, product details, manufacturing information, labelling, and supporting documentation.

7.Do you review cosmetic labels and CLP requirements?

Yes. We review cosmetic labels and CLP requirements to ensure all mandatory information and warnings are compliant.

8.Do you submit products on the SCPN and CPNP portals?

Yes. We provide full support for SCPN (UK) and CPNP (EU) notifications.
  • You are responsible for the accuracy and completeness of all information submitted.
  • You own or have the rights to use any formulations, ingredients, packaging, and labels you submit.
  • You will comply with applicable UK/EU regulations when bringing products to market.

9.What documents are needed for a CPSR?

We usually require the full formulation, ingredient MSDS/SDS, specifications, COA, and fragrance IFRA documentation and allergen declaration document if applicable.

10.How long does a CPSR take?

Turnaround time depends on formulation complexity, number of variants, and workload, ranging from 1 week to a maximum of 3–4 weeks.

11.Can you review existing CPSRs or PIFs?

Yes. We can review, update, or amend existing CPSRs and PIFs as required.

12.Do you work with start-ups and small businesses?

Yes. We support start-ups, indie brands, and manufacturers with affordable and reliable regulatory services.

13. Are your services compliant with UK and EU regulations?

Yes. All services comply with current UK and EU cosmetic regulations.

14. Can one CPSR be used for both the UK and EU markets?

Yes. The CPSR structure is the same for the UK and EU; however, separate SCPN (UK) and CPNP (EU) notifications and Responsible Person details are required.

15. Does a CPSR expire?

A CPSR does not have a fixed expiry date but must be reviewed and updated if regulations change or if the formulation, raw materials, supplier data, or intended use changes.

16. When does a CPSR require an update?

A CPSR must be updated if there are changes to:

  • Ingredient suppliers or specifications
  • Ingredient concentrations
  • Regulatory status of ingredients
  • Fragrance composition or IFRA amendment
  • Product use, packaging, or target population

17. Can a CPSR be issued without a COA?

In some cases, yes. However, a COA is strongly recommended and may be required depending on ingredient risk profile and assessor judgement.

18. Are essential oil–based products assessed differently?

Yes. Essential oils require additional scrutiny due to allergens, natural variability, and dermal exposure limits.

19. Can natural or “clean beauty” products still fail a CPSR?

Yes. Natural origin does not guarantee safety. Botanical extracts, essential oils, and preservatives are assessed against the same toxicological criteria as synthetic ingredients.

20. How are fragrance allergens assessed in a CPSR?

Fragrance allergens are assessed based on:

  • IFRA certification
  • Concentration in finished product
  • Product type (leave-on vs rinse-off)
  • Labelling thresholds under cosmetic regulations

21. Is an IFRA certificate mandatory?

Yes, for any product containing fragrance or fragrance components. The IFRA certificate must correspond to the correct amendment and product category.

22. Can one IFRA cover multiple variants?

Only if the fragrance composition and maximum usage levels remain unchanged across all variants.

23. What happens if an ingredient is restricted or banned after my CPSR is issued?

The CPSR must be reviewed and updated to ensure continued compliance with the latest regulatory amendments.

24. Can you assess products intended for children or babies?

Yes, but these products require additional safety considerations and are assessed under stricter exposure assumptions.

25. Does packaging affect the CPSR?

Yes. Packaging compatibility, material type, and potential migration are considered as part of the safety assessment.

26. What level of GMP evidence is required for the PIF?

A declaration of compliance with cosmetic GMP (ISO 22716 or equivalent) is required. Full certification is not mandatory but recommended.

27. Can private-label products use the manufacturer’s CPSR?

Only if the formulation, packaging, and Responsible Person details are identical. Otherwise, a new or revised CPSR is required.

28. Is a CPSR valid if raw materials come from outside the UK/EU?

Yes, provided the ingredients are compliant with UK/EU cosmetic regulations and supported by suitable documentation.

29. How do you determine exposure levels in a CPSR?

Exposure is calculated based on product type, frequency of use, application area, and consumer group, in line with SCCS guidance.

30. Can you review a CPSR prepared by another assessor?

Yes. We can review third-party CPSRs for compliance, accuracy, and regulatory robustness.

31. Will my formulation data remain confidential?

Yes. All client data and formulations are treated as strictly confidential.

32. What happens if amendments are requested after submission?
Will there be an additional fee?

Yes. Amendments requested after submission may incur an administrative fee, depending on the nature and extent of the changes required.

Once a regulatory document (such as a CPSR, PIF, CPNP/SCPN notification, label review, or compliance report) has been finalised and issued, it is considered complete based on the information originally provided. If changes are later requested, this may require additional regulatory review, document revision, version control updates, and in some cases reassessment.

33. When might an amendment fee apply?

An administrative fee may apply in situations such as:

  • Reformulation (ingredient changes, concentration adjustments, new fragrance/allergen profile)
  • Changes to product claims requiring new substantiation review
  • Updates to artwork affecting mandatory labelling elements
  • Addition of new product variants or shades
  • New packaging formats impacting stability or compatibility data
  • Post-issue corrections due to incomplete or inaccurate information initially provided

34. When might a fee not apply?

Minor administrative corrections may not incur a charge, for example:

  • Typographical errors that do not affect regulatory content
  • Minor formatting adjustments

35. Why is a fee necessary?

Amendments often require:

  • Regulatory reassessment against UK/EU Cosmetic Regulation
  • Updated toxicological evaluation
  • Revised documentation and controlled version re-issuance
  • Additional professional time and compliance verification
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