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Knowledge base

Questions and answers on cosmetic and chemical compliance

Clear answers to the questions brands ask most about Responsible Person, CPNP, CPSR, PIF, labels, UK, Türkiye, MoCRA, SDS, UFI and REACH.

110 questions

Responsible Person 17

What is a Responsible Person for cosmetics?Who can be the Responsible Person in the EU?Does a non-EU manufacturer need an EU Responsible Person?What are the obligations of the EU Responsible Person?Can an importer be the Responsible Person?When does a distributor become the Responsible Person?Whose address must appear on a cosmetic label?Is one Responsible Person enough for all EU countries?What is a Responsible Person mandate?Can I change my Responsible Person?What happens if a cosmetic product has no Responsible Person?Do I need an EU Responsible Person to sell cosmetics on Amazon or other marketplaces?What is the difference between manufacturer, importer and Responsible Person?Can the Responsible Person be an individual rather than a company?What does 'placing on the market' mean for cosmetics?What is a cosmetic product under EU law?Must the Responsible Person keep track of distributors?

CPNP notification 12

What is CPNP?When must a cosmetic product be notified on CPNP?What information is needed for a CPNP notification?Is a CPNP notification an approval or registration?Is there an official fee for CPNP notification?Who can see the data in a CPNP notification?Do I need a separate CPNP notification for each shade or variant?Must I update CPNP when the formula or label changes?What is a frame formulation in CPNP?What does a distributor notify on CPNP?Are there extra rules for cosmetics containing nanomaterials?How are CMR substances reported in CPNP?

Safety assessment (CPSR) 16

What is a CPSR (Cosmetic Product Safety Report)?What does Part A of the CPSR contain?What does Part B of the CPSR contain?Who can sign a CPSR?How long does it take to prepare a CPSR?Which tests are needed for a CPSR?What is a challenge test for cosmetics?What is the margin of safety (MoS) in a safety assessment?What is the systemic exposure dosage (SED)?Do I need a separate CPSR for every product?Does a CPSR expire?Can a safety report from outside the EU be used in the EU?Is animal testing allowed for cosmetics in the EU?What are the SCCS Notes of Guidance?Is a dermatological test mandatory for cosmetics?What is the difference between a CPSR and an SDS?

Product Information File 6

What is a Product Information File (PIF)?What must a Product Information File contain?Where must the Product Information File be kept?How long must the Product Information File be kept?In which language must the Product Information File be?What is GMP for cosmetics?

Labels & claims 14

What information is mandatory on an EU cosmetic label?How must the ingredient list be written on a cosmetic label?What is INCI?What is the period after opening (PAO) symbol?When is a 'best before' date required on cosmetics?Must fragrance allergens be listed on the label?In which language must a cosmetic label be?Is a batch number mandatory on cosmetics?What are the rules for cosmetic claims in the EU?Are 'free from' claims allowed on cosmetics?Can a cosmetic claim to treat or prevent a disease?Must the nominal content be shown on the label?What if the packaging is too small for all label information?Must the country of origin be on a cosmetic label?

United Kingdom 8

What is a UK Responsible Person for cosmetics?What is SCPN?Do I need a UK Responsible Person after Brexit?Does the UK accept an EU safety report (CPSR)?What are the label requirements for cosmetics in Great Britain?Which rules apply to cosmetics in Northern Ireland?Does the UK have its own ingredient restrictions for cosmetics?Who enforces cosmetic rules in the UK?

Türkiye 8

How are cosmetics regulated in Türkiye?What is ÜTS?Who must register in ÜTS?What is a responsible technical person (Sorumlu Teknik Eleman) in Türkiye?Is an EU safety report (CPSR) accepted in Türkiye?Do cosmetic labels in Türkiye need to be in Turkish?How can I export cosmetics from Türkiye to the EU?What is a Free Sales Certificate for cosmetics?

USA & MoCRA 10

What is MoCRA?What is FDA cosmetic facility registration?What is cosmetic product listing under MoCRA?What is a US Agent for cosmetics?Who is the 'responsible person' under MoCRA?What are the adverse event reporting rules under MoCRA?What is safety substantiation under MoCRA?Are small businesses exempt from MoCRA?Do cosmetics need FDA approval before sale?What label changes does MoCRA require?

SDS, CLP & REACH 10

What is a safety data sheet (SDS)?Do finished cosmetics need a safety data sheet?What are the 16 sections of a safety data sheet?What is the difference between MSDS and SDS?Does REACH apply to cosmetics?Does the CLP Regulation apply to cosmetics?How often must a safety data sheet be updated?What is the CLP Regulation?What is a REACH Only Representative?What is KKDİK?

Getting started 3

Which documents do I need to sell cosmetics in Europe?How long does it take to place a cosmetic product on the EU market?Which documents are needed to export cosmetics outside the EU?

UFI & poison centres 3

What is a UFI code?What is a poison centre notification (PCN)?Which products need a UFI and a PCN?

Biocides 1

Is a hand sanitiser a cosmetic or a biocidal product?

Laboratory testing 2

What is a stability test for cosmetics?What is an SPF test?