Search results for “EU Responsible Person”

An EU Responsible Person for cosmetics is the legal or natural person established in the European Union who is accountable for a cosmetic product's...

A UK Responsible Person for cosmetics is the person or company, established in the United Kingdom, that carries legal responsibility for a cosmetic...

Yes. Every perfume needs a fragrance CPSR (Cosmetic Product Safety Report) before it is sold in the UK or EU. Article 10 of Regulation (EC) No 1223...

A CPSR for a cosmetic product (Cosmetic Product Safety Report) is the documented safety assessment that Article 10 of Regulation (EC) No 1223/2009 ...

A Cosmetic Product Safety Report is the safety assessment every cosmetic product needs before sale, required by Article 10 of Regulation (EC) No 12...

A multi-variant CPSR is a single Cosmetic Product Safety Report that covers several shades, tones, finishes, scents or sizes built on the same base...

Under MoCRA, the responsible person is the company named on a cosmetic's label, with a US address or contact for adverse event reports. Phoenix Saf...

MoCRA requires every cosmetic facility outside the US to name a US agent in its FDA registration. Phoenix Safety Consultants LLC acts as your US ag...

MoCRA Essentials is a 12-month package for non-US cosmetic brands. It covers FDA facility registration and renewal management, Phoenix Safety Consu...

A Product Information File (PIF) for cosmetics is the technical dossier that the Responsible Person must keep for every cosmetic product placed on ...

A cosmetic regulatory consultation is a 30-minute advisory session with a compliance specialist, for brands that need a clear answer on UK, EU or U...

Foreign medical device establishments must name a US agent who lives or has a place of business in the US, under 21 CFR 807.40. Phoenix Safety Cons...

Compliant cosmetic label design is the creation of new label artwork that meets Article 19 of Regulation (EC) No 1223/2009 in the EU and Northern I...

A cosmetic label compliance review is an independent audit of label and packaging artwork you already have, checked against Article 19 of Regulatio...

MoCRA requires the responsible person to keep records showing adequate safety substantiation for each cosmetic sold in the US. FDA does not prescri...

A PIF for product variants is one consolidated Product Information File for several versions of the same cosmetic, such as a lip balm in five shade...

A cosmetic formulation review is an early-stage diagnostic check of a draft or existing formula. It tests whether every ingredient is permitted, us...

An SCPN notification is the pre-market notification of a cosmetic product on Submit Cosmetic Product Notifications (SCPN), the UK government servic...

Formulation compliance validation is the final compliance sign-off of a finished cosmetic formula, carried out just before the Cosmetic Product Saf...

A fragrance PIF is the Product Information File for a perfume, eau de parfum, eau de toilette or body mist. Like every cosmetic, a fragrance must h...

A cosmetic packaging compatibility assessment evaluates whether your formula and its packaging are compatible: that the product will not react with...