Search results for “uk responsible person”

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

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...

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...

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

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

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...

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

The Cosmetics Brand Founder's Compliance Handbook is a 62-page guide for founders launching or scaling a cosmetics brand in the UK and EU. In six p...

MoCRA Professional is a 12-month package for growing cosmetic brands. It includes everything in Essentials plus Phoenix Safety Consultants LLC as r...

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...

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 cosmetic facilities must register with the FDA under MoCRA and name a US agent. This package covers both: we prepare and submit your regist...

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

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

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

OTC drugs such as sunscreens, acne treatments and antiperspirants must carry a Drug Facts label in the format set by 21 CFR 201.66, with wording th...

US cosmetic labels must meet FDA's labelling regulations, the Fair Packaging and Labeling Act and MoCRA, which adds a US contact for adverse event ...

Under MoCRA, every facility that manufactures or processes cosmetics for US distribution must register with the FDA and renew every two years. We p...

Sunscreens, acne treatments, antiperspirants and other OTC monograph drugs are drugs in the US, not cosmetics. The establishment that makes them mu...

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...