Regulatory Expertise
OTC-Cosmetic Borderline
Determining whether a product is a cosmetic, a medicine or a medical device, and what changes if it crosses the line. The classification turns on claims and function, and it differs sharply between the EU, UK and US.
Some of the most expensive regulatory mistakes happen at the border between categories: a product sold as a cosmetic that the authorities consider a medicine, or the reverse. Getting the classification right before launch is far cheaper than getting it wrong after.
How the line is drawn
In the EU and UK, a cosmetic is defined by Article 2 of Regulation (EC) No 1223/2009. A product becomes a medicinal product, under Directive 2001/83/EC, either by presentation (the claims made for it) or by function (what it actually does pharmacologically), and the medicines authorities take both routes seriously. The MHRA and the EU competent authorities publish borderline guidance. Anti-dandruff, anti-acne, intimate and certain whitening products are common flashpoints, as are products that edge toward a medical-device function.
The US is different again
In the United States the classification is starker. Sunscreens, anti-dandruff shampoos, fluoride toothpastes and antiperspirants are over-the-counter drugs regulated under FDA monographs, not cosmetics, so they fall outside the cosmetic MoCRA pathway entirely. We assess the formula and the intended claims together, tell you which category the product belongs in for each market, and set the claims so it stays there.
Relevant services
CPSR
From £70 · 2 to 3 days
The Cosmetic Product Safety Report is the safety assessment required under Article 10 and Annex I of Regulation (EC) No 1223/2009 before a cosmetic product may be placed on the UK or EU market. Prepared and signed by a qualified safety assessor.
Learn more →FDA MoCRA
From £395
US market entry under MoCRA: a MoCRA-compliant Toxicological Risk Assessment with the state-level provisions for California, Washington, New York and Minnesota, prepared by the same assessor who signs our EU and UK CPSRs.
Learn more →Labelling
From £195 · from receipt of artwork
Independent review of packaging artwork against Article 19, and of product claims against the six Common Criteria of Regulation (EU) 655/2013. Label review £195; per-claim review from £125; substantiation dossiers from £1,495.
Learn more →Frequently asked questions
How are cosmetic claims regulated?
Cosmetic claims are regulated as statements of fact, not marketing copy. Article 20 of Regulation (EC) No 1223/2009 and Commission Regulation (EU) No 655/2013 establish six Common Criteria that every claim must meet: legal compliance, truthfulness, evidential support, honesty, fairness, and informed decision-making. Evidence must exist before a claim is published and remain on file. Oxford Biosciences reviews claims per claim (£125, minimum five) and prepares formal Claims Substantiation Dossiers suitable for the Product Information File and for production to a competent authority or the Advertising Standards Authority.
What is MoCRA?
MoCRA, the Modernization of Cosmetics Regulation Act 2022, is the first comprehensive federal cosmetics law in the United States. It amended the Federal Food, Drug, and Cosmetic Act to require registration of manufacturing facilities with the FDA, product listing, adequate substantiation of product safety, adverse event recordkeeping and reporting, and a named responsible person. Oxford Biosciences prepares the MoCRA-compliant Toxicological Risk Assessment that substantiates safety, with the relevant US state provisions addressed alongside it.
What is a CPSR?
A Cosmetic Product Safety Report (CPSR) is the safety assessment required by Article 10 and Annex I of Regulation (EC) No 1223/2009 before a cosmetic product is placed on the UK or EU market. Annex I sets out two parts: Part A, the cosmetic product safety information (composition, physico-chemical and microbiological characteristics, stability, exposure and the toxicological profile of each substance), and Part B, the safety assessment, in which a qualified assessor states and reasons the conclusion on safety. It is the pivotal scientific document held within the Product Information File.