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The Making

How colour cosmetics came to be regulated

Every regulated market now works from a positive list: these colours, at these levels, in these places. That approach was not obvious, and it was arrived at the hard way.

The front of an old apothecary drawer in dark stained wood with a worn brass cup pull.
Before the annexes, the answer to what is in this was whatever the maker decided to put in it.
In short

Colour regulation in cosmetics moved from a system of prohibiting known poisons to a positive list system in which only named colourants are permitted, at specified concentrations, for specified applications. In Britain and the European Union this is set out in the annexes to cosmetics legislation. The change followed documented injuries, most influentially a coal tar eyelash dye that blinded users in the United States in the 1930s, which contributed directly to the passage of the Federal Food, Drug, and Cosmetic Act of 1938.

There is a document, running to many pages of tables, that governs what colour a lipstick may be. It is not a style guide. It is an annex, and it lists colourants by index number, gives the applications each is permitted in, sets maximum concentrations, and notes any conditions. It is tedious to read and it is the single most important artefact in the modern cosmetics industry, which is why almost nobody writing about beauty has looked at one.

Before the list

For most of the history of cosmetics the question of what could go into a product had one answer: whatever the maker chose. Guild oversight, where it existed, set some standards of quality but did not operate a toxicology. Poisons legislation, which developed across the nineteenth century, took a different approach entirely. It named specific dangerous substances, arsenic prominently among them, and restricted their sale, requiring registers, signatures and, in some formulations, the presence of a witness. Britain's nineteenth century pharmacy and poisons legislation is a genuinely important strand of consumer protection history, and it worked on the principle of a negative list: these things are dangerous, control them.

A negative list has a structural weakness. It only covers what somebody has already identified as harmful. The nineteenth century produced an unprecedented flood of new synthetic organic compounds, particularly dyes derived from coal tar, and a negative list has nothing to say about a compound invented last year.

The consequences of that gap show up across the period. Arsenic based pigments, most famously the copper arsenite greens developed in the early nineteenth century, went into wallpaper, artificial flowers and dress fabrics, and sickened the people who made and wore them. Arsenic complexion wafers were advertised for sale, and the advertisements survive in newspaper archives. Mercury compounds appeared in skin lightening preparations, a use that persisted into the twentieth century and, in unregulated supply chains, well beyond it.

The front of an old apothecary drawer in dark stained wood with a worn brass pull.
Plate VI
The apothecary's drawer front is the physical form of a negative list. Behind it, poisons were kept separate, sometimes in ribbed or coloured bottles that could be identified by touch in the dark, and their sale was recorded in a register by name and purpose. This was real regulation and it worked reasonably well for a world in which the dangerous substances were a known set with known names. It could not survive an industry that could invent a new molecule faster than a legislature could name it, and the twentieth century answer, permitting only what has been assessed, is the exact inversion of the logic on this drawer.

The case that changed the law

The most consequential single episode in this history took place in the United States in the 1930s. A coal tar based eyelash and eyebrow dye was sold containing a derivative of paraphenylenediamine. Users suffered severe eye injuries, including ulceration and, in reported cases, blindness. The regulator of the day had no authority over cosmetics at all: the 1906 federal food and drugs legislation did not cover them.

The episode became a central exhibit in the campaign for stronger law, and it contributed directly to the passage of the Federal Food, Drug, and Cosmetic Act in 1938, which brought cosmetics within federal jurisdiction for the first time and established a regime for the certification of colour additives. The American regulator's own historical material describes this sequence, and it is one of the better documented cases of a specific injury producing a specific statute.

Circulates, but unverified
The claim
Mascara that blinded women led directly to a ban on all coal tar dyes in cosmetics, and the product's manufacturer was prosecuted and shut down.
Where it appears to come from
The core of this is true and the embellishments are not. The injuries and their role in the legislative campaign are documented. The additional details, about prosecutions, damages and total bans, accumulate in retellings, and the product is frequently misdescribed as a mascara rather than a permanent lash and brow dye, which is a different kind of product with different chemistry.
What is actually established
Established: a coal tar derived lash and brow dye caused severe eye injury including reported blindness; the case featured prominently in the campaign that produced the 1938 Act; that Act brought cosmetics under federal regulation and created a colour certification regime. Not established: that all coal tar dyes were banned, which they were not and are not. Hair dyes derived from the same chemistry remain in lawful use under specific conditions in most jurisdictions, including a longstanding exemption in the United States framework.

The positive list

The approach that emerged, and which is now standard in Britain, the European Union and many other markets, inverts the older logic. Rather than listing what is forbidden, the law lists what is allowed. A colourant may be used in a cosmetic only if it appears on the permitted list, and then only in the applications and at the concentrations specified. There are typically separate columns for products applied around the eyes, for products in contact with mucous membranes, for rinse off products and for products that stay on the skin, because exposure differs and the assessment differs with it.

Two further devices complete the system. A list of prohibited substances covers materials that may not be used at all, which is where lead and mercury compounds now sit. And a list of restricted substances covers materials permitted subject to conditions. The whole apparatus is maintained by scientific committees whose opinions are published, which means the reasoning behind a restriction is in the public record, a fact that is genuinely useful and almost entirely unknown to consumers.

In Britain this framework was carried over into domestic law after the United Kingdom left the European Union, with the annexes retained and subsequently amended separately. The practical effect is two closely related but diverging regimes, and the divergence is now large enough that a formulator selling into both markets must check both.

The most radical idea in cosmetics safety is not any particular ban. It is the reversal of the burden: nothing goes on a face until somebody has assessed it.

What the system does not do

Three limits are worth stating plainly, because the existence of a permitted list is often taken to mean more than it does.

It regulates colourants, not claims. What a product says about itself falls under advertising and consumer protection rules, which in Britain means the codes administered by the advertising regulator and the general law on misleading commercial practices. Those are a separate system and they were built for separate reasons.

It regulates products placed on the market lawfully. It has limited purchase on goods sold through informal channels, imported personally or bought from sellers outside the jurisdiction. Every significant contamination case of recent decades has involved supply chains that route around the system rather than through it.

It is not a guarantee of individual tolerance. A permitted colourant at a permitted concentration can still cause a reaction in a particular person. The list is a population level judgement about acceptable risk, and it was never designed to be anything else.

Why this is a cultural story

The annexes look like the least cultural document imaginable. They are in fact a precise record of what a society decided it would tolerate on a human face, revised whenever new evidence arrived, with the reasoning attached. Read historically they show the moment when the answer to what is in this stopped being a matter of the maker's discretion and became a matter of public record. That shift is as significant in the history of appearance as any change of fashion, and it happened because people were harmed first. The same pattern, harm then rule, runs through the lead story and through the wider record of cosmetic injury.

Where to look

Readers who want to go further should start with the holdings themselves rather than with summaries of them. The legislation.gov.uk and the US Food and Drug Administration both publish catalogue and research material relevant to this article. Both links are given for reference only. Neither institution has been assessed by us, neither has any connection to this magazine, and nothing here is an endorsement of any organisation.

Questions readers send us

Where can I read the permitted colours list?

In the annexes to the applicable cosmetics regulation. In Great Britain this is the retained and subsequently amended cosmetics regulation, published on the official legislation service; in the European Union it is the corresponding annexes to Regulation 1223/2009. Both are freely available.

Are coal tar dyes banned in cosmetics?

No. Certain specific compounds are prohibited or restricted, but dyes derived from coal tar chemistry remain in lawful use, notably in hair colourants, subject to conditions, concentration limits and in some cases mandatory warnings on the packaging.

Why are eye area products treated separately?

Because exposure differs. The eye area involves thin skin, proximity to a mucous membrane and the possibility of direct ocular contact, so a colourant acceptable in a body lotion may not be acceptable in an eyeliner. The permitted lists reflect this with separate columns of application.

Does a permitted colourant mean it is safe for me?

It means a scientific committee has assessed it as acceptable for general use at a specified level. Individual sensitivity is a different question, and the system does not claim to address it.

What happened to lead and mercury in cosmetics?

Both sit on the prohibited list in regulated markets. Trace contamination can occur in mineral derived materials and is subject to limits. Deliberate use persists in some unregulated imported products, particularly skin lightening preparations and traditional eye preparations, and has been the subject of repeated public health warnings.

Sources consulted
  1. legislation.gov.uk The applicable cosmetic products regulation and its annexes as they apply in Great Britain.
  2. US Food and Drug Administration Regulatory history of cosmetics in the United States, including the colour additive certification regime.
  3. Science Museum Group History of synthetic dyes, industrial chemistry and public health.
  4. Wellcome Collection History of poisons legislation, pharmacy and toxicology.
  5. The National Archives Records relating to nineteenth and twentieth century poisons and pharmacy legislation.
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