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If you are going to commission a cosmetic formula for the EU market, the brief you write decides most of what follows: which ingredients are possible, what a manufacturer can produce and what the safety assessment will have to cover. Brands that arrive with a clear brief get a formula they can take straight to a manufacturer. Brands that arrive with “a good face cream” get a round of questions first. Here is what to have decided, what a formula delivery contains and leaves out, and what has to happen before you can sell.
What to have decided before you commission a cosmetic formula
Type of product and intended use. Regulation (EC) 1223/2009 defines a cosmetic by its purpose: a substance or mixture meant to be put in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the mouth, with the exclusive or main purpose of cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours (Article 2(1)(a)). Name your product in those terms. A shampoo, a body lotion and a lip balm are different formulas, because the same ingredient can be allowed up to one limit in one product type and be subject to another limit, or to extra conditions, in another: Annex III, the list of restricted substances, sets its conditions by product type and by part of the body.
Who will use it, and how. The safety assessment is built on use. Annex I asks for the place and area of application, the amount applied, the duration and frequency of use, the routes of exposure and the target population, and its microbiological section singles out products used around the eyes, on mucous membranes or on damaged skin, and use by children under three, older people and people with an altered immune response. Adults or children, daily or occasional, face or body: settle it now, because the formula is designed for that use and the assessor will start from it (Article 10(1)(a)).
Presentation and characteristics. Cream, gel, serum, stick, powder or spray; texture, colour, fragrance or none. Presentation changes the exposure: Annex I tells the assessor to consider the unintended inhalation of aerosols and the effect of particle size, so a spray raises questions that a cream does not. Describe the product you want, not the promises you plan to print on the box: what you may say about a cosmetic is governed by Article 20, which forbids attributing to a product characteristics or functions it does not have, and it is a separate question from the formula.
Markets. Name the EU countries where you intend to sell. The notification records the Member State where the product is placed on the market (Article 13(1)(d)), and the language of several mandatory label particulars is set by the law of each Member State where the product reaches the end user (Article 19(5)). The formula is checked against EU rules; other markets keep their own lists of permitted ingredients and would need their own check.
What you receive when you commission a cosmetic formula
A formula proposal for the product you described: the list of ingredients, the percentage of each and the function each one performs. Before delivery, every ingredient is checked against the annexes of the Regulation: Annex II (prohibited substances), Annex III (substances allowed only with restrictions) and Annexes IV, V and VI, which list the admitted colourants, preservatives and UV filters. That is what our cosmetic formulation service delivers, and only that.
The first item of Annex I, Part A, the section every safety report must contain, is the qualitative and quantitative composition, with the chemical identity of each substance (INCI name, CAS number where possible) and its intended function. A formula with percentages and functions is the starting point of that section. You take it to your manufacturer, in the EU or in a third country, and ask for a quotation and a first sample. Who owns the formula and under what conditions you may use it are settled in our quotation, before you accept it.
What a formula does not include
A formula is a design on paper. Several things that brands assume come with it do not, and each has a different owner.
The label and the claims. Article 19 lists what must appear on the container and the packaging, among other particulars the name and address of the Responsible Person, the nominal content, the durability information and the ingredient list (which may appear on the packaging alone; small and unpackaged products have their own rules). Whatever you say about the product must be true, and when its nature or effect justifies it, the product information file must hold the evidence of the effect claimed (Article 11(2)(d)). Both are separate services.
The safety report (CPSR). Under Article 10(1), before a cosmetic is placed on the market the Responsible Person must make sure it has undergone a safety assessment and that a report has been drawn up in accordance with Annex I. A formula built on permitted ingredients is not, by itself, a safe product: the assessment looks at exposure, at the toxicological profile of each substance and at the margin of safety, and it must be carried out by a person holding a degree in pharmacy, toxicology, medicine or a similar discipline (Article 10(2)). Our guide to the cosmetic product safety report explains the document.
Stability, packaging compatibility and the challenge test. Annex I, Part A asks for the stability of the product under reasonably foreseeable storage conditions, its microbiological quality, including the result of the preservation efficacy test (the challenge test), and the relevant characteristics of the packaging material. All of it is measured on the real product in its real pack, so it can only exist once your manufacturer has made a sample. It stays with you and your manufacturer, and the results go into the safety report.
What comes after the formula
The order matters. First, a manufacturer that works to good manufacturing practice: Article 8 requires it, and in practice manufacturers show it through EN ISO 22716, so ask for evidence before you place an order. Second, the samples and the tests above. Third, the safety report on the final formulation, before any batch is sold. Fourth, the product information file that Article 11 requires the Responsible Person to hold, containing among other things the safety report, a description of the method of manufacture and a statement of good manufacturing practice. It is kept for ten years after the last batch was placed on the market (Article 11(1)).
Then the person and the portal. Only cosmetics for which a Responsible Person has been designated within the Union may be placed on the market (Article 4(1)). Who that is depends on where the product is made and who brings it in: the manufacturer established in the EU, the importer when the product is imported, or another person established in the EU designated by written mandate and accepting it in writing (Article 4(3) to (5)). If you have a product designed or made for you and sell it under your own name or trademark, the Regulation treats you as the manufacturer (Article 2(1)(d)). Our guide to the Responsible Person for cosmetics in the EU covers the role.
Before the product is placed on the market, the Responsible Person notifies it electronically through the Cosmetic Products Notification Portal (CPNP): category and name, name and address of the Responsible Person, country of origin for imports, Member State, a contact person and the frame formulation that allows rapid and appropriate medical treatment, among other data (Article 13(1)). The step-by-step CPNP guide walks through it.
Mistakes we see when brands commission a cosmetic formula
The most expensive is placing the production order before the safety assessment. A first batch is made, and only then does someone ask for the report. If the assessment finds that an ingredient level or a use does not hold up, the change means a new sample and, often, new stability tests. Assess first, produce second.
The second is a silent substitution. A raw material cannot be sourced, an equivalent takes its place and nobody tells the brand. A change of ingredient can change what the Regulation allows and the composition on which the safety report rests, so every substitution should come back for a check before it goes into production.
The third is a brief too vague to design from. “A moisturiser for sensitive skin” leaves open the use, the population, the presentation and the markets, which are exactly the questions above. Each one you leave open becomes a round of emails later.
Frequently asked questions
Do I need a manufacturer before I ask for a formula?
No. The formula does not depend on where it is made. Have your manufacturer review it before you place the order, because they confirm whether they can produce it with their equipment.
Can I change an ingredient after I receive the formula?
Any change in composition is handled as a new proposal: we tell you what it involves before we do it. It also changes the composition that the safety report and the notification are based on.
If you are planning a cosmetic for the EU market, tell us what product you have in mind through our contact page and we will send you a quotation for the formula, with ownership and conditions of use spelled out.