Formulation Review

The PIF includes the qualitative and quantitative composition of the cosmetic product, namely its formulation.

One of the Responsible Person’s main tasks is ensuring that the formula complies with EU law.

Cosmetic Product Composition

Each formulation shows the INCI name, CAS number, concentration and function of each ingredient. The formulation review is the very first step of the Product Information File compilation — Your Responsible Person will check all ingredients one by one.

It can result in either a positive or negative assessment. In the first case, the compliance project can proceed with the review of the other PIF documents. Otherwise, you will be requested to re-formulate your product.

Annexes to the EU Cosmetics Regulation

Annexes to the EU Cosmetics Regulation regulate the use of substances in cosmetic products.

Annex II

is the list of prohibited ingredients;

Annex III

comprises all the substances that must comply with certain restrictions (category, concentration, etc.)

Annexes IV, V, and VI

include colourants, preservatives, and UV filters, respectively, whose use is allowed in the EU. If a substance with those functions is not mentioned there, it cannot be used in cosmetic products.

The Annexes to the EU Cosmetics Regulation are constantly being updated, considering new scientific evidence on the safe use of substances in cosmetic products. Moreover, every time you change your product’s formula, you must inform your RP and update the documentation accordingly.

In light of this, your RP …

... keeps you informed on all the news on the regulatory status of cosmetic ingredients
... asks you to undergo a formulation review every few years to confirm its compliance
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Our team of lawyers, chemists, pharmacists, and other experts represents the largest centre in Europe for CE Marking and EC REP services.
Founded in 1988, Obelis is certified by ISO 9001:2015 and ISO 13485:2016, and partakes in various EU associations and EU commission working groups.
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