Policy fields

Internal market and industry, public health

Target

Any interested parties, including academic and other research institutes, EU countries’ authorities, manufacturers of cosmetic products, producers of the substances concerned, relevant industry and consumers associations.

Period of consultation

22 June 2020 – 22 October 2020

Request

The European  Commission would like to invite any interested parties, including academic and other research institutes, EU countries’ authorities, manufacturers of cosmetic products, producers of the  substances mentioned below and consumers’ associations, to submit any scientific information relevant to the safety assessment of prostaglandins and their analogues (the following list is non-exhaustive)

• Prostaglandins (CAS no. 13345-50-1, EC No. 634-333-3),
• Isopropyl Cloprostenate (CAS no.157283-66-4,)
• Bimatoprost (CAS no. 155206-00-1),
• Ethyl Tafluprostamide (INN name Tafluprost,  CAS: 209860-87-7),
• Other synthetic analogues of a prostaglandin (see Table 1 below).

Action proposed by the Commission

The Commission has concerns about the use of prostaglandins and their analogues in cosmetic products. Several EU countries recorded serious undesirable effects caused by the use of cosmetic products for eyelash growth containing prostaglandins and/or its analogues. There are also indications that prostaglandins and their analogues are used and placed on some EU country markets as active ingredients in medicinal products. See entry 3.3.5 of the borderline products manual for more.

We will mandate the EU Scientific Committee for the Safety of Consumers (SCCS) to assess the safety of the above mentioned cosmetic ingredients. In preparation, we invite interested parties to submit relevant scientific information on the safety of prostaglandins and their analogues in line with the requirements. See the following non-exhaustive list

• Prostaglandins (CAS no. 13345-50-1, EC No. 634-333-3),
• Isopropyl Cloprostenate (CAS no.157283-66-4,)
• Bimatoprost (CAS no. 155206-00-1),
• Ethyl Tafluprostamide (INN name Tafluprost, CAS: 209860-87-7),
• Other synthetic analogues of a prostaglandin (see Table 1 below).

Requirements

Please submit data on all physicochemical properties, toxicokinetics and toxicological end-points, assessment of exposure through consumer products and/or an indication on the suggested safe concentration limits for these ingredients, including data concerning medicinal products containing these ingredients.

Your input must include

a)      the template for submitting input – checklists
b)      a table of contents
c)      numbered references

Submit your data in line with the SCCS’ notes of guidance (testing of cosmetic ingredients and their safety evaluation - 10^th revision).

How to submit your contribution

Deliver any comments and/or information with the reference: ‘prostaglandins and their analogues in cosmetic products’ via post or e-mail by 21 October 2020 at the latest to

European Commission - Directorate General Internal Market, Industry, Entrepreneurship and SMEs   Unit D/4, Consumer Industry
Avenue d’Auderghem 45, BREY 12/23 - 1040 Brussels   Belgium

Email: GROW-D4@ec.europa.eu

Background

In 2018, the German Federal Institute for Risk Assessment (BfR) informed the European Commission that cosmetic products intended to promote the growth of eyelashes were increasingly available on the market. These eyelash growth treatments contain substances such as prostaglandins or their analogues.

According to the BfR’s assessment, the use of prostaglandins and their analogues as components of cosmetic products may include health risks for consumers. Prostaglandin analogues are also used in drugs to reduce ocular hypertension. Increased eyelash growth has been observed as a side effect, and furthermore, other adverse effects have been found.

As a result of this communication, EU countries’ competent authorities were invited to participate in a survey on products for eyelash growth containing prostaglandins and their analogues. The information collected helped to identify an uneven situation in terms of applicable regulatory framework (e.g. cosmetic products or medicinal products). Furthermore, several cases of serious undesirable health effects were recorded in many EU countries.

Last December 2019 the sub-working group on borderline products assessed this topic and considered that a SCCS opinion would be useful to assess the safety (lack of) of those products.

The Commission database for information on cosmetic substances and ingredients CosIng contains 14 cosmetic ingredients, each described as ‘a synthetic analogue of a prostaglandin’ (see table 1 below).

In addition, the EU cosmetic products notification portal (CPNP) contains notifications of cosmetic products containing prostaglandins and their analogues placed on the EU market.

Table 1 - CosIng cosmetic ingredients described as ‘a synthetic analogue of a prostaglandin’

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