Regulated substances in Cosmetics
There are several substance categories legislated by the regulation 1223/2009.
All banned substances in cosmetics are listed in Annex II of the European Cosmetic Regulation No 1223/2009. This blacklist includes more than 1370 substances.
The CMR substances case
Definition: Are considered as CMR agents all substances or all preparations that are either:
- Carcinogenic (C): substances and mixtures which can, by inhalation, ingestion or skin penetration cause cancer or raise its frequency.
- Mutagen (M): substances and mixtures which can, by inhalation, ingestion or skin penetration cause hereditary genetic defaults or raise their frequency.
- Toxic for reproduction (R) : substances and mixtures which can, by inhalation, ingestion or skin penetration produce or raise the frequency of non-hereditary harmful effects in offspring or hampering reproductive functions or capabilities.
Diverse categories exist to classify CMRs according to their degree of hazardousness or the knowledge acquired on the subject: CMR 1A (proven effect), CMR 1B (assumed effect), CMR 2 (suspected effect).
CMR: ban and exceptions
According to Cosmetic Regulations 1223/2009, CMR substances are forbidden in cosmetics “because of their hazardous properties”. However, there are exceptional cases where these ingredients can be used:
|Conditions||CMR 1A, 1B||CMR 2|
|Compliance with the European regulations on food No 178/2002 (and amendments)||✓|
|Absence of suitable alternative substances||✓|
|Positive evaluation from the SCCS* for a determined use||✓||✓|
The list of all restricted substances can be found in Annex II of the Regulation – there are about 290 substances in it.
These substances are only usable if they respect some conditions, which can often be combined:
- Product type: some ingredients are only restricted for some defined ranges of cosmetics
- Maximal concentration in ready-to-use preparations over a given threshold of the substance or its impurities, the ingredient isn’t authorized.
- The user: an ingredient can be limited or forbidden for some categories of user (e.g. children under 3 years old)
- Concerned area of skin: the use of the ingredient can be restricted to some areas of skin (e.g. forbidden on mucous membranes)
- The use: an ingredient can be restricted to a strict professional use
Today there are 3 Annexes that list the ingredients admitted under certain conditions.
|Category||Annex of the Cosmetic Regulation||Number of ingredients|
|Colorant allowed||IV||≈ 150|
|Preservatives allowed||V||≈ 50|
|UV-filters allowed||VI||≈ 25|
The Annexes lay down the rules for the use of these substances such as:
- The maximum concentrations in the ready-to-use preparations
- The type or product and/or body parts (e.g. Do not use in products destined to mucous membranes)
- The category of user
- The necessity to enter specifications on the packaging of chemical products
Ingredients on borrowed time
Currently, many substances are regulated by the European Commission. However, the regulatory texts are in a constant evolution: the regulations are updated on average every 3 months.
To illustrate these evolutions, here are 3 situations recently modified:
Preservatives and CMIT/MIT
Following the decrease of authorized preservatives in cosmetic products like some parabens, the population finds itself more frequently exposed to the same substances. They can have a serious allergen potential, and thus cause sensitization to the population. The case of Methylisothiazolinone (CAS 2682-20-4) (MIT) is a telling example of this problem.
In 2013, dermatologists alerted the populations on the extreme sensitizing potential of MIT, especially when associated with methylchloroisothiazolinone (CAS 26172-55-4) (CMIT). These ingredients were already regulated by Annex V of the Cosmetic Regulations at the time.
Following these statements, the European Commission decided to amend Annex V of the Cosmetic Regulations 1223/2009. Following the Amendment 1003/2014, no leave-on products containing the CMIT/MIT combination can be put on the European market since 2015. As for MIT, the Amendment 1198/2016 leaves the manufacturers until February 2017 to remove all leave-on products from the market.
Nanomaterials & titanium dioxide
Because of their high surface-to-volume ratio, nanomaterials possess different physicochemical properties than their non-nano counterparts causing toxicological effects that are poorly or wrongly evaluated on man. Plus, it is hard to characterize them despite the recent evolutions (see our article: “What if my cosmetic product contains nanomaterials?”). However, following the SCCS evaluations, some nanomaterials begin to be included in the Annexes of the Cosmetic Regulation, such as titanium dioxide.
Titanium dioxide (CAS 13463-67-7) is used in its nano-form or bulk form in the cosmetic products. Until July 2016, only the bulk form was present in the Annexes of the Cosmetic regulations. Following the Regulation 1143/2016 modifying Annex VI of the Cosmetic Regulation 1223/2009, the nano-form of this ingredient was authorized under certain conditions such as a UV filter.
Allergens and allergenic substances
In 1999, 26 substances with allergen potential were identified. Their presence in cosmetic products has to be notified to consumers via the list of ingredients, as soon as their concentration exceeds:
- 0,01 % rinse-off products
- 0,001 % in leave-on products
The SCCS (Scientific Committee on Consumer Safety) has reevaluated the situation in 2012 and recommended the following points:
- Adding more than fifty new substances to the list of allergens submitted to the mandatory notification
- Ban the HICC (Lyral), Atranol and Chloroatranol
- Restricting the use of 11 allergens to a concentration of 0.01% in the cosmetic products
The European Commission has yet to officially modify the regulation on allergens in cosmetics. It has made some proposal of modification though, each time colliding with industry. The actual situation on allergens is still subjected to debates.
Discover our European Cosmetics Regulation services
Please do not hesitate to contact us: [email protected], if you have any questions about cosmetic compliance or if you’re looking for specific services. EcoMundo acts as Responsible Person for Europe and can provide the following services:
- Regulation 1223/2009 services
- EU cosmetic compliance
- Responsible Person for Europe
- Formula review
- Claim review
- Cosmetic labeling services
- PIF creation
- Safety Assessment
- CPNP notification services
- Cosmetic certification for Europe
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