Many ingredients are affected by Cosmetic Regulation No. 1223/2009, in force since 2013. Between prohibited, restricted and authorized ingredients, EcoMundo offers you an overview of cosmetic regulations.
Regulated substances in cosmetics
There are several categories of substances regulated by Regulation 1223/2009.
Prohibited substances
All substances prohibited in cosmetics are listed in Annex II of the European Cosmetic Regulation No. 1223/2009. This negative list includes over 1370 substances.
The case of substances classified as CMR
Definition:
Any substance or preparation is considered to be CMR agents:
Carcinogens (C): substances and mixtures which, if inhaled, swallowed or penetrated into the skin, may cause cancer or increase its frequency.
or/and
Mutagens (M): substances and mixtures which, if inhaled, ingested or penetrated the skin, may produce hereditary genetic defects or increase their frequency.
or/and
Toxic for reproduction (R): substances and mixtures which, if inhaled, ingested or penetrated the skin, may produce or increase the frequency of non-hereditary harmful effects in the offspring or impair reproductive functions or capacities.
Various categories exist to classify CMRs according to their degree of danger or the knowledge we have acquired about them: CMR 1A (proven effect), CMR 1B (supposed effect), CMR 2 (suspected effect).
CMR: Prohibition and exceptions
According to Cosmetic Regulation 1223/2009, CMR substances are prohibited in cosmetics “because of their dangerous properties”. However, there are exceptional cases where these ingredients can be used:
CMR 1A, 1B CMR 2 requirements
Compliance with European Food Regulation 178/2002 (and amendments) ✓
Lack of appropriate substitutes ✓
Use for a particular purpose ✓
Positive assessment by the SCCS
* for a specific use ✓✓
*CSSC: European Scientific Committee for Consumer Safety
Restricted substances
The list of all restricted substances can be found in Schedule III of the Regulations.
These substances can only be used if they meet certain conditions that can often be combined, such as:
- The type of product : some ingredients are restricted only for defined classes of cosmetic products;
- Maximum concentrations in ready-to-use preparations: above a given concentration of the substance or of these impurities, the ingredient is no longer authorized;
- The user : an ingredient may be limited or prohibited for certain categories of users (e.g. children under 3 years of age);
- The targeted skin areas : the use of the ingredient may be restricted to certain skin areas (e.g.: Forbidden on mucous membranes);
- The use : an ingredient may be restricted to strict professional use.
Authorized substances
To date, there are 3 Annexes listing the ingredients allowed under certain conditions.
These Annexes set out the rules for the use of these substances such as:
- Maximum concentrations in ready-to-use preparations;
- Product type and/or body parts (ex: Do not use in products intended for mucous membranes);
- The user category ;
- The need to affix specific information on the packaging cosmetic products.
Suspended ingredients
To date, many substances are regulated by the European Commission. However, regulatory texts are constantly evolving: the regulation is updated on average every 3 months. To illustrate these developments, here are 3 situations that have recently been modified:
- Curators & CMIT/MIT
Following the reduction of preservatives authorized in cosmetic products such as certain parabens, the population is exposed more and more frequently to the same substances. The latter can have significant allergenic potential and therefore lead to population awareness. The case of Methylisothiazolinone (CAS 2682-20-4) (MIT) is particularly indicative of this problem. In 2013, dermatologists alerted populations to the extremely sensitizing potential of MIT, especially in combination with Methylchloroisothiazolinone (CAS 26172-55-4) (CMIT). These ingredients were then already regulated by Annex V of the Cosmetic Regulation. Following these findings, the European Commission decided to amend Annex V of the Cosmetic Regulation 1223/2009. Following Amendment 1003/2014, no more unrinsed products containing the CMIT/MIT combination can be placed on the European market since 2015. Regarding MIT, Amendment 1198/2016 gives manufacturers until February 2017 to remove non-rinsed products from the market.
- Nanomaterials & Titanium Dioxide
Because of their high surface area/volume ratio, nanomaterials have physicochemical properties different from their non-nano counterparts, resulting in toxicological effects that are poorly evaluated or poorly evaluated in humans. Moreover, it remains difficult to characterize them despite recent developments (see our article: “Nanomaterials in cosmetics: what obligations? ”). However, following the evaluations of the SCCS, some nanomaterials are beginning to be included in the Annexes to the Cosmetic Regulation, such as Titanium Dioxide. Titanium dioxide (CAS 13463-67-7) is used in its nanomaterial or non-nano form in cosmetic products. Until July 2016, only the non-nano form was present in the Annexes to the Cosmetic Regulation. Following Regulation 1143/2016 modifying Annex VI of Cosmetic Regulation 1223/2009, the nanomaterial form of this ingredient was authorized under certain conditions as a UV filter.
- Allergens & lists of allergenic substances
In 1999, 26 substances with allergenic potential were identified. Their presence in cosmetic products must be reported to consumers in the list of ingredients, as soon as their concentration exceeds:
- 0.01% in rinse-off products;
- 0.001% in leave-in products.
The SCCS (European Scientific Committee for Consumer Safety) re-assessed the situation in 2012 and recommended the following points:
- Add more than fifty new substances to the list of allergens subject to mandatory declaration;
- Banish HICC (Lyral), Atranol, and Chloroatranol;
- Restrict the use of 11 allergens to a concentration of 0.01% in cosmetic products.
Today, the European Commission has not yet officially amended the regulation on allergens in cosmetics. However, it made several proposals for changes, each time clashing with the industry. The current allergen situation is therefore still subject to debate.
To stay up to date on developments in the Cosmetics Regulation, do not hesitate to subscribe to our webinars or to watch the replays.
Do you want to know more about the conformity of cosmetic products?
For more information, do not hesitate to contact our experts.
Many ingredients are affected by Cosmetic Regulation No. 1223/2009, in force since 2013. Between prohibited, restricted and authorized ingredients, EcoMundo offers you an overview of cosmetic regulations.
Regulated substances in cosmetics
There are several categories of substances regulated by Regulation 1223/2009.
Prohibited substances
All substances prohibited in cosmetics are listed in Annex II of the European Cosmetic Regulation No. 1223/2009. This negative list includes over 1370 substances.
The case of substances classified as CMR
Definition:
Any substance or preparation is considered to be CMR agents:
Carcinogens (C): substances and mixtures which, if inhaled, swallowed or penetrated into the skin, may cause cancer or increase its frequency.
or/and
Mutagens (M): substances and mixtures which, if inhaled, ingested or penetrated the skin, may produce hereditary genetic defects or increase their frequency.
or/and
Toxic for reproduction (R): substances and mixtures which, if inhaled, ingested or penetrated the skin, may produce or increase the frequency of non-hereditary harmful effects in the offspring or impair reproductive functions or capacities.
Various categories exist to classify CMRs according to their degree of danger or the knowledge we have acquired about them: CMR 1A (proven effect), CMR 1B (supposed effect), CMR 2 (suspected effect).
CMR: Prohibition and exceptions
According to Cosmetic Regulation 1223/2009, CMR substances are prohibited in cosmetics “because of their dangerous properties”. However, there are exceptional cases where these ingredients can be used:
CMR 1A, 1B CMR 2 requirements
Compliance with European Food Regulation 178/2002 (and amendments) ✓
Lack of appropriate substitutes ✓
Use for a particular purpose ✓
Positive assessment by the SCCS
* for a specific use ✓✓
*CSSC: European Scientific Committee for Consumer Safety
Restricted substances
The list of all restricted substances can be found in Schedule III of the Regulations.
These substances can only be used if they meet certain conditions that can often be combined, such as:
- The type of product : some ingredients are restricted only for defined classes of cosmetic products;
- Maximum concentrations in ready-to-use preparations: above a given concentration of the substance or of these impurities, the ingredient is no longer authorized;
- The user : an ingredient may be limited or prohibited for certain categories of users (e.g. children under 3 years of age);
- The targeted skin areas : the use of the ingredient may be restricted to certain skin areas (e.g.: Forbidden on mucous membranes);
- The use : an ingredient may be restricted to strict professional use.
Authorized substances
To date, there are 3 Annexes listing the ingredients allowed under certain conditions.
These Annexes set out the rules for the use of these substances such as:
- Maximum concentrations in ready-to-use preparations;
- Product type and/or body parts (ex: Do not use in products intended for mucous membranes);
- The user category ;
- The need to affix specific information on the packaging cosmetic products.
Suspended ingredients
To date, many substances are regulated by the European Commission. However, regulatory texts are constantly evolving: the regulation is updated on average every 3 months. To illustrate these developments, here are 3 situations that have recently been modified:
- Curators & CMIT/MIT
Following the reduction of preservatives authorized in cosmetic products such as certain parabens, the population is exposed more and more frequently to the same substances. The latter can have significant allergenic potential and therefore lead to population awareness. The case of Methylisothiazolinone (CAS 2682-20-4) (MIT) is particularly indicative of this problem. In 2013, dermatologists alerted populations to the extremely sensitizing potential of MIT, especially in combination with Methylchloroisothiazolinone (CAS 26172-55-4) (CMIT). These ingredients were then already regulated by Annex V of the Cosmetic Regulation. Following these findings, the European Commission decided to amend Annex V of the Cosmetic Regulation 1223/2009. Following Amendment 1003/2014, no more unrinsed products containing the CMIT/MIT combination can be placed on the European market since 2015. Regarding MIT, Amendment 1198/2016 gives manufacturers until February 2017 to remove non-rinsed products from the market.
- Nanomaterials & Titanium Dioxide
Because of their high surface area/volume ratio, nanomaterials have physicochemical properties different from their non-nano counterparts, resulting in toxicological effects that are poorly evaluated or poorly evaluated in humans. Moreover, it remains difficult to characterize them despite recent developments (see our article: “Nanomaterials in cosmetics: what obligations? ”). However, following the evaluations of the SCCS, some nanomaterials are beginning to be included in the Annexes to the Cosmetic Regulation, such as Titanium Dioxide. Titanium dioxide (CAS 13463-67-7) is used in its nanomaterial or non-nano form in cosmetic products. Until July 2016, only the non-nano form was present in the Annexes to the Cosmetic Regulation. Following Regulation 1143/2016 modifying Annex VI of Cosmetic Regulation 1223/2009, the nanomaterial form of this ingredient was authorized under certain conditions as a UV filter.
- Allergens & lists of allergenic substances
In 1999, 26 substances with allergenic potential were identified. Their presence in cosmetic products must be reported to consumers in the list of ingredients, as soon as their concentration exceeds:
- 0.01% in rinse-off products;
- 0.001% in leave-in products.
The SCCS (European Scientific Committee for Consumer Safety) re-assessed the situation in 2012 and recommended the following points:
- Add more than fifty new substances to the list of allergens subject to mandatory declaration;
- Banish HICC (Lyral), Atranol, and Chloroatranol;
- Restrict the use of 11 allergens to a concentration of 0.01% in cosmetic products.
Today, the European Commission has not yet officially amended the regulation on allergens in cosmetics. However, it made several proposals for changes, each time clashing with the industry. The current allergen situation is therefore still subject to debate.
To stay up to date on developments in the Cosmetics Regulation, do not hesitate to subscribe to our webinars or to watch the replays.
Do you want to know more about the conformity of cosmetic products?
For more information, do not hesitate to contact our experts.
