on safety criteria for cosmetic products intended for infants1
(Adopted by the Committee of Ministers on 14 March 2012
at the 1137th meeting of the Ministers’ Deputies)
The Committee of Ministers, in its composition restricted to the representatives of the States Parties to the Convention on the Elaboration of a European Pharmacopoeia2 (“the Convention”),
Recalling the Declaration and Action Plan adopted by the Third Summit of Heads of State and Government of the Council of Europe (Warsaw 16-17 May 2005) – Chapter III “Building a more humane and inclusive Europe”, Article 1 “Ensuring social cohesion”, in particular laying down protection of health as a social human right and an essential condition for social cohesion and economic stability;
Recalling Resolution Res(59)23 of 16 November 1959 extending the activities of the Council of Europe in the Social and Public Health field on the basis of a Partial Agreement, and Resolutions Res(96)34 and Res(96)35 of 2 October 1996 revising the rules of the Partial Agreement;
Having regard to the decisions, taken by the Committee of Ministers at its meeting on 2 July 2008 (CM/Del/Dec(2008)1031/6.1), to dissolve the Partial Agreement in the Social and Public Health Field and to transfer activities related to cosmetics and food packaging to the European Directorate for the Quality of Medicines and HealthCare (EDQM) as of 1 January 2009, whereby the EDQM became responsible for developing harmonised approaches to ensure product quality and safety in the areas of cosmetic products and packaging materials for food and pharmaceutical products;
Considering the efforts made over several years (under the former Council of Europe Partial Agreement in the Social and Public Health Field) to improve the safe use of cosmetics;
Recalling Resolution ResAP(2005)4 on sun protection products to optimise consumer protection;
Recalling Resolution ResAP(2006)1 on a vigilance system for undesirable effects of cosmetic products (“cosmetovigilance”);
Recalling the Council of Europe Safety Survey on Active Ingredients used in Cosmetics (published in March 2008);
Recalling the Council of Europe Publications on Plants in Cosmetics (Vol. I published in September 2002; Vol. II published in September 2001; Vol. III published in September 2006);
Considering that a high level of health protection should be ensured for children;
Considering the generally positive attitude towards baby products and their benefits with the resulting risk of excessive use beyond hygienic purposes, in terms of the number of products used as well as the quantity used of the individual products;
Considering that cosmetic products may be ingested orally by infants due to specific behaviours including sucking and licking of hands, arms and feet;
Considering also that various cosmetics of the “leave-on” type are applied several times every day and that their ingredients may accumulate over time and contribute to long-term toxicities that are difficult to assess;
Recognising that infants are more sensitive to certain toxic effects of chemicals and, therefore, that special attention should be paid to the safety of cosmetic products that are intended to be used on them;
Acknowledging that several organs and vital physiological functions undergo significant development during childhood;
Being convinced that safety assessors and responsible persons for cosmetic products intended for infants will benefit from the specific recommendations laid down in a guidance document elaborated by the Committee of Experts on Cosmetic Products (P-SC-COS);
Taking into account the valuable contribution made by the Scientific Committee on Consumer Safety (SCCS) through their notes of guidance for the testing of cosmetic ingredients and their safety evaluation,3
Also taking into account Council Directive 76/768/EEC and Regulation (EC) No. 1223/2009 that lay down specific requirements for cosmetics for children under the age of three and that form the basis of the guidance document elaborated by the Committee of Experts on Cosmetic Products (P-SC-COS);
Recommends to the governments of States Parties to the Convention that they adopt legislative and other measures aimed at reducing the health risks for infants, arising from exposure to cosmetic products and their ingredients, according to the principles set out in the appendix to this resolution. These recommendations shall not prevent governments from maintaining or adopting national measures that implement stricter rules and regulations.
Appendix to Resolution CM/ResAP(2012)1
Article 1. Definitions
Cosmetic product – a product that complies with the definition given in Regulation (EC) No. 1223/2009 of 30 November 2009 on cosmetic products.
Cosmetic ingredient – any natural or synthetic substance or mixture that has been selected and intentionally added to the product composition.
Infant – a child under the age of three years.
Article 2. Scope
The provisions of this resolution relate to all cosmetic products placed on the market in one or more States Parties to the Convention that are intended or can reasonably be expected to be applied to infants for cosmetic purposes.
Article 3. General requirements
3.1 A cosmetic product intended for use on infants should be safe for his or her health when it is being used under normal and foreseeable conditions, taking into consideration the physiological characteristics, application area and infant-specific behaviour that may increase exposure to certain substances or to their toxic effects.
3.2 The product should comply with the basic requirements for cosmetic ingredients and finished cosmetic products, notably Regulation (EC) No. 1223/2009, and should follow the general principles stated in the Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation (SCCS).
3.3 The presentation of a cosmetic product intended for use on infants, and in particular its form, odour, colour, appearance, packaging, labelling, volume or size, should not endanger their health and safety due to confusion with food.
3.4 The cosmetic product should contain no more than a strict minimum number of ingredients; the following substances (including impurities) should not be present:
- substances with carcinogenic or mutagenic properties or substances that are toxic for reproduction (CMR),
- substances with endocrine disrupting activity,
- substances that are candidates for inclusion in Annex XIV of Regulation (EC) No. 1907/2006 (REACH),
- substances that are potent allergens.
3.5 Substances used in replacement of the substances stated above should adhere to the same safety criteria described herein.
3.6 The unintended presence of impurities or traces thereof, originating from raw materials, packaging materials, manufacturing process or from chemical changes or interactions in the finished product should be assessed.
3.7 Preservatives should be used at the lowest efficient concentrations.
3.8 The maximum tolerable concentration indicated in the guidance document for certain ingredients such as terpenes should not be exceeded.
3.9 The container and packaging of the cosmetic product should provide appropriate protection to ensure physicochemical stability and avoid microbiological contamination during storage, distribution and use. The materials used should be inert and should not release any toxic substances into the product.
Article 4. Risk assessment
4.1 When assessing risk, the exposure scenario should account for long-term toxicity and, as far as possible, cumulative daily exposure to the same ingredients originating from different sources.
4.2 On the basis of the toxicological data or in the absence of sufficient data, additional uncertainty factors proportionate to the degree of potential risk should be applied if there is reasonable cause for assuming higher sensitivity of an infant to a given substance.
Article 5. Documentation
5.1 The specific safety assessment of cosmetic products for infants should be documented as required by Regulation (EC) No. 1223/2009 and made readily accessible to the competent authorities.
5.2 Sufficient data on the toxicity profile of each ingredient, notably data reported in scientific literature, should be documented.
Article 6. Labelling
The instructions for use and general precautionary measures on the label should be sufficiently clear to ensure the safe use of the product and, in particular, to avoid any misuse.
Article 7. Guidance document
To support the implementation of the provisions of this resolution, a guidance document has been prepared by the Committee of Experts on Cosmetic Products (P-SC-COS), approved by the Consumer Health Protection Committee (CD-P-SC) and is available from the European Directorate for the Quality of Medicines and HealthCare (EDQM), a directorate of the Council of Europe. This guidance document will be regularly updated.
1 In the resolution and the guidance document that supplements it, the term “infant” is used to mean all children under the age of three.
2 States concerned: Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Montenegro, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, “the former Yugoslav Republic of Macedonia”, Turkey and United Kingdom.
3 The SCCS’s Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, 7th revision, SCCS/1416/11 (2011).