Resolution ResAP(2006)1

on a vigilance system for undesirable effects of cosmetic products (“cosmetovigilance”) in Europe

in order to protect public health

(Adopted by the Committee of Ministers on 8 November 2006
at the 979th meeting of the Ministers’ Deputies)

The Committee of Ministers, in its composition restricted to the Representatives of the States members of the Partial Agreement in the Social and Public Health Field,[1]

Recalling Resolution (59) 23 of 16 November 1959, on the extension of the activities of the Council of Europe in the social and cultural fields;

Having regard to Resolution (96) 35 of 2 October 1996 revising the Partial Agreement in the Social and Public Health Field, whereby it revised the structures of the Partial Agreement and resolved to continue, on the basis of revised rules replacing those set out in Resolution (59) 23, the activities hitherto carried out and developed by virtue of that resolution, these being aimed in particular at:

–          raising the level of health protection of consumers in its widest sense, including the making of a constant contribution to harmonising – in the field of products having a direct or indirect impact on the human food chain as well as in the fields of pesticides, pharmaceuticals and cosmetics – legislation, regulations and practices governing, on the one hand, quality, efficiency and safety controls for products, and, on the other hand, the safe use of toxic or noxious products;

–          integrating people with disabilities into the community; defining – and contributing to the implementation at a European level – of a model of coherent policy for people with disabilities, which takes account simultaneously of the principles of full citizenship and independent living; contributing to the elimination of barriers to people’s integration, whatever their nature, whether psychological, educational, family-related, cultural, social, professional, financial or architectural;

Having regard to the action carried out over several years for the purposes of harmonising their legislation and practices in the public health field and, in particular, to specific issues in the cosmetics sector;

Considering that “cosmetic products must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use ” (according to Directive 93/35/EEC of 14 June 1993 amending for the sixth time Directive 76/768/EEC (31976L0768) on the approximation of the laws of the member states relating to cosmetic products);

Taking into account the harm to consumers due to undesirable effects caused by cosmetics, as found out in the course of the pilot study on a cosmetovigilance system carried out by the Council of Europe’s Committee of Experts on Cosmetic Products in 2004-2005 (see the Note on national pilot studies on a harmonised and pragmatic cosmetovigilance system in the appendix to the present resolution);

Taking into account that undesirable effects caused by cosmetics may lead to acute and chronic suffering, for example lifelong intolerance to specific substances implying negative consequences for the individual as well as for the health care and social insurance systems;

Considering that national reporting systems are lacking in some countries, whilst in others, these systems show deficiencies as regards the assessment of reported data, the dissemination of information and the implementation of co-ordinated follow-up activities with all concerned stakeholders;

Considering that the lack of a harmonised cosmetovigilance system in Europe implies:

–          unknown true frequency of harmful effects and costs attributable to cosmetics;

–          incomparable data;

–          lack of information which entails that more efficient and rapid consumer protection and adequate follow-up as well as corrective measures taken subsequently by authorities and producers or their “… authorised agent or any other person responsible for placing the product on the market …” (according to Directive 93/35/EEC) are made problematic;

–          damage to consumers and deterioration of their quality of life;

–          hidden health care and social costs related to the necessity to treat the consequences of the undesirable effects caused by cosmetic products;

–          waste of the financial resources of persons who purchase a cosmetic product which they do not tolerate;

Taking into account the existing legislation in the member states of the Partial Agreement in the Social and Public Health Field regarding undesirable effects caused by cosmetic products,

Recommends that the governments of the member states of the Partial Agreement in the Social and Public Health Field implement in their national policies a cosmetovigilance system with an involvement of competent authorities and stakeholders like health professionals, producers, consumers, and which embraces the Intergovernmental Information Network for Cosmetic Products (INCOS) for exchange of information between governments about serious undesirable effects caused by cosmetic products, as set out in detail hereafter in the appendix to this resolution.

Any member state of the Partial Agreement in the Social and Public Health Field is free to impose stricter rules as well as to take a decision on whether the cosmetovigilance system should be introduced on an obligatory or voluntary basis.

Appendix to Resolution ResAP(2006)1

1.         Field of application

This resolution applies to cosmetovigilance embracing the following:

–          monitoring the occurrence and evaluating the risk of undesirable effects caused by cosmetic products;

–          reporting and recording of undesirable effects;

–          establishing and taking corrective measures;

–          conducting complementary assessments or studies relating to the safety of use of cosmetic products;

–          identifying cosmetic products and/or ingredients which can present a risk for consumer’s health.

2.         Definitions

An undesirable effect (UE) of a cosmetic product is a harmful reaction attributable to its normal or reasonably foreseeable use.

A serious undesirable effect (SUE) is a UE which has caused temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies or an immediate vital risk or death.

Non-exhaustive list of UEs observed in cosmetic products:

–          allergic contact dermatitis;

–          contact dermatitis caused by irritation;

–          photo-allergic contact dermatitis;

–          contact dermatitis caused by a phototoxic effect;

–          conjunctivitis;

–          urticaria;

–          acne cosmetica/acne-folliculitis;

–          hypo-pigmentation;

–          hyper-pigmentation;

–          granuloma;

–          onycholysis, subungal haemorrhage, anonychia;

–          alopecia;

–          desquamation of mucous membrane of the oral cavity;

–          irritation of the mucous membrane of the oral cavity;

–          sensitisation of the teeth;

–          different systemic effects.

3.         Undesirable effects to be reported

Health professionals and producers should report SUEs immediately to the competent authorities.

Health professionals should be encouraged to report UEs which do not meet the criteria of serious UEs but which they consider relevant to be reported.

Furthermore, they should be encouraged to report an increase in the number of UEs observed or cases of misuse.

4.         Reported undesirable effects to be taken into account for assessment

A minimum of information should be provided in order to validate a case of UE:

–          complete identification of the reporter;

–          minimum information on the consumer such as age and sex;

–          precise identification of the cosmetic product;

–          description of the UE.

It is strongly recommended that the information required for the assessment of UEs is communicated by the reporter with a notification form presenting the set of data as outlined in Table 1.

5.         Causality

5.1.       Introduction

It is essential to check whether there is a causal link between a UE and the cosmetic product(s) used.

The causality assessment should be started only after the information concerning the UE has been validated (presence of the minimum relevant information) and evaluated (for example, symptomatology, chronology, as well as types and results of tests performed).

Causality assessment is particularly useful when the same product is involved in the occurrence of several cases of UEs, when it makes it possible to determine the extent of a link of cause and effect between the cosmetic product and the UEs observed and then to take these effects into account in the subsequent drawing-up of corrective measures such as investigations, recommendations on the proper use of the product, or regulations at national or European level (restrictions on use, warnings on packaging labels, limited concentration or prohibition).

In order to assess the causality, a method is necessary which will make it possible to determine rationally and reproducibly the causal link between a UE and the product or products concerned.

The causality assessment method described under 5.2 should be used by both the industry and the competent authorities in order to provide a single reference for the causality assessment of UEs and to limit divergence between individual assessments to a minimum.

5.2.       Description of the causality assessment method

Three major criteria

The causality assessment method is based on three major criteria:

–          symptomatology: the precise description of the UEs observed (location, severity, unpredictability);

–          chronology: the time sequence between the application of the cosmetic product and the occurrence of the UEs;

–          results of specific tests: tests should be specific and relevant. They can be carried out with the ingredients and/or cosmetic products concerned or through a re-exposure to the cosmetic product.

Five levels of causality

After the information relating to these three criteria has been validated, the level of causality should be evaluated on the basis of a decision tree in which these criteria are combined.

The method uses five levels of causality: very likely, likely, possible, doubtful, and excluded. Depending on the documented criteria, the level of causality can be derived from Table 2.

Chart 1 presents the decision tree which mainly allows the evaluation of the level of causality according to the three criteria: symptomatology, chronology, and results of specific tests.

6.         Structure of a cosmetovigilance system

6.1.       Actors and their roles

Consumers

Results from pilot studies show that only a small percentage of consumers experiencing UEs usually report those either to health professionals, to competent authorities or to the person responsible for placing the product on the market. In some cases consumers contact a consumer association.

Consumers are the key element of a cosmetovigilance system because their behaviour will condition the quality and quantity of the data collected. Therefore they should be encouraged to consult a health professional if they notice any UE. In addition, they should be encouraged to keep suspected cosmetic product(s) for at least three months and seek relevant information from the industry. They should be provided with an easy access to the competent authorities to communicate their concerns on the UE.

Consumer associations

In order to minimise underreporting, consumer associations should encourage, by any appropriate means, those consumers who notice a UE to consult a health professional or to report to the competent authorities or at least to the person responsible for placing the product on the market.

Health professionals

Different categories of health professionals (for example, dermatologists, allergologists, other physicians, dentists, pharmacists, nurses) may be involved in the reporting of UEs of cosmetic products.

The establishment of (a) national network(s) of health professionals should be encouraged either as (a) formalised health-professional group(s), preferably collaborating with each other, or as individually operating network(s), which do not systematically communicate with each other. All networks should use standard operating procedures for testing and reporting.

Health professionals should report any UE as outlined in paragraph 3 to health authorities.

Health professionals should evaluate the seriousness of the UEs. However, the final diagnosis is under the responsibility of a medical doctor.

Considering the definition of an SUE, only medical practitioners are able to judge on the seriousness of UEs.

Competent authority

The role of a competent authority is to:

–          designate a dedicated unit to receive consumer complaints, reports on SUEs and UEs, as well as summary reports;

–          inform all stakeholders involved in the cosmetovigilance system of the details of this system;

–          co-ordinate the roles of all stakeholders in and their contributions to the cosmetovigilance system;

–          exchange information on the reported SUEs and UEs with the manufacturer;

–          initiate and supervise the elaboration of good cosmetovigilance practices;

–          assess the reported UEs regarding seriousness, quality of the notification, causality, and potential risks to public health;

–          refer the consumer, if necessary, to a medical doctor in case of direct report;

–          exchange information with other governments through an appropriate information network (for example, INCOS[2] – see paragraph 6.3);

–          take corrective and preventive follow-up action (“enforcement”);

–          inform other competent authorities through a rapid alert system (for example, RAPEX)[3];

–          encourage the manufacturer to report all UEs regularly (for example, once a year).

Manufacturers

Manufacturers should report SUEs immediately to the competent authorities.

In addition, manufacturers should be encouraged to report all other UEs to the competent authorities regularly on a voluntary basis (for example, once a year).

In order to minimise underreporting, manufacturers should encourage the consumers who notice a UE to consult a health professional.

In order to help to solve problems caused by UEs manufacturers should provide assistance to health professionals (for example, formulation, test materials).

European Commission

The European Commission is considered an important stakeholder and should be informed about relevant UEs.

6.2.       Relationship between stakeholders

The relationship between stakeholders is outlined in Chart 2.

6.3.       Tools

In order to standardise the reporting, to improve quality of data and to facilitate the exchange of information, some specific reporting forms have been developed:

–          Cosmetovigilance reporting form including a minimum set of data to be used by healthcare professionals (Table 1);

–          INCOS reporting form for competent authorities (Table 3).

7.         Implementation of a cosmetovigilance system

Procedure

The competent authorities should inform consumers, consumer associations, health professionals and the industry about all relevant details of the national cosmetovigilance system, including reporting procedures, recipients (specified contacts for reports), evaluation and follow-up.

Consumers should be informed by the competent authorities about how to deal with UEs caused by cosmetic products through printed leaflets, campaigns, the media, schools and the Internet.

Consumers should be able to report the UEs through health professionals, manufacturers and consumer associations, but also directly to the competent authorities. The competent authorities should make accessible the reporting forms to health professionals as wells as to manufacturers.

Health professionals and manufacturers should report relevant UEs to the official reporting body (to be determined by the competent authorities) by using the reporting form. It is left to the competent authorities to consult additional experts in order to assess the notification of an individual case.

Based on the assessment of one or several reports, the competent authorities may take action towards a particular cosmetic product.

Data compilation as well as statistical assessment of all reports should be encouraged and made available to all stakeholders.

In case of an SUE and other relevant UEs, the competent authorities should take specific measures, such as reporting the details of the UEs via INCOS to the other member states of the Partial Agreement in the Social and Public Health Field. INCOS reports can be related to either a product, an ingredient or a UE.

INCOS should be activated when a clearly identified cosmetic product-related risk to human health is identified.

Note: National pilot studies on a harmonised and pragmatic cosmetovigilance system

Summary

Background and aim

Regulations stipulate that cosmetic products must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use. On the other hand it is an indisputable fact that cosmetic products may have UEs. A UE is defined as a harmful reaction attributable to the normal or reasonably foreseeable use of a cosmetic product.

At present, there are no reliable systems established for monitoring UEs caused by cosmetic products. Against this background the Ad hoc Group of the Committee of Experts on Cosmetic Products of the Council of Europe conducted a series of pilot studies on a cosmetovigilance system. The aim was to monitor the risk of UEs attributed to cosmetic products including systematic reporting, registering, analysis and evaluation of data.

Methodology

France, Austria, Norway and Denmark conducted pilot studies which had similar features, but were also addressing different aspects of a possible future common cosmetovigilance system. Consumer complaints made through notifications were studied in Norway, France and Austria, and a telephone survey was carried out in Norway. UEs were reported by dermatologists co-operating in the dermato-allergovigilance network Revidal in France (60 dermatologists) and in Denmark (20 dermatologists), and further notifications from 280 dermatologists from two French regions and 600 dermatologists from Austria were collected and studied. In France, surveys were performed also addressing 50 pharmacists in one region, dentists and the industry. A list of minimum data to be used on a notification form was established and methods of assessing a causal relationship between UEs and the use of cosmetics products were developed.

Results

The survey showed that only a minority of consumers (25% to 36%) experiencing even very unpleasant UEs caused by cosmetic products consulted a physician. Data from consumer notifications in France and Austria support large underreporting of UEs due to cosmetics. Pilot studies in France showed that a noticeable proportion of notified UEs were serious (15%).

 

Allergic contact dermatitis is the most frequent UE reported by dermatologists (76.5% to 83.9% of the cases). Skincare products and hair dyes/hair preparations were the most frequent causal product categories, and fragrances, preservatives and hair dyes were identified as the most important allergens. Based on the French and Danish data the frequency of allergic contact dermatitis (ACD) related to cosmetic products and seen by dermatologists could be estimated at 0.004% to 0.03% (that is, between 4 and 30 per 100 000 inhabitants). Based on the estimate that one third or less seek medical advice and even fewer are seen by a dermatologist, the number of patients affected by ACD due to cosmetics is estimated to be at least 100 per 100 000 inhabitants (or 0.1% per year). Other effects are more likely to be reported by other health professionals, such as pharmacists and dentists, as shown in the French studies. Irritation, hair loss and dental hypersensitivity were reported and extrapolations showed that valuable information, complementing reports from dermatologists, are collected among these health professionals. The study with the industry showed that few notifications were received. Results from the Austrian study show that (self‑)motivation of health professionals, namely dermatologists, is a crucial factor for an efficient reporting system.

Conclusions

Despite the fact that cosmetic products must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use, pilot studies showed that there are UEs related to these cosmetic products. A noticeable number of SUEs were reported. A cosmetovigilance system giving reliable results should be established. In particular, SUEs should be reported without delay. The most effective reporting system relies on a motivated network (formal or informal) of health professionals (for example, dermatologists, dentists and pharmacists). Results from pilot studies show that only a small percentage of consumers experiencing UEs usually report those either to health professionals, to a competent authority or to the person responsible for placing the product on the market. Consumers who notice any UE should therefore be encouraged to seek medical attention.

Table 1 – Cosmetovigilance reporting form including a minimum set of data to be used by healthcare professionals

Table 2 – Classification of causality levels

Table 3 – INCOS reporting form for competent authorities

Chart 1 – Decision tree for the assessment of causality in cosmetovigilance

		It is important to note that a causality assessment can only be performed if there is sufficient information on the case history, in particular symptomatology and chronology.

 

Relevant specific medical investigations and/or challenge negative

Relevant specific medical investigations and/or challenge not performed, or equivocal results

Relevant specific medical investigations and/or challenge positive

Relevant specific medical investigations and/or challenge not performed, or equivocal results

Relevant specific medical investigations and/or challenge negative

 

Doubtful

Excluded

 

Symptoms: If the symptoms are not suggestive of the product effect, the level of causal relationship is decreased by one degree (very likely to likely, likely to possible, possible to doubtful).

Compatible chronology: A time sequence between product use and the occurrence of symptoms which is suggestive from a medical viewpoint and can be reasonably anticipated for this kind of product use and the UE.

This applies as well to the time sequence between the discontinuation of product use and the disappearance of the symptoms. If the chronology is not compatible, the causal relationship is excluded.

Chart 2 – Structure of a cosmetovigilance system