Ministers’ Deputies
    CM Documents

    CM(2005)149 12 October 20051
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    945 Meeting, 9 November 2005
    6 Social Cohesion


    6.1 Public Health Committee Partial Agreement (CD-P-SP) –

    Draft Resolution ResAP(2005)… on cosmetic sun protection products to optimise consumer protection2

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    Resolution ResAP(2005)… on sun protection products to optimise consumer protection

    The Committee of Ministers, in its composition restricted to the representatives of Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Slovenia, Spain, Sweden, Switzerland and the United Kingdom, member states of the Partial Agreement in the Social and Public Health Field,

    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, aimed in particular at:

    - raising the level of health protection of consumers in its widest sense, including a constant contribution to harmonise – in the field of products having a direct or indirect impact on the human food chain as well as in the field of pesticides, pharmaceuticals and cosmetics – the 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 its implementation at European level – of a model 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 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 purpose of harmonising their legislation in the public health field and, in particular, to specific issues in the cosmetics sector;

Considering that in its 1992 publication, “Solar and ultraviolet radiation”, the International Agency for Research on Cancer of the World Health Organisation (IARC)/WHO rated solar radiation as carcinogenic to humans based on sufficient supporting evidence;

Noting that the incidence of several sun-related skin cancers has increased considerably from the 1960s onwards in all European countries;

Taking into account current knowledge, namely that:

- people are exposed to ultraviolet (UV) radiation, be it intentionally or unintentionally;

- the proportion of ultraviolet rays absorbed by the skin causes damage which may lead, inter alia, to the appearance of erythema, photodermatoses, acceleration in skin ageing, induced photo-immunosuppression and, in the most serious cases, the appearance of some skin cancers;

- sun protection products have been known for decades to be effective in preventing erythema, caused mainly by UVB rays;

- UVB as well as UVA rays are involved in skin photo-carcinogenesis (carcinomas and melanomas);

- sun protection products claiming to prevent photodermatoses are considered as medicinal products;

- the effectiveness of external photoprotectors in preventing the ageing of human skin has not yet been demonstrated in humans. Studies concerning the prevention of cutaneous elastosis are in progress. However, a few studies have shown the significance of certain external photoprotectors in the prevention, in humans, of damage linked to photo-ageing. Work conducted on animals has shown the capacity of certain UVA filters to prevent the photo-ageing of dermal fibres undergoing chronic exposure;

- the most important feature of a sun protection product, if it is to play a role in carcinogenesis prevention strategy, is a broad spectrum of UVB/UVA protection and a balanced ratio of UVB/UVA protection factors;

- scientific evidence shows the efficacy of high UVB and in particular UVA protection against induced
photo-immunosuppression;

- concerning the prevention of skin cancers, epidemiological studies show the complexity of carcinogenesis mechanisms and how difficult they are to prevent, as the use of a broad spectrum sun protection product could prevent the onset of epidermoid carcinomas but not that of basal-cell carcinomas;

- there is currently no evidence to suggest that the use of sun protection products positively or negatively influences the incidence of melanoma;

- effective sun prevention strategies (for example the WHO global strategy) focus on avoidance of excessive sun exposure during the midday hours (that is 12 noon to 4 p.m.), appropriate clothing, shade, eye protection and correct use of appropriate sun protection products;

- implementation of a sun protection strategy is essential to avoid the harmful effects of UV radiation, and the application of sun protection products is only one of the means of achieving a certain degree of protection;

- repeated applications of sun protection products, without forgetting areas and in sufficient quantity, are necessary to achieve effectively prevent sunburn;

- usual consumer behaviour (sunbathing habits and perception of intensive sun exposure, insufficiently renewed application, uneven spreading, forgetting certain areas when using sun protection products) can lead to inadequate sun protection;

- proper instructions for use of the sun protection product are essential to achieve effective sun protection;

- consumers should be advised firstly on correct sun exposure behaviour, and secondly on the correct use of sun protection products;

- there is a lack of harmonisation of labelling concerning UVB and especially UVA sun protection factors, claims made and instructions for use;

- the information supplied with sun protection products must be clear and understandable for the consumer;

- there is a need for a simpler classification of sun protection levels, to facilitate the choice of a product;

- this classification should be based on the UVB and UVA protection factors;

- the classification of sun protection products into classes according to the sun protection level is a concept that must last over time, whereas the criteria which permit this classification are changeable elements;

Taking into account that in most member states the labelling of the efficacy of sun protection products is not covered by specific regulations;

Taking the view that member states need to introduce regulations related to the efficacy of sun protection products, conditions of use and methods used to measure protection parameters;

Considering that such regulations should be harmonised at European level;

Recommends that the governments of the member states of the Partial Agreement in the Social and Public Health Field implement the requirements concerning cosmetic sun protection products as one element of a comprehensive sun protection strategy as detailed in this resolution. Each government however, remains free to adopt stricter regulations.

Appendix to Resolution ResAP(2005)… on sun protection products to optimise consumer protection

1. Definition

A cosmetic product designed to protect the skin against UV rays is called a sun protection product. Such products should comply with the various requirements specified in the national regulations on cosmetics of the member states of the partial agreement.

2. Field of application

The resolution applies to:

- the efficacy of sun protection products;

- the determination of UVA and UVB protection;

- the labelling of cosmetic products used for sun protection and easy access to other relevant information for consumers.

This resolution does not apply to products with medical claims, for example photodermatosis prevention.

3. Properties

Sun protection products should have the following properties:

- sun protection products should deliver protection against both UVB and UVA;

- the UV protection should be assessed by harmonised and validated methods;

- product information should include the following general information which must be readily accessible to the consumer: correct sun exposure behaviour according to the WHO global strategy, and correct use of sun protection products

In order to ensure effective protection, certain other product characteristics should also be assessed, such as photo-ageing, harmlessness, skin tolerance, stability (including photostability) and resistance to water and perspiration.

Products must be classified according to protection level into categories which must be indicated prominently on the packaging

Product information must provide simple, easy-to-understand guidance enabling consumers to choose the appropriate sun protection product taking into account the product class, skin type and exposure intensity (see model product information in item 7).

4. Methods for the determination of UV protection

The development and validation of in vitro methods to determine UV protection should be strongly encouraged by the competent authorities. In the meantime, the following in vivo methods may be taken into consideration:

- determination of the anti-erythemal sun protection factor (SPF);

- determination of the UVA protection factor (UVA-PF) by measurement of persistent pigment darkening induced by UVA (PPD UVA-PF) and critical wavelength.

The results obtained using in vivo methods should be divided by an appropriate correction factor to allow for consumer behaviour in terms of the quantities of sun protection products applied. The cosmetic industry should provide more data in order to determine an alternative correction factor if necessary.

4.1 Determination of the anti-erythemal sun protection factor (SPF)

The recommended methodology for measuring anti-erythemal protection factors may be the one carried out in vivo in humans and proposed by the professional organisation representing the cosmetic industry at the European level, The European Cosmetic, Toiletry and Perfumery Association (COLIPA) (1).

It measures the (SPF) based on the ratio of the minimum erythemal dose (MED) on skin protected by the product (MEDp) to the minimum erythemal dose on unprotected skin (MEDu) (2) (3).

4.2 Determination of UVA protection

It is recommended that competent authorities urge companies to perform a series of appropriate trials to estimate the level of UVA protection. Information on methods and results must be readily available to the competent authorities.

Firstly the UVA protection factor may be determined by in vivo measurement of PPD (4) (5). As long as there is no international harmonisation concerning UVA-PF measurement, it is recommended to make this measurement according to the recommendations of the Japan Cosmetic Industry Association (JCIA) (6).

A multi-centre study with a view to international harmonisation must be carried out.

In addition, measurement of the critical wavelength (λc) is necessary to express the width of the absorption spectrum of the product considered, particularly its extension to the UVA range. The critical wavelength is defined as the wavelength in nanometres (nm) for which the section under the integrated optical density curve A(λ) from 290 nm to λc is equal to 90% of the integrated section from 290 to 400 nm. The value of the critical wavelength (λc) should be at least 370 nm as also recommended by the American Academy of Dermatology Association (AADA) (7).

5. Classification of sun protection products

The number of classes of sun protection products considered as cosmetic products available on the market should be limited.

Taking into account the correction factor of 2, the lowest acceptable corrected sun protection factor (SPFc)3 value is 3. According to the defined SPFc values4, which already include a correction factor of at least 2, four classes of protection level are proposed, as follows:

low protection

SPFc 3 or 4

medium protection

SPFc 7, 10 or 12

high protection

SPFc 15, 20 or 25

very high protection

SPFc 30 or 30+


    When the corrected protection factor exceeds 30, it should be labelled as 30+.

    Pending the development of standardised and harmonised in vitro methods, each sun protection product, irrespective of its protection class, must feature an in vivo ratio of SPF/UVA-PF equal to or less than 35.

    Specific claims and labelling of UVA protection are therefore no longer needed or acceptable.

    6. Product presentation and labelling

    Products should be labelled on the front side, using the wording recommended in the above section on classification of sun protection products.

    In order to focus on the global protection strategy and to avoid any association of sun product use with prolonged sun exposure, it is recommended to delete over an appropriate transition period the display of SPFc values on packaging.

    It is recommended to maintain the indication of the SPF values on the product labelling and information only during the transition period, after which it should no longer be allowed.

    For the transition period the SPFc value should appear in a less prominent position, that is should not appear on the front of the packaging and should be mentioned in a sentence in running text, such as: "The SPFc value of this product is … (number)".

    6.1 General information on correct sun exposure behaviour

    This information must be readily available to the consumer on the labelling:

    - Use sun protection products which suit your type of skin;

    - Avoid direct sun exposure during the midday hours (12 noon to 4 p.m.);

    - Sunburn is dangerous, particularly for children. Babies must never be exposed directly to the sun. Children should never be exposed directly to sun without proper protective clothing, accessories and suitable sun protection products;

    - Use suitable protective clothing and accessories (wide-brimmed hat, sunglasses, etc.).

    The following message must be conveyed to the consumer: even if it has not yet been proven in humans that sun protection products prevent ageing and cancers of the skin, the regular and appropriate use of a sun protection product which provides balanced UVA and UVB protection, is likely to reduce this risk.

    6.2 Guidance to help consumers to choose an appropriate sun protection product

    A proposed guidance model is attached, under item 7. This information should be made available to the public. Its aim is to enable consumers to choose the right sun protection product for their skin type and to be informed about foreseen conditions of exposure.

    6.3 General information on the correct use of sun protection products on the labelling

    This information must be readily available to the consumer on the labelling.

    The instructions for use should state the quantity of the product which should be applied. This quantity should be expressed in a way which is easily understandable by the consumer (for example using graphics or descriptions like one golf ball, bottle cap, etc.), or a measuring device should be included with the product.

    The following instructions should appear on the product labelling:

- Apply the sun protection product before exposure.

- Warning: reducing this quantity by half may divide the protection by 2 or 3.

    - Reapply the product (particularly in the event of sweating, bathing or rubbing during exposure) in order to ensure the protection.

    - Sun protection products must not be used to prolong sun exposure.

    7. Proposed guidance model for consumer to choose sun protection product

    Ø YOUR SKIN

Babies must not be exposed directly to the sun.

      Children > 1 year Children should never be exposed directly to the sun without proper protective clothing, accessories and suitable sun protection products. Under extreme conditions, sun exposure should be avoided. If this is not possible, use very high sun protection. Without protection, sunburn can occur after 5 to10 min of sun exposure.

      Subject extremely sensitive to the sun - skin type 1 (subject with milky-white skin, freckles, red

    hair, subject always sensitive to sunburn when exposed to the sun, history of skin cancer). Without protection, sunburn can occur after 5 to 10 min of sun exposure.

    Subject sensitive to the sun - skin type 2 (subject with pale skin, often a few freckles and/or strawberry blonde or red hair, subject often sensitive to sunburn when exposed to the sun, but can get a tan) Without protection, sunburn can occur after 10 to 20 minutes of sun exposure.

    Subject with intermediate skin - skin type 3 (pale skin which easily tans, no sunburn when exposed to very intense sun). Nevertheless, without protection, sunburn can occur after 20 to 30 minutes of sun exposure.

    Subject with quite resistant skin - skin type 4 (dark skin which easily tans without burning), Nevertheless, without protection, sunburn can occur after 30 to 45 minutes of sun exposure.

      Ø YOUR EXPOSURE

Extreme exposure (glaciers, tropics, etc.)

    High exposure (beaches, long outdoor activities, etc.)
    Moderate exposure (cloudy sky, early morning, late afternoon)

      Ø SUN PROTECTION: YOUR CHOICE DEPENDING ON YOUR SKIN AND EXPOSURE TYPES

 

   

Children
> 1 year

HIGH PROTECTION

VERY HIGH PROTECTION

Avoid all direct sun exposure if possible

If not possible VERY HIGH PROTECTION

HIGH PROTECTION

VERY HIGH PROTECTION

VERY HIGH PROTECTION

MEDIUM
PROTECTION

HIGH PROTECTION

VERY HIGH PROTECTION

LOW PROTECTION

MEDIUM PROTECTION

HIGH PROTECTION

LOW PROTECTION

MEDIUM PROTECTION

MEDIUM
PROTECTION

Note REFERENCES
Note References concerning the current knowledge (see resolution text)

International Agency for Research on Cancer (IARC). “Solar and ultraviolet radiation”, Monographs on the evaluation of carcinogenic risks to humans. Vol.55, IARC, Lyon, 1992.

Agar, N.S., Halliday, G.M., Barnetson, R. StC., Ananthaswamy, H.N., Wheeler, M., Jones, A.M.. “The basal layer in human squamous tumors harbors more UVA than UVB fingerprint mutations: a role for UVA in human skin carcinogenesis” communicated by Richard B. Setlow, Brookhaven National Laboratory, Upton, New York, 17 February 2004 (received for review 11 December 2003).

Seité, S., Colige, A., Piquemal-Vivenot, P., Montastier, C., Fourtanier, A., Lapiere, C., Nusgens, B., “ A full-UV spectrum absorbing daily use cream protects human skin against biological changes occurring in photoaeging”. Photodermatology Photoimmunology and Photomedicine. Vol. 16, Issue 4, August 2000, pp. 147-55.

Seité, S., Moyal, D., Richard, S., de Rigal, J., Lévêque, J.L., Hourseau, C., Fourtanier, A., “Mexoryl SX: a broad absorption UVA filter protects human skin from the effects of repeated suberythemal doses of UVA”. Journal of Photochemistry and Photobiology B: Biology. Vol. 44, 1998, pp. 69-76.

Fourtanier, A., Labat-Robert, J., Kern, P., Berrebi, C., Gracia, A.M., Boyer, B., “In vivo evaluation of photoprotection against chronic ultraviolet-A irradiation by a new sunscreen Mexoryl SX”. Photochemistry and Photobiology. Vol.55, Issue 4, April 1992, pp. 549-60.

De Laat, A., van der Leun, J.C., de Gruijl, F.R., “Carcinogenesis induced by UVA (365-nm) radiation: the dose-time dependence of tumor formation in hairless mice”. Carcinogenesis. Vol.18 No. 5, May 1997, pp. 1013-20.

Meunier, L., “Photoprotection and photo-immunosuppression in man”. European Journal of Dermatology, Vol. 8, No. 3, 1998, pp. 207-8.

Green, A., Williams, G., Neale, R., Hart, V., Leslie, D., Parsons, P., Marks, G.C., Gaffney, P., Battistutta, D., Frost, C., Lang, C., Russell, A., “Daily sunscreen application and beta-carotene supplementation in prevention of basal-cell and squamous-cell carcinomas of the skin: a randomised controlled trial”. Lancet, Vol. 354, Issue 9180, 28 August 1999, pp. 723-29. Erratum in: Lancet, Vol. 354, Issue 9183, 18 September 1999, p.103.

Huncharek, M., Kupelnick, B., “Use of topical sunscreens and the risk of malignant melanoma: meta-analysis of 9067 patients from 11 case-control studies”. American Journal of Public Health, Vol. 92, No. 7, July 2002, pp. 1173-7. Comment in: American Journal of Public Health, Vol. 93, No. 1, January 2003, author reply 12.

Dennis, .L.K. et al., “Sunscreen use and the risk for melanoma: a quantitative review”. Annals of Internal Medicine, Vol. 139, Issue 12, 16 December 2003, pp. 966-78. Comment in: Annals of Internal Medicine, Vol. 139, Issue 12, December 2003, p.116.

Dupuy, A., Dunant, A., Grob, J.J. with the RED (Réseau d’epidémiologie en dermatologie), “A Randomized Controlled Trial testing the impact of high protection sunscreens on sun behaviour”. Archives of Dermatology, 2005, (to be published), International Journal of Cancer, Vol. 61, 1995, pp. 749-55.

Guinot, C., Malvy, D., Latreille, J., Preziosi, P., Galan, P., Vaillant, I., Tenenhaus, M., Hercberg, S., Tschachler, E., “Sun exposure behaviour of a general adult population in France”, in Ring, J., Weidinger, S., Darsow, U. (eds), Proceedings of the 10th Congress of the European Academy of Dermatology, Monduzzi Editore, Bologna, 2001, pp. 1099-1106.

Mauger, E., Guinot, C., Malvy, D., Latreille, J., Ambroisine, I., Galan,P., Hercberg, S., Tschachler, E., “Etude du comportement d’exposition et de protection solaire chez des adultes français“, Chavent, L.M. (ed.), 2004, p 77-88, Capadués Editions: Toulouse, 2004, pp. 77-88.

Stoebner-Delbarre, A., Thezenas, C., Kuntz, B. Guillot, H., Sancho-Garnier, H., “ Connaissances, attitudes et comportements des adultes vis à vis de l’exposition solaire en France“, in Aubin, F. and Humbert, P. (eds), Rayonnement ultraviolet et peau, John Libbey Eurotext Ltd., Paris, 2001, pp. 135-40.., 135-140.

References concerning the Appendix of the resolution

(1) COLIPA (The European Cosmetic Toiletry and Perfumery Association), CTFA (Cosmetic, Toiletry and Fragrance Association of South Africa), JCIA (Japan Cosmetic Industry Association), International sun protection factor (SPF) test method, February 2003.

(2) Department of health, education and welfare, Food and Drug Administration (FDA), USA, “Sunscreen drug products for over-the-counter human use; proposed safety, effective and labelling conditions”. Federal register 43, No. 166, pp. 38206-269, 25 August 1978.

(3) Department of health and human services, FDA, USA, “Sunscreen drug products for over-the-counter human use; tentative final monograph; proposed rule”, Federal Register 58, No. 90, pp. 28194-302, 12 May 1993.

(4) Moyal, D., Chardon, A., Kollias, N., “Determination of UVA protection factors using the persistent pigment darkening (PPD) as the end point (Part 1) Calibration of the method”, Photodermatology Photoimmunology and Photomedicine, Vol.16, Issue 6, 2000, pp. 245-49.

(5) Moyal, D., Chardon, A., Kollias, N., “UVA protection efficacy of sunscreens can be determined by the persistent pigment darkening (PPD) method. (Part 2)”, Photodermatology Photoimmunology and Photomedicine, Vol. 16, Issue 6, 2000, pp. 250-55.

(6) JCIA, Standard sun protection factor test method and Japan Cosmetic Industry Association measurement standard for UVA protection efficacy, 1999.

(7) Limm, H.W. et al., “American Academy of Dermatology Consensus Conference on UVA protection of sunscreens : summary and recommendations. Journal of the American Academy of Dermatology, March 2001, Vol. 2, No. 3, pp. 505-5089.

Note 1 This document has been classified restricted at the date of issue. Unless the Committee of Ministers decides otherwise, it will be declassified according to the rules set up in Resolution Res(2001)6 on access to Council of Europe documents.
Note 2 The Public Health Committee (Partial Agreement) (CD-P-SP) approved the draft resolution ResAP(2005)… on sun protection products to optimise consumer protection by written procedure on 19 September 2005.
Note 3 SPFc: sun protection factor corrected by applying a correction factor of 2. If the exact correction factor differs from this value, the product formulation should be adjusted accordingly.
Note 4 It should be noted that two member states considered that during the transition period the classification of sun protection products should be made on the basis of the SPF and not on the SPFc values.
Note 5 Thus, the retained ratio of ≤ 3 is a compromise between the precautionary principle based on clinical considerations, the recommendations of the AADA, the technological capacities of the filters and quantification methods.


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