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Controversy about sun protector products agitates the market
Legislation - 12/07/2009

                        
                    Brands brings UVA indication in the packaging

                       
                       although legislations doesn´t requires

In spite of story published in first of December by newspaper O Estado de Sao Paulo and Jornal da Tarde which generates polemic during all the week in cosmetics market, the Association Brazilian of Consumer Defense (Pro Teste) has divulged its evaluation methods of ten products SPF30 of the market analyzed by the entity:

Labeling – We have verified if labels had all the information that we have judged important for consumers.

Composition – We have verified if products presents benzophenone-
3, an ingredient forbidden in other countries, for presenting esterogenicity, to enter in blood circulation and to be potentially a cancer cause.

Irritability – Through a user’s panel, we have verified If the products caused some kind of irritation.

Hydration – Verification if there is an increase of skin hydration after two, four and six hours of the use of protectors.

Protection – Through equipments, we measure the protection (FPS) UVA and UVB provided by protectors.

Resistance – We have measured products photo stability to verify if they are stable in the real use conditions, in other words, during sun exposure. We have measured the SPF before and after the product exposure to sun radiation and to 40oC heat for one hour. We have verified also if they resist to a dive: we have measured the SPF before and after the immersion in water at 22oC for 30 minutes.

The story published in the newspapers informs that, according to the analysis accomplished by the Pro Teste with products with SPF30 (sun protection factor to the UVB rays), for sensible skins, five of the ten main sun protector brands in lotion sold in the country are not efficacious – two products are not resistant to water and four do not blocks UVA rays.

Results have pointed by the story are serious: would put in risk the security of the consumer and in check the credibility of ten brands, among national and international ones which are market players, besides to put in check the own credibility of Anvisa – the National Health Survellance Agency.

Pro Teste is a civil association with no lucrative purposes and have 200 thousand associates, it integrates the National System of Consumer Defense - SNDC and is affiliated to the Euroconsumers and to the Consumers International, worldwide organizations of consumer’s defense, but the entity has caused controversy when pointed deficiencies of products and companies abstaining itself on lightening its methodology and informing the laboratory responsible by the analysis. The alleged reason was the one of “contract maters and to not jeopardize the researches”.

In a  moment in which Brazilian population, at cost of a lot of campaigns - governmental and entrepreneurial get conscious of the importance of protecting herself against skin cancer by improper exposure or without any protection, Pro Teste research confounds consumers.

One of the companies evaluated by the Pro Teste evaluation, L´Oreal, had one of the two products approved by the test (L’Oréal Solar Expertise and Cenoura & Bronze) and another reproved (Anthelios Helioblock FPS 30).

In response, company questions the test: “The method used by Pro Teste was never validated. L’Oréal uses methodology validated which attests the photo stability of all of its sun protectors, Anthelios Helioblock FPS 30 can prove its efficacy through 21 scientific studies”, company informs.

Contested Tests

The Dermatology Brazilian Society (SBG) declares in a note that ignores the evaluation methodology used by Pro Teste which puts in doubt the formulation and the efficiency of some sun protectors traded in Brazil. It declares yet that this test was not submited to its analysis and that the schedule used by the newspapers, in their respective stories was not made by SBG.

The greatest Brazilian cosmetic company Natura, mentioned in the story for having its product Fotoequilíbrio reproved in the evaluation informs that it has consulted the most renowned Brazilian laboratories, and they have informed that they have not realized Pro Teste test. Company states that “it has no idea of how the published research was accomplished, which is its rigor or even which laboratories have conducted the tests that would have been sponsored by the Pro Teste entity”.

Natura reinforces that the international cost for consistent tests with products like photo protectors have costs superior to US$ 15 thousand and questions: “The entity which declares to have evaluated ten products, does she have how to prove the US$ 150 thousand investment on the tests?”

Another controversial point is related to the affirmation by Pro Teste institutional coordinator Maria Ines Dolci, mentioned in the newspaper Jornal da Tarde, in which she says that the producers have received Pro Teste document and at least four companies mentioned in the story have informed cosmeticos br that they have not received any document.

Johnson & Johnson informs that company has not acquaintance, not even access to the methodologies used in the research.

La Roche-Posay brand ( L´Oreal) which, according to the company is recommended and recognized by more than 25 thousand dermatologists worldwide, was reproved in the evaluation.

“We were never notified by Pro Teste about this test and we don’t know the evaluation methods used by the entity”, declares Natura.

BDF Nivea informs that “it doesn’t have access to the study content in full, reason through which it is not possible to evaluate deeply, details about the methodology and result of it”.


Benzophenone-3 use

The story published objects also the use of benzophenone-3, ingredient which is already fobiden in other countries, for being potentially a cancer cause. Avon mentioned in the story, related to its product Avon Sun FPS 30 manifest itself in the folling way: “benzophenone-3 ingredient appears in the Allowed List of Sun Photo Protectors for skin (RDC 47, from 16 March 2006). The used concentration in Avon Sun products is in accord to the regulation of respected entities such as Anvisa, FDA  (USA Food and Drug Administration) and Colipa (The European Cosmetics Association” – from the European Community). In Brazil, it is allowed the concentration of until 10%”.

Natura informs that “all the raw materials used by the company in the producing of its photo protectors are considered secure and approved by national and international regulating entities, since the Anvisa to the SCCP (European Scientific Community)”. Nivea says that in its product Nivea Sun Solar Protetora FPS 30 attends, integrally to all the demands of Anvisa RDC 237 Resolution, which regulates the production of sun protectors and that the product attends closely to international protocols validated and that standardize the actuation of cosmetics producers. Johnson says that Sundown ® counts with a security and efficacy historical of more than 25 years and uss only ingredients that are equally evaluated and regulated as secure and efficacious by national health surveillance agencies such as Anvisa and international ones, such as FDA and Colipa.

Photo stability

In the photo stability test in which products SPF was measured before and after the exposure to a 40 degrees C temperature, with 5 brands reproved (Avon, Helioblock, Nivea, Banana Boat and Sundown). Avon informs that it guarantees the security and efficacy of all products developed and commercialized, realizing the needed tests and approved by the entities that regulates the cosmetic industry, in the more than 100 countries in which it actuates. Nivea whose sun protective lotion Nivea Sun SPF 30 follows the internationally valid  protocols and that regulates the actuation of the cosmetic producers, having being submitted and approved in tests accomplished by Anvisa being in total conformity with the in force legislation in Brazil.


Low UVA protection

Other of Pro Teste questions points out the obligatory of the UVA factor (whose rays reaches skin deepest coats, causing precocious ageing) be at minimum one third of the SPF of the product, as occurs in Europe, but the Brazilian legislation do not demand a minimum. Like this, according to Pro Teste tests results, “four of the protectors have low UVA protection, And five of them being not resistant to the light and to the heat, losing the efficiency”.

Currently, in Brazil, there is not yet a real  a legislation for a padronization of the indication of the UVA Protection Factor. The Resolution of 22 August 2002 in fact, obligation are the saying “the exposure to the UV rays increases the risk of skin câncer, precocious ageing and other cutaneous damages” and  “It is important to reduce the time of UV rays exposition, using protective clothes and sun filters are not  obliged in the labeling and this obligation is accomplished by the companies. However, three brands of the market mentions UVA protection factor: (Natura Fotoequilíbrio, with 90%, Cenoura e Bronze, 95% and L´Oreal with the indication UVA+++).

Avon said that, according to Resolution  RDC 237 by Anvisa – there is not the directing and the obligation of mentioning on the labeling the indication of the UVA sun Protection Factor, but that its sun protector is efficacious against the radiation.

Johnson informs that each product of Sundown® line is submitted to a tests battery and is Just traded if proves the efficacy on the determination of the protection factor, resistance to the water, determination of UVA protection and photo stability, according to the protocols defined by Anvisa, FDA, Colipa and European scientific  community, which guarantees the excellence of products protection.

Natura informs that tests its products according to the Australian methodology (AS/NZS 2604:1998), which is recognized internationally and approved at Anvisa. This methodology justifies the description of 90% of UVA protection in products labeling. There is not any legal determination or even recommendation for the use of other methodology.

According to L´Óreal every packaging of Anthelios Helioblock®  line traded in Brazil indicates the UVA  index and the symbol  UVA which shows that all line Sun protectors have an index of minimum protection of one third of its UVB protection.

Products evaluation after exposed to water

Products efficiency after exposed to water was also evaluated and Pro Teste informs that after the immersion for half and hour, resistance of Natura product has fallen to 30% of initial SPF and the one of Sundown to 55% of the indicated protection on the packaging.

Natura refute the accusation enlightening that every Fotoequilíbrio line products are tested according to the European methodology (Colipa, 1994), which is recognized by Anvisa and by European Union. According to this methodology, products are approved by means of test that evaluates the SPF after 2 hours of immersion in the water.

Finally, Abihpec – Brazilian Association of the Personal Care, Perfumery and Cosmetic positions that every company mentioned are its affiliated and have their products formulas approved by the National Agency of Health surveillance (Anvisa). 

The entity emphasizes that the orientations and recommendations described on the labels of our associated results of the studies recognized by the international scientific community, which guarantees the efficacy and the protections promised by products.

 
 
   
 
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