Uma revisão crítica da legislação brasileira acerca de embalagens especiais de proteção à criança
Este artigo é uma revisão bibliográfica em relação às Embalagens Especiais de Proteção à Criança (EEPCs), que apresenta os problemas de intoxicação, bem como o surgimento dessas embalagens. O artigo também aborda o Projeto de Lei nº 4841/94 em comparação com o atual protocolo de teste americano, visando apresentar sugestões de melhoria para os problemas encontrados.
Design, Ergonmia, Embalagens
TITLE: A critical review of brazilian legislation about child-resistant packaging
Poisoning is one of the problems related to the use of packaging. According to Bochner , in 2003, the main cases of human poisoning reported by CEATOX/SP (Toxicology Service Center of São Paulo) were medicines, poisonous animals and household cleaning products. So, the application of ergonomic parameters in the design of packaging should be a factor that minimizes some problems. The warnings on labels are the more conventional methods to prevent poisoning accidents in Brazil. However, they are not sufficient to prevent accidents . For example, children that are less than 5 years old cannot read or understand the messages . By the fact that many accidents related to intoxication with children under five years old were being reported, Child-Resistant Packagings (CRPs) became mandatory in the United States in 1970 . In the first 25 years after the establishment of the Poisoning Prevention Packaging Act, the tests with new CRPs in the United States were made only with children and adults from 18 to 45 years old. Elderly and disabled people were excluded from the tests and as a result they ended up having a lot of difficulty to access the CRPs. Therefore, in the early 1990s, the Consumer Product Safety Commission (CPSC) recognized the need to develop a new test protocol in order to make the CRPs more effective to the consumers. Then in 1995, the new American test protocol arises . This protocol describes three tests: with older adults, with young adults and with children, which are used to verify the design of new CRPs . In the test with older adults, it is selected 100 subjects between 50 and 70 y.o. who do not have any physical or mental disability. These individuals have up to 5 minutes, and then another minute at a second test, to open and close the packaging. The CRP passes the test if at least 90% of the subjects successfully perform the task. In the test with young adults, it is selected 100 adults aged between 18 and 45 y.o. who do not have any physical or mental disability. It is given only a period of 5 minutes to try to open and close the packaging. The test with children is done with a group of children between 42 and 51 months old. The number of children may vary from 50 to 200. The test for this group of individuals can last up to 10 minutes, and it is presented a demonstration of opening when necessary. The CRP passes in the test if at least 80% of the subjects cannot open the packaging. In Brazil, CRPs are not mandatory, but there is the Bill 4841/94  which determines the use of such packagings with medicines and chemical products for domestic use which present a risk to health, however, this project is in the Brazilian Congress since 1994. This project is based on other legislation, particularly the United States and Canada . The Brazilian Bill has only two tests to verify the effectiveness of CRPs: a test with young adults and a test with children between 42 and 51 months old. These tests fol-low the same procedures of the American test protocol cited above. Thus, the aim of this study was to evaluate the Brazilian Bill compared to the legislation of the USA, presenting some suggestions for problems and unconformities encountered.
Literature review for analysis and comparison of the American test protocol with the Brazilian Bill 4841/94.
Due to the lack of mandatory use of CRPs in Brazil, it generates a lack of standards in products, where the use of safety caps is up to the producing company. It is common to find the opening instructions in English, and so, many Brazilian users do not under-stand the opening procedures. In the Brazilian Bill the elderly are not considered in the packaging tests. It can be seen that Brazil follows the old test protocol of the United States. This can be explained by the fact that the Brazilian Bill have emerged in 1994, while the reformulation of the American test protocol happened only in 1995. However, many changes have been made in the Bill, and the introduction of a test with elderly people should have been considered. Another unconformity found in the Bill 4841/94 is the assertion that is made concerning the CRPs, where it is said that such packagings are simple devices. However, studies have shown that these devices become complex for many users [8-14]. Observing the inclusion of individuals with perceptive disabilities in some studies [13,14], it is found another problem with the Brazilian Bill. To participate in the CRP test, individuals need to be "normal", that is, without evident physical or mental disa-bility. However, a fact that has been noted by Bix et al.  is that a wheelchair user has an obvious physical disability, but at the same time he/she has the movements of the upper limbs and this person could participate in tests.
For the Bill 4841/94 achieve a good quality in its content, it is important to take into account the principles of universal design and ergonomic requirements. It is suggested that the Bill obliges the CRP opening statements to be written in the vernacular language, and preferably with illustrations. Furthermore, products containing substantial quantities of alcohol, as is the case of mouthwashes and alcoholic beverages, should be distributed in CRP. However there would be a lot of complaint from consumers of alcohol, but the main objective is the safety of children. Tests with elderly above 70 y.o. should replace the tests with adults, because this age group is the one that often uses large amounts of drugs, which are required to be sold in CRPs, and it is also the age group that most shows difficulties when opening those packagings. However, the possibility of requesting drugs in normal packaging should also be mentioned in the Bill. Finally, it is suggested to change the exclusion criteria of individuals in participating in the tests. As it has also been suggested by Bix et al. , instead of excluding individuals with evident physical or mental disabilities, the ideal would be that all the subjects that could pass the screening test (described in the American protocol) with the packagings that are not child-resistant should be considered able to participate in tests. Thus, wheelchair users, for example, could participate in the test.
Design, Ergonomics, Packaging
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