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Regulamentação dos produtos cosméticos: uma perspetiva da evolução em Portugal e na União Europeia
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Abstract(s)
Os produtos cosméticos são produtos de saúde destinados a contactar com as partes externas do corpo humano, dentes e mucosas bucais, tendo em vista, exclusiva ou principalmente, limpá-los, perfumá-los, modificar-lhes o aspeto, protegê-los, mantê-los em bom estado ou corrigir os odores corporais. A sua regulamentação na atual União Europeia (UE) começou por ser realizada a nível nacional, materializando-se em Portugal com a entrada em vigor do Decreto-Lei n.º 375/72. Após a fundação da Comunidade Económica Europeia (CEE), foi publicada a Diretiva 76/768/EEC que permitiu criar um mercado único através do estabelecimento de critérios comuns para a salvaguarda da segurança e tomada de decisão informada pelos consumidores. Com a entrada de Portugal na CEE em 1986, esta Diretiva e respetivas Emendas foram transpostas para o direito nacional ao longo dos anos 90 e na primeira década do século XXI. Paralelamente, em 2006 dá-se a publicação do Regulamento (EC) n.º 1907/2006 pela Agência Europeia dos Produtos Químicos (ECHA), que terá implicações no registo, avaliação, autorização e restrição de matérias-primas usadas pela indústria cosmética. O ano de 2009 marca a harmonização da regulamentação dos produtos cosméticos nos Estados Membros da UE através da publicação do Regulamento (CE) n.º 1223/2009, que introduz alterações relevantes à legislação anterior, a que se seguiu a publicação do Regulamento (CE) n.º 655/2013, relativo à fundamentação das alegações de produtos cosméticos. Atualmente, estes regulamentos encontram-se em vigor em todos os Estados Membros da UE, estando sujeitos a revisões periódicas. À data de hoje, o Regulamento (CE) n.º 1223/2009 foi sujeito a 110 e retificações. De salientar que existem ainda alguns temas que suscitam controvérsia na comunidade científica, e que poderão motivar importantes alterações regulamentares, como são a identificação e regulamentação de disruptores endócrinos e as substâncias com potencial alergénico de menção obrigatória na lista de ingredientes dos produtos cosméticos.
Cosmetic products are health products designed to contact the external parts of the human body, teeth and oral mucous membranes, with a view, exclusively or mainly, for cleaning, perfuming, protecting, changing their appearance, maintaining a good state or correcting body odors. Their regulation in the current European Union (EU) began at a national level. In Portugal, it was materialized with the entry into force of Decree no. 375/72. After the founding of the European Economic Community (EEC), the Directive 76/768/EEC was published, allowing for the creation of a single market through the establishment of common criteria for guaranteeing safety and informed decision-making by consumers. With Portugal’s entry into the EEC in 1986, this Directive and its Amendments were transposed into national law throughout the 1990s and in the first decade of the 21st century. Parallel to this, in 2006, the Regulation (EC) No. 1907/2006 was published by the European Chemicals Agency (ECHA), with implications for the registration, evaluation, authorization and restriction of raw materials used by the cosmetic industry. The year 2009 marks the harmonization of the regulation of cosmetic products in the EU Member States through the publication of Regulation (EC) No. 1223/2009, which introduces relevant changes to the previous legislation, followed by the publication of Regulation (EC) No. 655/2013, on the substantiation of cosmetic product claims. These regulations are currently in force in all EU Member States, being subject to periodic reviews. Until now, Regulation (EC) No. 1223/2009 has been subjected to 110 amendments. Noteworthy, that there are still some issues that are controversial in the scientific community, and may motivate important regulatory changes, such as the identification and regulation of endocrine disruptors and substances with allergenic potential that must be nmentioned in the ingredients list of cosmetic products.
Cosmetic products are health products designed to contact the external parts of the human body, teeth and oral mucous membranes, with a view, exclusively or mainly, for cleaning, perfuming, protecting, changing their appearance, maintaining a good state or correcting body odors. Their regulation in the current European Union (EU) began at a national level. In Portugal, it was materialized with the entry into force of Decree no. 375/72. After the founding of the European Economic Community (EEC), the Directive 76/768/EEC was published, allowing for the creation of a single market through the establishment of common criteria for guaranteeing safety and informed decision-making by consumers. With Portugal’s entry into the EEC in 1986, this Directive and its Amendments were transposed into national law throughout the 1990s and in the first decade of the 21st century. Parallel to this, in 2006, the Regulation (EC) No. 1907/2006 was published by the European Chemicals Agency (ECHA), with implications for the registration, evaluation, authorization and restriction of raw materials used by the cosmetic industry. The year 2009 marks the harmonization of the regulation of cosmetic products in the EU Member States through the publication of Regulation (EC) No. 1223/2009, which introduces relevant changes to the previous legislation, followed by the publication of Regulation (EC) No. 655/2013, on the substantiation of cosmetic product claims. These regulations are currently in force in all EU Member States, being subject to periodic reviews. Until now, Regulation (EC) No. 1223/2009 has been subjected to 110 amendments. Noteworthy, that there are still some issues that are controversial in the scientific community, and may motivate important regulatory changes, such as the identification and regulation of endocrine disruptors and substances with allergenic potential that must be nmentioned in the ingredients list of cosmetic products.
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Keywords
Regulamentação Cosméticos Produtos de saúde Portugal União Europeia Regulation Cosmetics Health products European Union
Citation
Publisher
Ordem dos Farmacêuticos