DGH - Relatórios científicos e técnicos
URI permanente para esta coleção:
Navegar
Entradas recentes
- SCCS - Scientific Opinion on Tea Tree Oil (CAS/EC No. 68647-73-4 /285-377-1)Publication . Scientific Committee on Consumer Safety (SCCS)The SCCS concludes the following: 1. In light of the data provided and taking under consideration the possible classification as ‘Repr.1B’ under Regulation (EC) No 1272/2008 (CLP Regulation) and the conditions laid out in Article 15 (2) (d) of the Regulation (EC) No 1223/2009, does the SCCS consider TTO safe when used as an anti-seborrheic and anti-microbial agent in rinse-off and leave-on cosmetic products up to the maximum concentrations provided by the applicant? The SCCS considers the use of Tea Tree Oil (TTO) as an anti-seborrheic and anti-microbial agent safe in four defended product types - up to the maximum concentration of 2.0% in shampoo, 1.0% in shower gel, 1.0% in face wash and 0.1% in face cream. The assessment has considered all available data, a possible classification as ‘Repr.1B’ under Regulation (EC) No 1272/2008, the conditions laid out in Article 15 (2) (d) of the Regulation (EC) No 1223/2009 including the aggregated exposure from the defended cosmetic products and non-cosmetics uses of TTO. This Opinion is only applicable to: • TTO with chemical composition that conforms to the updated International Standard (ISO 4730:2017) in the defended final cosmetic products. • the use of TTO in the defended dermally applied cosmetic products exclusively for adults, and not in aerosolised or sprayable delivery formats that may give rise to inhalation exposure of the consumer to TTO through airborne mist/droplets of the TTO-containing products. 2. Alternatively, what is according to the SCCS, the maximum concentration considered safe for use of TTO in cosmetic products? 3. Does the SCCS have any further scientific concerns regarding the use of TTO in cosmetic products? Based on the data provided, TTO is a moderate skin sensitiser. The submission did not provide any data on the stability of TTO under the conditions of storage and use. Since the chemical composition of TTO may change due to exposure to light, heat, air and /or moisture, it is not clear how TTO will be stabilised in the final cosmetic products to prevent degradation/transformation of the components. The SCCS is therefore of the opinion that stability of TTO must be maintained in the final cosmetic products so that the components remain within the specifications of the updated ISO 4730:2017 standard. The new version of ISO standard (ISO 4730:2025), which relates to enantiomeric distribution parameters for α-terpineol in the essential oil of Melaleuca, terpinen-4-ol type (tea tree oil), should also be taken into account. The SCCS mandate does not address environmental aspects. Therefore, this assessment has not covered the safety of TTO for the environment.
- SCCS opinion on biphenyl-2-ol and sodium 2-biphenylolate used in cosmetic products (CAS/EC No. 90–43–7/201–993–5 and 132–27–4/205–055–6)– SCCS/1669/24Publication . European Commission. Scientific Committee on Consumer SafetyThe SCCS concludes the following: 1. In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of Benzophenone-1, does the SCCS consider Benzophenone-1 safe when used as a light stabilizer in cosmetic products up to a maximum concentration of 2%? Having considered the data provided (including two new mutagenicity/genotoxicity studies submitted to ECHA as part of the REACH registration dossier), and the concerns relating to genotoxicity and potential endocrine disrupting properties, the SCCS considers Benzophenone-1 not safe when used as a light stabiliser in cosmetic products for the following reasons: • The available data indicate genotoxicity potential of Benzophenone-1. • The evidence assessed by the SCCS also shows that Benzophenone-1 is an endocrine-active substance due to clear demonstration of estrogenic activity and weak anti-androgenic activity both in vitro and in vivo, and potential activity against thyroid modality in vitro. A new (2023) OECD TG 422 study relating to ED effects submitted to ECHA as part of the REACH registration dossier has not been assessed by the SCCS at this stage because of the remaining concerns over genotoxicity of Benzophenone-1. The SCCS will be ready to assess the evidence in support of the safe use of Benzophenone-1 in cosmetic products when received in a new mandate. 2. Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Benzophenone-1 in cosmetic products? / 3. Does the SCCS have any further scientific concerns with regard to the use of Benzophenone-1 in cosmetic products? The SCCS mandate does not address environmental aspects. Therefore, this assessment has not covered the safety of BP-1 for the environment.
- SCCS - Scientific Opinion on Hydroxyapatite (nano) - Submission IVPublication . European Commission. Scientific Committee on Consumer Safety (SCCS)The SCCS concludes the following: (1) In view of the above, and taking into account the scientific data provided, does the SCCS consider Hydroxyapatite (nano) safe when used in toothpaste up to a maximum concentration of 29.5% and in mouthwash up to a maximum concentration of 10% according to the specifications as reported in the submission, taking into account reasonably foreseeable exposure conditions? Based on the data provided, the SCCS considers hydroxyapatite (nano) safe when used at concentrations up to 29.5% in toothpaste, and up to 10% in mouthwash. This conclusion is based on the available evidence, which shows that hydroxyapatite (nano) does not pose a mutagenic hazard or cytotoxicity or inflammatory effects even when tested at high concentrations in a buccal mucosa cell model. Any uptake of hydroxyapatite (nano) by buccal mucosa is considered negligible, and the epithelial cells with internalised particles will be shed out over time as they are continually replaced. Also, any unintentionally ingested HAP nanoparticles during the use of oral-care products will undergo rapid dissolution in the gastric fluid and therefore do not raise any nano-specific concern over safety. This safety evaluation only applies to the hydroxyapatite (nano) that have the following characteristics: - composed of rod-shaped particles of which at least 87% (in particle number) have aspect ratios equal to or less than 3, and the remaining 13% have aspect ratios not exceeding 9. - the HAP particles are not coated or surface modified. - the Opinion is related to HAP particles with max length of the HAP nanoparticles in the present Opinion, i.e. 122 ± 43 nm. 1. Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Hydroxyapatite (nano) in cosmetic products? / 2. Does the SCCS have any further scientific concerns with regard to the use of Hydroxyapatite (nano) in oral cosmetic products? This Opinion is not applicable to any hydroxyapatite (nano) material that is composed of or contains needle-shaped particles.
- SCCS - Scientific Advice on HC Red No. 18 (Colipa No. B124) (CAS No. 1444596-49-9) - Submission IIPublication . European Commission. Scientific Committee on Consumer SafetyThe SCCS concludes the following: (1) In light of the data provided, does the SCCS consider HC Red 18 safe, when used as an ingredient at 1.5% in oxidative hair dye and at 0.5% in non-oxidative hair dye formulations? In light of the data provided, the SCCS considers HC Red 18 safe when used as an ingredient at 1.5% in oxidative hair dye and at 0.5% in non-oxidative hair dye formulations. (2) Does the SCCS have any further scientific concerns with regard to the use of HC Red 18 in cosmetic products? /
- Scientific advice – children’s exposure to Methyl salicylate (methyl 2-hydroxybenzoate) - Revision of SCCS/1654/23Publication . European Commission. Scientific Committee on Consumer SafetyThe SCCS concludes the following: 1. Taking under consideration the conclusions of SCCS/1658/23 and the aggregate exposure, the SCCS is requested to re-assess the maximum concentration of Methyl Salicylate that is considered safe when used in products intended for children of age 0-3. The SCCS is of the view that, to be considered safe, the concentration of Methyl Salicylate should not exceed 0.4% in toothpaste and 0.02% in other products when used in products intended for children of age 0-3 years. 2. Does the SCCS have any further scientific concerns with regard to the use of Methyl Salicylate in cosmetic products and children’s exposure? The SCCS mandates do not address environmental aspects. Therefore, this assessment did not cover the safety of Methyl Salicylate for the environment.
- SCCS Opinion on Butylparaben (CAS No. 94-26-8, EC No. 202-318-7) - Children's exposurePublication . European Commission. Scientific Committee on Consumer Safety (SCCS)The SCCS concludes the following: 1. In light of the data provided and taking under consideration the conclusions of the SCCS/1651/23 Opinion on children exposure, does the SCCS consider Butylparaben safe for children, when used as a preservative up to a maximum concentration of 0.14 %? Based on the safety assessment carried out in consideration of all available information, including the potential endocrine effects, the SCCS is of the opinion that the use of Butylparaben as preservative at a maximum concentration of 0.14 % (as acid) in all cosmetic products included in this exposure assessment is not safe for children between 0.5-1 years, 1-3 years, 3-6 years and 6-10 years when used in combination. With the exception of body lotion, it is safe in single dermal and oral product categories, when used only in the respective product category. 2.Alternatively, what is, according to the SCCS, the maximum concentration of Butylparaben that is considered safe for the age groups of children considered in this opinion”? In the SCCS’s opinion, Butylparaben could be considered safe for children of all age groups that were evaluated, provided that the maximum concentration of Butylparaben is reduced in some product types so that the aggregate exposure does not exceed 245 μg/kg bw/day. During the public consultation, the SCCS received a proposal from the Applicant to maintain the concentration of Butylparaben at 0.14 % (as acid) in rinse-off products and reduce it to 0.002 % (as acid) in leave-on products and 0.092 % (as acid) in oral care products. Based on these reduced concentrations, Butylparaben is considered safe for children of all age groups and product types included in the assessment, whether used individually or in combination. 3. Does the SCCS have any further scientific concerns regarding the use of Butylparaben in cosmetic products and children’s exposure? This Opinion is not applicable to any sprayable product (including mouth spray) that may lead to exposure of end-user’s lungs by inhalation. The SCCS mandates do not address environmental aspects. Therefore, this assessment did not cover the safety of Butylparaben for the environment.
- Opinion on Ethylhexyl Methoxycinnamate (EHMC) (CAS No. 5466-77-3/83834-59-7, EC No. 226-775-7/629-661-9)Publication . European Comission. Scientific Committee on Consumer SafetyThe SCCS concludes the following: 1. In light of the data provided and taking under consideration the concerns related to potential endocrine disrupting properties of Ethylhexyl Methoxycinnamate, does the SCCS consider Ethylhexyl Methoxycinnamate safe when used as UV-Filter in cosmetic products up to a maximum concentration of 10%? The SCCS has noted that the available evidence shows that EHMC is an endocrineactive substance due to estrogenic activity and weak anti-androgenic activity both in vitro and in vivo. Having considered the data provided, and the concerns relating to potential endocrine disrupting properties of EHMC, the SCCS is of the opinion that EHMC is safe when used as a UV filter up to a maximum concentration of 10% in sunscreen lotion, face and hand cream, lipstick, sunscreen propellant spray and pump spray, when used separately or in combination. The SCCS is of the opinion that these products are also safe for children due to the high Margin of Safety, which precludes any difference between internal exposures in children that might be higher due to a different surface/body weight ratio than in adults. 2. Alternatively, what is according to the SCCS the maximum concentration considered safe for use of Ethylhexyl Methoxycinnamate in cosmetic products? 3. Does the SCCS have any further scientific concerns with regard to the use of Ethylhexyl Methoxycinnamate in cosmetic products? The SCCS mandate does not address environmental aspects. Therefore, this assessment did not cover the safety of EHMC for the environment.
- Scientific advice on the safety of Diethylamino Hydroxybenzoyl Hexyl Benzoate – DHHB -S83 (CAS/EC No. 302776-68-7/443-860-6)Publication . European Comission. Scientific Committee on Consumer SafetyThe SCCS concludes the following: 1. Considering the recent concerns over the presence of DnHexP as a contaminant in the production of Diethylamino Hydroxybenzoyl Hexyl Benzoate (DHHB) used as a UV-filter in cosmetic products, as well as in view of technical and scientific progress and taking under consideration in particular the various health concerns, the SCCS is requested to identify the maximum safe level of DnHexP as a contaminant in DHHB preparations Considering the health concerns associated with DnHexP, the SCCS calculated a maximum safe level of 0.026% (260 ppm) for this impurity in the UV filter DHHB. This applies when DHHB is used up to 10% in cosmetic products and only if DnHexP is an unavoidable impurity. 2. Does the SCCS have any further scientific concerns regarding the presence of DnHexP in DHHB as a UV-filter in cosmetic products? The SCCS has noted from the available information that DnHexP was below the level of detection in several DHHB containing sunscreen products and other DHHB sources, provided that a specific manufacturing process is applied. The information also showed that it is technically possible to lower the levels of DnHexP in DHHB down to 1 ppm. Considering the existence of such alternative manufacturing process for DHHB, the SCCS is of the opinion that a trace level of 1 ppm should be the target for the maximal level of DnHexP as an impurity in DHHB.
- Programa Nacional de Rastreio Neonatal: relatório 2023Publication . Vilarinho, Laura; Garcia, Paula; Pinho e Costa, Paulo; Comissão Executiva do ProgramaRelatório de atividades do Programa Nacional de Rastreio Neonatal (PNRN) relativo ao ano de 2023, elaborado pela Comissão Executiva do Programa. O documento refere todos os casos detetados, bem como os Centros de Tratamento de apoio aos doentes e a prevalência ao nascimento das doenças rastreadas, entre outra informação estatística. Do presente relatório de desenvolvimento do Programa, destaca-se o seguinte: - Em 2023, as 27 doenças integradas no painel do Programa Nacional de Rastreio Neonatal (Hipotiroidismo Congénito, Fibrose Quística, Drepanocitose (Anemia de Células Falciformes e 24 Doenças Hereditárias do Metabolismo) foram rastreadas de uma forma sistemática, em 85.764 recém-nascidos (RN) e identificados 136 doentes com uma média de idade de início de tratamento de 9,6 dias de vida; - No ano transato, teve início o estudo-piloto para o rastreio neonatal da Atrofia Muscular Espinal em 100.000 recém-nascidos que foi concluído no final deste ano com uma prevalência ao nascimento de 1:14.515; - A taxa de cobertura nacional mantém-se próxima dos 100%, o que constitui um excelente indicador de aceitação da população a este programa nacional de saúde pública; - Desde o início do Programa, foram rastreados 4.224.550 recém-nascidos e identificados 2.678 casos positivos; - Pela qualidade dos seus indicadores, número de patologias rastreadas, tempo médio de início de tratamento e taxa de cobertura a nível nacional, considera-se que é, de facto, um Programa de grande eficácia clínica e epidemiológica. Criado em 1979, este programa de saúde pública, conhecido como “teste do pezinho”, tem como objetivo primário o rastreio neonatal de doenças raras, de forma a evitar a evolução da patologia rastreada, através do diagnóstico pré-sintomático e da orientação para implementação precoce de terapia adequada. A Unidade de Rastreio Neonatal, Metabolismo e Genética do DGH, que funciona no Centro de Saúde Pública Doutor Gonçalves Ferreira do INSA no Porto, é o braço laboratorial do Programa, sendo composta pelo Laboratório Nacional de Rastreios, Laboratório de Metabolismo e Laboratório de Genética Molecular. Após 44 anos de atividade, o PNRN continua a apresentar um elevado padrão de qualidade e desenvolvimento que lhe confere um prestígio nacional e internacional por todos reconhecido e respeitado, mantendo uma trajetória e um dinamismo de que são sinais, para além dos indicadores de eficácia clínica e epidemiológica, o elevado nível de produção científica, a implementação de normas internacionais de qualidade e o alargamento do rastreio a novas entidades nosológicas.
- Programa Nacional de Rastreio Neonatal: relatório 2024Publication . Vilarinho, Laura; Garcia, Paula; Pinho e Costa, Paulo; Comissão Executiva do ProgramaRelatório de atividades do Programa Nacional de Rastreio Neonatal (PNRN) relativo ao ano de 2024, elaborado pela Comissão Executiva do Programa. O documento refere todos os casos detetados, bem como os Centros de Tratamento de apoio aos doentes e a prevalência ao nascimento das doenças rastreadas, entre outra informação estatística. Do presente relatório de desenvolvimento do Programa, destaca-se o seguinte: - Em 2024, as 27 doenças integradas no painel do Programa Nacional de Rastreio Neonatal (Hipotiroidismo Congénito, Fibrose Quística, Drepanocitose (Anemia de Células Falciformes e 24 Doenças Hereditárias do Metabolismo) foram rastreadas de uma forma sistemática, em 84.631 recém-nascidos (RN) e identificados 118 doentes com uma média de idade de início de tratamento de 9,5 dias de vida; - Em 2022, teve início o estudo-piloto para o rastreio neonatal da Atrofia Muscular Espinal, que foi concluído no final de 2024 com uma prevalência ao nascimento de 1:15.520 e foi proposta a sua integração no painel das doenças rastreadas; - A taxa de cobertura nacional mantém-se próxima dos 100%, o que constitui um excelente indicador de aceitação da população a este programa nacional de saúde pública; - Desde o início do Programa, foram rastreados 4.309.181 recém-nascidos e identificados 2.796 casos positivos; - Pela qualidade dos seus indicadores, número de patologias rastreadas, tempo médio de início de tratamento e taxa de cobertura a nível nacional, considera-se que é, de facto, um Programa de grande eficácia clínica e epidemiológica. Criado em 1979, este programa de saúde pública, conhecido como “teste do pezinho”, tem como objetivo primário o rastreio neonatal de doenças raras, de forma a evitar a evolução da patologia rastreada, através do diagnóstico pré-sintomático e da orientação para implementação precoce de terapia adequada. A Unidade de Rastreio Neonatal, Metabolismo e Genética do DGH, que funciona no Centro de Saúde Pública Doutor Gonçalves Ferreira do INSA no Porto, é o braço laboratorial do Programa, sendo composta pelo Laboratório Nacional de Rastreios, Laboratório de Metabolismo e Laboratório de Genética Molecular. Após 45 anos de atividade, o PNRN continua a apresentar um elevado padrão de qualidade e desenvolvimento que lhe confere um prestígio nacional e internacional por todos reconhecido e respeitado, mantendo uma trajetória e um dinamismo de que são sinais, para além dos indicadores de eficácia clínica e epidemiológica, o elevado nível de produção científica, a implementação de normas internacionais de qualidade e o alargamento do rastreio a novas entidades nosológicas.