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Cosmetic Regulatory Requirements in Italy

Italy adheres to the EU regulation (Regulation (EC) No 1223/2009). The Italian Ministry of Health oversees the regulation of cosmetic products in the country. Italian Ministry of Health In Italy, the oversight and enforcement of cosmetic regulations are managed by the Italian Ministry of Health (Ministero della Salute). This authority works in collaboration with the Istituto Superiore di Sanità (ISS), the national institute of health, to ensure compliance with EU regulations and to address spec...
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Cosmetic Regulatory Requirements in Poland

Poland regulates cosmetic products under the framework of the European Union (EU) legislation, specifically adhering to Regulation (EC) No 1223/2009 on cosmetic products. This regulation ensures the safety and compliance of cosmetics placed on the market within the EU, including Poland. Key Aspects of Cosmetic Regulatory Requirements in Poland Chief Sanitary Inspectorate (GIS) In Poland, the regulatory authority responsible for overseeing compliance with cosmetic regulations is the Chief Sanitar...
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Understanding Borderline Cosmetics in the EU

Understanding the distinctions between product classes within the European cosmetics landscape can be complex and ambiguous, often requiring input from authoritative bodies. Certain products may share similarities but fall under different regulatory frameworks. When products straddle these frameworks, they’re termed “borderline” by the European Commission (EC). Clear comprehension of a product category is vital to determine the regulatory requisites for the specific market. Dif...
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Beauty Beyond Borders: A Comprehensive Guide to Cosmetic Regulations in Saudi Arabia

In recent years, the beauty and cosmetics industry has witnessed exponential growth worldwide, breaking down geographical barriers and creating a global marketplace. One country that has embraced this transformative trend is Saudi Arabia, where the beauty industry has flourished, reflecting the changing cultural landscape. However, with growth comes the need for regulations to ensure consumer safety and product quality. Legal Framework for Saudi Arabia Cosmetic Regulations Saudi Arabia has estab...
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eCTD- Electronic Common Technical Document

eCTD-an overview In today’s economy, life science companies are seeking for strategies to continue growing despite impending patent expirations, increasing generic competition, and rising drug development costs.  The International Conference on Harmonization (ICH) created the Common Technical Document (CTD), which is quickly replacing other submission formats as the preferred or compulsory one by regulators in the major global markets and beyond. In Europe, Japan, and Canada, the CTD has be...
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Animal Testing for Cosmetics

The term “animal testing” refers to procedures carried out on living animals for research into basic biology and diseases, evaluating the efficacy of new pharmaceuticals, and testing the safety of consumer and industry products such as cosmetics, household cleaners, food additives, pharmaceuticals, and industrial/agrochemicals for human health and/or the environment. Since 1937, people have used animals to test cosmetics and pharmaceuticals. To determine a product’s safety, manufacturers w...
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FDA’s Adverse Event Reporting for Cosmetics

Cosmetic ingredients and products are not required to have FDA clearance before being sold in the U.S. The only exception is colour additives, which need to be authorised for their intended purpose (apart from the colouring agents used in coal-tar hair dyes). Companies and individuals that sell cosmetics have a legal obligation to guarantee the security of their products. The FDA requires trustworthy evidence that shows that a cosmetic product is harmful when used as directed by its label or in...
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Cosmetics Product Recall under FDA

Title 21 of the Code of Federal Regulations (CFR), section 7.3(g), describes a recall as a firm’s removal or correction of a marketed product that FDA judges to be in violation of the laws we administer and against which the FDA would start legal action, such as seizure. FDA strongly advises businesses to familiarise themselves with all of the regulations, including the elements of a recall strategy, in 21 CFR Part 7. What is the FDA’s responsibility in a recall of Cosmetics Product? The FD...
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Understanding Borderline Cosmetics in the EU

by OMC Medical | Dec 13, 2023 | Cosmetics, EU Understanding the distinctions between product classes within the European cosmetics landscape can be complex and ambiguous, often requiring input from authoritative bodies. Certain products may share similarities but fall under different regulatory frameworks. When products straddle these frameworks, they’re termed “borderline” by the European Commission (EC). Clear comprehension of a product category is vital to determine the regul...
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