Spanish agency Orders Immediate Recall of Several Cosmetic Products
Table of Contents
- Spanish agency Orders Immediate Recall of Several Cosmetic Products
- Affected Cosmetic Brands and Products
- Reasons for the Cosmetic Product Recall
- AEMPS Actions and Recommendations
- Regulatory Framework for Cosmetic Products in Spain
- Global Comarcos, SL: Background
- Cosmetic Regulations: A Global Outlook
- Frequently Asked Questions About Cosmetic Recalls
- Why are cosmetic products recalled?
- How can I find out if a cosmetic product I use has been recalled?
- What should I do if I have a recalled cosmetic product?
- Are there long-term health risks associated with using recalled cosmetics?
- How often are cosmetic products tested for safety?
- what are “good manufacturing practices” in the cosmetic industry?
- Who is responsible for ensuring the safety of cosmetic products?
Health Products (AEMPS) has ordered an immediate halt to the production and sale of specific cosmetic products due to regulatory violations.">
The Spanish Agency for Medicines and Health Products (AEMPS) has mandated an immediate cessation of production and marketing for a range of cosmetic products after discovering that the manufacturing facilities failed to meet established legal standards. Consumers are urged to check their cosmetic inventories for affected brands.
Affected Cosmetic Brands and Products
The recall impacts products from the following brands: pirinherbsan, Fontdeblack, mythological, and Extraroma. These brands were manufactured by Global Comarcos, SL, a company based in Barcelona [1].
More than 50 different products are included in the recall, spanning various cosmetic categories. These include creams, lotions, oils, ampoules, gels, and shampoos designed for a multitude of purposes.
Did You Know? The European Union Cosmetics Regulation 1223/2009 sets the standard for cosmetic product safety within the EU, ensuring high levels of health protection for consumers [1].
Reasons for the Cosmetic Product Recall
The General Subdirectorate of sanitary and Pharmaceutical Management,operating under the General Directorate of Sanitary Planning and Regulation of the Generalitat of Catalonia,conducted an inspection that revealed significant breaches of good manufacturing practices at the Global Comarcos,SL facilities.
Furthermore, authorities found that the affected products did not comply with mandatory labeling requirements. As an inevitable result, the Catalan health authority ordered the immediate shutdown of the manufacturing plant, the termination of all commercial activities, and the complete removal of all product lots from the market.
AEMPS Actions and Recommendations
The AEMPS is actively notifying points of sale, instructing them to remove any stock of the recalled brands from their shelves and to contact the responsible company for further instructions. Consumers who have purchased products from the affected brands are advised to discontinue their use promptly.
Pro Tip: Always check the AEMPS website for the latest health alerts and product recalls to stay informed about potential risks.
Regulatory Framework for Cosmetic Products in Spain
Royal Decree 85/2018, enacted on February 23, governs the manufacturing and health surveillance of cosmetic products in Spain. This decree implements European Union Regulation 1223/2009, which has been in effect as july 11, 2013. These regulations mandate adherence to good manufacturing and labeling practices to ensure the safety of cosmetic products.National authorities are responsible for overseeing compliance.
The AEMPS is the agency responsible for ensuring the health guarantees of cosmetic products in Spain. It operates a national alert network that disseminates information about potential risks and necessary measures to regional health authorities, affected groups, distribution centers, pharmacies, and large consumer establishments.
In 2024, the national cosmetic product safety surveillance network received 104 notifications, of which 14 were rejected. The 90 investigated cases represented a 25% decrease compared to the cases opened in 2023.
| Year | Notifications Received | Notifications Rejected | Cases Investigated |
|---|---|---|---|
| 2023 | N/A | N/A | 120 |
| 2024 | 104 | 14 | 90 |
Global Comarcos, SL: Background
According to its website, GLOBAL CITY (likely a typo for Global Comarcos) was a Barcelona-based laboratory with 28 years of experience. The company stated its mission was to offer professionals in manual and alternative therapies, complementary medicine, aesthetic, plastic, and reparative surgery a wide range of phyto-active treatments. The company also reportedly manufactured products for third-party brands.
Cosmetic Regulations: A Global Outlook
Cosmetic regulations vary significantly across the globe. The United States,for example,operates under the Food and Drug Management (FDA),while the European Union adheres to stricter guidelines under the EU Cosmetics Regulation. These regulations dictate everything from ingredient safety to labeling requirements, aiming to protect consumers from perhaps harmful products.Regular updates and revisions to these regulations reflect ongoing scientific advancements and emerging safety concerns.
Frequently Asked Questions About Cosmetic Recalls
Why are cosmetic products recalled?
Cosmetic products are typically recalled due to safety concerns, such as the presence of harmful ingredients, contamination, or failure to meet labeling requirements. Recalls are initiated to protect consumers from potential health risks.
How can I find out if a cosmetic product I use has been recalled?
You can stay informed about cosmetic product recalls by regularly checking the websites of your country’s health and safety agencies, such as the AEMPS in Spain or the FDA in the United states. Additionally, news outlets often report on significant product recalls.
What should I do if I have a recalled cosmetic product?
If you possess a recalled cosmetic product, discontinue its use immediately. Follow the instructions provided by the manufacturer or the relevant health authority, which may include returning the product for a refund or disposal.
Are there long-term health risks associated with using recalled cosmetics?
The long-term health risks associated with using recalled cosmetics vary depending on the nature of the safety concern. Some recalled products may cause skin irritation or allergic reactions, while others may pose more serious health risks with prolonged use. It is essential to seek medical advice if you experience any adverse effects.
How often are cosmetic products tested for safety?
The frequency of cosmetic product testing varies depending on the regulatory requirements of each country. In general, manufacturers are responsible for ensuring the safety of their products through rigorous testing and quality control measures. Regulatory agencies also conduct periodic inspections and testing to verify compliance.
what are “good manufacturing practices” in the cosmetic industry?
Good Manufacturing Practices (GMP) are a set of guidelines that ensure cosmetic products are consistently produced and controlled according to quality standards. These practices cover all aspects of production,from raw materials to manufacturing processes and packaging,to minimize risks to product safety and quality.
Who is responsible for ensuring the safety of cosmetic products?
Both cosmetic manufacturers and regulatory agencies share the responsibility for ensuring the safety of cosmetic products. Manufacturers are responsible for conducting thorough safety testing and adhering to GMP, while regulatory agencies oversee compliance and take action when safety concerns arise.
disclaimer: This article provides general information and should not be considered medical or professional advice.Consult with a healthcare professional for any health concerns.
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