Cosmetics:
Danish Study Warns of Food Allergy Risks from Certain Cosmetics
A recent study by the Danish Environmental Protection Agency (EPA) advises against adding food-based substances such as milk, almonds, or soy to cosmetics for babies and young children due to the risk of sensitization via skin contact, potentially leading to food allergies. The study highlights that individuals with compromised skin, such as those with eczema, may develop allergies if they come into contact with these allergens before ingesting the related foods and developing tolerance.
Key Findings:
- Allergen Risk in Cosmetics: The study found that some cosmetic products marketed for sensitive or damaged skin, particularly for children with atopic dermatitis, contain food allergens like almond oil, soy oil, oats, and milk proteins.
- Sensitization Concerns: Skin contact with these allergens poses a significant risk for sensitization, especially in individuals who have never consumed these foods, as they lack oral tolerance.
Data and Survey Analysis:
- The study reviewed data from the Kemiluppen app and found that 27% of cosmetics on the Danish market contain food-based ingredients, including 76 products aimed at children.
- Additionally, a dietary survey by the Technical University of Denmark (DTU) indicated that critical allergens, such as milk, cereals, eggs, and nuts, are introduced into children’s diets at varying ages, which affects their risk of developing allergies from skin exposure.
Precautionary Recommendations: Due to the lack of sufficient data to establish safe exposure levels for babies and young children, the Danish EPA recommends avoiding food proteins in cosmetics for children where oral tolerance is unlikely to have been established. This precautionary approach is crucial to minimizing the risk of food allergies.
This research calls attention to the need for stricter guidelines on the use of food-based ingredients in cosmetic products for vulnerable populations.
REACH:
The Italian Ministry of Health recently released an interpretive note clarifying the definitions of “downstream user” and “distributor” under the REACH regulation. This clarification is crucial for businesses to understand their specific obligations under REACH, particularly regarding activities such as repackaging, transferring, or handling chemical substances.
Key points include:
- Distributors are defined as entities that store and place substances or mixtures on the market without opening or manipulating their packaging.
- In contrast, any company that engages in activities like repackaging, refilling, or transferring chemicals between containers is classified as a downstream user. This is because these actions are considered “use” under the regulation, and the companies performing them are required to meet additional obligations, such as the notification of hazardous substances (PCN) to poison control centers.
This interpretive note aligns with guidance from ECHA and aims to ensure that companies comply with Article 45 of the CLP regulation, which involves the submission of safety information for emergency health responses.
Food:
European Commission Renews Authorization for GM Maize MON 810
Recently, the European Commission renewed the authorization for the sale of genetically modified (GM) maize MON 810 in food and feed products, under Regulation (EC) No. 1829/2003. This renewal allows continued use of MON 810 for food and feed purposes but does not permit its cultivation within the EU.
Key Points:
- Products Covered: The authorization applies to food, feed, and ingredients derived from GM maize MON 810.
- Safety and Monitoring: The decision was based on positive assessments from the European Food Safety Authority (EFSA), which found no new environmental risks. Annual monitoring for environmental impacts is still required.
- Replacement of Previous Authorization: This update replaces the 2017 authorization, ensuring compliance with EU regulations and ongoing safety checks.
The renewal highlights the EU’s stringent approach to GM products, ensuring continued safety monitoring while allowing the use of MON 810 in specific areas of the food chain.
Biocides:
Health Experts Oppose Pending CMR Classification of Ethanol
Call to Reconsider Ethanol’s Classification: A coalition of 29 global infection control expert groups has urged the European Union to avoid classifying ethanol as a reprotoxic category 2 substance. They argue that such a classification could severely impact the availability of ethanol-based hand antiseptics, the only effective solution against non-enveloped viruses like norovirus and hepatitis A. This reclassification would require warning labels that could deter use in healthcare settings, including restrictions under the Pregnant Workers Directive.
Ethanol’s Limbo in the EU: Ethanol’s approval under the Biocidal Products Regulation (BPR) has been delayed since 2007, awaiting its classification under the EU CLP Regulation. Initially proposed as carcinogenic and reprotoxic 1A, the classification was downgraded to reprotoxic category 2 by Greek authorities in 2020. However, infection control experts argue that this revised classification could still cause significant harm by discouraging the use of ethanol-based hand sanitizers.
Key Concerns:
- Hand Hygiene and Viral Control: Ethanol, alongside 2-propanol and 1-propanol, is a key ingredient in hand rubs. However, studies show ethanol is more effective against non-enveloped viruses. Without ethanol-based disinfectants, the EU could face increased public health risks from viral outbreaks.
- Misinterpreted Risks: The concern about ethanol’s reprotoxicity stems from alcohol consumption in pregnant women, but experts point out that transdermal absorption from hand rubs is far lower than from consuming alcohol in food or beverages.
Economic and Public Health Impact: The Ethanol REACH Association warns that reprotoxic classification could have widespread socio-economic consequences, affecting industries from healthcare to renewable fuels and cosmetics. Furthermore, without ethanol, controlling future outbreaks of emerging viruses may become more challenging.
Global Call for Action: The GMS paper advocating against the reclassification was signed by health organizations from across Europe, the US, Canada, and the Asia-Pacific region, emphasizing the critical need to maintain ethanol’s availability for hand antiseptics in the fight against viruses.
This plea highlights the need for careful regulatory decisions that balance public health safety with regulatory caution in classifying substances.
Consultation on 3-Iodo-2-propynylbutylcarbamate as a Candidate for Substitution
The European Chemicals Agency (ECHA) has opened a public consultation regarding the potential classification of 3-iodo-2-propynylbutylcarbamate as a candidate for substitution under the Biocidal Products Regulation (BPR). This fungicide is primarily used to protect wood against wood-rotting and wood-discoloring fungi, both for indoor and outdoor applications (product-type 8).
Key Information:
- The consultation invites stakeholders to submit comments and relevant information regarding this substance’s potential substitution.
- Comments can be submitted until 6 November.
This consultation is part of ECHA’s ongoing efforts to evaluate substances that may pose higher risks to human health or the environment and explore safer alternatives where possible.
PFAS:
EU Finalizes Restriction on PFHxA in Various Consumer Products
The European Commission has finalized a restriction on perfluorohexanoic acid (PFHxA), its salts, and related substances. This restriction targets their use in several consumer products such as food packaging, clothing, and cosmetics. The rule will officially enter into force 20 days after publication in the EU’s Official Journal and will include transition periods of 18 months to five years, depending on the application.
Scope of the Restriction: Initially proposed by Germany’s Federal Institute for Occupational Safety and Health (BAuA) in 2019, the original proposal aimed for a comprehensive ban on PFHxA-related substances. However, the final restriction has been narrowed and includes prohibitions in:
- Textiles, leather, and outdoor clothing for consumers.
- Food contact materials (FCMs), such as paper and cardboard.
- Waterproofing sprays and other mixtures for the general public.
- Cosmetic products.
- Certain firefighting foams for training and testing purposes.
Exemptions and Industrial Use: The restriction notably excludes industrial uses of PFHxA, such as in the semiconductor, battery, and green hydrogen sectors. PFHxA is widely used in many industrial applications, although it is not registered under EU REACH. However, its related substances, including ammonium salt, are registered and used in significant quantities in sectors like textiles and firefighting foams.
Commission’s Statement: According to Maroš Šefčovič, the European Commission’s vice president overseeing the Green Deal, this restriction aims to remove harmful substances from everyday consumer products while providing businesses with ample time to transition. This action is seen as a precursor to a broader ban on PFAS, which could affect thousands of similar substances.
This decision underscores the EU’s ongoing efforts to prioritize human health and environmental protection, focusing on reducing exposure to hazardous chemicals while considering socio-economic impacts.
