Food:
EFSA Updates on Terrestrial Ecotoxicology and Biodiversity Impact Assessment
Mandate on Terrestrial Ecotoxicology:
EFSA is currently updating its guidance document on terrestrial ecotoxicology. This update will review and refine the risk assessment methodology for:
- Non-target arthropods (excluding bees)
- In-soil organisms, including soil meso- and macrofauna and their effects on soil nitrogen transformation
- Non-target terrestrial plants outside the designated treatment area
Framework for Biodiversity Assessment:
In parallel, EFSA is developing a framework to assess potential indirect effects on biodiversity through trophic interactions under agro-environmental conditions. This initiative aims to better understand how plant protection products may indirectly impact ecosystems via food webs and other ecological interactions.
Scientific Colloquium Announcement:
To further advance these efforts, EFSA will host a scientific colloquium on 18 June 2025. The event will focus on evaluating indirect effects as part of the environmental risk assessment (ERA) of plant protection products (PPPs). More details regarding the agenda, venue, and registration process are available on the EFSA website.
These initiatives underscore EFSA’s commitment to enhancing environmental risk assessment methodologies and protecting biodiversity in agricultural settings.
PFAS Restrictions in EU Food Packaging to Take Effect in 2026
New Regulatory Thresholds: The European Commission has approved new restrictions on the use of per- and polyfluoroalkyl substances (PFAS) in food packaging under the Packaging and Packaging Waste Regulation (PPWR). Effective from 2026, these rules set specific thresholds for PFAS levels in food contact packaging:
- 25 ppb for a single PFAS,
- 250 ppb for a targeted sum of PFAS,
- 50 ppm for all PFAS, including polymeric forms.
These thresholds, proposed by the Belgian presidency as part of a compromise, mirror those in the broader EU-wide REACH restriction.
Evaluation and Transition Measures: To prevent overlap with other EU restrictions, the final regulation mandates that the European Commission evaluate the need to amend or repeal these PFAS provisions within five and a half years. The PPWR also requires manufacturers to limit heavy metals and other substances of concern in packaging design, in line with the Chemicals Strategy for Sustainability (CSS). The regulation will be published in the Official Journal in early 2025 and will enter into force 20 days after publication, with an 18-month transition period before the restrictions apply. Once in force, the PPWR will repeal the existing Packaging and Packaging Waste Directive (PPWD).
Industry Impact and Ambitious Targets: According to Dorota Napierska, Toxic-Free Circular Economy Policy Officer at NGO Zero Waste Europe, these measures provide the food packaging industry with the regulatory certainty needed to phase out PFAS, including polymeric variants. However, the industry is closely watching the implementation, especially due to concerns over the lack of robust analytical methods and issues of contamination versus intentional use.
The PPWR aims to cover the entire lifecycle of packaging with ambitious targets, including:
- Mandating minimum recycled content in certain plastic packaging, such as beverage bottles.
- Requiring all packaging on the market to be recyclable by 1 January 2030.
- Setting binding reduction targets for packaging waste: a 5% reduction by 2030, 10% by 2035, and 15% by 2040.
With over 40 pieces of secondary legislation expected to support its implementation, the PPWR represents a comprehensive step toward sustainable packaging, though regulators anticipate a significant workload for follow-up assessments and guidance development.
RoHS:
European Commission Issues RoHS Infringement Notice to Cyprus
Overview of the Infringement:
The European Commission has sent an infringement notice to Cyprus for failing to transpose a recent amendment to the RoHS directive—which restricts hazardous substances in electrical and electronic equipment—into its national legislation. The amendment introduces an exemption concerning cadmium in downshifting quantum dots that are directly deposited on LED semiconductor chips.
Deadline and Commission’s Statement:
Cyprus was required to update its national laws by 31 December to incorporate this exemption. The Commission noted that the delegated directive narrows the scope of the exemption in light of advanced technical progress, thereby reducing the amount of cadmium placed on the market. Additionally, Cyprus did not communicate any transposition measures to the EU institution as required.
Next Steps and Potential Consequences:
Cyprus now has two months from the date of receiving the infringement notice to respond and complete its transposition. Should Cyprus fail to comply within this period, the Commission may issue a formal ‘reasoned opinion’ as a further request for compliance. Persistent non-compliance could eventually lead the matter to be referred to the Court of Justice, which may impose penalties, although most cases are resolved before reaching this stage.
Cosmetics:
California Targets Noncompliant Toluene Levels in Nail Products
Enforcement Initiative:
California’s Department of Toxic Substances Control (DTSC) has identified potential violations of its regulations regarding toluene in nail products. Using its call-in authority under the state’s Safer Consumer Products (SCP) program, the DTSC plans to investigate further whether additional products are out of compliance and take enforcement actions if needed.
Background and Regulatory Context:
Designated as a priority product under the SCP program in January 2023, nail products containing toluene must either be removed from the market or undergo an alternatives analysis if toluene levels exceed a 100 ppm threshold. In March, DTSC compliance testing of over 500 nail products revealed that 27 products surpassed this threshold, with most lacking the required priority product notifications (PPNs).
Test Results and Findings:
A study involving 522 nail products from 145 manufacturers showed:
- 5% of products exceeded the 100 ppm threshold.
- 70% contained toluene below the threshold.
- 25% had no detectable toluene. These findings indicate that while the majority of products comply, a small yet significant number remain noncompliant.
Next Steps and Enforcement Actions:
Following these results, DTSC plans to use its information call-in authority to gather more data from manufacturers about their toluene-containing products. Under a 2022 law (SB 502), companies will have 30 days to respond, with potential daily fines of up to $50,000 for non-response. DTSC’s enforcement actions may range from issuing notices of noncompliance to imposing penalties and directing retailers and importers to cease sales of non-compliant products.
Future Reporting:
The DTSC expects to release a summary report on its toluene findings in early 2025 and will consider further enforcement actions for products even below the 100 ppm threshold if required under the SCP scheme.
French Regulator Warns of Kidney Damage Risk from Glyoxylic Acid in Hair Straightening Products
Scientific Findings: The Agency for Food, Environmental and Occupational Health & Safety (ANSES) in France has issued a scientific opinion warning that glyoxylic acid, used in hair straightening products (often known as “Brazilian hair straightening”), may cause acute kidney injury (AKI). After analyzing various reports and scientific data, ANSES concluded that it is “highly probable” that glyoxylic acid can lead to acute kidney failure. Excessive exposure to this chemical can result in the formation of oxalic acid and calcium oxalate crystals in the kidneys, as observed in both human biopsies and animal tests.
Background and Context: Glyoxylic acid was introduced into some semi-permanent hair straightening products as a perceived safer alternative to formaldehyde, a known carcinogen banned in the EU for cosmetic use. Despite its intended benefit, glyoxylic acid is classified under CLP as causing eye damage and as a skin sensitiser, and it is now under scrutiny due to its potential to cause severe kidney damage. ANSES’s concerns were initially raised via its national Cosmetovigilance system, following reports of acute kidney effects in a 28-year-old woman and additional international cases involving females aged 13 to 58, many of whom had no previous kidney issues.
Recommendations for Regulatory Action: In light of these findings, ANSES has recommended that the European Commission initiate a risk assessment process to consider restricting or banning glyoxylic acid in hair care products under the cosmetics regulation. This process would involve obtaining an opinion from the Scientific Committee on Consumer Safety (SCCS). Additionally, ANSES suggested that related substances, such as glyoxyloyl carbocysteine and glyoxylated amino acids of keratin—which can degrade to form glyoxylic acid—should also be assessed for risk.
Implications: If regulatory actions are taken, this could lead to stricter controls on the use of glyoxylic acid in cosmetic products, ensuring greater protection for consumers, particularly those undergoing hair straightening treatments.
Agro:
EU Agencies Collaborate to Combat Azole Fungicide Resistance in Aspergillus Fungi
One Health Approach to a Growing Threat:
A joint report by five EU health and environment agencies – ECHA, EFSA, ECDC, EEA, and EMA – with support from the European Commission’s Joint Research Centre (JRC) has highlighted the growing threat of azole fungicide resistance in Aspergillus fungi. Extensive use of azole fungicides, particularly in agriculture and horticulture, is contributing to resistance against azole medicines, which are essential for treating aspergillosis, a serious fungal infection.
Scope of Azole Use:
Azole substances are widely utilized across multiple sectors beyond human medicine. They are found in:
- Plant protection products to control fungal diseases in agriculture,
- Veterinary medicines for treating fungal infections in animals,
- Biocides used in wood preservatives,
- Industrial chemicals (e.g., intermediates and dyes), and
- Cosmetic products (e.g., anti-dandruff agents).
This broad usage increases environmental exposure, particularly in settings like agricultural and horticultural waste and freshly cut wood, which can foster the development of azole-resistant Aspergillus strains.
Data and Impact:
Data collected from EU/EEA countries between 2010 and 2021 indicate that plant protection products are the predominant source of azole fungicide sales. This extensive environmental presence raises concerns that resistance could undermine the effectiveness of crucial antifungal treatments in human healthcare.
Expert Commentary:
Dr. Sharon McGuinness, ECHA’s Executive Director, stated,
“ECHA proudly supports the European Union’s efforts to safeguard public health and the environment from the growing threat of antifungal resistance. Addressing azole resistance, arising from both human and environmental exposure to these chemicals, highlights the importance of a coordinated One Health approach.”
Key Recommendations:
The agencies recommend several measures to curb azole resistance in Aspergillus, including:
- Introducing new requirements in the approval and authorization processes for azole fungicides.
- Supporting research and development of alternative fungicides that do not induce resistance to antifungal medicines.
- Encouraging good agricultural and horticultural practices, effective waste management, and responsible use and disposal of azole-treated products.
- Implementing robust waste management practices for wood treated with azole-based biocides.
- Enhancing data collection on the use of azole fungicides and antifungals.
- Developing specific technical guidance and risk assessment methodologies to better manage and mitigate azole resistance.
- Conducting further research to address current uncertainties in the field.
Conclusion:
The report underscores the value of a One Health approach in addressing the complex issue of antifungal resistance. Through cross-sectoral collaboration and coordinated efforts, EU agencies aim to strengthen surveillance, advance research, and implement effective measures to protect public health, animal health, and the environment from the risks posed by azole-resistant Aspergillus fungi.
Environmental Risk Assessment of Pesticides
Overview: Before pesticides can be approved for use within the EU, they must undergo an Environmental Risk Assessment (ERA). This process evaluates the potential risks that a pesticide may pose to the environment, ensuring that only products with acceptable levels of risk are authorized.
Environmental Fate: Environmental fate examines what happens to a pesticide after its release into the environment. This includes:
- Breakdown: How the pesticide degrades over time.
- Accumulation: The buildup of pesticide residues in soil.
- Transformation: The conversion of the pesticide into other substances.
Ecotoxicology: Ecotoxicology studies the impact of pesticides on living organisms, including:
- Birds and mammals
- Plants and insects
- Fish and other aquatic life
These studies help determine how pesticides affect non-target organisms and overall ecosystem health.
Purpose of ERA: The assessments aim to identify and characterize the risks of undesired effects on non-target organisms, ecosystems, and biodiversity. By analyzing both environmental fate and ecotoxicology, the ERA ensures that pesticides do not adversely affect the environment when used as intended.
