This is Signal by Foresight, your weekly chemical regulation digest, promising everything you need to know in under 5 minutes.
Let’s dive in:
📰 Headlines at a glance
EPA and FDA webpage launch on animal product oversight
EU delays DEHP authorisation deadline for medical devices to 2030
EU Commission ends approvals for clofentezine and metiram
ECHA reports toxic chemicals in childcare products
Enforcement forum advises on universal PFAS restriction enforceability
IUCLID database updated with pharmaceutical data by ECHA
Next deadline for Poison Centre Notifications approaching
UK outlines UK REACH alternative transitional registration model (ATRm)
EU Court dismisses appeal by the Global Silicones Council and several other companies
EPA seeking nominees for Science Advisory Committee on Chemicals
Proposed updates for EPA's Safer Choice Standard
EPA report on biotechnology regulation under the Coordinated Framework
🔍 The headlines in focus
🔬 EPA and FDA unveil web guide for modern animal product oversight
The U.S. Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) have launched a new webpage to address common questions about their joint whitepaper on modernising the oversight of animal products regulated as pesticides or new animal drugs.
With an eye on transferring responsibilities for flea and tick products, this move could reshape industry and consumer landscapes.
🏥 EU postpones DEHP REACH authorisation requirement for medical devices to 2030
The European Commission has recently revised the REACH Regulation extending the use of bis(2-ethylhexyl) phthalate (DEHP) in medical devices. Originally, the use of DEHP was to be subject to authorisation requirements after May 2025, but the update postpones this deadline
🌱 EU commission withdraws PPP approvals for clofentezine and metiram
The EU makes a decisive move against substances posing health and environmental risks, with clofentezine and metiram approvals not being renewed. Despite the arguments put forward by the applicant, the concerns regarding the active substance could not be eliminated.
👶 ECHA finds hazardous chemicals in children's products
The European Chemicals Agency (ECHA) has detected hazardous chemicals in children's items such as car seats and bibs. These substances, which include carcinogens and reproductive toxins, have prompted ECHA to assist the European Commission in proposing additional action across the EU to protect children.
🌍 Enforcement forum weighs in on PFAS regulation
The forum's insights into the PFAS ban highlight the complexities of enforcement and the necessity for clear guidelines. Their advice could be the key to the effective implementation of these crucial environmental protections.
💊 IUCLID's pharmaceutical expansion
ECHA enriches IUCLID with extensive pharmaceutical data, paving the way for more humane, alternative testing methods and offering a treasure trove of information for safer chemical use and regulation.
⚠️ Poison centre notifications approaching for mixtures at industrial sites
On 1st January 2024, industry professionals must gear up for the new poison centre compliance requirements. Time is ticking for those dealing with industrial-use mixtures to align with the harmonised information requirements.
A consultation on the proposals will be published in early 2024.
🏛️ EU court upholds substance regulation decisions
Cases C-558/21 P and C-559/21 P involved appeals by the Global Silicones Council and other companies against decisions related to the regulation of chemicals under the EU's REACH Regulation. In Case C-558/21 P, the appellants sought to overturn a General Court judgement dismissing their action against Commission Regulation (EU) 2018/35, which restricted the use of octamethylcyclotetrasiloxane (D4) and decamethylcyclopentasiloxane (D5) due to their classification as persistent, bioaccumulative, and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances.
Case C-559/21 P involved an appeal against the General Court's dismissal of an action seeking to annul the European Chemicals Agency's decision to include D4, D5, and dodecamethylcyclohexasiloxane (D6) in a list of substances identified for eventual inclusion in Annex XIV to the REACH Regulation. The appellants argued against the assessment methods used for determining the substances' bioaccumulative properties and challenged the consideration of the hybrid nature of these chemicals.
🌱 EPA's proposed enhancements to Safer Choice Standard
The EPA's proposed updates aim to elevate the Safer Choice Standard, focusing on transparency and sustainability. Stakeholders are encouraged to review and provide feedback on these significant revisions.
🧬 Biotechnology regulation: seeking clarity and efficiency
A comprehensive report reflects on the complexities of biotechnological regulation, capturing the industry's quest for a streamlined and transparent regulatory process to foster innovation safely, as outlined in the report on the Coordinated Framework.
📅 Upcoming deadlines
2-pyrrolidone; pyrrolidin-2-one (EC 210-483-1, CAS 616-45-5) Classification
ECHA’s Risk Assessment Committee Meeting The meeting will cover various topics including authorisation applications, evaluation of occupational exposure limits, work plan, and other general issues. The RAC will discuss the Universal Per- and Polyfluoroalkyl Substances (U-PFAS) including an overview of third-party consultation outcomes and the work plan for 2024.