Regulatory questions, answered.
Questions asked in RegAffairs AI and answered from official sources, with every claim cited to the document it came from.
What is the regulatory status of hexabromocyclododecane (HBCDD) in the EU, the US and China?
Summary: HBCDD is effectively banned in the EU and China as a Stockholm Convention persistent organic pollutant (POP).
What is the acceptable daily intake (ADI) for glyphosate in the EU, US EPA, Codex (JMPR), Japan and Korea?
I found ADIs for all five jurisdictions, from 0.5 to 1.75 mg/kg bw/day.
Where do I find the current FDA-approved prescribing information (package insert) for Humira (adalimumab), and what does it cover?
Where to find it: The current FDA-approved prescribing information for Humira is AbbVie's own label on DailyMed (the NLM's repository of FDA labeling), set ID…
What does Natasha's Law require on labels for food prepacked for direct sale (PPDS) in the UK, and which 14 allergens must be emphasised?
Approach. I couldn't find the UK PPDS amendment ("Natasha's Law") itself in the datasets I can search.
What is environmental clearance (EC) in India under the EIA Notification 2006: which projects need it (Category A vs B), what is the process and documents, and how does state-level clearance through SEIAA work in states like Maharashtra, Gujarat and Karnataka?
I've written this from the original EIA Notification 2006 (S.O. 1533(E), 14 September 2006) and a few official MoEFCC and state documents.
What is a controlled substance schedule under the US Controlled Substances Act? Explain the five DEA schedules (I to V) and the criteria for each, give examples, and tell me where the official list lives (21 CFR 1308) and how a substance gets scheduled or rescheduled.
The Controlled Substances Act (CSA) places every federally controlled drug or chemical in one of five schedules.
How do I use the EU CosIng database to look up a cosmetic ingredient's INCI name and its regulatory status under Regulation (EC) 1223/2009 (annex entries, restrictions, functions), and how reliable is CosIng legally?
CosIng is the Commission's reference tool for the Cosmetics Regulation.