Regulatory questions, answered.
Questions asked in RegAffairs AI and answered from official sources, with every claim cited to the document it came from.
What are the GMP requirements for drugs in Canada? Cover Part C Division 2 of the Food and Drug Regulations (C.02.001 to C.02.030), Health Canada's GMP guide GUI-0001, GMP inspections and ratings, and how Canadian GMP compares with US FDA cGMP (21 CFR 210/211).
Canadian drug GMP is set out in Part C, Division 2 of the Food and Drug Regulations, and it is enforced through the drug establishment licence (DEL) required…
Quel est le statut réglementaire du glyphosate (CAS 1071-83-6) en France en 2026 ? Couvrir le renouvellement de l'approbation UE (règlement d'exécution (UE) 2023/2660), les produits autorisés par l'ANSES et leurs restrictions d'usage (retraits, limitations de 2020), l'interdiction pour les particuliers et les espaces publics (loi Labbé), l'importation de produits achetés en Espagne, les sanctions, le crédit d'impôt pour sortie du glyphosate, et où trouver les doses autorisées (E-Phy).
En 2026, le glyphosate est approuvé dans l'UE jusqu'au 15 décembre 2033 et autorisé en France.
D.Lgs. 81/2008 (Testo unico sicurezza sul lavoro): com'è strutturato (titoli e allegati), quali sono gli obblighi del datore di lavoro (art. 18, 26, 28) e dei lavoratori (art. 20), quali sono le modifiche più recenti e dove si legge il testo aggiornato?
Il D.Lgs. 81/2008 ha 13 titoli (più il Titolo X-bis) e una serie di allegati numerati da I a LI.
As a food business operator in India, how do I choose an FSSAI-notified or NABL-accredited food testing lab, what parameters (nutrition, pesticide residues, microbiology, contaminants) must be tested under FSSAI rules, and what must a food test report contain?
Short answer: Use a lab on FSSAI's current notified list and check that its NABL (ISO/IEC 17025) accreditation is valid on your test date and covers your…
How do I use the EU Pesticides Database to look up a pesticide active substance's approval status, expiry date, MRLs and hazard data under Regulation (EC) 1107/2009 and Regulation (EC) 396/2005, and what French sources (E-Phy, OFB C3PO) add for products authorised in France?
Search the EU Pesticides Database by active-substance name. It returns three things: the approval record under Reg. 1107/2009 (status, approval date, expiry…
ヒヤリハットとは何ですか？定義、語源、ハインリッヒの法則（1:29:300）、インシデントや労働災害との違い、そして厚生労働省の職場のあんぜんサイトでのヒヤリ・ハット事例の位置づけと、事業場でのヒヤリハット活動の目的を、公的な出典つきで教えてください。
ヒヤリハットとは、仕事中に「もう少しでけがをするところだった」場面のことです。 厚生労働省「職場のあんぜんサイト」は、この「ヒヤっとした、あるいはハッとした」経験を取り上げて災害防止につなげるのがヒヤリハット活動だと説明しています。危険有害要因を見つける方法の1つとして効果的、とも位置づけています（安全衛生キーワード…
Scheda di dati di sicurezza (SDS): quali sono le 16 sezioni secondo l'allegato II del REACH come modificato dal regolamento (UE) 2020/878, chi è obbligato a fornirla, quando va aggiornata, in che lingua, e quando è obbligatoria per sostanze e miscele non classificate come pericolose?
Risposta breve: La SDS deve essere fornita da ogni fornitore della catena (fabbricante, importatore, utilizzatore a valle, distributore).
How do I search National Pollutant Release Inventory (NPRI) data for a specific facility's reported releases and transfers in Canada? Cover the NPRI online data search tool, the NPRI map, the open data downloads (bulk datasets on the Open Government Portal), what substances and years are covered, and the reporting thresholds that determine which facilities appear.
To look up one facility's releases and transfers in Canada, start with ECCC's NPRI data search.
Which phthalates are restricted or banned in cosmetics and fragrance products? Cover what phthalates are, which ones cosmetics have used (DBP, DEP, DEHP, BBP and others), their status under EU Cosmetics Regulation 1223/2009 Annex II and III, UK cosmetics rules, Washington State's Toxic-Free Cosmetics Act (RCW 70A.560) ortho-phthalate ban and dates, California rules, FDA's position in the US, and what 'phthalate-free' claims mean.
Phthalates are banned or restricted in cosmetics mainly by ingredient-by-ingredient listing.
What is the regulatory status of bisphenol A (BPA, CAS 80-05-7) in Canada? Cover the 2010 CEPA toxic designation, the polycarbonate baby bottle ban, BPA in food can linings and thermal paper receipts, and any current or proposed Canadian measures including the bisphenols group assessment.
I found no federal BPA restriction in Canada beyond the baby bottle ban.
¿Qué información obligatoria debe llevar la etiqueta de composición de un producto textil vendido en España según el Reglamento (UE) 1007/2011 y el Real Decreto 928/1987: nombres de fibra, porcentajes, tolerancias, idioma, productos exentos y mezclas?
Para un textil vendido en España, la composición la rige directamente el Reglamento (UE) 1007/2011.
What does REACH Article 33 require for SVHCs in articles, and how does the SCIP database notification work: who must notify, what is the 0.1% w/w threshold, what information goes into a SCIP notification and what must suppliers tell customers and consumers?
Approach. I read the current consolidated REACH Regulation (EUR-Lex consolidated version of 11 May 2026) for Articles 3, 7, 33 and 59.
How does the FSA Food Hygiene Rating Scheme score food businesses, what does each rating from 0 to 5 mean, and what does a 0 or 1 rating say about a business's compliance with food hygiene law in England, Wales and Northern Ireland?
Summary: Local authority food officers inspect a business and give it penalty points on three elements.
What is RIDDOR, what does it require employers to report under the Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 2013, and who does it apply to?
Approach. None of the regulatory collections I can search holds the text of RIDDOR 2013.
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.