Regulatory questions, answered.
Questions asked in RegAffairs AI and answered from official sources, with every claim cited to the document it came from.
Is titanium dioxide (E171) permitted as a food additive in the EU, the UK, the US and Canada? Give the current status, legal basis and dates in each market, with citations.
The EU and the US/Canada now point in opposite directions. Titanium dioxide is banned as a food additive in the EU (including Northern Ireland).
Is cannabidiol (CBD) authorised as a novel food in the EU, and what is the status of CBD food products in Great Britain under the FSA public list? Cite the official sources.
No. Cannabidiol is not authorised as a novel food in the EU, and it is not yet authorised in Great Britain either.
What is the EU maximum level for aflatoxins in pistachios, and what RASFF notifications for aflatoxins in pistachios were reported in 2026, by origin country?
EU maximum levels: Under Annex I of Regulation (EU) 2023/915, as consolidated on 8 October 2025, the limits for pistachios depend on what happens to the nuts…
Has NICE issued a technology appraisal for tirzepatide (Mounjaro) in England, and what did it recommend? Is it reimbursed in Italy (AIFA) and South Korea (HIRA)? Cite each source.
England: Yes. NICE has published two technology appraisals for tirzepatide (Mounjaro, Eli Lilly).
Is apixaban (Eliquis) approved in Switzerland, Japan and Canada? Give the authorisation holder, approval date and product or registration numbers from Swissmedic, PMDA and Health Canada, with citations.
Yes. Apixaban is approved in all three countries, and the originator Eliquis is held by Bristol-Myers Squibb companies.
Is zinc pyrithione allowed in rinse-off cosmetic products in the EU and in Great Britain? Give the Annex entry and any restriction, with sources.
No. Zinc pyrithione cannot be used in rinse-off cosmetic products in either the EU or Great Britain.
Is DEHP (CAS 117-81-7) on the REACH Authorisation List (Annex XIV), and what latest application date and sunset date apply to its use in medical devices under the MDR and IVDR?
Yes. DEHP (EC 204-211-0, CAS 117-81-7) is entry 4 on the REACH Authorisation List (Annex XIV).
Medium-chain chlorinated paraffins (MCCP) are in a cable sheath we put in electronic products sold in the EU. Are MCCPs on the REACH Candidate List, restricted under REACH Annex XVII or the EU POPs Regulation, and what are our Article 33 and SCIP duties?
Short answer: Yes, MCCP is on the REACH Candidate List. It is not in REACH Annex XVII.
Which FDA warning letters were issued to drug manufacturers for CGMP violations in 2026? List company, date, facility country and the main cited violations (21 CFR 211), with links to the letters.
I found 29 FDA warning letters issued between January and September 2026 to drug manufacturers for CGMP violations under 21 CFR parts 210/211.
Is there a current shortage of amoxicillin in the US, EU, UK and Germany? Compare what FDA, EMA, MHRA and BfArM report, with dates.
Germany is the only one of the four with an open amoxicillin shortage: BfArM lists a single active report, for one product.
When did FDA first approve semaglutide, under which NDAs and brand names, and what indications were added later? Cite Drugs@FDA.
FDA first approved semaglutide on 5 December 2017, as Ozempic injection for type 2 diabetes under NDA 209637 (Novo Nordisk).
Is tirzepatide centrally authorised in the EU? Give the product names, marketing authorisation holder, authorisation date, approved indications and any EMA safety updates, citing the EPAR.
Yes. Tirzepatide is centrally authorised in the EU as one product, Mounjaro (EMEA/H/C/005620).
What patents and exclusivities are listed in the FDA Orange Book for apixaban (Eliquis), when do they expire, and which generic ANDAs are approved?
The FDA Orange Book lists two patents for Eliquis (apixaban) tablets: US 6,967,208, which expires Nov 21, 2026, and US 9,326,945, which expires Feb 24, 2031.
What is FDA product code DQY, what device class and regulation number is it, and list a few recent 510(k) clearances under it with K numbers.
FDA product code DQY is "Catheter, Percutaneous". It is a Class II device under 21 CFR 870.1250 (percutaneous catheter), cleared through the 510(k) pathway by…
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…