Regulatory questions, answered.
Questions asked in RegAffairs AI and answered from official sources, with every claim cited to the document it came from.
¿Cuál es la situación regulatoria de la icaridina (picaridina, CAS 119515-38-7) como repelente de insectos en la UE y en España: aprobación como sustancia activa biocida TP19, concentraciones autorizadas en los repelentes registrados por la AEMPS, y restricciones de uso en niños, bebés y embarazadas, comparada con DEET, IR3535 y citriodiol?
Respuesta: La icaridina está aprobada en la UE como sustancia activa biocida TP19 del 1/2/2022 al 31/1/2032 (Reglamento (UE) 2020/1086).
What is the AOAC use-dilution test for disinfectants, how does EPA use it for registration and in the Antimicrobial Testing Program, what are the performance criteria, and what happens when a registered hospital disinfectant fails?
The AOAC use-dilution method (UDM) is a carrier test for liquid disinfectants on hard surfaces.
Quais corantes alimentares são permitidos no Brasil pela Anvisa (RDC 778/2023 e IN 211/2023), quais são os limites e a rotulagem obrigatória para corantes artificiais como vermelho 40 (INS 129), amaranto (INS 123), azorrubina (INS 122), ponceau 4R (INS 124), caramelo IV (INS 150d) e carmim (INS 120)? Há alertas de segurança recentes (JECFA, EFSA, Anvisa)?
Resposta direta: A lista positiva da Anvisa (IN 211/2023, com as alterações posteriores) traz 57 entradas INS com função corante.
What are China's national food safety standards (GB standards) that a food exporter to China needs to comply with? Cover the CFSA catalogue and how many standards it holds, and the key standards: GB 2760 food additives, GB 2762 contaminants, GB 2763 pesticide MRLs, GB 7718 and GB 28050 prepackaged food labelling, and GB 4806 food contact materials, including current versions and any recent revisions or new versions taking effect.
China's food safety rules sit in a single national catalogue of mandatory "食品安全国家标准" GB standards, kept by CFSA.
Mag bamboe servies (bamboe-melamine borden, bekers en bakjes) nog op de Nederlandse/EU-markt worden gebracht? Wat zeggen Verordening (EU) 10/2011 en de NVWA-inspecties over bamboevezel in melamine voedselcontactmaterialen, en wat geldt voor melamine servies in de magnetron en vaatwasser?
Nee, bamboe-melamine servies mag niet op de Nederlandse of EU-markt worden gebracht.
Skin lightening creams sold in the UK: which ingredients (hydroquinone, mercury, corticosteroids such as clobetasol) are prohibited or restricted in cosmetics under the UK Cosmetics Regulation (Schedule 34 to the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, Annexes II and III), what recent OPSS product safety alerts and recalls say about skin lightening products, and what an importer or retailer must check to sell a compliant product?
Under the GB Cosmetics Regulation, none of these three can be used to lighten skin.
Qual è la definizione di malattia professionale nell'ordinamento italiano (DPR 1124/1965, INAIL)? Differenza rispetto all'infortunio sul lavoro, malattie tabellate e non tabellate, sistema misto, esempi e dati INAIL sulle denunce.
Nell'ordinamento italiano la malattia professionale è la patologia che il lavoratore contrae a causa dell'attività lavorativa, cioè per l'esposizione nel…
Comment rechercher un produit phytopharmaceutique dans E-Phy (ANSES) : numéro d'AMM, usages autorisés et doses, statut de retrait, par exemple Kerb Flo, Teppeki et Amistar ?
Kerb Flo (AMM 8400574), Teppeki (AMM 2050046) et Amistar (AMM 9600093) sont tous trois autorisés (AUTORISE) dans E-Phy.
トルエンは毒物及び劇物取締法上の劇物に該当しますか？指定令の該当号と濃度による除外の有無、メタノール、キシレン、アセトニトリル、クロロホルム、メチルエチルケトンについても該当条件を教えてください。
トルエンは劇物です。 毒物及び劇物指定令第2条第1項第76号の2に「トルエン」とだけ書かれており、「及びこれを含有する製剤」の文言はありません。条文上は物質そのもの（原体）だけが指定されているので、トルエンを含む製剤はこの号では劇物になりません。濃度による除外の規定もありません。6物質のうち濃度の線引きがあるのはアセ…
How is a surface disinfectant containing didecyldimethylammonium chloride (DDAC) regulated in the EU, Spain and the US: active substance approval status by product type, the authorisation route, and the relevant register entries?
Summary: In the EU, DDAC (EC 230-525-2, CAS 7173-51-5) is an approved active substance for PT2, the product type that covers surface disinfectants.
A textile is treated with a silver-based antimicrobial. Under the EU Biocidal Products Regulation, what does Article 58 require for this treated article (approval of the active substance for the right product type, labelling), and is silver zinc zeolite approved for product type 9?
Yes. Silver zinc zeolite (EC 603-404-0, CAS 130328-20-0) is approved for PT09 (fibre, leather, rubber and polymerised materials preservatives).
What is the EU approval status of permethrin under the Biocidal Products Regulation (EU) 528/2012: for which product types is it approved, when do the approvals expire, and what conditions apply to products containing it?
Permethrin (EC 258-067-9, CAS 52645-53-1) is approved under the BPR for two product types: PT08 (wood preservatives) and PT18 (insecticides, acaricides and…
Is salicylic acid allowed in leave-on cosmetics in the EU, the UK, Canada, South Korea and Japan? Give the maximum concentration, product types and required warnings in each market, citing each market's official list.
Yes, salicylic acid is allowed in leave-on cosmetics in all five markets, but the limits differ a lot.
What are the EU rules for retinol and retinyl esters in cosmetics after Commission Regulation (EU) 2024/996: Annex entry, maximum concentrations by product type, warnings, transition dates, and what the SCCS concluded?
Commission Regulation (EU) 2024/996 added a new Annex III entry, reference number 376, to Regulation (EC) No 1223/2009.
What rules apply to drawstrings and cords on children's clothing in the US, Canada, the UK and the EU, and which recalls or market surveillance alerts have regulators issued for children's hoodies and jackets with drawstrings?
All four jurisdictions treat cords and drawstrings at the hood and neck of children's outerwear as a strangulation hazard.
Which REACH Annex XVII restrictions apply to chemicals in clothing, textiles, leather and footwear sold in the EU? List each entry (for example azo dyes, chromium VI in leather, nickel, DMF, PAHs, nonylphenol ethoxylates and the CMR substances in textiles), the limit values and the dates they apply.
Answer: Under REACH Annex XVII, the restrictions that apply directly to clothing, textiles, leather and footwear on the EU market are entries 4, 7, 8, 20, 27…
What must a fibre content label on clothing show in the US (Textile Fiber Products Identification Act, 16 CFR 303), the EU (Regulation 1007/2011) and Canada (Textile Labelling Act)? Compare fibre names, percentages, tolerances, dealer identity numbers (RN, CA number) and language rules.
All three require fibre names and percentages by weight, but they differ on the details.
What are the maximum residue limits (MRLs) for acetamiprid on apples and on table grapes in the EU, the US, Codex, Japan and South Korea? Give each value with its legal source and date, and note any recent EU change.
I found apple and table-grape MRLs for acetamiprid in four of the five jurisdictions; I couldn't confirm a Japanese value from an official source.
What is the EU approval status of flufenacet under Regulation (EC) 1107/2009: was it renewed, what are the dates for withdrawing authorisations and the grace periods for sale and use of existing stocks, and what does this mean for products authorised in Germany and France?
Flufenacet was not renewed. Commission Implementing Regulation (EU) 2025/910 of 20 May 2025 refused renewal, and the EU Pesticides Database shows it as "Not…
Is paraquat allowed as a pesticide in Brazil, the EU, the UK and the US? Give the current status, the decision behind it and the date in each market, with citations.
Paraquat is allowed as a pesticide only in the US, where it remains registered under a 2021 interim decision with ongoing registration review.
Is PFHxA (CAS 307-24-4) restricted under REACH Annex XVII? Give the entry number, the uses covered, the concentration limits and the application dates, with citations.
Yes. PFHxA is restricted under REACH Annex XVII entry 79, "Undecafluorohexanoic acid (PFHxA), its salts and PFHxA-related substances".
Which national chemical inventories list formaldehyde (CAS 50-00-0)? Check the EU (EC number), US TSCA, Canada DSL, Australia AICIS, Japan ENCS, Korea KECI, China IECSC and Turkey KKDIK, with citations for each.
Formaldehyde (CAS 50-00-0) is listed in all eight jurisdictions you named.
What is the current harmonised classification and labelling of titanium dioxide (CAS 13463-67-7) under CLP Annex VI, and what changed after the EU General Court and Court of Justice rulings? Give the entry, hazard classes and dates, with citations.
There is no harmonised CLP classification for titanium dioxide (CAS 13463-67-7) in force today.
What are the occupational exposure limits for formaldehyde in the EU, Germany, the UK and the US (OSHA)? Give the 8-hour and short-term values, the legal source and the date each applies from, with citations.
Formaldehyde (CAS 50-00-0) limits: the EU and Germany have the same values, 0.3 ppm (0.37 mg/m³) over 8 hours and 0.6 ppm (0.74 mg/m³) short-term.
What are the reporting thresholds for ammonia releases to air from an industrial facility under the EU Industrial Emissions Portal Regulation (E-PRTR), Canada's NPRI and the US Toxics Release Inventory (TRI)? Cite each threshold.
Only the EU sets a threshold on the ammonia actually released to air: 10,000 kg/year.
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…
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.