Regulatory questions, answered.
Questions asked in RegAffairs AI and answered from official sources, with every claim cited to the document it came from.
What does a Prop 65 warning need to say?
A safe-harbor Prop 65 warning needs four things: the warning symbol, a signal word, a statement naming at least one listed chemical, and the type of harm…
Dove trovo le AIA rilasciate in Lombardia?
In Lombardia le AIA si consultano in due posti diversi, a seconda di chi è competente.
¿Qué es el antifouling y por qué es un biocida?
El antifouling (producto antiincrustante) es un recubrimiento, normalmente una pintura, que impide que los organismos marinos se fijen y crezcan sobre cascos…
O que é a reavaliação de agrotóxicos da Anvisa?
A reavaliação de agrotóxicos da Anvisa é a revisão toxicológica de um ingrediente ativo que já tem registro no Brasil.
Who has to register a drug establishment with the FDA?
Under 21 CFR 207.17, every manufacturer, repacker, relabeler and salvager of drugs has to register each establishment where it carries out those operations…
How do I get BIS certification for my product?
The route depends on what your product is and which BIS scheme covers it.
Is BPA in till receipts (thermal paper) restricted in the EU and UK, what does the REACH Annex XVII restriction on bisphenol A in thermal paper require, and what did the HSE / UK REACH assessment and ECHA say about BPS and other bisphenol alternatives in thermal paper?
Yes. BPA in till receipts is restricted in both the EU and Great Britain.
Under Victoria's Environment Protection Act 2017, when does a site need an environmental audit (e.g. Environmental Audit Overlay, EPA notices, change to sensitive use), who can conduct it (EPA-appointed environmental auditors), and what does an environmental audit statement and report mean for the site's use?
Under the Environment Protection Act 2017, a Victorian site needs an environmental audit when the planning system requires one before a more sensitive use…
Is glyfosaat verboden in Nederland? Wat is de huidige EU-goedkeuringsstatus van glyfosaat (verlenging tot 2033), welke beperkingen gelden er in Nederland voor professioneel en particulier gebruik (Ctgb, verbod buiten de landbouw), en welke MRL's gelden voor glyfosaatresiduen in voedsel?
Nee, glyfosaat is in Nederland niet volledig verboden. De stof is in de EU goedgekeurd tot 15 december 2033, en professionele gebruikers in de landbouw mogen…
How are nanomaterials in cosmetics regulated in the EU, UK and US? Cover the definition of a nanomaterial, [nano] labelling, notification, and the status of nano zinc oxide and nano titanium dioxide as UV filters, including SCCS opinions and ICCR reports.
EU and GB: both use the same legal definition of a nanomaterial, the same "(nano)" labelling rule and the same six-month pre-market notification, and both…
Hvilke stoffer regnes som miljøgifter i Norge (Miljødirektoratets prioritetsliste), hvilke er forbudt etter produktforskriften og POPs-reglene, og hvilke krever samtykke ved eksport etter PIC-forskriften / Rotterdamkonvensjonen?
Svaret er tre ulike lister med ulik rettsvirkning. Prioritetslisten er Miljødirektoratets liste over miljøgifter som skal fases ut.
What are the FD&C certified color additives permitted in US food, what does FD&C mean, how does FDA batch certification work under 21 CFR Part 74 and 21 CFR Part 80, and how must certified colors be declared on a food label? Include the current status of FD&C Red No. 3 and the FDA plan to phase out petroleum-based dyes.
The FDA currently allows seven FD&C certified colours in US food: Blue No. 1, Blue No. 2, Green No. 3, Red No. 3, Red No. 40, Yellow No. 5 and Yellow No. 6…
Was enthält die GESTIS-Stoffdatenbank der DGUV/IFA zu einem Stoff (z. B. Ethanol, Methanol, Aceton, Toluol, Schwefelsäure), wie sucht man dort nach Name oder CAS-Nummer, und welche Einstufung, Arbeitsplatzgrenzwerte und Wassergefährdungsklasse sind für diese Stoffe angegeben?
Die GESTIS-Stoffdatenbank des IFA (Stand der Datenblätter 31.08.2026) hat zu jedem Stoff ein vollständiges Datenblatt: Identifikation, Eigenschaften…
How does waste tracking work in Australia? Which wastes are trackable, regulated or controlled in Queensland and other states (e.g. waste codes J120, N120), what tracking certificates or records are required, and how are interstate movements of controlled waste tracked under the NEPM?
Australia has no single national waste-tracking system. Each state and territory tracks hazardous waste under its own law.
When was R-22 (HCFC-22) phased out in the US, when does India complete its HCFC phase-out, can R-22 still be used or bought, and what are the replacement refrigerants?
The US stopped production and import of new R-22 (HCFC-22) on 1 January 2020, after banning the manufacture and installation of new R-22 equipment from 1…
¿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.