Regulatory questions, answered.
Questions asked in RegAffairs AI and answered from official sources, with every claim cited to the document it came from.
化粧品を作って売るには何の許可が必要ですか？
日本で化粧品を作って売るには、薬機法上の許可が2種類あります。自社ブランドとして市場に出す者が受ける「化粧品製造販売業許可」と、製造を行う工場（製造所）ごとに受ける「化粧品製造業許可」です。さらに、品目ごとに発売前の届出（厚生労働大臣が指定する成分を含む場合は承認）が必要です。製造をすべて他社に委託する場合は、受託先…
What is a SCOMET declaration for exports?
In India, a SCOMET declaration is the exporter's statement at Customs on whether the goods being shipped are on the SCOMET list.
What is EudraLex Volume 4?
EudraLex Volume 4 is the European Commission's Guide to Good Manufacturing Practice (GMP).
How do I look up a chemical by its CAS number?
To look up a chemical by CAS number, type the number into your question on the RegAffairs AI landing page, together with what you want to know and where.
Hva står i avfallsforskriften?
Avfallsforskriften (forskrift om gjenvinning og behandling av avfall, FOR-2004-06-01-930) er Norges samleforskrift for avfall.
How are pesticides classified by toxicity?
Pesticides are mostly classified by acute toxicity: the LD50 (the dose that kills half of a test-animal population) by the oral and dermal routes, and in some…
What are the 14 allergens?
The "14 allergens" are the substances or products listed in Annex II of the EU Food Information to Consumers Regulation, Regulation (EU) No 1169/2011.
What is ISPM 15?
ISPM 15 is the international standard on wood packaging, issued by the International Plant Protection Convention (IPPC, under FAO).
What is WAC pricing for drugs?
WAC (wholesale acquisition cost) is a US drug pricing term. CMS defines it as "the manufacturer's list price for wholesalers or direct purchasers in the U.S…
Is cyclopentasiloxane banned in cosmetics?
No, not outright, but in the EU it is close. Under REACH Annex XVII entry 70, D5 at 0.1% by weight or more has been banned from EU wash-off cosmetics since 31…
Was ist das LFGB?
Das LFGB ist das deutsche Bundesgesetz für Lebensmittel, Futtermittel, Mittel zum Tätowieren, kosmetische Mittel und Bedarfsgegenstände, das Lebensmittel…
How do I check if a chemical is on the Canadian DSL?
Search the Domestic Substances List (DSL) by CAS Registry Number.
Welche Tierseuchen sind in Deutschland anzeigepflichtig?
„Anzeigepflichtige Tierseuchen“ gibt es in Deutschland rechtlich nicht mehr.
Is trichloroethylene banned in the US?
Mostly, but not completely. EPA's final rule under section 6 of the Toxic Substances Control Act (TSCA), published December 17, 2024, bans making and…
毒物及び劇物取締法ってどんな法律ですか？
毒物及び劇物取締法（昭和二十五年法律第三百三号、略称「毒劇法」）は、毒物と劇物について「保健衛生上の見地から必要な取締を行うことを目的とする」法律です（第1条）。対象物質を別表と政令で指定し、製造・輸入・販売の登録、取扱責任者の設置、表示、譲渡の手続き、廃棄、事故時の届出、罰則を定めています。所管は厚生労働省で、登録…
What is a product monograph in Canada?
In Canada, a product monograph (PM) is Health Canada's term for the approved reference document for a drug.
¿Cómo sé si un plaguicida tiene registro ICA en Colombia?
Para saber si un plaguicida tiene registro ICA, búsquelo en el registro público de productos plaguicidas de uso agrícola que el ICA publica en su plataforma…
Did the FDA finalize its new dietary ingredient guidance?
Partly. On October 19, 2026, FDA's Human Foods Program issued a final guidance titled "New Dietary Ingredient (NDI) Notifications and Related Issues; Identity…
Was bedeutet REACH-konform eigentlich?
„REACH-konform“ ist kein Begriff aus der Verordnung (EG) Nr.
¿Dónde puedo consultar las AAI otorgadas en España?
Las AAI otorgadas en España no están en un único registro estatal.