Regulatory questions, answered.
Questions asked in RegAffairs AI and answered from official sources, with every claim cited to the document it came from.
어린이제품 안전 특별법이 뭐예요?
「어린이제품 안전 특별법」은 만 13세 이하 어린이가 쓰는 제품(또는 어린이를 위해 쓰는 제품)의 안전을 관리하는 한국 법률입니다.
What has to be on a GHS label?
A GHS label carries six core elements: a product identifier, the supplier's name, address and telephone number, hazard pictogram(s), a signal word, hazard…
Wat is AMICE van het LMA?
AMICE is het meldsysteem van het Landelijk Meldpunt Afvalstoffen (LMA).
What is a PESO certificate?
"PESO certificate" is a common informal name for any licence, approval or certificate issued by India's Petroleum and Explosives Safety Organisation (PESO).
Quais são os tipos de licença ambiental?
No Brasil, a Lei nº 15.190/2025 (Lei Geral do Licenciamento Ambiental) prevê sete tipos de licença ambiental no seu art. 5º: Licença Prévia (LP), Licença de…
Qual è la normativa sugli integratori alimentari in Italia?
In Italia gli integratori alimentari seguono la Direttiva 2002/46/CE, recepita con il D.Lgs.
What is the REACH regulation?
REACH is the EU's main chemicals law: Regulation (EC) No 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals.
What do I need to export food to Japan?
To sell food in Japan, the shipment needs a Japanese importer who files an import notification with the Ministry of Health, Labour and Welfare (MHLW) for…
¿Qué es una SVHC?
Una SVHC (Substance of Very High Concern, en español «sustancia extremadamente preocupante») es, en el Reglamento REACH (CE) n.º 1907/2006, una sustancia que…
Co oznacza znak CE?
Znak CE to oznakowanie, którym producent deklaruje, że jego wyrób spełnia mające zastosowanie wymagania unijnego prawodawstwa harmonizacyjnego przewidującego…
What is Health Canada's Drug Product Database?
Health Canada's Drug Product Database (DPD) is the official searchable database of drugs authorized for sale in Canada.
What is the OSHA PEL for lead?
For inorganic lead, the OSHA PEL is 0.05 mg/m³ (50 µg/m³) as an 8-hour TWA, with an action level of 0.03 mg/m³.
A Anvisa proibiu ashwagandha em suplementos?
Sim. A Anvisa trata a ashwagandha (Withania somnifera) como ingrediente proibido em suplementos alimentares no Brasil.
CE işareti nedir?
CE işareti, üreticinin bir ürünün o ürünü kapsayan AB uyum mevzuatının gereklerine uygun olduğunu gösterdiği işarettir.
What's the difference between a 510(k) and a PMA?
A 510(k) asks the FDA to clear a device by showing it is "substantially equivalent" to a device already legally on the market (a "predicate").
What did EPA's draft risk evaluation find for 1,2-dichloropropane?
EPA's draft risk evaluation for 1,2-dichloropropane (CASRN 78-87-5) preliminarily found that it presents unreasonable risk to human health.
Do I need a waste carriers licence?
Probably yes, if you're in the UK and move, buy, sell or arrange disposal of waste as part of any business, even occasionally and even if it's only your own…
Do wax melts need a CLP label in the UK?
Yes, if the wax melt is classified as hazardous. Under GB CLP, anyone who places a hazardous mixture on the market must label and package it before supply…
What is a biologics license application?
A biologics license application (BLA) is the US FDA submission used to market a biological product in the US.
화평법이 뭔가요?
화평법은 「화학물질의 등록 및 평가 등에 관한 법률」의 약칭이고, 영어로는 K-REACH라고 부릅니다. 한국에서 화학물질을 등록·신고하게 하고, 유해성·위해성을 심사·평가하며, 위험한 물질을 허가·제한·금지 대상으로 지정하는 법입니다.