Regulatory questions, answered.
Questions asked in RegAffairs AI and answered from official sources, with every claim cited to the document it came from.
Türkiye’de tıbbi cihaz satışı ve reklamı için hangi kurallar geçerli?
Türkiye'de tıbbi cihazların satışı, reklamı ve tanıtımı esas olarak Tıbbi Cihaz Satış, Reklam ve Tanıtım Yönetmeliği ile düzenlenir (Resmî Gazete 15/5/2014…
How do I read an installation’s EUTL compliance data?
Each row in the EUTL compliance export is one installation (or aircraft or maritime operator account) in one annual compliance workbook.
リスクアセスメント対象物質はどう調べればいいですか？
結論： リスクアセスメント対象物かどうかは、厚生労働省の「ラベル表示・ＳＤＳ交付等の義務対象物質」一覧で、CAS番号や物質名を引いて確認します。この一覧に載っている物質が、そのまま対象物の範囲になります。法令上の対象物は、施行令第18条各号に掲げる物と、法第57条の2第1項の通知対象物です（安衛則第12条の5）。
What is the EPA limit for arsenic in drinking water?
Under EPA's National Primary Drinking Water Regulations, the Maximum Contaminant Level (MCL) for arsenic in drinking water is 0.010 mg/L, which is 10 µg/L.
What claims can dietary supplements make?
In the US, a dietary supplement can make four kinds of claim: structure/function statements (with the related general well-being and nutrient-deficiency…
Comment savoir si mes déchets sont dangereux ?
En droit européen et français, un déchet est dangereux s'il présente au moins une des 15 propriétés de danger (HP 1 à HP 15) de l'annexe III de la directive…
Hoe vraag ik een NVWA-erkenning aan voor mijn levensmiddelenbedrijf?
Een erkenning vraagt u digitaal aan bij de NVWA met het verleningenformulier (Erkenning aanvragen).
How do I classify waste in New South Wales?
In NSW, the waste generator is responsible for classifying its own waste.
¿Cuándo necesito un permiso de importación de COFEPRIS?
Necesitas permiso de COFEPRIS cuando tu mercancía está en una fracción arancelaria del Anexo I del Acuerdo de la Secretaría de Salud de 26/12/2020 (última…
日本の遺伝子組み換え表示はどう決めればいい？
日本の遺伝子組換え（GM）表示は、食品表示基準（平成27年内閣府令第10号）で決まります。判断の軸は3つです。①その原材料が9つの対象農産物か、②製品が別表第17の33食品群に入るか、そして当該原材料が「主な原材料」に当たるか、③分別生産流通管理（IPハンドリング）の証明があるか。下の順にたどれば、表示文言は一つに決…
How do Ontario's workplace chemical exposure limits work?
Ontario's workplace chemical exposure limits come from Regulation 833 (Control of Exposure to Biological or Chemical Agents) under the Occupational Health and…
What is industrial wastewater pretreatment?
Industrial wastewater pretreatment is treatment an industrial or other non-domestic facility gives its own wastewater before that wastewater goes into a…
MSDS nedir?
MSDS (Material Safety Data Sheet), Türkiye mevzuatında "güvenlik bilgi formu" (GBF) diye geçen belgedir.
What does Minnesota's PFAS law require?
Minnesota's PFAS law (Minn. Stat. § 116.943, "Amara's Law") has three parts.
What makes a pesticide qualify as minimum risk?
Under US federal law, a pesticide is "minimum risk" only if it meets every condition in 40 CFR 152.25(f).
Vad innebär Arbetsmiljöverkets föreskrifter för arbetsgivare?
Arbetsmiljöverkets föreskrifter (AFS) är bindande regler som preciserar arbetsmiljölagen.
What does GPSR require for selling products in the EU?
GPSR (Regulation (EU) 2023/988) has applied since 13 December 2024.
Who needs to report chemicals under EPA CDR?
Under TSCA section 8(a), CDR reporting falls on anyone who manufactures or imports a chemical on the TSCA Inventory for commercial purposes at 25,000 lb…
When must medical device problems be reported to the FDA?
Under 21 CFR Part 803, a device problem has to be reported to the FDA once a manufacturer, importer or device user facility becomes aware of information that…
What is the AFIRM RSL?
The AFIRM RSL is a voluntary Restricted Substances List for finished products.