Regulatory questions, answered.
Questions asked in RegAffairs AI and answered from official sources, with every claim cited to the document it came from.
What are the confined space entry requirements in India?
India's main statutory confined-space rule was section 36 of the Factories Act, 1948.
What are the EU CLP labelling requirements?
Under the EU CLP Regulation (EC) No 1272/2008, any substance or mixture classified as hazardous and sold in packaging must carry a label with the elements…
What does therapeutic equivalence mean in the Orange Book?
In the Orange Book, approved drug products are therapeutic equivalents "if they are pharmaceutical equivalents for which bioequivalence has been demonstrated…
What are some near miss examples at work?
A near miss is an unplanned event that could have injured someone, made them ill or caused damage, but didn't.
What happened to NICNAS in Australia?
NICNAS was replaced by AICIS on 1 July 2020. The Act behind NICNAS, the Industrial Chemicals (Notification and Assessment) Act 1989, was repealed and stopped…
Does my business need AICIS registration?
Your business needs AICIS registration if it imports industrial chemicals into Australia, or manufactures them there, during a registration year.
Quali obblighi prevede la normativa europea per vendere cosmetici in Italia?
Per vendere cosmetici in Italia si applica direttamente il Regolamento (CE) n.
Is methylene chloride banned in the US?
No, methylene chloride is not banned outright in the US. Its uses are heavily restricted.
¿Qué requisitos deben cumplir los fabricantes de cosméticos en España?
En España, un fabricante de cosméticos tiene que cumplir dos niveles de normas.
再生医療等製品とは何ですか？
再生医療等製品は、薬機法（医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律）第2条第9項が定義する独立した製品区分です。下の一号または二号に当たる物で（医薬部外品と化粧品は除く）、かつ政令で定めるものを指します 。
How do I make a RIDDOR report?
In Great Britain, the "responsible person" makes a RIDDOR report to HSE by filling in the right online form on HSE's notifications site.
How do I import cosmetics into India?
To import cosmetics into India, each product must first be registered with CDSCO.
What would the EU pesticide omnibus change?
The EU "pesticide omnibus" is the Commission's 16 December 2025 food and feed safety simplification package.
When are hazmat placards required in the US?
Short answer: Under 49 CFR 172.504(a), placards are required on each side and each end of every bulk packaging, freight container, unit load device, transport…
What do hazard statements mean?
A hazard statement is a standard phrase on a chemical's label (and safety data sheet) that tells you what kind of hazard the substance or mixture poses and…
Which toxicology databases should I use for chemical safety assessments?
There isn't one official list of toxicology databases you must use.
How do I find an EPA licence in Ireland?
You find Irish EPA licences in the EPA's LEAP public register (leap.epa.ie).
What are TCS foods?
"TCS food" stands for time/temperature control for safety food, a term from the FDA Food Code, the US model code for retail food.
How do I search the FDA clearance database?
You don't run a separate search screen. You ask your question in plain language from the RegAffairs AI landing page, and you get a cited answer with the…
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…