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 Washington's Toxic-Free Cosmetics Act ban?
Washington's Toxic-Free Cosmetics Act (Chapter 70A.560 RCW) bans the manufacture, knowing sale, offer for sale, or distribution for sale or use in the state…
What is INCHEM used for?
INCHEM (IPCS INCHEM) is a free website where you can look up peer-reviewed chemical safety information.
¿Qué son los LMR de plaguicidas en alimentos?
Los LMR (límites máximos de residuos) de plaguicidas son la concentración máxima de un residuo de plaguicida que la ley permite en un alimento o pienso, o…
What does the bosentan REMS program require?
The Bosentan REMS is a single shared-system REMS whose goal is to reduce the risk of hepatotoxicity (liver injury).
食品の残留農薬のポジティブリスト制度とは何ですか？
残留農薬等のポジティブリスト制度とは、日本の食品衛生法に基づき、基準が定められていない農薬等が「一律基準」0.01ppmを超えて残留する食品の販売等を原則として禁止する制度です。2006年（平成18年）5月29日に施行されました。…
Ecza deposu açmak için ne gerekiyor?
Türkiye'de "ecza deposu" artık mevzuatta ecza ticarethanesi olarak geçiyor.
PRTRの届出はどうすればいいですか？
日本のPRTR届出（化管法、正式名称は化学物質排出把握管理促進法）は、まず自社が届出対象事業者に当たるかを確認し、前年度（4月から翌年3月）の排出量と移動量を算出します。そのうえで、事業所ごとに届出書を作り、毎年4月1日から6月30日までに、事業所がある都道府県等の窓口へ提出します。方法は電子届出が基本です（環境省「…
What does REACH require of companies in Ireland?
REACH (Regulation (EC) No 1907/2006) applies directly in Ireland, as in every EU Member State.
Welcher Formaldehyd-Grenzwert gilt am Arbeitsplatz?
In Deutschland gilt für Formaldehyd (CAS 50-00-0) der verbindliche Arbeitsplatzgrenzwert (AGW) nach TRGS 900 von 0,3 ml/m³ (ppm) bzw.
Quando serve l'autorizzazione alle emissioni in atmosfera?
In Italia l'autorizzazione alle emissioni in atmosfera serve per ogni stabilimento che produce emissioni.
Como funciona a classificação toxicológica dos agrotóxicos no Brasil?
No Brasil, a classificação toxicológica dos agrotóxicos é feita pela ANVISA segundo a RDC nº 294/2019, com critérios do GHS (Sistema Globalmente Harmonizado).
What is IDMP in pharma?
IDMP (Identification of Medicinal Products) is a set of ISO standards that define standard data elements and definitions for identifying and describing human…
Hvad kræver CLP-forordningen af danske virksomheder?
CLP-forordningen (forordning (EF) nr. 1272/2008) gælder direkte i Danmark.
What does the FDA require under PREA?
PREA (FD&C Act section 505B, 21 U.S.C. 355c) requires sponsors of NDAs, BLAs and supplements for a new active ingredient, new indication, new dosage form, new…
What must chemical hazard labels show in Great Britain?
Under GB CLP Article 17, a substance or mixture classified as hazardous and supplied in packaging shall carry a label with eight elements.
When do dietary supplements need an FDA disclaimer?
A dietary supplement needs the FDA disclaimer when its label or labeling carries a statement made under FD&C Act section 403(r)(6), such as a…
¿Qué es el PNIR en seguridad alimentaria?
En España, el PNIR es el plan oficial que controla los residuos de medicamentos veterinarios y otras sustancias farmacológicamente activas (autorizadas…
When is health surveillance required under COSHH?
COSHH regulation 11(1) says that where health surveillance is appropriate to protect employees who are, or are liable to be, exposed to a substance hazardous…
What are inert ingredients in pesticides?
Inert ingredients are everything in a pesticide product that is not the active ingredient.
What are PSSRU unit costs?
PSSRU unit costs are the figures in the Unit Costs of Health and Social Care, an annual compendium of standard costs for health and social care services.