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 maximum residue limit mean in Australia?
In Australia, FSANZ defines a maximum residue limit (MRL) as "the highest amount of an agricultural or veterinary (agvet) chemical residue that is legally…
How do I validate an analytical method under ICH guidelines?
You validate an analytical method under ICH by showing it is fit for its intended purpose, following ICH Q2(R2) (Validation of Analytical Procedures, adopted…
Vilka företag måste anmäla kemiska produkter till produktregistret?
Anmälningsplikten gäller företag som yrkesmässigt tillverkar kemiska produkter eller biotekniska organismer i Sverige eller för in dem hit, om produkterna hör…
日本の家庭用品のホルムアルデヒド基準値は？
日本では「有害物質を含有する家庭用品の規制に関する法律施行規則」の別表第１に、ホルムアルデヒドの基準が2区分あります。生後24月以内の乳幼児用の繊維製品は、吸光度差0.05以下または試料1gあたり16μg以下です。それ以外の下着・寝衣・手袋・くつした・たびと、かつら・つけまつげ等に使う接着剤は、試料1gあたり75μg…
Quais enzimas alimentares podem ser usadas como coadjuvantes de tecnologia no Brasil?
Resposta direta: No Brasil, só podem ser usadas como coadjuvantes de tecnologia as enzimas do Anexo I da RDC nº 728/2022 (autorização geral) e as aprovadas…
What does New Jersey's Right to Know law require employers to do?
New Jersey's Worker and Community Right to Know Act (N.J.S.A. 34:5A-1 et seq.) and its rules (N.J.A.C. 8:59) make covered employers do five things: report the…
What is a harmonised classification under CLP?
A harmonised classification is a hazard classification for a substance that is set at EU level and written into Part 3 of Annex VI (Table 3) of the CLP…
What is a quasi-drug in Japan?
In Japan, a quasi-drug (医薬部外品, iyaku-bugaihin) is a product defined in Article 2(2) of the PMD Act (the Act on Securing Quality, Efficacy and Safety of…
Wat doet de KOAG/KAG bij reclame voor voedingssupplementen?
De Keuringsraad (voluit Keuringsraad Kennis en Advies Gezondheidsreclame, vroeger Keuringsraad KOAG/KAG) toetst in het kader van zelfregulering vooraf, op…
Who needs a drug establishment licence in Canada?
Under section C.01A.004 of the Food and Drug Regulations (Part C, Division 1A), you need a drug establishment licence if you fabricate, package/label or…
How do I look up a Canadian clothing label CA number?
You can look up a CA number in the Competition Bureau Canada's free online CA Identification Number search at ised-isde.canada.ca/app/cb/can.
What must a fabric content label say in the US?
A US fabric content label must give three things: the fiber content (generic fiber names with percentages by weight), the identity of the company responsible…
Which color additives can I use in cosmetics in the US?
In the US you can only use a color additive in a cosmetic if FDA has listed it for that use, and only within the conditions in its listing.
Hva er biocider?
Biocider (biocidprodukter) er stoffer eller blandinger som brukes for å ødelegge, avskrekke, uskadeliggjøre eller hindre virkningen av skadelige organismer…
O que mudou nas regras brasileiras para FDS e rotulagem de produtos químicos?
As maiores mudanças são três. A ABNT NBR 14725:2023 trocou a antiga FISPQ pela FDS (Ficha com Dados de Segurança).
Wobei hilft der REACH-Helpdesk Unternehmen in Deutschland?
Der REACH-CLP-Biozid Helpdesk der BAuA (Bundesstelle für Chemikalien) beantwortet Fragen von Unternehmen zur REACH-Verordnung, zur CLP-Verordnung und zur…
Come funziona il payback farmaceutico in Italia?
Il payback farmaceutico è il meccanismo con cui le aziende titolari di AIC restituiscono alle Regioni una parte della spesa SSN quando questa supera i tetti…
Kto musi złożyć raport KOBiZE?
Raport do Krajowej bazy KOBiZE musi złożyć każdy podmiot korzystający ze środowiska, którego działalność powoduje emisje.
How does the Rotterdam Convention control hazardous chemical exports?
The Rotterdam Convention doesn't ban exports. It controls them in two ways.
What are the workplace carbon monoxide exposure limits in Canada?
Canada has no single national carbon monoxide limit. Each province or territory sets its own, and federally regulated workplaces use the American Conference…