Author name: Pasquale Carvelli

Pasquale Carvelli is a Regulatory Strategy & International Compliance Advisor for Cosmereg, an international regulatory affairs company supporting manufacturers, distributors, and brand owners navigating complex compliance frameworks across multiple jurisdictions. Through a multidisciplinary network of certified safety assessors and regulatory experts, he oversees strategic compliance pathways for cosmetic, food, and supplement products entering regulated markets.

Pre-consultation Notice on the Proposal to Amend the Cosmetic Regulations

Canada Cosmetic Regulations / By

Pre-consultation Notice on the Proposal to Amend the Cosmetic Regulations   Health Canada calls for the attention of interested parties towards the proposal to amend the Cosmetic Regulations. The goal of this regulatory initiative is to achieve more transparency about the presence of specific allergens in cosmetic labels.    The notice specifies that the proposal […]

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FDA Requirements for Surgical and Non-Surgical Face Masks

US FDA Medical Devices / By

FDA Requirements for Surgical and Non-Surgical Face Masks In the United States, face masks are regulated by the Food and Drug Administration (FDA) based on their intended use. This article outlines the regulatory requirements for both surgical and non-surgical face masks. Surgical Masks Definition: Surgical masks are intended for use by healthcare professionals during procedures

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FDA Provides Extension for Unique Facility Identifier (UFI) Deadline of Food Facilities

FDA Provides Extension for Unique Facility Identifier (UFI) Deadline of Food Facilities

US FDA food regulations / By

FDA Provides Extension for Unique Facility Identifier (UFI) Deadline of Food Facilities The US Food and Drug Administration (FDA) announced in 2016 that food facilities would be required to have a Unique Facility Identifier (UFI) as part of their FDA registration as part of an update to Food Facility Registration processes. D-U-N-S® numbers are currently

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Responsible Person Cosmetics – Who is it?

EU Cosmetic Regulations / By

Cosmetics Responsible Person – Who is it?   Whether you’re EU manufacturers, Non-EU manufacturers, importers or distributors, it’s important to understand who is the Cosmetics Responsible Person (RP), what they do, and what is the benefit of appointing a RP.  Especially If you are a non-EU cosmetic company, You should consider assigning a professional Cosmetics Responsible

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FDA dietary supplement health claims

FDA Withdraw The New OTC Monograph User Fee for FY 2021

US FDA OTC regulations / By

FDA Withdraw The New OTC Monograph User Fee for FY 2021   January 5, 2021 Update: FDA decided to withdraw their newly published OMUFA fees on December 29, 2020 Federal Register Notice entitled “Fee Rates Under the Over-the-Counter Monograph User Fee Program for Fiscal Year 2021″ till further notice. In the past March, President Trump

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FDA Food Facility Registration Renewal: October 1 to December 31, 2020

US FDA food regulations / By

FDA Food Facility Registration Renewal: October 1 to December 31, 2020 FDA registration renewal is due between October 1 and December 31, 2020 for all food facilities. The renewal is required for any facilities that engage in the following US food for consumption activities: • Manufacturing • Packing • Processing • Storing Renewing the FDA

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