Regulatory Updates
Amendment of Resolution - RDC No. 432 of 4 November 2020
Distribution date: 09 June 2021
ANVISA Resolution number 432, 4 November 2020 - previously notified through G/TBT/N/BRA/608/Add.1 - which establishes the obligation to describe the composition in Portuguese on the labeling of personal care products, cosmetics and perfumes., was amended by Resolution - RDC number 499, 27 May 2021. The new text establishes that the chemical composition in Portuguese can be presented in digital format, by reading the code on the label through a mobile device, which gives direct access to this composition and whose code is preceded by the phrase "Composition (Portuguese):" or "Ingredients (English). The final text is available only in Portuguese and can be downloaded at: http://antigo.anvisa.gov.br/legislacao#/visualizar/451743
Products Covered: Labelling of personal hygiene products, cosmetics and perfumes...
Regulation Type: Addendum to Regular Notification
Regulation of the FDA No. 13 of 2020 on Flavoring Additives
Distribution date: 09 June 2021
The Regulation of Food and Drugs Agency No 11 of 2021 concerning Flavoring Additives is the additional version of Regulation No 13 of 2020 on Flavoring Additives
Products Covered:
Regulation Type: Addendum to Regular Notification
Regulation of the Chairman of NADFC RI No.22 of 2016 on The Requirement for The Use of Flavorings
Distribution date: 07 June 2021
Regulation of National Agency of Food and Drug Control (NAFDC) Number 11 Year 2021 on Amendments to The Regulation of NAFDC Number 13 of 2020 concerning Flavoring Additives is the additional version from The Regulation of NAFDC Number 13 Year 2020 on Flavoring Additives. Some changes from the previous regulations including provisions on flavoring adjunct, synthetic flavors, flavor compounds that are permitted to be used in food additives, compliance requirements with specifications in the Indonesian food codex, and the requirements for mixed food additives.
Products Covered: Food Additives, Flavoring
Regulation Type: Addendum to Regular Notification
Regulation of the Chairman of NADFC RI No.14 of 2016 on The Safety and Quality Standard of Alcoholic Beverages
Distribution date: 07 June 2021
National Agency of Food and Drug Control of the Republic of Indonesia has issued Regulation of National Agency of Food and Drug Control (NAFDC) Number 5 year 2021 concerning Safety and Quality Standard of Alcohol Beverages. The regulation revokes Regulation of NAFDC Chairman Number 14 year 2016 on Safety and Quality Standards of Alcoholic Beverages. This regulation mandates alcohol beverages that are produced domestically or imported and distributed in Indonesia market shall meet the standard of safety and quality as required in the regulation. Safety requirements include compliance to the maximum limit of methanol content, food additives, metal contamination, and chemical contamination. Quality requirements include compliance to: (a) requirement on methanol content and other requirements as listed in Appendix I, (b) other applicable regulations on quality requirements in food category.The regulations provides a-12 month grace period to allow industry to comply with the regulation.
Products Covered: Food
Regulation Type: Addendum to Regular Notification
Central American Technical Regulation (RTCA) No. 71.01.36:06: Cosmetic products. Labelling of cosmetic products.
Distribution date: 31 May 2021
The notified Regulation establishes the requirements as to what information must be included on the labels of cosmetic products of any capacity, so as to prevent their use from posing a risk to health. This Regulation does not apply to cosmetic products used exclusively in the hotel trade. __________
Products Covered: ICS: 71.100
Regulation Type: Addendum to Regular Notification
Nicaraguan Mandatory Technical Standard (NTON) No. 26 002-06/Central American Technical Regulation (RTCA) No. 71.01.36:06: Cosmetic products. Labelling of cosmetic products
Distribution date: 26 May 2021
On 28 July 2006, the Republic of Nicaragua notified, in document G/TBT/N/NIC/74, NTON No. 26 002-06/RTCA No. 71.01.36:06: Cosmetic products. Labelling of cosmetic products, with the aim of establishing the information required on the labels of cosmetic products of any kind to prevent their use posing a risk to health. This text has been amended and WTO Members are therefore advised that they may submit comments on the updated draft entitled "NTON No. 26 002-21/RTCA No. 71.03.36:21: Cosmetic products. Labelling of Cosmetic Products". __________
Products Covered: International Classification for Standards (ICS) Code 71.100
Regulation Type: Addendum to Regular Notification
Central American Technical Regulation (RTCA) No. 71.01.35:21: Cosmetic products. Sanitary registration and authorization of cosmetic products This Technical Regulation was notified on 2 August 2006 in document G/TBT/N/HND/35.
Distribution date: 19 April 2021
The purpose of the notified Technical Regulation is to establish the conditions and requirements for the registration and authorization of cosmetic products for marketing. The notified Technical Regulation applies to natural and legal persons producing or importing cosmetic products. This Regulation does not apply to cosmetic products used exclusively in the hotel trade. __________
Products Covered: International Classification for Standards (ICS) code 71.100
Regulation Type: Addendum to Regular Notification
Central American Technical Regulation (RTCA) No. 71.01.35:06: Cosmetic products. Sanitary registration and authorization of cosmetic products
Distribution date: 16 April 2021
The purpose of the notified Technical Regulation is to establish the conditions and requirements for the registration and authorization of cosmetic products for marketing. This Regulation does not apply to cosmetic products used exclusively in the hotel trade. __________
Products Covered: International Classification for Standards (ICS) code 71.100
Regulation Type: Addendum to Regular Notification
Central American Technical Regulation (RTCA) No. 71.01.35:06: Cosmetic products. Sanitary registration and authorization of cosmetic products
Distribution date: 16 April 2021
The purpose of the notified Technical Regulation is to establish the conditions and requirements for the registration and authorization of cosmetic products for marketing. This Regulation does not apply to cosmetic products used exclusively in the hotel trade. __________
Products Covered: International Classification for Standards (ICS) Code 71.100
Regulation Type: Addendum to Regular Notification
General Requirements for Supplier's Declaration of Conformity (RGDF Product) – Consolidated.
Distribution date: 12 April 2021
National Institute of Metrology, Quality and Technology – Inmetro, issued the Inmetro Ordinance 140, 19 March 2021, approving the General Requirements for Supplier's Declaration of Conformity (RGDF Product) - Consolidated. The following Inmetro Ordinances are revoked: I - Inmetro Ordinance 649, 12 December 2012, published in the Official Gazette on 14 December 2012, section 1, pages 138 to 139, previously notified through G/TBT/N/BRA/521; II - Inmetro Ordinance 1, 4 January 2007, published in the Federal Official Gazette 8 January 2007, section 1, page 57.
Products Covered: All products that are subject to a Supplier's Declaration of Conformity (SDoC) procedure; Quality management and quality assurance. (ICS: 03.120.10).
Regulation Type: Addendum to Regular Notification
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