Draft resolution (Consulta Pública) number 639, 21 May 2019. Published on D.O.U, 22 May 2019, page 63. Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=47525
Distribution date: 06 June 2019 | Final date for Comment: 12 July 2019
This draft resolution proposes to change the expiration date to 10 (ten) years of the market authorization for personal hygiene products, cosmetics, and perfumes; and also changes the RDC 7, 10 February 2015.
Products Covered: HS Codes: 3303; 3304; 3305; 3306;3307; 340111; 340130; 9616; 9619 (personal hygiene products, cosmetics, and perfumes)
Regulation Type: Regular notification
Draft resolution (Consulta Publica) number 653, 21 May 2019. 2 pages, Portuguese. Published on D.O.U, 27 May 2019, page 57. Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=47328
Distribution date: 06 June 2019 | Final date for Comment: 01 August 2019
This Draft Resolution corresponds to the adoption of the Guide to Good Manufacturing Practices for Medicinal Products of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) of 1 July 2018. The resolution – RDC represents the Part 1 of the guide that applies to all medicines without distinction. The Normative Instructions (IN) correspond to the annexes of the guide related to specific aspects of the good practices for the manufacture of medicines. RDC - Good Practice Guidelines for the Manufacture of Medicines: corresponds to Part I of the PIC/S guide; IN Complementary guidelines to the manufacture of sterile medicinal products (corresponds to annex 1 of the PIC/S guide); IN Complementary guidelines to the manufacture of biological medicinal substances and products for human use (corresponds to annex 2 of the PIC/S guide); IN Complementary guidelines to the manufacture of radiopharmaceuticals (corresponds to annex 3 of the PIC/S guide); IN Complementary guidelines to the manufacture of herbal medicinal products (corresponds to annex 7 of the PIC/S guide); IN Complementary guidelines to the manufacture of medicinal gases (corresponds to annex 6 of the PIC/S guide); IN Complementary guidelines to the sampling of starting and packaging materials (corresponds to annex 8 of the PIC/S guide); IN Complementary guidelines to the manufacture of liquids, creams and ointments (corresponds to annex 9 of the PIC/S guide); IN Complementary guidelines to the manufacture of pressurised metered dose aerosol preparations for inhalation (corresponds to annex 10 of the PIC/S guide); IN Complementary guidelines to computerised systems (corresponds to annex 11 of the PIC/S guide); IN Complementary guidelines to the use of ionising radiation in the manufacture of medicinal products (corresponds to annex 12 of the PIC/S guide); IN Complementary guidelines to the manufacture of investigational medicinal products (corresponds to annex 13 of the PIC/S guide); IN Complementary guidelines to the manufacture of medicinal products derived from human blood or plasma (corresponds to annex 14 of the PIC/S guide); IN Complementary guidelines to the qualification and validation (corresponds to annex 15 of the PIC/S guide); IN Complementary guidelines to the reference and retention samples (corresponds to annex 19 of the PIC/S guide); Considering that this is the adoption of a set of guides widely adopted internationally, it is not desirable that in Brazil be adopted divergent good manufacturing practices (BPF)requirements, unless a necessity to adopt different requirements to reach an adequate level for protection to health be proved.
Products Covered: HS Codes: 3003; 3004; 3005; 2941.
Regulation Type: Regular notification
Regulation for Notification of Non-special Cosmetics (Draft for Comments)
Distribution date: 06 June 2019 | Final date for Comment: 05 August 2019
This regulation adjusts the procedure and requirements of notification of non-special cosmetics in China.
Products Covered: Cosmetics (HS: 33)
Regulation Type: Regular notification
Ordinance 258, 27 May 2019
Distribution date: 07 June 2019 | Final date for Comment: 05 August 2019
Draft Technical Regulation laying down metrological and safety requirements for automotive Nitrogen Oxide (NOx) Liquid Reducing Agent (ARLA 32) volume measuring instruments.
Products Covered: HS Chapter 28 - Inorganic chemicals.
Regulation Type: Regular notification
TITLE: No Significant Risk Levels Section 25704 Exposures to Listed Chemicals in Coffee Posing No Significant Risk AGENCY: California Environmental Protection Agency, Office of Environmental Health Hazard Assessment (OEHHA) ACTION: Rule Adoption SUMMARY: On 3 June 2019, the State of California’s Office of Administrative Law approved the adoption of Title 27, California Code of Regulations, section 25704, Exposures to Listed Chemicals in Coffee Posing No Significant Risk. The regulation will be effective on 1 October 2019. Section 25704 states, “Exposures to chemicals in coffee, listed on or before 15 March 2019 as known to the state to cause cancer, that are created by and inherent in the processes of roasting coffee beans or brewing coffee do not pose a significant risk of cancer.” Effective 1 October 2019 Notice of Adoption: https://oehha.ca.gov/proposition-65/crnr/notice-adoption-section-25704-exposures-listed-chemicals-coffee-posing-no
Distribution date: 11 June 2019 | Final date for Comment: 03 May 2025
Products Covered: Coffee
Regulation Type: Addendum to Regular Notification
The Republic of Ecuador hereby advises that the draft first revision (1R) of Ecuadorian Standardization Institute Technical Regulation (RTE INEN) No. 088 "Surface tension agents", notified in document G/TBT/N/ECU/117/Rev.1 of 6 March 2018, has been repealed and is therefore null and void. The draft notification is therefore withdrawn. Text available at the Ministry of Production, Foreign Trade, Investment and Fisheries, Under-Secretariat for Quality, National Notification Authority: TBT enquiry point: Andrés Ramón Plataforma Gubernamental de Gestión Financiera - Piso 8, Bloque amarillo, Av. Amazonas entre Unión Nacional de Periodistas y Alfonso Pereira Quito - Ecuador Tel.: (+593-2) 3948760, Ext. 2252/2254 Email: [email protected] [email protected] [email protected] [email protected] www.normalizacion.gob.ec
Distribution date: 11 June 2019 | Final date for Comment: 03 May 2025
Products Covered: (HS code(s): 340119, 340130, 340220, 340290, 340540); (ICS code(s): 71.100.40)
Regulation Type: Addendum to Regular Notification
Health Canada's Proposal to Lower the Maximum Levels of Lead in Concentrated Infant Formula and Infant Formula When Ready-to-Serve in the List of Contaminants and Other Adulterating Substances in Foods – Reference Number: NOP/AVP C-2019-1
Distribution date: 12 June 2019 | Final date for Comment: 18 August 2019
Health Canada has conducted a scientific assessment which supports lowering the maximum level (ML) for lead in all types of infant formula that would apply to the food on an 'as consumed' basis. Health Canada is proposing to consolidate the two existing MLs for lead in concentrated infant formula and infant formula when ready‑to‑serve into a single, lower ML of 0.01 ppm. The purpose of this communication is to publically announce the Department's intention in this regard and to provide the appropriate contact information for any inquiries or for those wishing to submit any new scientific information relevant to Health Canada's scientific assessment.
Products Covered: Lead in concentrated infant formula and infant formula when ready-to-serve (ICS Code: 67.230)
Regulation Type: Regular notification
Resolution - RDC 290, 4 June 2019.
Distribution date: 12 June 2019 | Final date for Comment: 03 May 2025
This Resolution - RDC amends the articles 8 and 9 of the Resolution - RDC number 35, 15 June 2012, establishing exceptions for the purchase of reference medicine from another country other than Brazil.
Products Covered: HS CODE: 3822
Regulation Type: Regular notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (Revision of agricultural chemical residue standards)
Distribution date: 17 June 2019 | Final date for Comment: 03 May 2025
Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Tetraniliprole.
Products Covered: - Fish and crustaceans, molluscs and other aquatic invertebrates (HS Codes: 03.02, 03.03, 03.04, 03.06, 03.07 and 03.08) - Edible vegetables and certain roots and tubers (HS Codes: 07.02, 07.03, 07.04, 07.05, 07.07, 07.08, 07.09, 07.10 and 07.14) - Edible fruit (HS Codes: 08.06, 08.07, 08.08, 08.09, 08.10 and 08.11) - Tea (HS Code: 09.02) - Cereals (HS Codes: 10.05 and 10.06)- Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS Code: 12.01)
Regulation Type: Regular notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (Revision of agricultural chemical residue standards)
Distribution date: 17 June 2019 | Final date for Comment: 03 May 2025
Proposed maximum residue limits (MRLs) for the following agricultural chemical: Veterinary drug: Fluralaner.
Products Covered: - Meat and edible meat offal (HS Codes: 02.07 and 02.09) - Birds' eggs (HS Codes: 04.07 and 04.08) - Animal originated products (HS Code: 05.04)- Animal fats and oils (HS Code: 15.01)
Regulation Type: Regular notification
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