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

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

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

Distribution date: 06 June 2019

This resolution establishes technical requirements for investigation, control and elimination of nitrosamines potentially carcinogenic in active pharmaceutical ingredients (IFA) which are angiotensin II receptor antagonists; and is applied to companies that manufacture, import and fractionate active pharmaceutical ingredients (IFA).

Products Covered: HS Codes: 2941; 30. (active pharmaceutical ingredients)

Regulation Type: Regular notification

Distribution date: 06 June 2019 | Final date for Comment: 05 August 2019

The notified Ecuadorian Technical Regulation establishes the requirements concerning the maximum levels of phosphorus and minimum percentage of ultimate aerobic biodegradability to be met by surface tension agents found in detergents and soaps intended for household or industrial use, prior to the marketing of domestic and imported products, with the aim of protecting the environment and preventing deceptive practices. It applies to the following products for household or industrial use: · detergents · soaps It does not apply to: · products which claim to have cosmetic properties and a therapeutic purpose · products for veterinary use

Products Covered: - Soap and organic surface- Active products and preparations, in the form of bars, cakes, moulded pieces or shapes, and paper, wadding, felt and nonwovens, impregnated, coated or covered with soap or detergent: (HS code(s): 34011); Soap in the form of flakes, granules, powder, paste or in aqueous solution (HS code(s): 340120); Surface-active preparations, washing preparations, auxiliary washing preparations and cleaning preparations put up for retail sale (excl. organic surface-active agents, soap and organic surface-active preparations in the form of bars, cakes, moulded pieces or shapes, and products and preparations for washing the skin in the form of liquid or cream) (HS code(s): 340220); Surface-active preparations, washing preparations, incl. auxiliary washing preparations and cleaning preparations (excl. those put up for retail sale, organic surface-active agents, soap and organic surface-active preparations in the form of bars, cakes, moulded pieces or shapes, and products and preparations for washing the skin in the form of liquid or cream) (HS code(s): 340290); (ICS code(s): 71.100.40)

Regulation Type: Regular notification

Distribution date: 06 June 2019 | Final date for Comment: 12 July 2019

This draft resolution proposes to change the expiration date of the market registration for risk II sanitizing products to 10 (ten) years for the register of sanitizing products with Risk II and also changes the resolution – RDC number 42, 13 August 2009.

Products Covered: HS Codes: 3402; 340119; 340120; 330290 (sanitizing products).

Regulation Type: Regular notification

Distribution date: 05 June 2019 | Final date for Comment: 20 July 2019

This Draft resolution incorporates the following changes for the active ingredient A29 – ACETAMIPRIDO from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of foliar use (application): - includes passion fruit culture with MRL of 0.01 mg/kg and safety security period of 28 days; - changes the MRL from 0.5 to 0.7 mg/kg for fruits of the genus Capsicum or of the genus Pimenta, egg-plant, scarlet eggplant, pepper and okra cultures and safety security period from 3 days to 1 day.

Products Covered: HS Code(s): 070930, 09041, 070960, 08109090, 07099990, 07 ; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 05 June 2019 | Final date for Comment: 20 July 2019

This Draft resolution incorporates the following changes for the active ingredient B26 – BIFENTRINA from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of foliar use (application): - includes coconut culture with MRL of 0.05 mg/kg and safety security period of 7 days.

Products Covered: HS Code(s): 08011; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 05 June 2019 | Final date for Comment: 20 July 2019

This Draft resolution incorporates the following changes for the active ingredient E19 - ETOFENPROXI from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of foliar use (application): - includes passion fruit and papaya culture with MRL of 0.3 mg/kg and safety security period of 1 day;- includes paprika, eggplant, scarlet eggplant, pepper and okra culture with MRL of 0.7 mg/kg and safety security period of 1 day.

Products Covered: HS Code(s): 070930, 070960, 080720, 09041, 08109090, 07, 07099990; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 05 June 2019 | Final date for Comment: 20 July 2019

This Draft resolution incorporates the following changes for the active ingredient P34 – PIRIPROXIFEM from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers: - includes cane sugar culture with MRL of 0.01 mg/kg and safety security period of 210 days;- includes pasture for "non-food use", therefore there are not definition of LMR nor safety security period.

Products Covered: HS Code(s): 170111; ICS Code(s): 13, 65

Regulation Type: Regular notification