Regulatory Updates

Distribution date: 14 April 2022

This normative instruction contains provisions on an amendment to the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published by Normative Instruction number 103 - 19 October 2021 on the Brazilian Official Gazette (DOU - Diário Oficial da União).

Products Covered: HS Code(s): 52; ICS Code(s): 13

Regulation Type: Regular notification

Distribution date: 13 April 2022 | Final date for Comment: 13 June 2022

Proposed rule - The Environmental Protection Agency (EPA) is proposing a rule under the Toxic Substances Control Act (TSCA) to address  the unreasonable risk of injury to health it has identified for conditions of use of chrysotile asbestos following completion of the TSCA Risk Evaluation for Asbestos, Part 1: Chrysotile Asbestos. TSCA requires that EPA address the unreasonable risks of injury to health and environment by rule and to apply requirements to the extent necessary so that chrysotile asbestos no longer presents such risks. Therefore, to address the unreasonable risk identified in the TSCA Risk Evaluation for Asbestos, Part 1 from chrysotile asbestos, EPA is proposing to prohibit manufacture (including import), processing, distribution in commerce and commercial use of chrysotile asbestos for chrysotile asbestos diaphragms for use in the chlor-alkali industry, chrysotile asbestos-containing sheet gaskets used in chemical production, chrysotile asbestos-containing brake blocks used in the oil industry, aftermarket automotive chrysotile asbestos-containing brakes/linings, other chrysotile asbestos-containing vehicle friction products, and other chrysotile asbestos-containing gaskets. EPA also is proposing to prohibit manufacture (including import), processing, and distribution in commerce of aftermarket automotive chrysotile asbestos-containing brakes/linings for consumer use, and other chrysotile asbestos-containing gaskets for consumer use. EPA is also proposing disposal and recordkeeping requirements for these conditions of use.

Products Covered: Chrysotile Asbestos; Asbestos (excl. products made from asbestos) (HS code(s): 2524); Friction material and articles thereof, e.g., sheets, rolls, strips, segments, discs, washers, pads, not mounted, for brakes, clutches or the like, with a basis of asbestos, other mineral substances or cellulose, whether or not combined with textile or other materials (excl. mounted friction material) (HS code(s): 6813); Environmental protection (ICS code(s): 13.020); Air quality (ICS code(s): 13.040); Protection against dangerous goods (ICS code(s): 13.300); Road vehicle systems (ICS code(s): 43.040); Products of the chemical industry (ICS code(s): 71.100)

Regulation Type: Regular notification

Distribution date: 13 April 2022 | Final date for Comment: 13 June 2022

Proposed rule - The Environmental Protection Agency (EPA) is proposing a rule under the Toxic Substances Control Act (TSCA) to address  the unreasonable risk of injury to health it has identified for conditions of use of chrysotile asbestos following completion of the TSCA Risk Evaluation for Asbestos, Part 1: Chrysotile Asbestos. TSCA requires that EPA address the unreasonable risks of injury to health and environment by rule and to apply requirements to the extent necessary so that chrysotile asbestos no longer presents such risks. Therefore, to address the unreasonable risk identified in the TSCA Risk Evaluation for Asbestos, Part 1 from chrysotile asbestos, EPA is proposing to prohibit manufacture (including import), processing, distribution in commerce and commercial use of chrysotile asbestos for chrysotile asbestos diaphragms for use in the chlor-alkali industry, chrysotile asbestos-containing sheet gaskets used in chemical production, chrysotile asbestos-containing brake blocks used in the oil industry, aftermarket automotive chrysotile asbestos-containing brakes/linings, other chrysotile asbestos-containing vehicle friction products, and other chrysotile asbestos-containing gaskets. EPA also is proposing to prohibit manufacture (including import), processing, and distribution in commerce of aftermarket automotive chrysotile asbestos-containing brakes/linings for consumer use, and other chrysotile asbestos-containing gaskets for consumer use. EPA is also proposing disposal and recordkeeping requirements for these conditions of use.

Products Covered: Chrysotile Asbestos; Asbestos (excl. products made from asbestos) (HS code(s): 2524); Friction material and articles thereof, e.g., sheets, rolls, strips, segments, discs, washers, pads, not mounted, for brakes, clutches or the like, with a basis of asbestos, other mineral substances or cellulose, whether or not combined with textile or other materials (excl. mounted friction material) (HS code(s): 6813); Environmental protection (ICS code(s): 13.020); Air quality (ICS code(s): 13.040); Protection against dangerous goods (ICS code(s): 13.300); Road vehicle systems (ICS code(s): 43.040); Products of the chemical industry (ICS code(s): 71.100)

Regulation Type: Regular notification

Distribution date: 13 April 2022 | Final date for Comment: 14 June 2022

These measures will amend the Toys (Safety) Regulation 2011 as applicable in GB (“the Toys Regulations”) and the Cosmetics Regulation 1223/2009 as applicable in GB (“the Cosmetics Regulations”) as they apply in England, Wales and Scotland. They will amend permitted levels of certain chemicals in both the Toys Regulations and the Cosmetics Regulations. They will amend the Toy Regulations, to reduce the permitted limits of aluminium, aniline and formaldehyde as well as including provisions on three allergens used in fragrances, under the list of prohibited allergens in toys. We will be amending the Cosmetics Regulations to permit the use of salicylic acid for uses other than as a preservative only in specific product types, prohibit the use of deoxyarbutin and a set of chemicals classified as Carcinogenic, Mutagenic or Reprotoxic (CMR) under GB Classification, Labelling and Packaging (CLP) Regulations.

Products Covered: Toys and cosmetics products. More detail on product coverage can be found in regulation 4 of the Toys (Safety) Regulations 2011 and cosmetic products are defined by Article 2(1)(a) of Regulation (EC) No 1223/2009.  HS code:HS 95 (http://tariffdata.wto.org/ReportersAndProducts.aspx) for toys HS 33 http://tariffdata.wto.org/ReportersAndProducts.aspx for cosmetics ICS codes: ICS 97.200.50 https://www.iso.org/ics/97.200.50/x  for toysICS 71.100.70 https://www.iso.org/ics/71.100.70/x/ for cosmetics

Regulation Type: Regular notification

Distribution date: 13 April 2022 | Final date for Comment: 14 June 2022

These measures will amend the Toys (Safety) Regulation 2011 as applicable in GB (“the Toys Regulations”) and the Cosmetics Regulation 1223/2009 as applicable in GB (“the Cosmetics Regulations”) as they apply in England, Wales and Scotland. They will amend permitted levels of certain chemicals in both the Toys Regulations and the Cosmetics Regulations. They will amend the Toy Regulations, to reduce the permitted limits of aluminium, aniline and formaldehyde as well as including provisions on three allergens used in fragrances, under the list of prohibited allergens in toys. We will be amending the Cosmetics Regulations to permit the use of salicylic acid for uses other than as a preservative only in specific product types, prohibit the use of deoxyarbutin and a set of chemicals classified as Carcinogenic, Mutagenic or Reprotoxic (CMR) under GB Classification, Labelling and Packaging (CLP) Regulations.

Products Covered: Toys and cosmetics products. More detail on product coverage can be found in regulation 4 of the Toys (Safety) Regulations 2011 and cosmetic products are defined by Article 2(1)(a) of Regulation (EC) No 1223/2009.  HS code:HS 95 (http://tariffdata.wto.org/ReportersAndProducts.aspx) for toys HS 33 http://tariffdata.wto.org/ReportersAndProducts.aspx for cosmetics ICS codes: ICS 97.200.50 https://www.iso.org/ics/97.200.50/x  for toysICS 71.100.70 https://www.iso.org/ics/71.100.70/x/ for cosmetics

Regulation Type: Regular notification

Distribution date: 12 April 2022

This normative instruction contains provisions on Good Manufacturing Practices complementary to Biological Inputs and Medicines.

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification

Distribution date: 12 April 2022

This normative instruction contains provisions on Good Manufacturing Practices complementary to Biological Inputs and Medicines.

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification

Distribution date: 12 April 2022

This normative instruction contains provisions on Good Manufacturing Practices complementary to Ionizing Radiation in the manufacture of medicines.

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification

Distribution date: 12 April 2022

This normative instruction contains provisions on Good Manufacturing Practices complementary to Ionizing Radiation in the manufacture of medicines.

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification

Distribution date: 12 April 2022

This normative instruction contains provisions on Good Manufacturing Practices complementary to Experimental Medicines.

Products Covered: HS (3003-3004) - Medicaments

Regulation Type: Regular notification