Distribution date: 30 September 2020 | Final date for Comment: 06 November 2020

The technical regulations for the classification, labelling and packaging of substances and preparations will be updated and thus adapted to technical progress in the EU (15th ATP of the EU CLP Regulation; binding from 1 March 2022). This draft revision updates the list of harmonized classifications:- inclusion of 37 substances;- amendment of 21 existing entries;- deletion of two entries The latest developments in test methods for substances and preparations (OECD) are adopted. The requirements for the safety data sheet are adapted to the development of the UN-GHS and in the EU. Eight substances are included in the candidate list of substance of very high concern. This listing triggers information obligations along the supply chain.

Products Covered: INORGANIC CHEMICALS; ORGANIC OR INORGANIC COMPOUNDS OF PRECIOUS METALS, OF RARE-EARTH METALS, OF RADIOACTIVE ELEMENTS OR OF ISOTOPES (HS code(s): 28); ORGANIC CHEMICALS (HS code(s): 29); MISCELLANEOUS CHEMICAL PRODUCTS (HS code(s): 38); CHEMICAL TECHNOLOGY (ICS code(s): 71)

Regulation Type: Regular notification

Distribution date: 30 September 2020 | Final date for Comment: 06 November 2020

The technical regulations for the classification, labelling and packaging of substances and preparations will be updated and thus adapted to technical progress in the EU (15th ATP of the EU CLP Regulation; binding from 1 March 2022). This draft revision updates the list of harmonized classifications:- inclusion of 37 substances;- amendment of 21 existing entries;- deletion of two entries The latest developments in test methods for substances and preparations (OECD) are adopted. The requirements for the safety data sheet are adapted to the development of the UN-GHS and in the EU. Eight substances are included in the candidate list of substance of very high concern. This listing triggers information obligations along the supply chain.

Products Covered: INORGANIC CHEMICALS; ORGANIC OR INORGANIC COMPOUNDS OF PRECIOUS METALS, OF RARE-EARTH METALS, OF RADIOACTIVE ELEMENTS OR OF ISOTOPES (HS code(s): 28); ORGANIC CHEMICALS (HS code(s): 29); MISCELLANEOUS CHEMICAL PRODUCTS (HS code(s): 38); CHEMICAL TECHNOLOGY (ICS code(s): 71)

Regulation Type: Regular notification

Distribution date: 30 September 2020 | Final date for Comment: 06 November 2020

15 additional substances are included in the Annex of the ORRChim. When the transition period expires, it will be prohibited to supply these carcinogenic, mutagenic or reproductive toxicant (CMR) substances to the general public. This revision is based on the analogous requirements of the EU.

Products Covered: Carcinogenic, mutagenic or reproductive toxicant (CMR) substances

Regulation Type: Regular notification

Distribution date: 30 September 2020 | Final date for Comment: 06 November 2020

15 additional substances are included in the Annex of the ORRChim. When the transition period expires, it will be prohibited to supply these carcinogenic, mutagenic or reproductive toxicant (CMR) substances to the general public. This revision is based on the analogous requirements of the EU.

Products Covered: Carcinogenic, mutagenic or reproductive toxicant (CMR) substances

Regulation Type: Regular notification

Distribution date: 30 September 2020 | Final date for Comment: 24 October 2020

This Draft resolution incorporates the following changes for the active ingredient F66 – FLUBENDIAMIDA (flubendiamide) 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 the the bean culture with MRL of 0,01 mg/kg and safety security period of 20 days;-includes the peanut culture with MRL of  0,01 mg/kg and safety security period of 20 days;-includes the pea culture with MRL of  0,01 mg/kg and safety security period of 20 days;-includes wheat culture with MRL of 0,2 mg/kg and safety security period of 20 days;-includes the oats culture with MRL of 0,2 mg/kg and safety security period of 20 days;-includes the rye culture with MRL of 0,2 mg/kg and safety security period of 20 days;-includes the barley culture with MRL of 0,2 mg/kg and safety security period of 20 days;-includes the triticale culture with MRL of 0,2 mg/kg and safety security period of 20 days.-includes the phrase at item "L": Acute Reference Dose (ARfD) = 0,2 mg/kg b.w. (source: JMPR, 2010).

Products Covered: HS Code(s): 1001, 1002, 1003, 1004, 200811, 070820, 070810, triticale; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 30 September 2020 | Final date for Comment: 24 October 2020

This Draft resolution incorporates the following changes for the active ingredient F66 – FLUBENDIAMIDA (flubendiamide) 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 the the bean culture with MRL of 0,01 mg/kg and safety security period of 20 days;-includes the peanut culture with MRL of  0,01 mg/kg and safety security period of 20 days;-includes the pea culture with MRL of  0,01 mg/kg and safety security period of 20 days;-includes wheat culture with MRL of 0,2 mg/kg and safety security period of 20 days;-includes the oats culture with MRL of 0,2 mg/kg and safety security period of 20 days;-includes the rye culture with MRL of 0,2 mg/kg and safety security period of 20 days;-includes the barley culture with MRL of 0,2 mg/kg and safety security period of 20 days;-includes the triticale culture with MRL of 0,2 mg/kg and safety security period of 20 days.-includes the phrase at item "L": Acute Reference Dose (ARfD) = 0,2 mg/kg b.w. (source: JMPR, 2010).

Products Covered: HS Code(s): 1001, 1002, 1003, 1004, 200811, 070820, 070810, triticale; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 01 October 2020 | Final date for Comment: 21 November 2020

This Draft resolution incorporates the following changes for the active ingredient M15 - METIRAM (metiram) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers:-changes the phrase at item "k" from "Acceptable Daily Intake (ADI): 0,03 mg/kg b.w." to "Acceptable Daily Intake (ADI): 0,03 mg/kg b.w for Metiram and 0,0169 mg/kg b.w. for CS2 (source: ANVISA);-includes the phrase: "I) Acute Reference Dose (ARfD) : not applicable (source: EFSA*, 2005)";-includes the phrase: "*European Food Safety Authority";-includes the phrase at item "m": "for the purpose of residue definition for conformity to MRL, it will be considered the active ingredient metiram. expressed as CS2";-includes the phrase at item "n": "for the purpose of residue definition for dietary risk assessment it will be considered the substance Etilenobisditiocarbamatos (mancozeb or metiram), expressed as CS2"

Products Covered: HS Code(s): 38089910; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 01 October 2020 | Final date for Comment: 21 November 2020

This Draft resolution incorporates the following changes for the active ingredient M15 - METIRAM (metiram) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers:-changes the phrase at item "k" from "Acceptable Daily Intake (ADI): 0,03 mg/kg b.w." to "Acceptable Daily Intake (ADI): 0,03 mg/kg b.w for Metiram and 0,0169 mg/kg b.w. for CS2 (source: ANVISA);-includes the phrase: "I) Acute Reference Dose (ARfD) : not applicable (source: EFSA*, 2005)";-includes the phrase: "*European Food Safety Authority";-includes the phrase at item "m": "for the purpose of residue definition for conformity to MRL, it will be considered the active ingredient metiram. expressed as CS2";-includes the phrase at item "n": "for the purpose of residue definition for dietary risk assessment it will be considered the substance Etilenobisditiocarbamatos (mancozeb or metiram), expressed as CS2"

Products Covered: HS Code(s): 38089910; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 01 October 2020 | Final date for Comment: 21 November 2020

This Draft Resolution includes the active ingredient T70 -TOLFENPIRADE (Tolfenpyrad) in the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers.

Products Covered: HS Code(s): 38089910; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 01 October 2020 | Final date for Comment: 21 November 2020

This Draft Resolution includes the active ingredient T70 -TOLFENPIRADE (Tolfenpyrad) in the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers.

Products Covered: HS Code(s): 38089910; ICS Code(s): 13, 65

Regulation Type: Regular notification