Regulatory Updates

Distribution date: 27 July 2020

RDC 400 Defines the extraordinary and temporary criteria and procedures for the application of exceptionalities to specific labelling requirements and drug leaflets due to the international public health emergency resulting from the new Coronavirus.

Products Covered: Antibiotics (HS code(s): 2941); Medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3003); Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses "incl. those in the form of transdermal administration" or in forms or packings for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3004); Wadding, gauze, bandages and the like, e.g. dressings, adhesive plasters, poultices, impregnated or covered with pharmaceutical substances or put up for retail sale for medical, surgical, dental or veterinary purposes (HS code(s): 3005); Pharmaceutical preparations and products of subheading Nos 3006.10.10 to 3006.60.90 (HS code(s): 3006)

Regulation Type: Regular notification

Distribution date: 27 July 2020 | Final date for Comment: 12 September 2020

This Draft resolution incorporates the following changes for the active ingredient A02 - ACEFATO (acephate) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of seed treatment use (application):-includes the soya culture with MRL of 0,02 mg/kg and safety security period "Not determined due to the modality of use (application)".

Products Covered: HS Code(s): 1201; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 27 July 2020 | Final date for Comment: 12 September 2020

This Draft resolution incorporates the following changes for the active ingredient A02 - ACEFATO (acephate) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of seed treatment use (application):-includes the soya culture with MRL of 0,02 mg/kg and safety security period "Not determined due to the modality of use (application)".

Products Covered: HS Code(s): 1201; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 27 July 2020 | Final date for Comment: 12 September 2020

This Draft Resolution includes the active ingredient F73 - FENPIRAZAMINA (fenpyrazamine) 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: 27 July 2020 | Final date for Comment: 12 September 2020

This Draft Resolution includes the active ingredient F73 - FENPIRAZAMINA (fenpyrazamine) 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: 27 July 2020 | Final date for Comment: 12 September 2020

This Draft resolution incorporates the following changes for the active ingredient C49 - CARFENTRAZONA-ETÍLICA (carfentrazone-ethyl) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of post-emergency use (application):-includes the millet  and sorghum cultures with MRL of 0,05 mg/kg and safety security period of 84 days.

Products Covered: HS Code(s): 100820, 1007; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 27 July 2020 | Final date for Comment: 12 September 2020

This Draft resolution incorporates the following changes for the active ingredient C49 - CARFENTRAZONA-ETÍLICA (carfentrazone-ethyl) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of post-emergency use (application):-includes the millet  and sorghum cultures with MRL of 0,05 mg/kg and safety security period of 84 days.

Products Covered: HS Code(s): 100820, 1007; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 27 July 2020

This Technical Regulation establishes definitions, requirements, specifications, guarantees, tolerances, registration, packaging and labelling of organic fertilizers and biofertilizers, for agricultural use. It revokes the Technical Regulation No. 25, 23 July 2009.

Products Covered: Animal or vegetable fertilisers, whether or not mixed together or chemically treated; fertilisers produced by the mixing or chemical treatment of animal or vegetable products. (HS code(s): 3101); Fertilizers (ICS code(s): 65.080)

Regulation Type: Regular notification

Distribution date: 27 July 2020

This Technical Regulation establishes definitions, requirements, specifications, guarantees, tolerances, registration, packaging and labelling of organic fertilizers and biofertilizers, for agricultural use. It revokes the Technical Regulation No. 25, 23 July 2009.

Products Covered: Animal or vegetable fertilisers, whether or not mixed together or chemically treated; fertilisers produced by the mixing or chemical treatment of animal or vegetable products. (HS code(s): 3101); Fertilizers (ICS code(s): 65.080)

Regulation Type: Regular notification

Distribution date: 24 July 2020 | Final date for Comment: 22 September 2020

Purpose: This Notification provides for the matters to be observed by customized cosmetics sellers for the safety of procedures such as mixing customized cosmetics or dividing them into smaller quantities. The contents and raw materials used in customized cosmetics shall comply with the safety standards for cosmetics. The quality and safety of the final product shall be ensured by reviewing in advance the allowable range of mixture or division into smaller quantities. The shelf life for customized cosmetics shall be no longer than those of contents and raw materials. Customized cosmetics shall not be mixed or dividedin advance without identifying the skin type or preference of consumers.

Products Covered: Cosmetics (HS code 3303, 3304, 3305, 3307)

Regulation Type: Regular notification