Distribution date: 14 September 2022

This Resolution establishes a temporary optimized analysis procedure, in which the analyzes conducted by an Equivalent Foreign Regulatory Authority are used for the verified analysis of the market authorization and post-market authorization petitions of medicines, biological products and their inputs, and the letter of adequacy of the pharmaceutical ingredient dossier active. This Resolution is valid for 180 (one hundred and eighty) days from the date of its entry into force.

Products Covered: Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale. (HS code(s): 3003); Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale. (HS code(s): 3004)

Regulation Type: Regular notification

Distribution date: 14 September 2022

This Resolution contains provisions on validation and permeability assays with Caco-2 cells.  

Products Covered: Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale. (HS code(s): 3003); Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale. (HS code(s): 3004)

Regulation Type: Regular notification

Distribution date: 14 September 2022

The proposal notified in G/SPS/N/EU/491 (26 May 2021) is now adopted by Commission Regulation (EU) 2022/860 of 1 June 2022 amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards monacolins from red yeast rice (Text with EEA relevance) [OJ L 151, 2 June 2022, p. 37]. This Regulation entered into force on the twentieth day following its publication in the Official Journal of the European Union.

Products Covered: Food supplements

Regulation Type: Addendum to Regular Notification

Distribution date: 07 September 2022

This addendum is to inform that the ministerial regulation mandates Synthetic Dyestuffs: Reactive Dye to conform with the standard, B.E. 2565(2022).This regulation will enter into force on 19 August 2023.

Products Covered: Synthetic organic colouring matter, whether or not chemically defined; preparations based on synthetic organic colouring matter of a kind used to dye fabrics or produce colorant preparations; synthetic organic products of a kind used as fluorescent brightening agents or as luminophores, whether or not chemically defined (excl. preparations of heading 3207, 3208, 3209, 3210, 3213 and 3215) (HS code(s): 3204); Pigments and extenders (ICS code(s): 87.060.10)

Regulation Type: Addendum to Regular Notification

Distribution date: 07 September 2022

This addendum is to inform that the ministerial regulation mandates Synthetic Dyestuffs: Vat Dye to conform with the standard, B.E. 2565(2022).This regulation will enter into force on 19 August 2023.

Products Covered: Synthetic organic colouring matter, whether or not chemically defined; preparations based on synthetic organic colouring matter of a kind used to dye fabrics or produce colorant preparations; synthetic organic products of a kind used as fluorescent brightening agents or as luminophores, whether or not chemically defined (excl. preparations of heading 3207, 3208, 3209, 3210, 3213 and 3215) (HS code(s): 3204); Pigments and extenders (ICS code(s): 87.060.10)

Regulation Type: Addendum to Regular Notification

Distribution date: 07 September 2022

This addendum is to inform that the ministerial regulation mandates Synthetic Dyestuffs: Acid Dye to conform with the standard, B.E. 2565(2022).This regulation will enter into force on 19 August 2023.

Products Covered: Synthetic organic colouring matter, whether or not chemically defined; preparations based on synthetic organic colouring matter of a kind used to dye fabrics or produce colorant preparations; synthetic organic products of a kind used as fluorescent brightening agents or as luminophores, whether or not chemically defined (excl. preparations of heading 3207, 3208, 3209, 3210, 3213 and 3215) (HS code(s): 3204); Pigments and extenders (ICS code(s): 87.060.10)

Regulation Type: Addendum to Regular Notification

Distribution date: 07 September 2022

This addendum is to inform that the ministerial regulation mandates Synthetic Dyestuffs: Direct Dye to conform with the standard, B.E. 2565(2022).This regulation will enter into force on 19 August 2023.

Products Covered: Synthetic organic colouring matter, whether or not chemically defined; preparations based on synthetic organic colouring matter of a kind used to dye fabrics or produce colorant preparations; synthetic organic products of a kind used as fluorescent brightening agents or as luminophores, whether or not chemically defined (excl. preparations of heading 3207, 3208, 3209, 3210, 3213 and 3215) (HS code(s): 3204); Pigments and extenders (ICS code(s): 87.060.10)

Regulation Type: Addendum to Regular Notification

Distribution date: 07 September 2022

This addendum is to inform that the ministerial regulation mandates Synthetic Dyestuffs: Sulphur Dye to conform with the standard, B.E. 2565(2022).This regulation will enter into force on 19 August 2023.

Products Covered: Synthetic organic colouring matter, whether or not chemically defined; preparations based on synthetic organic colouring matter of a kind used to dye fabrics or produce colorant preparations; synthetic organic products of a kind used as fluorescent brightening agents or as luminophores, whether or not chemically defined (excl. preparations of heading 3207, 3208, 3209, 3210, 3213 and 3215) (HS code(s): 3204); Pigments and extenders (ICS code(s): 87.060.10)

Regulation Type: Addendum to Regular Notification

Distribution date: 07 September 2022 | Final date for Comment: 06 November 2022

Proposal of maximum residue limits (MRLs) for the following agricultural chemicalPesticide: Glufosinate

Products Covered: Meat and edible meat offal (HS: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09)Dairy produce and birds' eggs (HS: 04.01, 04.07 and 04.08)Animal originated products (HS: 05.04)Edible vegetables and certain roots and tubers (HS: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14)Edible fruit and nuts, peel of citrus fruit (HS: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14)Coffee, tea, mate and spices (HS: 09.01, 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10)Cereals (HS: 10.01, 10.03, 10.04, 10.05 and 10.06)Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS: 12.01, 12.02, 12.05, 12.06, 12.07, 12.10 and 12.12)Animal or vegetable fats and oils (HS: 15.01, 15.02, 15.06, 15.12 and 15.14)

Regulation Type: Regular notification

Distribution date: 07 September 2022 | Final date for Comment: 06 November 2022

Proposal of maximum residue limits (MRLs) for the following agricultural chemicalPesticide: Penthiopyrad

Products Covered: Meat and edible meat offal (HS: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09)Dairy produce and birds' eggs  (HS: 04.01, 04.07 and 04.08)Animal originated products (HS: 05.04)Edible vegetables and certain roots and tubers (HS: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14)Edible fruit and nuts, peel of citrus fruit (HS: 08.01, 08.02, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14)Mate and spices (HS: 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10)Cereals (HS: 10.01, 10.02, 10.03, 10.04, 10.05, 10.07 and 10.08)Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS: 12.01, 12.02, 12.05, 12.06, 12.07 and 12.12)Animal fats and oils (HS: 15.01, 15.02 and 15.06)        

Regulation Type: Regular notification