Regulatory Updates

Draft Resolution of the Cabinet of Ministers of Ukraine “On Amendments to Paragraph 20 of the Technical Regulation on Detergents”

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Distribution date: 16 June 2023 | Final date for Comment: 15 August 2023

The draft Resolution is aimed to bring the provisions of the Technical regulation on detergents, approved by the Resolution of the Cabinet of Ministers of Ukraine No. 717 of 20.08.2008 (as amended)  in compliance with the Law of Ukraine "On the Public Health System" No. 2573-IX of 06.09.2022  with regard to excluding the conclusion of the state sanitary and epidemiological expertise from the list of documents that form the technical documentation submitted by business entities to confirm the compliance of detergents with the established requirements.As of today, Paragraph 20 of the Technical regulation stipulates that the manufacturer or its authorized representative, in order to confirm the compliance of the detergent with the requirements set forth in the Technical Regulation, should form the technical documentation, that includes in particular, the conclusion of the state sanitary and epidemiological expertise of the product issued in accordance with the established procedure.The draft Resolution  suggests aligning the provisions of the Technical regulation on detergents with the provisions of the Law of Ukraine "On the Public Health System", which cancels the need for business entities to obtain a conclusion of the state sanitary and epidemiological expertise to confirm the compliance of products with the established requirements from 01.10.2023. 

Products Covered: Detergents

Regulation Type: Regular notification

DRAFT FINAL REGULATION LEAD IN PAINT

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Distribution date: 09 June 2023 | Final date for Comment: 08 August 2023

This Regulation makes mandatory in ECOWAS Member States ECOSTAND 092-2022 for Paints and Varnishes –Lead in Paints - Specifications. This Regulation shall apply to Paints, Varnishes and Coating Materials manufactured, imported or sold in any of the ECOWAS Member States. 

Products Covered: Paints and Varnishes

Regulation Type: Regular notification

Partial amendment to the Minimum Requirements for Biological Products.Partial amendment to The Public Notice on National Release Testing.

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Distribution date: 09 June 2023 | Final date for Comment: 09 July 2023

The Minimum Requirements for Biological Products will be amended as follows;The standard name of “nucleoside modified coronavirus RNA Vaccine (SARS-CoV-2)” will be amended to “coronavirus (SARS-CoV-2) RNA Vaccine”. Accordingly, the test for pH, storage and expiry date will be deleted and partially amended for the above-mentioned vaccine. The Public Notice on National Release Testing will be amended as follows; The standard name of “nucleoside modified coronavirus RNA Vaccine (SARS-CoV-2)” will be amended to “coronavirus (SARS-CoV-2) RNA Vaccine”. In addition, the criterion of “Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio Haemophilus TYPE b Combined Vaccine” will be partially amended. Accordingly, the fee, criterion, and quantity for National Release Testing of the above-mentioned vaccine will be partially amended.

Products Covered: Pharmaceutical products (HS: 30)

Regulation Type: Regular notification

E09. COVID-19 TBT Human health

Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards, final rule)

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Distribution date: 09 June 2023

The proposed maximum residue limits (MRLs) for Zoxamide notified in G/SPS/N/JPN/1158 (dated 2 December 2022) were adopted and published on 26 April 2023.The specified MRLs are available as below:

Products Covered:  Natural honey (HS code: 04.09) Edible vegetables and certain roots and tubers (HS codes: 07.01, 07.02, 07.03, 07.07, 07.09 and 07.10) Edible fruit and nuts (HS codes: 08.03, 08.06, 08.07 and 08.11)

Regulation Type: Addendum to Regular Notification

Maximum residue limits (MRLs) Pesticides Food safety Human health Adoption/publication/entry into force of reg.

Draft Commission Regulation amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use of Vitamin A, Alpha-Arbutin and Arbutin and certain substances with potential endocrine disrupting properties in cosmetic products

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Distribution date: 08 June 2023 | Final date for Comment: 07 August 2023

The measures proposed by the draft Commission Regulation are part of the on-going and regular adaptations of the Annexes to Regulation (EC) No 1223/2009 (Cosmetics Regulation - CPR). Based on the latest scientific opinions by the Scientific Committee on Consumer Safety (SCCS) the proposed measures aim at: - prohibiting the use of 4-MBC (i.e., delisting this UV-filter from Annex VI and introducing it in Annex II to the CPR);- establishing restrictions in Annex III for the substance 'Genistein', used as skin conditioning/protecting and antioxidant in cosmetic products;- establishing restrictions in Annex III for the substance 'Daidzein', used as skin conditioning/protecting and antioxidant in cosmetic products;- establishing restrictions in Annex III for the substance 'Kojic Acid', used as skin lightening/whitening or depigmenting agent in cosmetic products;- further restricting the use of the preservative 'Triclosan' in cosmetic products by amending the existing restrictions in Annex V;- further restricting the use of the preservative 'Triclocarban' in cosmetic products by amending the existing restrictions in Annex V; - establishing restrictions in Annex III for the Vitamin A compounds ‘Retinol’, ‘Retinyl Acetate’ and ‘Retinyl Palmitate’ used as skin conditioning agent in cosmetic products;- establishing restrictions in Annex III for the substance ‘Alpha-Arbutin’ used as skin bleaching and skin conditioning agents in cosmetic products;- establishing restrictions in Annex III for the substance ‘Arbutin’ used as skin bleaching and skin conditioning agents in cosmetic products.

Products Covered: Cosmetics

Regulation Type: Regular notification

Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards, final rule)

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Distribution date: 08 June 2023

The proposed maximum residue limits (MRLs) for Pyraziflumid notified in G/SPS/N/JPN/1155 (dated 2 December 2022) were adopted and published on 26 April 2023.The specified MRLs are available as below:

Products Covered:  Meat and edible meat offal (HS codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) Dairy produce, birds' eggs and natural honey (HS codes: 04.01, 04.07, 04.08 and 04.09) Animal originated products (HS code: 05.04) Edible vegetables and certain roots and tubers (HS codes: 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10 and 07.13) Edible fruit and nuts, peel of citrus fruit (HS codes: 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11 and 08.14) Mate and spices (HS codes: 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS codes: 12.01 and 12.07) Animal fats and oils (HS codes: 15.01, 15.02 and 15.06)

Regulation Type: Addendum to Regular Notification

Maximum residue limits (MRLs) Pesticides Food safety Human health Adoption/publication/entry into force of reg.

Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards, final rule)

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Distribution date: 08 June 2023

The proposed maximum residue limits (MRLs) for Isopyrazam notified in G/SPS/N/JPN/1154 (dated 2 December 2022) were adopted and published on 26 April 2023.The specified MRLs are available as below:

Products Covered:  Meat and edible meat offal (HS codes: 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 codes: 04.01, 04.07 and 04.08)  Animal originated products (HS code: 05.04)  Edible vegetables and certain roots and tubers (HS codes: 07.02, 07.04, 07.05, 07.06, 07.07, 07.09 and 07.10) Edible fruit and nuts (HS codes: 08.03, 08.04, 08.06, 08.07, 08.08, 08.09, 08.10 and 08.11) Cereals (HS codes: 10.01, 10.02, 10.03, 10.04, 10.07 and 10.08) Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS codes: 12.02 and 12.05) Animal fats and oils (HS codes: 15.01, 15.02 and 15.06)

Regulation Type: Addendum to Regular Notification

Maximum residue limits (MRLs) Pesticides Food safety Human health Adoption/publication/entry into force of reg.

Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards, final rule)

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Distribution date: 08 June 2023

The proposed maximum residue limits (MRLs) for Flutriafol notified in G/SPS/N/JPN/1153 (dated 2 December 2022) were adopted and published on 26 April 2023.The specified MRLs are available as below:

Products Covered:  Meat and edible meat offal (HS codes: 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 codes: 04.01, 04.07 and 04.08) Animal originated products (HS code: 05.04) Edible vegetables and certain roots and tubers (HS codes: 07.02, 07.04, 07.05, 07.07, 07.09 and 07.10) Edible fruit and nuts (HS codes: 08.03, 08.06, 08.07, 08.08, 08.09, 08.10 and 08.11) Coffee (HS code: 09.01) Cereals (HS codes: 10.01, 10.03, 10.04, 10.05, 10.07 and 10.08) Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS codes: 12.01, 12.02, 12.05, 12.07, 12.10 and 12.12) Animal fats and oils (HS codes: 15.01, 15.02 and 15.06)

Regulation Type: Addendum to Regular Notification

Maximum residue limits (MRLs) Pesticides Food safety Human health Adoption/publication/entry into force of reg.

Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards, final rule)

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Distribution date: 08 June 2023

The proposed maximum residue limits (MRLs) for Trinexapac-ethyl notified in G/SPS/N/JPN/1157 (dated 2 December 2022) were adopted and published on 26 April 2023.The specified MRLs are available as below:

Products Covered:  Meat and edible meat offal (HS codes: 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 codes: 04.01, 04.07 and 04.08) Animal originated products (HS code: 05.04) Cereals (HS codes: 10.01, 10.02, 10.03, 10.04, 10.06, 10.07 and 10.08) Products of the milling industry (HS code: 11.03) Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS codes: 12.05 and 12.12) Animal fats and oils (HS codes: 15.01, 15.02 and 15.06)        

Regulation Type: Addendum to Regular Notification

Maximum residue limits (MRLs) Pesticides Food safety Human health Adoption/publication/entry into force of reg.

Specifications and Standards for Foods, Food Additives, Etc. under the Food Sanitation Act (Revision of agricultural chemical residue standards, final rule)

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Distribution date: 08 June 2023

The proposed maximum residue limits (MRLs) for Pyridalyl notified in G/SPS/N/JPN/1156 (dated 2 December 2022) were adopted and published on 26 April 2023.The specified MRLs are available as below:

Products Covered:  Fish and crustaceans, molluscs and other aquatic invertebrates (HS codes: 03.02, 03.03, 03.04, 03.06, 03.07 and 03.08) Edible vegetables and certain roots and tubers (HS codes: 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 (HS codes: 08.07, 08.10 and 08.11) Mate and spices (HS code: 09.03 and 09.10) Cereals (HS codes: 10.05 and 10.08) Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS codes: 12.01 and 12.12)

Regulation Type: Addendum to Regular Notification

Maximum residue limits (MRLs) Pesticides Food safety Human health Adoption/publication/entry into force of reg.

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