Regulatory Updates

Distribution date: 20 January 2025

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of myoglobin as a color additive in ground meat and ground poultry analogue products. We are taking this action in response to a color additive petition (CAP) submitted by Motif FoodWorks, Inc. (Motif FoodWorks or petitioner). This order is effective 19 February 2025.

Products Covered: HS Code(s): 20, 3203; ICS Code(s): 67

Regulation Type: Addendum to Regular Notification

Distribution date: 20 January 2025 | Final date for Comment: 21 March 2025

The notified Interministerial Order makes the implementation of three amendments compulsory. Each amendment relates to a standard that has been made mandatory. This measure is an exemption from the marketing authorization referred to in Article L255-2 of the Rural and Maritime Fishing Code and provided for in Article L255-5(1) thereof.

Products Covered: Organic fertilizers - fertilizing materials with an agronomic additive - basic mineral soil conditioners

Regulation Type: Regular notification

Distribution date: 20 January 2025

This letter introduces a temporary restriction on import of live poultry, poultry products, eggs, equipment for poultry, feed and feed additives for birds from New Zealand to the territory of the Russian Federation and on transit of live birds through the Russian territory due to the outbreak of highly pathogenic avian influenza in New Zealand.

Products Covered: Live poultry, egg products, meat and edible offal of poultry, poultry meat products, incubation egg of poultry, Incubation egg (except poultry egg), live bird (except poultry), feed and feed additives for birds, equipment for the maintenance, slaughter and cutting of birds (HS code(s): 0105; 0207; 0208; 0209; 0210; 0407; 0408; 0410; 0504; 0505; 0511; 1506; 1510; 1516; 1518; 1601; 1602; 1603; 190220; 190420; 2102; 2104; 2106; 2309; 2936; 3504; 3507; 3808; 3824; 3923; 3926; 4206; 4415; 4416; 4421; 7020; 7309; 7310; 7326; 7616; 843610; 84362; 843680; 860691; 8609; 8716; 950810; 9705)

Regulation Type: Emergency notifications (SPS)

Distribution date: 17 January 2025

 The Food and Drug Administration (FDA or we) is granting a color additive petition submitted by Center for Science in the Public Interest, et al., by repealing the color additive regulations that permit the use of FD&C Red No. 3 in foods (including dietary supplements) and in ingested drugs. The petitioners provided data demonstrating that this additive induces cancer in male rats. Therefore, FDA is revoking the authorized uses in food and ingested drugs of FD&C Red No. 3 in the color additive regulations. DATES: This order is effective 15 January 2027, except for amendatory instruction 4, which is effective 18 January 2028. If any provisions are delayed or stayed by the filing of proper objections, FDA will publish such notification in the Federal Register. Submit either electronic or written objections and requests for a hearing on the order by 18 February 2025.

Products Covered: Inorganic or mineral colouring matter, n.e.s.; preparations based on inorganic or mineral colouring matter of a kind used for colouring any material or produce colorant preparations (excl. preparations of heading 3207, 3208, 3209, 3210, 3213 and 3215); inorganic products of a kind used as luminophores, whether or not chemically defined (HS code(s): 3206); Food technology (ICS code(s): 67)

Regulation Type: Addendum to Regular Notification

Distribution date: 17 January 2025 | Final date for Comment: 18 March 2025

Proposal of maximum residue limits (MRLs) for the following agricultural chemical:Pesticide: Mandestrobin.

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)Aquatic animals and crustaceans, molluscs and other aquatic invertebrates (HS codes: 03.02, 03.03, 03.04, 03.06, 03.07 and 03.08)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, 07.07, 07.08, 07.09, 07.10 and 07.13)Edible fruit  (HS codes: 08.06, 08.07, 08.08, 08.09, 08.10 and 08.11)Tea, mate and spices (HS codes: 09.02, 09.03 and 09.10)Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS codes: 12.01 and 12.05)Animal fats and oils (HS codes: 15.01, 15.02 and 15.06)

Regulation Type: Regular notification

Distribution date: 17 January 2025

Proposal of maximum residue limits (MRLs) for the following agricultural chemical:Pesticide: Flupyrimin.

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)Aquatic animals and crustaceans, molluscs and other aquatic invertebrates (HS codes: 03.02, 03.03, 03.04, 03.06, 03.07 and 03.08)Dairy produce and birds' eggs (HS codes: 04.01, 04.07 and 04.08)Animal originated products (HS code: 05.04)Cereals (HS code: 10.06)Animal fats and oils (HS codes: 15.01, 15.02 and 15.06)

Regulation Type: Regular notification

Distribution date: 17 January 2025 | Final date for Comment: 18 March 2025

Proposal of maximum residue limits (MRLs) for the following agricultural chemical:Pesticide: Fluazinam.

Products Covered: Meat and edible meat offal (HS codes: 02.01, 02.02 and 02.06)Dairy produce and natural honey (HS codes: 04.01 and 04.09)Animal originated products (HS code: 05.04)Edible vegetables and certain roots and tubers (HS codes: 07.01, 07.03, 07.04, 07.05, 07.06, 07.09, 07.10, 07.13 and 07.14)Edible fruit and peel of citrus fruit (HS codes: 08.04, 08.05, 08.06, 08.08, 08.09, 08.10, 08.11 and 08.14)Tea, mate and spices (HS codes: 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10)Cereals (HS code: 10.01)Oil seeds and oleaginous fruits, miscellaneous grains, seeds and fruit (HS codes: 12.02, 12.07 and 12.12)Animal fats and oils (HS code: 15.02)

Regulation Type: Regular notification

Distribution date: 16 January 2025 | Final date for Comment: 17 March 2025

This measure will amend Regulation (EC) No 1223/2009 (“the Cosmetics Regulation”) as it applies in Great Britain to restrict the use of methyl salicylate in a number of cosmetic products.

Products Covered: Cosmetic products are defined by Article 2(1)(a) of Regulation (EC) No 1223/2009. ESSENTIAL OILS AND RESINOIDS; PERFUMERY, COSMETIC OR TOILET PREPARATIONS (HS code(s): 33)

Regulation Type: Regular notification

Distribution date: 14 January 2025 | Final date for Comment: 15 March 2025

The proposed amendments aim to:  A. Support the reduction of time and cost required for developing standards and test methods by developing monographs of unregistered medicines of the Korean Pharmacopoeia. B. Distribute high-quality medicines by improving some standards, specifications, and general tests to meet the latest scientific standards, reflecting difficulties from the pharmaceutical industries. The main points of the amendments are as follows: A. Establishment of monographs for unregistered medicines and amendment of official substances (Refer to Annex 3, Annex 4, and Annex 5 of the draft) B. Establishment of tests in General Information (Refer to Annex 6 of the draft)- Establishment of alternative animal tests for pyrogen tests- Establishment of information on leachable/extract content management for quality control of containers/packaging or drug delivery system (DDS) C.  Establishment of the second quantitative method for 5 items including “Kamisoyosan Extract Granules” and amendment of Korean names of residual pesticides (24 types) in  purity tests for 155 items including “Terminalia Fruit” in Part Ⅱ of Monographs (Refer to Annex 4 of the draft)) D. Amendment of Korean names of residual pesticides in crude drug tests and reference standards, and change of range for measuring thiamethoxam, of General Tests (Refer to Annex 5 of the draft)

Products Covered: (HS code(s): 3002; 3004; 3006), Pharmaceuticals

Regulation Type: Regular notification

Distribution date: 13 January 2025 | Final date for Comment: 14 March 2025

This Draft East African Standard specifies requirements, sampling and test methods for men, women and children’s belts made from coated or synthetic material.

Products Covered: Men's or boys' overcoats, car coats, capes, cloaks, anoraks, incl. ski jackets, windcheaters, wind-jackets and similar articles (excl. knitted or crocheted, suits, ensembles, jackets, blazers and trousers) (HS code(s): 6201); Headgear. Clothing accessories. Fastening of clothing (ICS code(s): 61.040)

Regulation Type: Regular notification