Regulatory Updates

Distribution date: 09 January 2025

This draft Commission Implementing Regulation provides that the approval of the active substance flufenacet is not renewed in accordance with Regulation (EC) No 1107/2009. EU member States shall withdraw authorizations for plant protection products containing flufenacet as an active substance. The non-renewal of approval is based on the first evaluation of the substance for use as a pesticide active substance in the EU under Regulation (EC) No 1107/2009. The substance was formerly assessed and approved under Directive 91/414/ EEC.  In order for an active substance to be approved in accordance with Regulation (EC) No 1107/2009 (concerning the placing of plant protection products on G/TBT/N/EU/1105 - 2 - the market), it must be demonstrated that the substance is not harmful to human health, animal health or the environment. Criteria are listed in Article 4 of the Regulation (and also detailed in Annex II thereto) which must be met to enable approval.  During the evaluation and peer-review of flufenacet, a number of concerns and areas that could not be finalized were identified. These are detailed in the statement of the European Food Safety Authority (EFSA).  Flufenacet meets the criteria in points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 to be identified as an endocrine disruptor for the thyroid (T)-modality for humans and non-target organisms and it has not been demonstrated that the exposure of humans and non-target organisms to that active substance in a plant protection product, under realistic proposed conditions of use, is negligible.  High potential for contamination of ground water with trifluoroacetic acid was identified and that metabolite is considered to be to toxicologically relevant.  The risk assessment could not be finalized with respect to the non-relevance assessment of groundwater metabolites and the risks for the consumers.  These concerns mean that flufenacet does not meet the approval criteria as outlined in Regulation (EC) No 1107/2009. This decision only concerns the placing on the market of this substance and plant protection products containing it. Following non-approval and the expiry of all grace periods for stocks of products containing this substance, separate action will likely be taken on MRLs and a separate notification will be made in accordance with SPS procedures.  This draft Commission Implementing Regulation was also notified under the TBT Agreement in notice G/TBT/N/EU/1105.

Products Covered: Flufenacet (pesticide active substance)

Regulation Type: Regular notification

Distribution date: 09 January 2025

The Food and Drug Administration (FDA or we) is announcing its determination that the Food Contact Notifications (FCNs) listed in this notice are no longer effective. Several manufacturers notified FDA in writing that they ceased producing, supplying, or using the listed food contact substances (FCSs) for their intended use in the United States. We are taking this action in accordance with the process set out in our regulations, by which FDA may determine that an FCN is no longer effective.  DATES: Applicable date: This determination for the FCNs listed in table 1 and table 2 is effective 6 January 2025. Compliance date: 30 June 2025, is the compliance date for the FCSs listed in table 2 that were produced, supplied, or used by the manufacturer or supplier prior to the effective date of this determination. 

Products Covered: HS Code(s): 3923, 3924, 4811; ICS Code(s): 67

Regulation Type: Addendum to Regular Notification

Distribution date: 09 January 2025

The Committee for Veterinary Control and Surveillance of the Ministry of Agriculture of Kazakhstan reports that on the basis of the official notification of the World Organisation for Animal Health (WOAH), an outbreak of highly pathogenic avian influenza was registered in the Konya region of Türkiye. In this regard, since 28 November 2024, temporary restrictions have been introduced on the importation to the territory of Kazakhstan from the territory of the Konya region of Türkiye of live poultry and hatching eggs, down and feathers, poultry meat and all types of poultry products that have not undergone heat treatment (at least 70 °C), feed and feed additives for birds (except for feed additives of chemical and microbiological synthesis), hunting trophies that have not undergone taxidermy (game birds), used equipment for keeping, slaughtering and cutting birds, as well as for transit from the above territory through the territory of Kazakhstan of live birds.

Products Covered: Live poultry and hatching eggs, down and feathers, poultry meat and all types of poultry products, feed and feed additives for birds, hunting trophies, used equipment for keeping, slaughtering and cutting birds

Regulation Type: Emergency notifications (SPS)

Distribution date: 09 January 2025

The Committee for Veterinary Control and Surveillance of the Ministry of Agriculture of Kazakhstan reports that on the basis of the official notification of the World Organisation for Animal Health (WOAH) and the Animal and Plant Health Inspection Service of the United States Department of Agriculture (APHIS), an outbreak of highly pathogenic avian influenza was registered in States of Illinois and Arizona of the United States of America. In this regard, since 29 November 2024, temporary restrictions have been introduced on the importation to the territory of Kazakhstan from the territory of the States of Illinois and Arizona of the United States of America of live poultry and hatching eggs, down and feathers, poultry meat and all types of poultry products that have not undergone heat treatment (at least 70 °C), feed and feed additives for birds (except for feed additives of chemical and microbiological synthesis), hunting trophies that have not undergone taxidermy (game birds), used equipment for keeping, slaughtering and cutting birds, as well as for transit from the above territory through the territory of Kazakhstan of live birds.

Products Covered: Live poultry and hatching eggs, down and feathers, poultry meat and all types of poultry products, feed and feed additives for birds, hunting trophies, used equipment for keeping, slaughtering and cutting birds

Regulation Type: Emergency notifications (SPS)

Distribution date: 09 January 2025 | Final date for Comment: 10 March 2025

The notified draft Order of the National Office for Food Safety aims primarily to: • define products that are part of emulsified sauces (mayonnaise, mayonnaise sauce, salad sauce, etc.) as well as products that are classed as non-emulsified sauces (ketchup, soy sauce, mustard, Dijon mustard, old-style mustard, sweet mustard, chilli sauce, harissa, tomato sauce, etc.); • Determine the physico-chemical characteristics of marketed sauces; • Determine the ethanol content due to fermentation or as a flavouring, which must not exceed 0.5% (v/v) in marketed sauces.

Products Covered: Marketed sauces

Regulation Type: Regular notification

Distribution date: 08 January 2025 | Final date for Comment: 09 March 2025

This East African Draft Standard specifies requirements, sampling and test methods for chlorine bleach and liquid oxygen-based solution intended for domestic, professional and Industrial uses.

Products Covered: Organic surface-active agents (excl. soap); surface-active preparations, washing preparations, incl. auxiliary washing preparations, and cleaning preparations, whether or not containing soap (excl. those of heading 3401) (HS code(s): 3402); Surface active agents (ICS code(s): 71.100.40)

Regulation Type: Regular notification

Distribution date: 08 January 2025 | Final date for Comment: 09 March 2025

This Draft East African Standard specifies the requirements, sampling and test methods for household laundry detergents powders (hand wash, machine wash or both etc)

Products Covered: Organic surface-active agents (excl. soap); surface-active preparations, washing preparations, incl. auxiliary washing preparations, and cleaning preparations, whether or not containing soap (excl. those of heading 3401) (HS code(s): 3402); Surface active agents (ICS code(s): 71.100.40)

Regulation Type: Regular notification

Distribution date: 08 January 2025 | Final date for Comment: 09 March 2025

This Draft East African Standard specifies the requirements, sampling and test methods for household laundry detergents powders (hand wash, machine wash or both etc)

Products Covered: Organic surface-active agents (excl. soap); surface-active preparations, washing preparations, incl. auxiliary washing preparations, and cleaning preparations, whether or not containing soap (excl. those of heading 3401) (HS code(s): 3402); Surface active agents (ICS code(s): 71.100.40)

Regulation Type: Regular notification

Distribution date: 08 January 2025 | Final date for Comment: 09 March 2025

This Draft East African Standard specifies the requirements, sampling and test methods for household laundry detergents powders (hand wash, machine wash or both etc)

Products Covered: Organic surface-active agents (excl. soap); surface-active preparations, washing preparations, incl. auxiliary washing preparations, and cleaning preparations, whether or not containing soap (excl. those of heading 3401) (HS code(s): 3402); Surface active agents (ICS code(s): 71.100.40)

Regulation Type: Regular notification

Distribution date: 08 January 2025

Resolution 753, 28 September 2022 - previously notified through G/TBT/N/BRA/1095/Add.3 - which establishes criteria for the concession of market authorization for medicines with synthetic and semisynthetic active principles for human use categorized as new, innovative, generic, and similar, was changed by Resolution 948, 12 December 2024.    

Products Covered: 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 for 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 subheadings 3006.10.10 to 3006.60.90 (HS code(s): 3006); Pharmaceutics (ICS code(s): 11.120)

Regulation Type: Addendum to Regular Notification