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

This Draft East African Standard specifies requirements, sampling and test methods for finished leather to be used in shoe uppers.

Products Covered: Footwear with uppers of leather or composition leather (excl. with outer soles of rubber, plastics, leather or composition leather and uppers of leather, orthopaedic footwear and toy footwear) (HS code(s): 640510); Headgear. Clothing accessories. Fastening of clothing (ICS code(s): 61.040)

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 finished leather to be used in shoe uppers.

Products Covered: Footwear with uppers of leather or composition leather (excl. with outer soles of rubber, plastics, leather or composition leather and uppers of leather, orthopaedic footwear and toy footwear) (HS code(s): 640510); Headgear. Clothing accessories. Fastening of clothing (ICS code(s): 61.040)

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 protective leather gloves used for general purpose. It excludes specialised gloves used for protection against medical, chemical and electrical purpose.

Products Covered: Gloves, mittens and mitts, of leather or composition leather (excl. special sports gloves) (HS code(s): 420329); Headgear. Clothing accessories. Fastening of clothing (ICS code(s): 61.040)

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 protective leather gloves used for general purpose. It excludes specialised gloves used for protection against medical, chemical and electrical purpose.

Products Covered: Gloves, mittens and mitts, of leather or composition leather (excl. special sports gloves) (HS code(s): 420329); Headgear. Clothing accessories. Fastening of clothing (ICS code(s): 61.040)

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 protective leather gloves used for general purpose. It excludes specialised gloves used for protection against medical, chemical and electrical purpose.

Products Covered: Gloves, mittens and mitts, of leather or composition leather (excl. special sports gloves) (HS code(s): 420329); Headgear. Clothing accessories. Fastening of clothing (ICS code(s): 61.040)

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 protective leather gloves used for general purpose. It excludes specialised gloves used for protection against medical, chemical and electrical purpose.

Products Covered: Gloves, mittens and mitts, of leather or composition leather (excl. special sports gloves) (HS code(s): 420329); Headgear. Clothing accessories. Fastening of clothing (ICS code(s): 61.040)

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 protective leather gloves used for general purpose. It excludes specialised gloves used for protection against medical, chemical and electrical purpose.

Products Covered: Gloves, mittens and mitts, of leather or composition leather (excl. special sports gloves) (HS code(s): 420329); Headgear. Clothing accessories. Fastening of clothing (ICS code(s): 61.040)

Regulation Type: Regular notification

Distribution date: 10 January 2025 | Final date for Comment: 11 March 2025

The draft Order has been developed to regulate the procedure for issuing or refusing to issue permits for parallel import of medicines, aligning the procedures for ensuring the compliance of medical immunobiological products with national and international standards, and conducting pharmacovigilance in accordance with the legislation on parallel import of medicines.The draft Order provides for the approval of the Procedure for granting permits for parallel import of medicines, which outlines a detailed mechanism for issuing or refusing to issue permits for parallel import of medicines, amending, suspending, renewing, cancelling, and terminating the validity of such permits by the State Service of Ukraine on Medicines and Drugs Control.As Ukrainian legislation on medicines specifies that all medicines imported into Ukraine for sale (trade) or use in the production of finished medicines are subject to state quality control, the draft Order proposes amendments to several regulatory acts of the Ministry of Health of Ukraine regarding the regulation parallel import of medicines. A list of the relevant regulatory acts is provided in item 8 of the notification. 

Products Covered: Medicines

Regulation Type: Revision to Regular Notification

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