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

The existing Mandatory Standard, SI 1147, dealing with the general requirements for elastic bandages, shall be declared voluntary. This declaration aims to remove unnecessary trade obstacles and lower trade barriers.These bandages are listed in the Israel Medical Devices Law 5772-2012, which requires pre-registering in a Recognized Country and presenting a CE or FDA certification proving compliance with European and/or US medical devices regulations or other recognized regulatory bodies. The registration process in the Medical Devices Register is sufficient, and there is no need for regulatory duplication or overlap.This standard is also being revised, as notified in G/TBT/N/ISR/1359. Should the revision process be completed before this declaration, it will apply to the newly revised standard, SI 1147. 

Products Covered: Elastic bandages (HS code(s): 300590); (ICS code(s): 11.120.20)

Regulation Type: Regular notification

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

The existing Mandatory Standard, SI 597 part 1, dealing with medical cotton wool, shall be declared voluntary. This declaration aims to remove unnecessary trade obstacles and lower trade barriers.These medical cotton wools are listed in the Israel Medical Devices Law 5772-2012, which requires pre-registering in a Recognized Country and presenting a CE or FDA certification proving compliance with European and/or US medical devices regulations or other recognized regulatory bodies. The registration process in the Medical Devices Register is sufficient, and there is no need for regulatory duplication or overlap.

Products Covered: Medical cotton wool (HS code(s): 300590; 560121); (ICS code(s): 11.040.30; 11.120.20; 59.080.99)

Regulation Type: Regular notification

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

The existing Mandatory Standard, SI 14079 part 2, dealing with gauze bandages, shall be declared voluntary. This declaration aims to remove unnecessary trade obstacles and lower trade barriers.These gauzes are listed in the Israel Medical Devices Law 5772-2012, which requires pre-registering in a Recognized Country and presenting a CE or FDA certification proving compliance with European and/or US Regulations for medical devices or other recognized regulatory bodies. The registration process in the Medical Devices Register is sufficient, and there is no need for duplication or regulatory overlap.

Products Covered: Non-active medical devices - Gauze bandages (HS code(s): 300590); (ICS code(s): 11.120.20)

Regulation Type: Regular notification

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

The existing Mandatory Standard, SI 14079 part 1, dealing with absorbent gauzes, shall be declared voluntary. This declaration aims to remove unnecessary trade obstacles and lower trade barriers.These gauzes are listed in the Israel Medical Devices Law 5772-2012, which requires pre-registering in a Recognized Country and presenting a CE or FDA certification proving compliance with European and/or US medical devices regulations or other recognized regulatory bodies. The registration process in the Medical Devices Register is sufficient, and there is no need for regulatory duplication or overlap.

Products Covered: Non-active medical devices - Absorbent gauzes (HS code(s): 300590); (ICS code(s): 11.120.20)

Regulation Type: Regular notification

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

The existing Mandatory Standard, SI 1147 part 1, dealing with 1:3 bandages, shall be declared voluntary. This declaration aims to remove unnecessary trade obstacles and lower trade barriers. These types of bandages are listed in the Israel Medical Devices Law 5772-2012, which requires pre-registering in a Recognized Country and presenting a CE or FDA certification proving compliance with European and/or US medical devices regulations or other recognized regulatory bodies. The registration process in the Medical Devices Register is sufficient, and there is no need for regulatory duplication or overlap.This standard is also being revised, as notified in G/TBT/N/ISR/1359. Should the revision process be completed before this declaration, it will apply to the newly revised standard, SI 1147. 

Products Covered: Elastic bandages (HS code(s): 300590); (ICS code(s): 11.120.20)

Regulation Type: Regular notification

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

The existing Mandatory Standard, SI 1228, dealing with zinc oxide elastic adhesive bandages, shall be declared voluntary. This declaration aims to remove unnecessary trade obstacles and lower trade barriers.These bandages are listed in the Israel Medical Devices Law 5772-2012, which requires pre-registering in a Recognized Country and presenting a CE or FDA certification proving compliance with European and/or US medical devices regulations or other recognized regulatory bodies. The registration process in the Medical Devices Register is sufficient, and there is no need for regulatory duplication or overlap.

Products Covered: Zinc oxid elastic adhesive bandage (HS code(s): 300510); (ICS code(s): 11.120.20)

Regulation Type: Regular notification

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

The existing Mandatory Standard, SI 1147 part 3, dealing with elastic bandages, shall be declared voluntary. This declaration aims to remove unnecessary trade obstacles and lower trade barriers.These types of bandages are listed in the Israel Medical Devices Law 5772-2012, which requires pre-registering in a Recognized Country and presenting a CE or FDA certification proving compliance with European and/or US medical devices regulations or other recognized regulatory bodies. The registration process in the Medical Devices Register is sufficient, and there is no need for regulatory duplication or overlap.This standard is also being revised, as notified in G/TBT/N/ISR/1359. Should the revision process be completed before this declaration, it will apply to the newly revised standard, SI 1147. 

Products Covered: Elastic bandages (HS code(s): 300590); (ICS code(s): 11.120.20)

Regulation Type: Regular notification

Distribution date: 11 March 2025

The substance of riboflavin 5′- phosphate monosodium salt was authorised as feed additive for all animal species other than aquatic by Commission Implementing Regulation (EU) 2019/901 for a 10-year period. The current Implementing Regulation (EU) 2025/182 is correcting the chemical formula in the characterisation of the active substance laid down in Implementing Regulation (EU) 2019/901, which was not correct.

Products Covered: Preparations of a kind used in animal feeding (HS code(s): 2309)

Regulation Type: Regular notification

Distribution date: 10 March 2025 | Final date for Comment: 03 May 2025

This proposal proposes to: - Prohibit the retail sale of a food that is caffeine and prohibit the addition of caffeine to foods for retail sale unless expressly permitted- Expressly permit the addition of caffeine to Formulated supplementary sports foods (FSSF), subject to compositional, packaging and labelling requirements.

Products Covered: Foods for retail sale in Australia and New Zealand in which caffeine has been added, including sports foods.

Regulation Type: Regular notification

Distribution date: 07 March 2025 | Final date for Comment: 06 May 2025

The European Food Safety Authority concluded that the chronic intake of inorganic arsenic via the diet and/or drinking water is associated with an increased risk of several adverse outcomes including lung, bladder and skin cancers and that the current exposure to inorganic arsenic raises a health concerns. In order to continue lowering the exposure of the population to inorganic arsenic, it is therefore appropriate to establish maximum levels for fish and other seafood, which contribute to that exposure. Therefore, the draft Regulation establishes new maximum levels for inorganic arsenic in fish, crustacean and bivalve molluscs, which are listed in the Annex to Regulation (EU) 2023/915.

Products Covered: Fish, crustaceans and bivalve molluscs

Regulation Type: Regular notification