Regulatory Updates

Distribution date: 17 July 2025

Proposal of maximum residue limits (MRLs) for the following agricultural chemical:Veterinary drug:  Prallethrin.

Products Covered: Meat and edible meat offal (HS codes: 02.01, 02.02, 02.03, 02.06, 02.07 and 02.09)Dairy produce and birds' eggs (HS codes: 04.01, 04.07 and 04.08)Animal originated products (HS code: 05.04)Animal fats and oils (HS codes: 15.01 and 15.02)

Regulation Type: Regular notification

Distribution date: 16 July 2025

Acetamiprid is an approved active substance in Great Britain. The Health and Safety Executive received an application to set a new Maximum Residue Level (MRL) for acetamiprid in strawberries. Following the assessment, a new MRL has been introduced to accommodate a new authorisation of a plant protection product in Great Britain. The Evaluation Report/ Reasoned Opinion supporting the new MRL is available at the following link: The evaluation of a new MRL for acetamiprid in or on strawberries. The residue levels arising in food from the notified uses result in consumer exposures below the toxicological reference values and therefore harmful effects on human health are not expected. As the residue levels exceed the current MRLs in force, new MRLs are being adopted.  

Products Covered: Strawberries (0152000)  * For reference, the full list of GB commodity codes is set out in Part 1 of the GB pesticides Maximum Residue Level Statutory Register – see link). 

Regulation Type: Regular notification

Distribution date: 16 July 2025

Potassium phosphonates is an approved active substance in Great Britain. The Health and Safety Executive received an application to set a new Maximum Residue Level (MRL) for mangoes. Following the assessment, a new MRL has been introduced to accommodate an import tolerance on potassium phosphonates in mangoes.  The Evaluation Report/ Reasoned Opinion supporting the new MRL is available at the following link: The evaluation of a new MRL for potassium phosphonates in or on mangoes. The residue levels arising in food from the notified uses result in consumer exposures below the toxicological reference values and therefore harmful effects on human health are not expected. As the residue levels exceed the current MRL in force, a new MRL is being adopted. There are no CXLs  for potassium phosphonates on mangoes, nor for fosetyl aluminium (which can include residues arising from the use of potassium phosphonates) on mangoes.

Products Covered: Mangoes (0163030)  * For reference, the full list of GB commodity codes is set out in Part 1 of the GB pesticides Maximum Residue Level Statutory Register – see link).

Regulation Type: Regular notification

Distribution date: 09 July 2025 | Final date for Comment: 07 September 2025

Inclusion, in Appendix A to Annex II of Directive 2009/48/EC (List of CMR substances and their permitted uses in accordance with points 4, 5 and 6 of Part III) of three entries (derogations) for:In toys and toy components made of stainless steel, as an impurity in the nickel contained in the stainless steel.In toy components which are intended to conduct an electric current.In neodymium-based magnets (NdFeB magnets) used in toys if those magnets cannot be swallowed or inhaled

Products Covered: Children's toys, i.e. products designed or intended, whether or not exclusively, for use in play by children under 14 years of age.

Regulation Type: Regular notification

Distribution date: 08 July 2025

The present Order was issued for the implementation of Law No. 403/2023 on the placing on the market of plant protection products and for the amendment of certain legislative acts. Furthermore, the provisions of this Order transpose the requirements of Annex III to Regulation (EC) No. 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC.These provisions aim to align national regulations with EU standards, thereby facilitating the placing on the market of plant protection products, promoting their free movement, and ensuring that agricultural producers have access to the necessary products containing acceptable co-formulants. This contributes to the protection of public health, the environment, and consumer safety.The annexed list of unacceptable co-formulants prohibits their use in plant protection products, aligning the Republic of Moldova framework with EU rules and helping to ensure safety and transparency in international trade.

Products Covered: Miscellaneous chemical products (HS code(s): 38); Detailed HS code: Plant protection products: 3808

Regulation Type: Regular notification

Distribution date: 08 July 2025

The present Order was issued for the implementation of Article 5, paragraph (1) of Law No. 403 of 21 December 2023 on the placing on the market of plant protection products and the amendment of certain legislative acts. It also transposes Commission Implementing Regulation (EU) No. 540/2011 of 25 May 2011, implementing Regulation (EC) No. 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances. The purpose of these provisions is to harmonize the authorization procedure for plant protection products with the European Union's authorization procedures, aiming to prevent risks through a comprehensive risk assessment process for each active substance and for the products containing that substance, before they are authorized for marketing and use. At the same time, these provisions aim to enhance the transparency of the regulatory process, providing clarity for manufacturers and distributors regarding the substances allowed on the market, thereby improving food safety, environmental quality, and supporting agricultural exports.

Products Covered: Miscellaneous chemical products (HS code(s): 38); Detailed HS code: Plant protection products: 3808

Regulation Type: Regular notification

Distribution date: 07 July 2025 | Final date for Comment: 05 September 2025

Technical Standard No. 82, version 01-2025, seeks to establish requirements for demonstrating the bioequivalence and therapeutic equivalence of multi-origin medicines in order to guarantee their safety, quality and efficacy. It applies to multi-origin medicines manufactured in Guatemala and those imported by natural or legal persons that must demonstrate therapeutic equivalence, for the purpose of applying for and maintaining sanitary registration with the Department for the Regulation and Control of Pharmaceutical and Related Products.

Products Covered: Medicaments (excluding goods of heading 3002, 3005 or 3006) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale (HS code(s): 3003); Medicaments (excluding goods of heading 3002, 3005 or 3006) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale (HS code(s): 3004)

Regulation Type: Regular notification

Distribution date: 07 July 2025 | Final date for Comment: 23 July 2025

Updating Appendix No. 1 to the Rules of Good Manufacturing Practice (Requirements for the Production of Sterile Medicines), taking into account updated approaches to the production of sterile products, the emergence of new technologies for their production (including new technologies for sterilization and aseptic production), revision of international acts in the field of sterile products (documents of the International Council for Harmonization (ICH)), as well as the law enforcement practices of the authorized bodies of the member States of the Eurasian Economic Union

Products Covered: 3003 , 3004 (Pharmaceuticals)

Regulation Type: Regular notification

Distribution date: 04 July 2025 | Final date for Comment: 03 August 2025

The Therapeutic Goods Administration (TGA) administers Australia’s regulatory framework for the quality, safety and efficacy of therapeutic goods in Australia.There are provisions under the Therapeutic Goods Act 1989 (the Act) to establish Manufacturing Principles that are to be applied in the manufacture of therapeutic goods. The Therapeutic Goods (Manufacturing Principles) Determination 2020 (the Determination) is the legislative instrument that specifies the manufacture of therapeutic goods must comply with the applicable procedures and requirements in the Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guide to Good Manufacturing Practice (GMP).As a PIC/S member, Australia is expected to adopt and enforce the latest revisions to the GMP guide to achieve international harmonisation between member countries. Adoption of the PIC/S Guide to GMP as Australia’s Manufacturing Principles negates the need for Australian-specific standards, facilitates international trade and supports our international reputation. The TGA is proposing to amend the Determination to adopt version 17 of the PIC/s Guide to GMP except for Annexes 4, 5 and 14 as the manufacturing principles and register the amended Determination on the Federal Register of Legislation in September 2025.The adoption of an internationally harmonised standard minimises regulatory burden for companies involved in the manufacture, import and export of medicines, facilitating trade and helping to ensure the availability of medicines to the Australian public.  Please note: The uploaded measure is the current version of the Determination. A legislative instrument will be used to amend the definition of PIC/S Guide to GMP under Section 4 of the Determination to reflect Version 17 except for Annexes 4, 5 and 14. 

Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30)

Regulation Type: Regular notification

Distribution date: 04 July 2025

Proposal for the additional designation of 3 substances as Shitei Yakubutsu, and their proper uses under the Act.

Products Covered: Substances with probable effects on the central nervous system

Regulation Type: Regular notification