European Commission to Evaluate GLP Directives
The European Commission has announced an evaluation of the two EU directives on GLP (Good Laboratory Practice). The evaluation will focus on cost-benefit analysis and burden reduction of the directives, assessing their relevance, effectiveness, coherence and efficiency. The implementation of the initiative in Member States will also be analysed.
The Principles of Good Laboratory Practice, ‘GLP’, are recommended by the OECD (Organisation for Economic Co-operation and Development). Signing countries are part of a legally binding council decision on the mutual acceptance of data in the assessment of chemicals. This ensures data generated in a member country in accordance with OECD Principles of Good Laboratory Practice (GLP) shall be accepted in other member countries.
There are two main factors triggering this evaluation. Firstly, the Commission commented that a 2019 ‘Fitness Check of the most relevant chemicals legislation (excluding REACH)’ identified some potential shortcomings of the GLP Directives (2004/9/EC and 2004/10/EC). The OECD is also reviewing the Council Act and Annexes establishing GLP, so it is important for the EU directives to reflect any changes.
This initiative is currently in the ‘Call for Evidence’ phase, and comments will be accepted until 6th June 2025. Commission adoption is planned for Q1 2026.
Initiative details may be found here.
European Commission to Update Glossary of Common Ingredient Names for Cosmetics
On 13th March 2025, the European Commission notified the WTO (World Trade Organisation) of a draft Commission Decision to update the glossary of common ingredient names for use in cosmetic products, repealing Implementing Decision (EU) 2022/677. The draft is expected to be approved in Q2 2025, coming into effect twenty days after its publication in the Official Journal of the Commission. The Glossary will include new INCI names published by the PCPC (Personal Care Products Council), as well as corrections to existing ingredient names and the removal of outdated names.
Article 19(1), point (g), of Regulation (EC) No 1223/2009 requires the labelling information on cosmetic products to include a list of ingredients. Article 33 of the Regulation states the Commission shall update and compile a glossary of common ingredient names to be used in the labelling of cosmetic products. Commission Implementing Decision (EU) 2022/677 sets out the glossary of common ingredient names in accordance with Article 33. The common ingredient name as per the Glossary must be included on the cosmetic product label at the latest twelve months after its publication in the Glossary.
You may read the notification details here.
Australia’s TGA Decision to Amend the Poisons Standard
On 14th March 2025, the Therapeutic Goods Administration (TGA) published a notice on proposed amendments to the Poisons Standard. The notice sets out the interim decisions, made by a delegate of the Secretary of the Department of Health and Aged Care responsible for scheduling of medicines and chemicals, relating to proposed amendments by applicants. Cosmetic ingredients mentioned include ethylene oxide/propylene oxide/epichlorohydrin (in trace amounts) and symphytum officinalis (comfrey).
For ethylene oxide/propylene oxide/epichlorohydrin, the applicant proposed preparations containing less than 0.002% (20 ppm) to be exempted from the Schedule 7 (Dangerous Poisons) entries for these substances. The Delegate has decided not to amend the current Poisons Standard in relation to these substances. However, the Advisory Committee on Medicines and Scheduling has recommended that the Schedule 7 entries for ethylene oxide, propylene oxide, and epichlorohydrin be amended to include an exemption cut-off of 0.001% (10 ppm) or less for each substance.
For Symphytum officinalis (comfrey), the proposal was to amend its Schedule 5 (Caution) entry to allow dermal preparations for cosmetic use to be unscheduled when containing concentrations of 20% or less of comfrey. The Delegate has decided not to amend the current Poisons Standard in relation to this substance, i.e. all dermal preparations of comfrey are to be retained in Schedule 5 with no exceptions.
The notice may be found here.
Japan MHLW Revises Quasi-Drug Standards
On 21st March 2025, Japan's MHLW (Ministry of Health, Labour and Welfare) published a notification on the partial revision of the Standards of Quasi-Drug Ingredients. The revision involves changes to test methods along with revised specifications for some ingredients. A transition period is now in place until 30th September 2026 to allow companies to comply.
Click here to open the notification.
