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Regulation (EU) 2023/1545-labeling of fragrance allergens in cosmetic products

In the European market, the Cosmetic Regulation (EC) No 1223/2009 governs the release of cosmetic products and restricts the use of substances that may cause allergic reactions in consumers.

On July 26, 2023, the EU Commission published Regulation (EU) 2023/1545, amending Annex III of the Cosmetics Regulation (EC) 1223/2009 with regards to individual labelling requirements of fragrance allergens in cosmetic products.

The EU Regulation 2023/1545 amended the Annex III of the Cosmetics Regulation (EC) 1223/2009 by adding 56 new substances to the current list of 24 fragrance allergens, and these substances must be declared on labels when present in cosmetic products in concentrations exceeding 0.01% in rinse-off products and 0.001% in leave-on products.

Transitional periods

For new cosmetic products containing one of the new allergens and entering the EU market must comply with the new requirements by July 31, 2026 (within 3 years).

For cosmetic products already present on the EU market, the deadline for compliance is extended to 5 years until July 31, 2028.

For more information about fragrance allergens, please contact us at email: info@toxregulatoryaffairs.com

The Danish Medicines Agency (DMA) released a new guidance on Medical Cannabis

March 22, 2023

Attention medical cannabis professionals and manufactures of Danish made cannabis products!

On January 17, 2023, the Danish Medicines Agency released a new guideline for companies wishing to include cannabis products which are made from cannabis grown in Denmark in “the Medical Cannabis Pilot Programme”.

Brief about the medical Cannabis pilot programme:
December 15, 2017, the Danish Parliament passed the “Act on a Medical Cannabis Pilot Programme”, which came into force on January 1, 2018, and will run until December 31, 2025. The purpose of the pilot programme is to offer patients legal access to medical cannabis treatment if they have not benefited from authorized conventional medicines. Secondly, the Pilot Programme also allows cultivation and production of medical cannabis products in Denmark. Thus, companies are licensed by DMA to cultivate, produce, sell, and export medical cannabis materials and finished products. With this “Pilot Programme” medical cannabis was legalized in Denmark for dispense from a pharmacy where a physician has issued a prescription to the patient. The guideline provides, among other things, practical instructions for applications and the documentation required. For details on the  new guideline in Danish check out: https://laegemiddelstyrelsen.dk/da/nyheder/2023/ny-vejledning-til-forsoegsordningen-om-cannabisprodukter/

At Tox Regulatory Advisor we can assist you with preparation and submission of applications for cannabis intermediate products and imported cannabis primary products. 

Please contact us at info@toxregulatoryaffairs.com

MDCG 2023-1- Guidance on when In-house medical devices are exempt from MDR and IVDR

February 2023

Attention Medical device and IVD professionals!

January 10, 2023, the Medical Device Coordination Group (MDCG) released a new guidance on EU health institutions (in-house devices) exemption under Article 5(5) of Regulations (EU) 2017/745 medical devices Regulation, MDR) and (EU) 2017/746 (in vitro diagnostic medical devices Regulation, IVDR).

In-house medical devices are exempted from most of the provisions of MDR and IVDR provided that the health institution adheres to the requirements laid out in Article 5(5) of the relevant Regulation.

The Guidance is relevant for healthcare professionals and researchers of health institutions who aim to design, manufacture, modify and use in-house devices.
Check out: https://lnkd.in/dFyGUPTt

SPC IUCLID format replaces SPC Editor

February 2023

ECHA has announced that by the end of 2023, summary of product characteristics (SPCs) must be prepared in. i6z file format instead of the current SPC Editor. The new format is compatible with IUCLID. Additionally, the SPC dossiers must in the future be archived in IUCLID Cloud and used for product applications in the application system R4BP 3.

To prepare for the transition, a package of supporting material is now available on ECHA´s website to help companies implement the SPC IUCLID format.
At Tox Regulatory Advisor we can assist you with preparation of your biocidal product dossiers.

Please contact us at info@toxregulatoryaffairs.com

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