Will CBD be legalized in Israel?
Cannabis-derived ingredients, particularly CBD, are trendy compounds in the cosmetic industry. Overall, countries are adapting their legislations and allowing the use of CBD products. The Health Ministry of Israel has set up a Committee to look into legalizing CBD.
Picture of Marta Pinto

Marta Pinto

Regulatory Affairs Associate

CANNABIS PLANT AND CANNABIDIOL

Cannabidiol (CBD) is one of many different cannabinoids found and extracted from hemp (Cannabis sativa or Cannabis indica). Cannabidiol is normally located in the aerial parts of the plants (flowers, stems and leaves) and not in the roots or seeds. Although CBD is chemically similar to Tetrahydrocannabinol (THC), Cannabidiol does not cause a psychoactive effect (e.g. euphoric effects). Cannabigerol (CBG), another cannabinoid extracted from the plant, is a precursor molecule that can converted into other cannabinoids (like THC and CBD) during plant growth and is gaining more and more attention by consumers and the cosmetic industry. (see previous post)

The World Health Organization (WHO) concluded on its Critical Review Report on CBD that this cannabinoid is generally well tolerated with a good safety profile. Several countries have adapted and modified their regulations to allow the use of CBD in a variety of products.

CBD IN ISRAEL

Israel is considered one of the world leaders in medical cannabis consumption. Nevertheless, Israel has stringent regulations regarding the research, cultivation, processing, distribution and sale of cannabis.

The Israel’s Health Ministry issued a press release indicating the a Committee for evaluating the impact of excluding materials or products that contain CBD from the Dangerous Drugs Ordinance began operating. The press release also invited any parties of interest to present their position by email (until 28 December 2021).

The Committee is evaluating the impact of revoking the definition of CBD as a dangerous drug (under the Dangerous Drug Ordinance) in a way that will allow the sale of products containing this ingredient. Particular emphasis will be given to the potential use of CBD in the food and cosmetic industry.

How different countries approach the use of CBD will be analyzed by the Committee, as well as, necessary safety limits and how to ensure the implementation of the rules.

If you need any information regarding cosmetic products containing CBD and the applicable regulations, please do not hesitate to contact us at info@criticalcatalyst.com.

References:

  1. Ministry of Health. The Committee for Evaluating the Impact of Excluding Materials or Products that Contain CBD from the Dangerous Drugs Ordinance Began Operating and Invites any Parties of Interest to Present Their Position. . Press Releases. 22.12.2021.
  2. Israel to look into legalizing CBD. The Jerusalem Post. December, 2021.
  3. World Health Organization. Cannabidiol (CBD) – Critical Review Report. Expert Committee on Drug Dependence Fortieth Meeting. 2018

further
reading

medical devices

Safety Reporting in Clinical Investigations: a Gap Analysis of Guidance Documents 

Safety reporting in clinical investigations of medical devices shall be performed in line with Article 80(2) of the EU MDR. On May 2020, it was published the MDCG 2020-10/1, outlining the procedures for safety reporting in clinical investigations of medical devices under the EU MDR. However, on October 2022 the Medical Device Coordination Group (MDCG) published an updated version of the MDCG 2020-10/1, the MDCG 2020-10/1 Rev 1. This article highlights the updates included in the new revision, analysing the gaps between both documents.

Read More »
medical devices

Roles and Responsibilities of an Authorised Representative under EU MDR and IVDR 

If a medical device manufacturer is not established in a Member State, the devices can only be placed on the Union market if the manufacturer designates an authorised representative. The authorised representative plays a pivotal role in ensuring the compliance of the devices with EU regulation, serving as point of contact. The obligations and responsibilities of authorised representative are outlined on Article 11 of both MDR and IVDR, but clarification of relevant requirements is described in MDCG 2022-16 of October 2022.

Read More »
medical devices

Understanding the ISO Standards Lifecycle

ISO Standards cover a huge range of activities, representing the distilled wisdom of people with expertise in their subject matter and providing the regulators with a sound basis to develop better legislation. ISO Standards are diverse, addressing from the shoe size we wear to the quality of air we breathe. The medical device sector is no exception. ISO has many International Standards and guidance documents aimed at helping the sector ensure safe and effective medical devices while meeting the multitude of national, regional and international regulatory requirements. But how exactly is a Standard developed, reviewed and withdraw?

Read More »
medical devices

Amendments to the Transitional Provisions of the European Union MDR and IVDR

The proposed amendments aim to maintain patients’ access to a wide range of medical devices while ensuring the transition to the new framework. The ammendments proposal aims to extend the current transition period (Article 120 of the MDR), and it also deletes the ‘sell-off’ deadlines of both MDR and IVDR. The extension is staggered depending on the risk class of the device – until December 2027 for high-risk devices and December 2028 for medium and lower-risk devices.

Read More »
medical devices

EU MDR – Proposal for Extension of Transition Period

The transition to MDR has been slower than anticipated by the European Commission. Insufficient capacity of notified bodies and the low level of preparedness of manufacturers led to a proposal for extension of current MDR transition period with deadlines depending on the risk class of the devices.

Read More »
medical devices

MDCG 2022-18 – EU MDR Article 97

EU MDR Article 97 may be a temporary solution to avoid disruption of supply of Medical Devices on the EU Market. The MDCG 2022-18 presents a uniform approach for application of MDR Article 97 on non-compliant legacy devices under the conditions set by the competent authorities, while limiting the impact on the supply of safe and effective devices.

Read More »
parfum_fragrance_allergen_1
cosmetic products

EU to set Labelling Requirements for 56 additional Fragrance Allergens in Cosmetic Products

World Trade Organization (WTO) has been notified by the European Commission of a draft amendment to Regulation (EC) No 1223/2009 as regards labelling of fragrance allergens in Cosmetic Products. The proposed date of adoption of the new regulation is expected to be in the first half of 2023 and the propose date of entry in force 20 days from the publication in the Official Journal of the European Union.

Read More »
cosmetic products

New Amendments to the European Cosmetics Regulation – CMR Substances

The European Commission published the Commission Regulation (EU) 2022/1531, which amends Regulation (EC) No 1223/2009 in regards to the use in cosmetic products of certain substances classified as CMR. This amendment introduces new entries to Annex II and Annex III and revises an entry to Annex V to Regulation (EC) No 1223/2009.

Read More »