Israel Regulatory News

On 25 March 2024, Israel's Ministry of Health notified the World Trade Organization (WTO) of a new draft amendment to the Pharmacists Ordinance. The proposed amendment seeks to decrease trade b...

On 25 March 2024, Israel's Ministry of Health notified the World Trade Organization (WTO) of a new draft amendment to the Pharmacists Ordinance.

The proposed amendment seeks to decrease trade barriers by aligning the Israeli import system with the European Regulation (EC) No 1223/2009 on Cosmetic Products, which addresses prohibited and restricted compounds in cosmetics, dyes, sunscreens, and preservatives.

Details of the Proposed Amendment

The draft includes the following significant amendments:

• Implements EU regulations in Israel.
• Allows cosmetic importers from EU member countries, the UK, or Switzerland to import without access to product information or safety assessments.

Objectives and Justification

The objectives of the proposed amendment include:

• Harmonization
• Reduce trade barriers and facilitate trade
• Cost savings and increased productivity  

Harmonization will ensure consistency with international standards, reduce complexity for importers and exporters, and promote smoother trade relations. By aligning with EU regulations, Israel aims to streamline processes and increase efficiency in the cosmetic import sector, ultimately benefiting consumers and businesses alike.

Comments deadline

The last date for comments on the draft was 31 March 2024.

A draft Regulation governing the creation, marketing, and import of cosmetic items has been published by Israel's Ministry of Health. Israel sent the draft to the WTO on January 24.  Comments are acc...

A draft Regulation governing the creation, marketing, and import of cosmetic items has been published by Israel's Ministry of Health. Israel sent the draft to the WTO on January 24.  Comments are accepted until 25 March and the draft does not indicate a timeline for implementation.

There are annexes with a list of 329 banned ingredients and 1,683 chemicals that cannot be used in cosmetic products; it also contains affirmative lists of UV filters, preservatives, and color additives that are allowed.  With a few minor exceptions, these are virtually identical to those in the annexes to the EU cosmetic products Regulation.

The Israeli list is stricter than the EU one as some chemicals on Israel's list of prohibited substances are not listed on the EU equivalent list. These include; troxerutin, SD alcohol 40, and desmedipham.

The nation's proposal also complies with EU regulations on testing procedures and guidelines for designating a responsible individual for each cosmetic item.

The revision of the Mandatory Standard SI 562 part 3 was published in the Israel Official Gazette Section of Government Notice no. 10401 “ISO 8124-3:2020 Safety of toys — Part 3: Migration of cert...

The revision of the Mandatory Standard SI 562 part 3 was published in the Israel Official Gazette Section of Government Notice no. 10401 “ISO 8124-3:2020 Safety of toys — Part 3: Migration of certain elements “on 17 November 2022 and entered into force immediately, allowing for a transition period until 16 April 2023. During this time, products may be tested according to the old or the new standards.

The Israel Government circulated the official Gazette which specifies the maximum acceptable levels and the methods of sampling, extraction and determination for the migration of the certain elements from toy materials and from parts of toys.

Israel updated standard also follows the EU standard EN 71-3:2019 (Safety of Toys-Part 3: Migration of certain elements) which gives the requirements and test methods for the migration of 19 elements as well as a method for determining the migration level of chromium VI from scraped-off toy materials such as paint.

Standard SI 562 specifies requirements and test methods for the migration of coatings of paints, varnishes, lacquers, printing inks, polymers, paper/paperboard, textiles, glass/ceramic/metallic materials, pliable modelling materials, among others. The standard applies to toys and components of toys which are intended to come in contact with the mouth. It also applies to food toys, cosmetic toys, and writing material. Moreover, it includes toys for children under 72 months of age, as well as liquid, pastel, and gel paint or modelling compound.
Packaging materials are not included, unless they form part of the toy or have intended play value.

The standard includes requirements for the migration of chemical elements. Certain of the toy materials are listed under 3 categories (Category I - Dry, crisp, powder-like substances , Category II - subordinates liquid or sticky substances , Category III - Materials that can be removed by scratching ) which specifies requirements and test methods for the migration of the following elements: aluminum, antimony, arsenic, barium, boron, cadmium, trivalent chromium, hexavalent chromium, cobalt, copper, lead, manganese, mercury, nickel, selenium, strontium, tin, organic tin, and zinc

When Israel joined the OECD in 2010, the country planned to establish a national mechanism for registering chemicals. There are various regulations in Israel that regulate the practice of chemicals, a...

When Israel joined the OECD in 2010, the country planned to establish a national mechanism for registering chemicals. There are various regulations in Israel that regulate the practice of chemicals, aspects of import, production, occupation, use, maintenance, transportation, and so on. However, the existing regulation is decentralized and usually does not include a systematic assessment of the chemicals and their effects on the public and the environment in Israel.

Last year, Israel proposed a new draft law, the “Industrial Chemicals Registering Law, no 5781-2020”.  This law was notified to the World Trade Organization on January 6th, 2021. Comments can be submitted within 60 days of notification.

The mechanism proposed in the draft law is based on the following components:

• Establishment of existing chemical inventories - which will constitute a minimal information base in relation to chemicals manufactured or imported in Israel, and will include the properties of the chemical, quantities and uses for which it is intended (these predict the routes of exposure of man and the environment to him).
• Risk assessment from chemicals - is performed for selected chemicals according to criteria that relate to the risk assessment and the assessment of potential exposure to them. Additional criteria proposed in this memorandum are the existence of assessments and recommendations for the regulation of chemicals elsewhere in the world.
• Regulation of risk management from the chemical - creating limits to reduce the risk from exposure to the chemical - from the production process through the daily use of the final product to its disposal at the end of its life. It should be noted that the manner of regulation among the existing mechanisms in the world is not uniform and varies according to the powers of the mechanisms.

As part of the formulation of the bill, a comprehensive review of existing mechanisms in the world was conducted, a comprehensive consultation process took place with relevant regulators, with industry stakeholders and with environmental organizations and academic bodies involved in the subject.

Similar to the Toxic Substance Control Act (TSCA) of the US, there will be two sets of chemicals: existing and new. For new chemicals that are manufactured or imported into Israel, the Israeli entity that will be responsible for handling said chemical will have to register it 30 days prior to its manufacture or importation. The threshold for exemption from registration is 10 tonnes per year.

Israel’s Ministry of Environment Protection expects the country’s draft law to be approved by the end of 2021. With this timeline, the proposed effective date of the law is March 1, 2023, and if enacted, manufacturers and importers will have until September 1, 2024 to submit the required data and register the substances.