: Standardization
Significant amendments to the Standards Law and the Import and Export
.The ordinance is expected to take effect on January 1, 2025
Key Points of the Reform:
New Import track
A new track was created (optional, not mandatory), allowing product import, production, and marketing based on their compliance with European directives or regulations. For most products in this track, there will be no requirement to keep a test certificate (note: the importer is still responsible for ensuring product compliance and should be able to substantiate their claims).
This new track is expected to bridge the gap between Israel's standards and European requirements, reduce Israel's unique testing costs, ease
communication between importers and their foreign suppliers, and facilitate parallel imports.
Products imported through this track must be labeled according to Israeli law, except for labeling requirements specified in the official standard, unless otherwise stipulated in the Fifth Appendix to the law. Additionally, electrical products must comply with the Electricity Israeli Law requirements.
Directives and regulations that are relevant for this track. Effective from January
1, 2025 :
- REACH REGULATION EC/1907/2006**: Regulation for registering,
evaluating and restricting chemicals.
- LVD 2014/35**: Directive for low-voltage electrical safety (up to 1000
volts)—For low-voltage power cables, effective 18 months after the
mentioned date.
- Directive EMC 2014/30/EU**: Directive to prevent electromagnetic
interference.
- DIRECTIVE AEROSOL 75/324/EEC**: Directive for aerosol pressure
containers.
- REGULATION PPE 2016/425**: Regulation for personal protective
equipment.
- Directive 2014/53/EU - Radio Equipment**: Directive for radio
equipment.
- Directive 2009/125/EC**: Directive for ecological design requirements
for energy-related products.
Effective from Later Dates :
- TOYS SAFETY DIRECTIVE 2009/48/EC**: February 1, 2025.
- GPSD EC/2001/95**: February 1, 2025.
- (EU)10/2011 FOOD CONTACT PLASTICS REGULATION**: March 1,
2025.
- EC/1935/2004FCM**: March 1, 2025 .
- 84/500**EEC**: March 1, 2025 .
- -(EC)648/2004 REGULATION**: March 1, 2025 .
- 1272/2008**REGULATION**: July 1, 2025 .
- EU/2010/35 TPE**: 18 months from the start date.
- PE 2014/68/EU**: 18 months from the start date.
- MACHINERY DIRECTIVE 2006/42/EC**: 18 months from the start date.
- DIRECTIVE LIFT 2014/33/EU**: 18 months from the start date.
- REG BATTERIES 2023/1542**: 18 months from the start date.
- Regulation (EU) 2016/426**: 18 months from the start date.
- EU/2014/29 SPVD**: Two years from the start date.
- CONSTRUCTION PRODUCTS REG 305/2011**: Two years from the start date.
Ministry of Economy's Role :
The Ministry of Economy is tasked with expanding the adoption of European regulations and directives included in this reform and submitting an order on the subject within three months. This will include references to electric bicycles, medical equipment, and others.
Exclusions :
The new track does not apply to :
- Food as defined in the Public Health Protection (Food) Law, 2015.
- Motor vehicles as defined in the Traffic Ordinance.
- Any product subject to an official standard concerning fire safety, except for portable firefighting equipment not permanently connected to real estate or buildings, firefighting materials, and independent smoke detectors.
Exceptions :
The law includes various exceptions due to legal contradictions and demands
from different government ministries. These include :
- Laundry detergents, dishwasher powder, and dishwashing liquid: These are required to maintain existing chloride, sodium, and boron Israeli requirements .
- Portable electrical tools: These are required to meet existing safety regulations.
- Products in contact with drinking water (including faucets): required to meet the Israeli Standard 5452.
- Gas stoves and gas tanks.
Exceptions Committee:
Ministers responsible for products under official standards may request that the Exceptions Committee consider creating an exception or additional conditions. Representing organisations, including the Chamber of Commerce, can also bring topics for discussion to the Exceptions Committee.
Mapping Legal Contradictions :
The law includes a clause to thoroughly map out legal contradictions and, hopefully, resolve issues relating to conflicts with other laws, facilitating barrier removal, especially in the construction sector and with the exceptions mentioned.
Enforcement and Penalties:
Products remain obligated to meet standard requirements. Understanding these requirements and determining how to ensure compliance is important. The Ministry of Economy was provided with extensive enforcement tools.
Additional Easements :
Additional easements resulting from ongoing activities with the Ministry of Economy include :
- Exemption from standard compliance for imported samples not intended for marketing and distribution.
- Exemption from holding a test certificate for consumer product spare parts
- Exemption from financial penalties for businesses that are neither importers nor manufacturers under certain conditions.
These easements are expected to take effect when the law is published in the Official Gazette at the beginning of August 2024.
"Certification Mark" Alternative :
A definition for a "certification mark" granted by an approved laboratory that meets specified criteria has been created.
Import Restrictions for Used Goods :
The Import and Export Ordinance now includes a restriction that imported used goods (including refurbished ones) must always have a model approval, and every product in the shipment must be inspected unless otherwise specified by the Standards Commissioner.
Energy efficiency
Significant amendments to the energy efficiency law concerning the requirements for electrical and electronic products. The energy efficiency chapter was published in the Official Gazette on July 18, 2024.
Key Points of the Reform:
1. New Import track Based on European Product Registry (EPREL):
A new optional import track has been established, allowing products to be imported based on their registration in the European Product Registry for Energy Labelling (EPREL). Under this track, there is no need to hold a Declaration of Conformity (DOC) or an energy consumption test certificate to obtain approval from the Ministry of Energy. Instead, importers can rely on documents proving the product's registration in EPREL. Products must still display an energy efficiency label if required by European regulations. The Ministry of Energy will publish a list of energy-consuming devices registered in this track on its website.
Effective Date: November 1, 2024, with a potential extension to February 1, 2025.
2. Removal of Annual Validity Limitation for Ministry of Energy Approvals:
The requirement to renew the Ministry of Energy approval annually has been removed. Approvals will remain valid if the product remains the same and complies with the European energy efficiency requirements. If the requirements change, the Ministry of Energy will announce this on its website, specifying the expiry date of existing approvals, which will be at least one year from the announcement date. For updates, importers or manufacturers must check the Ministry's website every six months.
Effective Date: November 1, 2024, with a potential extension to February 1, 2025.
3. Exemption for Products with Only Standby Mode Power Requirements:
Certain products, such as digital converters, microwave ovens, printers, radios, amplifiers, cordless phones, and computers, will be exempt from the need for Ministry of Energy approval if they only require standby mode power. The products must still comply with European energy consumption regulations, and the importer or manufacturer must hold relevant documentation.
Effective Date: 18.8.2024
4. Enforcement and Financial Penalties:
New enforcement provisions include fines for importing devices without the appropriate documents, with penalties of up to 60,000 NIS for individuals and 120,000 NIS for corporations. Submitting false or misleading information can lead to even higher fines and a loss of trust status for up to a year.
Effective Date: 18.8.2024
Food
Significant amendments to the Public Health Protection (Food) Law
Key Objectives of the Reform:
The reform aims to remove barriers in the European import track for GIP (good importer practice), significantly expand the adoption of European Union law in Israel, and simplify the procedures for updating changes in the European law adopted in Israel. All while ensuring public health through an enforcement mechanism for non-compliant parties.
Summary of Key Points in the Legislative Amendment
1. Adoption of New European Regulations Starting January 1, 2025:
- The amendment includes the adoption of numerous European regulations, including labeling regulations (Regulation 1169/2011 on
food information to consumers, Regulation 828 on "gluten-free" labeling, and Regulation 1925 - addition of vitamins and minerals and of certain
other substances to foods), regulations on food additives, flavorings, packaging materials, and more.
- The second Annex of the law included adjustments, amendments, exclusions, and extensions. The Ministry of Health will publish detailed guides and hold training sessions on the adopted regulations.
2. European Import track:
- A five-year temporary provision was established, limiting the definition of food legislation for GIP in the European track, excluding certain
requirements such as official standards and various regulations detailed in the 13th Annex of the law.
- Significant changes were made to document requirements, easing the import process for food produced outside the EU but marketed there.
3. Improving the Service in the Sensitive Food track:
- The maximum period for pre-approval of sensitive food was extended from six years to a maximum of ten years.
- A temporary provision allows for pre-approval renewal based on declarations that the product has not changed, potentially speeding up approval processes.
4. Pesticide Residue:
- A temporary provision for one year, starting January 1, 2025, was established, stating that processed food produced in Israel that meets local pesticide residue regulations will not be enforced as a violation, with a possibility of extending the provision for another year. This will also apply to imported food as it is not imported via the European track.
5. Enforcement Powers:
- Various enforcement and penalty powers were defined, including the authority to impose financial penalties for new violations, with double the amount for fines.
- For European track imports, the Ministry of Health must give notice before imposing a financial penalty for violating an adopted regulation.
Cosmetics
On Sunday, July 7, 2024, the Knesset Health Committee approved the amendment to the Pharmacists Ordinance in the Cosmetics Chapter.
The core of the reform includes the recognition of a compliant importer. Such an importer will be able to declare that the product they wish to import is marketed in one of the reliance countries (EU, UK, or Switzerland) and will be permitted to import it to Israel.
The Ministry of Health will shift its focus from issuing licenses to enforcement and inspection activities. In the coming months, an enforcement procedure will be published to clarify the expectations from importers under the reform. Importers are expected to maintain a risk management system. Recently, a draft guideline for risk management was published in advisory language, and the Ministry of Health does not intend to enforce its implementation. However, enforcement will assess the actual implementation. The draft of norms for compliant importer route implementation will be published in the next few weeks.
Key Details of the Legislative Process and Reform:
1. Implementation Date: The reform will take effect on January 1, 2025. Two import tracks will be available for cosmetics: the notification track, effective since April 1, 2023, and the new compliant importer track. The licensing track will end on December 31, 2024, and no new products can
be submitted under this track afterwards.
2. Parallel Import: The licensing track for products that cannot be submitted under other tracks will end on December 31, 2024, in September 2026.
3. License Extensions: "Live" licenses—those valid until December 31, 2024—will receive an automatic administrative extension of four years.
4. Certificate of Free Sale: There was a significant debate over the requirement for a Certificate of Free Sale for both the notification track and the new track. This requirement imposes a regulatory burden and is not common in Western countries. The Ministry agreed to a number of concessions, such as expanding the list of recognized countries for the certificate and granting exemptions for products developed and manufactured abroad exclusively for the Israeli market, subject to importer declarations.
5. Exemptions: Sun protection products, products for nursing women, products for babies and children, and hair straightening products will not be included in this reform and will need to comply with Israeli regulations.
Overall, the reform is seen as highly beneficial for the cosmetics industry in Israel and is anticipated to substantially facilitate import procedures.
Disclaimer:
This summary provides an overview of the key points of the approved amendments to the relevant Israeli laws. The binding text is the final version published in the Official Gazette.
